[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Proposed Rules]
[Pages 42018-42360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15496]
[[Page 42017]]
Vol. 86
Wednesday,
No. 147
August 4, 2021
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 412, 416, 419, et al.
45 CFR Part 180
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; Price Transparency of Hospital Standard Charges; Radiation
Oncology Model; Request for Information on Rural Emergency Hospitals;
Proposed Rule
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 /
Proposed Rules
[[Page 42018]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 412, 416, 419, and 512
Office of the Secretary
45 CFR Part 180
[CMS-1753-P]
RIN 0938-AU43
Medicare Program: Hospital Outpatient Prospective Payment and
Ambulatory Surgical Center Payment Systems and Quality Reporting
Programs; Price Transparency of Hospital Standard Charges; Radiation
Oncology Model; Request for Information on Rural Emergency Hospitals
AGENCY: Centers for Medicare & Medicaid Services (CMS), Depatment of
Health and Human Services (HHS).
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise the Medicare hospital
outpatient prospective payment system (OPPS) and the Medicare
ambulatory surgical center (ASC) payment system for Calendar Year (CY)
2022 based on our continuing experience with these systems. In this
proposed rule, we describe the proposed changes to the amounts and
factors used to determine the payment rates for Medicare services paid
under the OPPS and those paid under the ASC payment system. Also, this
proposed rule would update and refine the requirements for the Hospital
Outpatient Quality Reporting (OQR) Program and the ASC Quality
Reporting (ASCQR) Program, update Hospital Price Transparency
requirements, and update and refine the design of the Radiation
Oncology Model. Finally, this proposed rule includes a Request for
Information (RFI) focusing on the health and safety standards, quality
measures and reporting requirements, and payment policies for Rural
Emergency Hospitals (REHs), a new Medicare provider type. The RFI will
be used to inform future rulemaking for REHs.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by September 17, 2021.
ADDRESSES: In commenting, please refer to file code CMS-1753-P when
commenting on the issues in this proposed rule. Because of staff and
resource limitations, we cannot accept comments by facsimile (FAX)
transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may (and we encourage you to) submit
electronic comments on this regulation to http://www.regulations.gov.
Follow the instructions under the ``submit a comment'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1753-P, P.O. Box 8010,
Baltimore, MD 21244-1850.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments via
express or overnight mail to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1753-P, Mail Stop C4-26-05, 7500 Security Boulevard,
Baltimore, MD 21244-1850.
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, we refer readers to the
beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Advisory Panel on Hospital Outpatient
Payment (HOP Panel), contact the HOP Panel mailbox at
[email protected].
Ambulatory Surgical Center (ASC) Payment System, contact Scott
Talaga via email at [email protected] or Mitali Dayal via email
at [email protected].
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
Administration, Validation, and Reconsideration Issues, contact Anita
Bhatia via email at [email protected].
Ambulatory Surgical Center Quality Reporting (ASCQR) Program
Measures, contact Cyra Duncan via email [email protected].
Blood and Blood Products, contact Josh McFeeters via email at
[email protected].
Cancer Hospital Payments, contact Scott Talaga via email at
[email protected].
CMS Web Posting of the OPPS and ASC Payment Files, contact Chuck
Braver via email at [email protected].
Composite APCs (Low Dose Brachytherapy and Multiple Imaging),
contact Au'Sha Washington via email at [email protected].
Comprehensive APCs (C-APCs), contact Mitali Dayal via email at
[email protected].
Hospital Inpatient Quality Reporting Program--Administration
Issues, contact Julia Venanzi, [email protected].
Hospital Outpatient Quality Reporting (OQR) Program Administration,
Validation, and Reconsideration Issues, contact Shaili Patel via email
[email protected].
Hospital Outpatient Quality Reporting (OQR) Program Measures,
contact Janis Grady via email [email protected].
Hospital Outpatient Visits (Emergency Department Visits and
Critical Care Visits), contact Elise Barringer via email at
[email protected].
Hospital Price Transparency, contact the Hospital Price
Transparency email box at [email protected].
Inpatient Only (IPO) Procedures List, contact Au'Sha Washington via
email at [email protected], or Allison Bramlett via email
[email protected], Lela Strong-Holloway via email
[email protected], or Abigail Cesnik at
[email protected].
Medical Review of Certain Inpatient Hospital Admissions under
Medicare Part A for CY 2021 and Subsequent Years (2-Midnight Rule),
contact Elise Barringer via email at [email protected].
New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga
via email at [email protected].
No Cost/Full Credit and Partial Credit Devices, contact Scott
Talaga via email at [email protected].
OPPS Brachytherapy, contact Scott Talaga via email at
[email protected].
OPPS Data (APC Weights, Conversion Factor, Copayments, Cost-to-
Charge Ratios (CCRs), Data Claims, Geometric Mean Calculation, Outlier
Payments, and Wage Index), contact Erick Chuang via email at
[email protected], or Scott Talaga via email at
[email protected], or Josh McFeeters via email at
[email protected].
OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar
Products, contact Josh McFeeters via email at
[email protected], or Gil Ngan via email at
[email protected], or Cory Duke via email at [email protected],
or Au'Sha
[[Page 42019]]
Washington via email at [email protected].
OPPS New Technology Procedures/Services, contact the New Technology
APC mailbox at [email protected].
OPPS Packaged Items/Services, contact Mitali Dayal via email at
[email protected] or Cory Duke via email at
[email protected].
OPPS Pass-Through Devices, contact the Device Pass-Through mailbox
at [email protected].
OPPS Status Indicators (SI) and Comment Indicators (CI), contact
Marina Kushnirova via email at [email protected].
Partial Hospitalization Program (PHP) and Community Mental Health
Center (CMHC) Issues, contact the PHP Payment Policy Mailbox at
[email protected].
Rural Hospital Payments, contact Josh McFeeters via email at
[email protected].
Skin Substitutes, contact Josh McFeeters via email at
[email protected].
Supervision of Outpatient Therapeutic Services in Hospitals and
CAHs, contact Josh McFeeters via email at [email protected].
All Other Issues Related to Hospital Outpatient and Ambulatory
Surgical Center Payments Not Previously Identified, contact Elise
Barringer via email at [email protected] or at 410-786-9222.
RO Model, contact [email protected] or at 844-711-2664,
Option 5.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to
view public comments. CMS will not post on Regulations.gov public
comments that make threats to individuals or institutions or suggest
that the individual will take actions to harm the individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
Addenda Available Only Through the Internet on the CMS Website
In the past, a majority of the Addenda referred to in our OPPS/ASC
proposed and final rules were published in the Federal Register as part
of the annual rulemakings. However, beginning with the CY 2012 OPPS/ASC
proposed rule, all of the Addenda no longer appear in the Federal
Register as part of the annual OPPS/ASC proposed and final rules to
decrease administrative burden and reduce costs associated with
publishing lengthy tables. Instead, these Addenda are published and
available only on the CMS website. The Addenda relating to the OPPS are
available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.
The Addenda relating to the ASC payment system are available at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices.
Current Procedural Terminology (CPT) Copyright Notice
Throughout this proposed rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2019 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR and Defense
Federal Acquisition Regulations (DFAR) apply.
Table of Contents
I. Summary and Background
A. Executive Summary of This Document
B. Legislative and Regulatory Authority for the Hospital OPPS
C. Excluded OPPS Services and Hospitals
D. Prior Rulemaking
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel
or the Panel)
F. Public Comments Received on the CY 2021 OPPS/ASC Final Rule
with Comment Period
II. Proposed Updates Affecting OPPS Payments
A. Proposed Recalibration of APC Relative Payment Weights
B. Proposed Conversion Factor Update
C. Proposed Wage Index Changes
D. Proposed Statewide Average Default Cost-to-Charge Ratios
(CCRs)
E. Proposed Adjustment for Rural Sole Community Hospitals (SCHs)
and Essential Access Community Hospitals (EACHs) under Section
1833(t)(13)(B) of the Act for CY 2021
F. Proposed Payment Adjustment for Certain Cancer Hospitals for
CY 2021
G. Proposed Hospital Outpatient Outlier Payments
H. Proposed Calculation of an Adjusted Medicare Payment From the
National Unadjusted Medicare Payment
I. Proposed Beneficiary Copayments
III. Proposed OPPS Ambulatory Payment Classification (APC) Group
Policies
A. Proposed OPPS Treatment of New and Revised HCPCS Codes
B. Proposed OPPS Changes--Variations Within APCs
C. Proposed New Technology APCs
D. Proposed OPPS APC-Specific Policies
IV. Proposed OPPS Payment for Devices
A. Proposed Pass-Through Payments for Devices
B. Proposed Device-Intensive Procedures
V. Proposed OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
A. Proposed OPPS Transitional Pass-Through Payment for
Additional Costs of Drugs, Biologicals, and Radiopharmaceuticals
B. Proposed OPPS Payment for Drugs, Biologicals, and
Radiopharmaceuticals Without Pass-Through Payment Status
VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Background
B. Proposed Estimate of Pass-Through Spending
VII. Proposed OPPS Payment for Hospital Outpatient Visits and
Critical Care Services
VIII. Payment for Partial Hospitalization Services
A. Background
B. Proposed PHP APC Update for CY 2021
C. Proposed Outlier Policy for CMHCs
IX. Proposed Services That Would Be Paid Only as Inpatient Services
A. Background
B. Proposed Changes to the Inpatient Only (IPO) List
C. Comment Solicitation
X. Proposed Nonrecurring Policy Changes
A. Proposed Changes in the Level of Supervision of Outpatient
Therapeutic Services in Hospitals and Critical Access Hospitals
(CAHs)
B. Proposed Medical Review of Certain Inpatient Hospital
Admissions Under Medicare Part A for CY 2021 and Subsequent Years
XI. Proposed CY 2021 OPPS Payment Status and Comment Indicators
A. Proposed CY 2021 OPPS Payment Status Indicator Definitions
B. Proposed CY 2021 Comment Indicator Definitions
XII. MedPAC Recommendations
A. Proposed OPPS Payment Rates Update
B. Proposed ASC Conversion Factor Update
C. Proposed ASC Cost Data
XIII. Proposed Updates to the Ambulatory Surgical Center (ASC)
Payment System
A. Background
B. Proposed ASC Treatment of New and Revised Codes
C. Proposed Update to the List of ASC Covered Surgical
Procedures and Covered Ancillary Services
D. Proposed Update and Payment for ASC Covered Surgical
Procedures and Covered Ancillary Services
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E. Proposed New Technology Intraocular Lenses (NTIOLs)
F. Proposed ASC Payment and Comment Indicators
G. Proposed Calculation of the ASC Payment Rates and the ASC
Conversion Factor
XIV. Advancing to Digital Quality Measurement and the Use of Fast
Healthcare Interoperability Resources (FHIR) in Outpatient Quality
Programs--Request for Information
XV. Proposed Requirements for the Hospital Outpatient Quality
Reporting (OQR) Program
A. Background
B. Proposed Hospital OQR Program Quality Measures
C. Administrative Requirements
D. Form, Manner, and Timing of Data Submitted for the Hospital
OQR Program
E. Proposed Payment Reduction for Hospitals That Fail To Meet
the Hospital OQR Program Requirements for the CY 2021 Payment
Determination
XVI. Requirements for the Ambulatory Surgical Center Quality
Reporting (ASCQR) Program
A. Background
B. Proposed ASCQR Program Quality Measures
C. Administrative Requirements
D. Form, Manner, and Timing of Data Submitted for the ASCQR
Program
E. Proposed Payment Reduction for ASCs That Fail To Meet the
ASCQR Program Requirements
XVII. Request for Information on Rural Emergency Hospitals
A. Background
B. Solicitation of Public Comments
C. RO Model Proposed Regulations
XVIII. Radiation Oncology Model
A. Introduction
B. Background
XIX. Proposed Updates to Requirements for Hospitals To Make Public a
List of Their Standard Charges
A. Introduction and Overview
B. Proposal To Increase the Civil Monetary Penalty Using a
Scaling Factor
C. Proposal To Deem Certain State Forensic Hospitals as Having
Met Requirements
D. Proposals Prohibiting Additional Barriers To Accessing the
Machine-Readable File
E. Clarifications and Requests for Comment
XX. Additional Hospital Inpatient Quality Reporting (IQR) Program
Policies
XXI. Additional Medicare Promoting Interoperability Program Policies
XXII. Files Available to the Public via the Internet
XXIII. Collection of Information Requirements
A. Statutory Requirement for Solicitation of Comments
B. ICRs for the Hospital OQR Program
C. ICRs for the ASCQR Program
D. ICRs for [placeholder for any rider]
E. Total Reduction in Burden Hours and in Costs
XXIV. Response to Comments
XXV. Economic Analyses
A. Statement of Need
B. Overall Impact for the Provisions of This Proposed Rule
C. Detailed Economic Analyses
D. Regulatory Review Costs
E. Regulatory Flexibility Act (RFA) Analysis
F. Unfunded Mandates Reform Act Analysis
G. Federalism Analysis
I. Summary and Background
A. Executive Summary of This Document
1. Purpose
In this proposed rule, we propose to update the payment policies
and payment rates for services furnished to Medicare beneficiaries in
hospital outpatient departments (HOPDs) and ambulatory surgical centers
(ASCs), beginning January 1, 2022. Section 1833(t) of the Social
Security Act (the Act) requires us to annually review and update the
payment rates for services payable under the Hospital Outpatient
Prospective Payment System (OPPS). Specifically, section 1833(t)(9)(A)
of the Act requires the Secretary to review certain components of the
OPPS not less often than annually, and to revise the groups, the
relative payment weights, and the wage and other adjustments that take
into account changes in medical practices, changes in technology, and
the addition of new services, new cost data, and other relevant
information and factors. In addition, under section 1833(i)(D)(v) of
the Act, we annually review and update the ASC payment rates. This
proposed rule also includes additional policy changes made in
accordance with our experience with the OPPS and the ASC payment system
and recent changes in our statutory authority. We describe these and
various other statutory authorities in the relevant sections of this
proposed rule. In addition, this proposed rule would update and refine
the requirements for the Hospital Outpatient Quality Reporting (OQR)
Program and the ASC Quality Reporting (ASCQR) Program.
2. Summary of the Major Provisions
OPPS Update: For 2022, we propose to increase the payment
rates under the OPPS by an Outpatient Department (OPD) fee schedule
increase factor of 2.3 percent. This increase factor is based on the
proposed hospital inpatient market basket percentage increase of 2.5
percent for inpatient services paid under the hospital inpatient
prospective payment system (IPPS) reduced by a proposed productivity
adjustment of 0.2 percentage point. Based on this update, we estimate
that total payments to OPPS providers (including beneficiary cost-
sharing and estimated changes in enrollment, utilization, and case-mix)
for calendar year (CY) 2022 would be approximately $82.704 billion, an
increase of approximately $10.757 billion compared to estimated CY 2021
OPPS payments.
We propose to continue to implement the statutory 2.0 percentage
point reduction in payments for hospitals that fail to meet the
hospital outpatient quality reporting requirements by applying a
reporting factor of 0.9805 to the OPPS payments and copayments for all
applicable services.
Data used in CY 2022 OPPS/ASC Ratesetting: To set CY 2022
OPPS and ASC payment rates, we would normally use the most updated
claims and cost report data available. However, because the CY 2020
claims data includes services furnished during the COVID-19 PHE, which
significantly affected outpatient service utilization, we have
determined that CY 2019 data would better approximate expected CY 2022
outpatient service utilization than CY 2020 data. As a result, we are
proposing to utilize CY 2019 data to set CY 2022 OPPS and ASC payment
rates.
Partial Hospitalization Update: For the CY 2022 OPPS/ASC
proposed rule, CMS is proposing to use the CMHC and hospital-based PHP
(HB PHP) geometric mean per diem costs, consistent with existing
methodology, but with a cost floor that would maintain the per diem
costs finalized in CY 2021. CMS is also proposing to use CY 2019 claims
and cost report data for each provider type. This proposal is
consistent with a broader CY 2022 OPPS ratesetting proposal to use
claims and cost report data prior to the PHE.
Changes to the Inpatient Only (IPO) List: For 2022, we
propose to halt the elimination of the IPO list and, after clinical
review of the services removed from the IPO list in CY 2021 against our
longstanding criteria for removal, we propose to add the 298 services
removed from the IPO list in CY 2021 back to the IPO list beginning in
CY 2022. CMS is also proposing to codify in regulation the five
longstanding criteria used to determine whether a procedure or service
should be removed from the IPO list. In addition, we solicit comment on
several policy modifications including whether CMS should maintain the
longer-term objective of eliminating the IPO list or maintain the IPO
list but continue to systematically scale the list back so that
inpatient only designations are consistent with current standards of
practice.
Medical Review of Certain Inpatient Hospital Admissions
under Medicare Part A for CY 2021 and Subsequent Years (2-Midnight
Rule): For CY 2022,
[[Page 42021]]
we propose to exempt procedures that are removed from the inpatient
only (IPO) list under the OPPS beginning on or January 1, 2021, from
site-of-service claim denials, Beneficiary and Family-Centered Care
Quality Improvement Organization (BFCC-QIO) referrals to Recovery Audit
Contractor (RAC) for persistent noncompliance with the 2-midnight rule,
and RAC reviews for ``patient status'' (that is, site-of-service) for a
time period of 2 years.
340B-Acquired Drugs: We propose to continue our current
policy of paying an adjusted amount of ASP minus 22.5 percent for drugs
and biologicals acquired under the 340B program. We are proposing to
continue to exempt Rural SCHs, PPS-exempt cancer hospitals and
children's hospitals from our 340B payment policy.
Device Pass-Through Payment Applications: For CY 2022, we
received eight applications for device pass-through payments. One of
these applications (the Shockwave C\2\ Coronary Intravascular
Lithotripsy (IVL) catheter) received preliminary approval for pass-
through payment status through our quarterly review process. We are
soliciting public comment on all eight of these applications and final
determinations on these applications will be made in the CY 2022 OPPS/
ASC final rule.
Equitable Adjustment for Device Category, Drugs, and
Biologicals with Expiring Pass-through Status: As a result of our
proposal to use CY 2019 claims data, rather than CY 2020 claims data,
to inform CY 2022 ratesetting, we are proposing to use our equitable
adjustment authority under 1833(t)(2)(E) to provide up to four quarters
of separate payment for 27 drugs and biologicals and one device
category whose pass-through payment status will expire between December
31, 2021 and September 30, 2022.
Cancer Hospital Payment Adjustment: For 2022, we propose
to continue to provide additional payments to cancer hospitals so that
a cancer hospital's payment-to-cost ratio (PCR) after the additional
payments is equal to the weighted average PCR for the other OPPS
hospitals using the most recently submitted or settled cost report
data. However, section 16002(b) of the 21st Century Cures Act requires
that this weighted average PCR be reduced by 1.0 percentage point.
Based on the data and the required 1.0 percentage point reduction, we
propose that a target PCR of 0.89 would be used to determine the CY
2022 cancer hospital payment adjustment to be paid at cost report
settlement. That is, the payment adjustments will be the additional
payments needed to result in a PCR equal to 0.89 for each cancer
hospital.
ASC Payment Update: For CYs 2019 through 2023, we adopted
a policy to update the ASC payment system using the hospital market
basket update. Using the hospital market basket methodology, for CY
2022, we propose to increase payment rates under the ASC payment system
by 2.3 percent for ASCs that meet the quality reporting requirements
under the ASCQR Program. This proposed increase is based on a hospital
market basket percentage increase of 2.5 percent reduced by a proposed
productivity adjustment of 0.2 percentage point. Based on this proposed
update, we estimate that total payments to ASCs (including beneficiary
cost-sharing and estimated changes in enrollment, utilization, and
case-mix) for CY 2022 would be approximately 5.16 billion, a decrease
of approximately 20 million compared to estimated CY 2021 Medicare
payments.
ASC Payment Policy for Non-Opioid Pain Management Drugs
and Biologicals under Section 6082 of the SUPPORT Act (Section
1833(t)(22) of the Social Security Act): Under section 1833(t)(22)(A)
of the Act, the Secretary was required to conduct a review (part of
which may include a request for information) of payments for opioids
and evidence-based non-opioid alternatives for pain management
(including drugs and devices, nerve blocks, surgical injections, and
neuromodulation) with a goal of ensuring that there are not financial
incentives to use opioids instead of non-opioid alternatives. Section
1833(t)(22)(A)(ii) provides that the Secretary may, as the Secretary
determines appropriate, conduct subsequent reviews of such payment.
In accordance with our review, for CY 2022, we are proposing to
continue to pay separately for two drugs currently receiving separate
payment in the ASC setting as non-opioid pain management drugs that
function as surgical supplies. For CY 2022, we propose to modify the
current non-opioid pain management payment policy and regulatory text
to require that evidence-based non opioid alternatives for pain
management must have Food and Drug Administration (FDA) approval, an
FDA-approved indication for pain management or analgesia, and for the
drugs and biologicals to have a per-day cost in excess of the OPPS drug
packaging threshold, which is proposed at $130 for CY 2022 and
described in section V.B.1.a., to qualify under this policy. Further,
we are soliciting comment on potential additional requirements the
Secretary should consider establishing for this policy as well as
whether any additional products meet the proposed criteria for CY 2022.
Changes to the List of ASC Covered Surgical Procedures:
For CY 2022, we are proposing to re-adopt the ASC Covered Procedures
List (CPL) criteria that were in effect in CY 2020 and to remove 258 of
the 267 procedures that were added to the ASC CPL in CY 2021. We are
requesting comments on whether any of the 258 procedures meet the CY
2020 criteria that we are proposing to reinstate. We are also proposing
to change the notification process adopted in CY 2021 to a nomination
process, under which stakeholders could nominate procedures they
believe meet the requirements to be added to the ASC CPL. The formal
nomination process would begin in CY 2023.
Hospital Outpatient Quality Reporting (OQR) Program: For the
Hospital OQR Program, we are proposing changes for the CY 2023, CY
2024, CY 2025, and CY 2026 payment determinations and subsequent years.
For the Hospital OQR Program measure set, we are proposing to: (1)
Remove the OP-02: Fibrinolytic Therapy Received Within 30 Minutes of ED
Arrival measure beginning with the CY 2025 payment determination; (2)
remove the OP-03: Median Time to Transfer to Another Facility for Acute
Coronary Intervention measure beginning with the CY 2025 payment
determination; (3) adopt the COVID-19 Vaccination Coverage Among Health
Care Personnel (HCP) measure beginning with the CY 2024 payment
determination; (4) adopt the Breast Screening Recall Rates measure
beginning with the CY 2023 payment determination; (5) adopt the ST-
Segment Elevation Myocardial Infarction (STEMI) electronic clinical
quality measure (eCQM) beginning with voluntary reporting for the CY
2023 reporting period and mandatory reporting beginning with the CY
2024 reporting period/CY 2026 payment determination; (6) make voluntary
the reporting of the OP-37a-e: Outpatient and Ambulatory Surgery
Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS)
Survey-based measures beginning with the CY 2023 reporting period and
mandatory beginning with the CY 2024 reporting period/CY 2026 payment
determination; and (7) make mandatory the reporting of the OP-31:
Cataracts: Improvement in Patient's Visual Function within 90 Days
Following Cataract Surgery measure beginning with the CY 2025 payment
determination. In addition, we are proposing data submission
[[Page 42022]]
requirements for the OAS CAHPS Survey-based measures and the COVID-19
Vaccination Coverage Among HCP measure. Similarly, we are proposing
data submission and certification requirements for eCQMs and expanding
our Extraordinary Circumstances Exemption (ECE) policy to these
measures.
Beginning with the CY 2024 payment determination, we are proposing
three updates to our validation requirements by proposing to: (1) Use
electronic file submissions for chart-abstracted measure medical record
requests; (2) change the chart validation requirements and methods; and
(3) update the targeting criteria. We are also requesting comment from
stakeholders on: (1) The potential future development and inclusion of
a patient-reported outcomes measure following elective total hip and/or
total knee arthroplasty (THA/TKA); (2) the possibility of expanding our
current disparities methods to include reporting by race and ethnicity;
and (3) the possibility of hospital collection of standardized
demographic information for quality reporting and measure
stratification. We are also requesting feedback across programs on
potential actions and priority areas that would enable the continued
transformation of our quality measurement toward greater digital
capture of data and use of the FHIR standard.
Ambulatory Surgical Center Quality Reporting (ASCQR)
Program: For the ASCQR Program, we are proposing changes for the CY
2024, CY 2025, and CY 2026 payment determinations and subsequent years.
For the ASCQR Program measure set, we are proposing to: (1) Adopt the
COVID-19 Vaccination Coverage Among HCP measure beginning with the CY
2024 payment determination; (2) resume data collection for four
measures beginning with the CY 2025 payment determination: (a) ASC-1:
Patient Burn; (b) ASC-2: Patient Fall; (c) ASC-3: Wrong Site, Wrong
Side, Wrong Patient, Wrong Procedure, Wrong Implant; and (d) ASC-4:
All-Cause Hospital Transfer/Admission; (3) require the ASC-11:
Cataracts: Improvement in Patient's Visual Function within 90 Days
Following Cataract Surgery measure beginning with the CY 2025 payment
determination; and (4) require the ASC-15a-e: OAS CAHPS Survey-based
measures with voluntary reporting beginning with the CY 2023 reporting
period and mandatory reporting beginning with the CY 2024 reporting
period/CY 2026 payment determination. In addition, we are proposing
data submission requirements for the OAS CAHPS Survey-based measures
and the COVID-19 Vaccination Coverage Among HCP measure.
We are requesting stakeholder comment on: (1) The potential future
development and inclusion of a patient-reported outcomes measure
following elective THA/TKA; (2) potential measurement approaches or
social risk factors that influence health disparities in the ASC
setting; and (3) the future inclusion of a measure to assess pain
management surgical procedures performed in ASCs. In this proposed
rule, we are also requesting feedback across programs on potential
actions and priority areas that would enable the continued
transformation of our quality measurement toward greater digital
capture of data and use of the FHIR standard.
Hospital Inpatient Quality Reporting (IQR) Program Update:
In this proposed rule, we are requesting information from stakeholders
on potential measure updates on reporting and submission requirements
for the Safe Use of Opioids--Concurrent Prescribing eCQM.
Updates to Requirements for Hospitals to Make Public a
List of Their Standard Charges: We are proposing to amend several
hospital price transparency policies codified at 45 CFR part 180 in
order to encourage compliance. We are proposing to: (1) Increase the
amount of the penalties for noncompliance through the use of a proposed
scaling factor based on hospital bed count; (2) deem state forensic
hospitals that meet certain requirements to be in compliance with the
requirements of 45 CFR part 180; and (3) prohibit certain conduct that
we have concluded are barriers to accessing the standard charge
information. In addition, we clarify the expected output of hospital
online price estimator tools when hospitals choose to use an online
price estimator tool in lieu of posting its standard charges for the
required shoppable services in a consumer-friendly format. Finally, we
seek comment on a variety of issues that we may consider in future
rulemaking, including improving standardization of the data disclosed
by hospitals.
Request for Information on Rural Emergency Hospitals
(REHs):
Congress enacted section 125 of the Consolidated Appropriations Act
(CAA) of 2021, which establishes REHs as a new provider type. In
accordance with the statutory requirements in the CAA, REHs will
provide emergency department services, observation care, and, at the
election of the REH, other medical and health services on an outpatient
basis, as specified by the Secretary through rulemaking. Additionally,
REHs must not provide acute care inpatient services, with the exception
of skilled nursing facility services furnished in a distinct part unit.
The REH must have a staffed emergency department 24 hours a day, 7 days
a week, with staffing requirements similar to those for Critical Access
Hospitals (CAHs). The CAA provides that the statutory provisions
governing Medicare payment to REHs shall apply to items and services
furnished on or after January 1, 2023. We are seeking public comment
via a Request for Information on the health and safety standards,
payment policies, the REH enrollment process, and quality measures and
reporting requirements for REHs to inform our policy making as we
establish this new provider type.
Radiation Oncology Model (RO Model): Section 133 of the
Consolidated Appropriations Act (CAA), 2021 (Pub. L. 116-260), enacted
on December 27, 2020, included a provision that prohibits the RO Model
from beginning before January 1, 2022. This law supersedes the RO Model
delayed start date established in the CY 2021 OPPS/ASC final rule. In
this proposed rule, we are proposing provisions related to the
additional delayed implementation due to the CAA, 2021, as well as
modifications to certain RO Model policies not related to the delay.
These proposals if finalized would necessitate modifying 42 CFR
512.205, 512.210, 512.217, 512.220, 512.230, 512.240, 512.245, 512.250,
512.255, 512.275, 512.280, and 512.285 and add 42 CFR 512.292 and
512.294.
Comment Solicitation on Temporary Policies for the PHE for
COVID-19: In response to the COVID-19 pandemic, CMS undertook emergency
rulemaking to implement a number of flexibilities to address the
pandemic, such as preventing spread of the infection and supporting
diagnosis of COVID-19. While many of these flexibilities will expire at
the conclusion of the PHE, we are seeking comment on whether there are
certain policies that should be made permanent. Specifically, we are
seeking comment on services furnished by hospital staff to
beneficiaries in their homes through use of communication technology,
direct supervision when the supervising practitioner is available
through two-way, audio/video communication technology, and code and
payment for COVID-19 specimen collection.
Changes to Beneficiary Coinsurance for Colorectal Cancer
Screening Test: Section 122 of the Consolidated Appropriations Act
(CAA) of 2021 amends section 1833(a) of the Act to
[[Page 42023]]
offer a special coinsurance rule for screening flexible sigmoidoscopies
and screening colonoscopies regardless of the code that is billed for
the establishment of a diagnosis as a result of the test, or for the
removal of tissue or other matter or other procedure, that is furnished
in connection with, as a result of, and in the same clinical encounter
as the colorectal cancer screening test. We propose that all surgical
services furnished on the same date as a planned screening colonoscopy
or planned flexible sigmoidoscopy could be viewed as being furnished in
connection with, as a result of, and in the same clinical encounter as
the screening test for purposes of determining the coinsurance required
of Medicare beneficiaries for planned colorectal cancer screening tests
that result in additional procedures furnished in the same clinical
encounter.
3. Summary of Costs and Benefit
In sections XXIV. and XXV. of this proposed rule, we set forth a
detailed analysis of the regulatory and federalism impacts that the
changes would have on affected entities and beneficiaries. Key
estimated impacts are described below.
a. Impacts of All OPPS Changes
Table U1 in section XXIV.B of this proposed rule displays the
distributional impact of all the OPPS changes on various groups of
hospitals and CMHCs for CY 2021 compared to all estimated OPPS payments
in CY 2020. We estimate that the policies in this proposed rule would
result in a 1.8 percent overall increase in OPPS payments to providers.
We estimate that total OPPS payments for CY 2021, including beneficiary
cost-sharing, to the approximately 3,662 facilities paid under the OPPS
(including general acute care hospitals, children's hospitals, cancer
hospitals, and CMHCs) would increase by approximately $1.3 billion
compared to CY 2020 payments, excluding our estimated changes in
enrollment, utilization, and case-mix.
We estimated the isolated impact of our OPPS policies on CMHCs
because CMHCs are only paid for partial hospitalization services under
the OPPS. Continuing the provider-specific structure we adopted
beginning in CY 2011, and basing payment fully on the type of provider
furnishing the service, we estimate a 1.6 percent increase in CY 2021
payments to CMHCs relative to their CY 2020 payments.
b. Impacts of the Proposed Updated Wage Indexes
We estimate that our proposed update of the wage indexes based on
the FY 2022 IPPS proposed rule wage indexes would result in no change
for urban hospitals under the OPPS and no change for rural hospitals.
These wage indexes include the continued implementation of the OMB
labor market area delineations based on 2010 Decennial Census data,
with updates, as discussed in section II.C. of this proposed rule.
c. Impacts of the Proposed Rural Adjustment and the Cancer Hospital
Payment Adjustment
There are no significant impacts of our CY 2022 payment policies
for hospitals that are eligible for the rural adjustment or for the
cancer hospital payment adjustment. We are not proposing to make any
change in policies for determining the rural hospital payment
adjustments. While we propose to implement the reduction to the cancer
hospital payment adjustment for CY 2022 required by section
1833(t)(18)(C) of the Act, as added by section 16002(b) of the 21st
Century Cures Act, the target payment-to-cost ratio (PCR) for CY 2021
is 0.89, equivalent to the 0.89 target PCR for CY 2021, and therefore
has no budget neutrality adjustment.
d. Impacts of the Proposed OPD Fee Schedule Increase Factor
For the CY 2021 OPPS/ASC, we propose to establish an OPD fee
schedule increase factor of 2.3 percent and apply that increase factor
to the conversion factor for CY 2021. As a result of the OPD fee
schedule increase factor and other budget neutrality adjustments, we
estimate that urban hospitals will experience an increase in payments
of approximately 2.3 percent and that rural hospitals would experience
an increase in payments of 2.3 percent. Classifying hospitals by
teaching status, we estimate nonteaching hospitals would experience an
increase in payments of 2.5 percent, minor teaching hospitals would
experience an increase in payments of 2.3 percent, and major teaching
hospitals would experience an increase in payments of 2.2 percent. We
also classified hospitals by the type of ownership. We estimate that
hospitals with voluntary ownership would experience an increase of 2.3
percent in payments, while hospitals with government ownership would
experience an increase of 2.4 percent in payments. We estimate that
hospitals with proprietary ownership would experience an increase of
2.5 percent in payments.
e. Impacts of the Proposed ASC Payment Update
For impact purposes, the surgical procedures on the ASC covered
surgical procedure list are aggregated into surgical specialty groups
using CPT and HCPCS code range definitions. The percentage change in
estimated total payments by specialty groups under the CY 2022 payment
rates, compared to estimated CY 2021 payment rates, generally ranges
between an increase of 2 and 4 percent, depending on the service, with
some exceptions. We estimate the impact of applying the hospital market
basket update to ASC payment rates would increase payments by $90
million under the ASC payment system in CY 2022.
B. Legislative and Regulatory Authority for the Hospital OPPS
When Title XVIII of the Act was enacted, Medicare payment for
hospital outpatient services was based on hospital-specific costs. In
an effort to ensure that Medicare and its beneficiaries pay
appropriately for services and to encourage more efficient delivery of
care, the Congress mandated replacement of the reasonable cost-based
payment methodology with a prospective payment system (PPS). The
Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) added section
1833(t) to the Act, authorizing implementation of a PPS for hospital
outpatient services. The OPPS was first implemented for services
furnished on or after August 1, 2000. Implementing regulations for the
OPPS are located at 42 CFR parts 410 and 419.
The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999 (BBRA) (Pub. L. 106-113) made major changes in the hospital OPPS.
The following Acts made additional changes to the OPPS: The Medicare,
Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000
(BIPA) (Pub. L. 106-554); the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173); the Deficit
Reduction Act of 2005 (DRA) (Pub. L. 109-171), enacted on February 8,
2006; the Medicare Improvements and Extension Act under Division B of
Title I of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA)
(Pub. L. 109-432), enacted on December 20, 2006; the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173),
enacted on December 29, 2007; the Medicare Improvements
[[Page 42024]]
for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275),
enacted on July 15, 2008; the Patient Protection and Affordable Care
Act (Pub. L. 111-148), enacted on March 23, 2010, as amended by the
Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152),
enacted on March 30, 2010 (these two public laws are collectively known
as the Affordable Care Act); the Medicare and Medicaid Extenders Act of
2010 (MMEA, Pub. L. 111-309); the Temporary Payroll Tax Cut
Continuation Act of 2011 (TPTCCA, Pub. L. 112-78), enacted on December
23, 2011; the Middle Class Tax Relief and Job Creation Act of 2012
(MCTRJCA, Pub. L. 112-96), enacted on February 22, 2012; the American
Taxpayer Relief Act of 2012 (Pub. L. 112-240), enacted January 2, 2013;
the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) enacted on
December 26, 2013; the Protecting Access to Medicare Act of 2014 (PAMA,
Pub. L. 113-93), enacted on March 27, 2014; the Medicare Access and
CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 114-10), enacted
April 16, 2015; the Bipartisan Budget Act of 2015 (Pub. L. 114-74),
enacted November 2, 2015; the Consolidated Appropriations Act, 2016
(Pub. L. 114-113), enacted on December 18, 2015, the 21st Century Cures
Act (Pub. L. 114-255), enacted on December 13, 2016; the Consolidated
Appropriations Act, 2018 (Pub. L. 115-141), enacted on March 23, 2018;
the Substance Use-Disorder Prevention that Promotes Opioid Recovery and
Treatment for Patients and Communities Act (Pub. L. 115-271), enacted
on October 24, 2018; the Further Consolidated Appropriations Act, 2020
(Pub. L. 116-94), enacted on December 20, 2019; the Coronavirus Aid,
Relief, and Economic Security Act (Pub. L. 116-136), enacted on March
27, 2020; and the Consolidated Appropriations Act, 2021 (Pub. L. 116-
260), enacted on December 27, 2020.
Under the OPPS, we generally pay for hospital Part B services on a
rate-per-service basis that varies according to the APC group to which
the service is assigned. We use the Healthcare Common Procedure Coding
System (HCPCS) (which includes certain Current Procedural Terminology
(CPT) codes) to identify and group the services within each APC. The
OPPS includes payment for most hospital outpatient services, except
those identified in section I.C. of this proposed rule. Section
1833(t)(1)(B) of the Act provides for payment under the OPPS for
hospital outpatient services designated by the Secretary (which
includes partial hospitalization services furnished by CMHCs), and
certain inpatient hospital services that are paid under Medicare Part
B.
The OPPS rate is an unadjusted national payment amount that
includes the Medicare payment and the beneficiary copayment. This rate
is divided into a labor-related amount and a nonlabor-related amount.
The labor-related amount is adjusted for area wage differences using
the hospital inpatient wage index value for the locality in which the
hospital or CMHC is located.
All services and items within an APC group are comparable
clinically and with respect to resource use, as required by section
1833(t)(2)(B) of the Act. In accordance with section 1833(t)(2)(B) of
the Act, subject to certain exceptions, items and services within an
APC group cannot be considered comparable with respect to the use of
resources if the highest median cost (or mean cost, if elected by the
Secretary) for an item or service in the APC group is more than 2 times
greater than the lowest median cost (or mean cost, if elected by the
Secretary) for an item or service within the same APC group (referred
to as the ``2 times rule''). In implementing this provision, we
generally use the cost of the item or service assigned to an APC group.
For new technology items and services, special payments under the
OPPS may be made in one of two ways. Section 1833(t)(6) of the Act
provides for temporary additional payments, which we refer to as
``transitional pass-through payments,'' for at least 2 but not more
than 3 years for certain drugs, biological agents, brachytherapy
devices used for the treatment of cancer, and categories of other
medical devices. For new technology services that are not eligible for
transitional pass-through payments, and for which we lack sufficient
clinical information and cost data to appropriately assign them to a
clinical APC group, we have established special APC groups based on
costs, which we refer to as New Technology APCs. These New Technology
APCs are designated by cost bands which allow us to provide appropriate
and consistent payment for designated new procedures that are not yet
reflected in our claims data. Similar to pass-through payments, an
assignment to a New Technology APC is temporary; that is, we retain a
service within a New Technology APC until we acquire sufficient data to
assign it to a clinically appropriate APC group.
C. Excluded OPPS Services and Hospitals
Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to
designate the hospital outpatient services that are paid under the
OPPS. While most hospital outpatient services are payable under the
OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for
ambulance, physical and occupational therapy, and speech-language
pathology services, for which payment is made under a fee schedule. It
also excludes screening mammography, diagnostic mammography, and
effective January 1, 2011, an annual wellness visit providing
personalized prevention plan services. The Secretary exercises the
authority granted under the statute to also exclude from the OPPS
certain services that are paid under fee schedules or other payment
systems. Such excluded services include, for example, the professional
services of physicians and nonphysician practitioners paid under the
Medicare Physician Fee Schedule (MPFS); certain laboratory services
paid under the Clinical Laboratory Fee Schedule (CLFS); services for
beneficiaries with end-stage renal disease (ESRD) that are paid under
the ESRD prospective payment system; and services and procedures that
require an inpatient stay that are paid under the hospital IPPS. In
addition, section 1833(t)(1)(B)(v) of the Act does not include
applicable items and services (as defined in subparagraph (A) of
paragraph (21)) that are furnished on or after January 1, 2017 by an
off-campus outpatient department of a provider (as defined in
subparagraph (B) of paragraph (21)). We set forth the services that are
excluded from payment under the OPPS in regulations at 42 CFR 419.22.
Under Sec. 419.20(b) of the regulations, we specify the types of
hospitals that are excluded from payment under the OPPS. These excluded
hospitals are:
Critical access hospitals (CAHs);
Hospitals located in Maryland and paid under Maryland's
All-Payer or Total Cost of Care Model;
Hospitals located outside of the 50 States, the District
of Columbia, and Puerto Rico; and
Indian Health Service (IHS) hospitals.
D. Prior Rulemaking
On April 7, 2000, we published in the Federal Register a final rule
with comment period (65 FR 18434) to implement a prospective payment
system for hospital outpatient services. The hospital OPPS was first
implemented for services furnished on or after August 1, 2000. Section
1833(t)(9)(A) of the Act requires the Secretary to review certain
components of the OPPS, not less often than
[[Page 42025]]
annually, and to revise the groups, the relative payment weights, and
the wage and other adjustments to take into account changes in medical
practices, changes in technology, the addition of new services, new
cost data, and other relevant information and factors.
Since initially implementing the OPPS, we have published final
rules in the Federal Register annually to implement statutory
requirements and changes arising from our continuing experience with
this system. These rules can be viewed on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.
E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the
Panel)
1. Authority of the Panel
Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of
Public Law 106-113, and redesignated by section 202(a)(2) of Public Law
106-113, requires that we consult with an expert outside advisory panel
composed of an appropriate selection of representatives of providers to
annually review (and advise the Secretary concerning) the clinical
integrity of the payment groups and their weights under the OPPS. In CY
2000, based on section 1833(t)(9)(A) of the Act, the Secretary
established the Advisory Panel on Ambulatory Payment Classification
Groups (APC Panel) to fulfill this requirement. In CY 2011, based on
section 222 of the Public Health Service Act, which gives discretionary
authority to the Secretary to convene advisory councils and committees,
the Secretary expanded the panel's scope to include the supervision of
hospital outpatient therapeutic services in addition to the APC groups
and weights. To reflect this new role of the panel, the Secretary
changed the panel's name to the Advisory Panel on Hospital Outpatient
Payment (the HOP Panel or the Panel). The HOP Panel is not restricted
to using data compiled by CMS, and in conducting its review, it may use
data collected or developed by organizations outside the Department.
2. Establishment of the Panel
On November 21, 2000, the Secretary signed the initial charter
establishing the Panel, and, at that time, named the APC Panel. This
expert panel is composed of appropriate representatives of providers
(currently employed full-time, not as consultants, in their respective
areas of expertise) who review clinical data and advise CMS about the
clinical integrity of the APC groups and their payment weights. Since
CY 2012, the Panel also is charged with advising the Secretary on the
appropriate level of supervision for individual hospital outpatient
therapeutic services. The Panel is technical in nature, and it is
governed by the provisions of the Federal Advisory Committee Act
(FACA). The current charter specifies, among other requirements, that
the Panel--
May advise on the clinical integrity of Ambulatory Payment
Classification (APC) groups and their associated weights;
May advise on the appropriate supervision level for
hospital outpatient services;
May advise on OPPS APC rates for ASC covered surgical
procedures;
Continues to be technical in nature;
Is governed by the provisions of the FACA;
Has a Designated Federal Official (DFO); and
Is chaired by a Federal Official designated by the
Secretary.
The Panel's charter was amended on November 15, 2011, renaming the
Panel and expanding the Panel's authority to include supervision of
hospital outpatient therapeutic services and to add critical access
hospital (CAH) representation to its membership. The Panel's charter
was also amended on November 6, 2014 (80 FR 23009), and the number of
members was revised from up to 19 to up to 15 members. The Panel's
current charter was approved on November 20, 2020, for a 2-year period.
The current Panel membership and other information pertaining to
the Panel, including its charter, Federal Register notices, membership,
meeting dates, agenda topics, and meeting reports, can be viewed on the
CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html.
3. Panel Meetings and Organizational Structure
The Panel has held many meetings, with the last meeting taking
place on August 31, 2020. Prior to each meeting, we publish a notice in
the Federal Register to announce the meeting, new members, and any
other changes of which the public should be aware. Beginning in CY
2017, we have transitioned to one meeting per year (81 FR 31941). In CY
2018, we published a Federal Register notice requesting nominations to
fill vacancies on the Panel (83 FR 3715). As published in this notice,
CMS is accepting nominations on a continuous basis.
In addition, the Panel has established an administrative structure
that, in part, currently includes the use of three subcommittee
workgroups to provide preparatory meeting and subject support to the
larger panel. The three current subcommittees include the following:
APC Groups and Status Indicator Assignments Subcommittee,
which advises and provides recommendations to the Panel on the
appropriate status indicators to be assigned to HCPCS codes, including
but not limited to whether a HCPCS code or a category of codes should
be packaged or separately paid, as well as the appropriate APC
assignment of HCPCS codes regarding services for which separate payment
is made;
Data Subcommittee, which is responsible for studying the
data issues confronting the Panel and for recommending options for
resolving them; and
Visits and Observation Subcommittee, which reviews and
makes recommendations to the Panel on all technical issues pertaining
to observation services and hospital outpatient visits paid under the
OPPS.
Each of these workgroup subcommittees was established by a majority
vote from the full Panel during a scheduled Panel meeting, and the
Panel recommended at the August 31, 2020, meeting that the
subcommittees continue. We accepted this recommendation.
Discussions of the other recommendations made by the Panel at the
August 31, 2020 Panel meeting, namely APC assignments for certain CPT
codes, a comprehensive APC for skin substitute products, a
comprehensive APC for autologous hematopoietic stem cell
transplantation, and packaging policies, were discussed in relevant
specific sections in the CY 2021 OPPS/ASC final rule with comment
period (85 FR 85866). For discussions of earlier Panel meetings and
recommendations, we refer readers to previously published OPPS/ASC
proposed and final rules, the CMS website mentioned earlier in this
section, and the FACA database at http://facadatabase.gov.
F. Public Comments Received on the CY 2020 OPPS/ASC Final Rule With
Comment Period
We received approximately 32 timely pieces of correspondence on the
CY 2021 OPPS/ASC final rule with comment period that appeared in the
Federal Register on December 2, 2020 (85 FR 85866), most of which were
[[Page 42026]]
outside of the scope of the final rule. In-scope comments related to
the interim APC assignments and/or status indicators of new or
replacement Level II HCPCS codes (identified with comment indicator
``NI'' in OPPS Addendum B, ASC Addendum AA, and ASC Addendum BB to that
final rule).
II. Proposed Updates Affecting OPPS Payments
A. Proposed Recalibration of APC Relative Payment Weights
1. Database Construction
a. Use of CY 2019 Data in the CY 2022 OPPS Ratesetting
We primarily use two data sources in OPPS ratesetting: Claims data
and cost report data. Our goal is always to use the best available data
overall for ratesetting. Ordinarily, the best available full year of
claims data would be 2 years prior to the calendar year that is the
subject of the rulemaking. As discussed in further detail in Section
X.E. of this CY 2022 OPPS/ASC proposed rule, given our concerns with CY
2020 data as a result of the COVID-19 PHE, in general, we are proposing
to use CY 2019 claims data and the data components related to it in
establishing the CY 2022 OPPS.
b. Database Source and Methodology
Section 1833(t)(9)(A) of the Act requires that the Secretary review
not less often than annually and revise the relative payment weights
for APCs. In the April 7, 2000 OPPS final rule with comment period (65
FR 18482), we explained in detail how we calculated the relative
payment weights that were implemented on August 1, 2000 for each APC
group.
For the CY 2022 OPPS, we propose to recalibrate the APC relative
payment weights for services furnished on or after January 1, 2022, and
before January 1, 2023 (CY 2022), using the same basic methodology that
we described in the CY 2021 OPPS/ASC final rule with comment period (85
FR 85873), using CY 2019 claims data. That is, we propose to
recalibrate the relative payment weights for each APC based on claims
and cost report data for hospital outpatient department (HOPD) services
to construct a database for calculating APC group weights.
For the purpose of recalibrating the proposed APC relative payment
weights for CY 2022, we began with approximately 180 million final
action claims (claims for which all disputes and adjustments have been
resolved and payment has been made) for HOPD services furnished on or
after January 1, 2019, and before January 1, 2020, before applying our
exclusionary criteria and other methodological adjustments. After the
application of those data processing changes, we used approximately 93
million final action claims to develop the proposed CY 2022 OPPS
payment weights. For exact numbers of claims used and additional
details on the claims accounting process, we refer readers to the
claims accounting narrative under supporting documentation for this
proposed rule on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
Addendum N to this proposed rule (which is available via the
internet on the CMS website) includes the proposed list of bypass codes
for CY 2022. The proposed list of bypass codes contains codes that are
reported on claims for services in CY 2019 and, therefore, includes
codes that were in effect in CY 2019 and used for billing. We propose
to retain deleted bypass codes on the proposed CY 2022 bypass list
because these codes existed in CY 2019 and were covered OPD services in
that period, and CY 2019 claims data were used to calculate proposed CY
2022 payment rates. Keeping these deleted bypass codes on the bypass
list potentially allows us to create more ``pseudo'' single procedure
claims for ratesetting purposes. ``Overlap bypass codes'' that are
members of the proposed multiple imaging composite APCs are identified
by asterisks (*) in the third column of Addendum N to the proposed
rule. HCPCS codes that we propose to add for CY 2022 are identified by
asterisks (*) in the fourth column of Addendum N.
c. Proposed Calculation and Use of Cost-to-Charge Ratios (CCRs)
For 2022, we propose to continue to use the hospital-specific
overall ancillary and departmental cost-to-charge ratios (CCRs) to
convert charges to estimated costs through application of a revenue
code-to-cost center crosswalk. To calculate the APC costs on which the
CY 2022 APC payment rates are based, we calculated hospital-specific
overall ancillary CCRs and hospital-specific departmental CCRs for each
hospital for which we had CY 2019 claims data by comparing these claims
data to hospital cost reports available for the CY 2021 OPPS/ASC final
rule with comment period ratesetting, which, in most cases, are from CY
2019. For the proposed CY 2022 OPPS payment rates, we used the set of
CY 2019 claims processed through June 30, 2020. We applied the
hospital-specific CCR to the hospital's charges at the most detailed
level possible, based on a revenue code-to-cost center crosswalk that
contains a hierarchy of CCRs used to estimate costs from charges for
each revenue code. To ensure the completeness of the revenue code-to-
cost center crosswalk, we reviewed changes to the list of revenue codes
for CY 2019 (the year of claims data we used to calculate the proposed
CY 2022 OPPS payment rates) and updates to the NUBC 2020 Data
Specifications Manual. That crosswalk is available for review and
continuous comment on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
In accordance with our longstanding policy, we calculate CCRs for
the standard and nonstandard cost centers accepted by the electronic
cost report database. In general, the most detailed level at which we
calculate CCRs is the hospital-specific departmental level. For a
discussion of the hospital-specific overall ancillary CCR calculation,
we refer readers to the CY 2007 OPPS/ASC final rule with comment period
(71 FR 67983 through 67985). The calculation of blood costs is a
longstanding exception (since the CY 2005 OPPS) to this general
methodology for calculation of CCRs used for converting charges to
costs on each claim. This exception is discussed in detail in the CY
2007 OPPS/ASC final rule with comment period and discussed further in
section II.A.2.a.(1) of this proposed rule.
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74840
through 74847), we finalized our policy of creating new cost centers
and distinct CCRs for implantable devices, magnetic resonance imaging
(MRIs), computed tomography (CT) scans, and cardiac catheterization.
However, in response to comments we received from our CY 2014 OPPS/ASC
proposed rule, we finalized a policy in the CY 2014 OPPS/ASC final rule
with comment period (78 FR 74847) to remove claims from providers that
use a cost allocation method of ``square feet'' to calculate CCRs used
to estimate costs associated with the APCs for CT and MRI. As finalized
in the CY 2020 OPPS/ASC final rule with comment period (84 FR 61152),
beginning in CY 2021, we use all claims with valid CT and MRI cost
center CCRs, including those that use a ``square feet'' cost allocation
method, to estimate costs for the CT and MRI APCs.
2. Proposed Data Development and Calculation of Costs Used for
Ratesetting
In this section of this proposed rule, we discuss the use of claims
to calculate the OPPS payment rates for CY 2022.
[[Page 42027]]
The Hospital OPPS page on the CMS website on which this proposed rule
is posted (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html) provides an accounting of
claims used in the development of the proposed payment rates. That
accounting provides additional detail regarding the number of claims
derived at each stage of the process. In addition, later in this
section we discuss the file of claims that comprises the data set that
is available upon payment of an administrative fee under a CMS data use
agreement. The CMS website, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html, includes
information about obtaining the ``OPPS Limited Data Set,'' which now
includes the additional variables previously available only in the OPPS
Identifiable Data Set, including ICD-10-CM diagnosis codes and revenue
code payment amounts. This file is derived from the CY 2019 claims that
were used to calculate the proposed payment rates for this CY 2022
OPPS/ASC proposed rule.
Previously, the OPPS established the scaled relative weights on
which payments are based using APC median costs, a process described in
the CY 2012 OPPS/ASC final rule with comment period (76 FR 74188).
However, as discussed in more detail in section II.A.2.f. of the CY
2013 OPPS/ASC final rule with comment period (77 FR 68259 through
68271), we finalized the use of geometric mean costs to calculate the
relative weights on which the CY 2013 OPPS payment rates were based.
While this policy changed the cost metric on which the relative
payments are based, the data process in general remained the same under
the methodologies that we used to obtain appropriate claims data and
accurate cost information in determining estimated service cost. For
2022, we propose to continue to use geometric mean costs to calculate
the relative weights on which the proposed CY 2022 OPPS payment rates
are based.
We used the methodology described in sections II.A.2.a. through
II.A.2.c. of this proposed rule to calculate the costs we used to
establish the proposed relative payment weights used in calculating the
OPPS payment rates for CY 2022 shown in Addenda A and B to this
proposed rule (which are available via the internet on the CMS
website). We refer readers to section II.A.4. of this proposed rule for
a discussion of the conversion of APC costs to scaled payment weights.
We note that under the OPPS, CY 2019 was the first year in which
the claims data used for setting payment rates (CY 2017 data) contained
lines with the modifier ``PN'', which indicates nonexcepted items and
services furnished and billed by off-campus provider-based departments
(PBDs) of hospitals. Because nonexcepted services are not paid under
the OPPS, in the CY 2019 OPPS/ASC final rule with comment period (83 FR
58832), we finalized a policy to remove those claim lines reported with
modifier ``PN'' from the claims data used in ratesetting for the CY
2019 OPPS and subsequent years. For the CY 2022 OPPS, we will continue
to remove claim lines with modifier ``PN'' from the ratesetting
process.
For details of the claims accounting process used in this proposed
rule, we refer readers to the claims accounting narrative under
supporting documentation for this CY 2022 OPPS/ASC proposed rule on the
CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
a. Proposed Calculation of Single Procedure APC Criteria-Based Costs
(1) Blood and Blood Products
Since the implementation of the OPPS in August 2000, we have made
separate payments for blood and blood products through APCs rather than
packaging payment for them into payments for the procedures with which
they are administered. Hospital payments for the costs of blood and
blood products, as well as for the costs of collecting, processing, and
storing blood and blood products, are made through the OPPS payments
for specific blood product APCs.
We propose to continue to establish payment rates for blood and
blood products using our blood-specific CCR methodology, which utilizes
actual or simulated CCRs from the most recently available hospital cost
reports to convert hospital charges for blood and blood products to
costs. This methodology has been our standard ratesetting methodology
for blood and blood products since CY 2005. It was developed in
response to data analysis indicating that there was a significant
difference in CCRs for those hospitals with and without blood-specific
cost centers, and past public comments indicating that the former OPPS
policy of defaulting to the overall hospital CCR for hospitals not
reporting a blood-specific cost center often resulted in an
underestimation of the true hospital costs for blood and blood
products. Specifically, to address the differences in CCRs and to
better reflect hospitals' costs, we propose to continue to simulate
blood CCRs for each hospital that does not report a blood cost center
by calculating the ratio of the blood-specific CCRs to hospitals'
overall CCRs for those hospitals that do report costs and charges for
blood cost centers. We also propose to apply this mean ratio to the
overall CCRs of hospitals not reporting costs and charges for blood
cost centers on their cost reports to simulate blood-specific CCRs for
those hospitals. We propose to calculate the costs upon which the
proposed CY 2022 payment rates for blood and blood products are based
using the actual blood-specific CCR for hospitals that reported costs
and charges for a blood cost center and a hospital-specific, simulated
blood-specific CCR for hospitals that did not report costs and charges
for a blood cost center.
We continue to believe that the hospital-specific, simulated blood-
specific, CCR methodology better responds to the absence of a blood-
specific CCR for a hospital than alternative methodologies, such as
defaulting to the overall hospital CCR or applying an average blood-
specific CCR across hospitals. Because this methodology takes into
account the unique charging and cost accounting structure of each
hospital, we believe that it yields more accurate estimated costs for
these products. We continue to believe that using this methodology in
CY 2022 would result in costs for blood and blood products that
appropriately reflect the relative estimated costs of these products
for hospitals without blood cost centers and, therefore, for these
blood products in general.
We note that we defined a comprehensive APC (C-APC) as a
classification for the provision of a primary service and all
adjunctive services provided to support the delivery of the primary
service. Under this policy, we include the costs of blood and blood
products when calculating the overall costs of these C-APCs. We propose
to continue to apply the blood-specific CCR methodology described in
this section when calculating the costs of the blood and blood products
that appear on claims with services assigned to the C-APCs. Because the
costs of blood and blood products would be reflected in the overall
costs of the C-APCs (and, as a result, in the proposed payment rates of
the C-APCs), we propose not to make separate payments for blood and
blood products when they appear on the same claims as services assigned
to the C-APCs (we refer readers to the CY 2015 OPPS/ASC final rule with
comment period (79 FR 66795 through 66796) for
[[Page 42028]]
more information about our policy not to make separate payments for
blood and blood products when they appear on the same claims as
services assigned to a C-APC).
We refer readers to Addendum B of this proposed rule (which is
available via the internet on the CMS website) for the proposed CY 2022
payment rates for blood and blood products (which are generally
identified with status indicator ``R''). For a more detailed discussion
of the blood-specific CCR methodology, we refer readers to the CY 2005
OPPS proposed rule (69 FR 50524 through 50525). For a full history of
OPPS payment for blood and blood products, we refer readers to the CY
2008 OPPS/ASC final rule with comment period (72 FR 66807 through
66810).
For CY 2022, we propose to continue to establish payment rates for
blood and blood products using our blood-specific CCR methodology.
(2) Brachytherapy Sources
Section 1833(t)(2)(H) of the Act mandates the creation of
additional groups of covered OPD services that classify devices of
brachytherapy consisting of a seed or seeds (or radioactive source)
(``brachytherapy sources'') separately from other services or groups of
services. The statute provides certain criteria for the additional
groups. For the history of OPPS payment for brachytherapy sources, we
refer readers to prior OPPS final rules, such as the CY 2012 OPPS/ASC
final rule with comment period (77 FR 68240 through 68241). As we have
stated in prior OPPS updates, we believe that adopting the general OPPS
prospective payment methodology for brachytherapy sources is
appropriate for a number of reasons (77 FR 68240). The general OPPS
methodology uses costs based on claims data to set the relative payment
weights for hospital outpatient services. This payment methodology
results in more consistent, predictable, and equitable payment amounts
per source across hospitals by averaging the extremely high and low
values, in contrast to payment based on hospitals' charges adjusted to
costs. We believe that the OPPS methodology, as opposed to payment
based on hospitals' charges adjusted to cost, also would provide
hospitals with incentives for efficiency in the provision of
brachytherapy services to Medicare beneficiaries. Moreover, this
approach is consistent with our payment methodology for the vast
majority of items and services paid under the OPPS. We refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70323
through 70325) for further discussion of the history of OPPS payment
for brachytherapy sources.
For CY 2022, except where otherwise indicated, we propose to use
the costs derived from CY 2019 claims data to set the proposed CY 2022
payment rates for brachytherapy sources because CY 2019 is the year of
data we propose to use to set the proposed payment rates for most other
items and services that would be paid under the CY 2022 OPPS. With the
exception of the proposed payment rate for brachytherapy source C2645
(Brachytherapy planar source, palladium-103, per square millimeter) and
brachytherapy source C2636 (Brachytherapy linear source, non-stranded,
palladium-103, per 1 mm), we propose to base the payment rates for
brachytherapy sources on the geometric mean unit costs for each source,
consistent with the methodology that we propose for other items and
services paid under the OPPS, as discussed in section II.A.2. of this
proposed rule. We also propose to continue the other payment policies
for brachytherapy sources that we finalized and first implemented in
the CY 2010 OPPS/ASC final rule with comment period (74 FR 60537). We
propose to pay for the stranded and nonstranded not otherwise specified
(NOS) codes, HCPCS codes C2698 (Brachytherapy source, stranded, not
otherwise specified, per source) and C2699 (Brachytherapy source, non-
stranded, not otherwise specified, per source), at a rate equal to the
lowest stranded or nonstranded prospective payment rate for such
sources, respectively, on a per-source basis (as opposed to, for
example, a per mCi), which is based on the policy we established in the
CY 2008 OPPS/ASC final rule with comment period (72 FR 66785). We also
propose to continue the policy we first implemented in the CY 2010
OPPS/ASC final rule with comment period (74 FR 60537) regarding payment
for new brachytherapy sources for which we have no claims data, based
on the same reasons we discussed in the CY 2008 OPPS/ASC final rule
with comment period (72 FR 66786; which was delayed until January 1,
2010 by section 142 of Pub. L. 110-275). Specifically, this policy is
intended to enable us to assign new HCPCS codes for new brachytherapy
sources to their own APCs, with prospective payment rates set based on
our consideration of external data and other relevant information
regarding the expected costs of the sources to hospitals. The proposed
CY 2022 payment rates for brachytherapy sources are included in
Addendum B to this proposed rule (which is available via the internet
on the CMS website) and identified with status indicator ``U''.
For CY 2018, we assigned status indicator ``U'' (Brachytherapy
Sources, Paid under OPPS; separate APC payment) to HCPCS code C2645
(Brachytherapy planar source, palladium-103, per square millimeter) in
the absence of claims data and established a payment rate using
external data (invoice price) at $4.69 per mm\2\. For CY 2019, in the
absence of sufficient claims data, we continued to establish a payment
rate for C2645 at $4.69 per mm\2\. Our CY 2018 claims data available
for the final CY 2020 OPPS/ASC final rule with comment period included
two claims with a geometric mean cost for HCPCS code C2645 of $1.02 per
mm\2\. In response to comments from stakeholders, we agreed with
commenters that given the limited claims data available and a new
outpatient indication for C2645, a payment rate for HCPCS code C2645
based on the geometric mean cost of 1.02 per mm\2\ may not adequately
reflect the cost of HCPCS code C2645. In the CY 2020 OPPS/ASC final
rule with comment period, we finalized our policy to use our equitable
adjustment authority under section 1833(t)(2)(E) of the Act, which
states that the Secretary shall establish, in a budget neutral manner,
other adjustments as determined to be necessary to ensure equitable
payments, to maintain the CY 2019 payment rate of $4.69 per mm\2\ for
HCPCS code C2645 for CY 2020. Similarly, in the absence of sufficient
claims data to establish an APC payment rate, in the CY 2021 OPPS/ASC
final rule with comment period, we finalized our policy to use our
equitable adjustment authority under section 1833(t)(2)(E) of the Act
to maintain the CY 2019 payment rate of $4.69 per mm\2\ for HCPCS code
C2645 for CY 2021.
As discussed in Section X.E. of this CY 2022 OPPS/ASC proposed
rule, given our concerns with CY 2020 data as a result of the COVID-19
PHE, in general we are proposing to use CY 2019 claims data and the
data components related to it in establishing the CY 2022 OPPS.
Therefore, we are proposing to use our equitable adjustment authority
under section 1833(t)(2)(E) of the Act to maintain the CY 2019 payment
rate of $4.69 per mm\2\ for HCPCS code C2645 for CY 2022.
Additionally, for CY 2022 and subsequent calendar years, as
discussed in Section X.C., we are proposing to establish a Low Volume
APC policy for New Technology APCs, clinical APCs, and brachytherapy
APCs. For these
[[Page 42029]]
APCs with fewer than 100 single claims that can be used for ratesetting
purposes in the existing claims year, we are proposing to use up to
four years of claims data to establish a payment rate for each item or
service as we currently do for low volume services assigned to New
Technology APCs. Further, we propose to calculate the cost for Low
Volume APCs based on the greatest of the arithmetic mean cost, median
cost, or geometric mean cost. We are proposing to designate 5
brachytherapy APCs as Low Volume APCs for CY 2022. For more information
on our Low Volume APC proposal, see Section X.C. of this CY 2022 OPPS/
ASC proposed rule.
We continue to invite hospitals and other parties to submit
recommendations to us for new codes to describe new brachytherapy
sources. Such recommendations should be directed via email to
[email protected] or by mail to the Division of Outpatient
Care, Mail Stop C4-01-26, Centers for Medicare and Medicaid Services,
7500 Security Boulevard, Baltimore, MD 21244. We will continue to add
new brachytherapy source codes and descriptors to our systems for
payment on a quarterly basis.
b. Comprehensive APCs (C-APCs) for CY 2022
(1) Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74861
through 74910), we finalized a comprehensive payment policy that
packages payment for adjunctive and secondary items, services, and
procedures into the most costly primary procedure under the OPPS at the
claim level. The policy was finalized in CY 2014 but the effective date
was delayed until January 1, 2015 to allow additional time for further
analysis, opportunity for public comment, and systems preparation. The
comprehensive APC (C-APC) policy was implemented effective January 1,
2015, with modifications and clarifications in response to public
comments received regarding specific provisions of the C-APC policy (79
FR 66798 through 66810).
A C-APC is defined as a classification for the provision of a
primary service and all adjunctive services provided to support the
delivery of the primary service. We established C-APCs as a category
broadly for OPPS payment and implemented 25 C-APCs beginning in CY 2015
(79 FR 66809 through 66810). In the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70332), we finalized 10 additional C-APCs to be
paid under the existing C-APC payment policy and added 1 additional
level to both the Orthopedic Surgery and Vascular Procedures clinical
families, which increased the total number of C-APCs to 37 for CY 2016.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79584
through 79585), we finalized another 25 C-APCs for a total of 62 C-
APCs. In the CY 2018 OPPS/ASC final rule with comment period, we did
not change the total number of C-APCs from 62. In the CY 2019 OPPS/ASC
final rule with comment period, we created 3 new C-APCs, increasing the
total number to 65 (83 FR 58844 through 58846). In the CY 2020 OPPS/ASC
final rule with comment period, we created two new C-APCs, increasing
the total number to 67 C-APCs (84 FR 61158 through 61166). Most
recently, in the CY 2021 OPPS/ASC final rule, we created two new C-
APCs, increasing the total number to 69 C-APCs (85 FR 85885).
Under our C-APC policy, we designate a service described by a HCPCS
code assigned to a C-APC as the primary service when the service is
identified by OPPS status indicator ``J1''. When such a primary service
is reported on a hospital outpatient claim, taking into consideration
the few exceptions that are discussed below, we make payment for all
other items and services reported on the hospital outpatient claim as
being integral, ancillary, supportive, dependent, and adjunctive to the
primary service (hereinafter collectively referred to as ``adjunctive
services'') and representing components of a complete comprehensive
service (78 FR 74865 and 79 FR 66799). Payments for adjunctive services
are packaged into the payments for the primary services. This results
in a single prospective payment for each of the primary, comprehensive
services based on the costs of all reported services at the claim
level.
Services excluded from the C-APC policy under the OPPS include
services that are not covered OPD services, services that cannot by
statute be paid for under the OPPS, and services that are required by
statute to be separately paid. This includes certain mammography and
ambulance services that are not covered OPD services in accordance with
section 1833(t)(1)(B)(iv) of the Act; brachytherapy seeds, which also
are required by statute to receive separate payment under section
1833(t)(2)(H) of the Act; pass-through payment drugs and devices, which
also require separate payment under section 1833(t)(6) of the Act;
self-administered drugs (SADs) that are not otherwise packaged as
supplies because they are not covered under Medicare Part B under
section 1861(s)(2)(B) of the Act; and certain preventive services (78
FR 74865 and 79 FR 66800 through 66801). A list of services excluded
from the C-APC policy is included in Addendum J to this proposed rule
(which is available via the internet on the CMS website).
In the interim final rule with request for comments (IFC) entitled,
``Additional Policy and Regulatory Revisions in Response to the COVID-
19 Public Health Emergency'', published on November 6, 2020, we stated
that, effective for services furnished on or after the effective date
of the IFC and until the end of the PHE for COVID-19, there is an
exception to the OPPS C-APC policy to ensure separate payment for new
COVID-19 treatments that meet certain criteria (85 FR 71158 through
71160). Under this exception, any new COVID-19 treatment that meets the
following two criteria will, for the remainder of the PHE for COVID-19,
always be separately paid and will not be packaged into a C-APC when it
is provided on the same claim as the primary C-APC service. First, the
treatment must be a drug or biological product (which could include a
blood product) authorized to treat COVID-19, as indicated in section
``I. Criteria for Issuance of Authorization'' of the FDA letter of
authorization for the emergency use of the drug or biological product,
or the drug or biological product must be approved by the FDA for
treating COVID-19. Second, the emergency use authorization (EUA) for
the drug or biological product (which could include a blood product)
must authorize the use of the product in the outpatient setting or not
limit its use to the inpatient setting, or the product must be approved
by the FDA to treat COVID-19 disease and not limit its use to the
inpatient setting. For further information regarding the exception to
the C-APC policy for COVID-19 treatments, please refer to the November
6, 2020 IFC (85 FR 71158 through 71160).
The C-APC policy payment methodology set forth in the CY 2014 OPPS/
ASC final rule with comment period for the C-APCs and modified and
implemented beginning in CY 2015 is summarized as follows (78 FR 74887
and 79 FR 66800):
Basic Methodology. As stated in the CY 2015 OPPS/ASC final rule
with comment period, we define the C-APC payment policy as including
all covered OPD services on a hospital outpatient claim reporting a
primary service that is assigned to status indicator ``J1'', excluding
services that are not covered
[[Page 42030]]
OPD services or that cannot by statute be paid for under the OPPS.
Services and procedures described by HCPCS codes assigned to status
indicator ``J1'' are assigned to C-APCs based on our usual APC
assignment methodology by evaluating the geometric mean costs of the
primary service claims to establish resource similarity and the
clinical characteristics of each procedure to establish clinical
similarity within each APC.
In the CY 2016 OPPS/ASC final rule with comment period, we expanded
the C-APC payment methodology to qualifying extended assessment and
management encounters through the ``Comprehensive Observation
Services'' C-APC (C-APC 8011). Services within this APC are assigned
status indicator ``J2''. Specifically, we make a payment through C-APC
8011 for a claim that:
Does not contain a procedure described by a HCPCS code to
which we have assigned status indicator ``T;''
Contains 8 or more units of services described by HCPCS
code G0378 (Hospital observation services, per hour);
Contains services provided on the same date of service or
1 day before the date of service for HCPCS code G0378 that are
described by one of the following codes: HCPCS code G0379 (Direct
admission of patient for hospital observation care) on the same date of
service as HCPCS code G0378; CPT code 99281 (Emergency department visit
for the evaluation and management of a patient (Level 1)); CPT code
99282 (Emergency department visit for the evaluation and management of
a patient (Level 2)); CPT code 99283 (Emergency department visit for
the evaluation and management of a patient (Level 3)); CPT code 99284
(Emergency department visit for the evaluation and management of a
patient (Level 4)); CPT code 99285 (Emergency department visit for the
evaluation and management of a patient (Level 5)) or HCPCS code G0380
(Type B emergency department visit (Level 1)); HCPCS code G0381 (Type B
emergency department visit (Level 2)); HCPCS code G0382 (Type B
emergency department visit (Level 3)); HCPCS code G0383 (Type B
emergency department visit (Level 4)); HCPCS code G0384 (Type B
emergency department visit (Level 5)); CPT code 99291 (Critical care,
evaluation and management of the critically ill or critically injured
patient; first 30-74 minutes); or HCPCS code G0463 (Hospital outpatient
clinic visit for assessment and management of a patient); and
Does not contain services described by a HCPCS code to
which we have assigned status indicator ``J1''.
The assignment of status indicator ``J2'' to a specific set of
services performed in combination with each other allows for all other
OPPS payable services and items reported on the claim (excluding
services that are not covered OPD services or that cannot by statute be
paid for under the OPPS) to be deemed adjunctive services representing
components of a comprehensive service and resulting in a single
prospective payment for the comprehensive service based on the costs of
all reported services on the claim (80 FR 70333 through 70336).
Services included under the C-APC payment packaging policy, that
is, services that are typically adjunctive to the primary service and
provided during the delivery of the comprehensive service, include
diagnostic procedures, laboratory tests, and other diagnostic tests and
treatments that assist in the delivery of the primary procedure; visits
and evaluations performed in association with the procedure; uncoded
services and supplies used during the service; durable medical
equipment as well as prosthetic and orthotic items and supplies when
provided as part of the outpatient service; and any other components
reported by HCPCS codes that represent services that are provided
during the complete comprehensive service (78 FR 74865 and 79 FR
66800).
In addition, payment for hospital outpatient department services
that are similar to therapy services and delivered either by therapists
or nontherapists is included as part of the payment for the packaged
complete comprehensive service. These services that are provided during
the perioperative period are adjunctive services and are deemed not to
be therapy services as described in section 1834(k) of the Act,
regardless of whether the services are delivered by therapists or other
nontherapist health care workers. We have previously noted that therapy
services are those provided by therapists under a plan of care in
accordance with section 1835(a)(2)(C) and section 1835(a)(2)(D) of the
Act and are paid for under section 1834(k) of the Act, subject to
annual therapy caps as applicable (78 FR 74867 and 79 FR 66800).
However, certain other services similar to therapy services are
considered and paid for as hospital outpatient department services.
Payment for these nontherapy outpatient department services that are
reported with therapy codes and provided with a comprehensive service
is included in the payment for the packaged complete comprehensive
service. We note that these services, even though they are reported
with therapy codes, are hospital outpatient department services and not
therapy services. We refer readers to the July 2016 OPPS Change Request
9658 (Transmittal 3523) for further instructions on reporting these
services in the context of a C-APC service.
Items included in the packaged payment provided in conjunction with
the primary service also include all drugs, biologicals, and
radiopharmaceuticals, regardless of cost, except those drugs with pass-
through payment status and SADs, unless they function as packaged
supplies (78 FR 74868 through 74869 and 74909 and 79 FR 66800). We
refer readers to Section 50.2M, Chapter 15, of the Medicare Benefit
Policy Manual for a description of our policy on SADs treated as
hospital outpatient supplies, including lists of SADs that function as
supplies and those that do not function as supplies.
We define each hospital outpatient claim reporting a single unit of
a single primary service assigned to status indicator ``J1'' as a
single ``J1'' unit procedure claim (78 FR 74871 and 79 FR 66801). Line
item charges for services included on the C-APC claim are converted to
line item costs, which are then summed to develop the estimated APC
costs. These claims are then assigned one unit of the service with
status indicator ``J1'' and later used to develop the geometric mean
costs for the C-APC relative payment weights. (We note that we use the
term ``comprehensive'' to describe the geometric mean cost of a claim
reporting ``J1'' service(s) or the geometric mean cost of a C-APC,
inclusive of all of the items and services included in the C-APC
service payment bundle.) Charges for services that would otherwise be
separately payable are added to the charges for the primary service.
This process differs from our traditional cost accounting methodology
only in that all such services on the claim are packaged (except
certain services as described above). We apply our standard data trims,
which exclude claims with extremely high primary units or extreme
costs.
The comprehensive geometric mean costs are used to establish
resource similarity and, along with clinical similarity, dictate the
assignment of the primary services to the C-APCs. We establish a
ranking of each primary service (single unit only) to be assigned to
status indicator ``J1'' according to its comprehensive geometric mean
costs. For the minority of claims reporting more than one primary
service assigned to status indicator ``J1'' or units thereof,
[[Page 42031]]
we identify one ``J1'' service as the primary service for the claim
based on our cost-based ranking of primary services. We then assign
these multiple ``J1'' procedure claims to the C-APC to which the
service designated as the primary service is assigned. If the reported
``J1'' services on a claim map to different C-APCs, we designate the
``J1'' service assigned to the C-APC with the highest comprehensive
geometric mean cost as the primary service for that claim. If the
reported multiple ``J1'' services on a claim map to the same C-APC, we
designate the most costly service (at the HCPCS code level) as the
primary service for that claim. This process results in initial
assignments of claims for the primary services assigned to status
indicator ``J1'' to the most appropriate C-APCs based on both single
and multiple procedure claims reporting these services and clinical and
resource homogeneity.
Complexity Adjustments. We use complexity adjustments to provide
increased payment for certain comprehensive services. We apply a
complexity adjustment by promoting qualifying paired ``J1'' service
code combinations or paired code combinations of ``J1'' services and
certain add-on codes (as described further below) from the originating
C-APC (the C-APC to which the designated primary service is first
assigned) to the next higher paying C-APC in the same clinical family
of C-APCs. We apply this type of complexity adjustment when the paired
code combination represents a complex, costly form or version of the
primary service according to the following criteria:
Frequency of 25 or more claims reporting the code
combination (frequency threshold); and
Violation of the 2 times rule, as stated in section
1833(t)(2) of the Act and section III.B.2. of this proposed rule, in
the originating C-APC (cost threshold).
These criteria identify paired code combinations that occur
commonly and exhibit materially greater resource requirements than the
primary service. The CY 2017 OPPS/ASC final rule with comment period
(81 FR 79582) included a revision to the complexity adjustment
eligibility criteria. Specifically, we finalized a policy to
discontinue the requirement that a code combination (that qualifies for
a complexity adjustment by satisfying the frequency and cost criteria
thresholds described above) also not create a 2 times rule violation in
the higher level or receiving APC.
After designating a single primary service for a claim, we evaluate
that service in combination with each of the other procedure codes
reported on the claim assigned to status indicator ``J1'' (or certain
add-on codes) to determine if there are paired code combinations that
meet the complexity adjustment criteria. For a new HCPCS code, we
determine initial C-APC assignment and qualification for a complexity
adjustment using the best available information, crosswalking the new
HCPCS code to a predecessor code(s) when appropriate.
Once we have determined that a particular code combination of
``J1'' services (or combinations of ``J1'' services reported in
conjunction with certain add-on codes) represents a complex version of
the primary service because it is sufficiently costly, frequent, and a
subset of the primary comprehensive service overall according to the
criteria described above, we promote the claim including the complex
version of the primary service as described by the code combination to
the next higher cost C-APC within the clinical family, unless the
primary service is already assigned to the highest cost APC within the
C-APC clinical family or assigned to the only C-APC in a clinical
family. We do not create new APCs with a comprehensive geometric mean
cost that is higher than the highest geometric mean cost (or only) C-
APC in a clinical family just to accommodate potential complexity
adjustments. Therefore, the highest payment for any claim including a
code combination for services assigned to a C-APC would be the highest
paying C-APC in the clinical family (79 FR 66802).
We package payment for all add-on codes into the payment for the C-
APC. However, certain primary service add-on combinations may qualify
for a complexity adjustment. As noted in the CY 2016 OPPS/ASC final
rule with comment period (80 FR 70331), all add-on codes that can be
appropriately reported in combination with a base code that describes a
primary ``J1'' service are evaluated for a complexity adjustment.
To determine which combinations of primary service codes reported
in conjunction with an add-on code may qualify for a complexity
adjustment for 2022, we propose to apply the frequency and cost
criteria thresholds discussed above, testing claims reporting one unit
of a single primary service assigned to status indicator ``J1'' and any
number of units of a single add-on code for the primary ``J1'' service.
If the frequency and cost criteria thresholds for a complexity
adjustment are met and reassignment to the next higher cost APC in the
clinical family is appropriate (based on meeting the criteria outlined
above), we make a complexity adjustment for the code combination; that
is, we reassign the primary service code reported in conjunction with
the add-on code to the next higher cost C-APC within the same clinical
family of C-APCs. As previously stated, we package payment for add-on
codes into the C-APC payment rate. If any add-on code reported in
conjunction with the ``J1'' primary service code does not qualify for a
complexity adjustment, payment for the add-on service continues to be
packaged into the payment for the primary service and is not reassigned
to the next higher cost C-APC. We list the complexity adjustments for
``J1'' and add-on code combinations for CY 2022, along with all of the
other proposed complexity adjustments, in Addendum J to this CY 2022
OPPS/ASC proposed rule (which is available via the internet on the CMS
website).
Addendum J to this proposed rule includes the cost statistics for
each code combination that would qualify for a complexity adjustment
(including primary code and add-on code combinations). Addendum J to
this proposed rule also contains summary cost statistics for each of
the paired code combinations that describe a complex code combination
that would qualify for a complexity adjustment and are proposed to be
reassigned to the next higher cost C-APC within the clinical family.
The combined statistics for all proposed reassigned complex code
combinations are represented by an alphanumeric code with the first 4
digits of the designated primary service followed by a letter. For
example, the proposed geometric mean cost listed in Addendum J for the
code combination described by complexity adjustment assignment 3320R,
which is assigned to C-APC 5224 (Level 4 Pacemaker and Similar
Procedures), includes all paired code combinations that are proposed to
be reassigned to C-APC 5224 when CPT code 33208 is the primary code.
Providing the information contained in Addendum J to this proposed rule
allows stakeholders the opportunity to better assess the impact
associated with the proposed reassignment of claims with each of the
paired code combinations eligible for a complexity adjustment.
[[Page 42032]]
(2) Exclusion of Procedures Assigned to New Technology APCs From the C-
APC Policy
Services that are assigned to New Technology APCs are typically new
procedures that do not have sufficient claims history to establish an
accurate payment for the procedures. Beginning in CY 2002, we retain
services within New Technology APC groups until we gather sufficient
claims data to enable us to assign the service to an appropriate
clinical APC. This policy allows us to move a service from a New
Technology APC in less than 2 years if sufficient data are available.
It also allows us to retain a service in a New Technology APC for more
than 2 years if sufficient data upon which to base a decision for
reassignment have not been collected (82 FR 59277).
The C-APC payment policy packages payment for adjunctive and
secondary items, services, and procedures into the most costly primary
procedure under the OPPS at the claim level. Prior to CY 2019, when a
procedure assigned to a New Technology APC was included on the claim
with a primary procedure, identified by OPPS status indicator ``J1'',
payment for the new technology service was typically packaged into the
payment for the primary procedure. Because the new technology service
was not separately paid in this scenario, the overall number of single
claims available to determine an appropriate clinical APC for the new
service was reduced. This was contrary to the objective of the New
Technology APC payment policy, which is to gather sufficient claims
data to enable us to assign the service to an appropriate clinical APC.
To address this issue and ensure that there is sufficient claims
data for services assigned to New Technology APCs, in the CY 2019 OPPS/
ASC final rule with comment period (83 FR 58847), we finalized
excluding payment for any procedure that is assigned to a New
Technology APC (APCs 1491 through 1599 and APCs 1901 through 1908) from
being packaged when included on a claim with a ``J1'' service assigned
to a C-APC. In the CY 2020 OPPS/ASC final rule with comment period, we
finalized that payment for services assigned to a New Technology APC
would be excluded from being packaged into the payment for
comprehensive observation services assigned status indicator ``J2''
when they are included on a claim with a ``J2'' service starting in CY
2020 (84 FR 61167). We proposed to continue to exclude payment for any
procedure that is assigned to a New Technology APC (APCs 1491 through
1599 and APCs 1901 through 1908) from being packaged when included on a
claim with a ``J1'' or ``J2'' service assigned to a C-APC.
(3) Additional C-APCs for CY 2022
For CY 2022 and subsequent years, we propose to continue to apply
the C-APC payment policy methodology. We refer readers to the CY 2017
OPPS/ASC final rule with comment period (81 FR 79583) for a discussion
of the C-APC payment policy methodology and revisions.
Each year, in accordance with section 1833(t)(9)(A) of the Act, we
review and revise the services within each APC group and the APC
assignments under the OPPS. As a result of our annual review of the
services and the APC assignments under the OPPS, we are not proposing
to convert any standard APCs to C-APCs in CY 2022, thus we propose that
the number of C-APCs for CY 2022 would be the same as the number for CY
2021, which is 69 C-APCs.
Table 1 lists the proposed C-APCs for CY 2022, all of which were
established in past rules. All C-APCs are displayed in Addendum J to
this proposed rule (which is available via the internet on the CMS
website). Addendum J to this proposed rule also contains all of the
data related to the C-APC payment policy methodology, including the
list of complexity adjustments and other information.
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c. Proposed Calculation of Composite APC Criteria-Based Costs
As discussed in the CY 2008 OPPS/ASC final rule with comment period
(72 FR 66613), we believe it is important that the OPPS enhance
incentives for hospitals to provide necessary, high quality care as
efficiently as possible. For CY 2008, we developed composite APCs to
provide a single payment for groups of services that are typically
performed together during a single clinical encounter and that result
in the provision of a complete service.
[[Page 42035]]
Combining payment for multiple, independent services into a single OPPS
payment in this way enables hospitals to manage their resources with
maximum flexibility by monitoring and adjusting the volume and
efficiency of services themselves. An additional advantage to the
composite APC model is that we can use data from correctly coded
multiple procedure claims to calculate payment rates for the specified
combinations of services, rather than relying upon single procedure
claims which may be low in volume and/or incorrectly coded. Under the
OPPS, we currently have composite policies for mental health services
and multiple imaging services. (We note that, in the CY 2018 OPPS/ASC
final rule with comment period, we finalized a policy to delete the
composite APC 8001 (LDR Prostate Brachytherapy Composite) for CY 2018
and subsequent years.) We refer readers to the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66611 through 66614 and 66650 through
66652) for a full discussion of the development of the composite APC
methodology, and the CY 2012 OPPS/ASC final rule with comment period
(76 FR 74163) and the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59241 through 59242 and 59246 through 52950) for more recent
background.
(1) Mental Health Services Composite APC
We propose to continue our longstanding policy of limiting the
aggregate payment for specified less resource-intensive mental health
services furnished on the same date to the payment for a day of partial
hospitalization services provided by a hospital, which we consider to
be the most resource-intensive of all outpatient mental health
services. We refer readers to the April 7, 2000 OPPS final rule with
comment period (65 FR 18452 through 18455) for the initial discussion
of this longstanding policy and the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74168) for more recent background.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79588
through 79589), we finalized a policy to combine the existing Level 1
and Level 2 hospital-based PHP APCs into a single hospital-based PHP
APC, and thereby discontinue APCs 5861 (Level 1--Partial
Hospitalization (3 services) for Hospital-Based PHPs) and 5862 (Level--
2 Partial Hospitalization (4 or more services) for Hospital-Based PHPs)
and replace them with APC 5863 (Partial Hospitalization (3 or more
services per day)).
In the CY 2018 OPPS/ASC proposed rule and final rule with comment
period (82 FR 33580 through 33581 and 59246 through 59247,
respectively), we proposed and finalized the policy for CY 2018 and
subsequent years that, when the aggregate payment for specified mental
health services provided by one hospital to a single beneficiary on a
single date of service, based on the payment rates associated with the
APCs for the individual services, exceeds the maximum per diem payment
rate for partial hospitalization services provided by a hospital, those
specified mental health services will be paid through composite APC
8010 (Mental Health Services Composite). In addition, we set the
payment rate for composite APC 8010 for CY 2018 at the same payment
rate that will be paid for APC 5863, which is the maximum partial
hospitalization per diem payment rate for a hospital, and finalized a
policy that the hospital will continue to be paid the payment rate for
composite APC 8010. Under this policy, the I/OCE will continue to
determine whether to pay for these specified mental health services
individually, or to make a single payment at the same payment rate
established for APC 5863 for all of the specified mental health
services furnished by the hospital on that single date of service. We
continue to believe that the costs associated with administering a
partial hospitalization program at a hospital represent the most
resource intensive of all outpatient mental health services. Therefore,
we do not believe that we should pay more for mental health services
under the OPPS than the highest partial hospitalization per diem
payment rate for hospitals.
We propose that when the aggregate payment for specified mental
health services provided by one hospital to a single beneficiary on a
single date of service, based on the payment rates associated with the
APCs for the individual services, exceeds the maximum per diem payment
rate for partial hospitalization services provided by a hospital, those
specified mental health services would be paid through composite APC
8010 for CY 2022. In addition, we propose to set the proposed payment
rate for composite APC 8010 at the same payment rate that we proposed
for APC 5863, which is the maximum partial hospitalization per diem
payment rate for a hospital, and that the hospital continue to be paid
the proposed payment rate for composite APC 8010.
(2) Multiple Imaging Composite APCs (APCs 8004, 8005, 8006, 8007, and
8008)
Effective January 1, 2009, we provide a single payment each time a
hospital submits a claim for more than one imaging procedure within an
imaging family on the same date of service, to reflect and promote the
efficiencies hospitals can achieve when performing multiple imaging
procedures during a single session (73 FR 41448 through 41450). We
utilize three imaging families based on imaging modality for purposes
of this methodology: (1) Ultrasound; (2) computed tomography (CT) and
computed tomographic angiography (CTA); and (3) magnetic resonance
imaging (MRI) and magnetic resonance angiography (MRA). The HCPCS codes
subject to the multiple imaging composite policy and their respective
families are listed in Table 2 below.
While there are three imaging families, there are five multiple
imaging composite APCs due to the statutory requirement under section
1833(t)(2)(G) of the Act that we differentiate payment for OPPS imaging
services provided with and without contrast. While the ultrasound
procedures included under the policy do not involve contrast, both CT/
CTA and MRI/MRA scans can be provided either with or without contrast.
The five multiple imaging composite APCs established in CY 2009 are:
APC 8004 (Ultrasound Composite);
APC 8005 (CT and CTA without Contrast Composite);
APC 8006 (CT and CTA with Contrast Composite);
APC 8007 (MRI and MRA without Contrast Composite); and
APC 8008 (MRI and MRA with Contrast Composite).
We define the single imaging session for the ``with contrast''
composite APCs as having at least one or more imaging procedures from
the same family performed with contrast on the same date of service.
For example, if the hospital performs an MRI without contrast during
the same session as at least one other MRI with contrast, the hospital
will receive payment based on the payment rate for APC 8008, the ``with
contrast'' composite APC.
We make a single payment for those imaging procedures that qualify
for payment based on the composite APC payment rate, which includes any
packaged services furnished on the same date of service. The standard
(noncomposite) APC assignments continue to apply for single imaging
procedures and multiple imaging
[[Page 42036]]
procedures performed across families. For a full discussion of the
development of the multiple imaging composite APC methodology, we refer
readers to the CY 2009 OPPS/ASC final rule with comment period (73 FR
68559 through 68569).
For CY 2022, we propose to continue to pay for all multiple imaging
procedures within an imaging family performed on the same date of
service using the multiple imaging composite APC payment methodology.
We continue to believe that this policy would reflect and promote the
efficiencies hospitals can achieve when performing multiple imaging
procedures during a single session.
For CY 2022, except where otherwise indicated, we propose to use
the costs derived from CY 2019 claims data to set the proposed CY 2022
payment rates. Therefore, for CY 2022, the payment rates for the five
multiple imaging composite APCs (APCs 8004, 8005, 8006, 8007, and 8008)
are based on proposed geometric mean costs calculated from CY 2019
claims available for this CY 2022 OPPS/ASC proposed rule that qualified
for composite payment under the current policy (that is, those claims
reporting more than one procedure within the same family on a single
date of service). To calculate the proposed geometric mean costs, we
used the same methodology that we have used to calculate the geometric
mean costs for these composite APCs since CY 2014, as described in the
CY 2014 OPPS/ASC final rule with comment period (78 FR 74918). The
imaging HCPCS codes referred to as ``overlap bypass codes'' that we
removed from the bypass list for purposes of calculating the proposed
multiple imaging composite APC geometric mean costs, in accordance with
our established methodology as stated in the CY 2014 OPPS/ASC final
rule with comment period (78 FR 74918), are identified by asterisks in
Addendum N to this CY 2022 OPPS/ASC proposed rule (which is available
via the internet on the CMS website) and are discussed in more detail
in section II.A.1.b. of this CY 2022 OPPS/ASC proposed rule.
For this CY 2022 OPPS/ASC proposed rule, we were able to identify
approximately 1.04 million ``single session'' claims out of an
estimated 2.2 million potential claims for payment through composite
APCs from our ratesetting claims data, which represents approximately
47 percent of all eligible claims, to calculate the proposed CY 2022
geometric mean costs for the multiple imaging composite APCs. Table 2
of this CY 2022 OPPS/ASC proposed rule lists the proposed HCPCS codes
that would be subject to the multiple imaging composite APC policy and
their respective families and approximate composite APC proposed
geometric mean costs for CY 2022.
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3. Proposed Changes to Packaged Items and Services
a. Background and Rationale for Packaging in the OPPS
Like other prospective payment systems, the OPPS relies on the
concept of averaging to establish a payment rate for services. The
payment may be more or less than the estimated cost of providing a
specific service or a bundle of specific services for a particular
beneficiary. The OPPS packages payments for multiple interrelated items
and services into a single payment to create incentives for hospitals
to furnish services most efficiently and to manage their resources with
maximum flexibility. Our packaging policies support our strategic goal
of using larger payment bundles in the OPPS to maximize hospitals'
incentives to provide care in the most efficient manner. For example,
where there are a variety of devices, drugs, items, and supplies that
could be used to furnish a service, some of which are more costly than
others, packaging encourages hospitals to use the most cost efficient
item that meets the patient's needs, rather than to routinely use a
more expensive item, which may occur if separate payment is provided
for the item.
Packaging also encourages hospitals to effectively negotiate with
manufacturers and suppliers to reduce the purchase price of items and
services
[[Page 42041]]
or to explore alternative group purchasing arrangements, thereby
encouraging the most economical health care delivery. Similarly,
packaging encourages hospitals to establish protocols that ensure that
necessary services are furnished, while scrutinizing the services
ordered by practitioners to maximize the efficient use of hospital
resources. Packaging payments into larger payment bundles promotes the
predictability and accuracy of payment for services over time. Finally,
packaging may reduce the importance of refining service-specific
payment because packaged payments include costs associated with higher
cost cases requiring many ancillary items and services and lower cost
cases requiring fewer ancillary items and services. Because packaging
encourages efficiency and is an essential component of a prospective
payment system, packaging payments for items and services that are
typically integral, ancillary, supportive, dependent, or adjunctive to
a primary service has been a fundamental part of the OPPS since its
implementation in August 2000. For an extensive discussion of the
history and background of the OPPS packaging policy, we refer readers
to the CY 2000 OPPS final rule (65 FR 18434), the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66580), the CY 2014 OPPS/ASC
final rule with comment period (78 FR 74925), the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66817), the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70343), the CY 2017 OPPS/ASC
final rule with comment period (81 FR 79592), the CY 2018 OPPS/ASC
final rule with comment period (82 FR 59250), the CY 2019 OPPS/ASC
final rule with comment period (83 FR 58854), the CY 2020 OPPS/ASC
final rule with comment period (84 FR 61173), and the CY 2021 OPPS/ASC
final rule with comment period (85 FR 85894). As we continue to develop
larger payment groups that more broadly reflect services provided in an
encounter or episode of care, we have expanded the OPPS packaging
policies. Most, but not necessarily all, categories of items and
services currently packaged in the OPPS are listed in 42 CFR 419.2(b).
Our overarching goal is to make payments for all services under the
OPPS more consistent with those of a prospective payment system and
less like those of a per-service fee schedule, which pays separately
for each coded item. As a part of this effort, we have continued to
examine the payment for items and services provided under the OPPS to
determine which OPPS services can be packaged to further achieve the
objective of advancing the OPPS toward a more prospective payment
system.
For CY 2022, we examined the items and services currently provided
under the OPPS, reviewing categories of integral, ancillary,
supportive, dependent, or adjunctive items and services for which we
believe payment would be appropriately packaged into payment for the
primary service that they support. Specifically, we examined the HCPCS
code definitions (including CPT code descriptors) and hospital
outpatient department billing patterns to determine whether there were
categories of codes for which packaging would be appropriate according
to existing OPPS packaging policies or a logical expansion of those
existing OPPS packaging policies.
For CY 2022, we propose no changes to the overall packaging policy
previously discussed. We propose to continue to conditionally package
the costs of selected newly identified ancillary services into payment
for a primary service where we believe that the packaged item or
service is integral, ancillary, supportive, dependent, or adjunctive to
the provision of care that was reported by the primary service HCPCS
code. Below we discuss a proposed change to an ASC payment system
packaging policy for CY 2022 and solicit comment on potential
additional changes to that policy and application of that policy to the
OPPS.
b. Proposed Payment Policy for Non-Opioid Pain Management Drugs and
Biologicals That Function as Surgical Supplies Under the ASC Payment
System
(1) Background on OPPS/ASC Non-Opioid Pain Management Packaging
Policies
In the CY 2018 OPPS/ASC proposed rule (82 FR 33588), within the
framework of existing packaging categories, such as drugs that function
as supplies in a surgical procedure or diagnostic test or procedure, we
requested stakeholder feedback on common clinical scenarios involving
currently packaged items and services described by HCPCS codes that
stakeholders believe should not be packaged under the OPPS. We also
expressed interest in stakeholder feedback on common clinical scenarios
involving separately payable HCPCS codes for which payment would be
most appropriately packaged under the OPPS. Commenters who responded to
the CY 2018 OPPS/ASC proposed rule expressed a variety of views on
packaging under the OPPS. While several commenters were in support of
maintaining packaging policies, most of the public comments ranged from
requests to unpackage most items and services that are unconditionally
packaged under the OPPS, including drugs and devices, to specific
requests for separate payment for a particular drug or device.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
52485), we reiterated our position with regard to payment for
Exparel[supreg], a non-opioid analgesic that functions as a surgical
supply, stating that we believed that payment for this drug is
appropriately packaged with the primary surgical procedure. We also
stated in the CY 2018 OPPS/ASC final rule with comment period that we
would continue to explore and evaluate packaging policies under the
OPPS and consider these policies in future rulemaking.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR
58855), we explained that, in addition to stakeholder feedback
regarding OPPS packaging policies, the President's Commission on
Combating Drug Addiction and the Opioid Crisis (the Commission)\1\ had
recently recommended that CMS examine payment policies for certain
drugs that function as a supply, specifically non-opioid pain
management treatments. The Commission was established in 2017 to study
the scope and effectiveness of the Federal response to drug addiction
and the opioid crisis and to make recommendations to the President for
improving the Federal response to the crisis. The Commission's report
included a recommendation for CMS to ``. . . review and modify
ratesetting policies that discourage the use of non-opioid treatments
for pain, such as certain bundled payments that make alternative
treatment options cost prohibitive for hospitals and doctors,
particularly those options for treating immediate postsurgical pain. .
. .'' We explained that, as discussed in the CY 2019 OPPS/ASC proposed
rule (83 FR 37068 through 37071), in response to stakeholder comments
on the CY 2018 OPPS/ASC proposed rule and in light of the
recommendations regarding payment policies for certain drugs, we had
recently evaluated the impact of our packaging policy for drugs that
function as a supply when used in a surgical
[[Page 42042]]
procedure on the utilization of these drugs in both the hospital
outpatient department and the ASC setting. We stated that, although we
found increases in utilization of Exparel when it was paid under the
OPPS, we noticed decreased utilization of Exparel under the ASC payment
system. Accordingly, in the CY 2019 OPPS/ASC final rule with comment
period (83 FR 58855 through 58860), we finalized a policy to unpackage
and pay separately at ASP plus 6 percent for non-opioid pain management
drugs that function as surgical supplies when they are furnished in the
ASC setting for CY 2019, due to decreased utilization in the ASC
setting. Historically, we stated that we consider all items related to
the surgical outcome and provided during the hospital stay in which the
surgery is performed, including postsurgical pain management drugs, to
be part of the surgery for purposes of our drug and biological surgical
supply packaging policy (79 FR 66875).
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On October 24, 2018, the Substance Use-Disorder Prevention that
Promotes Opioid Recovery and Treatment for Patients and Communities
(SUPPORT) Act (Pub. L. 115-271) was enacted. Section 1833(t)(22)(A)(i)
of the Act, as added by section 6082(a) of the SUPPORT Act, states that
the Secretary must review payments under the OPPS for opioids and
evidence-based non-opioid alternatives for pain management (including
drugs and devices, nerve blocks, surgical injections, and
neuromodulation) with a goal of ensuring that there are not financial
incentives to use opioids instead of non-opioid alternatives. As part
of this review, under section 1833(t)(22)(A)(iii) of the Act, the
Secretary must consider the extent to which revisions to such payments
(such as the creation of additional groups of covered OPD services to
separately classify those procedures that utilize opioids and non-
opioid alternatives for pain management) would reduce the payment
incentives for using opioids instead of non-opioid alternatives for
pain management. In conducting this review and considering any
revisions, the Secretary must focus on covered OPD services (or groups
of services) assigned to C-APCs, APCs that include surgical services,
or services determined by the Secretary that generally involve
treatment for pain management. If the Secretary identifies revisions to
payments pursuant to section 1833(t)(22)(A)(iii) of the Act, section
1833(t)(22)(C) of the Act requires the Secretary to, as determined
appropriate, begin making revisions for services furnished on or after
January 1, 2020. Revisions under this paragraph are required to be
treated as adjustments for purposes of paragraph (9)(B), which requires
any adjustments to be made in a budget neutral manner. Section
1833(i)(8), as added by section 6082(b) of the SUPPORT Act, requires
the Secretary to conduct a similar type of review as required for the
OPPS and to make revisions to the ASC payment system in an appropriate
manner, as determined by the Secretary.
For the CY 2020 OPPS/ASC proposed rule (84 FR 39423 through 39427),
as required by section 1833(t)(22)(A)(i) of the Act, we reviewed
payments under the OPPS for opioids and evidence-based non-opioid
alternatives for pain management (including drugs and devices, nerve
blocks, surgical injections, and neuromodulation) with a goal of
ensuring that there are not financial incentives to use opioids instead
of non-opioid alternatives. We used currently available data to analyze
the payment and utilization patterns associated with specific non-
opioid alternatives, including drugs that function as a supply, nerve
blocks, and neuromodulation products, to determine whether our
packaging policies may have reduced the use of non-opioid alternatives.
For the CY 2020 OPPS/ASC proposed rule (84 FR 39423 through 39427), we
proposed to continue our policy to pay separately at ASP plus 6 percent
for non-opioid pain management drugs that function as surgical supplies
in the performance of surgical procedures when they are furnished in
the ASC setting and to continue to package payment for non-opioid pain
management drugs that function as surgical supplies in the performance
of surgical procedures in the hospital outpatient department setting
for CY 2020. In the CY 2020 OPPS/ASC final rule with comment period (84
FR 61173 through 61180), after reviewing data from stakeholders and
Medicare claims data, we did not find compelling evidence to suggest
that revisions to our OPPS payment policies for non-opioid pain
management alternatives were necessary for CY 2020. We finalized our
proposal to continue to unpackage and pay separately at ASP plus 6
percent for non-opioid pain management drugs that function as surgical
supplies when furnished in the ASC setting for CY 2020. Under this
policy, for CY 2020, the only drug that qualified for separate payment
in the ASC setting as a non-opioid pain management drug that functions
as a surgical supply was Exparel.
In the CY 2021 OPPS/ASC final rule with comment period (85 FR 85896
to 85899), we continued the policy to pay separately at ASP plus 6
percent for non-opioid pain management drugs that function as surgical
supplies in the performance of surgical procedures when they are
furnished in the ASC setting and to continue to package payment for
non-opioid pain management drugs that function as surgical supplies in
the performance of surgical procedures in the hospital outpatient
department setting for CY 2021. For CY 2021, only two drug products met
the criteria as non-opioid pain management drugs that function as
surgical supplies in the ASC setting, and thus receive separate payment
under the ASC payment system. These drugs are Exparel and Omidria.
(2) CY 2022 Evaluation of Payments for Opioids and Non-Opioid
Alternatives for Pain Management and Comment Solicitation on Extending
the Policy to the OPPS
As noted in the background above, over the past several years we
have reviewed non-opioid alternatives and evaluated the impact of our
packaging policies on access to these products. In our previous
evaluations, we used currently available data to analyze the payment
and utilization patterns associated with specific non-opioid
alternatives, including drugs that function as a supply, nerve blocks,
and neuromodulation products, to determine whether our packaging
policies may have reduced the use of non-opioid alternatives. In the CY
2021 OPPS/ASC final rule with comment period (85 FR 85896 to 85899), we
stated that we would continue to analyze the issue of access to non-
opioid pain management alternatives in the HOPD and the ASC settings as
part of any reviews we conduct under section 1833(t)(22)(A)(ii), with a
specific focus on whether there is evidence that our current payment
policies are creating access barriers for other non-opioid pain
management alternatives for which there is evidence-based support that
these products help to deter or avoid prescription opioid use and
opioid use disorder.
For CY 2022, we conducted a subsequent review of payments for
opioids and non-opioid alternatives as authorized by section
1833(t)(22)(A)(ii). We analyzed utilization patterns in both the HOPD
and ASC settings for multiple non-opioid pain management drugs,
including the two drugs that are receiving separate payment when
furnished in the ASC setting under our current policy for CY 2021:
Exparel and Omidria. The results of our CY 2022 review were similar to
the results of our
[[Page 42043]]
reviews in previous years. Generally, utilization of non-opioid pain
management drugs continued to increase year after year in the HOPD
setting, where payment for these non-opioid alternatives is packaged
with the payment for the associated surgical procedure. In the ASC
setting, where Exparel and Omidria are separately paid, we also saw
utilization increases for these two drugs. However, in the ASC setting,
the rate of increase in utilization is much more substantial than in
the HOPD setting. In particular, in the HOPD setting where payment for
Exparel is packaged, utilization of Exparel increased from 19.7 million
units in 2019 to 21.8 million units in 2020, whereas utilization of
Exparel increased from 1.5 million units in 2019 to 3.3 million units
in 2020 in the ASC setting, where Exparel is separately paid. We note
that a number of reasons could explain this discrepancy other than our
policy to pay separately for Exparel under the ASC payment system,
including evolving clinical practice in the ASC setting, which could
increase the number of surgeries performed in ASCs for which Exparel is
an appropriate pain management drug.
We have consistently explained, including as recently as in the CY
2021 OPPS/ASC final rule with comment period (85 FR 85894), that our
packaging policies support our strategic goal of using larger payment
bundles in the OPPS to maximize hospitals' incentives to provide care
in the most efficient manner. For example, where there are a variety of
devices, drugs, items, and supplies that could be used to furnish a
service, some of which are more costly than others, packaging
encourages hospitals to use the most cost-efficient item that meets the
patient's needs, rather than to routinely use a more expensive item,
which may occur if separate payment is provided for the item. We have
not found conclusive evidence to support the notion that the OPPS
packaging policy, under which non-opioid drugs and biologicals are
packaged when they function as a supply in a surgical procedure, has
created financial incentives to use opioids instead of evidence-based
non-opioid alternatives for pain management. For example, we have not
observed decreased utilization of non-opioid alternatives for pain
management in the HOPD setting. Therefore, for CY 2022, we are
proposing to continue to package payment for non-opioid pain management
drugs that function as surgical supplies in the performance of surgical
procedures in the hospital outpatient department setting.
As explained earlier in this section, while packaging encourages
efficiency and is a fundamental component of a prospective payment
system, where there is an overriding policy objective to reduce
disincentives for use of non-opioid products to the extent possible, we
believe it may be appropriate to establish payment that reduces
disincentives for use of non-opioid drugs and biologicals for pain
management when there is evidence that use of those products reduces
unnecessary opioid use. For these reasons, we are soliciting comment as
to whether we should expand our current policy that only applies in the
ASC setting--to pay separately at ASP plus 6 percent for non-opioid
pain management drugs that function as surgical supplies in the
performance of surgical procedures when they are furnished in the ASC
setting--to the HOPD setting. We are interested in learning from
stakeholders whether similar disincentives for the use of non-opioid
pain management drugs and biologicals identified in the ASC setting
exist in the HOPD setting. Previously, in the CY 2019 OPPS/ASC final
rule with comment period (83 FR 59067), we identified several
disincentives that were unique to the ASC setting compared to the HOPD
setting, including the fact that ASCs tend to provide specialized care
and a more limited range of services in comparison to hospital
outpatient departments. Also, ASCs are paid, in aggregate,
approximately 55 percent of the OPPS rate. Therefore, fluctuations in
payment rates for specific services may affect these providers more
acutely than hospital outpatient departments; and ASCs may be less
likely to choose to furnish non-opioid postsurgical pain management
treatments, which are typically more expensive than opioids, as a
result. Additionally, we are seeking comment on what evidence supports
the expansion of this policy to the HOPD setting, including the
clinical benefit that Medicare beneficiaries may receive from the
availability of separate or modified payment for these products in the
HOPD setting.
Finally, we are seeking comment on if we should treat products the
same depending on the setting, ASC or HOPD. For example, we are seeking
comment on whether products should have the same eligibility
requirements to qualify for revised payment in the ASC and the HOPD
settings. We are additionally seeking comment on how the additional
comment solicitations described below, which refer to the ASC setting,
could also be applied to the HOPD setting.
(3) Proposed Criteria for Eligibility for Separate Payment Under the
ASC Payment System for Non-Opioid Pain Management Drugs and Biologicals
That Function as Surgical Supplies
As described in section 1833(t)(22)(A)(i) of the Act, the Secretary
shall conduct a review of payments for opioids and evidence-based non-
opioid alternatives for pain management with a goal of ensuring that
there are not financial incentives to use opioids instead of non-opioid
alternatives. In any future reviews the Secretary may determine
appropriate to conduct under section 1833(t)(22)(A)(ii) of the Act, we
believe it is important to establish the evidence-base for non-opioid
alternatives for pain management when evaluating whether current
payment policies result in an incentive for providers to use opioids
instead of such evidence-based non-opioid alternatives for pain
management. Accordingly, for CY 2022 and subsequent years, we are
proposing two criteria that non-opioid pain management drugs and
biologicals would be required to meet to be eligible for a payment
revision under the ASC payment system in accordance with section
1833(t)(22)(C). The proposed criteria are intended to identify non-
opioid pain management drugs and biologicals that function as supplies
in surgical procedures for which revised payment under the ASC payment
system would be appropriate.
Specifically, for CY 2022, we are proposing the following criteria
that non-opioid pain management drugs and biologicals would be required
to meet to be eligible for separate payment under the ASC payment
system in accordance with section 1833(t)(22)(C):
Criterion 1: FDA Approval and Indication for Pain Management or
Analgesia
We propose that the drug or biological product must be safe and
effective, as determined by the FDA. We propose that the drug must be
approved under a new drug application under section 505(c) of the
Federal Food, Drug, and Cosmetic Act (FDCA), generic drug application
under an abbreviated new drug application under section 505(j), or, in
the case of a biological product, be licensed under section 351 of the
Public Health Service Act. We further propose that the drug or
biological must also have an FDA-approved indication for pain
management or analgesia. We believe FDA approval is an appropriate
requirement for a drug or biological to
[[Page 42044]]
be eligible for this policy because the FDA reviews drugs and
biologicals for safety and effectiveness, which would allow us to
identify safe and effective non-opioid products to which this separate
payment policy should apply. Given that the FDA has an existing and
detailed review process already in place to review drugs and
biologicals, we believe it would be appropriate and administratively
efficient to utilize FDA approval as a requirement to ensure that the
drugs and biologicals approved under this policy are generally safe and
effective for beneficiaries. We believe the vast majority of drugs and
biologicals on the market have undergone FDA review and approval, and
we do not anticipate this criterion would prevent otherwise eligible
drugs or biologicals from qualifying. In addition, section
1833(t)(22)(C) of the Act, our current policy, and our proposed policy
all focus on pain management products. Specifically, section
1833(t)(22)(C) of the Act refers to reviews of opioid and evidence-
based non opioid products for pain management. Therefore, we propose to
require an FDA-approved indication for pain management or analgesia for
a drug or biological to qualify as a pain management product. The FDA
approval process would allow us to confirm that a drug or biological
is, in fact, a non-opioid. Drugs and biologicals that are approved as
opioids or opioid agonists, or that receive an opioid-related approval
from the FDA would not be eligible for separate payment under this
policy.
Criterion 2: Cost of the Product
Currently, under the OPPS, drugs that are not policy-packaged are
subject to the drug packaging threshold. In accordance with section
1833(t)(16)(B) of the Act, the threshold for establishing separate APCs
for payment of drugs and biologicals was set at $50 per administration
during CYs 2005 and 2006. We set the packaging threshold for
establishing separate APCs for drugs and biologicals through annual
notice and comment rulemaking. (Please see section V.B.1.a. of this
proposed rule for additional details on the drug packaging threshold
policy). The proposed per-day drug packaging threshold for CY 2022 is
$130.
As our second criterion, we are proposing that a drug or biological
would only be eligible for a payment revision under the ASC payment
system in accordance with section 1833(t)(22)(C) if its per-day cost
exceeds the drug packaging threshold described in section V.B.1.a. of
this rule. We believe this is an appropriate requirement because we
believe that not all non-opioid alternative treatments are equally
disincentivized by our packaging policies. In particular, the cost of
non-opioid drugs and biologicals below the packaging threshold of $130
per day does not generally have a significant impact on the overall
procedure costs, and we believe use of these drugs and biologicals is
unlikely to be disincentivized by CMS packaging policies. However, when
the per-day cost of the drug is above the drug packaging threshold, the
cost of these drugs or biologicals generally has a significant impact
on the overall procedure costs. Section 1833(t)(22)(A)(i) of the Act
discusses financial incentives to use opioids instead of non-opioid
alternative treatments. As such, we do not believe non-opioid pain
management drugs that are lower in cost are generally disincentivized
by our packaging policies, as their cost is more easily absorbed into
the payment for the primary procedure in which they are used when
compared to drugs and biologicals above the threshold. We are proposing
to use the existing OPPS drug packaging threshold as it is familiar to
stakeholders and its application to drugs and biologicals under this
policy creates uniformity across the OPPS and ASC payment systems.
Therefore, CMS is proposing that drugs and biologicals would be
required to have a per-day cost that exceeds the drug packaging
threshold that CMS sets annually through notice and comment rulemaking.
We also believe the use of this threshold as an eligibility
criterion for drugs under consideration for a payment revision under
this policy is appropriate, as it conforms with the broader goals of
the OPPS and ASC payment systems. Like other prospective payment
systems, the OPPS relies on the concept of averaging to establish a
payment rate for services. The payment may be more or less than the
estimated cost of providing a specific service or a bundle of specific
services for a particular beneficiary. The OPPS packages payments for
multiple interrelated items and services into a single payment to
create incentives for hospitals to furnish services most efficiently
and to manage their resources with maximum flexibility. Our packaging
policies, including the drug packaging threshold, support our strategic
goal of using larger payment bundles to maximize hospitals' incentives
to provide care in the most efficient manner. Packaging payments into
larger payment bundles promotes the predictability and accuracy of
payment for services over time. For the reasons mentioned above, we
believe it to be appropriate to package drugs under consideration for
this policy which fall below the OPPS drug packaging threshold.
We propose that non-opioid drugs and biologicals currently
receiving transitional drug pass-through status in the OPPS would not
be candidates for this policy as they are already paid separately under
the OPPS and ASC payment system. Please see section V.A., Proposed OPPS
Transitional Pass-Through Payment for Additional Costs of Drugs,
Biologicals, and Radiopharmaceuticals, of this proposed rule for
additional details on transitional pass-through payments for drugs and
biologicals. We propose that once transitional drug pass-through status
expires, the non-opioid drug or biological may qualify for separate
payment under the ASC payment system if it meets the proposed
eligibility requirements.
We seek comment on whether there are any other non-opioid drug or
biological products that would meet the proposed criteria if finalized.
(4) Proposed Regulation Text Changes
We propose to codify our proposed criteria for separate payment for
qualifying non-opioid pain management drugs and biologicals that
function as surgical supplies in the regulation text for the ASC
payment system in a new Sec. 416.174. In particular, we propose to
provide in a new Sec. 416.174(a)(1) that non-opioid pain management
drugs or biologicals that function as a supply in a surgical procedure
are eligible for separate payment if they are approved under a new drug
application under section 505(c) of the Federal Food, Drug, and
Cosmetic Act (FDCA), generic drug application under an abbreviated new
drug application under section 505(j), or, in the case of a biological
product, are licensed under section 351 of the Public Health Service
Act. Section 416.174(a)(1) would also provide that the drug or
biological must have an FDA-approved indication for pain management or
analgesia. New Sec. 416.174(a)(2) would require that the per-day cost
of the drug or biological must exceed the OPPS drug packaging threshold
set annually through notice and comment rulemaking.
We also propose to amend Sec. 416.164(b)(6) to provide that non-
opioid pain management drugs and biologicals that function as a supply
when used in a surgical procedure as determined by CMS under Sec.
416.174 are ancillary items that are integral to a
[[Page 42045]]
covered surgical procedure and for which separate payment is allowed.
We also propose to amend Sec. 416.171(b)(1) to provide that the
payment rate for non-opioid pain management drugs and biologicals that
function as a supply when used in a surgical procedure as determined by
CMS under Sec. 416.174 are paid an amount derived from the payment
rate for the equivalent item or service under the OPPS, and if such a
payment amount is unavailable, are contractor priced.
(5) Eligibility for Separate Payment in CY 2022 for Exparel, Omidria,
and Other Non-Opioid Products for Pain Management
As discussed in the CY 2021 OPPS/ASC final rule with comment
period, there are two products receiving separate payment in the ASC
setting under our current policy to pay separately for non-opioid pain
management treatments that function as surgical supplies when furnished
in the ASC setting (85 FR 86171). These two products are Exparel (HCPCS
Code C9290, Injection, bupivacaine liposome, 1 mg) and Omidria (HCPCS
Code J1097, phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml
ophthalmic irrigation solution, 1 ml). Based on the current information
available to us, as we explain below, we are proposing that both
products would be eligible for separate payment in CY 2022 under our
proposed policy. We have included our initial evaluation of these two
products below.
(a) Eligibility for Separate Payment in CY 2022 for Exparel Under the
Proposed Eligibility Criteria
We are proposing that Exparel would continue to receive separate
payment in the ASC setting as a non-opioid pain management drug that
functions as a surgical supply for CY 2022. Based on CMS's internal
review, we believe Exparel meets criterion 1. Exparel was approved by
the FDA with a New Drug Application (NDA #022496) on 10/28/2011.\2\
Exparel's FDA-approved indication is ``in patients 6 years of age and
older for single-dose infiltration to produce postsurgical local
analgesia (1). In adults as an interscalene brachial plexus nerve block
to produce postsurgical regional analgesia''.\3\ No component of
Exparel is opioid-based. Accordingly, we propose that Exparel meets
criterion one.
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\2\ Exparel. FDA Letter. 28 October 2011. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022496s000ltr.pdf.
\3\ Exparel. FDA Package Insert. 22 March 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022496s035lbl.pdf.
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As discussed in section (3) above, for criterion two we are
proposing that a drug or biological would only be eligible for separate
payment under this policy if its per-day cost exceeds the drug
packaging threshold described in section V.B.1.a. of this rule. The
proposed per day cost threshold for CY 2022 is $130. Using the
methodology described at V.B.1.a., the per day cost of Exparel exceeds
the $130 per day cost threshold. Therefore, we propose that Exparel
meets criterion two.
Therefore, we are proposing that Exparel meets criteria one and
two, and should receive separate payment under the ASC payment system
for CY 2022.
(b) Eligibility for Separate Payment for Omidria in CY 2022 Under the
Proposed Eligibility Criteria
We are proposing that Omidria would continue to receive separate
payment in the ASC setting as a non-opioid pain management drug that
functions as a surgical supply for CY 2022. Based on our internal
review, we believe Omidria would meet criterion one. Omidria was
approved by the FDA with a New Drug Application (NDA #205388) on 5/30/
2014.\4\ Additionally, Omidria's FDA-approved indication is as ``an
alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase
inhibitor indicated for: Maintaining pupil size by preventing
intraoperative miosis; Reducing postoperative pain''.\5\ No component
of Omidria is opioid-based. Therefore, we propose that Omidria would
meet proposed criterion one.
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\4\ Omidria. FDA Letter. 30 May 2014. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205388Orig1s000ltr.pdf.
\5\ Omidria. FDA Package Insert. 08 December 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205388s006lbl.pdf.
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Using the methodology described at V.B.1.a., the per day cost of
Omidria exceeds the $130 per day cost threshold. Therefore, we propose
that Omidria meets criterion two. Therefore, we are proposing that
Omidria meets criteria one and two, and should receive separate payment
under the ASC payment system for CY 2022.
(6) Comment Solicitation on Policy Modifications and Potential
Additional Criteria for Revised Payment for Non-Opioid Pain Management
Treatments
In addition to the proposed eligibility criteria above, we are also
soliciting comment on potential policy modifications and additional
criteria that may help further align this policy with the intent of
section 1833(t)(22) of the Act. Below we discuss potential additional
criteria. We note that, depending on the public comments we receive and
our continued consideration of these potential criteria, we may adopt
these criteria as part of our final policy and include them in the
final regulation text; accordingly, we are providing substantial
details, explanations, and considerations about these potential
criteria. We welcome input from stakeholders on these and any
additional policy modifications or criteria they believe would enhance
our proposed policy. We are also soliciting comment on other barriers
to access to non-opioid pain management products that may exist, and to
what extent our policies under the OPPS or ASC payment system could be
modified to address these barriers.
(a) Utilization of the Product
We have historically used utilization as a metric to determine
whether a change in our payment policy was necessary to determine
whether our policies create a disincentive to use non-opioid
alternatives. For example, as previously discussed, Exparel's
decreasing utilization in the ASC setting caused us to propose to pay
separately for non-opioid pain management drugs that function as
surgical supplies in the ASC setting. We have used currently available
claims data in prior years to analyze the payment and utilization
patterns associated with specific non-opioid alternatives to determine
whether our packaging policies may have reduced the use of non-opioid
alternatives. We believe that higher utilization may be a potential
indicator that the packaged payment is not causing an access to care
issue and that the payment rate for the primary procedure adequately
reflects the cost of the drug or biological. We also believe decreased
utilization could potentially indicate that our packaging policy is
discouraging use of drug or biological and that providers are choosing
less expensive treatments. We note that it is difficult to attribute
product-specific changes in utilization to our packaging policies
alone. Nonetheless, while we acknowledge certain limitations of
utilization data, we believe analyzing utilization either on a product-
specific basis or on a broader basis could be an important criterion in
determining whether separate payment is warranted for a non-opioid pain
management alternative.
Therefore, we are soliciting comment on whether specific evidence
of reduced utilization should be part of our evaluation and
determination of whether a non-opioid pain management product should
qualify for modified
[[Page 42046]]
payment. This data may help to demonstrate that our packaging policies
are causing an access issue for these products. Additionally, we
realize that new products to the market may not have utilization data
available, or reliable utilization data may be difficult to obtain for
some products; therefore, we are also requesting comment on whether
utilization data requirements should vary based on the newness of a
product or its FDA marketing approval date.
(b) FDA Indication for Pain Management or Analgesia for the Drug or
Biological Product
As previously discussed, section 1833(t)(22)(A) of the Act
specifically refers to reviews of opioid and evidence-based non opioid
products for pain management. We believe the majority of drugs and
biologicals that would meet the requirements of our proposed policy
would already have FDA approval as a pain management drug or as an
analgesic. However, we acknowledge there may be other non-opioid
products that would benefit from inclusion under this policy, but do
not have a specific FDA-approved indication for pain management or
analgesia, and would not satisfy criterion 1. Therefore, we are
soliciting comment on whether we should allow certain FDA-approved
drugs and biologicals to be eligible for separate payment under this
policy without a specific FDA-approved indication for pain management
or as an analgesic drug. In lieu of an FDA indication for pain
management or analgesia, we are seeking comment on whether it would be
appropriate to approve a product for inclusion under this policy if the
pain-management or analgesia attributes of the drug or biological are
recognized by a medical compendium. Similarly, we are seeking comment
as to whether we should consider specialty society or national
organization (such as a national surgery organization) recommendations
of non-opioid pain management products that function as surgical
supplies and reduce opioid use in the ASC setting, as evidence that a
product meets criterion one, where a drug or biological does not have
an FDA indication for pain management or analgesia.
(c) Peer-Reviewed Literature Requirement Comment Solicitation
We note that section 1833(t)(22)(B) requires the Secretary to focus
on covered OPD services (or groups of services) assigned to a
comprehensive ambulatory payment classification, ambulatory payment
classifications that primarily include surgical services, and other
services determined by the Secretary that generally involve treatment
for pain management. We are also soliciting comment as to whether we
should only adopt a payment revision to drugs and biologicals that
function as surgical supplies in the ASC setting when those products
have evidence in peer reviewed literature supporting that the product
actually decreases opioid. We believe this may be appropriate to ensure
Medicare payment policies would not financially incentivize use of
opioids rather than evidence-based non-opioid alternative treatments,
as required by section 1833(t)(22)(A)(iii) of the Act. Specifically, we
are seeking comment as to whether the drug or biological's use in a
surgical procedure as a non-opioid pain management product should be
supported by peer-reviewed literature demonstrating a clinically
significant decrease in opioid usage compared to the standard of care,
and we are seeking comment on whether such decreases in opioid usage
should be sustained decreases that continue into the post-operative
period.
Additionally, we are seeking input from commenters as to what they
believe the requirements for peer-reviewed literature requirements
should be. For example, we are seeking stakeholder feedback as to
whether peer-reviewed literature should demonstrate that use of the
drug or biological results in at least one, or several, of the
following: Decreased post-operative opioid use following surgery;
decreased opioid misuse following surgery; or decreased opioid use
disorder and dependency following surgery.
Additionally, we ask stakeholders if specific thresholds are
necessary to determine whether these decreases are statistically and
clinically significant and whether the decreases should simply be
measured against placebo or the standard of care. We also request
information on how stakeholders would define the standard of care in
these circumstances. When evaluating literature, we would expect to
examine the study methods, sample size, limitations, possible conflicts
of interest, patient populations studied, and how the evidence supports
the conclusion that the product can serve as a non-opioid pain
management product and provide a clinically significant reduction in
opioid use that continues into the post-operative period. However, we
welcome input from stakeholders about additional aspects of these
studies that they believe CMS should focus on for this potential
criterion. Additionally, we would expect to use our discretion to
assess whether the submitted studies meet these criteria, as well as
for clinical applicability, literature integrity, and potential biases
in consultation with our clinical advisors.
In order to provide stakeholders with some examples of what
supporting evidence CMS may consider for this potential criterion, we
believe it would be helpful for CMS to receive literature demonstrating
that use of a non-opioid drug or biological results in a statistically
and clinically significant decreased day supply of outpatient opioids
prescribed after surgery discharge compared to the generally accepted
standard of care, or a statistically and clinically significant
decreased morphine milligram equivalents (MME) per opioid dose
prescribed after surgery discharge compared to the generally accepted
standard of care. We would consider the generally accepted standard of
care to include pain management therapy a patient would receive in the
absence of the non-opioid alternative, such as the use of localized
analgesia and/or an opioid. As previously discussed, we would then
expect the use of a non-opioid pain management drug or biological to
result in a decline in opioids used compared to the pain management
therapy a patient would receive in the absence of the non-opioid
alternative. We would expect this decline in opioids to include a
decreased number of opioids received by a patient intraoperatively,
post-operatively, and most significantly at discharge. We are
soliciting comment on additional examples or measures that would be
beneficial for CMS to take into consideration. Additionally, we are
seeking comment on whether we should require a specific objective
measure for this criterion. We also seek input on how to assess whether
changes are statistically and clinically significant. We request
comment on whether stakeholders believe evidence of statistical
significance should be sufficient, or whether stakeholders believe the
literature should also demonstrate clinically significant differences
between treatment groups as well.
(d) Alternative Payment Mechanisms for Non-Opioid Drugs and Biologicals
As previously discussed, for CY 2022, we are proposing to pay
separately at ASP plus 6 percent for non-opioid pain management drugs
and biologicals that function as surgical supplies in the performance
of surgical procedures when they are furnished in the ASC setting and
meet our other proposed
[[Page 42047]]
criteria. Section 1833(t)(22)(A)(iii) requires the Secretary to
consider the extent to which revisions payments (such as the creation
of additional groups of covered OPD services to classify separately
those procedures that utilize opioids and non-opioid alternatives for
pain management) would reduce payment incentives to use opioids instead
of non-opioid alternatives for pain management. Accordingly, separate
payment is not the only possible revision that may be appropriate. We
seek comment on additional payment mechanisms that may be appropriate
aside from separate payment. For instance, we request feedback from
stakeholders as to whether a single, flat add-on payment, or separate
APC assignment, for products or procedures that use a product that
meets eligibility criteria would be preferable to separate payment. We
note that any revisions the Secretary determines appropriate under
section 1833(t)(22)(C) must be applied in a budget neutral manner under
section 1833(t)(9)(B). We also seek input from stakeholders on any
other innovative payment mechanisms for eligible non-opioid drugs and
biologicals for pain management.
(e) Non-Drug Products
We are also interested in information on any non-opioid non-drug
products that function as surgical supplies commenters believe should
be eligible for separate payment under this policy. Although we have
not currently identified any non-opioid pain management non-drug
products that are disincentivized by CMS packaging policies based on
utilization data, we believe it is reasonable to assume that if
disincentives exist for the use of non-opioid pain management drugs and
biological products under the ASC payment system, they may also exist
for non-opioid, non-drug products under the ASC payment system. If this
is the case, we would like to address these disincentives given the
severity, and importance of combatting, the opioid epidemic, regardless
of whether the non-opioid product is a drug, biological, or non-drug
product. We remain interested as to whether there are any non-opioid,
non-drug products that may meet the proposed eligibility criteria and
should qualify for separate or modified payment as discussed in section
(d) above, in the ASC setting. Similarly, we are also seeking comment
on if there are unique qualities of non-drug products that would make
revised payment in the HOPD setting appropriate instead of, or in
addition to, the ASC setting.
