[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Proposed Rules]
[Pages 42132-42208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14671]
[[Page 42131]]
Vol. 85
Monday,
No. 134
July 13, 2020
Part III
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Part 413
Medicare Program; End-Stage Renal Disease Prospective Payment System,
Payment for Renal Dialysis Services Furnished to Individuals With Acute
Kidney Injury, and End-Stage Renal Disease Quality Incentive Program;
Proposed Rule
Federal Register / Vol. 85 , No. 134 / Monday, July 13, 2020 /
Proposed Rules
[[Page 42132]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 413
[CMS-1732-P]
RIN 0938-AU08
Medicare Program; End-Stage Renal Disease Prospective Payment
System, Payment for Renal Dialysis Services Furnished to Individuals
With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive
Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would update and make revisions to the End-
Stage Renal Disease (ESRD) Prospective Payment System (PPS) for
calendar year (CY) 2021. This rule also proposes to update the payment
rate for renal dialysis services furnished by an ESRD facility to
individuals with acute kidney injury (AKI). In addition, this rule
proposes to update requirements for the ESRD Quality Incentive Program
(QIP).
DATES: To be assured consideration, comments must be submitted at one
of the addresses provided below, no later than September 4, 2020.
ADDRESSES: In commenting, please refer to file code CMS-1732-P. 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 submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
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-1732-P, P.O. Box 8010,
Baltimore, MD 21244-8010.
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 to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1732-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: [email protected], for issues
related to the ESRD PPS and coverage and payment for renal dialysis
services furnished to individuals with AKI.
Delia Houseal, (410) 786-2724, for issues related to the ESRD QIP.
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.
Table of Contents
To assist readers in referencing sections contained in this
preamble, we are providing a Table of Contents.
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Cost and Benefits
II. Calendar Year (CY) 2021 End-Stage Renal Disease (ESRD)
Prospective Payment System (PPS)
A. Background
B. Provisions of the Proposed Rule
C. Proposed Transitional Add-On Payment Adjustment for New and
Innovative Equipment and Supplies (TPNIES) for CY 2021 Payment
III. Calendar Year (CY) 2021 Payment for Renal Dialysis Services
Furnished to Individuals With Acute Kidney Injury (AKI)
A. Background
B. Proposed Annual Payment Rate Update for CY 2021
IV. End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
A. Background
B. Proposed Updates to Requirements Beginning With the PY 2023
ESRD QIP
C. Proposals for the PY 2023 ESRD QIP
V. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
B. Requirements in Regulation Text
C. Additional Information Collection Requirements
VI. Response to Comments
VII. Economic Analyses
A. Regulatory Impact Analysis
B. Detailed Economic Analysis
C. Accounting Statement
D. Regulatory Flexibility Act Analysis
E. Unfunded Mandates Reform Act Analysis
F. Federalism Analysis
G. Reducing Regulation and Controlling Regulatory Costs
H. Congressional Review Act
VIII. Files Available to the Public via the internet
Regulations Text
I. Executive Summary
A. Purpose
This rule contains proposals related to the End-Stage Renal Disease
(ESRD) Prospective Payment System (PPS), payment for renal dialysis
services furnished to individuals with acute kidney injury (AKI), and
the ESRD Quality Incentive Program (QIP).
1. End-Stage Renal Disease (ESRD) Prospective Payment System (PPS)
On January 1, 2011, we implemented the ESRD PPS, a case-mix
adjusted, bundled PPS for renal dialysis services furnished by ESRD
facilities as required by section 1881(b)(14) of the Social Security
Act (the Act), as added by section 153(b) of the Medicare Improvements
for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275).
Section 1881(b)(14) (F) of the Act, as added by section 153(b) of
MIPPA, and amended by section 3401(h) of the Patient Protection and
Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148),
established that beginning calendar year (CY) 2012, and each subsequent
year, the Secretary of the Department of Health and Human Services (the
Secretary) shall annually increase payment amounts by an ESRD market
basket increase factor, reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule
proposes updates and revisions to the ESRD PPS for CY 2021.
2. Coverage and Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury (AKI)
On June 29, 2015, the President signed the Trade Preferences
Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of the
TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for
renal dialysis services furnished on or after January 1, 2017, by a
renal dialysis facility or a provider of services paid under section
1881(b)(14) of the Act to an individual with acute kidney injury (AKI).
Section 808(b) of the TPEA amended section 1834 of the Act by adding a
new subsection (r) that provides for payment for renal dialysis
services furnished by renal dialysis facilities or providers of
services paid under section 1881(b)(14) of the Act to individuals with
AKI at the ESRD PPS base rate beginning January 1, 2017. This rule
proposes to update the AKI payment rate for CY 2021.
[[Page 42133]]
3. End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
The End-Stage Renal Disease Quality Incentive Program (ESRD QIP) is
authorized by section 1881(h) of the Act. The Program fosters improved
patient outcomes by establishing incentives for dialysis facilities to
meet or exceed performance standards established by the Centers for
Medicare & Medicaid Services (CMS). This proposed rule proposes several
updates for the payment years (PY) 2023 and 2024 ESRD QIP.
B. Summary of the Major Provisions
1. ESRD PPS
Update to the ESRD PPS base rate for CY 2021: The proposed
CY 2021 ESRD PPS base rate is $255.59. This proposed amount reflects
the application of the wage index budget-neutrality adjustment factor
(.998652), the proposed addition to the base rate of $12.06 to include
calcimimetics, and a productivity-adjusted market basket increase as
required by section 1881(b)(14)(F)(i)(I) of the Act (1.8 percent),
equaling $255.59 (($239.33 x .998652) + $12.06) x 1.018 = $255.59).
Annual update to the wage index: We adjust wage indices on
an annual basis using the most current hospital wage data and the
latest core-based statistical area (CBSA) delineations to account for
differing wage levels in areas in which ESRD facilities are located.
For CY 2021, we are proposing to update the wage index values based on
the latest available data.
New Office of Management and Budget (OMB) delineations and
2-year transition policy: We are proposing to adopt the Office of
Management and Budget (OMB) delineations as described in the September
14, 2018 OMB Bulletin No. 18-04, beginning with the CY 2021 ESRD PPS
wage index. In addition, we are proposing to apply a 5 percent cap on
any decrease in an ESRD facility's wage index from the ESRD facility's
wage index from the prior calendar year. This transition would be
phased in over 2 years, such that the estimated reduction in an ESRD
facility's wage index would be capped at 5 percent in CY 2021, and no
cap would be applied to the reduction in the wage index for the second
year, CY 2022.
Update to the outlier policy: We are proposing to update
the outlier policy using the most current data, as well as update the
outlier services fixed-dollar loss (FDL) amounts for adult and
pediatric patients and Medicare allowable payment (MAP) amounts for
adult and pediatric patients for CY 2021 using CY 2019 claims data.
Based on the use of the latest available data, the proposed FDL amount
for pediatric beneficiaries would increase from $41.04 to $47.73, and
the MAP amount would increase from $32.32 to $33.08, as compared to CY
2020 values. For adult beneficiaries, the proposed FDL amount would
increase from $48.33 to $133.52, and the MAP amount would increase from
$35.78 to $54.26. The 1.0 percent target for outlier payments was not
achieved in CY 2019. Outlier payments represented approximately 0.5
percent of total payments rather than 1.0 percent.
Inclusion of calcimimetics in the ESRD PPS base rate: We
are proposing the methodology for modifying the ESRD PPS base rate to
include calcimimetics in the ESRD PPS bundled payment. Using the
proposed methodology based on the latest available data, we are
proposing to add $12.06 to the ESRD PPS base rate beginning in CY 2021.
Changes to the eligibility criteria for the transitional
add-on payment adjustment for new and innovative equipment and supplies
(TPNIES): We are proposing changes to the transitional add-on payment
for new and innovative equipment and supplies (TPNIES) eligibility
criteria in light of the changes implemented in CY 2020 to provide
biannual coding cycles for code applications for new Healthcare Common
Procedure Coding System (HCPCS) codes for durable medical equipment,
orthotics, prosthetics and supplies (DMEPOS) items and services. We are
proposing that for purposes of eligibility for the TPNIES, a complete
HCPCS code application must be submitted by the HCPCS Level II code
application deadline for biannual Coding Cycle 2 for DMEPOS items and
services as specified in the HCPCS Level II coding guidance on the CMS
website. In addition, the Food and Drug Administration (FDA) marketing
authorization must be submitted to CMS by the HCPCS Level II code
application deadline for biannual Coding Cycle 2 for DMEPOS items and
services as specified in the HCPCS Level II coding guidance on the CMS
website in order for the equipment or supply to be eligible for the
TPNIES the following year. We are also proposing to define ``new'' for
purposes of the TPNIES policy as within 3 years beginning on the date
of the FDA marketing authorization.
Expansion of the TPNIES to include new and innovative
capital-related assets that are home dialysis machines when used in the
home for a single patient: We are proposing to expand eligibility for
the TPNIES to include certain capital-related assets that are home
dialysis machines when used in the home for a single patient. As with
other renal dialysis equipment and supplies potentially eligible for
the TPNIES, CMS would evaluate the application to determine whether the
home dialysis machine represents an advance that substantially
improves, relative to renal dialysis services previously available, the
diagnosis or treatment of Medicare beneficiaries, and meets the other
requirements under Sec. 413.236(b). We are proposing additional steps
the Medicare Administrative Contractors (MACs) would follow to
establish the basis payment of the TPNIES for these capital-related
assets that are home dialysis machines when used in the home. We would
pay 65 percent of the MAC-determined pre-adjusted per treatment amount
for 2-calendar years. We are proposing that after the 2-year TPNIES
period ends, the home dialysis machines would not become eligible
outlier services and no change would be made to the ESRD PPS base rate.
Low-Volume Payment Adjustment (LVPA): We are proposing to
hold harmless ESRD facilities that would otherwise qualify for the LVPA
but for a temporary increase in dialysis treatments furnished in 2020
due to the Public Health Emergency (PHE) for the coronavirus disease
2019 (COVID-19) pandemic. For purposes of determining LVPA eligibility
for payment years 2021, 2022, and 2023, we are proposing to only
consider total dialysis treatments furnished for any 6 months of a
facility's cost-reporting period ending in 2020; ESRD facilities would
select those 6 months (consecutive or non-consecutive) during which
treatments would be counted for purposes of the LVPA determination. We
are proposing that ESRD facilities would attest that their total
dialysis treatments for those 6 months of their cost-reporting period
ending in 2020 are less than 2,000 and that, although the total number
of treatments furnished in the entire year otherwise exceeded the LVPA
threshold, the excess treatments furnished were due to temporary
patient shifting resulting from the COVID-19 PHE. MACs would annualize
the total dialysis treatments for the total treatments reported in
those 6 months by multiplying by 2. ESRD facilities would be expected
to provide supporting documentation to the MACs upon request.
2. Payment for Renal Dialysis Services Furnished to Individuals With
AKI
We are proposing to update the AKI payment rate for CY 2021. The
proposed CY 2021 payment rate is $255.59, which
[[Page 42134]]
is the same as the base rate proposed under the ESRD PPS for CY 2021.
3. ESRD QIP
We propose to update the scoring methodology used to calculate the
Ultrafiltration Rate reporting measure so that facilities are scored
based on the number of eligible patient-months, instead of facility-
months, and to reduce the number of records that facilities selected
for National Health Safety Network (NHSN) validation are required to
submit. This rule also clarifies the timeline for facilities to make
changes to their NHSN Bloodstream Infection (BSI) clinical measure and
NHSN Dialysis Event reporting measure data for purposes of the ESRD
QIP. This rule also provides estimates for the performance standards
and payment reductions that would apply for PY 2023.
This rule does not propose any new requirements beginning with the
PY 2024 ESRD QIP.
C. Summary of Costs and Benefits
In section VII of this proposed rule, we set forth a detailed
analysis of the impacts that the proposed changes would have on
affected entities and beneficiaries. The impacts include the following:
1. Impacts of the Proposed ESRD PPS
The impact chart in section VII.B of this proposed rule displays
the estimated change in payments to ESRD facilities in CY 2021 compared
to estimated payments in CY 2020. The overall impact of the proposed CY
2021 changes is projected to be a 1.6 percent increase in payments.
Hospital-based ESRD facilities have an estimated 0.4 percent decrease
in payments compared with freestanding facilities with an estimated 1.6
percent increase.
We estimate that the aggregate ESRD PPS expenditures would increase
by approximately $190 million in CY 2021 compared to CY 2020. This
reflects a $230 million increase from the payment rate update, a $40
million increase due to the updates to the outlier threshold amounts,
and an $80 million decrease from the proposed addition to the ESRD PPS
base rate to include calcimimetics and no longer provide the
transitional drug add-on payment adjustment (TDAPA) for calcimimetics.
As a result of the projected 1.6 percent overall payment increase, we
estimate there would be an increase in beneficiary co-insurance
payments of 1.6 percent in CY 2021, which translates to approximately
$40 million.
These figures do not reflect estimated increases or decreases in
expenditures based on our proposal to expand the TPNIES to include
certain capital-related assets that are home dialysis machines when
used in the home. The fiscal impact of this proposal cannot be
determined because these new and innovative home dialysis machines are
not yet identified and would vary in uniqueness and costs.
2. Impacts of the Proposed Payment for Renal Dialysis Services
Furnished to Individuals With AKI
The impact chart in section VII.B of this proposed rule displays
the estimated change in proposed payments to ESRD facilities in CY 2021
compared to estimated payments in CY 2020. The overall impact of the
proposed CY 2021 changes is projected to be a 6.9 percent increase in
payments for individuals with AKI. Hospital-based and freestanding ESRD
facilities both have an estimated 6.9 percent increase in payments for
individuals with AKI. The overall impact reflects the effects of the
updated wage index, the proposed addition to the ESRD PPS base rate of
$12.06 to include calcimimetics in the ESRD PPS bundled payment, and
the payment rate update.
We estimate that the aggregate payments made to ESRD facilities for
renal dialysis services furnished to AKI patients at the proposed CY
2021 ESRD PPS base rate would increase by $5 million in CY 2021
compared to CY 2020.
3. Impacts of the Proposed ESRD QIP
We estimate that the overall economic impact of the PY 2023 ESRD
QIP would be approximately $221 million as a result of the policies we
have previously finalized and the proposals in this proposed rule. The
$221 million figure for PY 2023 includes costs associated with the
collection of information requirements, which we estimate would be
approximately $205 million, and $16 million in estimated payment
reductions across all facilities. We also estimate that the overall
economic impact of the PY 2024 ESRD QIP would be approximately $221
million as a result of the policies we have previously finalized. The
$221 million figure for PY 2024 includes costs associated with the
collection of information requirements, which we estimate would be
approximately $205 million.
II. Calendar Year (CY) 2021 End-Stage Renal Disease (ESRD) Prospective
Payment System (PPS)
A. Background
1. Statutory Background
On January 1, 2011, we implemented the End-Stage Renal Disease
(ESRD) Prospective Payment System (PPS), a case-mix adjusted bundled
PPS for renal dialysis services furnished by ESRD facilities, as
required by section 1881(b)(14) of the Social Security Act (the Act),
as added by section 153(b) of the Medicare Improvements for Patients
and Providers Act of 2008 (MIPPA). Section 1881(b)(14)(F) of the Act,
as added by section 153(b) of MIPPA and amended by section 3401(h) of
the Patient Protection and Affordable Care Act (the Affordable Care
Act), established that beginning with CY 2012, and each subsequent
year, the Secretary of the Department of Health and Human Services (the
Secretary) shall annually increase payment amounts by an ESRD market
basket increase factor, reduced by the productivity adjustment
described in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA)
(Pub. L. 112-240) included several provisions that apply to the ESRD
PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act,
which required the Secretary, by comparing per patient utilization data
from 2007 with such data from 2012, to reduce the single payment for
renal dialysis services furnished on or after January 1, 2014 to
reflect the Secretary's estimate of the change in the utilization of
ESRD-related drugs and biologicals (excluding oral-only ESRD-related
drugs). Consistent with this requirement, in the CY 2014 ESRD PPS final
rule we finalized $29.93 as the total drug utilization reduction and
finalized a policy to implement the amount over a 3- to 4-year
transition period (78 FR 72161 through 72170).
Section 632(b) of ATRA prohibited the Secretary from paying for
oral-only ESRD-related drugs and biologicals under the ESRD PPS prior
to January 1, 2016. And section 632(c) of ATRA required the Secretary,
by no later than January 1, 2016, to analyze the case-mix payment
adjustments under section 1881(b)(14)(D)(i) of the Act and make
appropriate revisions to those adjustments.
On April 1, 2014, the Protecting Access to Medicare Act of 2014
(PAMA) (Pub. L. 113-93) was enacted. Section 217 of PAMA included
several provisions that apply to the ESRD PPS. Specifically, sections
217(b)(1) and (2)
[[Page 42135]]
of PAMA amended sections 1881(b)(14)(F) and (I) of the Act and replaced
the drug utilization adjustment that was finalized in the CY 2014 ESRD
PPS final rule (78 FR 72161 through 72170) with specific provisions
that dictated the market basket update for CY 2015 (0.0 percent) and
how the market basket should be reduced in CY 2016 through CY 2018.
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to
provide that the Secretary may not pay for oral-only ESRD-related drugs
under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) of PAMA
further amended section 632(b)(1) of ATRA by requiring that in
establishing payment for oral-only drugs under the ESRD PPS, the
Secretary must use data from the most recent year available. Section
217(c) of PAMA provided that as part of the CY 2016 ESRD PPS
rulemaking, the Secretary shall establish a process for (1) determining
when a product is no longer an oral-only drug; and (2) including new
injectable and intravenous products into the ESRD PPS bundled payment.
Finally, on December 19, 2014, the President signed the Stephen
Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub.
L. 113-295). Section 204 of ABLE amended section 632(b)(1) of ATRA, as
amended by section 217(a)(1) of PAMA, to provide that payment for oral-
only renal dialysis services cannot be made under the ESRD PPS bundled
payment prior to January 1, 2025.
2. System for Payment of Renal Dialysis Services
Under the ESRD PPS, a single, per-treatment payment is made to an
ESRD facility for all of the renal dialysis services defined in section
1881(b)(14)(B) of the Act and furnished to individuals for the
treatment of ESRD in the ESRD facility or in a patient's home. We have
codified our definitions of renal dialysis services at Sec. 413.171,
which is in 42 CFR part 413, subpart H, along with other ESRD PPS
payment policies. The ESRD PPS base rate is adjusted for
characteristics of both adult and pediatric patients and accounts for
patient case-mix variability. The adult case-mix adjusters include five
categories of age, body surface area, low body mass index, onset of
dialysis, four comorbidity categories, and pediatric patient-level
adjusters consisting of two age categories and two dialysis modalities
(Sec. 413.235(a) and (b)).
The ESRD PPS provides for three facility-level adjustments. The
first payment adjustment accounts for ESRD facilities furnishing a low
volume of dialysis treatments (Sec. 413.232). The second adjustment
reflects differences in area wage levels developed from core based
statistical areas (CBSAs) (Sec. 413.231). The third payment adjustment
accounts for ESRD facilities furnishing renal dialysis services in a
rural area (Sec. 413.233).
The ESRD PPS provides a training add-on for home and self-dialysis
modalities (Sec. 413.235(c)) and an additional payment for high cost
outliers due to unusual variations in the type or amount of medically
necessary care when applicable (Sec. 413.237).
The ESRD PPS provides for a transitional drug add-on payment
adjustment (TDAPA) for certain new renal dialysis drugs and biological
products (Sec. 413.234(c)).
The ESRD PPS also provides for a transitional add-on payment
adjustment for new and innovative equipment and supplies (TPNIES) for
certain qualifying, new and innovative renal dialysis equipment and
supplies (Sec. 413.236(d)).
3. Updates to the ESRD PPS
Policy changes to the ESRD PPS are proposed and finalized annually
in the Federal Register. The CY 2011 ESRD PPS final rule was published
on August 12, 2010 in the Federal Register (75 FR 49030 through 49214).
That rule implemented the ESRD PPS beginning on January 1, 2011 in
accordance with section 1881(b)(14) of the Act, as added by section
153(b) of MIPPA, over a 4-year transition period. Since the
implementation of the ESRD PPS, we have published annual rules to make
routine updates, policy changes, and clarifications.
On November 8, 2019, we published a final rule in the Federal
Register titled, ``Medicare Program; End-Stage Renal Disease
Prospective Payment System, Payment for Renal Dialysis Services
Furnished to Individuals with Acute Kidney Injury, End-Stage Renal
Disease Quality Incentive Program, Durable Medical Equipment,
Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts,
DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements
for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject
to a Face-to-Face Encounter and Written Order Prior to Delivery and/or
Prior Authorization Requirements,'' referred to as the CY 2020 ESRD PPS
final rule. In that rule, we updated the ESRD PPS base rate, wage
index, and outlier policy, for CY 2020. We also finalized revisions to
the eligibility criteria for the TDAPA for certain new renal dialysis
drugs and biological products that fall within an existing ESRD PPS
functional category, modified the basis of payment for the TDAPA for
calcimimetics, established a new policy to condition the TDAPA payment
on our receipt of average sales price (ASP) data, established the
TPNIES to support ESRD facilities in their uptake of certain new and
innovative renal dialysis equipment and supplies, and discontinued the
erythropoiesis-stimulating agent (ESA) monitoring policy under the ESRD
PPS. For further detailed information regarding these updates, see 84
FR 60648.
B. Provisions of the Proposed Rule
1. Inclusion of Calcimimetics Into the ESRD PPS Bundled Payment
a. Background on Oral-Only Renal Dialysis Drugs
Section 1881(b)(14)(A)(i) of the Act requires the Secretary to
implement a payment system under which a single payment is made to a
provider of services or a renal dialysis facility for renal dialysis
services in lieu of any other payment. Section 1881(b)(14)(B) of the
Act defines renal dialysis services, and clause (iii) of such section
states that these services include other drugs and biologicals that are
furnished to individuals for the treatment of ESRD and for which
payment was made separately under this title, and any oral equivalent
form of such drug or biological.
We interpreted this provision as including not only injectable
drugs and biological products used for the treatment of ESRD (other
than erythropoiesis-stimulating agents (ESAs) and any oral form of
ESAs, which are included under clause (ii) of section 1881(b)(14)(B) of
the Act), but also all oral drugs and biological products used for the
treatment of ESRD and furnished under title XVIII of the Act. We also
concluded that, to the extent oral-only drugs or biological products
used for the treatment of ESRD do not fall within clause (iii) of
section 1881(b)(14)(B), such drugs or biological products would fall
under clause (iv) of such section, and constitute other items and
services used for the treatment of ESRD that are not described in
clause (i) of section 1881(b)(14)(B) of the Act.
We finalized and promulgated the payment policies for oral-only
renal dialysis service drugs and biological products in the CY 2011
ESRD PPS final rule (75 FR 49038 through 49053), where we defined renal
dialysis services at Sec. 413.171 as including other drugs and
biological products that are furnished to individuals for the treatment
of ESRD and for which payment was made separately prior to
[[Page 42136]]
January 1, 2011 under Title XVIII of the Act, including drugs and
biological products with only an oral form. We further described oral-
only drugs as those that have no injectable equivalent or other form of
administration (75 FR 49038 through 49039). Although we included oral-
only renal dialysis service drugs and biological products in the
definition of renal dialysis services in the CY 2011 ESRD PPS final
rule (75 FR 49044), we also finalized a policy to delay payment for
these drugs under the PPS until January 1, 2014. In the CY 2011 ESRD
PPS proposed and final rules (74 FR 49929 and 75 FR 49038,
respectively), we noted that the only oral-only drugs and biological
products that we identified were phosphate binders and calcimimetics,
which fall into the bone and mineral metabolism ESRD PPS functional
category. We stated that there were certain advantages to delaying the
implementation of payment for oral-only drugs and biological products,
including allowing ESRD facilities additional time to make operational
changes and logistical arrangements in order to furnish oral-only renal
dialysis service drugs and biological products to their patients.
Accordingly, we codified the delay in payment for oral-only renal
dialysis service drugs and biological products at Sec. 413.174(f)(6),
and provided that payment to an ESRD facility for renal dialysis
service drugs and biological products with only an oral form is
incorporated into the PPS payment rates effective January 1, 2014.
Since oral-only drugs are generally not a covered service under
Medicare Part B, this delay of payment under the ESRD PPS also allowed
the coverage under Medicare to continue under Part D.
On January 3, 2013, ATRA was enacted. Section 632(b) of ATRA
precluded the Secretary from implementing the policy under Sec.
413.176(f)(6) relating to oral-only renal dialysis service drugs and
biological products prior to January 1, 2016. Accordingly, in the CY
2014 ESRD PPS final rule (78 FR 72185 through 72186), we delayed
payment for oral-only renal dialysis service drugs and biological
products under the ESRD PPS until January 1, 2016. We implemented this
delay by revising the effective date at Sec. 413.174(f)(6) from
January 1, 2014 to January 1, 2016. In addition, we changed the date
when oral-only renal dialysis service drugs and biological products
would be eligible for outlier services under the outlier policy
described in Sec. 413.237(a)(1)(iv) from January 1, 2014 to January 1,
2016.
On April 1, 2014, PAMA was enacted. Section 217(a)(1) of PAMA
amended section 632(b)(1) of ATRA and precluded the Secretary from
implementing the policy under Sec. 413.174(f)(6) relating to oral-only
renal dialysis service drugs and biological products prior to January
1, 2024. We implemented this delay in the CY 2015 ESRD PPS final rule
(79 FR 66262) by modifying the effective date for providing payment for
oral-only renal dialysis service drugs and biological products under
the ESRD PPS at Sec. 413.174(f)(6) from January 1, 2016 to January 1,
2024. We also changed the date in Sec. 413.237(a)(1)(iv) regarding
outlier payments for oral-only renal dialysis service drugs made under
the ESRD PPS from January 1, 2016 to January 1, 2024. Section 217(a)(2)
of PAMA further amended section 632(b)(1) of ATRA by requiring that in
establishing payment for oral-only drugs under the ESRD PPS, the
Secretary must use data from the most recent year available.
On December 19, 2014, ABLE was enacted. Section 204 of ABLE amended
section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, and
precluded the Secretary from implementing the policy under Sec.
413.174(f)(6) relating to oral-only renal dialysis service drugs and
biological products prior to January 1, 2025. We implemented this delay
in the CY 2016 ESRD PPS final rule (80 FR 69027 through 69028) by
modifying the effective date for providing payment for oral-only renal
dialysis service drugs and biological products under the ESRD PPS at
Sec. 413.174(f)(6) from January 1, 2024 to January 1, 2025. We also
changed the date in Sec. 413.237(a)(1)(iv) regarding outlier payments
for oral-only renal dialysis service drugs made under the ESRD PPS from
January 1, 2024 to January 1, 2025.
b. ESRD PPS Drug Designation Process and Calcimimetics
In addition to delaying implementation of the policy for oral-only
renal dialysis service drugs and biological products under the ESRD
PPS, discussed previously in this proposed rule, PAMA included section
217(c), which provided that as part of the CY 2016 ESRD PPS rulemaking,
the Secretary shall establish a process for (1) determining when a
product is no longer an oral-only drug; and (2) including new
injectable and intravenous products into the ESRD PPS bundled payment.
Therefore, in the CY 2016 ESRD PPS final rule (80 FR 69013 through
69027), we finalized a process that allows us to recognize when an
oral-only renal dialysis service drug or biological product is no
longer oral-only, and a process to include new injectable and
intravenous (IV) products into the ESRD PPS bundled payment, and when
appropriate, modify the ESRD PPS payment amount to reflect the costs of
furnishing that product.
In accordance with section 217(c)(1) of PAMA, we established Sec.
413.234(d), which provides that an oral-only drug is no longer
considered oral-only if an injectable or other form of administration
of the oral-only drug is approved by FDA. We defined an oral-only drug
at Sec. 413.234(a) to mean a drug or biological with no injectable
equivalent or other form of administration other than an oral form.
Additionally, in accordance with section 217(c)(2) of PAMA, we
codified the drug designation process at Sec. 413.234(b). In the CY
2016 ESRD PPS final rule (80 FR 69024), we finalized that the drug
designation process is dependent upon the ESRD PPS functional
categories, consistent with our policy since the implementation of the
PPS in 2011. We provided a detailed discussion on how we accounted for
renal dialysis drugs and biological products in the ESRD PPS base rate
since its implementation on January 1, 2011 (80 FR 69013 through
69015). We explained that, in the CY 2011 ESRD PPS final rule (75 FR
49044 through 49053), in order to identify drugs and biological
products that are used for the treatment of ESRD and therefore meet the
definition of renal dialysis services (defined at Sec. 413.171) that
would be included in the ESRD PPS base rate, we performed an extensive
analysis of Medicare payments for Part B drugs and biological products
billed on ESRD claims and evaluated each drug and biological product to
identify its category by indication or mode of action. We stated in the
CY 2011 ESRD PPS final rule that categorizing drugs and biological
products on the basis of drug action allows us to determine which
categories (and therefore, the drugs and biological products within the
categories) would be considered used for the treatment of ESRD (75 FR
49047).
In the CY 2016 ESRD PPS final rule, we also explained that, in CY
2011 ESRD PPS rulemaking, we grouped the injectable and IV drugs and
biological products into ESRD PPS functional categories based on their
action (80 FR 69014). This was done for the purpose of adding new drugs
or biological products with the same functions to the ESRD PPS bundled
payment as expeditiously as possible after the drugs become
commercially available so that beneficiaries have access to them. In
the CY 2016 ESRD PPS final rule, we
[[Page 42137]]
finalized the definition of an ESRD PPS functional category in Sec.
413.234(a) as a distinct grouping of drugs or biologicals, as
determined by CMS, whose end action effect is the treatment or
management of a condition or conditions associated with ESRD (80 FR
69077).
We finalized a policy in the CY 2016 ESRD PPS final rule (80 FR
69017 through 69022) that, effective January 1, 2016, if a new
injectable or IV product is used to treat or manage a condition for
which there is an ESRD PPS functional category, the new injectable or
IV product is considered included in the ESRD PPS bundled payment and
no separate payment is available. The new injectable or IV product
qualifies as an outlier service. The ESRD bundled market basket updates
the PPS base rate annually and accounts for price changes of the drugs
and biological products reflected in the base rate.
We established in Sec. 413.234(b)(2) that, if the new injectable
or IV product is used to treat or manage a condition for which there is
not an ESRD PPS functional category, the new injectable or IV product
is not considered included in the ESRD PPS bundled payment and the
following steps occur. First, an existing ESRD PPS functional category
is revised or a new ESRD PPS functional category is added for the
condition that the new injectable or IV product is used to treat or
manage. Next, the new injectable or IV product is paid for using the
TDAPA described in Sec. 413.234(c). Finally, the new injectable or IV
product is added to the ESRD PPS bundled payment following payment of
the TDAPA.
In the CY 2016 ESRD PPS final rule, we finalized a policy in Sec.
413.234(c) to base the TDAPA on pricing methodologies under section
1847A of the Act and pay the TDAPA until sufficient claims data for
rate setting analysis for the new injectable or IV product are
available, but not for less than 2 years. During the time a new
injectable or IV product is eligible for the TDAPA, it is not eligible
as an outlier service. We established that, following payment of the
TDAPA, the ESRD PPS base rate will be modified, if appropriate, to
account for the new injectable or IV product in the ESRD PPS bundled
payment.
We also established, in the CY 2016 ESRD PPS final rule (80 FR
69024 through 69027), an exception to the drug designation process for
calcimimetics. We noted that in the CY 2011 ESRD PPS proposed and final
rules (74 FR 49929 and 75 FR 49038, respectively), the only oral-only
drugs and biological products we identified were phosphate binders and
calcimimetics, which fall into the bone and mineral metabolism ESRD PPS
functional category. We stated that we defined these oral-only drugs as
renal dialysis services in our regulations at Sec. 413.171 (75 FR
49044), delayed the Medicare Part B payment for these oral-only drugs
until CY 2014 at Sec. 413.174(f)(6), and continued to pay for them
under Medicare Part D. We explained in the CY 2016 ESRD PPS final rule
that, under Sec. 413.234(b)(1), if injectable or IV forms of phosphate
binders or calcimimetics are approved by FDA, these drugs would be
considered reflected in the ESRD PPS bundled payment because these
drugs are included in an existing functional category, so no additional
payment would be available for inclusion of these drugs.
However, we recognized the uniqueness of these drugs and stated
that we will not apply this process to injectable or IV forms of
phosphate binders and calcimimetics when they are approved because
payment for the oral forms of these drugs was delayed and dollars were
never included in the ESRD PPS base rate to account for these drugs.
Instead, we finalized a policy that once the injectable or IV phosphate
binder or calcimimetic is FDA approved and has a Healthcare Common
Procedure Coding System (HCPCS) code, we will issue a change request to
pay for all forms of the phosphate binder or calcimimetic using the
TDAPA based on the payment methodologies under section 1847A of the
Act, which could include ASP + 6 percent, for a period of at least 2
years. We explained in the CY 2016 ESRD PPS final rule that this will
allow us to collect data reflecting current utilization of both the
oral and injectable or IV forms of the drugs, as well as payment
patterns and beneficiary co-pays, before we add these drugs to the ESRD
PPS bundled payment. We stated that during this period we will not pay
outlier payments for these drugs. We further stated that at the end of
the 2 or more years, we will adopt the methodology for including the
phosphate binders and calcimimetics into the ESRD PPS bundled payment
through notice-and-comment rulemaking.
In 2017, FDA approved an injectable calcimimetic. In accordance
with the policy finalized in the CY 2016 ESRD PPS final rule, we issued
a change request to implement payment under the ESRD PPS for both the
oral and injectable forms of calcimimetics using the TDAPA. Change
Request 10065, Transmittal 1889, issued August 4, 2017, replaced by
Transmittal 1999, issued January 10, 2018, implemented the TDAPA for
calcimimetics effective January 1, 2018.
In CYs 2019 and 2020 ESRD PPS final rules (83 FR 56927 through
56949 and 84 FR 60653 through 60677, respectively), we made several
revisions to the drug designation process regulations at Sec. 413.234.
In the CY 2019 ESRD PPS final rule, for example, we revised regulations
at Sec. 413.234(a), (b), and (c) to reflect that the process applies
for all new renal dialysis drugs and biological products that are FDA
approved regardless of the form or route of administration, that is,
new injectable, IV, oral, or other form or route of administration (83
FR 56932). In addition, we revised Sec. 413.234(b) and (c) to expand
the TDAPA to all new renal dialysis drugs and biological products, not
just those in new ESRD PPS functional categories (83 FR 56942 through
56943). We also revised Sec. 413.234(c) to reflect that we base the
TDAPA on 100 percent of ASP (ASP + 0) instead of the pricing
methodologies available under section 1847A of the Act (which includes
ASP + 6). We explained that the 6 percent add-on to ASP has been used
to cover administrative and overhead costs, however, the ESRD PPS base
rate includes dollars for administrative complexities and overhead
costs for drugs and biological products, so we believe ASP + 0 is a
reasonable basis for the TDAPA under the ESRD PPS (83 FR 56943 through
56944). For circumstances when ASP data is not available, we finalized
that the TDAPA is based on wholesale acquisition cost (WAC) + 0 and,
when WAC is not available, the TDAPA is based on the drug
manufacturer's invoice (83 FR 56948). We also finalized a revision to
Sec. 413.234(c) to reflect that the basis of payment for the TDAPA for
calcimimetics would continue to be based on the pricing methodologies
available under section 1847A of the Act, which includes ASP + 6 (83 FR
56948). These provisions all had an effective date of January 1, 2020.
In the CY 2020 ESRD PPS final rule, we made several additional
revisions to the ESRD PPS drug designation process regulations at Sec.
413.234. For example, we revised Sec. 413.234(b) and added paragraph
(e) to codify certain eligibility criteria changes for new renal
dialysis drugs and biological products that fall within an existing
ESRD PPS functional category. That is, we excluded certain drugs from
being eligible for the TDAPA, effective January 1, 2020 (84 FR 60672).
Specifically, as detailed in the CY 2020 ESRD PPS final rule (85 FR
60565 through 60673), we excluded
[[Page 42138]]
generic drugs approved by FDA under section 505(j) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and drugs for which the new drug
application (NDA) is classified by FDA as Type 3, 5, 7 or 8, Type 3 in
combination with Type 2 or Type 4, or Type 5 in combination with Type
2, or Type 9 when the ``parent NDA'' is a Type 3, 5, 7 or 8--from being
eligible for the TDAPA. We also established at Sec. 413.234(c) a
policy to condition application of the TDAPA on our receipt of ASP data
(84 FR 60681).
In the CY 2020 ESRD PPS final rule (84 FR 60673), we also discussed
the duration of payment of the TDAPA for calcimimetics and changed the
basis of the TDAPA for such products. We stated that in accordance with
our policy for calcimimetics under the drug designation process, we
would pay for calcimimetics using the TDAPA for a minimum of 2 years
until sufficient claims data for rate setting analysis is available for
these products. We noted that at the time of the CY 2020 ESRD PPS
proposed rule we were still in the process of collecting utilization
claims data for both the oral and injectable form of calcimimetics.
Therefore, in the CY 2020 ESRD PPS proposed rule, we stated that we
would continue to pay for calcimimetics using the TDAPA in CY 2020 (84
FR 38347).
However, we also noted in the CY 2020 ESRD PPS proposed rule that
we had provided the TDAPA for calcimimetics at ASP + 6 percent for 2-
full years (that is, January 1, 2018 through December 31, 2019), and we
believed that was sufficient time for ESRD facilities to address any
administrative complexities and overhead costs that may have arisen
with regard to furnishing the calcimimetics. We noted that it was clear
that ESRD facilities were furnishing calcimimetics because payment for
them using the TDAPA had increased Medicare expenditures by $1.2
billion in CY 2018 (84 FR 60673). We explained that one of the
rationales for the 6 percent add-on to ASP was to cover administrative
and overhead costs, however, the ESRD PPS base rate has dollars
included for administrative complexities and overhead costs for drugs
and biological products. Therefore, in the CY 2020 ESRD PPS final rule,
we finalized a revision to Sec. 413.234(c) to reflect that the basis
of payment for the TDAPA for calcimimetics, beginning in CY 2020, would
be 100 percent of ASP (84 FR 60676). We explained this policy change
provided a balance between supporting ESRD facilities in their uptake
of these products and limiting the financial burden that increased
payments place on beneficiaries and Medicare expenditures. We also
noted that this policy is consistent with the policy finalized for all
other new renal dialysis drugs and biological products in the CY 2019
ESRD PPS final rule (83 FR 56948).
c. Proposed Methodology for Modifying the ESRD PPS Base Rate to Account
for Calcimimetics in the ESRD PPS Bundled Payment
As we discussed previously in section II.B.1.b of this proposed
rule, under Sec. 413.234(d), calcimimetics were no longer considered
to be an oral-only drug once FDA approved an injectable calcimimetic in
2017. We have paid for calcimimetics under the ESRD PPS using the TDAPA
since January 1, 2018. We stated in the CY 2016 ESRD PPS final rule
that for calcimimetics--for which there is an ESRD PPS functional
category, but no money is in the base rate--we will utilize the TDAPA
to collect utilization data before adding this drug to the ESRD PPS
base rate. This will allow us to collect data reflecting current
utilization of both the oral and injectable or IV forms of the drug, as
well as payment patterns and beneficiary co-pays, and at the end of the
2 or more years, we will adopt the methodology for including this drug
in the ESRD PPS bundled payment through notice-and-comment rulemaking.
We believe we have collected sufficient claims data for a rate
setting analysis for calcimimetics. Specifically, we have collected
robust claims data for 2-full years and analyzed the utilization of
every generic and brand name oral calcimimetic, along with the
utilization of the injectable calcimimetic. We monitored the ASP data
available during the specific utilization periods. Our overall analysis
of ESRD claims data for CYs 2018 and 2019 indicated an increase in the
utilization of the oral generic calcimimetic drugs with a steep decline
in the brand-name oral calcimimetic. This resulted in an overall
decrease in ASP as the generic calcimimetic drugs entered the market in
late 2018 and the beginning of 2019, since the generic version is less
expensive than the brand-name version. Since beneficiaries have a 20
percent co-pay under the ESRD PPS, a decrease in the payment for
calcimimetics results in a decrease in the beneficiary co-pay.
Therefore, we believe that we are at the step of the ESRD PPS drug
designation process where we propose to adopt the methodology for
modifying the ESRD PPS base rate to account for calcimimetics in the
ESRD PPS bundled payment through CY 2021 notice-and-comment rulemaking.
That is, in this proposed rule, we are proposing to add a per treatment
amount to the ESRD PPS base rate to include the calcimimetics in the
ESRD PPS bundled payment amount.
In developing the proposed methodology for including calcimimetics
into the ESRD PPS base rate, we considered the methodology that we used
when we included Part B drugs and biological products in the ESRD PPS
base rate as part of our implementation of the ESRD PPS. In the CY 2011
ESRD PPS final rule (75 FR 49074 through 49079), we discussed how we
established which renal dialysis drugs and biological products would be
reflected in the ESRD PPS base rate. We used the utilization of those
drugs and biological products from Medicare claims data and applied ASP
+ 6 percent to establish the price for each drug. Then we inflated each
drug's price to 2011 using the Producer Price Index (PPI) for
prescription drugs.
In addition, as discussed in the CY 2011 ESRD PPS final rule (75 FR
49064), we established a dialysis treatment as the unit of payment.
Consistent with the approach we used initially to include drugs and
biological products into the ESRD PPS base rate and the ESRD PPS unit
of payment, we are proposing a similar methodology in this rule to
calculate a one-time modification to the ESRD PPS base rate on a per-
treatment basis to account for calcimimetics. We believe the proposed
methodology is similar to the CY 2011 approach because we would
determine utilization of the drug, in this case, calcimimetics, along
with the payment amounts associated with each oral and injectable form
based on the ASP + 0 instead of ASP + 6, as discussed in the CY 2020
ESRD PPS final rule.
The following sections discuss each element of our proposed
methodology in detail. As an overview, we are proposing to calculate a
per-treatment amount for calcimimetics that would be added to the ESRD
PPS base rate. We would apply the value from the most recent calendar
quarter ASP calculations at 100 percent of ASP (that is, ASP + 0)
available to the public for calcimimetics to the utilization data for
calcimimetics from CYs 2018 and 2019 Medicare ESRD claims data. This
would provide the calcimimetic expenditure amount. We would divide the
calcimimetic expenditure amount by the total number of hemodialysis-
equivalent dialysis treatments paid in CYs 2018 and 2019 under the ESRD
PPS. We would reduce this average per treatment amount by 1 percent to
account for the outlier policy, since calcimimetics
[[Page 42139]]
would be ESRD outlier services eligible for outlier payments beginning
January 1, 2021. We propose to add the resulting amount to the ESRD PPS
base rate. We note that this amount will stay in the base rate and be
subject to the annual updates (productivity adjusted market basket
increase and application of wage index budget neutrality adjustment
factor). Under this proposal, CMS would stop paying for these drugs
using the TDAPA for dates of service on or after January 1, 2021.
We are proposing to revise our drug designation regulation at Sec.
413.234, by adding paragraph (f), to describe the methodology for
modifying the ESRD PPS base rate to account for the costs of
calcimimetics, including the data sources and the steps we would take
to calculate a per treatment amount. We propose, for dates of service
on or after January 1, 2021, calcimimetics would no longer be paid for
under the ESRD PPS using the TDAPA (Sec. 413.234(c)) and would be paid
for through the ESRD PPS base rate and eligible for outlier payments as
ESRD outlier services under Sec. 413.237.
We note that the methodology proposed in this rule is only for
modifying the ESRD PPS base rate to include calcimimetic drugs. We
stated in the CY 2016 ESRD PPS final rule (80 FR 69022) that the TDAPA
will be paid for a minimum of 2 years, during which time we will gather
utilization data. At the end of that time, the drug will be included
within its new functional category and the base rate may or may not be
modified to account for the cost of the drug, depending upon what the
utilization data show. Accordingly, our policy is to propose and adopt
the methodology for including any future eligible new renal dialysis
drugs and biological products into the ESRD PPS base rate through
notice-and-comment rulemaking.
(1) Determining Utilization of Calcimimetics
For use in the proposed calculation, we analyzed the utilization of
both the oral and injectable forms of calcimimetics reported on the
ESRD facility claims for CYs 2018 and 2019. ESRD facilities report this
information to CMS on Medicare ESRD facility claims, that is, the 837-
institutional form with bill type 072X. The oral calcimimetic is
reported as HCPCS J0604 (Cinacalcet, oral, 1 mg, (for ESRD on
dialysis)) and the injectable calcimimetic is reported as HCPCS J0606
(Injection, etelcalcetide, 0.1 mg), that is, one unit of J0604 is 1 mg,
and one unit of J0606 is 0.1 mg. For purposes of this rate setting
analysis, we consider utilization of calcimimetics as the units of the
product furnished to an ESRD beneficiary.
For the CY 2018 utilization data for calcimimetics, we propose to
use the latest available claims data based on the CY 2018 ESRD facility
claims updated through June 30, 2019 (that is, claims with dates of
service from January 1 through December 31, 2018, that were received,
processed, paid, and passed to the National Claims History (NCH) File
as of June 30, 2019) to calculate 2018 utilization. Claims that are
received, processed, paid, and passed to the NCH file are considered to
be ``complete'' because they have been adjudicated.
For the CY 2019 utilization data for calcimimetics, we propose to
use the latest available claims data based on the CY 2019 ESRD facility
claims to calculate 2019 utilization. For this proposed rule, the
latest available CY 2019 ESRD facility claims used were updated through
January 31, 2020 (that is, claims with dates of service from January 1
through December 31, 2019, that were received, processed, paid, and
passed to the NCH File as of January 31, 2020). For the CY 2021 ESRD
PPS final rule, the latest available CY 2019 ESRD facility claims we
would use for purposes of our final calculation would be updated
through June 30, 2020 (that is, claims with dates of service from
January 1 through December 31, 2019, that were received, processed,
paid, and passed to the NCH File as of June 30, 2020).
While we have continued to pay the TDAPA for calcimimetics for
dates of service in CY 2020, we are not proposing to use utilization
data from this period because practice patterns in CY 2020 have been
altered due to the COVID-19 pandemic and the resulting impact on data
is unknown at this time. However, our policy to continue paying for
calcimimetics using the TDAPA in CY 2020 has allowed us to analyze 2
full years of adjudicated Medicare claims since CY 2019 claims include
those claims from January 1, 2019 through December 31, 2019.
We solicit comments on the proposed use of CYs 2018 and 2019 claims
data to determine the utilization of calcimimetics for purposes of
calculating the proposed addition to the ESRD PPS base rate to account
for calcimimetics at proposed Sec. 413.234(f). While we believe using
claims data from CYs 2018 and 2019 is appropriate because those years
provide us with not only the most complete data set, but also the most
accurate data set reflecting paid claims, we are also soliciting
comments as to whether we should instead use a single year (CY 2018 or
CY 2019) rather than both CYs 2018 and 2019 in our methodology.
(2) Pricing of Calcimimetics--Methodology
For use in the proposed calculation, we would set the price for
calcimimetics using values from the most recent calendar quarter of ASP
calculations available to the public, at 100 percent of ASP (ASP + 0).
The ASP-based value is a CMS-derived weighted average of all of the
National Drug Code (NDC) sales prices submitted by drug manufacturers
and assigned by CMS to the two existing HCPCS codes for calcimimetics.
For each billing code, CMS calculates a weighted average sales price
using data submitted by manufacturers, which includes the following:
ASP data at the 11-digit NDC level, the number of units of the 11-digit
NDC sold and the ASP for those units. Next, the number of billing units
in an NDC is determined by the amount of drug in the package. CMS uses
the following weighting methodology to determine the payment limit: (1)
Sums the product of the manufacturer's ASP and the number of units of
the 11-digit NDC sold for each NDC assigned to the billing and payment
code; (2) Divides this total by the sum of the product of the number of
units of the 11-digit NDC sold and the number of billing units in that
NDC for each NDC assigned to the billing and payment code, and (3)
Weights the ASP for an NDC by the number of billing units sold for that
NDC. This calculation methodology is discussed in the CY 2009 Physician
Fee Schedule (PFS) final rule (73 FR 69752). The general methodology
for determining ASP-based payments for the PFS is authorized in section
1847A of the Act.
ASP-based payment limits published in the quarterly ASP Drug
Pricing files include a 6 percent add-on as required in section 1847A
of the Act. However, consistent with the TDAPA basis of payment for CY
2020, we use 100 percent of the weighted ASP value, in other words, ASP
+ 0. In the CY 2020 ESRD PPS final rule, we noted that the ESRD PPS
accounts for storage and administration costs and that ESRD facilities
do not have acquisition price variation issues when compared to
physicians. We explained that we believed ASP + 0 is reasonable for new
renal dialysis drugs and biological products that fall within an
existing functional category because there are already dollars in the
per treatment base rate for a new drug's respective category. We also
explained that we believed ASP + 0 is a reasonable basis for payment
for the TDAPA for new renal dialysis drugs and biological
[[Page 42140]]
products that do not fall within the existing functional category
because the ESRD PPS base rate has dollars built in for administrative
complexities and overhead costs for drugs and biological products (83
FR 56946).
We believe using a value based on the most recent calendar quarter
ASP calculations available to the public for both oral and injectable
versions of the calcimimetics would provide an accurate representation
of the price of calcimimetics for ESRD facilities because it uses
manufacturer sales information that includes discounts (that is,
rebates, volume discounts, prompt payment, cash payment specified in
section 1847A of the Act). Every calendar quarter, CMS publishes ASP-
based payment limits for certain Part B drugs and biological products
that are used for payment of such Part B covered drugs and biological
products for a specific quarter. The amount that we propose to use for
the base rate modifications associated with the oral and injectable
versions of the calcimimetics is based on the most recent information
on average sales prices net of discounts specified in section 1847A
submitted by the manufacturers of each of the drugs.
For this proposed rule, using values from the most recent calendar
quarter of ASP calculations available to the public at the time that
this rule is being written is the second quarter of 2020,\1\ and as a
result of two-quarter data lag this reflects manufacturer sales data
submitted into CMS for the fourth quarter of 2019. For the CY 2021 ESRD
PPS final rule, the most recent calendar quarter of ASP calculations
available to the public would be the fourth quarter of 2020, which
reflects manufacturer sales data submitted into CMS for the second
quarter of 2020, and we would use that value for purposes of our final
calculation.
---------------------------------------------------------------------------
\1\ https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/2020-asp-drug-pricing-files, April 2020 ASP Pricing
File.
---------------------------------------------------------------------------
We would update these prices by the proposed CY 2021 ESRD PPS base
rate update to reflect the estimated costs in CY 2021. That is, we
would first add the calculated per treatment payment amount to the ESRD
PPS base rate to include calcimimetics, and then we would apply the
annual payment rate update. The proposed calculation for the addition
to the ESRD PPS base rate is discussed in the following section.
Therefore, we propose to add Sec. 413.234(f) that CMS would use
100 percent of the values from the most recent calendar quarter ASP
calculations available to the public for the oral and injectable
calcimimetic to calculate a price for each form of the drug. We solicit
comments on the proposed use of the values from the most recent
calendar quarter ASP + 0 calculations available to the public for
calcimimetics for setting the price and the proposed language at Sec.
413.234(f).
(3) Calculation of the Addition to the ESRD PPS Base Rate To Include
Calcimimetics
To calculate the proposed amount for calcimimetics that would be
added to the ESRD PPS base rate, we applied the values from the most
recent calendar quarter 2020 ASP + 0 calculations available to the
public for calcimimetics to CYs 2018 and 2019 calcimimetic utilization
data to calculate the calcimimetic expenditure amount for both years.
As stated in section II.B.1.c.(1) of this proposed rule, one unit of
J0604 (oral calcimimetic, cinacalcet) is 1 mg and one unit of J0606
(injectable calcimimetic etelcalcetide) is 0.1 mg. That is, we
determined that 1,824,370,957 total units (mg) of oral calcimimetics
were used in CYs 2018 and 2019. With regard to injectable
calcimimetics, we determined that 306,714,207 total units (0.1 mg) were
used in CYs 2018 and 2019. This use indicates that 33.9 percent of ESRD
beneficiaries received calcimimetics in CYs 2018 and 2019. For this
proposed rule, we used the values from the most recent calendar quarter
ASP + 0 calculations available to the public, which is the second
quarter of 2020. This information can be found on the ESRD Payment
website: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/ESRD-Transitional-Drug. We used $0.231 per mg for the oral
calcimimetic and $2.20 per 0.1 mg for the injectable calcimimetic. The
prices per unit correspond to 1 mg and 0.1 mg for cinacalcet and
etelcalcetide respectively. (We note that, for the CY 2021 ESRD PPS
final rule, we would update the ASP + 0 based value on the most recent
calendar quarter calculations available to the public.) Multiplying the
utilization of the oral and injectable calcimimetics by their
respective ASP and then adding the expenditure amount for both forms of
calcimimetics together would be the total 2-year (CYs 2018 and 2019)
calculated calcimimetic expenditure amount. That is, for this proposed
rule, we calculated the total calcimimetic expenditure amount of
$1,096,200,947. The total number of paid hemodialysis-equivalent
dialysis treatments furnished to Medicare ESRD beneficiaries in CYs
2018 and 2019 was 90,014,098. This total number of paid treatments
reflects all paid dialysis treatments regardless of whether a
calcimimetic was furnished. Dividing the calcimimetic expenditure
amount by the total number of paid hemodialysis-equivalent dialysis
treatments provides an average per treatment payment amount of $12.18.
We then reduced this amount by 1 percent to account for the outlier
policy under Sec. 413.237 to get a total of $12.06 ($12.18 x .99 =
$12.06). Under our proposal, we would apply this 1 percent reduction
before increasing the base rate to account for outlier payments that
would be paid beginning January 1, 2021 for calcimimetics since they
would become ESRD outlier services eligible for outlier payments under
Sec. 413.237. As we discussed in section II.B.1.c of this proposed
rule, in developing the proposed methodology for including
calcimimetics in the ESRD PPS base rate, we considered the methodology
applied when we developed the ESRD PPS base rate. In the CY 2011 ESRD
PPS final rule (75 FR 49074 through 49075), we explained the budget
neutrality adjustments applied to the unadjusted ESRD PPS base rate to
account for statutorily mandated reductions. Because we are proposing
to modify the ESRD PPS base rate to include calcimimetics, which
beginning January 1, 2021 would become ESRD outlier services, we
focused on the outlier adjustment. That is, in CY 2011 we applied a 1
percent reduction to the unadjusted ESRD PPS base rate to account for
outlier payments. In order for the application of the 1 percent outlier
to be maintained, we believe the 1 percent must be excluded from the
addition to the ESRD PPS base rate for calcimimetics.
Then, to determine the estimated costs in CY 2021 we would inflate
the average per treatment payment amount for calcimimetics ($12.06) to
2021 using the CY 2021 ESRD PPS base rate update. As discussed in
section II.B.4.d of this proposed rule, the proposed CY 2021 ESRD PPS
base rate is $255.59. This amount reflects a proposed CY 2021 wage
index budget-neutrality adjustment factor of .998652, a proposed base
rate addition of $12.06 to include calcimimetics, and the proposed CY
2021 ESRD PPS payment rate update of 1.8 percent. We believe that using
the annual payment rate update effectively updates the prices set for
calcimimetics from CY 2020 to CY 2021 because this is consistent with
how the other components of the base rate are updated for inflation
each year, which includes drugs. We note, that the inflation factor
used for drugs and biological products for the ESRD bundled market
basket is
[[Page 42141]]
the Producer Price Index as discussed in the CY 2019 ESRD PPS final
rule (83 FR 56958 through 56959).
Therefore, we propose to add Sec. 413.234(f) that CMS would
multiply the utilization of the oral and injectable calcimimetics by
their respective prices and add the expenditure amount for both forms
together to calculate the total calcimimetic expenditure amount. Then,
CMS would divide the total calcimimetic expenditure amount by the total
number of paid hemodialysis-equivalent dialysis treatments in CYs 2018
and 2019, to calculate the average per-treatment payment amount. CMS
would reduce the average per-treatment payment amount by 1 percent to
account for the outlier policy under Sec. 413.237 in order to
determine the amount added to the ESRD PPS base rate.
In keeping with the principles of a PPS, which include motivating
healthcare providers to structure cost-effective, efficient patient
care that avoids unnecessary services, thereby reining in costs, we
believe the cost of the calcimimetics should be spread across all the
dialysis treatments, rather than be directed only to the patients
receiving the calcimimetics.
We solicit comments on the proposed revisions to Sec. 413.234 to
add paragraph (f) to Sec. 413.234 to establish the methodology for
modifying the ESRD PPS base rate to account for calcimimetics in the
ESRD PPS bundled payment.
As an alternative methodology, we considered dividing the total
Medicare expenditures for all calcimimetics in CYs 2018 and 2019
(approximately $2.3 billion) by the total number of paid hemodialysis-
equivalent dialysis treatments furnished during that same time period.
However, this approach would not factor in the impact of oral generic
calcimimetics, which entered the market from late December 2018 through
early January 2019. For example, under the proposed methodology, the
ASP calculations incorporate the more recent pricing of the oral
generic calcimimetics into the weighting which has resulted in a
significant decline in the ASP-based value. In addition, this
alternative methodology would not reflect our current policy to base
the TDAPA on ASP + 0, since in CYs 2018 and 2019 we paid for
calcimimetics using the TDAPA at ASP + 6. We believe it is more
appropriate for the ESRD PPS base rate to reflect the values from the
most recent calendar quarter of ASP calculations available since that
aligns with how ESRD facilities would be purchasing and furnishing the
oral calcimimetics rather than using expenditure data from previous
periods. We believe that ESRD facilities would want to support CMS's
goal of lower drug and biological products prices for its
beneficiaries. In addition, this alternative methodology would have a
more significant impact on beneficiary cost sharing in terms of a
higher 20 percent co-pay than the proposed methodology in this proposed
rule. We solicit comment on this alternative methodology, which would
entail dividing the total Medicare expenditures (that is, actual spend)
for all calcimimetics in CYs 2018 and 2019 by the total number of paid
hemodialysis-equivalent dialysis treatments furnished during that same
time period.
2. Proposed Changes to the TPNIES Eligibility Criteria
a. Background
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), CMS
established a transitional add-on payment adjustment for certain new
and innovative renal dialysis equipment and supplies under the ESRD
PPS, under the authority of section 1881(b)(14)(D)(iv) of the Act, in
order to support ESRD facility use and beneficiary access to these new
technologies. We established this payment adjustment to help address
the unique circumstances experienced by ESRD facilities when
incorporating new and innovative equipment and supplies into their
businesses and to support ESRD facilities transitioning or testing
these products during the period when they are new to market. We added
Sec. 413.236 to establish the eligibility criteria and payment
policies for the transitional add-on payment adjustment for new and
innovative renal dialysis equipment and supplies, which we call the
TPNIES.
We established in Sec. 413.236(b) that for dates of service
occurring on or after January 1, 2020, CMS will provide the TPNIES to
an ESRD facility for furnishing a covered equipment or supply only if
the item: (1) Has been designated by CMS as a renal dialysis service
under Sec. 413.171, (2) is new, meaning it is granted marketing
authorization by FDA on or after January 1, 2020, (3) is commercially
available by January 1 of the particular calendar year, meaning the
year in which the payment adjustment would take effect, (4) has a HCPCS
application submitted in accordance with the official Level II HCPCS
coding procedures by September 1 of the particular calendar year, (5)
is innovative, meaning it meets the criteria specified in Sec.
412.87(b)(1) and related guidance, and (6) is not a capital-related
asset that an ESRD facility has an economic interest in through
ownership (regardless of the manner in which it was acquired).
Regarding the innovation requirement in Sec. 413.236(b)(5), in the
CY 2020 ESRD PPS final rule (84 FR 60690), we stated that CMS will use
the following criteria to evaluate substantial clinical improvement
(SCI) for purposes of the TPNIES under the ESRD PPS, based on the
inpatient hospital prospective payment system (IPPS) SCI criteria in
Sec. 412.87(b)(1) and related guidance: Section 412.87(b)(1) includes
the criteria used under the IPPS new technology add-on payment (NTAP)
to determine whether a new technology represents an advance that
substantially improves, relative to renal dialysis services previously
available, the diagnosis or treatment of Medicare beneficiaries. First,
and most importantly, the totality of the circumstances is considered
when making a determination that a new renal dialysis equipment or
supply represents an advance that substantially improves, relative to
renal dialysis services previously available, the diagnosis or
treatment of Medicare beneficiaries. Second, a determination that a new
renal dialysis equipment or supply represents an advance that
substantially improves, relative to renal dialysis services previously
available, the diagnosis or treatment of Medicare beneficiaries means
one of the following:
The new renal dialysis equipment or supply offers a
treatment option for a patient population unresponsive to, or
ineligible for, currently available treatments; or
The new renal dialysis equipment or supply 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
allowed by currently available methods, and there must also be evidence
that use of the new renal dialysis service to make a diagnosis affects
the management of the patient; or
The use of the new renal dialysis equipment or supply
significantly improves clinical outcomes relative to renal dialysis
services previously available as demonstrated by one or more of the
following: (1) A reduction in at least one clinically significant
adverse event, including a reduction in mortality or a clinically
significant complication; (2) a decreased rate of at least one
subsequent diagnostic or
[[Page 42142]]
therapeutic intervention; (3) a decreased number of future
hospitalizations or physician visits; (4) a more rapid beneficial
resolution of the disease process treatment including, but not limited
to, a reduced length of stay or recovery time; (5) an improvement in
one or more activities of daily living; (6) an improved quality of
life; or (7) a demonstrated greater medication adherence or compliance;
or,
The totality of the circumstances otherwise demonstrates
that the new renal dialysis equipment or supply substantially improves,
relative to renal dialysis services previously available, the diagnosis
or treatment of Medicare beneficiaries.
Third, evidence from the following published or unpublished
information sources from within the United States (U.S.) or elsewhere
may be sufficient to establish that a new renal dialysis equipment or
supply represents an advance that substantially improves, relative to
renal dialysis services previously available, the diagnosis or
treatment of Medicare beneficiaries: Clinical trials, peer reviewed
journal articles; study results; meta-analyses; consensus statements;
white papers; patient surveys; case studies; reports; systematic
literature reviews; letters from major healthcare associations;
editorials and letters to the editor; and public comments. Other
appropriate information sources may be considered.
Fourth, the medical condition diagnosed or treated by the new renal
dialysis equipment or supply may have a low prevalence among Medicare
beneficiaries. Fifth, the new renal dialysis equipment or supply may
represent an advance that substantially improves, relative to renal
dialysis services previously available, the diagnosis or treatment of a
subpopulation of patients with the medical condition diagnosed or
treated by the new renal dialysis equipment or supply.
We also established a process modeled after IPPS's process of
determining if a new medical service or technology meets the SCI
criteria specified in Sec. 412.87(b)(1). Specifically, similar to the
IPPS NTAP, we wanted to align our goals with the agency's efforts to
transform the healthcare delivery system for the ESRD beneficiary
through competition and innovation to provide patients with better
value and results. We believe it is appropriate to facilitate access to
new and innovative equipment and supplies through add-on payments
similar to the IPPS NTAP program and to provide innovators with
standard criteria for both inpatient and outpatient settings. In Sec.
413.236(c), we established a process for our announcement of TPNIES
determinations and a deadline for consideration of new renal dialysis
equipment or supply applications under the ESRD PPS. CMS will consider
whether a new renal dialysis equipment or supply meets the eligibility
criteria specified in Sec. 413.236(b) and summarize the applications
received in the annual ESRD PPS proposed rules. Then, after
consideration of public comments, we will announce the results in the
Federal Register as part of our annual updates and changes to the ESRD
PPS in the ESRD PPS final rule. The TPNIES applications for CY 2021 are
discussed in section II.C. of this proposed rule. CMS will only
consider a complete application received by CMS by February 1 prior to
the particular calendar year, meaning the year in which the payment
adjustment would take effect, and FDA marketing authorization for the
equipment or supply must occur by September 1 prior to the particular
calendar year. We stated in the CY 2020 ESRD PPS final rule (80 FR
60690) that we would establish a workgroup of CMS medical and other
staff to review the studies and papers submitted as part of the TPNIES
application, the public comments we receive, and the FDA marketing
authorization and HCPCS application information and assess the extent
to which the product provides SCI over current technologies.
We established Sec. 413.236(d) to provide a payment adjustment for
a new and innovative renal dialysis equipment or supply. Section
413.236(d)(1) states that the TPNIES is paid for 2-calendar years.
Section 413.236(d)(2) provides that, following payment of the TPNIES,
the ESRD PPS base rate will not be modified and the new and innovative
renal dialysis equipment or supply will become an eligible outlier
service as provided in Sec. 413.237.
Under Sec. 413.236(e)(1), the Medicare Administrative Contractors
(MACs) on behalf of CMS will establish prices for the new and
innovative renal dialysis equipment and supplies that meet the
eligibility criteria specified in Sec. 413.236(b) using verifiable
information from the following sources of information, if available:
(1) The invoice amount, facility charges for the item, discounts,
allowances, and rebates; (2) the price established for the item by
other MACs and the sources of information used to establish that price;
(3) payment amounts determined by other payers and the information used
to establish those payment amounts; and (4) charges and payment amounts
required for other equipment and supplies that may be comparable or
otherwise relevant.
b. Proposed Changes to Eligibility for the TPNIES
Currently, in Sec. 413.236(b)(2), one eligibility requirement for
the TPNIES is that an equipment or supply must be new, meaning it is
granted marketing authorization by FDA on or after January 1, 2020. In
establishing this requirement, we tied what is considered new to
January 1, 2020, the effective date of the TPNIES policy. We explained
in the CY 2020 ESRD PPS final rule (84 FR 60685) that by including FDA
marketing authorizations on or after January 1, 2020, we intended to
support ESRD facility use and beneficiary access to the latest
technological improvements to renal dialysis equipment and supplies.
While we continue to believe it is appropriate to tie the newness
requirement to the date of the FDA marketing authorization for the
reasons discussed in the CY 2020 ESRD PPS final rule, we do not believe
newness should be tied to the effective date of the TPNIES policy going
forward, for the reasons discussed below. In addition, we believe this
eligibility criterion should address when an equipment or supply is no
longer considered new. Under the current requirement at Sec.
413.236(b)(2), we could receive an application for the TPNIES for
equipment and supplies many years after FDA marketing authorization,
when the equipment is no longer new.
In the CY 2020 ESRD PPS proposed rule (84 FR 38353), while we
proposed to define new renal dialysis equipment and supplies as those
that are granted marketing authorization by FDA on or after January 1,
2020, we also solicited comment on whether a different FDA marketing
authorization date, for example, on or after January 1, 2019, might be
appropriate. We explained in the CY 2020 ESRD PPS final rule (84 FR
60688 through 60689) that while some commenters expressed support for
the proposed definition, most of the comments were focused on the
merits of establishing a date for newness that precedes the effective
date of the TPNIES policy and whether all renal dialysis equipment and
supplies must seek FDA marketing authorization. None of the comments
addressed whether tying TPNIES eligibility to the TPNIES policy
effective date or any fixed date would limit the TPNIES to new and
innovative equipment and supplies.
After careful consideration of these comments, we decided to
finalize the proposed definition of new to mean the
[[Page 42143]]
renal dialysis equipment or supply was granted marketing authorization
by FDA on or after January 1, 2020. We stated that while we appreciated
that manufacturers of renal dialysis equipment and supplies that were
granted FDA marketing authorization in prior years would want these
products to be eligible for the TPNIES, our goal is not to provide a
payment adjustment for all the products that have received FDA
marketing authorization or for products that have had limited market
uptake, but rather to establish an add-on payment adjustment for
certain new and innovative products in order to support uptake by ESRD
facilities of new and innovative renal dialysis equipment and supplies.
In addition, we stated that we appreciated the complex issues the
commenters raised if we were to select an earlier FDA marketing
authorization date, and believed our approach will avoid the need to
address those issues. We noted that the ESRD PPS is a prospective
payment system, in which changes are generally made prospectively,
including eligibility requirements for add-on payment adjustments. In
addition, we noted that this FDA marketing authorization date of
January 1, 2020 or later is consistent with the TDAPA's definition of a
new renal dialysis drug or biological product.
After further consideration, we no longer believe an item should be
considered new based on the TPNIES policy effective date of January 1,
2020. Rather, we believe that it is important for the TPNIES policy to
provide a window of time when a new renal dialysis equipment or supply
is considered new to provide transparency to potential applicants. We
note that, under this proposal, the TPNIES policy would still be
effective as of January 1, 2020 and therefore no equipment or supply
receiving FDA marketing authorization before January 1, 2020 would be
eligible for the TPNIES. However, we are proposing to revise Sec.
413.236(b)(2) to remove ``on or after January 1, 2020'' and to reflect
the definition of new to mean, within 3 years beginning on the date of
FDA marketing authorization. By defining new in this manner, we would
be giving entities wishing to apply for the TPNIES for their equipment
or supply 3 years beginning on the date of FDA marketing authorization
in which to submit their applications, while still limiting eligibility
for the TPNIES to new technologies. We are proposing a 3-year newness
window to be consistent with the timeframes under the IPPS NTAP
requirements in Sec. 412.87(b)(2). Under the NTAP, new technologies
are considered to be new for 2 or 3 years after the point at which data
begin to become available reflecting the inpatient hospital code
assigned to the new service or technology. We note, under the hospital
outpatient PPS, the pass-through payment application for a medical
device must also be submitted within 3 years from the date of the
initial FDA approval or clearance, if required, unless there is a
documented, verifiable delay in U.S. market availability after FDA
approval or clearance 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.
In addition, we propose to revise Sec. 413.236(b) to remove ``For
dates of service occurring on or after January 1, 2020'' and to revise
Sec. 413.236(a) to reflect the January 1, 2020 effective date of the
TPNIES policy finalized in the CY 2020 ESRD PPS final rule. We also are
proposing other revisions to this paragraph, which are discussed in
section II.B.3.b.(1) of this proposed rule.
We are seeking comment on our proposal to define new for purposes
of the TPNIES eligibility as within 3 years beginning on the date of
FDA marketing authorization. In addition, it is our understanding that
there may be situations in which a manufacturer has FDA marketing
authorization for an item, but the process of manufacturing the item
has been delayed, for example, by a Public Health Emergency (PHE), such
as the current COVID-19 pandemic. Therefore, we are also seeking
comment on the number of years for an item to be considered new, or if
newness should be based on different criteria such as the later of
marketing availability or the date of FDA marketing authorization.
Currently, Sec. 413.236(b)(4) requires applicants for the TPNIES
to have a HCPCS application submitted in accordance with the official
Level II HCPCS coding procedures by September 1 of the particular
calendar year. Section 413.236(c) currently requires applicants for
TPNIES to have the FDA marketing authorization for the equipment or
supply by September 1 prior to the particular calendar year.
After publication of the CY 2020 ESRD PPS final rule, CMS updated
its HCPCS Level II coding procedures to enable shorter and more
frequent HCPCS code application cycles. Beginning in January 2020, CMS
implemented quarterly HCPCS code application opportunities for drugs
and biological products, and biannual application opportunities for
DMEPOS and other non-drug, non-biological items and services.
As the Administrator of CMS announced \2\ in May 2019, this change
is part of CMS' broader, comprehensive initiative to foster innovation
and expedite adoption of and patient access to new medical
technologies. CMS' delivery on this important goal necessitated
procedural changes that balance the need to code more frequently with
the amount of time necessary to accurately process applications. CMS
has released two documents with detailed information on the updated
HCPCS Level II coding procedures, application instructions, and
deadlines for 2020. Both documents, Healthcare Common Procedure Coding
System (HCPCS) Level II Coding Procedures,\3\ and Healthcare Common
Procedure Coding System (HCPCS) Level II Code Modification Application
Instructions for the 2020 Coding Cycle \4\ are available on the CMS
website. Under the new guidance, coding cycles for DMEPOS items and
services will occur no less frequently than biannually. For 2020, the
deadline for HCPCS Level II code applications for biannual Coding Cycle
1 for DMEPOS items and services was January 6, 2020 with issuance of
final code decisions occurring July 2020. These final code decisions
are effective October 1, 2020. For biannual Coding Cycle 2, the code
application deadline for DMEPOS items and services is June 29, 2020
with issuance of final code decisions occurring January 2021 or
earlier. These final code decisions are effective April 1, 2021. These
dates are specific for 2020 and may change annually. Specific dates for
biannual Coding Cycles 1 and 2 for future years will be published on
the HCPCS website annually.
---------------------------------------------------------------------------
\2\ https://www.cms.gov/newsroom/press-releases/cms-outlines-comprehensive-strategy-foster-innovation-transformative-medical-technologies.
\3\ https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2018-11-30-HCPCS-Level2-Coding-Procedure.pdf.
\4\ https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/2020-HCPCS-Application-and-Instructions.pdf.
---------------------------------------------------------------------------
Under the new biannual Coding Cycle 2 for DMEPOS items and
services, in order to obtain a final HCPCS Level II code decision by
January 1, 2021, the applicant must submit a complete HCPCS Level II
code application along with the FDA marketing authorization
documentation to CMS by June 29, 2020. In light of the change to
biannual coding cycles, we have reassessed the TPNIES eligibility
criterion in Sec. 413.236(b)(4), which is related to submission of the
HCPCS Level II code
[[Page 42144]]
application as well as Sec. 413.236(c), which discusses the deadlines
for consideration of new renal dialysis equipment or supply
applications and have found that they conflict with the current HCPCS
Level II coding guidelines.
Because our HCPCS Level II coding guidelines require that
applicants submit complete code applications for DMEPOS items and
services to CMS by the deadline for biannual Coding Cycle 2 as
specified in the HCPCS Level II coding guidance on the CMS website in
order for a final HCPCS Level II code decision to be made by the
following January 1 and require that documentation of FDA marketing
authorization be submitted by the applicant to CMS by the HCPCS Level
II code application deadline, we propose to align the TPNIES regulation
at Sec. 413.236(b)(4) and (c) with these guidelines. We believe this
alignment would provide consistency across CMS processes and
transparency on deadlines for applicants for the TPNIES. In the event
of a delay in the final HCPCS Level II coding decision, a miscellaneous
code will be used in the interim until a final coding decision is made.
We are also proposing to correct a technical error in Sec.
413.236(b)(4), which requires the HCPCS application to be submitted by
September 1 ``of'' the particular calendar year, meaning the year in
which the payment adjustment would take effect. In accordance with the
TPNIES policy, we would need to have the HCPCS application submitted
``prior to'' the particular calendar year to be able to make a
determination of TPNIES eligibility for payment to occur in the
particular calendar year.