We are also soliciting comment on whether it is appropriate to
require non-drug products to meet the same criteria being proposed for
drugs and biologicals. Additionally, we are seeking comment from
stakeholders on whether they believe it would be appropriate to create
a broad category for non-drug products, or if a more limited category,
such as for devices, would be appropriate. Specifically, we are seeking
comment on whether there is information in the FDA approval for devices
that would be an appropriate criterion to determine eligibility for
separate payment, similar to how we are proposing to require FDA
approval with an indication for pain management or analgesia for drugs
and biologicals. We are also seeking comment on whether, if the non-
drug product is a ``device'' as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act, the device should have received
FDA premarket approval, grant of a de novo request, 510(k) clearance or
meet an exemption from premarket review. We are soliciting comment on
all aspects of an extension of our current policy to include
appropriate products that are not drugs or biologicals.
We are also soliciting comment as to how peer-reviewed literature
and utilization claims data could be used as potential criteria for a
policy that would apply to non-drug products. Additionally, should a
payment revision be determined necessary, we are seeking comment on
appropriate payment mechanisms for non-opioid, non-drug products,
including assigning the non-drug product to its own APC to ensure that
the product is paid separately or establishing an add-on adjustment for
the cost of the non-drug product in addition to the payment for the APC
to which the non-drug product is assigned. Additionally, we seek
comment on whether it would be appropriate to subject non-drug products
to a cost threshold similar to the one we are proposing to apply to
drugs and biologicals.
4. Calculation of OPPS Scaled Payment Weights
We established a policy in the CY 2013 OPPS/ASC final rule with
comment period (77 FR 68283) of using geometric mean-based APC costs to
calculate relative payment weights under the OPPS. In the CY 2021 OPPS/
ASC final rule with comment period (85 FR 85902 through 85903), we
applied this policy and calculated the relative payment weights for
each APC for CY 2021 that were shown in Addenda A and B to that final
rule with comment period (which were made available via the internet on
the CMS website) using the APC costs discussed in sections II.A.1. and
II.A.2. of that final rule with comment period. For CY 2022, as we did
for CY 2021, we propose to continue to apply the policy established in
CY 2013 and calculate relative payment weights for each APC for CY 2022
using geometric mean-based APC costs.
For CY 2012 and CY 2013, outpatient clinic visits were assigned to
one of five levels of clinic visit APCs, with APC 0606 representing a
mid-level clinic visit. In the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75036 through 75043), we finalized a policy that created
alphanumeric HCPCS code G0463 (Hospital outpatient clinic visit for
assessment and management of a patient), representing any and all
clinic visits under the OPPS. HCPCS code G0463 was assigned to APC 0634
(Hospital Clinic Visits). We also finalized a policy to use CY 2012
claims data to develop the CY 2014 OPPS payment rates for HCPCS code
G0463 based on the total geometric mean cost of the levels one through
five CPT E/M codes for clinic visits previously recognized under the
OPPS (CPT codes 99201 through 99205 and 99211 through 99215). In
addition, we finalized a policy to no longer recognize a distinction
between new and established patient clinic visits.
For CY 2016, we deleted APC 0634 and reassigned the outpatient
clinic visit HCPCS code G0463 to APC 5012 (Level 2 Examinations and
Related Services) (80 FR 70372). For CY 2022, as we did for CY 2021, we
propose to continue to standardize all of the relative payment weights
to APC 5012. We believe that standardizing relative payment weights to
the geometric mean of the APC to which HCPCS code G0463 is assigned
maintains consistency in calculating unscaled weights that represent
the cost of some of the most frequently provided OPPS services. For CY
2022, as we did for CY 2021, we propose to assign APC 5012 a relative
payment weight of 1.00 and to divide the geometric mean cost of each
APC by the geometric mean cost for APC 5012 to derive the unscaled
relative payment weight for each APC. The choice of the APC on which to
standardize the relative payment weights does not affect payments made
under the OPPS because we scale the weights for budget neutrality.
We note that in the CY 2019 OPPS/ASC final rule with comment period
(83 FR 59004 through 59015) and the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61365 through 61369), we discuss our policy,
implemented on January 1, 2019, to
[[Page 42048]]
control for unnecessary increases in the volume of covered outpatient
department services by paying for clinic visits furnished at excepted
off-campus provider-based department (PBD) at a reduced rate. While the
volume associated with these visits is included in the impact model,
and thus used in calculating the weight scalar, the policy has a
negligible effect on the scalar. Specifically, under this policy, there
is no change to the relativity of the OPPS payment weights because the
adjustment is made at the payment level rather than in the cost
modeling. Further, under this policy, the savings that result from the
change in payments for these clinic visits are not budget neutral.
Therefore, the impact of this policy will generally not be reflected in
the budget neutrality adjustments, whether the adjustment is to the
OPPS relative weights or to the OPPS conversion factor. For a full
discussion of this policy, we refer readers to the CY 2020 OPPS/ASC
final rule with comment period (84 FR 61142).
Section 1833(t)(9)(B) of the Act requires that APC reclassification
and recalibration changes, wage index changes, and other adjustments be
made in a budget neutral manner. Budget neutrality ensures that the
estimated aggregate weight under the OPPS for CY 2022 is neither
greater than nor less than the estimated aggregate weight that would
have been calculated without the changes. To comply with this
requirement concerning the APC changes, we propose to compare the
estimated aggregate weight using the CY 2021 scaled relative payment
weights to the estimated aggregate weight using the proposed CY 2022
unscaled relative payment weights.
For CY 2021, we multiplied the CY 2021 scaled APC relative payment
weight applicable to a service paid under the OPPS by the volume of
that service from CY 2019 claims to calculate the total relative
payment weight for each service. We then added together the total
relative payment weight for each of these services in order to
calculate an estimated aggregate weight for the year. For CY 2022, we
propose to apply the same process using the estimated CY 2022 unscaled
relative payment weights rather than scaled relative payment weights.
We propose to calculate the weight scalar by dividing the CY 2021
estimated aggregate weight by the unscaled CY 2022 estimated aggregate
weight.
For a detailed discussion of the weight scalar calculation, we
refer readers to the OPPS claims accounting document available on the
CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Click on the CY 2022 OPPS
proposed rule link and open the claims accounting document link at the
bottom of the page.
We propose to compare the estimated unscaled relative payment
weights in CY 2022 to the estimated total relative payment weights in
CY 2021 using CY 2019 claims data, holding all other components of the
payment system constant to isolate changes in total weight. Based on
this comparison, we propose to adjust the calculated CY 2022 unscaled
relative payment weights for purposes of budget neutrality. We propose
to adjust the estimated CY 2022 unscaled relative payment weights by
multiplying them by a proposed weight scalar of 1.4436 to ensure that
the proposed CY 2022 relative payment weights are scaled to be budget
neutral. The proposed CY 2022 relative payment weights listed in
Addenda A and B to this proposed rule (which are available via the
internet on the CMS website) are scaled and incorporate the
recalibration adjustments discussed in sections II.A.1. and II.A.2. of
this proposed rule.
Section 1833(t)(14) of the Act provides the payment rates for
certain SCODs. Section 1833(t)(14)(H) of the Act provides that
additional expenditures resulting from this paragraph shall not be
taken into account in establishing the conversion factor, weighting,
and other adjustment factors for 2004 and 2005 under paragraph (9), but
shall be taken into account for subsequent years. Therefore, the cost
of those SCODs (as discussed in section V.B.2. of proposed rule) is
included in the budget neutrality calculations for the CY 2022 OPPS.
B. Proposed Conversion Factor Update
Section 1833(t)(3)(C)(ii) of the Act requires the Secretary to
update the conversion factor used to determine the payment rates under
the OPPS on an annual basis by applying the OPD fee schedule increase
factor. For purposes of section 1833(t)(3)(C)(iv) of the Act, subject
to sections 1833(t)(17) and 1833(t)(3)(F) of the Act, the OPD fee
schedule increase factor is equal to the hospital inpatient market
basket percentage increase applicable to hospital discharges under
section 1886(b)(3)(B)(iii) of the Act. In the FY 2022 IPPS/LTCH PPS
proposed rule (86 FR 25435), consistent with current law, based on IHS
Global, Inc.'s fourth quarter 2020 forecast of the FY 2022 market
basket increase, the proposed FY 2022 IPPS market basket update was 2.5
percent.
Specifically, section 1833(t)(3)(F)(i) of the Act requires that,
for 2012 and subsequent years, the OPD fee schedule increase factor
under subparagraph (C)(iv) be reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. Section
1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment as
equal to the 10-year moving average of changes in annual economy-wide,
private nonfarm business multifactor productivity (MFP) (as projected
by the Secretary for the 10-year period ending with the applicable
fiscal year, year, cost reporting period, or other annual period) (the
``MFP adjustment''). In the FY 2012 IPPS/LTCH PPS final rule (76 FR
51689 through 51692), we finalized our methodology for calculating and
applying the MFP adjustment, and then revised this methodology, as
discussed in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49509). In the
FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25435), the proposed MFP
adjustment for FY 2022 was 0.2 percentage point.
Therefore, we propose that the MFP adjustment for the CY 2022 OPPS
is 0.2 percentage point. We also propose that if more recent data
become subsequently available after the publication of this proposed
rule (for example, a more recent estimate of the market basket increase
and/or the MFP adjustment), we will use such updated data, if
appropriate, to determine the CY 2022 market basket update and the MFP
adjustment, which are components in calculating the OPD fee schedule
increase factor under sections 1833(t)(3)(C)(iv) and 1833(t)(3)(F) of
the Act, in the CY 2022 OPPS/ASC final rule.
We note that section 1833(t)(3)(F) of the Act provides that
application of this subparagraph may result in the OPD fee schedule
increase factor under section 1833(t)(3)(C)(iv) of the Act being less
than 0.0 percent for a year, and may result in OPPS payment rates being
less than rates for the preceding year. As described in further detail
below, we propose for CY 2022 an OPD fee schedule increase factor of
2.3 percent for the CY 2022 OPPS (which is the proposed estimate of the
hospital inpatient market basket percentage increase of 2.5 percent,
less the proposed 0.2 percentage point MFP adjustment).
We propose that hospitals that fail to meet the Hospital OQR
Program reporting requirements would be subject to an additional
reduction of 2.0 percentage points from the OPD fee schedule increase
factor adjustment to the conversion factor that would be used to
calculate the OPPS payment
[[Page 42049]]
rates for their services, as required by section 1833(t)(17) of the
Act. For further discussion of the Hospital OQR Program, we refer
readers to section XIV. of the proposed rule.
To set the OPPS conversion factor for 2022, we propose to increase
the CY 2021 conversion factor of $82.797 by 2.3 percent. In accordance
with section 1833(t)(9)(B) of the Act, we propose further to adjust the
conversion factor for CY 2022 to ensure that any revisions made to the
wage index and rural adjustment are made on a budget neutral basis. We
propose to calculate an overall budget neutrality factor of 1.0012 for
wage index changes by comparing proposed total estimated payments from
our simulation model using the proposed FY 2022 IPPS wage indexes to
those payments using the FY 2021 IPPS wage indexes, as adopted on a
calendar year basis for the OPPS.
For the CY 2022 OPPS, we propose to maintain the current rural
adjustment policy, as discussed in section II.E. of this proposed rule.
Therefore, the proposed budget neutrality factor for the rural
adjustment is 1.0000.
We propose to continue previously established policies for
implementing the cancer hospital payment adjustment described in
section 1833(t)(18) of the Act, as discussed in section II.F. of this
proposed rule. We propose to calculate a CY 2022 budget neutrality
adjustment factor for the cancer hospital payment adjustment by
comparing estimated total CY 2022 payments under section 1833(t) of the
Act, including the proposed CY 2022 cancer hospital payment adjustment,
to estimated CY 2022 total payments using the CY 2021 final cancer
hospital payment adjustment, as required under section 1833(t)(18)(B)
of the Act. The proposed CY 2022 estimated payments applying the
proposed CY 2022 cancer hospital payment adjustment were the same as
estimated payments applying the CY 2021 final cancer hospital payment
adjustment. Therefore, we propose to apply a budget neutrality
adjustment factor of 1.0000 to the conversion factor for the cancer
hospital payment adjustment. In accordance with section 1833(t)(18)(C),
as added by section 16002(b) of the 21st Century Cures Act (Pub. L.
114-255), we are applying a budget neutrality factor calculated as if
the proposed cancer hospital adjustment target payment-to-cost ratio
was 0.90, not the 0.89 target payment-to-cost ratio we applied as
stated in section II.F. of the proposed rule.
For this CY 2022 OPPS/ASC proposed rule, we estimated that proposed
pass-through spending for drugs, biologicals, and devices for CY 2022
would equal approximately $1.03 billion, which represented 1.24 percent
of total projected CY 2022 OPPS spending. Therefore, the proposed
conversion factor would be adjusted by the difference between the 0.92
percent estimate of pass-through spending for CY 2021 and the 1.24
percent estimate of proposed pass-through spending for CY 2022,
resulting in a proposed decrease to the conversion factor for CY 2022
of 0.32 percent.
Proposed estimated payments for outliers would remain at 1.0
percent of total OPPS payments for CY 2022. We estimate for the
proposed rule that outlier payments would be 1.06 percent of total OPPS
payments in CY 2021; the 1.00 percent for proposed outlier payments in
CY 2022 would constitute a 0.06 percent decrease in payment in CY 2022
relative to CY 2021.
For this CY 2022 OPPS/ASC proposed rule, we also propose that
hospitals that fail to meet the reporting requirements of the Hospital
OQR Program would continue to be subject to a further reduction of 2.0
percentage points to the OPD fee schedule increase factor. For
hospitals that fail to meet the requirements of the Hospital OQR
Program, we propose to make all other adjustments discussed above, but
use a reduced OPD fee schedule update factor of 0.3 percent (that is,
the proposed OPD fee schedule increase factor of 2.3 percent further
reduced by 2.0 percentage points). This would result in a proposed
reduced conversion factor for CY 2022 of $82.810 for hospitals that
fail to meet the Hospital OQR Program requirements (a difference of -
1.647 in the conversion factor relative to hospitals that met the
requirements).
In summary, for 2022, we propose to use a reduced conversion factor
of $82.810 in the calculation of payments for hospitals that fail to
meet the Hospital OQR Program requirements (a difference of -1.647 in
the conversion factor relative to hospitals that met the requirements).
For 2022, we propose to use a conversion factor of $84.457 in the
calculation of the national unadjusted payment rates for those items
and services for which payment rates are calculated using geometric
mean costs; that is, the proposed OPD fee schedule increase factor of
2.3 percent for CY 2022, the required proposed wage index budget
neutrality adjustment of approximately 1.0012, the proposed cancer
hospital payment adjustment of 1.0000, and the proposed adjustment of
0.32 percentage point of projected OPPS spending for the difference in
pass-through spending that resulted in a proposed conversion factor for
CY 2022 of $84.457.
C. Proposed Wage Index Changes
Section 1833(t)(2)(D) of the Act requires the Secretary to
determine a wage adjustment factor to adjust the portion of payment and
coinsurance attributable to labor-related costs for relative
differences in labor and labor-related costs across geographic regions
in a budget neutral manner (codified at 42 CFR 419.43(a)). This portion
of the OPPS payment rate is called the OPPS labor-related share. Budget
neutrality is discussed in section II.B. of this proposed rule.
The OPPS labor-related share is 60 percent of the national OPPS
payment. This labor-related share is based on a regression analysis
that determined that, for all hospitals, approximately 60 percent of
the costs of services paid under the OPPS were attributable to wage
costs. We confirmed that this labor-related share for outpatient
services is appropriate during our regression analysis for the payment
adjustment for rural hospitals in the CY 2006 OPPS final rule with
comment period (70 FR 68553). We propose to continue this policy for
the CY 2022 OPPS. We refer readers to section II.H. of this proposed
rule for a description and an example of how the wage index for a
particular hospital is used to determine payment for the hospital.
As discussed in the claims accounting narrative included with the
supporting documentation for this proposed rule (which is available via
the internet on the CMS website), for estimating APC costs, we would
standardize 60 percent of estimated claims costs for geographic area
wage variation using the same FY 2022 pre-reclassified wage index that
we would use under the IPPS to standardize costs. This standardization
process removes the effects of differences in area wage levels from the
determination of a national unadjusted OPPS payment rate and copayment
amount.
Under 42 CFR 419.41(c)(1) and 419.43(c) (published in the OPPS
April 7, 2000 final rule with comment period (65 FR 18495 and 18545)),
the OPPS adopted the final fiscal year IPPS post-reclassified wage
index as the calendar year wage index for adjusting the OPPS standard
payment amounts for labor market differences. Therefore, the wage index
that applies to a particular acute care, short-stay hospital under the
IPPS also applies to that hospital under the OPPS. As initially
explained in the September 8, 1998 OPPS proposed rule (63 FR 47576), we
believe that using the IPPS wage index as the source of an
[[Page 42050]]
adjustment factor for the OPPS is reasonable and logical, given the
inseparable, subordinate status of the HOPD within the hospital
overall. In accordance with section 1886(d)(3)(E) of the Act, the IPPS
wage index is updated annually.
The Affordable Care Act contained several provisions affecting the
wage index. These provisions were discussed in the CY 2012 OPPS/ASC
final rule with comment period (76 FR 74191). Section 10324 of the
Affordable Care Act added section 1886(d)(3)(E)(iii)(II) to the Act,
which defines a frontier State and amended section 1833(t) of the Act
to add paragraph (19), which requires a frontier State wage index floor
of 1.00 in certain cases, and states that the frontier State floor
shall not be applied in a budget neutral manner. We codified these
requirements at Sec. 419.43(c)(2) and (3) of our regulations. For
2022, we propose to implement this provision in the same manner as we
have since CY 2011. Under this policy, the frontier State hospitals
would receive a wage index of 1.00 if the otherwise applicable wage
index (including reclassification, the rural floor, and rural floor
budget neutrality) is less than 1.00. Because the HOPD receives a wage
index based on the geographic location of the specific inpatient
hospital with which it is associated, the frontier State wage index
adjustment applicable for the inpatient hospital also would apply for
any associated HOPD. We refer readers to the FY 2011 through FY 2021
IPPS/LTCH PPS final rules for discussions regarding this provision,
including our methodology for identifying which areas meet the
definition of ``frontier States'' as provided for in section
1886(d)(3)(E)(iii)(II) of the Act: for FY 2011, 75 FR 50160 through
50161; for FY 2012, 76 FR 51793, 51795, and 51825; for FY 2013, 77 FR
53369 through 53370; for FY 2014, 78 FR 50590 through 50591; for FY
2015, 79 FR 49971; for FY 2016, 80 FR 49498; for FY 2017, 81 FR 56922;
for FY 2018, 82 FR 38142; for FY 2019, 83 FR 41380; for FY 2020, 84 FR
42312; and for FY 2021, 85 FR 58765.
In addition to the changes required by the Affordable Care Act, we
note that the proposed FY 2022 IPPS wage indexes continue to reflect a
number of adjustments implemented in past years, including, but not
limited to, reclassification of hospitals to different geographic
areas, the rural floor provisions, an adjustment for occupational mix,
an adjustment to the wage index based on commuting patterns of
employees (the out-migration adjustment), and an adjustment to the wage
index for certain low wage index hospitals to help address wage index
disparities between low and high wage index hospitals. In addition, in
the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25405 through 25407), we
proposed to implement section 9831 of the American Rescue Plan Act of
2021 (Pub. L. 117-2) which reinstates the imputed floor wage index
adjustment under the IPPS for hospitals in all-urban states effective
for discharges on or after October 1, 2021 (FY 2022) using the
methodology described in Sec. 412.64(h)(4)(vi) as in effect for FY
2018. Specifically, section 1886(d)(3)(E)(iv)(I) and (II) of the Act,
as added by section 9831 of the American Rescue Plan Act, provides that
for discharges occurring on or after October 1, 2021, the area wage
index applicable under the IPPS to any hospital in an all-urban State
may not be less than the minimum area wage index for the fiscal year
for hospitals in that State established using the methodology described
in Sec. 412.64(h)(4)(vi) as in effect for FY 2018. We further noted in
the FY 2022 IPPS/LTCH PPS proposed rule that, given the recent
enactment of section 9831 of Public Law 117-2 on March 11, 2021, there
was not sufficient time available to incorporate the changes required
by this statutory provision (the reinstatement of the imputed floor
wage index) into the calculation of the IPPS provider wage index for
the FY 2022 IPPS/LTCH PPS proposed rule, and we stated that we would
include the imputed floor wage index adjustment in the calculation of
the IPPS provider wage index in the FY 2022 IPPS/LTCH PPS final rule.
We note that CMS posted, concurrent with the issuance of the FY 2022
IPPS/LTCH proposed rule, estimated imputed floor values by state in a
separate data file on the FY 2022 IPPS Proposed Rule web page on the
CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index. In addition, we stated in the FY 2022
IPPS/LTCH PPS proposed rule that, based on data available for the FY
2022 IPPS/LTCH PPS proposed rule, the following States would be all-
urban States as defined in section 1886(d)(3)(E)(iv)(IV) of the Act,
and thus hospitals in such States would be eligible to receive an
increase in their wage index due to application of the imputed floor
for FY 2022: New Jersey, Rhode Island, Delaware, Connecticut, and
Washington, DC. We refer readers to the FY 2022 IPPS/LTCH PPS proposed
rule (86 FR 25396 through 25417) for a detailed discussion of all
proposed changes to the FY 2022 IPPS wage indexes.
Furthermore, as discussed in the FY 2015 IPPS/LTCH PPS final rule
(79 FR 49951 through 49963) and in each subsequent IPPS/LTCH PPS final
rule, including the FY 2021 IPPS/LTCH PPS final rule (85 FR 58743
through 58755), the Office of Management and Budget (OMB) issued
revisions to the labor market area delineations on February 28, 2013
(based on 2010 Decennial Census data) that included a number of
significant changes, such as new Core Based Statistical Areas (CBSAs),
urban counties that became rural, rural counties that became urban, and
existing CBSAs that were split apart (OMB Bulletin 13-01). This
bulletin can be found at: https://obamawhitehouse.archives.gov/sites/default/files/omb/bulletins/2013/b13-01.pdf. In the FY 2015 IPPS/LTCH
PPS final rule (79 FR 49950 through 49985), for purposes of the IPPS,
we adopted the use of the OMB statistical area delineations contained
in OMB Bulletin No. 13-01, effective October 1, 2014. For purposes of
the OPPS, in the CY 2015 OPPS/ASC final rule with comment period (79 FR
66826 through 66828), we adopted the use of the OMB statistical area
delineations contained in OMB Bulletin No. 13-01, effective January 1,
2015, beginning with the CY 2015 OPPS wage indexes. In the FY 2017
IPPS/LTCH PPS final rule (81 FR 56913), we adopted revisions to
statistical areas contained in OMB Bulletin No. 15-01, issued on July
15, 2015, which provided updates to and superseded OMB Bulletin No. 13-
01 that was issued on February 28, 2013. For purposes of the OPPS, in
the CY 2017 OPPS/ASC final rule with comment period (81 FR 79598), we
adopted the revisions to the OMB statistical area delineations
contained in OMB Bulletin No. 15-01, effective January 1, 2017,
beginning with the CY 2017 OPPS wage indexes.
On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
provided updates to and superseded OMB Bulletin No. 15-01 that was
issued on July 15, 2015. The attachments to OMB Bulletin No. 17-01
provided detailed information on the update to the statistical areas
since July 15, 2015, and were based on the application of the 2010
Standards for Delineating Metropolitan and Micropolitan Statistical
Areas to Census Bureau population estimates for July 1, 2014 and July
1, 2015. For purposes of the OPPS, in the CY 2019 OPPS/ASC final rule
with comment period (83 FR 58863 through 58865), we adopted the updates
set forth in OMB Bulletin No. 17-01,
[[Page 42051]]
effective January 1, 2019, beginning with the CY 2019 wage index.
On April 10, 2018, OMB issued OMB Bulletin No. 18-03 which
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14,
2018, OMB issued OMB Bulletin No. 18-04 which superseded the April 10,
2018 OMB Bulletin No. 18-03. Typically, interim OMB bulletins (those
issued between decennial censuses) have only contained minor
modifications to labor market delineations. However, the April 10, 2018
OMB Bulletin No. 18-03 and the September 14, 2018 OMB Bulletin No. 18-
04 included more modifications to the labor market areas than are
typical for OMB bulletins issued between decennial censuses, including
some new CBSAs, urban counties that became rural, rural counties that
became urban, and some existing CBSAs that were split apart. In
addition, some of these modifications had a number of downstream
effects, such as reclassification changes. These bulletins established
revised delineations for Metropolitan Statistical Areas, Micropolitan
Statistical Areas, and Combined Statistical Areas, and provided
guidance on the use of the delineations of these statistical areas. For
purposes of the OPPS, in the CY 2021 OPPS/ASC final rule with comment
period (85 FR 85907 through 85908), we adopted the updates set forth in
OMB Bulletin No. 18-04 effective January 1, 2021, beginning with the CY
2021 wage index. For a complete discussion of the adoption of the
updates set forth in OMB Bulletin No. 18-04, we refer readers to the CY
2021 OPPS/ASC final rule with comment period.
On March 6, 2020, OMB issued Bulletin No. 20-01, which provided
updates to and superseded OMB Bulletin No. 18-04 that was issued on
September 14, 2018. The attachments to OMB Bulletin No. 20-01 provided
detailed information on the updates to statistical areas since
September 14, 2018, and were based on the application of the 2010
Standards for Delineating Metropolitan and Micropolitan Statistical
Areas to Census Bureau population estimates for July 1, 2017 and July
1, 2018. (For a copy of this bulletin, we refer readers to the
following website: https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.) In OMB Bulletin No. 20-01, OMB announced one
new Micropolitan Statistical Area, one new component of an existing
Combined Statistical Area and changes to New England City and Town Area
(NECTA) delineations. As we stated in the FY 2022 IPPS/LTCH PPS
proposed rule (86 FR 25397), after reviewing OMB Bulletin No. 20-01, we
determined that the changes in Bulletin 20-01 encompassed delineation
changes that would not affect the Medicare IPPS wage index for FY 2022.
Specifically, the updates consisted of changes to NECTA delineations
and the creation of a new Micropolitan Statistical Area, which was then
added as a new component to an existing Micropolitan Statistical Area.
The Medicare wage index does not utilize NECTA definitions, and, as
most recently discussed in FY 2021 IPPS/LTCH PPS final rule (85 FR
58746), we include hospitals located in Micropolitan Statistical areas
in each State's rural wage index. Therefore, consistent with our
discussion in the FY 2022 IPPS/LTCH PPS proposed rule, while we propose
to adopt the updates set forth in OMB Bulletin No. 20-01 consistent
with our longstanding policy of adopting OMB delineation updates, we
note that specific OPPS wage index updates would not be necessary for
CY 2022 as a result of adopting these OMB updates. In other words,
these OMB updates would not affect any hospital's geographic area for
purposes of the OPPS wage index calculation for CY 2022.
For CY 2022, we would continue to use the OMB delineations that
were adopted beginning with FY 2015 (based on the revised delineations
issued in OMB Bulletin No. 13-01) to calculate the area wage indexes,
with updates as reflected in OMB Bulletin Nos. 15-01, 17-01, and 18-04.
We note that, in connection with our adoption in FY 2021 of the
updates in OMB Bulletin 18-04, we adopted a policy to place a 5 percent
cap, for FY 2021, on any decrease in a hospital's wage index from the
hospital's final wage index in FY 2020 so that a hospital's final wage
index for FY 2021 would not be less than 95 percent of its final wage
index for FY 2020. We refer the reader to the FY 2021 IPPS/LTCH PPS
final rule (85 FR 58753 through 58755) for a complete discussion of
this transition. As finalized in the FY 2021 IPPS/LTCH PPS final rule,
this transition is set to expire at the end of FY 2021. However, as
discussed in the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25397),
given the unprecedented nature of the ongoing COVID-19 PHE, we sought
comment in the FY 2022 IPPS/LTCH PPS proposed rule on whether it would
be appropriate to continue to apply a transition for the FY 2022 IPPS
wage index for hospitals negatively impacted by our adoption of the
updates in OMB Bulletin 18-04. For example, we stated that such an
extended transition could potentially take the form of holding the FY
2022 IPPS wage index for those hospitals harmless from any reduction
relative to their FY 2021 wage index. We further stated that if we were
to apply a transition to the FY 2022 IPPS wage index for hospitals
negatively impacted by our adoption of the updates in OMB Bulletin 18-
04, we also sought comment on making this transition budget neutral
under the IPPS, as is our usual practice, in the same manner that the
FY 2021 IPPS wage index transition was made budget neutral as discussed
in the FY 2021 IPPS/LTCH PPS final rule (85 FR 58755).
CBSAs are made up of one or more constituent counties. Each CBSA
and constituent county has its own unique identifying codes. The FY
2018 IPPS/LTCH PPS final rule (82 FR 38130) discussed the two different
lists of codes to identify counties: Social Security Administration
(SSA) codes and Federal Information Processing Standard (FIPS) codes.
Historically, CMS listed and used SSA and FIPS county codes to identify
and crosswalk counties to CBSA codes for purposes of the IPPS and OPPS
wage indexes. However, the SSA county codes are no longer being
maintained and updated, although the FIPS codes continue to be
maintained by the U.S. Census Bureau. The Census Bureau's most current
statistical area information is derived from ongoing census data
received since 2010; the most recent data are from 2015. The Census
Bureau maintains a complete list of changes to counties or county
equivalent entities on the website at: https://www.census.gov/geo/reference/county-changes.html (which, as of May 6, 2019, migrated to:
https://www.census.gov/programs-surveys/geography.html). In the FY 2018
IPPS/LTCH PPS final rule (82 FR 38130), for purposes of crosswalking
counties to CBSAs for the IPPS wage index, we finalized our proposal to
discontinue the use of the SSA county codes and begin using only the
FIPS county codes. Similarly, for the purposes of crosswalking counties
to CBSAs for the OPPS wage index, in the CY 2018 OPPS/ASC final rule
with comment period (82 FR 59260), we finalized our proposal to
discontinue the use of SSA county codes and begin using only the FIPS
county codes. For CY 2022, under the OPPS, we are continuing to use
only the FIPS county codes for purposes of crosswalking counties to
CBSAs.
We propose to use the FY 2022 IPPS post-reclassified wage index for
urban and rural areas as the wage index for the OPPS to determine the
wage adjustments for both the OPPS payment
[[Page 42052]]
rate and the copayment rate for CY 2022. Therefore, any adjustments for
the FY 2022 IPPS post-reclassified wage index, including, but not
limited to, the imputed floor adjustment and any transition that may be
applied (as discussed previously), would be reflected in the final CY
2022 OPPS wage index beginning on January 1, 2022. (We refer readers to
the FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25396 through 25417) and
the proposed FY 2022 hospital wage index files posted on the CMS
website.) With regard to budget neutrality for the CY 2022 OPPS wage
index, we refer readers to section II.B. of this CY 2022 OPPS/ASC
proposed rule. We continue to believe that using the IPPS post-
reclassified wage index as the source of an adjustment factor for the
OPPS is reasonable and logical, given the inseparable, subordinate
status of the HOPD within the hospital overall.
Hospitals that are paid under the OPPS, but not under the IPPS, do
not have an assigned hospital wage index under the IPPS. Therefore, for
non-IPPS hospitals paid under the OPPS, it is our longstanding policy
to assign the wage index that would be applicable if the hospital was
paid under the IPPS, based on its geographic location and any
applicable wage index adjustments. In this CY 2022 OPPS/ASC proposed
rule, we propose to continue this policy for CY 2022, and are including
below a brief summary of the major proposed FY 2022 IPPS wage index
policies and adjustments that we propose to apply to these hospitals
under the OPPS for CY 2022. We referred readers to the FY 2022 IPPS/
LTCH PPS proposed rule (86 FR 25396 through 25417) for a detailed
discussion of the proposed changes to the FY 2022 IPPS wage indexes.
It has been our longstanding policy to allow non-IPPS hospitals
paid under the OPPS to qualify for the out-migration adjustment if they
are located in a section 505 out-migration county (section 505 of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)). Applying this adjustment is consistent with our policy of
adopting IPPS wage index policies for hospitals paid under the OPPS. We
note that, because non-IPPS hospitals cannot reclassify, they are
eligible for the out-migration wage index adjustment if they are
located in a section 505 out-migration county. This is the same out-
migration adjustment policy that would apply if the hospital were paid
under the IPPS. For CY 2022, we propose to continue our policy of
allowing non-IPPS hospitals paid under the OPPS to qualify for the
outmigration adjustment if they are located in a section 505 out-
migration county (section 505 of the MMA). Furthermore, we propose that
the wage index that would apply for CY 2022 to non-IPPS hospitals paid
under the OPPS would continue to include the rural floor adjustment and
any adjustments applied to the IPPS wage index to address wage index
disparities. In addition, the wage index that would apply to non-IPPS
hospitals paid under the OPPS would include any transition we may
finalize for the FY 2022 IPPS wage index as discussed previously.
For CMHCs, for CY 2022, we propose to continue to calculate the
wage index by using the post-reclassification IPPS wage index based on
the CBSA where the CMHC is located. Furthermore, we propose that the
wage index that would apply to CMHCs for CY 2022 would continue to
include the rural floor adjustment and any adjustments applied to the
IPPS wage index to address wage index disparities. In addition, the
wage index that would apply to CMHCs would include any transition we
may finalize for the FY 2022 IPPS wage index as discussed above. Also,
we propose that the wage index that would apply to CMHCs would not
include the outmigration adjustment because that adjustment only
applies to hospitals.
Table 4A associated with the FY 2022 IPPS/LTCH PPS proposed rule
(available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index)
identifies counties that would be eligible for the out-migration
adjustment. Table 2 associated with the FY 2022 IPPS/LTCH PPS proposed
rule (available for download via the website above) identifies IPPS
hospitals that would receive the out-migration adjustment for FY 2022.
We are including the outmigration adjustment information from Table 2
associated with the FY 2022 IPPS/LTCH PPS proposed rule as Addendum L
to this CY 2022 OPPS/ASC proposed rule with the addition of non-IPPS
hospitals that would receive the section 505 outmigration adjustment
under this proposed rule. Addendum L is available via the internet on
the CMS website. We refer readers to the CMS website for the OPPS at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index. At this link, readers will find a link to
the proposed FY 2022 IPPS wage index tables and Addendum L.
D. Proposed Statewide Average Default Cost-to-Charge Ratios (CCRs)
In addition to using CCRs to estimate costs from charges on claims
for ratesetting, we use overall hospital-specific CCRs calculated from
the hospital's most recent cost report to determine outlier payments,
payments for pass-through devices, and monthly interim transitional
corridor payments under the OPPS during the PPS year. For certain
hospitals, under the regulations at 42 CFR 419.43(d)(5)(iii), we use
the statewide average default CCRs to determine the payments mentioned
earlier if it is not possible to determine an accurate CCR for a
hospital in certain circumstances. This includes hospitals that are
new, hospitals that have not accepted assignment of an existing
hospital's provider agreement, and hospitals that have not yet
submitted a cost report. We also use the statewide average default CCRs
to determine payments for hospitals whose CCR falls outside the
predetermined ceiling threshold for a valid CCR or for hospitals in
which the most recent cost report reflects an all-inclusive rate status
(Medicare Claims Processing Manual (Pub. 100-04), Chapter 4, Section
10.11).
We discussed our policy for using default CCRs, including setting
the ceiling threshold for a valid CCR, in the CY 2009 OPPS/ASC final
rule with comment period (73 FR 68594 through 68599) in the context of
our adoption of an outlier reconciliation policy for cost reports
beginning on or after January 1, 2009. For details on our process for
calculating the statewide average CCRs, we refer readers to the CY 2022
OPPS proposed rule Claims Accounting Narrative that is posted on our
website. We propose to calculate the default ratios for CY 2022 using
cost report data from the same set of cost reports we originally used
in the CY 2021 OPPS ratesetting, consistent with the broader proposal
regarding 2022 OPPS ratesetting discussed in section X.E. of this
proposed rule.
We no longer publish a table in the Federal Register containing the
statewide average CCRs in the annual OPPS proposed rule and final rule
with comment period. These CCRs with the upper limit will be available
for download with each OPPS CY proposed rule and final rule on the CMS
website. We refer readers to our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html; click on the link on
the left of the page titled ``Hospital Outpatient Regulations and
Notices'' and then select the relevant regulation to download the
statewide CCRs and upper limit in the Downloads section of the web
page.
[[Page 42053]]
E. Proposed Adjustment for Rural Sole Community Hospitals (SCHs) and
Essential Access Community Hospitals (EACHs) Under Section
1833(t)(13)(B) of the Act for CY 2022
In the CY 2006 OPPS final rule with comment period (70 FR 68556),
we finalized a payment increase for rural sole community hospitals
(SCHs) of 7.1 percent for all services and procedures paid under the
OPPS, excluding drugs, biologicals, brachytherapy sources, and devices
paid under the pass-through payment policy, in accordance with section
1833(t)(13)(B) of the Act, as added by section 411 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(Pub. L. 108-173). Section 1833(t)(13) of the Act provided the
Secretary the authority to make an adjustment to OPPS payments for
rural hospitals, effective January 1, 2006, if justified by a study of
the difference in costs by APC between hospitals in rural areas and
hospitals in urban areas. Our analysis showed a difference in costs for
rural SCHs. Therefore, for the CY 2006 OPPS, we finalized a payment
adjustment for rural SCHs of 7.1 percent for all services and
procedures paid under the OPPS, excluding separately payable drugs and
biologicals, brachytherapy sources, items paid at charges reduced to
costs, and devices paid under the pass-through payment policy, in
accordance with section 1833(t)(13)(B) of the Act.
In the CY 2007 OPPS/ASC final rule with comment period (71 FR 68010
and 68227), for purposes of receiving this rural adjustment, we revised
our regulations at Sec. 419.43(g) to clarify that essential access
community hospitals (EACHs) are also eligible to receive the rural SCH
adjustment, assuming these entities otherwise meet the rural adjustment
criteria. Currently, two hospitals are classified as EACHs, and as of
CY 1998, under section 4201(c) of Public Law 105-33, a hospital can no
longer become newly classified as an EACH.
This adjustment for rural SCHs is budget neutral and applied before
calculating outlier payments and copayments. We stated in the CY 2006
OPPS final rule with comment period (70 FR 68560) that we would not
reestablish the adjustment amount on an annual basis, but we may review
the adjustment in the future and, if appropriate, would revise the
adjustment. We provided the same 7.1 percent adjustment to rural SCHs,
including EACHs, again in CYs 2008 through 2021. Further, in the CY
2009 OPPS/ASC final rule with comment period (73 FR 68590), we updated
the regulations at Sec. 419.43(g)(4) to specify, in general terms,
that items paid at charges adjusted to costs by application of a
hospital-specific CCR are excluded from the 7.1 percent payment
adjustment.
For CY 2022, we propose to continue the current policy of a 7.1
percent payment adjustment that is done in a budget neutral manner for
rural SCHs, including EACHs, for all services and procedures paid under
the OPPS, excluding separately payable drugs and biologicals,
brachytherapy sources, items paid at charges reduced to costs, and
devices paid under the pass-through payment policy.
F. Proposed Payment Adjustment for Certain Cancer Hospitals for CY 2021
1. Background
Since the inception of the OPPS, which was authorized by the
Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), Medicare has paid
the 11 hospitals that meet the criteria for cancer hospitals identified
in section 1886(d)(1)(B)(v) of the Act under the OPPS for covered
outpatient hospital services. These cancer hospitals are exempted from
payment under the IPPS. With the Medicare, Medicaid and SCHIP Balanced
Budget Refinement Act of 1999 (Pub. L. 106-113), the Congress added
section 1833(t)(7), ``Transitional Adjustment to Limit Decline in
Payment,'' to the Act, which requires the Secretary to determine OPPS
payments to cancer and children's hospitals based on their pre-BBA
payment amount (these hospitals are often referred to under this policy
as ``held harmless'' and their payments are often referred to as ``hold
harmless'' payments).
As required under section 1833(t)(7)(D)(ii) of the Act, a cancer
hospital receives the full amount of the difference between payments
for covered outpatient services under the OPPS and a ``pre-BBA
amount.'' That is, cancer hospitals are permanently held harmless to
their ``pre-BBA amount,'' and they receive transitional outpatient
payments (TOPs) or hold harmless payments to ensure that they do not
receive a payment that is lower in amount under the OPPS than the
payment amount they would have received before implementation of the
OPPS, as set forth in section 1833(t)(7)(F) of the Act. The ``pre-BBA
amount'' is the product of the hospital's reasonable costs for covered
outpatient services occurring in the current year and the base payment-
to-cost ratio (PCR) for the hospital defined in section
1833(t)(7)(F)(ii) of the Act. The ``pre-BBA amount'' and the
determination of the base PCR are defined at Sec. 419.70(f). TOPs are
calculated on Worksheet E, Part B, of the Hospital Cost Report or the
Hospital Health Care Complex Cost Report (Form CMS-2552-96 or Form CMS-
2552-10, respectively), as applicable each year. Section 1833(t)(7)(I)
of the Act exempts TOPs from budget neutrality calculations.
Section 3138 of the Affordable Care Act amended section 1833(t) of
the Act by adding a new paragraph (18), which instructs the Secretary
to conduct a study to determine if, under the OPPS, outpatient costs
incurred by cancer hospitals described in section 1886(d)(1)(B)(v) of
the Act with respect to APC groups exceed outpatient costs incurred by
other hospitals furnishing services under section 1833(t) of the Act,
as determined appropriate by the Secretary. Section 1833(t)(18)(A) of
the Act requires the Secretary to take into consideration the cost of
drugs and biologicals incurred by cancer hospitals and other hospitals.
Section 1833(t)(18)(B) of the Act provides that, if the Secretary
determines that cancer hospitals' costs are higher than those of other
hospitals, the Secretary shall provide an appropriate adjustment under
section 1833(t)(2)(E) of the Act to reflect these higher costs. In
2011, after conducting the study required by section 1833(t)(18)(A) of
the Act, we determined that outpatient costs incurred by the 11
specified cancer hospitals were greater than the costs incurred by
other OPPS hospitals. For a complete discussion regarding the cancer
hospital cost study, we refer readers to the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74200 through 74201).
Based on these findings, we finalized a policy to provide a payment
adjustment to the 11 specified cancer hospitals that reflects their
higher outpatient costs, as discussed in the CY 2012 OPPS/ASC final
rule with comment period (76 FR 74202 through 74206). Specifically, we
adopted a policy to provide additional payments to the cancer hospitals
so that each cancer hospital's final PCR for services provided in a
given calendar year is equal to the weighted average PCR (which we
refer to as the ``target PCR'') for other hospitals paid under the
OPPS. The target PCR is set in advance of the calendar year and is
calculated using the most recently submitted or settled cost report
data that are available at the time of final rulemaking for the
calendar year. The amount of the payment adjustment is made on an
aggregate basis at cost report settlement. We note that the changes
made by section
[[Page 42054]]
1833(t)(18) of the Act do not affect the existing statutory provisions
that provide for TOPs for cancer hospitals. The TOPs are assessed, as
usual, after all payments, including the cancer hospital payment
adjustment, have been made for a cost reporting period. Table 3
displays the target PCR for purposes of the cancer hospital adjustment
for CY 2012 through CY 2021.
[GRAPHIC] [TIFF OMITTED] TP04AU21.006
2. Proposed Policy for CY 2022
Section 16002(b) of the 21st Century Cures Act (Pub. L. 114-255)
amended section 1833(t)(18) of the Act by adding subparagraph (C),
which requires that in applying Sec. 419.43(i) (that is, the payment
adjustment for certain cancer hospitals) for services furnished on or
after January 1, 2018, the target PCR adjustment be reduced by 1.0
percentage point less than what would otherwise apply. Section 16002(b)
also provides that, in addition to the percentage reduction, the
Secretary may consider making an additional percentage point reduction
to the target PCR that takes into account payment rates for applicable
items and services described under section 1833(t)(21)(C) of the Act
for hospitals that are not cancer hospitals described under section
1886(d)(1)(B)(v) of the Act. Further, in making any budget neutrality
adjustment under section 1833(t) of the Act, the Secretary shall not
take into account the reduced expenditures that result from application
of section 1833(t)(18)(C) of the Act.
We propose to provide additional payments to the 11 specified
cancer hospitals so that each cancer hospital's final PCR is equal to
the weighted average PCR (or ``target PCR'') for the other OPPS
hospitals, using the most recent submitted or settled cost report data
that were available at the time of the development of the proposed
rule, reduced by 1.0 percentage point, to comply with section 16002(b)
of the 21st Century Cures Act. We are not proposing an additional
reduction beyond the 1.0 percentage point reduction required by section
16002(b) for CY 2022.
Under our established policy, to calculate the proposed CY 2022
target PCR, we would use the same extract of cost report data from
HCRIS used to estimate costs for the CY 2022 OPPS which would be the
most recently available hospital cost reports which, in most cases,
would be from CY 2020. However, as discussed in Section II.A.1.a of
this proposed rule, given our concerns with CY 2020 claims data as a
result of the PHE, we believe a target PCR based on CY 2020 claims and
the most recently available cost reports may provide a less accurate
estimation of cancer hospital PCRs and non-cancer hospital PCRs than
the data used for the CY 2021 rulemaking cycle. Therefore, for CY 2022,
we are proposing to continue to use the CY 2021 target PCR of 0.89.
This proposed CY 2022 target PCR of 0.89 includes the 1.0 percentage
point reduction required by section 16002(b) of the 21st Century Cures
Act for CY 2022. For a description of the CY 2021 target PCR
calculation, we refer readers to the CY 2021 OPPS/ASC final rule with
comment period (84 FR 85912 through 85914).
Table 4 shows the estimated percentage increase in OPPS payments to
each cancer hospital for CY 2022, due to the cancer hospital payment
adjustment policy. The actual amount of the CY 2022 cancer hospital
payment adjustment for each cancer hospital will be determined at cost
report settlement and will depend on each hospital's CY 2022 payments
and costs. We note that the requirements contained in section
1833(t)(18) of the Act do not affect the existing statutory provisions
that provide for TOPs for cancer hospitals. The TOPs will be assessed,
as usual, after all payments, including the cancer hospital payment
adjustment, have been made for a cost reporting period.
[[Page 42055]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.007
G. Proposed Hospital Outpatient Outlier Payments
1. Background
The OPPS provides outlier payments to hospitals to help mitigate
the financial risk associated with high-cost and complex procedures,
where a very costly service could present a hospital with significant
financial loss. As explained in the CY 2015 OPPS/ASC final rule with
comment period (79 FR 66832 through 66834), we set our projected target
for aggregate outlier payments at 1.0 percent of the estimated
aggregate total payments under the OPPS for the prospective year.
Outlier payments are provided on a service-by-service basis when the
cost of a service exceeds the APC payment amount multiplier threshold
(the APC payment amount multiplied by a certain amount) as well as the
APC payment amount plus a fixed-dollar amount threshold (the APC
payment plus a certain amount of dollars). In CY 2021, the outlier
threshold was met when the hospital's cost of furnishing a service
exceeded 1.75 times (the multiplier threshold) the APC payment amount
and exceeded the APC payment amount plus $5,300 (the fixed-dollar
amount threshold) (85 FR 85914 through 85916). If the cost of a service
exceeds both the multiplier threshold and the fixed-dollar threshold,
the outlier payment is calculated as 50 percent of the amount by which
the cost of furnishing the service exceeds 1.75 times the APC payment
amount. Beginning with CY 2009 payments, outlier payments are subject
to a reconciliation process similar to the IPPS outlier reconciliation
process for cost reports, as discussed in the CY 2009 OPPS/ASC final
rule with comment period (73 FR 68594 through 68599).
It has been our policy to report the actual amount of outlier
payments as a percent of total spending in the claims being used to
model the OPPS. Our estimate of total outlier payments as a percent of
total CY 2019 OPPS payments, using CY 2019 claims available for this CY
2022 OPPS/ASC proposed rule, is approximately 1.0 percent of the total
aggregated OPPS payments. Therefore, for CY 2019, we estimated that we
paid the outlier target of 1.0 percent of total aggregated OPPS
payments. Using an updated claims dataset for this CY 2022 OPPS/ASC
proposed rule, we estimate that we paid approximately 0.92 percent of
the total aggregated OPPS payments in outliers for CY 2019.
For this CY 2022 OPPS/ASC proposed rule, using CY 2019 claims data
and CY 2021 payment rates, we estimated that the aggregate outlier
payments for CY 2021 would be approximately 1.06 percent of the total
CY 2021 OPPS payments. We provided estimated CY 2021 outlier payments
for hospitals and CMHCs with claims included in the claims data that we
used to model impacts in the Hospital-Specific Impacts--Provider-
Specific Data file on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
2. Outlier Calculation for CY 2022
For CY 2022, we propose to continue our policy of estimating
outlier payments to be 1.0 percent of the estimated aggregate total
payments under the OPPS. We propose that a portion of that 1.0 percent,
an amount equal to less than 0.01 percent of outlier payments (or
0.0001 percent of total OPPS payments), would be allocated to CMHCs for
PHP outlier payments. This is the amount of estimated outlier payments
that would result from the proposed CMHC outlier threshold as a
proportion of total estimated OPPS outlier payments. We propose to
continue our longstanding policy that if a CMHC's cost for partial
hospitalization services, paid under APC 5853 (Partial
[[Page 42056]]
Hospitalization for CMHCs), exceeds 3.40 times the payment rate for
proposed APC 5853, the outlier payment would be calculated as 50
percent of the amount by which the cost exceeds 3.40 times the proposed
APC 5853 payment rate.
For further discussion of CMHC outlier payments, we refer readers
to section VIII.C. of this CY 2022 OPPS/ASC proposed rule.
To ensure that the estimated CY 2022 aggregate outlier payments
would equal 1.0 percent of estimated aggregate total payments under the
OPPS, we propose that the hospital outlier threshold be set so that
outlier payments would be triggered when a hospital's cost of
furnishing a service exceeds 1.75 times the APC payment amount and
exceeds the APC payment amount plus $6,100.
We calculated the proposed fixed-dollar threshold of $6,100 using
the standard methodology most recently used for CY 2021 (85 FR 85914
through 85916). For purposes of estimating outlier payments for the
proposed rule, we used the hospital-specific overall ancillary CCRs
available in the April 2020 update to the Outpatient Provider-Specific
File (OPSF). The OPSF contains provider-specific data, such as the most
current CCRs, which are maintained by the MACs and used by the OPPS
Pricer to pay claims. The claims that we use to model each OPPS update
lag by 2 years.
In order to estimate the CY 2022 hospital outlier payments for the
proposed rule, we inflated the charges on the CY 2019 claims using the
same inflation factor of 1.20469 that we used to estimate the IPPS
fixed-dollar outlier threshold for the FY 2022 IPPS/LTCH PPS proposed
rule (86 FR 25718). We used an inflation factor of 1.13218 to estimate
CY 2021 charges from the CY 2019 charges reported on CY 2019 claims.
The methodology for determining this charge inflation factor is
discussed in the FY 2021 IPPS/LTCH PPS final rule (85 FR 59039). As we
stated in the CY 2005 OPPS final rule with comment period (69 FR
65845), we believe that the use of these charge inflation factors is
appropriate for the OPPS because, with the exception of the inpatient
routine service cost centers, hospitals use the same ancillary and
outpatient cost centers to capture costs and charges for inpatient and
outpatient services.
As noted in the CY 2007 OPPS/ASC final rule with comment period (71
FR 68011), we are concerned that we could systematically overestimate
the OPPS hospital outlier threshold if we did not apply a CCR inflation
adjustment factor. Therefore, we propose to apply the same CCR
inflation adjustment factor that we propose to apply for the FY 2022
IPPS outlier calculation to the CCRs used to simulate the proposed CY
2022 OPPS outlier payments to determine the fixed-dollar threshold.
Specifically, for CY 2022, we propose to apply an adjustment factor of
0.94964 to the CCRs that were in the April 2020 OPSF to trend them
forward from CY 2020 to CY 2022. The methodology for calculating the
proposed adjustment is discussed in the FY 2022 IPPS/LTCH PPS proposed
rule (86 FR 25717 through 25719).
To model hospital outlier payments for this proposed rule, we
applied the overall CCRs from the April 2021 OPSF after adjustment
(using the proposed CCR inflation adjustment factor of 0.94964 to
approximate CY 2022 CCRs) to charges on CY 2019 claims that were
adjusted (using the proposed charge inflation factor of 1.20469 to
approximate CY 2022 charges). We simulated aggregated CY 2021 hospital
outlier payments using these costs for several different fixed-dollar
thresholds, holding the 1.75 multiplier threshold constant and assuming
that outlier payments would continue to be made at 50 percent of the
amount by which the cost of furnishing the service would exceed 1.75
times the APC payment amount, until the total outlier payments equaled
1.0 percent of aggregated estimated total CY 2021 OPPS payments. We
estimated that a proposed fixed-dollar threshold of $6,100, combined
with the proposed multiplier threshold of 1.75 times the APC payment
rate, would allocate 1.0 percent of aggregated total OPPS payments to
outlier payments. For CMHCs, we propose that, if a CMHC's cost for
partial hospitalization services, paid under APC 5853, exceeds 3.40
times the payment rate for APC 5853, the outlier payment would be
calculated as 50 percent of the amount by which the cost exceeds 3.40
times the APC 5853 payment rate.
Section 1833(t)(17)(A) of the Act, which applies to hospitals, as
defined under section 1886(d)(1)(B) of the Act, requires that hospitals
that fail to report data required for the quality measures selected by
the Secretary, in the form and manner required by the Secretary under
section 1833(t)(17)(B) of the Act, incur a 2.0 percentage point
reduction to their OPD fee schedule increase factor; that is, the
annual payment update factor. The application of a reduced OPD fee
schedule increase factor results in reduced national unadjusted payment
rates that will apply to certain outpatient items and services
furnished by hospitals that are required to report outpatient quality
data and that fail to meet the Hospital OQR Program requirements. For
hospitals that fail to meet the Hospital OQR Program requirements, we
propose to continue the policy that we implemented in CY 2010 that the
hospitals' costs will be compared to the reduced payments for purposes
of outlier eligibility and payment calculation. For more information on
the Hospital OQR Program, we refer readers to section XIV. of this
proposed rule.
H. Proposed Calculation of an Adjusted Medicare Payment From the
National Unadjusted Medicare Payment
The basic methodology for determining prospective payment rates for
HOPD services under the OPPS is set forth in existing regulations at 42
CFR part 419, subparts C and D. For this CY 2022 OPPS/ASC proposed
rule, the payment rate for most services and procedures for which
payment is made under the OPPS is the product of the conversion factor
calculated in accordance with section II.B. of this proposed rule and
the relative payment weight determined under section II.A. of this
proposed rule. Therefore, the proposed national unadjusted payment rate
for most APCs contained in Addendum A to this proposed rule (which is
available via the internet on the CMS website) and for most HCPCS codes
to which separate payment under the OPPS has been assigned in Addendum
B to this proposed rule (which is available via the internet on the CMS
website) was calculated by multiplying the proposed CY 2022 scaled
weight for the APC by the CY 2022 conversion factor.
We note that section 1833(t)(17) of the Act, which applies to
hospitals, as defined under section 1886(d)(1)(B) of the Act, requires
that hospitals that fail to submit data required to be submitted on
quality measures selected by the Secretary, in the form and manner and
at a time specified by the Secretary, incur a reduction of 2.0
percentage points to their OPD fee schedule increase factor, that is,
the annual payment update factor. The application of a reduced OPD fee
schedule increase factor results in reduced national unadjusted payment
rates that apply to certain outpatient items and services provided by
hospitals that are required to report outpatient quality data and that
fail to meet the Hospital OQR Program (formerly referred to as the
Hospital Outpatient Quality Data Reporting Program (HOP QDRP))
requirements. For further discussion of the payment reduction for
hospitals that fail to meet the requirements of the
[[Page 42057]]
Hospital OQR Program, we refer readers to section XIV of this proposed
rule.
We demonstrate the steps used to determine the APC payments that
will be made in a CY under the OPPS to a hospital that fulfills the
Hospital OQR Program requirements and to a hospital that fails to meet
the Hospital OQR Program requirements for a service that has any of the
following status indicator assignments: ``J1'', ``J2'', ``P'', ``Q1'',
``Q2'', ``Q3'', ``Q4'', ``R'', ``S'', ``T'', ``U'', or ``V'' (as
defined in Addendum D1 to the proposed rule, which is available via the
internet on the CMS website), in a circumstance in which the multiple
procedure discount does not apply, the procedure is not bilateral, and
conditionally packaged services (status indicator of ``Q1'' and ``Q2'')
qualify for separate payment. We note that, although blood and blood
products with status indicator ``R'' and brachytherapy sources with
status indicator ``U'' are not subject to wage adjustment, they are
subject to reduced payments when a hospital fails to meet the Hospital
OQR Program requirements.
Individual providers interested in calculating the payment amount
that they will receive for a specific service from the national
unadjusted payment rates presented in Addenda A and B to the proposed
rule (which are available via the internet on the CMS website) should
follow the formulas presented in the following steps. For purposes of
the payment calculations below, we refer to the national unadjusted
payment rate for hospitals that meet the requirements of the Hospital
OQR Program as the ``full'' national unadjusted payment rate. We refer
to the national unadjusted payment rate for hospitals that fail to meet
the requirements of the Hospital OQR Program as the ``reduced''
national unadjusted payment rate. The reduced national unadjusted
payment rate is calculated by multiplying the reporting ratio of 0.9805
times the ``full'' national unadjusted payment rate. The national
unadjusted payment rate used in the calculations below is either the
full national unadjusted payment rate or the reduced national
unadjusted payment rate, depending on whether the hospital met its
Hospital OQR Program requirements to receive the full CY 2022 OPPS fee
schedule increase factor.
Step 1. Calculate 60 percent (the labor-related portion) of the
national unadjusted payment rate. Since the initial implementation of
the OPPS, we have used 60 percent to represent our estimate of that
portion of costs attributable, on average, to labor. We refer readers
to the April 7, 2000 OPPS final rule with comment period (65 FR 18496
through 18497) for a detailed discussion of how we derived this
percentage. During our regression analysis for the payment adjustment
for rural hospitals in the CY 2006 OPPS final rule with comment period
(70 FR 68553), we confirmed that this labor-related share for hospital
outpatient services is appropriate.
The formula below is a mathematical representation of Step 1 and
identifies the labor-related portion of a specific payment rate for a
specific service.
X is the labor-related portion of the national unadjusted payment
rate.
X = .60 * (national unadjusted payment rate).
Step 2. Determine the wage index area in which the hospital is
located and identify the wage index level that applies to the specific
hospital. We note that, for the CY 2021 OPPS wage index (85 FR 85907
through 85908), we adopted the updated OMB delineations based on OMB
Bulletin No. 18-04 and related IPPS wage index adjustments finalized in
the FY 2021 IPPS/LTCH PPS final rule. The wage index values assigned to
each area would reflect the geographic statistical areas (which are
based upon OMB standards) to which hospitals are assigned for FY 2022
under the IPPS, reclassifications through the Medicare Geographic
Classification Review Board (MGCRB), section 1886(d)(8)(B) ``Lugar''
hospitals, and reclassifications under section 1886(d)(8)(E) of the
Act, as implemented in Sec. 412.103 of the regulations. We propose to
continue to apply for the CY 2022 OPPS wage index any adjustments for
the FY 2022 IPPS post-reclassified wage index, including, but not
limited to, the rural floor adjustment, a wage index floor of 1.00 in
frontier states, in accordance with section 10324 of the Affordable
Care Act of 2010, and an adjustment to the wage index for certain low
wage index hospitals. For further discussion of the wage index we
propose to apply for the CY 2022 OPPS, we refer readers to section
II.C. of this proposed rule.
Step 3. Adjust the wage index of hospitals located in certain
qualifying counties that have a relatively high percentage of hospital
employees who reside in the county, but who work in a different county
with a higher wage index, in accordance with section 505 of Public Law
108-173. Addendum L to this proposed rule (which is available via the
internet on the CMS website) contains the qualifying counties and the
associated wage index increase developed for the proposed FY 2022 IPPS
wage index, which are listed in Table 2 associated with the FY 2022
IPPS/LTCH PPS proposed rule and available via the internet on the CMS
website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. (Click on the link on the left
side of the screen titled ``FY 2022 IPPS Proposed Rule Home Page'' and
select ``FY 2022 Proposed Rule Tables.'') This step is to be followed
only if the hospital is not reclassified or redesignated under section
1886(d)(8) or section 1886(d)(10) of the Act.
Step 4. Multiply the applicable wage index determined under Steps 2
and 3 by the amount determined under Step 1 that represents the labor-
related portion of the national unadjusted payment rate.
The formula below is a mathematical representation of Step 4 and
adjusts the labor-related portion of the national unadjusted payment
rate for the specific service by the wage index.
Xa is the labor-related portion of the national unadjusted payment
rate (wage adjusted).
Xa = .60 * (national unadjusted payment rate) * applicable wage
index.
Step 5. Calculate 40 percent (the nonlabor-related portion) of the
national unadjusted payment rate and add that amount to the resulting
product of Step 4. The result is the wage index adjusted payment rate
for the relevant wage index area.
The formula below is a mathematical representation of Step 5 and
calculates the remaining portion of the national payment rate, the
amount not attributable to labor, and the adjusted payment for the
specific service.
Y is the nonlabor-related portion of the national unadjusted
payment rate.
Y = .40 * (national unadjusted payment rate).
Adjusted Medicare Payment = Y + Xa.
Step 6. If a provider is an SCH, as set forth in the regulations at
Sec. 412.92, or an EACH, which is considered to be an SCH under
section 1886(d)(5)(D)(iii)(III) of the Act, and located in a rural
area, as defined in Sec. 412.64(b), or is treated as being located in
a rural area under Sec. 412.103, multiply the wage index adjusted
payment rate by 1.071 to calculate the total payment.
The formula below is a mathematical representation of Step 6 and
applies the rural adjustment for rural SCHs.
Adjusted Medicare Payment (SCH or EACH) = Adjusted Medicare Payment
* 1.071.
We are providing examples below of the calculation of both the full
and reduced national unadjusted payment rates that will apply to
certain outpatient items and services performed by hospitals that meet
and that fail to meet the Hospital OQR Program requirements, using the
steps outlined previously. For purposes of this
[[Page 42058]]
example, we are using a provider that is located in Brooklyn, New York
that is assigned to CBSA 35614. This provider bills one service that is
assigned to APC 5071 (Level 1 Excision/Biopsy/Incision and Drainage).
The proposed CY 2022 full national unadjusted payment rate for APC 5071
is $638.48. The proposed reduced national unadjusted payment rate for
APC 5071 for a hospital that fails to meet the Hospital OQR Program
requirements is $626.03. This proposed reduced rate is calculated by
multiplying the reporting ratio of 0.9805 by the full unadjusted
payment rate for APC 5071.
The proposed FY 2022 wage index for a provider located in CBSA
35614 in New York, which includes the proposed adoption of IPPS 2022
wage index policies, is 1.3404. The labor-related portion of the
proposed full national unadjusted payment is approximately $513.49 (.60
* $638.48 * 1.3404). The labor-related portion of the proposed reduced
national unadjusted payment is approximately $503.48 (.60 * $626.03 *
1.3404). The nonlabor-related portion of the proposed full national
unadjusted payment is approximately $255.39 (.40 * $638.48). The
nonlabor-related portion of the proposed reduced national unadjusted
payment is approximately $250.41 (.40 * $626.03). The sum of the labor-
related and nonlabor-related portions of the proposed full national
adjusted payment is approximately $768.88 ($513.49 + $255.39). The sum
of the portions of the proposed reduced national adjusted payment is
approximately $753.89 ($503.48 + $250.41).
I. Proposed Beneficiary Copayments
1. Background
Section 1833(t)(3)(B) of the Act requires the Secretary to set
rules for determining the unadjusted copayment amounts to be paid by
beneficiaries for covered OPD services. Section 1833(t)(8)(C)(ii) of
the Act specifies that the Secretary must reduce the national
unadjusted copayment amount for a covered OPD service (or group of such
services) furnished in a year in a manner so that the effective
copayment rate (determined on a national unadjusted basis) for that
service in the year does not exceed a specified percentage. As
specified in section 1833(t)(8)(C)(ii)(V) of the Act, the effective
copayment rate for a covered OPD service paid under the OPPS in CY
2006, and in CYs thereafter, shall not exceed 40 percent of the APC
payment rate.
Section 1833(t)(3)(B)(ii) of the Act provides that, for a covered
OPD service (or group of such services) furnished in a year, the
national unadjusted copayment amount cannot be less than 20 percent of
the OPD fee schedule amount. However, section 1833(t)(8)(C)(i) of the
Act limits the amount of beneficiary copayment that may be collected
for a procedure (including items such as drugs and biologicals)
performed in a year to the amount of the inpatient hospital deductible
for that year.
Section 4104 of the Affordable Care Act eliminated the Medicare
Part B coinsurance for preventive services furnished on and after
January 1, 2011, that meet certain requirements, including flexible
sigmoidoscopies and screening colonoscopies, and waived the Part B
deductible for screening colonoscopies that become diagnostic during
the procedure. Our discussion of the changes made by the Affordable
Care Act with regard to copayments for preventive services furnished on
and after January 1, 2011, may be found in section XII.B. of the CY
2011 OPPS/ASC final rule with comment period (75 FR 72013).
2. Proposed OPPS Copayment Policy
For CY 2022, we propose to determine copayment amounts for new and
revised APCs using the same methodology that we implemented beginning
in CY 2004. (We refer readers to the November 7, 2003 OPPS final rule
with comment period (68 FR 63458).) In addition, we propose to use the
same standard rounding principles that we have historically used in
instances where the application of our standard copayment methodology
would result in a copayment amount that is less than 20 percent and
cannot be rounded, under standard rounding principles, to 20 percent.
(We refer readers to the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66687) in which we discuss our rationale for applying
these rounding principles.) The proposed national unadjusted copayment
amounts for services payable under the OPPS that would be effective
January 1, 2022 are included in Addenda A and B to the proposed rule
(which are available via the internet on the CMS website).
As discussed in section XIV.E. of this proposed rule, for CY 2022,
the Medicare beneficiary's minimum unadjusted copayment and national
unadjusted copayment for a service to which a reduced national
unadjusted payment rate applies will equal the product of the reporting
ratio and the national unadjusted copayment, or the product of the
reporting ratio and the minimum unadjusted copayment, respectively, for
the service.
We note that OPPS copayments may increase or decrease each year
based on changes in the calculated APC payment rates, due to updated
cost report and claims data, and any changes to the OPPS cost modeling
process. However, as described in the CY 2004 OPPS final rule with
comment period, the development of the copayment methodology generally
moves beneficiary copayments closer to 20 percent of OPPS APC payments
(68 FR 63458 through 63459).
In the CY 2004 OPPS final rule with comment period (68 FR 63459),
we adopted a new methodology to calculate unadjusted copayment amounts
in situations including reorganizing APCs, and we finalized the
following rules to determine copayment amounts in CY 2004 and
subsequent years.
When an APC group consists solely of HCPCS codes that were
not paid under the OPPS the prior year because they were packaged or
excluded or are new codes, the unadjusted copayment amount would be 20
percent of the APC payment rate.
If a new APC that did not exist during the prior year is
created and consists of HCPCS codes previously assigned to other APCs,
the copayment amount is calculated as the product of the APC payment
rate and the lowest coinsurance percentage of the codes comprising the
new APC.
If no codes are added to or removed from an APC and, after
recalibration of its relative payment weight, the new payment rate is
equal to or greater than the prior year's rate, the copayment amount
remains constant (unless the resulting coinsurance percentage is less
than 20 percent).
If no codes are added to or removed from an APC and, after
recalibration of its relative payment weight, the new payment rate is
less than the prior year's rate, the copayment amount is calculated as
the product of the new payment rate and the prior year's coinsurance
percentage.
If HCPCS codes are added to or deleted from an APC and,
after recalibrating its relative payment weight, holding its unadjusted
copayment amount constant results in a decrease in the coinsurance
percentage for the reconfigured APC, the copayment amount would not
change (unless retaining the copayment amount would result in a
coinsurance rate less than 20 percent).
If HCPCS codes are added to an APC and, after
recalibrating its relative payment weight, holding its unadjusted
copayment amount constant results in
[[Page 42059]]
an increase in the coinsurance percentage for the reconfigured APC, the
copayment amount would be calculated as the product of the payment rate
of the reconfigured APC and the lowest coinsurance percentage of the
codes being added to the reconfigured APC.
We noted in the CY 2004 OPPS final rule with comment period that we
would seek to lower the copayment percentage for a service in an APC
from the prior year if the copayment percentage was greater than 20
percent. We noted that this principle was consistent with section
1833(t)(8)(C)(ii) of the Act, which accelerates the reduction in the
national unadjusted coinsurance rate so that beneficiary liability will
eventually equal 20 percent of the OPPS payment rate for all OPPS
services to which a copayment applies, and with section 1833(t)(3)(B)
of the Act, which achieves a 20-percent copayment percentage when fully
phased in and gives the Secretary the authority to set rules for
determining copayment amounts for new services. We further noted that
the use of this methodology would, in general, reduce the beneficiary
coinsurance rate and copayment amount for APCs for which the payment
rate changes as the result of the reconfiguration of APCs and/or
recalibration of relative payment weights (68 FR 63459).
Section 122 of the Consolidated Appropriations Act (CAA) of 2021
(Pub. L. 116-260), Waiving Medicare Coinsurance for Certain Colorectal
Cancer Screening Tests, amends section 1833(a) of the Act to offer a
special coinsurance rule for screening flexible sigmoidoscopies and
screening colonoscopies, regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for the
removal of tissue or other matter or other procedure, that is furnished
in connection with, as a result of, and in the same clinical encounter
as the colorectal cancer screening test. We refer readers to section
X.B., ``Changes to Beneficiary Coinsurance for Certain Colorectal
Cancer Screening Tests'' of this rule for additional details.
3. Proposed Calculation of an Adjusted Copayment Amount for an APC
Group
Individuals interested in calculating the national copayment
liability for a Medicare beneficiary for a given service provided by a
hospital that met or failed to meet its Hospital OQR Program
requirements should follow the formulas presented in the following
steps.
Step 1. Calculate the beneficiary payment percentage for the APC by
dividing the APC's national unadjusted copayment by its payment rate.
For example, using APC 5071, $127.70 is approximately 20 percent of the
full national unadjusted payment rate of $638.48. For APCs with only a
minimum unadjusted copayment in Addenda A and B to this proposed rule
(which are available via the internet on the CMS website), the
beneficiary payment percentage is 20 percent.
The formula below is a mathematical representation of Step 1 and
calculates the national copayment as a percentage of national payment
for a given service.
B is the beneficiary payment percentage.
B = National unadjusted copayment for APC/national unadjusted
payment rate for APC.
Step 2. Calculate the appropriate wage-adjusted payment rate for
the APC for the provider in question, as indicated in Steps 2 through 4
under section II.H. of this proposed rule. Calculate the rural
adjustment for eligible providers, as indicated in Step 6 under section
II.H. of this proposed rule.
Step 3. Multiply the percentage calculated in Step 1 by the payment
rate calculated in Step 2. The result is the wage-adjusted copayment
amount for the APC.
The formula below is a mathematical representation of Step 3 and
applies the beneficiary payment percentage to the adjusted payment rate
for a service calculated under section II.H. of this proposed rule,
with and without the rural adjustment, to calculate the adjusted
beneficiary copayment for a given service.
Wage-adjusted copayment amount for the APC = Adjusted Medicare
Payment * B.
Wage-adjusted copayment amount for the APC (SCH or EACH) =
(Adjusted Medicare Payment * 1.071) * B.
Step 4. For a hospital that failed to meet its Hospital OQR Program
requirements, multiply the copayment calculated in Step 3 by the
reporting ratio of 0.9805.
The proposed unadjusted copayments for services payable under the
OPPS that will be effective January 1, 2022, are shown in Addenda A and
B to proposed rule (which are available via the internet on the CMS
website). We note that the proposed national unadjusted payment rates
and copayment rates shown in Addenda A and B to this proposed rule
reflect the CY 2022 OPD fee schedule increase factor discussed in
section II.B. of proposed rule.
In addition, as noted earlier, section 1833(t)(8)(C)(i) of the Act
limits the amount of beneficiary copayment that may be collected for a
procedure performed in a year to the amount of the inpatient hospital
deductible for that year.
III. Proposed OPPS Ambulatory Payment Classification (APC) Group
Policies
A. Proposed OPPS Treatment of New and Revised HCPCS Codes
Payments for OPPS procedures, services, and items are generally
based on medical billing codes, specifically, HCPCS codes, that are
reported on HOPD claims. The HCPCS is divided into two principal
subsystems, referred to as Level I and Level II of the HCPCS. Level I
is comprised of CPT (Current Procedural Terminology) codes, a numeric
and alphanumeric coding system maintained by the American Medical
Association (AMA), and consists of Category I, II, and III CPT codes.
Level II, which is maintained by CMS, is a standardized coding system
that is used primarily to identify products, supplies, and services not
included in the CPT codes. HCPCS codes are used to report surgical
procedures, medical services, items, and supplies under the hospital
OPPS. Specifically, CMS recognizes the following codes on OPPS claims:
Category I CPT codes, which describe surgical procedures,
diagnostic and therapeutic services, and vaccine codes;
Category III CPT codes, which describe new and emerging
technologies, services, and procedures; and
Level II HCPCS codes (also known as alphanumeric codes),
which are used primarily to identify drugs, devices, ambulance
services, durable medical equipment, orthotics, prosthetics, supplies,
temporary surgical procedures, and medical services not described by
CPT codes.
CPT codes are established by the American Medical Association (AMA)
and the Level II HCPCS codes are established by the CMS HCPCS
Workgroup. These codes are updated and changed throughout the year. CPT
and Level II HCPCS code changes that affect the OPPS are published
through the annual rulemaking cycle and through the OPPS quarterly
update Change Requests (CRs). Generally, these code changes are
effective January 1, April 1, July 1, or October 1. CPT code changes
are released by the AMA (via their website) while Level II HCPCS code
changes are released to the public via the CMS HCPCS website. CMS
recognizes the release of new CPT and Level II HCPCS codes and makes
the
[[Page 42060]]
codes effective (that is, the codes can be reported on Medicare claims)
outside of the formal rulemaking process via OPPS quarterly update CRs.
Based on our review, we assign the new codes to interim status
indicators (SIs) and APCs. These interim assignments are finalized in
the OPPS/ASC final rules. This quarterly process offers hospitals
access to codes that more accurately describe the items or services
furnished and provides payment for these items or services in a
timelier manner than if we waited for the annual rulemaking process. We
solicit public comments on the new CPT and Level II HCPCS codes, status
indicators, and APC assignments through our annual rulemaking process.
We note that, under the OPPS, the APC assignment determines the
payment rate for an item, procedure, or service. Those items,
procedures, or services not exclusively paid separately under the
hospital OPPS are assigned to appropriate status indicators. Certain
payment status indicators provide separate payment while other payment
status indicators do not. In section XI. of this proposed rule
(Proposed CY 2022 OPPS Payment Status and Comment Indicators), we
discuss the various proposed status indicators used under the OPPS. We
also provide a complete list of proposed status indicators and their
definitions in Addendum D1 to this CY 2022 OPPS/ASC proposed rule.
1. April 2021 HCPCS Codes for Which We Are Soliciting Public Comments
in This Proposed Rule
For the April 2021 update, 26 new HCPCS codes were established and
made effective on April 1, 2021. These codes and their long descriptors
are listed in Table 5 below. Through the April 2021 OPPS quarterly
update CR (Transmittal 10666, Change Request 12175, dated March 8,
2021), we recognized several new HCPCS codes for separate payment under
the OPPS. In this CY 2022 OPPS/ASC proposed rule, we are soliciting
public comments on the proposed APC and status indicator assignments
for the codes listed Table 5. The proposed status indicator, APC
assignment, and payment rate for each HCPCS code can be found in
Addendum B to this proposed rule. The complete list of proposed status
indicators and corresponding definitions used under the OPPS can be
found in Addendum D1 to this proposed rule. These new codes that are
effective April 1, 2021 are assigned to comment indicator ``NP'' in
Addendum B to this proposed rule to indicate that the codes are
assigned to an interim APC assignment and that comments will be
accepted on their interim APC assignments. Also, the complete list of
proposed comment indicators and definitions used under the OPPS can be
found in Addendum D2 to this proposed rule. We note that OPPS Addendum
B, Addendum D1, and Addendum D2 are available via the internet on the
CMS website.
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2. July 2021 HCPCS Codes for Which We Are Soliciting Public Comments in
This Proposed Rule
For the July 2021 update, 55 new codes were established and made
effective July 1, 2021. The codes and long descriptors are listed in
Table 6 below. Through the July 2021 OPPS quarterly update CR
(Transmittal 10825, Change Request 12316, dated June 11, 2021), we
recognized several new codes for separate payment and assigned them to
appropriate interim OPPS status indicators and APCs. In this CY 2022
OPPS/ASC proposed rule, we are
[[Page 42063]]
soliciting public comments on the proposed APC and status indicator
assignments for the codes implemented on July 1, 2021, all of which are
listed in Table 6. The proposed status indicator, APC assignment, and
payment rate for each HCPCS code can be found in Addendum B to this
proposed rule. The complete list of proposed status indicators and
corresponding definitions used under the OPPS can be found in Addendum
D1 to this proposed rule. These new codes that are effective July 1,
2021 are assigned to comment indicator ``NP'' in Addendum B to this
proposed rule to indicate that the codes are assigned to an interim APC
assignment and that comments will be accepted on their interim APC
assignments. Also, the complete list of proposed comment indicators and
definitions used under the OPPS can be found in Addendum D2 to this
proposed rule. We note that OPPS Addendum B, Addendum D1, and Addendum
D2 are available via the internet on the CMS website.
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3. October 2021 HCPCS Codes for Which We Will Be Soliciting Public
Comments in the CY 2022 OPPS/ASC Final Rule With Comment Period
As has been our practice in the past, we will solicit comments on
the new CPT and Level II HCPCS codes that will be effective October 1,
2021 in the CY 2022 OPPS/ASC final rule with comment period, thereby
allowing us to finalize the status indicators and APC assignments for
the codes in the CY 2023 OPPS/ASC final rule with comment period. The
HCPCS codes will be released to the public through the October 2021
OPPS Update CR and the CMS HCPCS website while the CPT codes will be
released to the public through the AMA website.
For CY 2022, we are proposing to continue our established policy of
assigning comment indicator ``NI'' in Addendum B to the OPPS/ASC final
rule with comment period to those new HCPCS codes that are effective
October 1, 2021 to indicate that we are assigning them an interim
status indicator, which is subject to public comment. We will be
inviting public comments in the CY 2022 OPPS/ASC final rule with
comment period on the status indicator and APC assignments, which would
then be finalized in the CY 2023 OPPS/ASC final rule with comment
period.
4. January 2022 HCPCS Codes
a. New Level II HCPCS Codes for Which We Will Be Soliciting Public
Comments in the CY 2022 OPPS/ASC Final Rule With Comment Period
Consistent with past practice, we will solicit comments on the new
Level II HCPCS codes that will be effective January 1, 2022 in the CY
2022 OPPS/ASC final rule with comment period, thereby allowing us to
finalize the status indicators and APC assignments for the codes in the
CY 2023 OPPS/ASC final rule with comment period. Unlike the CPT codes
that are effective January 1 and are included in the OPPS/ASC proposed
rules, and except for the G-codes listed in Addendum O of this proposed
rule, most Level II HCPCS codes are not released until sometime around
November to be effective January 1. Because these codes are not
available until November, we are unable to include them in the OPPS/ASC
proposed rules. Consequently, for CY 2022, we propose to include in
Addendum B to the CY 2022 OPPS/ASC final rule with comment period the
new Level II HCPCS codes effective January 1, 2022 that would be
incorporated in the January 2022 OPPS quarterly update CR. These codes
will be released to the public through the January OPPS quarterly
update CRs and via the CMS HCPCS website (for Level II HCPCS codes).
For CY 2022, we are proposing to continue our established policy of
assigning comment indicator ``NI'' in Addendum B to the OPPS/ASC final
rule with comment period to the new HCPCS codes that will be effective
January 1, 2022 to indicate that we are assigning them an interim
status indicator, which is subject to public comment. We will be
inviting public comments in the CY 2022 OPPS/ASC final rule with
comment period on the status indicator and APC assignments, which would
then be finalized in the CY 2023 OPPS/ASC final rule with comment
period.
b. CPT Codes for Which We Are Soliciting Public Comments in This
Proposed Rule
In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66841
through 66844), we finalized a revised process of assigning APC and
status indicators for new and revised Category I and III CPT codes that
would be effective January 1. Specifically, for the new/revised CPT
codes that we receive in a timely manner from the AMA's CPT Editorial
Panel, we finalized our proposal to include the codes that would be
effective January 1 in the OPPS/ASC proposed rules, along with proposed
APC and status indicator assignments for them, and to finalize the APC
and status indicator assignments in the OPPS/ASC final rules beginning
with the CY 2016 OPPS update. For those new/revised CPT codes that were
received too late for inclusion in the OPPS/ASC proposed rule, we
finalized our proposal to establish and use HCPCS G-codes that mirror
the predecessor CPT codes and retain the
[[Page 42069]]
current APC and status indicator assignments for a year until we can
propose APC and status indicator assignments in the following year's
rulemaking cycle. We note that even if we find that we need to create
HCPCS G-codes in place of certain CPT codes for the PFS proposed rule,
we do not anticipate that these HCPCS G-codes will always be necessary
for OPPS purposes. We will make every effort to include proposed APC
and status indicator assignments for all new and revised CPT codes that
the AMA makes publicly available in time for us to include them in the
proposed rule, and to avoid resorting to use of HCPCS G-codes and the
resulting delay in utilization of the most current CPT codes. Also, we
finalized our proposal to make interim APC and status indicator
assignments for CPT codes that are not available in time for the
proposed rule and that describe wholly new services (such as new
technologies or new surgical procedures), to solicit public comments in
the final rule, and to finalize the specific APC and status indicator
assignments for those codes in the following year's final rule.
For the CY 2022 OPPS update, we received the CPT codes that will be
effective January 1, 2022 from the AMA in time to be included in this
proposed rule. The new, revised, and deleted CPT codes can be found in
Addendum B to this proposed rule (which is available via the internet
on the CMS website). We note that the new and revised CPT codes are
assigned to comment indicator ``NP'' in Addendum B of this proposed
rule to indicate that the code is new for the next calendar year or the
code is an existing code with substantial revision to its code
descriptor in the next calendar year as compared to the current
calendar year with a proposed APC assignment, and that comments will be
accepted on the proposed APC assignment and status indicator.
Further, we note that the CPT code descriptors that appear in
Addendum B are short descriptors and do not accurately describe the
complete procedure, service, or item described by the CPT code.
Therefore, we are including the 5-digit placeholder codes and the long
descriptors for the new and revised CY 2022 CPT codes in Addendum O to
this proposed rule (which is available via the internet on the CMS
website) so that the public can adequately comment on our proposed APCs
and status indicator assignments. The 5-digit placeholder codes can be
found in Addendum O, specifically under the column labeled ``CY 2022
OPPS/ASC Proposed Rule 5-Digit AMA Placeholder Code''. The final CPT
code numbers will be included in the CY 2022 OPPS/ASC final rule with
comment period.
In summary, we are soliciting public comments on the proposed CY
2022 status indicators and APC assignments for the new and revised CPT
codes that will be effective January 1, 2022. Because the CPT codes
listed in Addendum B appear with short descriptors only, we list them
again in Addendum O to this proposed rule with long descriptors. In
addition, we are proposing to finalize the status indicator and APC
assignments for these codes (with their final CPT code numbers) in the
CY 2022 OPPS/ASC final rule with comment period. The proposed status
indicator and APC assignment for these codes can be found in Addendum B
to this proposed rule (which is available via the internet on the CMS
website).
Finally, in Table 7 below, we summarize our current process for
updating codes through our OPPS quarterly update CRs, seeking public
comments, and finalizing the treatment of these codes under the OPPS.
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B. Proposed OPPS Changes--Variations Within APCs
1. Background
Section 1833(t)(2)(A) of the Act requires the Secretary to develop
a classification system for covered hospital outpatient department
services. Section 1833(t)(2)(B) of the Act provides that the Secretary
may establish groups of covered OPD services within this classification
system, so that services classified within each group are comparable
clinically and with respect to the use of resources. In accordance with
these provisions, we developed a grouping classification system,
referred to as Ambulatory Payment Classifications (APCs), as set forth
in regulations at 42 CFR[thinsp]419.31. We use Level I (also known as
CPT codes) and Level II HCPCS codes (also known as alphanumeric codes)
to identify and group the services within each APC. The APCs are
organized such that each group is homogeneous both clinically and in
terms of resource use. Using this classification system, we have
established distinct groups of similar services. We also have developed
separate APC groups for certain medical devices, drugs, biologicals,
therapeutic radiopharmaceuticals, and brachytherapy devices that are
not packaged into the payment for the procedure.
We have packaged into the payment for each procedure or service
within an APC group the costs associated with those items and services
that are typically ancillary and supportive to a primary diagnostic or
therapeutic modality and, in those cases, are an integral part of the
primary service they support. Therefore, we do not make separate
payment for these packaged items or services. In general, packaged
items and services include, but are not limited to, the items and
services listed in regulations at 42 CFR 419.2(b). A further discussion
of packaged services is included in section II.A.3. of this proposed
rule.
Under the OPPS, we generally pay for covered hospital outpatient
services on a rate-per-service basis, where the service may be reported
with one or more HCPCS codes. Payment varies according to the APC group
to which the independent service or combination of services is
assigned. For CY 2022, we propose that each APC relative payment weight
represents the hospital cost of the services included in that APC,
relative to the hospital cost of the services included in APC 5012
(Clinic Visits and Related Services). The APC relative payment weights
are scaled to APC 5012 because it is the hospital clinic visit APC and
clinic visits are among the most frequently furnished services in the
hospital outpatient setting.
2. Application of the 2 Times Rule
Section 1833(t)(9)(A) of the Act requires the Secretary to review,
not less often than annually, and revise the APC groups, the relative
payment weights, and the wage and other adjustments described in
paragraph (2) to take into account changes in medical practice, changes
in technology, the addition of new services, new cost data, and other
relevant information and factors. Section 1833(t)(9)(A) of the Act also
requires the Secretary to consult with an expert outside advisory panel
composed of an appropriate selection of representatives of providers to
review (and advise the Secretary concerning)
[[Page 42071]]
the clinical integrity of the APC groups and the relative payment
weights. We note that the HOP Panel recommendations for specific
services for the CY 2022 OPPS update will be discussed in the relevant
specific sections throughout the CY 2022 OPPS/ASC final rule with
comment period.
In addition, section 1833(t)(2) of the Act provides that, subject
to certain exceptions, the items and services within an APC group
cannot be considered comparable with respect to the use of resources if
the highest cost for an item or service in the group is more than 2
times greater than the lowest cost for an item or service within the
same group (referred to as the ``2 times rule''). The statute
authorizes the Secretary to make exceptions to the 2 times rule in
unusual cases, such as for low-volume items and services (but the
Secretary may not make such an exception in the case of a drug or
biological that has been designated as an orphan drug under section 526
of the Federal Food, Drug, and Cosmetic Act). In determining the APCs
with a 2 times rule violation, we consider only those HCPCS codes that
are significant based on the number of claims. We note that, for
purposes of identifying significant procedure codes for examination
under the 2 times rule, we consider procedure codes that have more than
1,000 single major claims or procedure codes that both have more than
99 single major claims and contribute at least 2 percent of the single
major claims used to establish the APC cost to be significant (75 FR
71832). This longstanding definition of when a procedure code is
significant for purposes of the 2 times rule was selected because we
believe that a subset of 1,000 or fewer claims is negligible within the
set of approximately 100 million single procedure or single session
claims we use for establishing costs. Similarly, a procedure code for
which there are fewer than 99 single claims and that comprises less
than 2 percent of the single major claims within an APC will have a
negligible impact on the APC cost (75 FR 71832). In this section of
this proposed rule, for CY 2022, we propose to make exceptions to this
limit on the variation of costs within each APC group in unusual cases,
such as for certain low-volume items and services.
For the CY 2022 OPPS update, we have identified the APCs with
violations of the 2 times rule. Therefore, we propose changes to the
procedure codes assigned to these APCs in Addendum B to this proposed
rule. We note that Addendum B does not appear in the printed version of
the Federal Register as part of this CY 2022 OPPS/ASC proposed rule.
Rather, it is published and made available via the internet on the CMS
website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. To eliminate a violation of
the 2 times rule and improve clinical and resource homogeneity, we
propose to reassign these procedure codes to new APCs that contain
services that are similar with regard to both their clinical and
resource characteristics. In many cases, the proposed procedure code
reassignments and associated APC reconfigurations for CY 2022 included
in this proposed rule are related to changes in costs of services that
were observed in the CY 2019 claims data available for CY 2022
ratesetting. Addendum B to this CY 2021 OPPS/ASC proposed rule
identifies with a comment indicator ``CH'' those procedure codes for
which we propose a change to the APC assignment or status indicator, or
both, that were initially assigned in the July 1, 2021 OPPS Addendum B
Update (available via the internet on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates.html).
3. Proposed APC Exceptions to the 2 Times Rule
Taking into account the APC changes that we propose to make for CY
2022, we reviewed all of the APCs to determine which APCs would not
meet the requirements of the 2 times rule. We used the following
criteria to evaluate whether to propose exceptions to the 2 times rule
for affected APCs:
Resource homogeneity;
Clinical homogeneity;
Hospital outpatient setting utilization;
Frequency of service (volume); and
Opportunity for upcoding and code fragments.
Based on the CY 2019 claims data available for this CY 2022
proposed rule, we found 23 APCs with violations of the 2 times rule. We
applied the criteria as described above to identify the APCs for which
we propose to make exceptions under the 2 times rule for CY 2022, and
found that all of the 23 APCs we identified meet the criteria for an
exception to the 2 times rule based on the CY 2019 claims data
available for this proposed rule. We did not include in that
determination those APCs where a 2 times rule violation was not a
relevant concept, such as APC 5401 (Dialysis), which only has two HCPCS
codes assigned to it that have similar geometric mean costs and do not
create a 2 times rule violation. Therefore, we have only identified
those APCs, including those with criteria-based costs, such as device-
dependent CPT/HCPCS codes, with violations of the 2 times rule.
We note that, for cases in which a recommendation by the HOP Panel
appears to result in or allow a violation of the 2 times rule, we may
accept the HOP Panel's recommendation because those recommendations are
based on explicit consideration (that is, a review of the latest OPPS
claims data and group discussion of the issue) of resource use,
clinical homogeneity, site of service, and the quality of the claims
data used to determine the APC payment rates.
Table 8 of this proposed rule lists the 23 APCs for which we
propose to make an exception under the 2 times rule for CY 2021 based
on the criteria cited above and claims data submitted between January
1, 2019, and December 31, 2019, and processed on or before June 30,
2020, and updated CCRs, if available. The proposed geometric mean costs
for covered hospital outpatient services for these and all other APCs
that were used in the development of this proposed rule can be found on
the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.
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BILLING CODE 4120-01-C
C. Proposed New Technology APCs
1. Background
In the CY 2002 OPPS final rule (66 FR 59903), we finalized changes
to the time period in which a service can be eligible for payment under
a New Technology APC. Beginning in CY 2002, we retain services within
New Technology APC groups until we gather sufficient claims data to
enable us to assign the service to an appropriate clinical APC. This
policy allows us to move a service from a New Technology APC in less
than 2 years if sufficient data are available. It also allows us to
retain a service in a New Technology APC for more than 2 years if
sufficient data upon which to base a decision for reassignment have not
been collected.
In the CY 2004 OPPS final rule with comment period (68 FR 63416),
we restructured the New Technology APCs to make the cost intervals more
consistent across payment levels and refined the cost bands for these
APCs to retain two parallel sets of New Technology APCs, one set with a
status indicator of ``S'' (Significant Procedures, Not Discounted when
Multiple. Paid under OPPS; separate APC payment) and the other set with
a status indicator of ``T'' (Significant Procedure, Multiple Reduction
Applies. Paid under OPPS; separate APC payment). These current New
Technology APC configurations allow us to price new technology services
more appropriately and consistently.
For CY 2021, there were 52 New Technology APC levels, ranging from
the lowest cost band assigned to APC 1491 (New Technology--Level 1A
($0-$10)) through the highest cost band assigned to APC 1908 (New
Technology--Level 52 ($145,001-$160,000)). We note that the cost bands
for the New Technology APCs, specifically, APCs 1491 through 1599 and
1901 through 1908, vary with increments ranging from $10 to $14,999.
These cost bands identify the APCs to which new technology procedures
and services with estimated service costs that fall within those cost
bands are assigned under the OPPS. Payment for each APC is made at the
mid-point of the APC's assigned cost band. For example, payment for New
Technology APC 1507 (New Technology--Level 7 ($501--$600)) is made at
$550.50.
Under the OPPS, one of our goals is to make payments that are
appropriate for the services that are necessary for the treatment of
Medicare beneficiaries. The OPPS, like other Medicare payment systems,
is budget neutral and increases are limited to the annual hospital
market basket increase reduced by the productivity adjustment. We
believe that our payment rates reflect the costs that are associated
with providing care to Medicare beneficiaries and are adequate to
ensure access to services (80 FR 70374).
For many emerging technologies, there is a transitional period
during
[[Page 42073]]
which utilization may be low, often because providers are first
learning about the technologies and their clinical utility. Quite
often, parties request that Medicare make higher payments under the New
Technology APCs for new procedures in that transitional phase. These
requests, and their accompanying estimates for expected total patient
utilization, often reflect very low rates of patient use of expensive
equipment, resulting in high per-use costs for which requesters believe
Medicare should make full payment. Medicare does not, and we believe
should not, assume responsibility for more than its share of the costs
of procedures based on projected utilization for Medicare beneficiaries
and does not set its payment rates based on initial projections of low
utilization for services that require expensive capital equipment. For
the OPPS, we rely on hospitals to make informed business decisions
regarding the acquisition of high-cost capital equipment, taking into
consideration their knowledge about their entire patient base (Medicare
beneficiaries included) and an understanding of Medicare's and other
payers' payment policies. We refer readers to the CY 2013 OPPS/ASC
final rule with comment period (77 FR 68314) for further discussion
regarding this payment policy.
We note that, in a budget-neutral system, payments may not fully
cover hospitals' costs in a particular circumstance, including those
for the purchase and maintenance of capital equipment. We rely on
hospitals to make their decisions regarding the acquisition of high-
cost equipment with the understanding that the Medicare program must be
careful to establish its initial payment rates, including those made
through New Technology APCs, for new services that lack hospital claims
data based on realistic utilization projections for all such services
delivered in cost-efficient hospital outpatient settings. As the OPPS
acquires claims data regarding hospital costs associated with new
procedures, we regularly examine the claims data and any available new
information regarding the clinical aspects of new procedures to confirm
that our OPPS payments remain appropriate for procedures as they
transition into mainstream medical practice (77 FR 68314). For CY 2022,
we included the proposed payment rates for New Technology APCs 1491 to
1599 and 1901 through 1908 in Addendum A to this CY 2022 OPPS/ASC
proposed rule (which is available via the internet on the CMS website).
2. Establishing Payment Rates for Low-Volume New Technology Services
Services that are assigned to New Technology APCs are typically new
services that do not have sufficient claims history to establish an
accurate payment for the services. One of the objectives of
establishing New Technology APCs is to generate sufficient claims data
for a new service so that it can be assigned to an appropriate clinical
APC. Some services that are assigned to New Technology APCs have very
low annual volume, which we consider to be fewer than 100 claims. We
consider services with fewer than 100 claims annually to be low-volume
services because there is a higher probability that the payment data
for a service may not have a normal statistical distribution, which
could affect the quality of our standard cost methodology that is used
to assign services to an APC. In addition, services with fewer than 100
claims per year are not generally considered to be a significant
contributor to the APC ratesetting calculations and, therefore, are not
included in the assessment of the 2 times rule. As we explained in the
CY 2019 OPPS/ASC final rule with comment period (83 FR 58890), we were
concerned that the methodology we use to estimate the cost of a service
under the OPPS by calculating the geometric mean for all separately
paid claims for a HCPCS service code from the most recent available
year of claims data may not generate an accurate estimate of the actual
cost of the service for these low-volume services.
In accordance with section 1833(t)(2)(B) of the Act, services
classified within each APC must be comparable clinically and with
respect to the use of resources. As described earlier, assigning a
service to a New Technology APC allows us to gather claims data to
price the service and assign it to the APC with services that use
similar resources and are clinically comparable. However, where
utilization of services assigned to a New Technology APC is low, it can
lead to wide variation in payment rates from year to year, resulting in
even lower utilization and potential barriers to access to new
technologies, which ultimately limits our ability to assign the service
to the appropriate clinical APC. To mitigate these issues, we
determined in the CY 2019 OPPS/ASC final rule with comment period that
it was appropriate to utilize our equitable adjustment authority at
section 1833(t)(2)(E) of the Act to adjust how we determined the costs
for low-volume services assigned to New Technology APCs (83 FR 58892
through 58893). We have utilized our equitable adjustment authority at
section 1833(t)(2)(E) of the Act, which states that the Secretary shall
establish, in a budget neutral manner, other adjustments as determined
to be necessary to ensure equitable payments, to estimate an
appropriate payment amount for low-volume new technology services in
the past (82 FR 59281). Although we have used this adjustment authority
on a case-by-case basis in the past, we stated in the CY 2019 OPPS/ASC
final rule with comment period that we believed it was appropriate to
adopt an adjustment for low-volume services assigned to New Technology
APCs in order to mitigate the wide payment fluctuations that have
occurred for new technology services with fewer than 100 claims and to
provide more predictable payment for these services.
For purposes of this adjustment, we stated that we believed that it
was appropriate to use up to 4 years of claims data in calculating the
applicable payment rate for the prospective year, rather than using
solely the most recent available year of claims data, when a service
assigned to a New Technology APC has a low annual volume of claims,
which, for purposes of this adjustment, we defined as fewer than 100
claims annually. We adopted a policy to consider services with fewer
than 100 claims annually as low-volume services because there is a
higher probability that the payment data for a service may not have a
normal statistical distribution, which could affect the quality of our
standard cost methodology that is used to assign services to an APC. We
explained that we were concerned that the methodology we use to
estimate the cost of a service under the OPPS by calculating the
geometric mean for all separately paid claims for a HCPCS procedure
code from the most recent available year of claims data may not
generate an accurate estimate of the actual cost of the low-volume
service. Using multiple years of claims data will potentially allow for
more than 100 claims to be used to set the payment rate, which would,
in turn, create a more statistically reliable payment rate.
In addition, to better approximate the cost of a low-volume service
within a New Technology APC, we stated that we believed using the
median or arithmetic mean rather than the geometric mean (which
``trims'' the costs of certain claims out) could be more appropriate in
some circumstances, given the extremely low volume of claims. Low claim
volumes increase the impact of ``outlier'' claims; that is, claims with
either a very low or very high payment
[[Page 42074]]
rate as compared to the average claim, which would have a substantial
impact on any statistical methodology used to estimate the most
appropriate payment rate for a service. We also explained that we
believed having the flexibility to utilize an alternative statistical
methodology to calculate the payment rate in the case of low-volume new
technology services would help to create a more stable payment rate.
Therefore, in the CY 2019 OPPS/ASC final rule with comment period (83
FR 58893), we established that, in each of our annual rulemakings, we
would seek public comments on which statistical methodology should be
used for each low-volume service assigned to a New Technology APC. In
the preamble of each annual rulemaking, we stated that we would present
the result of each statistical methodology and solicit public comment
on which methodology should be used to establish the payment rate for a
low-volume new technology service. In addition, we explained that we
would use our assessment of the resources used to perform a service and
guidance from the developer or manufacturer of the service, as well as
other stakeholders, to determine the most appropriate payment rate.
Once we identified the most appropriate payment rate for a service, we
would assign the service to the New Technology APC with the cost band
that includes its payment rate.
For CY 2022, we propose to continue to utilize our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to
calculate the geometric mean, arithmetic mean, and median using up to
four years of claims data to select the appropriate payment rate for
purposes of assigning services with fewer than 100 claims per year to a
New Technology APC. However, we propose to utilize our equitable
adjustment authority through our proposed universal low volume APC
policy described in section X.C. of this proposed rule. Our proposed
universal low volume APC policy is similar to our current New
Technology APC low volume policy with the difference between the two
policies being that the universal low volume APC policy would apply to
clinical APCs and brachytherapy APCs, in addition to New Technology
APCs, and would use the highest of the geometric mean, arithmetic mean,
or median based on up to four years of claims data to set the payment
rate for the APC. For New Technology APCs with fewer than 100 single
claims at the procedure level that can be used for ratesetting, we
would apply our proposed methodology for determining a low volume APC's
cost, choosing the ``greatest of'' the median, arithmetic mean, or
geometric mean at the procedure level, to apply to the individual
services assigned to New Technology APCs and provide the final New
Technology APC assignment for each procedure. We propose to end our
separate New Technology APC low volume policy if we adopt the proposed
universal low volume APC policy, as it also applies to New Technology
APCs.
3. Procedures Assigned to New Technology APC Groups for CY 2022
As we described in the CY 2002 OPPS final rule with comment period
(66 FR 59902), we generally retain a procedure in the New Technology
APC to which it is initially assigned until we have obtained sufficient
claims data to justify reassignment of the procedure to a clinically
appropriate APC. In addition, in cases where we find that our initial
New Technology APC assignment was based on inaccurate or inadequate
information (although it was the best information available at the
time), where we obtain new information that was not available at the
time of our initial New Technology APC assignment, or where the New
Technology APCs are restructured, we may, based on more recent resource
utilization information (including claims data) or the availability of
refined New Technology APC cost bands, reassign the procedure or
service to a different New Technology APC that more appropriately
reflects its cost (66 FR 59903).
Consistent with our current policy, for CY 2022, we propose to
retain services within New Technology APC groups until we obtain
sufficient claims data to justify reassignment of the service to an
appropriate clinical APC. The flexibility associated with this policy
allows us to reassign a service from a New Technology APC in less than
2 years if we have not obtained sufficient claims data. It also allows
us to retain a service in a New Technology APC for more than 2 years if
we have not obtained sufficient claims data upon which to base a
reassignment decision (66 FR 59902).
a. Retinal Prosthesis Implant Procedure
CPT code 0100T (Placement of a subconjunctival retinal prosthesis
receiver and pulse generator, and implantation of intra-ocular retinal
electrode array, with vitrectomy) describes the implantation of a
retinal prosthesis, specifically, a procedure involving the use of the
Argus[supreg] II Retinal Prosthesis System. This first retinal
prosthesis was approved by FDA in 2013 for adult patients diagnosed
with severe to profound retinitis pigmentosa. For information on the
utilization and payment history of the Argus[supreg] II procedure and
the Argus[supreg] II device prior to CY 2020, please refer to the CY
2021 OPPS final rule (85 FR 85937 through 85938).
For CY 2020, we identified 35 claims reporting the procedure
described by CPT code 0100T for the 4-year period of CY 2015 through CY
2018. We found the geometric mean cost for the procedure described by
CPT code 0100T to be approximately $146,059, the arithmetic mean cost
to be approximately $152,123, and the median cost to be approximately
$151,267. All of the resulting estimates from using the three
statistical methodologies fell within the same New Technology APC cost
band ($145,001- $160,000), where the Argus[supreg] II procedure was
assigned for CY 2019. Consistent with our policy stated in section
III.C.2, we presented the result of each statistical methodology in the
proposed rule, and we sought public comments on which method should be
used to assign procedures described by CPT code 0100T to a New
Technology APC. All three potential statistical methodologies used to
estimate the cost of the Argus[supreg] II procedure fell within the
cost band for New Technology APC 1908, with the estimated cost being
between $145,001 and $160,000. Accordingly, we assigned CPT code 0100T
in APC 1908 (New Technology--Level 52 ($145,001-$160,000)), with a
payment rate of $152,500.50 for CY 2020.
For CY 2021, the number of reported claims for the Argus[supreg] II
procedure continued to be very low with a substantial fluctuation in
cost from year to year. The high annual variability of the cost of the
Argus[supreg] II procedure continued to make it difficult to establish
a consistent and stable payment rate for the procedure. As previously
mentioned, in accordance with section 1833(t)(2)(B) of the Act, we are
required to establish that services classified within each APC are
comparable clinically and with respect to the use of resources. We
identified 35 claims reporting the procedure described by CPT code
0100T for the 4-year period of CY 2016 through CY 2019. We found the
geometric mean cost for the procedure described by CPT code 0100T to be
approximately $148,148, the arithmetic mean cost to be approximately
$153,682, and the median cost to be approximately $151,974. All three
potential statistical methodologies used to estimate the cost of the
Argus[supreg] II procedure fell within
[[Page 42075]]
the cost band for New Technology APC 1908, with the estimated cost
being between $145,001 and $160,000, and accordingly, we assigned the
Argus II procedure to New Technology APC 1908 for CY 2021.
For 2022, we propose to utilize our equitable adjustment authority
under section 1833(t)(2)(E) of the Act to establish the universal low
volume APC policy described in section X.C. of this proposed rule.
Consistent with this proposed policy, we calculated the geometric mean,
arithmetic mean, and median costs using multiple years of claims data
to select the appropriate payment rate for purposes of assigning the
Argus[supreg] II procedure (CPT code 0100T) to a New Technology APC. We
propose to use claims data from CY 2016 through CY 2019, which are the
last four years of available OPPS claims data that we believe are
appropriate for ratesetting, to determine the proposed payment rate for
the Argus[supreg] II procedure for CY 2022. The claims data are the
same 35 claims that were used to determine the payment rate for CPT
code 0100T in CY 2021, and the estimates of the geometric mean
($148,148), the arithmetic mean ($153,682), and the median ($151,974)
are the same as the estimates for CY 2021. All three potential
statistical methodologies used to estimate the cost of the
Argus[supreg] II procedure are within the cost band for New Technology
APC 1908, with the proposed payment rate being between $145,001 and
$160,000. Accordingly, we propose to continue to assign the
Argus[supreg] II procedure to New Technology APC 1908 for CY 2022.
Please see Table 9 below for the proposed OPPS APC and status indicator
for the Argus[supreg] II procedure (CPT code 0100T) for CY 2022.
[GRAPHIC] [TIFF OMITTED] TP04AU21.017
b. Administration of Subretinal Therapies Requiring Vitrectomy (APC
1561)
Effective January 1, 2021, CMS established HCPCS code C9770
(Vitrectomy, mechanical, pars plana approach, with subretinal injection
of pharmacologic/biologic agent) and assigned it to a New Technology
APC based on the geometric mean cost of HCPCS code 67036. For CY 2021,
HCPCS code C9770 was assigned to APC 1561 (New Technology--Level 24
($3001-$3500)). This procedure may be used to describe the
administration of CPT code J3398 (Injection, voretigene neparvovec-
rzyl, 1 billion vector genomes). This procedure was previously
discussed in the CY 2021 OPPS/ASC Final Rule with comment period (85 FR
85939-85940).
CPT code J3398 (Injection, voretigene neparvovec-rzyl, 1 billion
vector genomes) is a gene therapy for a rare mutation-associated
retinal dystrophy. Voretigene neparvovec-rzyl (Luxturna[supreg]), was
approved by FDA in December of 2017, and is indicated as an adeno-
associated virus vector-based gene therapy indicated for the treatment
of patients with confirmed biallelic RPE65 mutation-associated retinal
dystrophy.\6\ This therapy is administered through a subretinal
injection, which stakeholders describe as an extremely delicate and
sensitive surgical procedure. The FDA package insert describes one of
the steps for administering Luxturna as, ``after completing a
vitrectomy, identify the intended site of administration. The
subretinal injection can be introduced via pars plana.''
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\6\ Luxturna. FDA Package Insert. Available: https://www.fda.gov/media/109906/download.
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Stakeholders, including the manufacturer of Luxturna[supreg],
recommended HCPCS code 67036 (Vitrectomy, mechanical, pars plana
approach) for the administration of the gene therapy.\7\ However, the
manufacturer previously contended the administration was not accurately
described by any existing codes as HCPCS code 67036 (Vitrectomy,
mechanical, pars plana approach) does not account for the
administration itself.
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\7\ LUXTURNA REIMBURSEMENT GUIDE FOR TREATMENT CENTERS. https://mysparkgeneration.com/pdf/Reimbursement_Guide_for_Treatment_Centers_Interactive_010418_FINAL.pdf.
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CMS recognized the need to accurately describe the unique
administration procedure that is required to administer the therapy
described by HCPCS code J3398. Therefore, in the CY 2021 OPPS/ASC
proposed rule (85 FR 48832), we proposed to establish a new HCPCS code,
C97X1 (Vitrectomy, mechanical, pars plana approach, with subretinal
injection of pharmacologic/biologic agent) to describe this process. We
stated that we believed that this new HCPCS code accurately described
the unique service associated with intraocular administration of HCPCS
code J3398. We recognized that HCPCS code 67036 represents a clinically
similar procedure and process that approximates similar resource
utilization that is associated with C97X1. However, we also recognized
that it is not prudent for the code that describes the administration
of this unique gene therapy, C97X1, to be assigned to the same C-APC to
which HCPCS code 67036 is assigned, as this would package the primary
therapy, HCPCS code J3398, into the code that represents the process to
administer the gene therapy.
Therefore, for CY 2021, we proposed to assign the services
described by C97X1 to a New Technology APC with
[[Page 42076]]
a cost band that contains the geometric mean cost for HCPCS code 67036.
The placeholder code C97X1 was replaced by C9770 in the final rule. For
CY 2021, we finalized our proposal to create C9770 (Vitrectomy,
mechanical, pars plana approach, with subretinal injection of
pharmacologic/biologic agent), and we assigned this code to APC 1561
(New Technology--Level 24 ($3001-$3500)) using the geometric mean cost
of HCPCS code 67036. See Table 10 for the finalized descriptor and APC
assignment of HCPCS code C9770 for CY 2021.
For CY 2022, we are proposing to continue our policy from CY 2021
to assign the services described by HCPCS code C9770 to a New
Technology APC with a cost band that contains the geometric mean cost
for HCPCS code 67036. We propose to continue to assign the services
described by C9770 to a New Technology APC with a payment band based on
the geometric mean cost for HCPCS code 67036 based on its geometric
mean cost using CY 2019 claims data for CY 2022. Based on this data,
the geometric mean cost of HCPCS code 67036 is $3,434.91. Therefore, we
propose to assign C9770 to the corresponding New Technology APC payment
band, APC 1561 New Technology--Level 24 ($3001-$3500) with a payment
rate of $3250.50. Please see Table 10 below for the proposed OPPS APC
and status indicator for HCPCS code C9770 for CY 2022.
[GRAPHIC] [TIFF OMITTED] TP04AU21.018
c. Bronchoscopy With Transbronchial Ablation of Lesion(s) by Microwave
Energy
Effective January 1, 2019, CMS established HCPCS code C9751
(Bronchoscopy, rigid or flexible, transbronchial ablation of lesion(s)
by microwave energy, including fluoroscopic guidance, when performed,
with computed tomography acquisition(s) and 3-D rendering, computer-
assisted, image-guided navigation, and endobronchial ultrasound (EBUS)
guided transtracheal and/or transbronchial sampling (for example,
aspiration[s]/biopsy[ies]) and all mediastinal and/or hilar lymph node
stations or structures and therapeutic intervention(s)). This microwave
ablation procedure utilizes a flexible catheter to access the lung
tumor via a working channel and may be used as an alternative procedure
to a percutaneous microwave approach. Based on our review of the New
Technology APC application for this service and the service's clinical
similarity to existing services paid under the OPPS, we estimated the
likely cost of the procedure would be between $8,001 and $8,500.
In claims data available for CY 2019 for the CY 2021 OPPS/ASC final
rule with comment period, there were 4 claims reported for bronchoscopy
with transbronchial ablation of lesions by microwave energy. Given the
low volume of claims for the service, we proposed for CY 2021 to apply
the policy we adopted in CY 2019, under which we utilize our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to
calculate the geometric mean, arithmetic mean, and median costs to
calculate an appropriate payment rate for purposes of assigning
bronchoscopy with transbronchial ablation of lesions by microwave
energy to a New Technology APC. We found the geometric mean cost for
the service to be approximately $2,693, the arithmetic mean cost to be
approximately $3,086, and the median cost to be approximately $3,708.
The median was the statistical methodology that estimated the highest
cost for the service and provided a reasonable estimate of the midpoint
cost of the three claims that have been paid for this service. The
payment rate calculated using this methodology fell within the cost
band for New Technology APC 1562 (New Technology--Level 25 ($3,501-
$4,000)). Therefore, we assigned HCPCS code C9751 to APC 1562 for CY
2021.
For CY 2022, the only available claims for HCPCS code C9751 are
from CY 2019. Therefore, we are proposing given the low number of
claims for this procedure to utilize our equitable adjustment authority
under section 1833(t)(2)(E) of the Act to calculate the geometric mean,
arithmetic mean, and median costs to calculate an appropriate payment
rate for purposes of assigning bronchoscopy with transbronchial
ablation of lesions by microwave energy to a New Technology APC,
consistent with our proposed universal low volume APC policy. Because
we are using the same claims as we did for CY 2021, we found the same
values for the geometric mean cost, arithmetic mean cost, and the
median cost for CY 2022. Once again, the median was the statistical
methodology that estimated the highest cost for the service and
provides a reasonable estimate of the midpoint cost of the three claims
that have been paid for this service. The payment rate calculated using
this methodology falls again within the cost band for New Technology
APC 1562 (New Technology--Level 25 ($3,501-$4,000)). Therefore, we
propose to continue to assign HCPCS code C9751 to APC 1562 (New
Technology--Level 25 ($3,501-$4,000)), with a proposed payment rate of
$3,750.50 for CY 2022. Details regarding HCPCS code C9751 are included
in Table 11.
[[Page 42077]]
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d. Fractional Flow Reserve Derived From Computed Tomography (FFRCT)
Fractional Flow Reserve Derived from Computed Tomography (FFRCT),
also known by the trade name HeartFlow, is a noninvasive diagnostic
service that allows physicians to measure coronary artery disease in a
patient through the use of coronary CT scans. The HeartFlow procedure
is intended for clinically stable symptomatic patients with coronary
artery disease, and, in many cases, may avoid the need for an invasive
coronary angiogram procedure. HeartFlow uses a proprietary data
analysis process performed at a central facility to develop a three-
dimensional image of a patient's coronary arteries, which allows
physicians to identify the fractional flow reserve to assess whether or
not patients should undergo further invasive testing (that is, a
coronary angiogram).
For many services paid under the OPPS, payment for analytics that
are performed after the main diagnostic/image procedure are packaged
into the payment for the primary service. However, in CY 2018, we
determined that HeartFlow should receive a separate payment because the
service is performed by a separate entity (that is, a HeartFlow
technician who conducts computer analysis offsite) rather than the
provider performing the CT scan. We assigned CPT code 0503T, which
describes the analytics performed, to New Technology APC 1516 (New
Technology--Level 16 ($1,401-$1,500)), with a payment rate of $1,450.50
based on pricing information provided by the developer of the procedure
that indicated the price of the procedure was approximately $1,500. We
did not have Medicare claims data in CY 2019 for CPT code 0503T, and we
continued to assign the service to New Technology APC 1516 (New
Technology--Level 16 ($1,401-$1,500)), with a payment rate of
$1,450.50.
CY 2020 was the first year for which we had Medicare claims data to
calculate the cost of HCPCS code 0503T. For the CY 2020 OPPS/ASC final
rule, there were 957 claims with CPT code 0503T of which 101 of the
claims were single frequency claims that were used to calculate the
geometric mean of the procedure. We planned to use the geometric mean
to report the cost of HeartFlow. However, the number of single claims
for CPT code 0503T was below the low-volume payment policy threshold
for the proposed rule, and this number of single claims was only two
claims above the threshold for the New Technology APC low-volume policy
for the final rule. Therefore, we decided to use our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to
calculate the geometric mean, arithmetic mean, and median using the CY
2018 claims data to determine an appropriate payment rate for HeartFlow
using our New Technology APC low-volume payment policy. While the
number of single frequency claims was just above our threshold to use
the low-volume payment policy, we still had concerns about the normal
cost distribution of the claims used to calculate the payment rate for
HeartFlow, and we decided the low-volume payment policy would be the
best approach to address those concerns.
Our analysis found that the geometric mean cost for CPT code 0503T
was $768.26, the arithmetic mean cost for CPT code 0503T was $960.12,
and the median cost for CPT code 0503T was $900.28. Of the three cost
methods, the highest amount was for the arithmetic mean. The arithmetic
mean fell within the cost band for New Technology APC 1511 (New
Technology--Level 11 ($901-$1,000)) with a payment rate of $950.50. The
arithmetic mean helped to account for some of the higher costs of CPT
code 0503T identified by the developer and other stakeholders that may
not have been reflected by either the median or the geometric mean.
For CY 2021, we observed a significant increase in the number of
claims billed with CPT code 0503T. Specifically, using CY 2019 data, we
identified 3,188 claims billed with CPT code 0503T including 465 single
frequency claims. These totals are well above the threshold of 100
claims for a procedure to be evaluated using the New Technology APC
low-volume policy. Therefore, we used our standard methodology rather
than the low-volume methodology we previously used to determine the
cost of CPT code 0503T. Our analysis found that the geometric mean for
CPT code 0503T was $804.35, and the geometric mean cost for the service
fell within the cost band for New Technology APC 1510 (New Technology--
Level 10 ($801-$900)). However, providers and other stakeholders have
noted that the FFRCT service costs $1,100 and that there are additional
staff costs related to the submission of coronary CT image data for
processing by HeartFlow.
We noted that HeartFlow is one of the first procedures utilizing
artificial intelligence to be separately payable in the OPPS, and
providers are still
[[Page 42078]]
learning how to accurately report their charges to Medicare when
billing for artificial intelligence services (85 FR 85943). This is
especially the case for allocating the cost of staff resources between
the HeartFlow procedure and the coronary CT imaging services.
Therefore, we decided it would be appropriate to use our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to assign
CPT code 0503T to the same New Technology APC in CY 2021 as in CY 2020
in order to provide payment stability and equitable payment for
providers as they continue to become more familiar with the proper cost
reporting for HeartFlow and other artificial intelligence services.
Accordingly, we assigned CPT code 0503T to New Technology APC 1511 (New
Technology--Level 11 ($901-$1,000)) with a payment rate of $950.50 for
CY 2020, and we continued to assign CPT code 0503T to New Technology
APC 1511 for CY 2021.
For CY 2022, we propose to use claims data from CY 2019 to estimate
the cost of the HeartFlow service. Because we are using the same claims
data as in CY 2021, these data continue to reflect that providers were
learning how to accurately report their charges to Medicare when
billing for artificial intelligence services. Therefore, we propose to
continue to use our equitable adjustment authority under section
1833(t)(2)(E) of the Act to assign CPT code 0503T to the same New
Technology APC in CY 2022 as in CY 2020 and CY 2021: New Technology APC
1511 (New Technology--Level 11 ($901-$1,000)), with a payment rate of
$950.50 for CY 2022, which is the same payment rate for the service as
in CY 2020 and CY 2021. Please see Table 12 below for the proposed OPPS
APC and status indicator for CPT code 0503T for CY 2022.
[GRAPHIC] [TIFF OMITTED] TP04AU21.020
e. Cardiac Positron Emission Tomography (PET)/Computed Tomography (CT)
Studies
Effective January 1, 2020, we assigned three CPT codes (78431,
78432, and 78433) that describe the services associated with cardiac
PET/CT studies to New Technology APCs. Table 13 lists the code
descriptors, status indicators, and APC assignments for these CPT
codes. CPT code 78431 was assigned to APC 1522 (New Technology--Level
22 ($2,001-$2,500)) with a payment rate of $2,250.50. CPT codes 78432
and 78433 were assigned to APC 1523 (New Technology--Level 23 ($2,501-
$3,000)) with a payment rate of $2,750.50. We did not receive any
claims data for these services for CY 2021. Therefore, we continued to
assign CPT code 78431 to APC 1522 (New Technology--Level 22 ($2,001-
$2,500)) with a payment rate of $2,250.50. Likewise, CPT codes 78432
and 78433 continued to be assigned to APC 1523 (New Technology--Level
23 ($2,501-$3,000)) with a payment rate of $2,750.50.
For CY 2022, we propose to use CY 2019 claims data to determine the
payment rates for CPT codes 78431, 78432, and 78433. Because these
codes did not become active until CY 2020, there are no claims for
these three services. Accordingly, we propose to continue to assign CPT
code 78431 to APC 1522 (New Technology--Level 22 ($2,001-$2,500)) with
a payment rate of $2,250.50. Likewise, we propose that CPT codes 78432
and 78433 would continue to be assigned to APC 1523 (New Technology--
Level 23 ($2,501-$3,000)) with a payment rate of $2,750.50. Table 13
lists code descriptors, status indicators, and APC assignments for
these CPT codes. The proposed CY 2022 payment rates for CPT codes
78431, 78432, and 78433 can be found in Addendum B to the CY 2022 OPPS/
ASC proposed rule.
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[[Page 42079]]
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f. V-Wave Medical Interatrial Shunt Procedure
A randomized, double-blinded, controlled IDE study is currently in
progress for the V-Wave interatrial shunt. The V-Wave interatrial shunt
is for patients with severe symptomatic heart failure and is designed
to regulate left atrial pressure in the heart. All participants who
passed initial screening for the study receive a right heart
catheterization procedure described by CPT code 93451 (Right heart
catheterization including measurement(s) of oxygen saturation and
cardiac output, when performed). Participants assigned to the
experimental group also receive the V-Wave interatrial shunt procedure
while participants assigned to the control group only receive right
heart catheterization. The developer of V-Wave was concerned that the
current coding of these services by Medicare would reveal to the study
participants whether they have received the interatrial shunt because
an additional procedure code, CPT code 93799 (Unlisted cardiovascular
service or procedure), would be included on the claims for participants
receiving the interatrial shunt. Therefore, for CY 2020, we created a
temporary HCPCS code to describe the V-wave interatrial shunt procedure
for both the experimental group and the control group in the study.
Specifically, we established HCPCS code C9758 (Blinded procedure for
NYHA class III/IV heart failure; transcatheter implantation of
interatrial shunt or placebo control, including right heart
catheterization, trans-esophageal echocardiography (TEE)/intracardiac
echocardiography (ICE), and all imaging with or without guidance (for
example, ultrasound, fluoroscopy), performed in an approved
investigational device exemption (IDE) study) to describe the service,
and we assigned the service to New Technology APC 1589 (New
Technology--Level 38 ($10,001-$15,000)).
We stated in the CY 2021 OPPS final rule that we believe that
similar resources and device costs are involved with the V-Wave
interatrial shunt procedure and the Corvia Medical interatrial shunt
procedure (85 FR 85946). Therefore, the difference in the payment for
HCPCS codes C9758 and C9760 is based on how often the interatrial shunt
is implanted when each code is billed. An interatrial shunt is
implanted one-half of the time HCPCS code C9758 is billed. Accordingly,
for CY 2021, we reassigned HCPCS code C9758 to New Technology APC 1590,
which reflects the cost of having surgery
[[Page 42080]]
every time and receiving the interatrial shunt one-half of the time
when the procedure is performed.
For CY 2022, we are using the same claims data that we did for CY
2021. Because there are no claims reporting HCPCS code C9758, we are
proposing to continue to assign HCPCS code C9758 to New Technology APC
1590 with a payment rate of $17,500.50 for CY 2022.
Details about the HCPCS code and its APC assignment are shown in
Table 14. The proposed CY 2022 payment rate for C9758 can be found in
Addendum B to the CY 2022 OPPS/ASC proposed rule.
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g. Corvia Medical Interatrial Shunt Procedure
Corvia Medical is currently conducting its pivotal trial for their
interatrial shunt procedure. The trial started in Quarter 1 of CY 2017
and is scheduled to continue through CY 2021.\8\ On July 1, 2020, we
established HCPCS code C9760 (Non-randomized, non-blinded procedure for
nyha class ii, iii, iv heart failure; transcatheter implantation of
interatrial shunt or placebo control, including right and left heart
catheterization, transeptal puncture, trans-esophageal echocardiography
(tee)/intracardiac echocardiography (ice), and all imaging with or
without guidance (for example, ultrasound, fluoroscopy), performed in
an approved investigational device exemption (ide) study) to facilitate
the implantation of the Corvia Medical interatrial shunt.
---------------------------------------------------------------------------
\8\ https://clinicaltrials.gov/ct2/show/NCT03088033?term=NCT03088033&rank=1.
---------------------------------------------------------------------------
As we stated in the CY 2021 OPPS final rule, we believe that
similar resources and device costs are involved with the Corvia Medical
interatrial shunt procedure and the V-Wave interatrial shunt procedure
(85 FR 85947). Therefore, the difference in the payment for HCPCS codes
C9760 and C9758 is based on how often the interatrial shunt is
implanted when each code is billed. The Corvia Medical interatrial
shunt is implanted every time HCPCS code C9760 is billed. Therefore,
for CY 2021, we assigned HCPCS code C9760 to New Technology APC 1592
(New Technology--Level 41 ($25,001-$30,000)) with a payment rate of
$27,500.50. We also modified the code descriptor for HCPCS code C9760
to remove the phrase ``or placebo control,'' from the descriptor. For
CY 2022, we propose to use the same claims data as in CY 2021 to
establish payment rates for services. Therefore, there are no claims
for HCPCS code C9760, and we propose to continue to assign HCPCS code
C9760 to New Technology APC 1592.
Details about the HCPCS code and its APC assignment are shown in
Table 15. The proposed CY 2022 payment rate for C9760 can be found in
Addendum B to the proposed rule.
[[Page 42081]]
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h. Supervised Visits for Esketamine Self-Administration (HCPCS Codes
G2082 and G2083 APCs 1508 and 1511)
On March 5, 2019, FDA approved Spravato\TM\ (esketamine) nasal
spray, used in conjunction with an oral antidepressant, for treatment
of depression in adults who have tried other antidepressant medicines
but have not benefited from them (treatment-resistant depression
(TRD)). Because of the risk of serious adverse outcomes resulting from
sedation and dissociation caused by Spravato administration, and the
potential for abuse and misuse of the product, it is only available
through a restricted distribution system under a Risk Evaluation and
Mitigation Strategy (REMS). A REMS is a drug safety program that FDA
can require for certain medications with serious safety concerns to
help ensure the benefits of the medication outweigh its risks.
A treatment session of esketamine consists of instructed nasal
self-administration by the patient, followed by a period of post-
administration observation of the patient under direct supervision of a
health care professional. Esketamine is a noncompetitive N-methyl D-
aspartate (NMDA) receptor antagonist. It is a nasal spray supplied as
an aqueous solution of esketamine hydrochloride in a vial with a nasal
spray device. This is the first FDA approval of esketamine for any use.
Each device delivers two sprays containing a total of 28 mg of
esketamine. Patients would require either two (2) devices (for a 56 mg
dose) or three (3) devices (for an 84 mg dose) per treatment.
Because of the risk of serious adverse outcomes resulting from
sedation and dissociation caused by Spravato administration, and the
potential for abuse and misuse of the product, Spravato is only
available through a restricted distribution system under a REMS;
patients must be monitored by a health care provider for at least 2
hours after receiving their Spravato dose; the prescriber and patient
must both sign a Patient Enrollment Form; and the product will only be
administered in a certified medical office where the health care
provider can monitor the patient. Please refer to the CY 2020 PFS final
rule and interim final rule for more information about supervised
visits for esketamine self-administration (84 FR 63102 through 63105).
To facilitate prompt beneficiary access to the new, potentially
life-saving treatment for TRD using esketamine, we created two new
HCPCS G codes, G2082 and G2083, effective January 1, 2020. HCPCS code
G2082 is for an outpatient visit for the evaluation and management of
an established patient that requires the supervision of a physician or
other qualified health care professional and provision of up to 56 mg
of esketamine nasal self-administration and includes 2 hours post-
administration observation. HCPCS code G2082 was assigned to New
Technology APC 1508 (New Technology--Level 8 ($601-$700)) with a
payment rate of $650.50. HCPCS code G2083 describes a similar service
to HCPCS code G2082, but involves the administration of more than 56 mg
of esketamine. HCPCS code G2083 was assigned to New Technology APC 1511
(New Technology--Level 11 ($901-$1,000)) with a payment rate of
$950.50.
For CY 2022, we are using CY 2019 claims data to determine the
payment rates for HCPCS codes G2082 and G2083. Since these codes did
not become active until CY 2020, there are no claims for these two
services. Therefore, for CY 2022, we propose to continue to assign
HCPCS code G2082 to New Technology APC 1508 (New Technology--Level 8
($601-$700)) and to assign HCPCS code G2083 to New Technology APC 1511
(New Technology--Level 11 ($901-$1,000)).
Details about the HCPCS codes and their APC assignments are shown
in Table 16. The proposed CY 2022 payment rate for esketamine self-
administration can be found in Addendum B to the proposed rule.
[[Page 42082]]
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BILLING CODE 4120-01-C
D. Proposed OPPS APC-Specific Policy: Stromal Vascular Fraction (SVF)
Therapy
SVF therapy is intended to treat knee osteoarthritis. To process
SVF, the patient's own body fat (usually from the abdomen), is
recovered, and then processed to isolate a cellular product, referred
to in CPT codes as an autologous cellular implant, and then injected
into the knee for pain relief. SVF therapy is currently described by
CPT codes 0565T and 0566T, which were effective January 1, 2020. The
long descriptors for both codes are as follows:
0565T: Autologous cellular implant derived from adipose
tissue for the treatment of osteoarthritis of the knees; tissue
harvesting and cellular implant creation.
0566T: Autologous cellular implant derived from adipose
tissue for the treatment of osteoarthritis of the knees; injection of
cellular implant into knee joint including ultrasound guidance,
unilateral.
For CY 2021, CPT code 0565T is assigned to APC 5733 (Level 3 Minor
Procedures) with a payment rate of $55.66, and CPT code 0566T is
assigned to APC 5441 (Level 1 Nerve Injections) with a payment rate of
$261.17. Based on recent information from the FDA, we found there is no
current FDA-approved autologous cellular product derived from
autologous body fat (referred to in CPT code 0565T and 0566T as
``autologous cellular implant'') associated with SVF therapy. In
addition, review of the clinical trials.gov website indicate that SVF
therapy is currently under clinical trial (ClinicalTrials.gov
Identifiers: NCT04440189 and NCT02726945), and has not received CMS
approval as investigational device exemption (IDE) studies. We note
that IDE studies that have been approved and met CMS' standards for
coverage are listed on the CMS Approved IDE Studies website,
specifically, at https://www.cms.gov/Medicare/Coverage/IDE/Approved-IDE-Studies.
Consequently, for CY 2022, we are proposing not to pay under the
OPPS for either code. Specifically, we are revising the status
indicator for CPT code 0565T from ``Q1'' (conditionally packaged;
separately payable) to ``E1'' to indicate that the code is not payable
by Medicare. Similarly, we are revising the status indicator for CPT
code 0566T from ``T'' (separately payable) to ``E1'' to indicate that
the code is not payable by Medicare and deleting the APC assignment for
this code.
We note that the CY 2022 proposed status indicators for CPT codes
0565T and 0566T can also be found in Addendum B to this proposed rule
with comment period. In addition, we refer readers to Addendum D1 of
this proposed rule with comment period for the status indicator (SI)
definitions for all codes reported under the OPPS. Both Addendum B and
D1 are available via the internet on the CMS website.
[[Page 42083]]
IV. OPPS Payment for Devices
A. Proposed Pass-Through Payment for Devices
1. Beginning Eligibility Date for Device Pass-Through Status and
Quarterly Expiration of Device Pass-Through Payments
a. Background
The intent of transitional device pass-through payment, as
implemented at Sec. 419.66, is to facilitate access for beneficiaries
to the advantages of new and truly innovative devices by allowing for
adequate payment for these new devices while the necessary cost data is
collected to incorporate the costs for these devices into the procedure
APC rate (66 FR 55861). Under section 1833(t)(6)(B)(iii) of the Act,
the period for which a device category eligible for transitional pass-
through payments under the OPPS can be in effect is at least 2 years
but not more than 3 years. Prior to CY 2017, our regulation at Sec.
419.66(g) provided that this pass-through payment eligibility period
began on the date CMS established a particular transitional pass-
through category of devices, and we based the pass-through status
expiration date for a device category on the date on which pass-through
payment was effective for the category. In the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79654), in accordance with section
1833(t)(6)(B)(iii)(II) of the Act, we amended Sec. 419.66(g) to
provide that the pass-through eligibility period for a device category
begins on the first date on which pass-through payment is made under
the OPPS for any medical device described by such category.
In addition, prior to CY 2017, our policy was to propose and
finalize the dates for expiration of pass-through status for device
categories as part of the OPPS annual update. This means that device
pass-through status would expire at the end of a calendar year when at
least 2 years of pass-through payments had been made, regardless of the
quarter in which the device was approved. In the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79655), we changed our policy to allow
for quarterly expiration of pass-through payment status for devices,
beginning with pass-through devices approved in CY 2017 and subsequent
calendar years, to afford a pass-through payment period that is as
close to a full 3 years as possible for all pass-through payment
devices. We also have an established policy to package the costs of the
devices that are no longer eligible for pass-through payments into the
costs of the procedures with which the devices are reported in the
claims data used to set the payment rates (67 FR 66763).
We refer readers to the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79648 through 79661) for a full discussion of the current
device pass-through payment policy.
b. Expiration of Transitional Pass-Through Payments for Certain Devices
As stated earlier, section 1833(t)(6)(B)(iii) of the Act requires
that, under the OPPS, a category of devices be eligible for
transitional pass-through payments for at least 2 years, but not more
than 3 years. There currently are 11 device categories eligible for
pass-through payment: C1823-Generator, neurostimulator (implantable),
nonrechargeable, with transvenous sensing and stimulation leads);
C1824-Generator, cardiac contractility modulation (implantable); C1982-
Catheter, pressure-generating, one-way valve, intermittently occlusive;
C1839-Iris prosthesis; C1734-Orthopedic/device/drug matrix for opposing
bone-to-bone or soft tissue-to bone (implantable); C2596-Probe, image-
guided, robotic, waterjet ablation; C1748-Endoscope, single-use (that
is disposable), Upper GI, imaging/illumination device (insertable);
C1052-Hemostatic agent, gastrointestinal, topical, C1062-Intravertebral
body fracture augmentation with implant (for example, metal, polymer);
C1825-Generator, neurostimulator (implantable), nonrechargeable with
carotid sinus baroreceptor stimulation lead(s); and C1761-Catheter,
transluminal intravascular lithotripsy, coronary.
Below, we detail the expiration dates of pass-through payment
status for each of the 11 devices currently receiving device pass-
through payment.
The pass-through payment status of the device category for HCPCS
code C1823 is scheduled to expire on December 31, 2021. Typically, we
would propose to package the costs of the device described by C1823
into the costs related to the procedure with which the device is
reported in the hospital claims data for CY 2022. The data for the CY
2022 OPPS proposed rule ratesetting for the procedure reported with
C1823 would have been set using CY 2020 outpatient claims data
processed through December 31, 2020, however, as described in section
IV.A.3 of this proposed rule, due to the effects of the COVID-19 PHE,
we are proposing to use CY 2019 claims data instead of CY 2020 claims
data in establishing the CY 2022 OPPS rates and to use cost report data
from the same set of cost reports originally used in final rule 2021
OPPS ratesetting. Therefore, we are proposing to use our equitable
adjustment authority under section 1833(t)(2)(E) of the Act to provide
separate payment for C1823 for four quarters of CY 2022 to end on
December 31, 2022. This would allow for CY 2021 claims data to inform
CY 2023 rate setting for the procedure reported with C1823. This is the
only device whose costs would typically be packaged into the related
procedure in CY 2022 using CY 2020 claims data for ratesetting and is
the only device to which this proposed policy would apply. A full
discussion of this proposed policy is included in section IV.A.3 of
this proposed rule.
The pass-through payment status of the device category for HCPCS
code C1823 will end on December 31, 2021. The pass-through payment
status of the device categories for HCPCS codes C1824, C1982, C1839,
C1734, and C2596 is set to expire on December 31, 2022. The pass-
through payment status of the device category for HCPCS code C1748 is
set to expire on June 30, 2023. The pass-through payment status of the
device category for HCPCS codes C1052, C1062, and C1825 is set to
expire on December 31, 2023 and the pass-through payment status of the
device category for HCPCS code C1761 is set to expire on June 30, 2024.
Table 17 shows the expiration of transitional pass-through payments for
these devices.
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[[Page 42084]]
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2. New Device Pass-Through Applications
a. Background
Section 1833(t)(6) of the Act provides for pass-through payments
for devices, and section 1833(t)(6)(B) of the Act requires CMS to use
categories in determining the eligibility of devices for pass-through
payments. As part of implementing the statute through regulations, we
have continued to believe that it is important for hospitals to receive
pass-through payments for devices that offer substantial clinical
improvement in the treatment of Medicare beneficiaries to facilitate
access by beneficiaries to the advantages of the new technology.
Conversely, we have noted that the need for additional payments for
devices that offer little or no clinical improvement over previously
existing devices is less apparent. In such cases, these devices can
still be used by hospitals, and hospitals will be paid for them through
appropriate APC payment. Moreover, a goal is to target pass-through
payments for those devices where cost considerations might be most
likely to interfere with patient access (66 FR 55852; 67 FR 66782; and
70 FR 68629). We note that, as discussed in section IV.A.4. of this CY
2022 OPPS/ASC proposed rule, we created an alternative pathway in the
CY 2020 OPPS/ASC final rule that granted fast-track device pass-through
payment under the OPPS for devices approved under the FDA Breakthrough
Device Program for OPPS device pass-through payment applications
received on or after January 1, 2020. We refer readers to section
IV.A.4. of this CY 2022 OPPS/ASC proposed rule for a complete
discussion of this pathway.
As specified in regulations at Sec. 419.66(b)(1) through (3), to
be eligible for transitional pass-through payment under the OPPS, a
device must meet the following criteria:
If required by FDA, the device must have received FDA
marketing authorization (except for a device that has received an FDA
investigational device exemption (IDE) and has been classified as a
Category B device by the FDA), or meet another appropriate FDA
exemption; and the pass-through
[[Page 42085]]
payment application must be submitted within 3 years from the date of
the initial FDA marketing authorization, if required, unless there is a
documented, verifiable delay in U.S. market availability after FDA
marketing authorization is granted, in which case CMS will consider the
pass-through payment application if it is submitted within 3 years from
the date of market availability;
The device is determined to be reasonable and necessary
for the diagnosis or treatment of an illness or injury or to improve
the functioning of a malformed body part, as required by section
1862(a)(1)(A) of the Act; and
The device is an integral part of the service furnished,
is used for one patient only, comes in contact with human tissue, and
is surgically implanted or inserted (either permanently or
temporarily), or applied in or on a wound or other skin lesion.
In addition, according to Sec. 419.66(b)(4), a device is not
eligible to be considered for device pass-through payment if it is any
of the following: (1) Equipment, an instrument, apparatus, implement,
or item of this type for which depreciation and financing expenses are
recovered as depreciation assets as defined in Chapter 1 of the
Medicare Provider Reimbursement Manual (CMS Pub. 15-1); or (2) a
material or supply furnished incident to a service (for example, a
suture, customized surgical kit, or clip, other than a radiological
site marker).
Separately, we use the following criteria, as set forth under Sec.
419.66(c), to determine whether a new category of pass-through payment
devices should be established. The device to be included in the new
category must--
Not be appropriately described by an existing category or
by any category previously in effect established for transitional pass-
through payments, and was not being paid for as an outpatient service
as of December 31, 1996;
Have an average cost that is not ``insignificant''
relative to the payment amount for the procedure or service with which
the device is associated as determined under Sec. 419.66(d) by
demonstrating: (1) The estimated average reasonable cost of devices in
the category exceeds 25 percent of the applicable APC payment amount
for the service related to the category of devices; (2) the estimated
average reasonable cost of the devices in the category exceeds the cost
of the device-related portion of the APC payment amount for the related
service by at least 25 percent; and (3) the difference between the
estimated average reasonable cost of the devices in the category and
the portion of the APC payment amount for the device exceeds 10 percent
of the APC payment amount for the related service (with the exception
of brachytherapy and temperature-monitored cryoablation, which are
exempt from the cost requirements as specified at Sec. 419.66(c)(3)
and (e)); and
Demonstrate a substantial clinical improvement, that is,
substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment.
Beginning in CY 2016, we changed our device pass-through evaluation
and determination process. Device pass-through applications are still
submitted to CMS through the quarterly subregulatory process, but the
applications will be subject to notice-and-comment rulemaking in the
next applicable OPPS annual rulemaking cycle. Under this process, all
applications that are preliminarily approved upon quarterly review will
automatically be included in the next applicable OPPS annual rulemaking
cycle, while submitters of applications that are not approved upon
quarterly review will have the option of being included in the next
applicable OPPS annual rulemaking cycle or withdrawing their
application from consideration. Under this notice-and-comment process,
applicants may submit new evidence, such as clinical trial results
published in a peer-reviewed journal or other materials for
consideration during the public comment process for the proposed rule.
This process allows those applications that we are able to determine
meet all of the criteria for device pass-through payment under the
quarterly review process to receive timely pass-through payment status,
while still allowing for a transparent, public review process for all
applications (80 FR 70417 through 70418).
In the CY 2020 annual rulemaking process, we finalized an
alternative pathway for devices that are granted a Breakthrough Device
designation (84 FR 61295) and receive Food and Drug Administration
(FDA) marketing authorization. Under this alternative pathway, devices
that are granted an FDA Breakthrough Device designation are not
evaluated in terms of the current substantial clinical improvement
criterion at Sec. 419.66(c)(2) for the purposes of determining device
pass-through payment status, but do need to meet the other requirements
for pass-through payment status in our regulation at Sec. 419.66.
Devices that are part of the Breakthrough Devices Program, have
received FDA marketing authorization, and meet the other criteria in
the regulation can be approved through the quarterly process and
announced through that process (81 FR 79655). Proposals regarding these
devices and whether pass-through payment status should continue to
apply are included in the next applicable OPPS rulemaking cycle. This
process promotes timely pass-through payment status for innovative
devices, while also recognizing that such devices may not have a
sufficient evidence base to demonstrate substantial clinical
improvement at the time of FDA marketing authorization.
More details on the requirements for device pass-through payment
applications are included on the CMS website in the application form
itself at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/passthrough_payment.html, in the
``Downloads'' section. In addition, CMS is amenable to meeting with
applicants or potential applicants to discuss research trial design in
advance of any device pass-through application or to discuss
application criteria, including the substantial clinical improvement
criterion.
b. Applications Received for Device Pass-Through Payment for CY 2022
We received eight complete applications by the March 1, 2021
quarterly deadline, which was the last quarterly deadline for
applications to be received in time to be included in the CY 2022 OPPS/
ASC proposed rule. We received three of the applications in the third
quarter of 2020, two of the applications in the fourth quarter of 2020,
and three of the applications in the first quarter of 2021. One of the
applications was approved for device pass-through payment during the
quarterly review process: The Shockwave C\2\ Coronary Intravascular
Lithotripsy (IVL) catheter, which received fast-track approval under
the alternative pathway effective July 1, 2021. As previously stated,
all applications that are preliminarily approved upon quarterly review
will automatically be included in the next applicable OPPS annual
rulemaking cycle. Therefore, the Shockwave C\2\ Coronary Intravascular
Lithotripsy (IVL) catheter is discussed below in section IV.2.b.1.
Applications received for the later deadlines for the remaining
2021 quarters (June 1, September 1, and December 1), if any, will be
discussed
[[Page 42086]]
in the CY 2023 OPPS/ASC proposed rule. We note that the quarterly
application process and requirements have not changed in light of the
addition of rulemaking review. Detailed instructions on submission of a
quarterly device pass-through payment application are included on the
CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/catapp.pdf.
A discussion of the applications received by the March 1, 2021
deadline is included below.
1. Alternative Pathway Device Pass-Through Applications
We received two device pass-through applications by the March 2021
quarterly application deadline for devices that have received
Breakthrough Device designation from FDA and FDA marketing
authorization, and therefore are eligible to apply under the
alternative pathway. As stated above in section IV.2.a of this proposed
rule, under this alternative pathway, devices that are granted an FDA
Breakthrough Device designation are not evaluated in terms of the
substantial clinical improvement criterion at Sec. 419.66(c)(2)(i) for
purposes of determining device pass-through payment status, but need to
meet the other requirements for pass-through payment status in our
regulation at Sec. 419.66.
(1) RECELL System
AVITA Medical submitted an application for a new device category
for transitional pass-through payment status for the RECELL System
(RECELL) for CY 2022. According to the applicant, RECELL is used to
process autologous donor tissue into a cell suspension autograft that
is then immediately applied to the surgically prepared acute thermal
burn wound.
The applicant stated RECELL is a stand-alone, single-use, battery-
powered device used to process and apply an autologous skin cell
suspension. According to the applicant, RECELL is a Category III
medical device indicated for the treatment of acute partial-thickness
and full-thickness/mixed depth thermal burn wounds and is not
categorized as a skin substitute.
According to the applicant, the autograft procedure utilizing the
RECELL system involves harvesting a small graft from the patient's
healthy skin and placing it into the RECELL System for immediate
processing into an autologous skin cell suspension. The applicant
asserts that a significantly smaller autograft harvest is needed for
procedures involving RECELL when compared to procedures involving a
split-thickness skin graft (STSG) without RECELL; where typical STSG
expansion ranges from 2:1 to 6:1, RECELL may expand skin by up to 80:1.
The applicant adds the entire procedure takes place in the operating
room, including surgically preparing the acute burn wound, harvesting
the autograft, processing the skin cell suspension through a
disaggregation process, and applying the cell suspension autograft to
the wound with no culturing in a laboratory.
The applicant described the RECELL procedure in 27 steps: (1) The
autograft site is identified; (2) the patient is anesthetized and
prepared; (3) the nurse opens and transfers the sterile RECELL System
to the operative field; (4) a self-test is performed; (5) the nurse
prepares and dispenses the enzyme into the incubation well; (6) the
buffer solution is drawn and dispensed into the buffering and rinsing
well; (7) the RECELL processing unit is activated to heat the enzyme;
(8) a thin epidermal autograft is harvested; (9) the harvested skin
graft is placed in the enzyme; (10) the donor graft incubates for 15-20
minutes; (11) the sample is placed dermal side down in the mechanical
scraping tray; (12) a scalpel is used to scrape the edges of the skin
sample; (13) once ready, the donor skin is rinsed in the buffer
solution; (14) the skin is returned to the mechanical scraping tray;
(15) buffer is applied to the skin sample; (16) the skin sample is held
in place with forceps; (17) the surgeon scrapes the epidermal cells;
(18) the buffer syringe is used to rinse the disaggregated skin cells;
(19) the surgeon draws up the autologous skin cell suspension from the
tray into a syringe; (20) the suspension is then dispensed through the
cell strainer to filter the suspension; (21) the filtered autologous
skin cell suspension is drawn into a new 10 ml syringe; (22) the cell
suspension autograft is prepared; (23) the burn wound is debrided; (24)
the primary dressing (non-adherent, non-absorbent, small pore) is fixed
or held only at the lower aspect of the burn wound; (25) the cell
suspension autograft is applied by either spraying or dripping over the
prepared wound bed; (26) after application, the primary dressing is
immediately secured over the wound bed; and (27) absorbent and
protective dressings are then applied as needed.
The applicant states the autologous skin cell suspension prepared
using the RECELL System contains keratinocytes, fibroblasts and
melanocytes. According to the applicant, keratinocytes are the primary
cells of the epidermis that are responsible for healing; fibroblasts
enable the creation of new extracellular matrix proteins; and
melanocytes produce melanin to allow restoration of normal
pigmentation. The applicant asserts the unique delivery system allows
for broad and even distribution of the cell suspension autograft
directly onto a prepared wound surface or in combination with a meshed
skin graft.
According to the applicant, there is one commercially available
product (Epicel) that is also used to create an autograft from the
patient's skin that is then applied to treat acute thermal burns. The
applicant's claims regarding the differences between the two products
are summarized in the following Table 18:
BILLING CODE 4120-01-P
[[Page 42087]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.026
With respect to the newness criterion at Sec. 419.66(b)(1), RECELL
received FDA Breakthrough Designation effective January 1, 2020. The
applicant states that RECELL received premarket approval (PMA) on
September 20, 2018. The applicant adds that RECELL is a Class III
medical device indicated for the treatment of acute thermal burn wounds
in patients 18 years of age and older. We received the application for
a new device category for transitional pass-through payment status for
RECELL on August 7, 2020, which is within 3 years of the date of the
initial FDA marketing authorization. We are inviting public comment on
whether the RECELL meets the newness criterion.
---------------------------------------------------------------------------
\9\ Instructions for use--RECELL[supreg] Autologous Cell
Harvesting Device. Food and Drug Administration. https://www.fda.gov/media/116382/download.
\10\ Ibid.
\11\ Humanitarian Device Exemption (HDE) Program--Guidance for
Industry and FDA Staff. U.S. Department of Health and Human
Services. Food and Drug Administration. Issued September 6, 2019.
Accessed on March 30, 2021 and available at: https://www.fda.gov/media/74307/download.
\12\ Manufacturer Important Drug Warning: Serious Risk with Use
of Epicel (cultured epidermal autografts): Squamous Cell Carcinoma
(SCC). June 2014. Food and Drug Administration. Accessed on March
30, 2021 and available at: https://www.fda.gov/media/102746/download.
\13\ Directions for Use--Epicel (cultured epidermal autografts).
Food and Drug Administration. https://www.fda.gov/vaccines-blood-biologics/approved-blood-products/epicel-cultured-epidermal-autografts.
\14\ Epicel Surgical Guidelines. Epicel website. Accessed on
March 30, 2021 and available at: https://www.epicel.com/pdfs/Epicel%20SurgicalGuide%202018%20DIGITAL.pdf.
---------------------------------------------------------------------------
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, RECELL is integral to the service provided,
is used for one patient only, comes in contact with human tissue, and
is surgically implanted or inserted (either permanently or temporarily)
or applied in or on a wound or other skin lesion. The applicant also
claimed that RECELL meets the device eligibility requirements of Sec.
419.66(b)(4) because it is not an instrument, apparatus, implement, or
item for which depreciation and financing expenses are recovered, and
it is not a supply or material furnished incident to a service.
However, given the applicant's description of RECELL as a device that
processes tissue into an autograft, it appears that the RECELL system
may
[[Page 42088]]
not be surgically implanted or inserted (either permanently or
temporarily) or applied in or on a wound or other skin lesion. We
believe the product of the RECELL system, the suspension, may be
applied on a wound, but we are not certain that this suspension
qualifies as a device. We are inviting public comments on whether
RECELL meets the eligibility criteria at Sec. 419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. We have not
yet identified an existing pass-through payment category that describes
RECELL. We are inviting public comment on whether RECELL meets the
device category criterion.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. As previously discussed in
section IV.2.a above, we finalized the alternative pathway for devices
that are granted a Breakthrough Device designation and receive FDA
marketing authorization in the CY 2020 OPPS/ASC final rule (84 FR
61295). The RECELL System has a Breakthrough Device designation and
marketing authorization from the FDA and therefore is not evaluated for
substantial clinical improvement. We note that the applicant has
applied for the New Technology Add-on Payment under the Alternative
Pathway for Breakthrough devices in the FY 2022 IPPS/LTCH proposed rule
(86 FR 25385 through 25388).
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that RECELL would be
reported with the HCPCS codes listed in the following Table 19:
[GRAPHIC] [TIFF OMITTED] TP04AU21.027
BILLING CODE 4120-01-C
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5054--Level 4 Skin
Procedures, which had a CY 2020 payment rate of $1,622.74 at the time
the application was received. Beginning in CY 2017, we calculate the
device offset amount at the HCPCS/CPT code level instead of the APC
level (81 FR 79657). HCPCS code 15110 had a device offset amount of
$13.47 at the time the application was received. According to the
applicant, the cost of the RECELL is $7,500.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $7,500 for RECELL is 462 percent of the
applicable APC payment amount for the service related to the category
of devices of $1,622.74 ((7,500/1,622.74) x 100 = 462.2 percent).
Therefore, we believe RECELL meets the first cost significance
requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides
[[Page 42089]]
that the estimated average reasonable cost of the devices in the
category must exceed the cost of the device-related portion of the APC
payment amount for the related service by at least 25 percent, which
means that the device cost needs to be at least 125 percent of the
offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $7,500 for
RECELL is 55,679 percent of the cost of the device-related portion of
the APC payment amount for the related service of $13.47 (($7,500/
$13.47) x 100 = 55,679.3 percent). Therefore, we believe that RECELL
meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $7,500 for RECELL and the portion of the APC payment
amount for the device of $13.47 is 461 percent of the APC payment
amount for the related service of $1,622.74 ((($7,500-$13.47)/
$1,622.74) x 100 = 461.4 percent). Therefore, we believe that RECELL
meets the third cost significance requirement.
We are inviting public comment on whether the RECELL meets the
device pass-through payment criteria discussed in this section,
including the cost criterion for device pass-through payment status.
(2) Shockwave C\2\ Coronary Intravascular Lithotripsy (IVL) Catheter
Shockwave Medical submitted an application for a new device
category for transitional pass-through payment status for the Shockwave
C\2\ Coronary Intravascular Lithotripsy (IVL) catheter (Coronary IVL)
for CY 2022. The applicant asserts the Coronary IVL catheter is a
proprietary lithotripsy device delivered through the coronary arterial
system of the heart to the site of an otherwise difficult to treat
calcified stenosis, including calcified stenosis that is anticipated to
exhibit resistance to full balloon dilation or subsequent uniform
coronary stent expansion. According to the applicant, energizing the
lithotripsy device generates intermittent sound waves within the target
treatment site, disrupting calcium within the lesion and allowing
subsequent dilation of a coronary artery stenosis using low balloon
pressure. According to the applicant, the Coronary IVL System is
comprised of the following components:
(1) IVL Generator--a portable, rechargeable power source that is
capital equipment and reusable.
(2) IVL Connect Cable--a reusable cable used to connect the IVL
Generator to the IVL Catheter.
(3) Coronary IVL Catheter--a sterile, single-use catheter that
delivers intravascular lithotripsy within the target coronary lesion.
According to the applicant, during a percutaneous coronary
intervention (PCI) procedure, the physician determines that a lesion
has severe calcification. The applicant states the Coronary IVL
catheter is introduced into the lesion where lithotripsy is delivered
to crack the calcification to facilitate the optimal dilatation of the
vessel and placement of a coronary stent. The applicant adds that the
catheter is removed, and the physician then implants a coronary stent
to treat the lesion.
The applicant asserts that Coronary IVL is different from other
devices used during PCI procedures as it delivers localized lithotripsy
to crack the calcified lesion prior to the placement of a coronary
stent. According to the applicant there are other devices that may be
utilized to remove calcium within the vessel (that is, atherectomy),
however, these devices utilize some form of cutting or laser to remove
or ablate the calcium and can only address the calcium nearest to the
vessel lumen. According to the applicant, Coronary IVL addresses the
calcium within the lumen as well as within the vessel walls.
According to the applicant, Coronary IVL is used to treat a subset
of patients identified for a PCI procedure to treat their coronary
artery disease where approximately 15 percent of lesions in patients
being eligible for a PCI procedure have severe calcification. The
applicant adds the Shockwave C2 Coronary IVL catheter is
utilized during PCI procedures and does not replace any devices
currently utilized to complete the procedure (for example, guidewires,
angioplasty balloons, stent(s), vascular closure, etc.) that are
packaged into the APC payment rate. According to the applicant, based
on the FDA labeling for the Coronary IVL catheter, it will be utilized
prior to the placement of a coronary stent.
With respect to the newness criterion at Sec. 419.66(b)(1), the
Coronary IVL received FDA premarket approval (PMA) for the Shockwave
Intravascular Lithotripsy (IVL) System with Shockwave C2
Coronary Intravascular Lithotripsy (IVL) Catheter on February 12, 2021
and is indicated for lithotripsy-enabled, low-pressure balloon
dilatation of severely calcified, stenotic de novo coronary arteries
prior to stenting. The Coronary IVL received FDA Breakthrough Device
designation on August 19, 2019, and is indicated for lithotripsy-
enabled, low-pressure dilatation of calcified, stenotic de novo
coronary arteries prior to stenting. We received the application for a
new device category for transitional pass-through payment status for
the Coronary IVL on February 26, 2021, which is within 3 years of the
date of the initial FDA marketing authorization. We are inviting public
comment on whether the Coronary IVL meets the newness criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, Coronary IVL is integral to the service
provided, is used for one patient only, comes in contact with human
tissue and is surgically inserted in a patient until the procedure is
completed. The applicant also claimed that Coronary IVL meets the
device eligibility requirements of Sec. 419.66(b)(4) because it is not
an instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service. We are inviting public comments on
whether Coronary IVL meets the eligibility criteria at Sec. 419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. The
applicant identified five established categories which they believe are
not appropriate representatives of the Coronary IVL: (1) C1714 and C
1724 include devices that use mechanical cutting tools, (2) C1725
includes balloon angioplasty, (3) C1885 which uses laser, beams of
light to break up vessel obstructions, and (4) C2623 which includes a
drug coated balloon. We have not identified an existing pass-through
payment category that describes Coronary IVL and we are inviting public
comment on this issue.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the
[[Page 42090]]
functioning of a malformed body part compared to the benefits of a
device or devices in a previously established category or other
available treatment; or (ii) for devices for which pass-through status
will begin on or after January 1, 2020, as an alternative to the
substantial clinical improvement criterion, the device is part of the
FDA's Breakthrough Devices Program and has received FDA marketing
authorization. As previously discussed in section IV.2.a above, we
finalized the alternative pathway for devices that are granted a
Breakthrough Device designation and receive FDA marketing authorization
in the CY 2020 OPPS/ASC final rule (84 FR 61295). Coronary IVL has a
Breakthrough Device designation and marketing authorization from the
FDA and therefore is not evaluated for substantial clinical
improvement. We note that the applicant has applied for the New
Technology Add-on Payment under the Alternative Pathway for
Breakthrough devices in the FY 2022 IPPS/LTCH proposed rule (86 FR
25388 through 25389).
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that Coronary IVL would
be reported with the HCPCS codes listed in the following Table 20:
[GRAPHIC] [TIFF OMITTED] TP04AU21.028
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5193--Level 3 Endovascular
Procedures, which had a CY 2021 payment rate of $10,042.94 at the time
the application was received. Beginning in CY 2017, we calculate the
device offset amount at the HCPCS/CPT code level instead of the APC
level (81 FR 79657). HCPCS code 92928 had a device offset amount of
$3,607.42 at the time the application was received.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost for Coronary IVL of $5,640 is 56 percent of the
applicable APC payment amount for the service related to the category
of devices of $10,042.94 (($5,640/10,042.94) x 100 = 56 percent).
Therefore, we believe Coronary IVL meets the first cost significance
requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost for Coronary IVL of
$5,640 is 156 percent of the cost of the device-related portion of the
APC payment amount for the related service of $3,607.42 (($5,640/
$3,607.42) x 100 = 156 percent). Therefore, we believe that Coronary
IVL meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $5,640 for Coronary IVL and the portion of the APC
payment amount for the device of $3,607.42 is 20 percent of the APC
payment amount for the related service of $10,042.94 (($5,640 -
$3,607.42)/$10,042.94) x 100= 20 percent. Therefore, we believe that
Coronary IVL meets the third cost significance requirement.
We are inviting public comment on whether the Coronary IVL meets
the device pass-through payment criteria discussed in this section,
including the cost criterion for device pass-through payment status.
[[Page 42091]]
As specified above, the Coronary IVL application was preliminarily
approved for transitional pass-through payment under the alternative
pathway effective July 1, 2021. We are inviting public comment on
whether the Coronary IVL should continue to receive transitional pass-
through payment under the alternative pathway for devices that are FDA
market authorized and that have an FDA Breakthrough Device designation.
2. Traditional Device Pass-Through Applications
(1) AngelMed Guardian[supreg] System
Angel Medical Systems submitted an application for a new device
category for transitional pass-through payment status for the AngelMed
Guardian[supreg] System (Guardian[supreg]) for CY 2022. The applicant
asserted that the Guardian[supreg] is a proactive diagnostic technology
that monitors a patient's heart's electrical activity for changes that
may indicate an Acute Coronary Syndrome (ACS) event (that is, STEMI,
NSTEMI, or unstable angina) related to blockage of a coronary artery
which prevents the heart muscle from receiving sufficient oxygen. The
Guardian[supreg] is a device implanted in the upper left chest and
connects to an active fixation intracardiac lead attached to the apex
of the right ventricle. The applicant asserts the Guardian[supreg]
consists of an implantable medical device (IMD) which is composed of
the header with an antenna for communication and the can with
circuitry, radio, vibratory motor, and battery. According to the
applicant, the Guardian[supreg] system also includes an external device
that communicates with the IMD and provides redundant patient
notification using auditory and visual alarms. Lastly, the applicant
states the Guardian[supreg] system includes a physician programmer, a
capital device, used to program the IMD and download cardiac data
captured by the IMD.
According to the applicant, the Guardian[supreg] system relies upon
the gold standard of changes to the ST-segment of a patient's heartbeat
to diagnose a heart attack. According to the applicant, the
Guardian[supreg] system uses an intracardiac lead to sense cardiac data
and proprietary machine learning algorithms to assess acute changes to
the ST-segment on a continuous, real-time basis. The applicant asserts
these changes are compared to a patient's normal baseline reference
that is computed over the prior twenty-four hours of monitored heart
activity. According to the applicant, if the Guardian[supreg] detects a
statistically abnormal acute change relative to this baseline, it
notifies the patient to the potential ACS event by providing an alarm:
The implanted device will vibrate, and the external device will flash
and beep. According to the applicant, patients are instructed to seek
urgent medical assistance when the system activates, even in the
absence of ACS symptoms.
According to the applicant, the Guardian[supreg] system
implantation will typically be an outpatient procedure and, following
10-14 days, is programmed in the physician office. The applicant
asserts the patient undergoes training on the Guardian[supreg] and has
follow-up visits every six months to review the device data. The
applicant states that the emergency alarm is intended to be used as an
adjunct to symptoms; in the absence of an emergency alarm patients are
instructed not to ignore symptoms of an ACS event. The applicant
asserts that while current technologies detect and provide therapy for
cardiac medical conditions related to abnormal heart rate and rhythm,
the AngelMed Guardian[supreg] system is the only FDA approved
technology for providing detection and patient notification of ACS
events so that patients more reliably and urgently seek medical care.
With respect to the newness criterion at Sec. 419.66(b)(1), the
AngelMed Guardian[supreg] system first received FDA 510(k) clearance on
April 9, 2018 under premarket approval (PMA) number P150009. The
manufacturers received a Category B Investigational Device Exemption
(IDE) as of January 27, 2020 for the use of the device in their
continued access study, AngelMed for Early Recognition and Treatment of
STEMI (ALERTS). According to the applicant, the device is anticipated
for U.S. market availability in quarter three of 2021. We received the
application for a new device category for transitional pass-through
payment status for the Guardian[supreg] system on February 28, 2021,
which is within 3 years of the date of the initial FDA marketing
authorization. We solicited public comment on whether the
Guardian[supreg] system meets the newness criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the Guardian[supreg] is integral to the
service provided, is used for one patient only, comes in contact with
human tissue, and is surgically inserted temporarily. The applicant
also claimed that Guardian[supreg] meets the device eligibility
requirements of Sec. 419.66(b)(4) because it is not an instrument,
apparatus, implement, or item for which depreciation and financing
expenses are recovered, and it is not a supply or material furnished
incident to a service. We are inviting public comments on whether
Guardian[supreg] meets the eligibility criteria at Sec. 419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. We have not
yet identified an existing pass-through payment category that describes
Guardian[supreg]. We are inviting public comment on whether
Guardian[supreg] meets the device category criterion.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization.
The applicant stated that Guardian[supreg] represents a substantial
clinical improvement over existing technologies. With respect to this
criterion, the applicant asserted that Guardian[supreg] offers the
ability to diagnose a medical condition in a patient population where
that medical condition is currently undetectable or offers the ability
to diagnose a medical condition earlier in a patient population than is
currently possible and this earlier diagnosis results in better
outcomes.\15\ In support of this claim the applicant submitted two
published articles, the first by Gibson et al. and the second by Holmes
et al.16 17
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\15\ 66 FR 55852, November 2, 2001.
\16\ Gibson, C.M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
\17\ Holmes, D.R., Jr, Krucoff, M.W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M.S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients with Acute Coronary Syndrome Events. JACC, 74(16),
2047-2055.
---------------------------------------------------------------------------
[[Page 42092]]
The first study is a randomized control trial with 907 subjects who
were implanted with the Guardian[supreg] system and randomized 1:1 to
either active or deactivated alarms.\18\ According to the authors, all
subjects received education regarding the importance of minimizing
symptom-to-door time in the presence of chest pain or ischemic
equivalents, regardless of alarm status. The authors state that
patients were not blinded to their randomization status. After
randomization patients returned for follow-up visits at 1, 3, 6, and
every six months thereafter. In all patients, the Guardian[supreg]
system captured electrogram data up to 24 hours before and 8 hours
after a triggered alarm for later review. According to the authors, the
primary safety endpoint was the absence of system-related complications
that required a system revision or invasive intervention to resolve in
at least 90 percent of subjects through six months. The primary
efficacy endpoint was a composite of: (1) Cardiac or unexplained death;
(2) new Q-wave MI; and (3) detection-to-presentation time >2 h for a
documented coronary occlusion event. Electrocardiogram (ECG) tracings
were obtained prior to implantation, at randomization, at 1, 3, and 6
months, and at every emergency presentation to evaluate for a Q-wave MI
not present at baseline. An exploratory dual baseline ECG analysis was
performed, according to the authors, because Q-waves may be transient
between implantation and randomization. The dual baseline ECG analysis
evaluates for the presence of new Q waves across subsequent ECGs. At
the start of the trial, 456 patients were identified as controls and
451 as treated; at six months, 446 controls remained and 437 treated
remained. The authors stated that subject enrollment ceased after 900
subjects were randomized and therefore an alpha penalty of 0.25 was
taken for the interim look at event rates after 600 subjects.
---------------------------------------------------------------------------
\18\ Gibson, C.M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
---------------------------------------------------------------------------
According to the authors, the control and treatment groups were
well matched at baseline.\19\ The primary safety endpoint was met with
96.7 percent freedom (posterior probability >0.999) with a total of 31
system-related complications in 30 (3.3 percent) subjects with
infections being the predominant cause of complications. The authors
stated that ACS events occurrence was low. At 7, 30, 50, 70, and 90
days there were no statistical differences between the control and
treated groups on the primary composite efficacy endpoint. At each time
interval, the treated group had lower rates of the primary endpoint
than the control group. Statistical differences were observed between
treated and control groups in the dual baseline ECG exploratory
analysis particularly at 50, 70, and 90 days after a confirmed
occlusive event favoring the treated group. At the pre-specified 7-day
look back window, the median time from Guardian[supreg] notification to
arrival at a medical facility was 51 minutes for the treated subjects
as compared to 30.6 hours for control subjects (Pr [pt < pc] >0.999).
Subject arrival within 2 hours of a detected and confirmed coronary
occlusion occurred in 85 percent (29 of 34) of the treatment group
compared with only 5 percent of the control group, with the majority of
patients in the control arm presenting after 7 days. However, the
authors asserted that despite a numerical reduction in new Q-wave MI
using single and dual baseline ECGs at any of the pre-specified look-
back windows, the posterior probability of superiority did not reach
statistical significance. The applicant added that 22 percent (42/193)
of the confirmed ACS events were detected due to Emergency Department
(ED) visits prompted by alarms in the absence of symptoms; that silent
MIs typically account for approximately 30 percent of all MIs and are
historically associated with increased rates of morbidity and
mortality.\20\
---------------------------------------------------------------------------
\19\ Gibson, C.M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
\20\ Gibson, C. M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
---------------------------------------------------------------------------
The second article expanded on the previously discussed study with
a post hoc analysis of two coprimary efficacy endpoints: Superiority of
positive predictive value (PPV) and noninferiority of false positive
rate for ED visits prompted by alarms compared to symptoms-only.\21\
According to the authors, these primary endpoints were assessed by
comparing ED visits for an Alarms OFF group (control subjects during
the randomized 6-month period) to those of an Alarms ON group
(including both the treatment subjects during the first 6 months and
all implanted patients beyond 6 months with alarms activated). The
authors stated the expanded analysis adjudicated ED visits into either
true or false-positive ACS events based on independent review of
cardiac test data. The authors stated that the annual rate for Clinical
Events Committee (CEC)--adjudicated ACS events was 0.151 (33 of 218.15)
in the Alarms OFF group and 0.124 (193 of 1,557.64) in the Alarms ON
group. In the Alarms OFF group, of the 181 ED visits, the CEC
adjudicated 33 (18 percent) as ACS events (MI = 22 [67 percent];
unstable angina (UA) \1/4\ 11 [33 percent]), with the remaining visits
adjudicated as due to either stable CAD or indeterminate etiology. The
median symptom-to-door time for Alarms OFF ACS events was 8.0 h (95
percent confidence interval [CI]: 3.2 to 47.5 h). In Alarms ON
subjects, of the 970 ED visits, the CEC adjudicated 193 (20 percent) as
ACS events, with the remainder classified as stable CAD, indeterminate
events, and/or a false-positive alarm. Of the 193 ACS events, 89 events
(46 percent) were prompted by alarms (with or without symptoms; MI \1/
4\ 40 [45 percent]; UA \1/4\ 49 [55 percent]). The remaining 104 visits
(54 percent) were prompted by symptoms only (MI \1/4\ 60 [58 percent];
UA \1/4\ 44 [42 percent]). An overall median arrival time of 1.7 h was
found for the Alarms ON group composite including all 3 prompt types
for ED arrival (alarms only, alarms [thorn] symptoms, or symptoms
only), which was significantly shorter than the 8.0 h delay of the
Alarms OFF group (p < 0.0001). The applicant asserts that the
Guardian[supreg] system allows patients with asymptomatic ACS events to
respond to the ED faster with a median pre-hospital delay of 1.4 hours.
---------------------------------------------------------------------------
\21\ Holmes, D.R., Jr, Krucoff, M.W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M.S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients with Acute Coronary Syndrome Events. JACC, 74(16),
2047-2055.
---------------------------------------------------------------------------
The applicant further asserts that the Guardian[supreg] system
offers more rapid beneficial resolution of the disease process treated
because of the use of the device. According to the applicant, the
Guardian[supreg] system increases the likelihood that a patient will
correctly seek medical care for an ACS event in a timely manner that
reduces pre-hospital delay and associated risk of heart damage (for
example, larger infarct size, ejection fraction decrement)
22 23 24
[[Page 42093]]
and associated downstream sequelae. More specifically, the applicant
asserts that based on the results of the second discussed study, the
Guardian[supreg] system Alarms ON group showed reduced pre-hospital
delays, with 55 percent (95 percent confidence interval [CI]: 46
percent to 63 percent) of Emergency department visits for ACS events <2
hours compared with 10 percent (95 percent CI: 2 percent to 27 percent)
in the Alarms OFF group (p < 0.0001).\25\ The applicant adds that
results were similar when restricted to myocardial infarction (MI)
events.\26\ The applicant states the median pre-hospital delay for MI
was 12.7 hours for Alarms OFF compared to 1.6 hours in Alarms ON
subjects (p < 0.0089) as reported in Holmes et al. (2019).\27\ The
applicant asserts that it is clinically recognized, due to numerous
lines of evidence, that shorter total ischemia time is associated with
better outcomes for ACS events.28 29 30 31 The applicant
asserts that prompt responsiveness to symptoms and decreased pre-
hospital delay is a universally understood benefit which improves the
health outcomes of ACS events. According to the applicant, the American
Heart Association (Mission Lifeline), American College of Cardiology
(Door to Balloon (D2B) Alliance), Society for Angiographic Intervention
(Seconds CountTM program) and the National Heart, Lung, and
Blood Institute have organized task forces and launched national
programs with the goal of improving patient awareness and response to
symptoms which are indicative of potential ACS events and reducing
total ischemia time (that is, prehospital delay and in-hospital delay)
to improve outcomes.
---------------------------------------------------------------------------
\22\ Weaver WD, Cerqueira M, Hallstrom AP, et al. Prehospital-
Initiated vs Hospital-Initiated Thrombolytic Therapy: The Myocardial
Infarction Triage and Intervention Trial. JAMA. 1993;270(10):1211-
1216.
\23\ Hasche ET, Fernandes C, Freedman SB, Jeremy RW. Relation
between ischemia time, infarct size, and left ventricular function
in humans. Circulation. 1995;92:710-719.
\24\ Liem AL, van `t Hof AW, Hoorntje JC, de Boer MJ,
Suryapranata H, Zijlstra F. Influence of treatment delay on infarct
size and clinical outcome in patients with acute myocardial
infarction treated with primary angioplasty. J Am Coll Cardiol.
1998;32:629-633.
\25\ Holmes, D.R., Jr, Krucoff, M.W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M.S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients With Acute Coronary Syndrome Events. Journal of
the American College of Cardiology, 74(16), 2047-2055.
\26\ Holmes, D.R., Jr, Krucoff, M. W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M.S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients With Acute Coronary Syndrome Events. Journal of
the American College of Cardiology, 74(16), 2047-2055.
\27\ Holmes, D.R., Jr, Krucoff, M.W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M. S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients With Acute Coronary Syndrome Events. Journal of
the American College of Cardiology, 74(16), 2047-2055.
\28\ Guerchicoff A, Brener SJ, Maehara A, et al. Impact of delay
to reperfusion on reperfusion success, infarct size, and clinical
outcomes in patients with ST-segment elevation myocardial
infarction: the INFUSE-AMI Trial (INFUSE-Anterior Myocardial
Infarction). JACC Cardiovasc Interv. 2014;7(7):733-740.
\29\ Flynn A, Moscucci M, Share D, et al. Trends in door-to-
balloon time and mortality in patients with ST elevation myocardial
infarction undergoing primary percutaneous coronary intervention.
Arch Intern Med. 2010;170(20):1842-1849.
\30\ De Luca G, Suryapranata H, Zijlstra F, et al. Symptom-
onset-to-balloon time and mortality in patients with acute
myocardial infarction treated by primary angioplasty. J Am Coll
Cardiol. 2003;42(6):991-997.
\31\ Gersh BJ, Stone GW. Pharmacological facilitation of
coronary intervention in ST-segment elevation myocardial infarction:
Time is of the essence. JACC Cardiovasc Interv. 2010;3(12):1292-
1294.
---------------------------------------------------------------------------
The applicant next asserts the device offers more rapid beneficial
resolution of the disease process because the use of the
Guardian[supreg] system, as compared to the standard of care relying on
symptoms alone, being in the Alarm ON group was associated with a
reduction in the rate of new onset of left ventricular dysfunction.\32\
---------------------------------------------------------------------------
\32\ Holmes, D.R., Jr, Krucoff, M.W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M.S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients With Acute Coronary Syndrome Events. Journal of
the American College of Cardiology, 74(16), 2047-2055.
---------------------------------------------------------------------------
Lastly the applicant asserts the use of the Guardian[supreg] system
will decrease the number of future hospitalizations or physician
visits. According to the applicant, the Guardian[supreg] system reduces
the annual false positive rate (FPR) of Emergency Department visits
(that is, spurious ED visits where no ACS is found) by 26 percent.\33\
The applicant states that the FPR for all alarms on emergency visits
was 0.499 per patient-year compared to 0.678 for alarms off (p
<0.001).\34\
---------------------------------------------------------------------------
\33\ Gibson, C.M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
\34\ Gibson, C.M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
---------------------------------------------------------------------------
Based on the evidence submitted with the application, we have the
following observations. Much of the claims for substantial clinical
improvement are derived from two primary studies identified by the
applicant and discussed above.35 36 We note that the first
study (Gibson et al. 2019) did not demonstrate statistically
significant superiority of the intervention during the pre-determined
study window. The authors noted a lower than expected frequency of
events and the study was terminated early, two factors which may have
affected these results. The results from the second study are based
entirely on a post hoc analysis of data from the first article. We note
that the findings presented are valuable but we seek comment on whether
a post hoc analysis provides sufficient evidence to support the claim
of substantial clinical improvement. Furthermore, we note that the
primary efficacy endpoint was a composite of three outcomes. We are not
certain that this endpoint is an appropriate measure with which to
evaluate substantial clinical improvement among patients experiencing
ACS events. We invite public comments on whether the Guardian[supreg]
system meets the substantial clinical improvement criterion.
---------------------------------------------------------------------------
\35\ Gibson, C.M., Holmes, D., Mikdadi, G., Presser, D., Wohns,
D., Yee, M.K., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd, Iteld, B.,
& Krucoff, M.W. (2019). Implantable Cardiac Alert System for Early
Recognition of ST-Segment Elevation Myocardial Infarction. Journal
of the American College of Cardiology, 73(15), 1919-1927.
\36\ Holmes, D.R., Jr, Krucoff, M.W., Mullin, C., Mikdadi, G.,
Presser, D., Wohns, D., Kaplan, A., Ciuffo, A., Eberly, A.L., 3rd,
Iteld, B., Fischell, D.R., Fischell, T., Keenan, D., John, M.S., &
Gibson, C.M. (2019). Implanted Monitor Alerting to Reduce Treatment
Delay in Patients With Acute Coronary Syndrome Events. Journal of
the American College of Cardiology, 74(16), 2047-2055.
---------------------------------------------------------------------------
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that Guardian[supreg]
would be reported with the HCPCS codes listed in the following Table
21:
[[Page 42094]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.029
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5222--Level 2 Pacemaker and
Similar Procedures, which had a CY 2021 payment rate of $8,152.58 at
the time the application was received. Beginning in CY 2017, we
calculate the device offset amount at the HCPCS/CPT code level instead
of the APC level (81 FR 79657). HCPCS code 0527T was assigned to APC
5222 and had a device offset amount of $1,598.72 at the time the
application was received.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost for Guardian is 126 percent of the applicable
APC payment amount for the service related to the category of devices
of $8,152.58. Therefore, we believe Guardian[supreg] meets the first
cost significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost for
Guardian[supreg] is 641 percent of the cost of the device-related
portion of the APC payment amount for the related service of $1,598.72.
Therefore, we believe that Guardian[supreg] meets the second cost
significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost for Guardian[supreg] and the portion of the APC payment
amount for the device of $1,598.72 is 106 percent of the APC payment
amount for the related service of $8,152.58. Therefore, we believe that
Guardian[supreg] meets the third cost significance requirement. We are
inviting public comment on whether the Guardian[supreg] meets the
device pass-through payment criteria discussed in this section,
including the cost criterion for device pass-through payment status.
(2) BONEBRIDGE Bone Conduction Implant System
MED-EL Corporation submitted an application for a new device
category for transitional pass-through payment status for the
BONEBRIDGE Bone Conduction Implant System (hereinafter referred to as
the BONEBRIDGE) by the March 2021 quarterly deadline for CY 2022. The
BONEBRIDGE is a transcutaneous, active auditory osseointegrated device
that replaces the function of the damaged outer or middle ear and can
help people for whom hearing aids are ineffective or not recommended.
According to the applicant, the device consists of a bone conduction
implant and electronics components, and an externally worn audio
processor. The bone conduction implant is called the BONEBRIDGE Bone
Conduction Implant (BCI 602) and the externally worn audio processor is
called the SAMBA 2 Audio Processor. The BCI 602 consists of two main
sections, the coil section and the transducer section. The BCI 602
consists of a magnet surrounded by the receiver coil, the transition,
the Bone Conduction Floating Mass Transducer (BC-FMT), and the
electronics package in a hermetic housing. The SAMBA 2 Audio Processor
is 30.4 mm x 36.4 mm x 10.2 mm and weighs 9.3 g, including the battery
and magnet (strength 1). It
[[Page 42095]]
has an 18-band digital equalizer, 18 independent compression channels,
and an audio frequency range of 250 Hz to 8 kHz. The audio processor is
powered by a non-rechargeable 675 zinc-air button cell with a nominal
1.4-volt supply and 600 mA-Hrs of capacity offering the user up to 133
hours (8 to 10 days) on a single battery.
The applicant stated that the bone conduction implant is surgically
attached to the skull, subcutaneous, and is connected to the external
audio processor by transcutaneous magnetic attraction. The external
audio processor picks up sound from the environment and converts those
sounds to a radiofrequency (RF) signal that that can be transmitted
across the skin to the implant. The implant converts the signal to
controlled vibrations which are conducted via the skull and perceived
as sound. More specifically, the applicant stated that the BCI 602 is
activated by placing the external audio processor over the magnet of
the BCI 602. The signal and the energy to drive the BC-FMT are
transferred via an inductive link to the internal coil, and then
relayed to the BC-FMT. The BC-FMT transduces the signal into mechanical
vibrations, which are conducted to the skull via the cortical titanium
screws. These vibrations stimulate the auditory system through the bone
conduction pathway to allow the patient to hear.
With respect to the newness criterion at Sec. 419.66(b)(1), the
FDA granted a de novo request classifying the BONEBRIDGE as a Class II
device under section 513(f)(2) of the Federal Food, Drug, and Cosmetic
Act on July 20, 2018. The BONEBRIDGE is indicated for use in the
following patients: (1) Patients 12 years of age or older; and (2)
patients who have a conductive or mixed hearing loss and still can
benefit from sound amplification. The pure tone average (PTA) bone
conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be
better than or equal to 45 dB HL; (3) Bilateral fitting of the
BONEBRIDGE is intended for patients having a symmetrically conductive
or mixed hearing loss. The difference between the left and right sides'
BC thresholds should be less than 10 dB on average measured at 0.5, 1,
2, and 3 kHz, or less than 15 dB at individual frequencies; (4)
Patients who have profound sensorineural hearing loss in one ear and
normal hearing in the opposite ear (that is, single-sided deafness or
``SSD''). The pure tone average air conduction hearing thresholds of
the hearing ear should be better than or equal to 20 dB HL (measured at
0.5, 1, 2, and 3 kHz); (5) The BONEBRIDGE for SSD is also indicated for
any patient who is indicated for an air conduction contralateral
routing of signals (AC CROS) hearing aid, but who for some reason
cannot or will not use an AC CROS. Prior to receiving the device, it is
recommended that an individual have experience with appropriately fit
air conduction or bone conduction hearing aids. We received the
application for a new device category for transitional pass-through
payment status for the BONEBRIDGE on December 10, 2020, which is within
3 years of the date of the initial FDA marketing authorization. We are
inviting public comments on whether the BONEBRIDGE meets the newness
criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the BONEBRIDGE is integral to the service
provided, is used for one patient only, comes in contact with human
skin and is surgically implanted or inserted. The applicant also
claimed that the BONEBRIDGE meets the device eligibility requirements
of Sec. 419.66(b)(4) because it is not an instrument, apparatus,
implement, or item for which depreciation and financing expenses are
recovered, and it is not a supply or material furnished incident to a
service. Additionally, the BONEBRIDGE is not subject to the hearing aid
exclusion at Sec. 411.15(d)(1). The BONEBRIDGE Bone Conduction Implant
(BCI 602) component is an osseointegrated implant, surgically attached
to the skull that converts a radiofrequency signal from an external
audio processor to controlled vibrations which are conducted via the
skull to the cochlea. Therefore, we believe the BONEBRIDGE meets the
criterion at Sec. 411.15(d)(2)(i) and is not subject to the hearing
aid exclusion. In accordance with the Medicare Benefit Policy Manual,
Chapter 16 ``General Exclusions from Coverage,'' section 100, certain
devices that produce perception of sound by replacing the function of
the middle ear, cochlea or auditory nerve are payable by Medicare as
prosthetic devices. These include osseointegrated implants, that is,
devices implanted in the skull that replace the function of the middle
ear and provide mechanical energy to the cochlea via a mechanical
transducer. We believe the BONEBRIDGE device meets the criteria of this
benefit category. We are inviting public comments on whether the
BONEBRIDGE meets the eligibility criteria at Sec. 419.66(b) as well as
the criterion at Sec. 411.15(d)(2)(i).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996.
The applicant stated that the previous category, L8690--Auditory
osseointegrated device, includes all internal and external components,
which was effective from January 1, 2007-December 31, 2008 did not
include the BONEBRIDGE. The applicant stated that at the time the
category was established, BONEBRIDGE did not exist and the devices
described by the category included auditory osseointegrated implant
(AOI) devices or bone-anchored hearing aids (BAHA). The applicant
claimed that AOI devices and BAHAs are distinct from the BONEBRIDGE
because they are implant systems composed of an external sound
processor connected via a percutaneous abutment to a titanium implant
that is implanted in the skull. In these devices, the titanium implant
protrudes through the skin creating a titanium post, which directly
attaches to an external sound processor. The system replaces the
function of the middle ear by transmitting mechanical energy from the
external transducer/sound processor directly to the titanium implant to
the cochlea thereby resulting in better hearing. The applicant stated
that the titanium abutment used by percutaneous systems permanently
pierce the skin to allow the sound processor to transmit sound and
create vibrations within the skull that stimulate the nerve fibers of
the inner ear. The applicant also stated that in the percutaneous
systems, the external component (sound processor) receives and
processes the sound and generates the vibrations.
The applicant claimed that the BONEBRIDGE is a new technology
compared to the AOI devices and BAHAs and unlike these devices, it does
not use a percutaneous abutment. The applicant described BONEBRIDGE as
an active, transcutaneous device that consists of a completely
implanted transducer and electronics components, and an externally worn
audio processor. The active implant is surgically attached to the
skull, is subcutaneous, and is connected to the external audio
processor by transcutaneous magnetic attraction. The external audio
processor picks up sound from the environment and converts those sounds
to a radiofrequency (RF) signal that can be transmitted across the skin
to the implant. The implant converts the
[[Page 42096]]
signal to controlled vibrations, which are conducted via the skull and
perceived as sound. The applicant proposed the device pass-through
category descriptor ``Auditory osseointegrated device, transcutaneous,
with implanted transducer and radiofrequency link to external sound
processor'' and suggested that L8690 be revised to read, ``Auditory
osseointegrated device, percutaneous, includes all internal and
external components''. The applicant stated that the Cochlear
OsiaTM 2 System, which also submitted a device pass-through
application for CY 2022, would also be described by the proposed
additional category.
We believe that the BONEBRIDGE is described by L8690--Auditory
osseointegrated device, includes all internal and external components.
The applicant has noted differences between the BONEBRIDGE and the
devices that were described by L8690, specifically percutaneous,
auditory osseointegrated devices, regarding the connection between the
implanted transducer and the external audio processor (percutaneous
abutment vs. transcutaneous magnetic attraction). However, we believe
that there is a similar mechanism of action for all these devices
specifically, vibratory stimulation of the skull to stimulate the
receptors in the cochlea (inner ear). Further, we believe that the
broad descriptor for L8690 of ``Auditory osseointegrated device,
includes all internal and external components'' includes the
applicant's device.
We are inviting public comment on whether the BONEBRIDGE meets the
device category criterion.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. With respect to the substantial
clinical improvement criterion, the applicant stated that the
BONEBRIDGE represents a substantial clinical improvement because it
provides a reduced rate of device-related complications and a more
rapid beneficial resolution of the disease process treated because of
the use of the device compared to currently available treatments. The
applicant submitted six studies to support these claims. The applicant
also submitted references for four retrospective case studies of
complications with percutaneous devices, specifically bone-anchored
hearing aids, including infections, pain, soft tissue hypertrophy, loss
of osseointegration, and need for further surgery. These studies did
not involve the applicant's device.
In support of the claim that the BONEBRIDGE reduced the rate of
device-related complications compared to currently available
treatments, the applicant submitted a white paper that reviewed the
literature reporting on safety outcomes in bone conduction implants
authored by the manufacturer of the BONEBRIDGE, MED-EL.\37\ The review
included five products used to treat conductive hearing loss, mixed
hearing loss or single side deafness, which were either percutaneous
systems that had an abutment that permanently pierced through the skin
or transcutaneous systems without permanent skin penetration. The
authors further defined the products as either active or passive,
depending on the placement of the vibrating (or active) device
component. According to the authors, active bone conduction systems,
the active device component, is located within the implantable part of
the system. According to the authors, passive bone conduction systems,
the vibrating device component, is located outside of the skull.\38\
---------------------------------------------------------------------------
\37\ MED-EL Medical Electronics. (2019). Safety outcomes of bone
conduction implants: A systematic review [White paper].
\38\ Ibid.
---------------------------------------------------------------------------
The literature review compared the safety outcomes of the BAHA
Connect and the Ponto, (passive, percutaneous systems,) the BONEBRIDGE,
(an active, transcutaneous systems), and the Sophono Alpha and the BAHA
Attract, (passive, transcutaneous systems). In total, 156 studies were
included in the literature review. There were seven studies with 234
patients reported on the Ponto, thirteen studies with 175 patients
reported on the BONEBRIDGE, twelve publications with 143 patients
reported on the Sophono Alpha, seven studies reported on the BAHA
Attract system with 114 patients, and 117 studies reported on the BAHA
Connect system with a total of 6,965 patients. Of all reported adverse
events, 38 percent were major and 62 percent were minor. Major adverse
events reported in the review included revision surgery, explantation,
removal at patient request, implant loss, implant device failure, skin
revision surgery or skin infection. Minor adverse events included skin
infections, soft tissue reactions, and healing difficulties. The
results showed that 9.8 percent of patients using the BONEBRIDGE system
experienced an adverse event (major or minor), compared to 68.4 percent
of BAHA Attract patients, 46.9 percent of Sophono Alpha patients, 44.0
percent of Ponto system patients and 51.7 percent of BAHA Connect
patients. When comparing the percentage of patients who experienced a
major adverse event, 2.9 percent of BONEBRIDGE patients had a major
adverse event compared to 1.8 percent of BAHA Attract patients, 4.2
percent of Sophono Alpha patients, 5.1 percent of Ponto system
patients, and 21.1 percent of BAHA Connect patients.
To support the claim that the BONEBRIDGE reduced the rate of
device-related complications compared to currently available
treatments, the applicant also submitted a systematic review of the
current literature on safety, efficacy and subjective benefit after
implantation with the BONEBRIDGE device.\39\ The systematic review
assessed 39 publications and included randomized controlled trials,
clinical controlled trials and cohort studies, case series and case
reports investigating subjective and objective outcomes. In the 39
publications included in the review, 487 participants were evaluated;
303 participants had conductive hearing loss, 67 participants had mixed
hearing loss, and 53 participants had single-sided deafness. The mean
age of the patients in the included studies was 35.6 16.9
years. Using the guidelines available from the Cochrane Collaboration,
a search strategy and review protocol was developed using PubMed
(MEDLINE) and Cochrane databases to identify all publications on the
BONEBRIDGE from 2012 to October 31, 2018. The researchers excluded
studies that assessed a device or treatment other than the BONEBRIDGE,
did not include human participants, focused on a type of hearing loss
other than the losses that BONEBRIDGE is indicated for (that is,
conductive hearing loss, mixed hearing loss or single-sided deafness),
did not report on safety or performance/quality of life data, were not
related to hearing loss or treatment thereof, lacked
[[Page 42097]]
sufficient information for evaluation, and included overlapping
samples.
---------------------------------------------------------------------------
\39\ Magele, A., Schoerg, P., Stanek, B. et al. (2019). Active
transcutaneous bone conduction hearing implants: Systematic review
and meta-analysis. PLoS ONE 14(9); e0221484 https://doi.org/10.1371/journal.pone.0221484.
---------------------------------------------------------------------------
The outcomes extracted from the studies were assessed via meta-
analysis. The safety of the device was assessed by collecting
information on complications during surgery and adverse events in the
postoperative period. Of the 39 identified studies, there were 25
studies that reported on safety during a mean period of 11.7 months
(range 3-36 months). The reported complications were categorized into
minor and major complications, with a major complication described as
requiring surgical attention leading to revision surgery or
explantation. Minor complications included skin edema or erythema, skin
infections, and hematomas. Out of 286 ears implanted with the device,
there were no complications in 259 ears (90.6 percent). Minor
complications occurred in 22 ears (7.7 percent) over a cumulative
period of reported mean follow-up of 12.7 years (mean: 11.7 months
4.5). Major complications occurred in three studies
comprising five ears (1.7 percent).\40\
---------------------------------------------------------------------------
\40\ Ibid.
---------------------------------------------------------------------------
The applicant submitted an additional study by Schmerber, et al. to
support the claim that the BONEBRIDGE reduced the rate of device-
related complications compared to currently available treatments.\41\
The study of 28 participants was a multicenter, prospective study with
intra-subject measurements with the purpose of the study to validate
the safety and efficacy of the BONEBRIDGE 12 months after
implementation. The study included nine university hospitals, seven in
France and two in Belgium. Sixteen participants with conductive or
mixed hearing loss with bone-conduction hearing thresholds under the
upper limit of 45 dB HL for each frequency from 500 to 4,000 Hz, and 12
participants with SSD (contralateral hearing within normal range) were
enrolled in the study. Three of the 28 participants (with mixed or
conductive hearing loss) did not complete the study; one requested that
the device be removed (due to ``severe psychological problems'') and
two were lost to follow up. The skin safety of the participants was
evaluated by the surgeon who implanted the device up to 12 months post-
operatively using an ordinal scale (``very good'', ``good'',
``acceptable'', ``bad skin condition'') and a visual analogue scale
(between 1 and 10 from ``very bad'' to ``excellent'') to rate cutaneous
tolerance. In the study, no complications or device failures occurred,
no revision surgery was necessary and no skin injury was reported. The
scoring was judged as `excellent' or `good' for all subjects (n = 25),
corresponding to scores 8 to 10 on the scale. No complication (0
percent) was observed [95 percent confidence interval = (0 percent-14.9
percent)]. The authors stated that there was a lower rate of
complications for the BONEBRIDGE device compared to percutaneous
systems, like the BAHA, whose complication rate was up to 24 percent in
a large series of 602 ears and a revision surgery rate of 12
percent.42 43
---------------------------------------------------------------------------
\41\ Schmerber, S., Deguine, O., Marx, M. et al. (2017). Safety
and effectiveness of the Bonebridge transcutaneous direct-drive
bone-conduction hearing implant at 1-year device use. Eur Arch
Otorhinolaryngol 274: 1835-1851 doi 10.1007/s00405-016-4228-6.
\42\ Schmerber, S., Deguine, O., Marx, M. et al. (2017). Safety
and effectiveness of the Bonebridge transcutaneous direct-drive
bone-conduction hearing implant at 1-year device use. Eur Arch
Otorhinolaryngol 274: 1835-1851 doi 10.1007/s00405-016-4228-6.
\43\ Hobson, J.C., Roper, A.J., Andrew, R., Rothera, M.P., Hill,
P., Green, K.M. (2010) Complications of bone-anchored hearing aid
implantation. J Laryngol Otol 124(2):132-136. doi:10.1017/
S0022215109991708.
---------------------------------------------------------------------------
The applicant also submitted a study by Siegel et al. as evidence
to support the claim that the BONEBRIDGE reduced the rate of device-
related complications compared to currently available treatments.\44\
The study was a retrospective review that included 37 adult patients
with conductive/mixed hearing loss who met the indications for use and
were implanted with BONEBRIDGE over a five-year period from April 2013
to May 2018. Patient charts were reviewed for surgical outcomes and
complications over the 6-year period. The mean time of follow-up was 32
months (range: 9-71 months). There were no events of surgical
complications in the patients included in the study, specifically no
instances of dural injury, cerebrospinal fluid (CSF) leak, or
intracranial bleeding. There were also no skin complications and no
postoperative symptoms of tinnitus/vertigo or dizziness.\45\
---------------------------------------------------------------------------
\44\ Siegel, L.H., You, P., Zimmerman, K. et al. (2020). Active
transcutaneous bone conduction implant: Adiometric outcomes
following a novel middle fossa approach with self-drilling screws.
Otol Neurotol 41(5): 605-613. doi: 10.1097/MAO.0000000000002597.
\45\ Siegel, L.H., You, P., Zimmerman, K. et al. (2020). Active
transcutaneous bone conduction implant: Audiometric outcomes
following a novel middle fossa approach with self-drilling screws.
Otol Neurotol 41(5): 605-613. doi: 10.1097/MAO.0000000000002597.
---------------------------------------------------------------------------
In support of the assertion that the use of BONEBRIDGE resulted in
a more rapid beneficial resolution of the disease process compared to
currently available treatments, the applicant also referenced the
Magele et al., and Siegel et al. studies as well as a study conducted
by Yang et al.46 47 48
---------------------------------------------------------------------------
\46\ Ibid.
\47\ Ibid.
\48\ Ibid.
---------------------------------------------------------------------------
As previously noted, the Magele et al. study assessed 39
publications that included 487 participants; 303 participants had
conductive hearing loss, 67 participants had mixed hearing loss, and 53
participants had single-sided deafness.\49\ Functional gain was
available for analysis from 14 articles and was measured as the
difference between unaided and aided (with the BONEBRIDGE) warble tone
thresholds. On average, functional gain of 32.7 dB 16 dB
was observed. Overall, the results showed a 30.89 dB (95 percent CI
27.53 dB-34.24 dB) improvement at speech presentation level; for the 30
conductive hearing loss patients, the improvement was 39.48 dB (95
percent CI 35.25 dB-43.71 dB); for the mixed hearing loss group, the
improvement was 29.08 dB (95 percent CI 26.32 dB-31.83 dB) and the
improvement was 28.94 dB (95 percent CI 16.92 dB-40.96 dB) for the 10
subjects with single-sided deafness.
---------------------------------------------------------------------------
\49\ Ibid.
---------------------------------------------------------------------------
The applicant also noted the study by Siegel et al. to support the
claim that the use of BONEBRIDGE resulted in a more rapid beneficial
resolution of the disease process compared to currently available
treatments.\50\ As previously stated, in this study, 37 adult patients
with conductive/mixed hearing loss who met the indications for use were
implanted with BONEBRIDGE over a six-year period. The patients' charts
were reviewed for surgical outcomes and complications over the six-year
period. Preoperative air conduction (AC), preoperative bone conduction
(BC), and 3-month postoperative aided thresholds were recorded. Speech
perception was assessed using two different tests, consonant-nucleus-
consonant (CNC) words and AzBio sentences. Pure-tone averages (PTAs;
measured at 0.5, 1.0, 2.0 and 3.0 kHz), air-bone gap (ABG), and
functional gain (FG) were calculated. The preoperative air-bone gap was
calculated as the difference between AC thresholds and BC thresholds of
the implanted ear. The postoperative ABG was calculated as the
difference between the preoperative BC and postoperative BONEBRIDGE
aided thresholds measured at 3 months postoperatively. Functional gain
was
[[Page 42098]]
calculated as the difference between preoperative AC thresholds and
BONEBRIDGE aided thresholds measured 3 months postoperatively.
---------------------------------------------------------------------------
\50\ Siegel, L.H., You, P., Zimmerman, K. et al. (2020). Active
transcutaneous bone conduction implant: Audiometric outcomes
following a novel middle fossa approach with self-drilling screws.
Otol Neurotol 41(5): 605-613. doi: 10.1097/MAO.0000000000002597.
---------------------------------------------------------------------------
The results of this study showed audiological improvement in the 37
patients with a functional gain (averaged over 4 frequencies, 500 kHz
to 3,000 kHz) of 40.3 dB ( 19.0 dB) for air conduction 3
months postoperatively. The difference between the average air to bone
conduction gap fell from 44.9 dB preoperative to 4.6 dB three months
after surgery. The postoperative air conduction thresholds for the 21
patients with mixed hearing loss ranged between 30-40 dB and the air
conduction thresholds for the 16 patients with conductive hearing loss
ranged between 20-30 dB. For patients with mixed hearing loss, nearly a
full ABG closure was achieved at all frequencies by 3 months
postoperatively.
In the same study, speech perception testing was available for 21
patients (57 percent). At activation, mean speech perception results
for CNC words (13 patients) and AzBio sentences (14 patients) were 79
and 93 percent, respectively. At six months postoperatively, CNC words
(17 patients) and AzBio sentences (21 patients) were 81 and 93 percent,
respectively. The authors stated that the results of the study were
comparable with what has been accomplished using traditional
percutaneous conduction devices and passive transcutaneous bone
conduction devices.
Lastly, to support the claim that the use of the BONEBRIDGE
resulted in a more rapid beneficial resolution of the disease process,
the applicant submitted a study that compared the use of the BONEBRIDGE
with a non-implantable bone conduction hearing aid (BCHA).\51\ This
single center, prospective study involved 100 patients in Beijing,
China with bilateral congenital microtia-atresia (CMA). The patients
had a mean age of 11.9 6.0 years old at the time the
BONEBRIDGE was implanted. All patients had worn the passive bone
anchored hearing aid for at least a year prior to the implantation of
the BONEBRIDGE and patients were tested an average of 25 weeks after
surgery. Measured outcomes in the study included sound field thresholds
(SFT), functional gain (FG) [aided threshold minus the unaided
threshold], word recognition, speech reception thresholds (SRT),
preoperative and postoperative bone and air conduction and patient
subjective satisfaction. Bone conduction of pure tones at any frequency
did not change significantly from preoperative to postoperative
testing. The mean bone-conduction pure-tone threshold (PTA) before
implantation was 8.7 6.1 dB HL and after surgery was 8.9
5.6 dB HL (p > .745, paired t-test). Furthermore, bone
conduction did not significantly change at any frequency after surgery
(p > .05, t-test). The mean SFT of the BONEBRIDGE (61.6
7.1 dB HL) was significantly higher than the BCHA (31.3
6.1 dB HL) (paired t-test, p < .001) and the SFT was significantly
better with BONEBRIDGE at 500, 1,000, 2,000, and 4,000 Hz sound
frequencies (paired t-test, p < .002). Further, the FG of the
BONEBRIDGE (31.2 9.5 dB HL) was significantly better than
the FG of the BCHA (26.5 10.3 dB HL) (paired t-test, p <
.001). The FG measured at 250 Hz in the two aided conditions had less
improvement compared to other frequencies (p < .001). A comparison of
BCHA and BONEBRIDGE resulted in a significant difference in word
recognition (68.0 percent for monosyllabic words and 79.0 percent for
disyllabic words with the BCHA vs. 78.0 percent for monosyllabic and
84.0 percent for disyllabic words with the BONEBRIDGE) in favor of the
BONEBRIDGE (p < .001).
---------------------------------------------------------------------------
\51\ Yang, J., Chen, P., Zhao, C. et al. 2020. Audiological and
subjective outcomes of 100 implanted transcutaneous bone conduction
devices and preoperative bone conduction hearing aids in patients
with bilateral microtia-atresia. Acta Oto-Laryngologica 140(6): 667-
673 https://doi.org/10.1080/00016489.2020.1762929.
---------------------------------------------------------------------------
Regarding the applicant's evidence of substantial clinical
improvement, we note that the studies submitted did not involve a
direct comparison to other currently available treatments, namely
percutaneous or passive, transcutaneous auditory osseointegrated
devices. Therefore, it was difficult to determine whether the
BONEBRIDGE provided a substantial clinical improvement over existing
devices. Also, the studies submitted included a small number of
participants which may affect the generalizability of the data provided
in support of the device.
In the white paper by MED-EL, the authors compared the complication
rates associated with various studies that differed by design,
population characteristics and follow-up time. We are not confident
that differences seen or elucidated by the applicant are due to the
differences in treatments or instead due to differences in study
characteristics. Additionally, although the overall, both major and
minor, adverse event ratio was significantly lower for the BONEBRIDGE
device (9.8 percent) versus other bone conduction hearing devices in
the study, when comparing the percent of patients who experienced a
major adverse event, BONEBRIDGE patients had a major adverse event (2.9
percent) that was more comparable to other devices included in the
paper. With regard to the Yang et al. study, given the young age of the
patients and the congenital nature of the hearing loss being treated,
we are concerned that these results may not be generalizable to the
Medicare population, which tends to be significantly older in age and
potentially less likely to have hearing loss related to congenital
causes. We invite public comments on whether BONEBRIDGE meets the
substantial clinical improvement criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that there were no
specific CPT codes that currently describe the implantation of
BONEBRIDGE. To demonstrate that the requested category met the cost
criterion, the applicant submitted the HCPCS codes used to describe
implantation of a percutaneous device, included in the following Table
22.
[[Page 42099]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.030
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5115--Level 5
Musculoskeletal Procedures, which had a CY 2020 payment rate of
$11,900.71 at the time the application was received. Beginning in CY
2017, we calculate the device offset amount at the HCPCS/CPT code level
instead of the APC level (81 FR 79657). HCPCS code 69714 had a device
offset amount of $7,742.60 at the time the application was received.
According to the applicant, the cost of the BONEBRIDGE is $11,500.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $11,500 for BONEBRIDGE is 97 percent of the
applicable APC payment amount for the service related to the category
of devices of $11,900.71 (($11,500/$11,900.71) x 100 = 96.6 percent).
Therefore, we believe BONEBRIDGE meets the first cost significance
requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $11,500 for
BONEBRIDGE is 149 percent of the cost of the device-related portion of
the APC payment amount for the related service of $7,742.60 (($11,500/
$7,742.60) x 100 = 148.5 percent). Therefore, we believe that
BONEBRIDGE meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $11,500 for BONEBRIDGE and the portion of the APC
payment amount for the device of $7,742.60 is 31.6 percent of the APC
payment amount for the related service of $11,900.71 ((($11,500-
$7,742.60)/$11,900.71) x 100 = 31.6 percent). Therefore, we believe
that BONEBRIDGE meets the third cost significance requirement.
We invite public comment on whether BONEBRIDGE meets the device
pass-through payment criteria discussed in this section, including the
cost criterion for device pass-through payment status.
(3) Eluvia\TM\ Drug-Eluting Vascular Stent System
Boston Scientific Corporation submitted an application for device
pass-through status for the Eluvia\TM\ Drug-Eluting Vascular Stent
System (Eluvia\TM\ system) for CY 2022. According to the applicant, the
Eluvia\TM\ system is a combination product composed of an implantable
endoprosthesis, a non-bonded freely dispersed drug layer (a formulation
of paclitaxel contained in a polymer matrix), and a stent delivery
system indicated for the treatment of symptomatic de novo or restenotic
lesions in the native superficial femoral artery (SFA) and/or proximal
popliteal artery (PPA).
According to the applicant, the Eluvia\TM\ system stent is a laser-
cut self-expanding stent composed of nickel titanium alloy with
radiopaque markers made of tantalum on the proximal and distal ends.
The applicant states that the 6-French delivery system is a triaxial
design with an outer shaft to stabilize the stent delivery system, a
middle shaft to protect and constrain the stent, and an inner shaft to
provide a guidewire lumen. The delivery system is compatible with 0.035
in (0.89mm) guidewires and is offered in two working lengths (75 and
130 cm).
According to the applicant, peripheral artery disease (PAD) occurs
when fatty or calcified material (plaque) builds up in the walls of the
arteries and makes them narrower, thus restricting blood flow. The
applicant asserts that when this occurs, the muscles in the legs cannot
get enough blood and oxygen, especially during exertion such as
exercise or walking. According to the applicant, the main symptoms of
PAD are pain, burning sensation, or general discomfort in the muscles
of the feet, calves, or thighs. As the disease progresses, plaque
accumulation may significantly reduce blood flow through the arteries,
resulting in claudication and increasing disability, with severe cases
often leading to amputation of the affected limb. The applicant states
that according to the Centers for Disease Control and Prevention
approximately 8.5 million people age 40 and older in the United States
have PAD, including 6-26 percent of individuals older than age 60.\52\
According to the applicant,
[[Page 42100]]
PAD disproportionately affects African American and American Indian
populations \53\ and nonrevascularized lower extremity PAD is among the
most common causes of lower extremity amputation.
---------------------------------------------------------------------------
\52\ Centers for Disease Control and Prevention. https://www.cdc.gov/heartdisease/pad.htm.
\53\ Virani SS, et al. AHA Statistical Update: Heart Disease and
Stroke Statistics--2020 Update, A Report from the American Heart
Association. Circulation. 2020;141:e139-e596.
---------------------------------------------------------------------------
According to the applicant, the Eluvia\TM\ system is designed to
restore blood flow in the peripheral arteries above the knee,
specifically the superficial femoral artery and proximal popliteal
artery. The applicant states that the stent features a unique drug-
polymer combination intended to facilitate sustained elution of the
drug paclitaxel that can prevent narrowing (restenosis) of the vessel.
The applicant adds that restenosis is often the cause of pain and
disability for patients diagnosed with PAD.
The applicant asserts that no other endovascular technologies that
are approved for the treatment of PAD provide sustained elution of a
drug over at least 12 months to prevent restenosis. According to the
applicant, two of the most common endovascular treatments for PAD are
angioplasty and stenting. The applicant states that following an
intervention within the SFA or PPA, these arteries elicit a healing
response that leads to restenosis starting with inflammation, followed
by smooth muscle cell proliferation and matrix formation.\54\ According
to the applicant, because of the unique mechanical forces in the SFA
and PPA, the restenotic process can continue well beyond 12 months from
the initial intervention. The applicant asserts the Eluvia\TM\ system
is designed to elute anti-restenotic drug paclitaxel beyond 12 months,
which is longer than the two-month duration of drug applied from drug-
coated balloons and the drug-coated stent Zilver PTX.
---------------------------------------------------------------------------
\54\ Forrester JS, et al. A paradigm for restenosis based on
cell biology: Clues for the development of new preventive therapies.
J Am Coll Cardiol. 1991 Mar 1;17(3):758-69.
---------------------------------------------------------------------------
With respect to the newness criterion at Sec. 419.66(b)(1), the
Eluvia\TM\ system received FDA premarket approval (PMA) on September
18, 2018. The application for a new device category for transitional
pass-through payment status for the Eluvia\TM\ system was received on
February 26, 2021, which is within 3 years of the date of the initial
FDA approval or clearance. We invite public comments on whether the
Eluvia\TM\ system meets the newness criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the Eluvia\TM\ system is integral to the
service provided, is used for one patient only, comes in contact with
human tissue, and is surgically impacted or inserted. The applicant
also claimed that the Eluvia\TM\ system meets the device eligibility
requirements of Sec. 419.66(b)(4) because it is not an instrument,
apparatus, implement, or items for which depreciation and financing
expenses are recovered, and it is not a supply or material furnished
incident to a service. Previously, we invited public comment and
subsequently determined that Eluvia\TM\ system device meets the
eligibility criterion (84 FR 61286). We invite public comments on
whether the Eluvia\TM\ system continues to meet the eligibility
criterion at Sec. 419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. We have not
identified an existing pass-through payment category that describes the
Eluvia\TM\ system. The applicant proposed a category descriptor for the
Eluvia\TM\ system of ``Stent, non-coronary, polymer matrix, minimum 12-
month sustained drug release, with delivery system.'' Previously, we
invited public comment and subsequently determined that Eluvia\TM\
system device meets the device category eligibility criterion. For a
complete discussion of comments received, please see the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61286-61287). We invite
public comments on whether the Eluvia\TM\ system continues to meet this
criterion.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines that a device to be included
in the category has demonstrated that it will substantially improve the
diagnosis or treatment of an illness or injury or improve the
functioning of a malformed body part compared to the benefits of a
device or devices in a previously established category or other
available treatment. With respect to this criterion, the applicant
claims the Eluvia\TM\ system provides a substantial clinical
improvement over existing technologies for the following reasons: (1)
The Eluvia\TM\ system achieves superior primary patency; (2) the
Eluvia\TM\ system achieves reduced lesion revascularization, leading to
a reduced rate of subsequent therapeutic interventions at one year and
a statistically significant reduction of target lesion
revascularization (TLR) at two years; (3) the Eluvia\TM\ system
decreases the number of future hospitalizations or physician visits;
(4) the Eluvia\TM\ system reduces hospital readmission rates; (5)
Eluvia reduces the rate of device related complications; and (6) the
Eluvia\TM\ system achieves similar functional outcomes and quality of
life index values while associated with half the rate of TLRs.
Many of the assertions made by the applicant are derived from the
IMPERIAL trial which is reported in three citations supplied by the
applicant.55 56 57 We discuss results from the MAJESTIC
study and then these publications from the IMPERIAL study to provide
context for the assertions made by the applicant.
---------------------------------------------------------------------------
\55\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
\56\ M[uuml]ller-H[uuml]lsbeck S et al. Two-Year Efficacy and
Safety Results from the IMPERIAL Randomized Study of the Eluvia
Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free
Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021;44:368-375.
\57\ Golzar J et al. Effectiveness and Safety of a Paclitaxel-
Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm:
One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of
the Eluvia Drug-Eluting Stent. Journal of Endovascular Therapy.
2020;27(2):296-303.
---------------------------------------------------------------------------
The first article, by M[uuml]ller-H[uuml]lsbeck et al., discusses
the three-year results of the MAJESTIC study, the first-in-human
prospective, single-arm, multicenter, clinical trial involving 57
patients with symptomatic lower limb ischemia and lesions in the
superficial femoral artery or proximal popliteal artery.\58\ Patients
who were treated with the Eluvia\TM\ system were followed for a three-
year time period during which they took acetylsalicylic acid as an
antiplatelet therapy. At 24 months, patients received a duplex
ultrasound, ankle-brachial index, and Rutherford classification at a
clinical visit. At 36 months patients completed a telephone or clinical
visit which included adverse event and antiplatelet medication
assessments. The authors report that long-term results from the
MAJESTIC study of the Eluvia\TM\ system continue to demonstrate good
technical and clinical outcomes (assessed through 2 years) and
[[Page 42101]]
a low reintervention rate (through 3 years).
---------------------------------------------------------------------------
\58\ M[uuml]ller-H[uuml]lsbeck S, Keirse K, Zeller T, Schroe H,
Diaz-Cartelle J. Long-Term Results from the MAJESTIC Trial of the
Eluvia Paclitaxel-Eluting Stent for Femoropopliteal Treatment: 3-
Year Followup. Cardiovasc Interv Ther. 2017;40(12):1832-1838.
---------------------------------------------------------------------------
The second article, by Gray et al., discusses the IMPERIAL trial, a
prospective randomized (2:1) (Eluvia\TM\ system vs. Zilver PTX),
single-blind, non-inferiority study in 465 patients with symptomatic
lower-limb ischemia manifesting as claudication with atherosclerotic
lesions in the native superficial femoral artery or proximal popliteal
artery across 65 centers and multiple countries.\59\ Of the 465
patients enrolled, 309 were assigned to the Eluvia\TM\ system and 156
were assigned to Zilver PTX. The authors state the overall sample size
in the randomised trial was selected to preserve adequate statistical
power for non-inferiority testing of the primary efficacy and safety
endpoints at a prespecified, one-sided significance level of 5 percent
for each, without adjustment for multiplicity.
---------------------------------------------------------------------------
\59\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): a
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
The authors state baseline demographic, clinical, and angiographic
characteristics were similar between the two study groups, indicative
of successful randomization. The primary efficacy endpoint of the trial
was primary vessel patency at 12 months which was a binary endpoint
based on a duplex ultrasound peak systolic velocity ratio of 2.4 or
lower in the absence of clinically driven target lesion
revascularization or bypass of the target lesion. Secondary endpoints
at 12 months were technical success, procedural success, adverse
events, stent integrity, major adverse events, and clinical outcomes.
The authors note that the funder of the study was involved in study
design, data collection, data analysis, data interpretation, and
writing of the report. To identify statistically meaningful results for
the non-inferiority test, the authors used a test such as the
Farrington-Manning method, to estimate the lower bound for the 95
percent CI of the difference between treatment groups.\60\ According to
the authors, if this lower bound was greater than the non-inferiority
margin of -10 percent, the Eluvia\TM\ system would be considered non-
inferior to Zilver PTX in terms of device efficacy. For all other
statistical comparisons, the authors used a p value of less than 0.05
as indicative of a significant difference.
---------------------------------------------------------------------------
\60\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
According to the authors, the primary non-inferiority analyses were
done when 409 patients (276 in the Eluvia group and 133 in the Zilver
PTX group) had completed 12 months of follow-up or had a primary
efficacy or safety endpoint event.\61\ Primary patency was observed for
231 (87 percent) of 266 patients in the Eluvia\TM\ system group and for
106 (82 percent) of 130 patients in the Zilver PTX stent group
(difference 5.3 percent [one-sided lower bound of 95 percent CI -0.66];
p<0[middot]0001). 259 (95 percent) of 273 patients in the Eluvia group
and 121 (91 percent) of 133 patients in the Zilver PTX group had not
had a major adverse event at 12 months (difference 3.9 percent [one-
sided lower bound of 95 percent CI -0[middot]46]; p<0[middot]0001).
According to the authors, superiority of the Eluvia\TM\ system over
Zilver PTX (primary patency in 86.8 percent vs. 77.5 percent
respectively, p = 0.0144) was met in the post-hoc analysis of 12 month
primary patency data in the full-analysis cohort. The authors summarize
by stating the proportions of patients with stent thrombosis or
clinically driven target lesion revascularisation in the Eluvia stent
group were about half those in the Zilver PTX group while both groups
showed improvements in clinical symptoms and walking function and the
occurrence of stent fracture was low.\62\
---------------------------------------------------------------------------
\61\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
\62\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
The third article, by Golzar et al, discusses the one-year follow
up of the single-arm long lesion substudy portion of the IMPERIAL
trial.\63\ Fifty patients were enrolled in the study where 20 patients
had diabetes, 16 were current smokers, 35 had moderately or severely
calcified lesions, and 16 lesions were total occlusions. To be
eligible, patients needed a lesion ranging from 140 mm to 190 mm which
required two overlapping Eluvia stents. At 12 months, no deaths, stent
thrombosis, or target limb amputation had occurred. The primary patency
rate was 87.0 percent at 12 months which exceeded the 60 percent
performance goal. Forty-three patients (91 percent) had Rutherford
category improvement without the need for TLR. The authors concluded
that one year patency with the Eluvia\TM\ system was independent of
lesion length.
---------------------------------------------------------------------------
\63\ Golzar J et al. Effectiveness and Safety of a Paclitaxel-
Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm:
One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of
the Eluvia Drug-Eluting Stent. Journal of Endovascular Therapy.
2020;27(2):296-303.
---------------------------------------------------------------------------
The fourth article, by M[uuml]ller-H[uuml]lsbeck et al., discusses
the two-year follow up to the IMPERIAL trial.\64\ The authors found
that through 24 months, the patency rates and Rutherford category
improvements were largely sustained, with a significantly lower
clinically driven TLR rate for Eluvia versus Zilver PTX at 2 years. At
two years the TLR rate for patients treated with Eluvia was 12.7
percent as compared to patients treated with Zilver PTX at 20.1 percent
(P = 0.0495). As with the previous citation, both study arms show
sustained clinical improvement (that is improvement in Rutherford
classification by one or more categories as compared with baseline and
without TLR) of 84.4 percent for patients treated with Eluvia and 78.2
percent for patients treated with Zilver PTX (p = 0.140). For all-cause
mortality, Eluvia (7.1 percent) and Zilver PTX (8.3 percent) did not
statistically differ (p = 0.6649). The authors conclude that the
IMPERIAL trial provides support for the benefit of drug-eluting
treatment in this population.
---------------------------------------------------------------------------
\64\ M[uuml]ller-H[uuml]lsbeck S et al. Two-Year Efficacy and
Safety Results from the IMPERIAL Randomized Study of the Eluvia
Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free
Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021;44:368-375.
\65\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
According to the applicant, the Eluvia\TM\ system achieves superior
primary patency compared to Zilver PTX. The applicant states that,
based on the IMPERIAL trial, the Eluvia\TM\ system demonstrated
superior primary patency over Zilver PTX, 86.8 percent vs. 77.5 percent
respectively (p=0.0144) based on pre-specific post-hoc analysis. The
applicant further states that at 12 months, the Eluvia\TM\ system had
greater primary patency than Zilver PTX at 88.5 percent vs. 79.5
percent respectively (p=0.0119). According to the applicant, these
results are consistent with the 96.4 percent primary patency rate at 12
months in the MAJESTIC study, the single-arm first-in-human study of
the Eluvia\TM\ system.\65\ Furthermore, in regard to this point, the
applicant asserts among patients 65 and older, the primary patency rate
in the Eluvia\TM\ system was 92.6 percent
[[Page 42102]]
compared to 75.0 percent in Zilver PTX (p=0.0386). Lastly, the
application states that among 50 patients with an average lesion length
of 162.8 mm (long lesions), each treated with two Eluvia stents, there
was a 12 month primary patency of 87 percent and a TLR of 6.5
percent.\66\
---------------------------------------------------------------------------
\66\ Golzar J et al. Effectiveness and Safety of a Paclitaxel-
Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm:
One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of
the Eluvia Drug-Eluting Stent. Journal of Endovascular Therapy.
2020;27(2):296-303.
---------------------------------------------------------------------------
According to the applicant, the Eluvia\TM\ system reduced
subsequent therapeutic interventions at one year and a reduction of
target lesion revascularization at two years. Based on the IMPERIAL
trial, the applicant asserts the Eluvia\TM\ system achieved a
substantial reduction in re-intervention with a target lesion
revascularization (TLR) of 4.5 percent compared to 9.0 percent
(p=0.0672) in the Zilver PTX group.\67\ The applicant states that at
two years the Eluvia\TM\ system had a statistically significantly lower
rate of TLRs than Zilver PTX of 12.7 percent vs. 20.1 percent
respectively (p=0.0495).\68\ The applicant notes that the published
analysis presented in this application has a slightly different
clinically-driven TLR rate at two years than internal analysis provided
in the Eluvia CY 2020 device pass-through application (12.7 percent and
20.1 percent (p=0.0495) vs. 12.9 percent and 20.5 percent (p=0.0472),
respectively). We note that the applicant provides a table which
compares TLR rates between the Eluvia\TM\ system and Zilver PTX by all
patients 65 and older, US patients 65 and older, and patients with
diabetes.
---------------------------------------------------------------------------
\67\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
\68\ M[uuml]ller-H[uuml]lsbeck S et al. Two-Year Efficacy and
Safety Results from the IMPERIAL Randomized Study of the Eluvia
Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free
Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021;44:368-375.
Published online 22 November 2020.
---------------------------------------------------------------------------
The applicant asserts that patients treated with the Eluvia\TM\
system required fewer days of hospital care than in the Zilver PTX
group. According to the applicant, patients treated with the Eluvia\TM\
system had fewer days in the hospital as compared to Zilver PTX for all
adverse events (13.9 vs. 17.7 respectively), TLR (2.8 vs. 7.1
respectively), and procedure and device related adverse events (2.7 vs.
4.5 respectively). We note that statistical significance was not
assessed.
The applicant asserts that patients treated with the Eluvia\TM\
system had reduced hospital readmission rates compared to those treated
with Zilver PTX at 12 months at 3.9 percent and 7.1 percent
respectively (p=0.1369).\69\
---------------------------------------------------------------------------
\69\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
The applicant asserts that while rates of adverse events were
similar in total between treatment arms in the IMPERIAL trial, device-
related adverse-events were reported in 8 percent of patients treated
with the Eluvia\TM\ system as compared to 14 percent of patients
treated with Zilver PTX.\70\
---------------------------------------------------------------------------
\70\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
Lastly, the applicant asserts that the Eluvia\TM\ system is able to
achieve similar functional outcomes to Zilver PTX while associated with
half the rate of TLRs. The applicant states while functional outcomes
appear similar between the Eluvia Stent System and Zilver PTX groups at
12 months, these improvements for the Zilver PTX group are associated
with twice as many TLRs to achieve similar EQ-5D index values.\71\ The
applicant provides multiple tables which show similar improvements in
walking, distance, speed, stair climbing, and health related quality of
life (EQ-5D) between the Eluvia\TM\ system and Zilver PTX.
---------------------------------------------------------------------------
\71\ Gray WA et al. A polymer-coated, paclitaxel-eluting stent
(Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX)
for endovascular femoropopliteal intervention (IMPERIAL): A
randomised, non-inferiority trial. Lancet. 2018;392:1541-51.
---------------------------------------------------------------------------
For a complete discussion of the applicant's previous submission
regarding substantial clinical improvement please see the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61287-61292). We note that we
did not approve the Eluvia\TM\ system for CY 2020 device transitional
payment due to the potential increased long-term mortality signal that
the FDA was at the time evaluating. We further note that in the FY 2021
IPPS/LTCH final rule (85 FR 58657), we stated that the FDA August 7,
2019 update, which concluded that the benefits of paclitaxel-coated
devices (for example, reduced reinterventions) should be considered in
individual patients along with potential risks (for example, late
mortality) as well as for individual patients judged to be at
particularly high risk for restenosis and repeat femoropopliteal
interventions, clinicians may determine that the benefits of using a
paclitaxel-coated device outweigh the risk of late mortality. The
applicant asserts that the Eluvia\TM\ system has demonstrated
substantial clinical improvement over Zilver PTX in the IMPERIAL trial
to include no increase in all-cause mortality. In response to this new
information, we no longer have concerns regarding the increased long-
term mortality signal we described in the CY 2020 OPPS/ASC final rule
with comment period.
In the CY 2020 OPPS/ASC final rule with comment period (84 FR
61289) we noted that the IMPERIAL study, which showed significant
differences in primary patency at 12 months, was designed for
noninferiority and not superiority. Therefore, we were concerned that
results showing primary patency at 12 months may not be valid given the
study design. In response, the applicant stated that a non-inferiority
study is consistent with accepted research methodology and is typical
of many head-to-head trials of medical devices. For the complete
response please see the CY 2020 OPPS/ASC final rule with comment period
(84 FR 61290). We invite public comments on whether the
EluviaTM Drug-Eluting Vascular Stent System meets the
substantial clinical improvement criterion with respect to a finding of
substantial clinical improvement for the EluviaTM system.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that Eluvia\TM\ system
would be reported with the HCPCS codes in the following Table 23:
[[Page 42103]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.031
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5193--Level 3 Endovascular
Procedures, which had a CY 2021 payment rate of $10,042.94 at the time
the application was received. Beginning in CY 2017, we calculate the
device offset amount at the HCPCS/CPT code level instead of the APC
level (81 FR 79657). HCPCS code 37226 had a device offset amount of
$4,843.71 at the time the application was received.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of Eluvia\TM\ system is 56 percent of the
applicable APC payment amount for the service related to the category
of devices of $10,042.94. Therefore, we believe the Eluvia\TM\ system
meets the first cost significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost for the Eluvia\TM\
system is 117 percent of the cost of the device-related portion of the
APC payment amount for the related service of $4,843.71. Therefore, we
do not believe that the Eluvia\TM\ system meets the second cost
significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost for the Eluvia\TM\ system and the portion of the APC
payment amount for the device of $4,843.71 is 8 percent of the APC
payment amount for the related service of $10,042.94. Therefore, we do
not believe that Eluvia\TM\ system meets the third cost significance
requirement.
We invite public comment on whether the Eluvia\TM\ system meets the
device pass-through payment criteria discussed in this section,
including the cost criterion for device pass-through payment status.
(4) CochlearTM Osia[supreg] 2 System
Cochlear Americas submitted an application for a new device
category for transitional pass-through payment status for the
CochlearTM Osia[supreg] 2 System (hereinafter referred to as
the Osia[supreg] 2 System) by the December 2020 quarterly deadline for
CY 2022. The Osia[supreg] 2 System is a transcutaneous, active auditory
osseointegrated device that replaces the function of the middle ear by
providing mechanical energy to the cochlea. According to the applicant,
the device consists of four components including: (1) An external sound
processor, the Osia 2 Sound Processor; (2) the Osia OSI200 Implant
Piezo PowerTM transducer; (3) the BI300 osseointegrated
implant for anchoring and single point transmission; and (4) a fixation
screw for attaching the OSI200 implant to the BI300 implant which is
implanted in the skull.
The external sound processor captures environmental sounds and
converts the sound signal into a digital signal transmitted as a
radiofrequency. The external sound processor also contains a magnet and
a battery (rechargeable 675 zinc air button 1.4Volt; 600 mA-hrs
capacity). The magnets couple the external and internal components
across the skin. The transducer (Piezo PowerTM) detects the
radiofrequency signals after they pass through the intact skin and
transforms the signal to vibrations, which are then transmitted to the
bone-implanted fixation screw. The screw vibrates the skull bone
(temporal portion) which stimulates the cochlea (inner ear) to transmit
the information to the brain so that the vibrations are perceived as
sounds. The implanted portion is 7.2 cm x 3 cm x 0.49 cm. The system
has a fitting range of 55 dB sensory neural hearing loss. The applicant
stated that unlike hearing aids, which make sounds louder, an auditory
osseointegrated device, such as the Osia[supreg] 2 System can improve
clarity of hearing and improve hearing at higher frequencies.
With respect to the newness criterion at Sec. 419.66(b)(1), the
Osia[supreg] 2 System received FDA 510(k) clearance on November 15,
2019, based on a determination of substantial equivalence to a legally
marketed predicate device. The Osia[supreg] 2 System is intended for
the following patients and indications: (1) Patients 12 years of age or
older; (2) patients who have a conductive or mixed hearing loss and
still can benefit from sound amplification. The pure tone average (PTA)
bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz)
should be better than or equal to 55 dBHL; (3) Bilateral fitting of the
Osia[supreg] 2 System is intended for patients having a symmetrically
conductive or mixed hearing loss. The difference between the left and
right sides' BC thresholds should be less than 10 dB on average
measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual
frequencies; (4) patients who have profound sensorineural hearing loss
in one ear and normal hearing in the opposite ear (that is, single-
sided deafness or ``SSD''). The pure tone average air conduction
hearing thresholds of the hearing ear should be better than or equal to
20 dB HL (measured at 0.5, 1, 2, and 3 kHz). The Osia[supreg] 2 System
for SSD is also indicated for any patient who is indicated for an air-
conduction contralateral routing of signals (AC CROS) hearing aid, but
who for some reason cannot or will not use an AC CROS. Prior to
receiving the device, it is recommended that an individual have
experience with appropriately fitted air conduction or bone conduction
hearing aids.
We received the application for a new device category for
transitional pass-through payment status for the Osia[supreg] 2 System
on December 1, 2020, which is
[[Page 42104]]
within 3 years of the date of the initial FDA marketing authorization.
We are inviting public comments on whether the Osia[supreg] 2 System
meets the newness criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the Osia[supreg] 2 System is integral to
the service provided, is used for one patient only, comes in contact
with human skin and is surgically implanted or inserted. The applicant
also claimed that the Osia[supreg] 2 System meets the device
eligibility requirements of Sec. 419.66(b)(4) because it is not an
instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service. Additionally, the Osia[supreg] 2
System is not subject to the hearing aid exclusion at Sec.
411.15(d)(1). As described in the application, the implanted components
of the Osia[supreg] 2 System consist of a piezoelectric transducer
(OSI200) that is attached directly to an osseointegrated implant
(BI300) with a fixation screw. Sound received by an external processor
(the Osia[supreg] 2 System) is converted to a digital radiofrequency
signal which is received and transformed into mechanical vibrations by
the OSI200 implant, which are transferred directly to the BI300
osseointegrated implant. These vibrations are conducted via the skull
to the cochlea. Therefore, we believe the Osia[supreg] 2 System meets
the criterion at Sec. 411.15(d)(2)(i) and is not subject to the
hearing aid exclusion.
In accordance with the Medicare Benefit Policy Manual, Chapter 16
``General Exclusions from Coverage,'' Sec. 100, certain devices that
produce perception of sound by replacing the function of the middle
ear, cochlea or auditory nerve are payable by Medicare as prosthetic
devices. These include osseointegrated implants, that is, devices
implanted in the skull that replace the function of the middle ear and
provide mechanical energy to the cochlea via a mechanical transducer.
We believe the Osia[supreg] 2 System as described by the application
meets the criteria for this benefit category. We are inviting public
comments on whether the Osia[supreg] 2 System meets the eligibility
criteria at Sec. 419.66(b) as well as the criterion at Sec.
411.15(d)(2)(i).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996.
The applicant stated that the Osia[supreg] 2 System differs
significantly from the devices that were included in the previous
category for auditory osseointegrated devices (L8690--Auditory
osseointegrated device, includes all internal and external components)
which was effective from effective from January 1, 2007 through
December 31, 2008. The applicant claimed that the devices that were
described by this category include a transducer/actuator and sound
processor that is worn externally with the transducer/actuator
connected to the skull by a percutaneous post or abutment that
penetrates the skin. In these devices, the sound processor converts
sound into a digital signal which the transducer/actuator converts to
vibrations that are transmitted to the skull through the abutment. The
vibrations are transmitted directly to the inner ear and are reproduced
as sound.
The applicant stated that the Osia[supreg] 2 System is distinct
from devices with a percutaneous connection between the transducer and
the sound processor because the transducer/actuator for the
Osia[supreg] 2 system is surgically implanted and has a magnetic
transcutaneous attachment to the external sound processor. The
applicant also claimed that the percutaneously coupled osseointegrated
devices included in the previous device pass-through category convert
sound to mechanical vibrations in the external sound processor/
actuator, then transmit the vibrations to the internal components. The
applicant claimed that the Osia[supreg] 2 system instead converts the
sound to mechanical vibrations after it has reached the internal
components. The applicant claimed that the technology to fully implant
the transducer/actuator did not exist when the previous device pass-
through category was established. The applicant proposed the device
pass-through category descriptor ``Auditory osseointegrated device,
including implanted transducer/actuator with radiofrequency link to
external sound processor''. The applicant stated that the BONEBRIDGE
Bone Conduction Implant System, which also submitted a device pass-
through application for CY 2022 and is described in this section under
number (2) above, would also be described by the proposed additional
category.
We believe that the Osia[supreg] 2 system is described by L8690--
Auditory osseointegrated device, includes all internal and external
components. The applicant has noted differences between the
Osia[supreg] 2 system and the devices that were described by L8690,
specifically percutaneous, auditory osseointegrated devices, regarding
the connection between the implanted transducer and the external audio
processor (percutaneous abutment vs. transcutaneous magnetic
attraction) however, we believe that there is a similar mechanism of
action for all these devices specifically, vibratory stimulation of the
skull to stimulate the receptors in the cochlea (inner ear). Further,
we believe that the broad descriptor for L8690 of ``Auditory
osseointegrated device, includes all internal and external components''
includes the applicant's device. We are inviting public comment on
whether the Osia[supreg] 2 system meets the device category criterion.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. With respect to the substantial
clinical improvement criterion, the applicant stated that the
Osia[supreg] 2 system represents a substantial clinical improvement
because it provides a reduced rate of device-related complications
compared to currently available treatments. The applicant submitted
five references to retrospective case series that studied the long-term
complications associated with percutaneous osseointegrated bone
conduction hearing devices, specifically bone-anchored hearing
aids.72 73 74 75 76
[[Page 42105]]
The applicant stated that complications associated with bone-anchored
hearing aids include irritation and/or infection of the skin
surrounding the abutment, skin flap necrosis, wound dehiscence,
bleeding or hematoma formation, soft tissue overgrowth and persistent
pain.77 78 79 80 81 Additionally, the applicant also
submitted five references to clinical studies and case series involving
the use of transcutaneous osseointegrated bone conduction hearing
devices. Of these five references, three of these studies involved the
use of the BONEBRIDGE device and have been previously discussed in this
section, one study that involved the use of the BAHA Attract device,
and one study that involved the use of the Osia[supreg] system, an
earlier version of the Osia[supreg] 2 system.
---------------------------------------------------------------------------
\72\ Kraai T, Brown C, Neeff M, Fisher K. Complications of bone-
anchored hearing aids in pediatric patients. Int J Pediatr
Otorhinolaryngol. 2011 Jun;75(6):749-53.
\73\ Badran K, Arya AK, Bunstone D, Mackinnon N. Long-term
complications of bone-anchored hearing aids: A 14-year experience. J
Laryngol Otol. 2009 Feb;123(2):170-6.
\74\ House JW, Kutz JW Jr. Bone-anchored hearing aids: Incidence
and management of postoperative complications. Otol Neurotol. 2007
Feb;28(2):213-7.
\75\ Asma A, Ubaidah MA, Hasan SS, Wan Fazlina WH, Lim BY, Saim
L, Goh BS. Surgical outcome of bone anchored hearing aid (baha)
implant surgery: A 10 years experience. Indian J Otolaryngol Head
Neck Surg. 2013 Jul;65(3):251-4.
\76\ Shirazi MA, Marzo SJ, Leonetti JP. Perioperative
complications with the bone-anchored hearing aid. Otolaryngol Head
Neck Surg. 2006 Feb;134(2):236-9.
\77\ Ibid.
\78\ Ibid.
\79\ Ibid.
\80\ Ibid.
\81\ Ibid.
---------------------------------------------------------------------------
In support of their claim that the Osia[supreg] 2 system reduced
the rate of device-related complications compared to currently
available treatments, the applicant submitted a multicenter prospective
within-subject study conducted at five centers in Europe, Australia,
and USA. This study investigated clinical performance, safety, and
benefit of the Osia[supreg] system and included 51 adult subjects with
mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided
sensorineural deafness (SSD, n = 14). In regard to safety outcomes,
patients experienced the following minor adverse events including pain
(n = 7), numbness (n = 1), vertigo (n = 3), swelling (n = 3), tension
implant site (n = 1), warmth at the SP site (n = 3), headache (n = 3),
hematoma/bleeding (n = 2).\82\ One participant developed an implant-
site infection three days after implantation, which subsequently
developed into skin necrosis and dehiscence. The implant had to be
removed 55 days after implantation.
---------------------------------------------------------------------------
\82\ Mylanos, E.A.M., Hua, H., Arndt, S. 2020. Multicenter
clinical investigation of a new active osseointegrated steady-state
implant system. Otol Neurotol 41: 1249-1257.
---------------------------------------------------------------------------
We are concerned that the applicant did not submit studies that
involved the use of the Osia[supreg] 2 system to demonstrate
substantial clinical improvement of the device. The applicant submitted
one study that investigated the Osia[supreg] system that utilizes an
earlier model of the device. We are also concerned that the evidence of
substantial clinical improvement submitted by the applicant did not
directly compare the Osia[supreg] 2 system to other currently available
treatments, namely percutaneous or passive, transcutaneous auditory
osseointegrated devices. Therefore, we are concerned that we are unable
to determine a substantial clinical improvement of the Osia 2 system as
compared to existing devices. We would be interested in any additional
studies that involve the use of the Osia[supreg] 2 system and compare
the device to other currently available auditory osseointegrated
devices. We invite public comments on whether the Osia[supreg] 2 system
meets the substantial clinical improvement criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that Osia[supreg] 2
system would be reported with the HCPCS codes listed in the following
Table 24:
[GRAPHIC] [TIFF OMITTED] TP04AU21.032
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5115--Level 5
Musculoskeletal Procedures, which had a CY 2020 payment rate of
$11,900.71 at the time the application was received. Beginning in CY
2017, we calculate the device offset amount at the HCPCS/CPT code level
instead of the APC level (81 FR 79657). HCPCS code 69714 had a device
offset amount of $7,742.60 at the time the application was received.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of the Osia[supreg] 2 system is 88 percent of
the applicable APC payment amount for the service related to the
category of devices of $11,900.71. Therefore, we believe the
Osia[supreg] 2 system meets the first cost significance requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost for the
Osia[supreg] 2 system is 136 percent of the cost of the device-related
portion of the APC payment amount for the related
[[Page 42106]]
service of $7,742.60. Therefore, we believe that the Osia[supreg] 2
system meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of the Osia[supreg] 2 system and the portion of the APC
payment amount for the device of $7,742.60 is 23 percent of the APC
payment amount for the related service of $11,900.71. Therefore, we
believe that the Osia[supreg] 2 system meets the third cost
significance requirement.
We invite public comment on whether the Osia[supreg] 2 system meets
the device pass-through payment criteria discussed in this section,
including the cost criterion for device pass-through payment status.
(5) Pure-Vu[supreg] System
Motus GI submitted an application for a new device category for
transitional pass-through payment status for the Pure-Vu[supreg] System
(Pure-Vu[supreg]) for CY 2022. The applicant asserted that the Pure-
Vu[supreg] System helps to avoid aborted and delayed colonoscopy
procedures due to poor visualization of the colon mucosa by creating a
unique High Intensity, Pulsed Vortex Irrigation Jet that consists of a
mixture of air and water to break-up fecal matter, blood clots, and
other debris, and scrub the walls of the colon while simultaneously
removing the debris through two suction channels. The applicant stated
that the suction channels have a sensor to detect the formation of a
clog in the channels, triggering the system to automatically purge and
then revert to suction mode once the channel is clear. According to the
applicant, this combination of the agitation of the fluid in the colon
via the pulsed vortex irrigation and simultaneous removal of the debris
allows the physician to visualize the colon and achieve a successful
colonoscopy or other advanced procedure through the colonoscope even if
the patient is not properly prepped and has debris either blocking the
ability to navigate the colon or covering the colon wall obscuring the
mucosa and any pathology that may be present. The applicant asserted
that the constant volume suction pumps do not cause the colon to
collapse, which allows the physician to continue to navigate the colon
while cleansing and avoids the need to constantly insufflate the colon,
which may be required with other colonoscopy irrigation systems.
The applicant stated that the Pure-Vu[supreg] System is comprised
of a workstation that controls the function of the system, a disposable
oversleeve that is mounted on a colonoscope and inserted into the
patient, and a disposable connector with tubing (umbilical tubing with
main connector) that provides the interface between the workstation,
the oversleeve, and off the shelf waste containers.
The applicant explained that the workstation has two main
functions: cleansing via irrigation and evacuation, and acting as the
user interface of the system. The applicant explained that the
irrigation into the colon is achieved by an electrical pump that
supplies pressurized gas (air) and a peristaltic pump that supplies the
liquid (water or saline). According to the applicant, the pressurized
gas and liquid flow through the ``main connector'' and are mixed upon
entry into the umbilical tubing that connects to the oversleeve. The
applicant explained that the gas pressure and flow are controlled via
regulators and the flow is adjusted up or down depending on the
cleansing mode selected. The applicant stated that a foot pedal
connected to the user interface activates the main functions of the
system so that the user's hands are free to perform the colonoscope
procedure in a standard fashion.
The applicant stated that the evacuation mode (also referred to as
suction) removes fecal matter and fluids out of the colon. The
applicant noted that the evacuation function is active during cleansing
so that fluid is inserted and removed from the colon simultaneously.
The applicant explained that the evacuation pumps are designed in a
manner that prevents the colon from collapsing when suctioning, which
facilitates the ability to simultaneously irrigate and evacuate the
colon. According to the applicant, during evacuation, the system
continuously monitors the pressure in the evacuation channels of the
oversleeve and if the pressure drops below pre-set limits the pumps
will automatically reverse the flow. The applicant explained that the
clog sensor triggers the system to automatically purge the material out
of the channel and back into the colon where it can be further
emulsified by the Pulsed Vortex Irrigation Jet, and then automatically
reverts back into evacuation mode once the channel is cleared. The
applicant stated that the evacuation (suction) that drains fecal matter
and fluids out of the colon is generated by peristaltic pumps that can
rotate in both directions, either to evacuate fluids and fecal matter
from the colon through the evacuation tubes and into a waste container,
or while in the reverse direction, to purge the evacuation tubes. The
applicant claimed the suction created by this type of pump creates a
constant volume draw of material from the colon and therefore prevents
the colon from collapsing rapidly. According to the applicant, purging
of evacuation tubes may be activated in two ways: the purging cycle is
automatically activated when low pressure is noted by the evacuation-
line sensor (it is also activated for the first 0.5 seconds when
evacuation is activated to make sure the line is clear from the start);
or a manual purge may be activated by the user by pushing the ``manual
purge'' button on the foot pedal. The applicant claimed the pressure-
sensing channel is kept patent by using an air perfusion mechanism
where an electrical pump is used to perfuse air through the main
connector and into the oversleeve, while the sensor located in the
workstation calculates the pressure via sensing of the channel.
The applicant explained the Pure-Vu[supreg] System is loaded over a
colonoscope and that the colonoscope with the Pure-Vu[supreg]
Oversleeve is advanced through the colon in the same manner as a
standard colonoscopy. The applicant stated that the body of the
oversleeve consists of inner and outer sleeves with tubes intended for
providing fluid path for the cleansing irrigation (2X), the evacuation
of fluids (2X), the evacuation sensor (1X) and that the flexible head
is at the distal end of the oversleeve and is designed to align with
the colonoscope's distal end in a consistent orientation. The applicant
explained that the distal cleansing and evacuation head contains the
irrigation ports, evacuation openings, and a sensing port. According to
the applicant, the system gives the physician the control to cleanse
the colon as needed based on visual feedback from the colonoscope to
make sure they have an unobstructed view of the colon mucosa to detect
and treat any pathology. The applicant noted that since the Pure-
Vu[supreg] System does not interfere with the working channel of the
colonoscope, the physician is able to perform all diagnostic or
therapeutic interventions in a standard fashion with an unobstructed
field of view.
With respect to the newness criterion at Sec. 419.66(b)(1), the
Pure-Vu[supreg] System first received FDA 510(k) clearance on September
22, 2016 under 510(k) number K60015. Per the applicant, this initial
device was very cumbersome to set up and required direct support from
[[Page 42107]]
the company and therefore was not viable for a small company with
limited resources to market the device. The applicant noted that the
initial device could have been sold starting on January 27, 2017 when
the first device came off the manufacturing line. Per the applicant,
the device was allocated for clinical evaluations but 10 institutions
throughout the country did purchase the device outside of any true
clinical study, mostly based on the fact that physicians wanted to try
the product prior to committing to a clinical trial. The applicant
further noted that minor modifications were made to the Pure-Vu[supreg]
System in additional 510(k) clearances dated December 12, 2017 and June
21, 2018. The current marketed Pure-Vu[supreg] System was then granted
510(k) clearance on June 6, 2019 under 510(k) number K191220. Per the
applicant, this clearance changed the entire set-up of the device,
redesigned the user interface, and reduced the size, among other
changes. According to the applicant, this updated version was
commercially available as of September 19, 2019. We have not identified
an existing pass-through payment category that describes the Pure-
Vu[supreg] System. We are inviting public comment on whether the Pure-
Vu[supreg] System meets the device category criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, Pure-Vu[supreg] is integral to the service
provided, is used for one patient only, comes in contact with human
tissue, and is surgically inserted temporarily. The applicant also
claimed that Pure-Vu[supreg] meets the device eligibility requirements
of Sec. 419.66(b)(4) because it is not an instrument, apparatus,
implement, or item for which depreciation and financing expenses are
recovered, and it is not a supply or material furnished incident to a
service. We are inviting public comments on whether Pure-Vu[supreg]
meets the eligibility criteria at Sec. 419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. We have not
identified an existing pass-through payment category that describes
Pure-Vu[supreg]. We are inviting public comment on whether Pure-
Vu[supreg] meets the device category criterion.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization. The applicant stated that Pure-
Vu[supreg] represents a substantial clinical improvement over existing
technologies. With respect to this criterion, the applicant submitted
studies that examined the impact of Pure-Vu[supreg] on endoscopic
hemostasis outcomes, rebleeding occurrence, and mortality. We note that
the applicant has applied for the New Technology Add-on Payment in the
FY 2022 IPPS/LTCH proposed rule (86 FR 25299 through 25304).
According to the applicant, the Pure-Vu[supreg] System offers the
ability to achieve rapid beneficial resolution of the disease process
treatment by achieving rapid and full visualization of the colon, which
will improve diagnostic yield and the effectiveness of treatment of
diseases of the bowel. The applicant claimed that Pure-Vu[supreg] is
indicated for use in emergent issues such as acute lower
gastrointestinal (GI) bleeding, unknown abdominal pain, foreign body
removal, chronic disease management, and preventive medicine such as
screening and surveillance. The applicant states these procedures are
typically performed using a colonoscope to visualize the colon and
provide a conduit to deliver therapeutic treatments. According to the
applicant, the current standard of care requires the colon to be
cleansed to ensure the success of any procedure. The applicant asserts
that in the case where pre-procedural preparations are not adequate to
achieve proper visualization, current technology provides limited
ability to remove debris from the colon during the procedure to
facilitate the process. The applicant states that regardless of
indication, the bowel preparation remains the constant across patients
who may have a wide range of comorbidities which may limit patient
tolerability. According to the applicant the consumption of a purgative
and the dietary restriction to be on clear liquids for approximately 24
hours can be problematic for the diabetic and elderly populations.\83\
---------------------------------------------------------------------------
\83\ Parra-Blanco A, Ruiz A, Alvarez-Lobos M, Amoros A, Gana JC,
Ibanez P, et al. Achieving the best bowel preparation for
colonoscopy. World J Gastroenterol. 2014;20(47):17709-26.
---------------------------------------------------------------------------
In support of its application, the applicant submitted three
outpatient clinical studies to demonstrate the Pure-Vu[supreg] System's
capability to convert patients to adequate preparation where
preparation was previously inadequate and the visualization was poor
based on the Boston Bowel Preparation Scale (BBPS). In the first study,
Perez J., et al. conducted an outpatient prospective pilot study using
the Pure-Vu[supreg] System.\84\ The study observed 50 patients with
poorly prepared colons undergoing colonoscopy at two outpatient
clinical sites in Spain and Israel, respectively. The applicant claimed
study patients underwent a reduced bowel preparation consisting of the
following: No dried fruits, seeds, or nuts starting 2 days before the
colonoscopy, a clear liquid diet starting 18 to 24 hours before
colonoscopy, and a split dose of 20mg oral bisacodyl. The study found
the number of patients with an adequate cleansing level (BBPS >=2 in
each colon segment) increased significantly from 31 percent (15/49)
prior to use of the Pure-Vu System (baseline) to 98 percent (48/49)
after use of the Pure-Vu[supreg] System (P<0.001), with no serious
adverse events reported.
---------------------------------------------------------------------------
\84\ Perez Jimenez J, Diego Bermudez L, Gralnek IM, Martin
Herrera L, Libes M. An Intraprocedural Endoscopic Cleansing Device
for Achieving Adequate Colon Preparation in Poorly Prepped Patients.
J Clin Gastroenterol. 2019;53(7):530-4.
---------------------------------------------------------------------------
In the second study provided by the applicant, van Keulen, et al.
also conducted a single-arm, prospective study on 47 patients with a
median age of 61 years in the outpatient setting in the Netherlands
using the Pure-Vu[supreg] System.\85\ Within the study, cecal
intubation was achieved in 46/47 patients. This multicenter feasibility
study found that the Pure-Vu[supreg] System significantly improved the
proportion of patients with adequate bowel cleansing from 19.1 percent
prior to the use of the Pure-Vu[supreg] System to 97.9 percent after
its use (P<0.001) and median BBPS score (from 3.0 [IQR 0.0-5.0] to 9.0
[IQR 8.0-9.0]).
---------------------------------------------------------------------------
\85\ Van Keulen KE, Neumann H, Schattenberg JM, Van Esch AAJ,
Kievit W, Spaander MCW, Siersema PD. A novel device for
intracolonoscopy cleansing of inadequately prepared colonoscopy
patients: A feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi:
10.1055/a-0632-1927. Epub 2018 Jul 11.
---------------------------------------------------------------------------
In the third study provided by the applicant that directly
evaluated the Pure-Vu[supreg] System in a clinical setting, Bertiger
G., et al. performed a United States-based single center, prospective,
[[Page 42108]]
outpatient study investigating regimes of reduced outpatient bowel
preparations, which included low doses of over-the-counter laxatives,
and eliminating the typical 24 hour clear liquid diet restriction,
which was replaced by a low residue diet the day before the
procedure.\86\ In this study, 46 of a possible 49 patients received a
colonoscopy, 8 of which took the over-the-counter laxative (``MiraLAX
arm''), 21 patients ingested two doses of 7.5oz Magnesium Citrate (MgC)
each taken with 19.5oz of clear liquid (``Mag Citrate 15oz arm''), and
18 patients ingested 2 doses of 5oz MgC taken with 16oz of clear liquid
(``Mag Citrate 10oz arm''). Of the 46 subjects, 59 percent were males
and there was a mean age of 61 9.48 years. The study found
that each of the 3 study arms revealed significant differences in BBPS
score between the baseline preparation and post-cleansing via Pure-
Vu[supreg]. All the preparation regimens resulted in inadequately
prepped colons. Comparing the mean BBPS rating for both pre- and post-
Pure-Vu[supreg] use, the MiraLAX arm was inferior (P<0.05) to both Mag
Citrate arms. For the MiraLAX arm, the mean BBPS Score improved from
1.50 to 8.63. For the Mag Citrate 15oz arm, the mean BBPS score
improved from 3.62 to 8.95. For the Mag Citrate 10oz arm, the mean BBPS
Score improved from 4.76 to 9.0.
---------------------------------------------------------------------------
\86\ Bertiger, Gerald MD Optimizing the Preparation Regimen
Prior to Colonoscopy Procedure With the Pure-Vu[supreg] System,
American Journal of Gastroenterology: October 2018--Volume 113--
Issue--p S119-S120.
---------------------------------------------------------------------------
The applicant also provided a self-sponsored, U.S.-based,
multicenter, prospective, single arm study in the inpatient setting,
analyzing 94 patients, 65 of which (68 percent) had a GI bleed.\87\ Of
the 94 patients (41 percent females/59 percent males), the mean age was
62 years. According to the applicant, the study's primary endpoint was
the rate of improved bowel cleansing level from baseline to after use
of the Pure-Vu[supreg] System per colon segment using the BBPS. The
BBPS score was recorded for each colorectal segment (left colon,
transverse colon, and right colon segments) both prior to (baseline)
and after colon cleansing with the Pure-Vu[supreg] System. An adequate
cleansing level was a priori defined as a BBPS >=2 in all evaluated
colon segments. The study found that in 79 of the 94 patients (84
percent), the physician was able to successfully diagnose or rule out a
GI bleed in the colon per the patients' colonoscopy indication using
only the Pure-Vu[supreg] System. The analysis showed statistically
significant visualization improvement in each colon segment after Pure-
Vu[supreg] use with a mean BBPS score in the descending colon, sigmoid,
and rectum of 1.74 pre-Pure-Vu[supreg] use and 2.89 post-Pure-
Vu[supreg] use (P<0.001); in the transverse colon of 1.74 pre-Pure-
Vu[supreg] use and 2.91 post Pure-Vu[supreg] use (P<0.001); and the
ascending colon and cecum of 1.50 pre-Pure-Vu[supreg] use and 2.86 post
Pure-Vu[supreg] use (P<0.001). The study found only 2 percent of cases
where the diagnosis could not be achieved due to inadequate
preparation. Overall, the 84 (89.4 percent) patients that received the
Pure-Vu[supreg] System within the study improved BBPS scores from 38
percent (95 percent CI 28, 49) to 96 percent (95 percent CI 90, 99) in
segments evaluated. The study noted one procedure related perforation
which required surgical repair, and the patient was discharged 48 hours
post operatively and recovered fully.
---------------------------------------------------------------------------
\87\ Helmut Neumann ML, Tim Zimmermann, Gabriel Lang, Jason B.
Samarasena, Seth A. Gross, Bhaumik Brahmbhatt, Haleh Pazwash,
Vladimir Kushnir. Evaluation of bowel cleansing efficacy in
hospitalized patient population using the pure-vu system.
Gastrointestinal Endoscopy. 2019;89(6).
---------------------------------------------------------------------------
In addition to the previously discussed studies, the applicant also
submitted two case studies to highlight the various clinical
presentations of lower gastrointestinal bleed (LGIB) with the use of
the Pure-Vu[supreg] System. In the first case, the applicant described
a patient with a history of scleroderma and chronic constipation who
was referred for a surveillance colonoscopy after a prior endoscopic
mucosal resection due to a large polyp. The applicant states this was
the patient's third colonoscopy in twelve months due to a history of
poor preparation in the prior exams. Despite an aggressive prep regime,
the applicant states the patient still had solid stool and debris
throughout the colon. The applicant states the Pure-Vu[supreg] system
was used extensively and the physician was able to fully cleanse the
colon during which the physician was able to uncover a poorly defined
over 1 cm sessile serrated polyp that could not be appreciated before
cleansing with Pure-Vu[supreg]. The applicant states a successful
polypectomy was performed.
In the second case, the applicant described a patient presenting
with hemorrhagic shock and acute kidney injury six days after a
colonoscopy where nine polyps were removed, including two polyps
greater than 2cm. The applicant states angiographic control of the
bleeding was not considered because of the patient's acute kidney
injury with a rising creatinine. According to the applicant, the
physician elected to use Pure-Vu[supreg] to immediately exam the
patient without any preparation doing a bedside colonoscopy in the ICU.
The applicant states, the physician was able to cleanse the colon,
locate the source of the bleed and create hemostasis by placing two
clips on the bleed. According to the applicant, the entire colon was
visualized to confirm there were no other sources of bleeding, the
physician was able to downgrade the patient out of the ICU that same
day, and the patient was discharged from the hospital the following
day.
The applicant concludes that based on the provided evidence, Pure-
Vu[supreg] has the ability to improve adenoma detection rates which can
reduce the rate of colorectal cancer (CRC) and diagnose and treat
emergent patients in a more expeditious fashion by removing the need to
have successful pre-procedural preparation that can take time and be
very burdensome to the most needy and fragile patients. According to
the applicant, Pure-Vu[supreg] can minimize the number of aborted and
early repeat colonoscopies that carry inherent risks and add
unnecessary costs to the healthcare system.
Based on the evidence submitted with the application, we have the
following observations. While the studies provided in support of the
Pure-Vu[supreg] System measure improvement of bowel preparation using
the BBPS, the applicant did not provide data indicating that the
improved BBPS directly leads to improved clinical outcomes (for
example, reduction of blood loss in LGIB or reduction of missed polyps)
based on use of the Pure-Vu[supreg] System. Additionally, we note that
the applicant has not provided any studies comparing the efficacy of
the Pure-Vu[supreg] System to other existing methods or products for
irrigation in support of its claims that the product is superior at
removing debris from the colon while simultaneously preventing the
colon from collapsing, allowing use of the working channel, or
improving outcomes. Furthermore, we note that many of the provided
studies were based on small sample sizes, which may affect the quality
and reliability of the data provided in support of the technology.
In addition, we note that it is unclear whether this device would
have less utility in the outpatient setting as compared to the
inpatient setting, given that patients will typically have time to
adequately prepare for scheduled outpatient procedures. We further note
that this device may not be broadly applicable in the outpatient
setting and are seeking comment for situations in which this device
will have a substantial clinical benefit for patients
[[Page 42109]]
or subpopulations of patients. For instance, in the outpatient setting,
we are not certain that it would be appropriate to use this device in
the case of a patient with a poorly prepared bowel as opposed to simply
rescheduling the appointment.
Lastly, we note that the Helmut et al. study noted one procedure-
related perforation which required surgical repair and we invite public
comments regarding the concern of procedure-related perforation.\88\
Based upon the evidence presented, we are inviting public comments on
whether the Pure-Vu[supreg] meets the substantial clinical improvement
criterion.
---------------------------------------------------------------------------
\88\ Helmut Neumann ML, Tim Zimmermann, Gabriel Lang, Jason B.
Samarasena, Seth A. Gross, Bhaumik Brahmbhatt, Haleh Pazwash,
Vladimir Kushnir. Evaluation of Bowel Cleansing Efficacy in
Hospitalized Patient Population Using the Pure-Vu System.