Therefore, we propose to revise at Sec. 413.236(b)(4) to add the
word ``complete'' and to replace ``September 1'' with ``the HCPCS Level
II code application deadline for biannual Coding Cycle 2 for DMEPOS
items and services as specified in the HCPCS Level II coding guidance
on the CMS website,'' and replace the word ``of'' with ``prior to'' to
reflect that the HCPCS code application for biannual Coding Cycle 2
must be complete and submitted as specified in the HCPCS Level II
coding guidance on the CMS website prior to the particular calendar
year. This HCPCS application submission deadline for a HCPCS Level II
code application may result in a final HCPCS code determination by
January 1, when the TPNIES payment would begin. We note that, for 2020
biannual Coding Cycle 2, final decisions on HCPCS Level II codes issued
by January 1, 2021 are not effective until April 1, 2021. For this
reason, during this interim period, we propose to use a miscellaneous
HCPCS code to provide the TPNIES payment. In the event of a delay in
the final HCPCS Level II coding decision, a miscellaneous code will be
used in the interim until the later effective date. In addition, we
propose a technical change to Sec. 413.236(b)(4) to be consistent with
how CMS references the HCPCS Level II coding procedures. That is, we
propose to revise Sec. 413.236(b)(4) from ``official Level II HCPCS
coding procedures'' to ``HCPCS Level II coding procedures on the CMS
website''.
In addition, we propose to revise Sec. 413.236(c) to replace
``September 1'' with ``the HCPCS Level II code application deadline for
biannual Coding Cycle 2 for DMEPOS items and services as specified in
the HCPCS Level II coding guidance on the CMS website'' to reflect that
FDA marketing authorization for the new and innovative equipment or
supply must accompany the HCPCS application prior to the particular
calendar year in order for the item to qualify for the TPNIES in the
next calendar year. Although applicants for TPNIES may submit a TPNIES
application while the equipment or supply is undergoing the FDA
marketing authorization process (since the deadline for the TPNIES
application is February 1), under our proposal, FDA marketing
authorization of the equipment or supply must be granted prior to the
HCPCS Level II code application deadline. If FDA marketing
authorization is not granted prior to the HCPCS Level II code
application deadline, the TPNIES application would be denied and the
applicant would need to reapply and submit an updated application by
February 1 of the following year or within 3 years beginning on the
date of FDA marketing authorization, in accordance with the proposed
revisions to Sec. 413.236(b)(2) discussed previously in this proposed
rule.
Currently, Sec. 413.236(b)(5) requires that the new equipment or
supply be innovative, meaning it meets the criteria specified in Sec.
412.87(b)(1) of this chapter and related guidance. As discussed
previously in this proposed rule, Sec. 412.87(b)(1) includes the
criteria used under the IPPS NTAP to determine whether a new technology
represents an advance that substantially improves, relative to
technologies previously available, the diagnosis or treatment of
Medicare beneficiaries. In Sec. 413.236(b)(5) we adopt the same SCI
criteria to determine if a new renal dialysis equipment or supply is
innovative for purposes of the TPNIES under the ESRD PPS. We also
stated in the CY 2020 ESRD PPS final rule (84 FR 60690) our intention
to adopt any future modifications to the IPPS SCI criteria so that
innovators would have standard criteria to meet for both settings.
While we adopted the IPPS SCI criteria under Sec. 412.87(b)(1), we did
not adopt the alternative pathway for breakthrough devices (84 FR
42296) under the ESRD PPS.
In the fiscal year (FY) 2020 IPPS final rule (84 FR 42180 through
42181), CMS codified additional SCI criteria that had been included in
manuals and other sub-regulatory guidance. In accordance with the
reference to Sec. 412.87(b)(1), we adopted the FY 2020 IPPS changes to
the SCI criteria, and any future changes to the SCI criteria, by
reference, unless and until we make any changes to the criteria through
notice-and-comment rulemaking. Although the codification of the related
guidance for the IPPS SCI occurred prior to the publication of the CY
2020 ESRD PPS final rule, we inadvertently included a reference to
related guidance in Sec. 413.236(b)(5). Therefore, we propose to
revise Sec. 413.236(b)(5) to remove ``and related guidance'' to
reflect that all related SCI guidance has now been incorporated into
Sec. 412.87(b)(1).
3. Proposed Expansion of the TPNIES for New and Innovative Capital-
Related Assets That are Home Dialysis Machines When Used in the Home
for a Single Patient
a. Background
In response to the proposed expansion of the TDAPA in the CY 2019
ESRD PPS proposed rule, we received several comments regarding payment
under the ESRD PPS for certain new, innovative equipment and supplies
used in the treatment of ESRD. For example, as we described in the CY
2019 ESRD PPS final rule (83 FR 56972), a device manufacturer and
device manufacturer association asked CMS to establish a transitional
add-on payment adjustment for new FDA approved devices. They commented
on the lack of FDA approved or authorized new devices for use in an
ESRD facility, highlighting the need to promote dialysis device
innovation.
Other commenters, including a professional association and a large
dialysis organization (LDO) urged CMS and other relevant policymakers
to prioritize the development of a clear pathway to add new devices to
the ESRD PPS bundled payment (83 FR 56973). A home dialysis patient
group also expressed concern regarding the absence of a pathway for
adding new devices to the ESRD PPS bundled
[[Page 42145]]
payment, stating that it left investors and industry wary of investing
in the development of new devices for patients. In response, we
expressed appreciation for the commenters' thoughts regarding payment
for new and innovative devices, and stated that because we did not
include any proposals regarding this issue in the CY 2019 ESRD PPS
proposed rule, we considered these suggestions to be beyond the scope
of that rule.
However, in response to this feedback, in the CY 2020 ESRD PPS
proposed rule (84 FR 38354 through 38355), we agreed that additional
payment for certain renal dialysis equipment and supplies may be
warranted under specific circumstances. We proposed to provide the
TPNIES for certain new and innovative renal dialysis equipment and
supplies furnished by ESRD facilities, but exclude from eligibility
capital-related assets, which are defined in the Provider Reimbursement
Manual (Pub. L. 15-1) (chapter 1, section 104.1) as assets that a
provider has an economic interest in through ownership (regardless of
the manner in which they were acquired). The Provider Reimbursement
Manual is available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021929. Examples of capital-related assets for ESRD facilities are
dialysis machines and water purification systems.
As we explained in the CY 2020 ESRD PPS proposed rule (84 FR
38354), we did not believe capital-related assets should be eligible
for additional payment through the TPNIES because the cost of these
items is captured in cost reports, they depreciate over time, and they
are generally used for multiple patients. In addition, we noted that
since the costs of these items are reported in the aggregate, there is
considerable complexity in establishing a cost on a per treatment
basis. For these reasons, we therefore believed capital-related assets
should be excluded from eligibility for the TPNIES at that time, and we
proposed an exclusion to the eligibility criteria in Sec.
413.236(b)(6). However, we noted that CMS uses capital-related asset
cost data from cost reports in regression analyses to refine the ESRD
PPS so that the cost of any new capital-related assets is accounted for
in the ESRD PPS payment.
In response to the proposed exclusion of capital-related assets, we
received comments from a device manufacturers' association, which
stated that since most medical equipment is purchased as a capital-
related asset, the TPNIES effectively would exclude the innovative
equipment identified in the title of the adjustment. The association
asserted that meaningful clinical improvements and patient experience
improvements are arguably more likely to come from innovation outside
single-use supplies. The association maintained that expanding the
TPNIES to include medical equipment, regardless of how it is purchased
by the provider, would stimulate greater investment in a broader array
of new technologies for ESRD patients.
In response, we stated in the CY 2020 ESRD PPS final rule (84 FR
60688) that we recognize that accounting for renal dialysis service
equipment can vary depending on the individual ESRD facility's business
model. For example, when the owner of the capital-related asset retains
title, then the renal dialysis service equipment is a depreciable asset
and depreciation expense could be itemized. When there is no ownership
of the renal dialysis service equipment, then the item is recorded as
an operating expense.
In addition, in response to comments regarding capital leases, we
noted that regulations at Sec. 413.130(b)(1) specify that leases and
rentals are includable in capital-related costs if they relate to the
use of assets that would be depreciable if the provider owned them
outright. We stated that in the future, we will be closely examining
the treatment of capital-related assets under Medicare, including our
regulations at Sec. 412.302 regarding capital costs in inpatient
hospitals and Sec. 413.130, as they relate to accounting for capital-
related assets, including capital leases and the newly implemented
guidance for finance lease arrangements, to determine if similar
policies would be appropriate under the ESRD PPS.
b. Proposed Additional Payment for New and Innovative Capital-Related
Assets That are Home Dialysis Machines When Used in the Home for a
Single Patient
Following publication of the CY 2020 ESRD PPS final rule, in which
we finalized the TPNIES policy, we continued to study the issue of
payment for capital-related assets under the ESRD PPS, taking into
account information from a wide variety of stakeholders and recent
developments and initiatives regarding kidney care. For example, we
received additional comments and information from dialysis equipment
and supply manufacturers, and a Technical Expert Panel (TEP) meeting
held in December 2019, regarding the need for additional payment for
capital-related assets under the ESRD PPS.
We also took into account the President's Executive Order, signed
on July 10, 2019, aimed at transforming kidney care in America. The
Executive Order discussed many new initiatives, including the launch of
a public awareness campaign to prevent patients from going into kidney
failure and proposals for the Secretary to support research regarding
preventing, treating, and slowing progression of kidney disease and
encouraging the development of breakthrough technologies to provide
patients suffering from kidney disease with better options for care
than those that are currently available. Currently, most dialysis is
furnished at ESRD facilities. In-center dialysis can be time-consuming
and burdensome for patients. In addition, the current system
prioritizes payment to in-center dialysis and the goal of the agency is
to incentivize in-home dialysis. A key focus of the Executive Order is
the effort to encourage in-home dialysis.
The Executive Order is available at: https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/.
In conjunction with the Executive Order, HHS laid out three goals
for improving kidney health (see https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html):
Reducing the number of Americans developing ESRD by 25
percent by 2030.
Having 80 percent of new ESRD patients in 2025 either
receiving dialysis at home or receiving a transplant; and
Doubling the number of kidneys available for transplant by
2030.
In addition, in connection with the President's Executive Order, on
July 10, 2019, CMS issued a proposed rule (84 FR 34478) to implement a
new mandatory payment model, known as the ESRD Treatment Choices (ETC)
Model, which would provide new incentives to encourage the provision of
dialysis in the home. The proposed ETC Model would be a mandatory
payment model, focused on encouraging greater use of home dialysis and
kidney transplants for ESRD beneficiaries among ESRD facilities and
Managing Clinicians located in selected geographic areas.
Lastly, we note that ESRD patients who receive in-center dialysis
are particularly vulnerable during a PHE and other disasters, and that
greater use of home dialysis modalities may expose these patients to
less risk. The U.S. is responding to an outbreak of respiratory
[[Page 42146]]
disease caused by a novel (new) coronavirus that was first detected in
China and which has now been detected in more than 190 countries
internationally, and all 50 States and the District of Columbia. The
virus has been named ``severe acute respiratory syndrome coronavirus
2'' (SARS-CoV-2) and the disease it causes has been named ``coronavirus
disease 2019'' (`COVID-19').
On January 30, 2020, the International Health Regulations Emergency
Committee of the World Health Organization (WHO) declared the outbreak
a ``Public Health Emergency of international concern.'' On January 31,
2020, the Secretary determined that a PHE exists for the U.S. to aid
the nation's healthcare community in responding to COVID-19 and on
April 21, 2020, the Secretary renewed, effective April 26, 2020, the
determination that a PHE exists. On March 11, 2020, the WHO publicly
declared COVID-19 a pandemic. On March 13, 2020, the President of the
U.S. declared the COVID-19 pandemic a national emergency.
The experience of multiple countries across the globe has
demonstrated that older patients and patients with multiple
comorbidities and underlying health conditions are patients who are
more susceptible to the virus and have a higher risk of morbidity than
younger patients without underlying health conditions. Per the CDC, the
risk factors for COVID-19 include older adults and people of any age
who have serious underlying medical conditions, such as diabetes and
chronic kidney disease undergoing dialysis. Medicare's ESRD population
aligns with the profile of patients who are more susceptible to COVID-
19. Therefore, it is important to reduce the risk of infection and this
can be done through isolating patients from in-center exposure by
encouraging home dialysis.
Home dialysis would mitigate the risks associated with dialysis for
these patients if the pandemic lasts longer than expected or is
refractory in some way.
(1) Proposed Expansion of the TPNIES to Certain New and Innovative
Capital-Related Assets That are Home Dialysis Machines When Used in the
Home for a Single Patient
In response to the President's Executive Order, the various HHS
home dialysis initiatives, and the particular benefits of home dialysis
for ESRD beneficiaries during PHEs like the current COVID-19 pandemic,
which we discussed in the previous section, and in consideration of the
feedback we have received from stakeholders, we agree that additional
payment through the TPNIES for certain capital-related assets may be
warranted under specific circumstances outlined in this section of the
proposed rule. We note that in the CY 2020 ESRD PPS final rule (84 FR
60607), we specifically excluded capital-related assets from the
TPNIES. In commenting on the proposed rule, most stakeholders expressed
concern that the TPNIES would exclude capital-related assets. In our
response to commenters, we acknowledged that significant innovation and
technology improvement is occurring with dialysis machines and
peritoneal dialysis cyclers, as well as innovation in the efficiency
and effectiveness of water systems. However, at that time we did not
have enough information regarding current usage of the various
financial and leasing arrangements, such as those involving capital
leases for depreciable assets versus operating leases recorded as
operating expenses. In addition, we noted that we would need to assess
methodological issues regarding depreciation to determine whether
TPNIES eligibility for these items would be appropriate.
We stated in the CY 2020 ESRD PPS final rule that we needed to
further study the specifics of the various business arrangements for
equipment related to renal dialysis services. This would include items
that are: (1) Purchased in their entirety and owned as capital-related
assets; (2) assets that are acquired through a capital lease
arrangement; (3) equipment obtained through a finance lease and
recorded as an asset per the Financial Accounting Standards Board
(FASB) guidance on leases (Topic 842) effective for fiscal years
beginning after December 15, 2018; \5\ or (4) equipment obtained
through an operating lease and recorded as an operating expense. In
addition to the variety of business arrangements, we noted, there are
unknown issues relating to ownership of the item and who retains title,
which may affect the equipment's maintenance expenses for capital-
related assets.
---------------------------------------------------------------------------
\5\ https://www.fasb.org/jsp/FASB/Document_C/DocumentPage?cid=1176167901010&acceptedDisclaimer=true.
---------------------------------------------------------------------------
Further, there is the issue of single use versus multiple use for
capital-related assets used for renal dialysis services. For example,
some capital-related assets used in-center and in the home setting,
such as skilled nursing facilities (SNFs) and nursing facilities, may
be used by multiple patients in a day, and by multiple patients over
their useful lifetime. Specifically, equipment classified as capital-
related assets may be refurbished and used by another patient. For
example, capital-related assets used by multiple patients in a day
could be Hoyer lifts to transfer patients and wheelchair scales. In
this proposed rule, we are not proposing to include capital-related
assets with multi-patient usage as being eligible for the TPNIES
because we are supporting the President's Executive Order and HHS goals
of promoting home dialysis, which involves a single machine for patient
use. In addition, as we discussed earlier in this section, it is more
complicated to develop a per treatment payment amount for those items.
However, we seek comments on this aspect of our proposal, and we intend
to gather additional information about how ESRD facilities obtain their
capital-related assets that have multi-patient usage in future meetings
with the TEP.
As we further studied this issue, we determined that one business
arrangement, that is, where the capital-related assets are purchased in
their entirety and owned as capital-related assets, could be considered
for TPNIES eligibility. We continue to analyze other business
arrangements, but we understand that this arrangement is more
straightforward due to ownership being clear, retained at the end of
the TPNIES period, and on the facility's balance sheet. CMS' intent
would be to pay for assets that are owned, whether purchased or
attained through a capital lease. The entity who holds the title to the
asset is the legal owner. At the end of the TPNIES period, the entity
retains ownership of the asset. We would not pay TPNIES for equipment
that is leased, as the ESRD facility has no ownership rights. We
believe this is an appropriate initial step to support home dialysis.
In support of the HHS goals and initiatives to increase home
dialysis following the President's Executive Order, we propose to
provide the TPNIES for eligible new and innovative capital-related
assets that are home dialysis machines when used in the home. We would
limit the payment for new and innovative dialysis machines to those
used for home dialysis in order to target the additional payment
through the TPNIES to equipment that supports the various home dialysis
initiatives currently underway, as discussed previously in this section
of the proposed rule. As more ESRD patients and their nephrologists and
other clinicians opt for home dialysis modalities, we would seek to
support ESRD facility use and beneficiary access to the latest
technological improvements to hemodialysis and peritoneal dialysis
[[Page 42147]]
home dialysis machines. As we explained in prior ESRD PPS rules
establishing the TDAPA and TPNIES, ESRD facilities face unique
challenges in incorporating new renal dialysis drugs, biological
products, equipment and supplies into their businesses and these add-on
payment adjustments are intended to support ESRD facilities' use of new
technologies during the uptake period for these new products.
To codify our proposals for expanding the TPNIES to include
capital-related assets that are home dialysis machines when used in the
home for a single patient, we are proposing further revisions to Sec.
413.236, in addition to the revisions proposed earlier in section
II.B.2 of this proposed rule.
Specifically, we propose to revise the heading at Sec. 413.236(a)
and adding paragraphs (a)(1) and (2) to distinguish this paragraph as
both the ``basis and definitions.'' We propose to define ``capital-
related asset'' at Sec. 413.236(a)(2) as an asset that an ESRD
facility has an economic interest in through ownership (regardless of
the manner in which it was acquired) and is subject to depreciation.
Equipment obtained by the ESRD facility through operating leases are
not considered capital-related assets. This proposed definition is
based on the definition of ``depreciable assets'' in the Provider
Reimbursement Manual (chapter 1, section 104.1). The Provider
Reimbursement Manual is available on the CMS website at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021929.
We propose to define ``home dialysis machines'' at Sec.
413.236(a)(2) as hemodialysis machines and peritoneal dialysis cyclers
in their entirety, meaning that one new part of a machine does not make
the entire capital-related asset new, that receive FDA marketing
authorization for home use and when used in the home for a single
patient. FDA provides a separate marketing authorization for equipment
intended for home use, and this proposal is focused on supporting
efforts to increase home dialysis.
We propose to define ``particular calendar year'' at Sec.
413.236(a)(2) as the year in which the payment adjustment specified in
paragraph (d) of Sec. 413.236 would take effect. We also propose to
include definitions for the terms ``depreciation,'' ``straight-line
depreciation method,'' and ``useful life,'' which are discussed in
section II.B.3.b.(2) of this proposed rule.
We propose to revise Sec. 413.236(b)(6) to provide an exception to
the general exclusion for capital-related assets from eligibility for
the TPNIES for capital-related assets that are home dialysis machines
when used in the home for a single patient and that meet the other
eligibility criteria in the proposed revisions to Sec. 413.236(b). We
also propose to remove ``that an ESRD facility has an economic interest
in through ownership (regardless of the manner in which it was
acquired)'' in Sec. 413.236(b)(6) since we are proposing a separate
definition for ``capital-related asset'' at Sec. 413.236(a)(2).
Under this proposal, we would continue to exclude other capital-
related assets from the TPNIES that are not home dialysis machines when
used in the home because those items would not be advancing HHS's goal
of increasing home dialysis. Examples of capital-related assets that
would continue to be excluded from TPNIES are water purification
systems and dialysis machines when they are used in-center. We continue
to believe that we should not provide additional payment for these
capital-related assets because the cost of these items are captured in
cost reports and reported in the aggregate, depreciate over time, are
generally used for multiple patients and, most importantly, it would
not support the goal of increasing use of home dialysis. However,
capital-related assets that are home dialysis machines when used in the
home are intended for use by a single patient and can be reported on a
per treatment basis on the ESRD facility's claim. These characteristics
provide for a simple methodology for aligning the use of the asset with
the per treatment TPNIES payment.
As we stated previously in this section, we are not proposing to
expand the TPNIES eligibility to in-center dialysis machines or home
dialysis machines when they are used in-center. Currently, our focus is
promoting the increase in home dialysis rather than in-center dialysis.
In addition, in-center dialysis machines are used by multiple patients
each day and would require additional analysis, along with 72X claims
and cost report modifications, in order to provide payment. For this
same reason, we are not proposing to provide the TPNIES for home
dialysis machines when they are used in SNFs and nursing facilities and
are used by multiple patients each day.
We believe the SCI criteria required under Sec. 413.236(b)(5),
with our proposed revisions, and the process used to evaluate SCI
currently applicable to TPNIES equipment and supplies are also
appropriate for identifying new and innovative capital-related assets
that are home dialysis machines that are worthy of temporary additional
payment under the ESRD PPS. This approach would provide consistent
criteria and evaluation for all equipment and supplies that are
potentially eligible for the TPNIES. In addition, we want to ensure
that we do not pay the TPNIES for new home dialysis machines that are
substantially similar to existing machines and not truly innovative.
Under our proposal, we would utilize the determination process we
established last year for the TPNIES and those requirements we are
proposing to revise in section II.B.2 of this proposed rule. That is,
pursuant to Sec. 413.236(c), interested parties would submit all
information necessary for determining that the home dialysis machine
meets the TPNIES eligibility criteria listed in Sec. 413.236(b). This
would include FDA marketing authorization information, the HCPCS
application information, and studies submitted as part of these two
standardized processes, an approximate date of commercial availability,
and any information necessary for SCI criteria evaluation. For example,
clinical trials, peer reviewed journal articles, study results, meta-
analyses, systematic literature reviews, and any other appropriate
information sources can be considered. We note, for purposes of
determining whether the home dialysis machine is new under Sec.
413.236(b)(2), we would look at the date the machine is granted
marketing authorization by FDA for home use.
Using our current process at Sec. 413.236(c), we would provide a
description of the new home dialysis machine and pertinent facts in the
ESRD PPS proposed rule so the public may comment on them and then
publish the results in the ESRD PPS final rule. We would consider
whether the new home dialysis machine meets the eligibility criteria
specified in the proposed revisions to Sec. 413.236(b) and announce
the results in the Federal Register as part of our annual updates and
changes to the ESRD PPS. Per Sec. 413.236(c), we would only consider,
for additional payment using the TPNIES for a particular calendar year,
an application for a capital-related asset that is a home dialysis
machine we receive by February 1 prior to the particular calendar year.
If the application is not received by February 1, the application would
be denied and the applicant would need to reapply within 3 years
beginning on the date of FDA marketing authorization in order to be
considered for the TPNIES, in accordance with the proposed revisions to
Sec. 413.236(b)(2). We note, applicants are expected to submit
information on the price of their home dialysis machine as part of the
TPNIES application. While we
[[Page 42148]]
recognize this information is proprietary, CMS requests this
information along with the equipment or supply's projected utilization.
For example, under our proposed revisions to Sec. 413.236, in
order for a particular home dialysis machine to be eligible for the
TPNIES under the ESRD PPS beginning in CY 2022, CMS must receive a
complete application meeting our requirements no later than February 1,
2021. FDA marketing authorization and submission of the HCPCS Level II
code application for Coding Cycle 2 for DMEPOS items and services must
occur as specified in the HCPCS Level II coding guidance on the CMS
website. We would include a discussion of the new capital-related asset
that is a home dialysis machine in the CY 2022 ESRD PPS proposed rule
and the CMS final determination would be announced in the CY 2022 ESRD
PPS final rule. If the home dialysis machine qualifies for the TPNIES,
the payment adjustment would begin January 1, 2022 with a miscellaneous
code and the designated HCPCS code would be effective April 1, 2022.
(2) Pricing of New and Innovative Capital-Related Assets That are Home
Dialysis Machines When Used in the Home
As we explained in the CY 2020 ESRD PPS final rule (84 FR 60692),
we are not aware of pricing compendia currently available to price
renal dialysis equipment and supplies for the TPNIES. We also noted
that, unlike new renal dialysis drugs and biological products eligible
for the TDAPA, ASP and WAC pricing do not exist for renal dialysis
equipment and supplies, including capital-related assets that are home
dialysis machines.
In addition, as we explained in the CY 2020 ESRD PPS final rule (84
FR 60692), ESRD facility charges are gross values; that is, charges
before the application of allowances and discounts deductions. We
believe the TPNIES payment amount should reflect the discounts, rebates
and other allowances the ESRD facility (or its parent company)
receives. These terms are defined in the Provider Reimbursement Manual
(chapter 8).\6\ If the TPNIES payment amount does not reflect
discounts, rebates and other allowances, the price would likely exceed
the facility's cost for the item and result in higher co-insurance
obligations for beneficiaries.
---------------------------------------------------------------------------
\6\ Medicare Provider Reimbursement Manual (chapter 8).
Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R450PR1.pdf.
---------------------------------------------------------------------------
For this reason, in Sec. 413.236(e), we established an invoice-
based approach for MACs to use on behalf of CMS to price new and
innovative renal dialysis equipment and supplies that meet the
eligibility criteria for the TPNIES. We require the MACs to establish a
price, using verifiable information from the following sources of
information, if available: (1) The invoice amount, facility charges for
the item, discounts, allowances, and rebates; (2) the price established
for the item by other MACs and the sources of information used to
establish that price; (3) payment amounts determined by other payers
and the information used to establish those payment amounts; and (4)
charges and payment amounts required for other equipment and supplies
that may be comparable or otherwise relevant. As discussed in the CY
2020 ESRD PPS final rule (84 FR 60692 through 60693), in order to
maintain consistency with the IPPS NTAP payment policy and to mitigate
the Medicare expenditures incurred as a result of the TPNIES, we
finalized a policy at Sec. 413.236(d) to base the TPNIES payment on 65
percent of the MAC-determined price.
We believe that the invoice-based approach established for the
TPNIES also should be applied to capital-related assets that are home
dialysis machines, which are the focus of this proposal. However,
capital-related assets that are home dialysis machines when used in the
home for a single patient are depreciable assets as defined in the
Provider Reimbursement Manual (chapter 1, section 104), which defines
depreciation as ``that amount which represents a portion of the
depreciable asset's cost or other basis which is allocable to a period
of operation.'' The Provider Reimbursement Manual provides the American
Institute of Certified Public Accountant's definition of depreciation
as a process of cost allocation: ``Depreciation accounting is a system
of accounting which aims to distribute the cost or other basic value of
tangible capital assets, less salvage (if any), over the estimated
useful life of the unit (which may be a group of assets) in a
systematic and rational manner. It is a process of allocation, not of
valuation. Depreciation for the year is the portion of the total charge
under such a system that is allocated to the year.''
Because capital-related assets that are home dialysis machines when
used in the home for a single patient are depreciable assets, we are
proposing to apply a 5-year straight-line depreciation method to
determine the basis of the TPNIES for these items. The Provider
Reimbursement Manual, (chapter 1, section 116.1) discusses the
straight-line depreciation method as a method where the annual
allowance is determined by dividing the cost of the capital-related
asset by the years of useful life. Section 104.17 of the Provider
Reimbursement Manual discusses that the useful life of a capital-
related asset is its expected useful life to the provider, not
necessarily the inherent useful or physical life. Further, the manual
provides that under the Medicare program, only the American Hospital
Association (AHA) guidelines may be used in selecting a proper useful
life for computing depreciation.
Using the Provider Reimbursement Manual definitions as the basis,
we propose to define the following terms at Sec. 413.236(a)(2):
``depreciation'' as the amount that represents a portion of the
capital-related asset's cost and that is allocable to a period of
operation; ``straight-line depreciation method'' as a method in
accounting in which the annual allowance is determined by dividing the
cost of the capital-related asset by the years of useful life; and
``useful life'' as the estimated useful life of a capital-related asset
is its expected useful life to the ESRD facility, not necessarily the
inherent useful or physical life.
In keeping with the Medicare policy, we propose to rely on the AHA
guidelines to determine the useful life of a capital-related asset that
is a home dialysis machine. That is, the useful life of a home dialysis
machine is 5 years. Since we are proposing a methodology using the
Provider Reimbursement Manual's guidance, we believe these terms are
appropriate to codify for purposes of calculating the price of a home
dialysis machine that is a capital-related asset.
That is, under Sec. 413.236(e), MACs, on behalf of CMS, would
establish prices, using verifiable information as described above, for
new and innovative capital-related assets that are home dialysis
machines when used in the home for a single patient that meet the
eligibility criteria specified in Sec. 413.236(b). This price would be
the only element used to determine the total cost basis for applying
the straight-line depreciation method. For example, we would exclude
financing, sales tax, freight, installation and testing, excise taxes,
legal or accounting fees, and maintenance. This specific price element
would act as the proxy for the all-encompassing cost basis in other
accounting methodologies. Using the straight-line depreciation method,
we would divide the MAC-determined price by the useful life of the
capital-related asset that is a home dialysis machine when used in the
home for a
[[Page 42149]]
single patient. The resulting number is the annual allowance.
We considered other depreciation methods, such as units of
production and accelerated depreciation methods such as double
declining balance and sum-of-the-years-digits, but concluded that these
methods would be more complex to implement and that the simpler method
would be preferable for the calculation of an add-on payment
adjustment. In addition, since we are not reimbursing the cost of the
equipment, nor are we revising the ESRD PPS at the end of the two-year
add-on payment period, based on the information gathered, we believe
this policy is appropriate for encouraging and supporting the uptake of
new and innovative renal dialysis equipment and supplies.
In order to determine the basis of payment for capital-related
assets that are home dialysis machines when used in the home for a
single patient, we are proposing certain additional steps that MACs
would take after determining the price to develop the TPNIES per
treatment payment amount. That is, we propose to add paragraph (f) to
Sec. 413.236 to establish the pricing for the TPNIES for capital-
related assets that are home dialysis machines when used in the home
for a single patient that meet the eligibility criteria in Sec.
413.236(b). We are proposing in Sec. 413.236(f)(1) that, using the
price determined under Sec. 413.236(e), the MACs would follow a 2-step
methodology for calculating a pre-adjusted per treatment amount.
Under the first step, the MACs would determine the annual
allowance, that represents the amount of the MAC-determined price that
is allocable to 1 year. To calculate the annual allowance, we propose
that the MACs would use the straight-line depreciation method by
dividing the MAC-determined price by the useful life of the home
dialysis machine. In accordance with the straight-line depreciation
method, the MAC would divide the MAC-determined price by 5 (the useful
life for dialysis machines established by the AHA is 5 years).
Under the second step, the MACs would calculate a pre-adjusted per
treatment amount by dividing the annual allowance by the expected
number of treatments to yield a pre-adjusted per treatment amount. That
is, the MACs would establish a pre-adjusted per treatment amount by
dividing the annual allowance by the number of treatments expected to
be furnished in a year. For home dialysis machines that are expected to
be used 3 times per week, the annual number of treatments is 156 (3
treatments/week x 52 weeks = 156 treatments/year). We note, for
purposes of calculating this TPNIES add-on payment adjustment, MACs do
not determine the number of expected treatments. This information will
be provided by CMS through the Change Request.
We note, below in section II.B.3.b.(3) of this proposed rule, we
are considering an alternative to our proposal. The alternative is a
methodology that would offset the pre-adjusted per treatment amount by
a value that would reflect the amount already included in the ESRD PPS
base rate.
Finally, consistent with the policies finalized last year in Sec.
413.236(d) for the TPNIES, we propose to revise Sec. 413.236(d) to
reflect that we would pay 65 percent of the pre-adjusted per treatment
amount for capital-related assets that are home dialysis machines when
used in the home for a single patient. That is, as discussed in the CY
2020 ESRD PPS final rule (84 FR 60692 through 60693), we finalized a
policy to base the TPNIES payment on 65 percent of the MAC-determined
price in order to maintain consistency with the IPPS NTAP payment
policy and to mitigate the Medicare expenditures incurred as a result
of the TPNIES. Therefore, we propose to pay 65 percent of the pre-
adjusted per treatment amount for these machines.
For example, for a home dialysis machine that has a MAC-determined
price of $25,000 and a 5-year useful life, using the proposed straight-
line depreciation method, the annual allowance would equate to $5,000
per year. At 156 treatments per year, the pre-adjusted per treatment
amount is $32.05 ($5,000/156) and 65 percent of that amount equals a
TPNIES per treatment add-on payment amount of $20.83 ($32.05 x .65). We
note that at this time the useful life of 5 years and the expected
number of treatments of 156 is fixed since these variables have been
established by CMS. That is, as we discussed above in this section with
regard to the use of the AHA guidance that dialysis machines have a 5-
year useful life. With regard to the expected number of treatments,
this is based on the current payment policy of 3 treatments per week.
In the future, if an innovative home dialysis machine is designed
to require fewer treatments per week relative to existing machines,
MACs, using the same methodology could account for fewer treatments in
the denominator in the calculation of the pre-adjusted per treatment
amount. This change to the denominator would allow the total TPNIES
amount paid at the end of the year to be equivalent to the annual
allowance and we would then proceed with the calculation to achieve the
targeted 65 percent of that annual allowance. The following example
demonstrates that the annual allowance stays fixed even if there is a
change in the number of treatments the machine is expected to deliver
per year. The TPNIES payment adjustment would increase because the
annual allowance would be spread over less treatments so that the
targeted amount would pay out by the end of the year.
For a home dialysis machine that is used two times per week, using
the same example as above, the annual allowance for TPNIES would remain
at $5,000 per year. Two treatments per week equals 104 treatments per
year (2 treatments per week x 52 weeks = 104 treatments per year). The
annual allowance (numerator) would be divided by the number of
treatments (denominator). At 104 treatments per year, the pre-adjusted
per treatment amount would be $48.08 ($5,000/104 treatments = $48.08);
and 65 percent of that amount would yield a TPNIES per treatment add-on
payment of $31.25.
For a peritoneal dialysis cycler that is used 7 times per week,
using the same example as above, the annual allowance for TPNIES would
remain at $5,000 per year. A daily modality, or 7 treatments per week,
equals 364 treatments per year (7 treatments per week x 52 weeks = 364
treatments per year). The annual allowance (numerator) would be divided
by the number of treatments (denominator). At 364 treatments per year,
the pre-adjusted per treatment amount would be $13.74 ($5,000/364
treatments = $13.74); and 65 percent of that amount would yield a
TPNIES per treatment add-on payment of $8.93.
The methodology is the same. The two variables, regardless of
modality, are: (1) The cost of the machine used to calculate annual
allowance (2) the number of treatments the machine is expected to
deliver per year.
We are inviting public comment on using this proposed method for
determining the pricing of capital-related assets that are home
dialysis machines when used in the home for a single patient and that
meet the eligibility criteria in Sec. 413.236(b), including the
proposed revisions discussed in section II.B.3.b.(1) of this proposed
rule.
Consistent with the TPNIES policy and in accordance with Sec.
413.236(d)(1), we would apply the TPNIES for these home dialysis
machines for 2-calendar years from the effective date of the change
request, which would coincide
[[Page 42150]]
with the effective date of a CY ESRD PPS final rule. In the change
request we would specify that the add-on payment adjustment would be
applicable to home dialysis treatments and provide the billing guidance
on how to report the miscellaneous code for the eligible item on the
claim until a permanent HCPCS is available.
We believe the duration of the application of the TPNIES for all
equipment and supplies determined eligible for this payment adjustment
should be consistent, and that 2 years would be a sufficient timeframe
for ESRD facilities to set up or adjust business practices so that
there is seamless access to the new and innovative home dialysis
machines. In addition, in light of the current COVID-19 pandemic,
stakeholders are increasingly aware of the importance of having home
dialysis readily available and in place to prevent ESRD patients from
being exposed to asymptomatic or pre-symptomatic infections that
contribute to COVID-19 transmission by having to utilize in-center
dialysis.
We further believe providing the TPNIES for 2 years for these
machines would address the stakeholders' concerns regarding additional
payment to account for higher cost of more new and innovative home
dialysis machines that they believe may not be adequately captured by
the dollars allocated in the ESRD PPS base rate. That is, this TPNIES
would give these new and innovative home dialysis machines a foothold
in the market and the opportunity to compete with the other dialysis
machines. We note that this proposal would increase Medicare
expenditures, which would result in increases to ESRD beneficiary co-
insurance, since we have not previously provided a payment adjustment
for any capital-related assets in the past. However, to support HHS's
goals and initiatives to increase home dialysis and the President's
Executive Order of July 10, 2019, we believe that the proposed
expansion of the TPNIES to capital-related assets that are home
dialysis machines when used in the home for a single patient would be
appropriate to support ESRD facility uptake in furnishing new and
innovative renal dialysis equipment to ESRD patients.
The intent of the proposed TPNIES for new and innovative capital-
related assets that are home dialysis machines when used in the home
would be to provide a transition period to support ESRD facility use of
these machines when they are new and innovative to the market. At this
time, we do not believe that it would be appropriate to add dollars to
the ESRD PPS base rate for new and innovative home dialysis machines
because, as noted previously in this proposed rule, the ESRD PPS base
rate includes the cost of equipment and supplies used to furnish a
dialysis treatment.
While we would monitor renal dialysis service utilization trends
during the TPNIES payment period, we propose that these capital-related
assets that are home dialysis machines when used in the home would not
be eligible outlier services as provided in Sec. 413.237. As assets,
capital-related home dialysis machines are distinct from operating
expenses such as the disposable supplies and leased equipment with no
conveyed ownership rights. These expenses are generally accounted for
on a per patient basis and therefore, when used in excess of the
average constitute outlier use, which makes them eligible for outlier
payments.
Therefore, we are proposing revisions at Sec. 413.236(d)(2) to
reflect that following payment of the TPNIES for new and innovative
capital-related assets that are home dialysis machines when used in the
home for a single patient, the ESRD PPS base rate will not be modified
and the equipment would not be an eligible outlier service as provided
in Sec. 413.237. In addition, we propose revisions at Sec.
413.237(a)(1)(v) to exclude capital-related assets that are home
dialysis machines when used in the home for a single patient from
outlier eligibility after the TPNIES period ends. We also propose minor
editorial changes to paragraph (a)(1)(i) to remove the semicolon at the
end of the sentence and adding a period in its place; and in paragraph
(a)(1)(iv) to remove ``; and'' and adding a period in its place.