Gastrointestinal Endoscopy. 2019;89(6).
---------------------------------------------------------------------------
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that Pure-Vu[supreg]
would be reported with the HCPCS codes listed in the following Table
25:
[GRAPHIC] [TIFF OMITTED] TP04AU21.033
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5311--Level 1 Lower GI
Procedures, which had a CY 2020 payment rate of $763.88 at the time the
application was received. Beginning in CY 2017, we calculate the device
offset amount at the HCPCS/CPT code level instead of the APC level (81
FR 79657). HCPCS code 45378 had a device offset amount of $1.07 at the
time the application was received. According to the applicant, the cost
of the Pure-Vu[supreg] is $975.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $975 for Pure-Vu[supreg] is 128 percent of
the applicable APC payment amount for the service related to the
category of devices of $763.80 (($975/$763.88) x 100 = 127.7 percent).
Therefore, we believe Pure-Vu[supreg] meets the first cost significance
requirement.
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $975 for Pure-
Vu[supreg] is 91,122 percent of the cost of the device-related portion
of the APC payment amount for the related service of $1.07 (($975/
$1.07) x 100 = 91,121.5 percent). Therefore, we believe that Pure-
Vu[supreg] meets the second cost significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $975 for Pure-Vu[supreg] and the portion of the APC
payment amount for the device of $1.07 is 128 percent of the APC
payment amount for the related service of $763.88 ((($975-$1.07)/
$763.80) x 100 = 127.5 percent). Therefore, we believe that Pure-
Vu[supreg] meets the third cost significance requirement.
We are inviting public comment on whether the Pure-Vu[supreg] meets
the device pass-through payment criteria discussed in this section,
including the cost criterion for device pass-through payment status.
(6) Xenocor XenoscopeTM
Xenocor Inc. submitted an application for a new device category for
transitional pass-through payment status for the Articulating Xenoscope
Laparoscope (hereinafter referred to as the XenoscopeTM) by
the March 2021 quarterly deadline for CY 2022. The applicant described
the XenoscopeTM as a disposable laparoscope which consists
of a high-definition camera chip on the tip of a composite shaft,
paired with led lights with a handle comprised of a clamshell design
and made with molded plastic. The applicant stated that the
XenoscopeTM provides visualization in the abdominal and
thoracic cavities through small, minimally invasive incisions for
diagnostic and therapeutic laparoscopic procedures in a similar fashion
to established, reusable versions of laparoscopes. It is paired with an
image processing unit, the Xenobox, that can plug into any HD monitor
to
[[Page 42110]]
display anatomy in the abdomen, pelvis or chest. The Xenobox uses pre-
installed firmware that is upgradable.
The applicant claimed that the XenoscopeTM is the first
disposable laparoscope. The applicant also claimed that the use of the
XenoscopeTM reduces the number of cords in the operating
room, eliminates intraoperative fogging and associated image compromise
and eliminates up-front capital enditures associated with reusable
laparoscopes.
With respect to the newness criterion, the XenoscopeTM
received FDA 510(k) clearance on January 27, 2020, based on a
determination of substantial equivalence to a legally marketed
predicate device. The XenoscopeTM is indicated for use in
diagnostic and therapeutic procedures for endoscopy and endoscopic
surgery within the thoracic and peritoneal cavities including the
female reproductive organs. We received the application for a new
device category for transitional pass-through payment status for the
XenoscopeTM on August 6, 2020, which is within 3 years of
the date of the initial FDA marketing authorization. We are inviting
public comments on whether the XenoscopeTM meets the newness
criterion.
With respect to the eligibility criterion at Sec. 419.66(b)(3),
according to the applicant, the use of the XenoscopeTM is
integral to the service, is used for one patient only, comes in contact
with human skin, and is surgically implanted or inserted into the
patient. Specifically, the applicant explained that the
XenoscopeTM is plugged into the Xenobox image processing
unit (which is connected to an HD monitor and an A/C power source). A
surgeon then makes a small incision and a trocar (tube-like device with
a seal to maintain abdominal pressure) is inserted to gain access to
the body cavity. The XenoscopeTM is then inserted through
the trocar in order to provide a full view of the anatomy for
diagnostic and therapeutic procedures.
The applicant also claimed the XenoscopeTM meets the
device eligibility requirements of Sec. 419.66(b)(4) because it is not
an instrument, apparatus, implement, or item for which depreciation and
financing expenses are recovered, and it is not a supply or material
furnished incident to a service. We are inviting public comments on
whether the XenoscopeTM meets the eligibility criteria at
Sec. 419.66(b).
The criteria for establishing new device categories are specified
at Sec. 419.66(c). The first criterion, at Sec. 419.66(c)(1),
provides that CMS determines that a device to be included in the
category is not appropriately described by any of the existing
categories or by any category previously in effect, and was not being
paid for as an outpatient service as of December 31, 1996. The
applicant described the XenoscopeTM as disposable
laparoscope. The applicant reported that it does not believe that the
XenoscopeTM is described by an existing category and
requested category descriptor ``Single-use laparoscopes.'' The
applicant also stated that the currently existing category, C1748--
Endoscope, single-use (that is, disposable), upper gi, imaging/
illumination device (insertable), did not describe this device because
it is limited to single-use duodenoscopes inserted orally, to reach the
small intestine versus minimally invasive abdominal surgery
(laparoscopy). We have not identified an existing pass-through payment
category that is applicable to the XenoscopeTM. We are
inviting public comments on this issue.
The second criterion for establishing a device category, at Sec.
419.66(c)(2), provides that CMS determines either of the following: (i)
That a device to be included in the category has demonstrated that it
will substantially improve the diagnosis or treatment of an illness or
injury or improve the functioning of a malformed body part compared to
the benefits of a device or devices in a previously established
category or other available treatment; or (ii) for devices for which
pass-through status will begin on or after January 1, 2020, as an
alternative to the substantial clinical improvement criterion, the
device is part of the FDA's Breakthrough Devices Program and has
received FDA marketing authorization.
With respect to the substantial clinical improvement criterion, the
applicant stated that the XenoscopeTM provides a substantial
clinical improvement over reusable laparoscopes because of its single-
use nature. Specifically, the applicant claimed, that because the
XenoscopeTM is a disposable, single-use device, the
XenoscopeTM provides for less risk of scope-related cross-
contamination and infection from improperly handled or reprocessed
scopes compared to traditional laparoscopy.
The applicant also claimed that the XenoscopeTM includes
a fog-free scope and provides a substantial clinical improvement over
currently available laparoscopes which, according to the applicant, fog
often, and can put patients at risk for surgical errors and more time
under anesthesia. Additionally, the applicant claimed that the
XenoscopeTM reaches 104 degrees Fahrenheit at the tip,
eliminating risk of patient burns and drape fires associated with
hotter Xenon bulbs used in currently available laparoscopes.
Lastly, that applicant stated that there can be significant
economic benefits through the use of the XenoscopeTM due to
the processing costs and up-front capital expenditures required for
reusable laparoscopes.
In support of the assertion that the XenoscopeTM reduces
the risk of cross-contamination from improperly cleaned reusable
laparoscopic instruments, the applicant referenced two articles. The
first article was published in 2002 and describes the problem of
surgical site infection (SSI), the Centers for Disease Control (CDC)
guidelines for SSI, and some cases of SSI related to improper cleaning
of reusable laparoscopic instruments. The article also discusses
practices to avoid these infections.\89\ The applicant also submitted a
draft of a manuscript titled ``Novel Laparoscopic System for Quality
Improvement and Increased Efficiency'' that summarizes some of the
evidence that laparoscopy, in general, is superior to open surgical
approaches in terms of pain management and infection risk.\90\
---------------------------------------------------------------------------
\89\ Hewitt, A. (2002, November 1). Laparoscopic Instruments:
Handle with Care. Infection Control Today. https://www.infectioncontroltoday.com/view/laparoscopic-instruments-handle-care.
\90\ Elliott, K.W. & Heilbraun, E. (2020). Novel Laparoscopic
System for Quality Improvement and Increased Efficiency. Manuscript
submitted for publication.
---------------------------------------------------------------------------
In support of the claim that the XenoscopeTM eliminates
the risk of patient burns and drape fires associated with Xenon bulbs
used by currently available laparoscopes, the applicant submitted two
articles. The first was an article published in 2011 that discusses the
problem of laparoscopic related burn injuries and a potential solution
using Active Electrode Monitoring (AEM).\91\ AEM instruments reportedly
use a ``shielded and monitored'' design to prevent the risk of stray
energy burn injury from insulation failure and capacitive coupling.
According to the article, the AEM technology is currently licensed by
Intuitive Surgical's da Vinci[supreg] Surgical Systems. The applicant
does not compare the XenoscopeTM to AEM technology in terms
of burn injury reduction. The second article examined the variation and
extent of thermal injuries that could be induced by laparoscopic light
sources to porcine tissue. In the study, the maximum temperature at the
tip of the optical cable varied between 119.5 degrees C and 268.6
degrees C. When surgical
[[Page 42111]]
drapes were exposed to the tip of the light source, the time to char
was 3-6 seconds. The degree and volume of injury increased with longer
exposure times, and significant injury was recorded with the optical
cable 3 mm from the skin.\92\
---------------------------------------------------------------------------
\91\ Encision Inc. (2011, April 1). Method of Reducing Stray
Energy Burns in Laparoscopic Surgery. Medical Design Briefs. https://www.medicaldesignbriefs.com/component/content/article/mdb/tech-briefs/9500.
\92\ Hindle, A. K., Brody, F., Hopkins, V., Rosales, G.,
Gonzalez, F., & Schwartz, A. (2009). Thermal injury secondary to
laparoscopic fiber-optic cables. Surgical endoscopy, 23(8), 1720-
1723. https://doi.org/10.1007/s00464-008-0219-z.
---------------------------------------------------------------------------
In support of the claim that there could be significant economic
benefits realized through the use the XenoscopeTM compared
to reusable laparoscopes, the applicant also referenced the manuscript
entitled ``Novel Laparoscopic System for Quality Improvement and
Increased Efficiency''.\93\ In this study, a three-page survey was
created to collect data regarding laparoscope-related practices and
costs. The survey was completed by three different institutions,
including an ambulatory surgery center (ASC), a rural hospital and a
suburban hospital. The sites provided the capital equipment cost
required at the time of purchase at their facility which ranged from
$837,184 to $2,786,348. The average cost per use for one surgical
procedure involving a reusable laparoscope was $1,019.24 across the
three institutions.
---------------------------------------------------------------------------
\93\ Ibid.
---------------------------------------------------------------------------
We are concerned that the application and the articles submitted as
evidence of substantial clinical improvement discuss potential adverse
effects from laparoscopic procedures, but do not appear to directly
show any clinical improvement that result from the use of the
XenoscopeTM. The applicant has provided evidence which seems
to rely on indirect inferences from other sources of data. The articles
provided did not involve the clinical use of the XenoscopeTM
and did not compare the device to an appropriate comparator, such as a
reusable laparoscope. Therefore, it is difficult to determine whether
the XenoscopeTM offers substantial clinical improvement over
standard, reusable laparoscopes based on the information provided. In
order to demonstrate substantial clinical improvement over currently
available treatments, we consider supporting evidence, preferably
published peer-reviewed clinical trials, that shows improved clinical
outcomes, such as reduction in mortality, complications, subsequent
interventions, future hospitalizations, recovery time, pain, or a more
rapid beneficial resolution of the disease process compared to the
standard of care.
We are invite public comment on whether the XenoscopeTM
meets the substantial clinical improvement criterion.
The third criterion for establishing a device category, at Sec.
419.66(c)(3), requires us to determine that the cost of the device is
not insignificant, as described in Sec. 419.66(d). Section 419.66(d)
includes three cost significance criteria that must each be met. The
applicant provided the following information in support of the cost
significance requirements. The applicant stated that the
XenoscopeTM would be reported with HCPCS codes listed in the
following Table 26:
[GRAPHIC] [TIFF OMITTED] TP04AU21.034
To meet the cost criterion for device pass-through payment status,
a device must pass all three tests of the cost criterion for at least
one APC. For our calculations, we used APC 5361 Level 1 Laparoscopy and
Related Services, which had a CY 2020 payment rate of $4,833.71.
Beginning in CY 2017, we calculated the device offset amount at the
HCPCS/CPT code level instead of the APC level (81 FR 79657). CPT code
49320 had a device offset amount of $107.79 at the time the application
was received. According to the applicant, the cost of the
XenoscopeTM is $1,500.
Section 419.66(d)(1), the first cost significance requirement,
provides that the estimated average reasonable cost of devices in the
category must exceed 25 percent of the applicable APC payment amount
for the service related to the category of devices. The estimated
average reasonable cost of $1,500 for the XenoscopeTM is 31
percent of the applicable APC payment amount for the service related to
the category of devices of XenoscopeTM (($1,500/$4,833.71) x
100 = 31.0 percent). Therefore, we believe XenoscopeTM meets
the first cost significance requirement.
[[Page 42112]]
The second cost significance requirement, at Sec. 419.66(d)(2),
provides that the estimated average reasonable cost of the devices in
the category must exceed the cost of the device-related portion of the
APC payment amount for the related service by at least 25 percent,
which means that the device cost needs to be at least 125 percent of
the offset amount (the device-related portion of the APC found on the
offset list). The estimated average reasonable cost of $1,500 for the
XenoscopeTM is 1,392 percent of the cost of the device-
related portion of the APC payment amount for the related service of
$107.79 (($1,500/$107.79) x 100 = 1,391.6 percent). Therefore, we
believe that the XenoscopeTM meets the second cost
significance requirement.
The third cost significance requirement, at Sec. 419.66(d)(3),
provides that the difference between the estimated average reasonable
cost of the devices in the category and the portion of the APC payment
amount for the device must exceed 10 percent of the APC payment amount
for the related service. The difference between the estimated average
reasonable cost of $1,500 for the XenoscopeTM and the
portion of the APC payment amount for the device of $107.79 is 29
percent of the APC payment amount for the related service of $4,833.71
(($1,500-$107.79)/$4,833.71) = 28.8 percent). Therefore, we believe
that the XenoscopeTM meets the third cost significance
requirement.
We invite public comment on whether the XenoscopeTM
meets the device pass-through payment criteria discussed in this
section, including the cost criterion.
B. Proposed Device-Intensive Procedures
1. Background
Under the OPPS, prior to CY 2017, device-intensive status for
procedures was determined at the APC level for APCs with a device
offset percentage greater than 40 percent (79 FR 66795). Beginning in
CY 2017, CMS began determining device-intensive status at the HCPCS
code level. In assigning device-intensive status to an APC prior to CY
2017, the device costs of all the procedures within the APC were
calculated and the geometric mean device offset of all of the
procedures had to exceed 40 percent. Almost all of the procedures
assigned to device-intensive APCs utilized devices, and the device
costs for the associated HCPCS codes exceeded the 40-percent threshold.
The no cost/full credit and partial credit device policy (79 FR 66872
through 66873) applies to device-intensive APCs and is discussed in
detail in section IV.B.4. of this CY 2022 OPPS/ASC proposed rule. A
related device policy was the requirement that certain procedures
assigned to device-intensive APCs require the reporting of a device
code on the claim (80 FR 70422) and is discussed in detail in Section
IV.B.3 of this CY 2022 OPPS/ASC proposed rule. For further background
information on the device-intensive APC policy, we refer readers to the
CY 2016 OPPS/ASC final rule with comment period (80 FR 70421 through
70426).
a. HCPCS Code-Level Device-Intensive Determination
As stated earlier, prior to CY 2017, under the device-intensive
methodology we assigned device-intensive status to all procedures
requiring the implantation of a device that were assigned to an APC
with a device offset greater than 40 percent and, beginning in CY 2015,
that met the three criteria listed below. Historically, the device-
intensive designation was at the APC level and applied to the
applicable procedures within that APC. In the CY 2017 OPPS/ASC final
rule with comment period (81 FR 79658), we changed our methodology to
assign device-intensive status at the individual HCPCS code level
rather than at the APC level. Under this policy, a procedure could be
assigned device-intensive status regardless of its APC assignment, and
device-intensive APC designations were no longer applied under the OPPS
or the ASC payment system.
We believe that a HCPCS code-level device offset is, in most cases,
a better representation of a procedure's device cost than an APC-wide
average device offset based on the average device offset of all of the
procedures assigned to an APC. Unlike a device offset calculated at the
APC level, which is a weighted average offset for all devices used in
all of the procedures assigned to an APC, a HCPCS code-level device
offset is calculated using only claims for a single HCPCS code. We
believe that this methodological change results in a more accurate
representation of the cost attributable to implantation of a high-cost
device, which ensures consistent device-intensive designation of
procedures with a significant device cost. Further, we believe a HCPCS
code-level device offset removes inappropriate device-intensive status
for procedures without a significant device cost that are granted such
status because of their APC assignment.
Under our existing policy, procedures that meet the criteria listed
in section IV.B.1.b. of this CY 2022 OPPS/ASC proposed rule are
identified as device-intensive procedures and are subject to all the
policies applicable to procedures assigned device-intensive status
under our established methodology, including our policies on device
edits and no cost/full credit and partial credit devices discussed in
sections IV.B.3. and IV.B.4. of this CY 2022 OPPS/ASC proposed rule,
respectively.
b. Use of the Three Criteria To Designate Device-Intensive Procedures
We clarified our established policy in the CY 2018 OPPS/ASC final
rule with comment period (82 FR 52474), where we explained that device-
intensive procedures require the implantation of a device and
additionally are subject to the following criteria:
All procedures must involve implantable devices that would
be reported if device insertion procedures were performed;
The required devices must be surgically inserted or
implanted devices that remain in the patient's body after the
conclusion of the procedure (at least temporarily); and
The device offset amount must be significant, which is
defined as exceeding 40 percent of the procedure's mean cost.
We changed our policy to apply these three criteria to determine
whether procedures qualify as device-intensive in the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66926), where we stated that we
would apply the no cost/full credit and partial credit device policy--
which includes the three criteria listed previously--to all device-
intensive procedures beginning in CY 2015. We reiterated this position
in the CY 2016 OPPS/ASC final rule with comment period (80 FR 70424),
where we explained that we were finalizing our proposal to continue
using the three criteria established in the CY 2007 OPPS/ASC final rule
with comment period for determining the APCs to which the CY 2016
device intensive policy will apply. Under the policies we adopted in
CYs 2015, 2016, and 2017, all procedures that require the implantation
of a device and meet the previously described criteria are assigned
device-intensive status, regardless of their APC placement.
2. Device-Intensive Procedure Policy for CY 2019 and Subsequent Years
As part of our effort to better capture costs for procedures with
significant device costs, in the CY 2019 OPPS/ASC final rule with
comment period (83 FR 58944 through 58948), for CY 2019, we modified
our criteria for device-intensive procedures. We had heard
[[Page 42113]]
from stakeholders that the criteria excluded some procedures that
stakeholders believed should qualify as device-intensive procedures.
Specifically, we were persuaded by stakeholder arguments that
procedures requiring expensive surgically inserted or implanted devices
that are not capital equipment should qualify as device-intensive
procedures, regardless of whether the device remains in the patient's
body after the conclusion of the procedure. We agreed that a broader
definition of device-intensive procedures was warranted, and made two
modifications to the criteria for CY 2019 (83 FR 58948). First, we
allowed procedures that involve surgically inserted or implanted
single-use devices that meet the device offset percentage threshold to
qualify as device-intensive procedures, regardless of whether the
device remains in the patient's body after the conclusion of the
procedure. We established this policy because we no longer believe that
whether a device remains in the patient's body should affect a
procedure's designation as a device-intensive procedure, as such
devices could, nonetheless, comprise a large portion of the cost of the
applicable procedure. Second, we modified our criteria to lower the
device offset percentage threshold from 40 percent to 30 percent, to
allow a greater number of procedures to qualify as device-intensive. We
stated that we believe allowing these additional procedures to qualify
for device-intensive status will help ensure these procedures receive
more appropriate payment in the ASC setting, which will help encourage
the provision of these services in the ASC setting. In addition, we
stated that this change would help to ensure that more procedures
containing relatively high-cost devices are subject to the device
edits, which leads to more correctly coded claims and greater accuracy
in our claims data. Specifically, for CY 2019 and subsequent years, we
finalized that device-intensive procedures will be subject to the
following criteria:
All procedures must involve implantable devices assigned a
CPT or HCPCS code;
The required devices (including single-use devices) must
be surgically inserted or implanted; and
The device offset amount must be significant, which is
defined as exceeding 30 percent of the procedure's mean cost (83 FR
58945).
In addition, to further align the device-intensive policy with the
criteria used for device pass-through payment status, we finalized, for
CY 2019 and subsequent years, that for purposes of satisfying the
device-intensive criteria, a device-intensive procedure must involve a
device that:
Has received FDA marketing authorization, has received an
FDA investigational device exemption (IDE), and has been classified as
a Category B device by FDA in accordance with Sec. Sec. 405.203
through 405.207 and 405.211 through 405.215, or meets another
appropriate FDA exemption from premarket review;
Is an integral part of the service furnished;
Is used for one patient only;
Comes in contact with human tissue;
Is surgically implanted or inserted (either permanently or
temporarily); and
Is not either of the following:
(a) Equipment, an instrument, apparatus, implement, or item of the
type for which depreciation and financing expenses are recovered as
depreciable assets as defined in Chapter 1 of the Medicare Provider
Reimbursement Manual (CMS Pub. 15-1); or
(b) A material or supply furnished incident to a service (for
example, a suture, customized surgical kit, scalpel, or clip, other
than a radiological site marker) (83 FR 58945).
In addition, for new HCPCS codes describing procedures requiring
the implantation of devices that do not yet have associated claims
data, in the CY 2017 OPPS/ASC final rule with comment period (81 FR
79658), we finalized a policy for CY 2017 to apply device-intensive
status with a default device offset set at 41 percent for new HCPCS
codes describing procedures requiring the implantation or insertion of
a device that did not yet have associated claims data until claims data
are available to establish the HCPCS code-level device offset for the
procedures. This default device offset amount of 41 percent was not
calculated from claims data; instead, it was applied as a default until
claims data were available upon which to calculate an actual device
offset for the new code. The purpose of applying the 41-percent default
device offset to new codes that describe procedures that implant or
insert devices was to ensure ASC access for new procedures until claims
data become available.
As discussed in the CY 2019 OPPS/ASC proposed rule and final rule
with comment period (83 FR 37108 through 37109 and 58945 through 58946,
respectively), in accordance with our policy stated previously to lower
the device offset percentage threshold for procedures to qualify as
device-intensive from greater than 40 percent to greater than 30
percent, for CY 2019 and subsequent years, we modified this policy to
apply a 31-percent default device offset to new HCPCS codes describing
procedures requiring the implantation of a device that do not yet have
associated claims data until claims data are available to establish the
HCPCS code-level device offset for the procedures. In conjunction with
the policy to lower the default device offset from 41 percent to 31
percent, we continued our current policy of, in certain rare instances
(for example, in the case of a very ensive implantable device),
temporarily assigning a higher offset percentage if warranted by
additional information such as pricing data from a device manufacturer
(81 FR 79658). Once claims data are available for a new procedure
requiring the implantation or insertion of a device, device-intensive
status is applied to the code if the HCPCS code-level device offset is
greater than 30 percent, according to our policy of determining device-
intensive status by calculating the HCPCS code-level device offset.
In addition, in the CY 2019 OPPS/ASC final rule with comment
period, we clarified that since the adoption of our policy in effect as
of CY 2018, the associated claims data used for purposes of determining
whether or not to apply the default device offset are the associated
claims data for either the new HCPCS code or any predecessor code, as
described by CPT coding guidance, for the new HCPCS code. Additionally,
for CY 2019 and subsequent years, in limited instances where a new
HCPCS code does not have a predecessor code as defined by CPT, but
describes a procedure that was previously described by an existing
code, we use clinical discretion to identify HCPCS codes that are
clinically related or similar to the new HCPCS code but are not
officially recognized as a predecessor code by CPT, and to use the
claims data of the clinically related or similar code(s) for purposes
of determining whether or not to apply the default device offset to the
new HCPCS code (83 FR 58946). Clinically related and similar procedures
for purposes of this policy are procedures that have little or no
clinical differences and use the same devices as the new HCPCS code. In
addition, clinically related and similar codes for purposes of this
policy are codes that either currently or previously describe the
procedure described by the new HCPCS code. Under this policy, claims
data from clinically related and similar codes are included as
associated claims data for a new code, and where an existing HCPCS code
is found to be
[[Page 42114]]
clinically related or similar to a new HCPCS code, we apply the device
offset percentage derived from the existing clinically related or
similar HCPCS code's claims data to the new HCPCS code for determining
the device offset percentage. We stated that we believe that claims
data for HCPCS codes describing procedures that have minor differences
from the procedures described by new HCPCS codes will provide an
accurate depiction of the cost relationship between the procedure and
the device(s) that are used, and will be appropriate to use to set a
new code's device offset percentage, in the same way that predecessor
codes are used. If a new HCPCS code has multiple predecessor codes, the
claims data for the predecessor code that has the highest individual
HCPCS-level device offset percentage is used to determine whether the
new HCPCS code qualifies for device-intensive status. Similarly, in the
event that a new HCPCS code does not have a predecessor code but has
multiple clinically related or similar codes, the claims data for the
clinically related or similar code that has the highest individual
HCPCS level device offset percentage is used to determine whether the
new HCPCS code qualifies for device-intensive status.
As we indicated in the CY 2019 OPPS/ASC proposed rule and final
rule with comment period, additional information for our consideration
of an offset percentage higher than the default of 31 percent for new
HCPCS codes describing procedures requiring the implantation (or, in
some cases, the insertion) of a device that do not yet have associated
claims data, such as pricing data or invoices from a device
manufacturer, should be directed to the Division of Outpatient Care,
Mail Stop C4-01-26, Centers for Medicare & Medicaid Services, 7500
Security Boulevard, Baltimore, MD 21244-1850, or electronically at
[email protected]. Additional information can be submitted
prior to issuance of an OPPS/ASC proposed rule or as a public comment
in response to an issued OPPS/ASC proposed rule. Device offset
percentages will be set in each year's final rule.
As discussed in Section X.E of this proposed rule, given our
concerns regarding CY 2020 data as a result of the COVID-PHE, we are
proposing to use CY 2019 claims data to establish CY 2022 prospective
rates. While we continue to believe CY 2019 represents the best full
year of claims data for ratesetting, we believe our policy of
temporarily assigning a higher offset percentage if warranted by
additional information would provide a more accurate device offset
percentage for certain procedures. Specifically, for procedures that
were assigned device-intensive status, but were assigned a default
device offset percentage of 31 percent or a device offset percentage
based on claims from a clinically-similar code in the absence of CY
2019 claims data, we are proposing to assign a device offset percentage
for such procedures based on CY 2020 data if CY 2020 claims information
is available. While we believe that CY 2019 claims data is a better
basis for CY 2022 OPPS rates overall, because we have specifically
noted that we would consider using more recent data than the data
available for ratesetting in a given year to determine device offset
percentages for services that do not have any claims data in the year
used for ratesetting, we believe it would be consistent with this
policy for us to use CY 2020 claims data to determine the device offset
percentage for services that meet the above criteria.
For CY 2022, our proposal would assign device offset percentages
using CY 2020 claims data to the following 11 procedures:
0266T (Implantation or replacement of carotid sinus
baroreflex activation device; total system (includes generator
placement, unilateral or bilateral lead placement, intra-operative
interrogation, programming, and repositioning, when performed));
0414T (Removal and replacement of permanent cardiac
contractility modulation system pulse generator only);
0511T (Removal and reinsertion of sinus tarsi implant);
0587T (Percutaneous implantation or replacement of
integrated single device neurostimulation system including electrode
array and receiver or pulse generator, including analysis, programming,
and imaging guidance when performed, posterior tibial nerve);
0600T (Ablation, irreversible electroporation; 1 or more
tumors per organ, including imaging guidance, when performed,
percutaneous);
0614T (Removal and replacement of substernal implantable
defibrillator pulse generator);
66987 (Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1-stage procedure), manual or mechanical
technique (for example, irrigation and aspiration or
phacoemulsification), complex, requiring devices or techniques not
generally used in routine cataract surgery (for example, iris ansion
device, suture support for intraocular lens, or primary posterior
capsulorrhexis) or performed on patients in the amblyogenic
developmental stage; with endoscopic cyclophotocoagulation);
66988 (Extracapsular cataract removal with insertion of
intraocular lens prosthesis (1 stage procedure), manual or mechanical
technique (for example, irrigation and aspiration or
phacoemulsification); with endoscopic cyclophotocoagulation);
C9757 (Laminotomy (hemilaminectomy), with decompression of
nerve root(s), including partial facetectomy, foraminotomy and excision
of herniated intervertebral disc, and repair of annular defect with
implantation of bone anchored annular closure device, including annular
defect measurement, alignment and sizing assessment, and image
guidance; 1 interspace, lumbar);
C9765 (Revascularization, endovascular, open or
percutaneous, lower extremity artery(ies), except tibial/peroneal; with
intravascular lithotripsy, and transluminal stent placement(s),
includes angioplasty within the same vessel(s), when performed); and
C9767 (Revascularization, endovascular, open or
percutaneous, lower extremity artery(ies), except tibial/peroneal; with
intravascular lithotripsy and transluminal stent placement(s), and
atherectomy, includes angioplasty within the same vessel(s), when
performed).
We are soliciting comments on our proposal to establish the CY 2022
device offset percentage using CY 2020 claims data for device-intensive
procedures with no claims in the CY 2019 claims data. The full listing
of the proposed CY 2022 device-intensive procedures can be found in
Addendum P to this CY 2022 OPPS/ASC proposed rule (which is available
via the internet on the CMS website). Further, our claims accounting
narrative contains a description of our device offset percentage
calculation. Our claims accounting narrative for this proposed rule can
be found under supporting documentation for the CY 2022 OPPS/ASC
proposed rule on our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
3. Device Edit Policy
In the CY 2015 OPPS/ASC final rule with comment period (79 FR
66795), we finalized a policy and implemented claims processing edits
that require any of the device codes used in the previous device-to-
procedure edits to be present on the claim whenever a procedure code
assigned to any of the APCs listed in Table 5 of the CY 2015 OPPS/ASC
final rule with comment period (the CY 2015
[[Page 42115]]
device-dependent APCs) is reported on the claim. In addition, in the CY
2016 OPPS/ASC final rule with comment period (80 FR 70422), we modified
our previously existing policy and applied the device coding
requirements exclusively to procedures that require the implantation of
a device that are assigned to a device-intensive APC. In the CY 2016
OPPS/ASC final rule with comment period, we also finalized our policy
that the claims processing edits are such that any device code, when
reported on a claim with a procedure assigned to a device-intensive APC
(listed in Table 42 of the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70422)) will satisfy the edit.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79658
through 79659), we changed our policy for CY 2017 and subsequent years
to apply the CY 2016 device coding requirements to the newly defined
device-intensive procedures. For CY 2017 and subsequent years, we also
specified that any device code, when reported on a claim with a device-
intensive procedure, will satisfy the edit. In addition, we created
HCPCS code C1889 to recognize devices furnished during a device-
intensive procedure that are not described by a specific Level II HCPCS
Category C-code. Reporting HCPCS code C1889 with a device-intensive
procedure will satisfy the edit requiring a device code to be reported
on a claim with a device-intensive procedure. In the CY 2019 OPPS/ASC
final rule with comment period, we revised the description of HCPCS
code C1889 to remove the specific applicability to device-intensive
procedures (83 FR 58950). For CY 2019 and subsequent years, the
description of HCPCS code C1889 is ``Implantable/insertable device, not
otherwise classified''.
We are not proposing any changes to this policy for CY 2022.
4. Adjustment to OPPS Payment for No Cost/Full Credit and Partial
Credit Devices
a. Background
To ensure equitable OPPS payment when a hospital receives a device
without cost or with full credit, in CY 2007, we implemented a policy
to reduce the payment for specified device-dependent APCs by the
estimated portion of the APC payment attributable to device costs (that
is, the device offset) when the hospital receives a specified device at
no cost or with full credit (71 FR 68071 through 68077). Hospitals were
instructed to report no cost/full credit device cases on the claim
using the ``FB'' modifier on the line with the procedure code in which
the no cost/full credit device is used. In cases in which the device is
furnished without cost or with full credit, hospitals were instructed
to report a token device charge of less than $1.01. In cases in which
the device being inserted is an upgrade (either of the same type of
device or to a different type of device) with a full credit for the
device being replaced, hospitals were instructed to report as the
device charge the difference between the hospital's usual charge for
the device being implanted and the hospital's usual charge for the
device for which it received full credit. In CY 2008, we expanded this
payment adjustment policy to include cases in which hospitals receive
partial credit of 50 percent or more of the cost of a specified device.
Hospitals were instructed to append the ``FC'' modifier to the
procedure code that reports the service provided to furnish the device
when they receive a partial credit of 50 percent or more of the cost of
the new device. We refer readers to the CY 2008 OPPS/ASC final rule
with comment period for more background information on the ``FB'' and
``FC'' modifiers payment adjustment policies (72 FR 66743 through
66749).
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75005
through 75007), beginning in CY 2014, we modified our policy of
reducing OPPS payment for specified APCs when a hospital furnishes a
specified device without cost or with a full or partial credit. For CY
2013 and prior years, our policy had been to reduce OPPS payment by 100
percent of the device offset amount when a hospital furnishes a
specified device without cost or with a full credit and by 50 percent
of the device offset amount when the hospital receives partial credit
in the amount of 50 percent or more of the cost for the specified
device. For CY 2014, we reduced OPPS payment, for the applicable APCs,
by the full or partial credit a hospital receives for a replaced
device. Specifically, under this modified policy, hospitals are
required to report on the claim the amount of the credit in the amount
portion for value code ``FD'' (Credit Received from the Manufacturer
for a Replaced Device) when the hospital receives a credit for a
replaced device that is 50 percent or greater than the cost of the
device. For CY 2014, we also limited the OPPS payment deduction for the
applicable APCs to the total amount of the device offset when the
``FD'' value code appears on a claim. For CY 2015, we continued our
policy of reducing OPPS payment for specified APCs when a hospital
furnishes a specified device without cost or with a full or partial
credit and to use the three criteria established in the CY 2007 OPPS/
ASC final rule with comment period (71 FR 68072 through 68077) for
determining the APCs to which our CY 2015 policy will apply (79 FR
66872 through 66873). In the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70424), we finalized our policy to no longer specify a
list of devices to which the OPPS payment adjustment for no cost/full
credit and partial credit devices would apply and instead apply this
APC payment adjustment to all replaced devices furnished in conjunction
with a procedure assigned to a device-intensive APC when the hospital
receives a credit for a replaced specified device that is 50 percent or
greater than the cost of the device.
b. Policy for No Cost/Full Credit and Partial Credit Devices
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79659
through 79660), for CY 2017 and subsequent years, we finalized a policy
to reduce OPPS payment for device-intensive procedures, by the full or
partial credit a provider receives for a replaced device, when a
hospital furnishes a specified device without cost or with a full or
partial credit. Under our current policy, hospitals continue to be
required to report on the claim the amount of the credit in the amount
portion for value code ``FD'' when the hospital receives a credit for a
replaced device that is 50 percent or greater than the cost of the
device.
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75005
through 75007), we adopted a policy of reducing OPPS payment for
specified APCs when a hospital furnishes a specified device without
cost or with a full or partial credit by the lesser of the device
offset amount for the APC or the amount of the credit. We adopted this
change in policy in the preamble of the CY 2014 OPPS/ASC final rule
with comment period and discussed it in subregulatory guidance,
including Chapter 4, Section 61.3.6 of the Medicare Claims Processing
Manual. Further, in the CY 2021 OPPS/ASC final rule with comment period
(85 FR 86017 through 86018, 86302), we made conforming changes to our
regulations at Sec. 419.45(b)(1) and (2) that codified this policy.
We are not proposing any changes to our policies regarding payment
for no cost/full credit and partial credit devices in CY 2022.
[[Page 42116]]
5. Payment Policy for Low-Volume Device-Intensive Procedures
In CY 2016, we used our equitable adjustment authority under
section 1833(t)(2)(E) of the Act and used the median cost (instead of
the geometric mean cost per our standard methodology) to calculate the
payment rate for the implantable miniature telescope procedure
described by CPT code 0308T (Insertion of ocular telescope prosthesis
including removal of crystalline lens or intraocular lens prosthesis),
which is the only code assigned to APC 5494 (Level 4 Intraocular
Procedures) (80 FR 70388). We noted that, as stated in the CY 2017
OPPS/ASC proposed rule (81 FR 45656), we proposed to reassign the
procedure described by CPT code 0308T to APC 5495 (Level 5 Intraocular
Procedures) for CY 2017, but it would be the only procedure code
assigned to APC 5495. The payment rates for a procedure described by
CPT code 0308T (including the predecessor HCPCS code C9732) were
$15,551 in CY 2014, $23,084 in CY 2015, and $17,551 in CY 2016. The
procedure described by CPT code 0308T is a high-cost device-intensive
surgical procedure that has a very low volume of claims (in part
because most of the procedures described by CPT code 0308T are
performed in ASCs). We believe that the median cost is a more
appropriate measure of the central tendency for purposes of calculating
the cost and the payment rate for this procedure because the median
cost is impacted to a lesser degree than the geometric mean cost by
more extreme observations. We stated that, in future rulemaking, we
would consider proposing a general policy for the payment rate
calculation for very low-volume device-intensive APCs (80 FR 70389).
For CY 2017, we proposed and finalized a payment policy for low-
volume device-intensive procedures that is similar to the policy
applied to the procedure described by CPT code 0308T in CY 2016. In the
CY 2017 OPPS/ASC final rule with comment period (81 FR 79660 through
79661), we established our current policy that the payment rate for any
device-intensive procedure that is assigned to a clinical APC with
fewer than 100 total claims for all procedures in the APC be calculated
using the median cost instead of the geometric mean cost, for the
reasons described previously for the policy applied to the procedure
described by CPT code 0308T in CY 2016. For CYs 2019 through 2021, we
continued our policy of establishing the payment rate for any device-
intensive procedure that is assigned to a clinical APC with fewer than
100 total claims for all procedures in the APC by using the median cost
instead of the geometric mean (85 FR 86019).
As discussed in further detail in Section X.C of this proposed
rule, we are proposing to establish a universal low volume APC policy
for clinical APCs, brachytherapy APCs, and New Technology APCs with
fewer than 100 single claims in the claims data used for ratesetting
(for CY 2022 rates, this is proposed to be the CY 2019 claim data). For
APCs designated as low volume APCs (those with fewer than 100 single
claims in the claims year) under our proposed policy, we propose to
establish a payment rate using the highest of the median cost,
arithmetic mean cost, or the geometric mean cost. In conjunction with
our new, broader low volume APC proposal for clinical APCs,
brachytherapy APCs, and New Technology APCs, we are proposing to
eliminate our payment policy for low-volume device-intensive procedures
for CY 2022 and subsequent calendar years. Currently, CPT code 0308T is
the only code subject to our low-volume device-intensive policy. Given
that our proposed universal low volume APC policy would utilize a
greater number of claims and provide additional cost metric
alternatives for ratesetting than our existing low-volume device-
intensive policy, we believe that the cost and ratesetting issues
previously discussed with respect to CPT code 0308T would be
appropriately addressed under our broader universal low volume APC
proposal.
We are soliciting comments on our proposal to eliminate our payment
policy for low-volume device-intensive procedures and address low-
volume, device-intensive procedures through our broader proposal to
designate low volume APCs among eligible clinical APCs, brachytherapy
APCs, and New Technology APCs.
V. Proposed OPPS Payment Changes for Drugs, Biologicals, and
Radiopharmaceuticals
A. Proposed OPPS Transitional Pass-Through Payment for Additional Costs
of Drugs, Biologicals, and Radiopharmaceuticals
1. Background
Section 1833(t)(6) of the Act provides for temporary additional
payments or ``transitional pass-through payments'' for certain drugs
and biologicals. Throughout the proposed rule, the term ``biological''
is used because this is the term that appears in section 1861(t) of the
Act. A ``biological'' as used in the proposed rule includes (but is not
necessarily limited to) a ``biological product'' or a ``biologic'' as
defined under section 351 of the Public Health Service Act. As enacted
by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of
1999 (BBRA) (Pub. L. 106-113), this pass-through payment provision
requires the Secretary to make additional payments to hospitals for:
Current orphan drugs for rare diseases and conditions, as designated
under section 526 of the Federal Food, Drug, and Cosmetic Act; current
drugs and biologicals and brachytherapy sources used in cancer therapy;
and current radiopharmaceutical drugs and biologicals. ``Current''
refers to those types of drugs or biologicals mentioned above that are
hospital outpatient services under Medicare Part B for which
transitional pass-through payment was made on the first date the
hospital OPPS was implemented.
Transitional pass-through payments also are provided for certain
``new'' drugs and biologicals that were not being paid for as an HOPD
service as of December 31, 1996, and whose cost is ``not
insignificant'' in relation to the OPPS payments for the procedures or
services associated with the new drug or biological. For pass-through
payment purposes, radiopharmaceuticals are included as ``drugs.'' As
required by statute, transitional pass-through payments for a drug or
biological described in section 1833(t)(6)(C)(i)(II) of the Act can be
made for a period of at least 2 years, but not more than 3 years, after
the payment was first made for the drug as a hospital outpatient
service under Medicare Part B. Proposed CY 2022 pass-through drugs and
biologicals and their designated APCs are assigned status indicator
``G'' in Addenda A and B to the proposed rule (which are available via
the internet on the CMS website).
Section 1833(t)(6)(D)(i) of the Act specifies that the pass-through
payment amount, in the case of a drug or biological, is the amount by
which the amount determined under section 1842(o) of the Act for the
drug or biological exceeds the portion of the otherwise applicable
Medicare OPD fee schedule that the Secretary determines is associated
with the drug or biological. The methodology for determining the pass-
through payment amount is set forth in regulations at 42 CFR 419.64.
These regulations specify that the pass-through payment equals the
amount determined under section 1842(o) of the Act minus the portion of
the APC payment that CMS determines is associated with the drug or
biological.
[[Page 42117]]
Section 1847A of the Act establishes the average sales price (ASP)
methodology, which is used for payment for drugs and biologicals
described in section 1842(o)(1)(C) of the Act furnished on or after
January 1, 2005. The ASP methodology, as applied under the OPPS, uses
several sources of data as a basis for payment, including the ASP, the
wholesale acquisition cost (WAC), and the average wholesale price
(AWP). In the proposed rule, the term ``ASP methodology'' and ``ASP-
based'' are inclusive of all data sources and methodologies described
therein. Additional information on the ASP methodology can be found on
our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.
The pass-through application and review process for drugs and
biologicals is described on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/passthrough_payment.html.
2. Transitional Pass-Through Payment Period for Pass-Through Drugs,
Biologicals, and Radiopharmaceuticals and Quarterly Expiration of Pass-
Through Status
As required by statute, transitional pass-through payments for a
drug or biological described in section 1833(t)(6)(C)(i)(II) of the Act
can be made for a period of at least 2 years, but not more than 3
years, after the payment was first made for the drug or biological as a
hospital outpatient service under Medicare Part B. Our current policy
is to accept pass-through applications on a quarterly basis and to
begin pass-through payments for newly approved pass-through drugs and
biologicals on a quarterly basis through the next available OPPS
quarterly update after the approval of a drug's or biological's pass-
through status. However, prior to CY 2017, we expired pass-through
status for drugs and biologicals on an annual basis through notice-and-
comment rulemaking (74 FR 60480). In the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79662), we finalized a policy change,
beginning with pass-through drugs and biologicals newly approved in CY
2017 and subsequent calendar years, to allow for a quarterly expiration
of pass-through payment status for drugs, biologicals, and
radiopharmaceuticals to afford a pass-through payment period that is as
close to a full 3 years as possible for all pass-through drugs,
biologicals, and radiopharmaceuticals.
This change eliminated the variability of the pass-through payment
eligibility period, which previously varied based on when a particular
application was initially received. We adopted this change for pass-
through approvals beginning on or after CY 2017, to allow, on a
prospective basis, for the maximum pass-through payment period for each
pass-through drug without exceeding the statutory limit of 3 years.
Notice of drugs whose pass-through payment status is ending during the
calendar year will continue to be included in the quarterly OPPS Change
Request transmittals.
3. Drugs and Biologicals With Expiring Pass-Through Payment Status in
CY 2021
There are 25 drugs and biologicals whose pass-through payment
status will expire during CY 2021, as listed in Table 27. Most of these
drugs and biologicals will have received OPPS pass-through payment for
3 years during the period of April 1, 2018, through December 31, 2020.
In accordance with the policy finalized in CY 2017 and described
earlier, pass-through payment status for drugs and biologicals newly
approved in CY 2017 and subsequent years will expire on a quarterly
basis, with a pass-through payment period as close to 3 years as
possible. With the exception of those groups of drugs and biologicals
that are always packaged when they do not have pass-through payment
status (specifically, anesthesia drugs; drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure (including diagnostic
radiopharmaceuticals, contrast agents, and stress agents); and drugs
and biologicals that function as supplies when used in a surgical
procedure), our standard methodology for providing payment for drugs
and biologicals with expiring pass-through payment status in an
upcoming calendar year is to determine the product's estimated per day
cost and compare it with the OPPS drug packaging threshold for that
calendar year (which is proposed to be $130 for CY 2022), as discussed
further in section V.B.1. of this proposed rule. We proposed that if
the estimated per day cost for the drug or biological is less than or
equal to the applicable OPPS drug packaging threshold, we would package
payment for the drug or biological into the payment for the associated
procedure in the upcoming calendar year. If the estimated per day cost
of the drug or biological is greater than the OPPS drug packaging
threshold, we proposed to provide separate payment at the applicable
ASP-based payment amount (which is proposed at ASP+6 percent for non-
340B drugs for CY 2022, as discussed further in section V.B.2. of this
proposed rule).
BILLING CODE 4120-01-P
[[Page 42118]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.035
[[Page 42119]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.036
BILLING CODE 4120-01-C
[[Page 42120]]
4. Drugs, Biologicals, and Radiopharmaceuticals With Pass-Through
Payment Status Expiring in CY 2022
We propose to end pass-through payment status in CY 2022 for 26
drugs and biologicals. These drugs and biologicals, which were approved
for pass-through payment status between April 1, 2019, and January 1,
2020, are listed in Table 28. The APCs and HCPCS codes for these drugs
and biologicals, which have pass-through payment status that will end
by December 31, 2022, are assigned status indicator ``G'' in Addenda A
and B to this proposed rule (which are available via the internet on
the CMS website).
Section 1833(t)(6)(D)(i) of the Act sets the amount of pass-through
payment for pass-through drugs and biologicals (the pass-through
payment amount) as the difference between the amount authorized under
section 1842(o) of the Act and the portion of the otherwise applicable
OPD fee schedule that the Secretary determines is associated with the
drug or biological. For 2022, we propose to continue to pay for pass-
through drugs and biologicals at ASP+6 percent, equivalent to the
payment rate these drugs and biologicals would receive in the
physician's office setting in CY 2022. We propose that a $0 pass-
through payment amount would be paid for pass-through drugs and
biologicals that are not policy-packaged as described in Section
V.B.1.c. under the CY 2022 OPPS because the difference between the
amount authorized under section 1842(o) of the Act, which is proposed
at ASP+6 percent, and the portion of the otherwise applicable OPD fee
schedule that the Secretary determines is appropriate, which is
proposed at ASP+6 percent, is $0.
In the case of policy-packaged drugs (which include the following:
Anesthesia drugs; drugs, biologicals, and radiopharmaceuticals that
function as supplies when used in a diagnostic test or procedure
(including contrast agents, diagnostic radiopharmaceuticals, and stress
agents); and drugs and biologicals that function as supplies when used
in a surgical procedure), we propose that their pass-through payment
amount would be equal to ASP+6 percent for CY 2022 minus a payment
offset for the portion of the otherwise applicable OPD fee schedule
that the Secretary determines is associated with the drug or biological
as described in section V.A.6. of this proposed rule. We propose this
policy because, if not for the pass-through payment status of these
policy-packaged products, payment for these products would be packaged
into the associated procedure.
We propose to continue to update pass-through payment rates on a
quarterly basis on the CMS website during CY 2022 if later quarter ASP
submissions (or more recent WAC or AWP information, as applicable)
indicate that adjustments to the payment rates for these pass-through
payment drugs or biologicals are necessary. For a full description of
this policy, we refer readers to the CY 2006 OPPS/ASC final rule with
comment period (70 FR 68632 through 68635).
For CY 2022, consistent with our CY 2021 policy for diagnostic and
therapeutic radiopharmaceuticals, we propose to provide payment for
both diagnostic and therapeutic radiopharmaceuticals that are granted
pass-through payment status based on the ASP methodology. As stated
earlier, for purposes of pass-through payment, we consider
radiopharmaceuticals to be drugs under the OPPS. Therefore, if a
diagnostic or therapeutic radiopharmaceutical receives pass-through
payment status during CY 2022, we propose to follow the standard ASP
methodology to determine the pass-through payment rate that drugs
receive under section 1842(o) of the Act, which is proposed at ASP+6
percent. If ASP data are not available for a radiopharmaceutical, we
propose to provide pass-through payment at WAC+3 percent (consistent
with our proposed policy in section V.B.2.b. of this proposed rule),
the equivalent payment provided to pass-through drugs and biologicals
without ASP information. Additional detail on the WAC+3 percent payment
policy can be found in section V.B.2.b. of this proposed rule. If WAC
information also is not available, we propose to provide payment for
the pass-through radiopharmaceutical at 95 percent of its most recent
AWP.
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5. Drugs, Biologicals, and Radiopharmaceuticals With Pass-Through
Payment Status Continuing in CY 2022
We propose to continue pass-through payment status in CY 2022 for
46 drugs and biologicals. These drugs and biologicals, which were
approved for pass-through payment status with effective dates beginning
between April 1, 2020, and April 1, 2021, are listed in Table 29. The
APCs and HCPCS codes for these drugs and biologicals, which have pass-
through payment status that will continue after December 31, 2022, are
assigned status indicator ``G'' in Addenda A and B to this proposed
rule (which are available via the internet on the CMS website).
Section 1833(t)(6)(D)(i) of the Act sets the amount of pass-through
payment for pass-through drugs and biologicals (the pass-through
payment amount) as the difference between the amount authorized under
section 1842(o) of the Act and the portion of the otherwise applicable
OPD fee schedule that the Secretary determines is associated with the
drug or biological. For 2023, we propose to continue to pay for pass-
through drugs and biologicals at ASP+6 percent, equivalent to the
payment rate these drugs and+ biologicals would receive in the
physician's office setting in CY 2022. We propose that a $0 pass-
through payment amount would be paid for pass-through drugs and
biologicals that are not policy-packaged as described in Section
V.B.1.c. under the CY 2022 OPPS because the difference between the
amount authorized under section 1842(o) of the Act, which is proposed
at ASP+6 percent, and the portion of the otherwise applicable OPD fee
schedule that the Secretary determines is appropriate, which is
proposed at ASP+6 percent, is $0.
In the case of policy-packaged drugs (which include the following:
Anesthesia drugs; drugs, biologicals, and radiopharmaceuticals that
function as supplies when used in a diagnostic test or procedure
(including contrast
[[Page 42123]]
agents, diagnostic radiopharmaceuticals, and stress agents); and drugs
and biologicals that function as supplies when used in a surgical
procedure), we propose that their pass-through payment amount would be
equal to ASP+6 percent for CY 2022 minus a payment offset for any
predecessor drug products contributing to the pass-through payment as
described in section V.A.6. of this proposed rule. We propose this
policy because, if not for the pass-through payment status of these
policy-packaged products, payment for these products would be packaged
into the associated procedure.
We propose to continue to update pass-through payment rates on a
quarterly basis on our website during CY 2022 if later quarter ASP
submissions (or more recent WAC or AWP information, as applicable)
indicate that adjustments to the payment rates for these pass-through
payment drugs or biologicals are necessary. For a full description of
this policy, we refer readers to the CY 2006 OPPS/ASC final rule with
comment period (70 FR 68632 through 68635).
For CY 2022, consistent with our CY 2021 policy for diagnostic and
therapeutic radiopharmaceuticals, we propose to provide payment for
both diagnostic and therapeutic radiopharmaceuticals that are granted
pass-through payment status based on the ASP methodology. As stated
earlier, for purposes of pass-through payment, we consider
radiopharmaceuticals to be drugs under the OPPS. Therefore, if a
diagnostic or therapeutic radiopharmaceutical receives pass-through
payment status during CY 2023, we propose to follow the standard ASP
methodology to determine the pass-through payment rate that drugs
receive under section 1842(o) of the Act, which is proposed at ASP+6
percent. If ASP data are not available for a radiopharmaceutical, we
propose to provide pass-through payment at WAC+3 percent (consistent
with our proposed policy in section V.B.2.b. of this proposed rule),
the equivalent payment provided to pass-through drugs and biologicals
without ASP information. Additional detail on the WAC+3 percent payment
policy can be found in section V.B.2.b. of this proposed rule. If WAC
information also is not available, we propose to provide payment for
the pass-through radiopharmaceutical at 95 percent of its most recent
AWP.
The drugs and biologicals that we propose to have pass-through
payment status expire after December 31, 2022, are shown in Table 29.
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6. Provisions for Reducing Transitional Pass-Through Payments for
Policy-Packaged Drugs, Biologicals, and Radiopharmaceuticals To Offset
Costs Packaged Into APC Groups
Under the regulation at 42 CFR 419.2(b), nonpass-through drugs,
biologicals, and radiopharmaceuticals that function as supplies when
used in a diagnostic test or procedure are packaged in the OPPS. This
category includes diagnostic radiopharmaceuticals, contrast agents,
stress agents, and other diagnostic drugs. Also under the regulation at
42 CFR 419.2(b), nonpass-through drugs and biologicals that function as
supplies in a surgical procedure are packaged in the OPPS. This
category includes skin substitutes and other surgical-supply drugs and
biologicals. As described earlier, section 1833(t)(6)(D)(i) of the Act
specifies that the transitional pass-through payment amount for pass-
through drugs and biologicals is the difference between the amount paid
under section 1842(o) of the Act and the otherwise applicable OPD fee
schedule amount. Because a payment offset is necessary in order to
provide an appropriate transitional pass-through payment, we deduct
from the pass-through payment for policy-packaged drugs, biologicals,
and radiopharmaceuticals an amount reflecting the portion of the APC
payment associated with predecessor products in order to ensure no
duplicate payment is made. This amount reflecting the portion of the
APC payment associated with predecessor products is called the payment
offset.
The payment offset policy applies to all policy-packaged drugs,
biologicals, and radiopharmaceuticals. For a full description of the
payment offset policy as applied to policy-packaged drugs, which
include diagnostic radiopharmaceuticals, contrast agents, stress
agents, and skin substitutes, we refer readers to the discussion in the
CY 2016 OPPS/ASC final rule with comment period (80 FR 70430 through
70432). For CY 2022, as we did in CY 2021, we propose to continue to
apply the same policy-packaged offset policy to payment for pass-
through diagnostic radiopharmaceuticals, pass-through contrast agents,
pass-through stress
[[Page 42127]]
agents, and pass-through skin substitutes. The proposed APCs to which a
payment offset may be applicable for pass-through diagnostic
radiopharmaceuticals, pass-through contrast agents, pass-through stress
agents, and pass-through skin substitutes are identified in Table 30.
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We propose to continue to post annually on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Annual-Policy-Files.html a file that contains the
APC offset amounts that will be used for that year for purposes of both
evaluating cost significance for candidate pass-through payment device
categories and drugs and biologicals and establishing any appropriate
APC offset amounts. Specifically, the file will continue to provide the
amounts and percentages of APC payment associated with packaged
implantable devices, policy-packaged drugs, and threshold packaged
drugs and biologicals for every OPPS clinical APC.
B. Proposed OPPS Payment for Drugs, Biologicals, and
Radiopharmaceuticals Without Pass-Through Payment Status
1. Proposed Criteria for Packaging Payment for Drugs, Biologicals, and
Radiopharmaceuticals
a. Proposed Packaging Threshold
In accordance with section 1833(t)(16)(B) of the Act, the threshold
for establishing separate APCs for
[[Page 42128]]
payment of drugs and biologicals was set to $50 per administration
during CYs 2005 and 2006. In CY 2007, we used the four quarter moving
average Producer Price Index (PPI) levels for Pharmaceutical
Preparations (Prescription) to trend the $50 threshold forward from the
third quarter of CY 2005 (when the Pub. L. 108-173 mandated threshold
became effective) to the third quarter of CY 2007. We then rounded the
resulting dollar amount to the nearest $5 increment in order to
determine the CY 2007 threshold amount of $55. Using the same
methodology as that used in CY 2007 (which is discussed in more detail
in the CY 2007 OPPS/ASC final rule with comment period (71 FR 68085
through 68086)), we set the packaging threshold for establishing
separate APCs for drugs and biologicals at $130 for CY 2021 (84 FR
61312 through 61313).
Following the CY 2007 methodology, for this CY 2022 OPPS/ASC
proposed rule, we used the most recently available four quarter moving
average PPI levels to trend the $50 threshold forward from the third
quarter of CY 2005 to the third quarter of CY 2022 and rounded the
resulting dollar amount ($132.44) to the nearest $5 increment, which
yielded a figure of $130. In performing this calculation, we used the
most recent forecast of the quarterly index levels for the PPI for
Pharmaceuticals for Human Use (Prescription) (Bureau of Labor
Statistics series code WPUSI07003) from CMS' Office of the Actuary. For
this CY 2022 OPPS/ASC proposed rule, based on these calculations using
the CY 2007 OPPS methodology, we propose a packaging threshold for CY
2022 of $130.
b. Proposed Packaging of Payment for HCPCS Codes That Describe Certain
Drugs, Certain Biologicals, and Therapeutic Radiopharmaceuticals Under
the Cost Threshold (``Threshold-Packaged Drugs'')
To determine the proposed CY 2022 packaging status for all nonpass-
through drugs and biologicals that are not policy packaged, we
calculated, on a HCPCS code-specific basis, the per day cost of all
drugs, biologicals, and therapeutic radiopharmaceuticals (collectively
called ``threshold-packaged'' drugs) that had a HCPCS code in CY 2019
and were paid (via packaged or separate payment) under the OPPS. We
used data from CY 2019 claims processed through June 30, 2020 for this
calculation. However, we did not perform this calculation for those
drugs and biologicals with multiple HCPCS codes that include different
dosages, as described in section V.B.1.d. of the proposed rule, or for
the following policy-packaged items that we propose to continue to
package in CY 2022: Anesthesia drugs; drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure; and drugs and biologicals that function
as supplies when used in a surgical procedure.
In order to calculate the per day costs for drugs, biologicals, and
therapeutic radiopharmaceuticals to determine their proposed packaging
status in CY 2022, we use the methodology that was described in detail
in the CY 2006 OPPS proposed rule (70 FR 42723 through 42724) and
finalized in the CY 2006 OPPS final rule with comment period (70 FR
68636 through 68638). For each drug and biological HCPCS code, we used
an estimated payment rate of ASP+6 percent (which is the payment rate
we propose for separately payable drugs and biologicals (other than
340B drugs) for CY 2022, as discussed in more detail in section
V.B.2.b. of the proposed rule) to calculate the CY 2022 proposed rule
per day costs. We used the manufacturer-submitted ASP data from the
fourth quarter of CY 2020 (data that were used for payment purposes in
the physician's office setting, effective April 1, 2021) to determine
the proposed rule per day cost. While the CY 2020 ASP data was
collected during the PHE, ASP data are not affected by changes in
utilization the way non-drug services are for setting payment rates,
and so we believe ASP data continues to be representative of the price
of drugs in the market. We have continued to use ASP data from CY 2020
to report quarterly drug rates for CY 2020 and CY 2021.
As is our standard methodology, for 2022, we propose to use payment
rates based on the ASP data from the fourth quarter of CY 2020 for
budget neutrality estimates, packaging determinations, impact analyses,
and completion of Addenda A and B to the proposed rule (which are
available via the internet on the CMS website) because these are the
most recent data available for use at the time of development of the
proposed rule. These data also were the basis for drug payments in the
physician's office setting, effective April 1, 2021. For items that did
not have an ASP-based payment rate, such as some therapeutic
radiopharmaceuticals, we used their mean unit cost derived from the CY
2019 hospital claims data to determine their per day cost.
We propose to package items with a per day cost less than or equal
to $130, and identify items with a per day cost greater than $130 as
separately payable unless they are policy-packaged. Consistent with our
past practice, we cross-walked historical OPPS claims data from the CY
2019 HCPCS codes that were reported to the CY 2021 HCPCS codes that we
display in Addendum B to this proposed rule (which is available via the
internet on the CMS website) for proposed payment in CY 2022.
Our policy during previous cycles of the OPPS has been to use
updated ASP and claims data to make final determinations of the
packaging status of HCPCS codes for drugs, biologicals, and therapeutic
radiopharmaceuticals for the OPPS/ASC final rule with comment period.
We note that it is also our policy to make an annual packaging
determination for a HCPCS code only when we develop the OPPS/ASC final
rule with comment period for the update year. Only HCPCS codes that are
identified as separately payable in the final rule with comment period
are subject to quarterly updates. For our calculation of per day costs
of HCPCS codes for drugs and biologicals in this CY 2022 OPPS/ASC
proposed rule, we proposed to use ASP data from the fourth quarter of
CY 2020, which is the basis for calculating payment rates for drugs and
biologicals in the physician's office setting using the ASP
methodology, effective April 1, 2021, along with updated hospital
claims data from CY 2019. We note that we also propose to use these
data for budget neutrality estimates and impact analyses for this CY
2022 OPPS/ASC proposed rule.
Payment rates for HCPCS codes for separately payable drugs and
biologicals included in Addenda A and B of the final rule with comment
period will be based on ASP data from the second quarter of CY 2021.
These data will be the basis for calculating payment rates for drugs
and biologicals in the physician's office setting using the ASP
methodology, effective October 1, 2021. These payment rates would then
be updated in the January 2022 OPPS update, based on the most recent
ASP data to be used for physicians' office and OPPS payment as of
January 1, 2022. For items that do not currently have an ASP-based
payment rate, we proposed to recalculate their mean unit cost from all
of the CY 2019 claims data and update cost report information available
for the CY 2022 final rule with comment period to determine their final
per day cost.
Consequently, the packaging status of some HCPCS codes for drugs,
biologicals, and therapeutic radiopharmaceuticals in the proposed rule
may be different from the same drugs' HCPCS codes' packaging status
[[Page 42129]]
determined based on the data used for the final rule with comment
period. Under such circumstances, we proposed to continue to follow the
established policies initially adopted for the CY 2005 OPPS (69 FR
65780) in order to more equitably pay for those drugs whose costs
fluctuate relative to the proposed CY 2022 OPPS drug packaging
threshold and the drug's payment status (packaged or separately
payable) in CY 2021. These established policies have not changed for
many years and are the same as described in the CY 2016 OPPS/ASC final
rule with comment period (80 FR 70434). Specifically, for CY 2022,
consistent with our historical practice, we proposed to apply the
following policies to these HCPCS codes for drugs, biologicals, and
therapeutic radiopharmaceuticals whose relationship to the drug
packaging threshold changes based on the updated drug packaging
threshold and on the final updated data:
HCPCS codes for drugs and biologicals that were paid
separately in CY 2021 and that are proposed for separate payment in CY
2022, and that then have per day costs equal to or less than the CY
2022 final rule drug packaging threshold, based on the updated ASPs and
hospital claims data used for the CY 2022 final rule, would continue to
receive separate payment in CY 2022.
HCPCS codes for drugs and biologicals that were packaged
in CY 2021 and that are proposed for separate payment in CY 2022, and
that then have per day costs equal to or less than the CY 2022 final
rule drug packaging threshold, based on the updated ASPs and hospital
claims data used for the CY 2022 final rule, would remain packaged in
CY 2022.
HCPCS codes for drugs and biologicals for which we
proposed packaged payment in CY 2022 but that then have per-day costs
greater than the CY 2022 final rule drug packaging threshold, based on
the updated ASPs and hospital claims data used for the CY 2022 final
rule, would receive separate payment in CY 2022.
c. Policy-Packaged Drugs, Biologicals, and Radiopharmaceuticals
As mentioned earlier in this section, under the OPPS, we package
several categories of nonpass-through drugs, biologicals, and
radiopharmaceuticals, regardless of the cost of the products. Because
the products are packaged according to the policies in 42 CFR 419.2(b),
we refer to these packaged drugs, biologicals, and radiopharmaceuticals
as ``policy-packaged'' drugs, biologicals, and radiopharmaceuticals.
These policies are either longstanding or based on longstanding
principles and inherent to the OPPS and are as follows:
Anesthesia, certain drugs, biologicals, and other
pharmaceuticals; medical and surgical supplies and equipment; surgical
dressings; and devices used for external reduction of fractures and
dislocations (Sec. 419.2(b)(4));
Intraoperative items and services (Sec. 419.2(b)(14));
Drugs, biologicals, and radiopharmaceuticals that function
as supplies when used in a diagnostic test or procedure (including, but
not limited to, diagnostic radiopharmaceuticals, contrast agents, and
pharmacologic stress agents) (Sec. 419.2(b)(15)); and
Drugs and biologicals that function as supplies when used
in a surgical procedure (including, but not limited to, skin
substitutes and similar products that aid wound healing and implantable
biologicals) (Sec. 419.2(b)(16)).
The policy at Sec. 419.2(b)(16) is broader than that at Sec.
419.2(b)(14). As we stated in the CY 2015 OPPS/ASC final rule with
comment period: ``We consider all items related to the surgical outcome
and provided during the hospital stay in which the surgery is
performed, including postsurgical pain management drugs, to be part of
the surgery for purposes of our drug and biological surgical supply
packaging policy'' (79 FR 66875). The category described by Sec.
419.2(b)(15) is large and includes diagnostic radiopharmaceuticals,
contrast agents, stress agents, and some other products. The category
described by Sec. 419.2(b)(16) includes skin substitutes and some
other products. We believe it is important to reiterate that cost
consideration is not a factor when determining whether an item is a
surgical supply (79 FR 66875).
d. Packaging Determination for HCPCS Codes That Describe the Same Drug
or Biological But Different Dosages
In the CY 2010 OPPS/ASC final rule with comment period (74 FR 60490
through 60491), we finalized a policy to make a single packaging
determination for a drug, rather than an individual HCPCS code, when a
drug has multiple HCPCS codes describing different dosages because we
believe that adopting the standard HCPCS code-specific packaging
determinations for these codes could lead to inappropriate payment
incentives for hospitals to report certain HCPCS codes instead of
others. We continue to believe that making packaging determinations on
a drug-specific basis eliminates payment incentives for hospitals to
report certain HCPCS codes for drugs and allows hospitals flexibility
in choosing to report all HCPCS codes for different dosages of the same
drug or only the lowest dosage HCPCS code. Therefore, we propose to
continue our policy to make packaging determinations on a drug-specific
basis, rather than a HCPCS code-specific basis, for those HCPCS codes
that describe the same drug or biological but different dosages in CY
2022.
For CY 2022, in order to propose a packaging determination that is
consistent across all HCPCS codes that describe different dosages of
the same drug or biological, we aggregated both our CY 2019 claims data
and our pricing information at ASP+6 percent across all of the HCPCS
codes that describe each distinct drug or biological in order to
determine the mean units per day of the drug or biological in terms of
the HCPCS code with the lowest dosage descriptor. The following drugs
did not have pricing information available for the ASP methodology for
this CY 2022 OPPS/ASC proposed rule, and as is our current policy for
determining the packaging status of other drugs, we used the mean unit
cost available from the CY 2019 claims data to make the proposed
packaging determinations for these drugs: HCPCS code C9257 (Injection,
bevacizumab, 0.25 mg); HCPCS code J1840 (Injection, kanamycin sulfate,
up to 500 mg); HCPCS code J1850 (Injection, kanamycin sulfate, up to 75
mg); HCPCS code J3472 (Injection, hyaluronidase, ovine, preservative
free, per 1000 usp units); HCPCS code J7100 (Infusion, dextran 40, 500
ml); and HCPCS code J7110 (Infusion, dextran 75, 500 ml).
For all other drugs and biologicals that have HCPCS codes
describing different doses, we then multiplied the proposed weighted
average ASP+6 percent per unit payment amount across all dosage levels
of a specific drug or biological by the estimated units per day for all
HCPCS codes that describe each drug or biological from our claims data
to determine the estimated per day cost of each drug or biological at
less than or equal to the proposed CY 2022 drug packaging threshold of
$130 (so that all HCPCS codes for the same drug or biological would be
packaged) or greater than the proposed CY 2022 drug packaging threshold
of $130 (so that all HCPCS codes for the same drug or biological would
be separately payable). The proposed packaging status of each drug and
biological HCPCS code to which this methodology would apply in CY 2022
is displayed in Table 31.
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2. Payment for Drugs and Biologicals Without Pass-Through Status That
Are Not Packaged
a. Payment for Specified Covered Outpatient Drugs (SCODs) and Other
Separately Payable Drugs and Biologicals
Section 1833(t)(14) of the Act defines certain separately payable
radiopharmaceuticals, drugs, and biologicals and mandates specific
payments for these items. Under section 1833(t)(14)(B)(i) of the Act, a
``specified covered outpatient drug'' (known as a SCOD) is defined as a
covered outpatient drug, as defined in section 1927(k)(2) of the Act,
for which a separate APC has been established and that either is a
radiopharmaceutical agent or is a drug or biological for which payment
was made on a pass-through basis on or before December 31, 2002.
Under section 1833(t)(14)(B)(ii) of the Act, certain drugs and
biologicals are designated as exceptions and are not included in the
definition of SCODs. These exceptions are--
A drug or biological for which payment is first made on or
after January 1, 2003, under the transitional pass-through payment
provision in section 1833(t)(6) of the Act.
A drug or biological for which a temporary HCPCS code has
not been assigned.
During CYs 2004 and 2005, an orphan drug (as designated by
the Secretary).
Section 1833(t)(14)(A)(iii) of the Act requires that payment for
SCODs in CY 2006 and subsequent years be equal to the average
acquisition cost for the drug for that year as determined by the
Secretary, subject to any adjustment for overhead costs and taking into
account the hospital acquisition cost survey data collected by the
Government Accountability Office (GAO) in CYs 2004 and 2005, and later
periodic surveys conducted by the Secretary as set forth in the
statute. If hospital acquisition cost data are not available, the law
requires that payment be equal to payment rates established under the
methodology described in section 1842(o), section 1847A, or section
1847B of the Act, as calculated and adjusted by the Secretary as
necessary for purposes of paragraph (14). We refer to this alternative
methodology as the ``statutory default.'' Most physician Part B drugs
are paid at ASP+6 percent in accordance with section 1842(o) and
section 1847A of the Act.
Section 1833(t)(14)(E)(ii) of the Act provides for an adjustment in
OPPS payment rates for SCODs to take into account overhead and related
expenses, such as pharmacy services and handling costs. Section
1833(t)(14)(E)(i) of the Act required MedPAC to study pharmacy overhead
and related expenses and to make recommendations to the Secretary
regarding whether, and if so how, a payment adjustment should be made
to compensate hospitals for overhead and related expenses. Section
1833(t)(14)(E)(ii) of the Act authorizes the Secretary to adjust the
weights for ambulatory procedure classifications for SCODs to take into
account the findings of the MedPAC study.\94\
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\94\ Medicare Payment Advisory Committee. June 2005 Report to
the Congress. Chapter 6: Payment for pharmacy handling costs in
hospital outpatient departments. Available at: http://www.medpac.gov/docs/default-source/reports/June05_ch6.pdf?sfvrsn=0.
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It has been our policy since CY 2006 to apply the same treatment to
all separately payable drugs and biologicals, which include SCODs, and
drugs and biologicals that are not SCODs. Therefore, we apply the
payment methodology in section 1833(t)(14)(A)(iii) of the Act to SCODs,
as required by statute, but we also apply it to separately payable
drugs and biologicals that are not SCODs, which is a policy
determination rather than a statutory requirement. In this CY 2022
OPPS/ASC proposed rule, we proposed to apply section
1833(t)(14)(A)(iii)(II) of the Act to all separately payable drugs and
biologicals, including SCODs. Although we do not distinguish SCODs in
this discussion, we note that we are required to apply section
1833(t)(14)(A)(iii)(II) of the Act to
[[Page 42132]]
SCODs, but we also are applying this provision to other separately
payable drugs and biologicals, consistent with our history of using the
same payment methodology for all separately payable drugs and
biologicals.
For a detailed discussion of our OPPS drug payment policies from CY
2006 to CY 2012, we refer readers to the CY 2013 OPPS/ASC final rule
with comment period (77 FR 68383 through 68385). In the CY 2013 OPPS/
ASC final rule with comment period (77 FR 68386 through 68389), we
first adopted the statutory default policy to pay for separately
payable drugs and biologicals at ASP+6 percent based on section
1833(t)(14)(A)(iii)(II) of the Act. We have continued this policy of
paying for separately payable drugs and biologicals at the statutory
default for CYs 2014 through 2021.
b. Proposed CY 2022 Payment Policy
For 2022, we propose to continue our payment policy that has been
in effect since CY 2013 to pay for separately payable drugs and
biologicals, with the exception of 340B-acquired drugs, at ASP+6
percent in accordance with section 1833(t)(14)(A)(iii)(II) of the Act
(the statutory default). We propose to pay for separately payable
nonpass-through drugs acquired with a 340B discount at a rate of ASP
minus 22.5 percent (as described in section V.B.6). We refer readers to
the CY 2018 OPPS/ASC final rule with comment period (82 FR 59353
through 59371), and the CY 2021 OPPS/ASC final rule with comment period
(85 FR 86042 through 86055) for more information about our current
payment policy for drugs and biologicals acquired with a 340B discount.
In the case of a drug or biological during an initial sales period
in which data on the prices for sales of the drug or biological are not
sufficiently available from the manufacturer, section 1847A(c)(4) of
the Act permits the Secretary to make payments that are based on WAC.
Under section 1833(t)(14)(A)(iii)(II) of the Act, the amount of payment
for a separately payable drug equals the average price for the drug for
the year established under, among other authorities, section 1847A of
the Act. As explained in greater detail in the CY 2019 PFS final rule,
under section 1847A(c)(4) of the Act, although payments may be based on
WAC, unlike section 1847A(b) of the Act (which specifies that payments
using ASP or WAC must be made with a 6 percent add-on), section
1847A(c)(4) of the Act does not require that a particular add-on amount
be applied to WAC-based pricing for this initial period when ASP data
is not available. Consistent with section 1847A(c)(4) of the Act, in
the CY 2019 PFS final rule (83 FR 59661 to 59666), we finalized a
policy that, effective January 1, 2019, WAC-based payments for Part B
drugs made under section 1847A(c)(4) of the Act will utilize a 3-
percent add-on in place of the 6-percent add-on that was being used
according to our policy in effect as of CY 2018. For the CY 2019 OPPS,
we followed the same policy finalized in the CY 2019 PFS final rule (83
FR 59661 to 59666). For CYs 2020 and 2021, we adopted a policy to
utilize a 3-percent add-on instead of a 6-percent add-on for drugs that
are paid based on WAC under section 1847A(c)(4) of the Act pursuant to
our authority under section 1833(t)(14)(A)(iii)(II) (84 FR 61318 and 85
FR 86039). For 2022, we propose to continue to utilize a 3-percent add-
on instead of a 6-percent add-on for drugs that are paid based on WAC
pursuant to our authority under section 1833(t)(14)(A)(iii)(II) of the
Act, which provides, in part, that the amount of payment for a SCOD is
the average price of the drug in the year established under section
1847A of the Act. We also propose to apply this provision to non-SCOD
separately payable drugs. Because we propose to establish the average
price for a drug paid based on WAC under section 1847A of the Act as
WAC+3 percent instead of WAC+6 percent, we believe it is appropriate to
price separately payable drugs paid based on WAC at the same amount
under the OPPS. We propose that, if finalized, our proposal to pay for
drugs or biologicals at WAC+3 percent, rather than WAC+6 percent, would
apply whenever WAC-based pricing is used for a drug or biological under
1847A(c)(4). For drugs and biologicals that would otherwise be subject
to a payment reduction because they were acquired under the 340B
Program, the payment amount for these drugs (proposed as a rate of WAC
minus 22.5 percent) would continue to apply. We refer readers to the CY
2019 PFS final rule (83 FR 59661 to 59666) for additional background on
this policy.
We propose that payments for separately payable drugs and
biologicals would be included in the budget neutrality adjustments,
under the requirements in section 1833(t)(9)(B) of the Act. We also
propose that the budget neutral weight scalar would not be applied in
determining payments for these separately payable drugs and
biologicals.
We note that separately payable drug and biological payment rates
listed in Addenda A and B to this proposed rule (available via the
internet on the CMS website), which illustrate the proposed CY 2022
payment of ASP+6 percent for separately payable nonpass-through drugs
and biologicals and ASP+6 percent for pass-through drugs and
biologicals, reflect either ASP information that is the basis for
calculating payment rates for drugs and biologicals in the physician's
office setting effective April 1, 2021, or WAC, AWP, or mean unit cost
from CY 2019 claims data and updated cost report information available
for this proposed rule. In general, these published payment rates are
not the same as the actual January 2022 payment rates. This is because
payment rates for drugs and biologicals with ASP information for
January 2022 will be determined through the standard quarterly process
where ASP data submitted by manufacturers for the third quarter of CY
2021 (July 1, 2021 through September 30, 2021) will be used to set the
payment rates that are released for the quarter beginning in January
2022 near the end of December 2021. In addition, payment rates for
drugs and biologicals in Addenda A and B to the proposed rule for which
there was no ASP information available for April 2021 are based on mean
unit cost in the available CY 2019 claims data. If ASP information
becomes available for payment for the quarter beginning in January
2022, we will price payment for these drugs and biologicals based on
their newly available ASP information. Finally, there may be drugs and
biologicals that have ASP information available for the proposed rule
(reflecting April 2021 ASP data) that do not have ASP information
available for the quarter beginning in January 2022. These drugs and
biologicals would then be paid based on mean unit cost data derived
from CY 2019 hospital claims. Therefore, the proposed payment rates
listed in Addenda A and B to the proposed rule are not for January 2022
payment purposes and are only illustrative of the CY 2022 OPPS payment
methodology using the most recently available information at the time
of issuance of the proposed rule.
c. Biosimilar Biological Products
For CY 2016 and CY 2017, we finalized a policy to pay for
biosimilar biological products based on the payment allowance of the
product as determined under section 1847A of the Act and to subject
nonpass-through biosimilar biological products to our annual threshold-
packaged policy (for CY 2016, 80 FR 70445 through 70446; and for CY
2017, 81 FR 79674). In the CY 2018 OPPS/ASC proposed rule (82
[[Page 42133]]
FR 33630), for CY 2018, we proposed to continue this same payment
policy for biosimilar biological products.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59351), we noted that, with respect to comments we received regarding
OPPS payment for biosimilar biological products, in the CY 2018 PFS
final rule, CMS finalized a policy to implement separate HCPCS codes
for biosimilar biological products. Therefore, consistent with our
established OPPS drug, biological, and radiopharmaceutical payment
policy, HCPCS coding for biosimilar biological products is based on the
policy established under the CY 2018 PFS final rule.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59351), after consideration of the public comments we received, we
finalized our proposed payment policy for biosimilar biological
products, with the following technical correction: All biosimilar
biological products are eligible for pass-through payment and not just
the first biosimilar biological product for a reference product. In the
CY 2019 OPPS/ASC proposed rule (83 FR 37123), for CY 2019, we proposed
to continue the policy in place from CY 2018 to make all biosimilar
biological products eligible for pass-through payment and not just the
first biosimilar biological product for a reference product.
In addition, in CY 2018, we adopted a policy that biosimilars
without pass-through payment status that were acquired under the 340B
Program would be paid the ASP of the biosimilar minus 22.5 percent of
the reference product's ASP (82 FR 59367). We adopted this policy in
the CY 2018 OPPS/ASC final rule with comment period because we believe
that biosimilars without pass-through payment status acquired under the
340B Program should be treated in the same manner as other drugs and
biologicals acquired through the 340B Program. As noted earlier,
biosimilars with pass-through payment status are paid their own ASP+6
percent of the reference product's ASP. Separately payable biosimilars
that do not have pass-through payment status and are not acquired under
the 340B Program are also paid their own ASP plus 6 percent of the
reference product's ASP. If a biosimilar does not have ASP pricing, but
instead has WAC pricing, the WAC pricing add-on of either 3 percent or
6 percent is calculated from the biosimilar's WAC and is not calculated
from the WAC price of the reference product.
As noted in the CY 2019 OPPS/ASC proposed rule (83 FR 37123),
several stakeholders raised concerns to us that the payment policy for
biosimilars acquired under the 340B Program could unfairly lower the
OPPS payment for biosimilars not on pass-through payment status because
the payment reduction would be based on the reference product's ASP,
which would generally be expected to be priced higher than the
biosimilar, thus resulting in a more significant reduction in payment
than if the 22.5 percent was calculated based on the biosimilar's ASP.
We agreed with stakeholders that the current payment policy could
unfairly lower the price of biosimilars without pass-through payment
status that are acquired under the 340B Program. In addition, we noted
that we believed that these changes would better reflect the resources
and production costs that biosimilar manufacturers incur. We also
stated that we believe this approach is more consistent with the
payment methodology for 340B-acquired drugs and biologicals, for which
the 22.5 percent reduction is calculated based on the drug or
biological's ASP, rather than the ASP of another product. In addition,
we explained that we believed that paying for biosimilars acquired
under the 340B Program at ASP minus 22.5 percent of the biosimilar's
ASP, rather than 22.5 percent of the reference product's ASP, will more
closely approximate hospitals' acquisition costs for these products.
Accordingly, in the CY 2019 OPPS/ASC proposed rule (83 FR 37123),
we proposed changes to our Medicare Part B drug payment methodology for
biosimilars acquired under the 340B Program. Specifically, for CY 2019
and subsequent years, in accordance with section
1833(t)(14)(A)(iii)(II) of the Act, we proposed to pay nonpass-through
biosimilars acquired under the 340B Program at ASP minus 22.5 percent
of the biosimilar's ASP instead of the biosimilar's ASP minus 22.5
percent of the reference product's ASP. This proposal was finalized
without modification in the CY 2019 OPPS/ASC final rule with comment
period (83 FR 58977).
For 2022, we propose to continue our policy to make all biosimilar
biological products eligible for pass-through payment and not just the
first biosimilar biological product for a reference product. We also
propose to continue our current policy of paying for nonpass-through
biosimilars acquired under the 340B program at the biosimilar's ASP
minus 22.5 percent of the biosimilar's ASP instead of the biosimilar's
ASP minus 22.5 percent of the reference product's ASP, in accordance
with section 1833(t)(14)(A)(iii)(II) of the Act.
3. Payment Policy for Therapeutic Radiopharmaceuticals
For CY 2022, we propose to continue the payment policy for
therapeutic radiopharmaceuticals that began in CY 2010. We pay for
separately payable therapeutic radiopharmaceuticals under the ASP
methodology adopted for separately payable drugs and biologicals. If
ASP information is unavailable for a therapeutic radiopharmaceutical,
we base therapeutic radiopharmaceutical payment on mean unit cost data
derived from hospital claims. We believe that the rationale outlined in
the CY 2010 OPPS/ASC final rule with comment period (74 FR 60524
through 60525) for applying the principles of separately payable drug
pricing to therapeutic radiopharmaceuticals continues to be appropriate
for nonpass-through, separately payable therapeutic
radiopharmaceuticals in CY 2022. Therefore, we propose for CY 2022 to
pay all nonpass-through, separately payable therapeutic
radiopharmaceuticals at ASP+6 percent, based on the statutory default
described in section 1833(t)(14)(A)(iii)(II) of the Act. For a full
discussion of ASP-based payment for therapeutic radiopharmaceuticals,
we refer readers to the CY 2010 OPPS/ASC final rule with comment period
(74 FR 60520 through 60521). We also propose to rely on CY 2019 mean
unit cost data derived from hospital claims data for payment rates for
therapeutic radiopharmaceuticals for which ASP data are unavailable and
to update the payment rates for separately payable therapeutic
radiopharmaceuticals according to our usual process for updating the
payment rates for separately payable drugs and biologicals on a
quarterly basis if updated ASP information is unavailable. For a
complete history of the OPPS payment policy for therapeutic
radiopharmaceuticals, we refer readers to the CY 2005 OPPS final rule
with comment period (69 FR 65811), the CY 2006 OPPS final rule with
comment period (70 FR 68655), and the CY 2010 OPPS/ASC final rule with
comment period (74 FR 60524). The proposed CY 2022 payment rates for
nonpass-through, separately payable therapeutic radiopharmaceuticals
are included in Addenda A and B to this proposed rule (which are
available via the internet on the CMS website).
[[Page 42134]]
4. Payment for Blood Clotting Factors
For CY 2021, we provided payment for blood clotting factors under
the same methodology as other nonpass-through separately payable drugs
and biologicals under the OPPS and continued paying an updated
furnishing fee (85 FR 86041). That is, for CY 2021, we provided payment
for blood clotting factors under the OPPS at ASP+6 percent, plus an
additional payment for the furnishing fee. We note that when blood
clotting factors are provided in physicians' offices under Medicare
Part B and in other Medicare settings, a furnishing fee is also applied
to the payment. The CY 2021 updated furnishing fee was $0.238 per unit.
For 2022, we propose to pay for blood clotting factors at ASP+6
percent, consistent with our proposed payment policy for other nonpass-
through, separately payable drugs and biologicals, and to continue our
policy for payment of the furnishing fee using an updated amount. Our
policy to pay a furnishing fee for blood clotting factors under the
OPPS is consistent with the methodology applied in the physician's
office and in the inpatient hospital setting. These methodologies were
first articulated in the CY 2006 OPPS final rule with comment period
(70 FR 68661) and later discussed in the CY 2008 OPPS/ASC final rule
with comment period (72 FR 66765). The proposed furnishing fee update
is based on the percentage increase in the Consumer Price Index (CPI)
for medical care for the 12-month period ending with June of the
previous year. Because the Bureau of Labor Statistics releases the
applicable CPI data after the PFS and OPPS/ASC proposed rules are
published, we are not able to include the actual updated furnishing fee
in the proposed rules. Therefore, in accordance with our policy, as
finalized in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66765), we propose to announce the actual figure for the percent change
in the applicable CPI and the updated furnishing fee calculated based
on that figure through applicable program instructions and posting on
our website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/index.html.
We propose to provide payment for blood clotting factors under the
same methodology as other separately payable drugs and biologicals
under the OPPS and to continue payment of an updated furnishing fee. We
will announce the actual figure of the percent change in the applicable
CPI and the updated furnishing fee calculation based on that figure
through the applicable program instructions and posting on the CMS
website.
5. Payment for Nonpass-Through Drugs, Biologicals, and
Radiopharmaceuticals With HCPCS Codes But Without OPPS Hospital Claims
Data
For CY 2022, we propose to continue to use the same payment policy
as in CY 2021 for nonpass-through drugs, biologicals, and
radiopharmaceuticals with HCPCS codes but without OPPS hospital claims
data, which describes how we determine the payment rate for drugs,
biologicals, or radiopharmaceuticals without an ASP. For a detailed
discussion of the payment policy and methodology, we refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70442
through 70443). The proposed CY 2022 payment status of each of the
nonpass-through drugs, biologicals, and radiopharmaceuticals with HCPCS
codes but without OPPS hospital claims data is listed in Addendum B to
this proposed rule, which is available via the internet on the CMS
website.
6. CY 2022 OPPS Payment Methodology for 340B Purchased Drugs
a. Overview and Background
Under the OPPS, payment rates for drugs are typically based on
their average acquisition cost. This payment is governed by section
1847A of the Act, which generally sets a default rate of average sales
price (ASP) plus 6 percent for certain drugs; however, the Secretary
has statutory authority to adjust that rate under the OPPS. As
described below, beginning in CY 2018, the Secretary adjusted the 340B
drug payment rate to ASP minus 22.5 percent to approximate a minimum
average discount for 340B drugs, which was based on findings of the GAO
and MedPAC that hospitals were acquiring drugs at a significant
discount under HRSA's 340B Drug Pricing Program. As described in the
following sections, in December 2018, the United States District Court
for the District of Columbia (the district court) concluded that the
Secretary lacks the authority to bring the default rate in line with
average acquisition cost unless the Secretary obtains survey data from
hospitals on their acquisition costs. On July 10, 2019, the district
court entered final judgment. The agency appealed to the United States
Court of Appeals for the District of Columbia Circuit (hereinafter
referred to as ``the D.C. Circuit''), and on July 31, 2020 the court
entered an opinion reversing the district court's judgment in this
matter. Following the D.C. Circuit's reversal of the lower's court
decision, appellees' petition for panel rehearing and petition for
rehearing en banc were denied on October 16, 2020. For CY 2021, CMS
continued its policy of paying for drugs and biologicals acquired
through the 340B Program at ASP minus 22.5 percent.
On January 10, 2021, the appellees filed a petition for a writ of
certiorari in the United States Supreme Court. On July 2, 2021, the
Supreme Court granted their petition for a writ of certiorari, and
directed the parties to argue whether the petitioners' suit challenging
HHS's 340B drugs payment adjustment is precluded by section 1833(t)
(12).\95\
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\95\ https://www.supremecourt.gov/orders/courtorders/070221zor_4gc5.pdf. Accessed July 8, 2021.
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Background
In the CY 2018 OPPS/ASC proposed rule (82 FR 33558 through 33724),
we proposed changes to the OPPS payment methodology for drugs and
biologicals (hereinafter referred to collectively as ``drugs'')
acquired under the 340B Program. We proposed these changes to better,
and more accurately, reflect the resources and acquisition costs that
these hospitals incur. We stated our belief that such changes would
allow Medicare beneficiaries (and the Medicare program) to pay a more
appropriate amount when hospitals participating in the 340B Program
furnish drugs to Medicare beneficiaries that are purchased under the
340B Program. Subsequently, in the CY 2018 OPPS/ASC final rule with
comment period (82 FR 59369 through 59370), we finalized our proposal
and adjusted the payment rate for separately payable drugs and
biologicals (other than drugs with pass-through payment status and
vaccines) acquired under the 340B Program from average sales price
(ASP) plus 6 percent to ASP minus 22.5 percent. We stated that our goal
was to make Medicare payment for separately payable drugs more aligned
with the resources expended by hospitals to acquire such drugs, while
recognizing the intent of the 340B Program to allow covered entities,
including eligible hospitals, to stretch scarce resources in ways that
enable hospitals to continue providing access to care for Medicare
beneficiaries and other patients. Congress created the 340B Drug
Pricing Program so that the eligible entities, safety net providers,
identified in statute, could stretch scarce Federal resources as far as
possible, reaching more eligible patients and providing more
comprehensive services. By
[[Page 42135]]
design, the 340B Program increases the resources available to these
safety net providers by providing discounts on covered outpatient drugs
that generate savings that can be used to support patient care or other
services. When the program was created, there was an understanding that
many of the patients seen by these safety net providers were Medicare
and Medicaid beneficiaries. This rule aims to fulfill the goals of
different Federal programs, each of which helps ensure access to care
for vulnerable populations. Critical access hospitals are not paid
under the OPPS, and therefore are not subject to the OPPS payment
policy for 340B-acquired drugs. We also excepted rural sole community
hospitals, children's hospitals, and PPS-exempt cancer hospitals from
the 340B payment adjustment in CY 2018. In addition, as stated in the
CY 2018 OPPS/ASC final rule with comment period, this policy change
does not apply to drugs with pass-through payment status, which are
required to be paid based on the ASP methodology, or vaccines, which
are excluded from the 340B Program.
In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79699
through 79706), we implemented section 603 of the Bipartisan Budget Act
of 2015. As a general matter, applicable items and services furnished
in certain off-campus outpatient departments of a provider on or after
January 1, 2017 are not considered covered outpatient services for
purposes of payment under the OPPS and are paid ``under the applicable
payment system,'' which is generally the Physician Fee Schedule (PFS).
However, consistent with our policy to pay separately payable, covered
outpatient drugs and biologicals acquired under the 340B Program at ASP
minus 22.5 percent, rather than ASP+6 percent, when billed by a
hospital paid under the OPPS that is not excepted from the payment
adjustment, in the CY 2019 OPPS/ASC final rule with comment period (83
FR 59015 through 59022), we finalized a policy to pay ASP minus 22.5
percent for 340B-acquired drugs and biologicals furnished in non-
excepted off-campus PBDs paid under the PFS. We adopted this payment
policy effective for CY 2019 and subsequent years.
We clarified in the CY 2019 OPPS/ASC proposed rule (83 FR 37125)
that the 340B payment adjustment applies to drugs that are priced using
either WAC or AWP, and that it has been our policy to subject 340B-
acquired drugs that use these pricing methodologies to the 340B payment
adjustment since the policy was first adopted. The 340B payment
adjustment for WAC-priced drugs is WAC minus 22.5 percent. 340B-
acquired drugs that are priced using AWP are paid an adjusted amount of
69.46 percent of AWP. The 69.46 percent of AWP is calculated by first
reducing the original 95 percent of AWP price by 6 percent to generate
a value that is similar to ASP or WAC with no percentage markup. Then
we apply the 22.5 percent reduction to ASP/WAC-similar AWP value to
obtain the 69.46 percent of AWP, which is similar to either ASP minus
22.5 percent or WAC minus 22.5 percent.
As discussed in the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59369 through 59370), to effectuate the payment adjustment for
340B-acquired drugs, we implemented modifier ``JG'', effective January
1, 2018. Hospitals paid under the OPPS, other than a type of hospital
excluded from the OPPS (such as critical access hospitals), or excepted
from the 340B drug payment policy for CY 2018, were required to report
modifier ``JG'' on the same claim line as the drug HCPCS code to
identify a 340B-acquired drug. For CY 2018, rural sole community
hospitals, children's hospitals and PPS-exempt cancer hospitals were
excepted from the 340B payment adjustment. These hospitals were
required to report informational modifier ``TB'' for 340B-acquired
drugs, and continue to be paid ASP+6 percent. We refer readers to the
CY 2018 OPPS/ASC final rule with comment period (82 FR 59353 through
59370) for a full discussion and rationale for the CY 2018 policies and
use of modifiers ``JG'' and ``TB''.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR
58981), we continued the Medicare 340B payment policies that were
implemented in CY 2018 and adopted a policy to pay for nonpass-through
340B-acquired biosimilars at ASP minus 22.5 percent of the biosimilar's
ASP, rather than of the reference product's ASP. In the CY 2020 OPPS/
ASC final rule with comment period (84 FR 61321), we continued the 340B
policies that were implemented in CY 2018 and CY 2019.
Our CY 2018 and 2019 OPPS payment policies for 340B-acquired drugs
have been the subject of ongoing litigation. On December 27, 2018, in
the case of American Hospital Association, et al. v. Azar, et al., the
district court concluded in the context of reimbursement requests for
CY 2018 that the Secretary exceeded his statutory authority by
adjusting the Medicare payment rates for drugs acquired under the 340B
Program to ASP minus 22.5 percent for that year.\96\ In that same
decision, the district court recognized the `` `havoc that piecemeal
review of OPPS payment could bring about' in light of the budget
neutrality requirement,'' and ordered supplemental briefing on the
appropriate remedy.\97\ On May 6, 2019, after briefing on remedy, the
district court issued an opinion that reiterated that the 2018 rate
reduction exceeded the Secretary's authority, and declared that the
rate reduction for 2019 (which had been finalized since the Court's
initial order was entered) also exceeded his authority.\98\ Rather than
ordering HHS to pay plaintiffs their alleged underpayments, however,
the district court recognized that crafting a remedy is ``no easy task,
given Medicare's complexity,'' \99\ and initially remanded the issue to
HHS to devise an appropriate remedy while also retaining jurisdiction.
The district court acknowledged that ``if the Secretary were to
retroactively raise the 2018 and 2019 340B rates, budget neutrality
would require him to retroactively lower the 2018 and 2019 rates for
other Medicare Part B products and services.'' \100\ Id. at 19. ``And
because HHS has already processed claims under the previous rates, the
Secretary would potentially be required to recoup certain payments made
to providers; an expensive and time-consuming prospect.'' \101\
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\96\ American Hosp. Ass'n, et al. v. Azar, et al., No. 1:18-cv-
2084 (D.D.C. Dec. 27, 2018).
\97\ Id. at 35 (quoting Amgen, Inc. v. Smith, 357 F.3d 103, 112
(D.C. Cir. 2004) (citations omitted)).
\98\ See May 6, 2019 Memorandum Opinion, Granting in Part
Plaintiffs' Motion for a Permanent Injunction; Remanding the 2018
and 2019 OPPS Rules to HHS at 10-12.
\99\ Id. at 13.
\100\ Id. at 19.
\101\ Id. (citing Declaration of Elizabeth Richter).
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We respectfully disagreed with the district court's understanding
of the scope of the Secretary's adjustment authority. On July 10, 2019,
the district court entered final judgment. The agency appealed to the
United States Court of Appeals for the District of Columbia Circuit,
(hereinafter referred to as ``the D.C. Circuit''), and on July 31, 2020
the court entered an opinion reversing the district court's judgment in
this matter. Following the D.C. Circuit's decision, appellees' petition
for panel rehearing and petition for rehearing en banc were denied on
October 16, 2020. On January of 2021, appellees petitioned the United
States Supreme Court for a writ of certiorari. On July 2, 2021, the
Court granted the petition.
Before the D.C. Circuit upheld our authority to pay ASP minus 22.5
[[Page 42136]]
percent, we stated in the CY 2020 OPPS/ASC final rule with comment
period that we were taking the steps necessary to craft an appropriate
remedy in the event of an unfavorable decision on appeal. Notably,
after the CY 2020 OPPS/ASC proposed rule was issued, we announced in
the Federal Register (84 FR 51590) our intent to conduct a 340B
hospital survey to collect drug acquisition cost data for certain
quarters in CY 2018 and 2019. We stated that such survey data may be
used in setting the Medicare payment amount for drugs acquired by 340B
hospitals for cost years going forward, and also may be used to devise
a remedy for prior years if the district court's ruling was upheld on
appeal. The district court itself acknowledged that CMS may base the
Medicare payment amount on average acquisition cost when survey data
are available.\102\ No 340B hospital disputed in the rulemakings for CY
2018 and 2019 that the ASP minus 22.5 percent formula was a
conservative adjustment that represented the minimum discount that
hospitals receive for drugs acquired through the 340B program, which is
significant because 340B hospitals have internal data regarding their
own drug acquisition costs. We stated in the CY 2020 OPPS/ASC final
rule with comment period that we thus anticipated that survey data
collected for CY 2018 and 2019 would confirm that the ASP minus 22.5
percent rate is a conservative amount that overcompensates covered
entity hospitals for drugs acquired under the 340B program. We also
explained that a remedy that relies on such survey data could avoid the
complexities referenced in the district court's opinion. For a complete
discussion of the Hospital Acquisition Cost Survey for 340B-Acquired
Specified Covered Outpatient Drugs, we refer readers to the CY 2021
OPPS/ASC Proposed Rule (85 FR 48882 through 48891) and the CY 2021
OPPS/ASC Final Rule with comment period (85 FR 86042 through 86055).
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\102\ See American Hosp. Assoc. v. Azar, 348 F. Supp. 3d 62, 82
(D.D.C. 2018).
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We proposed a payment rate for 340B drugs of ASP minus 28.7 percent
based on survey data, and also proposed in the alternative that the
agency could continue its current policy of paying ASP minus 22.5
percent for CY 2021. We explained that we adopted the OPPS 340B payment
policy based on the average minimum discount for 340B-acquired drugs
being approximately ASP minus 22.5 percent. The estimated discount was
based on a MedPAC analysis identifying 22.5 percent as a conservative
minimum discount that 340B entities receive when they purchase drugs
under the 340B program, which we discussed in the CY 2018 OPPS/ASC
final rule with comment period (82 FR 52496). We emphasized that we
continue to believe that ASP minus 22.5 percent is an appropriate
payment rate for 340B-acquired drugs under the authority of section
1833(t)(14)(A)(iii)(II) for the reasons we stated when we adopted this
policy in CY 2018 (82 FR 59216). We pointed out that on July 31, 2020,
the D.C. Circuit reversed the decision of the district court, holding
that this interpretation of the statute was reasonable. Therefore, we
also proposed in the alternative that the agency could continue the
current Medicare payment policy for CY 2021. If adopted, we stated that
this proposed policy would continue the current Medicare payment policy
for CY 2021.
Based on feedback from stakeholders, we stated that we believed
maintaining the current payment policy of paying ASP minus 22.5 percent
for 340B drugs was appropriate in order to maintain consistent and
reliable payment for these drugs both for the remainder of the PHE and
after its conclusion to give hospitals some certainty as to payments
for these drugs. We explained that continuing our current policy also
gives us more time to conduct further analysis of hospital survey data
for potential future use for 340B drug payment. We also noted that any
changes to the current 340B payment policy would be adopted through
public notice and comment rulemaking.
Finally, we stated that while we believe our methods to conduct the
340B Drug Acquisition Cost Survey, as well as the methodology we used
to calculate the proposed average or typical discount received by 340B
entities on 340B drugs, are valid, we nonetheless recognize the
comments that we received from stakeholders. Utilization of the survey
data is complex, and we emphasized that we wish to continue to evaluate
how to balance and weigh the use of the survey data, the necessary
adjustments to the data, and the weighting and incorporation of ceiling
prices--all to determine how best to take the relevant factors into
account for potentially using the survey to set Medicare OPPS drug
payment policy. We stated that we would continue to assess commenters'
feedback as we explore whether survey data should be considered
hospital acquisition cost data for purposes of paying for drugs
acquired under section 1833(t)(14)(A)(iii)(I).
CY 2022 Proposed 340B Drug Payment Policy
For CY 2022, we are proposing to continue our current policy
without modification of paying ASP minus 22.5 percent for 340B-acquired
drugs and biologicals, including when furnished in nonexcepted off-
campus PBDs paid under the PFS. We are proposing, in accordance with
section 1833(t)(14)(A)(iii)(II) of the Act, to pay for separately
payable Medicare Part B drugs and biologicals (assigned status
indicator ``K''), other than vaccines and drugs on pass-through status,
that are acquired through the 340B Program at ASP minus 22.5 percent
when billed by a hospital paid under the OPPS that is not excepted from
the payment adjustment. We propose to continue our current policy for
calculating payment for 340B-acquired biosimilars, which is discussed
in section V.B.2.c. of the CY 2019 OPPS/ASC final rule with comment
period, and would continue the policy we finalized in CY 2019 to pay
ASP minus 22.5 percent for 340B-acquired drugs and biologicals
furnished in nonexcepted off-campus PBDs paid under the PFS.
We are also proposing to continue the 340B payment adjustment for
WAC-priced drugs, which is WAC minus 22.5 percent. 340B-acquired drugs
that are priced using AWP would continue to be paid an adjusted amount
of 69.46 percent of AWP. Additionally, we are proposing to continue to
exempt rural sole community hospitals (as described under the
regulations at Sec. 412.92 and designated as rural for Medicare
purposes), children's hospitals, and PPS-exempt cancer hospitals from
the 340B payment adjustment. These hospitals will continue to report
informational modifier ``TB'' for 340B-acquired drugs, and will
continue to be paid ASP plus 6 percent. We may revisit our policy to
exempt rural SCHs, as well as other hospital types, from the 340B drug
payment reduction in future rulemaking.
We are also continuing to require hospitals to use modifiers to
identify 340B-acquired drugs. We refer readers to the CY 2018 OPPS/ASC
final rule with comment period (82 FR 59353 through 59370) for a full
discussion and rationale for the CY 2018 policies and the requirements
for use of modifiers ``JG'' and ``TB''. We believe maintaining the
current policy of paying ASP minus 22.5 percent for 340B drugs is
appropriate given the July 31, 2020 D.C. Circuit decision, which
reversed the district court's decision and found that the
interpretation of the statute was reasonable when the 340B drug
[[Page 42137]]
payment policy was implemented in CY 2018. We note that any changes to
the current 340B payment policy would be adopted through public notice
and comment rulemaking.
While we believe the Secretary has discretion to propose a payment
rate for 340B drugs based on the 2020 survey results, we also continue
to believe that the current payment rate of ASP minus 22.5 percent
represents the minimum discount that 340B covered entities receive,
which more closely aligns the payment rate with the resources expended
by 340B hospitals to acquire such drugs compared to a payment rate of
ASP plus 6 percent, while also recognizing the intent of the 340B
program to allow covered entities, including eligible hospitals, to
stretch scarce resources in ways that enable hospitals to continue
providing access to care for Medicare beneficiaries and other patients.
Additionally, we continue to believe it is important to provide
consistency and reliable payment for these drugs both for the remainder
of the Public Health Emergency (PHE) and after its conclusion to give
hospitals some certainty as to payments for these drugs.
7. High Cost/Low Cost Threshold for Packaged Skin Substitutes
a. Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR
74938), we unconditionally packaged skin substitute products into their
associated surgical procedures as part of a broader policy to package
all drugs and biologicals that function as supplies when used in a
surgical procedure. As part of the policy to package skin substitutes,
we also finalized a methodology that divides the skin substitutes into
a high cost group and a low cost group, in order to ensure adequate
resource homogeneity among APC assignments for the skin substitute
application procedures (78 FR 74933).
Skin substitutes assigned to the high cost group are described by
HCPCS codes 15271 through 15278. Skin substitutes assigned to the low
cost group are described by HCPCS codes C5271 through C5278. Geometric
mean costs for the various procedures are calculated using only claims
for the skin substitutes that are assigned to each group. Specifically,
claims billed with HCPCS code 15271, 15273, 15275, or 15277 are used to
calculate the geometric mean costs for procedures assigned to the high
cost group, and claims billed with HCPCS code C5271, C5273, C5275, or
C5277 are used to calculate the geometric mean costs for procedures
assigned to the low cost group (78 FR 74935).
Each of the HCPCS codes described earlier are assigned to one of
the following three skin procedure APCs according to the geometric mean
cost for the code: APC 5053 (Level 3 Skin Procedures): HCPCS codes
C5271, C5275, and C5277); APC 5054 (Level 4 Skin Procedures): HCPCS
codes C5273, 15271, 15275, and 15277); or APC 5055 (Level 5 Skin
Procedures): HCPCS code 15273). In CY 2021, the payment rate for APC
5053 (Level 3 Skin Procedures) was $524.17, the payment rate for APC
5054 (Level 4 Skin Procedures) was $1,715.36, and the payment rate for
APC 5055 (Level 5 Skin Procedures) was $3,522.15. This information also
is available in Addenda A and B of the CY 2021 OPPS/ASC final rule with
comment period, as issued with the final rule correction notice (86 FR
11428) (the correction notice and corrected Addenda A and B are
available via the internet on the CMS website).
We have continued the high cost/low cost categories policy since CY
2014, and we propose to continue it for CY 2022. Under the current
policy, skin substitutes in the high cost category are reported with
the skin substitute application CPT codes, and skin substitutes in the
low cost category are reported with the analogous skin substitute HCPCS
C-codes. For a discussion of the CY 2014 and CY 2015 methodologies for
assigning skin substitutes to either the high cost group or the low
cost group, we refer readers to the CY 2014 OPPS/ASC final rule with
comment period (78 FR 74932 through 74935) and the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66882 through 66885).
For a discussion of the high cost/low cost methodology that was
adopted in CY 2016 and has been in effect since then, we refer readers
to the CY 2016 OPPS/ASC final rule with comment period (80 FR 70434
through 70435). Beginning in CY 2016 and in subsequent years, we
adopted a policy where we determined the high cost/low cost status for
each skin substitute product based on either a product's geometric mean
unit cost (MUC) exceeding the geometric MUC threshold or the product's
per day cost (PDC) (the total units of a skin substitute multiplied by
the mean unit cost and divided by the total number of days) exceeding
the PDC threshold. We assigned each skin substitute that exceeded
either the MUC threshold or the PDC threshold to the high cost group.
In addition, we assigned any skin substitute with a MUC or a PDC that
does not exceed either the MUC threshold or the PDC threshold to the
low cost group (85 FR 86059).
However, some skin substitute manufacturers have raised concerns
about significant fluctuation in both the MUC threshold and the PDC
threshold from year to year using the methodology developed in CY 2016.
The fluctuation in the thresholds may result in the reassignment of
several skin substitutes from the high cost group to the low cost group
which, under current payment rates, can be a difference of over $1,000
in the payment amount for the same procedure. In addition, these
stakeholders were concerned that the inclusion of cost data from skin
substitutes with pass-through payment status in the MUC and PDC
calculations would artificially inflate the thresholds. Skin substitute
stakeholders requested that CMS consider alternatives to the current
methodology used to calculate the MUC and PDC thresholds and also
requested that CMS consider whether it might be appropriate to
establish a new cost group in between the low cost group and the high
cost group to allow for assignment of moderately priced skin
substitutes to a newly created middle group.
We share the goal of promoting payment stability for skin
substitute products and their related procedures as price stability
allows hospitals using such products to more easily anticipate future
payments associated with these products. We have attempted to limit
year-to-year shifts for skin substitute products between the high cost
and low cost groups through multiple initiatives implemented since CY
2014, including: establishing separate skin substitute application
procedure codes for low-cost skin substitutes (78 FR 74935); using a
skin substitute's MUC calculated from outpatient hospital claims data
instead of an average of ASP+6 percent as the primary methodology to
assign products to the high cost or low cost group (79 FR 66883); and
establishing the PDC threshold as an alternate methodology to assign a
skin substitute to the high cost group (80 FR 70434 through 70435).
To allow additional time to evaluate concerns and suggestions from
stakeholders about the volatility of the MUC and PDC thresholds, in the
CY 2018 OPPS/ASC proposed rule (82 FR 33627), we proposed that a skin
substitute that was assigned to the high cost group for CY 2017 would
be assigned to the high cost group for CY 2018, even if it did not
exceed the CY 2018 MUC or PDC thresholds. We finalized this policy in
the CY 2018 OPPS/ASC final rule with comment
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period (82 FR 59347). We stated in the CY 2018 OPPS/ASC proposed rule
that the goal of our proposal to retain the same skin substitute cost
group assignments in CY 2018 as in CY 2017 was to maintain similar
levels of payment for skin substitute products for CY 2018 while we
study our skin substitute payment methodology to determine whether
refinements to the existing policies are consistent with our policy
goal of providing payment stability for skin substitutes.
We stated in the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59347) that we would continue to study issues related to the
payment of skin substitutes and take these comments into consideration
for future rulemaking. We received many responses to our request for
comments in the CY 2018 OPPS/ASC proposed rule about possible
refinements to the existing payment methodology for skin substitutes
that would be consistent with our policy goal of providing payment
stability for these products. In addition, several stakeholders have
made us aware of additional concerns and recommendations since the
release of the CY 2018 OPPS/ASC final rule with comment period. As
discussed in the CY 2019 OPPS/ASC final rule with comment period (83 FR
58967 through 58968), we identified four potential methodologies that
have been raised to us that we encouraged the public to review and
provide comments on. We stated in the CY 2019 OPPS/ASC final rule with
comment period that we were especially interested in any specific
feedback on policy concerns with any of the options presented as they
relate to skin substitutes with differing per day or per episode costs
and sizes and other factors that may differ among the dozens of skin
substitutes currently on the market.
For CY 2020, we sought more extensive comments on the two policy
ideas that generated the most comment from the CY 2019 comment
solicitation. One of the ideas was to establish a payment episode
between 4 to 12 weeks where a lump-sum payment would be made to cover
all of the care services needed to treat the wound. There would be
options for either a complexity adjustment or outlier payments for
wounds that require a large amount of resources to treat. The other
policy idea would be to eliminate the high cost and low cost categories
for skin substitutes and have only one payment category and set of
procedure codes for the application of all graft skin substitute
products. Please refer to the CY 2019 OPPS final rule (83 FR 58967 to
58968) and the CY 2020 OPPS final rule (84 FR 61328 to 61331) for a
detailed summary and discussion of the comments we received in response
to these comment solicitations. We are continuing to consider the
comments we received in response to these comment solicitations.
b. Proposals for Packaged Skin Substitutes for CY 2022
For CY 2022, consistent with our policy since CY 2016, we propose
to continue to determine the high cost/low cost status for each skin
substitute product based on either a product's geometric mean unit cost
(MUC) exceeding the geometric MUC threshold or the product's per day
cost (PDC) (the total units of a skin substitute multiplied by the mean
unit cost and divided by the total number of days) exceeding the PDC
threshold. Consistent with the methodology as established in the CY
2014 through CY 2018 final rules with comment period, we analyzed CY
2019 claims data to calculate the MUC threshold (a weighted average of
all skin substitutes' MUCs) and the PDC threshold (a weighted average
of all skin substitutes' PDCs). The proposed CY 2022 MUC threshold is
$48 per cm\2\ (rounded to the nearest $1) and the proposed CY 2022 PDC
threshold is $949 (rounded to the nearest $1). We also propose that our
definition of skin substitutes includes synthetic skin substitute
products in addition to biological skin substitute products as
described in section V.B.7.d. of this proposed rule. We also want to
clarify that the availability of an HCPCS code for a particular human
cell, tissue, or cellular or tissue-based product (HCT/P) does not mean
that that product is appropriately regulated solely under section 361
of the PHS Act and the FDA regulations in 21 CFR part 1271.
Manufacturers of HCT/Ps should consult with the FDA Tissue Reference
Group (TRG) or obtain a determination through a Request for Designation
(RFD) on whether their HCT/Ps are appropriately regulated solely under
section 361 of the PHS Act and the regulations in 21 CFR part 1271.
For CY 2022, as we did for CY 2021, we propose to assign each skin
substitute that exceeds either the MUC threshold or the PDC threshold
to the high cost group. In addition, we propose to assign any skin
substitute with a MUC or a PDC that does not exceed either the MUC
threshold or the PDC threshold to the low cost group. For CY 2022, we
propose that any skin substitute product that was assigned to the high
cost group in CY 2021 would be assigned to the high cost group for CY
2022, regardless of whether it exceeds or falls below the CY 2022 MUC
or PDC threshold. This policy was established in the CY 2018 OPPS/ASC
final rule with comment period (82 FR 59346 through 59348).
For 2022, we propose to continue to assign skin substitutes with
pass-through payment status to the high cost category. We propose to
assign skin substitutes with pricing information but without claims
data to calculate a geometric MUC or PDC to either the high cost or low
cost category based on the product's ASP+6 percent payment rate as
compared to the MUC threshold. If ASP is not available, we propose to
use WAC+3 percent to assign a product to either the high cost or low
cost category. Finally, if neither ASP nor WAC is available, we propose
to use 95 percent of AWP to assign a skin substitute to either the high
cost or low cost category. We propose to continue to use WAC+3 percent
instead of WAC+6 percent to conform to our proposed policy described in
section V.B.2.b. of this proposed rule to establish a payment rate of
WAC+3 percent for separately payable drugs and biologicals that do not
have ASP data available. New skin substitutes without pricing
information would be assigned to the low cost category until pricing
information is available to compare to the CY 2022 MUC and PDC
thresholds. We also propose to continue to include synthetic products
in addition to biological products in our description of skin
substitutes. For a discussion of our existing policy under which we
assign skin substitutes without pricing information to the low cost
category until pricing information is available, we refer readers to
the CY 2016 OPPS/ASC final rule with comment period (80 FR 70436). For
a discussion of how we determined that synthetic skin graft sheet
products can be reported with graft skin substitute procedure codes, we
refer readers to the CY 2021 OPPS/ASC final rule (85 FR 86064 to
86067). Table 32 displays the final CY 2022 cost category assignment
for each skin substitute product.
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VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs,
Biologicals, Radiopharmaceuticals, and Devices
A. Background
Section 1833(t)(6)(E) of the Act limits the total projected amount
of transitional pass-through payments for drugs, biologicals,
radiopharmaceuticals, and categories of devices for a given year to an
``applicable percentage,'' currently not to exceed 2.0 percent of total
program payments estimated to be made for all covered services under
the OPPS furnished for that year. If we estimate before the beginning
of the calendar year that the total amount of pass-through payments in
that year would exceed the applicable percentage, section
1833(t)(6)(E)(iii) of the Act requires a uniform prospective reduction
in the amount of each of the transitional pass-through payments made in
that year to ensure that the limit is not exceeded. We estimate the
pass-through spending to determine whether payments exceed the
[[Page 42144]]
applicable percentage and the appropriate pro rata reduction to the
conversion factor for the projected level of pass-through spending in
the following year to ensure that total estimated pass-through spending
for the prospective payment year is budget neutral, as required by
section 1833(t)(6)(E) of the Act.
For devices, developing a proposed estimate of pass-through
spending in CY 2022 entails estimating spending for two groups of
items. The first group of items consists of device categories that are
currently eligible for pass-through payment and that will continue to
be eligible for pass-through payment in CY 2022. The CY 2008 OPPS/ASC
final rule with comment period (72 FR 66778) describes the methodology
we have used in previous years to develop the pass-through spending
estimate for known device categories continuing into the applicable
update year. The second group of items consists of items that we know
are newly eligible, or project may be newly eligible, for device pass-
through payment in the remaining quarters of CY 2021 or beginning in CY
2022. The sum of the proposed CY 2022 pass-through spending estimates
for these two groups of device categories equaled the proposed total CY
2022 pass-through spending estimate for device categories with pass-
through payment status. We based the device pass-through estimated
payments for each device category on the amount of payment as
established in section 1833(t)(6)(D)(ii) of the Act, and as outlined in
previous rules, including the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75034 through 75036). We note that, beginning in CY 2010,
the pass-through evaluation process and pass-through payment
methodology for implantable biologicals newly approved for pass-through
payment beginning on or after January 1, 2010, that are surgically
inserted or implanted (through a surgical incision or a natural
orifice) use the device pass-through process and payment methodology
(74 FR 60476). As has been our past practice (76 FR 74335), in the
proposed rule, we propose to include an estimate of any implantable
biologicals eligible for pass-through payment in our estimate of pass-
through spending for devices. Similarly, we finalized a policy in CY
2015 that applications for pass-through payment for skin substitutes
and similar products be evaluated using the medical device pass-through
process and payment methodology (76 FR 66885 through 66888). Therefore,
as we did beginning in CY 2015, for CY 2022, we also propose to include
an estimate of any skin substitutes and similar products in our
estimate of pass-through spending for devices.
For drugs and biologicals eligible for pass-through payment,
section 1833(t)(6)(D)(i) of the Act establishes the pass-through
payment amount as the amount by which the amount authorized under
section 1842(o) of the Act (or, if the drug or biological is covered
under a competitive acquisition contract under section 1847B of the
Act, an amount determined by the Secretary equal to the average price
for the drug or biological for all competitive acquisition areas and
year established under such section as calculated and adjusted by the
Secretary) exceeds the portion of the otherwise applicable fee schedule
amount that the Secretary determines is associated with the drug or
biological. Our estimate of drug and biological pass-through payment
for CY 2022 for this group of items is $462.4 million, as discussed
below, because we propose that most non pass-through separately payable
drugs and biologicals would be paid under the CY 2022 OPPS at ASP+6
percent with the exception of 340B-acquired separately payable drugs,
which we propose would be paid at ASP minus 22.5 percent, and because
we propose to pay for CY 2022 pass-through payment drugs and
biologicals at ASP+6 percent, as we discuss in section V.A. of this CY
2022 OPPS/ASC proposed rule.
Furthermore, payment for certain drugs, specifically diagnostic
radiopharmaceuticals and contrast agents without pass-through payment
status, is packaged into payment for the associated procedures, and
these products will not be separately paid. In addition, we policy-
package all non pass-through drugs, biologicals, and
radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure, drugs and biologicals that function as
supplies when used in a surgical procedure, drugs and biologicals used
for anesthesia, and drugs and biologicals, as discussed in section
V.B.1.c. of this CY 2022 OPPS/ASC proposed rule. We propose that all of
these policy-packaged drugs and biologicals with pass-through payment
status will be paid at ASP+6 percent, like other pass-through drugs and
biologicals, for CY 2022. Therefore, our estimate of pass-through
payment for policy-packaged drugs and biologicals with pass-through
payment status approved prior to CY 2022 is not $0, as discussed below.
In section V.A.6. of this proposed rule, we discuss our policy to
determine if the costs of certain policy-packaged drugs or biologicals
are already packaged into the existing APC structure. If we determine
that a policy-packaged drug or biological approved for pass-through
payment resembles predecessor drugs or biologicals already included in
the costs of the APCs that are associated with the drug receiving pass-
through payment, we propose to offset the amount of pass-through
payment for the policy-packaged drug or biological. For these drugs or
biologicals, the APC offset amount is the portion of the APC payment
for the specific procedure performed with the pass-through drug or
biological, which we refer to as the policy-packaged drug APC offset
amount. If we determine that an offset is appropriate for a specific
policy-packaged drug or biological receiving pass-through payment, we
propose to reduce our estimate of pass-through payments for these drugs
or biologicals by this amount.
Similar to pass-through spending estimates for devices, the first
group of drugs and biologicals requiring a pass-through payment
estimate consists of those products that were recently made eligible
for pass-through payment and that will continue to be eligible for
pass-through payment in CY 2022. The second group contains drugs and
biologicals that we know are newly eligible, or project will be newly
eligible, in the remaining quarters of CY 2021 or beginning in CY 2022.
The sum of the CY 2022 pass-through spending estimates for these two
groups of drugs and biologicals equals the total CY 2022 pass-through
spending estimate for drugs and biologicals with pass-through payment
status.
B. Proposed Estimate of Pass-Through Spending
For 2022, we propose to set the applicable pass-through payment
percentage limit at 2.0 percent of the total projected OPPS payments
for CY 2022, consistent with section 1833(t)(6)(E)(ii)(II) of the Act
and our OPPS policy from CY 2004 through CY 2021 (85 FR 86068).
For the first group, consisting of device categories that are
currently eligible for pass-through payment and will continue to be
eligible for pass-through payment in CY 2022, there are 9 active
categories for CY 2022. The active categories are described by HCPCS
codes C2596, C1734, C1982, C1824, C1839, C1748, C1825, C1052, and
C1062. Based on the information from the device manufacturers, we
estimate that HCPCS code C2596 will cost $11.3 million in pass-through
expenditures in CY 2022, HCPCS C1734 will cost $36.9 million in pass-
through
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expenditures in CY 2022, HCPCS code C1982 will cost $116.3 million in
pass-through expenditures in CY 2022, HCPCS code C1824 will cost $46
million in pass-through expenditures in CY 2022, HCPCS code C1839 will
cost $500,000 in pass-through expenditures in CY 2022, HCPCS code C1748
will cost $39.1 million in pass-through expenditures in CY 2022, HCPCS
code C1825 will cost $3.5 million in pass-through expenditures in CY
2022, HCPCS code C1052 will cost $40 million in pass-through
expenditures in CY 2022, and HCPCS code C1062 will cost $14.3 million
in pass-through expenditures in CY 2022. Therefore, we propose an
estimate for the first group of devices of $307.9 million.
In estimating our proposed CY 2022 pass-through spending for device
categories in the second group, we included: Device categories that we
assumed at the time of the development of this proposed rule will be
newly eligible for pass-through payment in CY 2022; additional device
categories that we estimated could be approved for pass-through status
after the development of the proposed rule and before January 1, 2022;
and contingent projections for new device categories established in the
second through fourth quarters of CY 2022. For CY 2022, we propose to
use the general methodology described in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66778), while also taking into account
recent OPPS experience in approving new pass-through device categories.
The proposed estimate of CY 2022 pass-through spending for this second
group of device categories is $244.4 million.
To estimate proposed CY 2022 pass-through spending for drugs and
biologicals in the first group, specifically those drugs and
biologicals recently made eligible for pass-through payment and
continuing on pass-through payment status for at least one quarter in
CY 2022, we propose to use the CY 2019 Medicare hospital outpatient
claims data regarding their utilization, information provided in the
respective pass-through applications, other historical hospital claims
data, pharmaceutical industry information, and clinical information
regarding those drugs or biologicals to project the CY 2022 OPPS
utilization of the products.
For the known drugs and biologicals (excluding policy-packaged
diagnostic radiopharmaceuticals, contrast agents, drugs, biologicals,
and radiopharmaceuticals that function as supplies when used in a
diagnostic test or procedure, and drugs and biologicals that function
as supplies when used in a surgical procedure) that will be continuing
on pass-through payment status in CY 2022, we estimate the pass-through
payment amount as the difference between ASP+6 percent and the payment
rate for non pass-through drugs and biologicals that will be separately
paid. Separately payable drugs are paid at a rate of ASP+6 percent with
the exception of 340B-acquired drugs, for which we propose to pay ASP
minus 22.5 percent. Therefore, the payment rate difference between the
pass-through payment amount and the non pass-through payment amount is
$462.4 million for this group of drugs. Because payment for policy-
packaged drugs and biologicals is packaged if the product was not paid
separately due to its pass-through payment status, we proposed to
include in the CY 2022 pass-through estimate the difference between
payment for the policy-packaged drug or biological at ASP+6 percent (or
WAC+6 percent, or 95 percent of AWP, if ASP or WAC information is not
available) and the policy-packaged drug APC offset amount, if we
determine that the policy-packaged drug or biological approved for
pass-through payment resembles a predecessor drug or biological already
included in the costs of the APCs that are associated with the drug
receiving pass-through payment, which we estimate for CY 2022 for the
first group of policy-packaged drugs to be $0 since there are currently
no policy-packaged drugs for which we have cost data that will be on
pass-through in CY 2022.
To estimate proposed CY 2022 pass-through spending for drugs and
biologicals in the second group (that is, drugs and biologicals that we
knew at the time of development of the proposed rule were newly
eligible or recently became eligible for pass-through payment in CY
2022, additional drugs and biologicals that we estimated could be
approved for pass-through status subsequent to the development of the
proposed rule and before January 1, 2022 and projections for new drugs
and biologicals that could be initially eligible for pass-through
payment in the second through fourth quarters of CY 2022), we propose
to use utilization estimates from pass-through applicants,
pharmaceutical industry data, clinical information, recent trends in
the per unit ASPs of hospital outpatient drugs, and projected annual
changes in service volume and intensity as our basis for making the CY
2022 pass-through payment estimate. We also propose to consider the
most recent OPPS experience in approving new pass-through drugs and
biologicals. Using our proposed methodology for estimating CY 2022
pass-through payments for this second group of drugs, we calculate a
proposed spending estimate for this second group of drugs and
biologicals of approximately $10 million.
We estimate that total pass-through spending for the device
categories and the drugs and biologicals that are continuing to receive
pass-through payment in CY 2022 and those device categories, drugs, and
biologicals that first become eligible for pass-through payment during
CY 2022 would be approximately $1,024.7 million (approximately $552.3
million for device categories and approximately $472.4 million for
drugs and biologicals) which represents 1.24 percent of total projected
OPPS payments for CY 2022 (approximately $83 billion). Therefore, we
estimate that pass-through spending in CY 2022 will not amount to 2.0
percent of total projected OPPS CY 2022 program spending.
As discussed in section X.E. of this proposed rule, due to the
effects of the COVID-19 PHE, we are proposing to generally use CY 2019
claims data instead of CY 2020 claims data in establishing the CY 2022
OPPS rates and to use cost report data from the same set of cost
reports originally used in CY 2021 final rule OPPS ratesetting. If our
proposal to use CY 2019 data, rather than CY 2020 data, to inform CY
2022 ratesetting, is finalized, we would effectively remove
approximately one year of pass-through data collection time for
ratesetting purposes. Therefore, for CY 2022, in section X.E. of this
proposed rule, we are proposing to use our equitable adjustment
authority under 1833(t)(2)(E) to provide up to four quarters of
separate payment for 21 drugs and biologicals whose pass-through
payment status will expire on March 31, 2022, June 30, 2022, or
September 30, 2022 and six drugs and biologicals and one device
category whose pass-through payment status will expire on December 31,
2021. This would ensure that we have a full year of claims data from CY
2021 to use for CY 2023 ratesetting and would allow us to avoid using
CY 2020 data to set rates for these pass-through drugs, biologicals,
and the device category for CY 2022.
We estimated the spending for the drugs, biologicals, and device
category for which we are proposing to provide separate payment for the
remainder of CY 2022 using our equitable adjustment authority. To
estimate proposed CY 2022 spending for the one device pass-through
category with pass-through status expiring on December 31, 2021, we
also used the general methodology
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described in the CY 2008 OPPS/ASC final rule with comment period (72 FR
66778). For this device category, we calculate a proposed spending
estimate of $3.5 million. To estimate proposed CY 2022 spending for the
six drugs with pass-through status expiring on December 21, 2021 and
the 18 drugs and three biologicals with pass-through status expiring on
March 30, 2022, June 30, 2022, and September 30, 2022 we performed an
analysis similar to the analysis for the first group of drugs and
biologicals described earlier in this section where we estimated the
pass-through payment amount as the difference between ASP+6 percent and
the payment rate for non pass-through drugs and biologicals that will
be separately paid. For this group, we calculate a proposed spending
estimate for CY 2022 of $61.5 million. We estimate that total spending
for these 27 drugs and biologicals and one device category would be
approximately $65 million for CY 2022. The drugs, biologicals, and
device category for which we propose to provide separate payment for
one to four quarters in CY 2022 are listed in table 33 below.
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VII. OPPS Payment for Hospital Outpatient Visits and Critical Care
Services
For CY 2022, we propose to continue with our current clinic and
emergency department (ED) hospital outpatient visits payment policies.
For a description of the current clinic and ED hospital outpatient
visits policies, we refer readers to the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70448). We also propose to continue our
payment policy for critical care services for CY 2022. For a
description of the current payment policy for critical care services,
we refer readers to the CY 2016 OPPS/ASC final rule with comment period
(80 FR 70449), and for the history of the payment policy for critical
care services, we refer readers to the CY 2014 OPPS/ASC final rule with
comment period (78 FR 75043). In this proposed rule, we are seeking
public comments on any changes to these codes that we should consider
for future rulemaking cycles. We continue to encourage commenters to
provide the data and analysis necessary to justify any suggested
changes.
We are continuing the clinic visit payment policy for CY 2022 and
beyond. We will continue to utilize a PFS-equivalent payment rate for
the hospital outpatient clinic visit service described by HCPCS code
G0463 when it is furnished by excepted off-campus provider-based
departments. The PFS-equivalent rate for CY 2022 is 40 percent of the
proposed OPPS payment (that is, 60 percent less than the proposed OPPS
rate). Under this policy, these departments will be paid approximately
40 percent of the OPPS rate (100 percent of the OPPS rate minus the 60-
percent payment reduction that is applied in CY 2022) for the clinic
visit service in CY 2022. We will continue to monitor the effect of
this change in Medicare payment policy, including the volume of these
types of OPD services.
VIII. Payment for Partial Hospitalization Services
A. Background
A partial hospitalization program (PHP) is an intensive outpatient
program of psychiatric services provided as an alternative to inpatient
psychiatric care for individuals who have an acute mental illness,
which includes, but is not limited to, conditions such as depression,
schizophrenia, and substance use disorders. Section 1861(ff)(1) of the
Act defines partial hospitalization services as the items and services
described in paragraph (2) prescribed by a physician and provided under
a program described in paragraph (3) under the supervision of a
physician pursuant to an individualized, written plan of treatment
established and periodically reviewed by a physician (in consultation
with appropriate staff participating in such program), which sets forth
the physician's diagnosis, the type, amount, frequency, and duration of
the items and services provided
[[Page 42149]]
under the plan, and the goals for treatment under the plan. Section
1861(ff)(2) of the Act describes the items and services included in
partial hospitalization services. Section 1861(ff)(3)(A) of the Act
specifies that a PHP is a program furnished by a hospital to its
outpatients or by a community mental health center (CMHC), as a
distinct and organized intensive ambulatory treatment service, offering
less than 24-hour-daily care, in a location other than an individual's
home or inpatient or residential setting. Section 1861(ff)(3)(B) of the
Act defines a CMHC for purposes of this benefit. We refer readers to
sections 1833(t)(1)(B)(i), 1833(t)(2)(B), 1833(t)(2)(C), and
1833(t)(9)(A) of the Act and 42 CFR 419.21, for additional guidance
regarding PHP.
In CY 2008, we began efforts to strengthen the PHP benefit through
extensive data analysis, along with policy and payment changes by
implementing two refinements to the methodology for computing the PHP
median. For a detailed discussion on these policies, we refer readers
to the CY 2008 OPPS/ASC final rule with comment period (72 FR 66670
through 66676). In CY 2009, we implemented several regulatory, policy,
and payment changes. For a detailed discussion on these policies, we
refer readers to the CY 2009 OPPS/ASC final rule (73 FR 68688 through
68697). In CY 2010, we retained the two-tier payment approach for
partial hospitalization services and used only hospital-based PHP data
in computing the PHP APC per diem costs, upon which PHP APC per diem
payment rates are based (74 FR 60556 through 60559). In CY 2011 (75 FR
71994), we established four separate PHP APC per diem payment rates:
Two for CMHCs (APC 0172 and APC 0173) and two for hospital-based PHPs
(APC 0175 and APC 0176) and instituted a 2-year transition period for
CMHCs to the CMHC APC per diem payment rates. For a detailed
discussion, we refer readers to section X.B. of the CY 2011 OPPS/ASC
final rule with comment period (75 FR 71991 through 71994). In CY 2012,
we determined the relative payment weights for partial hospitalization
services provided by CMHCs based on data derived solely from CMHCs and
the relative payment weights for partial hospitalization services
provided by hospital-based PHPs based exclusively on hospital data (76
FR 74348 through 74352). In the CY 2013 OPPS/ASC final rule with
comment period, we finalized our proposal to base the relative payment
weights that underpin the OPPS APCs, including the four PHP APCs (APCs
0172, 0173, 0175, and 0176), on geometric mean costs rather than on the
median costs. For a detailed discussion on this policy, we refer
readers to the CY 2013 OPPS/ASC final rule with comment period (77 FR
68406 through 68412).
In the CY 2014 OPPS/ASC proposed rule (78 FR 43621 through 43622)
and CY 2015 OPPS/ASC final rule with comment period (79 FR 66902
through 66908), we continued to apply our established policies to
calculate the four PHP APC per diem payment rates based on geometric
mean per diem costs using the most recent claims data for each provider
type. For a detailed discussion on this policy, we refer readers to the
CY 2014 OPPS/ASC final rule with comment period (78 FR 75047 through
75050). In the CY 2016, we described our extensive analysis of the
claims and cost data and ratesetting methodology, corrected a cost
inversion that occurred in the final rule data with respect to
hospital-based PHP providers and renumbered the PHP APCs. In CY 2017
OPPS/ASC final rule with comment period (81 FR 79687 through 79691), we
continued to apply our established policies to calculate the PHP APC
per diem payment rates based on geometric mean per diem costs and
finalized a policy to combine the Level 1 and Level 2 PHP APCs for
CMHCs and for hospital-based PHPs. We also implemented an eight-percent
outlier cap for CMHCs to mitigate potential outlier billing
vulnerabilities. For a comprehensive description of PHP payment policy,
including a detailed methodology for determining PHP per diem amounts,
we refer readers to the CY 2016 and CY 2017 OPPS/ASC final rules with
comment period (80 FR 70453 through 70455 and 81 FR 79678 through
79680).
In the CYs 2018 and 2019 OPPS/ASC final rules with comment period
(82 FR 59373 through 59381, and 83 FR 58983 through 58998,
respectively), we continued to apply our established policies to
calculate the PHP APC per diem payment rates based on geometric mean
per diem costs, designated a portion of the estimated 1.0 percent
hospital outpatient outlier threshold specifically for CMHCs, and
proposed updates to the PHP allowable HCPCS codes. We finalized these
proposals in the CY 2020 OPPS/ASC final rule with comment period (84 FR
61352). We refer readers to section VIII.D. of this proposed rule for a
discussion of the proposed updates and the applicability for CY 2021.
In the CY 2020 OPPS/ASC final rule with comment period (84 FR 61339
through 61350), we finalized our proposal to use the calculated CY 2020
CMHC geometric mean per diem cost and the calculated CY 2020 hospital-
based PHP geometric mean per diem cost, but with a cost floor equal to
the CY 2019 final geometric mean per diem costs as the basis for
developing the CY 2020 PHP APC per diem rates. Also, we continued to
designate a portion of the estimated 1.0 percent hospital outpatient
outlier threshold specifically for CMHCs, consistent with the
percentage of projected payments to CMHCs under the OPPS, excluding
outlier payments.
In the April 30, 2020 interim final rule with comment (85 FR 27562
through 27566), effective as of March 1, 2020 and for the duration of
the COVID-19 Public Health Emergency (PHE), hospital and CMHC staff are
permitted to furnish certain outpatient therapy, counseling, and
educational services (including certain PHP services), incident to a
physician's services, to beneficiaries in temporary expansion
locations, including the beneficiary's home, so long as the location
meets all conditions of participation to the extent not waived. A
hospital or CMHC can furnish such services using telecommunications
technology to a beneficiary in a temporary expansion location if that
beneficiary is registered as an outpatient. These provisions apply only
for the duration of the COVID-19 PHE.
In the CY 2021 final rule (85 FR 86073 through 86080), we finalized
a CMHC geometric mean per diem cost of $136.14 and a final hospital-
based PHP geometric mean per diem cost of $253.76 using the most recent
updated claims and cost data. In the CY 2021 proposed rule (85 FR 48901
through 48905), we had proposed, for CY 2021 and subsequent years, to
use the CY 2021 CMHC geometric mean per diem cost calculated in
accordance with our existing methodology, but with a cost floor equal
to the per diem cost for CMHCs of $121.62 that was calculated for CY
2020 ratesetting (84 FR 61339 through 61344), as the basis for
developing the CY 2021 CMHC APC per diem rate. We had also proposed,
for CY 2021 and subsequent years, to use the CY 2021 hospital-based
geometric mean per diem cost calculated in accordance with our existing
methodology, but with a cost floor equal to the per diem cost for
hospital-based providers of $222.76 that was calculated for CY 2020
ratesetting (84 FR 61344 through 61345). We explained in the final rule
that the final calculated geometric mean per diem costs for both CMHCs
and hospital-based PHPs were significantly higher than each proposed
cost floor,
[[Page 42150]]
therefore a floor was not necessary at the time, and we did not
finalize the proposed cost floors in the CY 2021 OPPS/ASC final rule
with comment period.
B. Proposed PHP APC Update for CY 2022
1. Proposed PHP APC Geometric Mean Per Diem Costs
In summary, for CY 2022 only, we propose to use the CY 2022 CMHC
geometric mean per diem cost calculated in accordance with our existing
methodology, but with a cost floor equal to the per diem cost for CMHCs
of $136.14, which is the final CMHC geometric mean per diem cost
calculated last year for CY 2021 ratesetting (85 FR 86080), as the
basis for developing the CY 2022 CMHC APC per diem rate. We also
propose, for CY 2022 only, to use the CY 2022 hospital-based geometric
mean per diem cost calculated in accordance with our existing
methodology, but with a cost floor equal to the per diem cost for
hospital-based providers of $253.76 calculated last year for CY 2021
ratesetting (85 FR 86080). Following this methodology, we propose to
use the cost floor value of $136.14 for CMHCs as the basis for
developing the CY 2022 CMHC APC per diem rate, and to use the cost
floor value of $253.76 as the basis for developing the CY 2021
hospital-based APC per diem rate. As discussed in section VIII.B.2 of
this proposed rule, we propose to use the latest available CY 2019
claims and cost data from the CY 2021 rulemaking to determine CY 2022
geometric mean per diem costs in this proposed rule, and we propose
that if the final CY 2022 cost for CMHCs or hospital-based PHPs is
calculated to be above the proposed floor for that provider type, we
would use the final calculated cost instead of the floor. The rationale
behind this proposal is discussed in greater detail in sections
VIII.B.2.a and VIII.B.2.b of this proposed rule.
Lastly, in accordance with our longstanding policy, we propose to
continue to use CMHC APC 5853 (Partial Hospitalization (three or More
Services Per Day)) and hospital-based PHP APC 5863 (Partial
Hospitalization (three or More Services Per Day)). These proposals are
discussed in more detail below.
2. Development of the Proposed PHP APC Geometric Mean Per Diem Costs
In preparation for CY 2022, we followed the PHP ratesetting
methodology described in section VIII.B.2. of the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70462 through 70466) to calculate
the PHP APCs' geometric mean per diem costs and payment rates for APCs
5853 and 5863, incorporating the modifications made in the CY 2017
OPPS/ASC final rule with comment period. As discussed in section
VIII.B.1. of the CY 2017 OPPS/ASC final rule with comment period (81 FR
79680 through 79687), the geometric mean per diem cost for hospital-
based PHP APC 5863 is based upon actual hospital-based PHP claims and
costs for PHP service days providing three or more services. Similarly,
the geometric mean per diem cost for CMHC APC 5853 is based upon actual
CMHC claims and costs for CMHC service days providing three or more
services. In addition, for this CY 2022 proposed rulemaking, we used
cost and charge data from the Hospital Cost Report Information System
(HCRIS) as the source for the CMHC cost-to-charge ratios (CCRs),
instead of using the Outpatient Provider Specific File (OPSF). We
discuss this proposed change in greater detail in section VIII.B.2.a of
this OPPS/ASC proposed rule.
As discussed in section X.E of this OPPS/ASC proposed rule, we
analyzed OPPS cost and claims information from CY 2019 and CY 2020 to
better understand the effects of the COVID-19 PHE on outpatient
services, including PHP, and to identify which data would be the best
available for ratesetting. As discussed in that section, we observed a
number of changes, likely as a result of the COVID-19 PHE, in the CY
2020 OPPS claims that we would ordinarily use for ratesetting, and this
includes changes in the claims for partial hospitalization. For PHP
services in particular, we identified that for hospital-based PHPs, the
number of PHP days in our trimmed CY 2020 claims dataset was
approximately 53 percent less than the number of PHP days in our
trimmed CY 2019 claims dataset; and for CMHCs, the number of PHP days
in our trimmed CY 2020 claims dataset was approximately 45 percent less
than the number of PHP days in our trimmed CY 2019 claims dataset.
For this CY 2022 ratesetting, we are proposing to use CY 2019
claims and the cost information from prior to the COVID-19 PHE, that
is, the cost information that was available for the CY 2021 OPPS/ASC
rulemaking. We believe this is appropriate and necessary for PHP
services, because of the substantial decrease in the number of PHP days
in the CY 2020 claims dataset, which we would normally use for
ratesetting. Furthermore, there was a substantial decrease in the
number of PHP providers in the CY 2020 data. Our trimmed CY 2020 claims
dataset contains cost and claim information from 35 fewer hospital-
based PHP providers than are in the CY 2019 data. These significant
decreases in utilization and in the number of hospital-based PHP
providers who submitted CY 2020 claims lead us to believe that CY 2020
data are not the best overall approximation of expected PHP services in
CY 2022. We believe that CY 2019 data, as the most recent complete
calendar year of data prior to the COVID-19 PHE, are a better
approximation of expected CY 2022 PHP services. Therefore, as discussed
in section X.E of this OPPS/ASC proposed rule, and consistent with what
CMS is proposing to do for other APCs under the OPPS, we are proposing
to use CY 2019 claims and the cost information from prior to the COVID-
19 PHE, that is, the cost information that was available for the CY
2021 OPPS/ASC rulemaking, for calculating the CY 2022 CMHC and
hospital-based PHP APC per diem costs.
The CMHC or hospital-based PHP APC per diem costs are the provider-
type specific costs derived from the latest updated CY 2019 claims and
cost data from the CY 2021 rulemaking. The CMHC or hospital-based PHP
APC per diem payment rates are the national unadjusted payment rates
calculated from the CMHC or hospital-based PHP APC geometric mean per
diem costs, after applying the OPPS budget neutrality adjustments
described in section XX of this proposed rule.
a. CMHC Data Preparation: Data Trims, Exclusions, and CCR Adjustments
For this CY 2022 OPPS/ASC proposed rule, we prepared data
consistent with our policies as described in the CY 2016 OPPS/ASC final
rule with comment period (80 FR 70463 through 70465). However, as
discussed above, we propose to use CY 2019 claims data and the cost
information from prior to the COVID-19 PHE, that is, the cost
information that was available for the CY 2021 OPPS/ASC rulemaking, for
calculating the CY 2022 CMHC PHP APC per diem cost.
For this CY 2022 proposed rule, we also used cost and charge
information from HCRIS as the basis for determining the CMHC CCRs used
to calculate the geometric mean per diem cost for CMHC APC 5853.
Following the methodology described in the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70462), we calculated the CCR based on
Medicare costs and charges. However, we note that CMHCs are now
reporting their costs using the newer cost
[[Page 42151]]
reporting form, Form CMS 2088-17, which has different lines and columns
than the ones described in the CY 2016 OPPS/ASC final rule for Form CMS
2088-92. Therefore, to calculate each CMHC's CCR for this proposed
rulemaking, we divided costs from Worksheet C, Line 50, Column 5 by
charges from Worksheet C, Line 50, Column 4.
As noted above, prior to this year's proposed rulemaking, our
longstanding methodology for calculating CCRs for CMHCs has been to use
the CCRs from the OPSF. As discussed in the CY 2004 OPPS/ASC final rule
(68 FR 63468), a Program Memorandum was issued on January 17, 2003,
which directed the fiscal intermediaries to recalculate hospital and
CMHC cost-to-charge ratios and to update the cost-to-charge ratios on
an ongoing basis in the OPSF, which was used as the basis for the CCRs
used in calculating the geometric mean per diem costs for CMHCs.
Subsequently, in the CY 2009 OPPS/ASC final rule (73 FR 68690),
commenters addressed the fact that cost report information for CMHCs
was not at that time included in HCRIS, and recommended that CMS base
its calculations only in the cost report information that the agency
can verify directly and not on data provided by the fiscal
intermediary. CMS responded in the same OPPS/ASC final rule that it was
working to include CMHC cost reports in the system, but that the CCRs
from the OPSF continued to be the best available data for ratesetting.
In the CY 2011 OPPS/ASC final rule (75 FR 71993 through 71994),
commenters requested that CMHC cost report information be included in
HCRIS, and CMS explained that CMHC cost reports would begin to be
available in HCRIS starting in early 2011. Since that time, CMHC cost
reports have become available in HCRIS. Because the data is now
available and consistently populated based on the cost reports that
CMHCs submit, we believe that using cost information from HCRIS would
be more consistent with the methodology for calculating most other OPPS
services, including hospital-based PHP services. Therefore, we are
proposing for CY 2022 and future years to use HCRIS as the source for
CMHC cost information used for calculating the geometric mean per diem
cost for CMHC APC 5853.
Prior to calculating the proposed geometric mean per diem cost for
CMHC APC 5853, we prepare the data by first applying trims and data
exclusions, and assessing CCRs as described in the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70463 through 70465), so that
ratesetting is not skewed by providers with extreme data. Before any
trims or exclusions were applied, there were 40 CMHCs in the PHP claims
data file. Under the 2 standard deviation trim policy, we
exclude any data from a CMHC for ratesetting purposes when the CMHC's
geometric mean cost per day was more than 2 standard
deviations from the geometric mean cost per day for all CMHCs. In
applying this trim for CY 2022 ratesetting, one CMHC had geometric mean
costs per day below the trim's lower limit of $32.84, and one had
geometric mean costs per day above the trim's upper limit of $491.85.
Therefore, we are excluding data for ratesetting from these 2 CMHCs
because of the 2 standard deviation trim.
In accordance with our PHP ratesetting methodology (80 FR 70465),
we also remove service days with no wage index values, because we use
the wage index data to remove the effects of geographic variation in
costs prior to APC geometric mean per diem cost calculation (80 FR
70465). For this CY 2022 proposed rule ratesetting, no CMHC was missing
wage index data for all of its service days and, therefore, no CMHC was
excluded. We also exclude providers without any days containing 3 or
more units of PHP-allowable services. One provider is excluded from
ratesetting because it had no days containing 3 or more units of PHP-
allowable services. In addition to our trims and data exclusions,
before calculating the PHP APC geometric mean per diem costs, we also
assess CCRs (80 FR 70463). Our longstanding PHP OPPS ratesetting
methodology defaults any CMHC CCR that is not available or any CMHC CCR
greater than one to the statewide hospital CCR associated with the
provider's urban/rural designation and their state location (80 FR
70463). For this CY 2022 OPPS/ASC proposed rule ratesetting, there are
3 CMHCs with CCRs greater than one, and 12 CMHCs with missing CCR
information. Therefore, we are defaulting the CCRs for these 15 CMHCs
for ratesetting to the applicable statewide hospital CCR for each CMHC
based on its urban/rural designation and its state location.
In summary, these data preparation steps adjusted the CCR during
our ratesetting process for 15 CMHCs having either a CCR greater than
one or having no CCR. We are also excluding one CMHC because it had no
days containing 3 or more services and 2 CMHCs for failing the 2 standard deviation trim, resulting in the inclusion of 37
CMHCs. There were 564 CMHC claims removed during data preparation steps
due to the 2 standard deviation trim or because they either
had no PHP allowable- codes or had zero payment days, leaving 10,370
CMHC claims in our CY 2022 proposed rule ratesetting modeling. After
applying all of the previously listed trims, exclusions, and
adjustments, we followed the methodology described in the CY 2016 OPPS/
ASC final rule with comment period (80 FR 70464 through 70465) and
modified in the CY 2017 OPPS/ASC final rule with comment period (81 FR
79687 through 79688, and 79691), using the CMHC CCRs calculated based
on the cost information from HCRIS as discussed in this OPPS/ASC
proposed rule, to calculate the CMHC APC geometric mean per diem
cost.\103\ The calculated CY 2022 geometric mean per diem cost for all
CMHCs for providing three or more services per day (CMHC APC 5853) is
$130.41, a decrease from $136.14 calculated last year for CY 2021
ratesetting (85 FR 86080).
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\103\ Each revenue code on the CMHC claim must have a HCPCS code
and charge associated with it. We multiply each claim service line's
charges by the CMHC's overall CCR (or statewide CCR, where the
overall CCR was greater than 1 or was missing) to estimate CMHC
costs. Only the claims service lines containing PHP allowable HCPCS
codes and PHP allowable revenue codes from the CMHC claims remaining
after trimming are retained for CMHC cost determination. The costs,
payments, and service units for all service lines occurring on the
same service date, by the same provider, and for the same
beneficiary are summed. CMHC service days must have three or more
services provided to be assigned to CMHC APC 5853. The final
geometric mean per diem cost for CMHC APC 5853 is calculated by
taking the nth root of the product of n numbers, for days where
three or more services were provided. CMHC service days with costs
3 standard deviations from the geometric mean costs
within APC 5853 are deleted and removed from modeling. The remaining
PHP service days are used to calculate the final geometric mean per
diem cost for each PHP APC by taking the nth root of the product of
n numbers for days where three or more services were provided.
---------------------------------------------------------------------------
We considered whether a geometric mean per diem cost for CMHCs of
$130.41 would be appropriate for calculating the CMHC APC 5853 per diem
payment rate for CY 2022. As discussed above, we used the latest
available CY 2019 claims and the cost information from prior to the
COVID-19 PHE, that is, the cost information that was available for the
CY 2021 OPPS/ASC rulemaking, for calculating the CY 2022 CMHC PHP APC
per diem cost, because decreases that we observed in utilization and in
the number of hospital-based PHP providers who submitted CY 2020 claims
have led us to believe that the CY 2019 data, rather than the CY 2020
data, are the best overall approximation of expected PHP services in CY
2022. We considered what effect a decrease from the $136.14 calculated
last year for the CY 2021 CMHC PHP APC might have on CMHCs
[[Page 42152]]
and Medicare beneficiaries. Recognizing the disruption that the ongoing
COVID-19 PHE appears to be having on CMHCs' operations, we believe it
is important for CMS to continue to support Medicare beneficiaries'
access to critical PHP services during the COVID-19 PHE by helping
maintain the stability of payments to PHP providers. We are concerned
that a decrease in the geometric mean per diem cost for CMHC APC 5853
would result in a disruption to CMHC payments at a time when, despite
the large decrease in the number of PHP days that we observed in our CY
2020 PHP claims data, the need for mental health services has
increased.\104\ Therefore, rather than proposing to calculate the CMHC
APC 5853 payment rate based on the calculated geometric mean per diem
cost of $130.41, we are instead proposing a cost floor to stabilize the
geometric mean per diem costs finalized in the prior year, CY 2021. The
final CY 2021 geometric mean per diem cost for CMHC APC 5853, which was
calculated for the CY 2021 OPPS/ASC final rule based on CY 2019 claims,
is $136.14, which we are proposing as the cost floor for CY 2022.
Therefore, because the calculated geometric mean per diem cost for CMHC
APC 5853 is below the cost floor, we are proposing to calculate the CY
2022 CMHC APC 5853 payment rate based on the cost floor of $136.14. We
also propose that if the final CY 2022 geometric mean per diem cost is
calculated to be higher than $136.14, then we would use the calculated
geometric mean per diem cost.
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\104\ https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e2.htm.
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As discussed earlier in this section, 3 CMHCs in our dataset had
CCRs greater than 1, and 12 CMHCs had missing CCRs. We want to remind
readers that our PHP ratesetting methodology depends heavily on
provider-reported costs. We strongly encourage CMHCs to review cost
reporting instructions to be sure they are reporting their costs
correctly. These instructions are available in chapter 45 of the
Provider Reimbursement Manual (PRM), Part 2, available on the CMS
website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals. We want to reiterate that it is a
requirement for CMHCs, unless they are approved as a low-utilization or
no-utilization provider in accordance with PRM-1, chapter 1, section
110 (42 CFR 413.24(g) and (h)), to file full cost reports, to help us
capture accurate CMHC costs in rate setting. We furthermore encourage
those CMHCs that do not file full cost reports to consider doing so.
We continue to recognize that because the CMHC ratesetting dataset
is small (n=37), changes in costs from a small number of providers can
influence the overall geometric mean per diem cost calculation. We are
considering approaches to address cost fluctuations in future years,
however, we are not proposing a methodology at this time.
b. Hospital-Based PHP Data Preparation: Data Trims and Exclusions
For this CY 2022 proposed rule, we prepared data consistent with
our policies as described in the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70463 through 70465) for hospital-based PHP
providers, which is similar to that used for CMHCs. However, as
discussed above, we propose to use CY 2019 claims data and the cost
information from prior to the COVID-19 PHE, that is, the cost
information that was available for the CY 2021 OPPS/ASC rulemaking, for
calculating the CY 2022 hospital-based PHP APC per diem cost. The CY
2019 PHP claims included data for 449 hospital-based PHP providers for
our calculations in this CY 2022 OPPS/ASC proposed rule.
Consistent with our policies, as stated in the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70463 through 70465), we prepared
the data by applying trims and data exclusions. We applied a trim on
hospital service days for hospital-based PHP providers with a CCR
greater than 5 at the cost center level. To be clear, the CCR greater
than 5 trim is a service day-level trim in contrast to the CMHC 2 standard deviation trim, which is a provider-level trim.
Applying the CCR greater than 5 trim removed affected service days from
one hospital-based PHP provider from our proposed ratesetting. However,
100 percent of the service days for this hospital-based PHP provider
had at least one service associated with a CCR greater than 5, so the
trim removed this provider entirely from our proposed ratesetting. In
addition, 68 hospital-based PHPs were removed for having no days with
PHP payment. Two hospital-based PHPs were removed because none of their
days included PHP-allowable HCPCS codes. No hospital-based PHPs were
removed for missing wage index data, and a single hospital-based PHP
was removed by the OPPS 3 standard deviation trim on costs
per day. (We refer readers to the OPPS Claims Accounting Document,
available online at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1717-P-2020-OPPS-Claims-Accounting.pdf.
Overall, we removed 72 hospital-based PHP providers (1 with all
service days having a CCR greater than 5) + (68 with no PHP payment) +
(2 with no PHP-allowable HCPCS codes) + (1 provider with geometric mean
costs per day outside the 3 SD limits)], resulting in 377
(449 total-72 excluded) hospital-based PHP providers in the data used
for calculating ratesetting.
After completing these data preparation steps, we calculated the CY
2022 geometric mean per diem cost for hospital-based PHP APC 5863 by
following the methodology described in the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70464 through 70465) and modified in the CY
2017 OPPS/ASC final rule with comment period (81 FR 79687 and
79691).\105\ The calculated CY 2022 hospital-based PHP APC geometric
mean per diem cost for hospital-based PHP providers that provide three
or more services per service day (hospital-based PHP APC 5863) is
$253.08, which is a very slight decrease from $253.76 calculated last
year for CY 2021 ratesetting (85 FR 86080).
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\105\ Each revenue code on the hospital-based PHP claim must
have a HCPCS code and charge associated with it. We multiply each
claim service line's charges by the hospital's department-level CCR;
in CY 2020 and subsequent years, that CCR is determined by using the
PHP-only revenue-code-to-cost-center crosswalk. Only the claims
service lines containing PHP-allowable HCPCS codes and PHP-allowable
revenue codes from the hospital-based PHP claims remaining after
trimming are retained for hospital-based PHP cost determination. The
costs, payments, and service units for all service lines occurring
on the same service date, by the same provider, and for the same
beneficiary are summed. Hospital-based PHP service days must have
three or more services provided to be assigned to hospital-based PHP
APC 5863. The final geometric mean per diem cost for hospital-based
PHP APC 5863 is calculated by taking the nth root of the product of
n numbers, for days where three or more services were provided.
Hospital-based PHP service days with costs 3 standard
deviations from the geometric mean costs within APC 5863 are deleted
and removed from modeling. The remaining hospital-based PHP service
days are used to calculate the final geometric mean per diem cost
for hospital-based PHP APC 5863.
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As we discussed above, we observed a number of changes, likely as a
result of the COVID-19 PHE, in the CY 2020 OPPS claims that we would
ordinarily use for ratesetting, and this includes changes in the claims
for partial hospitalization. We considered what effect this very slight
decrease from the $253.76 calculated last year for the CY 2021 CMHC PHP
APC might have on CMHCs and Medicare beneficiaries. In general, a
decrease of this magnitude would not be unexpected due to normal
variation in cost and claims data. However, recognizing the disruption
[[Page 42153]]
that the ongoing COVID-19 PHE appears to be having on the operations of
hospital-based PHPs, we believe it is important for CMS to continue to
support Medicare beneficiaries' access to critical PHP services during
the COVID-19 PHE by helping to maintain the stability of payments to
PHP providers. While the decrease in the geometric mean per diem cost
for hospital-based PHP APC 5863 would be very slight based on the CY
2019 claims and cost data used for this CY 2022 OPPS/ASC proposed rule,
we continue to believe, as we have stated before in recent years, that
access is better supported when geometric mean per diem costs do not
fluctuate greatly. The proposed cost floor would protect access to PHP
services at hospital-based PHPs if the final CY 2022 calculated
hospital-based PHP APC geometric mean per diem cost is significantly
less. We are concerned that such a decrease may result in a disruption
to hospital-based PHP payments at a time when, as discussed earlier in
section VII.B.2.a of this OPPS/ASC proposed rule, the need for mental
health services has increased. Therefore, we are proposing to calculate
the hospital-based PHP APC 5863 payment rate based on a cost floor to
maintain the geometric mean per diem costs finalized in the prior year,
CY 2021. The final CY 2021 geometric mean per diem cost for hospital-
based PHP APC 5863, which was calculated for the CY 2021 OPPS/ASC final
rule based on CY 2019 claims, is $253.76, which we are proposing as the
cost floor for CY 2022. Therefore, because the calculated geometric
mean per diem cost for hospital-based PHP APC 5863 is below the cost
floor, we are proposing to calculate the CY 2022 hospital-based PHP APC
5863 payment rate based on the cost floor of $253.76. We also propose
that if the final CY 2022 geometric mean per diem cost is calculated to
be higher than $253.76, then we would use the calculated geometric mean
per diem cost.
We continue to recognize, as we have noted in past years, that
changes in costs from a small number of providers can influence the
overall geometric mean per diem cost calculation. We are considering
approaches to address cost fluctuations in future years, however we are
not proposing a methodology at this time.
These proposed CY 2022 PHP geometric mean per diem costs are shown
in Table 34 and are used to derive the proposed CY 2022 PHP APC per
diem rates for CMHCs and hospital-based PHPs. The proposed CY 2022 PHP
APC per diem rates are included in Addendum A to this proposed rule
(which is available on our website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html).\106\
---------------------------------------------------------------------------
\106\ As discussed in section XX. of this CY 2022 OPPS/ASC
proposed rule, OPPS APC geometric mean per diem costs (including PHP
APC geometric mean per diem costs) are divided by the geometric mean
per diem costs for APC 5012 (Clinic Visits and Related Services) to
calculate each PHP APC's unscaled relative payment weight. An
unscaled relative payment weight is one that is not yet adjusted for
budget neutrality. Budget neutrality is required under section
1833(t)(9)(B) of the Act, and ensures that the estimated aggregate
weight under the OPPS for a calendar year is neither greater than
nor less than the estimated aggregate weight that would have been
made without the changes. To adjust for budget neutrality (that is,
to scale the weights), we compare the estimated aggregated weight
using the scaled relative payment weights from the previous calendar
year at issue. We refer readers to the ratesetting procedures
described in Part 2 of the OPPS Claims Accounting narrative and in
section II. of this proposed rule for more information on scaling
the weights, and for details on the final steps of the process that
leads to final PHP APC per diem payment rates. The OPPS Claims
Accounting narrative is available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.
[GRAPHIC] [TIFF OMITTED] TP04AU21.052
C. Proposed Outlier Policy for CMHCs
For 2022, we propose to continue to calculate the CMHC outlier
percentage, cutoff point and percentage payment amount, outlier
reconciliation, outlier payment cap, and fixed dollar- threshold
according to previously established policies. These topics are
discussed in more detail. We refer readers to section II.G.1 of this CY
2022 OPPS/ASC proposed rule for our general policies for hospital
outpatient outlier payments.
1. Background
As discussed in the CY 2004 OPPS final rule with comment period (68
FR 63469 through 63470), we noted a significant difference in the
amount of outlier payments made to hospitals and CMHCs for PHP
services. Given the difference in PHP charges between hospitals and
CMHCs, we did not believe it was appropriate to make outlier payments
to CMHCs using the outlier percentage target amount and threshold
established for hospitals. Therefore, beginning in CY 2004, we created
a separate outlier policy specific to the estimated costs and OPPS
payments provided to CMHCs. We designated a portion of the estimated
OPPS outlier threshold specifically for CMHCs, consistent with the
percentage of projected payments to CMHCs under the OPPS each year,
excluding outlier payments, and established a separate outlier
threshold for CMHCs. This separate outlier threshold for CMHCs resulted
in $1.8 million in outlier payments to CMHCs in CY 2004 and $0.5
million in outlier payments to CMHCs in CY 2005 (82 FR 59381). In
contrast, in CY 2003, more than $30 million was paid to CMHCs in
outlier payments (82 FR 59381).
2. CMHC Outlier Percentage
In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59267
through 59268), we described the current outlier policy for hospital
outpatient payments and CMHCs. We note that we also discussed our
outlier policy for CMHCs in more detail in section VIII.C. of that same
final rule (82 FR 59381). We set our projected target for all OPPS
aggregate outlier payments at 1.0 percent of the estimated aggregate
total payments under the OPPS (82 FR
[[Page 42154]]
59267). This same policy was also reiterated in the CY 2019 OPPS/ASC
final rule with comment period (83 FR 58996), the CY 2020 OPPS/ASC
final rule with comment period (84 FR 61350), and the CY 2021 OPPS/ASC
final rule with comment period (85 FR 86082).
We estimate CMHC per diem payments and outlier payments by using
the most recent available utilization and charges from CMHC claims,
updated CCRs, and the updated payment rate for APC 5853. For increased
transparency, we are providing a more detailed explanation of the
existing calculation process for determining the CMHC outlier
percentages. To calculate the CMHC outlier percentage, we follow three
steps:
Step 1: We multiply the OPPS outlier threshold, which is
1.0 percent, by the total estimated OPPS Medicare payments (before
outliers) for the prospective year to calculate the estimated total
OPPS outlier payments:
(0.01 x Estimated Total OPPS Payments) = Estimated Total OPPS
Outlier Payments.
Step 2: We estimate CMHC outlier payments by taking each
provider's estimated costs (based on their allowable charges multiplied
by the provider's CCR) minus each provider's estimated CMHC outlier
multiplier threshold (we refer readers to section VIII.C.3. of this
proposed rule). That threshold is determined by multiplying the
provider's estimated paid days by 3.4 times the CMHC PHP APC payment
rate. If the provider's costs exceed the threshold, we multiply that
excess by 50 percent, as described in section VIII.C.3. of this
proposed rule, to determine the estimated outlier payments for that
provider. CMHC outlier payments are capped at 8 percent of the
provider's estimated total per diem payments (including the
beneficiary's copayment), as described in section VIII.C.5. of this
proposed rule, so any provider's costs that exceed the CMHC outlier cap
will have its payments adjusted downward. After accounting for the CMHC
outlier cap, we sum all of the estimated outlier payments to determine
the estimated total CMHC outlier payments.
(Each Provider's Estimated Costs--Each Provider's Estimated
Multiplier Threshold) = A. If A is greater than 0, then (A x 0.50) =
Estimated CMHC Outlier Payment (before cap) = B. If B is greater than
(0.08 x Provider's Total Estimated Per Diem Payments), then cap
adjusted- B = (0.08 x Provider's Total Estimated Per Diem Payments);
otherwise, B = B. Sum (B or cap-adjusted B) for Each Provider = Total
CMHC Outlier Payments.
Step 3: We determine the percentage of all OPPS outlier
payments that CMHCs represent by dividing the estimated CMHC outlier
payments from Step 2 by the total OPPS outlier payments from Step 1:
(Estimated CMHC Outlier Payments/Total OPPS Outlier Payments).
We propose to continue to calculate the CMHC outlier percentage
according to previously established policies, and we do not propose any
changes to our current methodology for calculating the CMHC outlier
percentage for CY 2022. Therefore, based on our CY 2022 payment
estimates, CMHCs are projected to receive 0.02 percent of total
hospital outpatient payments in CY 2022, excluding outlier payments. We
propose to designate approximately less than 0.01 percent of the
estimated 1.0 percent hospital outpatient outlier threshold for CMHCs.
This percentage is based upon the formula given in Step 3.
3. Cutoff Point and Percentage Payment Amount
As described in the CY 2018 OPPS/ASC final rule with comment period
(82 FR 59381), our policy has been to pay CMHCs for outliers if the
estimated cost of the day exceeds a cutoff point. In CY 2006, we set
the cutoff point for outlier payments at 3.4 times the highest CMHC PHP
APC payment rate implemented for that calendar year (70 FR 68551). For
CY 2018, the highest CMHC PHP APC payment rate is the payment rate for
CMHC PHP APC 5853. In addition, in CY 2002, the final OPPS outlier
payment percentage for costs above the multiplier threshold was set at
50 percent (66 FR 59889). In CY 2018, we continued to apply the same 50
percent outlier payment percentage that applies to hospitals to CMHCs
and continued to use the existing cutoff point (82 FR 59381).
Therefore, for CY 2018, we continued to pay for partial hospitalization
services that exceeded 3.4 times the CMHC PHP APC payment rate at 50
percent of the amount of CMHC PHP APC geometric mean per diem costs
over the cutoff point. For example, for CY 2018, if a CMHC's cost for
partial hospitalization services paid under CMHC PHP APC 5853 exceeds
3.4 times the CY 2018 payment rate for CMHC PHP APC 5853, the outlier
payment would be calculated as 50 percent of the amount by which the
cost exceeds 3.4 times the CY 2018 payment rate for CMHC PHP APC 5853
[0.50 x (CMHC Cost-(3.4 x APC 5853 rate))]. This same policy was also
reiterated in the CY 2019 OPPS/ASC final rule with comment period (83
FR 58996 through 58997), CY 2020 OPPS/ASC final rule with comment
period (84 FR 61351) and the CY 2021 OPPS/ASC final rule with comment
period (85 FR 86082 through 86083). For CY 2022, we propose to continue
to pay for partial hospitalization services that exceed 3.4 times the
proposed CMHC PHP APC payment rate at 50 percent of the CMHC PHP APC
geometric mean per diem costs over the cutoff point. That is, for CY
2022, if a CMHC's cost for partial hospitalization services paid under
CMHC PHP APC 5853 exceeds 3.4 times the payment rate for CMHC APC 5853,
the outlier payment will be calculated as [0.50 x (CMHC Cost - (3.4 x
APC 5853 rate))].
4. Outlier Reconciliation
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68594
through 68599), we established an outlier reconciliation policy to
address charging aberrations related to OPPS outlier payments. We
addressed vulnerabilities in the OPPS outlier payment system that lead
to differences between billed charges and charges included in the
overall CCR, which are used to estimate cost and would apply to all
hospitals and CMHCs paid under the OPPS. We initiated steps to ensure
that outlier payments appropriately account for the financial risk when
providing an extraordinarily costly and complex service, but are only
being made for services that legitimately qualify for the additional
payment.
For a comprehensive description of outlier reconciliation, we refer
readers to the CY 2019 OPPS/ASC final rules with comment period (83 FR
58874 through 58875 and 81 FR 79678 through 79680).
We propose to continue these policies for partial hospitalization
services provided through PHPs for CY 2022. The current outlier
reconciliation policy requires that providers whose outlier payments
meet a specified threshold (currently $500,000 for hospitals and any
outlier payments for CMHCs) and whose overall ancillary CCRs change by
plus or minus 10 percentage points or more, are subject to outlier
reconciliation, pending approval of the CMS Central Office and Regional
Office (73 FR 68596 through 68599). The policy also includes provisions
related to CCRs and to calculating the time value of money for
reconciled outlier payments due to or due from Medicare, as detailed in
the CY 2009 OPPS/ASC final rule with comment period and in the Medicare
Claims Processing Manual (73 FR 68595 through 68599 and Medicare Claims
Processing internet Only Manual, Chapter 4, Section 10.7.2 and its
subsections, available online at: https://www.cms.gov/Regulations-and-
[[Page 42155]]
Guidance/Guidance/Manuals/Downloads/clm104c04.pdf).
5. Outlier Payment Cap
In the CY 2017 OPPS/ASC final rule with comment period, we
implemented a CMHC outlier payment cap to be applied at the provider
level, such that in any given year, an individual CMHC will receive no
more than a set percentage of its CMHC total per diem payments in
outlier payments (81 FR 79692 through 79695). We finalized the CMHC
outlier payment cap to be set at 8 percent of the CMHC's total per diem
payments (81 FR 79694 through 79695). This outlier payment cap only
affects CMHCs, it does not affect other provider types (that is,
hospital-based PHPs), and is in addition to and separate from the
current outlier policy and reconciliation policy in effect. In the CY
2020 OPPS/ASC final rule with comment period (84 FR 61351), we
finalized a proposal to continue this policy in CY 2020 and subsequent
years. In this proposed rule, we are not proposing any changes to this
policy.
6. Fixed-Dollar Threshold
In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59267
through 59268), for the hospital outpatient outlier payment policy, we
set a fixed--dollar threshold in addition to an APC multiplier
threshold. Fixed-dollar thresholds are typically used to drive outlier
payments for very costly items or services, such as cardiac pacemaker
insertions. CMHC PHP APC 5853 is the only APC for which CMHCs may
receive payment under the OPPS, and is for providing a defined set of
services that are relatively low cost when compared to other OPPS
services. Because of the relatively low cost of CMHC services that are
used to comprise the structure of CMHC PHP APC 5853, it is not
necessary to also impose a fixed-dollar threshold on CMHCs. Therefore,
in the CY 2018 OPPS/ASC final rule with comment period, we did not set
a fixed--dollar threshold for CMHC outlier payments (82 FR 59381). This
same policy was also reiterated in the CY 2020 OPPS/ASC final rule with
comment period (84 FR 61351) and the CY 2021 OPPS/ASC final rule with
comment period (85 FR 86083). We propose to continue this policy for CY
2022.
IX. Proposed Services That Will Be Paid Only as Inpatient Services
A. Background
Established in rulemaking as part of the initial implementation of
the OPPS, the inpatient only (IPO) list identifies services for which
Medicare will only make payment when the services are furnished in the
inpatient hospital setting because of the nature of the procedure, the
underlying physical condition of the patient, or the need for at least
24 hours of postoperative recovery time or monitoring before the
patient can be safely discharged (70 FR 68695). The IPO list was
created based on the premise (rooted in the practice of medicine at
that time), that Medicare should not pay for procedures furnished as
outpatient services that are performed on an inpatient basis virtually
all of the time for the Medicare population, either because of the
invasive nature of the procedures, the need for postoperative care, or
the underlying physical condition of the patient who would require such
surgery, because performing these procedures on an outpatient basis
would not be safe or appropriate, and therefore not reasonable and
necessary under Medicare rules (63 FR 47571). Services included on the
IPO list were those determined to require inpatient care, such as those
that are highly invasive, result in major blood loss or temporary
deficits of organ systems (such as neurological impairment or
respiratory insufficiency), or otherwise require intensive or extensive
postoperative care (65 FR 67826). There are some services designated as
inpatient only that, given their clinical intensity, would not be
expected to be performed in the outpatient setting. For example, we
have traditionally considered certain surgically invasive procedures on
the brain, heart, and abdomen, such as craniotomies, coronary-artery
bypass grafting, and laparotomies, to require inpatient care (65 FR
18456). Designation of a service as inpatient-only does not preclude
the service from being furnished in a hospital outpatient setting, but
means that Medicare will not make payment for the service if it is
furnished to a Medicare beneficiary in the outpatient setting (65 FR
18443). Conversely, the absence of a procedure from the list should not
be interpreted as identifying those procedures as appropriately
performed only in the outpatient setting (70 FR 68696).
As part of the annual update process, we have historically worked
with interested stakeholders, including professional societies,
hospitals, surgeons, hospital associations, and beneficiary advocacy
groups, to evaluate the IPO list and to determine whether services
should be added to or removed from the list. Stakeholders were
encouraged to request reviews for a particular code or group of codes;
and we have asked that their requests include evidence that
demonstrates that the procedure was performed on an outpatient basis in
a safe and appropriate manner in a variety of different types of
hospitals--including but not limited to--operative reports of actual
cases, peer-reviewed medical literature, community medical standards
and practice, physician comments, outcome data, and post-procedure care
data (67 FR 66740).
Prior to CY 2021, we traditionally used five criteria to determine
whether a procedure should be removed from the IPO list (65 FR 18455).
As noted in the CY 2012 OPPS/ASC final rule with comment period (76 FR
74353), we assessed whether a procedure or service met these criteria
to determine whether or not it should be removed from the IPO list and
assigned to an APC group for payment under the OPPS when provided in
the hospital outpatient setting. We have explained that a procedure is
not required to meet all of the established criteria to be removed from
the IPO list. The criteria for assessing procedures for removal from
the IPO list prior to CY 2021 are the following:
Most outpatient departments are equipped to provide the
services to the Medicare population.
The simplest procedure described by the code may be
furnished in most outpatient departments.
The procedure is related to codes that we have already
removed from the IPO list.
A determination is made that the procedure is being
furnished in numerous hospitals on an outpatient basis.
A determination is made that the procedure can be
appropriately and safely furnished in an ASC and is on the list of
approved ASC services or has been proposed by us for addition to the
ASC list.
In the past, we have requested that stakeholders submit
corresponding evidence in support of their claims that a code or group
of codes met the longstanding criteria for removal from the IPO list
and was safe to perform on the Medicare population in the outpatient
setting--including, but not limited to case reports, operative reports
of actual cases, peer-reviewed medical literature, medical professional
analysis, clinical criteria sets, and patient selection protocols. Our
medical advisors thoroughly reviewed all information submitted within
the context of the established criteria and if, following this review,
we determined that there was sufficient evidence to confirm that the
code could be safely
[[Page 42156]]
and appropriately performed on an outpatient basis, we assigned the
services to an APC and included it as a payable procedure under OPPS
(67 FR 66740).
We stated in prior rulemaking that, over time, given advances in
technology and surgical technique, we would continue to evaluate
services to determine whether they should be removed from the IPO list.
Our goal is to ensure that inpatient only designations are consistent
with current standards of practice. We have asserted in prior
rulemaking that, insofar as advances in medical practice mitigate
concerns about these procedures being performed on an outpatient basis,
we would be prepared to remove procedures from the IPO list and provide
for payment for them under the OPPS (65 FR 18443). Prior to CY 2021,
changes to the IPO list have been gradual. Further, CMS has at times
had to reclassify codes as inpatient only services with the emergence
of new information.
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74352 through 74353) for a full discussion of our
historic policies for identifying services that are typically provided
only in an inpatient setting and, therefore, that will not be paid by
Medicare under the OPPS, as well as the criteria we have used to review
the IPO list to determine whether or not any services should be removed
from the list.
In the CY 2021 OPPS/ASC final rule with comment period (85 FR 86084
through 86088), we significantly adjusted our approach to the IPO list.
As we stated in that final rule, we no longer saw the need for CMS to
restrict payment for certain procedures by maintaining the IPO list to
identify services that require inpatient care. In that final rule, we
acknowledged the seriousness of the concerns regarding patient safety
and quality of care that various stakeholders expressed regarding
removing procedures from the IPO list or eliminating the IPO list
altogether. But we stated that we believed that the developments in
surgical technique and technological advances in the practice of
medicine, as well as various safeguards, including, but not limited to,
physician clinical judgment, state and local regulations, accreditation
requirements, medical malpractice laws, hospital conditions of
participation, CMS quality and monitoring initiatives and programs and
other CMS initiatives would continue to ensure that procedures removed
from the IPO list and provided in the outpatient setting could be
performed safely on appropriately selected beneficiaries. We also
stated that given our increasing ability to measure the safety of
procedures performed in the outpatient setting and to monitor the
quality of care, in addition to the other safeguards detailed above, we
believed that quality of care was unlikely to be affected by the
elimination of the IPO list. We noted that we do not require services
that are not included on the IPO list to be performed solely in the
outpatient setting and that services that were previously identified as
inpatient only can continue to be performed in the inpatient setting.
We emphasized that physicians should use their clinical knowledge and
judgment, together with consideration of the beneficiary's specific
needs, to determine whether a procedure can be performed appropriately
in a hospital outpatient setting or whether inpatient care is required
for the beneficiary, subject to the general coverage rules requiring
that any procedure be reasonable and necessary. We also stated that the
elimination of the IPO list would ensure maximum availability of
services to beneficiaries in the outpatient setting. Finally, we
stressed that as medical practice continues to develop, we believed
that the difference between the need for inpatient care and the
appropriateness of outpatient care has become less distinct for many
services.
Accordingly, in the CY 2021 OPPS/ASC final rule with comment period
(85 FR 86084 through 86088), we finalized, with modification, our
proposal to eliminate the IPO list over the course of three years (85
FR 86093). We revised our regulation at Sec. 419.22(n) to state that,
effective on January 1, 2021, the Secretary shall eliminate the list of
services and procedures designated as requiring inpatient care through
a three-year transition. As part of the first phase of this elimination
of the IPO list, we removed 298 codes from the list beginning in CY
2021 and, because we proposed to eliminate the IPO list entirely, the
removed procedures were not assessed against our longstanding criteria
for removal (85 FR 86094).
B. Proposed Changes to the Inpatient Only (IPO) List
In this proposed rule, for CY 2022, we propose to halt the
elimination of the IPO list and, after clinical review of the services
removed from the IPO list in CY 2021 as part of the first phase of
eliminating the IPO list, we propose to add the 298 services removed
from the IPO list in CY 2021 back to the IPO list beginning in CY 2022.
In accordance with this proposal, we propose to amend the regulation at
Sec. 419.22(n) to remove the reference to the elimination of the list
of services and procedures designated as requiring inpatient care
through a three-year transition. We also propose to codify the five
longstanding criteria for determining whether a service or procedure
should be removed from the IPO list in the regulation in a newSec.
419.23.
1. Stakeholder Feedback on Eliminating the IPO List
We received a significant number of stakeholder comments throughout
the CY 2021 rulemaking cycle and following issuance of the final rule
about eliminating the IPO list. Many commenters, including hospital
associations and hospital systems, professional associations, and
medical specialty societies, vociferously opposed eliminating the IPO
list. These commenters primarily cited patient safety concerns, stating
that the IPO list serves as an important programmatic safeguard and
maintains a common standard of medical judgment in the Medicare
program. Stakeholders stated that they support maintaining the IPO list
and consider it an important tool to indicate which services may be
appropriate to furnish in the outpatient setting (by virtue of the
procedures not being on the IPO list) and to ensure that Medicare
beneficiaries receive quality care. Commenters argued that many of the
procedures that we designated as ``inpatient only'' are currently
performed appropriately and safely only in the inpatient setting, and
therefore, should remain on the IPO list. Additionally, commenters
opposed eliminating the IPO list and stated that high-risk, invasive
procedures that require post-operative monitoring would not be safe to
perform on Medicare beneficiaries in an outpatient setting. While some
commenters acknowledged that eliminating the IPO list would provide
increased beneficiary access to care, these commenters were concerned
that the increased access would be to lower quality care.
Many commenters who were opposed to eliminating the IPO list stated
that CMS should retain the current methodology for evaluating and
removing procedures from the IPO list through rulemaking.
Alternatively, several commenters requested that instead of eliminating
the IPO list, CMS should instead maintain the list specifically for a
smaller number of procedures that are complex, surgically invasive, and
that commenters believe should never be performed in the outpatient
setting. The commenters suggested that these procedures be considered
appropriate for inpatient
[[Page 42157]]
hospital admission and payment under Medicare Part A regardless of the
expected length of stay.
While some commenters believed that eliminating the IPO list would
remove regulatory barriers and provide patients with more choices for
where to receive affordable care, other commenters expressed concerns
that eliminating the IPO list would cause administrative and financial
burdens for beneficiaries, hospitals, and payers given the number of
transitioning codes and the speed with which they would be removed from
the list.
A minority of commenters (including providers and trade
associations) supported CMS eliminating the IPO list and stated that
deference should be given to physicians' judgment on site-of-service
decisions. These commenters stated that there is no clinical difference
between a surgery performed on an inpatient versus an outpatient, and
that eliminating the IPO list would create more flexibility for
physicians and beneficiaries. The commenters also believed that
eliminating the IPO list could potentially decrease overall healthcare
costs and improve clinical outcomes for patients.
Commenters who supported delaying the elimination of the IPO list
suggested various timeframes that ranged from three years to seven
years. Several hospital associations recommended we delay eliminating
the IPO list until we address patient safety concerns and provide
national guidelines to identify patients who are appropriate candidates
for care in the inpatient hospital versus outpatient hospital settings.
During the 2021 rulemaking cycle, a few stakeholders suggested that we
remove the proposed musculoskeletal services from the IPO list and then
monitor the transition of those services to the outpatient hospital
setting and the effect on beneficiary outcomes for a period of time
before removing any additional services.
Following the CY 2021 OPPS/ASC final rule with comment period,
stakeholders continued to express concerns regarding the pace at which
the IPO list would be eliminated, the perceived lack of transparency in
determining the order of removal of procedures over the course of the
elimination process, and what stakeholders believed were insufficient
details concerning rate setting for procedures for which payment would
be made when furnished in the HOPD setting, as well as the accuracy of
those rates for the HOPD setting. We have received stakeholder requests
to reconsider the elimination of the IPO list, to reevaluate procedures
removed from the IPO list due to safety and quality concerns, and to,
at a minimum, extend the timeframe for eliminating the list.
2. Proposal To Halt the Elimination of the IPO List in CY 2022
After further consideration of the policy we adopted in last year's
final rule with comment period and the concerns stakeholders have
raised since the final rule was issued, we believe that we should halt
the elimination of the IPO list to ensure that any service removed from
the IPO list is evaluated against the previous longstanding criteria
for removal from the IPO list before it is removed. We believe
assessing whether a procedure or service meets the criteria for removal
would allow for a more gradual removal of services from the IPO list--
which would also allow stakeholders more time to evaluate the safety of
the service in the HOPD and to prepare to safely furnish the services
migrating off of the IPO list, if they so choose.
After further consideration, we continue to believe that the
inpatient only list is a valuable tool for ensuring that the OPPS only
pays for services that can safely be performed in the hospital
outpatient setting, and we have reconsidered eliminating the inpatient
only list at this time. We believe that there are many surgical
procedures that cannot be safely performed on a typical Medicare
beneficiary in the hospital outpatient setting, and therefore, it would
be inappropriate for us to assign them separately payable status
indicators and establish payment rates in the OPPS (78 FR 75055). We
recognize that while physicians are able to make safety determinations
for a specific beneficiary, CMS is in the position to make safety
determinations for the broader population of Medicare beneficiaries,
that is, the typical Medicare beneficiary. While we want to afford
physicians and hospitals the maximum flexibility in choosing the most
clinically appropriate site of service for the procedure, as long as
the characteristics of the procedure are consistent with the criteria
listed above, we believe that the IPO list is a necessary safeguard
that considers the broader Medicare population.
In the CY 2021 OPPS/ASC final rule with comment period, we
recognized that stakeholders may need time to adjust to the removal of
procedures from the list, especially given the significant number of
services removed beginning in CY 2021 (85 FR 86085 and 86092). We
recognized that providers may need time to prepare, update their
billing systems, and gain experience with newly removed procedures
eligible to be paid under either the IPPS or the OPPS (85 FR 86086). We
also acknowledged that it will take time for clinical staff and
providers to gain experience furnishing these services to the
appropriate Medicare beneficiaries in the HOPD, and to develop
comprehensive patient selection criteria and other protocols to
identify whether a beneficiary can safely have these procedures
performed in the outpatient setting (85 FR 86088).
Separately, we also acknowledged the numerous challenges that
providers are facing due to the COVID-19 PHE (85 FR 86089). After
further experience with the PHE and its impact on provider and
beneficiary behavior, we recognize that the COVID-19 PHE has likely
reduced providers' ability to prepare to furnish these services in the
outpatient setting in the manner they would absent the PHE. We
recognize that the COVID-19 PHE may have negatively impacted the time
and resources that providers have to adapt to the removal of these
procedures from the IPO list--making it more difficult for providers to
prepare, update their billing systems, and gain experience with newly
removed procedures eligible to be paid under either the IPPS or the
OPPS. We also recognize that the COVID-19 PHE has negatively impacted
clinical staff and providers' opportunity to develop the comprehensive
patient selection criteria and other protocols necessary to identify
whether a Medicare beneficiary could safely have these procedures
performed in the outpatient setting while guaranteeing them appropriate
quality of care.
After further consideration and review of the additional feedback
from stakeholders, we recognize that the timeframe we finalized in the
CY 2021 final rule with comment period for eliminating the IPO list did
not, and would not, give us a sufficient opportunity to carefully
assess whether a procedure should be payable in the HOPD setting, with
considerations to beneficiary safety and medical advancements. We also
recognize that the unprecedented removal of the 298 codes from the IPO
list transpired quickly. Given the significant policy shift and work
required to operationalize the elimination of the IPO list, we
recognize that more time is required to separately evaluate and
consider the inpatient only classification of each service and its
potential APC assignment. In addition, we believe that we should
continue to use the longstanding criteria for removing services from
the IPO list to evaluate each service before proposing
[[Page 42158]]
to remove it from the list, and, as noted above, we propose to codify
these criteria in the regulation in a new Sec. 419.23.
CMS still believes that as medical practice continues to develop,
the difference between the need for inpatient care and the
appropriateness of outpatient care has become less distinct for many
services. While we recognize that there are services currently
classified as inpatient only that may be appropriate in the outpatient
setting for some Medicare beneficiaries, CMS continues to strive to
balance the goals of increasing physician and patient choice of setting
of care with considerations to patient safety for all Medicare
beneficiaries. We must also consider the timing with which we remove
services from the IPO list and the availability of evidence that may
support the removal of those services. We believe that with additional
time stakeholders can provide supportive evidence to aid in the
evaluations of each individual procedure's assignment to the IPO list,
and where appropriate the APC assignment and corresponding payment for
any codes as well, including but not limited to case reports, operative
reports of actual cases, peer-reviewed medical literature, medical
professional analysis, clinical criteria sets, and patient selection
protocols.
An initial review of 2021 billing data through May 21, 2021,
supports our proposal to halt the elimination of the list, revealing
that 131 of the 298 codes removed from the IPO list in last year's
final rule appeared on either zero or one OPPS claims and 269 of the
298 codes appeared on fewer than 100 claims. These data indicate that
fewer than 3 percent of the services removed from the IPO list in 2021
have seen notable volume in the outpatient setting following their
removal from the IPO list. For perspective, we also note that even
before we removed these codes from the IPO list, it was not uncommon to
see at least some volume for these codes in the claims data. In CY
2020, when these codes were still not payable under the OPPS, 188 of
the codes had at least one outpatient claim and 18 codes had greater
than 100 claims, for reasons undetermined. As a result, it is likely
that not all of the reported claims represent services provided in the
outpatient setting due to these services being removed from the IPO
list in CY 2021.
We propose to halt the elimination of the IPO list in order to
allow for greater consideration of the impact removing services from
the list has on beneficiary safety and to allow providers impacted by
the COVID-19 PHE additional time to prepare to furnish appropriate
services safely and efficiently before continuing to remove large
numbers of services from the list. Below we solicit comments on the
potential future elimination of the IPO list and what commenters
believe the effects of that elimination would be. We also solicit
comment on if CMS should maintain the IPO list but continue to
systematically scale back the list by looking at groups of services
that can safely and effectively be performed in the outpatient setting.
Specifically, CMS is requesting comments on whether CMS should maintain
the longer-term objective of eliminating the IPO list and if so,
suggestions for a reasonable timeline for the elimination and what
method should be employed to evaluate procedure removal. We request
that commenters submit evidence on what effect, if any, they believe
eliminating or scaling back the IPO list will have on beneficiary
quality of care and what effect, if any, would the elimination or
scaling back of the IPO list have on provider behavior, incentives, or
innovation. We are also interested in stakeholders' viewpoints on the
clinical, financial, and administrative impact of removing services
from the IPO list. Additionally, we are interested in stakeholders'
suggestions for refining the approach to inpatient only code evaluation
to keep pace with advances in technology and surgical techniques that
allow for more services to appropriately take place in the outpatient
setting if we were to retain the IPO list.
We reiterate that the removal of a particular procedure from the
IPO list does not require that all beneficiaries be treated in the
hospital outpatient setting, but we are cognizant that it does require
the physician and clinical care team to exercise complex medical
judgment to determine the appropriate setting of care, in accordance
with the two-midnight rule guidance. The services that we are proposing
to maintain or add back to the IPO list reflect those services that we
believe may pose increased safety risk to the typical Medicare
beneficiary. However, we recognize that there may be a subset of
Medicare beneficiaries who, on a case by case basis, may nonetheless be
appropriate to treat in the outpatient setting; and we seek comment
below on whether any services that were removed in CY 2021, but are
being proposed to be added back to the IPO for CY 2022, should in fact,
remain off the IPO list.
3. Proposal To Return Procedures Removed in CY 2021 to the IPO List for
CY 2022
CMS continues to believe that physicians must use their clinical
knowledge and judgment, together with consideration of the
beneficiary's needs, to determine the appropriate site of service, but
we recognize that the broad removal of services from the IPO list in CY
2021 did not assess whether procedures proposed for removal met the
longstanding removal criteria that we have historically used in
consideration of the typical Medicare beneficiary. We also recognize
that given the clinical intensity of some of the services removed from
the IPO list (which include, for example, amputations), the 298 codes
that were removed from the list included services that clinically would
not be expected to be performed in the outpatient setting and would be
unlikely to meet the criteria. As discussed previously, to ensure
beneficiary safety, we have historically used longstanding criteria to
determine if a procedure should be removed from the IPO list, but the
removed procedures were not assessed against these criteria as part of
the broad removal of services from the IPO list in CY 2021 because we
proposed to eliminate the IPO list entirely. After further
consideration, we believe it is important to continue to assess whether
services individually meet any of the criteria for removal from the IPO
list before being removed. Further, CMS recognizes that the impact of
the COVID-19 PHE on providers' ability to safely and comprehensively
prepare to furnish these services in the outpatient setting may be
greater than previously anticipated. After a clinical review and an
evaluation using the five longstanding criteria for removing services
from the IPO list discussed earlier in Section IX(A) we now believe
that the services removed from the IPO list in CY 2021 do not currently
meet our longstanding removal criteria and we propose to add them back
to the IPO list for CY 2022.
As discussed earlier in Section IX(A), we typically evaluate
whether a service should be removed from the IPO list using five
criteria and, while a service does not need to meet all of the criteria
to be removed from the IPO list, it should meet at least one criterion
and the case for removing the service from the IPO list is strengthened
with the more criteria the service meets. For CY 2021, in light of our
proposal to eliminate the IPO list over a three-year transition, we
proposed that musculoskeletal services would be the
[[Page 42159]]
first group of services removed from the IPO list. We stated that we
proposed to remove this group of services first for several reasons. In
recent years, due to new technologies and advances in surgical care
protocols, expedited rehabilitation protocols, and significant
enhancements in postoperative processes, we have removed TKA and THA,
which are both musculoskeletal services, from the IPO list. During the
process of proposing and finalizing removing TKA and THA from the IPO
list, stakeholders have continuously requested that CMS remove other
musculoskeletal services from the IPO list as well, citing shortened
length of stay times, advancements in technologies and surgical
techniques, and improved postoperative processes. Additionally, we
noted that, more often than not, stakeholders historically requested
that we remove musculoskeletal services from the IPO list more than
other types of services. We also recognized that there is already a set
of comprehensive APCs for musculoskeletal services for payment under
the OPPS, which facilitates payment for these services and further
supported their removal for CY 2021. Specifically, because we have
previously removed codes from the IPO list that are similar clinically
and in terms of resource cost and assigned them to these comprehensive
APCs, we explained that these APCs generally describe appropriate
ranges for the musculoskeletal codes removed in CY 2021, which we
believed allowed for appropriate payment. We also proposed to remove
additional related services that were recommended for removal by
stakeholders during the annual HOP panel meeting.
As stated above, because these services were being removed from the
IPO list as the first phase of the elimination of the list, we did not
evaluate each of these services against the longstanding criteria for
removing a service from the IPO list. While a number of commenters
supported the removal of the 298 services, the vast majority of
commenters were opposed to removing the services and shared concerns
regarding their inability to properly review the clinical nature of
this large number of procedures and to provide comprehensive feedback
on their removal from the list. Some commenters were able to review the
individual services and requested that specific CPT codes remain
payable in the inpatient setting only, including CPT codes 27280
(Arthrodesis, open, sacroiliac joint, including obtaining bone graft,
including instrumentation, when performed) and 22857 (Total disc
arthroplasty (artificial disc), anterior approach, including discectomy
to prepare interspace (other than for decompression), single
interspace, lumbar) due to concerns about the safety of these
procedures if they are performed in the outpatient setting.
As previously stated in the CY 2021 final rule (85 FR 86087), an
overwhelming number of stakeholders supported the previously
established methodology for identifying appropriate changes to the IPO
list. CMS received numerous requests to continue to use the established
criteria to review and analyze services proposed for removal as opposed
to removing large numbers of services in groups or categories.
Commenters noted that they preferred the historical process for
assessing services for removal from the IPO list using the five
criteria, as they believed this process was more manageable for
patients, providers, and other like stakeholders, allowing them to
provide meaningful input on a procedure-by-procedure basis. Because we
are proposing to halt elimination of the IPO list, we also believe it
is appropriate to continue to evaluate services that we propose for
removal against the longstanding criteria, and include with our
proposals an in depth analysis of whether most outpatient departments
are equipped to provide the services to the Medicare population;
whether the simplest procedure described by the code may be performed
in most outpatient departments; whether the procedure is related to
codes that we have already removed from the IPO list; our determination
of whether the procedure is being performed in numerous hospitals on an
outpatient basis; and our determination of whether the procedure can be
appropriately and safely performed in an ASC, is on the list of
approved ASC procedures, or has been proposed by us for addition to the
ASC list. Historically, we have included discussions of the individual
codes proposed for removal in the proposed rule and stakeholders have
had the opportunity to comment in kind with evidence in support of or
opposition to the service's assignment to the IPO list, and we believe
it is appropriate to continue to do so.
In light of ongoing stakeholder feedback, we have now, for CY 2022,
reviewed each of the procedures removed from the IPO list in CY 2021 to
determine whether they individually meet the longstanding criteria for
removal from the list. Our review considered the clinical intensity and
characteristics of the service, the underlying condition of the
beneficiary who would require the service, peer-reviewed medical
literature, case reports, clinical criteria sets, and utilization data.
This review determined that none of the services removed in CY 2021
have sufficient supporting evidence that the service can be safely
performed on the Medicare population in the outpatient setting, that
most outpatient departments are equipped to provide the services to the
Medicare population, or that the services are being performed safely on
an outpatient basis. For a large number of the removed services, we did
not find vignettes, claims or utilization data, or literature to
support their removal under our longstanding criteria. For the few
services that did have some data supporting their removal from the
list, we found the data to be either incomplete or to be countered by
conflicting data. For example, a few services, including CPT code 21627
(sternal debridement), showed increasing migration to the outpatient
setting, but we could not locate supportive medical literature case
studies, or outcomes data to support that the services are safe for the
Medicare population in the outpatient setting. Some services, such as
CPT code 22558 (Lumbar spine fusion) and CPT code 23472 (reconstruct
shoulder joint), show increasing outpatient claims data, but have high
length of stay times and extensive post-operative care needs that
indicate these services may not be appropriate for the Medicare
population in the outpatient setting. Other services, such as CPT code
22846 (Anterior instrumentation; 4 to 7 vertebral segments), lack
medical literature or case studies, lack supportive claims data, and
have conflicting stakeholder feedback for the safety of the service in
the outpatient setting. We were unable to find literature and data for
services that included outcomes specific to the Medicare population,
particularly in the outpatient setting.
Given that our review of each of the services removed from the list
in CY 2021 using the five criteria mentioned in Section IX(A) did not
find sufficient evidence that any of these services would be safe to
perform on the Medicare population in the outpatient setting, we do not
believe it would be appropriate for Medicare to pay for these services
when performed in an outpatient setting. In particular, we found that
the simplest procedures described by the codes for these services
cannot be furnished safely in most outpatient departments, most
outpatient departments are not equipped to
[[Page 42160]]
provide these services to the Medicare population, and the procedures
are not being performed in numerous hospitals on an outpatient basis.
We also do not believe the services can be appropriately and safely
furnished in an ASC.
As a result of this review, we are proposing to return all of the
procedures removed in last year's final rule to the IPO list for CY
2022 because we do not believe they meet the previously established
criteria for removal from the IPO list. Therefore, after further
clinical review and additional consideration of safety and quality of
care concerns for the group of services removed from the IPO list in
the CY 2021 final rule, for CY 2022 we are proposing to return these
298 services to the IPO list, as shown in Table 35 below. The complete
list of codes describing services that we propose to designate as
inpatient-only services beginning in CY 2022 is included as Addendum E
to this CY 2022 OPPS/ASC proposed rule, which is available via the
internet on the CMS website.
We solicit public comment on whether there are services that were
removed from the IPO list in CY 2021 that stakeholders believe do meet
the longstanding criteria for removing services from the IPO list and
should continue to be payable in the outpatient setting in CY 2022. If
so, we request that commenters submit corresponding evidence--
including, but not limited to, case reports, operative reports of
actual cases, peer-reviewed medical literature, medical professional
analysis, clinical criteria sets, and patient selection protocols--that
the service meets the longstanding criteria for removal from the IPO
list and is safe to perform on the average Medicare population in the
outpatient setting.
As mentioned above, the services that we are proposing to add back
to the IPO list reflect those services that we believe may pose
increased safety risk to the typical Medicare beneficiary. However, we
recognize that there may be a subset of Medicare beneficiaries who, on
a case by case basis, may nonetheless be appropriate to treat in the
outpatient setting and we seek comment below on whether any services
that were removed in CY 2021, but are being proposed to be added back
to the IPO for CY 2022, should in fact, remain off the IPO list.
Table 35 below contains the proposed additions to the IPO list for
CY 2022.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP04AU21.053
[[Page 42161]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.054
[[Page 42162]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.055
[[Page 42163]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.056
[[Page 42164]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.057
[[Page 42165]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.058
[[Page 42166]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.059
[[Page 42167]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.060
[[Page 42168]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.061
[[Page 42169]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.062
[[Page 42170]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.063
[[Page 42171]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.064
[[Page 42172]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.065
[[Page 42173]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.066
[[Page 42174]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.067
[[Page 42175]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.068
BILLING CODE 4120-01-C
[[Page 42176]]
4. Topics and Questions Posed for Public Comments
In addition to our proposal to halt the elimination of the IPO list
and return services summarily removed from the IPO list last year that
our clinicians have determined do not meet the criteria for removal
from the IPO list, as provided in Table 35, we are also interested in
feedback from stakeholders on whether CMS should maintain the longer-
term objective of eliminating the IPO list or if CMS should maintain
the IPO list but continue to systematically scale the list back to so
that inpatient only designations are consistent with current standards
of practice. Specifically, CMS is requesting comments on the following:
Should CMS maintain the longer-term objective of
eliminating the IPO list? If so, what is a reasonable timeline for
eliminating the list? What method do stakeholders suggest CMS use to
approach removing codes from the list?
Should CMS maintain the IPO list but continue to
streamline the list of services included on the list and, if so,
suggestions for ways to systematically scale the list back to allow for
the removal of codes, or groups of codes, that can safely and
effectively be performed on a typical Medicare beneficiary in the
hospital outpatient setting so that inpatient only designations are
consistent with current standards of practice?
What effect do commenters believe the elimination or
scaling back of the IPO list would have on safety and quality of care
for Medicare beneficiaries?
What effect do commenters believe elimination or the
scaling back of the IPO list would have on provider behavior,
incentives, or innovation?
What information or support would be helpful for providers
and physicians in their considerations of site-of-service selections?
Should CMS's clinical evaluation of the safety of a
service in the outpatient setting consider the safety and quality of
care for the typical Medicare beneficiary or a smaller subset of
Medicare beneficiaries for whom the outpatient provision of a service
may have fewer risk factors?
Are there services that were removed from the IPO list in
CY 2021 that stakeholders believe meet the longstanding criteria for
removal from the IPO list and should continue to be payable in the
outpatient setting in CY 2022? If so, what evidence supports the
conclusion that the service meets the longstanding criteria for removal
from the IPO list and is safe to perform on the Medicare population in
the outpatient setting?
X. Proposed Nonrecurring Policy Changes
A. Proposed Medical Review of Certain Inpatient Hospital Admissions
Under Medicare Part A for CY 2022 and Subsequent Years
1. Background on the 2-Midnight Rule
In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50913 through
50954), we clarified our policy regarding when an inpatient admission
is considered reasonable and necessary for purposes of Medicare Part A
payment. Under this policy, we established a benchmark providing that
surgical procedures, diagnostic tests, and other treatments would be
generally considered appropriate for inpatient hospital admission and
payment under Medicare Part A when the physician expects the patient to
require a stay that crosses at least 2 midnights and admits the patient
to the hospital based upon that expectation. Conversely, when a
beneficiary enters a hospital for a surgical procedure not designated
as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n),
a diagnostic test, or any other treatment, and the physician expects to
keep the beneficiary in the hospital for only a limited period of time
that does not cross 2 midnights, the services would be generally
inappropriate for payment under Medicare Part A, regardless of the hour
that the beneficiary came to the hospital or whether the beneficiary
used a bed. With respect to services designated under the OPPS as IPO
list procedures, we explained that because of the intrinsic risks,
recovery impacts, or complexities associated with such services, these
procedures would continue to be appropriate for inpatient hospital
admission and payment under Medicare Part A regardless of the expected
length of stay. We also indicated that there might be further ``rare
and unusual'' exceptions to the application of the benchmark, which
would be detailed in subregulatory guidance.
In the FY 2014 IPPS/LTCH PPS final rule (78 FR 50913 through
50954), we also finalized the 2-Midnight presumption, which is related
to the 2-Midnight benchmark but is a separate medical review policy.
The 2-Midnight benchmark represents guidance to reviewers to identify
when an inpatient admission is generally reasonable and necessary for
purposes of Medicare Part A payment, while the 2-Midnight presumption
relates to instructions to medical reviewers regarding the selection of
claims for medical review. Specifically, under the 2-Midnight
presumption, inpatient hospital claims with lengths of stay greater
than 2 midnights after the formal admission following the order are
presumed to be appropriate for Medicare Part A payment and are not the
focus of medical review efforts, absent evidence of systematic gaming,
abuse, or delays in the provision of care in an attempt to qualify for
the 2-Midnight presumption.
In the CY 2016 OPPS/ASC final rule with comment period (80 FR 70538
through 70549), we revisited the previous rare and unusual exceptions
policy and finalized a proposal to allow for case-by-case exceptions to
the 2-Midnight benchmark, whereby Medicare Part A payment may be made
for inpatient admissions where the admitting physician does not expect
the patient to require hospital care spanning 2 midnights, if the
documentation in the medical record supports the physician's
determination that the patient nonetheless requires inpatient hospital
care.
In the CY 2016 OPPS/ASC final rule with comment period, we
reiterated our position that the 2-Midnight benchmark provides clear
guidance on when a hospital inpatient admission is appropriate for
Medicare Part A payment, while respecting the role of physician
judgment. We stated that the following criteria will be relevant to
determining whether an inpatient admission with an expected length of
stay of less than 2 midnights is nonetheless appropriate for Medicare
Part A payment:
Complex medical factors such as history and comorbidities;
The severity of signs and symptoms;
Current medical needs; and
The risk of an adverse event.
The exceptions for procedures on the IPO list and for ``rare and
unusual'' circumstances designated by CMS as national exceptions were
unchanged by the CY 2016 OPPS/ASC final rule with comment period.
As we stated in the CY 2016 OPPS/ASC final rule with comment
period, the decision to formally admit a patient to the hospital is
subject to medical review. For instance, for cases where the medical
record does not support a reasonable expectation of the need for
hospital care crossing at least 2 midnights, and for inpatient
admissions not related to a surgical procedure specified by Medicare as
an IPO procedure under 42 CFR 419.22(n) or for which there is not a
national exception, payment of the claim under Medicare Part A is
subject to the clinical judgment
[[Page 42177]]
of the medical reviewer. The medical reviewer's clinical judgment
involves the synthesis of all submitted medical record information (for
example, progress notes, diagnostic findings, medications, nursing
notes, and other supporting documentation) to make a medical review
determination on whether the clinical requirements in the relevant
policy have been met. In addition, Medicare review contractors must
abide by CMS' policies in conducting payment determinations, but are
permitted to take into account evidence-based guidelines or commercial
utilization tools that may aid such a decision. While Medicare review
contractors may continue to use commercial screening tools to help
evaluate the inpatient admission decision for purposes of payment under
Medicare Part A, such tools are not binding on the hospital, CMS, or
its review contractors. This type of information also may be
appropriately considered by the physician as part of the complex
medical judgment that guides their decision to keep a beneficiary in
the hospital and formulation of the expected length of stay.
2. Current Policy for Medical Review of Inpatient Hospital Admissions
for Procedures Removed From the Inpatient Only List
In the CY 2020 OPPS/ASC final rule with comment period we finalized
a policy to exempt procedures that have been removed from the IPO list
from certain medical review activities to assess compliance with the 2-
Midnight rule within the 2 calendar years following their removal from
the IPO list. We stated that these procedures will not be considered by
the Beneficiary and Family-Centered Care Quality Improvement
Organizations (BFCC-QIOs) in determining whether a provider exhibits
persistent noncompliance with the 2-Midnight rule for purposes of
referral to the RAC nor will these procedures be reviewed by RACs for
``patient status.'' We explained that during this 2-year period, BFCC-
QIOs will have the opportunity to review such claims in order to
provide education for practitioners and providers regarding compliance
with the 2-Midnight rule, but claims identified as noncompliant will
not be denied with respect to the site-of-service under Medicare Part
A.
In CY 2021 we proposed to continue the 2-year exemption from site-
of-service claim denials, BFCC-QIO referrals to RACs, and RAC reviews
for ``patient status'' (that is, site-of-service) for procedures that
are removed from the IPO list under the OPPS beginning on January 1,
2021. However, we finalized our proposal with modifications in the CY
2021 OPPS/ASC final rule with comment period. Instead of the 2-year
exemption, procedures removed from the IPO list after January 1, 2021
were indefinitely exempted from site-of-service claim denials under
Medicare Part A, eligibility for BFCC-QIO referrals to RACs for
noncompliance with the 2-Midnight rule, and RAC reviews for ``patient
status'' (that is, site-of-service). We stated that this exemption
would last until we have Medicare claims data indicating that the
procedure is more commonly performed in the outpatient setting than the
inpatient setting. Thus, for the exemption to end for a specific
procedure, in a single calendar year we would need to have Medicare
claims data indicating that the procedure was performed more than 50
percent of the time in the outpatient setting. We stated that we would
revisit in rulemaking whether an exemption for a procedure should be
ended or whether we may consider additional metrics in the future that
could assist us in determining when the exemption period should end for
a procedure. Even during this exemption period, the BFCC-QIOs retain
the authority to review such claims in order to provide education for
practitioners and providers regarding compliance with the 2-Midnight
rule, but claims identified as noncompliant will not be denied with
respect to the site-of-service under Medicare Part A. Additionally, we
stated that we may still conduct medical review in cases in which we
believe there is potential fraud or abuse occurring. We explained that
the elimination of the IPO list was a large scale change that created
brand new considerations in determining site-of-service for providers
and beneficiaries. At the time we believed a change of this
significance required us to reevaluate our stance on the exemption
period for procedures removed from the IPO list.
Finally, in the CY 2021 OPPS/ASC final rule with comment period we
amended 42 CFR 412.3 to clarify when a procedure removed from the IPO
is exempt from certain medical review activities. We stated that for
those services and procedures removed between January 1 and December
31, 2020, this exemption will last for 2 years from the date of such
removal. For those services and procedures removed on or after January
1, 2021, this exemption will last until the Secretary determines that
the service or procedure is more commonly performed in the outpatient
setting.
3. Medical Review of Inpatient Hospital Admissions for Procedures
Removed From the Inpatient Only List for CY 2022 and Subsequent Years
As stated earlier in this section, services on the IPO list are not
subject to the 2-Midnight rule for purposes of determining whether
payment is appropriate under Medicare Part A. However, the 2-Midnight
rule is applicable once services have been removed from the IPO list.
Outside of the exemption periods discussed above, services that have
been removed from the IPO list are subject to initial medical reviews
of claims for short-stay inpatient admissions conducted by BFCC-QIOs.
BFCC-QIOs may also refer providers to the RACs for further medical
review due to exhibiting persistent noncompliance with Medicare payment
policies, including, but not limited to:
Having high denial rates;
Consistently failing to adhere to the 2-Midnight rule; or
Failing to improve their performance after QIO educational
intervention.
However, as finalized in the CY 2021 OPPS/ASC final rule with
comment period, procedures that have been removed from the IPO list
January 1, 2021 or later were indefinitely exempted from site-of-
service claim denials under Medicare Part A, eligibility for BFCC-QIO
referrals to RACs for noncompliance with the 2-Midnight rule, and RAC
reviews for ``patient status'' (that is, site-of-service). We stated
that this exemption would last until we have Medicare claims data
indicating that the procedure is more commonly performed in the
outpatient setting than the inpatient setting.
As stated in section IX, CMS is proposing to halt the elimination
of the IPO list. In accordance with this proposal, we are proposing to
amend 42 CFR 419.22(n) to remove the reference to the elimination of
the list of services and procedures designated as requiring inpatient
care through a three-year transition. We are also proposing to return
298 procedures removed from the IPO list in CY 2021 to the IPO list for
CY 2022.
Regardless of the status of the IPO list, we believe that the 2-
Midnight benchmark remains an important metric to help guide when Part
A payment for inpatient hospital admissions is appropriate. As
technology advances and more services may be safely performed in the
hospital outpatient setting and paid under the OPPS, it is
[[Page 42178]]
increasingly important for physicians to exercise their clinical
judgment in determining the generally appropriate clinical setting for
their patient to receive a procedure, whether that be as an inpatient
or on an outpatient basis. Importantly, removal of a service from the
IPO list has never meant that a beneficiary cannot receive the service
as a hospital inpatient--as always, the physician should use his or her
complex medical judgment to determine the appropriate setting on a case
by case basis.
As stated previously, our current policy regarding IPO list
procedures is that they are appropriate for inpatient hospital
admission and payment under Medicare Part A regardless of the expected
length of stay. Halting the elimination of the IPO list would mean that
this will remain true for all services that are still on the list. As
in previous years, any services that are removed from the list in the
future will be subject to the 2-Midnight benchmark and 2-Midnight
presumption. This means that for services removed from the IPO list,
under the 2-Midnight presumption, inpatient hospital claims with
lengths of stay greater than 2 midnights after admission will be
presumed to be appropriate for Medicare Part A payment and would not be
the focus of medical review efforts, absent evidence of systematic
gaming, abuse, or delays in the provision of care in an attempt to
qualify for the 2-Midnight presumption. Additionally, under the 2-
Midnight benchmark, services formerly on the IPO list will be generally
considered appropriate for inpatient hospital admission and payment
under Medicare Part A when the physician expects the patient to require
a stay that crosses at least 2 midnights and admits the patient to the
hospital based upon that expectation.
As finalized in the CY 2021 OPPS/ASC final rule with comment
period, procedures removed from the IPO list after January 1, 2021 were
indefinitely exempted from site-of-service claim denials under Medicare
Part A, eligibility for BFCC-QIO referrals to RACs for noncompliance
with the 2-Midnight rule, and RAC reviews for ``patient status'' (that
is, site-of-service). These procedures are not considered by the BFCC-
QIOs in determining whether a provider exhibits persistent
noncompliance with the 2-Midnight rule for purposes of referral to the
RAC nor will claims for these procedures be reviewed by RACs for
``patient status.'' During the exemption period, BFCC-QIOs have the
opportunity to review such claims in order to provide education for
practitioners and providers regarding compliance with the 2-Midnight
rule, but claims identified as noncompliant are not denied with respect
to the site-of-service under Medicare Part A. Again, information
gathered by the BFCC-QIO when reviewing procedures as they are newly
removed from the IPO list can be used for educational purposes and does
not result in a claim denial during the exemption period.
Because we are proposing to halt the elimination of the IPO list
and add 298 services that were removed back to the IPO list, we believe
this proposed change requires us to reexamine the applicable exemption
period. We noted in the CY 2021 OPPS/ASC final rule with comment period
that we may shorten the exemption period for a procedure if necessary.
We heard from many commenters last year that the 2-year exemption was
appropriate when CMS was removing a smaller volume of procedures from
the IPO list. However, commenters believed that the unprecedented
volume of procedures becoming subject to the 2-Midnight rule with the
phased elimination of the IPO list would necessitate a longer exemption
period. While these commenters expressed their support for continuing
the 2-year exemption, they further stated that a longer exemption
period may be more appropriate. Some commenters suggested that anywhere
between 3 to 6 years or indefinitely would be appropriate. Commenters
expressed their belief that increasing the length of the exemption
would be necessary to allow hospitals and practitioners sufficient time
to adjust their billing and clinical systems, as well as processes used
to determine the appropriate setting of care. For a full description of
the comments received please refer to the CY 2021 OPPS/ASC final rule
with comment period (85 FR 86115).
We believe that the indefinite exemption was appropriate when the
agency was removing an unprecedented volume of procedures from the IPO
list in a short period of time. That would have resulted in a large
number of procedures becoming subject to the 2-Midnight rule in a
three-year span. However, should we finalize our proposal to halt the
elimination of the IPO list, there will no longer be an unprecedented
volume of procedures removed from the IPO list at once, and thus the
indefinite exemption may no longer be appropriate. As we explained in
the CY 2021 OPPS/ASC final rule with comment period, the indefinite
exemption was necessary given the magnitude of the change for
providers. Now, however, we are proposing to move toward a much smaller
volume of procedures becoming subject to the 2-Midnight rule at one
time. We believe that, in the event that we finalize the proposed halt
in the elimination of the IPO list, an indefinite exemption from
medical review activities related to the 2-Midnight rule will no longer
be warranted.
We continue to believe that, in order to facilitate compliance with
our payment policy for inpatient admissions, some exemption from
certain medical review activities for services removed from the IPO
list under the OPPS is appropriate. Accordingly, we propose to rescind
the indefinite exemption and instead apply a 2-year exemption from two
midnight medical review activities for services removed from the IPO
list on or after January 1, 2021. As finalized in the CY 2020 OPPS/ASC
final rule with comment period, and unchanged by the CY 2021
rulemaking, services removed from the IPO list between January 1 and
December 30, 2020, are currently subject to a 2-year exemption.
Accordingly, under this proposal, the same 2-year exemption would apply
to all service removed from the IPO list on or after January 1, 2020.
As we explained in the CY 2020 OPPS/ASC final rule with comment period,
we believe that a 2-year exemption from certain medical review
activities for procedures removed from the IPO list would allow
sufficient time for providers to become more familiar with how to
comply with the 2-Midnight rule and for hospitals and clinicians to
become used to the availability of payment under both the hospital
inpatient and outpatient setting for procedures removed from the IPO
list. Should we finalize our proposal to halt the elimination of the
IPO list, we believe that this rationale applies equally to the smaller
number of services that may be removed from the list at any one time in
the future, and thus that the same 2-year exemption period is
appropriate.
As with the previous 2-year exemption period for services removed
from the IPO list between January 1 and December 30, 2020, applying a
2-year exemption period to services removed from the IPO list on or
after January 1, 2021, would allow providers time to gather information
on procedures newly removed from the IPO list to help inform education
and guidance for the broader provider community, develop patient
selection criteria to identify which patients are, and are not,
appropriate candidates for outpatient procedures, and to develop
related policy protocols. We believe that this exemption period would
aid in
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compliance with our payment policy for inpatient admissions.
It is important to note that whether there is a limited timeframe
or an indefinite exemption from the specified medical review
activities, providers are still expected to comply with the 2-Midnight
rule. It is also important to note that the 2-Midnight rule does not
prohibit procedures from being performed or billed on an inpatient
basis. Whether a procedure has an exemption or not does not change what
site of service is medically necessary or appropriate for an individual
beneficiary. Providers are still expected to use their complex medical
judgment to determine the appropriate site of service for each patient
and to bill in compliance with the 2-Midnight rule. The exemption is
not from the 2-Midnight rule but from certain medical review procedures
and site-of-service claim denials.
Absent the removal of an unprecedented number of services at once
from the IPO list, we continue to believe that a 2-year exemption from
BFCC-QIO referral to RACs and RAC ``patient status'' review of the
setting for procedures removed from the IPO list under the OPPS and
performed in the inpatient setting would be an adequate amount of time
to allow providers to gain experience with application of the 2-
Midnight rule to these procedures and the documentation necessary for
Part A payment for those patients for which the admitting physician
determines that the procedures should be furnished in an inpatient
setting. Furthermore, it is our belief that the 2-year exemption from
referrals to RACs, RAC patient status review, and claims denials would
be sufficient to allow providers time to update their billing systems
and gain experience with respect to newly removed procedures eligible
to be paid under either the IPPS or the OPPS, while avoiding potential
adverse site-of-service determinations. We solicit public comments
regarding the appropriate period of time for this exemption. Commenters
may indicate whether and why they believe the 2-year period is
appropriate, or whether they believe a longer or shorter exemption
period would be more appropriate.
In summary, for CY 2021 and subsequent years, we propose to return
to the 2-year exemption from site-of-service claim denials, BFCC-QIO
referrals to RACs, and RAC reviews for ``patient status'' (that is,
site-of-service) for procedures that are removed from the IPO list
under the OPPS on January 1, 2021 or later. Under this proposal,
services removed beginning on January 1, 2021 would receive the same 2-
year exemption from 2-Midnight medical review activities as currently
applies to services removed between January 1 and December 30, 2020,
and not the indefinite exemption finalized in the CY 2021 OPPS/ASC
final rule with comment period. We encourage BFCC-QIOs to review these
cases for medical necessity in order to educate themselves and the
provider community on appropriate documentation for Part A payment when
the admitting physician determines that it is medically reasonable and
necessary to conduct these procedures on an inpatient basis. We note
that we will monitor changes in site-of-service to determine whether
changes may be necessary to certain CMS Innovation Center models. While
we are proposing to halt the elimination of the IPO list, we are
seeking comment on whether a 2-year time period is appropriate, or if a
longer or shorter period may be more warranted. If we do not finalize
our proposal to halt the elimination of the IPO list we may continue
with the indefinite exemptions. Finally, we are proposing to amend
Sec. 412.3 of the Code of Federal Regulations to clarify when a
procedure removed from the IPO list is exempt from certain medical
review activities. For all services and procedures removed after
January 1, 2020, this exemption will last for 2 years from the date of
such removal. This would include those services and procedures removed
on or after January 1, 2021, for which this exemption would also be for
2 years from the date of such removal.
B. Changes to Beneficiary Coinsurance for Certain Colorectal Cancer
Screening Tests
Section 122 of the Consolidated Appropriations Act (CAA) of 2021
(Pub. L. 116-260), Waiving Medicare Coinsurance for Certain Colorectal
Cancer Screening Tests, amends section 1833(a) of the Act to offer a
special coinsurance rule for screening flexible sigmoidoscopies and
screening colonoscopies, regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for the
removal of tissue or other matter or other procedure, that is furnished
in connection with, as a result of, and in the same clinical encounter
as the colorectal cancer screening test. The reduced coinsurance will
be phased in beginning January 1, 2022. Currently, the addition of any
procedure beyond a planned colorectal cancer screening test (for which
there is no coinsurance), results in the beneficiary having to pay
coinsurance.
Section 1861(pp) of the Act defines ``colorectal cancer screening
tests'' and, under sections 1861(pp)(1)(B) and (C) of the Act,
identifies ``screening flexible sigmoidoscopy'' and ``screening
colonoscopy'' as two of the recognized procedures. During the course of
either one of these two procedures, removal of tissue or other matter
may become necessary for diagnostic purposes. Among other things,
section 1861(pp)(1)(D) of the Act authorizes the Secretary to include
in the definition, other tests or procedures and modifications to the
tests and procedures described under this subsection, with such
frequency and payment limits as the Secretary determines appropriate,
in consultation with appropriate organizations. Section 1861(s)(2)(R)
of the Act includes colorectal cancer screening tests in the definition
of the medical and other health services that fall within the scope of
Medicare Part B benefits described in section 1832(a)(1) of the Act.
Section 1861(ddd)(3) of the Act includes colorectal cancer screening
tests within the definition of ``preventive services.'' In addition,
section 1833(a)(1)(Y) of the Act provides for payment for a preventive
service under the PFS at 100 percent of the lesser of the actual charge
or the fee schedule amount for these colorectal cancer screening tests,
and under the OPPS at 100 percent of the OPPS payment amount, when the
preventive service is recommended by the United States Preventive
Services Task Force (USPSTF) with a grade of A or B. As such, there is
no beneficiary coinsurance for recommended colorectal cancer screening
tests as defined in section 1861(pp)(1) of the Act.
Under these statutory provisions, we have issued regulations
governing payment for colorectal cancer screening tests at Sec.
410.152(l)(5). We pay 100 percent of the Medicare payment amount
established under the applicable payment methodology for the setting
for providers and suppliers, and beneficiaries are not required to pay
Part B coinsurance for colorectal cancer screening tests (except for
barium enemas, which are not recommended by the USPSTF with a grade of
A or B).
In addition to colorectal cancer screening tests, which typically
are furnished to patients in the absence of signs or symptoms of
illness or injury, Medicare also covers various diagnostic tests (see
Sec. 410.32). In general, diagnostic tests must be ordered by the
physician or practitioner who is treating the beneficiary and who uses
the results of the diagnostic test in the management of the patient's
specific medical
[[Page 42180]]
condition. Under Part B, Medicare may cover flexible sigmoidoscopies
and colonoscopies as diagnostic tests when those tests are reasonable
and necessary as specified in section 1862(a)(1)(A) of the Act. When
these services are furnished as diagnostic tests rather than as
screening tests, patients are responsible for the 20 percent of the
Part B coinsurance associated with these services.
We define colorectal cancer screening tests in our regulation at
Sec. 410.37(a)(1) to include ``flexible screening sigmoidoscopies''
and ``screening colonoscopies, including anesthesia furnished in
conjunction with the service.'' Under our current regulations, we
exclude from the definition of colorectal screening services,
colonoscopies and sigmoidoscopies that begin as screening services, but
where a polyp or other growth is found and removed as part of the
procedure. The exclusion of these services from the definition of
colorectal cancer screening services is based upon longstanding
provisions of the statute under section 1834(d)(2)(D) dealing with the
detection of lesions or growths during procedures (See CY 1998 PFS
final rule at 62 FR 59048, 59082).
Prior to the enactment of section 122 of the CAA, section
1834(d)(2)(D) of the Act provided that if, during the course of a
screening flexible sigmoidoscopy, a lesion or growth is detected which
results in a biopsy or removal of the lesion or growth, payment under
Medicare Part B shall not be made for the screening flexible
sigmoidoscopy, but shall be made for the procedure classified as a
flexible sigmoidoscopy with such biopsy or removal. Similarly, prior to
the recent legislative change, section 1834(d)(3)(D) of the Act
provided that if, during the course of a screening colonoscopy, a
lesion or growth is detected that results in a biopsy or removal of the
lesion or growth, payment under Medicare Part B shall not be made for
the screening colonoscopy but shall be made for the procedure
classified as a colonoscopy with such biopsy or removal. In these
situations, Medicare pays for the flexible sigmoidoscopy and
colonoscopy tests as diagnostic tests rather than as screening tests
and the 100 percent payment rate for recommended preventive services
under section 1833(a)(1)(Y) of the Act, as codified in our regulation
at Sec. 410.152(l)(5), has not applied. As such, beneficiaries
currently are responsible for the usual 20 percent coinsurance that
applies to the services.
Under section 1833(b) of the Act, before making payment under
Medicare Part B for expenses incurred by a beneficiary for covered Part
B services, beneficiaries must first meet the applicable deductible for
the year. Section 4104 of the Affordable Care Act (that is, the Patient
Protection and Affordable Care Act (Pub. L. 111-148, March 23, 2010),
and the Health Care and Education Reconciliation Act of 2010 (Pub. L.
111-152, March 30, 2010), collectively referred to as the ``Affordable
Care Act'') amended section 1833(b)(1) of the Act to make the
deductible inapplicable to expenses incurred for certain preventive
services that are recommended with a grade of A or B by the USPSTF,
including colorectal cancer screening tests as defined in section
1861(pp) of the Act. Section 4104 of the Affordable Care Act also added
a sentence at the end of section 1833(b)(1) of the Act specifying that
the exception to the deductible shall apply with respect to a
colorectal cancer screening test regardless of the code that is billed
for the establishment of a diagnosis as a result of the test, or for
the removal of tissue or other matter or other procedure that is
furnished in connection with, as a result of, and in the same clinical
encounter as the screening test. Although amendments made by the
Affordable Care Act addressed the applicability of the deductible in
the case of a colorectal cancer screening test that involves biopsy or
tissue removal, they did not alter the coinsurance provision in section
1833(a) of the Act for such procedures. Although public commenters
encouraged the agency to eliminate the coinsurance in these
circumstances, the agency found that statute did not provide for
elimination of the coinsurance (75 FR 73170 at 73431).
Beneficiaries have continued to contact us noting their concern
that a coinsurance percentage applies (20 or 25 percent depending upon
the setting) under circumstances where they expected to receive only a
colorectal screening test to which coinsurance does not apply. Instead,
these beneficiaries received what Medicare considers to be a diagnostic
procedure because, for example, polyps were discovered and removed
during the procedure. Similarly, physicians have expressed concern
about the reactions of beneficiaries when they are informed that they
will be responsible for coinsurance if polyps are discovered and
removed during a procedure that they had expected to be a screening
procedure to which coinsurance does not apply.
Section 122 of the CAA addresses this coinsurance issue by
successively reducing, over a period of years, the percentage amount of
coinsurance for which the beneficiary is responsible. Ultimately, for
services furnished on or after January 1, 2030, the coinsurance will be
zero.
To implement the amendments made by section 122 of the CAA, we are
proposing in the CY 2022 PFS proposed rule to modify our regulations to
reflect the changes to statute. As amended, the statute effectively
provides that, for services furnished on or after January 1, 2022, a
flexible sigmoidoscopy or a colonoscopy can be considered a screening
flexible sigmoidoscopy or a screening colonoscopy test even if an
additional procedure is furnished to remove tissue or other matter
during the screening test. Specifically, section 122(a)(3) of the CAA
added a sentence to the end of section 1833(a) of the Act to include as
colorectal screening tests described in section 1833(a)(1)(Y) of the
Act, a colorectal cancer screening test, regardless of the code that is
billed for the establishment of a diagnosis as a result of the test, or
for the removal of tissue or other matter or other procedure that is
furnished in connection with, as a result of, and in the same clinical
encounter as the screening test. We note that only flexible screening
sigmoidoscopies and screening colonoscopies are recognized currently as
colorectal cancer screening tests that might involve removal of tissue
or other matter. This new sentence added under section 1833(a) uses the
same language that was used to amend the statute at section 1833(b)(1)
of the Act to broaden the scope of colorectal cancer screening tests to
which a deductible does not apply. Section 122(b)(1) of the CAA then
limits application of the 100 percent Medicare payment rate (that is,
no beneficiary coinsurance) under section 1833(a)(1)(Y) of the Act for
the additional colorectal cancer screening tests (those that are not
screening tests ``but for'' the new sentence at the end of section
1833(a) of the Act) by making payment for them subject to a new section
1833(dd) of the Act. Section 1833(dd) of the Act provides for a series
of increases in the Medicare payment rate percentage for those services
over successive periods of years through CY 2029. Thereafter, section
1833(dd) of the Act has no effect, so payment for all colorectal cancer
screening tests would be made at 100 percent under section
1833(a)(1)(Y) of the Act.
To codify the amendments made by section 122 of the CAA in our
regulations, we are proposing in the CY 2022 PFS proposed rule to make
two modifications to current regulations.
At Sec. 410.37, we propose in the CY 2022 PFS proposed rule to
modify our
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regulation where we define conditions for and limitations on coverage
for colorectal cancer screening tests by adding a new paragraph (j).
That paragraph would provide that, effective January 1, 2022, when a
planned colorectal cancer screening test, that is, screening flexible
sigmoidoscopy or colonoscopy screening test, requires a related
procedure, including removal of tissue or other matter, furnished in
connection with, as a result of, and in the same clinical encounter as
the screening test, it is considered to be a colorectal cancer
screening test.
At Sec. 410.152(l)(5), we propose in the CY 2022 PFS proposed rule
to modify our regulation. Here we describe payment for colorectal
cancer screening tests. Effective January 1, 2022, we propose to
provide for an increase in the Medicare payment percentage that is
phased in over time. As the Medicare payment percentage increases, the
beneficiary coinsurance percentage decreases. We propose to revise
section 410.152(l)(5) to provide that Medicare payment in a specified
year is equal to a specified percent of the lesser of the actual charge
for the service or the amount determined under the fee schedule that
applies to the test. The phased in Medicare payment percentages for
colorectal cancer screening services described in the amendments we
propose in the CY 2022 PFS proposed rule to our regulation at section
410.37(j) (and the corresponding reduction in coinsurance) are as
follows:
80 percent payment for services furnished in CY 2022 (with
coinsurance equal to 20 percent);
85 percent payment for services furnished in CY 2023 (with
coinsurance equal to 15 percent);
90 percent payment for services furnished in 2027 through
2029 (with coinsurance equal to 10 percent); and
100 percent payment for services furnished from CY 2030
onward (with coinsurance equal to zero percent).
Thus, between CYs 2022 and 2030, the coinsurance required of
Medicare beneficiaries for planned colorectal cancer screening tests
that result in additional procedures furnished in the same clinical
encounter will be reduced from 20 or 25 percent to 0 percent. We refer
readers to the CY 2022 Medicare Physician Fee Schedule (PFS) proposed
rule for the full discussion of these proposed changes. Comments on
this proposed policy, including the proposed changes to the regulations
at Sec. Sec. 410.37 and 410.152(l)(5), should be submitted in response
to the CY 2022 PFS proposed rule.
In the CY 2011 OPPS/ASC final rule with comment period (75 FR 72019
through 72020), we adopted a policy that all surgical services
furnished on the same date as a planned screening colonoscopy, planned
flexible sigmoidoscopy, or barium enema be viewed as being furnished in
connection with, as a result of, and in the same clinical encounter as
the screening test for purposes of implementing section 4104(c)(2) of
the Affordable Care Act. We created the HCPCS modifier PT for providers
to append to the diagnostic procedure code that is reported instead of
the screening colonoscopy, screening flexible sigmoidoscopy HCPCS code,
or as a result of the barium enema when the screening test becomes a
diagnostic service. Where the modifier appears on a claim, the claims
processing system does not apply the Part B deductible for all surgical
services on the same date as the diagnostic test. We stated that we
believed this interpretation was appropriate because we believe that it
would be very rare for an unrelated surgery to occur on the same date
as one of these scheduled screening tests (75 FR 72019). We also stated
that we would reassess the appropriateness of the proposed definition
of services that are furnished in connection with, as a result of, and
in the same clinical encounter as the colorectal cancer screening test
that becomes diagnostic in the event of a legislative change to this
policy (for example, a statutory change that would remove the
coinsurance for these related services in addition to the deductible).
As we did for purposes of implementing section 4104(c)(2) of the
Affordable Care Act, to implement the amendments made by section 122 of
the CAA we propose that all surgical services furnished on the same
date as a planned screening colonoscopy or planned flexible
sigmoidoscopy would be viewed as being furnished in connection with, as
a result of, and in the same clinical encounter as the screening test
for purposes of determining the coinsurance required of Medicare
beneficiaries for planned colorectal cancer screening tests that result
in additional procedures furnished in the same clinical encounter. We
believe this interpretation is appropriate because we continue to
believe that it is very rare for an unrelated surgery to occur on the
same date as a scheduled colorectal cancer screening. Providers must
continue to report HCPCS modifier ``PT'' to indicate that a planned
colorectal cancer screening service converted to a diagnostic service.
We note that if this proposal is finalized, we will examine the claims
data, monitor for any increases in surgical services unrelated to the
colorectal cancer screening test performed on the same date as the
screening test, and consider revising our policy through rulemaking if
there is a notable increase.
C. Low Volume Policy for Clinical, Brachytherapy, and New Technology
APCs
Historically, we have used our equitable adjustment authority at
section 1833(t)(2)(E) of the Act on a case-by-case basis to adjust how
we determine the costs for certain low volume services. In the CY 2016
OPPS/ASC final rule with comment period, we acknowledged that for low
volume procedures with significant device costs, the median cost would
be a more appropriate measure of the central tendency for purposes of
calculating the cost and the payment rate for low volume procedures (80
FR 70388 through 70389). We explained that the median cost is impacted
to a lesser degree than the geometric mean cost by more extreme
observations. Therefore, in the CY 2016 OPPS/ASC final rule with
comment period, we used our equitable adjustment authority under
section 1833(t)(2)(E) of the Act to use the median cost, rather than
the geometric mean, to calculate the payment rate for the procedure
described by CPT code 0308T (Insertion of ocular telescope prosthesis
including removal of crystalline lens or intraocular lens prosthesis)
for CY 2016.
In the CY 2017 OPPS/ASC final rule with comment period, we adopted
a payment policy for low-volume device-intensive procedures similar to
the policy we applied to the procedure described by CPT code 0308T.
Under this policy, we calculate the payment rate for any device-
intensive procedure that is assigned to an APC with fewer than 100
single claims for all procedures in the APC using the median cost
instead of the geometric mean cost (81 FR 79660 through 79661). We
explained that we believed this policy would help mitigate to some
extent the significant year-to-year payment rate fluctuations while
preserving accurate claims data-based payment rates for these
procedures.
In the CY 2019 OPPS/ASC final rule with comment period, we
developed a policy for establishing payment rates for low-volume
procedures assigned to New Technology APCs (83 FR 58892 through 58893).
In that rule, we explained that procedures assigned to New Technology
APCs are typically new procedures that do not have sufficient claims
history to establish an accurate payment for them (83 FR 58892). One of
the objectives of
[[Page 42182]]
establishing New Technology APCs is to generate sufficient claims data
for a new procedure so that it can be assigned to an appropriate
clinical APC. We stated that some procedures that are assigned to New
Technology APCs have very low annual volume, which we consider to be
fewer than 100 claims. There is a higher probability that payment data
for a procedure with fewer than 100 claims per year may not have a
normal statistical distribution, which we were concerned could affect
the quality of our standard cost methodology for assigning services to
clinical APCs. We also noted that services with fewer than 100 claims
per year are not generally considered to be significant contributors to
the APC ratesetting calculations, and therefore, are not included in
the assessment of the 2 times rule. For these low-volume procedures, we
were concerned that the methodology we use to estimate the cost of a
procedure under the OPPS--calculating the geometric mean for all
separately paid claims for a HCPCS procedure code from the most recent
available year of claims data--may not generate an accurate estimate of
the actual cost of these procedures.
We noted that low utilization of services can lead to wide
variation in payment rates from year to year. This volatility in
payment rates from year to year can result in even lower utilization
and potential barriers to access for these new technologies, which in
turn limits our ability to assign the service to an appropriate
clinical APC. To mitigate these issues, we believed that it was
appropriate to utilize our equitable adjustment authority at section
1833(t)(2)(E) of the Act to adjust how we determine the costs for low-
volume services assigned to New Technology APCs. We finalized a policy
to calculate payment rates for low-volume procedures with fewer than
100 claims per year that are assigned to a New Technology APC by using
up to 4 years of claims data to calculate the geometric mean, the
median, and the arithmetic mean, to include the result of each
statistical methodology in annual rulemaking, and to solicit comment on
which methodology should be used to establish the payment rate. We
explained that once we identify a payment rate for a low-volume
service, we would assign the service to the New Technology APC with the
cost band that includes its payment rate (83 FR 58893).
While we believe that the policies we have adopted to calculate
payment rates for low-volume procedures have mitigated concerns
regarding payment rates for new technologies and device-intensive
procedures, we also believe that additional items and services may
benefit from a policy that applies to clinical APCs with significantly
low claims volume available for ratesetting purposes. In particular, we
believe that where there are fewer than 100 single claims from the most
recent year available for ratesetting for an APC, there is often
significant volatility in the payment rate for those APCs that could be
addressed with a low-volume adjustment policy similar to our low-volume
policies for device-intensive procedures and New Technology APCs. For
example, for CY 2022 ratesetting purposes, there are only 43 single
claims from CY 2019 available for determining the geometric mean cost
for APC 5244 (Level 4 Blood Product Exchange and Related Services) and
the payment rate for this APC has fluctuated significantly from year to
year. The geometric mean cost of APC 5244 was $30,424.15 in CY 2018
(based on CY 2016 claims), increased by 25.6 percent to $38,220.27 in
CY 2019 (based on CY 2017 claims), and decreased by 18.9 percent to
$31,015.17 in CY 2021 (based on CY 2019 claims).
Additionally, for CY 2022 ratesetting purposes, there are only 22
single claims from CY 2019 available for determining the geometric mean
cost of APC 2632 (Iodine i-125 sodium iodide). The payment rates for
this APC have also fluctuated significantly, with a geometric mean cost
of $26.63 in CY 2018 (based on CY 2016 claims), which increased by 43.4
percent to $38.20 in CY 2019 (based on CY 2017 claims), and decreased
by 31.8 percent to $26.04 in CY 2021 (based on CY 2019 claims).
We believe that APCs with low claims volume available for
ratesetting could also benefit from a low-volume adjustment policy
similar to the one we currently utilize to set payment rates for
device-intensive procedures and procedures assigned to New Technology
APCs. Specifically, we propose to designate clinical APCs,
brachytherapy APCs, and New Technology APCs with fewer than 100 single
claims that can be used for ratesetting purposes in the claims year
used for ratesetting for the prospective year (the CY 2019 claims year
for this CY 2022 proposed rule) as low volume APCs. While our proposed
criterion for a clinical or brachytherapy APC to qualify as a low
volume APC policy is that the APC have fewer than 100 single claims
that can be used for ratesetting, we acknowledge that New Technology
APCs are different from clinical APCs in that they contain procedures
that may not be clinically similar to other procedures assigned to the
same New Technology APC based on cost and are only assigned to a New
Technology APC because there is not sufficient data to assign these
procedures to a clinical APC. Therefore, we propose that for New
Technology APCs with fewer than 100 single claims at the procedure
level that can be used for ratesetting, we would apply our proposed
methodology for determining a low volume APC's cost, choosing the
``greatest of'' the median, arithmetic mean, or geometric mean at the
procedure level, to apply to the individual services assigned to New
Technology APCs and provide the final New Technology APC assignment for
each procedure.
We are proposing that the threshold for the low volume APC
designation would be fewer than 100 single claims per year for the APC
that can be used for ratesetting purposes, as this is how we have
traditionally defined low volume under our existing policies. As
previously mentioned, the threshold would be 100 single claims at the
procedure level for New Tech APCs. We have defined low volume as fewer
than 100 single claims under our existing policies as there is a higher
probability that payment data for a procedure with fewer than 100
claims per year may not have a normal statistical distribution, which
we were concerned could affect how we set payment rates for low volume
APCs. For items and services assigned to APCs we propose to designate
as low volume APCs, we are proposing to use up to 4 years of claims
data to establish a payment rate for each item or service as we
currently do for low volume services assigned to New Technology APCs.
The availability of multiple years of claims data will allow for more
claims to be used for ratesetting purposes and create a more
statistically reliable payment rate for these APCs than setting rates
for APCs with low claims volume based on one year of data alone.
Further, using multiple years of claims data, we are proposing to use
the greatest of the median, arithmetic mean, or geometric mean cost to
approximate the cost of items and services assigned to a low volume
APC. In previous years, we have received few to no public comments on
which statistical methodology to use and have usually chosen the
methodology that yields the highest rate to set the payment rate for
procedures assigned to New Technology APCs. Going forward, we are
proposing to formalize this approach for low volume New Technology,
clinical, and brachytherapy APCs, as we believe using the greatest of
these three methodologies provides a simple and consistent approach to
determining the cost metric to be used for ratesetting for
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these APCs and avoids uncertainty where multiple cost metrics could be
used to set the APC's cost. Additionally, due to the payment volatility
and low volume nature of these products, we believe that choosing the
methodology that yields the highest rate will ensure that these
products receive sufficient payment and that payment is not a barrier
to access for these procedures.
Given the different nature of policies that affect the partial
hospitalization program (PHP), we are not proposing to apply this low
volume APC policy to APC 5853 Partial Hospitalization for CMHCs or APC
5863 Partial Hospitalization for Hospital-based PHPs. We are also not
proposing to apply this low volume APC policy to APC 2698 (Brachytx,
stranded, nos) or APC 2699 (Brachytx, non-stranded, nos), as we believe
our current methodology for determining payment rates for non-specified
brachytherapy sources, as discussed in Section II.A.2.a.(2) of this
proposed rule, is appropriate. Further, as discussed in additional
detail in Section IV.B.5 of this proposed rule, we are proposing to
eliminate our low volume Device-Intensive Procedure policy, for which
HCPCS code 0308T has been the only procedure subject to this policy,
and subsume the ratesetting for HCPCS code 0308T within our broader low
volume APC proposal.
For this CY 2022 OPPS/ASC proposed rule, we evaluated certain New
Technology APCs to determine if such APCs meet our low volume APC
criteria. As previously mentioned, we are proposing to use the
``greatest of'' the geometric mean, the median, or the arithmetic mean
at the procedure level for determining the low volume APC cost of the
individual services assigned to New Technology APCs, rather than
soliciting comment on which methodology to use. In claims data
available for this CY 2022 OPPS/ASC proposed rule, there were 5 claims
for APC 1562 (which reflects the assignment of new technology procedure
HCPCS code C9751 (bronchoscopy with transbronchial ablation of lesions
by microwave energy)) and 35 claims for APC 1908 (New Technology--Level
52 ($145,001-$160,000)) which reflects the assignment of new technology
procedure CPT code 0100T (Placement of a subconjunctival retinal
prosthesis receiver and pulse generator, and implantation of intra-
ocular retinal electrode array, with vitrectomy).
Given the low volume of claims for HCPCS code C9751, we propose for
CY 2022 to calculate the geometric mean, arithmetic mean, and median
costs to calculate an appropriate payment rate for purposes of
assigning HCPCS code C9751 to a New Technology APC. We found the
greatest cost metric for HCPCS code C9751 to be $3,707.76. Therefore,
for this proposed rule, we are proposing to assign HCPCS code C9751 to
APC 1562 (New Technology--Level 25 ($3,501-$4,000)) and we are
proposing to designate APC 1562 (New Technology--Level 25 ($3,501-
$4,000)) as a low volume APC with a proposed APC cost and payment rate
of $3,750.50. Details regarding APC 1562 are shown in Table 36.
Additionally, given the low volume of claims for APC 1908 (New
Technology--Level 52 ($145,001-$160,000)) which reflects the assignment
of new technology procedure CPT code 0100T (Placement of a
subconjunctival retinal prosthesis receiver and pulse generator, and
implantation of intra-ocular retinal electrode array, with vitrectomy),
we propose for CY 2022 to calculate the geometric mean, arithmetic
mean, and median costs to calculate an appropriate payment rate for
purposes of assigning CPT code 0100T to a New Technology APC. We found
the greatest cost metric for CPT code 0100T to be $155,412.90.
Therefore, for this proposed rule, we are proposing to assign CPT code
0100T to APC 1908 (New Technology--Level 52 ($145,001-$160,000)) and we
are proposing to designate APC 1908 (New Technology--Level 52
($145,001-$160,000)) as a low volume APC with a proposed APC cost and
payment rate of $152,500.50. Details regarding APC 1908 are shown in
Table 36.
Further, for CY 2022, in addition to the 2 New Technology APCs we
are proposing to designate as low volume APCs, we are also proposing to
designate 4 clinical APCs and 5 brachytherapy APCs as low volume APCs
under the OPPS. The 4 clinical APCs and 5 brachytherapy APCs meet our
criteria of having fewer than 100 single claims in the claims year (CY
2019 for this CY 2022 OPPS/ASC proposed rule) and therefore, we propose
that they would be subject to our new low volume APC policy, if
finalized. Table 36 illustrates the APC geometric mean cost without the
low volume APC designation, the median, arithmetic mean, and geometric
mean cost using up to 4 years of claims data, as well as the
statistical methodology we are proposing to use as the APC's cost for
ratesetting purposes for CY 2022. As discussed in Section II.A.1.a of
this proposed rule, given our concerns with CY 2020 claims data as a
result of the PHE, the 4 years of claims data are based on CY 2016
claims through CY 2019 claims.
BILLING CODE 4120-01-P
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[GRAPHIC] [TIFF OMITTED] TP04AU21.069
BILLING CODE 4120-01-C
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Based on the number of available claims from the standard
ratesetting methodology used for ASC ratesetting purposes, for CY 2022,
under the ASC payment system, we propose to designate 2 New Technology
APCs, 3 clinical APCs, and 5 brachytherapy APCs as Low Volume APCs that
meet our criteria of having fewer than 100 single claims in the claims
year (CY 2019 for this CY 2022 OPPS/ASC proposed rule) and would be
subject to our new Low Volume APC. Under our proposed Low Volume APC
policy, the payment rates for these APCs would be set at the highest
amount among the geometric mean, median, or arithmetic mean, calculated
using up to four years of data, which in the case of these APCs, would
be claims data from 2016 through 2019.
As discussed in Section II.A.1.a of this proposed rule, given our
concerns with CY 2020 claims data as a result of the PHE, the 4 years
of claims data are based on claims from CY 2016 through CY 2019. We are
soliciting comments from the public on our proposal to establish a Low
Volume APC policy for clinical APCs, brachytherapy APCs, and New
Technology APCs. This includes our criterion for designating an APC as
a Low Volume APC, the use of the highest of the geometric mean, median,
and arithmetic mean to determine the payment rate for clinical and
brachytherapy APCs, as well as individual services assigned to New
Technology APCs, and our use of claims data from CY 2016 through 2019
to calculate the geometric mean, median, and arithmetic mean for
purposes of determining the CY 2022 payment rates for these APCs.
D. Comment Solicitation on Temporary Policies To Address the COVID-19
PHE
In response to the COVID-19 pandemic, CMS issued waivers and
undertook emergency rulemaking to implement a number of temporary
policies to address the pandemic, including policies to prevent spread
of the infection and support diagnosis of COVID-19. Many of these
flexibilities were available because certain statutory or regulatory
provisions were waived. These waivers will expire at the conclusion of
the PHE. We are seeking comment on the extent to which stakeholders
utilized the flexibilities available under these waivers, as well as
whether stakeholders believe certain of these temporary policies should
be made permanent to the extent possible within our existing authority.
Specifically, we are seeking comment on stakeholders' experience with
hospital staff furnishing services remotely to beneficiaries in their
homes through use of communications technology; providers furnishing
services in which the direct supervision for cardiac rehabilitation,
intensive cardiac rehabilitation, and pulmonary rehabilitation services
requirement was met by the supervising practitioner being available
through audio/video real-time communications technology; and the need
for specific coding and payment to remain available under the OPPS for
specimen collection for COVID-19.
1. Mental Health Services Furnished Remotely by Hospital Staff to
Beneficiaries in Their Homes
Under the Physician Fee Schedule (PFS), Medicare makes payment to
professionals and other suppliers for physicians' services, including
certain diagnostic tests and preventive services. Section 1834(m) of
the Act specifies the payment amounts and circumstances under which
Medicare makes payment for a discrete set of Medicare telehealth
services, all of which must ordinarily be furnished in-person, when
they are instead furnished using interactive, real-time
telecommunications technology. When furnished as Medicare telehealth
services under section 1834(m), many of these services are still
reported using codes that describe ``face-to-face'' services even
though they are furnished using audio/video, real-time communications
technology instead of in-person (82 FR 53006). Section 1834(m) of the
Act specifies the types of health care professionals that can furnish
and be paid by Medicare for telehealth services (referred to as distant
site practitioners) and the types and locations of settings where a
beneficiary can be located when receiving telehealth services (referred
to as originating sites). In the CY 2003 PFS final rule with comment
period (67 FR 79988), we established a regulatory process for adding
services to or deleting services from the Medicare telehealth services
list in accordance with section 1834(m)(4)(F)(ii) of the Act (42 CFR
410.78(f)). This process provides the public with an ongoing
opportunity to submit requests for adding services, which we consider
and review through the annual PFS rulemaking process. The regulation at
Sec. 410.78(a)(3) also defines the requirements for the interactive
telecommunications systems that may be used to furnish Medicare
telehealth services.
Due to the circumstances of the COVID-19 pandemic, particularly the
need to maintain physical distance to avoid exposure to the virus, we
anticipated that health care practitioners would develop new approaches
to providing care using various forms of technology when they are not
physically present with the patient. We have established several
flexibilities to accommodate these changes in the delivery of care. For
Medicare telehealth services, using waiver authority under section
1135(b)(8) of the Act in response to the PHE for the COVID-19 pandemic,
we have removed the geographic and site of service originating site
restrictions in section 1834(m)(4)(C) of the Act, as well as the
restrictions in section 1834(m)(4)(E) of the Act on the types of
practitioners who may furnish telehealth services, for the duration of
the PHE for the COVID-19 pandemic. We also used waiver authority to
allow certain telehealth services to be furnished via audio-only
communication technology during the PHE.
According to MedPAC's report, Telehealth in Medicare after the
Coronavirus Public Health Emergency,\107\ there were 8.4 million
telehealth services paid under the PFS in April 2020, compared with
102,000 in February 2020. MedPAC also reported that during focus groups
held in the summer of 2020, clinicians and beneficiaries supported
continued access to telehealth visits with some combination of in-
person visits. They cited benefits of telehealth, including improved
access to care for those with physical impairments, increased
convenience from not traveling to an office, and increased access to
specialists outside of a local area. In their annual beneficiary
survey, over 90 percent of respondents who had a telehealth visit
reported being ``somewhat'' or ``very satisfied'' with their video or
audio visit, and nearly two-thirds reported being ``very satisfied.''
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\107\ http://medpac.gov/docs/default-source/reports/mar21_medpac_report_ch14_sec.pdf?sfvrsn=0.
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Recently enacted legislation modified the circumstances under which
Medicare makes payment for mental health services furnished via
telehealth technology under the PFS following the PHE. Division CC,
section 123 of the CAAremoved the geographic originating site
restrictions and added the home of the individual as a permissible
originating site for Medicare telehealth services when furnished for
the purposes of diagnosis, evaluation, or treatment of a mental health
disorder.\108\
[[Page 42186]]
This change correlates with a growing acceptance of the use of
technology in the provision of mental health care. According to the
Commonwealth Fund,\109\ the provision of mental and behavioral health
services via communications technology, in particular, has a robust
evidence base and numerous studies have demonstrated its effectiveness
across a range of modalities and mental health diagnoses (e.g.,
depression, substance use disorders). Clinicians furnishing tele-
psychiatry services at Massachusetts General Hospital Department of
Psychiatry during the PHE observed several advantages of the virtual
format for furnishing psychiatric services, noting that patients with
psychiatric pathologies that interfere with their ability to leave home
(e.g., immobilizing depression, anxiety, agoraphobia, and/or time-
consuming obsessive-compulsive rituals) were able to access care more
consistently since eliminating the need to travel to a psychiatry
clinic can increase privacy and therefore decrease stigma-related
barriers to treatment, potentially bringing care to many more patients
in need, as well as enhanced ease of scheduling, decreased rate of no-
shows, increased understanding of family and home dynamics, and
protection for patients and practitioners with underlying health
conditions.\110\
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\108\ There is a longstanding statutory payment exclusion that
prohibits Medicare payment for services that are not furnished
within the United States (see section 1862(a)(4) of the Act). This
payment exclusion was not changed by the CAA.
\109\ https://www.commonwealthfund.org/blog/2020/using-telehealth-meet-mental-health-needs-during-covid-19-crisis.
\110\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347331/.
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These findings are consistent with our analysis of Medicare claims
data that indicate that interactive communications technology for
mental health care is likely to continue to be in broad use beyond the
circumstances of the pandemic. According to our analysis of Medicare
Part B claims data for services furnished via Medicare telehealth
during the PHE, use of telehealth for many professional services spiked
in utilization around April 2020 and diminished over time. In contrast,
Medicare claims data suggest that for mental health services added to
the Medicare Telehealth list both permanently and temporarily,
subsequent to April 2020, the trend is toward maintaining a steady
state of usage over time. Given this information, broad acceptance in
the public and medical community, and the relatively stable Medicare
utilization of mental health services during the COVID-19 pandemic, we
believe use of interactive communication technology in furnishing
mental health care is becoming an established part of medical practice,
very likely to persist after the COVID-19 pandemic, and available
across the country under the Medicare statute for the range of
professionals furnishing mental health care and paid under the PFS.
In many cases, hospitals provide hospital outpatient mental health
services (including behavioral health), education, and training
services that are furnished by hospital-employed counselors or other
licensed professionals. Examples of these services include
psychoanalysis, psychotherapy, diabetes self-management training, and
medical nutrition therapy. With few exceptions, the Medicare statute
does not have a benefit category that would allow these types of
professionals (for example, mental health counselors and registered
nurses) to bill Medicare directly for their services. These services
can, in many cases, be billed by providers such as hospitals under the
OPPS or by physicians and other practitioners as services incident to
their professional services under the PFS. We also note that while
partial hospitalization services are paid under the OPPS, section
1861(ff)(3)(A) of the Act explicitly prohibits partial hospitalization
services from being furnished in an individual's home or residential
setting.
As we explained in the interim final rule with comment period
published on May 8, 2020 titled ``Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency and Delay
of Certain Reporting Requirements for the Skilled Nursing Facility
Quality Reporting Program'' (the May 8th COVID-19 IFC) (85 FR 27550,
27563), outpatient mental health services, education, and training
services require communication and interaction. We stated that facility
staff can effectively furnish these services using telecommunication
technology and, unlike many hospital services, the clinical staff and
patient are not required to be in the same location to furnish them. We
further explained that blanket waivers in effect during the COVID-19
PHE allow the hospital to consider the beneficiary's home, and any
other temporary expansion location operated by the hospital during the
COVID-19 PHE, to be a provider-based department (PBD) of the hospital,
so long as the hospital can ensure the locations meet all of the
conditions of participation, to the extent not waived. In light of the
need for infection control and a desire for continuity of behavioral
health care and treatment services, we recognized the ability of the
hospital's clinical staff to continue to deliver these services even
when they are not physically located in the hospital. Therefore, in the
May 8th COVID-19 IFC (85 FR 27564), we made clear that when a
hospital's clinical staff are furnishing hospital outpatient mental
health services, education, and training services to a patient in the
hospital (which can include the patient's home so long as it is
provider-based to the hospital), and the patient is registered as an
outpatient of the hospital, we will consider the requirements of the
regulations at Sec. [thinsp]410.27(a)(1) to be met. We reminded
readers that the physician supervision level for the vast majority of
hospital outpatient therapeutic services is currently general
supervision under Sec. [thinsp]410.27. This means a service must be
furnished under the physician's overall direction and control, but the
physician's presence is not required during the performance of the
service.
In the May 8th COVID-19 IFC we emphasized that all services
furnished by the hospital still require an order by a physician or
qualified NPP and must be supervised by a physician or other NPP
appropriate for supervising the service given their hospital admitting
privileges, state licensing, and scope of practice, consistent with the
requirements in Sec. [thinsp]410.27 (85 FR 27563). We noted that
hospitals may bill for these services as if they were furnished in the
hospital and consistent with any specific requirements for billing
Medicare in general, including any relevant modifications in effect
during the COVID-19 PHE. We also noted that when these services are
provided by clinical staff of the physician or other practitioner and
furnished incident to their professional services, and are not provided
by staff of the hospital, the hospital would not bill for the services.
We stated that in those circumstances, the physician or other
practitioner should bill for such services incident to their own
services and would be paid under the PFS.
Given that the widespread use of communications technology to
furnish services during the PHE has illustrated acceptance within the
medical community and among Medicare beneficiaries of the possibility
of furnishing and receiving care through the use of that technology, we
are interested in information on the role of hospital staff in
providing care to beneficiaries remotely in their homes. During the
PHE, hospital staff have had the flexibility to provide these kinds of
services to beneficiaries in their homes through communications
technology; however, this flexibility is tied to
[[Page 42187]]
waivers and other temporary policies that expire at the end of the PHE.
In instances where a beneficiary may be receiving mental health
services from a hospital clinical staff member who cannot bill Medicare
independently for their professional service, the beneficiary would
then need to physically travel to the hospital to continue receiving
the services post-PHE. We are concerned that this could have a negative
impact on access to care in areas where beneficiaries may only be able
to access mental health services provided by hospital staff and, during
the PHE, have become accustomed to receiving these services in their
homes. We also note that the ability to receive mental health services
in their homes may help expand access to care for beneficiaries who
prefer additional privacy for the treatment of their condition.
We are concerned that, during the PHE, practice patterns may have
shifted to support expanded virtual services. During the PHE, we have
not required any claims-based modifier identifying specifically when a
service is furnished by clinical staff of the hospital to a beneficiary
in their home through communications technology, and therefore we are
not able to gauge the magnitude of these practice pattern shifts.
Therefore, we are seeking comment on the extent to which hospitals have
been billing for mental health services provided to beneficiaries in
their homes through communications technology during the PHE, and
whether they would anticipate continuing demand for this model of care
following the conclusion of the PHE. As described in preceding
paragraphs, billing for Medicare telehealth services has increased
dramatically during the PHE, particularly for mental health services.