With regard to the TPNIES application, we would post any final
changes to both the timing of the various eligibility criteria and the
content of the TPNIES application to the TPNIES website, along with
information about all renal dialysis equipment and supplies that CMS
has determined are eligible for the TPNIES, consistent with the
policies we finalize in the CY 2021 ESRD PPS final rule. The TPNIES
website is available at: https://www.cms.gov/medicare/esrd-pps/esrd-pps-transitional-add-payment-adjustment-new-and-innovative-equipment-and-supplies-tpnies.
(3) Alternative To Offset the Proposed Pre-Adjusted per Treatment
Amount
In the CY 2011 ESRD PPS final rule (75 FR 49075), we stated that
when we computed the ESRD PPS base rate, we used the composite rate
payments made under Part B in 2007 for dialysis in computing the ESRD
PPS base rate. These are identified in Table 19 of the CY 2011 ESRD PPS
final rule (75 FR 49075) as ``composite rate services.'' Sections
1881(b)(14)(A)(i) and 1881(b)(14)(B) of the Act specify the renal
dialysis services that must be included in the ESRD PPS bundled
payment, which includes items and services that were part of the
composite rate for renal dialysis services as of December 31, 2010. As
we indicated in the CY 2011 ESRD PPS proposed rule (74 FR 49928), the
case-mix adjusted composite payment system represents a limited PPS for
a bundle of outpatient renal dialysis services that includes
maintenance dialysis treatments and all associated services including
historically defined dialysis-related drugs, laboratory tests,
equipment, supplies and staff time (74 FR 49928). In the CY 2011 ESRD
PPS final rule (75 FR 49062), we noted that total composite rate costs
in the per treatment calculation included costs incurred for training
expenses, as well as all home dialysis costs.
In addition, as we discussed in section II.B.3.(a) of this proposed
rule, these composite rate payments, and consequently the ESRD PPS base
rate, include an amount associated with the costs of capital-related
assets that are home dialysis machines. We believe that capital-related
assets are distinguishable from drugs and biological products and
supplies, which are single-use or disposable items, whereas ESRD
facilities can continually use a home dialysis machine past its
expected useful life and for multiple patients (consecutively).
Therefore, we believe that an offset of the proposed TPNIES pre-
adjusted per treatment amount may be warranted so that the TPNIES would
cover the estimated marginal costs of new and innovative home dialysis
machines. That is, ESRD facilities using the new and innovative home
dialysis machine would receive a per treatment payment to cover some of
the cost of the new machine per treatment minus a per treatment payment
amount that we estimate to be included in the ESRD PPS base rate for
current home dialysis machines that they already own.
To account for the costs already paid through the ESRD PPS base
rate for current home dialysis machines that ESRD facilities already
own, we are considering an alternative to our proposal that would
include an additional step to calculating the TPNIES. That is, we could
apply an offset to the pre-adjusted per treatment amount. The following
section discusses
[[Page 42151]]
the methodology that we would use for determining the offset. If we
were to adopt an offset in the final rule, we would add language to the
proposed Sec. 413.236(f) specifying the methodology used to compute
the offset and its place--the final step--in the computation of the
TPNIES for new and innovative home dialysis machines that meet the
eligibility criteria.
(4) Methodology for Estimating Home Machine and Equipment Cost per Home
Treatment
As we stated in the previous section, we considered proposing an
alternative to our proposed methodology for calculating the pre-
adjusted per treatment amount, which would involve applying an offset
to the pre-adjusted per treatment amount. This section discusses the
methodology we would use for determining the value of that offset,
which would be an estimate of an average home dialysis machine and
equipment cost per hemodialysis (HD)-equivalent home dialysis treatment
to use as the offset amount. First, we would estimate annualized
dialysis machine and equipment cost and treatment counts from cost
reports for each ESRD facility for 2018. Next, we would compute an HD-
equivalent home dialysis treatment percentage for each ESRD facility by
dividing the annualized HD-equivalent home treatment counts by the
annualized HD-equivalent treatment counts across all modalities. Then
we would apply the home dialysis treatment percentage to the annualized
dialysis machine and equipment cost to derive an estimated home
dialysis machine and equipment cost for each ESRD facility. Next, we
would aggregate the home dialysis machine and equipment costs and the
HD-equivalent home treatment counts to derive an average home dialysis
machine and equipment cost per home dialysis treatment across all ESRD
facilities. Finally, we would scale the 2018 average home dialysis
machine and equipment cost per home treatment to 2021 using the ESRDB
market basket less productivity update for CY 2019, CY 2020, and CY
2021.
We would obtain annualized dialysis machine and equipment cost and
treatment counts from freestanding and hospital-based ESRD cost
reports. For independent/freestanding ESRD facilities, we would use
renal facility cost reports (CMS form 265-11). We would obtain dialysis
machine and equipment cost \7\ from Worksheet B, Column 4, and sum up
Lines 8.01 through 17.02. We would obtain dialysis treatment counts by
modality from Worksheet D, Column 1, Lines 1 through 10. Since home
continuous ambulatory peritoneal dialysis (CAPD) and continuous cycling
peritoneal dialysis (CCPD) treatment counts are reported in patient
weeks, we would multiply them by 3 to get HD-equivalent counts.
Finally, we would aggregate all home dialysis treatment counts to
obtain each ESRD facility's HD-equivalent home dialysis treatment
counts and we would aggregate the treatment counts to obtain each
freestanding ESRD facility's HD-equivalent dialysis treatment counts
for all modalities.
---------------------------------------------------------------------------
\7\ Here dialysis machine and equipment cost includes capital-
related costs of moveable equipment, rented and/or purchased, and
maintenance on the dialysis machine and any support equipment. This
also includes the equipment and associated maintenance and repair
and installation costs necessary to render the water acceptable for
use in dialysis.
---------------------------------------------------------------------------
For hospital-based ESRD facilities, we would use hospital cost
reports (CMS form 2552-10). We would obtain dialysis machine and
equipment cost from Worksheet I-2, Column 2, and then sum up Lines 2
through 11. We would derive dialysis treatment counts by modality from
Worksheet I-4, Column 1, Lines 1 through 10. Home CAPD and CCPD
treatment counts are reported in patient weeks, so we would multiply
them by 3 to get HD-equivalent counts. We would aggregate all home
treatment counts to obtain each hospital-based ESRD facility's HD-
equivalent home dialysis treatment counts. Then we would aggregate all
treatment counts to obtain each hospital-based ESRD facility's HD-
equivalent dialysis treatment counts for all modalities.
Using this methodology for both freestanding and hospital-based
ESRD facilities, it would result in an offset of $9.23. If we were to
adopt this approach, the MAC would apply this additional step in
calculating the pre-adjusted per treatment amount. That is, the MAC
would offset the pre-adjusted per treatment amount by deducting $9.23
to account for the costs already paid through the ESRD PPS base rate
for current home dialysis machines that ESRD facilities already own. We
believe that this methodology would provide an approximation of the
cost of the home dialysis machine in the base rate. Further, we believe
that deducting it from the calculated pre-adjusted per treatment amount
would be reasonable because the beneficiary would not be using two home
dialysis machines at the same time and at the end of the 2 years, the
ESRD facility would retain ownership of the asset, specifically, the
home dialysis machine.
Using the example from section II.B.3.b.(2), for a home dialysis
machine that has a MAC-determined price of $25,000 and a 5-year useful
life, using the proposed straight-line depreciation method, the annual
allowance would equate to $5,000 per year. At 156 treatments per year,
the pre-adjusted per treatment amount is $32.05 ($5,000/156). Under the
alternative to our proposal, we would offset the pre-adjusted per
treatment amount of $32.05 by deducting $9.23. This would result in a
per treatment amount of $22.82 ($32.05-$9.23). Then 65 percent of that
amount would equal a TPNIES per treatment add-on payment amount of
$14.83 ($22.82 x .65). After the TPNIES per treatment add-on payment
amount is determined, there would be no change in the policy as
described in section II.B.3.b.(2) with regard to the TPNIES duration,
process, and the ESRD PPS base rate, that is, no change to the base
rate would be made.
We are soliciting comment on this alternative approach to apply an
offset to the proposed pre-adjusted per treatment amount. We are
specifically soliciting comment on the methodology we would use to
compute the value of the offset.
4. Proposed CY 2021 ESRD PPS Update
a. Proposed CY 2021 ESRD Bundled (ESRDB) Market Basket Update,
Productivity Adjustment, and Labor-Related Share
In accordance with section 1881(b)(14)(F)(i) of the Act, as added
by section 153(b) of MIPPA and amended by section 3401(h) of the
Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts
are required to be annually increased by an ESRD market basket increase
factor and reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity
adjustment may result in the increase factor being less than 0.0 for a
year and may result in payment rates for a year being less than the
payment rates for the preceding year. The statute also provides that
the market basket increase factor should reflect the changes over time
in the prices of an appropriate mix of goods and services used to
furnish renal dialysis services.
As required under section 1881(b)(14)(F)(i) of the Act, CMS
developed an all-inclusive ESRD Bundled (ESRDB) input price index (75
FR 49151 through 49162). In the CY 2015 ESRD PPS final rule we rebased
and revised the ESRDB input price
[[Page 42152]]
index to reflect a 2012 base year (79 FR 66129 through 66136).
Subsequently, in the CY 2019 ESRD PPS final rule, we finalized a
rebased ESRDB input price index to reflect a 2016 base year (83 FR
56951 through 56962).
Although ``market basket'' technically describes the mix of goods
and services used for ESRD treatment, this term is also commonly used
to denote the input price index (that is, cost categories, their
respective weights, and price proxies combined) derived from a market
basket. Accordingly, the term ``ESRDB market basket,'' as used in this
document, refers to the ESRDB input price index.
We propose to use the CY 2016-based ESRDB market basket as
finalized and described in the CY 2019 ESRD PPS final rule (83 FR 56951
through 56962) to compute the CY 2021 ESRDB market basket increase
factor based on the best available data. Consistent with historical
practice, we propose to estimate the ESRDB market basket update based
on IHS Global Inc.'s (IGI), forecast using the most recently available
data. IGI is a nationally recognized economic and financial forecasting
firm that contracts with CMS to forecast the components of the market
baskets. Using this methodology and the IGI first quarter 2020 forecast
of the CY 2016-based ESRDB market basket (with historical data through
the fourth quarter of 2019), the proposed CY 2021 ESRDB market basket
increase factor is 2.2 percent.
Under section 1881(b)(14)(F)(i) of the Act, for CY 2012 and each
subsequent year, the ESRD market basket percentage increase factor
shall be reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act. The multifactor productivity (MFP) is
derived by subtracting the contribution of labor and capital input
growth from output growth. We finalized the detailed methodology for
deriving the MFP projection in the CY 2012 ESRD PPS final rule (76 FR
40503 through 40504). The most up-to-date MFP projection methodology is
available on the CMS website at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/Downloads/MFPMethodology.pdf. Using this
methodology and the IGI first quarter 2020 forecast, the proposed MFP
adjustment for CY 2021 (the 10-year moving average of MFP for the
period ending CY 2021) is projected to be 0.4 percent.
As a result of these provisions, the proposed CY 2021 ESRD market
basket adjusted for MFP is 1.8 percent (2.2-0.4). This market basket
increase is calculated by starting with the proposed CY 2021 ESRDB
market basket percentage increase factor of 2.2 percent and reducing it
by the proposed MFP adjustment (the 10-year moving average of MFP for
the period ending CY 2021) of 0.4 percent.
As is our general practice, we are proposing that if more recent
data become available after the publication of this proposed rule and
before the publication of the final rule (for example, a more recent
estimate of the market basket update or MFP), we would use such data,
if appropriate, to determine the final CY 2021 market basket update
and/or MFP adjustment.
For the CY 2021 ESRD payment update, we propose to continue using a
labor-related share of 52.3 percent for the ESRD PPS payment, which was
finalized in the CY 2019 ESRD PPS final rule (83 FR 56963).
b. The Proposed CY 2021 ESRD PPS Wage Indices
(1) Background
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD
PPS may include a geographic wage index payment adjustment, such as the
index referred to in section 1881(b)(12)(D) of the Act, as the
Secretary determines to be appropriate. In the CY 2011 ESRD PPS final
rule (75 FR 49200), we finalized an adjustment for wages at Sec.
413.231. Specifically, CMS adjusts the labor-related portion of the
base rate to account for geographic differences in the area wage levels
using an appropriate wage index, which reflects the relative level of
hospital wages and wage-related costs in the geographic area in which
the ESRD facility is located. We use the Office of Management and
Budget's (OMB's) core-based statistical area (CBSA)-based geographic
area designations to define urban and rural areas and their
corresponding wage index values (75 FR 49117). OMB publishes bulletins
regarding CBSA changes, including changes to CBSA numbers and titles.
The bulletins are available online at https://www.whitehouse.gov/omb/information-for-agencies/bulletins/.
For CY 2021, we would update the wage indices to account for
updated wage levels in areas in which ESRD facilities are located using
our existing methodology. We use the most recent pre-floor, pre-
reclassified hospital wage data collected annually under the inpatient
PPS. The ESRD PPS wage index values are calculated without regard to
geographic reclassifications authorized under sections 1886(d)(8) and
(d)(10) of the Act and utilize pre-floor hospital data that are
unadjusted for occupational mix. For CY 2021, the updated wage data are
for hospital cost reporting periods beginning on or after October 1,
2016 and before October 1, 2017 (FY 2017 cost report data).
We have also adopted methodologies for calculating wage index
values for ESRD facilities that are located in urban and rural areas
where there is no hospital data. For a full discussion, see CY 2011 and
CY 2012 ESRD PPS final rules at 75 FR 49116 through 49117 and 76 FR
70239 through 70241, respectively. For urban areas with no hospital
data, we compute the average wage index value of all urban areas within
the state to serve as a reasonable proxy for the wage index of that
urban CBSA, that is, we use that value as the wage index. For rural
areas with no hospital data, we compute the wage index using the
average wage index values from all contiguous CBSAs to represent a
reasonable proxy for that rural area. We apply the statewide urban
average based on the average of all urban areas within the state to
Hinesville-Fort Stewart, Georgia (78 FR 72173), and we apply the wage
index for Guam to American Samoa and the Northern Mariana Islands (78
FR 72172). We note that for the CY 2020 ESRD PPS final rule, we did not
apply the statewide urban average to Carson City, Nevada because
hospital data was available to compute the wage index.
A wage index floor value (0.5000) is applied under the ESRD PPS as
a substitute wage index for areas with very low wage index values.
Currently, all areas with wage index values that fall below the floor
are located in Puerto Rico. However, the wage index floor value is
applicable for any area that may fall below the floor. A description of
the history of the wage index floor under the ESRD PPS can be found in
the CY 2019 ESRD PPS final rule (83 FR 56964 through 56967).
An ESRD facility's wage index is applied to the labor-related share
of the ESRD PPS base rate. In the CY 2019 ESRD PPS final rule (83 FR
56963), we finalized a labor-related share of 52.3 percent, which is
based on the 2016-based ESRDB market basket. Thus, for CY 2021, the
labor-related share to which a facility's wage index would be applied
is 52.3 percent.
For CY 2021, in addition to proposing to update the ESRD PPS wage
index to use more recent hospital wage data, we are also proposing to
adopt new OMB delineations and a transition policy in a budget-neutral
manner as discussed in sections II.B.4.b.(2) and II.B.4.b.(3),
respectively, of this proposed rule. The proposed CY 2021 ESRD PPS wage
[[Page 42153]]
index is set forth in Addendum A and is available on the CMS website at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html. Addendum A provides a crosswalk between the CY 2020 wage
index for an ESRD facility using the current OMB delineations in effect
in CY 2020, the CY 2021 wage index using the current OMB delineations
in effect in CY 2020, and the CY 2021 wage index using the proposed new
OMB delineations. Addendum B provides an ESRD facility-level impact
analysis. In Addendum B are the proposed transition wage index values
that would be in effect in CY 2021 if these proposed changes are
finalized. Addendum B is available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html.
(2) Proposed Implementation of New OMB Labor Market Delineations
As discussed previously in this proposed rule, the wage index used
for the ESRD PPS is calculated using the most recent pre-floor, pre-
reclassified hospital wage data collected annually under the inpatient
PPS and is assigned to an ESRD facility on the basis of the labor
market area in which the ESRD facility is geographically located. ESRD
facility labor market areas are delineated based on the CBSAs
established by the OMB. In accordance with our established methodology,
we have historically adopted through rulemaking CBSA changes that are
published in the latest OMB bulletin. Generally, OMB issues major
revisions to statistical areas every 10 years, based on the results of
the decennial census. However, OMB occasionally issues minor updates
and revisions to statistical areas in the years between the decennial
censuses.
In the CY 2015 ESRD PPS final rule (79 FR 66137 through 66142), we
finalized changes to the ESRD PPS wage index based on the newest OMB
delineations, as described in OMB Bulletin No. 13-01 \8\ issued on
February 28, 2013. We implemented these changes with a 2-year
transition period (79 FR 66142). OMB Bulletin No. 13-01 established
revised delineations for U.S. Metropolitan Statistical Areas,
Micropolitan Statistical Areas, and Combined Statistical Areas based on
the 2010 Census. OMB Bulletin No. 13-01 also provided guidance on the
use of the delineations of these statistical areas using standards
published on June 28, 2010 in the Federal Register (75 FR 37246 through
37252).
---------------------------------------------------------------------------
\8\ https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/bulletins/2013/b13-01.pdf.
---------------------------------------------------------------------------
On July 15, 2015, OMB issued OMB Bulletin No. 15-01,\9\ which
updated and superseded OMB Bulletin No. 13-01 issued on February 28,
2013. The attachment to OMB Bulletin No. 15-01 provided detailed
information on the update to statistical areas since February 28, 2013.
These updates were based on the application of the 2010 Standards for
Delineating Metropolitan and Micropolitan Statistical Areas to the U.S.
Census Bureau population estimates for July 1, 2012 and July 1, 2013.
---------------------------------------------------------------------------
\9\ 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,\10\ which
updated and superseded OMB Bulletin No. 15-01 issued on July 15, 2015.
The attachment to OMB Bulletin No. 17-01 provided detailed information
on the update to statistical areas since July 15, 2015. These updates
were based on the application of the 2010 Standards for Delineating
Metropolitan and Micropolitan Statistical Areas to the U.S. Census
Bureau population estimates for July 1, 2014 and July 1, 2015. In OMB
Bulletin No. 17-01, OMB announced a new urban CBSA, Twin Falls, Idaho
(CBSA 46300).
---------------------------------------------------------------------------
\10\ 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 \11\ which
updated and superseded OMB Bulletin No. 17-01 issued on August 15,
2017. The attachment to OMB Bulletin No. 18-03 provided detailed
information on the update to statistical areas since August 15, 2017.
On September 14, 2018, OMB issued OMB Bulletin No. 18-04,\12\ which
updated and superseded OMB Bulletin No. 18-03 issued on April 10, 2018.
OMB Bulletin Numbers 18-03 and 18-04 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. These updates were based on
the application of the 2010 Standards for Delineating Metropolitan and
Micropolitan Statistical Areas to the U.S. Census Bureau population
estimates for July 1, 2015 and July 1, 2016.
---------------------------------------------------------------------------
\11\ https://www.whitehouse.gov/wp-content/uploads/2018/04/OMB-BULLETIN-NO.-18-03-Final.pdf.
\12\ https://www.whitehouse.gov/wp-content/uploads/2018/09/Bulletin-18-04.pdf.
---------------------------------------------------------------------------
While OMB Bulletin No. 18-04 is not based on new census data, there
were some material changes to the CBSA-based geographic area
designations based on the new OMB delineations. For example, if we
adopt the new OMB delineations, there would be new CBSAs, urban
counties that would become rural, rural counties that would become
urban, and some existing CBSAs would be split apart. We believe that
the new OMB delineations accurately reflect the local economies and
wage levels of the areas where ESRD facilities are located. We believe
it is important for the ESRD PPS to use the new OMB delineations
available in order to maintain a more accurate and up-to-date payment
system that reflects the reality of population shifts and labor market
conditions. We further believe that using the new OMB delineations
would increase the integrity of the ESRD PPS wage index system by
creating a more accurate representation of geographic variations in
wage levels.
Therefore, we are proposing to adopt the new OMB delineations
established in OMB Bulletin No. 18-04 effective for CY 2021 under the
ESRD PPS. We are also proposing a wage index transition applicable to
all ESRD facilities that experience negative impacts due to the
proposed implementation of the new OMB delineations. This transition
policy is discussed in section II.B.4.b.(3) of this proposed rule.
We note that, on March 6, 2020, OMB issued OMB Bulletin 20-01
(available at https://www.whitehouse.gov/wp-content/uploads/2020/03/Bulletin-20-01.pdf.). While the March 6, 2020 OMB Bulletin 20-01 was
not issued in time for development of this proposed rule, we were able
to review the updates it provides and have determined that they are
minor. While we do not believe the minor updates included in OMB
Bulletin 20-01 would impact our CY 2021 proposed updates to the CBSA-
based labor market area delineations, if appropriate, we would propose
any updates from this Bulletin in the CY 2022 ESRD PPS proposed rule.
For CY 2021, to implement the new OMB delineations established in
OMB Bulletin No. 18-04 under the ESRD PPS, it is necessary to identify
the new labor market area delineation for each affected county and ESRD
facility in the U.S. We discuss these changes in more detail in the
following sections.
(a) Urban Counties That Would Become Rural Under the New OMB
Delineations
As previously discussed in this proposed rule, we are proposing to
[[Page 42154]]
implement the new OMB labor market area delineations (based upon the
2010 Decennial Census data) beginning in CY 2021. Our analysis of the
new OMB delineations shows that a total of 34 counties (and county
equivalents) that are currently considered part of an urban CBSA would
be considered located in a rural area, beginning in CY 2021. Table 1
shows the 34 urban counties that would be rural if we finalize our
proposal to adopt the new OMB delineations beginning in CY 2021.
BILLING CODE 4120-01-C
[GRAPHIC] [TIFF OMITTED] TP13JY20.001
[[Page 42155]]
We are proposing that the wage data for all ESRD facilities located
in the counties listed above would now be considered rural, beginning
in CY 2021, when calculating their respective State's rural wage index.
We recognize that rural areas typically have lower area wage index
values than urban areas, and ESRD facilities located in these counties
may experience a negative impact in their payment under the ESRD PPS
due to the proposed adoption of the new OMB delineations. A discussion
of the proposed wage index transition policy due to these proposed
changes is available in section II.B.4.b.(3) of this proposed rule.
(b) Rural Counties That Would Become Urban Under the New OMB
Delineations
As previously discussed in this proposed rule, we are proposing to
implement the new OMB labor market area delineations (based upon the
2010 Decennial Census data) beginning in CY 2021. Our analysis of the
new OMB delineations shows that a total of 47 counties (and county
equivalents) that are currently considered located in rural areas would
be considered located in urban CBSAs, beginning in CY 2021. Table 2
shows the 47 rural counties that would be urban if we finalize our
proposal to adopt the new OMB delineations beginning in CY 2021.
BILLING CODE 4120-01-P
[[Page 42156]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.002
[[Page 42157]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.003
BILLING CODE 4120-01-C
We are proposing that when calculating the area wage index,
beginning with CY 2021, the wage data for ESRD facilities located in
these counties would be included in their new respective urban CBSAs.
Typically, ESRD facilities located in an urban area receive a higher
wage index value than or equal wage index value to ESRD facilities
located in their state's rural area. A discussion of the proposed wage
index transition policy due to these proposed changes is available in
section II.B.4.b.(3) of this proposed rule.
(c) Urban Counties That Would Move to a Different Urban CBSA Under the
New OMB Delineations
In certain cases, adopting the new OMB delineations would involve a
change only in CBSA name and/or number, while the CBSA continues to
encompass the same constituent counties. For example, CBSA 19380
(Dayton, OH) would experience both a change to its number and its name,
and become CBSA 19430 (Dayton-Kettering, OH), while all of its three
constituent counties would remain the same. In other cases, only the
name of the CBSA would be modified, and none of the currently assigned
counties would be reassigned to a different urban CBSA. Table 3 shows
the current CBSA code and our proposed CBSA code where we are proposing
to change either the name or CBSA number only.
BILLING CODE 4120-01-P
[[Page 42158]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.004
[[Page 42159]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.005
BILLING CODE 4120-01-C
As we explained previously in this proposed rule, ESRD facilities
located in an urban area that, due to the new OMB delineations,
involves a change only in the CBSA name or number would not experience
a consequential change in their wage index value.
However, in other cases, if we adopt the new OMB delineations,
counties would shift between existing and new CBSAs, changing the
constituent makeup of the CBSAs. We consider these types of changes,
where CBSAs are split into multiple new CBSAs or a CBSA loses one or
more counties to another urban CBSAs, to be significant modifications.
Table 4 (CY 2021 Proposed Urban to a Different Urban CBSA
Crosswalk) shows the urban counties that would move from one urban CBSA
to another a newly proposed or modified CBSA, if we adopt the new OMB
delineations.
[[Page 42160]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.006
If ESRD facilities located in these counties move from one CBSA to
another under the new OMB delineations, there may be impacts, both
negative and positive, to their specific wage index values. A
discussion of the proposed wage index transition policy due to these
proposed changes is available in section II.B.4.b.(3) of this proposed
rule.
(d) Changes to the Statewide Rural Wage Index
ESRD facilities currently located in a rural area may remain rural
under the new OMB delineations but experience a change in their rural
wage index value due to the movement of constituent counties. If ESRD
facilities located in these counties move from one CBSA to another
under the new OMB delineations, there may be impacts, both negative and
positive, upon their specific wage index values. A discussion of the
proposed wage index transition policy due to these proposed changes is
available in section II.B.4.b.(3) of this proposed rule.
We believe these revisions to the CBSA-based labor market area
delineations as established in OMB Bulletin 18-04 would ensure that the
ESRD PPS area wage level adjustment most appropriately accounts for and
reflects the relative wage levels in the geographic area of the ESRD
facility. Therefore, we are proposing to adopt the new OMB delineations
under the ESRD PPS, effective January 1, 2021.
We invite public comment on the proposal to adopt the new OMB
delineations, effective beginning with the CY 2021 ESRD PPS wage index.
(3) Proposed Transition for ESRD Facilities Negatively Impacted
To mitigate the potential impacts of proposed policies on ESRD
facilities, we
[[Page 42161]]
have in the past provided for transition periods when adopting changes
that have significant payment implications, particularly large negative
impacts. For example, we have proposed and finalized budget-neutral
transition policies to help mitigate negative impacts on ESRD
facilities following the adoption of the new OMB delineations as
described in the February 28, 2013 OMB Bulletin No. 13-01 (79 FR
66142). Specifically, as part of the CY 2015 ESRD PPS rulemaking, we
implemented a 2-year transition blended wage index for all ESRD
facilities. ESRD facilities received 50 percent of their CY 2015 wage
index value based on the OMB delineations for CY 2014 and 50 percent of
their CY 2015 wage index value based on the new OMB delineations. This
resulted in an average of the two values. Then, in CY 2016, an ESRD
facility's wage index value was based 100 percent on the new OMB
delineations.
We considered having no transition period and fully implementing
the proposed new OMB delineations beginning in CY 2021, which would
mean that all ESRD facilities would have payments based on updated
hospital wage data and the new OMB delineations starting on January 1,
2021. However, because the overall amount of ESRD PPS payments would
increase slightly due to the new OMB delineations, the wage index
budget neutrality factor would be higher. This higher factor would
reduce the ESRD PPS per treatment base rate for all ESRD facilities
paid under the ESRD PPS, despite the fact that the majority of ESRD
facilities would be unaffected by the new OMB delineations. Thus, we
believe it would be appropriate to provide for a transition period to
mitigate the resulting short-term instability of a lower ESRD PPS base
rate as well as consequential negative impacts to ESRD facilities that
experience reduced payments. For example, ESRD facilities currently
located in CBSA 35614 (New York-Jersey City-White Plains, NY-NJ) that
would be located in new CBSA 35154 (New Brunswick-Lakewood, NJ) under
the proposed changes to the OMB delineations would experience a nearly
17 percent decrease in the wage index as a result of the proposed
change.
Therefore, under the authority of section 1881(b)(14)(D)(iv)(II) of
the Act and consistent with past practice, we are proposing a
transition policy to help mitigate any significant, negative impacts
that ESRD facilities may experience due to our proposal to adopt the
new OMB delineations under the ESRD PPS. Specifically, as a transition
for CY 2021, we are proposing to apply a 5 percent cap on any decrease
in an ESRD facility's wage index from the ESRD facility's wage index
from the prior calendar year. This transition would allow the effects
of our proposed adoption of the new OMB delineations to be phased in
over 2 years, where the estimated reduction in an ESRD facility's wage
index would be capped at 5 percent in CY 2021, and no cap would be
applied to the reduction in the wage index for the second year, CY
2022. We believe a 5 percent cap on the overall decrease in an ESRD
facility's wage index value, regardless of the circumstance causing the
decline, would be an appropriate transition for CY 2021 as it would
provide predictability in payment levels from CY 2020 to the upcoming
CY 2021 and additional transparency because it is administratively
simpler than our prior 2-year 50/50 blended wage index approach. We
believe 5 percent is a reasonable level for the cap because it would
effectively mitigate any significant decreases in an ESRD facility's
wage index for CY 2021. We solicit comment on the proposal to apply a 5
percent cap on any decrease in an ESRD facility's wage index for CY
2021 from the ESRD facility's wage index from the prior calendar year,
CY 2020.
(4) Proposed Budget Neutrality Adjustments for Changes to the ESRD PPS
Wage Index
Consistent with the historical wage index budget-neutrality
adjustment policy finalized in the CY 2012 ESRD PPS final rule (76 FR
70241 through 70242) under the authority of section
1881(b)(14)(D)(iv)(II) of the Act, we are proposing that the proposed
adoption of the new OMB delineations and the proposed transition policy
would not result in any change of estimated aggregate ESRD PPS payments
by applying a budget neutrality factor to the ESRD PPS base rate. We
note budget neutrality was also applied to the adoption of new OMB
delineations and transition policy in the CY 2015 ESRD PPS final rule
(79 FR 66128 through 66129). Our proposed methodology for calculating
this proposed budget neutrality factor is discussed in section
II.B.4.d.(2) of this proposed rule.
The proposed CY 2021 ESRD PPS wage index is set forth in Addendum A
and is available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html. Addendum A provides a
crosswalk between the CY 2020 wage index for an ESRD facility using the
current OMB delineations in effect in CY 2020, the CY 2021 wage index
using the current OMB delineations in effect in CY 2020, and the CY
2021 wage index using the proposed new OMB delineations. Addendum B
provides an ESRD facility-level impact analysis. In Addendum B are the
proposed transition wage index values that would be in effect in CY
2021 if these proposed changes are finalized. Addendum B is available
on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ESRDpayment/End-Stage-Renal-Disease-ESRD-Payment-Regulations-and-Notices.html.
c. Proposed CY 2021 Update to the Outlier Policy
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS
include a payment adjustment for high cost outliers due to unusual
variations in the type or amount of medically necessary care, including
variability in the amount of ESAs necessary for anemia management. Some
examples of the patient conditions that may be reflective of higher
facility costs when furnishing dialysis care would be frailty, obesity,
and comorbidities, such as secondary hyperparathyroidism. The ESRD PPS
recognizes high cost patients, and we have codified the outlier policy
and our methodology for calculating outlier payments at Sec. 413.237.
The policy provides that the following ESRD outlier items and services
are included in the ESRD PPS bundle: (1) Renal dialysis drugs and
biological products that were or would have been, prior to January 1,
2011, separately billable under Medicare Part B; (2) Renal dialysis
laboratory tests that were or would have been, prior to January 1,
2011, separately billable under Medicare Part B; (3) Renal dialysis
medical/surgical supplies, including syringes, used to administer renal
dialysis drugs and biological products that were or would have been,
prior to January 1, 2011, separately billable under Medicare Part B;
(4) Renal dialysis drugs and biological products that were or would
have been, prior to January 1, 2011, covered under Medicare Part D,
including renal dialysis oral-only drugs effective January 1, 2025; and
(5) Renal dialysis equipment and supplies that receive the transitional
add-on payment adjustment as specified in Sec. 413.236 after the
payment period has ended.
In the CY 2011 ESRD PPS final rule (75 FR 49142), we stated that
for purposes of determining whether an ESRD facility would be eligible
for an outlier payment, it would be necessary for the facility to
identify the actual
[[Page 42162]]
ESRD outlier services furnished to the patient by line item (that is,
date of service) on the monthly claim. Renal dialysis drugs, laboratory
tests, and medical/surgical supplies that are recognized as outlier
services were originally specified in Attachment 3 of Change Request
7064, Transmittal 2033 issued August 20, 2010, rescinded and replaced
by Transmittal 2094, dated November 17, 2010. Transmittal 2094
identified additional drugs and laboratory tests that may also be
eligible for ESRD outlier payment. Transmittal 2094 was rescinded and
replaced by Transmittal 2134, dated January 14, 2011, which included
one technical correction.
Furthermore, we use administrative issuances and guidance to
continually update the renal dialysis service items available for
outlier payment via our quarterly update CMS Change Requests, when
applicable. We use this separate guidance to identify renal dialysis
service drugs that were or would have been covered under Medicare Part
D for outlier eligibility purposes and in order to provide unit prices
for calculating imputed outlier services. In addition, we identify
through our monitoring efforts items and services that are either
incorrectly being identified as eligible outlier services or any new
items and services that may require an update to the list of renal
dialysis items and services that qualify as outlier services, which are
made through administrative issuances.
Under Sec. 413.237, an ESRD facility is eligible for an outlier
payment if its actual or imputed Medicare allowable payment (MAP)
amount per treatment for ESRD outlier services exceeds a threshold. The
MAP amount represents the average incurred amount per treatment for
services that were or would have been considered separately billable
services prior to January 1, 2011. The threshold is equal to the ESRD
facility's predicted ESRD outlier services MAP amount per treatment
(which is case-mix adjusted and described in the following paragraphs)
plus the fixed-dollar loss (FDL) amount. In accordance with Sec.
413.237(c), facilities are paid 80 percent of the per treatment amount
by which the imputed MAP amount for outlier services (that is, the
actual incurred amount) exceeds this threshold. ESRD facilities are
eligible to receive outlier payments for treating both adult and
pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule and at Sec. 413.220(b)(4),
using 2007 data, we established the outlier percentage, which is used
to reduce the per treatment base rate to account for the proportion of
the estimated total payments under the ESRD PPS that are outlier
payments, at 1.0 percent of total payments (75 FR 49142 through 49143).
We also established the FDL amounts that are added to the predicted
outlier services MAP amounts. The outlier services MAP amounts and FDL
amounts are different for adult and pediatric patients due to
differences in the utilization of separately billable services among
adult and pediatric patients (75 FR 49140). As we explained in the CY
2011 ESRD PPS final rule (75 FR 49138 through 49139), the predicted
outlier services MAP amounts for a patient are determined by
multiplying the adjusted average outlier services MAP amount by the
product of the patient-specific case-mix adjusters applicable using the
outlier services payment multipliers developed from the regression
analysis used to compute the payment adjustments.
In the CY 2020 ESRD PPS final rule (84 FR 60705), we stated that
based on the CY 2018 claims data, outlier payments represented
approximately 0.5 percent of total payments. We also noted that,
beginning in CY 2020, the total expenditure amount includes add-on
payment adjustments made for calcimimetics under the TDAPA policy. We
projected that for each dialysis treatment furnished, the average
amount attributed to the TDAPA was $21.03 (84 FR 60704).
For CY 2021, we propose that the outlier services MAP amounts and
FDL amounts would be derived from claims data from CY 2019. Because we
believe that any adjustments made to the MAP amounts under the ESRD PPS
should be based upon the most recent data year available in order to
best predict any future outlier payments, we propose the outlier
thresholds for CY 2021 would be based on utilization of renal dialysis
items and services furnished under the ESRD PPS in CY 2019. We note
that, for CY 2020, the total expenditure amount includes add-on payment
adjustments made for calcimimetics under the TDAPA policy (calculated
to be $14.87 per treatment). However, as discussed in section II.B.1 of
this proposed rule, for CY 2021 we propose to modify the ESRD PPS base
rate by adding $12.06 to account for calcimimetics in the ESRD PPS
bundled payment and no longer pay for these drugs using the TDAPA. In
addition, we are proposing that beginning January 1, 2021,
calcimimetics would be eligible outlier services.
As discussed in section II.B.4.c.(2) of this proposed rule, CY 2019
claims data show outlier payments represented approximately 0.5 percent
of total payments. We recognize that the utilization of ESAs and other
outlier services have continued to decline under the ESRD PPS, and that
we have lowered the MAP amounts and FDL amounts every year under the
ESRD PPS. For CY 2021, the predicted outlier services MAP amounts and
FDL amounts have increased as a result of our proposal to incorporate
oral and injectable calcimimetics into the outlier policy.
(1) CY 2021 Update to the Outlier Services MAP Amounts and FDL Amounts
For CY 2021, we propose to update the outlier services MAP amounts
and FDL amounts to reflect the utilization of outlier services reported
on 2019 claims. For this proposed rule, the outlier services MAP
amounts and FDL amounts were updated using 2019 claims data. The impact
of this update is shown in Table 5, which compares the outlier services
MAP amounts and FDL amounts used for the outlier policy in CY 2020 with
the updated proposed estimates for this rule. The estimates for the
proposed CY 2021 outlier policy, which are included in Column II of
Table 5, were inflation adjusted to reflect projected 2021 prices for
outlier services.