We are seeking comment on whether hospitals have experienced a similar
increase during the PHE in utilization of mental health services
provided by hospital staff to beneficiaries in their homes through
communications technology. We are also seeking comment on whether there
are changes commenters believe CMS should make to account for shifting
patterns of practice that rely on communication technology to provide
mental health services to beneficiaries in their homes.
2. Direct Supervision by Interactive Communications Technology
In the interim final rule with comment period titled ``Policy and
Regulatory Provisions in Response to the COVID-19 Public Health
Emergency'' published on April 6, 2020 (the April 6th COVID-19 IFC) (85
FR 19230, 19246, 19286), we changed the regulation at 42 CFR
410.27(a)(1)(iv)(D) to provide that, during a Public Health Emergency
as defined in Sec. 400.200, the presence of the physician for purposes
of the direct supervision requirement for pulmonary rehabilitation,
cardiac rehabilitation, and intensive cardiac rehabilitation services
includes virtual presence through audio/video real-time communications
technology when use of such technology is indicated to reduce exposure
risks for the beneficiary or practitioner. Specifically, the required
direct physician supervision can be provided through virtual presence
using audio/video real-time communications technology (excluding audio-
only) subject to the clinical judgment of the supervising practitioner.
We further amended Sec. 410.27(a)(1)(iv)(D) in the CY 2021 OPPS/ASC
final rule with comment period to provide that this flexibility
continues until the end of the PHE as defined in Sec. 400.200 or
December 31, 2021, whichever is later (85 FR 86113). We noted that the
public comments we received, along with feedback we have received since
the implementation of the policy in the April 6th COVID-19 IFC allowing
for direct supervision through virtual presence (85 FR 19246) have
convinced us that we need more information on the issues involved with
direct supervision through virtual presence before implementing this
policy permanently. We acknowledge that the additional time between the
issuance of the CY 2021 OPPS/ASC final rule with comment period and the
issuance of this proposed rule may have allowed providers to collection
more information that could inform CMS' decision making and are
therefore seeking additional comment on whether this policy should be
adopted on a permanent basis. While we are not proposing to maintain
this flexibility after the later of the end of the PHE or December 31,
2021, we are seeking comment on whether and to what extent hospitals
have relied upon this flexibility during the PHE and whether providers
expect this flexibility would be beneficial outside of the PHE. We are
seeking comment on whether we should continue to allow direct
supervision for these services to include presence of the supervising
practitioner via two-way, audio/video communication technology
permanently, or for some period of time after the conclusion of the PHE
or beyond December 31, 2021, to facilitate a gradual sunset of the
policy. We are also seeking comment on whether there are safety and/or
quality of care concerns regarding adopting this policy beyond the PHE
and what policies CMS could adopt to address those concerns if the
policy were extended post-PHE. Finally, if this policy is made
permanent, we are seeking comment on whether a service-level modifier
should be required to identify when the requirements for direct
supervision for pulmonary rehabilitation, cardiac rehabilitation, and
intensive cardiac rehabilitation services were met using audio/video
real-time communications technology.
3. Payment for COVID-19 Specimen Collection in Hospital Outpatient
Departments
Also in the May 8th COVID-19 IFC, we created a new E/M code to
support COVID-19 testing during the PHE: HCPCS code C9803 (Hospital
outpatient clinic visit specimen collection for severe acute
respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease
[covid-19]), any specimen source) (85 FR 27604). In our review of
available HCPCS and CPT codes for the May 8th COVID-19 IFC, we did not
identify a code that explicitly described the exact services of symptom
assessment and specimen collection that HOPDs were undertaking to
facilitate widespread testing for COVID-19. As stated in the May 8th
COVID-19 IFC, we believed that HCPCS code C9803 was necessary to meet
the resource requirements for HOPDs to provide extensive testing for
the duration of the COVID-19 PHE. This code was created only to meet
the need of the COVID-19 PHE and we stated that we expected to retire
this code at the conclusion of the COVID-19 PHE (85 FR 27605).
We assigned HCPCS code C9803 to APC 5731--Level 1 Minor Procedures
effective March 1, 2020 for the duration of the COVID-19 PHE. In
accordance with Section 1833(t)(2)(B) of the Act, APC 5731--Level 1
Minor Procedures contains services similar to HCPCS code C9803. APC
5731--Level 1 Minor Procedures has a payment rate of $24.67 for CY
2021. HCPCS code C9803 was also assigned a status indicator of ``Q1.''
The Q1 status indicator indicates that the OPPS will package services
billed under HCPCS code C9803 when billed with a separately payable
primary service in the same encounter. When HCPCS code C9803 is billed
without another separately payable primary service, we will make
separate payment for the service under the OPPS. The OPPS also makes
separate payment for HCPCS code C9803 when it is billed with a clinical
diagnostic laboratory test with a status indicator of ``A'' on Addendum
B of the OPPS.
[[Page 42188]]
We are soliciting public comments on whether we should keep HCPCS
code C9803 active beyond the conclusion of the COVID-19 PHE and whether
we should extend or make permanent the OPPS payment associated with
specimen collection for COVID-19 tests after the COVID-19 PHE ends,
including why commenters believe it would be necessary to continue to
provide OPPS payment for this service, as well as how long commenters
believe payment should be extended for this code.
E. Use of CY 2019 Claims Data for CY 2022 OPPS and ASC Payment System
Ratesetting Due to the PHE
As described in section I.A. of this proposed rule with comment
period, section 1833(t) of the Social Security Act requires the
Secretary to annually review and update the payment rates for services
payable under the Hospital Outpatient Prospective Payment System
(OPPS). Specifically, Section 1833(t)(9)(A) of the Act requires the
Secretary to review not less often than annually and to revise the
groups, the relative payment weights, and the wage and other
adjustments described in paragraph (2) to take into account changes in
medical practice, changes in technology, the addition of new services,
new cost data, and other relevant information and factors.
In updating the OPPS payment rates and system for each rulemaking
cycle we primarily use two sources of information: The outpatient
Medicare claims data and HCRIS cost report data. The claims data source
is the Outpatient Standard Analytic File, which includes final action
Medicare outpatient claims for services furnished in a given calendar
year. For the OPPS ratesetting process, our goal is to use the best
available data for ratesetting so that we can accurately estimate the
costs associated with furnishing outpatient services, and thus set
appropriate payment rates. Ordinarily, the best available claims data
is the set of data from 2 years prior to the calendar year that is the
subject of rulemaking. For CY 2022 OPPS/ASC proposed rule ratesetting,
this typically would have been the set of CY 2020 calendar year
outpatient claims data processed through December 31, 2020. The cost
report data source is typically the Medicare hospital cost report data
files from the most recently available quarterly HCRIS file as we begin
the ratesetting process. For example, ordinarily, the best available
cost report data used in developing the OPPS relative weights would be
from cost reports beginning 3 fiscal years prior to the year that is
the subject of the rulemaking. For CY 2022 OPPS ratesetting, under
ordinary circumstances, that would be cost report data from HCRIS
extracted in December 2020, which would contain many cost reports
ending in FY 2020 based on each hospital's cost reporting period.
As discussed in section I.F. of the FY 2022 IPPS/LTCH proposed
rule, there are a number of issues related to the use of the standard
hospital data we would otherwise use for purposes of CY 2022
ratesetting because data from the applicable time period would include
the effects of the COVID-19 PHE (86 FR 25086 through 25090). Even
though the specific data elements might be slightly different between
the inpatient and outpatient hospital settings, the same questions and
challenges exist for hospital data from CY/FY 2020. Some of the issues
are focused on the source data and the degree to which the utilization
of services and cost patterns found in them are affected by the PHE.
Other issues are more prospective in nature and concern whether
hospital claims data from this time period might be consistent with our
expectations for the prospective year, particularly in a changing
environment with regards to COVID-19 vaccinations and treatment.
In the FY 2022 IPPS proposed rule, we proposed to use FY 2019 data
for FY 2022 IPPS ratesetting based on our determination that the FY
2019 data would be more representative of FY 2022 inpatient hospital
experience than the FY 2020 data (86 FR 25089). We note that there are
a number of policies that apply and interact across the IPPS and OPPS,
in part because they both concern services furnished in the hospital
setting. We have noted in annual rulemaking in regards to adopting the
fiscal year IPPS wage index into the OPPS, the ``inseparable,
subordinate status of the HOPD within the hospital overall'' (85 FR
85908). It is in this context where inpatient and outpatient hospital
departments are inherently connected to each other, as parts of the
broader hospital setting overall, that we have identified many of the
same reasons to use 2019 data for 2022 ratesetting as discussed in the
FY 2022 IPPS proposed rule.
We note that we observe a number of changes, likely as a result of
the PHE, in the CY 2020 OPPS claims data that we would ordinarily use
for ratesetting. The most significant difference compared to prior
years is the decrease in the overall volume of outpatient hospital
claims--with approximately 20 percent fewer claims usable for
ratesetting purposes when compared to the prior year. In addition, this
decrease in outpatient claims volume applied to a majority of the
clinical APCs in the OPPS.
In some cases, we saw broad changes as a result of the PHE,
including in the APCs for hospital emergency department and clinic
visits. Among those APCs, the decrease in volume was approximately 30
percent--some of which may be related to changing practice patterns
during the PHE. For example, we see a significant increase in the use
of the HCPCS code Q3014 (Telehealth originating site facility fee) in
the hospital outpatient claims, with the approximately 35,000 services
billed in the CY 2019 OPPS claims increasing to 1.8 million services in
the CY 2020 OPPS claims. This example highlights two types of
differences we see in the CY 2020 set of claims when comparing to more
typical claims data. One difference is likely due to the degree to
which elective procedures/services were not performed as often during
the PHE. The other difference is the result of site of service changes
due to flexibilities available during the PHE.
In other cases, we saw changes in the claims data that were
associated with specific services that were furnished more frequently
during the PHE. For example, two notable exceptions to this decrease in
claims volume between CY 2019 and CY 2020 are for APC 5731 (Level 1
Minor Procedures) and APC 5801 (Ventilation Initiation and Management).
In the case of APC 5731, HCPCS code C9803 was made effective for
services furnished on or after March 1, 2020 through the interim final
rule with comment period titled ``Additional Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency and Delay
of Certain Reporting Requirements for the Skilled Nursing Facility
Quality Reporting Program'' (85 FR 27602 through 27605) to describe a
COVID-19 Specimen collection. In the CY 2020 claims, HCPCS C9803 has
1,023,957 single claims available for cost modeling, representing
approximately 93% of claims used to model the APC cost. While in some
cases this would be appropriate in establishing the APC cost, we
generally would not expect the same volume of the procedure in the CY
2022 OPPS because we anticipate that specimen collection for COVID-19
testing will be significantly lower than it was in CY 2020. Similarly,
the estimated increase in the geometric mean cost of APC 5801 based on
the CY 2020 claims data may not be predictive of CY 2022 costs for APC
5801 if there is less use of this service in CY 2022 than in CY 2020.
As a result of a number of COVID-19 PHE-related factors, including
the
[[Page 42189]]
changes in services potentially related to the COVID-19 PHE, the
significant decrease in volume suggesting that patients may have been
deferring elective care during CY 2020, the changes in APC relative
weights for services, and the increasing number of Medicare
beneficiaries vaccinated against COVID-19, we believe that CY 2020 data
are not the best overall approximation of expected outpatient hospital
services in CY 2022. Instead we believe that CY 2019 data, as the most
recent complete calendar year of data prior to the COVID-19 PHE, are a
better approximation of expected CY 2022 hospital outpatient services.
We analyzed the extent the decision to use CY 2019 or CY 2020
claims data as the basis for ratesetting differentially impacts the CY
2022 OPPS rates. To do this, we estimated the difference in case-mix
under the CY 2019-based weights and the CY 2020-based weights if the CY
2022 outpatient experience ended up being the reverse of the assumption
made when calculating that set of relative weights. In other words, we
compared estimated case-mix calculated under four different scenarios.
For the CY 2019-based weights, we calculated the case-mix using claims
from the CY 2019-based claims extract as an approximation of the actual
CY 2022 experience (Scenario A), and using claims from the CY 2020
based claims extract as an approximation of the actual CY 2022
experience (Scenario B). For the CY 2020-based weights, we calculated
the case-mix using claims from the CY 2020 claims based extract as an
approximation of the actual CY 2022 outpatient experience (Scenario C),
and using claims from the CY 2019 claims based extract as an
approximation of the actual CY 2022 experience (Scenario D). The
results are shown in the following table 37.
[GRAPHIC] [TIFF OMITTED] TP04AU21.070
In Scenario A and Scenario C, there is no differential impact as a
result of a less accurate assumption made when the OPPS relative
weights were calculated: The CY 2022 outpatient experience matches the
assumption made when the OPPS relative weights were calculated. In
Scenario B and Scenario D, the actual experience is the reverse of the
assumption used when the OPPS relative weights were calculated.
In Scenario B, when the CY 2019-based weights were used, but the CY
2022 outpatient experience turns out to be more similar to CY 2020
claims data, the less accurate assumption slightly affects the
calculated case-mix, by 0.1 percent. This can be seen by comparing the
modeled case mix under Scenario B (5.056) with the modeled case-mix
under Scenario C (5.051). In other words, if we use the CY 2019-based
weights and CY 2022 outpatient experience turns out to be more similar
to the CY 2020 data, then the modeled case-mix is slightly lower than
if we had accurately used the CY 2020-based weights. This suggests
that, while there is some impact from using the CY 2019 data if CY 2022
outpatient service utilization ends up being more similar to CY 2020
utilization, that impact would be limited.
In Scenario D, where the CY 2020-based weights were used, but the
CY 2022 outpatient experience turns out to be more similar to CY 2019
claims data, this inaccurate assumption has a somewhat more significant
effect. In this case, the modeled case-mix is-0.44 percent lower than
it would be if we had correctly assumed that CY 2022 outpatient
services utilization would be more like CY 2019 than CY 2020. This can
be seen by comparing the modeled case-mix under Scenario D (4.600) to
the modeled case-mix under Scenario A (4.620). In other words, if we
use the CY 2020-based weights and the CY 2022 outpatient experience
turns out to be more similar to CY 2019 data, the modeled case-mix is-
0.44 percent lower than if we had used the CY 2019-based weights.
In addition to our expectation that CY 2019 is a more likely
approximation of the CY 2022 outpatient experience for the reasons
discussed earlier, the previous analysis indicates that the
differential effect of making an incorrect assumption about which
year's data to use to set the CY 2022 OPPS relative weights is more
limited if the CY 2019-based weights are used than it is if the CY
2020-based weights are used. While CY 2022 outpatient hospital services
data is unlikely to look exactly like either CY 2019 data or CY 2020
data, we believe that it will be more similar to a standard year (not
having the effects of the PHE) as pandemic-related issues decline and
more of the U.S. population is vaccinated against COVID-19. Since the
update provided in the FY 2022 IPPS final rule, continued progress has
been made in vaccinating the U.S. population, with approximately 320
million doses administered as of July 1, 2021, as reported to the
Centers for Disease Control (CDC) https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covidview/index.html.
Consistent with the proposal to use CY 2019 claims data in
establishing the CY 2022 OPPS rates, we are also proposing to use cost
report data from
[[Page 42190]]
the same set of cost reports we originally used in final rule 2021 OPPS
ratesetting, where we ordinarily would have used the most updated
available cost reports available in HCRIS in determining the proposed
CY 2022 OPPS APC relative weights (as discussed in greater detail in
section II.E. of this proposed rule). As discussed previously, if we
were to proceed with the standard ratesetting process of using updated
cost reports, we would have used approximately 1,000 cost reports with
the fiscal year ending in CY 2020 based on each hospital's cost
reporting period. We note that Medicare outpatient claims data and cost
report data from the HCRIS file are examples of data sources for which
we discuss the proposed use of CY 2019 data for CY 2022 OPPS
ratesetting. While we are generally using CY 2019 claims data and the
data components related to it in establishing the CY 2022 OPPS, we note
in this rule the specific cases where we are using updated information,
such as the ASP data used in determining drug packaging status
discussed in section V. of this proposed rule with comment period.
We also considered the alternative of continuing with our standard
process of using the most updated claims and cost report data
available. To facilitate comment on this alternative proposal for CY
2022, we are making available the cost statistics and addenda utilizing
the CY 2020 data we would ordinarily have provided in conjunction with
this proposed rule. We are providing a file comparing the budget
neutrality and certain other ratesetting adjustments calculated under
our proposal with those adjustments calculated under this alternative
approach. Finally, we are making available other proposed rule
supporting data files based on the use of the CY 2020 data that we
ordinarily would have provided, including: The OPPS Impact File, cost
statistics files, addenda, and budget neutrality factors. We refer the
reader to the CMS website for this proposed rule for more information
on where these supplemental files may be found.
F. Proposal To Provide Separate Payment in CY 2022 for the Device
Category, Drugs, and Biologicals With Transitional Pass-Through Payment
Status Expiring Between December 31, 2021 and September 30, 2022
In the CY 2021 OPPS/ASC final rule (85 FR 86012 through 86013), we
discussed the public comments we received in response to the comment
solicitation we included in the CY 2021 OPPS/ASC proposed rule
regarding whether we should utilize our equitable adjustment authority
under section 1833(t)(2)(E) of the Act to provide separate payment for
some period of time after pass-through status ends for devices with
expiring pass-through status in order to account for the period of time
that utilization for the devices was reduced due to the PHE.\111\
Although we only solicited comments on use of our equitable adjustment
authority to pay separately for devices with pass-through status during
the PHE, we received public comments both suggesting that drugs,
biologicals, and biosimilar biological products with pass-through
status during the same time period should also be subject to an
adjustment to extend the pass-through period for those products, but
also pointing out that most of these products continue to be separately
paid after their pass-through status expires, and therefore, it would
be unnecessary to utilize the equitable adjustment authority to
``extend'' pass-through status for these products.
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\111\ On January 31, 2020, HHS Secretary Azar determined that a
PHE exists retroactive to January 27, 2020, under section 319 of the
Public Health Service Act (42 U.S.C. 247d) in response to COVID-19,
and on April 21, 2020 Secretary Azar renewed, effective April 26,
2020, and again effective July 25, 2020, the determination that a
PHE exists. On March 13, 2020, the President of the United States
declared that the COVID-19 outbreak in the U.S. constitutes a
national emergency, retroactive to March 1, 2020.
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As discussed elsewhere in section X.E. of this proposed rule and
section I.F of the FY 2022 IPPS/LTCH proposed rule (86 FR 25211-25212),
our goal is to use the best available data for ratesetting. Ordinarily,
the best available claims data is the set of data from 2 years prior to
the calendar year that is the subject of rulemaking, and accordingly,
we would have used claims data from CY 2020 for calculating proposed
rates for this CY 2022 OPPS/ASC proposed rule. As noted in section
X.E., however, we are proposing to use CY 2019 claims data in
establishing the CY 2022 OPPS rates and to use cost report data from
the same set of cost reports originally used in the final rule for 2021
OPPS ratesetting. We recognize that due to the effects of the PHE, the
CY 2020 claims data may not be the best available data for ratesetting,
including for purposes of ratesetting for devices, drugs, and
biologicals for which pass-through status expires between December 31,
2021 and September 30, 2022.
For this reason, and after consideration of the public comments we
received in response to the comment solicitation included in the CY
2021 OPPS/ASC proposed rule (85 FR 48862), we propose a one-time
equitable adjustment under section 1833(t)(2)(E) to continue separate
payment for the remainder of CY 2022 for devices, drugs, and
biologicals with pass-through status that expires between December 31,
2021 and September 30, 2022. We have consistently explained that
transitional pass-through payment for drugs, biologicals, and devices
is intended as an interim measure to allow for adequate payment of
certain new technology while we collect the necessary data to
incorporate the costs for these items into the procedure APC rate (66
FR 55861). We believe an equitable adjustment to continue separate
payment for devices, drugs, and biologicals with pass-through status
that expires between December 31, 2021 and September 30, 2022 is
necessary to ensure that we have full claims data from CY 2021 with
which to set payment rates beginning in CY 2023. We also believe it is
necessary to pay separately for these products in CY 2022 in a manner
that mimics continued pass-through status, rather than having to set
rates and make APC assignments and packaging decisions for these
products for CY 2022 based on data from CY 2020, which we do not
believe is the best available data for this purpose.
For those drugs, biologicals and the device for which payment would
be packaged following expiration of their pass-through status, we
believe providing separate payment for up to a full year in CY 2022 is
warranted to ensure there is a full year of data for ratesetting,
including to ensure appropriate APC assignments for the services with
which these products are billed. For drugs and biologicals that would
generally remain separately payable after their pass-through status
expires, we believe providing separate payment for up to a full year in
CY 2022 is necessary to ensure that these drugs and biologicals would,
in fact, be separately payable when their pass-through status expires,
including to ensure that their payment would be packaged if the drug's
cost is below the per-day packaging threshold. Specifically, for
threshold packaged drugs and biologicals, CMS requires current,
appropriate data to determine whether the drug should be packaged and
then to determine the impact of that packaging on the associated
service rates. We also believe separate payment in CY 2022 is necessary
to ensure we have sufficient data in the event payment for the drug is
packaged with payment for a primary C-APC service. Finally, consistent
with our goal of ensuring that the equitable adjustment
[[Page 42191]]
to provide separate payment for drugs and biologicals with pass-through
status that expires between December 31, 2021 and September 30, 2022
mimics pass-through payment to the extent possible, we propose that
separately payable drugs and biologicals that are eligible for this
adjustment would not be paid the proposed reduced amount of ASP minus
22.5 percent when they are acquired under the 340B program, and would
generally continue to be paid ASP plus 6 percent for the duration of
the time period during which the adjustment applies.
Under our proposal, the device category, drugs, and biologicals
that would be affected are as follows. One device category, HCPCS code
C1823 (Generator, neurostimulator (implantable), nonrechargeable, with
transvenous sensing and stimulation leads), would receive adjusted
payment equivalent to an additional four quarters of device pass-
through status. There are 27 drugs and biologicals whose pass-through
payment status expires between December 31, 2021 and September 30,
2022. Based on the CY 2020 data, payment for three of the 27 drugs and
biologicals would otherwise be packaged after the expiration of their
pass-through status. The remaining 24 drugs and biologicals would be
paid separately and would otherwise receive reduced payment at the
proposed rate of ASP minus 22.5 percent when they are acquired under
the 340B program.
There are currently six drugs and one device category whose pass-
through payment status will expire on December 31, 2021, nine drugs and
three biologicals whose pass-through status will expire on March 31,
2022, seven drugs whose pass-through status will expire on June 30,
2022, and two drugs whose pass-through payment status will expire on
September 30, 2022. Because pass-through status can expire at the end
of a quarter, the proposed adjusted payment would be made for between
one and four quarters, depending on when the pass-through period
expires for the device category, drug, or biological. In particular,
separate payment would be made a full year for the device category and
6 drugs for which pass-through status will expire on December 31, 2021,
three quarters for the 12 drugs and biologicals for which pass-through
status will expire on March 31, 2022, two quarters for the 7 drugs for
which pass-through status will expire on June 30, 2022, and one quarter
for the 2 drugs for which pass-through status will expire on September
30, 2022.
Table 38 lists pass-through drugs, biologicals and the device
category that we propose would receive adjusted separate payment, their
pass-through payment period effective dates and end dates, as well as
the number of quarters of separate payment equivalent to an extension
of pass-through status that we propose each drug or device category
would receive.
BILLING CODE 4120-01-P
[[Page 42192]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.071
[[Page 42193]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.072
BILLING CODE 4120-01-C
We are soliciting comments on our proposal to utilize our equitable
adjustment authority to pay separately for the remainder of CY 2022 for
the device category, drugs and biologicals with pass-through status
that expires between December 31, 2021 and September 30, 2022.
XI. Proposed CY 2022 OPPS Payment Status and Comment Indicators
A. Proposed CY 2022 OPPS Payment Status Indicator Definitions
Payment status indicators (SIs) that we assign to HCPCS codes and
APCs serve an important role in determining payment for services under
the OPPS. They indicate whether a service represented by a HCPCS code
is payable under the OPPS or another payment system, and also whether
particular OPPS policies apply to the code.
For CY 2022, we are not proposing to make any changes to the
existing definitions of status indicators that were listed in Addendum
D1 to the CY 2021 OPPS/ASC final rule with comment period available on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.
We are requesting public comments on the proposed definitions of
the OPPS status indicators for CY 2022.
The complete list of the proposed payment status indicators and
their definitions that would apply for CY 2022 is displayed in Addendum
D1 to this proposed rule, which is available on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
The proposed CY 2022 payment status indicator assignments for APCs
and HCPCS codes are shown in Addendum A and Addendum B, respectively,
to this proposed rule, which are available on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
B. Proposed CY 2022 Comment Indicator Definitions
In this proposed rule, we propose to use four comment indicators
for the CY 2022 OPPS. These comment indicators, ``CH'', ``NC'', ``NI'',
and ``NP'', are in effect for CY 2021 and we propose to continue their
use in CY 2022. The proposed CY 2022 OPPS comment indicators are as
follows:
``CH''--Active HCPCS code in current and next calendar
year, status indicator and/or APC assignment has changed; or active
HCPCS code that will be discontinued at the end of the current calendar
year.
[[Page 42194]]
``NC''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year, as compared to current calendar year for which we
requested comments in the proposed rule, final APC assignment; comments
will not be accepted on the final APC assignment for the new code.
``NI''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year, as compared to current calendar year, interim APC
assignment; comments will be accepted on the interim APC assignment for
the new code.
``NP''--New code for the next calendar year or existing
code with substantial revision to its code descriptor in the next
calendar year, as compared to current calendar year, proposed APC
assignment; comments will be accepted on the proposed APC assignment
for the new code.
The definitions of the proposed OPPS comment indicators for CY 2022
are listed in Addendum D2 to this proposed rule, which is available on
the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.
We believe that the existing CY 2021 definitions of the OPPS
comment indicators continue to be appropriate for CY 2022. Therefore,
we propose to use those definitions without modification for CY 2022.
XII. MedPAC Recommendations
The Medicare Payment Advisory Commission (MedPAC) was established
under section 1805 of the Act in large part to advise the U.S. Congress
on issues affecting the Medicare program. As required under the
statute, MedPAC submits reports to the Congress no later than March and
June of each year that present its Medicare payment policy
recommendations. The March report typically provides discussion of
Medicare payment policy across different payment systems and the June
report typically discusses selected Medicare issues. We are including
this section to make stakeholders aware of certain MedPAC
recommendations for the OPPS and ASC payment systems as discussed in
its March 2021 report.
A. Proposed OPPS Payment Rates Update
The March 2021 MedPAC ``Report to the Congress: Medicare Payment
Policy,'' recommended that Congress update Medicare OPPS payment rates
by 2 percent, with the difference between this and the update amount
specified in current law to be used to increase payments in a new
suggested Medicare quality program, the ``Hospital Value Incentive
Program (HVIP).'' We refer readers to the March 2021 report for a
complete discussion of these recommendations.\112\ We appreciate
MedPAC's recommendations, but as MedPAC acknowledged in its March 2021
report, the Congress would need to change current law to enable us to
implement its recommendations.
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\112\ Medicare Payment Advisory Committee. March 2021 Report to
the Congress. Chapter 3: Hospital Inpatient and outpatient services,
pp.81-82. Available at: http://medpac.gov/docs/default-source/reports/mar21_medpac_report_to_the_congress_sec.pdf?sfvrsn=0.
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B. Proposed ASC Conversion Factor Update
In the March 2021 MedPAC ``Report to the Congress: Medicare Payment
Policy,'' MedPAC found that, based on its analysis of indicators of
payment adequacy, the number of ASCs had increased, beneficiaries' use
of ASCs had increased, and ASC access to capital has been
adequate.\113\ As a result, for CY 2022, MedPAC stated that payments to
ASCs are adequate and recommended that in the absence of cost report
data no payment update should be given for CY 2022 (that is, the update
factor would be zero percent).
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\113\ Medicare Payment Advisory Committee. March 2020 Report to
the Congress. Chapter 5: Ambulatory surgical center services, p.147.
Available at: http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0.
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In the CY 2019 OPPS/ASC final rule with comment period (83 FR
59079), we adopted a policy, which we codified at 42 CFR 416.171(a)(2),
to apply the productivity-adjusted hospital market basket update to ASC
payment system rates for an interim period of 5 years. We refer readers
to the CY 2019 OPPS/ASC final rule with comment period for complete
details regarding our policy to use the productivity-adjusted hospital
market basket update for the ASC payment system for CY 2019 through CY
2023. Therefore, consistent with our policy for the ASC payment system,
as discussed in section XIII.G. of this proposed rule, we propose to
apply a 2.3 percent productivity-adjusted hospital market basket update
factor to the CY 2021 ASC conversion factor for ASCs meeting the
quality reporting requirements to determine the CY 2022 ASC payment
amounts.
C. ASC Cost Data
In the March 2021 MedPAC ``Report to the Congress: Medicare Payment
Policy,'' MedPAC recommended that Congress require ASCs to report cost
data to enable the Commission to examine the growth of ASCs' costs over
time and analyze Medicare payments relative to the costs of efficient
providers, and that CMS could use ASC cost data to examine whether an
existing Medicare price index is an appropriate proxy for ASC costs or
an ASC specific market basket should be developed. Further, MedPAC
suggested that CMS could limit the scope of the cost reporting system
to minimize administrative burden on ASCs and the program but should
make cost reporting a condition of ASC participation in the Medicare
program.\114\
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\114\ Medicare Payment Advisory Committee. March 2021 Report to
the Congress. Chapter 5: Ambulatory surgical center services, p.157.
Available at: http://medpac.gov/docs/default-source/reports/mar21_medpac_report_to_the_congress_sec.pdf?sfvrsn=0.
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While we recognize that the submission of cost data could place
additional administrative burden on most ASCs, and we are not proposing
any cost reporting requirements for ASCs in this CY 2022 OPPS/ASC
proposed rule, we are interested in public comment on methods that
would mitigate the burden of reporting costs on ASCs while also
collecting enough data to reliably use such data in the determination
of ASC costs. Such cost data would be beneficial in establishing an
ASC-specific market basket index for updating payment rates under the
ASC payment system.
The full March 2021 MedPAC Report to Congress can be downloaded
from MedPAC's website at: http://www.medpac.gov.
XIII. Updates to the Ambulatory Surgical Center (ASC) Payment System
A. Background
1. Legislative History, Statutory Authority, and Prior Rulemaking for
the ASC Payment System
For a detailed discussion of the legislative history and statutory
authority related to payments to ASCs under Medicare, we refer readers
to the CY 2012 OPPS/ASC final rule with comment period (76 FR 74377
through 74378) and the June 12, 1998 proposed rule (63 FR 32291 through
32292). For a discussion of prior rulemaking on the ASC payment system,
we refer readers to the CYs 2012, 2013, 2014, 2015, 2016, 2017, 2018,
2019, 2020, and 2021 OPPS/ASC final rules with comment period (76 FR
74378 through 74379; 77 FR 68434 through 68467; 78 FR 75064 through
75090; 79 FR 66915 through 66940; 80 FR 70474 through 70502; 81 FR
79732 through 79753; 82 FR 59401 through 59424; 83 FR 59028 through
[[Page 42195]]
59080; 84 FR 61370 through 61410, and 85 FR 86121 through 86179,
respectively).
2. Policies Governing Changes to the Lists of Codes and Payment Rates
for ASC Covered Surgical Procedures and Covered Ancillary Services
Under Sec. Sec. 416.2 and 416.166 of the Medicare regulations,
subject to certain exclusions, covered surgical procedures in an ASC
are surgical procedures that are separately paid under the OPPS, are
not designated as requiring inpatient care under Sec. 419.22(n) as of
December 31, 2020, are not only able to be reported using a CPT
unlisted surgical procedure code, and are not otherwise excluded under
Sec. 411.15.
In previous years, we identified surgical procedures as those
described by Category I CPT codes in the surgical range from 10000
through 69999 as well as those Category III CPT codes and Level II
HCPCS codes that directly crosswalk or are clinically similar to
procedures in the CPT surgical range that we have determined do not
pose a significant safety risk, that we would not expect to require an
overnight stay when performed in ASCs, and that are separately paid
under the OPPS (72 FR 42478).
Covered ancillary services are specified in Sec. 416.164(b) and,
as stated previously, are eligible for separate ASC payment. As
provided at 42 CFR 416.164(b), we make separate ASC payments for the
following ancillary items and services when they are provided integral
to ASC covered surgical procedures: (1) Brachytherapy sources; (2)
certain implantable items that have pass-through payment status under
the OPPS; (3) certain items and services that we designate as
contractor-priced, including, but not limited to, procurement of
corneal tissue; (4) certain drugs and biologicals for which separate
payment is allowed under the OPPS; (5) certain radiology services for
which separate payment is allowed under the OPPS; and (6) non-opioid
pain management drugs that function as a supply when used in a surgical
procedure. Payment for ancillary items and services that are not paid
separately under the ASC payment system is packaged into the ASC
payment for the covered surgical procedure.
We update the lists of, and payment rates for, covered surgical
procedures and covered ancillary services in ASCs in conjunction with
the annual proposed and final rulemaking process to update the OPPS and
the ASC payment system (Sec. 416.173; 72 FR 42535). We base ASC
payment and policies for most covered surgical procedures, drugs,
biologicals, and certain other covered ancillary services on the OPPS
payment policies, and we use quarterly change requests (CRs) to update
services paid for under the OPPS. We also provide quarterly update CRs
for ASC covered surgical procedures and covered ancillary services
throughout the year (January, April, July, and October). We release new
and revised Level II HCPCS codes and recognize the release of new and
revised CPT codes by the American Medical Association (AMA) and make
these codes effective (that is, the codes are recognized on Medicare
claims) via these ASC quarterly update CRs. We recognize the release of
new and revised Category III CPT codes in the July and January CRs.
These updates implement newly created and revised Level II HCPCS and
Category III CPT codes for ASC payments and update the payment rates
for separately paid drugs and biologicals based on the most recently
submitted ASP data. New and revised Category I CPT codes, except
vaccine codes, are released only once a year, and are implemented only
through the January quarterly CR update. New and revised Category I CPT
vaccine codes are released twice a year and are implemented through the
January and July quarterly CR updates. We refer readers to Table 41 in
the CY 2012 OPPS/ASC proposed rule for an example of how this process
is used to update HCPCS and CPT codes, which we finalized in the CY
2012 OPPS/ASC final rule with comment period (76 FR 42291; 76 FR 74380
through 74384).
In our annual updates to the ASC list of, and payment rates for,
covered surgical procedures and covered ancillary services, we
undertake a review of excluded surgical procedures, new codes, and
codes with revised descriptors, to identify any that we believe meet
the criteria for designation as ASC covered surgical procedures or
covered ancillary services. Updating the lists of ASC covered surgical
procedures and covered ancillary services, as well as their payment
rates, in association with the annual OPPS rulemaking cycle is
particularly important because the OPPS relative payment weights and,
in some cases, payment rates, are used as the basis for the payment of
many covered surgical procedures and covered ancillary services under
the revised ASC payment system. This joint update process ensures that
the ASC updates occur in a regular, predictable, and timely manner.
3. Definition of ASC Covered Surgical Procedures
Since the implementation of the ASC prospective payment system, we
have historically defined a ``surgical'' procedure under the payment
system as any procedure described within the range of Category I CPT
codes that the CPT Editorial Panel of the AMA defines as ``surgery''
(CPT codes 10000 through 69999) (72 FR 42478). We also have included as
``surgical,'' procedures that are described by Level II HCPCS codes or
by Category III CPT codes that directly crosswalk or are clinically
similar to procedures in the CPT surgical range.
As we noted in the August 7, 2007 final rule that implemented the
revised ASC payment system, using this definition of surgery would
exclude from ASC payment certain invasive, ``surgery-like'' procedures,
such as cardiac catheterization or certain radiation treatment services
that are assigned codes outside the CPT surgical range (72 FR 42477).
We stated in that final rule that we believed continuing to rely on the
CPT definition of surgery is administratively straightforward, is
logically related to the categorization of services by physician
experts who both establish the codes and perform the procedures, and is
consistent with a policy to allow ASC payment for all outpatient
surgical procedures.
However, in the CY 2019 OPPS/ASC final rule with comment period (83
FR 59029 through 59030), after consideration of public comments
received in response to the CY 2019 OPPS/ASC proposed rule and earlier
OPPS/ASC rulemaking cycles, we revised our definition of a surgical
procedure under the ASC payment system. In that final rule, we defined
a surgical procedure under the ASC payment system as any procedure
described within the range of Category I CPT codes that the CPT
Editorial Panel of the AMA defines as ``surgery'' (CPT codes 10000
through 69999) (72 FR 42476), as well as procedures that are described
by Level II HCPCS codes or by Category I CPT codes or by Category III
CPT codes that directly crosswalk or are clinically similar to
procedures in the CPT surgical range that we determined met the general
standards established in previous years for addition to the CPL. These
criteria included that a procedure is not expected to pose a
significant risk to beneficiary safety when performed in an ASC, that
standard medical practice dictates that the beneficiary would not
typically be expected to require an overnight stay following the
procedure, and that the procedure is separately
[[Page 42196]]
paid under the OPPS. In CY 2021, we revised the definition of covered
surgical procedures to surgical procedures specified by the Secretary
that are separately paid under the OPPS, are not designated as
requiring inpatient care under Sec. [thinsp]419.22(n) as of December
31, 2020, are not only able to be reported using a CPT unlisted
surgical procedure code, and are not otherwise excluded under Sec.
[thinsp]411.15 (85 FR 86153).
B. Proposed ASC Treatment of New and Revised Codes
1. Background on Current Process for Recognizing New and Revised HCPCS
Codes
Payment for ASC procedures, services, and items are generally based
on medical billing codes, specifically, HCPCS codes, that are reported
on ASC claims. HCPCS codes are used to report procedures, services,
items, and supplies under the ASC payment system. Specifically, we
recognize the following codes on ASC claims:
Category I CPT codes, which describe surgical procedures,
diagnostic and therapeutic services, and vaccine codes;
Category III CPT codes, which describe new and emerging
technologies, services, and procedures; and
Level II HCPCS codes (also known as alpha-numeric codes),
which are used primarily to identify and track drugs, devices,
supplies, temporary procedures, and services not described by CPT
codes.
We finalized a policy in the August 2, 2007 final rule (72 FR 42533
through 42535) to evaluate each year all new and revised Category I and
Category III CPT codes and Level II HCPCS codes that describe surgical
procedures, and to make preliminary determinations during the annual
OPPS/ASC rulemaking process regarding whether or not they meet the
criteria for payment in the ASC setting as covered surgical procedures
and, if so, whether or not they are office-based procedures. In
addition, we identify new and revised codes as ASC covered ancillary
services based upon the final payment policies of the revised ASC
payment system. In prior rulemakings, we refer to this process as
recognizing new codes. However, this process has always involved the
recognition of new and revised codes. We consider revised codes to be
new when they have substantial revision to their code descriptors that
necessitate a change in the current ASC payment indicator. We refer to
these codes as new and revised in this CY 2022 OPPS/ASC proposed rule.
We have separated our discussion below based on when the codes are
released and whether we are proposing to solicit public comments in
this proposed rule (and respond to those comments in the CY 2022 OPPS/
ASC final rule with comment period) or whether we will be soliciting
public comments in the CY 2022 OPPS/ASC final rule with comment period
(and responding to those comments in the CY 2023 OPPS/ASC final rule
with comment period).
2. April 2021 HCPCS Codes for Which We Are Soliciting Public Comments
in This Proposed Rule
For the April 2021 update, there was one new CPT code and there
were 11 new Level II HCPCS codes. In the April 2021 ASC quarterly
update (Transmittal 10702, CR 12183, dated April 1, 2021), we added 11
new Level II HCPCS codes to the list of ASC covered surgical procedures
and the list of covered ancillary services. Table 39 below lists the
new Level II HCPCS codes that were implemented April 1, 2021, along
with their proposed payment indicators for CY 2022. The proposed
comment indicators, payment indicators and payment rates, where
applicable, for these April codes can be found in Addendum BB to this
proposed rule. The list of proposed ASC payment indicators and
corresponding definitions can be found in Addendum DD1 to this proposed
rule. These new codes that are effective April 1, 2021 are assigned to
comment indicator ``NP'' in Addendum BB to this proposed rule to
indicate that the codes are assigned to an interim APC assignment and
that comments will be accepted on their interim APC assignments. Also,
the list of proposed comment indicators and definitions used under the
ASC payment system can be found in Addendum DD2 to this proposed rule.
We note that ASC Addenda AA, BB, DD1, and DD2 are available via the
internet on the CMS website.
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[[Page 42197]]
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We are inviting public comments on these proposed payment
indicators for the new HCPCS codes that were recognized as ASC covered
surgical procedures and ancillary services in April 2021 through the
quarterly update CRs, as listed in Table 39 above. We are proposing to
finalize their payment indicators in the CY 2022 OPPS/ASC final rule
with comment period.
3. July 2021 HCPCS Codes for Which We Are Soliciting Public Comments in
This Proposed Rule
In the July 2021 ASC quarterly update (Transmittal 10858, Change
Request 12341, dated June 25, 2021), we added several separately
payable CPT and Level II HCPCS codes to the list of covered surgical
procedures and ancillary services. Table 40 below lists the new HCPCS
codes that are effective July 1, 2021. The proposed payment indicators
and payment rates for these codes can be found in Addendum AA and
Addendum BB to this proposed rule. The list of proposed ASC payment
indicators and corresponding definitions can be found in Addendum DD1
to this proposed rule. These new codes that are effective July 1, 2021
are assigned comment indicator ``NP'' in Addendum BB to this proposed
rule to indicate that the codes are assigned to an interim APC
assignment and that comments will be accepted on those assignments. The
list of proposed comment indicators and definitions used under the ASC
payment system can be found in Addendum DD2 to this proposed rule. We
note that ASC Addenda AA, BB, DD1, and DD2 are available via the
internet on the CMS website.
[[Page 42198]]
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In addition, through the July 2021 quarterly update CR, we added 11
new Category III CPT codes to the list of ASC covered ancillary
services, effective July 1, 2021. This code is listed in Table 41
below, along with the proposed comment indicator and payment indicator.
The CY 2022 proposed payment rate for these new Category III CPT codes
can be found in Addendum BB. As noted above, the lists of proposed
payment indicators and comment indicators used under the ASC payment
system are included in Addenda DD1 and DD2, respectively, of this
proposed rule. We note that ASC Addenda AA, BB, DD1, and DD2 are
available via the internet on the CMS website.
[[Page 42199]]
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[[Page 42200]]
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We are inviting public comments on the proposed comment indicators
and payment indicators for the new Level II HCPCS codes newly
recognized as ASC covered surgical procedures and covered ancillary
services and the new Category III CPT codes for covered ancillary
services beginning in July 2021 through the quarterly update CRs, as
listed in Tables 39, 40, and 41 above. We are proposing to finalize the
proposed payment indicators in the CY 2022 OPPS/ASC final rule with
comment period.
4. October 2021 HCPCS Codes for Which We Will Be Soliciting Public
Comments in the CY 2022 OPPS/ASC Final Rule With Comment Period
For CY 2022, consistent with our established policy, we are
proposing that the Level II HCPCS codes that will be effective October
1, 2021 would be flagged with comment indicator ``NI'' in Addendum B to
the CY 2022 OPPS/ASC final rule with comment period to indicate that we
have assigned the codes an interim OPPS payment status for CY 2022. We
will invite public comments in the CY 2022 OPPS/ASC final rule with
comment period on the interim payment indicators, which would then be
finalized in the CY 2023 OPPS/ASC final rule with comment period.
5. January 2022 HCPCS Codes
a. Level II HCPCS Codes for Which We Will Be Soliciting Public Comments
in the CY 2022 OPPS/ASC Final Rule With Comment Period
As has been our practice in the past, we incorporate those new
Level II HCPCS codes that are effective January 1 in the final rule
with comment period, thereby updating the ASC payment system for the
calendar year. We note that unlike the CPT codes that are effective
January 1 and are included in the OPPS/ASC proposed rules, and except
for the G-codes listed in Addendum O to this proposed rule, most Level
II HCPCS codes are not released until sometime around November to be
effective January 1. Because these codes are not available until
November, we are unable to include them in the OPPS/ASC proposed rules.
Therefore, these Level II HCPCS codes will be released to the public
through the January 2022 ASC Update CR, and included on the CMS HCPCS
website and in the CY 2022 OPPS/ASC final rule with comment period.
In addition, for CY 2022, we propose to continue our established
policy of assigning comment indicator ``NI'' in Addendum AA and
Addendum BB to the OPPS/ASC final rule with comment period to the new
Level II HCPCS codes that will be effective January 1, 2022 to indicate
that we are assigning them an interim payment indicator, which is
subject to public comment. We will be inviting public comments in the
CY 2022 OPPS/ASC final rule with comment period on the payment
indicator assignments, which would then be finalized in the CY 2023
OPPS/ASC final rule with comment period.
b. CPT Codes for Which We Are Soliciting Public Comments in This
Proposed Rule
For new and revised CPT codes effective January 1, 2022 that were
received in time to be included in this proposed rule, we are proposing
the appropriate payment indicator assignments, and soliciting public
comments on the payment assignments. We will accept comments and
finalize the payment indicators in the CY 2022 OPPS/ASC final rule with
comment period. For those new/revised CPT codes that are received too
late for inclusion in this OPPS/ASC proposed rule, we may either make
interim final assignments in the CY 2022 OPPS/ASC final rule with
comment period or use HCPCS G codes that mirror the predecessor CPT
codes and retain the current APC and status indicator assignments for a
year until we can propose APC and status indicator assignments in the
following year's rulemaking cycle.
For the CY 2022 ASC update, the new and revised Category I and III
CPT codes that will be effective on January 1, 2022 can be found in ASC
Addendum AA and Addendum BB to this proposed rule (which are available
via the internet on the CMS website). The CPT codes are assigned to
comment indicator ``NP'' to indicate that the code is new for the next
calendar year or the code is an existing code with substantial revision
to its code descriptor in the next calendar year as compared to the
current calendar year and that comments will be accepted on the
proposed payment indicator. Further, we remind readers that the CPT
code descriptors that appear in Addendum AA and Addendum BB are short
descriptors and do not describe the complete procedure, service, or
item described by the CPT code. Therefore, we include the 5-digit
placeholder codes and their long descriptors for the new and revised CY
2022 CPT codes in Addendum O to this proposed rule (which is available
via the internet on
[[Page 42201]]
the CMS website) so that the public can comment on our proposed payment
indicator assignments. The 5-digit placeholder codes can be found in
Addendum O to this proposed rule, specifically under the column labeled
``CY 2021 OPPS/ASC Proposed Rule 5-Digit Placeholder Code.'' The final
CPT code numbers will be included in the CY 2022 OPPS/ASC final rule
with comment period.
In summary, we are soliciting public comments on the proposed CY
2022 payment indicators for the new and revised Category I and III CPT
codes that will be effective January 1, 2022. Because these codes are
listed in Addenda AA and Addendum BB with short descriptors only, we
are listing them again in Addendum O with the long descriptors. We are
also proposing to finalize the payment indicator for these codes (with
their final CPT code numbers) in the CY 2022 OPPS/ASC final rule with
comment period. The proposed payment indicator and comment indicator
for these codes can be found in Addendum AA and BB to this proposed
rule. The list of ASC payment indicators and corresponding definitions
can be found in Addendum DD1 to this proposed rule. These new CPT codes
that will be effective January 1, 2022 are assigned to comment
indicator ``NP'' in Addendum AA and BB to this proposed rule to
indicate that the codes are assigned to an interim payment indicator
and that comments will be accepted on their interim ASC payment
assignments. Also, the list of comment indicators and definitions used
under the ASC can be found in Addendum DD2 to this proposed rule. We
note that ASC Addenda AA, BB, DD1, and DD2 are available via the
internet on the CMS website.
Finally, in Table 42 below, we summarize our process for updating
codes through our ASC quarterly update CRs, seeking public comments,
and finalizing the treatment of these new codes under the ASC payment
system.
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C. Proposed Update to the List of ASC Covered Surgical Procedures and
Covered Ancillary Services
1. Covered Surgical Procedures
a. Covered Surgical Procedures Designated as Office-Based
(1) Background
In the August 2, 2007 ASC final rule, we finalized our policy to
designate as ``office-based'' those procedures that are added to the
ASC Covered Procedures List (CPL) in CY 2008 or later years that we
determine are furnished predominantly (more than 50 percent of the
time) in physicians' offices based on consideration of the most recent
available volume and utilization data for each individual procedure
code and/or, if appropriate, the clinical characteristics, utilization,
and volume of related codes. In that rule, we also finalized our policy
to exempt all procedures on the CY 2007 ASC list from application of
the office-based classification (72 FR 42512). The procedures that were
added to the ASC CPL beginning in CY 2008 that we determined were
office-based were identified in Addendum AA to that rule
[[Page 42202]]
with payment indicator ``P2'' (Office-based surgical procedure added to
ASC list in CY 2008 or later with MPFS nonfacility PE RVUs; payment
based on OPPS relative payment weight); ``P3'' (Office-based surgical
procedures added to ASC list in CY 2008 or later with MPFS nonfacility
PE RVUs; payment based on MPFS nonfacility PE RVUs); or ``R2'' (Office-
based surgical procedure added to ASC list in CY 2008 or later without
MPFS nonfacility PE RVUs; payment based on OPPS relative payment
weight), depending on whether we estimated the procedure would be paid
according to the standard ASC payment methodology based on its OPPS
relative payment weight or at the MPFS nonfacility PE RVU-based amount.
Consistent with our final policy to annually review and update the
ASC CPL to include all covered surgical procedures eligible for payment
in ASCs, each year we identify covered surgical procedures as either
temporarily office-based (these are new procedure codes with little or
no utilization data that we have determined are clinically similar to
other procedures that are permanently office-based), permanently
office-based, or non office-based, after taking into account updated
volume and utilization data.
(2) Proposed Changes for CY 2022 to Covered Surgical Procedures
Designated as Office-Based
In developing this CY 2022 OPPS/ASC proposed rule, we followed our
policy to annually review and update the covered surgical procedures
for which ASC payment is made and to identify new procedures that may
be appropriate for ASC payment (described in detail in section
XIII.C.1.d), including their potential designation as office-based.
Historically, we would also review the most recent claims volume and
utilization data (CY 2020 claims) and the clinical characteristics for
all covered surgical procedures that are currently assigned a payment
indicator in CY 2020 of ``G2'' (Non office-based surgical procedure
added in CY 2008 or later; payment based on OPPS relative payment
weight), as well as for those procedures assigned one of the temporary
office-based payment indicators, specifically ``P2'', ``P3'', or ``R2''
in the CY 2021 OPPS/ASC final rule with comment period (85 FR 86131
through 86139). However, as discussed in Section II.A.1.a of this
proposed rule, given our concerns with CY 2020 claims data as a result
of the PHE, we are not proposing to review the most recent claims
volume and utilization data from CY 2020 claims and instead we are
proposing not to assign permanent office-based designations for CY 2022
to any covered surgical procedure currently assigned a payment
indicator of ``G2'' (Non office-based surgical procedure added in CY
2008 or later; payment based on OPPS relative payment weight).
Similarly, we are also proposing not to use the most recent claims
volume and utilization data and other information for procedures
designated as temporarily office-based and temporarily assigned one of
the office-based payment indicators, specifically ``P2,'' ``P3'' or
``R2,'' as shown in Table 56 and Table 57 in the CY 2021 OPPS/ASC final
rule with comment period (85 FR 86136 through 86137). Instead, we
propose to continue to designate these procedures, shown in Table 43,
as temporarily office-based for CY 2022. The procedures we propose to
designate as temporarily office-based for CY 2022 are identified with
an asterisk in Addendum AA to this proposed rule with comment period
(which is available via the internet on the CMS website).
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As discussed in the August 2, 2007 revised ASC payment system final
rule (72 FR 42533 through 42535), we finalized our policy to designate
certain new surgical procedures as temporarily office-based until
adequate claims data are available to assess their predominant sites of
service, whereupon if we confirm their office-based nature, the
procedures would be permanently assigned to the list of office-based
[[Page 42204]]
procedures. In the absence of claims data, we stated we would use other
available information, including our clinical advisors' judgment,
predecessor CPT and Level II HCPCS codes, information submitted by
representatives of specialty societies and professional associations,
and information submitted by commenters during the public comment
period.
For CY 2022, we propose to designate two new CY 2022 CPT codes for
ASC covered surgical procedures as temporarily office-based. After
reviewing the clinical characteristics, utilization, and volume of
related procedure codes, we determined that the procedures listed in
Table 44 would be predominantly performed in physicians' offices. We
believe the procedure described by CPT code 42XXX (Drug-induced sleep
endoscopy, with dynamic evaluation of velum, pharynx, tongue base, and
larynx for evaluation of sleep-disordered breathing, flexible,
diagnostic) is similar to CPT code 31505 (Laryngoscopy, indirect;
diagnostic (separate procedure)) which is currently on the list of ASC
covered surgical procedures and was assigned a final payment indicator
of ``P3''--Office-based surgical procedure added to ASC list in CY 2008
or later with MPFS nonfacility PE RVUs; payment based on MPFS
nonfacility PE RVUs.--in CY 2021. Additionally, we believe the
procedure described by CPT code 53XX4 (Periurethral transperineal
adjustable balloon continence device; percutaneous adjustment of
balloon(s) fluid volume) is similar to CPT code 0551T (Transperineal
periurethral balloon continence device; adjustment of balloon(s) fluid
volume), which is currently on the list of ASC covered surgical
procedures and was assigned a final payment indicator of ``R2''--
Office-based surgical procedure added to ASC list in CY 2008 or later
without MPFS nonfacility PE RVUs; payment based on OPPS relative
payment weight--for CY 2021. As such, we propose to add CPT codes 42XXX
and 53XX4 in Table 44 to the list of ASC covered surgical procedures
designated as temporarily office-based for CY 2022.
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b. Proposed Device-Intensive ASC Covered Surgical Procedures
(1) Background
We refer readers to the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59040 through 59041), for a summary of our existing
policies regarding ASC covered surgical procedures that are designated
as device-intensive.
(2) Changes to List of ASC Covered Surgical Procedures Designated as
Device-Intensive for CY 2022
In the CY 2019 OPPS/ASC final rule with comment period (83 FR
590401 through 59043), for CY 2019, we modified our criteria for
device-intensive procedures to better capture costs for procedures with
significant device costs. We adopted a policy to allow procedures that
involve surgically inserted or implanted, high-cost, single-use devices
to qualify as device-intensive procedures. In addition, we modified our
criteria to lower the device offset percentage threshold from 40
percent to 30 percent. Specifically, for CY 2019 and subsequent years,
we adopted a policy that device-intensive procedures would be subject
to the following criteria:
All procedures must involve implantable devices assigned a
CPT or HCPCS code;
The required devices (including single-use devices) must
be surgically inserted or implanted; and
The device offset amount must be significant, which is
defined as exceeding 30 percent of the procedure's mean cost. For
consistency with this change in the cost criterion, we adopted a policy
that the default device offset for new codes that describe procedures
that involve the implantation of medical devices will be 31 percent
beginning in CY 2019. For new codes describing procedures that are
payable when furnished in an ASC involving the implantation of a
medical device, we adopted a policy that the default device offset
would be applied in the same
[[Page 42205]]
manner as the policy we adopted in section IV.B.2. of the CY 2019 OPPS/
ASC final rule with comment period (83 FR 58944 through 58948). We
amended Sec. 416.171(b)(2) of the regulations to reflect these new
device criteria.
In addition, as also adopted in section IV.B.2. of CY 2019 OPPS/ASC
final rule with comment period, to further align the device-intensive
policy with the criteria used for device pass-through status, we
specified, for CY 2019 and subsequent years, that for purposes of
satisfying the device-intensive criteria, a device-intensive procedure
must involve a device that:
Has received Food and Drug Administration (FDA) marketing
authorization, has received an FDA investigational device exemption
(IDE) and has been classified as a Category B device by the FDA in
accordance with Sec. Sec. 405.203 through 405.207 and 405.211 through
405.215, or meets another appropriate FDA exemption from premarket
review;
Is an integral part of the service furnished;
Is used for one patient only;
Comes in contact with human tissue;
Is surgically implanted or inserted (either permanently or
temporarily); and
Is not any of the following:
++ Equipment, an instrument, apparatus, implement, or item of this
type for which depreciation and financing expenses are recovered as
depreciable assets as defined in Chapter 1 of the Medicare Provider
Reimbursement Manual (CMS Pub. 15-1); or
++ A material or supply furnished incident to a service (for
example, a suture, customized surgical kit, scalpel, or clip, other
than a radiological site marker).
Based on these criteria, for 2022, we propose to update the ASC CPL
to indicate procedures that are eligible for payment according to our
device-intensive procedure payment methodology, based on the proposed
individual HCPCS code device-offset percentages using the CY 2019 OPPS
claims and cost report data available for the CY 2022 OPPS/ASC proposed
rule.
The ASC covered surgical procedures that we propose to designate as
device-intensive, and therefore subject to the device-intensive
procedure payment methodology for CY 2022, are assigned payment
indicator ``J8'' and are included in ASC Addendum AA to this proposed
rule (which is available via the internet on the CMS website). The CPT
code, the CPT code short descriptor, and the proposed CY 2022 ASC
payment indicator, and an indication of whether the full credit/partial
credit (FB/FC) device adjustment policy would apply because the
procedure is designated as device-intensive are also included in
Addendum AA to the proposed rule (which is available via the internet
on the CMS website).
Under current policy, the payment rate under the ASC payment system
for device-intensive procedures furnished with an implantable or
inserted medical device are calculated by applying the device offset
percentage based on the standard OPPS APC ratesetting methodology to
the OPPS national unadjusted payment based on the standard ratesetting
methodology to determine the device cost included in the OPPS payment
rate for a device-intensive ASC covered surgical procedure, which we
then set as equal to the device portion of the national unadjusted ASC
payment rate for the procedure. We calculate the service portion of the
ASC payment for device intensive procedures by applying the uniform ASC
conversion factor to the service (non-device) portion of the OPPS
relative payment weight for the device-intensive procedure. Finally, we
sum the ASC device portion and ASC service portion to establish the
full payment for the device-intensive procedure under the ASC payment
system (82 FR 59409).
In past rulemaking (79 FR 66924), we have stated that the device-
intensive methodology for ASCs should align with the device-intensive
policies under the OPPS. Further, we have stated that we do not believe
that procedures are device-intensive in one setting and not in another
setting. We have heard concerns from stakeholders that our methodology
does not provide device-intensive status to certain procedures even
though the procedures' device offset percentages are greater than our
30 percent threshold when calculated under the standard ASC ratesetting
methodology. We have also heard concerns from stakeholders that
procedures designated as device-intensive under the OPPS are not
assigned device-intensive status under the ASC payment system even
though the procedure has significant device costs.
The different ratesetting methodologies used under the OPPS and ASC
payment system can create conflicts when determining device-intensive
status. For example, procedures with device offset percentages greater
than 30 percent under the OPPS may not have device offset percentages
greater than 30 percent when calculated under the standard ASC
ratesetting methodology. Under current policy, procedures must be
device-intensive in the OPPS setting to be eligible for device-
intensive status under the ASC payment system. However, this
methodology has caused confusion among stakeholders and has denied
device-intensive status to procedures with significant device costs.
While we believe that device-intensive policies under the ASC payment
system should align with device-intensive policies under the OPPS, we
believe device-intensive status under the ASC payment system should, at
a minimum, reflect a procedure's estimated device costs under the ASC
standard ratesetting methodology. Therefore, for CY 2022 and subsequent
years, we are proposing to assign device-intensive status to procedures
that involve surgically inserted or implanted, high-cost, single-use
devices to qualify as device-intensive procedures if their device
offset percentage exceeds 30 percent under the ASC standard ratesetting
methodology, even if the procedure is not designated as device-
intensive under the OPPS.
Further, in situations where a procedure is designated as device-
intensive under the OPPS but the procedure's device offset percentage
is below the device-intensive threshold under the standard ASC
ratesetting methodology, we believe that deference should be given to
the OPPS designation to address this conflict in status. Since the
comprehensive ratesetting methodology under the OPPS packages a greater
amount of non-device costs into the primary procedure and is typically
able to use a greater number of claims in its ratesetting methodology,
we believe that if a device receives OPPS device-intensive status, the
device should also be device-intensive in the ASC setting, give that
fewer non-device costs are generally packaged into a procedure's cost
under the ASC methodology compared to the OPPS methodology. Therefore,
for CY 2022 and subsequent years, we are proposing that if a procedure
is assigned device-intensive status under the OPPS, but has a device
offset percentage below the device-intensive threshold under the
standard ASC ratesetting methodology, the procedure will be assigned
device-intensive status under the ASC payment system with a default
device offset percentage of 31 percent.
We are soliciting comments on our proposed changes related to
designating surgical procedures as device-intensive under the ASC
payment system.
[[Page 42206]]
c. Adjustment to ASC Payments for No Cost/Full Credit and Partial
Credit Devices
Our ASC payment policy for costly devices implanted or inserted in
ASCs at no cost/full credit or partial credit is set forth in Sec.
416.179 of our regulations, and is consistent with the OPPS policy that
was in effect until CY 2014. We refer readers to the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66845 through 66848) for a full
discussion of the ASC payment adjustment policy for no cost/full credit
and partial credit devices.) ASC payment is reduced by 100 percent of
the device offset amount when a hospital furnishes a specified device
without cost or with a full credit and by 50 percent of the device
offset amount when the hospital receives partial credit in the amount
of 50 percent or more of the cost for the specified device.
Effective CY 2014, under the OPPS, we finalized our proposal to
reduce OPPS payment for applicable APCs by the full or partial credit a
provider receives for a device, capped at the device offset amount.
Although we finalized our proposal to modify the policy of reducing
payments when a hospital furnishes a specified device without cost or
with full or partial credit under the OPPS, in the CY 2014 OPPS/ASC
final rule with comment period (78 FR 75076 through 75080), we
finalized our proposal to maintain our ASC policy for reducing payments
to ASCs for specified device-intensive procedures when the ASC
furnishes a device without cost or with full or partial credit. Unlike
the OPPS, there is currently no mechanism within the ASC claims
processing system for ASCs to submit to CMS the actual credit received
when furnishing a specified device at full or partial credit.
Therefore, under the ASC payment system, we finalized our proposal for
CY 2014 to continue to reduce ASC payments by 100 percent or 50 percent
of the device offset amount when an ASC furnishes a device without cost
or with full or partial credit, respectively.
Under current ASC policy, all ASC device-intensive covered surgical
procedures are subject to the no cost/full credit and partial credit
device adjustment policy. Specifically, when a device-intensive
procedure is performed to implant or insert a device that is furnished
at no cost or with full credit from the manufacturer, the ASC would
append the HCPCS ``FB'' modifier on the line in the claim with the
procedure to implant or insert the device. The contractor would reduce
payment to the ASC by the device offset amount that we estimate
represents the cost of the device when the necessary device is
furnished without cost or with full credit to the ASC. We continue to
believe that the reduction of ASC payment in these circumstances is
necessary to pay appropriately for the covered surgical procedure
furnished by the ASC.
Effective in CY 2019 (83 FR 59043 through 59044), for partial
credit, we adopted a policy to reduce the payment for a device-
intensive procedure for which the ASC receives partial credit by one-
half of the device offset amount that would be applied if a device was
provided at no cost or with full credit, if the credit to the ASC is 50
percent or more (but less than 100 percent) of the cost of the new
device. The ASC will append the HCPCS ``FC'' modifier to the HCPCS code
for the device-intensive surgical procedure when the facility receives
a partial credit of 50 percent or more (but less than 100 percent) of
the cost of a device. To report that the ASC received a partial credit
of 50 percent or more (but less than 100 percent) of the cost of a new
device, ASCs have the option of either: (1) Submitting the claim for
the device-intensive procedure to their Medicare contractor after the
procedure's performance, but prior to manufacturer acknowledgment of
credit for the device, and subsequently contacting the contractor
regarding a claim adjustment, once the credit determination is made; or
(2) holding the claim for the device implantation or insertion
procedure until a determination is made by the manufacturer on the
partial credit and submitting the claim with the ``FC'' modifier
appended to the implantation procedure HCPCS code if the partial credit
is 50 percent or more (but less than 100 percent) of the cost of the
device. Beneficiary coinsurance would be based on the reduced payment
amount. As finalized in the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66926), to ensure our policy covers any situation
involving a device-intensive procedure where an ASC may receive a
device at no cost or receive full credit or partial credit for the
device, we apply our ``FB''/``FC'' modifier policy to all device-
intensive procedures.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59043
through 59044) we stated we would reduce the payment for a device-
intensive procedure for which the ASC receives partial credit by one-
half of the device offset amount that would be applied if a device was
provided at no cost or with full credit, if the credit to the ASC is 50
percent or more (but less than 100 percent) of the cost of the device.
In the CY 2020 OPPS/ASC final rule with comment period, we finalized
continuing our existing policies for CY 2020. We note that we
inadvertently omitted language that this policy would apply not just in
CY 2019 but also in subsequent calendar years. We intended to apply
this policy in CY 2019 and subsequent calendar years. Therefore, we
propose to apply our policy for partial credits specified in the CY
2019 OPPS/ASC final rule with comment period (83 FR 59043 through
59044) in CY 2022 and subsequent calendar years. Specifically, for CY
2022 and subsequent calendar years, we would reduce the payment for a
device-intensive procedure for which the ASC receives partial credit by
one-half of the device offset amount that would be applied if a device
was provided at no cost or with full credit, if the credit to the ASC
is 50 percent or more (but less than 100 percent) of the cost of the
device. To report that the ASC received a partial credit of 50 percent
or more (but less than 100 percent) of the cost of a device, ASCs have
the option of either: (1) Submitting the claim for the device intensive
procedure to their Medicare contractor after the procedure's
performance, but prior to manufacturer acknowledgment of credit for the
device, and subsequently contacting the contractor regarding a claim
adjustment, once the credit determination is made; or (2) holding the
claim for the device implantation or insertion procedure until a
determination is made by the manufacturer on the partial credit and
submitting the claim with the ``FC'' modifier appended to the
implantation procedure HCPCS code if the partial credit is 50 percent
or more (but less than 100 percent) of the cost of the device.
Beneficiary coinsurance would be based on the reduced payment amount.
We are not proposing any other changes to our policies related to no/
cost full credit or partial credit devices.
d. Additions to the List of ASC Covered Surgical Procedures
Section 1833(i)(1) of the Act requires us, in part, to specify, in
consultation with appropriate medical organizations, surgical
procedures that are appropriately performed on an inpatient basis in a
hospital but that can also be safely performed in an ASC, a CAH, or an
HOPD, and to review and update the list of ASC procedures at least
every 2 years. We evaluate the ASC covered procedures list (ASC CPL)
each year to determine whether procedures should be added to or removed
from the list, and changes to the list are often made
[[Page 42207]]
in response to specific concerns raised by stakeholders.
From CY 2008 through CY 2020, under our regulations at Sec. Sec.
416.2 and 416.166, covered surgical procedures furnished on or after
January 1, 2008 were surgical procedures that met the general standards
specified in Sec. 416.166(b) and were not excluded under the general
exclusion criteria specified in Sec. 416.166(c). Specifically, under
Sec. 416.166(b), the general standards provided that covered surgical
procedures were surgical procedures specified by the Secretary and
published in the Federal Register and/or via the internet on the CMS
website that were separately paid under the OPPS, that would not be
expected to pose a significant safety risk to a Medicare beneficiary
when performed in an ASC, and for which standard medical practice
dictated that the beneficiary would not typically be expected to
require active medical monitoring and care at midnight following the
procedure. Section 416.166(c) set out the general exclusion criteria
used under the ASC payment system to evaluate the safety of procedures
for performance in an ASC. The general exclusion criteria provided that
covered surgical procedures do not include those surgical procedures
that: (1) Generally result in extensive blood loss; (2) require major
or prolonged invasion of body cavities; (3) directly involve major
blood vessels; (4) are generally emergent or life threatening in
nature; (5) commonly require systemic thrombolytic therapy; (6) are
designated as requiring inpatient care under Sec. 419.22(n); (7) can
only be reported using a CPT unlisted surgical procedure code; or (8)
are otherwise excluded under Sec. 411.15. For a discussion of the
history of our policies for adding surgical procedures to the ASC CPL,
we refer readers to the CY 2021 OPPS/ASC final rule with comment period
(85 FR 86143 through 86145).
In the CY 2021 OPPS/ASC Final Rule, we significantly revised our
policy for adding surgical procedures to the ASC CPL. We revised the
definition of covered surgical procedures at 42 CFR 416.166(a) and (b)
to add new subparagraphs to provide that, for services furnished on or
after January 1, 2021, covered surgical procedures for purposes of the
ASC CPL are surgical procedures specified by the Secretary and
published in the Federal Register and/or via the internet on the CMS
website that: Are separately paid under the OPPS; and are not:
Designated as requiring inpatient care as of December 31, 2020; only
able to be reported using a CPT unlisted surgical procedure code; or
otherwise excluded under Sec. 411.15.
We added a new paragraph (d) to 42 CFR 416.166 to provide that the
general exclusion and general standard criteria that we used to
identify covered surgical procedures furnished between January 1, 2008,
and December 31, 2020, would, beginning January 1, 2021, be safety
factors that physicians consider as to a specific beneficiary when
determining whether to perform a covered surgical procedure. We also
added a new paragraph (e) to 42 CFR 416.166 to provide that, on or
after January 1, 2021, we add surgical procedures to the list of ASC
covered surgical procedures either when we identify a surgical
procedure that meets the requirements of paragraph (b)(2) or we are
notified of a surgical procedure that could meet the requirements of
paragraph (b)(2) and we confirm that such procedure meets those
requirements. We added 267 surgical procedures to the ASC CPL that met
the revised criteria for covered surgical procedures beginning in CY
2021.
As we explained in the CY 2021 OPPS/ASC final rule with comment
period, there were a number of reasons that we made changes to our ASC
CPL policy, including that ASCs are increasingly able to safely provide
services that meet some of the general exclusion criteria. We explained
that we believed it was important that we adapt the ASC CPL in light of
significant advances in medical practice, surgical techniques, and ASC
capabilities (85 FR 86150). We stated that, while many of the
procedures we were adding to the ASC CPL were performed on non-Medicare
patients who tend to be younger and have fewer comorbidities than the
Medicare population, we believed careful patient selection can identify
Medicare beneficiaries who are suitable candidates to receive these
services in the ASC setting. We also emphasized the importance of
ensuring that the healthcare system has as many access points and
patient choices for Medicare beneficiaries as possible, which includes
enabling physicians and patients to choose the ASC as the site of care
when appropriate. Finally, we reiterated the critical role that
physicians play in determining the appropriate site of care for their
patients, including whether a surgical procedure can be safely
performed in the ASC setting for an individual patient.
1. Proposed Changes to the List of ASC Covered Surgical Procedures for
CY 2022
Since the CY 2021 OPPS/ASC final rule was published, we have
reexamined our ASC CPL policy and the public comments we received in
response to the CY 2021 OPPS/ASC proposed rule, considered the concerns
we received from stakeholders since the final rule was published, and
conducted an internal clinical review of the 267 procedures we added to
the ASC CPL under our revised policy beginning in CY 2021. After
examining our revised policy and the feedback we have received, and
reviewing the procedures we added to the ASC CPL under our revised
policy, we have reconsidered our policy and believe that the policy may
not appropriately assess the safety of performing surgical procedures
on a typical Medicare beneficiary in an ASC, and that the 258 surgical
procedures we added to the ASC CPL beginning in CY 2021 under our
revised policy may not be appropriate to be performed on a typical
beneficiary in the ASC setting. We believe that our current policy--to
shift consideration of the general standards and exclusion criteria we
have historically used to determine whether a surgical procedure should
be added to the ASC CPL from CMS to physicians--needs to be modified to
better ensure that surgical procedures added to the ASC CPL under the
revised criteria can be performed safely in the ASC setting on the
typical Medicare beneficiary. We recognize that appropriate patient
selection and physicians' complex medical judgment could help mitigate
risks for patient safety. But while we are always striving to balance
the goals of increasing physician and patient choice, and expanding
site neutral options with patient safety considerations, we nonetheless
believe the current policy could be improved with additional patient
safety considerations in determining whether a surgical procedure
should be added to the ASC CPL.
One issue we identified with our revised policy is that many of the
procedures added in CY 2021 would only be appropriate for Medicare
beneficiaries who are healthier and have less complex medical
conditions than the typical beneficiary. Upon further review, we
believe the subset of Medicare beneficiaries who may be suitable
candidates to receive these procedures in an ASC setting do not
necessarily represent the average Medicare beneficiary. After
evaluating the 267 surgery or surgery-like codes
[[Page 42208]]
that were added last year, CMS clinicians determined that 258 of these
surgical procedures may pose a significant safety risk to a typical
Medicare beneficiary when performed in an ASC, and that nearly all
would likely require active medical monitoring and care at midnight
following the procedure. In the CY 2021 OPPS/ASC Final Rule, we
established that physicians would consider certain safety factors as to
a specific beneficiary when determining whether to perform a covered
surgical procedure in an ASC. However, while a physician can make
safety determinations for a specific beneficiary, CMS is in the
position to make safety determinations for the broader population of
Medicare beneficiaries.
While there could be some appropriately selected patient
populations for which some of these procedures could be safely
performed in the ASC setting, that may not be the case for the typical
Medicare beneficiary, due to comorbidities and other health risks that
may require more intensive care and monitoring than provided in an ASC
setting among this population. We believe it is appropriate to assess
the safety of these procedures in the context of the typical Medicare
beneficiary, whose health status is representative of the broader
Medicare population. Thus, we believe evaluating procedures for their
potential to require additional care and monitoring for the typical
beneficiary is an appropriate consideration for CMS to make in
determining which procedures can safely be performed in an ASC.
We are concerned that, under our current policy, we do not make an
active enough determination about whether a procedure is suitable to
perform on a typical Medicare beneficiary in an ASC setting. The policy
finalized last year allows individual physicians discretion to perform
a number of procedures in the ASC setting that would not necessarily be
appropriate for the typical Medicare beneficiary in that setting.
Clinicians apply appropriate screening criteria to determine either
that the procedure should not be performed in the ASC setting because
of the risks to the specific beneficiary, or that the specific
beneficiary presents a low enough risk profile that the procedure could
be safely performed in the ASC setting.
However, we want to reiterate that, in accordance with section
1833(i)(1)(A) of the Act, the Secretary shall specify those surgical
procedures that are appropriately (when considered in terms of the
proper utilization of hospital inpatient facilities) performed on an
inpatient basis in a hospital but that also can be performed safely on
an ambulatory basis in an ambulatory surgical center. That is, if
Medicare allows payment for these services in the ASC setting, it means
that Medicare has determined that the procedure is safe to perform on
the typical Medicare beneficiary.
Accordingly, the addition of a procedure to the ASC CPL can signal
to physicians that the procedure is safe to perform on the typical
Medicare beneficiary in the ASC setting, even though the current
criteria, adopted in CY 2021, for adding procedures to the ASC CPL do
not include safety criteria other than ensuring that the procedure was
not on the IPO list as of CY 2020. We recognize that, while there are
similarities between the ASC and HOPD settings, there are also
significant differences between the two care settings. The HOPD setting
has additional capabilities, resources, and certifications that are not
required for the ASC setting. For example, hospitals operate 24/7 and
are subject to EMTALA requirements, while ASCs are not. Therefore, a
procedure that can be furnished in the HOPD setting is not necessarily
safe and appropriate to perform in an ASC setting simply because we
make payment for the procedure when it is furnished in the HOPD
setting.
In light of these concerns, in this CY 2022 OPPS/ASC proposed rule,
we propose to revise the criteria and process for adding procedures to
the ASC CPL by reinstating the ASC CPL policy and regulation text that
were in place in CY 2020. While this approach is a departure from the
revised policy we adopted for CY 2021, it is consistent with our policy
from CY 2008 through CY 2020 where we gradually expanded the ASC CPL
while giving careful consideration to safety concerns and risks to the
typical beneficiary. This approach would also continue to support our
efforts to maximize patient access to care by, when appropriate, adding
procedures to the ASC CPL to further increase the availability of ASCs
as an alternative, lower cost site of care. While expanding the ASC CPL
offers benefits like preserving the capacity of hospitals to treat more
acute patients and promoting site neutrality, it is also essential that
any expansion of the ASC CPL be done in a carefully calibrated fashion
to ensure that Medicare is appropriately signaling that a procedure is
safe to be performed in the ASC setting for a typical Medicare
beneficiary.
Accordingly, for CY 2022, we propose to revise the requirements for
covered surgical procedures in the regulation at Sec. 416.166 to
reinstate the specifications we had established prior to CY 2021.
Specifically, we propose that, effective for services furnished on or
after January 1, 2022, covered surgical procedures are those procedures
that meet the general standards and do not meet the general exclusions.
We propose to again provide in paragraph (b) of Sec. 416.166 that,
subject to the exclusions we propose to again include in paragraph (c),
covered surgical procedures are surgical procedures specified by the
Secretary and published in the Federal Register and/or via the internet
on the CMS website that are separately paid under the OPPS, that would
not be expected to pose a significant safety risk to a Medicare
beneficiary when performed in an ASC, and for which standard medical
practice dictates that the beneficiary would not typically be expected
to require active medical monitoring and care at midnight following the
procedure. We propose to revise paragraph (c) to again include the five
criteria currently included in paragraph (d) of the regulation as
safety factors physicians consider. We propose that revised paragraph
(c) would provide that, notwithstanding paragraph (b), covered surgical
procedures do not include those surgical procedures that: (1) Generally
result in extensive blood loss; (2) require major or prolonged invasion
of body cavities; (3) directly involve major blood vessels; (4) are
generally emergent or life-threatening in nature; (5) commonly require
systemic thrombolytic therapy; (6) are designated as requiring
inpatient care under Sec. 419.22(n); (7) can only be reported using a
CPT unlisted surgical procedure code; or (8) are otherwise excluded
under Sec. 411.15. We propose to remove the physician considerations
at Sec. 416.166(d) and change the notification process at Sec.
416.166(e) to a nomination process, which is discussed further in
section (d)(2) below.
We expect that we would continue to expand the ASC CPL in future
years under our proposed revised criteria as the practice of medicine
and medical technology continue to evolve. We believe that adding
appropriate procedures to the ASC CPL, that meet the safety criteria
that we are proposing to reinstate, has beneficial effects for Medicare
beneficiaries and healthcare professionals, including increased access,
better utilization of existing healthcare resources, and expansion of
the capacity of the healthcare system.
[[Page 42209]]
(1) Comment Solicitation on Procedures That Were Added to the ASC CPL
in CY 2021 and Would Not Meet the Proposed Revised CY 2022 Criteria
As stated above, we are proposing to remove 258 procedures from the
ASC CPL for CY 2022 that were added to the ASC CPL in CY 2021 that we
believe do not meet the proposed revised CY 2022 ASC CPL criteria,
listed in Table 45. Based on our internal review of preliminary claims
submitted to Medicare, we do not believe that ASCs have been furnishing
the majority of the 267 procedures finalized in 2021. Because of this,
we believe it is unlikely that ASCs have made practice changes in
reliance on the policy we adopted in CY 2021. Therefore, we do not
anticipate that ASCs would be significantly affected by the removal of
these 258 procedures from the ASC CPL. For the final rule, we seek
input from commenters who believe any of the 258 procedures added to
the ASC CPL in CY 2021 meet the proposed revised CY 2022 criteria and,
if those revised criteria are finalized, should remain on the ASC CPL
for CY 2022. We request any clinical evidence or literature to support
commenters' views that any of these procedures meet the proposed
revised CY 2022 criteria and should remain on the ASC CPL for CY 2022.
Nomination Process Proposal
For CY 2022, we propose to change the current notification process
for adding surgical procedures to the ASC CPL to a nomination process.
We propose that external parties, for example, medical specialty
societies or other members of the public, could nominate procedures to
be added to the ASC CPL. CMS anticipates that stakeholders, such as
specialty societies that specialize in and have a deep understanding of
the complexities involved in providing certain procedures, would be
able to provide valuable suggestions as to which additional procedures
may reasonably and safely be performed in an ASC. While members of the
public may already suggest procedures to be added to the ASC CPL
through meetings with CMS or through public comments on the proposed
rule, we believe it may be beneficial to enable the public,
particularly specialty societies who are very familiar with procedures
in their specialty, to formally nominate procedures based on the latest
evidence available as well as input from their memberships.
We propose to include the nomination process in a new subparagraph
(d)(1) of Sec. 416.166. We propose that the regulation at Sec.
416.166(d)(2) would provide that, if we identify a surgical procedure
that meets the requirements at paragraph (a) of this section, including
a surgical procedure nominated by an external party under paragraph
(d)(1), we will propose to add the surgical procedure to the list of
ASC covered surgical procedures in the next available annual
rulemaking. Under this proposal, we would propose to add a nominated
procedure to the ASC CPL if it meets the proposed general standards for
covered surgical procedures at proposed Sec. 416.166(b), and does not
meet the general exclusions in proposed Sec. 416.166(c).
Specifically, for the OPPS/ASC rulemaking for a calendar year, we
would request stakeholder nominations by March 1 of the year prior to
the calendar year for the next applicable rulemaking cycle in order to
be included in that rulemaking cycle. For example, stakeholders would
need to send in nominations by March 1, 2022, to be considered for the
CY 2023 rulemaking cycle and potentially have their nomination
effective by January 1, 2023. We would evaluate procedures nominated by
stakeholders based on the applicable statutory and regulatory
requirements for ASC covered surgical procedures. We propose to address
nominated procedures beginning in the CY 2023 rulemaking cycle. We
would address in rulemaking nominated procedures for which stakeholders
have provided sufficient information for us to evaluate the procedure.
We propose to include in the applicable proposed rule, a summary of the
justification for proposing to add or not add each nominated procedure,
which would allow members of the public to assess and comment on
nominated procedures during the public comment period. After reviewing
comments provided during the public comment period, we would indicate
whether or not we are adding the procedures to ASC CPL in the final
rule. In the event that CMS determines that a nominated procedure does
not meet the criteria to be added to the ASC CPL, we would provide our
rationale in the rulemaking. In certain cases, we may need to defer a
proposal regarding a nominated procedure to the next regulatory cycle
or future rulemaking in order to have sufficient time to evaluate and
make an appropriate proposal about the nominated procedure.
We are also seeking comment on how we might prioritize our review
of nominated procedures, in the event we receive an unexpectedly or
extraordinarily large volume of nominations for which CMS has
insufficient resources to address in the annual rulemaking. For
example, if we could not address every nomination in a rulemaking cycle
due to a large volume, we may need to prioritize our review such that
we would only address in rulemaking those nominations that merit
priority. Therefore, we are seeking comments as to how CMS should
prioritize nominations. For example, whether we would prioritize the
nominations that have codes nominated by multiple organizations or
individuals, codes recently removed from the IPO list, codes
accompanied by evidence that other payers are paying for the service on
an outpatient basis or in an ASC setting, or a variety of other
factors. If we were to finalize a prioritization hierarchy for CMS's
review of nominated procedures to the ASC CPL, we would indicate in
regulation text, likely in proposed Sec. 416.166(d)(2) Inclusion in
Rulemaking: (1) That CMS would apply a prioritization hierarchy for
reviewing nominated procedures if necessary because of an unexpectedly
or extraordinarily large volume of nominations; and (2) specify CMS's
prioritization hierarchy.
We believe that this nominations proposal allows for the expansion
of the ASC CPL in a more gradual fashion, which would better balance
the goals of increasing patient choice and expanding site neutral
options with patient safety considerations. We believe a nomination
process will take time to develop because we want to incorporate
stakeholder input on the most effective way to structure this process.
We also acknowledge that stakeholders will need time to consider and
evaluate potential surgical procedures to nominate. We propose to
accept nominations for surgical procedures to be added to the ASC CPL
beginning in CY 2023.
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2. Covered Ancillary Services
We are proposing to continue our existing policies relating to
covered ancillary services with a proposed revision to the regulation
at 42 CFR 416.164(b)(6) regarding our policy related to payment for
non-opioid pain management drugs and biologicals.
In the CY 2019 OPPS/ASC final rule (83 FR 59062 through 59063),
consistent with the established ASC payment system policy (72 FR
42497), we finalized the policy to update the ASC list of covered
ancillary services to reflect the payment status for the services under
the CY 2019 OPPS final rule. As discussed in prior rulemaking,
maintaining consistency with the OPPS may result in changes to ASC
payment indicators for some covered ancillary services because of
changes that are being finalized under the OPPS for CY 2022. For
example, if a covered ancillary service was separately paid under the
ASC payment system in CY 2021, but will be packaged under the CY 2022
OPPS, to maintain consistency with the OPPS, we would also package the
ancillary service under the ASC payment system for CY 2022. In the CY
2019 OPPS/ASC final rule, we finalized the policy to continue this
reconciliation of packaged status for subsequent calendar years.
Comment indicator ``CH'', which is discussed in section XIII.F. of the
CY 2021 OPPS/ASC proposed rule, is used in Addendum BB to this CY 2022
OPPS/ASC final rule (which is available via the internet on the CMS
website) to indicate covered ancillary services for which we are
finalizing a change in the ASC payment indicator to reflect a finalized
change in the OPPS treatment of the service for CY 2021.
For CY 2022, as discussed in section II.A.3.b, we propose to revise
42 CFR 416.164(b)(6) to include, as ancillary items that are integral
to a covered surgical procedure and for which separate payment is
allowed, non-opioid pain management drugs and biologicals that function
as a supply when used in a surgical procedure as determined by CMS in
proposed new Sec. 416.174.
New CPT and HCPCS codes for covered ancillary services and their
proposed payment indicators for CY 2022 can be found in section XIII.B
of this CY 2022 OPPS/ASC proposed rule. All ASC covered ancillary
services and their proposed payment indicators for CY 2022 are also
included in Addendum BB to this CY 2022 OPPS/ASC proposed rule (which
is available via the internet on the CMS website).
D. Proposed Update and Payment for ASC Covered Surgical Procedures and
Covered Ancillary Services
1. Proposed ASC Payment for Covered Surgical Procedures
a. Background
Our ASC payment policies for covered surgical procedures under the
revised ASC payment system are described in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66828 through 66831). Under our
established policy, we use the ASC standard ratesetting methodology of
multiplying the ASC relative payment weight for the procedure by the
ASC conversion factor for that same year to calculate the national
unadjusted payment rates for procedures with payment indicators ``G2''
and ``A2''. Payment indicator ``A2'' was developed to identify
procedures that were included on the list of ASC covered
[[Page 42225]]
surgical procedures in CY 2007 and, therefore, were subject to
transitional payment prior to CY 2011. Although the 4-year transitional
period has ended and payment indicator ``A2'' is no longer required to
identify surgical procedures subject to transitional payment, we
retained payment indicator ``A2'' because it is used to identify
procedures that are exempted from the application of the office-based
designation.
The rate calculation established for device-intensive procedures
(payment indicator ``J8'') is structured so only the service portion of
the rate is subject to the ASC conversion factor. In the CY 2021 OPPS/
ASC final rule with comment period (85 FR 86122 through 86179), we
updated the CY 2020 ASC payment rates for ASC covered surgical
procedures with payment indicators of ``A2'', ``G2'', and ``J8'' using
CY 2019 data, consistent with the CY 2021 OPPS update. We also updated
payment rates for device-intensive procedures to incorporate the CY
2021 OPPS device offset percentages calculated under the standard APC
ratesetting methodology, as discussed earlier in this section.
Payment rates for office-based procedures (payment indicators
``P2'', ``P3'', and ``R2'') are the lower of the PFS nonfacility PE
RVU-based amount or the amount calculated using the ASC standard rate
setting methodology for the procedure. In the CY 2021 OPPS/ASC final
rule with comment period, we updated the payment amounts for office-
based procedures (payment indicators ``P2'', ``P3'', and ``R2'') using
the most recent available MPFS and OPPS data. We compared the estimated
CY 2021 rate for each of the office-based procedures, calculated
according to the ASC standard rate setting methodology, to the PFS
nonfacility PE RVU-based amount to determine which was lower and,
therefore, would be the CY 2021 payment rate for the procedure under
our final policy for the revised ASC payment system (Sec. 416.171(d)).
In the CY 2014 OPPS/ASC final rule with comment period (78 FR
75081), we finalized our proposal to calculate the CY 2014 payment
rates for ASC covered surgical procedures according to our established
methodologies, with the exception of device removal procedures. For CY
2014, we finalized a policy to conditionally package payment for device
removal procedures under the OPPS. Under the OPPS, a conditionally
packaged procedure (status indicators ``Q1'' and ``Q2'') describes a
HCPCS code where the payment is packaged when it is provided with a
significant procedure but is separately paid when the service appears
on the claim without a significant procedure. Because ASC services
always include a covered surgical procedure, HCPCS codes that are
conditionally packaged under the OPPS are always packaged (payment
indicator ``N1'') under the ASC payment system. Under the OPPS, device
removal procedures are conditionally packaged and, therefore, would be
packaged under the ASC payment system. There would be no Medicare
payment made when a device removal procedure is performed in an ASC
without another surgical procedure included on the claim; therefore, no
Medicare payment would be made if a device was removed but not
replaced. To ensure that the ASC payment system provides separate
payment for surgical procedures that only involve device removal--
conditionally packaged in the OPPS (status indicator ``Q2'')--we
continued to provide separate payment since CY 2014 and assigned the
current ASC payment indicators associated with these procedures.
b. Changes to Beneficiary Coinsurance for Certain Colorectal Cancer
Screening Tests
Section 122 of the Consolidated Appropriations Act (CAA) of 2021
(Pub. L. 116-260), Waiving Medicare Coinsurance for Certain Colorectal
Cancer Screening Tests, amends section 1833(a) of the Act to offer a
special coinsurance rule for screening flexible sigmoidoscopies and
screening colonoscopies, regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for the
removal of tissue or other matter or other procedure, that is furnished
in connection with, as a result of, and in the same clinical encounter
as the colorectal cancer screening test. The reduced coinsurance will
be phased-in beginning January 1, 2022. Our proposals to implement this
legislation are included in the CY 2022 PFS proposed rule and section
X.B., ``Changes to Beneficiary Coinsurance for Certain Colorectal
Cancer Screening Tests'' of this proposed rule.
c. Proposed Update to ASC Covered Surgical Procedure Payment Rates for
CY 2022
We propose to update ASC payment rates for CY 2022 and subsequent
years using the established rate calculation methodologies under Sec.
416.171 and using our definition of device-intensive procedures, as
discussed in section XII.C.1.b. of this CY 2022 OPPS/ASC proposed rule.
Because the proposed OPPS relative payment weights are generally based
on geometric mean costs, the ASC system would generally use the
geometric mean cost to determine proposed relative payment weights
under the ASC standard methodology. We propose to continue to use the
amount calculated under the ASC standard ratesetting methodology for
procedures assigned payment indicators ``A2'' and ``G2''.
We propose to calculate payment rates for office-based procedures
(payment indicators ``P2'', ``P3'', and ``R2'') and device-intensive
procedures (payment indicator ``J8'') according to our established
policies and, for device-intensive procedures, using our modified
definition of device-intensive procedures, as discussed in section
XII.C.1.b. of this CY 2022 OPPS/ASC proposed rule. Therefore, we
propose to update the payment amount for the service portion of the
device-intensive procedures using the standard ASC ratesetting
methodology and the payment amount for the device portion based on the
proposed CY 2022 device offset percentages that have been calculated
using the standard OPPS APC ratesetting methodology. Payment for
office-based procedures would be at the lesser of the proposed CY 2022
MPFS nonfacility PE RVU-based amount or the proposed CY 2022 ASC
payment amount calculated according to the ASC standard ratesetting
methodology.
As we did for CYs 2014 through 2021, for CY 2022 we propose to
continue our policy for device removal procedures, such that device
removal procedures that are conditionally packaged in the OPPS (status
indicators ``Q1'' and ``Q2'') would be assigned the current ASC payment
indicators associated with those procedures and would continue to be
paid separately under the ASC payment system.
d. Proposed Limit on ASC Payment Rates for Procedures Assigned to Low
Volume APCs
As stated in section XIII.D.1.b. of this CY 2022 OPPS/ASC proposed
rule, the ASC payment system generally uses OPPS geometric mean costs
under the standard methodology to determine proposed relative payment
weights under the standard ASC ratesetting methodology. However, for
low-volume device-intensive procedures, the proposed relative payment
weights are based on median costs, rather than geometric mean costs, as
discussed in section IV.B.5. of this CY 2022 OPPS/ASC proposed rule.
In the CY 2020 OPPS/ASC final rule with comment period (84 FR
61400), we finalized our policy to limit the ASC payment rate for low-
volume device-intensive procedures to a payment rate equal to the OPPS
payment rate for that
[[Page 42226]]
procedure. Under this policy, where the ASC payment rate based on the
standard ASC ratesetting methodology for low volume device-intensive
procedures would exceed the rate paid under the OPPS for the same
procedure, we establish an ASC payment rate for such procedures equal
to the OPPS payment rate for the same procedure.
As discussed in Section X of this CY 2022 OPPS/ASC proposed rule,
we are proposing a low volume APC policy for CY 2022 and subsequent
calendar years. Under our proposal, a clinical APC, brachytherapy APC,
or new technology APC with fewer than 100 claims per year would be
designated as a low volume APC. For items and services assigned to APCs
we propose to designate as low volume APCs, we are proposing to use up
to 4 years of claims data to establish a payment rate for each item or
service as we currently do for low volume services assigned to New
Technology APCs. The payment rate for a low volume APC would be based
on the highest of the median cost, arithmetic mean cost, or geometric
mean cost calculated using multiple years of claims data. Because we
are proposing to adopt a low volume APC policy, we are also proposing
to eliminate our low volume device-intensive procedure policy and
subsume the ratesetting issues associated with HCPCS code 0308T within
our broader low volume APC proposal. Consequently, we are proposing to
modify our existing regulations at Sec. 416.171(b)(4) to apply our ASC
payment rate limitation to services assigned to low volume APCs rather
than low volume device-intensive procedures.
We seek comments on our proposal to modify our existing regulations
at Sec. 416.171(b)(4) and limit the ASC payment rate for services
assigned to low volume APCs to the payment rate for the OPPS.
2. Proposed Payment for Covered Ancillary Services
a. Background
Our payment policies under the ASC payment system for covered
ancillary services generally vary according to the particular type of
service and its payment policy under the OPPS. Our overall policy
provides separate ASC payment for certain ancillary items and services
integrally related to the provision of ASC covered surgical procedures
that are paid separately under the OPPS and provides packaged ASC
payment for other ancillary items and services that are packaged or
conditionally packaged (status indicators ``N'', ``Q1'', and ``Q2'')
under the OPPS. In the CY 2013 OPPS/ASC rulemaking (77 FR 45169 and 77
FR 68457 through 68458), we further clarified our policy regarding the
payment indicator assignment for procedures that are conditionally
packaged in the OPPS (status indicators ``Q1'' and ``Q2''). Under the
OPPS, a conditionally packaged procedure describes a HCPCS code where
the payment is packaged when it is provided with a significant
procedure but is separately paid when the service appears on the claim
without a significant procedure. Because ASC services always include a
surgical procedure, HCPCS codes that are conditionally packaged under
the OPPS are generally packaged (payment indictor ``N1'') under the ASC
payment system (except for device removal procedures, as discussed in
section IV. of this CY 2022 OPPS/ASC proposed rule). Thus, our policy
generally aligns ASC payment bundles with those under the OPPS (72 FR
42495). In all cases, in order for those ancillary services also to be
paid, ancillary items and services must be provided integral to the
performance of ASC covered surgical procedures for which the ASC bills
Medicare.
Our ASC payment policies generally provide separate payment for
drugs and biologicals that are separately paid under the OPPS at the
OPPS rates and package payment for drugs and biologicals for which
payment is packaged under the OPPS. However, as discussed in section
XIII.D.3. of this CY 2022 OPPS/ASC proposed rule, for CY 2022, we are
proposing a policy to unpackage and pay separately at ASP plus 6
percent for the cost of non-opioid pain management drugs and
biologicals that function as a supply when used in a surgical procedure
as determined by CMS under proposed new Sec. 416.174. We generally pay
for separately payable radiology services at the lower of the PFS
nonfacility PE RVU-based (or technical component) amount or the rate
calculated according to the ASC standard ratesetting methodology (72 FR
42497). However, as finalized in the CY 2011 OPPS/ASC final rule with
comment period (75 FR 72050), payment indicators for all nuclear
medicine procedures (defined as CPT codes in the range of 78000 through
78999) that are designated as radiology services that are paid
separately when provided integral to a surgical procedure on the ASC
list are set to ``Z2'' so that payment is made based on the ASC
standard ratesetting methodology rather than the MPFS nonfacility PE
RVU amount (``Z3''), regardless of which is lower (Sec.
416.171(d)(1)).
Similarly, we also finalized our policy to set the payment
indicator to ``Z2'' for radiology services that use contrast agents so
that payment for these procedures will be based on the OPPS relative
payment weight using the ASC standard ratesetting methodology and,
therefore, will include the cost for the contrast agent (Sec.
416.171(d)(2)).
ASC payment policy for brachytherapy sources mirrors the payment
policy under the OPPS. ASCs are paid for brachytherapy sources provided
integral to ASC covered surgical procedures at prospective rates
adopted under the OPPS or, if OPPS rates are unavailable, at
contractor-priced rates (72 FR 42499). Since December 31, 2009, ASCs
have been paid for brachytherapy sources provided integral to ASC
covered surgical procedures at prospective rates adopted under the
OPPS.
Our ASC policies also provide separate payment for: (1) Certain
items and services that CMS designates as contractor-priced, including,
but not limited to, the procurement of corneal tissue; and (2) certain
implantable items that have pass-through payment status under the OPPS.
These categories do not have prospectively established ASC payment
rates according to ASC payment system policies (72 FR 42502 and 42508
through 42509; Sec. 416.164(b)). Under the ASC payment system, we have
designated corneal tissue acquisition and hepatitis B vaccines as
contractor-priced. Corneal tissue acquisition is contractor-priced
based on the invoiced costs for acquiring the corneal tissue for
transplantation. Hepatitis B vaccines are contractor-priced based on
invoiced costs for the vaccine.
Devices that are eligible for pass-through payment under the OPPS
are separately paid under the ASC payment system and are contractor-
priced. Under the revised ASC payment system (72 FR 42502), payment for
the surgical procedure associated with the pass-through device is made
according to our standard methodology for the ASC payment system, based
on only the service (non-device) portion of the procedure's OPPS
relative payment weight if the APC weight for the procedure includes
other packaged device costs. We also refer to this methodology as
applying a ``device offset'' to the ASC payment for the associated
surgical procedure. This ensures that duplicate payment is not provided
for any portion of an implanted device with OPPS pass-through payment
status.
[[Page 42227]]
In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66933
through 66934), we finalized that, beginning in CY 2015, certain
diagnostic tests within the medicine range of CPT codes for which
separate payment is allowed under the OPPS are covered ancillary
services when they are integral to an ASC covered surgical procedure.
We finalized that diagnostic tests within the medicine range of CPT
codes include all Category I CPT codes in the medicine range
established by CPT, from 90000 to 99999, and Category III CPT codes and
Level II HCPCS codes that describe diagnostic tests that crosswalk or
are clinically similar to procedures in the medicine range established
by CPT. In the CY 2015 OPPS/ASC final rule with comment period, we also
finalized our policy to pay for these tests at the lower of the PFS
nonfacility PE RVU-based (or technical component) amount or the rate
calculated according to the ASC standard ratesetting methodology (79 FR
66933 through 66934). We finalized that the diagnostic tests for which
the payment is based on the ASC standard ratesetting methodology be
assigned to payment indicator ``Z2'' and revised the definition of
payment indicator ``Z2'' to include a reference to diagnostic services
and those for which the payment is based on the PFS nonfacility PE RVU-
based amount be assigned payment indicator ``Z3,'' and revised the
definition of payment indicator ``Z3'' to include a reference to
diagnostic services.
b. Proposed Payment for Covered Ancillary Services for CY 2022
We propose to update the ASC payment rates and to make changes to
ASC payment indicators, as necessary, to maintain consistency between
the OPPS and ASC payment system regarding the packaged or separately
payable status of services and the proposed CY 2022 OPPS and ASC
payment rates and subsequent year payment rates. We also propose to
continue to set the CY 2022 ASC payment rates and subsequent year
payment rates for brachytherapy sources and separately payable drugs
and biologicals equal to the OPPS payment rates for CY 2022 and
subsequent year payment rates.
Covered ancillary services and their proposed payment indicators
for CY 2022 are listed in Addendum BB of this CY 2022 OPPS/ASC proposed
rule (which is available via the internet on the CMS website). For
those covered ancillary services where the payment rate is the lower of
the proposed rates under the ASC standard rate setting methodology and
the PFS final rates, the proposed payment indicators and rates set
forth in the proposed rule are based on a comparison using the proposed
PFS rates effective January 1, 2022. For a discussion of the PFS rates,
we refer readers to the CY 2022 PFS proposed rule, which is available
on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
3. CY 2022 ASC Packaging Policy for Non-Opioid Pain Management Drugs
and Biologicals
Please refer to Section II.A.3.b for a discussion of the proposed
CY 2022 OPPS/ASC for payment for non-opioid pain management drugs and
biologicals.
E. Proposed New Technology Intraocular Lenses (NTIOLs)
New Technology Intraocular Lenses (NTIOLs) are intraocular lenses
that replace a patient's natural lens that has been removed in cataract
surgery and that also meet the requirements listed in Sec. 416.195.
1. NTIOL Application Cycle
Our process for reviewing applications to establish new classes of
NTIOLs is as follows:
Applicants submit their NTIOL requests for review to CMS
by the annual deadline. For a request to be considered complete, we
require submission of the information requested in the guidance
document entitled ``Application Process and Information Requirements
for Requests for a New Class of New Technology Intraocular Lenses
(NTIOLs) or Inclusion of an IOL in an Existing NTIOL Class'' posted on
the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/NTIOLs.html.
We announce annually, in the proposed rule updating the
ASC and OPPS payment rates for the following calendar year, a list of
all requests to establish new NTIOL classes accepted for review during
the calendar year in which the proposal is published. In accordance
with section 141(b)(3) of Public Law 103-432 and our regulations at
Sec. 416.185(b), the deadline for receipt of public comments is 30
days following publication of the list of requests in the proposed
rule.
In the final rule updating the ASC and OPPS payment rates
for the following calendar year, we--
++ Provide a list of determinations made as a result of our review
of all new NTIOL class requests and public comments.
++ When a new NTIOL class is created, identify the predominant
characteristic of NTIOLs in that class that sets them apart from other
IOLs (including those previously approved as members of other expired
or active NTIOL classes) and that is associated with an improved
clinical outcome.
++ Set the date of implementation of a payment adjustment in the
case of approval of an IOL as a member of a new NTIOL class
prospectively as of 30 days after publication of the ASC payment update
final rule, consistent with the statutory requirement.
++ Announce the deadline for submitting requests for review of an
application for a new NTIOL class for the following calendar year.
2. Requests To Establish New NTIOL Classes for CY 2022
We did not receive any requests for review to establish a new NTIOL
class for CY 2022 by March 1, 2021, the due date published in the CY
2021 OPPS/ASC final rule with comment period (85 FR 86173).
3. Payment Adjustment
The current payment adjustment for a 5-year period from the
implementation date of a new NTIOL class is $50 per lens. Since
implementation of the process for adjustment of payment amounts for
NTIOLs in 1999, we have not revised the payment adjustment amount, and
we are not proposing to revise the payment adjustment amount for CY
2022.
F. Proposed ASC Payment and Comment Indicators
1. Background
In addition to the payment indicators that we introduced in the
August 2, 2007 final rule, we created final comment indicators for the
ASC payment system in the CY 2008 OPPS/ASC final rule with comment
period (72 FR 66855). We created Addendum DD1 to define ASC payment
indicators that we use in Addenda AA and BB to provide payment
information regarding covered surgical procedures and covered ancillary
services, respectively, under the revised ASC payment system. The ASC
payment indicators in Addendum DD1 are intended to capture policy-
relevant characteristics of HCPCS codes that may receive packaged or
separate payment in ASCs, such as whether they were on the ASC CPL
prior to CY 2008; payment designation, such as device-intensive or
office-based, and the corresponding ASC payment methodology; and their
classification as separately payable ancillary services,
[[Page 42228]]
including radiology services, brachytherapy sources, OPPS pass-through
devices, corneal tissue acquisition services, drugs or biologicals, or
NTIOLs.
We also created Addendum DD2 that lists the ASC comment indicators.
The ASC comment indicators included in Addenda AA and BB to the
proposed rules and final rules with comment period serve to identify,
for the revised ASC payment system, the status of a specific HCPCS code
and its payment indicator with respect to the timeframe when comments
will be accepted. The comment indicator ``NI'' is used in the OPPS/ASC
final rule to indicate new codes for the next calendar year for which
the interim payment indicator assigned is subject to comment. The
comment indicator ``NI'' also is assigned to existing codes with
substantial revisions to their descriptors such that we consider them
to be describing new services, and the interim payment indicator
assigned is subject to comment, as discussed in the CY 2010 OPPS/ASC
final rule with comment period (74 FR 60622).
The comment indicator ``NP'' is used in the OPPS/ASC proposed rule
to indicate new codes for the next calendar year for which the proposed
payment indicator assigned is subject to comment. The comment indicator
``NP'' also is assigned to existing codes with substantial revisions to
their descriptors, such that we consider them to be describing new
services, and the proposed payment indicator assigned is subject to
comment, as discussed in the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70497).
The ``CH'' comment indicator is used in Addenda AA and BB to the
proposed rule (which are available via the internet on the CMS website)
to indicate that the payment indicator assignment has changed for an
active HCPCS code in the current year and the next calendar year, for
example if an active HCPCS code is newly recognized as payable in ASCs;
or an active HCPCS code is discontinued at the end of the current
calendar year. The ``CH'' comment indicators that are published in the
final rule with comment period are provided to alert readers that a
change has been made from one calendar year to the next, but do not
indicate that the change is subject to comment.
In the CY 2021 OPPS/ASC final rule, we finalized the addition of
ASC payment indicator ``K5''--Items, Codes, and Services for which
pricing information and claims data are not available. No payment
made.--to ASC Addendum DD1 (which is available via the internet on the
CMS website) to indicate those services and procedures that CMS
anticipates will become payable when claims data or payment information
becomes available.
2. ASC Payment and Comment Indicators for CY 2022
For 2022, we propose new and revised Category I and III CPT codes
as well as new and revised Level II HCPCS codes. Therefore, proposed
Category I and III CPT codes that are new and revised for CY 2022 and
any new and existing Level II HCPCS codes with substantial revisions to
the code descriptors for CY 2022, compared to the CY 2021 descriptors,
are included in ASC Addenda AA and BB to this proposed rule and labeled
with proposed comment indicator ``NP'' to indicate that these CPT and
Level II HCPCS codes are open for comment as part of this proposed
rule. Proposed comment indicator ``NP'' meant a new code for the next
calendar year or an existing code with substantial revision to its code
descriptor in the next calendar year, as compared to the current
calendar year; and denoted that comments would be accepted on the
proposed ASC payment indicator for the new code.
We will respond to public comments on ASC payment and comment
indicators and finalize their ASC assignment in the CY 2022 OPPS/ASC
final rule with comment period. We refer readers to Addenda DD1 and DD2
of this proposed rule (which are available via the internet on the CMS
website) for the complete list of ASC payment and comment indicators
proposed for the CY 2022 update. Addenda DD1 and DD2 to this proposed
rule (which are available via the internet on the CMS website) contain
the complete list of ASC payment and comment indicators for CY 2022.
G. Proposed Calculation of the ASC Payment Rates and the ASC Conversion
Factor
1. Background
In the August 2, 2007 final rule (72 FR 42493), we established our
policy to base ASC relative payment weights and payment rates under the
revised ASC payment system on APC groups and the OPPS relative payment
weights. Consistent with that policy and the requirement at section
1833(i)(2)(D)(ii) of the Act that the revised payment system be
implemented so that it would be budget neutral, the initial ASC
conversion factor (CY 2008) was calculated so that estimated total
Medicare payments under the revised ASC payment system in the first
year would be budget neutral to estimated total Medicare payments under
the prior (CY 2007) ASC payment system (the ASC conversion factor is
multiplied by the relative payment weights calculated for many ASC
services in order to establish payment rates). That is, application of
the ASC conversion factor was designed to result in aggregate Medicare
expenditures under the revised ASC payment system in CY 2008 being
equal to aggregate Medicare expenditures that would have occurred in CY
2008 in the absence of the revised system, taking into consideration
the cap on ASC payments in CY 2007, as required under section
1833(i)(2)(E) of the Act (72 FR 42522). We adopted a policy to make the
system budget neutral in subsequent calendar years (72 FR 42532 through
42533; Sec. 416.171(e)).
We note that we consider the term ``expenditures'' in the context
of the budget neutrality requirement under section 1833(i)(2)(D)(ii) of
the Act to mean expenditures from the Medicare Part B Trust Fund. We do
not consider expenditures to include beneficiary coinsurance and
copayments. This distinction was important for the CY 2008 ASC budget
neutrality model that considered payments across the OPPS, ASC, and
MPFS payment systems. However, because coinsurance is almost always 20
percent for ASC services, this interpretation of expenditures has
minimal impact for subsequent budget neutrality adjustments calculated
within the revised ASC payment system.
In the CY 2008 OPPS/ASC final rule with comment period (72 FR 66857
through 66858), we set out a step-by-step illustration of the final
budget neutrality adjustment calculation based on the methodology
finalized in the August 2, 2007 final rule (72 FR 42521 through 42531)
and as applied to updated data available for the CY 2008 OPPS/ASC final
rule with comment period. The application of that methodology to the
data available for the CY 2008 OPPS/ASC final rule with comment period
resulted in a budget neutrality adjustment of 0.65.
For CY 2008, we adopted the OPPS relative payment weights as the
ASC relative payment weights for most services and, consistent with the
final policy, we calculated the CY 2008 ASC payment rates by
multiplying the ASC relative payment weights by the final CY 2008 ASC
conversion factor of $41.401. For covered office-based surgical
procedures, covered ancillary radiology services (excluding covered
ancillary radiology services involving certain nuclear medicine
procedures or involving the use of contrast agents, as discussed in
section XII.D.2. of this CY
[[Page 42229]]
2022 OPPS/ASC proposed rule), and certain diagnostic tests within the
medicine range that are covered ancillary services, the established
policy is to set the payment rate at the lower of the MPFS unadjusted
nonfacility PE RVU-based amount or the amount calculated using the ASC
standard ratesetting methodology. Further, as discussed in the CY 2008
OPPS/ASC final rule with comment period (72 FR 66841 through 66843), we
also adopted alternative ratesetting methodologies for specific types
of services (for example, device-intensive procedures).
As discussed in the August 2, 2007 final rule (72 FR 42517 through
42518) and as codified at Sec. 416.172(c) of the regulations, the
revised ASC payment system accounts for geographic wage variation when
calculating individual ASC payments by applying the pre-floor and pre-
reclassified IPPS hospital wage indexes to the labor-related share,
which is 50 percent of the ASC payment amount based on a GAO report of
ASC costs using 2004 survey data. Beginning in CY 2008, CMS accounted
for geographic wage variation in labor costs when calculating
individual ASC payments by applying the pre-floor and pre-reclassified
hospital wage index values that CMS calculates for payment under the
IPPS, using updated Core Based Statistical Areas (CBSAs) issued by OMB
in June 2003.
The reclassification provision in section 1886(d)(10) of the Act is
specific to hospitals. We believe that using the most recently
available pre-floor and pre-reclassified IPPS hospital wage indexes
results in the most appropriate adjustment to the labor portion of ASC
costs. We continue to believe that the unadjusted hospital wage
indexes, which are updated yearly and are used by many other Medicare
payment systems, appropriately account for geographic variation in
labor costs for ASCs. Therefore, the wage index for an ASC is the pre-
floor and pre-reclassified hospital wage index under the IPPS of the
CBSA that maps to the CBSA where the ASC is located.
Generally, OMB issues major revisions to statistical areas every 10
years, based on the results of the decennial census. On February 28,
2013, OMB issued OMB Bulletin No. 13-01, which provides the
delineations of all Metropolitan Statistical Areas, Metropolitan
Divisions, Micropolitan Statistical Areas, Combined Statistical Areas,
and New England City and Town Areas in the United States and Puerto
Rico based on the standards published on June 28, 2010 in the Federal
Register (75 FR 37246 through 37252) and 2010 Census Bureau data. (A
copy of this bulletin may be obtained at: https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2013/b13-01.pdf). In the FY
2015 IPPS/LTCH PPS final rule (79 FR 49951 through 49963), we
implemented the use of the CBSA delineations issued by OMB in OMB
Bulletin 13-01 for the IPPS hospital wage index beginning in FY 2015.
OMB occasionally issues minor updates and revisions to statistical
areas in the years between the decennial censuses. On July 15, 2015,
OMB issued OMB Bulletin No. 15-01, which provides updates to and
supersedes OMB Bulletin No. 13-01 that was issued on February 28, 2013.
OMB Bulletin No. 15-01 made changes that are relevant to the IPPS and
ASC wage index. We refer readers to the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79750) for a discussion of these changes and
our implementation of these revisions. (A copy of this bulletin may be
obtained at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2015/15-01.pdf).
On August 15, 2017, OMB issued OMB Bulletin No. 17-01, which
provided updates to and superseded OMB Bulletin No. 15-01 that was
issued on July 15, 2015. We refer readers to the CY 2019 OPPS/ASC final
rule with comment period (83 FR 58864 through 58865) for a discussion
of these changes and our implementation of these revisions. (A copy of
this bulletin may be obtained at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2017/b-17-01.pdf).
On April 10, 2018, OMB issued OMB Bulletin No. 18-03 which
superseded the August 15, 2017 OMB Bulletin No. 17-01. On September 14,
2018, OMB issued OMB Bulletin 18-04 which superseded the April 10, 2018
OMB Bulletin No. 18-03. A copy of OMB Bulletin No. 18-04 may be
obtained at https://www.whitehouse.gov/wpcontent/uploads/2018/90/Bulletin-18-04.pdf. We are utilizing the revised delineations as set
forth in the April 10, 2018 OMB Bulletin No. 18-03 and the September
14, 2018 OMB Bulletin No. 18-04 to calculate the CY 2021 ASC wage index
effective beginning January 1, 2021.
For CY 2022, we noted that the proposed CY 2022 ASC wage indexes
fully reflects the OMB labor market area delineations (including the
revisions to the OMB labor market delineations discussed above, as set
forth in OMB Bulletin Nos. 15-01, 17-01, 18-03, and 18-04). We note
that, in certain instances, there might be urban or rural areas for
which there is no IPPS hospital that has wage index data that could be
used to set the wage index for that area. For these areas, our policy
has been to use the average of the wage indexes for CBSAs (or
metropolitan divisions as applicable) that are contiguous to the area
that has no wage index (where ``contiguous'' is defined as sharing a
border). For example, for CY 2022, we applied a proxy wage index based
on this methodology to ASCs located in CBSA 25980 (Hinesville-Fort
Stewart, GA).
When all of the areas contiguous to the urban CBSA of interest are
rural and there is no IPPS hospital that has wage index data that could
be used to set the wage index for that area, we determine the ASC wage
index by calculating the average of all wage indexes for urban areas in
the state (75 FR 72058 through 72059). In other situations, where there
are no IPPS hospitals located in a relevant labor market area, we have
continued our current policy of calculating an urban or rural area's
wage index by calculating the average of the wage indexes for CBSAs (or
metropolitan divisions where applicable) that are contiguous to the
area with no wage index.
2. Calculation of the ASC Payment Rates
a. Updating the ASC Relative Payment Weights for CY 2022 and Future
Years
We update the ASC relative payment weights each year using the
national OPPS relative payment weights (and PFS nonfacility PE RVU-
based amounts, as applicable) for that same calendar year and uniformly
scale the ASC relative payment weights for each update year to make
them budget neutral (72 FR 42533). The OPPS relative payment weights
are scaled to maintain budget neutrality for the OPPS. We then scale
the OPPS relative payment weights again to establish the ASC relative
payment weights. To accomplish this, we hold estimated total ASC
payment levels constant between calendar years for purposes of
maintaining budget neutrality in the ASC payment system. That is, we
apply the weight scalar to ensure that projected expenditures from the
updated ASC payment weights in the ASC payment system equal to what
would be the current expenditures based on the scaled ASC payment
weights. In this way we ensure budget neutrality and that the only
changes to total payments to ASCs result from increases or decreases in
the ASC payment update factor.
Where the estimated ASC expenditures for an upcoming year are
higher than the estimated ASC
[[Page 42230]]
expenditures for the current year, the ASC weight scalar is reduced, in
order to bring the estimated ASC expenditures in line with the
expenditures for the baseline year. This frequently results in ASC
relative payment weights for surgical procedures that are lower than
the OPPS relative payment weights for the same procedures for the
upcoming year. Therefore, over time, even if procedures performed in
the HOPD and ASC receive the same update factor under the OPPS and ASC
payment system, payment rates under the ASC payment system would
increase at a lower rate than payment for the same procedures performed
in the HOPD as a result of applying the ASC weight scalar to ensure
budget neutrality.
As discussed in Section II.A.1.a of this proposed rule, given our
concerns with CY 2020 claims data as a result of the PHE, we are using
the CY 2019 claims data to be consistent with the OPPS claims data for
this CY 2022 OPPS/ASC proposed rule. Consistent with our established
policy, we propose to scale the CY 2022 relative payment weights for
ASCs according to the following method. Holding ASC utilization, the
ASC conversion factor, and the mix of services constant from CY 2019,
we propose to compare the total payment using the CY 2021 ASC relative
payment weights with the total payment using the CY 2022 ASC relative
payment weights to take into account the changes in the OPPS relative
payment weights between CY 2021 and CY 2022. We propose to use the
ratio of CY 2021 to CY 2022 total payments (the weight scalar) to scale
the ASC relative payment weights for CY 2022. The proposed CY 2022 ASC
weight scalar is 0.8591. Consistent with historical practice, we would
scale the ASC relative payment weights of covered surgical procedures,
covered ancillary radiology services, and certain diagnostic tests
within the medicine range of CPT codes, which are covered ancillary
services for which the ASC payment rates are based on OPPS relative
payment weights.
Scaling would not apply in the case of ASC payment for separately
payable covered ancillary services that have a predetermined national
payment amount (that is, their national ASC payment amounts are not
based on OPPS relative payment weights), such as drugs and biologicals
that are separately paid or services that are contractor-priced or paid
at reasonable cost in ASCs. Any service with a predetermined national
payment amount would be included in the ASC budget neutrality
comparison, but scaling of the ASC relative payment weights would not
apply to those services. The ASC payment weights for those services
without predetermined national payment amounts (that is, those services
with national payment amounts that would be based on OPPS relative
payment weights) would be scaled to eliminate any difference in the
total payment between the current year and the update year.
For any given year's ratesetting, we typically use the most recent
full calendar year of claims data to model budget neutrality
adjustments. At the time of this proposed rule, we have available 100
percent of CY 2019 ASC claims data.
b. Updating the ASC Conversion Factor
Under the OPPS, we typically apply a budget neutrality adjustment
for provider-level changes, most notably a change in the wage index
values for the upcoming year, to the conversion factor. Consistent with
our final ASC payment policy, for the CY 2017 ASC payment system and
subsequent years, in the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79751 through 79753), we finalized our policy to
calculate and apply a budget neutrality adjustment to the ASC
conversion factor for supplier-level changes in wage index values for
the upcoming year, just as the OPPS wage index budget neutrality
adjustment is calculated and applied to the OPPS conversion factor. For
CY 2022, we calculated the proposed adjustment for the ASC payment
system by using the most recent CY 2019 claims data available and
estimating the difference in total payment that would be created by
introducing the proposed CY 2022 ASC wage indexes. Specifically,
holding CY 2019 ASC utilization, service-mix, and the proposed CY 2022
national payment rates after application of the weight scalar constant,
we calculated the total adjusted payment using the CY 2021 ASC wage
indexes and the total adjusted payment using the proposed CY 2022 ASC
wage indexes. We used the 50-percent labor-related share for both total
adjusted payment calculations. We then compared the total adjusted
payment calculated with the CY 2021 ASC wage indexes to the total
adjusted payment calculated with the proposed CY 2022 ASC wage indexes
and applied the resulting ratio of 0.9999 (the proposed CY 2022 ASC
wage index budget neutrality adjustment) to the CY 2021 ASC conversion
factor to calculate the proposed CY 2022 ASC conversion factor.
Section 1833(i)(2)(C)(i) of the Act requires that, if the Secretary
has not updated amounts established under the revised ASC payment
system in a calendar year, the payment amounts shall be increased by
the percentage increase in the Consumer Price Index for all urban
consumers (CPI-U), U.S. city average, as estimated by the Secretary for
the 12-month period ending with the midpoint of the year involved. The
statute does not mandate the adoption of any particular update
mechanism, but it requires the payment amounts to be increased by the
CPI-U in the absence of any update. Because the Secretary updates the
ASC payment amounts annually, we adopted a policy, which we codified at
Sec. 416.171(a)(2)(ii)), to update the ASC conversion factor using the
CPI-U for CY 2010 and subsequent calendar years.
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59075
through 59080), we finalized our proposal to apply the productivity-
adjusted hospital market basket update to ASC payment system rates for
an interim period of 5 years (CY 2019 through CY 2023), during which we
will assess whether there is a migration of the performance of
procedures from the hospital setting to the ASC setting as a result of
the use of a productivity-adjusted hospital market basket update, as
well as whether there are any unintended consequences, such as less
than expected migration of the performance of procedures from the
hospital setting to the ASC setting. In addition, we finalized our
proposal to revise our regulations under Sec. 416.171(a)(2), which
address the annual update to the ASC conversion factor. During this 5-
year period, we intend to assess the feasibility of collaborating with
stakeholders to collect ASC cost data in a minimally burdensome manner
and could propose a plan to collect such information. We refer readers
to that final rule for a detailed discussion of the rationale for these
policies.
The proposed hospital market basket update for CY 2022 is projected
to be 2.5 percent, as published in the FY 2022 IPPS/LTCH PPS proposed
rule (86 FR 25435), based on IHS Global Inc.'s (IGI's) 2020 fourth
quarter forecast with historical data through the third quarter of
2020.
Section 1886(b)(3)(B)(xi)(II) of the Act, defines the productivity
adjustment to be equal to the 10-year moving average of changes in
annual economy-wide private nonfarm business multifactor productivity
(MFP). We finalized the methodology for calculating the productivity
adjustment in the CY 2011 PFS final rule with comment period (75 FR
73394 through 73396) and revised it
[[Page 42231]]
in the CY 2012 PFS final rule with comment period (76 FR 73300 through
73301) and the CY 2016 OPPS/ASC final rule with comment period (80 FR
70500 through 70501). The proposed productivity adjustment for CY 2022
is projected to be 0.2 percentage point, as published in the FY 2022
IPPS/LTCH PPS proposed rule (86 FR 25435) based on IGI's 2020 fourth
quarter forecast.
For 2022, we propose to utilize the hospital market basket update
of 2.5 percent reduced by the productivity adjustment of 0.2 percentage
point, resulting in a productivity-adjusted hospital market basket
update factor of 2.3 percent for ASCs meeting the quality reporting
requirements. Therefore, we propose to apply a 2.3 percent
productivity-adjusted hospital market basket update factor to the CY
2021 ASC conversion factor for ASCs meeting the quality reporting
requirements to determine the CY 2022 ASC payment amounts. The ASCQR
Program affected payment rates beginning in CY 2014 and, under this
program, there is a 2.0 percentage point reduction to the update factor
for ASCs that fail to meet the ASCQR Program requirements. We refer
readers to section XIV.E. of the CY 2019 OPPS/ASC final rule with
comment period (83 FR 59138 through 59139) and section XIV.E. of this
CY 2022 OPPS/ASC proposed rule for a detailed discussion of our
policies regarding payment reduction for ASCs that fail to meet ASCQR
Program requirements. We propose to utilize the hospital market basket
update of 2.5 percent reduced by 2.0 percentage points for ASCs that do
not meet the quality reporting requirements and then reduced by the 0.2
percentage point productivity adjustment. Therefore, we propose to
apply a 0.3 percent productivity-adjusted hospital market basket update
factor to the CY 2021 ASC conversion factor for ASCs not meeting the
quality reporting requirements. We also propose that if more recent
data are subsequently available (for example, a more recent estimate of
the hospital market basket update or productivity adjustment), we would
use such data, if appropriate, to determine the CY 2022 ASC update for
the CY 2022 OPPS/ASC final rule with comment period.
For 2022, we propose to adjust the CY 2021 ASC conversion factor
($48.952) by the proposed wage index budget neutrality factor of 0.9993
in addition to the productivity-adjusted hospital market basket update
of 2.3 percent discussed above, which results in a proposed CY 2022 ASC
conversion factor of $50.043 for ASCs meeting the quality reporting
requirements. For ASCs not meeting the quality reporting requirements,
we propose to adjust the CY 2021 ASC conversion factor ($48.952) by the
proposed wage index budget neutrality factor of 0.9993 in addition to
the quality reporting/productivity-adjusted hospital market basket
update of 0.3 percent discussed above, which results in a proposed CY
2022 ASC conversion factor of $49.064.
3. Display of Proposed CY 2022 ASC Payment Rates
Addenda AA and BB to this proposed rule (which are available on the
CMS website) display the proposed ASC payment rates for CY 2022 for
covered surgical procedures and covered ancillary services,
respectively. Historically, for those covered surgical procedures and
covered ancillary services where the payment rate is the lower of the
proposed rates under the ASC standard ratesetting methodology and the
MPFS proposed rates, the proposed payment indicators and rates set
forth in this proposed rule are based on a comparison using the PFS
rates that would be effective January 1, 2022. For a discussion of the
PFS rates, we refer readers to the CY 2022 PFS proposed rule that is
available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The proposed payment rates included in addenda AA and BB to this
proposed rule reflect the full ASC payment update and not the reduced
payment update used to calculate payment rates for ASCs not meeting the
quality reporting requirements under the ASCQR Program. These addenda
contain several types of information related to the proposed CY 2022
payment rates. Specifically, in Addendum AA, a ``Y'' in the column
titled ``To be Subject to Multiple Procedure Discounting'' indicates
that the surgical procedure would be subject to the multiple procedure
payment reduction policy. As discussed in the CY 2008 OPPS/ASC final
rule with comment period (72 FR 66829 through 66830), most covered
surgical procedures are subject to a 50-percent reduction in the ASC
payment for the lower-paying procedure when more than one procedure is
performed in a single operative session.
Display of the comment indicator ``CH'' in the column titled
``Comment Indicator'' indicates a change in payment policy for the item
or service, including identifying discontinued HCPCS codes, designating
items or services newly payable under the ASC payment system, and
identifying items or services with changes in the ASC payment indicator
for CY 2021. Display of the comment indicator ``NI'' in the column
titled ``Comment Indicator'' indicates that the code is new (or
substantially revised) and that comments will be accepted on the
interim payment indicator for the new code. Display of the comment
indicator ``NP'' in the column titled ``Comment Indicator'' indicates
that the code is new (or substantially revised) and that comments will
be accepted on the ASC payment indicator for the new code.
For 2021, we finalized adding a new column to ASC Addendum BB
titled ``Drug Pass-Through Expiration during Calendar Year'' where we
flag through the use of an asterisk each drug for which pass-through
payment is expiring during the calendar year (that is, on a date other
than December 31st).
The values displayed in the column titled ``Proposed CY 2021
Payment Weight'' are the proposed relative payment weights for each of
the listed services for CY 2021. The proposed relative payment weights
for all covered surgical procedures and covered ancillary services
where the ASC payment rates are based on OPPS relative payment weights
were scaled for budget neutrality. Therefore, scaling was not applied
to the device portion of the device-intensive procedures, services that
are paid at the MPFS nonfacility PE RVU-based amount, separately
payable covered ancillary services that have a predetermined national
payment amount, such as drugs and biologicals and brachytherapy sources
that are separately paid under the OPPS, or services that are
contractor-priced or paid at reasonable cost in ASCs. This includes
separate payment for non-opioid pain management drugs.
To derive the proposed CY 2022 payment rate displayed in the
``Proposed CY 2022 Payment Rate'' column, each ASC payment weight in
the ``Proposed CY 2022 Payment Weight'' column was multiplied by the
proposed CY 2022 conversion factor of $50.043. The conversion factor
includes a budget neutrality adjustment for changes in the wage index
values and the annual update factor as reduced by the productivity
adjustment. The proposed CY 2022 ASC conversion factor uses the CY 2022
productivity-adjusted hospital market basket update factor of 2.3
percent (which is equal to the projected hospital market basket update
of 2.5 percent reduced by a projected productivity adjustment of 0.2
percentage point).
In Addendum BB, there are no relative payment weights displayed in
the ``Proposed CY 2022 Payment Weight'' column for items and services
[[Page 42232]]
with predetermined national payment amounts, such as separately payable
drugs and biologicals. The ``Proposed CY 2021 Payment'' column displays
the proposed CY 2022 national unadjusted ASC payment rates for all
items and services. The proposed CY 2022 ASC payment rates listed in
Addendum BB for separately payable drugs and biologicals are based on
ASP data used for payment in physicians' offices in 2020.
Addendum EE provides the HCPCS codes and short descriptors for
surgical procedures that are proposed to be excluded from payment in
ASCs for CY 2022.
XIV. Advancing to Digital Quality Measurement and the Use of Fast
Healthcare Interoperability Resources (FHIR) in Outpatient Quality
Programs--Request for Information
We aim to move fully to digital quality measurement in the Centers
for Medicare & Medicaid Services (CMS) quality reporting and value-
based purchasing (VBP) programs by 2025. As part of this modernization
of our quality measurement enterprise, we are issuing this request for
information (RFI). The purpose of this RFI is to gather broad public
input solely for planning purposes for our transition to digital
quality measurement. Any updates to specific program requirements
related to providing data for quality measurement and reporting
provisions would be addressed through future rulemaking, as necessary.