[[Page 42163]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.007
As demonstrated in Table 5, the estimated FDL amount per treatment
that determines the CY 2021 outlier threshold amount for adults (Column
II; $133.52) is higher than that used for the CY 2020 outlier policy
(Column I; $48.33). The higher threshold is accompanied by an increase
in the adjusted average MAP for outlier services from $35.78 to $54.26.
For pediatric patients, there is an increase in the FDL amount from
$41.04 to $47.73. There is a corresponding increase in the adjusted
average MAP for outlier services among pediatric patients, from $32.32
to $33.08.
As we stated previously, the predicted outlier services MAP amounts
and FDL amounts have increased as a result of our proposal to
incorporate oral and injectable calcimimetics into the outlier policy.
Approximately 30 percent of ESRD beneficiaries receive calcimimetics
and a subset of these beneficiaries tend to have the highest ESRD PPS
expenditures, which trigger outlier payments under the ESRD PPS. Since
the highest per-beneficiary ESRD PPS expenditures would increase under
our proposal for calcimimetics to become eligible ESRD outlier
services, the outlier FDL would increase to ensure that total outlier
payments project to 1 percent of total Medicare ESRD PPS expenditures.
We estimate that the percentage of patient months qualifying for
outlier payments in CY 2021 would be 4.91 percent for adult patients
and 8.65 percent for pediatric patients, based on the 2019 claims data.
The outlier MAP and FDL amounts continue to be lower for pediatric
patients than adults due to the continued lower use of outlier services
(primarily reflecting lower use of calcimimetics, ESAs and other
injectable drugs).
(2) Outlier Percentage
In the CY 2011 ESRD PPS final rule (75 FR 49081) and under Sec.
413.220(b)(4), we reduced the per treatment base rate by 1 percent to
account for the proportion of the estimated total payments under the
ESRD PPS that are outlier payments as described in Sec. 413.237. Based
on the 2019 claims, outlier payments represented approximately 0.5
percent of total payments, which is below the 1 percent target due to
declines in the use of outlier services. Recalibration of the
thresholds using 2019 data is expected to result in aggregate outlier
payments close to the 1 percent target in CY 2021.
We believe the update to the outlier MAP and FDL amounts for CY
2021 would increase payments for ESRD beneficiaries requiring higher
resource utilization and move us closer to meeting our 1 percent
outlier policy because we are using more current data for computing the
MAP and FDL, which is more in line with current outlier services
utilization rates. The proposed inclusion of calcimimetics as ESRD
outlier services in CY 2021 would fundamentally change the per-
treatment distribution of outlier services relative to previous CYs. In
2019 claims, roughly 33 percent of ESRD beneficiaries and 28 percent of
dialysis treatments are associated with calcimimetics and those that
often have significantly higher utilization of ESRD outlier services
relative to beneficiaries who do not receive calcimimetics. The MAP and
FDL increases account for this change. We note that recalibration of
the FDL amounts in this proposed rule would result in no change in
payments to ESRD facilities for beneficiaries with renal dialysis items
and services that are not eligible for outlier payments.
d. Proposed Impacts to the CY 2021 ESRD PPS Base Rate
(1) ESRD PPS Base Rate
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), we
established the methodology for calculating the ESRD PPS per-treatment
base rate, that is, ESRD PPS base rate, and the determination of the
per-treatment payment amount, which are codified at Sec. Sec. 413.220
and 413.230. The
[[Page 42164]]
CY 2011 ESRD PPS final rule also provides a detailed discussion of the
methodology used to calculate the ESRD PPS base rate and the
computation of factors used to adjust the ESRD PPS base rate for
projected outlier payments and budget neutrality in accordance with
sections 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) of the Act,
respectively. Specifically, the ESRD PPS base rate was developed from
CY 2007 claims (that is, the lowest per patient utilization year as
required by section 1881(b)(14)(A)(ii) of the Act), updated to CY 2011,
and represented the average per treatment MAP for composite rate and
separately billable services. In accordance with section 1881(b)(14)(D)
of the Act and our regulation at Sec. 413.230, the per-treatment
payment amount is the sum of the ESRD PPS base rate, adjusted for the
patient specific case-mix adjustments, applicable facility adjustments,
geographic differences in area wage levels using an area wage index,
any applicable outlier payment and training adjustment add-on, the
TDAPA, and the TPNIES.
(2) Annual Payment Rate Update for CY 2021
We are proposing an ESRD PPS base rate for CY 2021 of $255.59. This
update reflects several factors, described in more detail as follows:
Wage Index Budget-Neutrality Adjustment Factor: We compute
a wage index budget-neutrality adjustment factor that is applied to the
ESRD PPS base rate. For CY 2021, we are not proposing any changes to
the methodology used to calculate this factor, which is described in
detail in the CY 2014 ESRD PPS final rule (78 FR 72174). We computed
the proposed CY 2021 wage index budget-neutrality adjustment factor
using treatment counts from the 2019 claims and facility-specific CY
2020 payment rates to estimate the total dollar amount that each ESRD
facility would have received in CY 2020. The total of these payments
became the target amount of expenditures for all ESRD facilities for CY
2021. Next, we computed the estimated dollar amount that would have
been paid for the same ESRD facilities using the ESRD PPS wage index
for CY 2021. As discussed in section II.B.4.b of this proposed rule,
the proposed ESRD PPS wage index for CY 2021 includes an update to the
most recent hospital wage data, the proposed adoption of the new OMB
delineations, and a 5 percent cap on wage index decreases applied for
CY 2021. The total of these payments becomes the new CY 2021 amount of
wage-adjusted expenditures for all ESRD facilities. The wage index
budget-neutrality factor is calculated as the target amount divided by
the new CY 2021 amount. When we multiplied the wage index budget-
neutrality factor by the applicable CY 2021 estimated payments,
aggregate payments to ESRD facilities would remain budget neutral when
compared to the target amount of expenditures. That is, the wage index
budget-neutrality adjustment factor ensures that wage index adjustments
do not increase or decrease aggregate Medicare payments with respect to
changes in wage index updates. The CY 2021 proposed wage index budget-
neutrality adjustment factor is .998652. This application would yield a
CY 2021 ESRD PPS proposed base rate of $239.01, ($239.33 x .998652 =
$239.01), prior to the proposed addition to the ESRD PPS base rate to
include calcimimetics and the application of the proposed market basket
increase.
Addition to the ESRD PPS Base Rate to Include
Calcimimetics: As discussed in section II.B.1 of this proposed rule,
for CY 2021 we are proposing to modify the ESRD PPS base rate by adding
$12.06 to account for calcimimetics in the ESRD PPS bundled payment.
This application would yield a CY 2021 ESRD PPS proposed base rate of
$251.07 ($239.01 + $12.06 = $251.07), prior to the application of the
proposed market basket increase.
Market Basket Increase: Section 1881(b)(14)(F)(i)(I) of
the Act provides that, beginning in 2012, the ESRD PPS payment amounts
are required to be annually increased by the ESRD market basket
percentage increase factor. The latest CY 2021 projection for the
proposed ESRDB market basket is 2.2 percent. In CY 2021, this amount
must be reduced by the productivity adjustment described in section
1886(b)(3)(B)(xi)(II) of the Act, as required by section
1881(b)(14)(F)(i)(II) of the Act. As discussed previously, the proposed
MFP adjustment for CY 2021 is 0.4 percent, thus yielding a proposed
update to the base rate of 1.8 percent for CY 2021. Therefore, the CY
2021 ESRD PPS proposed base rate is $255.59 ($251.07 x 1.018 =
$255.59).
In summary, we are proposing a CY 2021 ESRD PPS base rate of
$255.59. This amount reflects a proposed CY 2021 wage index budget-
neutrality adjustment factor of .998652, a proposed addition of $12.06
to the ESRD PPS base rate to include calcimimetics, and the CY 2021
ESRD PPS payment update of 1.8 percent.
5. Proposed Changes to the Low-Volume Payment Adjustment
a. Background
As required by section 1881(b)(14)(D)(iii) of the Act, the ESRD PPS
includes a payment adjustment that reflects the extent to which costs
incurred by low-volume facilities in furnishing renal dialysis services
exceed the costs incurred by other facilities in furnishing such
services. We have established a LVPA factor of 23.9 percent for ESRD
facilities that meet the definition of a low-volume facility. Under
Sec. 413.232(b), a low-volume facility is an ESRD facility that, based
on the submitted documentation--(1) Furnished less than 4,000
treatments in each of the 3 cost reporting years (based on as-filed or
final settled 12-consecutive month cost reports, whichever is most
recent) preceding the payment year; and (2) Has not opened, closed, or
received a new provider number due to a change in ownership in the 3
cost reporting years (based on as-filed or final settled 12-consecutive
month cost reports, whichever is most recent) preceding the payment
year. Under Sec. 413.232(c), for purposes of determining the number of
treatments furnished by the ESRD facility, the number of treatments
considered furnished by the ESRD facility equals the aggregate number
of treatments furnished by the ESRD facility and the number of
treatments furnished by other ESRD facilities that are both under
common ownership with, and 5 road miles or less from, the ESRD facility
in question.
For purposes of determining eligibility for the LVPA,
``treatments'' mean total hemodialysis (HD) equivalent treatments
(Medicare and non-Medicare as well as ESRD and non-ESRD). For
peritoneal dialysis (PD) patients, 1 week of PD is considered
equivalent to 3 HD treatments. As noted, we base eligibility on the 3
years preceding the payment year and those years are based on cost
reporting periods. Specifically, under Sec. 413.232(g), the ESRD
facility's cost reports for the periods ending in the 3 years preceding
the payment year must report costs for 12-consecutive months (76 FR
70237).
In order to receive the LVPA under the ESRD PPS, an ESRD facility
must submit a written attestation statement to its Medicare
Administrative Contractor (MAC) confirming that it meets all of the
requirements specified in Sec. 413.232 and qualifies as a low-volume
ESRD facility. The attestation is required because: (1) ESRD facility's
cost reporting periods vary and may not be based on the
[[Page 42165]]
calendar year; and (2) the cost reports are due 5 months after the
close of the cost reporting period (that is, there is a lag in the cost
reporting submission). Thus, the MACs may not have the cost report for
the third year to determine eligibility and would need to rely on the
attestation for that year until the cost report is available. Section
413.232(e) imposes a yearly November 1 deadline for attestation
submissions, with a few exceptions where the deadline is December 31.
The November 1 timeframe provides 60 days for a MAC to verify that an
ESRD facility meets the LVPA eligibility criteria (76 FR 70236).
As stated in the Medicare Benefit Policy Manual, (Pub. L. 100-02),
(chapter 11, section 60.B.1),\13\ once the attested ESRD facility's
cost report is submitted to the MAC, the MAC verifies the as-filed cost
report for the third eligibility year and finds that the ESRD facility
met the eligibility criteria, the ESRD facility would then receive the
LVPA payment for all the Medicare-eligible treatments in the payment
year. However, if the attested ESRD facility's cost report for the
third eligibility year exceeds the total dialysis treatment threshold,
then the MAC recoups by reprocessing claims paid during the payment
year in which the ESRD facility incorrectly received the LVPA.
Recoupment also occurs if any cost reports used for eligibility are
subsequently found to have not met the low-volume criteria, for
example, reopening or appeals.
---------------------------------------------------------------------------
\13\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c11.pdf.
---------------------------------------------------------------------------
Further information regarding the administration of the LVPA is
provided in the Medicare Benefit Policy Manual, chapter 11, section
60.B.1.\14\
---------------------------------------------------------------------------
\14\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c11.pdf.
---------------------------------------------------------------------------
b. Revisions to the LVPA Requirements and Regulations
As we discussed in the CY 2019 ESRD PPS final rule (83 FR 56949),
we have heard from stakeholders that low-volume facilities rely on the
low-volume adjustment and loss of the adjustment could result in
beneficiary access issues. Specifically, stakeholders expressed concern
that the eligibility criteria in the LVPA regulations are very explicit
and leave little room for flexibility in certain circumstances.
As discussed in section II.B.2 of this proposed rule, according to
the Centers for Disease Control and Prevention (CDC), the risk factors
for COVID-19 include older adults and people of any age who have
serious underlying medical conditions, such as diabetes and chronic
kidney disease undergoing dialysis. Medicare's ESRD population aligns
with the profile of patients who are more susceptible to COVID-19. As a
result, ESRD facilities are working together to keep the risk of
spreading COVID-19 down as much as possible by shifting patients among
the ESRD facilities in the same area. In some cases, this shifting of
patients has caused some low-volume ESRD facilities to temporarily
dialyze patients that they otherwise would not have dialyzed if there
had not been a PHE. In addition, since cases of acute kidney injury
(AKI) have increased in certain areas of the country due to COVID-19,
there is also an increase in the number of patients discharged that
need outpatient dialysis for some period of time while their kidneys
regain normal function. We are concerned that these increases in
dialysis treatments due to the COVID-19 PHE in CY 2020 may put certain
low-volume facilities over the LVPA's treatment threshold causing the
loss of, or the inability to qualify for, the 23.9 percent per
treatment payment adjustment for payment years 2021, 2022, and 2023. We
note that in CY 2020, 338 ESRD facilities receive the LVPA. We also
note that in a typical year, we estimate that between 50-60 facilities
lose their LVPA status. That is, there are between 50-60 ESRD
facilities that typically lose their LVPA status because their patient
population grew for reasons other than the COVID-19 PHE.
In light of the unique circumstance due to the COVID-19 PHE, we are
proposing to hold ESRD facilities harmless if an increase in their
treatment counts in 2020 is COVID-19-related such that the increase
would prevent them from qualifying for the LVPA. We propose that the
ESRD facility would attest that the increase in treatments, meaning
total HD equivalent treatments (for ESRD and AKI), was temporary and
related to the redistribution of patients in response to the COVID-19
PHE. When this occurs, instead of using total dialysis treatments
furnished in cost reporting periods ending in 2020, CMS would rely on
the facility's attestation that the increase in total dialysis
treatments was due to the PHE for the COVID-19 pandemic. We propose for
purposes of determining LVPA eligibility for payment years 2021, 2022,
and 2023, we would only consider total dialysis treatments furnished
for 6 months of a facility's cost-reporting period ending in 2020, and
that an ESRD facility would decide which 6 months to use (consecutive
or non-consecutive) for purposes of reporting total treatments. That
is, ESRD facilities would attest that, while it furnished 4,000 or more
treatments in its cost-reporting period ending in 2020, the number of
treatments exceeding the allowed threshold to otherwise qualify for the
LVPA was due to temporary patient shifting as a result of the COVID-19
PHE, and that their total dialysis treatments for any 6 months of that
period is less than 2,000. MACs would annualize the total dialysis
treatments for those 6 months by multiplying by 2. ESRD facilities
would be expected to provide supporting documentation to the MACs upon
request.
This proposal is responsive to requests we have received from
stakeholders, and would prevent the loss of, or the inability to
qualify for, the LVPA for facilities who accommodated additional
patients in 2020 because of the COVID-19 PHE. We believe this proposal
targets just those facilities that would not qualify for the LVPA for
the reason that they accommodated additional patients in response to
the COVID-19 PHE to, for example, prevent the spread of the infection.
We propose to revise Sec. 413.232(g) by adding paragraph (g)(4) to
reflect that, for purposes of determining LVPA eligibility for payment
years 2021, 2022, and 2023, an ESRD facility's attestation must
indicate that the ESRD facility meets all the LVPA criteria except
that, for a facility that does not otherwise meet the number-of-
treatments criterion (that is, less than 4,000 in a year) because of
the COVID-19 PHE, the facility furnished less than 2,000 treatments in
any 6 months during its cost-reporting period ending in 2020 due to
temporary patient shifting as a result of the COVID-19 PHE. We also
propose that the MAC would rely on the facility's attestation and would
annualize the total dialysis treatments for the 6 months by multiplying
those collective 6 month treatments by 2.
In addition, since CMS changed cost reporting deadlines due to the
COVID-19 PHE, we believe the extraordinary circumstances of the COVID-
19 pandemic justify an exception to the November 1, 2020 attestation
deadline. Therefore, for payment year 2021, we propose to allow more
time for ESRD facilities to submit attestations by extending the
deadline to December 31, 2020. We would reflect this change in Sec.
413.232(e) by reformatting the section to reflect already established
exceptions to the November 1 attestation deadline in paragraphs (e)(1)
through (3), and to include in new paragraph (e)(4) that, for
[[Page 42166]]
payment year 2021, the attestation must be provided by December 31,
2020.
We are proposing a technical change at Sec. 413.232(b) to remove
the heading ``Definition of low-volume facility'' to be consistent with
the current CFR requirements.\15\
---------------------------------------------------------------------------
\15\ Document Drafting Handbook, chapter 2, section 2.10, page
2-18: https://www.archives.gov/files/federal-register/write/handbook/ddh.pdf.
---------------------------------------------------------------------------
We are also proposing a technical change at Sec. 413.232(e) and
(g). We propose to add ``MAC'' in Sec. 413.232(e) to establish the
acronym for Medicare Administrative Contractor. We propose to replace
``Medicare Administrative Contractor (MAC)'' with ``MAC'' in Sec.
413.232(g) since the acronym would now be established in Sec.
413.232(e).
c. Clarification for MAC LVPA Determinations
As we discuss in section II.B.5.(a) of this proposed rule, in order
to receive the LVPA, an ESRD facility must meet the requirements of
Sec. 413.232, including submitting attestations to the MACs indicating
its eligibility for the adjustment. In its attestation for the third
eligibility year, which is the cost-reporting year immediately
preceding the payment year, a facility attests that it will be eligible
for the adjustment; this attestation typically occurs prior to the MAC
having the facility's cost report for the third eligibility year, in
which case the MAC relies on the facility's attestation to determine if
the facility qualifies for the LVPA. When an ESRD facility qualifies
for the adjustment, the LVPA would be applied to all the Medicare-
eligible treatments for the entire payment year. If the MAC
subsequently determines, however, that the ESRD facility failed to
qualify for the LVPA, and the facility had already begun to receive the
adjustment to which the MAC has determined it is not entitled, the MAC
would reprocess the claims to remove and recoup the low-volume
payments.
We understand that in some instances, MACs may be discontinuing
LVPA payments to a facility in the payment year for which the facility
is eligible for the adjustment. However, the established policy is such
that, if an ESRD facility meets the LVPA eligibility criteria in Sec.
413.232, it is entitled to the payment adjustment for the entire
payment year. Because there may be some inconsistent application of
this policy, we are taking this opportunity to make this aspect of the
LVPA policy clear in the regulation text.
We propose to revise Sec. 413.232 by adding paragraph (h) to
specify that, if an ESRD facility provides an attestation in accordance
with Sec. 413.232(e) for the third eligibility year, the MAC verifies
the as-filed cost report. If the MAC determines an ESRD facility meets
the definition of a low-volume facility, CMS adjusts the low-volume
facility's base rate for the entire payment year. However, if the MAC
determines an ESRD facility does not meet the definition of a low-
volume facility, the MAC reprocesses claims and recoups low volume
adjustments paid during the payment year.
C. Proposed Transitional Add-On Payment Adjustment for New and
Innovative Equipment and Supplies for CY 2021 Payment
1. Background
As we discussed in section II.B.2.a in the CY 2020 ESRD PPS final
rule, we finalized the establishment of a transitional add-on payment
adjustment for new and innovative equipment and supplies (TPNIES) to
support ESRD facilities in the uptake of certain new and innovative
renal dialysis equipment and supplies under the ESRD PPS. Under our
current regulation at Sec. 413.236(b), we will provide the TPNIES to
an ESRD facility for furnishing a covered equipment or supply only if
the item: (1) Has been designated by CMS as a renal dialysis service
under Sec. 413.171, (2) is new, meaning it is granted marketing
authorization by FDA on or after January 1, 2020, (3) is commercially
available by January 1 of the particular calendar year, meaning the
year in which the payment adjustment would take effect; (4) has a
Healthcare Common Procedure Coding System (HCPCS) application submitted
in accordance with the official Level II HCPCS coding procedures by
September 1 of the particular calendar year; (5) is innovative, meaning
it meets the criteria specified in Sec. 412.87(b)(1) of this chapter
and related guidance; and (6) is not a capital-related asset that an
ESRD facility has an economic interest in through ownership (regardless
of the manner in which it was acquired). Specifically, the equipment or
supply must represent an advance that substantially improves, relative
to renal dialysis services previously available, the diagnosis or
treatment of Medicare beneficiaries.
Under the first criterion, as reflected in the CY 2020 ESRD PPS
final rule, renal dialysis equipment and supplies will be considered
``new'' if FDA grants them marketing authorization on or after January
1, 2020. By including FDA marketing authorizations on or after January
1, 2020, we intended to support ESRD facility use and beneficiary
access to the latest technological improvements to renal dialysis
equipment and supplies. We note in section II.B.2.b of this proposed
rule, we are proposing to refine the newness criteria (year in which
the product was approved) and establish that an equipment or supply is
considered ``new'' within 3 years beginning on the date of FDA
marketing authorization for that equipment or supply. For capital-
related assets that are dialysis machines when used in the home
setting, the 3 years would begin from the date of FDA marketing
authorization for home use.
We stated in the CY 2020 ESRD PPS proposed rule that, for new and
innovative equipment and supplies, we believed the IPPS SCI criteria
and the process used to evaluate SCI under the IPPS could be used for
identifying new and innovative equipment and supplies worthy of
additional payment under the ESRD PPS. We noted that under the IPPS,
CMS has been assessing new technologies for many years to assure that
the additional new technology add-on payments to hospitals are made
only for truly innovative and transformative products, and we stated
that CMS is proposing to adopt the IPPS SCI criteria under the ESRD PPS
for the same reason. We explained that we wanted to ensure that the
add-on payment adjustments made under the ESRD PPS are limited to new
equipment and supplies that are truly innovative. In addition, since
renal dialysis services are routinely furnished to hospital inpatients
and outpatients, we stated that we believed the same SCI criteria
should be used to assess whether a new renal dialysis equipment or
supply warrants additional payment under Medicare.
We finalized the adoption of IPPS's SCI criteria specified in Sec.
412.87(b)(1), including modifications finalized in future IPPS final
rules, to determine when a new and innovative renal dialysis equipment
or supply is eligible for the TPNIES under the ESRD PPS. That is, we
would adopt IPPS's SCI criteria in Sec. 412.87(b)(1) and any
supporting policy around these criteria as discussed in IPPS preamble
language. We stated that we believed that by incorporating the IPPS SCI
criteria for new and innovative renal dialysis equipment under the ESRD
PPS, we would be consistent with IPPS and innovators would have
standard criteria to meet for both settings. We also proposed to
establish a process modeled after IPPS's process of determining if a
new medical service or technology meets the SCI criteria specified in
Sec. 412.87. That is, we proposed that CMS
[[Page 42167]]
would use a similar process to determine whether the renal dialysis
equipment or supply meets the eligibility criteria proposed in newly
added Sec. 413.236(b). Similar to how we evaluate whether a new renal
dialysis drug or biological product is eligible for the TDAPA, as
discussed in the CY 2016 ESRD PPS final rule (80 FR 69019), we would
need to determine whether the renal dialysis equipment and supply meets
our eligibility criteria for the TPNIES.
Specifically, under Sec. 413.236(b)(5) we evaluate SCI for
purposes of the TPNIES under the ESRD PPS based on the IPPS SCI
criteria (see Sec. 412.87(b)(1)). We note that in section II.B.2.a of
this proposed rule we provide a detailed discussion of the SCI
criteria. In addition, in section II.B.2.b of this proposed rule we are
proposing to revise Sec. 413.236(b)(5) to remove ``and related
guidance'' to reflect that all related SCI guidance has now been
incorporated into Sec. 412.87(b)(1).
As we discuss in section II.B.2.a, in the CY 2020 ESRD PPS final
rule (84 FR 60681 through 60698), we established in Sec. 413.236(c) a
process for our announcement of TPNIES determinations and a deadline
for consideration of new renal dialysis equipment or supply
applications under the ESRD PPS. CMS will consider whether a new renal
dialysis equipment or supply meets the eligibility criteria specified
in Sec. 413.236(b). Then, after consideration of public comments we
will announce the results in the Federal Register as part of our annual
ESRD PPS final rule. We noted we would only consider a complete
application received by February 1 prior to the particular calendar
year. FDA marketing authorization for the equipment or supply must
occur by September 1 prior to the particular calendar year. We note in
section II.B.2.b of this proposed rule we are proposing to revise Sec.
413.236(c) to replace ``September 1'' with ``the HCPCS Level II code
application deadline for Coding Cycle 2 for DMEPOS items and services
as specified in the HCPCS Level II coding guidance on the CMS website''
to reflect that FDA marketing authorization for the new and innovative
equipment or supply must accompany the HCPCS application prior to the
particular calendar year in order for the item to qualify for the
TPNIES in the next calendar year.
2. CY 2021 Applications for the TPNIES
We received two applications for the TPNIES for CY 2021. A
discussion of these applications is presented below.
a. Theranova 400 Dialyzer and Theranova 500 Dialyzer
(1) Baxter Healthcare Corporation (Baxter) Application
Baxter submitted an application for the Theranova 400 Dialyzer/
Theranova 500 Dialyzer. The 400 and 500 denote differences in surface
area. The applicant stated that Theranova represents an SCI over
currently available hemodialysis (HD) therapies for the treatment of
renal failure. The applicant stated that Theranova is a new class of
hollow-fiber, single-use dialyzer intended to treat renal failure by
HD. The applicant stated that it features an innovative 3-layer
membrane structure that offers a higher permeability than high-flux
dialyzers, with improved removal of large proteins up to 45 kilodaltons
(kDa) while selectively maintaining essential proteins such as
albumin.16 17 18 The applicant stated that Theranova has the
potential to transform in-center HD by allowing Medicare beneficiaries
with renal failure to benefit from expanded hemodialysis (HDx). HDx is
defined as a process of blood purification that includes the clearance
of small uremic toxins through large middle molecule (LMM) (categorized
as uremic solute whose molecular size is 25kDa up to 60 kDa) toxins
without the need for an external infusion of replacement fluid. For
purposes of the application, HDx is collectively referred to in the
application as ``Theranova''. The applicant asserted that the Theranova
dialyzer integrates with existing HD machines that an ESRD facility
already owns and replaces other dialyzers.
---------------------------------------------------------------------------
\16\ Boschetti-de-Fierro, A., et al., ``MCO Membranes: Enhanced
Selectivity in High-Flux Cases,'' www.nature.com/Scientific Reports,
[5:18448]DOI: 10.1038/srep18448.
\17\ Krause, B., et al., ``Highly selective membranes for Blood
purification,'' Gambro Dialysatoren GmbH, Hechingen/Germany,
Presentation abstract March 26, 2015.
\18\ Zweigart, C., et al., ``Medium cut-off membranes--closer to
the natural kidney removal function,'' Int. J Artif Organs, 2017,
40(7), pp. 328-334. DOI: 10.5301/uijao.5000603.
---------------------------------------------------------------------------
The applicant described the Theranova membrane as unique and stated
it allows for the removal of an expanded range of solutes, creating a
filtration profile closer to a natural kidney. The applicant described
the membrane structure as being divided into three distinct layers: A
fingerlike porous outer layer, a sponge-like intermediate layer, and a
very thin inner layer (skin). By reducing the inner diameter of the
membrane, internal filtration is increased, allowing for enhanced
clearance of LMMs through additional convective transport.\19\ The
Theranova dialyzer enables the efficient removal of uremic toxins (up
to 45 kDa).20 21 The applicant included an adapted figure
from a book titled, ``Modelling and Control of Dialysis Systems \22\ to
compare removal of toxins by Theranova to the kidney and to other
dialysis therapies, such as low flux dialyzers (LF), high flux
dialyzers (HFD) and hemodiafiltration (HDF). The applicant's adapted
figure showed the following: LF, HFD, HDF and HDx remove urea (60
Daltons (Da)), phosphate (96 Da), Parathyroid hormone (9,500 Da); HFD,
HDF and HDx remove Beta 2 microglobulin (12 kDa), cystatin C (13 kDa),
Myoglobulin (17 kDa), and, kappa free-light-chains (23 kDa); HDF and
HDx remove complement factor D (24 kDa), Interleukin (IL)-6 (25 kDa),
alpha 1 microglopbulin (33 kDa); and, HDx removes Chitinase-3-like
protein 1 (40 kDa), lambda free-light-chains (45 kDa) and albumin (67
kDa).
---------------------------------------------------------------------------
\19\ Lorenzin, A., et al., ``Quantification of Internal
Filtration in Hollow Fiber Hemodialyzers with Medium Cut-Off
Membrane,'' Blood Purif, 2018, 46, pp. 196-204.
\20\ Boschetti-de-Fierro, A., et al., ``MCO Membranes: Enhanced
Selectivity in High-Flux Cases,'' www.nature.com/Scientific Reports,
[5:18448] DOI: 10.1038/srep18448.
\21\ Boschetti-de-Fierro, A., et al., ``MCO Dialyzers: Enhanced
Selectivity High-Flux,'' Gambro Dialysatoren GmbH, Research and
Development, Hechingen, Germany, Poster No. SAT-481 (Baxter).
\22\ Azar, A.T. and Canaud, B., ``Chapter 8: Hemodialysis
System,'' Modeling and Control of Dialysis Systems, 2013, pp. 99-
106, SCI 404 Berlin, Springer-Verlag, Berlin, Heidelberg. ISBN: 978-
3642274572.
---------------------------------------------------------------------------
The applicant stated that compared with low-flux HD, high-flux HD,
and HDF, the Theranova dialyzer filtration profile is more similar to
that of a natural kidney, as shown in vitro 23 24 giving it
expanded clearance of uremic toxins.
---------------------------------------------------------------------------
\23\ Krause, B., et al., ``Highly selective membranes for Blood
purification,'' Gambro Dialysatoren GmbH, Hechingen/Germany,
Presentation abstract March 26, 2015.
\24\ Boschetti-de-Fierro, A., et al., ``MCO Membranes: Enhanced
Selectivity in High-Flux Cases,'' www.nature.com/Scientific Reports,
[5:18448] DOI: 10.1038/srep18448.
---------------------------------------------------------------------------
The applicant asserted that the design of the Theranova dialyzer
allows for use on any HD machine, made by any manufacturer, by merely
changing the dialyzer. The applicant stated that the membrane is
compatible with standard fluid quality and does not require any
additional fluid quality control measure.
Theranova received approval for Investigational Device Exemption
(IDE) protocol from the FDA, on August 31, 2017 and then received
approval for coverage on September 13, 2017. The Class II
investigational device exemption received the code
[[Page 42168]]
G170157.\25\ The FDA requested a 6-month clinical study to validate
efficacy of large toxin removal and safety. According to the applicant,
safety is defined in part by albumin loss. The applicant stated that it
is seeking authorization through the FDA's De Novo pathway and
marketing authorization this year for the May 2020 cycle. The applicant
stated that it plans to submit a HCPCS application to CMS in June 2020.
---------------------------------------------------------------------------
\25\ Available on p. 49828 at: https://www.federalregister.gov/documents/2017/10/27/2017-23447/medicare-and-medicaid-programs-quarterly-listing-of-program-issuances-july-through-september-2017.
---------------------------------------------------------------------------
The applicant noted that it has not submitted an application for
pass-through payments under the Medicare Outpatient Prospective Payment
System (OPPS) or the NTAP program under the Medicare IPPS for the
Theranova 400 Dialyzer/Theranova 500 Dialyzer.
The applicant stated that it expects Theranova to be commercially
available immediately after receiving marketing authorization and will
provide proof of commercial availability.
With regard to demonstrating the requirements for SCI, the
applicant asserted that Theranova represents an SCI in outcomes for
Medicare beneficiaries over currently available HD therapies treating
renal failure. The applicant noted that ESRD patients on current HD
therapies suffer unsatisfactorily high mortality and morbidity from
cardiovascular disease and infections.\26\
---------------------------------------------------------------------------
\26\ United States Renal Data System. 2018 USRDS annual data
report: Epidemiology of kidney disease in the United States.
National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases, Bethesda, MD, 2018.
---------------------------------------------------------------------------
In addition, the applicant stated that the HDx enabled by Theranova
effectively targets the removal of LMM uremic toxins (25 kDa to 60
kDa), which are linked to the development of inflammation,
cardiovascular disease, and other comorbidities in dialysis patients.
The applicant stated that this results in improved clinical outcomes,
relative to current dialyzers in four clinical categories. First, a
decreased rate of subsequent therapeutic interventions, including fewer
infections, reduced hospitalization duration, and reduced medication
usage. Specifically, the applicant stated that patients treated with
HDx therapy have decreased infections. A prospective cross-over study
found an average of seven episodes of infection for patients treated
with HDx versus 18 for high flux HD (p=0.003).\27\ The applicant also
stated that patients receiving HDx therapy with Theranova had hospital
stays averaging 4.4 days versus 5.9 days for patients receiving
traditional HD (p=0.0001) along with lower hospitalization rates (71
percent versus 77 percent (p=0.69)).\28\ The U.S. IDE Randomized
Controlled Trial (NCT032574 l 0) of 172 patients, although not powered
for all-cause hospitalization events, showed a 49 percent decreased
number of hospitalization events in the Theranova arm (18 events) as
compared to the control arm (37 events).\29\ With regard to improved
medication usage, the applicant stated that patients receiving HDx
therapy had reduced medication usage. The applicant cited three studies
that showed a significant decrease in erythropoietin stimulating agents
(ESA) usage.30 31 32 One study also found a substantial
reduction in the need for iron usage.33 34 Two studies saw
an improvement in EPO resistance index (ERI) and one study showed a
statistically significant decrease in phosphate binder (calcium
carbonate) usage.35 36
---------------------------------------------------------------------------
\27\ Cozzolino, C., et al., ``Effects of a medium cut-off
(Theranova) dialyzer on haemodialaysis patients: a prospective,
cross-over study,'' Clinical Kidney Journal, 2019, pp. 1-8. Doi
10.1093/ckj/sfz 155.
\28\ Sanabria, R.M., et al., ``Expanded Hemodialysis and its
effects on hospitalizations and medication usage,'' Submitted for
publication.
\29\ Weiner, D.E., et al., 2019, ``Efficacy and Safety of
Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized
Control Trial,'' Abstract at ASN meeting, FR-PO 488.
\30\ Gallo, M., ``The Real-Life Study on Expanded Hemodialysis
(HDx): 9 Months Experience of a Single Hemodialysis Unit,''
Nephrology Dialysis Transplantation, 34, Issue Supplement_1, June
2019, gfz106.FP539, https://doi.org/10.1093/ndt/gfz106.FP539.
\31\ Sanabria, R.M., et al., Ibid.
\32\ Lim, J-H., et al., ``Novel Medium Cut-Off Dialyzer Improves
Erythropoietin Stimulating Agent Resistance in Maintenance
Hemodialysis Patients: A Randomized Controlled Trial,'' Manuscript
submitted for publication.
\33\ Sanabria, R.M., et al., Ibid.
\34\ Lim, J-H., et al., Ibid.
\35\ Sanabria, R.M., et al., Ibid.
\36\ Lim, J-H., et al., Ibid.
---------------------------------------------------------------------------
The second clinical improvement category listed by the applicant is
a more rapid beneficial resolution of the disease process treatment.
The applicant cited a 2019 publication which noted that the average
recovery time after dialysis is reduced with HDx therapy, with the
median self-reported recovery time at 120 minutes, 60 min., 60 min.,
and 105 min. at 3,6,9, and 12 months compared to a baseline 240 min.
(p<0.01 for 6, 9, and 12-month ratings; N=110).\37\
---------------------------------------------------------------------------
\37\ Bolton, S., et al., ``Dialysis symptom burden and recovery
time in expanded hemodialysis,'' Manuscript submitted.
---------------------------------------------------------------------------
The third category of improved clinical outcomes listed by the
applicant is reduced inflammation in patients receiving HDx Therapy
with Theranova. The applicant referenced a 2018 review article, which
notes that chronic inflammation in ESRD patients is associated with the
build-up of known uremic toxins spanning the molecular size spectrum
from 12kDa to 45kDa such as beta- 2-microglobulin, soluble tumor
necrosis factor (TNF), Receptor 2, IL-1, Prolactin, IL-18, IL-6,
Hyaluronic Acid, TNF-a, Soluble TNF Receptor 1, Pentraxin-3, and
Advanced Glycation End-Products. The same article notes the following:
(1) LMM (25 kDa to 60 kDa) have been associated with inflammation,
cardiovascular events and other dialysis-related comorbidities; (2)
current dialytic therapies, though efficient in removing small solutes,
have limited capability in removing LMM; (3) current dialyzer design,
limited by membrane permeability, does not provide long-lasting,
effective reduction of the full spectrum of small molecular uremic
toxins (<500 Da), conventional middle molecular uremic toxins (500 Da
to <25 kDa) and large middle molecular uremic toxins (25 kDa to 60kDa),
even when their usage is enhanced with convective transport; and (4) a
broad spectrum of uremic toxins are not effectively treated by
conventional HD nor HDF which is not readily utilized in the U.S.\38\
The applicant asserted that for the first time, HDx enabled by
Theranova results in the superior removal of the aggregate of small,
conventional middle and large middle molecular uremic toxins.\39\ The
applicant asserted that Theranova, in effectively targeting the
spectrum of uremic toxins, that this spectrum encompasses the totality
of these inflammation-modulating molecules.
---------------------------------------------------------------------------
\38\ Wolley, M., et al., ``Exploring the Clinical Relevance of
Providing Increased Removal of Large Middle Molecules,'' Cli, J Am
Soc Nephrol, 2018, 13, pp.805-813.
\39\ Kirsch AH, Lyko R, Nilsson LG., et al., Performance of
hemodialysis with novel medium cut-off dialyzers. Nephrol Dial
Transplant, 2017; 32: 165-172.
---------------------------------------------------------------------------
[[Page 42169]]
The applicant also asserted that when analyzing the full set of
studies utilizing Theranova dialyzers, the collective evidence shows
consistent improvement in these inflammatory marker levels. Of 14
measurements of inflammation across four studies,40 41 42 43
71 percent (10 of 14) showed statistically significant improvement in
the inflammatory marker. For the remaining 29 percent of the measured
inflammatory markers, all showed improvement in the inflammatory
profile but were not statistically significant. In most of the
situations where statistically significant results were not achieved,
the applicant asserted, the studies were underpowered to demonstrate
statistically significant change of the particular marker.
---------------------------------------------------------------------------
\40\ Belmouaz, M., et al., ``Comparison of the Removal of Uremic
Toxins with Medium Cut-Off and High Flux Dialyzers: A Randomized
Clinical Trial,'' Nephrol Dial Transplant, 2020, 35, pp. 328-335.
\41\ Kharbanda, K., et al., ``A Randomised Study Investigating
the Effect of Medium Cut-Off Haemodialysis on Markers of Vascular
Health Compared with On-Line Haemodiafiltration (MoDal Study)''.
Poster presented at the American Society of Nephrology, 2019.
\42\ Cozzolino, M, ``Effects of Mediun Cut-Off (Theranova)
Dialyzer on Hemodialysis Patients: A Prospective Cross-Over Study
[Abstract].'' J Am Soc Nephrol, 29. 2018, pp. 616-617.
\43\ Cantaluppi, V., et al., ``Removal of Large Middle Molecules
on Expanded Hemodialysis (HDx): A Multicentric Observantional Study
of 6 Months Follow-Up,'' J Am Soc Nephrol, 29, 2018, Poster TH-PO
357.
---------------------------------------------------------------------------
The applicant stated that studies have demonstrated stable albumin
levels,44 45 and a reduction of endothelial dysfunction and
Albumin and C-Reactive Protein (CRP) levels.46 47 48 In
addition, the applicant specifically described a single cohort study
(N=41) showing a significant decrease in serum levels for urea,
[beta]2m, kappa and lambda free light chain at 3 months. At 3 and 6
months, there was a substantial decrease in serum CRP levels. Also,
blood assay demonstrated a decline in the production of IL-6.\49\ In a
40-participant cross-over prospective study, HDx with Theranova versus
high flux HD demonstrated both a higher reduction ratio and a decrease
in serum levels for lambda free light chains.50 51 52
---------------------------------------------------------------------------
\44\ Krishnasamy, R., et al., ``Trial evaluating mid cut-off
value membrane clearance of albumin and light chains in hemodialysis
patients (REMOVAL-HD): a safety and efficacy study,'' 2018, ASN 2018
Kidney Week Abstract TH-P0353.
\45\ Bunch, A., et al., ``Long-Term Effects of Expanded
Hemodialysis (HDx) on Clinical and Laboratory Parameters in a Large
Cohort of Dialysis Patients,'' 2018, ASN 2018 Kidney Week Abstract
FR-P0766.
\46\ Kharbanda, k., et al. 2019, Ibid.
\47\ Cantaluppi, V., et al., Ibid.
\48\ Cantaluppi, V., et al., ``Removal of Large- Middle
Molecules, Inhibition of Neutrophil Activation and Modulation of
Inflammation-Related Endothelial Dysfunction During Expanded
Hemodialysis (HDx),'' June 2019, Nephrol Dial Transplantation, 34,
Issue Supplement_1. gfz096.FO048, https://doi.org/10.1093/ndt/gfz096.FO048.
\49\ Cantaluppi, V., et al., Ibid.
\50\ Belmouaz, M., et al., ``Comparison of the Removal of Uremic
Toxins with Medium Cut-Off and High Flux Dialyzers: A Randomized
Clinical Trial,'' J Am Soc Nephrol, 2018, 29, Poster TH-PO348.
\51\ Belmouaz M, et al., ``Comparison of hemodialysis with
medium cut-off dialyzer and on-line hemodiafiltration on the removal
of small and middle-sized molecules,'' Clin Nephrol. Jan 2018, 89
(2018)(1):50-56.
\52\ Belmouaz, M., et al., ``Comparison of the Removal of Uremic
Toxins with Medium Cut-Off and High-Flux Dialyzers: A Randomized
Clinical Trial,'' Nephrol Dial Transplant, 2020, 35, pp. 328-335.
---------------------------------------------------------------------------
The applicant also noted that, in addition to IL-6, a well-
recognized biological marker of inflammation, there is also a broader
spectrum of uremic toxins associated with inflammation. The applicant
listed references for elevated levels of IL-6 leading to the following:
Hepcidin production with decreased iron availability; \53\ increased
endothelial damage; 54 55 increased CRP and decreased
albumin production.\56\ The applicant attested that with the use of
Theranova, patients present clinically with the opposite of each of the
above listed concerns, suggesting that chronic inflammation mediated by
IL-6 is reduced by treatment with Theranova. However, the applicant
submitted a reference which concluded that when compared to HD using
high flux membrane, HD using a medium cut-off (MCO) membrane may be not
inferior in albumin loss.\57\
---------------------------------------------------------------------------
\53\ Caramelo, C., et al., ``Anemia: Pathophysiology,
pathogenesis, treatment, incognitate,'' Rev Esp Cardiol., 2007, 60,
pp. 848-60.
\54\ Kharbanda, K., et al., ``A randomized study investigating
the effect of medium cut off haemodialysis on markers of vascular
health compared with on-line hemodiafiltration (MoDal Study),''
2019, Presented at the Scientific Congress American Society of
Nephrology, 2019.
\55\ Cozzolino, C., et al., ``Effects of a medium cut-off
(Theranova) dialyzer on haemodialaysis patients: a prospective,
cross-over study,'' Clinical Kidney Journal, 2019, pp. 1-8. Doi
10.1093/ckj/sfz 155.
\56\ Gillerot, G., et al. ``Genetic and Clinical Factors
Influence the Baseline Permeability of the Peritoneal Membrane,''
Kidney Int. 2005, 67, pp. 2477-2487.
\57\ Jung, J.H., et al., ``A 6-Month Study on the Efficacy of
Hemodialysis Therapy Using Dialyzers with Mediun Cut-Off Membranes
in Asian Patients with End-Stage Renal Disease,'' Nephrol Dial
Transplant, June 2019. 84, Issue Supplement, gfz103.SP487, https://doi.org/10.1093/ndt/gfz103.SP487.
---------------------------------------------------------------------------
An additional prospective cross-over study (N=20) showed reduced
levels of IL-6 (6.4561.57 pg/m vs. 9.4862.15 pg/ml) in patients treated
with HDx.\58\ The applicant included findings from their U.S. IDE Study
in the TPNIES application. Although the IL-6 level was not a primary
endpoint of the U.S. IDE Study (NCT03257410), nor was the study
sufficiently powered to statistically prove a change in IL-6 level, the
analysis of the U.S. IDE Study (NCT03257410), comparing Theranova to HD
with Elisio 17H, indicates a trend for difference in the pre- to post-
dialysis change in plasma IL-6 level, favoring Theranova (p=0.07 and
p=0.08 at 4 weeks and 24 weeks, respectively). The pre-dialysis level
of IL-6 shows a positive trend for Theranova (p=0.2).\59\ The applicant
stated that the accumulation of IL-6 and lambda free light chains may
contribute to the chronic inflammation state of ESRD patients,
increasing the risk of chronic vascular disease and bacterial
infections, respectively. The applicant noted that the company is
exploring options to assess the impact of the reduction of these
solutes via HDx in ongoing studies.
---------------------------------------------------------------------------
\58\ Cozzolino, C., et al., 2019, Ibid.
\59\ Weiner, D.E., et al., 2019 ``Efficacy and Safety of
Expanded Hemodialysis with the Theranova 400 Dialyzer: A Randomized
Control Trial,'' Abstract at ASN meeting, FR-PO 488.
---------------------------------------------------------------------------
Finally, the last category of improved clinical outcomes listed by
the applicant is enhanced quality of life across many different
measures, including, but not limited to, decreased recovery time,
decreased restless leg syndrome, and reduced pruritus. The applicant
stated that there was decreased symptom burden, citing a study of
patients who switched to HDx with Theranova in a multicenter 6-month
observational study (N=992), who had statistically significant
improvements in measures of symptoms of kidney disease, effects of
kidney disease, and the burden of kidney disease.\60\ The applicant
also stated that there was improved reported mental health component
and statistically significant reduced Restless Leg Syndrome
diagnosis.61 62 63 64
[[Page 42170]]
Regarding improved physical functioning and decreased pruritis, the
applicant submitted an article reporting the results of a randomized
control trial (N=50), where Theranova resulted in improved results for
physical functioning and physical role, and the mean scores of mean
pruritus distribution and frequency of scratching during sleep were
significantly lower with Theranova.\65\ In another study (single
cohort, N=14), Theranova was associated with statistically significant
improvement in the physical and mental component quality of life
measures.\66\ The applicant also submitted a case report of a HD
patient with pruritis who responded to the initiation of HDx using a
MCO dialysis membrane.\67\
---------------------------------------------------------------------------
\60\ Alarcon, J.C., et al., ``Real World Evidence on the Impact
of Expanded Hemodialysis (HDx) Therapy on Patient Reported Outcomes
(PROs): COREXH Registry,'' Manuscript submitted for Publication.
\61\ Alarcon, J.C., Manuscript submitted for publication, Ibid.
\62\ Gernone, G., et al., ``Mid-term Evaluation of the New
Medium Cut-Off Filter (Theranova) on Removal Efficiency and Quality
of Life,'' Nephrology Dialysis Transplantation, 2018, ERA EDTA
Scientific Congress Abstract, SP 489, doi.10.1093/ndt/gfy104.
\63\ Florens, N and Juillard, L., ``Expanded haemodialysis: news
from the field,'' Nephrol Dial Transplant, 2018, 33, pp. iii48-
iii52.
\64\ Bunch, A., et al. ``Long-Term Effects of Expanded
Hemodialysis (HDx) on Clinical and Laboratory Parameters in a Large
Cohort of Dialysis Patients'' ASN 2018 Kidney Week Abstract FR-
P0766.
\65\ Lim, J-H., et al. ``Novel medium cut off dialyzer improves
erythropoietin stimulating agent resistance in maintenance
hemodialysis: a randomized controlled trial,'' Submitted for
publication.
\66\ Gernone, G., et al., ``Mid-term Evaluation of the New
Medium Cut-Off Filter (Theranova) on Removal Efficiency and Quality
of Life,'' Nephrology Dialysis Transplantation, 2018, ERA EDTA
Scientific Congress Abstract, SP 489, doi.10.1093/ndt/gfy104.
\67\ Penny, J., et al. ``Pruritus: Is there a salty truth?''
Submitted for publication.
---------------------------------------------------------------------------
(2) CMS TPNIES Work Group Analysis
(a) Summary of Current Equipment or Supply by the CMS TPNIES Work Group
The following discussion was part of the content of the CMS TPNIES
Work Group evaluative meetings.
Patients with ESRD requiring dialysis are at high risk of mortality
due to the presence of uremic toxins.\68\ However, identifying the
putative uremic toxin (or toxins) has proven challenging; the European
Uremic Toxin Work Group previously identified at least 90 compounds
that are retained in patients undergoing dialysis.\69\ Current HD
technology relies on diffusion of toxins across a semi-permeable
membrane to allow for the removal of small-sized (<500 Da) water-
soluble molecules. While HD is generally able to remove water-soluble
small toxins (<500 Da), HD has limited ability to clear protein bound
solutes, those that are sequestered, or LMM solutes (>500
Da).70 71 72 The accumulation of uremic toxins with higher
molecular weight is associated with immunodeficiency, inflammation,
protein-wasting, and cardiovascular complications. For instance,
solutes such as Beta-2 microglobulin (11.8 kDa) 73 74 are
associated with increased mortality.\75\ Protein-bound solutes such as
indoxyl sulfate and p-cresol sulfate also appear to be poorly
dialyzable and are associated with the uremic syndrome and
cardiovascular disease.\76\
---------------------------------------------------------------------------
\68\ Boschetti-de-Fierro, A., et al., ``MCO Membranes: Enhanced
Selectivity in High-Flux Cases,'' www.nature.com/Scientific Reports,
[5:18448] DOI: 10.1038/srep18448.
\69\ Vanholder R, et al., European Uremic Toxin Work Group
(EUTox). Review on uremic toxins: Classification, concentration, and
interindividual variability. Kidney Int, 2003 May;63 (5):1934-43.
\70\ Mac[iacute]as N., et al., ``Middle molecule elimination in
expanded haemodialysis: only convective transport'' Clin Kidney J.,
Dec. 2018, 15;12 (3), pp. 447-455.
\71\ Garc[iacute]a-Prieto, A., et al., ``Evaluation of the
efficacy of a medium cut-off dialyser and comparison with other
high-flux dialysers in conventional haemodialysis and online
haemodiafiltration.'' Clin Kidney J., Oct. 2018, 11(5):742-746.
\72\ Dobre, M., et al., ``Searching for Uremic Toxins'' Clinical
Journal of American Society of Nephrology. February 2013, 8 (2) 322-
327.
\73\ Belmouaz, M., et al. ``Comparison of the Removal of Uremic
Toxins with Medium Cut-Off and High-Flux Dialyzers: A Randomized
Clinical Trial,'' J Am Soc Nephrol, 29, 2018, Poster TH-PO348.
\74\ Belmouaz, M., et al., ``Comparison of hemodialysis with
medium cut-off dialyzer and on-line hemodiafiltration on the removal
of small and middle-sized molecules,'' Clin Nephrol. Jan 2018, 89
(2018)(1):50-56.
\75\ Cordeiro, I., et al.'' High-Flux versus High-Retention-
Onset Membranes: In vivo Small and Middle Molecules Kinetics in
Convective Dialysis Modalities,'' Blood Purification, Jul 2019,
30:1-8.
\76\ Vanholder, R., et al., ``Protein-bound uremic solutes: The
forgotten toxin,'' Kidney International. Feb 2001, 59 (78), S266-
S270.
---------------------------------------------------------------------------
While dialysis can eliminate the immediate risk of death from
uremia, it does not replace functioning kidneys. Patients receiving
adequate dialysis do not completely recover from the uremic syndrome,
indicating that other uremic toxins may not fully be
cleared.77 78 Compared to the general population, patients
with ESRD who receive dialysis are at an increased risk of death,
commonly suffer from uremic symptoms such as itching, restless legs,
and malnutrition, and are at increased infection risk. Conventional
dialysis is effective in removing small molecules, but is less
effective in removing larger molecules, sequestered molecules, and
protein-bound toxins. Accumulation of middle molecule and protein-bound
toxins may contribute to adverse outcomes among patients receiving
dialysis \79\ and may explain why even a small amount of ``residual''
kidney function is strongly associated with increased survival
80 81 and higher quality of life.82 83
---------------------------------------------------------------------------
\77\ Tanaka H, Sirich TL, Plummer NS, Weaver DS, Meyer TW. An
Enlarged Profile of Uremic Solutes. PLoS One. 2015; 10(8): e0135657.
\78\ Sirich, T.L, et al., ``The Frequent Hemodialysis Network
Trial Group. Limited reduction in uremic solute concentrations with
increased dialysis frequency and time in the Frequent Hemodialysis
Network Daily Trial.Kidney Int, May 2017, 91 (5): 1186-
1192.doi:10,1016/j.kint.2016.11.002.Epub 2017 Jan 12.
\79\ Clark,W.R.' et al. ``Uremic Toxins and their Relation to
Dialysis Efficacy.'' Blood Purif., 2019,48(4), pp.299-314. Epub 2019
Sep 27.
\80\ Obi, Y., et al., ``Residual Kidney Function Decline and
Mortality in Incident Hemodialysis Patients,'' J Am Soc Nephrol.,
Dec. 2016, 27(12), pp. 3758-3768. Epub 2016 May 11.
\81\ Wang, A.Y. and Lai, K.N. ``The importance of residual renal
function in dialysis patients.'' Kidney Int., May, 2006, 69(10), pp.
1726-32.
\82\ Dobre, M., et al., ``Searching for Uremic Toxins'' Clinical
Journal of American Society of Nephrology. February 2013, 8 (2) 322-
327.
\83\ Bargman, J.M., et al., ``CANUSA Peritoneal Dialysis Study
Group. Relative contribution of residual renal function and
peritoneal clearance to adequacy of dialysis: a reanalysis of the
CANUSA Study,'' J Am Soc Nephrol., Oct. 2001, 12(10), pp. 2158-62.
---------------------------------------------------------------------------
Innovations in dialysis care include the development of
technologies that might remove potential toxins resistant to clearance
using current devices. One technology called HDF removes larger
molecules by combining convection with diffusion. Convection relies on
pressure gradients across the dialyzer membrane, leading to more
effective removal of middle to large molecules from the blood.
Substantial fluid losses with convection, must be replaced via infusion
of typically ultrapure water and dialysis fluids.\84\ This newer
technology was later supplemented by online HDF, which enables dialysis
providers with ultrapure water systems to generate replacement fluid
solution. Although HDF has been associated with improvements to
survival in retrospective, observational studies,\85\ randomized
controlled trials have been less consistent.86 87 88 89
Online HDF has become more widely used in Europe,
[[Page 42171]]
but it not commonly used in the U.S. due to costs associated with the
need for ultrapure water.\90\
---------------------------------------------------------------------------
\84\ Zweigart, C., et al., ``Medium cut-off membranes--closer to
the natural kidney removal function,'' Int. J Artif Organs, 2017,
40(7), pp. 328-334. DOI: 10.5301/uijao.5000603.
\85\ Garc[iacute]a-Prieto, A., et al., ``Evaluation of the
efficacy of a medium cut-off dialyser and comparison with other
high-flux dialysers in conventional haemodialysis and online
haemodiafiltration.'' Clin Kidney J., Oct. 2018, 11(5):742-746.
\86\ Grooteman, M.P., et al.; ``CONTRAST Investigators. Effect
of online hemodiafiltration on all-cause mortality and
cardiovascular outcomes,'' J Am Soc Nephrol., June 2012, 23(6),
pp.1087-1096.
\87\ Maduell, F., et al., ``ESHOL Study Group. High-efficiency
postdilution online hemodiafiltration reduces all-cause mortality in
hemodialysis patients'' J Am Soc Nephrol., Feb 2013, 24(3), pp. 487-
497. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14. Erratum in: J Am
Soc Nephrol. 2014 May; 25(5):1130.
\88\ Morena, M., et al., ``FRENCHIE Study Investigators.
Treatment tolerance and patient-reported outcomes favor online
hemodiafiltration compared to high-flux hemodialysis in the
elderly,'' Kidney Int., June 2017, 91(6):1495-1509.
\89\ Ok, E., et al., ``Online Haemodiafiltration Study.
Mortality and cardiovascular events in online haemodiafiltration
(OL-HDF) compared with high-flux dialysis: results from the Turkish
OL-HDF Study,'' Nephrol Dial Transplant, Jan 2013, 28(1), pp. 192-
202.
\90\ Zweigart, C., 2017. Ibid.
---------------------------------------------------------------------------
Newer dialysis membranes aimed at improved middle molecule
clearance are an active area of research.\91\ High flux membranes with
larger pore sizes can remove larger molecules, including inflammatory
cytokines and immunoglobulin light chains but at the cost of albumin
loss.\92\ This is significant because low albumin levels are associated
with higher mortality rates in patients with ESRD.\93\
---------------------------------------------------------------------------
\91\ Zweigart, C., 2017. Ibid.
\92\ Krause, B., et al., ``Highly selective membranes for Blood
purification,'' Gambro Dialysatoren GmbH, Hechingen/Germany,
Presentation abstract March 26, 2015.
\93\ Zweigart, C., et al., ``Medium cut-off membranes--closer to
the natural kidney removal function,'' Int. J Artif Organs, 2017,
40(7), pp. 328-334. DOI: 10.5301/uijao.5000603.
---------------------------------------------------------------------------
In addition to potential risks associated with efforts to remove
larger molecules during dialysis (such as the loss of albumin and
immunoglobulins), benefits of improved middle molecule clearance have
not been demonstrated in large, randomized-controlled trials. In 2002,
a large multicenter randomized controlled trial (HEMO) compared
patients receiving maintenance dialysis via high-flux versus low-flux
dialyzer membranes. There was no difference in the primary endpoint
(death from all causes) or in secondary endpoints (hospitalizations for
cardiac cause or death, and hospitalizations for infection or death)
between the two groups. In rhabdomyolysis, myoglobin clearance has been
demonstrated with large pore dialyzers and HDF, but clinical benefit
remains largely unproven.\94\ Similarly, HDF has historically garnered
much attention in sepsis due to its ability to efficiently clear
inflammatory cytokines like IL-6, but numerous studies have shown no
mortality benefit in sepsis with possible downsides in the form of
shortened filter life.\95\ No trials have examined the potential
benefit of removing larger quantities of middle molecules than is
typically achieved from high-flux membranes.
---------------------------------------------------------------------------
\94\ Amyot, S.L, et al., ``Myoglobin clearance and removal
during continuous venovenous hemofiltration,'' Intensive Care
Medicine, 1999 (25), PP. 1169-1172.
\95\ Friedrich J.O., et al., ``Hemofiltration compared to
hemodialysis for acute kidney injury: systematic review and meta-
analysis,'' Critical Care, Aug 6, 2012 (16): R146.
---------------------------------------------------------------------------
The clearance of protein-bound and sequestered molecules remains a
technical challenge and may explain why HDF and other technologies
aimed at improved middle-molecule clearance have not significantly
changed clinical outcomes.\96\ Theoretically, intensive long-duration
dialysis should improve the clearance of these difficult to remove
substances.\97\ In practice, large randomized trials have not shown any
difference in the level of substances like indoxyl sulfate and p-cresol
sulfate.98 99 Improving clearance of these molecules could
improve clinical outcomes in patients without residual renal function
and would be a boon to the dismal outcomes faced by patients undergoing
dialysis.
---------------------------------------------------------------------------
\96\ Vanholder, R., et al., ``Protein-bound uremic solutes: The
forgotten toxin,'' Kidney International. Feb 2001, 59 (78), S266-
S270.
\97\ Sirich, T.L, et al., ``The Frequent Hemodialysis Network
Trial Group. Limited reduction in uremic solute concentrations with
increased dialysis frequency and time in the Frequent Hemodialysis
Network Daily Trial.'' Kidney Int, May 2017, 91 (5): 1186-
1192.doi:10,1016/j.kint.2016.11.002. Epub 2017 Jan 12.
\98\ Kalim, S., et al., ``Extended Duration Nocturnal
Hemodialysis and Changes in Plasma Metabolite Profiles,'' Clin J Am
Soc Nephrol, Mar 7, 2018, 13(3), pp.436-444.
\99\ Sirich, T.L., et al., ``The Frequent Hemodialysis Network
Trial Group. Limited reduction in uremic solute concentrations with
increased dialysis frequency and time in the Frequent Hemodialysis
Network Daily Trial.'' Kidney Int, May 2017, 91 (5): 1186-
1192.doi:10,1016/j.kint.2016.11.002.Epub 2017 Jan 12.
---------------------------------------------------------------------------
(b) Assessment of Substantial Similarity to Currently Available
Equipment or Supplies
With regard to the criterion as to whether Theranova uses the same
or a similar mechanism of action to achieve a therapeutic outcome, the
CMS TPNIES Work Group believes that this product slightly modifies
existing HD technology. A MCO membrane was designed for use in HD (but
not HFD or HDF) modes. These modifications include the removal of
larger molecules and increased convection compared to existing HD. As
to whether the new use of the technology involves treatment of the same
or similar type of disease and the same or similar patient population,
the CMS TPNIES Work Group notes that Theranova treats similar patients,
specifically, patients with ESRD.
(c) Preliminary Assessment of SCI (see Sec. Sec. 413.236(b)(5) and
412.87(b)(1))
With regard to the SCI criteria, we note that Theranova is a
treatment modality and does not offer the ability to diagnose a medical
condition as discussed in Sec. 412.87(b)(1)(ii)(B). We note that
Theranova does not offer a treatment option for a patient population
unresponsive to, or ineligible for, currently available treatments. The
patients who are eligible for this treatment would also be eligible for
HD, HDF, or online HDF. The CMS TPNIES Work Group carefully analyzed
the evidence submitted as to whether Theranova significantly improves
the treatment and clinical outcomes of Medicare beneficiaries relative
to renal dialysis services previously available as demonstrated by the
totality of the circumstances. Below, we have summarized the clinical
evidence for claims of SCI, along with the references submitted by the
applicant.
There is significant literature on the topic of MCO membranes and
high retention onset dialyzers. To evaluate this specific technology,
the CMS TPNIES Work Group performed a literature search for published
articles using the Theranova dialyzer and reviewed all articles
submitted by the applicant. They are categorized according to an
estimated degree of peer review. Summaries are also provided beneath
each citation with disclosures also noted. On the studies with more
clinically significant measures, there is more annotation added.
(d) Clinical Evidence for Claims of SCI
Below is a list of references for SCI based on evidence beginning
with the highest form of evidence, peer-reviewed journals. We summarize
the studies grouped by listings with the most rigorous review to those
with the least rigorous review, specifically, those published in Peer-
Reviewed Journals, then Review Articles and Editorials, to Posters and
Abstracts, including submitted manuscripts, and ending with Incomplete
Manuscripts.
Published in Peer-Reviewed Journals
Belmouaz M, et al.\100\ is a retrospective analysis of 10
patients treated with online HDF and then switched to MCO dialysis over
1 year. The authors evaluated three dialysis sessions per patient and
noted that there were not significant differences between the two
methods in clearance of urea, creatinine, [beta]2-microglobulin, and
myoglobin. The authors received funding support by Baxter.
---------------------------------------------------------------------------
\100\ Belmouaz M, Diolez J, Bauwens M, Duthe F, Ecotiere L,
Desport E, Bridoux F. Comparison of hemodialysis with medium cut-off
dialyzer and online HDF on the removal of small and middle-sized
molecules. Clin Nephrol. 2018 Jan;89 (2018)(1):50-56.
---------------------------------------------------------------------------
Belmouaz M, et al.\101\ is a cross-over prospective study
performed in France. It included 40 patients randomly assigned to
receive either 3 months of medium cut-off hemodialysis (MCO-
[[Page 42172]]
HD) followed by 3 months of high-flux HD (HF-HD), or vice versa. The
primary endpoint was myoglobin reduction ratio (RR) after 3 months of
MCO-HD. Secondary endpoints were the effect of MCO-HD on other middle-
weight toxins and protein-bound toxins, and on parameters of nutrition,
inflammation, anemia, and oxidative stress. Compared with HF-HD, MCO-HD
provides higher myoglobin and other middle molecules RR and is
associated with moderate hypoalbuminemia. The authors noted that the
potential benefits of this strategy on long-term clinical outcomes
deserve further evaluation. This study was supported by Baxter.
---------------------------------------------------------------------------
\101\ Belmouaz M, Bauwens M, Hauet T, Bossard V, Jamet P, Joly
F, Chikhi E, Joffrion S, Gand E, Bridoux F. Comparison of the
removal of uremic toxins with medium cut-off and high-flux
dialysers: A randomized clinical trial. Nephrol Dial Transplant.
2020:35:328-335.
---------------------------------------------------------------------------
Boschetti-de-Fierro A, et al.\102\ is a report on in vitro
testing of four prototypes for MCO membranes as compared to high-flux,
high cut-off membranes, and a rat glomerular membrane model. Sieving
characteristics were evaluated before and after blood contact. Authors
note that increasing pore sizes often results in loss of albumin but
controlling the pore size diameter and variance results in enhanced
selection for middle sized proteins. A protein layer also forms along
the synthetic membrane, further restricting the loss of albumin. All
authors were employed by Gambro Dialysatoren, which is part of Baxter
International Inc.
---------------------------------------------------------------------------
\102\ Boschetti-de-Fierro A, Voigt M, Storr M, Krause B. MCO
Membranes: Enhanced Selectivity in High-Flux Class. Sci. Rep. 5,
18448; doi: 10.1038/srep18448 (2015).
---------------------------------------------------------------------------
Cordeiro ISF, et al.\103\ is a prospective crossover trial
of 16 patients undergoing HF-HD and switched to online
hemodiafiltration (olHDF) and high retention onset (HRO) HD for 4
weeks. Molarity concentrations were lowered to greater extent in olHDF
and HRO-HD.
---------------------------------------------------------------------------
\103\ Cordeiro ISF, Cordeiro L, Wagner CS, et al. High-Flux
versus High-Retention-Onset Membranes: In vivo Small and Middle
Molecules Kinetics in Convective Dialysis Modalities. Blood
Purification. 2019 Jul 30:1-8.
---------------------------------------------------------------------------
Cozzolino M, et al.\104\ is an Italian prospective, open-
label, cross-over study in 20 patients which compared the Theranova 400
HDx membrane to conventional HD, showing a non-significant trend of
lower IL-1B and IL-6 levels with HDx. Although infections were
statistically more likely in the HD population, the definition of
infection was vague, and most of them appeared to be with respiratory
tract and fever of unknown origin. Because culture evidence was not
required, the risk of bias in the categorization of infection is high
(for example, upper respiratory tract infections inappropriately
treated with antibiotics). The HDx had a non-significant trend towards
fewer hospitalizations. Potential risks from HDx include an allergic
reaction to polysulphone and lower serum albumin levels. The small
sample size, single center disease, and short follow-up mean that the
results, while promising, require substantial corroborating evidence in
the form of a multi-center, blinded randomized controlled trial. The
study was supported by an unrestricted grant from Baxter.
---------------------------------------------------------------------------
\104\ Cozzolino M. Magagnoli L, Ciceri P, Conte F, Galassi A.
Effects of a medium cut-off (Theranova) dialyser on haemodialysis
patients: A prospective, cross-over study. Clinical Kidney Journal,
2019, 1-8.
---------------------------------------------------------------------------
Garc[iacute]a-Prieto A, et al.\105\ is a crossover study
of 18 HD patients who received online HDF for one week, then
conventional HD the second week, and the use of a MCO membrane for the
third week. Authors collected RR and albumin losses and noted that MCO
membranes were similar in efficacy as olHDF. Both online and MCO
methods had greater reduction of middle molecules. The study was
conducted in Spain and authors did not declare any conflicts of
interest.
---------------------------------------------------------------------------
\105\ Garc[iacute]a-Prieto A,Vega A, Linares T, Abad S,
Mac[iacute]as N, Aragoncillo I, Torres E, Hern[aacute]ndez A,
Barbieri D, Lu[ntilde]o J. Evaluation of the efficacy of a medium
cut-off dialyser and comparison with other high-flux dialysers in
conventional haemodialysis and online haemodiafiltration. Clin
Kidney J. 2018 Oct;11(5):742-746.
---------------------------------------------------------------------------
Gillerot G, et al.\106\ is a research paper submitted by
the applicant in which the investigators tested the role of IL-6 gene
expression on 156 peritoneal dialysis (PD) patients and its putative
role in inflammation. They tested a homogeneous population of 152 from
Belgium and the North of France. The investigators believe their
findings substantiate the critical role played by IL-6 in the
peritoneal membrane and support the hypothesis that underlying
mechanisms (regulation of IL-6 gene expression) could regulate systemic
and local inflammation in association with comorbidity and uremia.
However, they note that confirmation of this hypothesis will require
well-designed, adequately powered studies, in different populations and
different settings. This study was focused on PD and the Theranova
membrane is used in HD, so extrapolation of the IL-6 data to that
modality is questionable. These studies were supported by Baxter
Belgium.
---------------------------------------------------------------------------
\106\ Gillerot G, Goffin E, Michel C, Evenepoel P, Van Biesen W,
TIntillier M, Stenvinkel P, Heimburger O, Lindholm B, Nordfors L,
Robert A, Devuyst O. Genetic and Clinical Factors Influence the
Baseline Permeability of the Peritoneal Membrane. Kid Int. 2005; 76:
2477-2487.
---------------------------------------------------------------------------
Lorenzin A, et al.\107\ is a performed mathematical
modeling, and through it, the authors calculated that the HRO membranes
allowed for internal filtration and high convective volumes.
---------------------------------------------------------------------------
\107\ Lorenzin A, Neri M, Clark WR, et al. Ronco C (ed):
Expanded Hemodialysis--Innovative Clinical Approach in Dialysis.
Contrib Nephrol. Basel, Karger, 2017, vol 191, pp 127-141.
---------------------------------------------------------------------------
Lorenzin A, et al.\108\ is a paper in which the authors
used semi-empirical methods to estimate convective volumes for
Theranova 400 and Theranova 500 under standard 4-hour HD conditions.
Using their ``most complex'' mathematical model that incorporated
gradients and blood changes along the dialyzer length, authors
estimated internal filtration rates of 300ml/min and 400 ml/min for
both hemodialyzers.
---------------------------------------------------------------------------
\108\ Lorenzin A, Neri M, Clark WR, Garzotto F, Brendolan A,
Nalesso F, Marchionna N, Zanella M, Sartori M, Fiore GB, Ronco C.
Modeling of Internal Filtration in Theranova Hemodialyzers. Contrib
Nephrol. 2017;191:127-141.
---------------------------------------------------------------------------
Lorenzin A, et al.\109\ is an in vitro test of Theranova
400 and 500 at zero net ultrafiltration. Albumin macro-aggregates were
labeled with Technetium-99m (99mTc) to assess cross filtration through
the length of the filter. Using a gamma camera, local cross filtration
and internal filtration were calculated. Authors noted that the MCO
membrane allowed for clearance of medium-large molecular weight solutes
(~11 KDa) and retention of more albumin without requiring special
equipment. The authors had no disclosures.
---------------------------------------------------------------------------
\109\ Lorenzin A, Neri M, Lupi A, Todesco M, Santimaria M,
Alghisi A, Brendolan A, Ronco C. Quantification of Internal
Filtration in Hollow Fiber Hemodialyzers with Medium Cut-Off
Membrane. Blood Purif. 2018;46(3):196-204.
---------------------------------------------------------------------------
Mac[iacute]as N, et al.\110\ is a prospective study of 14
patients on maintenance olHDF. Patients underwent a midweek dialysis
session with the Theranova-500 machine under their usual dialysis
conditions. Researchers measured the presence of uremic toxins at
various molecular weights pre-dialysis, and post-dialysis. Pressures at
the inlet and outlet of dialyzer compartments were also measured to
estimate direct filtration and back filtration volumes. Researchers
used semi-empirical methods to determine that diffusive clearance was
more prominent than convective transport (which requires higher
volumes). No funding or financial contribution was supplied. Membranes,
monitors, and laboratory
[[Page 42173]]
tests were those routinely used in the dialysis unit.
---------------------------------------------------------------------------
\110\ Mac[iacute]as N, Vega A, Abad S, Aragoncillo I,
Garc[iacute]a-Prieto AM, Santos A, Torres E, Lu[ntilde]o J. Middle
molecule elimination in expanded haemodialysis: Only convective
transport? Clin Kidney J. 2018 Dec 15;12(3):447-455.
---------------------------------------------------------------------------
Reque J, et al.\111\ is a prospective study of eight
patients who either underwent olHDF or underwent HDx with Theranova 500
for 24 sessions. After a 1-week washout with HF-HD, all patients
crossed over to the alternative method. Laboratory values were obtained
before and after each session, specifically of urea, creatinine,
phosphorous, beta2-microglobulin, myoglobin, and prolactin. The urea
and beta2-microglobulin reduction ratios were the same but HDx
demonstrated higher RR of myoglobin (60 percent compared to 35 percent
in HDF). The authors had no disclosures.
---------------------------------------------------------------------------
\111\ Reque J, P[eacute]rez Alba A, Panizo N, S[aacute]nchez-
Canel JJ, Pascual MJ, Pons Prades R. Is Expanded Hemodialysis an
Option to Online Hemodiafiltration for Small- and Middle-Sized
Molecules Clearance? Blood Purif. 2019;47(1-3):126-131.
---------------------------------------------------------------------------
Review Articles/Editorials
This is the second grouping in the list of evidence for SCI from
most compelling to least compelling. We summarize the studies the
applicant provided as follows:
Caramelo C, et al.\112\ is an article that reviews the
clinical and pathophysiological characteristics of anemia in this
context. Particular emphasis has been placed on cellular and molecular
regulatory mechanisms, and their implications for treatment. The
applicant referenced the review article's language on hepcidin, because
it is considered the homeostatic regulator of iron in its intestinal
absorption, its recycling by macrophages and its mobilization from
liver stores. Its transcription is markedly induced in inflammatory
processes, especially by cytokines like IL-6.
---------------------------------------------------------------------------
\112\ Caramelo C, Just S, Gil P. Anemia in Heart Failure:
Pathophysiology, Pathogenesis, Treatment and Incognitae. Rev Esp
Cardiol. 2007; 60(8): 848-860.
---------------------------------------------------------------------------
Florens N, et al.\113\ is a review article included by the
applicant in their application. It summarizes feedback from the first
routine use of HDx therapy under real-life conditions in European
facilities. The authors reported no adverse event after 5,191 HDx
treatments, and opined that patients suffering from itching, restless
legs syndrome, persistent asthenia or malnourishment could benefit from
HDx therapy. While they discuss here the promising applications in
which HDx could be valuable (myeloma, rhabdomyolysis or cardiovascular
diseases), the message is mitigated by reminding why and how prudence
should be taken in the design of future HDx studies, particularly with
poor de-aeration of the filter in automatic mode and manual
intervention required to prime the membrane. Some patients requiring
more anti-coagulation using the Theranova membrane, and patients being
aware of the use of the Theranova device because of lack of logo
removal. The authors note that although promising, the clinical
evidence is incomplete. Both authors received a grant Investigator
Initiated research for the evaluation of HDx in clinical practice and
one performed occasional lectures for Baxter.