This RFI contains five parts:
Background. This part provides information on our quality
measurement programs and our goal to move fully to digital quality
measurement by 2025. This part also provides a summary of recent HHS
policy developments that are advancing interoperability and could
support our move towards full digital quality measurement.
Definition of Digital Quality Measures (dQMs). This part
provides a potential definition for dQMs. Specific requests for input
are included in the section.
Use of Fast Healthcare Interoperability Resources
(FHIR[supreg]) for Current Electronic Clinical Quality Measures
(eCQMs). This part provides information on current activities underway
to align CMS eCQMs with the FHIR standard and support quality
measurement via application programming interfaces (APIs), and
contrasts this approach to current eCQM standards and practice.
Changes Under Consideration to Advance Digital Quality
Measurement: Potential Actions in Four Areas to Transition to dQMs by
2025. This part introduces four possible steps that would enable
transformation of CMS' quality measurement enterprise to be fully
digital by 2025. Specific requests for input are included in the
section.
Solicitation of Comments. This part lists all requests for
input included in the sections of this RFI.
A. Background
As required by law, we implement quality measurement and VBP
programs across a broad range of inpatient acute care, outpatient, and
post-acute care (PAC) settings consistent with our mission to improve
the quality of health care for Americans through measurement,
transparency, and increasingly, value-based purchasing. These quality
programs are foundational for incentivizing value-based care,
contributing to improvements in health care, enhancing patient
outcomes, and informing consumer choice. In October 2017, we launched
the Meaningful Measures Framework. This framework for quality
measurement captures our vision to better address health care quality
priorities and gaps, including emphasizing digital quality measurement,
reducing measurement burden, and promoting patient perspectives, while
also focusing on modernization and innovation. The scope of the
Meaningful Measures Framework evolves as the health care environment
continues to change.\115\ Consistent with the Meaningful Measures
Framework, we aim to move fully to digital quality measurement by 2025.
We acknowledge facilities within the various care and practice settings
covered by our quality programs may be at different stages of readiness
and, therefore, the timeline for achieving full digital quality
measurement across our quality reporting programs may vary.
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\115\ Meaningful Measures 2.0: Moving from Measure Reduction to
Modernization. Available at: https://www.cms.gov/meaningful-measures-20-moving-measure-reduction-modernization.
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We also continue to evolve the Medicare Promoting Interoperability
Program's focus on the use of certified electronic health record (EHR)
technology, from an initial focus on electronic data capture to
enhancing information exchange and expanding quality measurement (83 FR
41634). However, reporting data for quality measurement via EHRs
remains burdensome, and our current approach to quality measurement
does not readily incorporate emerging data sources such as patient-
reported outcomes (PRO) and patient-generated health data (PGHD).\116\
There is a need to streamline our approach to data collection,
calculation, and reporting to fully leverage clinical and patient-
centered information for measurement, improvement, and learning.
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\116\ What are patient generated health data: https://www.healthit.gov/topic/otherhot-topics/what-are-patient-generated-health-data.
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Additionally, advancements in technical standards and associated
regulatory initiatives to improve interoperability of healthcare data
are creating an opportunity to significantly improve our quality
measurement systems. In May 2020, we finalized interoperability
requirements in the CMS Interoperability and Patient Access final rule
(85 FR 25510) to support beneficiary access to data held by certain
payers. At the same time, the Office of the National Coordinator for
Health Information Technology (ONC) finalized policies in the ONC 21st
Century Cures Act final rule (85 FR 25642) to advance the
interoperability of health information technology (IT) as defined in
section 4003 of the 21st Century Cures Act, including the ``complete
access, exchange, and use of all electronically accessible health
information.'' Closely working with ONC, we collaboratively identified
Health Level 7 (HL7[supreg]) FHIR Release 4.0.1 as the standard to
support API policies in both rules. ONC, on behalf of HHS, adopted the
HL7 FHIR Release 4.0.1 for APIs and related implementation
specifications at 45 CFR 170.215. We believe the FHIR standard has the
potential to be a more efficient and modular standard to enable APIs.
We also believe this standard enables collaboration and information
sharing, which is essential for delivering high-quality care and better
outcomes at a lower cost. By aligning technology requirements for
payers, health care facilities, and health IT developers HHS can
advance an interoperable health IT infrastructure that ensures
healthcare facilities and patients have access to health data when and
where it is needed.
In the ONC 21st Century Cures Act final rule, ONC adopted a
``Standardized API for Patient and Population Services'' certification
criterion for health IT that requires the use of FHIR Release 4 and
several implementation specifications. Health IT certified to this
criterion will offer single patient and multiple patient services that
can be accessed by third party applications (85 FR 25742).\117\ The
[[Page 42233]]
ONC 21st Century Cures Act final rule also requires health IT
developers to update their certified health IT to support the United
States Core Data for Interoperability (USCDI) standard.\118\ The scope
of patient data identified in the USCDI and the data standards that
support this data set are expected to evolve over time, starting with
data specified in Version 1 of the USCDI. In November 2020, ONC issued
an interim final rule with comment period extending the date when
health IT developers must make technology meeting updated certification
criteria available under the ONC Health IT Certification Program until
December 31, 2022 (85 FR 70064).\119\
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\117\ Application Programming Interfaces (API) Resource Guide,
Version 1.0. Available at: https://www.healthit.gov/sites/default/files/page/2020-11/API-Resource-Guide_v1_0.pdf.
\118\ https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.
\119\ Information Blocking and the ONC Health IT Certification
Program: Extension of Compliance Dates and Timeframes in Response to
the Covid-19 Public Health Emergency. Available at: https://www.govinfo.gov/content/pkg/FR-2020-11-04/pdf/2020-24376.pdf.
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The CMS Interoperability and Patient Access final rule (85 FR
25510) and program policies build on the ONC 21st Century Cures Act
final rule (85 FR 25642). The CMS Interoperability and Patient Access
final rule and policies require certain payers (for example, Medicare
Advantage organizations, Medicaid and Child Health Insurance Program
(CHIP) Fee-for-Service (FFS) programs, Medicaid managed care plans,
CHIP managed care entities, and issuers of certain Qualified Health
Plan (QHP) on the Federally-facilitated Exchanges (FFEs)) to implement
and maintain a standards-based Patient Access API using HL7 FHIR
Release 4.0.1 to make available claims and encounter data to their
enrollees and beneficiaries (called ``patients'' in the CMS
interoperability rule) with the intent of ensuring enrollees and
beneficiaries have access to their own health care information through
third-party software applications.
The CMS Interoperability and Patient Access final rule also
established new conditions of participation for Medicare and Medicaid
participating hospitals and critical access hospitals (CAHs), requiring
them to send electronic notifications to another healthcare facility or
community provider or practitioner when a patient is admitted,
discharged, or transferred (85 FR 25603).
In the calendar year (CY) 2021 Physician Fee Schedule (PFS) final
rule (85 FR 84472), we finalized a policy to align the certified EHR
technology required for use in the Promoting Interoperability Programs
and the Merit-based Incentive Payment System (MIPS) Promoting
Interoperability performance category with the updates to health IT
certification criteria finalized in the ONC 21st Century Cures Act
final rule. Under this policy, MIPS eligible clinicians, and eligible
hospitals and CAHs participating in the Promoting Interoperability
Programs, must use technology meeting the updated certification
criteria for performance and reporting periods beginning in 2023 (85 FR
84825).
The use of APIs can also reduce long-standing barriers to quality
measurement. Currently, health IT developers are required to implement
individual measure specifications within their health IT products. The
health IT developer must also accommodate how that product connects
with the unique variety of systems within a specific care setting.\120\
This may be further complicated by systems that integrate a wide range
of data schemas. This process is burdensome and costly, and it is
difficult to reliably obtain high quality data across systems. As
health IT developers map their health IT data to the FHIR standard and
related implementation specifications, APIs can enable these structured
data to be easily accessible for quality measurement or other use
cases, such as care coordination, clinical decision support, and
supporting patient access.
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\120\ The Office of the National Coordinator for Health
Information Technology, Strategy on Reducing Regulatory and
Administrative Burden Relating to the Use of Health IT and EHRs,
Final Report (Feb. 2020). Available at: https://www.healthit.gov/sites/default/files/page/2020-02/BurdenReport_0.pdf.
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We believe the emerging data standardization and interoperability
enabled by APIs will support the transition to full digital quality
measurement by 2025, and are committed to exploring and seeking input
on potential solutions for the transition to digital quality
measurement as described in this RFI.
B. Definition of Digital Quality Measures
In this section we seek to refine the definition of digital quality
measures (dQMs) to further operationalize our objective of fully
transitioning to dQMs by 2025. We previously noted dQMs use ``sources
of health information that are captured and can be transmitted
electronically and via interoperable systems'' (85 FR 84845). In this
RFI, we seek input on future elaboration that would define a dQM as a
software that processes digital data to produce a measure score or
measure scores. Data sources for dQMs may include administrative
systems, electronically submitted clinical assessment data, case
management systems, EHRs, instruments (for example, medical devices and
wearable devices), patient portals or applications (for example, for
collection of patient-generated health data), health information
exchanges (HIEs) or registries, and other sources. We also note that
dQMs are intended to improve the patient experience including quality
of care, improve the health of populations, and/or reduce costs. We
discuss one potential approach to developing dQM software in section
XIV.D.2. of the preamble of this proposed rule. In this section, we are
seeking comment on the potential definition of dQMs in this RFI.
We also seek feedback on how leveraging advances in technology (for
example, FHIR-based APIs) to access and electronically transmit
interoperable data for dQMs could reinforce other activities to support
quality measurement and improvement (for example, the aggregation of
data across multiple data sources, rapid-cycle feedback, and alignment
of programmatic requirements).
The transition to dQMs relies on advances in data standardization
and interoperability. As providers and payers work to implement the
required advances in interoperability over the next several years, we
will continue to support reporting of eCQMs through CMS quality
reporting programs and through the Promoting Interoperability
Programs.\121\ These fully digital measures continue to be important
drivers of interoperability advancement and learning. As discussed in
the next section, we are currently re-specifying and testing these
measures to use FHIR rather than the currently adopted Quality Data
Model (QDM) in anticipation of the wider use of FHIR standards. CMS
intends to apply significant components of the output of this work,
such as the re-specified measure logic and the learning done through
measure testing with FHIR-based APIs, to define and build future dQMs
that take advantage of the expansion of standardized, interoperable
data.
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\121\ eCQI Resource Center. Available at: https://ecqi.healthit.gov/.
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C. Use of FHIR for Current eCQMs
Since we adopted eCQMs in our hospital and clinician quality
programs, we have heard from stakeholders about the technological
challenges, burden, and related costs of reporting eCQM data. The CMS
eCQM Strategy Project engaged with stakeholders through site visits and
listening sessions with health
[[Page 42234]]
systems and provider organizations to learn about their experiences.
This stakeholder feedback identified recommendations to improve
processes related to alignment; development; implementation and
reporting; certification; and communication, education, and outreach.
Over the past 2 years, we have focused on opportunities to streamline
and modernize quality data collection and reporting processes, such as
exploring FHIR (http://hl7.org/fhir) as a framework for measure
structure and data submission for quality reporting programs,
specifically for eCQMs. FHIR is a free and open source standards
framework (in both commercial and government settings) created by HL7
International that establishes a common language and process for all
health information technology. FHIR allows systems to communicate and
information to be shared seamlessly, with a lower burden for hospitals,
providers, clinicians, vendors, and quality measurement stakeholders.
Specifically, for quality reporting, FHIR enables representing the data
in eCQMs as well as provides a structure for eCQMs and reporting, using
FHIR as the standard for all. Whereas today, multiple standards being
used to report eCQMs is challenging and burdensome.
We are working to convert current eCQMs to the FHIR standard. We
are currently testing the exchange of data elements represented in FHIR
to CMS through ongoing HL7 Connectathons and integrated system testing
by using and refining implementation guides (IGs). Submitting data
through FHIR-based APIs has the potential to improve data exchange by
providing consistent security, performance, scalability, and structure
to all users. In addition, development of FHIR-based APIs could
decrease provider burden by automating more of the measure data
collection process. We continue to explore and expand potential
applications of the FHIR standard and testing with eCQM use cases, and
we are strongly considering a transition to FHIR-based quality
reporting with the use of the FHIR standard for eCQMs in quality and
value-based reporting programs. As we move to an all-dQM format for
quality programs, we are depending on testing results and community
readiness to improve interoperability, reduce burden, and facilitate
better patient care. We will continue to consider how to leverage the
interoperability advantages offered by the FHIR standards and API-based
data submission, including digital quality measurement.
D. Changes Under Consideration To Advance Digital Quality Measurement:
Potential Actions in Four Areas To Transition to Digital Quality
Measures by 2025
Building on the advances in interoperability and learning from
testing of FHIR-converted eCQMs, we aim to move fully to dQMs,
originating from sources of health information that are captured and
can be transmitted electronically via interoperable systems, by 2025.
To enable this transformation, we are considering further
modernization of the quality measurement enterprise in four major ways:
(1) Leverage and advance standards for digital data and obtain all EHR
data required for quality measures via provider FHIR-based APIs; (2)
redesign our quality measures to be self-contained tools; (3) better
support data aggregation; and (4) work to align measure requirements
across our reporting programs, other Federal programs and agencies, and
the private sector where appropriate.
These changes would enable us to collect and utilize more timely,
actionable, and standardized data from diverse sources and care
settings to improve the scope and quality of data used in quality
reporting and payment programs, reduce quality reporting burden, and
make results available to stakeholders in a rapid-cycle fashion. Data
collection and reporting efforts would become more efficient, supported
by advances in interoperability and data standardization. Aggregation
of data from multiple sources would allow assessments of costs and
outcomes to be measured across multiple care settings for an individual
patient or clinical conditions. We believe that aggregating data for
measurement can incorporate a more holistic assessment of an
individual's health and health care and produce the rich set of data
needed to enable patients and caregivers to make informed decisions by
combining data from multiple sources (for example, patient reported
data, EHR data, and claims data) for measurement.
Perhaps most importantly, these steps would help us deliver on the
full promise of quality measurement and drive us toward a learning
health system that transforms healthcare quality, safety, and
coordination and effectively measures and achieves value-based care.
The shift from a static to a learning health system hinges on the
interoperability of healthcare data, and the use of standardized data.
dQMs would leverage this interoperability to deliver on the promise of
a learning health system wherein standards-based data sharing and
analysis, rapid-cycle feedback, and quality measurement and incentives
are aligned for continuous improvement in patient-centered care.
Similarly, standardized, interoperable data used for measurement can
also be used for other use cases, such as clinical decision support,
care coordination and care decision support, which impacts health care
and care quality.
We are requesting comments on four potential future actions that
would enable transformation to a fully digital quality measurement
enterprise by 2025.
1. Leveraging and Advancing Standards for Digital Data and Obtaining
All EHR Data Required for Quality Measures via Provider FHIR-Based APIs
We are considering targeting the data required for our quality
measures that utilize EHR data to be data retrieved via FHIR-based APIs
based on standardized, interoperable data. Utilizing standardized data
for EHR-based measurement (based on FHIR and associated IGs) and
aligning where possible with interoperability requirements can
eliminate the data collection burden providers currently experience
with required chart-abstracted quality measures and reduce the burden
of reporting digital quality measure results. We can fully leverage
this advance to adapt eCQMs and expand to other dQMs through the
adoption of interoperable standards across other digital data sources.
We are considering methods and approaches to leverage the
interoperability data requirements for APIs in certified health IT set
by the ONC 21st Century Cures Act final rule to support modernization
of CMS quality measure reporting. As discussed previously, these
requirements will be included in certified technology in future years
(85 FR 84825) including availability of data included in the USCDI via
standards-based APIs, and CMS will require clinicians and hospitals
participating in MIPS and the Promoting Interoperability Programs,
respectively, to transition to use of certified technology updated
consistent with the 2015 Cures Edition Update (85 FR 84825).
Digital data used for measurement could also expand beyond data
captured in traditional clinical settings, administrative claims data,
and EHRs. Many important data sources are not currently captured
digitally, such as survey and PGHD. We intend to work to innovate and
broaden the digital data used across the quality measurement enterprise
beyond the clinical EHR and administrative claims. Agreed upon
[[Page 42235]]
standards for these data, and associated implementation guides will be
important for interoperability and quality measurement. We will
consider developing clear guidelines and requirements for these digital
data that align with interoperability requirements, for example,
requirements for expressing data in standards, exposing data via
standards-based APIs, and incentivizing technologies that innovate data
capture and interoperability.
High quality data are also essential for reliable and valid
measurement. Hence, in implementing the shift to collect all clinical
EHR data via FHIR-based APIs, we would support efforts to strengthen
and test the quality of the data obtained through FHIR-based APIs for
quality measurement. We currently conduct audits of eCQM data submitted
under our quality programs, including the Hospital Inpatient Quality
Reporting (IQR) Program, with functions including checks for data
completeness and data accuracy, confirmation of proper data formatting,
alignment with standards, and appropriate data cleaning (82 FR 38398
through 38402). These functions would continue and be applied to dQMs
and further expanded to automate the manual validation of the data
compared to the original data source (for example, the medical record)
where possible. Analytic advancements such as natural language
processing, big data analytics, and artificial intelligence, can
support this evolution. These techniques can be applied to validating
observed patterns in data and inferences or conclusions drawn from
associations, as data are received, to ensure high quality data are
used for measurement.
We are seeking feedback on the goal of aligning data needed for
quality measurement with interoperability requirements and the
strengths and limitations of this approach. We are also seeking
feedback on the importance of and approaches to supporting inclusion of
PGHD and other currently non-standardized data. We also welcome comment
on approaches for testing data quality and validity.
2. Redesigning Quality Measures To Be Self-Contained Tools
We are considering approaches for including quality measures that
take advantage of standardized data and interoperability requirements
that have expanded flexibility and functionality compared to CMS'
current eCQMs. We are considering defining and developing dQM software
as end-to-end measure calculation solutions that retrieve data from
primarily FHIR-based resources maintained by providers, payers, CMS,
and others; calculate measure score(s); and produce reports. In
general, we believe to optimize the use of standardized and
interoperable data, the software solution for dQMs should do the
following:
Have the flexibility to support calculation of single or
multiple quality measure(s).
Perform three functions --
++ Obtain data via automated queries from a broad set of digital
data sources (initially from EHRs, and in the future from claims, PRO,
and PGHD);
++ Calculate the measure score according to measure logic; and
++ Generate measure score report(s).
Be compatible with any data source systems that implement
standard interoperability requirements.
Exist separately from digital data source(s) and respect
the limitations of the functionality of those data sources.
Be tested and updated independently of the data source
systems.
Operate in accordance with health information protection
requirements under applicable laws and comply with governance functions
for health information exchange.
Have the flexibility to be deployed by individual health
systems, health IT vendors, data aggregators, and health plans; and/or
run by CMS depending on the program and measure needs and
specifications.
Be designed to enable easy installation for supplemental
uses by medical professionals and other non-technical end-users, such
as local calculation of quality measure scores or quality improvement.
Have the flexibility to employ current and evolving
advanced analytic approaches such as natural language processing.
Be designed to support pro-competitive practices for
development, maintenance, and implementation as well as diffusion of
quality measurement and related quality improvement and clinical tools
through, for example, the use of open-source core architecture.
We seek comment on these suggested functionalities and other
additional functionalities that quality measure tools should ideally
have particularly in the context of the possible expanding availability
of standardized and interoperable data (for example, standardized EHR
data available via FHIR-based APIs).
We are also interested whether and how this more open, agile
strategy may facilitate broader engagement in quality measure
development, the use of tools developed for measurement for local
quality improvement, and/or the application of quality tools for
related purposes such as public health or research.
3. Building a Pathway to Data Aggregation in Support of Quality
Measurement
Using multiple sources of collected data to inform measurement
would reduce data fragmentation (or, different pieces of data regarding
a single patient stored in many different places). Additionally, we are
considering expanding and establishing policies and processes for data
aggregation and measure calculation by third-party aggregators that
include, but are not limited to, HIEs and clinical registries.
Qualified Clinical Data Registries and Qualified Registries that report
quality measures for eligible clinicians in the MIPS program are
potential examples \122\ at 42 CFR 414.1440(b)(2)(iv) and (v) and
(c)(2)(iii) and (iv) and can also support measure reporting. We are
considering establishing similar policies for third-party aggregators
to maintain the integrity of our measure reporting process and to
encourage market innovation.
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\122\ CY 2021 Physician Fee Schedule Final Rule: Finalized (New
and Updated) Qualified Clinical Data Registry (QCDR) and Qualified
Registry Policies, https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1362/QCDR%20and%20QR%20Updates%202021%20Final%20Rule%20Fact%20Sheet.pdf.
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We seek feedback on aggregation of data from multiple sources to
inform measurement and potential policy considerations. We also seek
feedback on the role data aggregators can and should play in CMS
quality measure reporting in collaboration with providers, and how we
can best facilitate and enable aggregation.
4. Potential Future Alignment of Measures Across Reporting Programs,
Federal and State Agencies, and the Private Sector
We are committed to using policy levers and working with
stakeholders to solve the issue of interoperable data exchange and to
transition to full digital quality measurement. We are considering the
future potential development and multi-staged implementation of a
common portfolio of dQMs across our regulated programs, agencies, and
private payers. This common portfolio would require alignment of: (1)
Measure concepts and specifications including narrative statements,
measure logic, and value sets; and (2) the individual data elements
used to build these measure
[[Page 42236]]
specifications and calculate the measure logic. Further, the required
data elements would be limited to standardized, interoperable data
elements to the fullest extent possible; hence, part of the alignment
strategy will be the consideration and advancement of data standards
and IGs for key data elements. We would coordinate closely with quality
measure developers, Federal and state agencies, and private payers to
develop and to maintain a cohesive dQM portfolio that meets our
programmatic requirements and that fully aligns across Federal and
state agencies and payers to the extent possible.
We intend for this coordination to be ongoing and allow for
continuous refinement to ensure quality measures remain aligned with
evolving healthcare practices and priorities (for example, PROs,
disparities, and care coordination), and track with the transformation
of data collection, alignment with health IT module updates including
capabilities and standards adopted by ONC (for example, standards to
enable APIs). This coordination would build on the principles outlined
in HHS' National Health Quality Roadmap.\123\ It would focus on the
quality domains of safety, timeliness, efficiency, effectiveness,
equitability, and patient-centeredness. It would leverage several
existing Federal and public-private efforts including our Meaningful
Measures 2.0 Framework; the Federal Electronic Health Record
Modernization (Department of Defense and Veterans Affairs (DoD/VA));
the Agency for Healthcare Research and Quality's (AHRQ) Clinical
Decision Support Initiative; the Centers for Disease Control and
Prevention's (CDC) Adapting Clinical Guidelines for the Digital Age
initiative; Core Quality Measure Collaborative, which convenes
stakeholders from America's Health Insurance Plans (AHIP), CMS,
National Quality Forum (NQF), provider organizations, private payers,
and consumers and develops consensus on quality measures for provider
specialties; and the NQF-convened Measure Applications Partnership
(MAP), which recommends measures for use in public payment and
reporting programs. We would coordinate with HL7's ongoing work to
advance FHIR resources in critical areas to support patient care and
measurement such as social determinants of health. Through this
coordination, we would identify which existing measures could be used
or evolved to be used as dQMs, in recognition of current healthcare
practice and priorities.
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\123\ Department of Health and Human Services, National Health
Quality Roadmap (May 2020). Available at: https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.
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This multi-stakeholder, joint Federal, state, and industry effort,
made possible and enabled by the pending advances towards true
interoperability, would yield a significantly improved quality
measurement enterprise. The success of the dQM portfolio would be
enhanced by the degree to which the measures achieve our programmatic
requirements for measures as well as the requirements of other agencies
and payers.
We seek feedback on initial priority areas for the dQM portfolio
given evolving interoperability requirements (for example, measurement
areas, measure requirements, tools, and data standards). We also seek
to identify opportunities to collaborate with other Federal agencies,
states, and the private sector to adopt standards and technology-driven
solutions to address our quality measurement priorities across sectors.
E. Solicitation of Comments
As noted previously, we seek input on the future development of the
following:
Definition of Digital Quality Measures. We are seeking
feedback on the following as described in section XIV.2. of the
preamble of this proposed rule:
++ Do you have feedback on the potential future dQM definition?
++ Does this approach to defining and deploying dQMs to interface
with FHIR-based APIs seem promising? We also welcome more specific
comments on the attributes or functions to support such an approach of
deploying dQMs.
Use of FHIR for Current eCQMs. We are seeking feedback on
the following as described in section XIV.3. of the preamble of this
proposed rule:
++ Would a transition to FHIR-based quality reporting reduce burden
on health IT vendors and providers? Please explain.
++ Would access to near real-time quality measure scores benefit
your practice? How so?
++ What parts of the current CMS Quality Reporting Data
Architecture (QRDA) IGs cause the most burden (please explain the
primary drivers of burden)?
++ In what ways could CMS FHIR Reporting IG be modified to reduce
burden on providers and vendors?
Changes Under Consideration to Advance Digital Quality
Measurement: Actions in Four Areas to Transition to Digital Quality
Measures by 2025.
++ We are seeking feedback on the following as described in section
XIV.4.a. of the preamble of this proposed rule:
--Do you agree with the goal of aligning data needed for quality
measurement with interoperability requirements? What are the strengths
and limitations of this approach? Are there specific FHIR IGs suggested
for consideration?
--How important is a data standardization approach that also supports
inclusion of PGHD and other currently non-standardized data?
--What are possible approaches for testing data quality and validity?
++ We are seeking feedback on the following as described in section
XIV.4.b. of the preamble of this proposed rule:
--What functionalities, described in section (4)(b) or others, should
quality measure tools ideally have in the context of the pending
availability of standardized and interoperable data (for example,
standardized EHR data available via FHIR-based APIs)?
--How would this more open, agile strategy for end-to-end measure
calculation facilitate broader engagement in quality measure
development, the use of tools developed for measurement for local
quality improvement, and/or the application of quality tools for
related purposes such as public health or research?
++ We seek feedback on the following as described in section
XIV.4.c. of the preamble of this proposed rule:
--What are key policy considerations for aggregation of data from
multiple sources being used to inform measurement?
--What role can or should data aggregators play in CMS quality measure
reporting in collaboration with providers? How can CMS best facilitate
and enable aggregation?
++ We seek feedback on the following as described in section
XIV.4.d. of the preamble of this proposed rule:
--What are initial priority areas for the dQM portfolio given evolving
interoperability requirements (for example, measurement areas, measure
requirements, tools)?
--We also seek to identify opportunities to collaborate with other
Federal agencies, states, and the private sector to adopt standards and
technology-driven solutions to address our quality measurement
priorities and across sectors.
Commenters should consider provisions in the CMS Interoperability
and Patient Access final rule (85 FR
[[Page 42237]]
25510), CMS CY 2021 PFS final rule (85 FR 84472), and the ONC 21st
Century Cures Act final rule (85 FR 25642).
We plan to continue working with other agencies and stakeholders to
coordinate and to inform any potential transition to dQMs by 2025.
While we will not be responding to specific comments submitted in
response to this Request for Information in the CY 2022 OPPS/ASC final
rule, we will actively consider all input as we develop future
regulatory proposals or future subregulatory policy guidance. Any
updates to specific program requirements related to quality measurement
and reporting provisions would be addressed through separate and future
notice-and-comment rulemaking, as necessary.
XV. Requirements for the Hospital Outpatient Quality Reporting (OQR)
Program
A. Background
1. Overview
CMS seeks to promote higher quality and more efficient healthcare
for Medicare beneficiaries. Consistent with these goals, CMS has
implemented quality reporting programs for multiple care settings
including the quality reporting program for hospital outpatient care,
known as the Hospital Outpatient Quality Reporting (OQR) Program.
2. Statutory History of the Hospital OQR Program
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72064 through 72065) for a detailed discussion of the
statutory history of the Hospital OQR Program. The Hospital OQR Program
regulations are codified at 42 CFR[thinsp]419.46. In the CY 2021 OPPS/
ASC final rule (85 FR 86179), we finalized to update the regulations to
include a reference to the statutory authority for the Hospital OQR
Program. Section 1833(t)(17)(A) of the Social Security Act (the Act)
states that subsection (d) hospitals (as defined under section
1886(d)(1)(B) of the Act) that do not submit data required for measures
selected with respect to such a year, in the form and manner required
by the Secretary, will incur a 2.0 percentage point reduction to their
annual Outpatient Department (OPD) fee schedule increase factor. In the
CY 2021 OPPS/ASC final rule (85 FR 86179) we codified the Hospital OQR
Program's statutory authority at Sec. 419.46(a).
3. Regulatory History of the Hospital OQR Program
We refer readers to the CY 2008 through 2021 OPPS/ASC final rules
with comment period for detailed discussions of the regulatory history
of the Hospital OQR Program:
The CY 2008 OPPS/ASC final rule (72 FR 66860 through
66875);
The CY 2009 OPPS/ASC final rule (73 FR 68758 through
68779);
The CY 2010 OPPS/ASC final rule (74 FR 60629 through
60656);
The CY 2011 OPPS/ASC final rule (75 FR 72064 through
72110);
The CY 2012 OPPS/ASC final rule (76 FR 74451 through
74492);
The CY 2013 OPPS/ASC final rule (77 FR 68467 through
68492);
The CY 2014 OPPS/ASC final rule (78 FR 75090 through
75120);
The CY 2015 OPPS/ASC final rule (79 FR 66940 through
66966);
The CY 2016 OPPS/ASC final rule (80 FR 70502 through
70526);
The CY 2017 OPPS/ASC final rule (81 FR 79753 through
79797);
The CY 2018 OPPS/ASC final rule (82 FR 59424 through
59445);
The CY 2019 OPPS/ASC final rule (83 FR 59080 through
59110);
The CY 2020 OPPS/ASC final rule (84 FR 61410 through
61420); and
The CY 2021 OPPS/ASC final rule (85 FR 86179 through
86187).
We have codified certain requirements under the Hospital OQR
Program at 42 CFR[thinsp]419.46. We refer readers to section XV.E. of
this proposed rule for a detailed discussion of the payment reduction
for hospitals that fail to meet Hospital OQR Program requirements for
the CY 2024 payment determination.
B. Hospital OQR Program Quality Measures
1. Considerations in Selecting Hospital OQR Program Quality Measures
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74458 through 74460) for a detailed discussion of the
priorities we consider for the Hospital OQR Program quality measure
selection. We are not proposing any changes to these policies in this
proposed rule.
2. Retention of Hospital OQR Program Measures Adopted in Previous
Payment Determinations
We previously finalized and codified at Sec. 419.46(h)(1) a policy
to retain measures from a previous year's Hospital OQR Program measure
set for subsequent years' measure sets, unless removed (77 FR 68471 and
83 FR 59082). We are not proposing any changes to these policies in
this proposed rule.
3. Removal of Quality Measures From the Hospital OQR Program Measure
Set
a. Immediate Removal
We previously finalized and codified at Sec. 419.46(i)(2) and (3)
a process for removal and suspension of Hospital OQR Program measures,
based on evidence that the continued use of the measure as specified
raises patient safety concerns (74 FR 60634 through 60635, 77 FR 68472,
and 83 FR 59082).\124\ We are not proposing any changes to these
policies in this proposed rule.
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\124\ We refer readers to the CY 2013 OPPS/ASC final rule with
comment period (77 FR 68472 through 68473) for a discussion of our
reasons for changing the term ``retirement'' to ``removal'' in the
Hospital OQR Program.
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b. Consideration Factors for Removing Measures
We previously finalized and codified at Sec. 419.46(i)(3) policies
to use the regular rulemaking process to remove a measure for
circumstances for which we do not believe that continued use of a
measure raises specific patient safety concerns (74 FR 60635 and 83 FR
59082).\125\ We are not proposing any changes to these policies in this
proposed rule.
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\125\ We initially referred to this process as ``retirement'' of
a measure in the 2010 OPPS/ASC proposed rule, but later changed it
to ``removal'' during final rulemaking.
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c. Proposed Removals Beginning With the CY 2023 Reporting Period/CY
2025 Payment Determination: OP-02 (Fibrinolytic Therapy Received Within
30 Minutes of ED Arrival) and OP-03 (Median Time To Transfer to Another
Facility for Acute Coronary Intervention)
In this proposed rule, we are proposing to remove two chart-
abstracted measures under removal Factor 4--the availability of a more
broadly applicable (across settings, populations, or conditions)
measure for the particular topic:
Fibrinolytic Therapy Received Within 30 Minutes of
Emergency Department (ED) Arrival (OP-2); and
Median Time to Transfer to Another Facility for Acute
Coronary Intervention (OP-3).
The OP-2 measure assesses the number of acute myocardial infarction
(AMI) patients with: (a) ST-segment elevation on the electrocardiogram
closest to arrival time receiving fibrinolytic therapy during the ED
visit; and (b) a time from hospital arrival to fibrinolysis of 30
minutes or less. For
[[Page 42238]]
more details on this measure, we refer readers to the CY 2008 OPPS/ASC
final rule with comment period (72 FR 66865), where this measure was
designated as ED-AMI-3, and the CY 2009 OPPS/ASC final rule with
comment period (73 FR 68761), where this measure was relabeled OP-2
(for the CY 2010 payment determination and subsequent years). The OP-3
measure assesses the median number of minutes before outpatients with
chest pain or possible heart attack who needed specialized care were
transferred to another hospital capable of offering such specialized
care. For more details on this measure, we refer readers to the CY 2008
OPPS/ASC final rule with comment period (72 FR 66865), where this
measure was designated as ED-AMI-5, and the CY 2009 OPPS/ASC final rule
with comment period (73 FR 68761), where this measure was relabeled OP-
3 (for the CY 2010 payment determination and subsequent years).
In this proposed rule, we are proposing to remove these two
measures (Fibrinolytic Therapy Received Within 30 Minutes of Emergency
Department (ED) Arrival (OP-2) and Median Time to Transfer to Another
Facility for Acute Coronary Intervention (OP-3)) beginning with the CY
2023 reporting period/CY 2025 payment determination due to the
availability of a more broadly applicable measure. Specifically, in
this proposed rule, we are proposing to adopt the ST-Segment Elevation
Myocardial Infarction (STEMI) electronic clinical quality measure
(eCQM) into the Hospital OQR Program measure set, which would serve as
a replacement for these two measures. We refer readers to section
XV.B.4.c. of this proposed rule for further discussion of the STEMI
eCQM, including the measure overview, data sources, and measure
calculation.
OP-2 and OP-3 measure the proportion of eligible STEMI patients who
receive timely fibrinolytic therapy and timely transfer from an ED to
another facility to receive appropriate care, respectively. The STEMI
eCQM is a proposed electronic process measure that includes both the
populations of OP-2 and OP-3. It measures the percentage of ED patients
diagnosed with STEMI that received timely fibrinolytic therapy (within
30 minutes) or timely transfer to a percutaneous coronary intervention
(PCI)-capable facility (within 45 minutes). Additionally, the STEMI
eCQM captures transfer and non-transfer patients at a PCI-capable
facility who receive PCI (within 90 minutes). Pursuant to removal
Factor 4, we believe that the adoption of the STEMI eCQM would capture
the OP-2 and OP-3 measure populations and expand beyond these
populations to comprehensively measure the timeliness and
appropriateness of STEMI care.
Furthermore, the OP-2 and OP-3 measures are chart-abstracted
measures, which result in greater provider burden due to manual
abstraction. The STEMI eCQM allows for the retrieval of data directly
from the electronic health record (EHR) using patient-level data. As a
result, we believe the STEMI eCQM is a more broadly applicable measure
and transitions the Hospital OQR Program toward the use of EHR data for
quality measurement. We note that removal of these measures is
contingent on the finalization of the STEMI eCQM. We invite public
comment on our proposals to remove these measures.
4. Proposals To Adopt New Measures for the Hospital OQR Program Measure
Set
In this proposed rule, we are proposing to adopt three new
measures: (1) COVID-19 Vaccination Coverage Among Health Care Personnel
(HCP) measure, beginning with the CY 2022 reporting period; (2) Breast
Screening Recall Rates measure, beginning with the CY 2022 reporting
period; and (3) STEMI eCQM, beginning as a voluntary measure with the
CY 2023 reporting period, and then as a mandatory measure beginning
with the CY 2024 reporting period. We refer readers to the following
sections for more information.
a. Proposal To Adopt the COVID-19 Vaccination Coverage Among Health
Care Personnel (HCP) Measure Beginning With the CY 2022 Reporting
Period/CY 2024 Payment Determination
(1) Background
On January 31, 2020, the Secretary declared a public health
emergency (PHE) for the United States (U.S.) in response to the global
outbreak of SARS-CoV-2, a novel (new) coronavirus that causes a disease
named ``coronavirus disease 2019'' (COVID-19).\126\ COVID-19 is a
contagious respiratory infection\127\ that can cause serious illness
and death. Older individuals, some racial and ethnic minorities, and
those with underlying medical conditions are considered to be at higher
risk for more serious complications from COVID-19.128 129 As
of July 2, 2021, the U.S. has reported over 33 million cases of COVID-
19 and over 600,000 COVID-19 deaths.\130\ Hospitals and health systems
saw significant surges of COVID-19 patients as community infection
levels increased.\131\ Between December 2, 2020 and January 30, 2021,
more than 100,000 Americans with COVID-19 were hospitalized at the same
time.\132\
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\126\ U.S. Dept of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response. (2020).
Determination that a Public Health Emergency Exists. Available at:
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
\127\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
\128\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
\129\ Centers for Disease Control and Prevention. (2020). Health
Equity Considerations and Racial and Ethnic Minority Groups.
Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
\130\ This information has been updated from the proposed rule
to reflect current data from the Centers for Disease Control and
Prevention. (2021). CDC COVID Data Tracker. Available at: https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days.
\131\ Associated Press. Tired to the Bone. Hospitals Overwhelmed
with Virus Cases. November 18, 2020. Accessed on December 16, 2020,
at https://apnews.com/article/hospitals-overwhelmed-coronavirus-cases-74a1f0dc3634917a5dc13408455cd895. Also see: New York Times.
Just how full are U.S. intensive care units? New data paints an
alarming picture. November 18, 2020. Accessed on December 16, 2020,
at: https://www.nytimes.com/2020/12/09/world/just-how-full-are-us-intensive-care-units-new-data-paints-an-alarming-picture.html.
\132\ US Currently Hospitalized [bond] The COVID Tracking
Project. Accessed January 31, 2021 at: https://covidtracking.com/data/charts/us-currently-hospitalized.
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Evidence indicates that COVID-19 primarily spreads when individuals
are in close contact with one another.\133\ Ongoing research indicates
that fully vaccinated people without immunocompromising conditions are
able to engage in most activities with very low risk of acquiring or
transmitting SARS-CoV-2, and the Centers for Disease Control and
Prevention (CDC) issued new guidance for fully vaccinated individuals
on May 28, 2021.\134\ The virus is typically transmitted through
respiratory droplets or small particles created when someone who is
infected with the virus coughs, sneezes, sings, talks or breathes.\135\
Thus, the CDC advises that infections mainly occur through exposure to
respiratory droplets when a person is in close contact with someone
[[Page 42239]]
who has COVID-19.\136\ Experts believe that COVID-19 spreads less
commonly through contact with a contaminated surface \137\ and that in
certain circumstances, infection can occur through airborne
transmission.\138\ According to the CDC, those at greatest risk of
infection are persons who have had prolonged, unprotected close contact
(that is, within 6 feet for 15 minutes or longer) with an individual
with confirmed COVID-19 infection, regardless of whether the individual
has symptoms.\139\ Although personal protective equipment (PPE) and
other infection-control precautions can reduce the likelihood of
transmission in health care settings, COVID-19 can spread between HCP
and patients or from patient to patient given the close contact that
may occur during the provision of care.\140\ The CDC has emphasized
that health care settings, including long-term care (LTC) settings, can
be high-risk places for COVID-19 exposure and transmission.\141\
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\133\ Centers for Disease Control and Prevention. (2021). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\134\ Centers for Disease Control and Prevention. (2021).
Interim Public Health Recommendations for Fully Vaccinated People.
Accessed on June 2, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.
\135\ Ibid.
\136\ Ibid.
\137\ Ibid.
\138\ Centers for Disease Control and Prevention. (2020). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\139\ Centers for Disease Control and Prevention. (2021). When
to Quarantine. Accessed on April 2, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html.
\140\ Centers for Disease Control and Prevention. 2021). Interim
U.S. Guidance for Risk Assessment and Work Restrictions for
Healthcare Personnel with Potential Exposure to COVID-19.
\141\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb
Mortal Wkly Rep. 2020; 69(49): 1857-1859.
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Vaccination is a critical part of the nation's strategy to
effectively counter the spread of COVID-19 and ultimately help restore
societal functioning.\142\ On December 11, 2020, the Food and Drug
Administration (FDA) issued the first Emergency Use Authorization (EUA)
for a COVID-19 vaccine in the U.S.\143\ Subsequently, the FDA issued
EUAs for additional COVID-19 vaccines.144 145
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\142\ Centers for Disease Control and Prevention. (2020). COVID-
19 Vaccination Program Interim Playbook for Jurisdiction Operations.
Accessed on December 18 at: https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
\143\ U.S. Food and Drug Administration. (2020). Pfizer-BioNTech
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144412/download.
\144\ U.S. Food and Drug Administration. (2021). Moderna COVID-
19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download.
\145\ U.S. Food and Drug Administration. (2021). Janssen COVID-
19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/146303/download.
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As part of its national strategy to address COVID-19, the White
House stated on March 25, 2021 that it would work with states and the
private sector to execute an aggressive vaccination strategy and has
outlined a goal of administering 200 million shots in 100 days.\146\ On
April 21, 2021, it was announced that this goal had been achieved.\147\
Although the goal of the U.S. Government is to ensure that every
American who wants to receive a COVID-19 vaccine can receive one, the
Department of Health and Human Services (HHS), the Department of
Defense (DoD), and the CDC, recommended that early vaccination efforts
focus on those critical to the PHE response, including HCP, and
individuals at highest risk for developing severe illness from COVID-
19.\148\ For example, the CDC's Advisory Committee on Immunization
Practices (ACIP) recommended that HCP should be among those individuals
prioritized to receive the initial, limited supply of the COVID-19
vaccination, given the potential for transmission in health care
settings and the need to preserve health care system capacity.\149\
Research suggests most states followed this recommendation,\150\ and
HCP began receiving the vaccine in mid-December of 2020.\151\
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\146\ The White House. Remarks by President Biden on the COVID-
19 Response and the State of Vaccinations. Accessed on April 3, 2021
at: https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/03/29/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations/.
\147\ The White House. Remarks by President Biden on the COVID-
19 Response and the State of Vaccinations. Accessed on June 2, 2021
at: https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/04/21/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations-2/.
\148\ Health and Human Services, Department of Defense. (2020)
From the Factory to the Frontlines: The Operation Warp Speed
Strategy for Distributing a COVID-19 Vaccine. Accessed December 18
at: https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf; Centers for Disease Control
(2020). COVID-19 Vaccination Program Interim Playbook for
Jurisdiction Operations. Accessed December 18 at: https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
\149\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb.
Mortal Wkly Rep. 2020; 69(49): 1857-1859. ACIP also recommended that
long-term care residents be prioritized to receive the vaccine,
given their age, high levels of underlying medical conditions, and
congregate living situations make them high risk for severe illness
from COVID-19.
\150\ Kates, J, Michaud, J, Tolbert, J. ``How Are States
Prioritizing Who Will Get the COVID-19 Vaccine First?'' Kaiser
Family Foundation. December 14, 2020. Accessed on December 16 at
https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/.
\151\ Associated Press. `Healing is Coming:' US Health Workers
Start Getting Vaccine. December 15, 2020. Accessed on December 16
at: https://apnews.com/article/us-health-workers-coronavirus-vaccine-56df745388a9fc12ae93c6f9a0d0e81f.
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Frontline healthcare workers, such as those employed in hospitals,
have been prioritized for vaccination in most locations. There are
approximately 18 million healthcare workers in the U.S.\152\ A survey
of HCP found that 66 percent of hospital HCP and 64 percent of
outpatient clinic HCP reported receiving at least one dose of the
vaccine.\153\ As of July 2, 2021, the CDC reported that over 328
million doses of COVID-19 vaccine had been administered and
approximately 155.9 million people were fully vaccinated.\154\ The
White House indicated on April 6, 2021, that the U.S. retains
sufficient vaccine supply, and every adult became eligible to receive
the vaccine beginning April 19, 2021.\155\
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\152\ Centers for Disease Control and Prevention. Healthcare
Workers. (2017) Accessed February 18, 2021 at: https://www.cdc.gov/niosh/topics/healthcare/default.html.
\153\ KFF/The Washington Post Frontline Health Care Workers
Survey. (2021). Accessed June 2, 2021 at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-washington-post-health-care-workers/.
\154\ This information has been updated from the proposed rule
to reflect current data from the Centers for Disease Control and
Prevention. COVID Data Tracker. COVID-19 Vaccinations in the United
States. (2021). Available at: https://covid.cdc.gov/covid-data-tracker/#vaccinations.
\155\ The White House. Remarks by President Biden Marking the
150 Millionth COVID-19 Vaccine Shot. Accessed April 8, 2021 at:
https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/04/06/remarks-by-president-biden-marking-the-150-millionth-covid-19-vaccine-shot/.
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We believe it is important to require that hospital outpatient
departments (HOPDs) report HCP vaccination information for health care
facilities to assess whether these facilities are taking steps to limit
the spread of COVID-19 among their health care workers and to help
sustain the ability of HOPDs to continue serving their communities
throughout the PHE and beyond. Therefore, we are proposing to adopt a
new measure, COVID-19 Vaccination Coverage Among HCP, beginning with
the CY 2024 payment determination. For that payment year, hospitals
would be required to report data quarterly on the measure for the
January 2022 through December 2022 reporting period. The measure would
assess the proportion of a hospital's health care workforce that has
been vaccinated against COVID-19.
HCP are at risk of transmitting COVID-19 infection to patients,
experiencing illness or death as a result of COVID-19 themselves, and
[[Page 42240]]
transmitting it to their families, friends, and the general public. We
believe HOPDs should report the level of vaccination among their HCP as
part of their efforts to assess and reduce the risk of transmission of
COVID-19 within their facilities. HCP vaccination can reduce illness
that leads to work absence and limit disruptions to providing care
\156\ with major reductions in SARS-CoV-2 infections among those
receiving two dose COVID-19 vaccine despite a high community infection
rate.\157\ Data from influenza vaccination demonstrates that provider
vaccination is associated with that provider recommending vaccination
to patients,\158\ and we believe HCP COVID-19 vaccination in HOPDs
could similarly increase uptake among that patient population. We also
believe that publicly reporting the HCP vaccination rates would be
helpful to many patients, including those who are at high-risk for
developing serious complications from COVID-19, as they choose HOPDs
for treatment. Under CMS' Meaningful Measures Framework, the COVID-19
measure addresses the quality priority of ``Promote Effective
Prevention and Treatment of Chronic Disease'' through the Meaningful
Measures Area of ``Preventive Care.''
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\156\ Centers for Disease Control and Prevention. Overview of
Influenza Vaccination among Health Care Personnel. October 2020.
(2020) Accessed March 16, 2021 at: https://www.cdc.gov/flu/toolkit/long-term-care/why.htm.
\157\ Benenson S, Oster Y, Cohen MJ, Nir-Paz R. BNT162b2 mRNA
Covid-19 Vaccine Effectiveness among Health Care Workers. N Engl J
Med. 2021. See also: Keehner J, Horton LE, Pfeffer MA, Longhurst CA,
Schooley RT, Currier JS, et al. SARS-CoV-2 Infection after
Vaccination in Health Care Workers in California. N Engl J Med.
2021.
\158\ Measure Application Committee Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
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(2) Overview of Measure
The COVID-19 Vaccination Coverage Among HCP measure (``COVID-19 HCP
vaccination measure'') is a process measure developed by the CDC to
track COVID-19 vaccination coverage among HCP in non-LTC facilities
including outpatient hospitals.
(a) Measure Specifications
The denominator for the HCP measure is the number of HCP eligible
to work in the hospital for at least 1 day during the self-selected
week, excluding persons with contraindications to COVID-19 vaccination
that are described by the CDC.\159\
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\159\ Centers for Disease Control and Prevention.
Contraindications and precautions. (2021) Accessed March 15, 2021
at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Contraindications.
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The numerator for the HCP measure is the cumulative number of HCP
eligible to work in at the hospital for at least 1 day during the self-
selected week and who received a complete vaccination course against
COVID-19 using an FDA-authorized or FDA-approved vaccine for COVID-19
(whether the FDA issued an approval or EUA).\160\ A complete
vaccination course is defined under the specific FDA authorization and
may require multiple doses or regular revaccination.\161\ Vaccination
coverage for purposes of this measure is defined as the estimated
percentage (given the potential for week-to-week variation) of HCP
eligible to work at the hospital for at least 1 day who received a
COVID-19 vaccine. Acute care facilities would count HCP working in all
inpatient or outpatient units that are physically attached to the
inpatient acute care facility site and share the same CMS certification
number (CCN), regardless of the size or type of unit. Facilities would
also count HCP working in inpatient and outpatient departments that are
affiliated with the specific acute care facility (such as sharing
medical privileges or patients), regardless of distance from the acute
care facility and also share the same CCN. The decision to include or
exclude HCP from the acute care facility's HCP vaccination counts would
be based on whether individuals meet the specified National Healthcare
Safety Network (NHSN) criteria and are physically working in a location
that is considered any part of the on-site acute care facility that is
being monitored.\162\ The proposed specifications for the COVID-19
vaccination coverage among HCP measure is available on the NQF website
at: https://www.cdc.gov/nhsn/nqf/index.html.\163\
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\160\ Measure Application Partnership Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
\161\ Measure Application Partnership Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
\162\ Centers for Disease Control and Prevention. CMS Reporting
Requirements FAQs. Accessed June 2, 2021 at: https://www.cdc.gov/nhsn/PDFs/CMS/faq/FAQs-CMS-Reporting-Requirements.pdf.
\163\ https://www.cdc.gov/nhsn/nqf/index.html.
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(b) Review by the Measure Applications Partnership
The COVID-19 HCP vaccination measure was included on the publicly
available ``List of Measures Under Consideration for December 21,
2020,'' \164\ a list of measures under consideration for use in various
Medicare programs. The Measure Applications Partnership (MAP) hospital
workgroup convened on January 11, 2021, and it reviewed the list of
Measures Under Consideration (MUC) including the COVID-19 HCP
vaccination measure. The MAP hospital workgroup agreed that the
proposed measure represents a promising effort to advance measurement
for an evolving national pandemic and that it could bring value to the
Hospital OQR Program measure set by providing transparency about an
important COVID-19 intervention to help prevent infections in HCP and
patients.\165\ The MAP hospital workgroup also stated in its
preliminary recommendations that collecting information on COVID-19
vaccination coverage among HCP and providing feedback to hospitals
would allow hospitals to benchmark coverage rates and improve coverage
in their facility, and that reducing COVID-19 infection rates in HCP
may reduce transmission among patients and reduce instances of staff
shortages due to illness.\166\
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\164\ The National Quality Forum. (2021) Accessed March 14, 2021
at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94212.
\165\ Measure Applications Partnership. MAP Preliminary
Recommendations 2020-2021. Accessed on January 24, 2021 at: http://www.qualityforum.org/Project_Pages/MAP_Hospital_Workgroup.aspx.
\166\ Ibid.
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In its preliminary recommendations, the MAP hospital workgroup did
not support this measure for rulemaking, subject to the potential for
mitigation.\167\ To mitigate its concerns, the MAP hospital workgroup
believed that the measure needed well-documented evidence, finalized
specifications, testing, and National Quality Forum (NQF) endorsement
prior to implementation.\168\ Subsequently, the MAP Coordinating
Committee met on January 25, 2021, and reviewed the COVID-19 HCP
vaccination measure. In the 2020-2021 MAP Final Recommendations, the
MAP offered conditional support for rulemaking contingent on CMS
bringing the measure back to MAP once the specifications were further
refined. The MAP specifically stated, ``the incomplete specifications
require immediate mitigation and further development should continue.''
\169\ In its
[[Page 42241]]
final report, the MAP noted that the measure would add value by
providing visibility into an important intervention to limit COVID-19
infections in HCP and the patients for whom they provide care.\170\ The
spreadsheet of final recommendations no longer cited concerns regarding
evidence, testing, or NQF endorsement.\171\ In response to the MAP
final recommendation request that CMS bring the measure back to the MAP
once the specifications are further refined, CMS and the CDC met with
the MAP Coordinating Committee on March 15, 2021. Additional
information was provided to address vaccine availability, alignment of
the COVID-19 HCP vaccination measure as closely as possible with the
data collection for the Influenza HCP vaccination measure (NQF #0431),
and clarification related to how HCP are defined. CMS and the CDC also
presented preliminary findings from the testing of the numerator of the
COVID-19 HCP vaccination measure, which is currently in process. These
preliminary findings show numerator data should be feasible to collect
and reliable. Testing of the measure numerator (the number of HCP
vaccinated) involves a comparison of the data collected through the
NHSN and independently reported through the Federal pharmacy
partnership program for delivering vaccination to LTC facilities. These
are two completely independent data collection systems. In initial
analyses of the first month of vaccination, the number of healthcare
workers vaccinated in approximately 1,200 facilities for which data
from both systems was available, the number of healthcare personnel
vaccinated was highly correlated between the two systems with a
correlation coefficient of nearly 90 percent in the second two weeks of
reporting.\172\ Because of the high correlation across a large number
of facilities and high number of HCP within those facilities receiving
at least one dose of the COVID-19 vaccine, we believe the measure is
feasible and reliable for use in HOPDs. After reviewing this additional
information, the MAP retained its final recommendation of conditional
support, and expressed support for CMS' efforts to use the measure as
part of the solution for the COVID-19 public health crisis.\173\
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\167\ Ibid.
\168\ Ibid.
\169\ Measure Applications Partnership. 2020-2021 MAP Final
Recommendations. Accessed on February 23, 2021 at: http://www.qualityforum.org/Project_Pages/MAP_Hospital_Workgroup.aspx.
\170\ Ibid.
\171\ Ibid.
\172\ For more information on testing results and other measure
updates, please see the Meeting Materials (including Agenda,
Recording, Presentation Slides, Summary, and Transcript) of the
March 15, 2021 meeting available at https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75367.
\173\ Ibid.
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Section 1890A(a)(4) of the Act, as added by section 3014(b) of the
Affordable Care Act, requires the Secretary to take into consideration
input from multi-stakeholder groups in selecting certain quality and
efficiency measures. While we value input from the MAP, we believe it
is important to propose the measure as quickly as possible to address
the urgency of the COVID-19 PHE and its impact on high risk
populations, including hospitals. CMS continues to engage with the MAP
to mitigate concerns and appreciates the MAP's conditional support for
the measure.
(c) Measure Endorsement
Under section 1833(t)(17)(C)(i) of the Act, unless the exception of
subclause (ii) applies, measures selected for the quality reporting
program must have been set forth by the entity with a contract under
section 1890(a) of the Act. The NQF currently holds this contract.
Under section 1833(t)(17)(C)(ii) of the Act, in the case of a specified
area or medical topic determined appropriate by the Secretary for which
a feasible and practical measure has not been endorsed by the entity
with a contract under section 1890(a) of the Act, the Secretary may
specify a measure that is not so endorsed as long as due consideration
is given to measures that have been endorsed or adopted by a consensus
organization identified by the Secretary.
In general, we prefer to adopt measures that have been endorsed by
the NQF because it is a national multi-stakeholder organization with a
well-documented and rigorous approach to consensus development.
However, as we have noted in previous rulemaking (for example, 75 FR
72065 and 76 FR 74494 for the Hospital OQR and ASCQR Programs,
respectively), the requirement that measures reflect consensus among
affected parties can be achieved in other ways, including through the
measure development process, through broad acceptance, use of the
measure(s), and through public comment.
The proposed COVID-19 HCP vaccination measure is not NQF endorsed
and has not been submitted to NQF for endorsement consideration. We
will consider the potential for future NQF endorsement as part of its
ongoing work with the MAP.
Because this measure is not NQF-endorsed, we considered whether
there are other available measures that assess COVID-19 vaccination
rates among HCP. We found no other feasible and practical measures on
the topic of COVID-19 vaccination among HCP.
(d) Data Collection, Submission, and Reporting
Given the time sensitive nature of this measure considering the
current PHE, we are proposing that hospitals would be required to begin
reporting data on the proposed COVID-19 HCP vaccination measure
beginning January 1, 2022, for the CY 2024 payment determination for
the Hospital OQR Program. Thereafter, we propose quarterly reporting
periods. While we considered annual reporting periods for the Hospital
OQR Program, we are proposing quarterly reporting periods given the
immediacy of the PHE and the importance of alignment across quality
payment programs proposing this measure.
If our proposal to adopt this measure is finalized, hospitals would
report the measure through the CDC's NHSN web-based surveillance
system.\174\ While the Hospital OQR Program does not currently require
use of the NHSN web-based surveillance system, we have previously
required use of this system for submitting data. We refer readers to
the CY 2014 OPPS/ASC final rule with comment period in which we adopted
the Influenza Vaccination Coverage Among Health Care Personnel (NQF
#0431) measure (78 FR 75096 through 75099) and section XV.D.5.b.(1). of
this proposed rule for additional information on reporting through the
NHSN web-based surveillance system under the Hospital OQR Program.
Hospitals also have experience reporting acute care hospital measures
to the CDC's NHSN under the Hospital IQR Program.
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\174\ Centers for Disease Control and Prevention. Surveillance
for Weekly HCP COVID-19 Vaccination. Accessed at: https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html on February 10,
2021.
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To report this measure, we are proposing that hospitals would
collect the numerator and denominator for the COVID-19 HCP vaccination
measure for at least one, self-selected week during each month of the
reporting quarter and submit the data to the NHSN Healthcare Personal
Safety (HPS) Component before the quarterly deadline to meet Hospital
OQR Program requirements. While we believe that it would be ideal to
have HCP vaccination data for every week of each month, we are mindful
of the time and resources that hospitals would need to report the data.
Thus, in collaboration with the CDC, we determined that data from at
least one week of each month would be sufficient to obtain a reliable
snapshot of vaccination levels among a hospital's
[[Page 42242]]
HCP while balancing the costs of reporting. If a hospital submits more
than one week of data in a month, the most recent week's data would be
used to calculate the measure. For example, if first and third week
data are submitted, third week data would be used. If first, second,
and fourth week data are submitted, fourth week data would be used.
Each quarter, we are proposing that the CDC would calculate a single
quarterly COVID-19 HCP vaccination coverage rate for each hospital,
which would be calculated by taking the average of the data from the
three submission periods submitted by the hospital for that quarter. If
finalized, CMS would publicly report each quarterly COVID-19 HCP
vaccination coverage rate as calculated by the CDC.
Hospitals would submit the number of HCP eligible to have worked at
the facility during the self-selected week that the hospital reports
data in NHSN (denominator) and the number of those HCP who have
received a complete course of a COVID-19 vaccination (numerator) during
the same self-selected week. As previously stated, acute care
facilities would count HCP working in all inpatient or outpatient units
that share the same CCN, regardless of the size or type of unit.\175\
---------------------------------------------------------------------------
\175\ Ibid.
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We invite public comment on our proposal.
b. Proposal To Adopt the Breast Screening Recall Rates Measure
Beginning With the CY 2023 Payment Determination
(1) Background
Performing breast imaging in the outpatient setting facilitates
early detection of malignancies.\176\ However, performing diagnostic
mammography or digital breast tomosynthesis (DBT) as a result of a
false-positive screening study or other errant data has the potential
to expose women to unnecessary follow-up.\177\ This could result in
increased prevalence of radiation-induced cancers in younger women,
including those carrying related gene mutations, such as BRCA-1 and
BRCA-2 178 179 or additional imaging and biopsies, which
could lead to unnecessary procedures for women who do not have breast
cancer.180 181 In contrast, recalling too few women for
follow-up imaging may lead to delayed diagnoses, higher stages at
diagnosis, and/or undetected cases of breast cancer.\182\ Given the
potential negative consequences associated with too many or too few
diagnostic mammography and DBT studies performed within the population,
evidence from the clinical literature suggests appropriate recall rates
should fall between 5 to 12 percent.183 184
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\176\ Coleman, C. (2017). Early detection and screening for
breast cancer. Seminars in Oncology Nursing, 33(2), 141-155. http://dx.doi.org/10.1016/j.soncn.2017.02.009.
\177\ Bernardi D., Li T., Pellegrini M., Macaskill, P.,
Valentini, M., Fanto, C., Ostillo, L., & Houssami, N. (2018). Effect
of integrating digital breast tomosynthesis (3D-mammography) with
acquired or synthetic 2D-mammography on radiologists' true positive
and false-positive detection in a population screening trial: A
descriptive study. European Journal of Radiology, 106, 26-31.
\178\ Berrington de Gonzalez, A., Berg, C.D., Visvanathan, K., &
Robson, M. (2009). Estimated risk of radiation-induced breast cancer
from mammographic screening for young BRCA mutation carriers.
Journal of the National Cancer Institute, 101(3), 205-209. https://doi.org/10.1093/jnci/djn440.
\179\ Miglioretti, D.L., Lange, J., van den Broek, J. J., Lee,
C.I., van Ravesteyn, N.T., Ritley, D., Kerlikowske, K., Fenton,
J.J., Melnikow, J., de Koning, H.J., & Hubbard, R.A. (2016).
Radiation-induced breast cancer incidence and mortality from digital
mammography screening: a modeling study. Annals of internal
medicine, 164(4), 205-214. https://doi.org/10.7326/M15-1241.
\180\ Long, H., Brooks, J.M., Harvie, M., Maxwell, A., & French,
D.P. (2019). How do women experience a false-positive test result
from breast screening? A systematic review and thematic synthesis of
qualitative studies. British journal of cancer, 121(4), 351-358.
https://doi.org/10.1038/s41416-019-0524-4.
\181\ Nelson, H.D., Pappas, M., Cantor, A., Griffin, J., Daeges,
M., & Humphrey, L. (2016). Harms of breast cancer screening:
systematic review to update the 2009 U.S. preventive services task
force recommendation. Annals of internal medicine, 164(4), 256-267.
https://doi.org/10.7326/M15-0970.
\182\ Nelson, H.D., Tyne, K., Naik, A., Bougatsos, C., Chan,
B.K., & Humphrey, L. (2009). Screening for breast cancer: Systematic
evidence review update for the U.S. Preventive Services Task Force.
Ann Intern Med, 151(10):727-W242.
\183\ Carney, P.A., Sickles, E. A., Monsees, B.S., Bassett,
L.W., Brenner, R.J., Feig, S.A., Smith, R.A., Rosenberg, R.D.,
Bogart, T.A., Browning, S., Barry, J.W., Kelly, M.M., Tran, K.A., &
Miglioretti, D.L. (2010). Identifying minimally acceptable
interpretive performance criteria for screening mammography.
Radiology, 255(2), 354-361. https://pubmed.ncbi.nlm.nih.gov/20413750/.
\184\ D'Orsi, C.J., Sickles, E.A., Mendelson, E.B., Morris E.A.,
et al. (2013). ACR BI-RADS[supreg] atlas, breast imaging reporting
and data system. Reston, VA: American College of Radiology.
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To address the health and clinical risks associated with too many
or too few breast screening recalls, we are proposing to adopt the
Breast Screening Recall Rates measure beginning with the CY 2023
payment determination using a data collection period of July 1, 2020,
to June 30, 2021, and then data collection periods from July 1 through
June 30 of the following year starting 3 years before the applicable
payment calendar year for subsequent years. We intend for this measure
to move facilities toward the 5 to 12 percent range of recall rates.
Facilities that are above or below the range should consider
implementation of internal quality-improvement procedures to ensure
they are not missing cases or recalling individuals unnecessarily. This
measure would fill the gap in women's health and oncology care that was
left in the Hospital OQR Program portfolio following the removal of the
Mammography Follow Up Rates measure (OP-9).\185\ More specifically,
this measure would directly address the reason OP-9 was removed from
the Hospital OQR Program by bringing the measure into alignment with
current clinical practice and emerging scientific evidence through the
addition of screening and diagnostic DBT (83 FR
59096).186 187 188 189 190 191 192 193 The Breast Screening
Recall Rates measure would be added to a measure set focused on imaging
efficiency. While this measure, as currently specified, would not
provide data on outcomes (that is, the number of patients who were
recalled and subsequently diagnosed with cancer), it would give
[[Page 42243]]
facilities information to use in examining their own imaging practices.
Results from the measure could be used to identify opportunities for
improving the efficiency and quality of care provided and would be
added to a measure set focused on imaging efficiency.
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\185\ CMS finalized OP-9 for removal from the Hospital OQR
Program in the CY 2019 Outpatient Payment Prospective System and
Ambulatory Surgical Center Payment System final rule (CMS-1695-FC)
(83 FR 58818).
\186\ Aase, H.S., Holen, A.S., Pedersen, K., Houssami, N.,
Haldorsen, I.S., Sebuodegard, S., & Hofvind, S. (2019). A randomized
controlled trial of digital breast tomosynthesis versus digital
mammography in population-based screening in Bergen: Interim
analysis of performance indicators from the To-Be trial. 29(3),
1175-1186. doi: 10.1007/s00330-018-5690-x.
\187\ Aujero, M.P., Gavenonis, S.C., Benjamin, R., Zhang, Z., &
Holt, J.S. (2017). Clinical performance of synthesized two-
dimensional mammography combined with tomosynthesis in a large
screening population. Radiology, 283(1), 70-76. doi: 10.1148/
radiol.2017162674.
\188\ Bian, T., Lin, Q., Cui, C., Li, L., Qi, C., Fei, J., & Su,
X. (2016). Digital breast tomosynthesis: A new diagnostic method for
mass-like lesions in dense breasts. Breast J, 22(5), 535-540. doi:
10.1111/tbj.12622.
\189\ Caumo, F., Zorzi, M., Brunelli, S., Romanucci, G., Rella,
R., Cugola, L., Bricolo, P., Fedato, C., Montemezzi, S., & Houssami,
N. (2018). Digital breast tomosynthesis with synthesized two-
dimensional images versus full-field digital mammography for
population screening: Outcomes from the Verona screening program.
Radiology, 287(1), 37-46. https://doi.org/10.1148/radiol.2017170745.
\190\ Conant, E.F., Beaber, E.F., Sprague, B.L., Herschorn,
S.D., Weaver, D.L., Onega, T., . . . Barlow, W.E. (2016). Breast
cancer screening using tomosynthesis in combination with digital
mammography compared to digital mammography alone: A cohort study
within the PROSPR consortium. Breast Cancer Res Treat, 156(1), 109-
116. doi: 10.1007/s10549-016-3695-1.
\191\ Pattacini, P., Nitrosi, A., & Giorgi Rossi, P. (2018).
Digital mammography versus digital mammography plus tomosynthesis
for breast cancer screening: The Reggio Emilia tomosynthesis
randomized trial. 288(2), 375-385. doi: 10.1148/radiol.2018172119.
\192\ Pozz, A., Corte, A.D., Lakis, M.A., & Jeong, H. (2016).
Digital breast tomosynthesis in addition to conventional 2D
mammography reduces recall rates and is cost effective. Asian Pac J
Cancer Prev, 17(7), 3521-3526.
\193\ Skaane, P. (2017). Breast cancer screening with digital
breast tomosynthesis. Breast Cancer, 24(1), 32-41. doi: 10.1007/
s12282-016-0699-y.
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(2) Overview of Measure
This claims-based process measure documents breast screening recall
rates at the facility level. The Breast Screening Recall Rates measure
would calculate the percentage of Medicare fee-for-service (FFS)
beneficiaries for whom a traditional mammography or DBT screening study
was performed that was then followed by a diagnostic mammography, DBT,
ultrasound of the breast, or magnetic resonance imaging (MRI) of the
breast in an outpatient or office setting on the same day or within 45
calendar days of the index image. In assessing this measure based on
clinical quality and efficiency, there are potential negative
consequences of high and low mammography and DBT recall rates. A
middle-range number is the ideal value for this measure. A high
cumulative dose of low-energy radiation can be a consequence of too
many false-positive mammography and DBT recall studies. Alternatively,
inappropriately low recall rates may lead to delayed diagnoses or
undetected cases of breast cancer. The inclusion of DBT in evaluating
recall care may improve recall rates and positive predictive values
compared to metrics that focus solely on mammography.
Although this measure is not based on a specific clinical
guidelines, expert clinical consensus and support from publications in
the peer-reviewed literature emphasize the importance of appropriate
recall rates.194 195 The adoption of this measure could
potentially fill a gap in breast screening measures for the Hospital
OQR Program. This measure would address the Meaningful Measure priority
area of ``Making Care Safer.'' The measure addresses this Meaningful
Measure area by: (1) Promoting appropriate use of breast cancer
screening and diagnostic imaging by encouraging facilities to aim for a
performance score within the target recall range; (2) reducing the
harms associated with too many recalls, which can lead to unnecessary
radiation exposure, anxiety and distress, and increased costs or
resource utilization; 196 197 and (3) addressing the issue
of inappropriately low recall rates, which may lead to delayed
diagnoses, diagnoses at a later stage, or undetected cases of breast
cancer.\198\
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\194\ Nelson, H.D., Tyne, K., Naik, A., Bougatsos, C., Chan,
B.K., & Humphrey, L. (2009). Screening for breast cancer: Systematic
evidence review update for the U.S. Preventive Services Task Force.
Ann Intern Med, 151(10):727-W242.
\195\ D'Orsi, C.J., Sickles, E.A., Mendelson, E.B., Morris EA,
et al. (2013). ACR BI-RADS[supreg] atlas, breast imaging reporting
and data system. Reston, VA: American College of Radiology.
\196\ Long, H., Brooks, J.M., Harvie, M., Maxwell, A., & French,
D.P. (2019). How do women experience a false-positive test result
from breast screening? A systematic review and thematic synthesis of
qualitative studies. British journal of cancer, 121(4), 351-358.
https://doi.org/10.1038/s41416-019-0524-4.
\197\ Nelson, H.D., Pappas, M., Cantor, A., Griffin, J., Daeges,
M., & Humphrey, L. (2016). Harms of breast cancer screening:
Systematic review to update the 2009 U.S. preventive services task
force recommendation. Annals of internal medicine, 164(4), 256-267.
https://doi.org/10.7326/M15-0970.
\198\ Nelson, H.D., Tyne, K., Naik, A., Bougatsos, C., Chan,
B.K., & Humphrey, L. (2009). Screening for breast cancer: Systematic
evidence review update for the U.S. Preventive Services Task Force.
Ann Intern Med, 151(10):727-W242.
---------------------------------------------------------------------------
The measure was included on the publicly available ``List of
Measures Under Consideration for December 21, 2020,'' a list of
measures under consideration for use in various Medicare programs.\199\
In January 2021, the Breast Screening Recall Rates measure was reviewed
by both the MAP's rural health workgroup and hospital workgroup,
overseen by the Coordinating Committee (MUC20-0005).\200\ Both groups
and the Coordinating Committee voted to conditionally support the
measure, pending NQF endorsement.\201\ Concerns cited during the
January 2021 MAP review included: (1) The proposed recall range is not
based on clinical practice guidelines, but rather expert consensus and
synthesis of findings from the scientific literature; (2) use of a
range (as opposed to a targeted high or low value) may be difficult for
clinicians, patients, and other stakeholders to interpret; (3) the
measure does not address social determinants of health, which may
impact the rate of recall at some facilities; and (4) the measure does
not provide complementary information about patient outcomes (for
example, breast cancer detection rate), which could aid in the
interpretation and usefulness of the measure's data.\202\ Despite these
concerns, some members of the rural health workgroup, hospital
workgroup, and Coordinating Committee expressed support of the Breast
Screening Recall Rates measure and noted that feedback provided by the
MAP did not preclude measure implementation, given its importance to
the clinical community and the public.\203\ As a part of measure
implementation, we would develop a suite of education and outreach
materials to aid stakeholders in the interpretation of measure
performance data. These materials would explain the measure structure
(including use of a range representing ideal performance) to ensure
stakeholders understand values within and outside of the target range.
Once implemented, the measure would be re-evaluated annually, which
would include a consideration of changes to the evidence base and
potential integration of social determinants of health (that is,
stratification or risk adjustment); updates to the measure
specifications would be made iteratively, as appropriate, on an annual
basis.
---------------------------------------------------------------------------
\199\ The National Quality Forum. ``List of Measures Under
Consideration for December 21, 2020''. (2020) Accessed May 14, 2021.
Available at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94212.
\200\ The National Quality Forum. ``List of Measures Under
Consideration for December 21, 2020''. (2020) Accessed May 14, 2021
at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94212.
\201\ Measure Applications Partnership. 2020-2021 Measure
Applications Partnership. 2020-2021 Considerations for Implementing
Measures Final Report--Clinicians, Hospitals, and PAC-LTC. Accessed
on May 14, 2021 at: https://www.qualityforum.org/Publications/2021/03/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report_-_Clinicians,_Hospitals,_and_PAC-LTC.aspx.
\202\ Measure Application Partnership Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
\203\ Measure Applications Partnership. 2020-2021 Measure
Applications Partnership. 2020-2021 Considerations for Implementing
Measures Final Report--Clinicians, Hospitals, and PAC-LTC. Accessed
on May 14, 2021 at: https://www.qualityforum.org/Publications/2021/03/MAP_2020-2021_Considerations_for_Implementing_Measures_Final_Report_-_Clinicians,_Hospitals,_and_PAC-LTC.aspx.
---------------------------------------------------------------------------
Section 1833(t)(17)(C)(i) of the Act authorizes the Secretary to
specify a measure for addition to a program that is not endorsed by the
NQF, as long as due consideration is given to other measures that have
been endorsed or adopted by a consensus organization (for example,
NQF). We have reviewed those NQF-endorsed measures that are related to
breast imaging and have not identified any that focus on recall rates
specifically. As such, we are proposing to adopt this measure for use
in the Hospital OQR Program because of its importance to women's health
and its ability to fill a gap in CMS' Meaningful Measure portfolio even
though it has not yet been reviewed by NQF. Submission for NQF
endorsement would be considered for this measure in the future.
[[Page 42244]]
(3) Measure Calculation
This claims-based process measure documents breast screening recall
rates at the facility level. The Breast Screening Recall Rates measure
would calculate the percentage of Medicare FFS beneficiaries for whom a
traditional mammography or DBT screening study was performed that was
then followed by a diagnostic mammography, DBT, ultrasound of the
breast, or MRI of the breast in an outpatient or office setting on the
same day or within 45 days of the index image. Specifically, the
measure denominator includes Medicare FFS beneficiaries who received a
screening mammography or DBT study at a facility paid under the OPPS.
The numerator consists of individuals from the denominator who had a
diagnostic mammography study, DBT, ultrasound of the breast, or MRI of
the breast following a screening mammography or DBT study on the same
day or within 45 days of the screening study. The Breast Screening
Recall Rates measure does not have any exclusions. This measure is not
risk adjusted. As a process-of-care measure, the decision to image a
beneficiary should not be influenced by sociodemographic status
factors; rather, risk adjustment for such sociodemographic factors
could potentially mask important inequities in care delivery for
beneficiaries seen at facilities providing data for this measure. If
performance scores for this measure vary across populations, this may
be reflective of differences in the quality of care provided to the
diverse populations included in the measure's denominator.
Although this measure is not based on a specific clinical
guideline, expert clinical consensus and support from the peer-reviewed
literature emphasize the importance of appropriate recall rates.\204\
We refer readers to the QualityNet website at http://www.QualityNet.cms.gov for the full measure specifications.
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\204\ Nelson, H.D., Tyne, K., Naik, A., Bougatsos, C., Chan,
B.K., & Humphrey, L. (2009). Screening for breast cancer: Systematic
evidence review update for the U.S. Preventive Services Task Force.
Ann Intern Med, 151(10):727-W242.
---------------------------------------------------------------------------
(4) Data Sources
The Breast Screening Recall Rates measure would be calculated using
data from final claims that facilities submit for Medicare
beneficiaries enrolled in Medicare FFS. As such, facilities would not
have to submit any additional data for this measure. The measurement
period for the Breast Screening Recall Rates measure is 12 months. As
noted previously, we would use final claims data from July 1, 2020 to
June 30, 2021 to calculate the measure for the CY 2023 payment
determination and then data collection periods from July 1 through June
30 of the following year starting 3 years before the applicable payment
calendar year for subsequent years. Please note that claims for the
initial patient population would be identified from July 1 through May
17 of each year, with numerator cases occurring from July 1 through
June 30 annually. The data would be calculated only for facilities paid
under the OPPS for mammography and DBT screening in the hospital
outpatient setting. Data from the hospital outpatient and carrier files
would be used to determine beneficiary inclusion (for example, a
mammography follow-up study can occur in any location and be eligible
for inclusion in the measure's numerator).
We invite public comment on our proposal.
c. Proposal To Adopt the ST-Segment Elevation Myocardial Infarction
(STEMI) eCQM Beginning With Voluntary Reporting for the CY 2023
Reporting Period and Mandatory for the CY 2024 Reporting Period/CY 2026
Payment Determination and Subsequent Years
(1) Background
An ST-segment elevation myocardial infarction (STEMI) is a form of
heart attack in which there is a complete occlusion of one of the heart
arteries.\205\ Each year over 250,000 Americans experience a STEMI,
approximately 50 percent of whom are Medicare
beneficiaries.206 207 This is represented on the
electrocardiogram as an elevation of the ST segment--the interval
between ventricular depolarization and repolarization (which represents
the duration of an average ventricular contraction).\208\ Time is of
the essence in STEMI treatment, and the prompt identification of STEMI
and restoration of blood flow to the heart (reperfusion therapy) is a
key determinant of health outcomes.209 210 211 Primary
percutaneous coronary intervention (PCI), which is the use of balloons
and stents to restore blood flow, is the preferred reperfusion
modality.\212\ The 2013 American College of Cardiology Foundation
(ACCF)/American Heart Association (AHA) guidelines recommend the
initiation of PCI within 120 minutes from first medical contact
(FMC).\213\ Specifically, if a patient presents to a PCI-capable
facility, primary PCI is recommended within 90 minutes of FMC.\214\ If
a patient presents to a non-PCI-capable facility, the patient should be
expeditiously transported to a PCI-capable facility and receive PCI
within a total of 120 minutes.\215\ However, in care settings where it
is not possible for a patient to receive PCI or be transferred and
receive primary PCI within the 120-minute timeframe, fibrinolytic
therapy (medications to dissolve blood clots and restore flow) should
be administered rapidly for reperfusion in the absence of
contraindications.\216\ The guidelines recommend that eligible patients
should receive fibrinolytic therapy within 30 minutes of hospital
arrival.
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\205\ Anderson JL, Morrow DA. Acute Myocardial Infarction. New
England Journal of Medicine. 2017;376(21):2053-2064.
\206\ Ward et al. Incidence of Emergency Department Visits for
ST-Elevation Myocardial Infarction in a Recent 6-Year Period in the
United States. Am J Cardiol. 2015 Jan 15; 115(2): 167-170.
\207\ Vallabhajosyula S, Kumar V, Sundaragiri PR, et al.
Influence of primary payer status on the management and outcomes of
ST-segment elevation myocardial infarction in the United States.
PLoS One. 2020;15(12):e0243810.
\208\ Vogel B, Claessen BE, Arnold SV, Chan D, Cohen DJ,
Giannitsis E, Gibson CM, Goto S, Katus HA, Kerneis M, Kimura T,
Kunadian V, Pinto DS, Shiomi H, Spertus JA, Steg PG, Mehran R. ST-
segment elevation myocardial infarction. (2019). Nature Reviews
Disease Primers, 5(39). Available at https://doi.org/10.1038/s41572-019-0090-3.
\209\ Boersma E, Maas AC, Deckers JW, Simoons ML. Early
thrombolytic treatment in acute myocardial infarction: reappraisal
of the golden hour. Lancet. 1996;348(9030):771-775.
\210\ Cannon CP, Gibson CM, Lambrew CT, et al. Relationship of
symptom-onset-to-balloon time and door-to-balloon time with
mortality in patients undergoing angioplasty for acute myocardial
infarction. Jama. 2000;283(22):2941-2947.
\211\ McNamara RL, Wang Y, Herrin J, et al. Effect of door-to-
balloon time on mortality in patients with ST-segment elevation
myocardial infarction. J Am Coll Cardiol. 2006;47(11):2180-2186.
\212\ Anderson JL, Morrow DA. Acute Myocardial Infarction. New
England Journal of Medicine. 2017;376(21):2053-2064.
\213\ O'Gara P, Kushner F, Ascheim D, Casey D, Chung M, de Lemos
J, Ettinger S, Fang J, Fesmire F, Franklin B, Granger C, Krumholz H,
Linderbaum J, Morrow D, Newby L, Ornato J, Ou N, Radford M, Tamis-
Holland J, Tommaso C, Tracy C, Woo Y, Zhao D, Anderson J, Jacobs A,
Halperin J, Albert N, Brindis R, Creager M, DeMets D, Guyton R,
Hochman J, Kovacs R, Kushner F, Ohman E, Stevenson W, Yancy C.
(2013). 2013 ACCF/AHA guideline for the management of ST-elevation
myocardial infarction: a report of the American College of
Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines. Circulation, 127(4): e362-425. Available at
https://www.ncbi.nlm.nih.gov/pubmed/23247304.
\214\ Ibid.
\215\ Ibid.
\216\ Ibid.
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(2) Overview of Measure
The STEMI eCQM measures the percentage of ED patients with a
diagnosis of STEMI who received timely delivery of guideline-based
reperfusion therapies appropriate for the care setting and delivered in
the absence of contraindications. The Meaningful Measures Framework
aims to address
[[Page 42245]]
issues that are most vital to delivering quality, value-based care to
improve patient outcomes.\217\ In alignment with the Meaningful
Measures quality priority of promoting effective prevention and
treatment of chronic disease, we believe this STEMI eCQM encourages
timely, effective and appropriate treatment using clinical data
available in certified electronic health record technology (CEHRT) and
that this measure has the potential to reduce adverse health outcomes.
---------------------------------------------------------------------------
\217\ Meaningful Measures 2.0: Moving from Measure Reduction to
Modernization. Available at: https://www.cms.gov/meaningful-measures-20-moving-measure-reduction-modernization.
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The measure was included on the publicly available ``List of
Measures Under Consideration for December 21, 2020,'' a list of
measures under consideration for use in various Medicare programs.\218\
In January 2021, the STEMI eCQM was reviewed by the MAP's rural health
workgroup, hospital workgroup, and Coordinating Committee (MUC20-
0004).\219\ The MAP rural health workgroup conducted discussion
regarding the appropriate treatment time for STEMI and how this may be
impacted in rural settings due to proximity and transportation issues,
especially with getting someone to a PCI-capable facility, and
supported the STEMI eCQM for rural providers in the Hospital OQR
Program.\220\ The MAP voted to conditionally support the measure,
pending NQF endorsement.\221\ We note that on-site facilities can
perform a PCI (if they have the capability to do so), use fibrinolysis,
or they can transfer a patient to a facility that provides PCI. These
three treatment scenarios are all captured by the measure, including
relative treatment times (non-transfer patients receiving PCI at a PCI-
capable facility within 90 minutes of arrival and patients transferred
from a non-PCI-capable to a PCI-capable facility within 45 minutes).
---------------------------------------------------------------------------
\218\ The National Quality Forum. (2021). List of Measures under
Consideration for December 21, 2020. Accessed March 14, 2021 at:
https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94212.
\219\ The National Quality Forum. (2021). Meeting Summary
Measure Applications Partnership Rural Health Workgroup Virtual
Review Meeting. Accessed on May 17, 2021 at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94656.
\220\ The National Quality Forum. (2021). Measure Applications
Partnership 2020-2021. Considerations for Implementing Measures in
Federal Programs: Clinician, Hospital & PAC/LTC. Accessed on May 17,
2021 at: https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94893.
\221\ Ibid.
---------------------------------------------------------------------------
Section 1833(t)(17)(C)(i) of the Act requires the Secretary to
develop measures appropriate for the measurement of the quality of care
(including medication errors) furnished by hospitals in outpatient
settings, that these measures reflect consensus among affected parties
and, to the extent feasible and practicable, that these measures
include measures set forth by one or more national consensus building
entities (for example, NQF). We also note that section 1833(t)(17) of
the Act does not require that each measure we adopt for the Hospital
OQR Program be endorsed by a national consensus building entity. We
have reviewed and identified two related NQF-endorsed chart-abstracted
measures--OP-2 (Fibrinolytic Therapy Received within 30 Minutes of ED
Arrival) and OP-3 (Median Time to Transfer to Another Facility for
Acute Coronary Intervention).
In section XV.B.3.c. of this proposed rule, we are proposing to
remove these two related chart-abstracted measures--OP-2 (Fibrinolytic
Therapy Received within 30 Minutes of ED Arrival) and OP-3 (Median Time
to Transfer to Another Facility for Acute Coronary Intervention)--and
replace them with this eCQM. The use of the STEMI eCQM measure, in lieu
of the OP-2 and OP-3 measures, would eliminate the need for manual
chart-abstraction. It would also broaden the group of measured STEMI
patients including patients who present to and receive primary PCI at a
PCI-capable facility, which is the vast majority of STEMI patients,
instead of only including patients presenting to non-PCI-capable
facilities and receiving either fibrinolytics or being transferred to a
PCI-capable facility. The STEMI eCQM better supports compliance with
the full group of STEMI patients covered in the 2013 ACCF and AHA
guidelines for the management of STEMI by measuring timeliness and
appropriateness of care for STEMI patients in the ED.\222\ We believe
that the STEMI eCQM would efficiently and comprehensively measure
timeliness of STEMI care by reducing the burden on facilities currently
reporting these two chart-abstracted measures, broadening the STEMI
population for which performance scores could be publicly reported, and
incorporating contraindications to enhance the clinical applicability
of the measure. We refer readers to section XV.B.3.c. of this proposed
rule for further discussion on our proposal to remove the OP-2 and OP-3
measures from the Hospital OQR Program.
---------------------------------------------------------------------------
\222\ O'Gara P, Kushner F, Ascheim D, Casey D, Chung M, de Lemos
J, Ettinger S, Fang J, Fesmire F, Franklin B, Granger C, Krumholz H,
Linderbaum J, Morrow D, Newby L, Ornato J, Ou N, Radford M, Tamis-
Holland J, Tommaso C, Tracy C, Woo Y, Zhao D, Anderson J, Jacobs A,
Halperin J, Albert N, Brindis R, Creager M, DeMets D, Guyton R,
Hochman J, Kovacs R, Kushner F, Ohman E, Stevenson W, Yancy C.
(2013). 2013 ACCF/AHA guideline for the management of ST-elevation
myocardial infarction: a report of the American College of
Cardiology Foundation/American Heart Association Task Force on
Practice Guidelines. Circulation, 127(4): e362-425. Available at
https://www.ncbi.nlm.nih.gov/pubmed/23247304.
---------------------------------------------------------------------------
As such, we are proposing to adopt the STEMI eCQM for use in the
Hospital OQR Program because of its importance in measuring timely
delivery of guideline-based reperfusion therapies appropriate for the
care of ED patients with a diagnosis of STEMI and its ability to fill a
gap in CMS' Meaningful Measure portfolio. The measure was submitted to
NQF in January 2021 and is under review.
(3) Measure Calculation
The STEMI eCQM is a process measure that assesses the percentage of
ED patients aged 18 years or older with a diagnosis of STEMI who
received appropriate treatment. The denominator includes all ED
patients 18 years or older diagnosed with STEMI who do not have
contraindications to fibrinolytic, antithrombotic, and anticoagulation
therapies.
The numerator includes:
ED-based STEMI patients whose time from ED arrival to
fibrinolytic therapy is 30 minutes or fewer; or
Non-transfer ED-based STEMI patients who received PCI at a
PCI-capable hospital within 90 minutes of arrival; or
ED-based STEMI patients who were transferred to a PCI-
capable hospital within 45 minutes of ED arrival at a non-PCI-capable
hospital.
For more information on the STEMI eCQM, we refer readers to the
full measure specifications available on the Electronic Clinical
Quality Improvement (eCQI) Resource Center website, available at:
https://ecqi.healthit.gov/pre-rulemaking-eh-oqr-ecqms.
(4) Data Sources
The proposed measure is an eCQM that uses data routinely collected
through the EHR and is designed to be calculated by the hospitals'
CEHRT using patient-level data and submitted to CMS. In 2020, using
data from 2018, the STEMI eCQM was tested at two hospital systems (20
EDs in total) with two different EHR platforms for feasibility,
validity, and reliability testing, based on the endorsement criteria
outlined by NQF.\223\ The
[[Page 42246]]
feasibility testing showed that the measure is feasible and the key
features of the eCQM, such as the code sets and measure logic, were
readily interpreted by both sites as assessed by the feasibility
scorecard and exit interviews conducted at the two sites. The validity
testing results showed a wide range of agreement among data elements
between the electronic and manual data extracts. Some data elements
were collected but not fully interoperable within providers' EHRs.
However, as hospitals and EHR vendors meet ONC requirements for
interoperability under the ONC 21st Century Cures Act final rule (85 FR
25642 through 25961) and map data elements for interoperability via the
FHIR-based API required by December 31, 2022 (85 FR 70075), these data
elements would be accessible without special effort.
---------------------------------------------------------------------------
\223\ National Quality Forum. What NQF Endorsement Means.
Available at: http://https://www.qualityforum.org/Measuring_Performance/ABCs/What_NQF_Endorsement_Means.aspx.
---------------------------------------------------------------------------
(5) Implementation
We propose to start with voluntary reporting beginning with the CY
2023 reporting period and then with mandatory reporting beginning with
the CY 2024 reporting period/CY 2026 payment determination and for
subsequent years. We believe that taking an incremental approach to
implementing this measure would allow hospitals time to implement
workflow changes as necessary to better prepare for submitting data and
to increase familiarity with data submission with the introduction of
an eCQM into the Hospital OQR Program. We refer readers to section
XV.D.6. of this proposed rule for additional proposals related to eCQM
data submission and reporting requirements under the Hospital OQR
Program.
We invite public comment on our proposal.
5. Modifications to Previously Adopted Measures
a. Proposal To Require OP-37a-e: Outpatient and Ambulatory Surgery
Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS)
Survey-Based Measures Beginning With Voluntary Reporting for the CY
2023 Reporting Period and Mandatory Reporting Beginning With the CY
2024 Reporting Period/CY 2026 Payment Determination and for Subsequent
Years
We previously adopted the OP-37a-e: Outpatient and Ambulatory
Surgery Consumer Assessment of Healthcare Providers and Systems (OAS
CAHPS) measures to assess patient experience with care following a
procedure or surgery in a HOPD. These survey-based measures rate
patient experience as a means for empowering patients and improving the
quality of their care (82 FR 59432). For further details on these
measures, we refer readers to the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79771 through 79784), in which we adopted these
measures beginning with the CY 2020 payment determination.
Subsequently, in the CY 2018 OPPS/ASC final rule with comment
period (82 FR 59432 through 59433), we delayed implementation of OP-
37a-e for the Hospital OQR Program beginning with the CY 2020 payment
determination due to lack of sufficient operational and implementation
data. At that time, we believed that our ongoing National OAS CAHPS
voluntary reporting program for the survey measures, which began in
January 2016 \224\ and is unrelated to either the Hospital OQR Program
or ASCQR Program, would provide valuable information moving forward.
Specifically, we wanted to use the information from the National OAS
CAHPS voluntary reporting program to: (1) Ensure that the survey
measures appropriately account for patient response rates, both
aggregate and by survey administration method; (2) reaffirm the
reliability of national implementation of OAS CAHPS Survey data; and
(3) appropriately account for the burden associated with administering
the survey in the outpatient setting of care.
---------------------------------------------------------------------------
\224\ Participation in the program is open to any interested
Medicare-certified Hospital Outpatient Departments (HOPDs) and free-
standing ambulatory surgery centers (ASCs). More information on the
National OAS CAHPS voluntary reporting program is available at:
https://oascahps.org/General-Information/National-Implementation and
https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/CAHPS/OAS-CAHPS.
---------------------------------------------------------------------------
In this proposed rule, we are proposing to restart the OP-37a-e
measure by requiring the measure in the Hospital OQR Program beginning
with the CY 2024 reporting period/CY 2026 payment determination.
Specifically, for the Hospital OQR Program, we are proposing voluntary
data collection and reporting beginning with the CY 2023 reporting
period, followed by mandatory data collection and reporting beginning
with the CY 2024 reporting period/CY 2026 payment determination. As
noted previously, the National OAS CAHPS voluntary reporting program is
independent of the Hospital OQR Program and the ASCQR Program. This
proposal is intended to make the distinction that HOPDs that
voluntarily report the OAS CAHPS survey-based measures during the CY
2023 reporting period would do so as part of the Hospital OQR Program
until mandatory reporting begins, if these proposals are finalized. The
reporting process for HOPDs to submit OAS CAHPS data would remain
unchanged for HOPDs (that is, they would not duplicate submissions to
the program and National OAS CAHPS voluntary reporting program). We
refer readers to section XV.D.4.b. of the preamble of this proposed
rule for our related proposals regarding the form, manner, and timing
for reporting the OP-37a-e survey-based measures.
Having had the opportunity during the delayed implementation to
investigate the concerns about patient response rates and data
reliability, we believe that patients are able to respond to OAS CAHPS
survey questions, and that those responses are reliable based on our
prior experiences collecting voluntary data for public reporting since
CY 2016 (available at https://data.cms.gov/provider-data/). We reaffirm
that the OAS CAHPS survey-based measures assess important aspects of
care where the patient is the best or only source of information (81 FR
79771). Furthermore, in section XV.D.4.b.(1)., we are proposing
additional collection modes using a web-based module (web with mail
follow-up of non-respondents and web with telephone follow-up of non-
respondents) for administering the survey, which would be available
beginning in CY 2023 under the Hospital OQR Program and for subsequent
years.\225\ We believe this would address some burden concerns raised
during the CY 2017 OPPS/ASC final rule with comment period (81 FR
79777) because the web-based modules would produce similar results but
at lower costs of collection.\226\ We also continue to believe that the
benefits of this measure, such as giving patients the opportunity to
compare and assess quality of care in the outpatient setting in a
standardized and comparable manner, outweigh the burdens (81 FR 79778).
As we stated in the CY 2018 OPPS/ASC final rule with comment period, we
continue to believe that implementation of these measures will enable
objective and meaningful comparisons between hospital outpatient
departments (82 FR 59432)
[[Page 42247]]
and rating patient experience still provides important information to
hospital outpatient departments and patients and enables objective and
meaningful comparisons between hospital outpatient departments (82 FR
59432).
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\225\ We note that the mixed modes will be available as part of
the National OAS CAHPS voluntary reporting program beginning in CY
2022.
\226\ Bergeson SC, Gray J, Ehrmantraut LA, Laibson T, Hays RD.
Comparing Web-based with Mail Survey Administration of the Consumer
Assessment of Healthcare Providers and Systems (CAHPS[supreg])
Clinician and Group Survey. Prim Health Care. 2013;3:1000132.
doi:10.4172/2167-1079.1000132.
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We refer readers to section XV.D.4.b. for our related proposals
regarding form, manner, and timing for reporting the OP-37a-e survey-
based measures. We invite public comment on our proposal.
We also refer readers to section XVI.B.4.c. of this proposed rule
where we are also proposing modifications to this measure in the ASCQR
Program.
b. Proposal To Require OP-31: Cataracts: Improvement in Patient's
Visual Function Within 90 Days Following Cataract Surgery (NQF #1536)
Beginning With the CY 2023 Reporting Period/CY 2025 Payment
Determination
(1) Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75102
through 75104) we finalized the adoption of the OP-31: Cataracts:
Improvement in Patient's Visual Function with 90 Days Following
Cataract Surgery \227\ measure beginning with the CY 2016 payment
determination. This measure assesses the percentage of patients aged 18
years and older who had cataract surgery and had improvement in visual
function achieved within 90 days following the cataract surgery (78 FR
75102). The measure data consists of pre-operative and post-operative
visual function surveys. The implementation of this measure has been
the subject of a number of changes as discussed in this section for the
proposed rule.
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\227\ We note that this measure was endorsed by the NQF under
NQF #1536 at the time of adoption but has subsequently had its
endorsement removed.
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During the CY 2014 OPPS/ASC proposed rule, some commenters
expressed concern about the burden of collecting pre-operative and
post-operative visual function surveys (78 FR 75103). In response to
those comments, we modified and finalized our implementation strategy
in a manner that we believed would significantly minimize collection
and reporting burden (78 FR 75103). Specifically, we applied a sampling
scheme and a low case threshold exemption to address commenters'
concerns regarding burden (78 FR 75114). With those changes, we
intended to decrease burden and facilitate data reporting by allowing
random sampling of cases when volume is high, instead of collecting
information for all eligible patients (78 FR 75114). For further
details, we refer readers to the CY 2014 OPPS/ASC final rule with
comment period (78 FR 75102 through 75104).
Shortly thereafter, we became concerned about the use of
inconsistent surveys to assess visual function. The measure
specifications allowed for the use of any validated survey and we were
not positive about the impact the use of varying surveys might have.
Therefore, we issued guidance stating that we would delay the
implementation of OP-31.\228\
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\228\ The implementation was first delayed by 3 months--from
January 1, 2014 to April 1, 2014, for the CY 2016 payment
determination, via guidance issued December 31, 2013. Available at:
https://qualitynet.cms.gov/outpatient/notifications8772854917.
Because of continuing concerns, on April 2, 2014, we issued
additional guidance stating that we would further delay the
implementation of the measure from April 1, 2014 to January 1, 2015
for the CY 2016 payment determination. Available at: https://qualitynet.cms.gov/outpatient/notifications.
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Subsequently, in the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66947 through 66948), we finalized our proposal to
exclude OP-31 from the CY 2016 payment determination measure set, and
for subsequent years. We proposed to exclude OP-31 for a few reasons.
First, we understood it was operationally difficult for hospitals to
collect and report on the measure (79 FR 66947). Notably, the results
of the survey used to assess the pre-operative and post-operative
visual function of the patient were not consistently shared across
clinicians, making it difficult for hospitals to have knowledge of the
visual function of the patient before and after surgery (79 FR 66947).
Second, the concern about use of various versions of the survey
persisted. Specifically, we were concerned that if physicians used
different surveys to assess visual function, then the measure could
produce inconsistent results (79 FR 66947). By excluding OP-31 from the
measure set used for the CY 2016 payment determination and subsequent
years, hospitals were excused from reporting on it. Hospitals that did
not report on OP-31 for the CY 2016 payment determination were not
subject to a payment reduction (79 FR 66947). In conjunction with
excusing hospitals from reporting on OP-31 for the CY 2016 payment
determination and subsequent years, we finalized allowing hospitals to
voluntarily report OP-31 data for the CY 2015 reporting period/CY 2017
payment determination and subsequent years (79 FR 66948).
(2) Proposal To Require Hospitals Report on OP-31 Beginning With the CY
2023 Reporting Period/CY 2025 Payment Determination and for Subsequent
Years
We now believe it is appropriate to require hospitals to report on
OP-31. Our earlier concerns have been ameliorated. At this point,
hospitals have had several years to familiarize themselves with OP-31,
prepare to operationalize it, and opportunity to practice reporting the
measure since the CY 2015 reporting period/CY 2017 payment
determination. We note that a small number of facilities have
consistently reported data for this measure and these data have been
made publicly available. As to our second concern, research indicates
that using different surveys will not result in inconsistencies, as the
allowable surveys are scientifically validated.\229\ Research has
demonstrated that of 16 different cataract surgery outcome
questionnaires, all were able to detect clinically important
change.\230\
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\229\ McAlinden C, Gothwal VK, Khadka J, Wright TA, Lamoureux
EL, Pesudovs K. A head-to-head comparison of 16 cataract surgery
outcome questionnaires. Ophthalmology. 2011 Dec;118(12):2374-81.
doi: 10.1016/j.ophtha.2011.06.008. Epub 2011 Sep 25. PMID: 21945088.
\230\ McAlinden C, Gothwal VK, Khadka J, Wright TA, Lamoureux
EL, Pesudovs K. A head-to-head comparison of 16 cataract surgery
outcome questionnaires. Ophthalmology. 2011 Dec;118(12):2374-81.
doi: 10.1016/j.ophtha.2011.06.008. Epub 2011 Sep 25. PMID: 21945088.
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Therefore, in this proposed rule, we are proposing to require
reporting of the OP-31 measure beginning with the CY 2023 reporting
period/CY 2025 payment determination and for subsequent years. As we
stated in the CY 2014 OPPS/ASC final rule with comment period, as well
as the CY 2015 OPPS/ASC final rule with comment period, and consistent
with the MAP recommendation, we continue to maintain that this measure
``addresses a high-impact condition'' that is not otherwise adequately
addressed in our current measure set (78 FR 75103 and 79 FR 66947,
respectively). Moreover, OP-31 serves to improve patient-centered care
by representing an important patient reported outcome (78 FR 75103).
This measure provides opportunities for care coordination as well as
direct patient feedback.
We refer readers to section XV.D.5.a. of this proposed rule for
information about submitting data via a CMS web-based tool.
We invite public comment on our proposal.
[[Page 42248]]
6. Summary of Previously Finalized and Proposed Hospital OQR Program
Measure Sets
a. Summary of Previously Finalized and Proposed Hospital OQR Program
Measure Set for the CY 2023 Payment Determination
We refer readers to the CY 2021 OPPS/ASC final rule with comment
period (85 FR 86180 through 86181) for a summary of the previously
adopted Hospital OQR Program measure set for the CY 2023 payment
determination and subsequent years. If finalized as proposed in this
proposed rule, the CY 2023 payment determination and subsequent years
would also include the Breast Screening Recall Rates measure. Table 46
summarizes the previously finalized and newly proposed Hospital OQR
Program measure set for the CY 2023 payment determination:
[GRAPHIC] [TIFF OMITTED] TP04AU21.095
b. Summary of Previously Finalized and Proposed Hospital OQR Program
Measure Set for the CY 2024 Payment Determination
Table 47 summarizes the previously finalized and newly proposed
Hospital OQR Program measure set for the CY 2024 payment determination,
which includes the proposed COVID-19 Vaccination Coverage Among HCP
measure:
[[Page 42249]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.096
c. Summary of Previously Finalized and Proposed Hospital OQR Program
Measure Set for the CY 2025 Payment Determination
Table 48 summarizes the previously finalized and newly proposed
Hospital OQR Program measure set for the CY 2025 payment determination,
which includes the proposed OP-39: ST-Segment Elevation Myocardial
Infarction (STEMI) eCQM and proposed removals of the OP-2 and OP-3
measures:
[[Page 42250]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.097
d. Summary of Previously Finalized and Proposed Hospital OQR Program
Measure Set for the CY 2026 Payment Determination and Subsequent Years
Table 49 summarizes the previously finalized and newly proposed
Hospital OQR Program measure set for the CY 2026 payment determination
and subsequent years, which includes the proposed mandatory reporting
of the ST-Segment Elevation Myocardial Infarction (STEMI) eCQM and the
proposed requirement of the OAS CAHPS measures (OP-37a-e):
[[Page 42251]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.098
7. Hospital OQR Program Measures and Topics for Future Considerations
a. Request for Comment on Potential Adoption of Future Measures for the
Hospital OQR Program
We seek to adopt a comprehensive set of quality measures for
widespread use to inform decision-making regarding care and for quality
improvement efforts in the hospital outpatient setting. In the CY 2021
OPPS/ASC final rule with comment period (85 FR 86083 through 86110),
under the OPPS we finalized the elimination of the Inpatient Only (IPO)
list over a 3-year transitional period, beginning with the removal of
approximately 300 primarily musculoskeletal-related services, with the
list to be completely phased out by CY 2024.\231\ As discussed in
section IX. of this rule, we have continued to receive stakeholder
requests to reconsider the elimination of the IPO list, to reevaluate
services removed from the IPO list due to safety and quality concerns,
and to, at a minimum, extend the timeframe for eliminating the list.
After further consideration and review of the additional feedback from
stakeholders, we believe that the timeframe we adopted for removing
services from the IPO list does not give us a sufficient opportunity to
carefully assess whether a procedure can be removed from the IPO list
while still ensuring beneficiary safety. For CY 2022, we are proposing
to halt the elimination of the IPO list and, after clinical review of
the services removed from the IPO list in CY 2021, we propose to add
the 298 services removed from the IPO list in CY 2021 back to the IPO
list beginning in CY 2022.
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\231\ Centers for Medicare & Medicaid Services. (2020, December
2). CY 2021 Medicare Hospital Outpatient Prospective Payment System
and Ambulatory Surgical Center Payment System Final Rule (CMS-1736-
FC). Retrieved from www.cms.gov/newsroom: https://www.cms.gov/newsroom/fact-sheets/cy-2021-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0.
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However, as technology and surgical techniques advance, services
will continue to transition off of the IPO list, becoming payable in
the outpatient setting. We recognize that there may be a need for more
measures that inform decision-making regarding care and for quality
improvement efforts, particularly focused on the behaviors of services
that become newly eligible for payment in the outpatient setting. In
light of this, we seek comment on potential future adoption of measures
that would allow better tracking of the quality of care for services
that transition from the IPO list and become eligible for payment in
the outpatient setting.
Therefore, we invite public comment on the potential future
adoption of measures for our consideration that address care quality in
the hospital outpatient setting given the transition of procedures from
inpatient settings to outpatient settings of care.
b. Request for Comment on Potential Future Adoption and Inclusion of a
Hospital-Level, Risk-Standardized Patient Reported Outcomes Measure
Following Elective Primary Total Hip and/or Total Knee Arthroplasty
(THA/TKA)
As described in section XV.B.7.a., we are seeking comment on
priorities for quality measurement in outpatient settings due to
changes to the IPO procedure list (82 FR 59385 and 84 FR 61355) and the
ASC covered procedures list (CPL) (84 FR 61388 and 85 FR 86146)
announced in the CY 2021 OPPS/ASC final rule with comment period.
We are also requesting comment on the potential future adoption of
a respecified version of a patient-reported outcome-based performance
measure
[[Page 42252]]
(PRO-PM) for two such procedures--elective primary total hip
arthroplasty (THA) and total knee arthroplasty (TKA), which were
removed from the IPO list effective with CY 2020 and CY 2018,
respectively. We recently solicited public comment on the potential
future inclusion of a hospital-level Risk-Standardized Patient-Reported
Outcomes Measure Following Elective Primary Total Hip and/or Total Knee
Arthroplasty (Hospital-level THA/TKA PRO-PM (NQF #3559)) in the FY 2022
IPPS/LTCH PPS proposed rule for the inpatient hospital setting (86 FR
25589). This measure reports the hospital-level risk-standardized
improvement rate (RSIR) in patient-reported outcomes (PROs) following
elective primary THA/TKA for Medicare FFS beneficiaries aged 65 years
and older. Substantial clinical improvement is measured by achieving a
pre-defined improvement in score on one of the two validated joint-
specific PRO instruments measuring hip or knee pain and functioning:
(1) The Hip dysfunction and Osteoarthritis Outcome Score for Joint
Replacement (HOOS, JR) for completion by THA recipients; and (2) the
Knee injury and Osteoarthritis Outcome Score for Joint Replacement
(KOOS, JR) for completion by TKA recipients. Improvement is measured
from the preoperative assessment (data collected 90 to 0 days before
surgery) to the postoperative assessment (data collected 300 to 425
days following surgery). Improvement scores are risk adjusted to
account for differences in patient case mix. Potential non-response
bias in measure scores due to the voluntary nature of PROs is
incorporated in the measure calculation with stabilized inverse
probability weighting based on likelihood of response.
Currently, the volume of THA and TKA procedures performed is lower
among HOPDs than in the inpatient setting. Given the relatively recent
removal of TKA and THA from the IPO list, we expect that the volume of
THA and TKA procedures will continue to increase in HOPDs, and that
significant numbers of Medicare beneficiaries 65 and older will
potentially undergo these procedures in the outpatient setting in
future years.
We recognize that potential future adoption and implementation of a
respecified version of the THA/TKA PRO-PM in the Hospital OQR Program
would require sufficient numbers of procedures for each measured HOPD
to ensure a reliable measure score. Additionally, implementing a THA/
TKA PRO-PM would require providers to successfully collect pre- and
post-operative PRO data for each procedure. Specifically, the inpatient
THA/TKA PRO-PM discussed in the FY 2022 IPPS/LTCH PPS proposed rule
proposes to require a minimum of 25 cases with completed pre- and post-
operative PRO data per hospital to ensure a reliable measure score. For
more details on the inpatient THA/TKA PRO-PM, we refer readers to the
FY 2022 IPPS/LTCH PPS proposed rule (86 FR 25589) and the PROs
Following Elective Primary Total Hip and/or Total Knee Arthroplasty:
Hospital-Level Performance Measure -- Measure Methodology Report,
available on the CMS website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.
We will continue to monitor the number of THA and TKA procedures in
the outpatient setting and when we believe there is a sufficient number
of such procedures performed in these settings to reliably measure a
meaningful number of facilities, we may consider expanding the PRO-PM
to these settings. We also note that, as finalized in the CY 2017 OPPS/
ASC final rule with comment period (81 FR 79764 through 79771), the
Hospital OQR Program currently includes a Hospital Visits after
Hospital Outpatient Surgery (OP-36) measure using claims data, which
provides facilities with important information on patient outcomes for
Medicare FFS beneficiaries following surgery at HOPDs and is publicly
reported on CMS' Care Compare website (https://www.medicare.gov/care-compare/). The measure calculates a facility-specific risk-standardized
hospital visit ratio within 7 days of hospital outpatient surgery, and
has as outcomes of interest unplanned hospital admissions, ED visits,
and observation stays thereby providing valuable quality information as
these procedures are increasingly conducted as outpatient surgeries.
As described in our Meaningful Measures 2.0 Framework, we aim to
promote better collection and integration of patients' voices by
developing PRO measures as an additional tool for measuring and
improving quality. Given the unique challenges and opportunities for
PRO-PMs for THA and TKA procedures in the outpatient setting, we invite
public comment on the potential future adoption of a respecified
version of PRO measures for elective THA/TKA PRO-PM for the Hospital
OQR Program. Specifically, we invite public comment on the following:
Input on the mechanism of PRO data collection and
submission, including anticipated barriers and solutions to data
collection and submission.
Usefulness of having an aligned set of PRO-PMs across
settings where elective THA/TKA are performed, that is, hospital
inpatient setting, hospital outpatient departments, and ASCs for
patients, providers, and other stakeholders. Specifically, usefulness
and considerations for a hospital that performs both inpatient and
outpatient elective THA/TKAs.
Considerations unique to THA/TKAs performed in the
hospital outpatient setting such as the volume of procedures performed
or the measure cohort, outcome, or risk adjustment approach.
c. Request for Comment on Potential Future Efforts To Address Health
Equity in the Hospital OQR Program
(1) Introduction and Expansion of the CMS Disparity Methods to Hospital
OQR Program Setting
Significant and persistent inequities in health care outcomes exist
in the U.S.\232\ Belonging to a racial or ethnic minority group; living
with a disability; being a member of the lesbian, gay, bisexual,
transgender, and queer (LGBTQ+) community; living in a rural area; and
being near or below the poverty level, are often associated with worse
health outcomes.233 234 235 236 237 238 239 240 Such
disparities in health outcomes are the
[[Page 42253]]
result of number of factors, including social, economic, and
environmental factors, but importantly for CMS programs, although not
the sole determinant, negative experiences, poor access, and provision
of lower quality health care can contribute to health inequities. For
instance, numerous studies have shown that among Medicare
beneficiaries, racial and ethnic minority individuals often receive
lower quality of care, report lower experiences of care, and experience
more frequent hospital readmissions and procedural
complications.241 242 243 244 245 246 Readmission rates for
common conditions in the Hospital Readmissions Reduction Program (HRRP)
are higher for Black Medicare beneficiaries and higher for Hispanic
Medicare beneficiaries with congestive heart failure and acute
myocardial infarction.247 248 249 250 251 Studies have also
shown that African Americans are significantly more likely than White
Americans to die prematurely from heart disease and stroke.\252\ The
COVID-19 pandemic has further highlighted many of these longstanding
health inequities with higher rates of infection, hospitalization, and
mortality among Black, Latino, and Indigenous and Native American
persons relative to White persons.253 254 As noted by the
CDC, ``long-standing systemic health and social inequities have put
many people from racial and ethnic minority groups at increased risk of
getting sick and dying from COVID-19.'' \255\ One important strategy
for addressing these important inequities is by improving data
collection to allow for better measurement and reporting on equity
across our programs and policies.
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\232\ United States Department of Health and Human Services.
``Healthy People 2020: Disparities. 2014.'' Available at: https://www.healthypeople.gov/2020/about/foundation-health-measures/Disparities.
\233\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\234\ Lindenauer PK, Lagu T, Rothberg MB, et al. Income
Inequality and 30 Day Outcomes After Acute Myocardial Infarction,
Heart Failure, and Pneumonia: Retrospective Cohort Study. British
Medical Journal. 2013;346.
\235\ Trivedi AN, Nsa W, Hausmann LRM, et al. Quality and Equity
of Care in U.S. Hospitals. New England Journal of Medicine.
2014;371(24):2298-2308.
\236\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
\237\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018. Available at: https://www.ruralhealthresearch.org/assets/2200-8536/rural-communities-age-income-health-status-recap.pdf.
\238\ https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\239\ www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\240\ Poteat TC, Reisner SL, Miller M, Wirtz AL. COVID-19
Vulnerability of Transgender Women With and Without HIV Infection in
the Eastern and Southern U.S. Preprint. medRxiv.
2020;2020.07.21.20159327. Published 2020 Jul 24. doi:10.1101/
2020.07.21.20159327.
\241\ Martino, SC, Elliott, MN, Dembosky, JW, Hambarsoomian, K,
Burkhart, Q, Klein, DJ, Gildner, J, and Haviland, AM. Racial,
Ethnic, and Gender Disparities in Health Care in Medicare Advantage.
Baltimore, MD: CMS Office of Minority Health. 2020.
\242\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\243\ Singh JA, Lu X, Rosenthal GE, Ibrahim S, Cram P. Racial
disparities in knee and hip total joint arthroplasty: An 18-year
analysis of national Medicare data. Ann Rheum Dis. 2014
Dec;73(12):2107-15.
\244\ Rivera-Hernandez M, Rahman M, Mor V, Trivedi AN. Racial
Disparities in Readmission Rates among Patients Discharged to
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
\245\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\246\ Tsai TC, Orav EJ, Joynt KE. Disparities in surgical 30-day
readmission rates for Medicare beneficiaries by race and site of
care. Ann Surg. Jun 2014;259(6):1086-1090.
\247\ Rodriguez F, Joynt KE, Lopez L, Saldana F, Jha AK.
Readmission rates for Hispanic Medicare beneficiaries with heart
failure and acute myocardial infarction. Am Heart J. Aug
2011;162(2):254-261 e253.
\248\ Centers for Medicare and Medicaid Services. Medicare
Hospital Quality Chartbook: Performance Report on Outcome Measures;
2014.
\249\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\250\ Prieto-Centurion V, Gussin HA, Rolle AJ, Krishnan JA.
Chronic obstructive pulmonary disease readmissions at minority-
serving institutions. Ann Am Thorac Soc. Dec 2013;10(6):680-684.
\251\ Joynt KE, Orav E, Jha AK. Thirty-Day Readmission Rates for
Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\252\ HHS. Heart disease and African Americans. (March 29,
2021). https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\253\ https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\254\ Ochieng N, Cubanski J, Neuman T, Artiga S, and Damico A.
Racial and Ethnic Health Inequities and Medicare. Kaiser Family
Foundation. February 2021. Available at: https://www.kff.org/medicare/report/racial-and-ethnic-health-inequities-and-medicare/.
\255\ https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
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We are committed to achieving equity in health care outcomes for
our beneficiaries by supporting providers in quality improvement
activities to reduce health inequities, enabling them to make more
informed decisions, and promoting provider accountability for health
care inequities.\256\ For the purposes of this proposed rule, we are
using a definition of equity established in Executive Order 13985,
issued on January 25, 2021, as ``the consistent and systematic fair,
just, and impartial treatment of all individuals, including individuals
who belong to underserved communities that have been denied such
treatment, such as Black, Latino, and Indigenous and Native American
persons, Asian Americans and Pacific Islanders and other persons of
color; members of religious minorities; LGBTQ+ persons; persons with
disabilities; persons who live in rural areas; and persons otherwise
adversely affected by persistent poverty or inequality.'' \257\ We note
that this definition was recently established and provides a useful,
common definition for equity across different areas of government,
although numerous other definitions of equity exist.
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\256\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\257\ https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government.
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Our ongoing commitment to closing the equity gap in CMS quality
programs is demonstrated by a portfolio of programs aimed at making
information on the quality of health care providers and services,
including disparities, more transparent to consumers and providers. The
CMS Equity Plan for Improving Quality in Medicare outlines a path to
equity which aims to support Quality Improvement Network Quality
Improvement Organizations (QIN-QIOs); Federal, state, local, and tribal
organizations; providers; researchers; policymakers; beneficiaries and
their families; and other stakeholders in activities to achieve health
equity.\258\
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\258\ Centers for Medicare & Medicaid Services Office of
Minority Health. The CMS Equity Plan for Improving Quality in
Medicare. 2015-2021. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
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We refer readers to the FY 2022 IPPS/LTCH PPS proposed rule (86 FR
25070) which summarizes our existing initiatives aimed at closing the
equity gap in outcomes for Medicare beneficiaries, including the CMS
Disparity Methods. The methods were finalized in the FY 2018 IPPS/LTCH
PPS final rule (82 FR 38405 through 38407) and the FY 2020 IPPS/LTCH
PPS final rule (84 FR 42496 through 42500), and results are currently
reported confidentially across six quality measures in the HRRP
stratified by dual eligibility status. As described in the FY 2022
IPPS/LTCH PPS proposed rule (86 FR 25070), we are considering further
expanding the confidential reporting to include measurement of racial
and ethnic disparities for one measure in the Hospital IQR Program, the
Hospital-Wide All-Cause Unplanned Readmission Measure (NQF #1789).
We have developed two complementary disparity methods to report
stratified measure results for outcome measures. The first method (the
Within-Hospital Disparity Method) promotes quality improvement by
calculating differences in outcome rates among patient groups within a
hospital while accounting for their clinical risk factors. This method
also allows for a comparison of the magnitude of disparity across
hospitals at a given point in time, so hospitals could assess how well
they are closing disparity gaps compared to other hospitals. The second
methodological approach (the Across-Hospital Disparity Method) is
complementary to the first method and assesses hospitals' outcome rates
for patients with a given risk factor, across facilities, allowing for
a comparison among hospitals on their performance caring for their
patients with social risk
[[Page 42254]]
factors. These methods were first confidentially reported for the
inpatient setting in 2019 for the Pneumonia Readmission (NQF #0506) and
Pneumonia Mortality (NQF #0468) measures, stratified dual eligibility
for Medicare and Medicaid, and confidential reporting for hospitals has
since expanded to include additional measures. For additional
information on the two disparity methods, we refer readers to the FY
2018 IPPS/LTCH PPS final rule (82 FR 38405 through 38407) and the 2020
Disparity Methods Updates and Specifications Report.\259\ As discussed
in the FY 2019 IPPS/LTCH PPS final rule (83 FR 41599) and the FY 2022
IPPS/LTCH PPS proposed rule (86 FR 25070), the two disparity methods do
not place any additional collection or reporting burden on hospitals
because social risk factor data are readily available in claims data.
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\259\ https://qualitynet.cms.gov/inpatient/measures/disparity-methods/methodology.
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In this proposed rule, we are seeking comment on expanding our
efforts to provide results of the disparity methods to promote health
equity and improve healthcare quality. Specifically, we are seeking
comment on the idea of stratifying the performance results in the
hospital outpatient setting. We have identified six priority measures
included in the Hospital OQR Program as candidate measures for
disparities reporting stratified by dual eligibility:
MRI Lumbar Spine for Low Back Pain (OP-8);
Abdomen CT--Use of Contract Material (OP-10);
Cardiac Imaging for Preoperative Risk Assessment for Non-
Cardiac Low Risk Surgery (OP-13);
Facility 7-Day Risk-Standardized Hospital Visit Rate after
Outpatient Colonoscopy (OP-32);
Admissions and ED Visits for Patients Receiving Outpatient
Chemotherapy (OP-35); and
Hospital Visits after Hospital Outpatient Surgery (OP-36).
To identify these measures, we considered evidence of existing
disparities, procedure volume, and statistical reliability. For more
information about these measures, we refer readers to the Hospital
Outpatient Quality Reporting Specifications Manual available on the
QualityNet website.\260\ We are seeking public comment on potential
future confidential reporting of the six aforementioned measures, as
well as other potential measures described in section XV.B.4.,
stratified by dual eligibility status, if technically feasible,
adequately representative, and statistically reliable.
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\260\ https://qualitynet.cms.gov/outpatient/specifications-manuals.
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(2) Additional Social Risk Factors
We are committed to advancing health equity by improving data
collection to better measure and analyze disparities across programs
and policies.\261\ As we described earlier, we have been considering,
among other things, expanding our efforts to stratify data by
additional social risk factors and demographic variables, optimizing
the ease-of-use of the results, enhancing public transparency of equity
results, and building towards provider accountability for health
equity. Following potential confidential reporting using dual
eligibility as an indicator of social risk, we are exploring the
possibility of further expanding stratified reporting to include race
and ethnicity.
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\261\ Centers for Medicare & Medicaid Services. CMS Quality
Strategy. 2016. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
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We refer readers to the ``Closing the Health Equity Gap in CMS
Hospital Quality Programs'' section of the FY 2022 IPPS/LTCH PPS
proposed rule which summarizes the existing challenges in accurately
determining race and ethnicity in our administrative data, and the need
for using advanced statistical methods for enhancing the accuracy of
race and ethnicity disparity estimates (86 FR 25554).
As we stated in the ``Closing the Health Equity Gap in CMS Hospital
Quality Programs'' section of the FY 2022 IPPS/LTCH PPS proposed rule
(86 FR 25554), because development of sustainable and consistent
programs to collect demographic information related to health
disparities, such as race and ethnicity, can be considerable
undertakings, we recognize that another method to identify more
accurate race and ethnicity disparities is needed in the short term. In
working with our contractors, two algorithms have been developed to
indirectly estimate the race and ethnicity of Medicare beneficiaries
(as described further in the next section). We believe that using
indirect estimation can help to overcome some of the current
limitations of demographic information and enable timelier reporting of
equity results until longer term collaborations to improve demographic
data quality across the health care sector materialize. The use of
indirectly estimated race and ethnicity for conducting stratified
reporting does not place any additional collection or reporting burdens
on facilities as these data are derived using existing administrative
and census-linked data.
Indirect estimation relies on a statistical imputation method for
inferring a missing variable or improving an imperfect administrative
variable using a related set of information that is more readily
available. Indirectly estimated data are most commonly used at the
population level (such as the hospital or health plan-level) where
aggregated results form a more accurate description of the population
than existing, imperfect data sets. For missing race and ethnicity
information, these methods use a combination of other data sources
which estimate self-identified race and ethnicity, such as language
preference, information about race and ethnicity in our administrative
records, first and last names matched to validated lists of names
correlated to specific national origin groups, and the racial and
ethnic composition of the surrounding neighborhood. Indirect estimation
has been used in other settings to support population-based equity
measurement when self-identified data are not available.\262\
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\262\ Institute of Medicine. 2009. Race, Ethnicity, and Language
Data: Standardization for Health Care Quality Improvement.
Washington, DC: The National Academies Press. Available at: https://www.ahrq.gov/sites/default/files/publications/files/iomracereport.pdf.
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As described previously, we have previously supported the
development of two such methods of indirect estimation of race and
ethnicity of Medicare beneficiaries. One indirect estimation approach
developed by our contractor uses Medicare administrative data, first
name and surname matching, derived from the U.S. Census and other
sources, with beneficiary language preference, state of residence, and
the source of the race and ethnicity code in Medicare administrative
data to reclassify some beneficiaries as Hispanic or Asian/Pacific
Islander (API).\263\ In recent years, we have also worked with another
contractor to develop a new approach, the Medicare Bayesian Improved
Surname Geocoding (MBISG), which combines Medicare administrative data,
first and surname matching, geocoded residential address linked to the
2010 U.S. Census data,
[[Page 42255]]
applying both Bayesian updating and multinomial logistic regression to
estimate the probability of belonging to each of the six racial/ethnic
groups.\264\
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\263\ Bonito AJ, Bann C, Eicheldinger C, Carpenter L. Creation
of New Race-Ethnicity Codes and Socioeconomic Status (SES)
Indicators for Medicare Beneficiaries. Final Report, Sub-Task 2.
(Prepared by RTI International for the Centers for Medicare and
Medicaid Services through an interagency agreement with the Agency
for Healthcare Research and Policy, under Contract No. 500-00-0024,
Task No. 21) AHRQ Publication No. 08-0029-EF. Rockville, MD, Agency
for Healthcare Research and Quality. January 2008.
\264\ Haas, A, Elliott, MN, Dembosky, JW, et al. Imputation of
race/ethnicity to enable measurement of HEDIS performance by race/
ethnicity. Health Serv Res. 2019; 54: 13-23. https://doi.org/10.1111/1475-6773.13099.
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The MBISG model is currently used to conduct the national,
contract-level, stratified reporting of Medicare Part C & D performance
data for Medicare Advantage Plans by race and ethnicity.\265\
Validation testing reveals concordances between 0.88-0.95 between
indirectly estimated and self-reported race and ethnicity among those
who identify as White, Black, Hispanic, and API for the MBISG version
2.0 and concordances with self-reported race and ethnicity of 0.96-0.99
for these same groups for MBISG version 2.1.266 267 The
algorithms under consideration are considerably less accurate for
individuals who self-identify as American Indian/Alaskan Native or
multiracial.\268\ Indirect estimation is a statistically reliable
approach for calculating aggregate results for groups of individuals
(such as the facility-level) and is not intended, nor being considered,
as an approach for predicting the race and ethnicity of individuals.
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\265\ https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
\266\ The Office of Minority Health (2020). Racial, Ethnic, and
Gender Disparities in Health Care in Medicare Advantage, The Centers
for Medicare and Medicaid Services, (pg vii). https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
\267\ https://www.cms.gov/About-CMS/Agency-Information/OMH/research-and-data/statistics-and-data/stratified-reporting.
\268\ Haas, A, Elliott, MN, Dembosky, JW, et al. Imputation of
race/ethnicity to enable measurement of HEDIS performance by race/
ethnicity. Health Serv Res. 2019; 54: 13- 23. https://doi.org/10.1111/1475-6773.13099.
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Despite the high degree of accuracy of the indirect estimation
algorithms under consideration there remains the small risk of
introducing measurement bias. For example, if the indirect estimation
is not as accurate in correctly estimating race and ethnicity in
certain geographies or populations it could lead to some bias in the
method results. Such bias might result in slight overestimation or
underestimation of the quality of care received by a given group. We
believe this risk of bias is considerably less than would be expected
if stratified reporting were conducted using the race and ethnicity
currently contained in our administrative data. Indirect estimation of
race and ethnicity is envisioned as an intermediate step, filling the
pressing need for more accurate demographic information for the
purposes of exploring inequities in service delivery, while allowing
newer approaches, as described in the next section, for improving
demographic data collection to progress. We are interested in learning
more about, and soliciting comments about, the potential benefits and
challenges associated with measuring facility equity using indirect
estimation to enhance existing administrative data quality for race and
ethnicity until self-reported information is sufficiently available.
(a) Improving Demographic Data Collection
Stratified facility-level reporting using indirectly estimated race
and ethnicity would represent an important advance in our ability to
provide accurate equity reports to facilities. However, self-reported
race and ethnicity data remain the gold standard for classifying an
individual according to race or ethnicity. The CMS Quality Strategy
outlines our commitment to strengthening infrastructure and data
systems by ensuring that standardized demographic information is
collected to identify disparities in health care delivery
outcomes.\269\ Collection and sharing of a standardized set of social,
psychological, and behavioral data by hospitals, including race and
ethnicity, using electronic data definitions which permit nationwide,
interoperable health information exchange, can significantly enhance
the accuracy and robustness of our equity reporting.\270\ This could
potentially include expansion of stratified reporting to additional
social risk factors, such as language preference and disability status,
where accuracy of administrative data is currently limited. We are
mindful that additional resources, including data collection and staff
training may be necessary to ensure that conditions are created whereby
all patients are comfortable answering demographic questions, and that
individual preferences for non-response are maintained.
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\269\ Centers for Medicare & Medicaid Services. CMS Quality
Strategy. 2016. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\270\ The Office of the National Coordinator for Health
Information Technology. United State Core Data for Interoperability
Draft Version 2. 2021. Available at: https://www.healthit.gov/isa/sites/isa/files/2021-01/Draft-USCDI-Version-2-January-2021-Final.pdf.
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We note that facilities participating in the Medicare Promoting
Interoperability Program must use CEHRT that has been certified to the
2015 Edition of health IT certification criteria as defined at 45 CFR
170.102. As noted earlier, the certification criterion for Demographics
under the 2015 Edition (45 CFR 170.315(a)(5)) supports collection of
data using both the OMB standards for collecting data on race and
ethnicity as well as the more granular ``Race & Ethnicity--CDC''
standard. In the 2020 ONC 21st Century Cures Act final rule, ONC also
adopted a new framework for the core data set which certified health IT
products must exchange, called the USCDI (85 FR 25669). The USCDI
incorporates the demographic data and associated code sets finalized
for the 2015 Edition certification criteria.
As noted previously, ONC also finalized a certification criterion
in the 2015 Edition which supports a certified health IT product's
ability to collect social, psychological, and behavioral data (45 FR
170.315(a)(15)). However, this functionality is not included as part of
the CEHRT required by the Medicare Promoting Interoperability Program.
While the technical functionality exists to achieve the gold standard
of data collection, we understand challenges and barriers exist in
using the technologies with these capabilities.