---------------------------------------------------------------------------
\113\ Florens N, Juillard L. ``Expanded Haemodialysis: News from
the Field,'' Nephrol Dial Transplant, 2018; 33: iii48-iii52.
---------------------------------------------------------------------------
Wolley M, et al.\114\ is a clinical review article that
recognizes that advances in dialysis technology do not always improve
patient outcomes, and it reviews the clinical relevance regarding the
removal of LMMs, particularly those involved in chronic inflammation,
atherosclerosis, structural heart disease, and secondary
immunodeficiency. The authors note that single-center safety and
efficacy studies have identified that use of these membranes in
maintenance dialysis populations is associated with limited loss of
albumin and increased clearance of large middle molecules. When the
review was published in 2018, the authors noted that larger, robustly
conducted, multicenter studies were evaluating these findings. They
concluded that after completion of these safety and efficacy studies,
the perceived clinical benefits of providing clearance of LMMs must be
assessed in rigorously conducted, randomized clinical studies. One of
the authors received research funding from Baxter and participated on
advisory boards and speaker bureaus for Baxter.
---------------------------------------------------------------------------
\114\ Wolley M, Jardin M, Hutchinson, C. ``Exploring the
Clinical Relevance of Providing Increased Removal of Large Middle
Molecules,'' Cli, J Am Soc Nephrol 2018;13: 805-813.
---------------------------------------------------------------------------
Zweigart C, et al.\115\ is an editorial review submitted
by the applicant on MCOs, which was generally favorable with regard to
high quality and good performance. All of the authors are employees of
the Gambro Dialysatoren GmbH, Hechingen (Germany) or Gambro Lundia AG.
Gambro AB (including all direct and indirect subsidiaries) is now part
of Baxter International Inc.
---------------------------------------------------------------------------
\115\ Zweigart C, Boschetti-de-Fierro A, Hulko M, Nilsson L-G,
Beck W, Storr M, Krause B. Medium Cut-Off Membranes--Closer to the
Natural Kidney Removal Function.Int j Artif Organs. 2017; 40(7);
328-334.
---------------------------------------------------------------------------
Posters and Abstracts
This is the third grouping in the list of evidence for SCI from
most compelling to least compelling. We summarize the poster sessions
and abstracts, including submitted manuscripts which the applicant
provided as follows:
Belmouaz M, et al.\116\ is a randomized open label
crossover study in which 46 patients underwent MCO-HD and HF-H). MCO-HD
had higher medium RRs of myoglobin and beta-2 microglobulin and
increased albumin loss compared to HF-HD. The authors received funding
support by Baxter.
---------------------------------------------------------------------------
\116\ Belmouaz M, Bauwens M, Bouteau I, Thierry A, Ecotiere L,
Bridoux F. Comparison of the Removal of Uremic Toxins with Medium
Cut-Off and High-Flux Dialyzers: A Randomized Clinical Trial. TH-
PO348, 2018.
---------------------------------------------------------------------------
Boschetti-de-Fierro A, et al.\117\ is a poster in which
the investigators assessed the performance of the MCO devices in
simulated HD and HDF treatments. The applicant's submission of the
material presented in this poster was incomplete regarding date and
location of the poster session. This study was funded by Baxter.
---------------------------------------------------------------------------
\117\ Boschetti-de-Fierro A, Voigt M, Huiko M, Krause B. MCO
Dialyzers: Enhanced Selectivity in High-Flux. Gambro Dialysatoren
GmbH, Research and Development, Hechingen, Germany, Poster No. SAT-
481 (Baxter).
---------------------------------------------------------------------------
Kharbanda K, et al.\118\ is a randomized study funded by
Baxter Healthcare and the National Institute for Health Research which
compared HDF with HDx and suggested an improved recovery time with HDx.
The study showed lower levels of endothelial cell microvesicles in HDx.
However, the study did not have comparable baseline recovery times (for
example, 41 percent with <2 hours with HDx versus 35 percent with HDF)
and the authors performed a per-protocol rather than an intention to
treat analysis, exacerbating bias in the study.
---------------------------------------------------------------------------
\118\ Kharbanda K, Herring A, Wilkinson F, Alexander Y, Mitra S.
A Randomised Study Investigating the Effect of Medium Cut-Off
Haemodialysis on Markers of Vascular Health Compared with On-Line
Haemodiafiltration (MoDal Study). Manchester Metropolitan
University. 2019
---------------------------------------------------------------------------
Kirsch AH, et al.\119\ is a poster that summarizes a two
pilot randomized controlled prospective open-label crossover studies,
in which 39 HD patients underwent treatment with MCO membranes, a HFD,
and HDF. Authors concluded that MCO-HD removed middle molecules (free
light chain) more effectively than high-flux and high-volume HDF.
However, the authors noted that there are several limitations of the
study. First, compared to the control dialyzers used, the experimental
membranes used were different, less tight membranes. Second, the study
[[Page 42174]]
design was confined to only one single treatment with each dialyzer for
each patient and the study did not examine the long term effects of
such membranes on serum levels of middle molecules and albumin. The
authors conclude that future studies should assess whether the
performance of MCO-HD improves clinical outcomes. The study was
conducted in Germany and funded by Baxter, and the conflicts of
interest statement in the paper lists three of the ten authors as
employees of Baxter.
---------------------------------------------------------------------------
\119\ Kirsch AH, Lyko R, Nilsson LG., et al. Performance of
hemodialysis with novel medium cut-off dialyzers. Nephrol Dial
Transplant 2017; 32: 165-172.
---------------------------------------------------------------------------
Bunch, A, et al.\120\ is a multicenter prospective study
in prevalent HD patients, older than 18 years old; enrolled from
September 1 to November 30, 2017, and converted to HDx using Theranova
400. The investigators found an initial small decrease in serum albumin
level, which stabilized and was within the normal range per their
Bogata, Columbia laboratory references. Although Table 1 and Table 2
were cited in the abstract, both were missing. Dialysis performance
adequacy (Kt/V) was achieved. No clinically significant differences in
laboratory values at 6 months with November 30 of 2017, and converted
to HDx using Theranova 400 (3 sessions per week, 4 hours per session,
same heparin dose). The lead author has been listed as the medical
director of Renal Therapy Services, owned by Baxter, in Bogota,
Columbia.
---------------------------------------------------------------------------
\120\ Bunch A., Nilsson L, Vesga J, Ardila F, Zuniga E, Alarcon
J. ``Long-Term Effects of Expanded Hemodialysis (HDx) on Clinical
and Laboratory Parameters in a Large Cohort of Dialysis Patients''
ASN 2018 Kidney Week Abstract FR-P0766.
---------------------------------------------------------------------------
Cantaluppi V, et al.\121\ is a multicentric observational
study of 6 months follow-up. American Society of Nephrology (ASN) Week,
2018, Abstract, Thu-PO357. This multicenter (Italy) study evaluated 41
HD patients comparing standard HD molecular levels versus HDx and found
a significant decrease in urea, beta-2-microglobulin, and free light
chains. The study did not evaluate clinical outcomes.
---------------------------------------------------------------------------
\121\ Cantaluppi V, Donati G, Lacquaniti A, Cosa F, Gernone G,
Marengo M, Teatii U Removal of large-middle molecules on expanded
hemodialysis (HDx): A multicentric observational study of 6 months
follow-up. ASN Week, 2018, Abstract, Thu-PO357.
---------------------------------------------------------------------------
Cantaluppi V, et al.\122\ is an abstract submitted by the
applicant reporting on a study where 41 HD patients (age 67,613,4) in standard high flux HD were shifted to HDx using
Theranova 400 (1.7 m2, Baxter). Each patient was studied at baseline HD
(T0), 3 months (T3) and 6 months (T6) after HDx, after which they were
evaluated the following pre-dialysis parameters: Urea, Creatinine,
Phosphate, Beta2-microglobulin, Myoglobin, Free Light Chains,
Hemoglobin, Albumin and CRP. For in vitro studies, T0 and T6 plasma
were used to evaluate neutrophil activation (ROS generation, apoptosis,
adhesion) and endothelial dysfunction/senescence. The investigators
concluded that HDx therapy provided high removal of different LMMs,
leading to a significant reduction of molecules involved in uremia-
associated inflammation and organ dysfunction (in particular Free Light
Chains kappa and lambda). Long-term studies with a larger sample size
are needed to evaluate the clinical impact of HDx.
---------------------------------------------------------------------------
\122\ Cantaluppi V, Marengo M, Allessandro Q, Berto M, Donati G,
Antonio L, Cosa F, Gernone G, Teatini U, Migliori M, Panichi V.
Removal of Large-Middle Molecules, Inhibition of Neutrophil
Activation and Modulation of Inflammation-Related Endothelial
Dysfunction During Expanded Hemodialysis (HDx), Nephrol Dial
Transplantation, June 2019, 34, Issue Supplement_1. gfz096.FO048,
https://doi.org/10.1093/ndt/gfz096.FO048.
---------------------------------------------------------------------------
Cozzolino, M.\123\ is an abstract of a pilot study with 20
prevalent HD patients studied for six months in two dialysis
treatments: One MCO (Theranova) dialyzer and one high-flux dialyzer.
The author claims the pilot study shows the Theranova dialyzer has a
good tolerance profile and reduces the cumulative number of infections
in HD patients. The study was funded by an unrestricted grant from
Baxter.
---------------------------------------------------------------------------
\123\ ``Effects of Medium Cut-Off (Theranova) Dialyzer on
Hemodialysis Patients: A Prospective Cross-Over Study [Abstract].''
J Am Soc Nephrol, 29. 2018, pp. 616-617.
---------------------------------------------------------------------------
Gallo M.\124\ is a single cohort study in Italy which
compared HDx to baseline HD treatments in 15 patients and showed no
difference in uremic toxins, though there was a change in ESA dose.
---------------------------------------------------------------------------
\124\ Gallo M. The Real-Life study on expanded hemodialysis
(HDx): 9 months experience of a single hemodialysis unit. Nephrol
Dial Transplantation and Transplantation, June 2019, ERA EDTA
Abstract. FP539.
---------------------------------------------------------------------------
Gernone G, et al.\125\ is a single cohort study in Italy
which investigated 14 patients using Theranova with baseline HD and
showed no statistical change in outcomes, clearance, or quality of
life.
---------------------------------------------------------------------------
\125\ Gernone G, Montemurro M, Capurso D, Colucci G., Dell'Anna
D, Deltomaso F, LaRosa R, La Volpe M, Partipilo F., Pepe V, Ripa E.
Mid-term evaluation of the new medium cut-off filter (Theranova) on
removal efficiency and quality of life. Nephrology and
Transplantation, Abstract. SP489.
---------------------------------------------------------------------------
Jung JH, et al.\126\ is a study that was questionably
designed since they chose young, well-nourished patients at the start
of the study, which made it difficult to analyze the comparison of the
two groups at various points in time. This observational study of 42
Korean patients comparing HD to HDx showed no comparative difference
between the two groups in any markers.
---------------------------------------------------------------------------
\126\ Jung JH, Song JH, Ahn S-H. A 6-month study on the efficacy
of hemodialysis therapy using dialyzers with medium cut-off
membranes in Asian patients with end-stage renal disease. Nephrol
Dial Transplantation, June 2019, 84 Issues Supplement-1,
gfz103.SP487, https://doi.org/10.1093/ndt/gfz103.SP487.
---------------------------------------------------------------------------
Krishnasamy R, and Hutchinson C.\127\ is an abstract
submitted by the applicant from this single-arm, multi-center study
with 92 Australian/New Zealand patients. The study examined the safety
and efficacy and patient-centered outcomes of MCO dialyzer use in
chronic HD patients over 6 months. The investigators concluded that
there was a small but acceptable reduction in serum albumin in regular
HD using the MCO dialyzer. However, the figures were not included in
the abstract sent by the applicant for review by the CMS TPNIES Work
Group. The investigator noted that future randomized controlled trials
should assess the impact of the MCO dialyzer on clinical and long-term
patient-centered outcomes.
---------------------------------------------------------------------------
\127\ Krishnasamy R, and Hutchinson C. Trial Evaluating Mid Cut-
Off Value Membrane Clearance of Albumin and Light Chains in
Hemodialysis Patients (REMOVAL-HD): A Safety and Efficacy Study.
Oct. 2018 ASN Scientific Congress Abstract TH-PO363.
---------------------------------------------------------------------------
Krause B, et al.\128\ is a description of membrane
manufacturing utilizing hollow fiber technology.
---------------------------------------------------------------------------
\128\ Krause B, Boschetti-de-Fierro A, Dutczak S, Zweigart C.
Highly Selective Membranes for Blood Purification. Jahrestreffen der
Fachgruppen ``Fluidverfahrenstechnik'' und ``Membrantechnik'' 26 Mar
2015.
---------------------------------------------------------------------------
Weiner DE, et al.\129\ included two items for this U.S.
based study at a large academic medical center. The first was the ASN
2019 Scientific Congress abstract and the second was a copy of the
poster session at the ASN annual meeting in 2019. This open label
randomized controlled trial in 172 patients who underwent 24 weeks of
Theranova 400 MCO dialyzer compared to a high flux dialyzer showed a
potential decrease in hospitalizations with HDx, but the authors did
not produce statistical tests of significance. While this was a
randomized control trial (RCT), covariates were not well-balanced,
including substantially more patients with diabetes in the conventional
HD arm. The study showed lower lambda free light chains in HDx compared
to high flux HD. Albumin levels were maintained in both. The presenters
concluded that larger studies of longer duration are needed to assess
if better larger molecule clearance is associated with
[[Page 42175]]
improvements in clinical outcomes, including vascular disease, quality
of life, and mortality. The authors received commercial support from
Baxter.
---------------------------------------------------------------------------
\129\ Weiner DE, Falzon L, Beck W, Xiao M, Tran H, Bernardo AA.
Efficacy and Safety of Expanded Hemodialysis Enabled by a Medium
Cut-Off Membrane: A Randomized Control Trial. FR-PO488, ASN 2019.
---------------------------------------------------------------------------
Alarcon J, et al.\130\ describes a study over 12 months in
which 992 patients from 12 renal clinics were followed after switching
from high-flux HD to HDx. The authors assessed many patient quality of
life outcomes using the short form kidney disease quality of life
(KDQoL-SF36), dialysis symptom index (DSI) and prevalence of restless
leg syndrome (RLS) and found modest reductions in DSI severity scores,
increases in KDQoL-SF36 scores in some domains (but unchanged in the
mental and physical domains), and reduced prevalence of restless leg
syndrome. Unfortunately, the authors did not provide a control group.
Also, the authors performed a large number of statistical tests without
adjustment, further increasing the risk of Type 1 error. The study was
supported by Renal Therapy Services-Columbia, owned by Baxter. Five of
the eight authors are employees of Renal Therapy Services. One author
is a full-time employee of Baxter and has a patent pending for RLS
medication.
---------------------------------------------------------------------------
\130\ Alarcon J, Bunch A, Ardila F, Zuniga E, Vesga J, Rivera A,
Sanchez R, Sanabria M. Real world evidence on the impact of expanded
hemodialysis (HDx) therapy on Patient Reported Outcomes (PROs):
CPREXH Registry (in submission).
---------------------------------------------------------------------------
Ariza J, et al.\131\ is a manuscript that was provided by
the applicant. Cost estimates were extrapolated using an observational
design, which suggested lower hospital days (but not hospitalizations)
and lower medication use in the HDx. However, the lack of randomization
makes this study difficult to evaluate. Furthermore, the authors did
not show any difference in costs between HDx and HD. The study was
funded by Baxter.
---------------------------------------------------------------------------
\131\ Ariza J., Walton SM, Sanabria M, Vega J, Suarez A, Rivera
A. An Initial Evaluation of the Potential Cost Impact and Cost
Effectiveness of Expanded Hemodialysis (in submission).
---------------------------------------------------------------------------
Penny JD, et al.\132\ is a manuscript in submission that
was included by the applicant. It is a single case-study of a HD
patient with pruritis and extreme levels of tissue sodium. Both
responded to HDx therapy. The authors acknowledge that further robust
clinical exploration is required.
---------------------------------------------------------------------------
\132\ Penny JD, Salerno F, Akbari A, McIntyre, C. ``Pruritis-Is
There a Salty Truth?'' (in submission). The applicant included a
manuscript in submission.
---------------------------------------------------------------------------
Sanabria RM, et al.\133\ is manuscript provided by the
applicant and has not been published. The observational study followed
81 patients receiving high-flux HD for 1 year who subsequently switched
to HDx for 1 year. While there was a significant reduction in number of
hospital days (but no change in hospitalization rate) and medication
use, findings were limited by the lack of a control group. The
shortening of hospital stays could be attributed to a systematic change
in admission practice patterns, rather than HDx. Furthermore, Kt/V was
higher in the HDx group, but the authors did not standardize dialysis
dosing, making it difficult to attribute effects to HDx or to other
causes of increased dialysis adequacy. Hemoglobin levels, albumin,
hsCRP were not statistically different in the two arms. All
investigators are employees of RTS Ltd, Columbia, an affiliate of
Baxter Healthcare. The study was supported by Renal Therapy Services-
Columbia, an independent entity owned by Baxter International, Inc.
---------------------------------------------------------------------------
\133\ Sanabria RM,Vesga JI, Ariza J, Sanchez R, Suarez A,
Bernardo A, Rivera A. Expanded Hemodialysis and its effects on
hospitalization and medication usage: An exploratory study. (in
submission).
---------------------------------------------------------------------------
Incomplete Manuscripts
This is the fourth and final grouping in the list of evidence for
SCI from most compelling to least compelling. We summarize the
incomplete manuscripts which the applicant provided as follows:
Bolton S, et al.\134\ is a manuscript provided by the
applicant and is unfinished. It describes a crossover study of patients
previously treated with high-flux HD and switched to Theranova. Patient
reported outcome measures (PROMs) suggested decreased self-reported
dialysis recovery time and symptom burden, especially at 6 months.
However, regression to the mean appeared common, and there was no
control group.
---------------------------------------------------------------------------
\134\ Bolton S, Gair S, Metthews M, Stewart L, McCullagh N, A 1-
year routine assessment of patient-reported symptom burden after
implementing expanded hemodialysis, 2019. (in process).
---------------------------------------------------------------------------
Lim J, et al.\135\ is a manuscript provided by the
applicant, reporting a randomized trial comparing MCO to high-flux HD,
with 50 patients undergoing 12 weeks of treatment in Korea. The study
was small, and the authors performed a large number of statistical
tests comparing quality-of-life outcomes, with only a couple
statistically significant. Without adjusting p-values for the number of
statistical test, the risk for Type 1 error is large and not
unexpected. A second trial suggested lower medication doses, but again
results were statistically significant only for a few of the parameters
of interest. The study is small and requires replication at additional
centers to confirm results.
---------------------------------------------------------------------------
\135\ Lim J, Park Y, Yook J, Choi S, Jung H, Choi J, Park S, Kim
C, Kim Y, Cho J. Randomized controlled trial of medium cut-off
versus high-flux dialyzers on quality-of-life outcomes in
maintenance hemodialysis patients. (in submission).
---------------------------------------------------------------------------
Lim J-H, et al.\136\ is a manuscript provided by the
applicant, reporting a randomized trial comparing MCO to high-flux HD,
with 50 patients undergoing 12 weeks of treatment in Korea. Its purpose
was to evaluate the effects of ESA resistance of HD using a MCO
dialyzer. The number of registered patients was small and the study
duration not long enough to assess definite results. Also, the study
was not blinded to clinicians, which may have affected the ESA and iron
supplementation prescriptions. Additional studies need to be performed
to assess clinical outcomes.
---------------------------------------------------------------------------
\136\ Lim J-H, Yook J-M, Choi S-Y, Jung H-Y, Choi, J-Y, Park S-
H, Kim C-D, Kim Y-L, Cho H-H. Novel Medium Cut-Off Dialyzer Improves
Erythropoiesis Stimulating Agent Resistance in Maintenance
Hemodialysis Patients: A Randomized Control Trial. (in submission).
---------------------------------------------------------------------------
(e) Comments by the Members of the CMS TPNIES Work Group
The CMS TPNIES Work Group consists of CMS Medical Officers, senior
staff, a senior technical adviser, a biomedical engineer and contracted
physicians, including nephrologists. All materials sent by the
applicant were reviewed by the members of the CMS TPNIES Work Group.
The members of the CMS TPNIES Work Group voiced the specific concerns
regarding the evidence submitted for proof of eligibility via the SCI
criteria. While Theranova represents a unique technology, the CMS
TPNIES Work Group noted that the current evidence supporting SCI is
lacking but that other evidence may be forthcoming during the comment
period. It is too early to tell if the patient-recorded outcomes, such
as fewer cardiovascular events, are significant because of the small
numbers in the studies. Specifically, a study for infection was cited
with an N=20; another had an N=10. Also, the definition of the
infection was vague. Although hospitalization rates are discussed in
the articles, the cause of the hospitalization was unknown. Patient lab
results should be correlated with patient-reported results. In the
submitted articles, the studies are all open-label and observational,
with tenuous findings; there should be larger studies focused on the
U.S. dialysis population's patient health outcomes; the patients need
to be blinded in these studies.
[[Page 42176]]
The background information provided by the applicant and researched
by the group is conflicting. This may be due to the variation in the
location of the studies, including Colombia, France, Belgium, England,
Ireland, Australia, New Zealand, and Korea. One of the CMS TPNIES Work
Group members suggested a meta-analysis be done, along with the
heterogeneity of dialysis care in those countries as compared to the
care received by the Medicare population in the U.S.
At this time, while HDx appears to be a promising technology, the
CMS TPNIES Work Group has concerns that the current state of evidence
insufficiently demonstrates SCI in Medicare patients undergoing
dialysis, but that additional evidence may be forthcoming in the
comment period does not believe that the current state of evidence
sufficiently demonstrates SCI in Medicare patients undergoing dialysis.
In general, the dialyzer appears to have improved middle molecule
clearance. While observational studies show an association between high
levels of middle molecules and poor outcomes, these correlations do not
prove causation. For instance, a growing body of evidence suggests that
protein-bound solutes such as indoxyl sulfate and p-cresol sulfate
could be responsible for the uremic syndrome. Conventional HD, HDF, and
HDx do not effectively clear protein-bound toxins.
A summary of the current body of evidence is as follows:
Theranova more effectively removes middle molecules
compared to conventional dialysis with high-flux membranes. These
include molecules that have varying degrees of plausible toxicity (for
example, beta 2 microglobulin to cytokines to endothelial proteins).
Because nephrologists have not identified the putative uremic toxin, it
is not certain that clearance of these toxins will lead to improved
clinical outcomes.
Although small before and after studies suggest potential
clinical benefits from MCO dialyzer membranes compared with
conventional HD via high-flux membranes, such as reduced infection,
improved itching and restless legs, and shorter recovery time from
dialysis, these studies are mostly observational, small in nature, with
a high potential for bias. A large, multi-center trial would be
necessary to prove substantial benefit from HDx over conventional HD.
Several small studies suggest that MCO dialyzer membranes
are comparable to HDF in removal of middle molecules, but online HDF is
not generally available in the U.S. Furthermore, online HDF has not
consistently shown to improve health outcomes relative to conventional
HD with high-flux membranes.
There may be increased removal of albumin with MCO
membranes compared to conventional high-flux dialysis, which could have
negative health consequences.
A large randomized controlled clinical trial examining the
effects of removing larger molecules did not demonstrate clinical
benefits from removing larger molecules, although it did not examine
newer technologies which are more effective. This negative study
provides reason to be somewhat skeptical about the benefits of HDx over
HD.
Following the FDA-requested 6-month clinical study to
validate efficacy of large toxin removal and safety, the applicant
stated that it anticipates FDA marketing approval in May 2020. However,
we note that, per the application, safety is defined in part by albumin
loss. At this time we do not believe the clinical trials included
safety and efficacy studies for the large middle molecules the
applicant asserts to be the cause of inflammation. Therefore, the
perceived clinical benefits of providing clearance of those large
middle molecules were not assessed in rigorously conducted, randomized
clinical studies.
In summary, while HDx is a promising new technology, there is
insufficient evidence at this time to demonstrate a clear clinical
benefit for Medicare dialysis patients. However, additional evidence
may be forthcoming in the comment period. Therefore, we are inviting
public comment as to whether Theranova meets the TPNIES SCI criteria.
b. Tablo[supreg] Cartridge for the Tablo Hemodialysis System
(1) Outset Medical Application
For CY 2021, Outset Medical submitted an application for the TPNIES
for the Tablo[supreg] Cartridge for use with the Tablo[supreg]
Hemodialysis System. The applicant stated that the Tablo[supreg]
Cartridge is intended to substantially improve the treatment of
Medicare beneficiaries with ESRD by removing barriers to home dialysis.
The applicant noted that the Tablo[supreg] Cartridge is necessary
to operate the Tablo[supreg] Hemodialysis System for use in home. The
cartridge is comprised of a pre-strung blood tubing set and series of
sensor-receptors mounted to a user-friendly organizer, and together
these are referred to as the Cartridge. The blood tubing set comprises
a blood pump tubing segment that interfaces with a peristaltic (blood)
pump mounted on the inner front panel of the Tablo[supreg] console and
arterial and venous lines that connect to the corresponding lines on
the patient. Additional components to the cartridge include consumable
supplies: Bicarbonate and acid concentrate jugs and straws, and an
adapter for disinfectant use.
The applicant stated that the blood tubing set is primarily
comprised of one arterial line and one venous line and is enhanced with
a recirculating adaptor, a bifurcated saline line, a pressure
transducer protector, a drip chamber with clot filter, and an arterial
pressure pod.
According to the applicant, in addition to the blood lines, there
is an integrated saline line that enables automatic priming as well as
monitored delivery of saline boluses during treatment. There is also an
infusion line and two infusion ports (arterial and venous) for manual
delivery of medicine, anticlotting agents, and blood sampling.
In describing what the Tablo[supreg] Cartridge does, the applicant
states that it was designed with features to seamlessly integrate with
sensors on the front panel of the console (for example, air sensing,
arterial and venous pressure sensing) and to reduce touch points during
priming and blood return (for example, recirculating adapter and
bifurcated saline line) to minimize contamination. The blood pump draws
blood from the patient into the blood tubing set and passes the blood
through a dialyzer before returning the treated blood to the patient.
The applicant specifically stated that the Tablo[supreg]
Hemodialysis System includes the Tablo[supreg] Cartridge. In its
entirety, it has been specifically designed for patient-driven self-
care using an iterative human factors process, with key design
objectives being to facilitate learning and to minimize device training
time.\137\ Human factors studies performed in a laboratory setting have
demonstrated that patients can accurately learn and manage the
Tablo[supreg] Hemodialysis System after a brief training
period.138 139 A recent prospective,
[[Page 42177]]
multicenter, open-label, crossover trial comparing in-center and in-
home HD using Tablo[supreg] Hemodialysis System further supports the
clinical efficacy, safety, and ease of use of the system.\140\
---------------------------------------------------------------------------
\137\ Alvarez, Luis, et al. ``Clinical Experience with a New
Hemodialysis System Designed for In-Center Self-Care Hemodialysis.''
Self-Care, vol.8, no. 3, 2017, pp. 12-18. Self-Care vol. 8, no. 3,
2017, pp.12-18
\138\ Wilcox, Stephen B., et al. ``Results of Human Factors
Testing in a Novel Hemodialysis System Designed for Ease of Patient
Use.'' Hemodialysis International, vol. 20, no. 4,16 May 2016, pp.
643-649.doi:10.1111/hdi.12430
\139\ Alvarez, Luis, et al. ``Tablet-Based Training for In-
Center Self Dialysis -A Pilot Study.'' Journal of the American
Society of Nephrology, vol. 27, no. Abstract Edition, Nov. 2016, p.
895A.
\140\ Plumb, Troy et al. ``Safety and efficacy of the Tablo
hemodialysis system for in-center and home hemodialysis.''
Hemodialysis International, Online, 2019, DOI:10.1111/hdi.12795.
---------------------------------------------------------------------------
The applicant stated that the Tablo[supreg] Hemodialysis System is
the first and only all-in-one technology and includes a number of
features that make it new and different from current standard of home
dialysis care. These unique features include (1) A single-use
Tablo[supreg] Cartridge with user-friendly pre-strung blood, saline,
and infusion tubing and an integrated blood pressure monitor that
interfaces with the console to enable automated features such as air
removal, priming, and blood return which minimize use user errors, save
time and streamline the user experience; \141\ (2) on demand water and
dialysate production using a standard tap water source, eliminating the
need for time-consuming advance water preparation, bagged dialysate or
dialysate batching; \142\ (3) a consumer-centric touchscreen interface
that guides users with step-by-step instructions including non-
technical language, animation, and color-coded parts, to enable easier
training, faster set-up and simpler management including clear alarm
explanations and resolution instructions; \143\ and (4) electronic data
capture and automatic wireless transmission to eliminate the need for
manual record keeping by the patient, care partner, or nurse.\144\
---------------------------------------------------------------------------
\141\ Outset Medical, ``Safety Reference Guide.'' DOC-0004336
Rev 04, 2019.
\142\ Outset Medical, ``Tablo Preconfigured System White
Paper.'' DOC-0004252 Rev 01, 2019.
\143\ Alvarez, Luis, et al. ``Tablet-Based Training for In-
Center Self Dialysis -A Pilot Study.'' Journal of the American
Society of Nephrology, vol. 27, no. Abstract Edition, Nov. 2016, p.
895A.
\144\ Outset Medical, ``Tablo Information Security Design White
Paper.'' DOC-0003639 Rev 03, 2019.
---------------------------------------------------------------------------
The applicant asserted, both in the written application and at an
in-person meeting with CMS, that the observational studies with the
Tablo[supreg] Hemodialysis System were able to achieve CMS adequacy
targeted on three times per week dialysis at an average treatment time
of less than 4 hours. Tablo[supreg] has demonstrated the ability to
treat to adequacy targets within the Medicare standard reimbursement of
three treatments per week.
The applicant has not submitted an application for pass-through
payments under the Medicare OPPS or the NTAP program under the Medicare
IPPS for the Tablo Hemodialysis System, including the Tablo[supreg]
Cartridge.
This application for TPNIES is only for the Tablo[supreg] Cartridge
and its components for use in the home, which the applicant stated that
it intended to begin marketing in March 2020 following FDA clearance of
the Tablo[supreg] Hemodialysis System for home use. On March 31, 2020,
Outset Medical received FDA clearance to market the device for use in
the home, and CMS received a copy of this letter.
The applicant submitted a Premarket Notification 510(k) for
marketing clearance of Tablo[supreg]. Previous 510(k) authorizations
for the Tablo[supreg] Hemodialysis System and Tablo[supreg] Cartridge
were for hospital and outpatient clinic use only. The applicant could
not use or market the Tablo[supreg] Cartridge in the home setting until
the Tablo[supreg] Hemodialysis System was granted marketing
authorization by the FDA (note: Table Hemodialysis System and cartridge
was granted FDA market authorization in November 2016). While the
cartridge was previously cleared through a separate 510k and was not
necessary to include in the submission for marketing clearance for home
use, the Tablo[supreg] Hemodialysis System cannot be operated without
the Tablo[supreg] Cartridge. According to the applicant, the cartridge
was included in the use instructions for the home approval.
The applicant noted that the Tablo[supreg] Cartridge is not
currently available for marketing in the home setting. As explained
above, the applicant intended to begin marketing in the home setting in
March 2020, after the FDA clears the Tablo[supreg] Hemodialysis System
for marketing for home use. The applicant expected the first shipments
of the Tablo[supreg] Cartridge for use in the home to occur March 2020.
However, it is our understanding that to-date, the first patient to
start training is scheduled to begin June 1, 2020.
The applicant does have an IDE to study the Tablo[supreg]
Hemodialysis System's safety and efficacy for use in the home, which
has been completed as of the filing of the TPNIES application. The
applicant stated that the IDE would be closed once marketing
authorization for the use of the Tablo[supreg] Hemodialysis System in
the home is approved. The IDE study reference number is G140098. The
Tablo[supreg] Cartridge is assigned a Class II device category.
The applicant stated that it would submit a HCPCS application for
the Tablo[supreg] Cartridge in advance of the September 1, 2020
deadline.
The applicant identified and described how the new and innovative
renal dialysis equipment or supply meets the criteria for SCI over
existing renal dialysis services. The applicant states the
Tablo[supreg] Cartridge is necessary to operate the Tablo[supreg]
Hemodialysis System and therefore enables the system to deliver the
treatments that meet CMS's SCI criteria.
The applicant states that the Tablo[supreg] Hemodialysis System
enables a treatment option for a patient population unresponsive to, or
ineligible or, currently available treatments. As supporting background
material, the applicant notes that home HD is a highly underutilized
treatment for ESRD patients. Currently 90 percent of patients receive
HD in a clinic. Fewer than 2 percent have HD treatment at home.
Contributing to this low penetration rate is also a high dropout rate
with the incumbent home devices of 25 percent and 35 percent at 12 and
24 months, respectively.\145\ The barriers to home dialysis adoption
and retention have been well studied and include: (1) Treatment burden
for patients and care partner fatigue; (2) technical challenges
operating HD machine; (3) space, home modifications, and supplies
management; (4) patients not wanting medical equipment in the home; and
(5) safety concerns.146 147 The applicant asserts that
Tablo[supreg] is the first new home HD system in over 15 years,
designed to address many of the above-mentioned barriers that currently
result in patients resigning themselves to in-center care and/or
stopping home modalities due to the associated burden of self-managed
therapy. Among other things, the objective of this order is for 80
percent of ESRD patients starting kidney replacement therapy (KRT) with
a transplant or home dialysis by 2025.\148\ The applicant states that
this goal will require a multi-faceted solution, inclusive of less
burdensome technology, to address the key barriers to home dialysis.
---------------------------------------------------------------------------
\145\ Sehasi, Rebecca et al. Factors Associated With
Discontinuation of Home Hemodialysis, American Journal of Kidney
Disease, Volume 67, Issue 4, 2016, Pages 629-637.
\146\ Seshasai, R.K., et al. The home hemodialysis patient
experience: A qualitative assessment of modality use and
discontinuation. Hemodialysis International, 23: 139-150, 2019.
doi:10.1111/hdi.12713.
\147\ Chan, Christopher T. et al. Exploring Barriers and
Potential Solutions in Home Dialysis: An NKF-KDOQI Conference
Outcomes Report, Mar 2019, American Journal of Kidney Diseases,
Volume 73, Issue 3, 363-371.
\148\ U.S. Department of Health and Human Services, Office of
the Assistant Secretary for Planning and Evaluation, Advancing
American Kidney Health, July 10, 2019.
---------------------------------------------------------------------------
The applicant believes that the Tablo[supreg] Hemodialysis System
has the potential to significantly increase home dialysis.
[[Page 42178]]
The applicant conducted an IDE study for the primary purpose of
evaluating the safety and efficacy of Tablo[supreg] Hemodialysis System
use in the home setting. The applicant stated that the results from the
IDE study demonstrate the following: (1) Patients will opt for home
dialysis if the Tablo[supreg] Hemodialysis System is available; (2)
patients have confidence in the safety and efficacy of the
Tablo[supreg] Hemodialysis System; (3) the unique features of the
Tablo[supreg] Cartridge as part of the Tablo[supreg] Hemodialysis
System simplify set-up and use; and (4) the wireless transmission of
data feature is reassuring to patients because it relieves patients of
the burden of recording and fear that the patient may forget to
document some aspect of treatment. The applicant claims that the IDE
study results show that these key features will facilitate growth and
ongoing use of the Tablo[supreg] Hemodialysis System in the home
setting.
During the course of the study, with an average treatment time of
3.4 hours, twenty-eight out of thirty patients completed all phases of
the trial and no patient dropouts occurred during the in-home phase.
There is only one other mobile HD machine on the market. Its IDE, based
on six times per week therapy at an average treatment duration of 2.8
hours, showed a higher drop-out rate (19 percent vs Tablo's[supreg] 7
percent) and lower adherence to treatment at home (89 percent vs
Tablo's[supreg] 99 percent).149 150
---------------------------------------------------------------------------
\149\ Kraus, M., et al., A comparison of center-based vs. home-
based daily hemodialysis for patients with end-stage renal disease.
Hemodialysis International, 11: 468-477 2007 doi:10.1111/j.1542-
4758.2007.00229.x.
\150\ Plumb, T.J., Alvarez, et al. Safety and efficacy of the
Tablo hemodialysis system for in-center and home hemodialysis.
Hemodialysis Internationa 2019l. doi:10.1111/hdi.12795.
---------------------------------------------------------------------------
The applicant asserts that the Tablo[supreg] Hemodialysis System
significantly reduces training time for both patients and their
caregivers, improving training completion and reducing patient
technique failure and care partner burden. The applicant state that the
cartridge element of the Tablo[supreg] Hemodialysis System removes many
of the manual steps and minimizes both set up time, and the need to
make difficult connections, which requires training to avoid
contamination. In human factors testing submitted to the FDA, the use
of the cartridge resulted in 90 percent of the users being able to set
up Tablo[supreg] in under 10 minutes.\151\ The applicant stated that
the Tablo[supreg] Hemodialysis System home IDE data demonstrates that
on average it takes 3.5 training sessions to learn the Tablo[supreg]
Hemodialysis System compared to 14.5 sessions on the device that is the
current standard of care for home HD.\152\ The applicant asserts that
reduced training time increases likelihood of successful completion,
reduces patient technique failure, and decreases caregiver burden. The
applicant notes the following: (1) The graphical user interface guides
users through the treatment and eliminates the need for memorization
and mental math; (2) sensors and automation eliminate multiple manual
steps in treatment set-up; and (3) contextual alarms instantly alert
patients to any issues with their treatment and provide video and text
direction on how to resolve them. This is in comparison to numerical
alarm codes with the incumbent device that requires reference to the
user manual or memorization with no video guidance available.