We are interested in learning about and soliciting comments on
current data collection practices by facilities to capture demographic
data elements (such as race, ethnicity, sex, sexual orientation and
gender identity (SOGI), primary language, and disability status).
Further, we are interested in potential challenges facing facility
collection, on the day of service, of a minimum set of demographic data
elements in alignment with national data collection standards (such as
the standards finalized by the Affordable Care Act \271\) and standards
for interoperable exchange (such as the USCDI incorporated into
certified health IT products as part of the 2015 Edition of health IT
certification criteria \272\). Advancing data interoperability through
collection of a minimum set of demographic data collection, and
incorporation into quality measure specifications, has the potential
for improving the robustness of the disparity method results,
potentially permitting reporting using more accurate, self-reported
information, such as race and ethnicity, and expanding reporting to
additional dimensions of equity, including stratified reporting by
disability status.
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\271\ https://minorityhealth.hhs.gov/assets/pdf/checked/1/Fact_Sheet_Section_4302.pdf.
\272\ https://www.healthit.gov/sites/default/files/2020-08/2015EdCures_Update_CCG_USCDI.pdf.
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[[Page 42256]]
(b) Solicitation of Public Comments
We are currently seeking comment on the possibility of expanding
our current disparities methods to include reporting by race and
ethnicity using indirect estimation. We are also seeking comment on the
possibility of facility collection of standardized demographic
information for the purposes of potential future quality reporting and
measure stratification to permit more robust equity measurement.
Additionally, we are seeking comment on the design of a Facility Equity
Score for presenting combined results across multiple social risk
factors and measures, including race/ethnicity and disability. Any data
pertaining to these areas that are recommended for collection for
measure reporting for a CMS program and potential public disclosure on
Care Compare or successor website would be addressed through a separate
and future notice-and-comment rulemaking. We plan to continue working
with the Office of the Assistant Secretary for Planning and Evaluation,
facilities, the public, and other key stakeholders on this important
issue to identify policy solutions that achieve the goals of attaining
health equity for all beneficiaries and minimizing unintended
consequences.
Specifically, we are inviting public comment on the following:
The potential future application to the Hospital OQR
Program measures of the two disparity methods currently used to
confidentially report stratified measures in HRRP.
The possibility of reporting stratified results
confidentially in Facility-Specific Reports (FSRs) using dual
eligibility as a proxy for social risk.
The possibility of reporting stratified results using dual
eligibility as the proxy for social risk publicly on Care Compare in
future years.
The potential future application of an algorithm to
indirectly estimate race and ethnicity to permit stratification of
measures (in addition to dual-eligibility) for facility-level disparity
reporting until more accurate forms of self-identified demographic
information are available.
The possibility of facility collection, on the day of
service, of a minimum set of demographic data using standardized and
interoperable electronic health record standards.
8. Maintenance of Technical Specifications for Quality Measures
CMS maintains technical specifications for previously adopted
Hospital OQR Program measures. These specifications are updated as we
modify the Hospital OQR Program measure set. The manuals that contain
specifications for the previously adopted measures can be found on the
QualityNet website at: https://qualitynet.cms.gov/outpatient/specifications-manuals. We refer readers to the CY 2019 OPPS/ASC final
rule with comment period (83 FR 59104 through 59105), where we changed
the frequency of the Hospital OQR Program Specifications Manual release
beginning with CY 2019 and subsequent years, such that we will release
a manual once every 12 months and release addenda as necessary. We are
not proposing any changes to these policies in this proposed rule.
In section XV.B.4. of this proposed rule, we are proposing the
adoption of eCQMs into the Hospital OQR Program measure set beginning
with the CY 2023 reporting period. Therefore, we are also proposing the
manner to update the technical specifications for eCQMs. We propose
that the technical specifications for eCQMs used in the Hospital OQR
Program would be contained in the CMS Annual Update for the Hospital
Quality Reporting Programs (Annual Update). The Annual Update and
implementation guidance documents are available on the eCQI Resource
Center website at: https://ecqi.healthit.gov/. For eCQMs, we would
generally update the measure specifications on an annual basis through
the Annual Update which includes code updates, logic corrections,
alignment with current clinical guidelines, and additional guidance for
hospitals and EHR vendors to use in order to collect and submit data on
eCQMs from hospital EHRs.
Hospitals would be required to register and submit quality data
through the Hospital Quality Reporting (HQR) System (formerly referred
to as the QualityNet Secure Portal). The HQR System is safeguarded in
accordance with the HIPAA Privacy and Security Rules to protect
submitted patient information. See 45 CFR parts 160 and 164, subparts
A, C, and E, for more information. We invite public comment on our
proposal.
We also refer readers to section XIV. of this proposed rule where
we request information on potential actions and priority areas that
would enable the continued transformation of our quality measurement
enterprise toward greater digital capture of data and use of the FHIR
standard (as described in that section).
9. Public Display of Quality Measures
a. Background
We refer readers to the CY 2009, CY 2014, and CY 2017 OPPS/ASC
final rules with comment period (73 FR 68777 through 68779, 78 FR
75092, and 81 FR 79791, respectively) for our previously finalized
policies regarding public display of quality measures. We are not
proposing any changes to these policies in this proposed rule.
b. Overall Hospital Quality Star Rating
In the CY 2021 OPPS/ASC final rule (85 FR 86182), we finalized a
methodology to calculate the Overall Hospital Quality Star Rating
(Overall Star Rating). We refer readers to section XVI. (``Overall
Hospital Quality Star Rating Methodology for Public Release in CY 2021
and Subsequent Years'') of the CY 2021 OPPS/ASC final rule with comment
period for details. We are not proposing any changes to this policy in
this proposed rule.
C. Administrative Requirements
1. QualityNet Account and Security Administrator/Security Official
a. Background
The previously finalized QualityNet security administrator
requirements, including setting up a QualityNet account and the
associated timelines, are described in the CY 2014 OPPS/ASC final rule
with comment period (78 FR 75108 through 75109). We codified these
procedural requirements at Sec. 419.46(b) in that final rule with
comment period. In the CY 2021 OPPS/ASC final rule with comment period
(85 FR 86182), we finalized to use the term ``security official''
instead of ``security administrator'' to denote the exercise of
authority invested in the role. The term ``security official'' would
refer to ``the individual(s)'' who have responsibilities for security
and account management requirements for a hospital's QualityNet
account. This update in terminology did not change the individual's
responsibilities or add burden. We are not proposing any changes to
this policy.
b. Active Security Official Account and Maintenance Requirements for
Data Submission
The previously finalized QualityNet security administrator (now
referred to as a security official) requirements, including those for
setting up a QualityNet account and the associated timelines, are
described in the CY 2014 OPPS/ASC final rule with comment period (78 FR
75108 through 75109).
[[Page 42257]]
In the CY 2011 OPPS/ASC final rule with comment period (75 FR
72099) and the CY 2012 OPPS/ASC final rule with comment period (76 FR
74479), we indicated that hospitals would be required to maintain a
current QualityNet security administrator (now referred to as a
security official) for as long as the hospital participates in the
Program. In this proposed rule, we are clarifying that failing to
maintain an active QualityNet security official once a hospital has
successfully registered to participate in the Hospital OQR Program will
not result in a finding that the hospital did not successfully
participate in the Hospital OQR Program. Again, we refer readers to
requirements at Sec. 419.46(b).
2. Requirements Regarding Participation Status
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75108 through 75109), the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70519), and the CY 2019 OPPS/ASC final rule
with comment period (83 FR 59103 through 59104) for requirements for
participation and withdrawal from the Hospital OQR Program. We codified
these requirements at Sec. 419.46(b) and (c). We are not proposing any
changes to these policies in this proposed rule.
D. Form, Manner, and Timing of Data Submitted for the Hospital OQR
Program
1. Hospital OQR Program Annual Submission Deadlines
We refer readers to the CYs 2014, 2016, and 2018 OPPS/ASC final
rules with comment period (78 FR 75110 through 75111; 80 FR 70519
through 70520; and 82 FR 59439, respectively) where we finalized our
policies for clinical data submission deadlines. We codified these
submission requirements at Sec. 419.46(d). The clinical data
submission deadlines for the CY 2024 payment determination are
illustrated in Table 50.
[GRAPHIC] [TIFF OMITTED] TP04AU21.099
We are not proposing any changes to these policies in this proposed
rule.
2. Requirements for Chart-Abstracted Measures Where Patient-Level Data
Are Submitted Directly to CMS for the CY 2024 Payment Determination and
Subsequent Years
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68481 through 68484) for a discussion of the form,
manner, and timing for data submission requirements of chart-abstracted
measures for the CY 2014 payment determination and subsequent years. We
are not proposing any changes to these policies in this proposed rule.
The following previously finalized Hospital OQR Program chart-
abstracted measures will require patient-level data to be submitted for
the CY 2023 payment determination and subsequent years:
OP-2: Median Time from ED Arrival to ED Departure for
Discharged ED Patients (NQF #0496); \273\
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\273\ In this year's proposed rule we are proposing to remove
OP-2 beginning with the CY 2023 reporting period/CY 2025 payment
determination.
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OP-3: Median Time from ED Arrival to ED Departure for
Discharged ED Patients (NQF #0496); \274\
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\274\ In this year's proposed rule we are proposing to remove
OP-3 beginning with the CY 2023 reporting period/CY 2025 payment
determination.
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OP-18: Median Time from ED Arrival to ED Departure for
Discharged ED Patients (NQF #0496); and
OP-23: Head CT Scan Results for Acute Ischemic Stroke or
Hemorrhagic Stroke Patients who Received Head CT Scan Interpretation
Within 45 Minutes of ED Arrival (NQF #0661).
3. Claims-Based Measure Data Requirements for the CY 2024 Payment
Determination and Subsequent Years
Currently, in addition to the proposed Breast Screening Recall
Rates measure, the following previously finalized Hospital OQR Program
claims-based measures are required for the CY 2023 payment
determination and subsequent years:
OP-8: MRI Lumbar Spine for Low Back Pain (NQF #0514);
OP-10: Abdomen CT--Use of Contrast Material;
OP-13: Cardiac Imaging for Preoperative Risk Assessment
for Non-Cardiac, Low Risk Surgery (NQF #0669);
OP-32: Facility 7-Day Risk-Standardized Hospital Visit
Rate after Outpatient Colonoscopy (NQF #2539);
OP-35: Admissions and Emergency Department Visits for
Patients Receiving Outpatient Chemotherapy;
OP-36: Hospital Visits after Hospital Outpatient Surgery
(NQF #2687); and
Breast Screening Recall Rates.\275\
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\275\ We note that, if finalized, an OP/measure number will be
assigned for this measure in the final rule.
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We refer readers to the CY 2019 OPPS/ASC final rule with comment
period (83 FR 59106 through 59107), where we established a 3-year
reporting period for OP-32: Facility 7-Day Risk-Standardized Hospital
Visit Rate after Outpatient Colonoscopy beginning with the CY 2020
payment determination and for subsequent years. In that final rule with
comment period (83 FR 59136 through 59138), we established a similar
policy under the ASCQR Program. We are not proposing any changes to
these policies in this proposed rule. We refer readers to section
XV.B.4.b. of this proposed rule where we are also proposing a 3-year
reporting period for the Breast Screening Recall Rates measure.
[[Page 42258]]
4. Data Submission Requirements for the OP-37a-e: Outpatient and
Ambulatory Surgery Consumer Assessment of Healthcare Providers and
Systems (OAS CAHPS) Survey-Based Measures for the CY 2024 Reporting
Period/CY 2026 Payment Determination and Subsequent Years
a. Background
We refer readers to the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79792 through 79794) for a discussion of the previously
finalized requirements related to survey administration and vendors for
the OAS CAHPS Survey-based measures. In addition, we refer readers to
the CY 2018 OPPS/ASC final rule with comment period (82 FR 59432
through 59433), where we finalized a policy to delay implementation of
the OP-37a-e OAS CAHPS Survey-based measures beginning with the CY 2020
payment determination (2018 reporting period) until further action in
future rulemaking.
b. Proposed Form, Manner, and Timing for OP-37a-e: Outpatient and
Ambulatory Surgery Consumer Assessment of Healthcare Providers and
Systems (OAS CAHPS) Survey-Based Measures Beginning With the CY 2024
Reporting Period/CY 2026 Payment Determination
As discussed in section XV.B.5.a. of this proposed rule, we are
proposing to begin data collection of five survey-based measures
derived from the OAS CAHPS Survey beginning with voluntary data
collection and reporting for the CY 2023 reporting period/CY 2025
payment determination,\276\ followed by mandatory reporting beginning
with the CY 2024 reporting period/CY 2026 payment determination and for
subsequent years. The OAS CAHPS survey contains three OAS CAHPS
composite survey-based measures and two global survey-based measures.
In this section, we are proposing requirements related to survey
administration, vendors, and oversight activities.
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\276\ As stated in section XV.B.5.a., we note that National OAS
CAHPS voluntary reporting program is independent of the Hospital OQR
Program, but the submission process will otherwise remain unchanged.
This proposal is intended to clarify that voluntary reporting of OAS
CAHPS would begin as part of the Hospital OQR Program in the CY 2023
reporting period until mandatory reporting would begin in the CY
2024 reporting period/CY 2026 payment determination and for
subsequent years, if both proposals are finalized.
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In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79792
through 79794), we previously discussed the form, manner, and timing of
this survey. In this proposed rule, we are reaffirming our approach to
the form, manner, and timing which OAS CAHPS information will be
submitted and we are now proposing to add two additional data
collection modes (web with mail follow-up of non-respondents and web
with telephone follow-up of non-respondents),\277\ beginning with
voluntary data collection for the CY 2023 reporting period/CY 2025
payment determination and continuing for mandatory reporting for
subsequent years. For more information about the modes of
administration, we refer readers to the OAS CAHPS website: https://oascahps.org. We reiterate our clarification from when we adopted these
measures in the CY 2017 OPPS/ASC final rule with comment period that,
when implemented, hospital outpatient departments that anticipate
receiving more than 300 surveys would be required to either: (1)
Randomly sample their eligible patient population; or (2) survey their
entire OAS CAHPS eligible patient population (81 FR 79773). We also
refer readers to section XVI.D.1.d. of the preamble of this proposed
rule where we are proposing similar policies for the ASCQR Program.
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\277\ The two additional modes will be available as part of
National OAS CAHPS voluntary reporting program in 2022.
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(1) Survey Requirements
The data collection modes as currently specified for the survey
include three administration modes: (1) Mail-only; (2) telephone-only;
and (3) mixed mode (mail with telephone follow-up of non-respondents).
We refer readers to the Protocols and Guidelines Manual for the OAS
CAHPS Survey (https://oascahps.org/Survey-Materials) for materials for
each mode of survey administration. In the 2018 OPPS/ASC final rule
with comment period, we expressed interest in investigating the
feasibility of offering the OAS CAHPS Survey using a web-based format
(82 FR 59433). As a result, we designed a mode experiment to assess the
impact of adding web-based survey administration. This mode experiment
tested five administration modes with patients who receive outpatient
surgical care: (1) Mail-only; (2) telephone-only; (3) web-only; (4) web
with mail follow-up; and (5) web with a telephone follow-up. Data
collection was completed in the fall of 2019. Response rates by mode in
the experiment were: 35 percent (mail-only); 19 percent (telephone-
only); 29 percent (web-only); 39 percent (web with mail follow-up); and
35 percent (web with telephone follow-up).
Based on these results, in addition to the three previously
established modes, in this proposed rule we are proposing to
incorporate two more administration methods: (1) Mixed mode web with
mail follow-up of non-respondents, and (2) mixed mode web with
telephone follow-up of non-respondents. This would allow a total of
five methods of survey administration for reporting beginning with
voluntary data collection and reporting as part of the Hospital OQR
Program for the CY 2023 reporting period/CY 2025 payment determination
\278\ and mandatory reporting for the CY 2024 reporting period/CY 2026
payment determination--the first year the survey would be required if
our proposal in section XV.B.5.a. is finalized as proposed. We are not
proposing a purely web-based format at this time because the use of a
web-based mode is included in the two mixed modes options being
proposed and the purely web-based format would create response bias
since not all patients have the ability to respond by web.
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\278\ As stated in section XV.B.5.a., we note that the two modes
(web with mail follow-up of non-respondents; and web with telephone
follow-up of non-respondents) will be available beginning in CY 2022
for National OAS CAHPS voluntary reporting, and then if finalized,
available as part of OQR Program's reporting beginning in the CY
2023 reporting period and subsequent years.
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For all five proposed modes of administration as part of the
Hospital OQR Program, we are proposing that data collection must be
initiated no later than 21 calendar days after the month in which a
patient has a surgery or procedure at a hospital and completed within 6
weeks (42 days) after initial contact of eligible patient begins,
beginning with voluntary reporting in the CY 2023 reporting period/CY
2025 payment determination and subsequent years. Under this proposal,
hospitals, via their CMS-approved vendors (discussed in section
XV.D.4.b.(2) of this proposed rule.), must make multiple attempts to
contact eligible patients unless the patient refuses or the vendor
learns that the patient is ineligible to participate in the survey. In
addition, we are proposing that hospitals, via their CMS-approved
survey vendor, collect survey data for eligible patients using the
established quarterly deadlines to report data to CMS for each data
collection period unless the hospital has been exempted from the OAS
CAHPS Survey requirements under the low volume exemption. We refer
readers to the CY 2017 OPPS/ASC final rule with comment period (81 FR
79774) where we previously established the low volume exemption, which
[[Page 42259]]
exempts hospital outpatient departments with fewer than 60 survey-
eligible patients during the ``eligibility period,'' (which is the
calendar year before the data collection period), that submit the
participation exemption request form, which would be made available on
the OAS CAHPS Survey website (https://oascahps.org) on or before May 15
of the data collection year. As finalized previously, all exemption
requests would be reviewed and evaluated by CMS (81 FR 79774). For
hospitals that do not have an exemption, the submission deadlines would
be posted on the OAS CAHPS Survey website (https://oascahps.org). Late
submissions would not be accepted.
As discussed in more detail in this section of the proposed rule,
compliance with the OAS CAHPS Survey protocols and guidelines,
including this monthly data collection requirement as part of each
quarterly data submission, would be overseen by CMS or its contractor
who would receive approved vendors' monthly submissions, review the
data, and analyze the results. We previously finalized (81 FR 79774)
all data collection and submission for the OAS CAHPS Survey measures
would be reported at the Medicare participating hospital level, as
identified by its CCN. If data collection and reporting becomes
mandatory beginning with the CY 2024 reporting period as proposed,
under this proposal, all locations that offer outpatient services, of
each eligible Medicare participating hospital, would be required to
participate in the OAS CAHPS Survey (81 FR 79793), except for those
that meet and receive an exception for having fewer than 60 survey-
eligible patients during the year preceding the data collection period
(81 FR 79773). Therefore, the survey data reported using a Medicare
participating hospital's CCN must include all eligible patients from
all outpatient locations (whether the hospital outpatient department is
on campus or off campus) of an eligible Medicare participating
hospital; or if more than 300 completed surveys are anticipated, a
hospital can choose to randomly sample their eligible patient
population (81 FR 79784).
In this proposed rule, we also propose that survey vendors acting
on behalf of hospitals must submit data by the specified data
submission deadlines, which generally would be posted on the OAS CAHPS
Survey website located at https://oascahps.org/Data-Submission/Data-Submission-Deadlines. If a hospital's data are submitted after the data
submission deadline, it would not fulfill the OAS CAHPS quality
reporting requirements. Therefore, in regard to any OAS CAHPS
reporting, we would strongly encourage hospitals to be fully apprised
of the methods and actions of their survey vendors--especially the
vendors' full compliance with OAS CAHPS Survey administration
protocols--and to carefully inspect all data warehouse reports in a
timely manner.
We reiterate that the use of predictive or auto dialers in
telephonic survey administration is governed by the Telephone Consumer
Protection Act (TCPA) (47 U.S.C. 227) and subsequent regulations
promulgated by the Federal Communications Commission (FCC) (47 CFR
64.1200) and Federal Trade Commission. We refer readers to the FCC's
declaratory ruling released on July 10, 2015 further clarifying the
definition of an auto dialer, available at: https://apps.fcc.gov/edocs_public/attachmatch/FCC-15-72A1.pdf. In the telephone-only and
mixed mode survey administration methods involving telephone, hospitals
and vendors must comply with the regulations and any other applicable
regulations. To the extent that any existing CMS technical guidance
conflicts with the TCPA or its implementing regulations regarding the
use of predictive or auto dialers, or any other applicable law, CMS
would expect vendors to comply with applicable law.
We invite comments on our proposals as discussed previously.
(2) Vendor Requirements
We are not proposing new vendor requirements, but reiterate the
vendor requirements finalized in the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79793 through 79794) to ensure that patients
respond to the survey in a way that reflects their actual experiences
with outpatient care, and is not influenced by the hospital. We
finalized that hospitals must contract with a CMS-approved OAS CAHPS
Survey vendor to conduct or administer the survey. We believe that a
neutral third-party should administer the survey for hospitals, and it
is our belief that an experienced survey vendor would be best able to
ensure reliable results. CAHPS Survey-approved vendors are also already
used or required in the following CMS quality programs: The Hospital
IQR Program (71 FR 68203 through 68204); the Hospital VBP Program (76
FR 26497, 26502 through 26503, and 26510); the End Stage Renal Disease
Quality Improvement Program (76 FR 70269 through 70270); the Home
Health QRP (80 FR 68709 through 68710); and the Hospice QRP (80 FR
47141 through 47207).
Information about the list of approved survey vendors and how to
authorize a vendor to collect data on a hospital's behalf is available
through the OAS CAHPS Survey website at: https://oascahps.org. The web
portal has both public and secure (restricted access) sections to
ensure the security and privacy of selected interactions. As mentioned
previously, requirements for survey vendors were previously finalized
in the CY 2017 OPPS/ASC final rule with comment period (81 FR 79793
through 79794) and codified at Sec. 419.46(h)(2). Hospitals will need
to register on the OAS CAHPS Survey website (https://oascahps.org) in
order to authorize the CMS-approved vendor to administer the survey and
submit data on their behalf. Each hospital must then administer (via
its vendor) the survey to all eligible patients (or for those
anticipating more than 300 completed surveys, randomly sample their
eligible patient population) treated during the data collection period
on a monthly basis according to the guidelines in the Protocols and
Guidelines Manual (https://oascahps.org) and report the survey data to
CMS on a quarterly basis by the deadlines posted on the OAS CAHPS
Survey website.
5. Data Submission Requirements for Measures Submitted via a Web-Based
Tool for the CY 2023 Payment Determination and Subsequent Years
a. Data Submission Requirements for Measures Submitted via a CMS Web-
Based Tool
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75112 through 75115), the CY 2016 OPPS/ASC final rule
with comment period (80 FR 70521), and the QualityNet website available
at: https://qualitynet.cms.gov for a discussion of the requirements for
measure data submitted via the HQR System (formerly referred to as the
QualityNet Secure Portal) for the CY 2017 payment determination and
subsequent years. We are not proposing any changes to these policies.
The following previously adopted quality measures require data to
be submitted via a CMS web-based tool for the CY 2022 reporting period/
CY 2024 payment determination and subsequent years:
OP-22: Left Without Being Seen (NQF #0499); and
OP-29: Endoscopy/Polyp Surveillance: Appropriate Follow-up
[[Page 42260]]
Interval for Normal Colonoscopy in Average Risk Patients (NQF #0658).
(1) Proposed Form, Manner, and Timing for Reporting OP-31: Cataracts:
Improvement in Patient's Visual Function Within 90 Days Following
Cataract Surgery (NQF #1536)
The following measure that is being proposed for modification in
this proposed rule would require data to be submitted via a CMS web-
based tool for the CY 2023 reporting period/CY 2025 payment
determination and subsequent years:
OP-31: Cataracts: Improvement in Patient's Visual Function
within 90 Days Following Cataract Surgery (NQF #1536).
We propose that this measure would be submitted according to our
existing policies for data submitted via the HQR System (formerly
referred to as the QualityNet Secure Portal). As noted earlier, we are
not proposing changes to those policies. We invite public comment on
our proposal.
b. Data Submission Requirements for Measures Submitted via the CDC NHSN
Website
We refer readers to the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75097 through 75100) for a discussion of the previously
finalized requirements for measure data submitted via the CDC NHSN
website. While we are not proposing any changes to those policies in
this proposed rule, we are proposing policies specific to the proposed
COVID-19 Vaccination Coverage Among HCP measure, which would be
submitted via the CDC NHSN website.
(1) Proposed Form, Manner, and Timing for the COVID-19 Vaccination
Coverage Among HCP Measure Beginning With the CY 2022 Reporting Period/
CY 2024 Payment Determination and Subsequent Years
For the COVID-19 Vaccination Coverage Among HCP measure, we are
proposing to require reporting data on the number of HCP who have
received the completed vaccination course of a COVID-19 vaccine by each
individual facility's CCN.
For the COVID-19 Vaccination Coverage Among HCP measure, we are
proposing that facilities would report COVID-19 vaccination data to the
NHSN for at least one week each month, beginning with the January 1,
2022 through December 31, 2022 reporting period affecting the CY 2024
payment determination and continuing with quarterly reporting deadlines
for subsequent years. If facilities report more than one week of data
in a month, the most recent week's data would be used for measure
calculation purposes. We propose that hospitals would report the
measure through the NHSN web-based surveillance system.\279\
Specifically, hospitals would use the COVID-19 vaccination data
reporting modules in the NHSN Healthcare Personnel Safety (HPS)
Component to report the number of HCP eligible to have worked at the
facility that week (denominator) and the number of those HCP who have
received COVID-19 vaccination (numerator). Specific details on data
submission for this measure can be found in the CDC's Overview of the
Healthcare Safety Component, available at https://www.cdc.gov/nhsn/PDFs/slides/NHSN-Overview-HPS_Aug2012.pdf. We refer readers to the CY
2014 OPPS/ASC final rule (78 FR 75097 through 75100) for details about
requirements for measure data submitted via the NHSN. Each quarter, the
CDC would calculate a summary measure of COVID-19 vaccination coverage
from the reporting periods for the quarter in four-quarter increments,
when four quarters of data are available.
---------------------------------------------------------------------------
\279\ Centers for Disease Control and Prevention. Surveillance
for Weekly HCP COVID-19 Vaccination. Accessed at: https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html on February 10,
2021.
---------------------------------------------------------------------------
With respect to public reporting of this measure, for each CCN, a
percentage of the HCP who received a complete course of the COVID-19
vaccine would be calculated and publicly reported on the Care Compare
website, so that the public would know what percentage of the HCP have
been vaccinated in each hospital. Once four quarters are available,
data would be refreshed on a quarterly basis with the most recent four
quarters. This quarterly average COVID-19 vaccination coverage would be
publicly reported. We invite public comment on our proposals.
6. Proposed eCQM Reporting and Submission Requirements
a. Background
We believe that collection and reporting of data through health
information technology would greatly simplify and streamline reporting
for many CMS quality reporting programs. Through electronic reporting,
hospitals will be able to leverage EHRs to capture, calculate, and
electronically submit quality data to CMS for the Hospital OQR Program.
We believe that automated electronic extraction and reporting of
clinical quality data would significantly reduce the administrative
burden on hospitals for the Hospital OQR Program. We believe that the
use of CEHRT can effectively and efficiently help providers improve
internal care delivery practices, support management of patient care
across the continuum, and support the reporting of eCQMs. In previous
rules, we stated our intent and assessment of the inclusion of eCQMs
into the Hospital OQR Program, and we have sought public comment on the
addition of such measures into the measure set. We refer readers to the
CY 2014 OPPS/ASC final rule with comment period (78 FR 75106 through
75107), the CY 2015 OPPS/ASC final rule with comment period (79 FR
66956 through 66961), the CY 2016 OPPS/ASC final rule with comment
period (80 FR 70516 through 70518), the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79785 through 79790), and the CY 2018 OPPS/
ASC final rule with comment period (82 FR 59435 through 59438) for more
details on previous discussion regarding future measure concepts
related to eCQMs and electronic reporting of data for the Hospital OQR
Program, including stakeholder support for the introduction of eCQMs
into the Program. Measure stewards and developers have worked to
advance eCQMs that would be reported in the outpatient setting and we
believe the introduction of eCQMs in the Hospital OQR Program is
timely. We also believe this is important in aligning the Hospital OQR
Program with the Medicare Promoting Interoperability Program and the
Hospital IQR Program.
b. Proposed eCQM Reporting and Data Submission Requirements Beginning
With the CY 2023 Reporting Period/CY 2025 Payment Determination
In section XV.B.4.c. of the preamble of this proposed rule, we
discuss the proposed adoption of the STEMI eCQM. In this proposed rule,
we are proposing a progressive increase in the number of quarters for
which hospitals report eCQM data. Increasing the number of reported
quarters to be reported has several benefits. Primarily, a single
quarter of data is not enough to capture trends in performance over
time. Evaluating multiple quarters of data would provide a more
reliable and accurate picture of overall performance. Further,
reporting multiple quarters of data would provide hospitals with a more
continuous information stream to monitor their levels of performance.
Ongoing, timely data analysis can better identify a change in
performance that may necessitate investigation and potentially
corrective action.
However, we believe that starting with limited voluntary reporting
would
[[Page 42261]]
give hospitals more time to gain experience with reporting data
(including time to implement the eCQM and provide training to support
eCQM reporting, if necessary). Similar to what was established for the
Hospital IQR Program (82 FR 38355), we believe that increasing the
number of quarters for which hospitals report eCQM data would produce
more comprehensive and reliable quality measure data for patients and
providers. In section XV.B.4.c. of this proposed rule, we are proposing
to adopt the STEMI eCQM with voluntary reporting beginning with the CY
2023 reporting period. For the CY 2023 reporting period, we propose
that hospitals that submit STEMI eCQM data during this reporting period
voluntarily submit any quarter(s) of data. Hospitals that chose to
submit voluntarily must submit in compliance with the eCQM
certification requirements proposed in sections XV.D.6.c., XV.D.6.d,
and XV.D.6.e. of this proposed rule.
For the CY 2024 reporting period/CY 2026 payment determination, we
propose that hospitals report one self-selected calendar quarter of
data for the STEMI eCQM. We note that in section XV.B.4.c. of this
proposed rule, we are proposing that the STEMI eCQM is required
beginning with the CY 2024 reporting period/CY 2026 payment
determination.
For the CY 2025 reporting period/CY 2027 payment determination, we
propose to increase the amount of data required. We are proposing that
hospitals report two self-selected calendar quarters of data for the
required STEMI eCQM.
For the CY 2026 reporting period/CY 2028 payment determination, we
propose to further increase the amount of data required for the STEMI
eCQM. Specifically, in this proposed rule, we are proposing to require
that hospitals report three self-selected calendar quarters of data for
the CY 2026 reporting period/CY 2028 payment determination for the
required STEMI eCQM. Beginning with the CY 2027 reporting period/CY
2029 payment determination, we propose to require that hospitals report
all four calendar quarters (one calendar year) of data for the required
STEMI eCQM.
We also refer readers to Table 51 for a summary of the proposed
quarterly data increase in eCQM reporting beginning with the CY 2023
reporting period.
[GRAPHIC] [TIFF OMITTED] TP04AU21.100
We invite public comment on our proposals.
c. Proposed Electronic Quality Measure Certification Requirements for
eCQM Reporting
(1) Proposal To Require Use of 2015 Edition Cures Update Certified
Technology Beginning With the CY 2023 Reporting Period/CY 2025 Payment
Determination
In May 2020, the ONC 21st Century Cures Act final rule (85 FR 25642
through 25961) finalized updates to the 2015 Edition of health IT
certification criteria (hereto referred to as the ``2015 Edition Cures
Update''). These updates included revisions to the clinical quality
measurement certification criterion at 45 CFR 170.315(c)(3) to refer to
CMS Quality Reporting Data Architecture (QRDA) IGs and remove the
Health Level 7 (HL7[supreg]) QRDA standard from the relevant health IT
certification criteria (85 FR 25645). The ONC 21st Century Cures Act
final rule provided health IT developers up to 24 months from May 1,
2020 to make technology certified to the updated and/or new criteria
available to their customers (85 FR 25670). In November 2020, ONC
issued an interim final rule with comment (85 FR 70064) which extended
the compliance deadline for the update to the Clinical Quality
Measures-Report criterion until December 31, 2022 (85 FR 70075). These
updates were finalized to reduce burden on health IT developers under
the ONC Health IT certification program (85 FR 25686) and have no
impact on providers' existing reporting practices for CMS programs.
For the Hospital OQR Program, we propose to require hospitals to
utilize certified technology updated consistent with the 2015 Edition
Cures Update for the CY 2023 reporting period/CY 2025 payment
determination and subsequent years, which includes both the voluntary
period and required submissions. We note that this proposal is in
alignment with the Hospital IQR Program proposal in the FY 2022 IPPS/
LTCH PPS proposed rule that requires use of technology updated
consistent with 2015 Edition Cures Update beginning with the CY 2023
reporting period/FY 2025 payment determination (86 FR 25595). We invite
public comment on our proposal.
d. File Format for EHR Data, Zero Denominator Declarations, and Case
Threshold Exemptions
(1) File Format for EHR Data
Data can be collected in EHRs and health information technology
systems using standardized formats to promote consistent representation
and interpretation, as well as to allow for systems to compute data
without needing human interpretation. As described in the FY 2016 IPPS/
LTCH PPS final rule (80 FR 49701), these standards are referred to as
content exchange standards because the standard details how data should
be represented and the relationships between data elements. This allows
the data to be exchanged across EHRs and health IT systems while
retaining their meaning. Commonly used content exchange standards
include the QRDA. The QRDA standard provides a document format and
standard structure to electronically report quality measure data. We
believe electronically reporting data elements formatted according to
the QRDA standard would promote consistent representation and more
efficient calculation of eCQM measure results.
[[Page 42262]]
Therefore, in alignment with the Hospital IQR Program file format
requirements (85 FR 58940), we are proposing the requirements beginning
with the CY 2023 reporting period/CY 2025 payment determination.
Specifically, we are proposing that hospitals: (1) Must submit eCQM
data via the QRDA Category I (QRDA I) file format; \280\ (2) may use
third parties to submit QRDA I files on their behalf; and (3) may
either use abstraction or pull the data from non-certified sources in
order to then input these data into CEHRT for capture and reporting
QRDA I. Hospitals could meet the reporting requirements by submitting
data via QRDA I files, zero denominator declaration, or case threshold
exemptions. We discuss the zero denominator declaration and case
threshold exemptions in the subsequent sections. We also refer readers
to section XV.B.8. where we outline the maintenance of technical
specifications including those for eCQMs.
---------------------------------------------------------------------------
\280\ QRDA I is an individual patient-level quality report that
contains quality data for one patient for one or more eCQMs. QRDA
creates a standard method to report quality measure results in a
structured, consistent format and can be used to exchange eCQM data
between systems. For further detail on QRDA I, the most recently
available QRDA I specifications and Implementation Guides (IGs) can
be found at: https://ecqi.healthit.gov/qrda.
---------------------------------------------------------------------------
Under this proposal, we expect QRDA I files to reflect data for one
patient per file per quarter with five key elements necessary to
identify the file:
CMS Certification Number (CCN);
CMS Program Name;
EHR Patient ID;
Reporting period specified in the Reporting Parameters
Section; and
EHR Submitter ID.
We invite public comment on our proposal.
(2) Zero Denominator Declarations
We understand there may be situations in which a hospital does not
have data to report on a particular eCQM. Therefore, we propose if the
hospital's EHR is certified to an eCQM, but the hospital does not have
patients that meet the denominator criteria of that eCQM, the hospital
can submit a zero in the denominator for that eCQM. Submission of a
zero in the denominator for an eCQM counts as a successful submission
for that eCQM for the Hospital OQR Program. For example, if the
hospital within the previously mentioned health system does not provide
fibrinolytic therapy, but one of the eCQMs the health system's EHR is
certified to is a fibrinolytic therapy measure, that hospital's EHR may
render a zero in the denominator for that eCQM. The hospital would
therefore report a zero denominator for that fibrinolytic therapy eCQM,
and this would count toward the required eCQMs for the Hospital OQR
Program. Hospitals within that health system for which that
fibrinolytic therapy eCQM does apply would provide data on that
measure. We invite public comment on our proposal.
(3) Case Threshold Exemptions
We understand that in some cases, a hospital may not meet the case
threshold of discharges for a particular eCQM. We propose to align with
the case threshold exemption from the Medicare Promoting
Interoperability Program (77 FR 54080) and the Hospital IQR Program (79
FR 50324). As stated for the Hospital IQR Program, the case threshold
exemption means that for each quality measure for which hospitals do
not have a minimum number of patients that meet the patient population
denominator criteria for the relevant reporting period, hospitals would
have the ability to declare a ``case threshold exemption'' if they have
five or fewer applicable discharges. Specifically, for the Hospital OQR
Program we propose that beginning with the CY 2023 reporting period/CY
2025 payment determination, if a hospital's EHR system is certified to
report an eCQM and the hospital experiences 5 or fewer outpatient
discharges per quarter or 20 or fewer outpatient discharges per year
(Medicare and non-Medicare combined), as defined by an electronic
clinical quality measure's denominator population, that hospital could
be exempt from reporting on that electronic clinical quality measure.
Case threshold exemptions are entered on the Denominator Declaration
screen within the HQR System (formerly referred to as the QualityNet
Secure Portal) available during the submission period.\281\ The
exemption would not have to be used; hospitals could report those
individual cases if they would like to. We invite public comment on our
proposal.
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\281\ CMS Adds New Features to Denominator Declaration Screen
for eCQM Reporting, available at: https://qualitynet.cms.gov/news/5fa161829314190021d3c262.
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e. Submission Deadlines for eCQM Data
In the FY 2017 IPPS/LTCH PPS final rule (81 FR 57172), the Hospital
IQR Program aligned their eCQM submission deadline with that of the
Medicare Promoting Interoperability Program. The eCQM submission
deadline for those two programs is the end of two months following the
close of the CY (beginning with the CY 2017 reporting period/FY 2019
payment determination and for subsequent years).
In this proposed rule, for the Hospital OQR Program, we are also
proposing to require eCQM data submission by the end of 2 months
following the close of the calendar year for the CY 2023 reporting
period/CY 2025 payment determination and for subsequent years. We
believe that by aligning with the Hospital IQR and Promoting
Interoperability Programs' deadlines, we would not add unnecessary
burden. For example, for the CY 2023 reporting period/CY 2025 payment
determination, hospitals that choose to voluntarily report that
calendar year would be required to submit eCQM data by February 29,
2024, which is the end of 2 months following the close of the calendar
year (December 31, 2023).
In crafting this proposal, we also considered proposing a
submission deadline of May 15 to align with the submission deadline for
Hospital OQR web-based measures. Under the Hospital OQR Program, the
data submission period for web-based measures (for example, OP-29 and
OP-31) extends through May 15 (we note the submission deadline may be
moved to the next business day if it falls on a weekend or Federal
holiday). However, we ultimately proposed instead to align eCQM data
submission deadlines across quality reporting programs, because we
believe that it would be less burdensome for hospitals.
We invite public comment on our proposal.
7. Population and Sampling Data Requirements for the CY 2022 Payment
Determination and Subsequent Years
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72100 through 72103) and the CY 2012 OPPS/ASC final rule
with comment period (76 FR 74482 through 74483) for discussions of our
population and sampling requirements. We are not proposing any changes
to these policies in this proposed rule. We note that we are not
proposing any population and sampling data policies related to eCQM
reporting, because we would expect data for all patients who meet the
patient population denominator criteria to be reported, if our eCQM-
related proposals are finalized as proposed.
8. Review and Corrections Period for Measure Data Submitted to the
Hospital OQR Program
a. Chart-Abstracted Measures
We refer readers to the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66964 and 67014) where
[[Page 42263]]
we formalized a review and corrections period for chart-abstracted
measures in the Hospital OQR Program. We are not proposing any changes
to these policies in this proposed rule.
b. Web-Based Measures
In the CY 2021 OPPS/ASC final rule (85 FR 86184), we finalized and
codified to expand our review and corrections policy to apply to
measure data submitted via the CMS web-based tool beginning with data
submitted for the CY 2023 payment determination and subsequent years.
We are not proposing any changes to these policies in this proposed
rule.
c. Electronic Clinical Quality Measures (eCQMs)
In this proposed rule, we are proposing that hospitals would have a
review and corrections period for eCQM data submitted to the Hospital
OQR Program. We propose a review and corrections period for eCQM data
which would run concurrently with the data submission period. The
review and corrections period is from the time the submission period
opens to the submission deadline. In the HQR System (formerly referred
to as the QualityNet Secure Portal), providers can submit QRDA Category
I test and production data files and can correct QRDA Category I test
and production data files before production data is submitted for final
reporting. We encourage early testing and the use of pre-submission
testing tools to reduce errors and inaccurate data submissions in eCQM
reporting. The HQR System does not allow data to be submitted or
corrected after the annual deadline. We refer readers to the HQR System
website (available at: https://hqr.cms.gov/hqrng/login) and the eCQI
Resource Center (available at: https://ecqi.healthit.gov/) for more
resources on eCQM reporting.
We invite public comment on our proposal.
d. OAS CAHPS Measures
Each hospital administers (via its vendor) the survey for all
eligible patients treated during the data collection period on a
monthly basis according to the guidelines in the Protocols and
Guidelines Manual (https://oascahps.org) and report the survey data to
CMS on a quarterly basis by the deadlines posted on the OAS CAHPS
Survey website as stated in section XV.D.4.b.(2). of this proposed
rule. As finalized in the CY 2017 OPPS/ASC final rule with comment
period, data cannot be altered after the data submission deadline but
can be reviewed prior to the submission deadline (81 FR 79793).
9. Hospital OQR Program Validation Requirements
a. Background
We refer readers to the CY 2011 OPPS/ASC final rule with comment
period (75 FR 72105 through 72106), the CY 2013 OPPS/ASC final rule
with comment period (77 FR 68484 through 68487), the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66964 through 66965), the CY 2016
OPPS/ASC final rule with comment period (80 FR 70524), the CY 2018
OPPS/ASC final rule with comment period (82 FR 59441 through 59443),
and 42 CFR[thinsp]419.46(f) for our policies regarding validation.
b. Proposal To Use Electronic File Submissions for Chart-Abstracted
Measure Medical Records Requests Beginning With the CY 2022 Reporting
Period/CY 2024 Payment Determination and Subsequent Years
Currently, hospitals may choose to submit paper copies of medical
records for chart-abstracted measure validation, or they may submit
copies of medical records for validation by securely transmitting
electronic versions of medical information (79 FR 66965 through 66966).
Submission of electronic versions can either entail downloading or
copying the digital image of the medical record onto Compact Disc (CD),
Digital Video Disc (DVD), or flash drive, or submission of Portable
Document Format (PDF) using a secure file transmission process after
logging into the HQR System (formerly referred to as the QualityNet
Secure Portal) (79 FR 66966). We reimburse hospitals at $3.00 per chart
(FY 2016 IPPS/LTCH PPS final rule (80 FR 49763)).
We strive to provide the public with accurate quality data while
maintaining alignment with hospital recordkeeping practices. We
appreciate that hospitals have rapidly adopted EHR systems as their
primary source of information about patient care, which can facilitate
the process of producing electronic copies of medical records.
Additionally, we monitor the medical records submissions to the CMS
Clinical Data Abstraction Center (CDAC) contractor and have found that
almost two-thirds of hospitals already use the option to submit PDF
copies of medical records as electronic files. In our assessment based
on this monitoring, we believe requiring electronic file submissions
can be a more effective and efficient process for hospitals selected
for validation.
Therefore, in this proposed rule, we are proposing to discontinue
the option for hospitals to send paper copies of, or CDs, DVDs, or
flash drives containing medical records for validation affecting the CY
2024 payment determination (that is, beginning with data submission for
Q1 of CY 2022). We are proposing to require hospitals to instead submit
only electronic files when submitting copies of medical records for
validation of chart-abstracted measures, beginning with validation
affecting the CY 2024 payment determination (that is, Q1 of CY 2022)
and for subsequent years. Under this proposal, hospitals would be
required to submit PDF copies of medical records using direct
electronic file submission via a CMS-approved secure file transmission
process as directed by CDAC. We would continue to reimburse hospitals
at $3.00 per chart, consistent with the current reimbursement amount
for electronic submissions of charts. We note that this process would
align with that for the Hospital IQR Program (FY 2016 IPPS/LTCH PPS
final rule (85 FR 58949)).
Requiring electronic file submissions reduces the burden of not
only coordinating numerous paper-based pages of medical records, but
also of having to then ship the papers or physical digital media
storage to the CDAC. Therefore, we believe it is appropriate to require
that hospitals use electronic file submissions via a CMS-approved
secure file transmission process. We invite public comment on our
proposal.
c. Proposal To Change the Time Period for Chart-Abstracted Measure Data
Validation for Validations Affecting the CY 2024 Payment Determination
and Subsequent Years
We refer readers to the chart-abstracted validation requirements
and methods we adopted in the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75117 through 75118) and codified at 42 CFR 419.46(f)(1)
for the CY 2024 payment determination and subsequent years. In previous
years, charts were requested by the CMS CDAC contractor and hospitals
were given 45 calendar days from the date of the request to submit the
requested records. If any record(s) were not received by the 45-day
requirement, the CMS CDAC contractor assigned a ``zero'' validation
score to each measure in a missing record. Using data from the CDAC, we
have found that a large majority of hospitals that have participated in
Hospital OQR Program data validation efforts have submitted their
records prior to 30 calendar days in the current process. Furthermore,
[[Page 42264]]
outpatient records typically contain significantly fewer pages than the
inpatient records that hospitals have been submitting to the Hospital
IQR Program for several years, which suggests that outpatient records
could be gathered in less time and use less resources.
Therefore, in this proposed rule, we are proposing to revise Sec.
419.46(f)(1) to change the time period given to hospitals to submit
medical records to the CDAC contractor from 45 calendar days to 30
calendar days, beginning with medical record submissions for encounters
in Q1 of CY 2022/validations affecting the CY 2024 payment
determination and for subsequent years. We are proposing this deadline
modification to reduce the time needed to complete validation, provide
hospitals with feedback on their abstraction accuracy in a timelier
manner, and to further align with the Hospital IQR Program's validation
policy (76 FR 51645). We invite public comment on our proposal.
d. Targeting Criteria
(1) Background
In the CY 2012 OPPS/ASC final rule with comment period (76 FR
74485), we finalized a validation selection process in which we select
a random sample of 450 hospitals for validation purposes and select an
additional 50 hospitals based on specific criteria. We finalized a
policy in the CY 2013 OPPS/ASC final rule with comment period (77 FR
68485 through 68486), that for the CY 2014 payment determination and
subsequent years, a hospital will be preliminarily selected for
validation based on targeting criteria if it fails the validation
requirement that applies to the previous year's payment determination.
We also refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68486 through 68487) for a discussion of finalized
policies regarding our medical record validation procedure
requirements. We codified at Sec. 419.46(f)(3) that we select a random
sample of 450 hospitals for validation purposes, and select an
additional 50 hospitals for validation purposes based on the following
criteria:
The hospital fails the validation requirement that applies
to the previous year's payment determination; or
The hospital has an outlier value for a measure based on
the data it submits. An ``outlier value'' is a measure value that is
greater than 5 standard deviations from the mean of the measure values
for other hospitals and indicates a poor score.
In the CY 2018 OPPS/ASC final rule with comment period (82 FR
59441), we clarified that an ``outlier value'' for purposes of this
targeting is defined as a measure value that appears to deviate
markedly from the measure values for other hospitals.
(2) Proposal To Add Targeting Criteria
Beginning with validations affecting the CY 2022 reporting period/
CY 2024 payment determination and subsequent years, we are proposing to
add to the two established targeting criteria used to select the 50
additional hospitals. Specifically, we are proposing to revise Sec.
419.46(f)(3) to add the following criteria for targeting the additional
50 hospitals:
Any hospital that has not been randomly selected for
validation in any of the previous 3 years.
Any hospital that passed validation in the previous year,
but had a two-tailed confidence interval that included 75 percent.
We believe these proposals would allow more hospitals the
opportunity for validation. First, by adding targeting criteria for any
hospital that has not been randomly selected for validation in any of
the previous 3 years, we can ensure that hospitals are eligible to be
validated on a regular basis even if they are not selected under the
randomly selected sample. Second, the option to selectively review
hospitals that have a confidence interval that includes 75 percent is
important because hospitals whose confidence interval includes 75
percent indicates a higher level of uncertainty as to the reliability
of data for that particular hospital. By adding the targeting criteria
for hospitals with two-tailed confidence interval that includes 75
percent, we can target those hospitals that are in the statistical
margin of error for their accuracy (which includes hospitals that both
pass and fail on this level). These proposals also align Hospital OQR
Program validation with additional aspects of Hospital IQR Program
validation (77 FR 53553). We believe that these proposed additional
criteria would improve data quality by increased targeting of hospitals
with possible or confirmed past data quality issues. Additionally, this
proposal would respond to concerns that CMS does not have a methodology
to address hospitals for which both passing and falling levels of
accuracy were included for the statistical margin of error.\282\ We
invite public comment on our proposals.
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\282\ Government Accountability Office. ``Hospital Quality Data.
CMS needs more rigorous methods to ensure reliability of publicly
released data''. GAO-06-54, January 2006.
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e. Educational Review Process and Score Review and Correction Period
for Chart-Abstracted Measures
We refer readers to the CY 2018 OPPS/ASC final rule with comment
period (82 FR 59441 through 59443) and the CY 2021 OPPS/ASC final rule
with comment period (85 FR 86185), where we finalized and codified a
policy to formalize the Educational Review Process for Chart-Abstracted
Measures, including Validation Score Review and Correction.
We are not proposing any changes to these policies in this proposed
rule.
10. Extraordinary Circumstances Exception (ECE) Process for the CY 2022
Payment Determination and Subsequent Years
a. Background
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68489), the CY 2014 OPPS/ASC final rule with comment
period (78 FR 75119 through 75120), the CY 2015 OPPS/ASC final rule
with comment period (79 FR 66966), the CY 2016 OPPS/ASC final rule with
comment period (80 FR 70524), the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79795), the CY 2018 OPPS/ASC final rule with
comment period (82 FR 59444), and 42 CFR 419.46(e) for a complete
discussion of our extraordinary circumstances exception (ECE) process
under the Hospital OQR Program.
b. Proposal To Expand the Extraordinary Circumstances Exemption to
eCQMs
As part of our proposed policies in support of the introduction of
eCQMs into the Hospital OQR Program, beginning with the CY 2024
reporting period/CY 2026 payment determination and for subsequent
years, we are proposing to expand our established Extraordinary
Circumstances Exceptions policy to allow hospitals to request an
exception from the Hospital OQR Program's eCQM reporting requirements
based on hardships preventing hospitals from electronically reporting.
We note that our proposal aligns with the Hospital IQR Program's
Extraordinary Circumstances Exceptions policy for eCQMs (80 FR 49695,
42 CFR 412.140(c)(2)).
Under this proposal, applicable hardships could include, but are
not limited to, infrastructure challenges (hospitals must demonstrate
that they are in an area without sufficient internet access or face
insurmountable barriers to obtaining infrastructure) or unforeseen
circumstances, such as
[[Page 42265]]
vendor issues outside of the hospital's control (including a vendor
product losing certification). In addition, under the Hospital OQR
Program, we may consider being a newly participating hospital as
undergoing hardship such that newly participating hospitals can apply
for an exemption for the applicable program year. Newly participating
hospitals are required to begin data submission under the Hospital OQR
Program procedural requirements at Sec. 419.46(d)(1), which describes
submission and validation of Hospital OQR Program data.
We also propose that a hospital participating in the Hospital OQR
Program that wishes to request an exception must submit its request to
CMS by April 1 following the end of the reporting calendar year in
which the extraordinary circumstances occurred. For example, if an
extraordinary circumstance occurred on or by December 31, 2024, the ECE
request must be submitted by April 1, 2025. Specific requirements for
submission of a request for an exception would be available on the
QualityNet website available at: https://qualitynet.cms.gov/.
We invite public comment on our proposals.
11. Hospital OQR Program Reconsideration and Appeals Procedures for the
CY 2022 Payment Determination and Subsequent Years
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68487 through 68489), the CY 2014 OPPS/ASC final rule
with comment period (78 FR 75118 through 75119), the CY 2016 OPPS/ASC
final rule with comment period (80 FR 70524), the CY 2017 OPPS/ASC
final rule with comment period (81 FR 79795), the CY 2021 OPPS/ASC
final rule with comment period (85 FR 68185), and 42 CFR 419.46(g) for
our reconsideration and appeals procedures. We are not proposing any
changes to these policies in this proposed rule.
E. Proposed Payment Reduction for Hospitals That Fail To Meet the
Hospital OQR Program Requirements for the CY 2022 Payment Determination
1. Background
Section 1833(t)(17) of the Act, which applies to subsection (d)
hospitals (as defined under section 1886(d)(1)(B) of the Act), states
that hospitals that fail to report data required to be submitted on
measures selected by the Secretary, in the form and manner, and at a
time, specified by the Secretary will incur a 2.0 percentage point
reduction to their Outpatient Department (OPD) fee schedule increase
factor; that is, the annual payment update factor. Section
1833(t)(17)(A)(ii) of the Act specifies that any reduction applies only
to the payment year involved and will not be taken into account in
computing the applicable OPD fee schedule increase factor for a
subsequent year.
The application of a reduced OPD fee schedule increase factor
results in reduced national unadjusted payment rates that apply to
certain outpatient items and services provided by hospitals that are
required to report outpatient quality data in order to receive the full
payment update factor and that fail to meet the Hospital OQR Program
requirements. Hospitals that meet the reporting requirements receive
the full OPPS payment update without the reduction. For a more detailed
discussion of how this payment reduction was initially implemented, we
refer readers to the CY 2009 OPPS/ASC final rule with comment period
(73 FR 68769 through 68772).
The national unadjusted payment rates for many services paid under
the OPPS equal the product of the OPPS conversion factor and the scaled
relative payment weight for the APC to which the service is assigned.
The OPPS conversion factor, which is updated annually by the OPD fee
schedule increase factor, is used to calculate the OPPS payment rate
for services with the following status indicators (listed in Addendum B
to the proposed rule, which is available via the internet on the CMS
website): ``J1'', ``J2'', ``P'', ``Q1'', ``Q2'', ``Q3'', ``R'', ``S'',
``T'', ``V'', or ``U''. In the CY 2017 OPPS/ASC final rule with comment
period (81 FR 79796), we clarified that the reporting ratio does not
apply to codes with status indicator ``Q4'' because services and
procedures coded with status indicator ``Q4'' are either packaged or
paid through the Clinical Laboratory Fee Schedule and are never paid
separately through the OPPS. Payment for all services assigned to these
status indicators will be subject to the reduction of the national
unadjusted payment rates for hospitals that fail to meet Hospital OQR
Program requirements, with the exception of services assigned to New
Technology APCs with assigned status indicator ``S'' or ``T''. We refer
readers to the CY 2009 OPPS/ASC final rule with comment period (73 FR
68770 through 68771) for a discussion of this policy.
The OPD fee schedule increase factor is an input into the OPPS
conversion factor, which is used to calculate OPPS payment rates. To
reduce the OPD fee schedule increase factor for hospitals that fail to
meet reporting requirements, we calculate two conversion factors--a
full market basket conversion factor (that is, the full conversion
factor), and a reduced market basket conversion factor (that is, the
reduced conversion factor). We then calculate a reduction ratio by
dividing the reduced conversion factor by the full conversion factor.
We refer to this reduction ratio as the ``reporting ratio'' to indicate
that it applies to payment for hospitals that fail to meet their
reporting requirements. Applying this reporting ratio to the OPPS
payment amounts results in reduced national unadjusted payment rates
that are mathematically equivalent to the reduced national unadjusted
payment rates that would result if we multiplied the scaled OPPS
relative payment weights by the reduced conversion factor. For example,
to determine the reduced national unadjusted payment rates that applied
to hospitals that failed to meet their quality reporting requirements
for the CY 2010 OPPS, we multiplied the final full national unadjusted
payment rate found in Addendum B of the CY 2010 OPPS/ASC final rule
with comment period by the CY 2010 OPPS final reporting ratio of 0.980
(74 FR 60642).
We note that the only difference in the calculation for the full
conversion factor and the calculation for the reduced conversion factor
is that the full conversion factor uses the full OPD update and the
reduced conversion factor uses the reduced OPD update. The baseline
OPPS conversion factor calculation is the same since all other
adjustments would be applied to both conversion factor calculations.
Therefore, our standard approach of calculating the reporting ratio as
described earlier in this section is equivalent to dividing the reduced
OPD update factor by that of the full OPD update factor. In other
words:
Full Conversion Factor = Baseline OPPS conversion factor * (1 + OPD
update factor)
Reduced Conversion Factor = Baseline OPPS conversion factor * (1 + OPD
update factor - 0.02)
Reporting Ratio = Reduced Conversion Factor/Full Conversion Factor
Which is equivalent to:
Reporting Ratio = (1 + OPD Update factor - 0.02)/(1 + OPD update
factor)
In the CY 2009 OPPS/ASC final rule with comment period (73 FR 68771
through 68772), we established a policy that the Medicare beneficiary's
minimum unadjusted copayment and national unadjusted copayment for a
service to which a reduced national unadjusted payment rate applies
would each equal the product of the reporting
[[Page 42266]]
ratio and the national unadjusted copayment or the minimum unadjusted
copayment, as applicable, for the service. Under this policy, we apply
the reporting ratio to both the minimum unadjusted copayment and
national unadjusted copayment for services provided by hospitals that
receive the payment reduction for failure to meet the Hospital OQR
Program reporting requirements. This application of the reporting ratio
to the national unadjusted and minimum unadjusted copayments is
calculated according to Sec. 419.41 of our regulations, prior to any
adjustment for a hospital's failure to meet the quality reporting
standards according to Sec. 419.43(h). Beneficiaries and secondary
payers thereby share in the reduction of payments to these hospitals.
In the CY 2009 OPPS/ASC final rule with comment period (73 FR
68772), we established the policy that all other applicable adjustments
to the OPPS national unadjusted payment rates apply when the OPD fee
schedule increase factor is reduced for hospitals that fail to meet the
requirements of the Hospital OQR Program. For example, the following
standard adjustments apply to the reduced national unadjusted payment
rates: The wage index adjustment, the multiple procedure adjustment,
the interrupted procedure adjustment, the rural sole community hospital
adjustment, and the adjustment for devices furnished with full or
partial credit or without cost. Similarly, OPPS outlier payments made
for high cost and complex procedures will continue to be made when
outlier criteria are met. For hospitals that fail to meet the quality
data reporting requirements, the hospitals' costs are compared to the
reduced payments for purposes of outlier eligibility and payment
calculation. We established this policy in the OPPS beginning in the CY
2010 OPPS/ASC final rule with comment period (74 FR 60642). For a
complete discussion of the OPPS outlier calculation and eligibility
criteria, we refer readers to section II.G. of this proposed rule.
2. Reporting Ratio Application and Associated Adjustment Policy for CY
2022
We propose to continue our established policy of applying the
reduction of the OPD fee schedule increase factor through the use of a
reporting ratio for those hospitals that fail to meet the Hospital OQR
Program requirements for the full CY 2022 annual payment update factor.
For this CY 2022 OPPS/ASC proposed rule, the proposed reporting ratio
is 0.9805, which when multiplied by the proposed full conversion factor
of $84.457 equals a proposed conversion factor for hospitals that fail
to meet the requirements of the Hospital OQR Program (that is, the
reduced conversion factor) of $82.810. We propose to continue to apply
the reporting ratio to all services calculated using the OPPS
conversion factor. We propose to continue to apply the reporting ratio,
when applicable, to all HCPCS codes to which we have proposed status
indicator assignments of ``J1'', ``J2'', ``P'', ``Q1'', ``Q2'', ``Q3'',
``R'', ``S'', ``T'', ``V'', and ``U'' (other than new technology APCs
to which we have proposed status indicator assignment of ``S'' and
``T''). We propose to continue to exclude services paid under New
Technology APCs. We propose to continue to apply the reporting ratio to
the national unadjusted payment rates and the minimum unadjusted and
national unadjusted copayment rates of all applicable services for
those hospitals that fail to meet the Hospital OQR Program reporting
requirements. We also propose to continue to apply all other applicable
standard adjustments to the OPPS national unadjusted payment rates for
hospitals that fail to meet the requirements of the Hospital OQR
Program. Similarly, we propose to continue to calculate OPPS outlier
eligibility and outlier payment based on the reduced payment rates for
those hospitals that fail to meet the reporting requirements. In
addition to our proposal to implement the policy through the use of a
reporting ratio, we also propose to calculate the reporting ratio to
four decimals (rather than the previously used three decimals) to more
precisely calculate the reduced adjusted payment and copayment rates.
For CY 2022, the proposed reporting ratio is 0.9805, which when
multiplied by the final full conversion factor of 84.457 equals a
proposed conversion factor for hospitals that fail to meet the
requirements of the Hospital OQR Program (that is, the reduced
conversion factor) of 82.810.
XVI. Requirements for the Ambulatory Surgical Center Quality Reporting
(ASCQR) Program
A. Background
1. Overview
We refer readers to section XIV.A.1. of the CY 2020 OPPS/ASC final
rule with comment period (84 FR 61410) for a general overview of our
quality reporting programs and to the CY 2019 OPPS/ASC final rule with
comment period (83 FR 58820 through 58822) where we previously
discussed our Meaningful Measures Framework.
2. Statutory History of the ASCQR Program
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74492 through 74494) for a detailed discussion of the
statutory history of the ASCQR Program.
3. Regulatory History of the ASCQR Program
We refer readers to the CY 2014 through 2021 OPPS/ASC final rules
with comment period for an overview of the regulatory history of the
ASCQR Program:
CY 2014 OPPS/ASC final rule (78 FR 75122);
CY 2015 OPPS/ASC final rule (79 FR 66966 through 66987);
CY 2016 OPPS/ASC final rule (80 FR 70526 through 70538);
CY 2017 OPPS/ASC final rule (81 FR 79797 through 79826);
CY 2018 OPPS/ASC final rule (82 FR 59445 through 59476);
CY 2019 OPPS/ASC final rule (83 FR 59110 through 59139);
CY 2020 OPPS/ASC final rule (84 FR 61420 through 61434);
and
CY 2021 OPPS/ASC final rule (85 FR 86187 through 86193).
We have codified requirements under the ASCQR Program at 42 CFR,
part 16, subpart H (42 CFR 416.300 through 416.330).
B. ASCQR Program Quality Measures
1. Considerations in the Selection of ASCQR Program Quality Measures
We refer readers to the CY 2013 OPPS/ASC final rule with comment
period (77 FR 68493 through 68494) for a detailed discussion of the
priorities we consider for the ASCQR Program quality measure selection.
We are not proposing any changes to these policies in this proposed
rule.
2. Retention and Removal of Quality Measures From the ASCQR Program
a. Retention of Previously Adopted ASCQR Program Measures
We previously finalized a policy that quality measures adopted for
an ASCQR Program measure set for a previous payment determination year
be retained in the ASCQR Program for measure sets for subsequent
payment determination years, except when such measures are removed,
suspended, or replaced as indicated (76 FR 74494 and 74504; 77 FR 68494
through 68495; 78 FR 75122; and 79 FR 66967 through 66969). We are not
proposing any changes to this policy in this proposed rule.
[[Page 42267]]
b. Removal Factors for ASCQR Program Measures
In the CY 2019 OPPS/ASC final rule with comment period (83 FR 59111
through 59115), we clarified, finalized, and codified at Sec. 416.320
an updated set of factors \283\ and the process for removing measures
from the ASCQR Program. We are not proposing any changes to the measure
removal factors in this proposed rule.
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\283\ We note that we previously referred to these factors as
``criteria'' (for example, 79 FR 66967 through 66969); we now use
the term ``factors'' to align the ASCQR Program terminology with the
terminology we use in other CMS quality reporting and pay-for-
performance (value-based purchasing) programs.
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3. Proposal To Adopt a New Measure for the ASCQR Program Measure Set
In this proposed rule, we are proposing to adopt one new measure:
COVID-19 Vaccination Coverage Among Health Care Personnel (HCP) measure
beginning with the CY 2022 reporting period/2024 payment determination.
a. Proposal To Adopt the COVID-19 Vaccination Coverage Among Health
Care Personnel (HCP) Measure Beginning With the CY 2022 Reporting
Period/CY 2024 Payment Determination
(1) Background
On January 31, 2020, the Secretary declared a public health
emergency (PHE) for the United States (U.S.) in response to the global
outbreak of SARS-CoV-2, a novel coronavirus that causes a disease named
``coronavirus disease 2019'' (COVID-19).\284\ COVID-19 is a contagious
respiratory infection \285\ that can cause serious illness and death.
Older individuals, some racial and ethnic minorities, and those with
underlying medical conditions are considered to be at higher risk for
more serious complications from COVID-19.286 287 As of July
2, 2021, the U.S. has reported over 33 million cases of COVID-19 and
over 600,000 COVID-19 deaths.\288\ Hospitals and health systems
significant surges of COVID-19 patients as community infection levels
increased.\289\ From December 2, 2020 through January 30, 2021, more
than 100,000 Americans with COVID-19 were hospitalized at the same
time.\290\
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\284\ U.S. Dept of Health and Human Services, Office of the
Assistant Secretary for Preparedness and Response. (2020).
Determination that a Public Health Emergency Exists. Available at:
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
\285\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
\286\ Centers for Disease Control and Prevention. (2020). Your
Health: Symptoms of Coronavirus. Available at https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
\287\ Centers for Disease Control and Prevention. (2020). Health
Equity Considerations and Racial and Ethnic Minority Groups.
Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
\288\ This information has been updated from the proposed rule
to reflect current data from the Centers for Disease Control and
Prevention. (2020). CDC COVID Data Tracker. Available at: https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days.
\289\ Associated Press. Tired to the Bone. Hospitals Overwhelmed
with Virus Cases. November 18, 2020. Accessed on December 16, 2020,
at https://apnews.com/article/hospitals-overwhelmed-coronavirus-cases-74a1f0dc3634917a5dc13408455cd895. Also see: New York Times.
Just how full are U.S. intensive care units? New data paints an
alarming picture. November 18, 2020. Accessed on December 16, 2020,
at: https://www.nytimes.com/2020/12/09/world/just-how-full-are-us-intensive-care-units-new-data-paints-an-alarming-picture.html.
\290\ US Currently Hospitalized [verbar] The COVID Tracking
Project. Accessed January 31, 2021 at: https://covidtracking.com/data/charts/us-currently-hospitalized.
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Evidence indicates that COVID-19 primarily spreads when individuals
are in close contact with one another.\291\ Ongoing research indicates
that fully vaccinated people without immunocompromising conditions are
able to engage in most activities with very low risk of acquiring or
transmitting SARS-CoV-2, and the Centers for Disease Control and
Prevention (CDC) issued new guidance for fully vaccinated individuals
on May 28, 2021.\292\ The virus is typically transmitted through
respiratory droplets or small particles created when someone who is
infected with the virus coughs, sneezes, sings, talks or breathes.\293\
Thus, the CDC advises that infections mainly occur through exposure to
respiratory droplets when a person is in close contact with someone who
has COVID-19.\294\ Experts believe that COVID-19 spreads less commonly
through contact with a contaminated surface \295\ and that in certain
circumstances, infection can occur through airborne transmission.\296\
According to the CDC, those at greatest risk of infection are persons
who have had prolonged, unprotected close contact (that is, within 6
feet for 15 minutes or longer) with an individual with confirmed COVID-
19 infection, regardless of whether the individual has symptoms.\297\
Although personal protective equipment (PPE) and other infection-
control precautions can reduce the likelihood of transmission in health
care settings, COVID-19 can spread between HCP and patients or from
patient to patient given the close contact that may occur during the
provision of care.\298\ The CDC has emphasized that health care
settings can be high-risk places for COVID-19 exposure and
transmission.\299\
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\291\ Centers for Disease Control and Prevention. (2021). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\292\ Centers for Disease Control and Prevention. (2021).
Interim Public Health Recommendations for Fully Vaccinated People.
Accessed on June 2, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.
\293\ Centers for Disease Control and Prevention (2021). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\294\ Centers for Disease Control and Prevention (2021). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\295\ Centers for Disease Control and Prevention (2021). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\296\ Centers for Disease Control and Prevention. (2021). How
COVID-19 Spreads. Accessed on April 3, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html.
\297\ Centers for Disease Control and Prevention. (2021). When
to Quarantine. Accessed on April 2, 2021 at: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html.
\298\ Centers for Disease Control and Prevention. (2021).
Interim U.S. Guidance for Risk Assessment and Work Restrictions for
Healthcare Personnel with Potential Exposure to COVID-19. Accessed
on April 2 at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/faq.html#Transmission.
\299\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb
Mortal Wkly Rep. 2020; 69(49): 1857-1859.
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Vaccination is a critical part of the nation's strategy to
effectively counter the spread of COVID-19 and ultimately help restore
societal functioning.\300\ On December 11, 2020, the Food and Drug
Administration (FDA) issued the first Emergency Use Authorization (EUA)
for a COVID-19 vaccine in the U.S.\301\ Subsequently, the FDA issued
EUAs for additional COVID-19 vaccines.302 303
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\300\ Centers for Disease Control and Prevention. (2020). COVID-
19 Vaccination Program Interim Playbook for Jurisdiction Operations.
Accessed on December 18 at: https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
\301\ U.S. Food and Drug Administration. (2020). Pfizer-BioNTech
COVID-19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144412/download.
\302\ U.S. Food and Drug Administration. (2021). Moderna COVID-
19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/144636/download.
\303\ U.S. Food and Drug Administration. (2021). Janssen COVID-
19 Vaccine EUA Letter of Authorization. Available at https://www.fda.gov/media/146303/download.
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As part of its national strategy to address COVID-19, the White
House stated on March 25, 2021 that it would work with states and the
private sector to execute an aggressive vaccination strategy and
outlined a goal of
[[Page 42268]]
administering 200 million shots in 100 days \304\ On April 21, 2021, it
was announced that this goal had been achieved.\305\ Although the goal
of the U.S. Government is to ensure that every American who wants to
receive a COVID-19 vaccine can receive one, the Department of Health
and Human Services, the Department of Defense, and the CDC, recommended
that early vaccination efforts focus on those critical to the PHE
response, including HCP, and individuals at highest risk for developing
severe illness from COVID-19.\306\ The CDC's Advisory Committee on
Immunization Practices (ACIP) recommended that HCP should be among
those individuals prioritized to receive the initial, limited supply of
the COVID-19 vaccination, given the potential for transmission in
health care settings and the need to preserve health care system
capacity.\307\ Reportedly most states followed this
recommendation,\308\ and HCP began receiving the vaccine in mid-
December of 2020.\309\
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\304\ The White House. Remarks by President Biden on the COVID-
19 Response and the State of Vaccinations. Accessed on April 3, 2021
at: https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/03/29/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations/.
\305\ The White House. Remarks by President Biden on the COVID-
19 Response and the State of Vaccinations. Accessed on June 2, 2021
at: https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/04/21/remarks-by-president-biden-on-the-covid-19-response-and-the-state-of-vaccinations-2/.
\306\ Health and Human Services, Department of Defense. (2020)
From the Factory to the Frontlines: The Operation Warp Speed
Strategy for Distributing a COVID-19 Vaccine. Accessed December 18
at: https://www.hhs.gov/sites/default/files/strategy-for-distributing-covid-19-vaccine.pdf; Centers for Disease Control
(2020). COVID-19 Vaccination Program Interim Playbook for
Jurisdiction Operations. Accessed December 18 at: https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf.
\307\ Dooling, K, McClung, M, et al. ``The Advisory Committee on
Immunization Practices' Interim Recommendations for Allocating
Initial Supplies of COVID-19 Vaccine--United States, 2020.'' Morb.
Mortal Wkly Rep. 2020; 69(49): 1857-1859. ACIP also recommended that
long-term care residents be prioritized to receive the vaccine,
given their age, high levels of underlying medical conditions, and
congregate living situations make them high risk for severe illness
from COVID-19.
\308\ Kates, J, Michaud, J, Tolbert, J. ``How Are States
Prioritizing Who Will Get the COVID-19 Vaccine First?'' Kaiser
Family Foundation. December 14, 2020. Accessed on December 16 at
https://www.kff.org/policy-watch/how-are-states-prioritizing-who-will-get-the-covid-19-vaccine-first/.
\309\ Associated Press. `Healing is Coming:' US Health Workers
Start Getting Vaccine. December 15, 2020. Accessed on December 16
at: https://apnews.com/article/us-health-workers-coronavirus-vaccine-56df745388a9fc12ae93c6f9a0d0e81f.
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Frontline healthcare workers, such as those employed in ASCs, have
been prioritized for vaccination in most locations. There are
approximately 18 million healthcare workers in the U.S.\310\ A survey
of HCP found that 66 percent of hospital HCP and 64 percent of
outpatient clinic HCP reported receiving at least one dose of the
vaccine.\311\ As of July 2, 2021, the CDC reported that over 328
million doses of COVID-19 vaccine had been administered and
approximately 155.9 million people had received full doses.\312\ The
White House indicated on April 6, 2021 that the U.S. retains sufficient
vaccine supply, and every adult became eligible to receive the vaccine
beginning April 19, 2021.\313\
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\310\ Centers for Disease Control and Prevention. Healthcare
Workers. (2017) Accessed February 18, 2021 at: https://www.cdc.gov/niosh/topics/healthcare/default.html.
\311\ KFF/The Washington Post Frontline Health Care Workers
Survey. (2021). Accessed June 2, 2021 at: https://www.kff.org/coronavirus-covid-19/poll-finding/kff-washington-post-health-care-workers/.
\312\ This information has been updated from the proposed rule
to reflect current data from the Centers for Disease Control and
Prevention. COVID Data Tracker. COVID-19 Vaccinations in the United
States. Available at: https://covid.cdc.gov/covid-data-tracker/#vaccinations.
\313\ The White House. Remarks by President Biden Marking the
150 Millionth COVID-19 Vaccine Shot. Accessed April 8, 2021 at:
https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/04/06/remarks-by-president-biden-marking-the-150-millionth-covid-19-vaccine-shot/.
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We believe it is important to require that ASCs report HCP
vaccination information for health care facilities to assess whether
these facilities are taking steps to limit the spread of COVID-19 among
their health care workers and to help sustain the ability of ASCs to
continue serving their communities throughout the PHE and beyond.
Therefore, we are proposing to adopt a new measure, COVID-19
Vaccination Coverage Among HCP, beginning with the CY 2024 payment
determination. For that payment year, ASCs would be required to report
data quarterly on the measure for the January 2022 through December
2022 reporting period. The measure would assess the proportion of an
ASC's health care workforce that has been vaccinated against COVID-19.
HCP are at risk of transmitting COVID-19 infection to patients,
experiencing illness or death as a result of COVID-19 infection
themselves, and transmitting it to their families, friends, and the
general public. We believe ASCs should report the level of vaccination
among their HCP as part of their efforts to assess and reduce the risk
of transmission of COVID-19 within their facilities. HCP vaccination
can reduce illness that leads to work absence and limit disruptions to
providing care \314\ with major reductions in SARS-CoV-2 infections
among those receiving a two dose COVID-19 vaccine despite a high
community infection rate.\315\ Data from influenza vaccination
demonstrate that provider vaccination is associated with that provider
recommending vaccination to patients \316\ and we believe HCP COVID-19
vaccination in ASCs could similarly increase vaccination among that
patient population. We also believe that publishing the HCP vaccination
rates will be helpful to many patients, particularly those who are at
high-risk for developing serious complications from COVID-19, as they
choose among ASCs for treatment. Under CMS' Meaningful Measures
Framework, the COVID-19 measure addresses the quality priority of
``Promote Effective Prevention and Treatment of Chronic Disease''
through the Meaningful Measures Area of ``Preventive Care.''
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\314\ Centers for Disease Control and Prevention. Overview of
Influenza Vaccination among Health Care Personnel. October 2020.
(2020) Accessed March 16, 2021 at: https://www.cdc.gov/flu/toolkit/long-term-care/why.htm.
\315\ Benenson S, Oster Y, Cohen MJ, Nir-Paz R. BNT162b2 mRNA
Covid-19 Vaccine Effectiveness among Health Care Workers. N Engl J
Med. 2021. See also: Keehner J, Horton LE, Pfeffer MA, Longhurst CA,
Schooley RT, Currier JS, et al. SARS-CoV-2 Infection after
Vaccination in Health Care Workers in California. N Engl J Med.
2021.
\316\ Measure Application Committee Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
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(2) Overview of Measure
The COVID-19 Vaccination Coverage Among HCP measure (``COVID-19 HCP
vaccination measure'') is a process measure developed by the CDC to
track COVID-19 vaccination coverage among HCP in non-LTC facilities
including ASCs.
(a) Measure Specifications
The denominator for the HCP measure is the number of HCP eligible
to work in the ASC for at least 1 day during the reporting period,
excluding persons with contraindications to COVID-19 vaccination that
are described by the CDC.\317\
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\317\ Centers for Disease Control and Prevention.
Contraindications and precautions. (2021) Accessed March 15, 2021
at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html#Contraindications.
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The numerator for the HCP measure is the cumulative number of HCP
eligible to work in at the ASC for at least 1 day during the reporting
period and who received a complete vaccination course against COVID-19
using an FDA-authorized or FDA-approved vaccine for COVID-19 (whether
the FDA issued an
[[Page 42269]]
approval or EUA).\318\ A complete vaccination course is defined under
the specific FDA authorization and may require multiple doses or
regular revaccination.\319\ Vaccination coverage for purposes of this
measure is defined as the estimated percentage (given the potential for
week-to-week variation) of HCP eligible to work at the ASC for at least
1 day who received a COVID-19 vaccine. For reporting, facilities would
count HCP working in all facilities that share the same CMS
certification number (CCN).\320\ The proposed specifications for the
COVID-19 HCP vaccination measure are available on the NQF website at:
https://www.cdc.gov/nhsn/nqf/index.html.\321\
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\318\ Measure Application Partnership Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
\319\ Measure Application Partnership Coordinating Committee
Meeting Presentation. March 15, 2021. (2021) Accessed March 16, 2021
at: http://www.qualityforum.org/Project_Pages/MAP_Coordinating_Committee.aspx.
\320\ Centers for Disease Control and Prevention. CMS Reporting
Requirements FAQs. Accessed June 2, 2021 at: https://www.cdc.gov/nhsn/PDFs/CMS/faq/FAQs-CMS-Reporting-Requirements.pdf.
\321\ https://www.cdc.gov/nhsn/nqf/index.html.
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(b) Review by the Measure Applications Partnership
The COVID-19 HCP vaccination measure was included on the publicly
available ``List of Measures Under Consideration for December 21,
2020,'' \322\ a list of measures under consideration for use in various
Medicare programs. The Measure Applications Partnership (MAP) hospital
workgroup convened on January 11, 2021 and reviewed the Measures Under
Consideration (MUC) List including the COVID-19 HCP vaccination
measure. The MAP hospital workgroup agreed that the proposed measure
represents a promising effort to advance measurement for an evolving
national pandemic and that it could bring value to the ASCQR Program
measure set by providing transparency about an important COVID-19
intervention to help prevent infections in HCP and patients.\323\ The
MAP hospital workgroup also stated in its recommendations that
collecting information on COVID-19 vaccination coverage among HCP and
providing feedback to facilities will allow facilities to benchmark
coverage rates and improve coverage in their facility, and that
reducing COVID-19 infection rates in HCP may reduce transmission among
patients and reduce instances of staff shortages due to illness.\324\
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\322\ https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=94212.
\323\ Measure Applications Partnership. MAP Preliminary
Recommendations 2020-2021. Accessed on January 24, 2021 at: http://www.qualityforum.org/Project_Pages/MAP_Hospital_Workgroup.aspx.
\324\ Ibid.
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In its preliminary recommendations, the MAP hospital workgroup did
not support this measure for rulemaking, subject to potential for
mitigation.\325\ To mitigate its concerns, the MAP hospital workgroup
believed that the measure needed well-documented evidence, finalized
specifications, testing, and National Quality Forum (NQF) endorsement
prior to implementation.\326\ Subsequently, the MAP Coordinating
Committee met on January 25, 2021 and reviewed the COVID-19 HCP
vaccination measure. In the 2020 and 2021 MAP Final Recommendations,
the MAP offered conditional support for rulemaking contingent on CMS
bringing the measures back to MAP once the specifications are further
refined.\327\ The MAP stated, ``the incomplete specifications require
immediate mitigation and further development should continue.'' \328\
In its final report, the MAP noted that the measure would add value by
providing visibility into an important intervention to limit COVID-19
infections in HCP and the patients for whom they provide care.\329\ The
spreadsheet of final recommendations no longer cited concerns regarding
evidence, testing, or NQF endorsement.\330\ In response to the MAP
final recommendation request that CMS bring the measure back to the MAP
once the specifications are further refined, CMS and the CDC met with
the MAP Coordinating Committee on March 15, 2021. CMS and CDC provided
additional information to address vaccine availability, alignment of
the COVID-19 HCP vaccination measure as being as closely as possible
with the data collection for the Influenza HCP vaccination measure (NQF
#0431), and provided clarification on how HCP are defined. CMS and the
CDC also presented preliminary findings from the testing of the
numerator of the COVID-19 HCP vaccination measure, which is currently
in process. These preliminary findings show numerator data should be
feasible to collect and reliable. Testing of the measure numerator (the
number of HCP vaccinated) involves a comparison of the data collected
through the National Healthcare Safety Network (NHSN) and independently
reported through the Federal pharmacy partnership program for
delivering vaccination to LTC facilities. These are two independent
data collection systems. In initial analyses of the first month of
vaccination, the number of healthcare workers vaccinated in
approximately 1,200 facilities for which data from both systems were
available, the number of healthcare personnel vaccinated was highly
correlated between the two systems with a correlation coefficient of
nearly 90 percent in the second two weeks of reporting.\331\ Because of
the high correlation across a large number of facilities and high
number of HCP within those facilities receiving at least one dose of
the COVID-19 vaccine, we believe the measure is feasible and reliable
for use in ASCs. After reviewing this additional information, the MAP
retained its final recommendation of conditional support, and expressed
support for CMS' efforts to use the measure as part of the solution for
the COVID-19 public health crisis.\332\
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\325\ Ibid.
\326\ Ibid.
\327\ Measure Applications Partnership. 2020-2021 MAP Final
Recommendations. Accessed on February 3, 2021 at: http://www.qualityforum.org/Setting_Priorities/Partnership/Measure_Applications_Partnership.aspx.
\328\ Measure Applications Partnership. 2020-2021 MAP Final
Recommendations. Accessed on February 23, 2021 at: http://www.qualityforum.org/Project_Pages/MAP_Hospital_Workgroup.aspx.
\329\ Ibid.
\330\ Ibid.
\331\ For more information on testing results and other measure
updates, please see the Meeting Materials (including Agenda,
Recording, Presentation Slides, Summary, and Transcript) of the
March 15, 2021 meeting available at https://www.qualityforum.org/ProjectMaterials.aspx?projectID=75367.
\332\ Ibid.
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Section 1890A(a)(4) of the Act, as added by section 3014(b) of the
Affordable Care Act, requires the Secretary to take into consideration
input from multi-stakeholder groups in selecting certain quality and
efficiency measures. While we value input from the MAP, we believe it
is important to propose the measure as quickly as possible to address
the urgency of the COVID-19 PHE and its impact on vulnerable
populations. CMS continues to engage with the MAP to mitigate concerns
and appreciates the MAP's conditional support for the measure.
(c) Measure Endorsement
Section 1833(i)(7)(B) of the Act states that section 1833(t)(17) of
the Act shall apply with respect to ASC services in a similar manner in
which it applies to hospitals for the Hospital OQR Program, except as
the Secretary may otherwise provide. The requirements at section
1833(t)(17)(C)(i) of the Act state that measures developed shall ``be
appropriate for the measurement of the quality of care (including
medication
[[Page 42270]]
errors) furnished by hospitals in outpatient settings and that reflect
consensus among affected parties and, to the extent feasible and
practicable, shall include measures set forth by one or more national
consensus building entities.''
In general, we prefer to adopt measures that have been endorsed by
the NQF because it is a national multi-stakeholder organization with a
well-documented and rigorous approach to consensus development.
However, as we have noted in previous rulemaking (for example, 75 FR
72065 and 76 FR 74494 for the Hospital OQR and ASCQR Programs,
respectively), the requirement that measures reflect consensus among
affected parties can be achieved in other ways, including through the
measure development process, through broad acceptance, use of the
measure(s), and through public comment.
The proposed COVID-19 HCP vaccination measure is not NQF endorsed
and has not been submitted to NQF for endorsement consideration.
However, at this time, we find no other feasible and practicable
measures on the topic of COVID-19 vaccination among HCP. CMS will
consider the potential for future NQF endorsement as part of its
ongoing work with the MAP. Section 1886(b)(3)(B)(viii)(IX)(bb) of the
Act states that in the case of a specified area or medical topic
determined appropriate by the Secretary for which a feasible and
practicable measure has not been endorsed by the entity with a contract
under section 1890(a) (currently the NQF), the Secretary may specify a
measure that is not so endorsed as long as due consideration is given
to measures that have been endorsed or adopted by a consensus
organization identified by the Secretary. Therefore, with the above
considerations, we believe there is sufficient basis to propose
adoption of this measure at this time.
(d) Data Collection, Submission, and Reporting
Given the time sensitive nature of this measure considering the
current PHE, we are proposing that ASCs would be required to begin
reporting data on the proposed COVID-19 HCP vaccination measure
beginning January 1, 2022, for the CY 2024 payment determination for
the ASCQR Program. Thereafter, we propose quarterly reporting periods.
While we considered annual reporting periods for the ASCQR Program, we
are proposing quarterly reporting periods given the immediacy of the
PHE and the importance of alignment across quality payment programs
proposing this measure.
If our proposal to adopt this measure is finalized, ASCs would
report the measure through the CDC NHSN web-based surveillance
system.\333\ While the ASCQR Program does not currently require use of
the NHSN web-based surveillance system, we have previously required use
of this system for submitting program data. We refer readers to the CY
2014 OPPS/ASC final rule with comment period in which we adopted the
Influenza Vaccination Coverage Among HCP (NQF #0431) measure (78 FR
75110 through 75117) and section XVI.D.1.c.(2). of this proposed rule
for additional information on reporting through the NHSN web-based
surveillance system under the ASCQR Program. The Influenza Vaccination
Coverage Among HCP (NQF #0431) measure was removed from the ASCQR
Program in the CY 2019 OPPS/ASC final rule as CMS observed that
reporting measure data through the NHSN could be more burdensome for
ASCs compared to the relative burden for hospitals participating in the
Hospital IQR Program and the HAC Reduction Program and especially for
freestanding ASCs (83 FR 59115 through 59117). However, the COVID-19
pandemic and associated PHE have had a more significant effect on most
aspects of society than influenza, including availability of the
healthcare system. With respect to reporting for the COVID-19 HCP
vaccination measure, CDC guidance for entering data requires submission
of HCP count at the facility level \334\ and the measure requires
reporting consistent with that guidance. We believe that the public
health benefits to having these data available outweigh the burden of
reporting for systems with multiple facilities or locations. While we
recognize that there may be some elements of the measure specifications
that increase burden for some ASCs, given the impact that the COVID-19
PHE has had on society and the healthcare system, we believe that the
benefits outweigh this reporting burden. For more information on the
associated burden of this measure, we refer readers to XXV.C.5.b. of
the proposed rule.
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\333\ Centers for Disease Control and Prevention. Surveillance
for Weekly HCP COVID-19 Vaccination. Accessed at: https://www.cdc.gov/nhsn/hps/weekly-covid-vac/index.html. on February 10,
2021.
\334\ COVID-19 Vaccination Non-LTC Healthcare Personnel TOI
(cdc.gov).
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To report this measure, we are proposing that ASCs would collect
the numerator and denominator for the COVID-19 HCP vaccination measure
for at least one, self-selected week during each month of the reporting
quarter and submit the data to the NHSN Healthcare Personal Safety
(HPS) Component before the quarterly deadline to meet ASCQR Program
requirements. While we believe that it would be ideal to have HCP
vaccination data for every week of each month, we are mindful of the
time and resources that ASCs would need to report the data. Thus, in
collaboration with the CDC, we determined that data from at least one
week of each month would be sufficient to obtain a reliable estimate of
vaccination levels among an ASC's HCP while balancing the costs of
reporting. If an ASC submits more than one week of data in a month, the
most recent week's data would be used to calculate the measure. For
example, if first and third week data are submitted, third week data
would be used. If first, second, and fourth week data are submitted,
fourth week data would be used. Each quarter, we are proposing that the
CDC would calculate a single quarterly COVID-19 HCP vaccination
coverage rate for each ASC, which would be calculated by taking the
average of the data from the three submission periods submitted by the
ASC for that quarter. If finalized, CMS would publicly report each
quarterly COVID-19 HCP vaccination coverage rate as calculated by the
CDC.
ASCs would submit the number of HCP eligible to have worked at the
facility during the self-selected week that the ASC reports data in
NHSN (denominator) and the number of those HCP who have received a
complete course of a COVID-19 vaccination (numerator) during the same
self-selected week. As previously stated, facilities would count HCP
working in all facilities that share the same CCN.\335\
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\335\ Ibid.
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We invite public comment on our proposal.
4. Proposed Changes to Previously Adopted Measures in the ASCQR Program
Measure Set
We previously adopted the following measures into the ASCQR measure
set: ASC-1: Patient Burn; ASC-2: Patient Fall; ASC-3: Wrong Site, Wrong
Side, Wrong Patient, Wrong Procedure, Wrong Implant; ASC-4: All-Cause
Hospital Transfer/Admission; ASC-11: Cataracts--Improvement in
Patient's Visual Function with 90 Days Following Cataract Surgery; and
ASC-15a-e: Outpatient and Ambulatory Surgery Consumer Assessment of
Healthcare Providers and Systems. For various reasons discussed in
sections XVI.B.4.a., XVI.B.4.b., and XVI.B.4.c., these measures were
either paused or suspended from the ASCQR Program.
[[Page 42271]]
We now believe that previous concerns related to the data submission
method previously utilized for these measures can be addressed and we
are now proposing to return to requiring data submission for these
measures.
a. Proposal To Require Previously Suspended ASC-1, ASC-2, ASC-3, and
ASC-4 Measures Beginning With the CY 2023 Reporting Period/CY 2025
Payment Determination and Subsequent Years
(1) Background
We refer readers to the CY 2012 OPPS/ASC final rule with comment
period (76 FR 74497 through 74498) where we adopted ASC-1: Patient Burn
beginning with the CY 2014 payment determination. This outcome measure
assesses the percentage of ASC admissions experiencing a burn prior to
discharge. We refer readers to the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74498) where we adopted ASC-2: Patient Fall
beginning with the CY 2014 payment determination (NQF #0266). This
measure assesses the percentage of ASC admissions experiencing a fall
at the ASC. We refer readers to the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74498 through 74499) where we adopted ASC-3:
Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant
beginning with the CY 2014 payment determination (NQF #0267). This
outcome measure assesses the percentage of ASC admissions experiencing
a wrong site, wrong side, wrong patient, wrong procedure, or wrong
implant. We refer readers to the CY 2012 OPPS/ASC final rule with
comment period (76 FR 74499) where we adopted ASC-4: All-Cause Hospital
Transfer/Admission beginning with the CY 2014 payment determination
(NQF #0265). This outcome measure assesses the rate of ASC admissions
requiring a hospital transfer or hospital admission upon discharge from
the ASC.
In the CY 2019 OPPS/ASC proposed rule, we proposed to remove ASC-1,
ASC-2, ASC-3, and ASC-4 under measure removal Factor 1--measure
performance among ASCs is so high and unvarying that meaningful
distinctions and improvements in performance can no longer be made--for
the CY 2021 payment determination and subsequent years (83 FR 37198
through 37199). We noted that the ASCQR Program had previously
finalized two criteria for determining when a measure is ``topped-
out,'' including: (1) When there is statistically indistinguishable
performance at the 75th and 90th percentiles of national facility
performance; and (2) when the measure's truncated coefficient of
variation (TCOV) is less than or equal to 0.10.\336\ We presented data
demonstrating that each of these four measures met the criteria for
topped-out status and stated that we believed their removal from the
ASCQR Program measure set was appropriate as there was little room for
improvement. In addition, we stated that removal would alleviate the
maintenance costs and administrative burden to ASCs associated with
retaining the measures. As such, we believed the burden associated with
reporting these measures outweighed the benefits of keeping them in the
program (83 FR 37198 through 37199).
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\336\ In the CY 2019 OPPS/ASC proposed rule, we also clarified
how we calculated the TCOV for ASC-1, ASC-2, ASC-3, and ASC-4, which
assess the rate of rare, undesired events for which a lower rate is
preferred. Typically, for measures for which a higher rate is
preferred, we determine the TCOV by calculating the truncated
standard deviation (SD) in performance divided by the truncated mean
of performance (the mean of positive events). For these four
measures, we employed an alternate methodology utilizing the mean of
non-adverse events in our calculation of the TCOV. This substitution
resulted in a TCOV that was comparable to that calculated for other
measures and allowed us to assess rare event measures by still
generally using our previously finalized topped-out criteria. For
more information, see 83 FR 37196 through 37197.
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However, in the CY 2019 OPPS/ASC final rule with comment period, we
stated that we had re-evaluated the data due to public comments and
reviewed many studies demonstrating the importance of measuring and
reporting the data for these measures (83 FR 59118). It became clear to
us that these measures are more valuable to stakeholders than we had
initially perceived. We agreed that it was important to continue to
monitor these types of events, considering the potential negative
impacts to patients' morbidity and mortality, in order to continue to
prevent their occurrence and ensure that they remain rare. We
acknowledged that these measures provided critical data to
beneficiaries and were valuable to the ASC community. We also
acknowledged that having measures that apply to all ASCs provides
beneficiaries with the most comprehensive patient safety data to use
when making decisions about a site of care. Therefore, in the CY 2019
OPPS/ASC final rule with comment period, we did not finalize our
proposals to remove ASC-1, ASC-2, ASC-3, and ASC-4 (83 FR 59118). We
believed it was more prudent to keep them in the measure set in order
to continue to detect and prevent these events.
However, we also stated in the CY 2019 OPPS/ASC final rule with
comment period that we were concerned about some of the data submitted
for these measures (83 FR 59119). We explained that the data submission
method for these measures, which involved adding specific QDCs onto
eligible claims, may impact the completeness and accuracy of the data.
Specifically, we were concerned that ASCs lacked the ability to correct
the QDC codes that are used to calculate these measures from Medicare
FFS claims (83 FR 59119) if the claim had been submitted and processed
for payment. We stated that we believed that revising the data
submission method for the measures, such as via QualityNet, would
address this issue and allow facilities to correct any data submissions
errors, resulting in more complete and accurate data (83 FR 59119).
Therefore, we suspended the data collection of ASC-1, ASC-2, ASC-3,
and ASC-4 beginning with the CY 2019 reporting period/CY 2021 payment
determination (83 FR 59119). Starting with the CY 2021 payment
determination, facilities were not required to submit data for these
four measures as part of ASCQR Program requirements, even though the
measures remained in the ASCQR Program measure set. We stated that as
we developed future revisions for the data collected for these
measures, we would take into consideration other data submission
methods that may allow for the reporting of adverse events across
payers and would consider commenters' feedback toward the future
updates to the measures (83 FR 59119).
(2) Proposal To Require ASC-1, ASC-2, ASC-3, and ASC-4 Measures
Beginning With the CY 2023 Reporting Period/CY 2025 Payment
Determination and Subsequent Years
In this proposed rule, we are proposing to again require and resume
data collection for ASC-1, ASC-2, ASC-3, and ASC-4 beginning with the
CY 2023 reporting period/CY 2025 payment determination and subsequent
years. Under our proposal, providers would submit data via the HQR
System (formerly referred to as the QualityNet Secure Portal). We
believe that web-based submission will make reporting easier and more
efficient for facilities and will allow facilities to review and
correct submitted data until the data submission deadline; our review
and corrections policy is discussed in more detail at section
XVI.D.1.f.
We stated that we believed that revising the data submission method
for
[[Page 42272]]
the measures, such as via QualityNet (now known as the HQR System)
would address this issue and allow facilities to correct any data
submissions errors, resulting in more complete and accurate data (83 FR
59119). Facilities would be able to review and correct their data
submissions up to the data submission deadline. As we stated above, we
also believe that while these measures have been ``topped-out'', the
public continues to believe that it is important to monitor these types
of events, considering the potential negative impacts to patients'
morbidity and mortality, to continue to prevent their occurrence and
ensure that they remain rare.
We refer readers to section XVI.D.1.c.(1). of this proposed rule,
where we discuss the data submission process for web-based measures,
for more detail on how ASCs would be expected to submit data.
We invite public comment on our proposals.
b. Proposal To Require ASC-11: Cataracts--Improvement in Patient's
Visual Function Within 90 Days Following Cataract Surgery (NQF #1536)
Beginning With the CY 2023 Reporting Period/CY 2025 Payment
Determination
(1) Background
In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75124
through 75129) we finalized the adoption of the ASC-11: Cataracts--
Improvement in Patient's Visual Function within 90 Days Following
Cataract Surgery measure.\337\ This measure assesses the percentage of
patients aged 18 years and older who had cataract surgery and had
improvement in visual function achieved within 90 days following the
cataract surgery (78 FR 75129). The measure data consists of pre-
operative and post-operative visual function surveys. The
implementation of this measure underwent a number of changes aimed to
address concerns regarding burden and survey instrument usage that we
believe are resolved so that this measure can now be proposed as
mandatory.
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\337\ We note that this measure was endorsed by the NQF under
NQF #1536 at the time of adoption but has subsequently had its
endorsement removed.
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During the CY 2014 OPPS/ASC rule cycle, some commenters expressed
concern about the burden of collecting pre-operative and post-operative
visual function surveys (78 FR 75129 and 75138). In response to those
comments, we modified our implementation strategy in a manner that we
believed would significantly minimize collection and reporting burden
(78 FR 75129). Specifically, we applied a sampling scheme and a low
case threshold exemption to address commenters' concerns regarding
burden (78 FR 75138 through 75139). With those changes, we intended to
decrease burden and facilitate data reporting by allowing random
sampling of cases when volume is high, instead of collecting
information for all eligible patients (78 FR 75138 through 75139). For
further details, we refer readers to the CY 2014 OPPS/ASC final rule
with comment period (78 FR 75129; 75138 through 75139).
Shortly thereafter, we became concerned about the use of what we
believed at the time were inconsistent surveys to assess visual
function. The measure specifications allowed for the use of any
validated survey and we were unclear about the impact the use of
varying surveys might have. Therefore, we issued guidance stating that
we would delay the implementation of ASC-11.\338\
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\338\ The implementation was first delayed by 3 months--from
January 1, 2014 to April 1, 2014, for the CY 2016 payment
determination, via guidance issued December 31, 2013. Available at:
https://qualitynet.cms.gov/asc/notifications. Because of continuing
concerns, on April 2, 2014, we issued additional guidance stating
that we would further delay the implementation of the measure from
April 1, 2014 to January 1, 2015 for the CY 2016 payment
determination. Available at: https://qualitynet.cms.gov/asc/notifications.
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Subsequently, in the CY 2015 OPPS/ASC final rule with comment
period (79 FR 66984 through 66985), we finalized our proposal to
exclude ASC-11 from the CY 2016 payment determination measure set, and
for subsequent years. We proposed to exclude ASC-11 for a few reasons.
First, we understood it was operationally difficult for ASCs to collect
and report on the measure (79 FR 66984). Notably, the results of the
survey used to assess the pre-operative and post-operative visual
function of the patient were not consistently shared across clinicians,
making it difficult for ASCs to have knowledge of the visual function
of the patient before and after surgery (79 FR 66984). Second, the
concern about use of various versions of the survey persisted.
Specifically, we were concerned that if physicians used different
surveys to assess visual function, then the measure could produce
inconsistent results (79 FR 66984).
By excluding ASC-11 from the measure set used for the CY 2016
payment determination and subsequent years, ASCs were excused from
reporting on it (79 FR 66984). ASCs that did not report on ASC-11 for
the CY 2016 payment determination were not subject to a payment
reduction (79 FR 66984). In conjunction with excusing ASCs from
reporting on ASC-11 for the CY 2016 payment determination and
subsequent years, we finalized allowing ASCs to voluntarily report ASC-
11 data for the CY 2015 reporting period/CY 2017 payment determination
and subsequent years (79 FR 66984).
(2) Proposal To Require the ASC-11 Measure Beginning With the CY 2023
Reporting Period/CY 2025 Payment Determination and for Subsequent Years
We now believe it is appropriate to require that ASCs report on
ASC-11 as our earlier concerns have been allayed. At this point, ASCs
have had several years to familiarize themselves with ASC-11, prepare
to operationalize it, and opportunity to practice reporting the measure
since the CY 2015 reporting period/CY 2017 payment determination. We
note that a small number of facilities have consistently reported data
for this measure and these data have been made publicly available.
Furthermore, research indicates that using different surveys will not
result in inconsistencies, as the allowable surveys are scientifically
validated.\339\ Research has demonstrated that of 16 different cataract
surgery outcome questionnaires, all were able to detect clinically
important change.\340\
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\339\ McAlinden C, Gothwal VK, Khadka J, Wright TA, Lamoureux
EL, Pesudovs K. A head-to-head comparison of 16 cataract surgery
outcome questionnaires. Ophthalmology. 2011 Dec;118(12):2374-81.
doi: 10.1016/j.ophtha.2011.06.008. Epub 2011 Sep 25. PMID: 21945088.
\340\ McAlinden C, Gothwal VK, Khadka J, Wright TA, Lamoureux
EL, Pesudovs K. A head-to-head comparison of 16 cataract surgery
outcome questionnaires. Ophthalmology. 2011 Dec;118(12):2374-81.
doi: 10.1016/j.ophtha.2011.06.008. Epub 2011 Sep 25. PMID: 21945088.
---------------------------------------------------------------------------
Therefore, we are proposing to require reporting for the NQF-
endorsed ASC-11 measure beginning with the CY 2023 reporting period/CY
2025 payment determination and subsequent years. As we stated in the CY
2014 OPPS/ASC final rule with comment period, as well as the CY 2015
OPPS/ASC final rule with comment period, and consistent with the MAP
recommendation, we continue to believe that this measure ``addresses a
high-impact condition'' that is not otherwise adequately addressed in
our current measure set (78 FR 75129 and 79 FR 66984, respectively).
Moreover, ASC-11 serves to drive coordination of care (78 FR 75129 and
79 FR 66984) in multiple ways, including the operational requisites for
conducting--and sharing the results of--the surveys. This measure
provides opportunities for care
[[Page 42273]]
coordination as well as direct patient feedback.
We refer readers to section XVI.D.1.c.(1). for information about
submitting data via a CMS web-based tool. We invite public comment on
our proposal.
c. Proposal To Require ASC-15a-e: Outpatient and Ambulatory Surgery
Consumer Assessment of Healthcare Providers and Systems (OAS CAHPS)
Survey-Based Measures Beginning With Voluntary Reporting in CY 2023
Reporting Period and Mandatory Reporting Beginning With the CY 2024
Reporting Period/CY 2026 Payment Determination and for Subsequent Years
(1) Background
We previously adopted the ASC-15a-e: Outpatient and Ambulatory
Surgery Consumer Assessment of Healthcare Providers and Systems (OAS
CAHPS) survey-based measures to assess patient experience with care
following a procedure or surgery in an ASC. These survey-based measures
rate patient experience as a means for empowering patients and
improving the quality of their care (82 FR 59450). For further details
on this measure, we refer readers to the CY 2017 OPPS/ASC final rule
with comment period (81 FR 79803 through 79817), in which we adopted
these measures beginning with the CY 2020 payment determination.
Subsequently, in the CY 2018 OPPS/ASC final rule with comment
period (82 FR 49450 through 49451), we delayed implementation of ASC-
15a-e for the ASCQR Program beginning with the CY 2020 payment
determination due to lack of sufficient operational and implementation
data. At that time, we believed that our ongoing National OAS CAHPS
voluntary reporting program for the survey, which began in January 2016
\341\ and is unrelated to either the Hospital OQR Program or ASCQR
Program, would provide valuable information moving forward.
Specifically, we wanted to use the information from the National OAS
CAHPS voluntary reporting program to: (1) Ensure that the survey
measures appropriately account for patient response rates, both
aggregate and by survey administration method; (2) reaffirm the
reliability of national implementation of OAS CAHPS Survey data; and
(3) appropriately account for the burden associated with administering
the survey in the outpatient care setting.
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\341\ Participation in the program is open to any interested
Medicare-certified Hospital Outpatient Departments (HOPDs) and free-
standing ambulatory surgery centers (ASCs). More information on the
National OAS CAHPS voluntary reporting program is available at:
https://oascahps.org/General-Information/National-Implementation and
https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/CAHPS/OAS-CAHPS.
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Having had the opportunity during the delayed implementation to
investigate the concerns about patient response rates and data
reliability, we believe that patients are able to respond to OAS CAHPS
questions, and that those responses are reliable based on prior
experience collecting voluntary data for public reporting since CY 2016
(available at https://www.medicare.gov/care-compare/). We reaffirm that
the OAS CAHPS survey-based measures assess important aspects of care
where the patient is the best or only source of information (81 FR
79803). Regarding the burden associated with the survey, we believe
that rating patient experience still provides important information to
ASCs and patients, especially for assessing the quality of care
provided at an ASC (82 FR 59450). Furthermore, in section
XVI.D.1.d.(2)., we are proposing additional collection modes using a
web-based module (web with mail follow-up of non-respondents and web
with telephone follow-up of non-respondents) for administering the
survey, which would be available beginning in CY 2023 under the ASCQR
Program and for subsequent years.\342\ We believe this would further
address some burden concerns raised during the CY 2017 OPPS/ASC final
rule with comment period (81 FR 59450) because the web-based modules
may produce similar results but at lower costs of collection.\343\ As
we stated in the CY 2018 OPPS/ASC final rule with comment period, we
continue to believe that implementation of these measures will enable
objective and meaningful comparisons between ASCs (82 FR 59450) and
that patient experience of care data is valuable in assessing the
quality of care provided at an ASC and assisting patients in selecting
a provider for their care (82 FR 59450).
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\342\ We note that the mixed modes will be available as part of
the National OAS CAHPS voluntary reporting program beginning in CY
2022.
\343\ Bergeson SC, Gray J, Ehrmantraut LA, Hays RD. Comparing
Web-based with Mail Survey Administration of the Consumer Assessment
of Healthcare Providers and Systems (CAHPS[supreg]) Clinician and
Group Survey. Prim Health Care. 2013 Sept; doi: 10.4172/2167-
1079.1000132. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3783026/.
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In this proposed rule, we are proposing to restart the ASC-15a-e
measures by proposing to link reporting of measure data with payment
determinations as part of the ASCQR Program beginning with the CY 2024
reporting period/CY 2026 payment determination. Specifically, for the
ASCQR Program, we are proposing voluntary data collection and reporting
beginning with the CY 2023 reporting period, followed by mandatory data
collection and reporting beginning with the CY 2024 reporting period/CY
2026 payment determination. As noted above, the National OAS CAHPS
voluntary reporting program is independent of the ASCQR Program and the
Hospital OQR Program. This proposal is intended to make the distinction
that ASCs that voluntarily report the OAS CAHPS survey-based measures
during the CY 2023 reporting period would do so as part of the ASCQR
Program until mandatory reporting begins, if these proposals are
finalized. The reporting process for ASCs to submit OAS CAHPS data
would remain unchanged for ASCs (that is, they would not duplicate
submissions to the program and National OAS CAHPS voluntary reporting
program) and we refer readers to section XVI.D.1.d. for our related
proposals regarding the form, manner, and timing for reporting the ASC-
15a-e survey-based measures.
We initially considered a 2-year voluntary period, that is, the CY
2023 and CY 2024 reporting periods, because we believed that ASCs may
require additional preparation time for OAS CAHPS implementation
including contracting with OAS CAHPS vendors. We also considered the
challenges that many ASCs may have experienced during the COVID-19
pandemic and the additional operational constraints that they may still
be experiencing. However, since voluntary reporting, including the two
new modes of data collection we are proposing in section
XVI.D.1.d.(2)., will be available in 2022 as part of the National OAS
CAHPS voluntary reporting program, and we are proposing one year of
voluntary reporting as part of the ASCQR Program for the CY 2023
reporting period, we believe that ASCs will have sufficient time to
familiarize themselves with OAS CAHPS measures and OAS CAHPS vendors
prior to mandatory reporting in the CY 2024 reporting period/CY 2026
payment determination and for subsequent years.
We refer readers to section XVI.D.1.d. for our related proposals
regarding the form, manner, and timing for reporting the ASC-15a-e
survey-based measures.
We invite public comment on our proposal. We also refer readers to
section XV.B.5.a. of this proposed rule where we are also proposing to
restart this measure in the Hospital OQR Program.
[[Page 42274]]
5. Summary of Previously Finalized and Proposed ASCQR Program Quality
Measure Set
a. Summary of Previously Finalized and Proposed ASCQR Program Quality
Measure Set for the CY 2022 Reporting Period/CY 2024 Payment
Determination
Table 52 summarizes the previously finalized and proposed ASCQR
Program measure set for the CY 2022 reporting period/CY 2024 payment
determination.
[GRAPHIC] [TIFF OMITTED] TP04AU21.101
b. Summary of Previously Finalized and Proposed ASCQR Program Quality
Measure Set for the CY 2023 Reporting Period/CY 2025 Payment
Determination
Table 53 summarizes the previously finalized and proposed ASCQR
Program measure set for the CY 2023 reporting period/CY 2025 payment
determination.
[[Page 42275]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.102
c. Summary of Previously Finalized and Proposed ASCQR Program Quality
Measure Set for the CY 2024 Reporting Period/CY 2026 Payment
Determination and Subsequent Years
Table 54 summarizes the previously finalized and proposed ASCQR
Program measure set for the CY 2024 reporting period/CY 2026 payment
determination and subsequent years.
[[Page 42276]]
[GRAPHIC] [TIFF OMITTED] TP04AU21.103
6. ASCQR Program Measures and Topics for Future Consideration
a. Request for Comment on Potential Adoption of Future Measures for the
ASCQR Program
We seek to adopt a comprehensive set of quality measures for
widespread use to inform decision-making regarding care and for quality
improvement efforts in the ASC setting. In the CY 2021 OPPS/ASC final
rule with comment period (85 FR 86083 through 86110), under the OPPS we
finalized the elimination of the Inpatient Only (IPO) list over a 3-
year transitional period, beginning with the removal of approximately
300 primarily musculoskeletal-related services, with the list to be
completely phased out by CY 2024.\344\ As discussed in section IX. of
this rule, we have continued to receive stakeholder requests to
reconsider the elimination of the IPO list, to reevaluate services
removed from the IPO list due to safety and quality concerns, and to,
at a minimum, extend the timeframe for eliminating the list. After
further consideration and review of the additional feedback from
stakeholders, we believe that the timeframe we adopted for removing
services from the IPO list does not give us a sufficient opportunity to
carefully assess whether a procedure can be removed from the IPO list
while still ensuring beneficiary safety. For CY 2022, we are proposing
to halt the elimination of the IPO list and, after clinical review of
the services removed from the IPO list in CY 2021, we propose to add
the 298 services removed from the IPO list in CY 2021 back to the IPO
list beginning in CY 2022.
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\344\ Centers for Medicare & Medicaid Services. (2020, December
2). CY 2021 Medicare Hospital Outpatient Prospective Payment System
and Ambulatory Surgical Center Payment System final rule (CMS-1736-
FC). Retrieved from www.cms.gov/newsroom: https://www.cms.gov/newsroom/fact-sheets/cy-2021-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0.
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We are also proposing to reinstate the CY 2020 criteria used to add
procedures to the ASC Covered Procedures List (CPL) and remove 258 of
the additional 267 surgical procedures that were added to the ASC CPL
beginning in CY 2021, under the CY 2021 revised criteria \345\ with
additional procedures being proposed for addition for CY 2022.
However, as technology and surgical techniques advance, services
will continue to transition off of the IPO list, becoming payable in
the outpatient hospital setting and being eligible for addition to the
ASC covered procedures list in subsequent years. We recognize that
there may be a need for more measures that inform decision-making
regarding care and for quality improvement efforts, particularly
focused on the behaviors of services that become newly eligible for
payment in the ASC setting. In light of this, we seek comment on
potential future adoption of measures that would allow better tracking
of the quality of care for services that transition from the IPO list
and may subsequently become eligible for addition to the ASC CPL.
Therefore, we invite public comment on the potential future
adoption of measures for our consideration that address care quality in
the ASC setting given the transition of procedures from inpatient
settings to outpatient settings of care.
b. Request for Comment on Potential Future Adoption and Inclusion of an
ASC-Level, Risk-Standardized Patient Reported Outcomes Measure
Following Elective Primary Total Hip and/or Total Knee Arthroplasty
(THA/TKA)
As described in section XVI.B.6.a. above, we are seeking comment on
priorities for quality measurement in outpatient settings due to
changes to the IPO procedure list (82 FR 59385 and 84
[[Page 42277]]
FR 61355) and the ASC CPL (84 FR 61388 and 85 FR 86146).
We are also requesting comment on the potential future adoption of
a re-specified version of a patient-reported outcome-based performance
measure (PRO-PM) for two such procedures, elective primary total hip
arthroplasty (THA) and total knee arthroplasty (TKA), which were
removed from the IPO list effective for CY 2020 and CY 2018,
respectively, and added to the ASC CPL effective for CY 2021 and CY
2020, respectively. We recently solicited public comment on the
potential future inclusion of a Hospital-level THA/TKA PRO-PM (NQF
#3559) in the FY 2022 IPPS/LTCH PPS proposed rule for the inpatient
hospital setting (86 FR 25589). This measure reports the hospital-level
risk-standardized improvement rate (RSIR) in patient-reported outcomes
(PROs) following elective primary THA/TKA for Medicare fee-for-service
(FFS) beneficiaries aged 65 years and older. Substantial clinical
improvement is measured by achieving a pre-defined improvement in score
on one of the two validated joint-specific PRO instruments measuring
hip or knee pain and functioning: (1) The Hip dysfunction and
Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR) for
completion by THA recipients; and (2) the Knee injury and
Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR) for
completion by TKA recipients. Improvement is measured from the
preoperative assessment (data collected 90 to 0 days before surgery) to
the postoperative assessment (data collected 300 to 425 days following
surgery). Improvement scores are risk adjusted to account for
differences in patient case mix. Potential non-response bias in measure
scores due to the voluntary nature of PROs is incorporated in the
measure calculation with stabilized inverse probability weighting based
on likelihood of response.
Given the recent changes in the ASC CPL, we expect that THA and TKA
procedures will increasingly be performed in ASCs and that the volume
of these procedures on Medicare beneficiaries 65 and older will also
increase in ASCs in future years.
We recognize that potential future adoption and implementation of a
re-specified version of the THA/TKA PRO-PM in the ASCQR Program would
require sufficient numbers of procedures for each measured ASC to
ensure a reliable measure score. Only a subset of ASCs perform
orthopedic procedures, so the measure would likely apply to a minority
of ASCs. Additionally, implementing a THA/TKA PRO-PM would require
providers to successfully collect pre- and post-operative PRO data for
each procedure. Specifically, the inpatient THA/TKA PRO-PM discussed in
the FY 2022 IPPS/LTCH PPS proposed rule requires a minimum of 25 cases
with completed pre- and post-operative PRO data per hospital to ensure
a reliable facility-level score. For more details on the inpatient THA/
TKA PRO-PM, we refer readers to the FY 2022 IPPS/LTCH PPS proposed rule
(86 FR 25589) and the PROs Following Elective Primary Total Hip and/or
Total Knee Arthroplasty: Hospital-Level Performance Measure--Measure
Methodology Report, available on the CMS website at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/HospitalQualityInits/Measure-Methodology.
We will continue to monitor the number of THA and TKA procedures in
ASCs and when we believe there is a sufficient number of such
procedures performed in ASCs to reliably measure a meaningful number of
facilities, we may consider expanding the PRO-PM to this setting. We
also note that, as finalized in the CY 2018 OPPS/ASC final rule with
comment period (82 FR 59455 through 59463), the ASCQR Program currently
includes a Hospital Visits After Orthopedic Ambulatory Surgical Center
Procedures (ASC-17) measure using claims data which provides facilities
with important information on patient outcomes for Medicare FFS
beneficiaries following orthopedic surgery at ASCs and this measure
includes THA and TKA procedures. The ASC-17 measure calculates a
facility-specific risk-standardized hospital visit ratio within 7 days
of an orthopedic procedure performed at an ASC and has as outcomes of
interest unplanned hospital admissions, emergency department (ED)
visits, and observation stays, thereby, providing valuable quality
information for these procedures as they expand into the ASC setting.
As described in our Meaningful Measures 2.0 Framework, we aim to
promote better collection and integration of patients' voices by
developing PRO measures as an additional tool for measuring and
improving quality. Given the unique challenges and opportunities for
PRO-PMs for THA and TKA procedures in the ASC setting, we invite public
comment on the potential future adoption of a re-specified version of
PRO measures for elective THA/TKA PRO-PM for the ASCQR Program.
Specifically, we invite public comment on the following:
Input on the mechanism of PRO data collection and
submission, including anticipated barriers and solutions to data
collection and submission.
Usefulness of having an aligned set of PRO-PMs across
settings where elective THA/TKA are performed, that is, hospital
inpatient setting, hospital outpatient departments, and ASCs for
patients, providers, and other stakeholders. Specifically, usefulness
and considerations for a healthcare system that performs inpatient and/
or outpatient and ASC elective THA/TKAs.
Considerations unique to THA/TKAs performed in the ASC
setting such as the volume of procedures performed or the measure
cohort, outcome, or risk adjustment approach.
We invite public comment on the adoption of a re-specified version
of a PRO-PM measure for elective primary THA and TKA and future
inclusion of such in the ASCQR Program measure set.
c. Request for Comment on Potential Future Efforts To Address Health
Equity in the ASCQR Program
(1) Background
Significant and persistent inequities in health care outcomes exist
in the U.S. Belonging to racial or ethnic minority group; living with a
disability; being a member of the lesbian, gay, bisexual, transgender,
and queer (LGBTQ+) community; living in a rural area; and being near or
below the poverty level, are often associated with worse health
outcomes.346 347 348 349 350 351 352 353 Such
[[Page 42278]]
disparities in health outcomes are the result of number of factors, but
importantly for CMS programs, although not the sole determinant,
negative experiences, poor access, and provision of lower quality
health care contribute to health disparities. For instance, numerous
studies have shown that among Medicare beneficiaries, racial and ethnic
minority individuals often receive lower quality of care, report lower
experiences of care, and experience more frequent hospital readmissions
and procedural complications.354 355 356 357 358 359
Readmission rates for common conditions in the Hospital Readmissions
Reduction Program (HRRP) are higher for Black Medicare beneficiaries
and higher for Hispanic Medicare beneficiaries with Congestive Heart
Failure and Acute Myocardial Infarction.360 361 362 363 364
Studies have also shown that African Americans are significantly more
likely than White Americans to die prematurely from heart disease and
stroke.\365\ The COVID-19 pandemic has further highlighted many of
these longstanding health inequities with higher rates of infection,
hospitalization, and mortality among Black, Latino, and Indigenous and
Native American persons relative to White persons.366 367 As
noted by the CDC, ``long-standing systemic health and social inequities
have put many people from racial and ethnic minority groups at
increased risk of getting sick and dying from COVID-19.'' \368\ One
important strategy for addressing these important inequities is by
improving data collection to allow for better measurement and reporting
on equity across our programs and policies.
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\346\ Joynt K.E., Orav E., Jha A.K. Thirty-Day Readmission Rates
for Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\347\ Lindenauer P.K., Lagu T., Rothberg M.B., et al. Income
Inequality and 30 Day Outcomes After Acute Myocardial Infarction,
Heart Failure, and Pneumonia: Retrospective Cohort Study. British
Medical Journal. 2013;346.
\348\ Trivedi A.N., Nsa W., Hausmann LRM, et al. Quality and
Equity of Care in U.S. Hospitals. New England Journal of Medicine.
2014;371(24):2298-2308.
\349\ Polyakova, M., et al. Racial Disparities In Excess All-
Cause Mortality During The Early COVID-19 Pandemic Varied
Substantially Across States. Health Affairs. 2021; 40(2): 307-316.
\350\ Rural Health Research Gateway. Rural Communities: Age,
Income, and Health Status. Rural Health Research Recap. November
2018. Available at: https://www.ruralhealthresearch.org/assets/2200-8536/rural-communities-age-income-health-status-recap.pdf.
\351\ U.S. Department of Health and Human Services Office of
Minority Health. 2020 Update on the Action Plan to Reduce Racial and
Ethnic Health Disparities, FY 2020. Available at: https://www.minorityhealth.hhs.gov/assets/PDF/Update_HHS_Disparities_Dept-FY2020.pdf.
\352\ Heslin K.C., Hall J.E. Sexual Orientation Disparities in
Risk Factors for Adverse COVID-19-Related Outcomes, by Race/
Ethnicity--Behavioral Risk Factor Surveillance System, United
States, 2017-2019. MMWR Morb Mortal Wkly Rep 2021;70:149-154. DOI:
http://dx.doi.org/10.15585/mmwr.mm7005a1. Available at: www.cdc.gov/mmwr/volumes/70/wr/mm7005a1.htm.
\353\ Poteat T.C., Reisner S.L., Miller M., Wirtz A.L. COVID-19
Vulnerability of Transgender Women With and Without HIV Infection in
the Eastern and Southern U.S. Preprint. medRxiv.
2020;2020.07.21.20159327. Published 2020 Jul 24. doi:10.1101/
2020.07.21.20159327.
\354\ Martino, S.C., Elliott, M.N., Dembosky, J.W.,
Hambarsoomian, K., Burkhart, Q., Klein, D.J., Gildner, J., and
Haviland, A.M. Racial, Ethnic, and Gender Disparities in Health Care
in Medicare Advantage. Baltimore, MD: CMS Office of Minority Health.
2020.
\355\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\356\ Singh J.A., Lu X., Rosenthal G.E., Ibrahim S., Cram P.
Racial disparities in knee and hip total joint arthroplasty: An 18-
year analysis of national Medicare data. Ann Rheum Dis. 2014
Dec;73(12):2107-15.
\357\ Rivera-Hernandez M., Rahman M., Mor V., Trivedi A.N.
Racial Disparities in Readmission Rates among Patients Discharged to
Skilled Nursing Facilities. J Am Geriatr Soc. 2019 Aug;67(8):1672-
1679.
\358\ Joynt K.E., Orav E., Jha A.K. Thirty-Day Readmission Rates
for Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\359\ Tsai T.C., Orav E.J., Joynt K.E. Disparities in surgical
30-day readmission rates for Medicare beneficiaries by race and site
of care. Ann Surg. Jun 2014;259(6):1086-1090.
\360\ Rodriguez F., Joynt K.E., Lopez L., Saldana F., Jha A.K.
Readmission rates for Hispanic Medicare beneficiaries with heart
failure and acute myocardial infarction. Am Heart J. Aug
2011;162(2):254-261 e253.
\361\ Centers for Medicare and Medicaid Services. Medicare
Hospital Quality Chartbook: Performance Report on Outcome Measures;
2014.
\362\ Guide to Reducing Disparities in Readmissions. CMS Office
of Minority Health. Revised August 2018. Available at: https://www.cms.gov/About-CMS/Agency-Information/OMH/Downloads/OMH_Readmissions_Guide.pdf.
\363\ Prieto-Centurion V., Gussin H.A., Rolle A.J., Krishnan
J.A. Chronic obstructive pulmonary disease readmissions at minority-
serving institutions. Ann Am Thorac Soc. Dec 2013;10(6):680-684.
\364\ Joynt K.E., Orav E., Jha A.K. Thirty-Day Readmission Rates
for Medicare Beneficiaries by Race and Site of Care. JAMA.
2011;305(7):675-681.
\365\ HHS. Heart disease and African Americans.. (March 29,
2021). https://www.minorityhealth.hhs.gov/omh/browse.aspx?lvl=4&lvlid=19.
\366\ CMS. Preliminary Medicare COVID-19 Data Snapshot. (April
16, 2021). Available at: https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-fact-sheet.pdf.
\367\ Ochieng N., Cubanski J., Neuman T., Artiga S., and Damico
A. Racial and Ethnic Health Inequities and Medicare. Kaiser Family
Foundation. February 2021. Available at: https://www.kff.org/medicare/report/racial-and-ethnic-health-inequities-and-medicare/.
\368\ CDC. Health Equity Considerations & Racial & Ethnic
Minority Groups. (April 19, 2021). Available at: https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html.
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We are committed to achieving equity in health care outcomes for
our beneficiaries by supporting providers in quality improvement
activities to reduce health inequities, enabling them to make more
informed decisions, and promoting provider accountability for health
care disparities.\369\ For the purposes of this proposed rule, we are
using a definition of equity established in Executive Order 13985,
issued on January 25, 2021, as ``the consistent and systematic fair,
just, and impartial treatment of all individuals, including individuals
who belong to underserved communities that have been denied such
treatment, such as Black, Latino, and Indigenous and Native American
persons, Asian Americans and Pacific Islanders and other persons of
color; members of religious minorities; LGBTQ+ persons; persons with
disabilities; persons who live in rural areas; and persons otherwise
adversely affected by persistent poverty or inequality.'' \370\ We note
that this definition was recently established and provides a useful,
common definition for equity across different areas of government,
though numerous other definitions of equity exist.
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\369\ CMS. CMS Quality Strategy. (2016). Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Downloads/CMS-Quality-Strategy.pdf.
\370\ Executive Order 13985. Advancing Racial Equity and Support
for Underserved Communities Through the Federal Government. 86 FR
7009 (Jan. 20, 2021). Available at: https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government.
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Our ongoing commitment to closing the equity gap in CMS quality
programs is demonstrated by a portfolio of programs aimed at making
information on the quality of health care providers and services,
including disparities, more transparent to consumers and providers. The
CMS Equity Plan for Improving Quality in Medicare outlines a path to
equity which aims to support Quality Improvement Network Quality
Improvement Organizations (QIN-QIOs); Federal, state, local, and tribal
organizations; providers; researchers; policymakers; beneficiaries and
their families; and other stakeholders in activities to achieve health
equity.\371\
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\371\ Centers for Medicare & Medicaid Services Office of
Minority Health. The CMS Equity Plan for Improving Quality in
Medicare. 2015-2021. https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
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We refer readers to the FY 2022 IPPS/LTCH PPS proposed rule (86 FR
25070) which summarizes our existing initiatives aimed at closing the
equity gap in outcomes for Medicare beneficiaries. We also refer
readers to the section XV.B.7.c.(1). of this proposed rule which
describes the policy and statute which have informed the creation of
the CMS Disparity Methods to provide confidential stratified results
for measures in the hospital inpatient setting using dual eligibility
as a proxy for social risk. Our efforts to stratify outcome measures by
dual eligibility are supported by national recommendations from the
Assistant Secretary for Planning and Evaluation (ASPE) and the National
Academies of Sciences, Engineering, and Medicine, which identified dual
eligibility, as an indicator of social risk, as a powerful predictor of
poor health outcomes among the social risk factors that were
tested.372 373
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\372\ https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicaresvalue-based-purchasing-
programs.
\373\ National Academies of Sciences, Engineering, and Medicine.
2017. Accounting for social risk factors in Medicare payment.
Washington, DC: The National Academies Press.
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[[Page 42279]]
To date, we have not expanded disparities reporting to the ASC
setting. Internally testing the two disparities methods (Within- and
Across-Hospital Disparity Methods) on ASCQR Program quality measures
calculated using Medicare FFS claims revealed several unique challenges
to measuring disparities for dually eligible individuals in the ASC
setting, principally, relatively low volumes of dual eligible patients
in many facilities, and large diversity in the types and patient mix
between ASCs as these facilities tend to specialize. In our initial
analysis, few facilities met the minimum sample size required to yield
technically feasible, adequately representative, and statistically
reliable disparity results. We are considering social risk factors,
including neighborhood-level social determinants of health, such as the
poverty, education, and housing quality, which can adversely influence
health outcomes, contributing to health inequities, in order to report
more information regarding equity gaps in the care provided in the ASC
setting. There are several different approaches for quantifying the
health impacts of adverse neighborhood level socioeconomic factors. One
approach is the Agency for Healthcare Research and Quality (AHRQ)
neighborhood Socioeconomic Status (SES) Index, which uses information
from the U.S. Census at the census block-group level to estimate the
range of socioeconomic status in the beneficiary's neighborhood.\374\
In this proposed rule, we are seeking comment on and are interested in
learning more about the potential for measuring disparities in care
provided in this setting.
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\374\ Bonito A.J., Bann C., Eicheldinger C., Carpenter L.
Creation of New Race-Ethnicity Codes and Socioeconomic Status (SES)
Indicators for Medicare Beneficiaries. Final Report, Sub-Task 2.
(Prepared by RTI International for the Centers for Medicare and
Medicaid Services through an interagency agreement with the Agency
for Healthcare Research and Policy, under Contract No. 500-00-0024,
Task No. 21) AHRQ Publication No. 08-0029-EF. Rockville, MD, Agency
for Healthcare Research and Quality. January 2008.
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(2) Solicitation of Public Comments
We are seeking comment on the possibility of providing equity
reporting in the ASCQR Program in a way that maximally supports
facilities in improving the quality of care for all Medicare
beneficiaries, regardless of their socioeconomic status or other risk
factors. We are particularly interested in learning about measurement
approaches or social risk factors which may permit illuminating social-
based disparities in facilities which have relatively few individuals
who possess social risk factors. Specifically, we are inviting public
comment on the following:
Ways to address the unique challenges of measuring
disparities in the ASC setting, such as small sample sizes, ASC
specialization, and the relatively smaller proportion of patients with
social risk factors.