---------------------------------------------------------------------------
\151\ Alvarez, Luis, et al. ``Clinical Experience with a New
Hemodialysis System Designed for In-Center Self-Care Hemodialysis.''
Self-Care, vol.8, no. 3, 2017, pp. 12-18. Self-Care vol. 8, no. 3,
2017, pp.12-18.
\152\ Chahal, Yaadveer, Decreased Time to Independence with the
Tablo Hemodialysis System: A Subset Analysis of the Tablo Home
Clinical Trial, Abstract accepted for the National Kidney Foundation
Spring Clinical Meeting 2020.
---------------------------------------------------------------------------
The applicant states that the Tablo[supreg] Hemodialysis System
significantly reduces set up and treatment time reducing treatment
burden, improving retention at home, and reducing the need for and
involvement of a care partner. The applicant noted that data from
Outset Medical's Tablo[supreg] Hemodialysis System home IDE trial
showed that a patient could set up the Tablo[supreg] Hemodialysis
System in 9.2 minutes.\153\ With the average number of treatments of
3.6 per week for an average duration of 3.4 hours,\154\ a Tablo[supreg]
Hemodialysis System user treating 4 times per week can expect to spend
approximately 14 hours a week preparing for and conducting treatments,
versus 40 hours a week on the incumbent device for patients who batch
solutions.155 156 The applicant states that this significant
reduction in setup and treatment time is a result of software and
workflow improvements incorporated in the Tablo[supreg] Hemodialysis
System and its cartridge, many of which were driven by patient
feedback. Reducing overall treatment burden improves modality retention
at home on behalf of the patient and limits the care partner burden by
reducing the need for their active involvement in treatment.
---------------------------------------------------------------------------
\153\ Outset Medical subset analysis of Home IDE Trial data on
set up time for Tablo Cartridge and concentrates.
\154\ Plumb, T.J., Alvarez, et al. Safety and efficacy of the
Tablo hemodialysis system for in-center and home hemodialysis.
Hemodialysis International, 2019l. doi:10.1111/hdi.12795.
\155\ NxStage Medical, Transitional Dialysis Care Operational
Guidance, June 2019, https://www.nxstage.com/wpcontent/uploads/2019/06/APM2548-Rev-B-TDC-Operational-Guidance.pdf.
\156\ Kraus, M., et al., A comparison of center-based vs. home-
based daily hemodialysis for patients with end-stage renal disease.
Hemodialysis International, 11: 468-477 2007 doi:10.1111/j.1542-
4758.2007.00229.x.
---------------------------------------------------------------------------
The applicant states that the cartridge portion of the
Tablo[supreg] Hemodialysis System is pre-strung and requires only two
connections to operate as compared to other systems that require
stringing, hanging, snapping, and tapping multiple lines. In the home
IDE time set up of dialysate concentrates, the Tablo[supreg] Cartridge
took less than 12 minutes on average. With an average time of 8
minutes, an uninterrupted patient can initiate therapy in as little as
20 minutes.\157\ This is a significant improvement in the standard of
care, which can take approximately 45 minutes.\158\ The applicant
asserts that the Tablo[supreg] Hemodialysis System's automatic and
integrated sensors and automated degassing and priming also make the
machine easier to use and quicker to set up and get to treatment.
---------------------------------------------------------------------------
\157\ Outset Medical subset analysis of Home IDE Trial data on
set up time for Tablo Cartridge and concentrates.
\158\ Informal interviews with NxStage patients.
---------------------------------------------------------------------------
The applicant states that the Tablo[supreg] Hemodialysis System is
the only system with a fully integrated water treatment system that
allows for real-time water purification and dialysate produced on
demand with no need to batch solutions or hang bags of dialysate. In
addition, the applicant noted that it requires only a standard,
grounded electrical outlet and Environmental Protection Agency quality
tap water to operate, obviating the need to store bags of dialysate in
the home, significantly reducing the number of supplies patients need
to receive each month.
The applicant notes that the Tablo[supreg] Hemodialysis System
reduces patient/care partner burden and technique failure.
Specifically, the applicant stated that automation of processes such as
prime and rinse back reduces the overall number of treatment related
steps. In addition, the applicant says that the Tablo[supreg]
Hemodialysis System's easy to use touchscreen interface walks users
through each step of setup, treatment, and take down; the treatment
information displays data that patients most wanted to see. The
applicant asserts that this automation and patient-centric design
reduces technique failure as evidence by results from the IDE study,
which demonstrated a significant
[[Page 42179]]
increase in treatment adherence and high rate of study completion
compared to the current standard.
The applicant further states that the Tablo[supreg] Hemodialysis
System eliminates documentation burden and reduces reporting errors,
and that it is the only HD system with 2-way wireless transmission
delivering HIPAA compliant data to the healthcare provider without any
need for additional equipment. This frees patients from the need to
manually document treatment data by hand or on a separate tablet and
ensures higher data accuracy.
The 28 patients who entered the home phase of the Tablo[supreg]
Hemodialysis System home IDE answered weekly if they needed help with
treatment over the prior seven days. The applicant stated that by the
end of the study, 216 of 224 possible responses were obtained. The care
partner burden rating for prior in-home patients who were previously
dialyzing on the incumbent device decreased from 3.1 to 2.4 on
Tablo[supreg]. Among prior in-home patients, 69 percent of patients
reported needing help from a trained individual with their prior device
with 46 percent of respondents stating the help needed was device
related, 15 percent related to cannulation alone, and 8 percent
reported other. By contrast, while on Tablo[supreg], only 38 percent of
patients reported needing help with treatment--only 22 percent needed
help related to use of Tablo[supreg] while 16 percent needed help
related to cannulation. The applicant asserts that this data
underscores a significant decrease in patients needing assistance with
treatment at home.
The applicant states that Tablo[supreg] Hemodialysis System's
unique features increase patient safety and satisfaction. The applicant
notes that Tablo[supreg] Hemodialysis System's integrated, 2-way
wireless connection provides clinicians with the ability to monitor
patients in real time without any separate equipment necessary. The
applicant asserts that the Tablo[supreg] Hemodialysis System is the
only HD technology with this function, which allows for early
identification and intervention by a patient's healthcare team as a key
safety feature. At 34 inches tall, Tablo[supreg] Hemodialysis System
user interface matches the height of a user while seated in a standard
dialysis chair allowing patients to directly, and quickly engage with
the integrated touch screen to view progress of the treatment, resolve
alarms, and adjust certain functions to tailor the treatment to his or
her needs. As an example, a patient with limited mobility can reach the
interactive touch screen to adjust the flow rate if they feel cramping
coming on. The IDE generated data that demonstrated how the technology
enabled more rapid resolution of alarms. During the home arm of the
study, patients were able to resolve alarms on the Tablo[supreg]
Hemodialysis System in 5 seconds.\159\ The applicant asserts that rapid
resolution of alarms and enhanced communication improve safety by
facilitating rapid correction of any treatment related events, limiting
treatment interruptions and improving communication between the patient
and provider.
---------------------------------------------------------------------------
\159\ Wilcox, Stephen B. et al., Results of human factors
testing in a novel hemodialysis system designed for ease of patient
use, Hemodialysis International 2016; 20:643-649.
---------------------------------------------------------------------------
Once approved for home use, the applicant states that the
Tablo[supreg] Hemodialysis System will provide a simpler, easier to use
system that is likely to increase the number of people who are able to
receive and remain on dialysis at home by addressing many of the well-
documented, key barriers to home dialysis reported in peer-reviewed
literature.
In addressing the way in which the Tablo[supreg] Hemodialysis
System with its cartridge significantly improves clinical outcomes
relative to the renal dialysis services previously available, the
applicant focused on hospitalization and quality of life. The applicant
stated that the Tablo[supreg] Hemodialysis System's 2-way wireless
connection allows for real-time intervention to prevent
hospitalizations. The applicant stated that during the Tablo[supreg]
Hemodialysis System home IDE, the patients using the Tablo[supreg]
Hemodialysis System had an all cause admission rate of 426 per 1,000
patient years. In the general dialysis population, the all cause
admission rate is 1688 per 1,000 patient years and for patients who do
PD, the hospitalization rate is 1460 per 1,000 patient years,
highlighting that the Tablo[supreg] Hemodialysis System may
significantly reduce hospitalizations and lower cost of care.\160\ The
applicant states that Tablo[supreg] Hemodialysis System's integrated,
2-way wireless connection provides clinicians the ability to monitor
patients in real time without any separate equipment necessary, and is
the only equipment with this embedded functionality which allows for
earlier identification and intervention by a patient's healthcare team
and could prevent unnecessary hospitalizations for dialysis related
events or missed treatments.
---------------------------------------------------------------------------
\160\ United States Renal Data System. 2019 USRDS annual data
report: Epidemiology of kidney disease in the United States.
National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases, Bethesda, MD, 2019, Executive Summary
Reference Table G2.
---------------------------------------------------------------------------
The applicant stated that the Tablo[supreg] Hemodialysis System can
effectively deliver adequacy with 3-4 treatments per week, potentially
reducing Medicare expenditures on additional dialysis treatments per
week. The applicant said that among home HD patients, Medicare payment
for dialysis treatments was highly variable across different regions at
3.5 to 5.7 per week.\161\ In the IDE for the Tablo[supreg] Hemodialysis
System, the applicant asserted that there was effectively delivered
adequacy with 4 treatments per week with an average session length of
3.4 hours, resulting in an average weekly treatment duration of ~13.6
hours. An average weekly standard Kt/V of 2.8 was achieved and 94
percent of patients achieved an ultrafiltration rate within 10 percent
of the prescribed value.\162\ The applicant noted that a previous study
of Tablo[supreg] Hemodialysis System used in the clinic showed
achievement of a spKt/V of 1.2 based on 3 treatments per week including
for patients over 90kg. While the frequency of how often patients
should receive dialysis is a clinical decision that should be made
between the physician and the patient, the Tablo[supreg] Hemodialysis
System is the only mobile HD system with clinical data showing
achievement of adequacy standards and ultrafiltration endpoints for 3
and 4 treatments per week regardless of the size of the
patient.163 164 The applicant concludes that in this way,
the Tablo[supreg] Hemodialysis System has the potential to reduce
Medicare expenditures on the billing of additional dialysis treatments.
---------------------------------------------------------------------------
\161\ Wilk, Adam S. et al., Persistent Variation in Medicare
Payment Authorization for Home Hemodialysis Treatments Health
services research vol. 53,2 (2018): 649-670.
\162\ Plumb, T.J., Alvarez, et al. Safety and efficacy of the
Tablo hemodialysis system for in-center and home hemodialysis.
Hemodialysis International, 2019. doi:10.1111/hdi.12795.
\163\ Alvarez, Luis et al. Urea Clearance Results in Patients
Dialyzed Thrice Weekly Using a Dialysate Flow of 300 mL/min,
clinical abstract, presented March 2019, Annual Dialysis Conference,
Dallas, TX.
\164\ Alvarez, Luis and Chertow, Glenn, Real World In-Center
Urea Clearance Experience with a Novel Hemodialysis System, clinical
abstract, presented March 2019, Annual Dialysis Conference, Dallas,
TX.
---------------------------------------------------------------------------
The applicant states that Tablo[supreg] Hemodialysis System's
ability to deliver adequacy on fewer treatments per week may also
reduce vascular access complications due to frequent cannulation.\165\
---------------------------------------------------------------------------
\165\ Agency for Healthcare Quality and Research, End Stage
Renal Disease in the Medicare Population: Frequency and Duration of
Hemodialysis and Quality of Life Assessment, Draft Technology
Assessment, Agency for Healthcare Quality and Research November 22,
2019.
---------------------------------------------------------------------------
[[Page 42180]]
The applicant submitted several examples in four topics to
demonstrate how the Tablo[supreg] Hemodialysis System improves the
quality of life. The applicant noted that patients value having a high-
quality daily life, ability to live well, and feeling empowered to
control their outcomes over mortality.\166\ The applicant asserted that
the use of the Tablo[supreg] Hemodialysis System at home allows
patients to have an improved quality of life and control over their
outcomes.
---------------------------------------------------------------------------
\166\ Urquhart-Secord, Rachel et al Patient and Caregiver
Priorities for Outcomes in Hemodialysis: An International Nominal
Group Technique Study American Journal of Kidney Diseases, Sept.
2016, Volume 68, Issue 3, 444-454.
---------------------------------------------------------------------------
The first topic of improved quality of life focused on sleep and
reduction in fatigue. The applicant noted that kidney patients
participating in an international research collaborative to identify
outcome measures most important to them ranked fatigue/energy as their
top priority.\167\ The applicant reported that patients in the IDE who
were on home HD with an incumbent device experienced a 14 percent
improvement in waking up feeling rested while on the Tablo[supreg]
Hemodialysis System. Additionally, 22 percent fewer patients reported
having trouble staying asleep, and 15 percent fewer patients reported
waking up several times during the night while on the Tablo[supreg]
Hemodialysis System.\168\ The applicant asserted that this data shows
that the Tablo[supreg] Hemodialysis System is able to make a clinically
significant improvement in the quality of life indicator most valued by
dialysis patients.
---------------------------------------------------------------------------
\167\ Ibid.
\168\ Plumb, T.J., Alvarez, L., Ross, D.L., Lee, J.J., Mulhern,
J.G., Bell, J.L., Abra, G., Prichard, S.S., Chertow, G.M. and
Aragon, M.A. (2019), Safety and efficacy of the Tablo hemodialysis
system for in-center and home hemodialysis. Hemodialysis
International. doi:10.1111/hdi.12795.
---------------------------------------------------------------------------
The second topic of improved quality of life discussed by the
applicant was improvement in the patients' experience of hypotensive
events. The applicant submitted that investigators report that a drop
in blood pressure was also ranked in the top 10 of symptoms rated by
patients that impact their quality of life.\169\ The applicant reported
that a total of 12 (40.0 percent) and 8 (26.7 percent) subjects
reported hypotensive events during the Tablo[supreg] Hemodialysis
System treatments during the In-Center and In-Home treatment periods,
respectively, compared to 27 (90.0 percent) subjects reporting
hypotensive events at baseline on another HD machine. All patients who
reported hypotensive events while on dialysis in the study had also
reported hypotension in their baseline history.\170\
---------------------------------------------------------------------------
\169\ Urquhart-Secord, Rachel et al. Patient and Caregiver
Priorities for Outcomes in Hemodialysis: An International Nominal
Group Technique Study American Journal of Kidney Diseases, Sept.
2016, Volume 68, Issue 3, 444-454.
\170\ Outset Medical Data from Home IDE Trial, pg 33 of clinical
report submitted to the Food and Drug Administration, data table 43,
2019.
---------------------------------------------------------------------------
The third topic of improved quality of life was that fewer patients
reported feeling cold. The applicant reported that a total of 15 (50.0
percent) subjects during the in-center treatment period and 12 (40.0
percent) subjects during the In-Home treatment period reported feeling
cold while dialyzing on the Tablo[supreg] Hemodialysis System compared
to 28 (93.3 percent) subjects who reported feeling cold at baseline
while dialyzing on another dialysis machine. The applicant asserted
that the Tablo[supreg] Hemodialysis System's design results in tight
control of dialysate temperature and allows patients to easily and
accurately adjust temperature through the graphical user
interface.\171\
---------------------------------------------------------------------------
\171\ Ibid.
---------------------------------------------------------------------------
The fourth topic of improved quality of life was patient preference
for the Tablo[supreg] Hemodialysis System. The applicant stated that
the Kidney Health Initiative (KHI), a public private partnership
between the FDA and the American Society of Nephrology, Renal
Replacement Therapy (RRT) Roadmap prioritizes patient-centered
innovation, which includes dialysis equipment that is more portable,
removes barriers to home dialysis and improves patients ease of use to
increase opportunities for self-care. The RRT, which was developed in
conjunction with patients, also prioritizes patient centered outcomes
and technology that reduces disruption in social and family life.\172\
The applicant reported that among prior home HD users in the IDE trial,
85 percent reported they preferred the Tablo[supreg] Hemodialysis
System to their current equipment.\173\ Patients also rated
Tablo[supreg] as easier to set-up, treat, and take down. Ease of use
ratings comparing the patient's prior device to Tablo[supreg] were as
follows: Set up--3.5 to 4.5, Treatment--3.3 to 4.6, Take Down--3.8 to
4.6.\174\
---------------------------------------------------------------------------
\172\ Kidney Health Initiative, Technology Roadmap for
Innovative Approaches to Renal Replacement Therapy, prepared by the
Nexight Group, October 2018, https://www.asnonline.org/g/blast/files/KHI_RRT_Roadmap1.0_FINAL_102318_web.pdf.
\173\ Chahal, Yaadveer, Patient Device Preference for Home
Hemodialysis: A Subset Analysis of the Tablo Home IDE Trial,
Abstract Accepted by the National Kidney Foundation Spring Clinical
Meeting 2020.
\174\ Outset Medical Data from Home IDE Trial, pg 33 of clinical
report submitted to the Food and Drug Administration, data table 43,
2019.
---------------------------------------------------------------------------
In summary, the applicant submitted that the Tablo[supreg]
Hemodialysis System has the potential to significantly expand the
number of patients who are able to receive home HD and persist on the
therapy. The applicant stated that it is an innovative HD system that
removes most of the device-related key barriers, reduces dialysis-
related symptoms, is mobile and easy to use, and therefore minimizes
dialysis-related disruptions in patients' lives.
(2) CMS TPNIES Work Group
(a) Summary of current technology by CMS TPNIES Work Group
Patients with ESRD who are not able to receive a kidney transplant
must undergo maintenance dialysis therapy. Patients can receive
dialysis 3-4 days a week at an in-center HD facility, or they can
administer dialysis themselves at home. Due to the reliance on
outpatient dialysis units, numbers of patients utilizing home dialysis
in the U.S. have remained low. In 2017, only 10.8 percent of US
dialysis patients received home-based therapies.\175\ Patients and
caregivers cite concerns with self-cannulation, fears of needle
disconnect and complications.\176\ Home dialysis use is lower than many
other rich countries.\177\
---------------------------------------------------------------------------
\175\ United States Renal Data System (USRDS). 2019 Annual Data
Report: Reference Tables. https://www.usrds.org/reference.aspx. Last
Access Date Feb 20, 2020.
\176\ Young BA, Chan C, Blagg C, Lockridge R, Golper T,
Finkelstein F, Shaffer R, Mehrotra R; ASN Dialysis Advisory Group.
How to overcome barriers and establish a successful home HD program.
Clin J Am Soc Nephrol. 2012 Dec;7(12):2023-32. doi: 10.2215/
CJN.07080712. Epub 2012 Oct 4.
\177\ Wilkie M. Home dialysis-an international perspective. NDT
Plus. 2011 Dec;4(Suppl 3):iii4-iii6.
---------------------------------------------------------------------------
Most patients administering dialysis at home use PD. However, home
HD has more recently re-emerged as an alternative way for patients to
dialyze at home. Home HD may offer many of the advantages observed with
peritoneal dialysis, such as increased flexibility and quality-of-life
benefits. However, adoption of home HD has been limited, with
approximately only 1 percent of ESRD patients utilizing this
modality.\178\
---------------------------------------------------------------------------
\178\ Mailloux LU, Blagg CR. Berns JS (ed.) Home Hemodialysis.
Uptodate. Nov 18, 2016.
---------------------------------------------------------------------------
Observational studies do not indicate significant differences in
survival when comparing home dialysis to in-center dialysis.\179\ Yet,
there are some potential
[[Page 42181]]
benefits to home-based dialysis. Prior analyses have noted that home-
based dialysis affords greater patient flexibility, improved quality of
life,\180\ increased likelihood of employment,\181\ and improved
cost.\182\ However, regarding cost comparisons, it is important to note
that many cost analyses of home-based dialysis include estimates from
peritoneal dialysis. The machines for HD are costly and there may be
higher rates of infection from self-cannulation, which could offset any
savings. Since such a small percentage of patients receive home-based
HD, it is challenging to know actual cost without pooling it with
peritoneal dialysis estimates. Regardless, due to an executive order
issued in 2019, economic incentives for home dialysis (both peritoneal
and home HD) were increased with the goal of expanding its use.\183\
---------------------------------------------------------------------------
\179\ Chiu YW, Jiwakanon S, Lukowsky L, Duong U, Kalantar-Zadeh
K, Mehrotra R. An update on the comparisons of mortality outcomes of
hemodialysis and peritoneal dialysis patients. Semin Nephrol.
2011;31:152-158.
\180\ Rubin HR, Fink NE, Plantinga LC, Sadler JH, Kliger AS,
Powe NR. Patient ratings of dialysis care with peritoneal dialysis
vs hemodialysis. JAMA. 2004;291:697-703.
\181\ Muehrer RJ, Schatell D, Witten B, Gangnon R, Becker BN,
Hofmann RM. Factors affecting employment at initiation of dialysis.
Clin J Am Soc Nephrol. 2011 Mar;6(3):489-96.
\182\ Berger A, Edelsberg J, Inglese GW, Bhattacharyya SK, Oster
G. Cost comparison of peritoneal dialysis versus hemodialysis in
end-stage renal disease. American Journal of Managed Care.
2009;15:509-518.
\183\ The White House. Executive Order on Advancing American
Kidney Health. July 10, 2019. https://www.whitehouse.gov/presidential-actions/executive-order-advancing-american-kidney-health/ . Last Access Date Feb 18, 2020.
---------------------------------------------------------------------------
(b) Description of New Technology by the CMS TPNIES Work Group
The first personal HD system on the market was called the Aksys
personal HD (Aksys Ph.D.) system. It created its own ultrapure
dialysate and was FDA cleared in 2002. It later underwent recall in
2006 due to marketing inconsistencies with system design.\184\
Eventually, the manufacturer shut down operations after difficulties in
securing financing.\185\ In addition to these issues, it was a large
machine that required significant patient utility resources and
specialized maintenance.\186\ Around this time, development of the
Allient dialysis system began, which utilizes a sorbent column to
regenerate dialysate from tap water.\187\ It is still in development
for potential home based therapy.
---------------------------------------------------------------------------
\184\ Food and Drug Administration. Class 2 Device Recall Aksys
Ph.D. Personal Hemodialysis System. Medical Devices Database. June
2006. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46686.
\185\ Modern Healthcare. Dialyais machine firm Aksys shuts down.
Feb 21, 2007. https://www.modernhealthcare.com/article/20070221/NEWS/70221010/dialysis-machine-firm-aksys-shuts-down. Last Access
Date Feb 18, 2020.
\186\ Mailloux LU, Blagg CR. Berns JS (ed.) Home Hemodialysis.
Uptodate. Nov 18, 2016.
\187\ Ash SR. The Allient dialysis system. Semin Dial. 2004 Mar-
Apr;17(2):164-6.
---------------------------------------------------------------------------
Several home dialysis machines are currently available. Recently,
the NxStage[supreg] System One dialysis machine was FDA approved for
510(k) premarket status in August 2017.\188\ It has a smaller profile
than the Aksys machine but requires 4 to 6 large bags of ultrapure
dialysate and comes with home storage requirements. The NxStage[supreg]
PureFlow SL was subsequently developed for use with the NxStage[supreg]
System One. It allows patients to prepare dialysate from tap water with
a reduced need to store dialysate bags. The NxStage[supreg] system
advertises an easier experience learning how to administer home
dialysis. Within this arena, the Tablo[supreg] Hemodialysis System has
recently emerged and been approved for use in hospitals and outpatient
settings. The Tablo[supreg] Hemodialysis System is most comparable to
NxStage System One combined with NxStage[supreg] PureFlow, in that it
may be easier to use than conventional home dialysis machines and can
be used from a tap water source. The applicant is currently pursuing
approval for use of cartridges for the Tablo[supreg] Hemodialysis
System in the home setting. While this application centers on
reimbursement of the Tablo[supreg] Cartridge, this cartridge is only
compatible with the Tablo[supreg] Hemodialysis System. The cartridge is
made up of a rigid ``Organizer'' which mounts the necessary tubing to
allow for greater ease in set-up. This self-contained and single-use
cartridge houses both the arterial and venous lines, an adaptor to
connect the lines, a saline line, and an infusion line. There is also a
pressure transducer protector, venous drip chamber with clot filter,
and an arterial pressure pod. The applicant noted that the cartridge
simplifies connection to the Tablo[supreg] Hemodialysis System and
reduces set-up time. It would seem that this cartridge would be most
useful in the home-setting, since hospital and clinic settings would
normally have trained personnel to assist with set-up. Although
separate from the Tablo[supreg] Cartridge, the Tablo[supreg]
Hemodialysis System also performs real-time water purification on
demand dialysate production.
---------------------------------------------------------------------------
\188\ Food and Drug Administration. Traditional Section 510(k)
Premarket Notification Letter, Number K171331. August 24, 2017.
https://www.accessdata.fda.gov/cdrh_docs/pdf17/K171331.pdf.
---------------------------------------------------------------------------
A significant challenge to increasing the use of home dialysis
includes burn out (or technique failure) and return to in-center HD.
According to one recent observational study, approximately 25 percent
of patients who initiate home HD return to in-center HD within the
first year.\189\ A good measure of a home-based system's success would
be in its ability to allow patients to remain on the therapy long-term.
Failure to maintain home HD, and low use of home HD, may be a result of
anxiety and unease that many patients have about performing the
treatment themselves (or with the help of care
takers).190 191 192 This includes fear of self-cannulation
in order to access the blood for dialysis and a lack of self-efficacy
in performing the therapy. By simplifying the process of setting up
dialysis tubing, offered by the Tablo[supreg] Hemodialysis System
cartridge, some patients may be able to successfully perform home HD.
---------------------------------------------------------------------------
\189\ Seshasai RK, Mitra N, Chaknos CM, Li J, Wirtalla C,
Negoianu D, Glickman JD, Dember LM. Factors Associated With
Discontinuation of Home Hemodialysis. Am J Kidney Dis. 2016
Apr;67(4):629-37.
\190\ Cafazzo JA, Leonard K, Easty AC, Rossos PG, Chan CT.
Patient-perceived barriers to the adoption of Nocturnal Home
Hemodialysis. Clin J Am Soc Nephrol. 2009;4:784-789.
\191\ Suri RS, Larive B, Garg AX, et al. Burden on caregivers as
perceived by hemodialysis patients in the frequent Hemodialysis
network (FHN) trials. Nephrol Dial Transplant. 2011;26:2316-2322.
\192\ Zhang AH, Bargman JM, Lok CE, et al. Dialysis modality
choices among chronic kidney disease patients: Identifying the gaps
to support patients on home-based therapies. Int Urol Nephrol.
2010;42:759-764
---------------------------------------------------------------------------
(c) Approvals
The applicant has not previously submitted applications for pass-
through or add-on payments. The applicant has received 510(k) marketing
clearance for the machine to be used in hospital and outpatient clinic
use only. As such, the applicant is pursuing FDA authorization for use
in the home setting for February 2020. The Tablo[supreg] Hemodialysis
System cartridge received FDA marketing approval in December, 2019 and
the Tablo[supreg] Hemodialysis System received FDA marketing
authorization for home setting in March 2020. The applicant noted that
upon approval, the company plans to ship that same month. The
technology had an investigational device exemption for use in the home
and which closed after approval of marketing authorization. It is
assigned as a Class II device category.
[[Page 42182]]
(d) Assessment of Substantial Similarity to Currently Available
Technology
The NxStage[supreg] One is the only home-based HD system that is
FDA has approved at this time. The Tablo[supreg] Hemodialysis System
differs from the NxStage[supreg] in that dialysate is produced on
demand whereas the NxStage[supreg] requires that patients batch
dialysate or use pre-filled concentrate with the PureFlow. The
Tablo[supreg] Hemodialysis System also includes a cartridge (which is
the portion being evaluated for TPNIES) designed to facilitate the
connection of tubing in the appropriate configuration.
This product treats similar patients, notably patients with ESRD
requiring HD.
(e) Assessment of SCI (see Sec. Sec. 413.236(b)(5) and 412.87(b)(1))
The Tablo[supreg] Hemodialysis System is a treatment modality, not
a diagnostic tool. With regard to the question as to whether this new
renal dialysis equipment offers a treatment option for a patient
population unresponsive to, or ineligible for, currently available
treatments, we note that patients who are eligible for this treatment
would currently be eligible for in-center HD, home HD with currently
available treatments, and possibly PD.
(f) Clinical Evidence for Claims of SCI
The applicant included an annotated bibliography in its
application. Many of the articles describe the features of the HD
system: straightforward and relatively efficient set-up and training,
presence of safety features, water purification system, and wireless
communication. In terms of clinical outcomes and improvements, the
referenced authors have presented or published data on safety,
clearance and treatment times, hypotensive events and cold symptoms,
and patient preference. As these are arguably more important
considerations, we are focusing on the evidence with those claims of
clinical improvement or patient reported outcomes.
Below is a list of references for SCI based on evidence published
from several sources. We summarize the studies grouped by listings with
the most rigorous review to those with the least rigorous review,
specifically, Trials Published in Peer-Reviewed Journals, then Posters
and Abstracts, and ending with Unpublished Data.
Trials Published in Peer-Reviewed Journals
Plumb TJ, et al.\193\ describes the IDE study, which was a
prospective, multicenter, open-label crossover trial evaluating in-
center versus in-home use of the Tablo[supreg] Hemodialysis System.
Thirty patients underwent a run-in period, 8 weeks of in-center therapy
(4 treatments a week), then a 4-week transition period, and finally an
8-week in-home treatment (4 times a week). Authors evaluated efficacy
in effective removal of uremic toxins, as measured by a weekly standard
Kt/Vurea >=2.1 and a secondary endpoint of delivered ultrafiltration
within 10 percent of prescribed. Twenty-eight out of 30 patients
completed the study. One patient died from cardiac arrest and the
authors felt it was unrelated to the treatments. Another patient
withdrew prior to starting in-home HD. There were primary outcomes,
secondary outcomes, adverse event rates, alarms per treatment, and
alarm response times between the two groups. Patients demonstrated high
adherence rates of 96 percent, and 99 percent for the in-center and in-
home groups, respectively. There is bias from the open-label study and
this is a small study conducted over a short period of 12 weeks total,
4 weeks of in-home dialysis. Long-term and larger studies would be
helpful to capture any safety signals. Some authors serve as Chief
Medical Officer or consultants for Outset Medical.
---------------------------------------------------------------------------
\193\ Plumb TJ, Alvarez L, Ross DL, Lee JJ, Mulhern JG, Bell JL,
Abra G, Prichard SS, Chertow GM, Aragon MA. Safety and efficacy of
the Tablo hemodialysis system for in-center and home hemodialysis.
Hemodial Int. 2020 Jan;24(1):22-28. doi: 10.1111/hdi.12795. Epub
2019 Nov 7.
---------------------------------------------------------------------------
Kraus M, et al.\194\ is a study involving the comparator
technology known as NxStage[supreg] System, which is a portable HD
unit. This was a prospective, open-label, crossover study comparing in-
center HD versus home HD in 32 patients over 18 weeks total. The
primary endpoint was delivery of 90 percent prescribed fluid volume,
which was achieved in similar fashion and >90 percent in both groups.
There were statistically significant differences in adverse events,
which favored the home HD group. The applicant included this study to
demonstrate similar evidence as well as compare time spent in
performing the home sessions. Treatment durations were slightly shorter
than what was noted in the IDE study above (mean 2.8 hours for
NxStage[supreg] versus mean 3.4 hours with Tablo[supreg] Hemodialysis
System). This study was supported by NxStage[supreg] Medical Inc.
---------------------------------------------------------------------------
\194\ Kraus M, Burkart J, Hegeman R, Solomon R, Coplon N, Moran
J, A comparison of center-based vs. home-based daily hemodialysis
for patients with end-stage renal disease. Hemodialysis
International,11: 468-477, (2007).
---------------------------------------------------------------------------
Posters/Abstracts
Alvarez, Luis et al.\195\ is a retrospective study, 29
patients underwent HD with the Tablo[supreg] Hemodialysis System at a
lower flow rate than what is used in conventional in-center HD. Average
treatment times were slightly higher in the Tablo[supreg] Hemodialysis
System group compared to those using non-Tablo[supreg] systems. After
patient weight stratification at 90 kg, authors felt that both groups
achieved similar weight changes (extrapolated from pre and post
weights), as well as Kt/Vurea change. This research was funded by
Outset Medical, Inc.
---------------------------------------------------------------------------
\195\ Alvarez L, Spry L. Mulhern J, PPrichard S, Shallall C,
Chertow G, Aragon, M, Urea Clearance Results in Patients Dialyzed
Thrice Weekly Using a Dialysate Flow of 300 mL/min, clinical
abstract, presented March 2019, Annual Dialysis Conference, Dallas,
TX.
---------------------------------------------------------------------------
Alvarez, Luis et al.\196\ utilized lower flow rates of 300
ml/min, and evaluated patients as they transitioned to in-center but
self-directed HD with Tablo[supreg] Hemodialysis System. Patients
underwent 3 times a week treatment and data was collected over a 3-
month period. Based on urea samples and calculated Kt/Vurea, authors
concluded that this treatment resulted in adequate clearance.
---------------------------------------------------------------------------
\196\ Alvarez, Luis and Chertow, Glenn, Real World In-Center
Urea Clearance Experience with a Novel Hemodialysis System, clinical
abstract, presented March 2019, Annual Dialysis Conference, Dallas,
TX.
---------------------------------------------------------------------------
Chahal, Yaadveer \197\ is a study that focused on the
patient experience through surveys and compared the patient's responses
to prior in-home and in-center experiences. As part of the IDE study,
13 participants provided survey responses to compare their experience
with the Tablo[supreg] Hemodialysis System to their prior experience
with in-home dialysis. Of those 13 participants, 85.6 percent found
this system easier to use. While this is promising, the true test of
superiority in this realm would be rates of discontinuation at 1 year.
Issues of self-cannulation and the burden of this responsibility still
remain with this system. The primary study was undertaken by Outset
Medical.
---------------------------------------------------------------------------
\197\ Chahal, Yaadveer. Patient Device Preference for Home
Hemodialysis: A Subset Analysis of the Tablo Home IDE Trial,
Abstract Accepted by the National Kidney Foundation Spring Clinical
Meeting 2020.
---------------------------------------------------------------------------
[[Page 42183]]
Unpublished Data
Outset Medical Data \198\ is a limited section, in which
the applicant submitted cold and hypotensive events while on in-center
or in-home HD. From just raw numbers, there were lower percentages of
either sign/symptom within the home dialysis group compared to in-
center.
---------------------------------------------------------------------------
\198\ Outset Medical Data from Home IDE Trial, page 33 of
clinical report submitted to the FDA, data Table 43, 2019.
---------------------------------------------------------------------------
(g) Comments of the CMS TPNIES Work Group
Only the Tablo[supreg] Cartridge portion of the Tablo[supreg]
Hemodialysis System is being evaluated in this application, but it is
important to note that it can only be used with the Tablo[supreg]
Hemodialysis System. Although there are changes to the Tablo[supreg]
Hemodialysis System for home use, the cartridge portion remains
unchanged from its original FDA approval. Therefore, the cartridge
itself is not new. Also, it is unclear as to whether the Tablo[supreg]
Hemodialysis System can be used in-center without the cartridge. As
such, much of the evidence presented in this application is really
about the system itself, such as ease of training, its various
features, and less about the incremental benefit of using the
cartridge. Additionally, the system itself may have its own risks and
benefits which are not within the scope of this application, and
peripherally and incompletely addressed with the provided materials.
For example, a study should be conducted determining the number of
patients who were back in the hospital for a dialysis-related
condition.
To evaluate the cartridge, it would be helpful to have studies on
whether there are any issues with the components of the cartridge (that
is, any dialyzer reactions to tubing, any issues affecting clearance).
Since the primary intent of the cartridge is to facilitate patient set-
up at home, the most useful evidence would be in the form of larger
studies of patient-reported outcomes, quality of life, analyses of
patient/caregiver burnout, and sustained adherence (beyond 1 year) to
the use of this home-based modality. If the applicant is claiming to
improve the patients' quality of life, then it needs to be proven for
patient-specific outcomes and with a risk-benefit analysis to the
patient. In some of the references cited, the patient factors affecting
home HD are self-cannulation, burdens to caregivers, and concerns for
complications, yet the cartridge has not demonstrated improvements in
addressing these issues.
The cartridge is a promising concept to encourage home HD but
again, the evaluation of this technology is complicated by the need to
also peripherally assess the system. There does not appear to be a need
for this cartridge in the hospital or clinic setting as trained
personnel should be able to assist with set-up. Within the larger
policy context of FDA approval and the fact that TPNIES does not
currently cover capital-related assets, the CMS TPNIES Work Group
believes there are some irregularities and misalignments in the current
application, and is concerned that the stand-alone cartridge cannot be
evaluated for meeting the criteria for SCI.
We invite public comment as to whether the stand-alone cartridge of
the Tablo[supreg] Hemodialysis System meets the SCI criteria for the
TPNIES.
III. CY 2021 Payment for Renal Dialysis Services Furnished to
Individuals With Acute Kidney Injury (AKI)
A. Background
The Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27)
was enacted on June 29, 2015, and amended the Act to provide coverage
and payment for dialysis furnished by an ESRD facility to an individual
with acute kidney injury (AKI). Specifically, section 808(a) of the
TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for
renal dialysis services furnished on or after January 1, 2017, by a
renal dialysis facility or a provider of services paid under section
1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the
TPEA amended section 1834 of the Act by adding a subsection (r) to
provide payment, beginning January 1, 2017, for renal dialysis services
furnished by renal dialysis facilities or providers of services paid
under section 1881(b)(14) of the Act to individuals with AKI at the
ESRD PPS base rate, as adjusted by any applicable geographic adjustment
applied under section 1881(b)(14)(D)(iv)(II) of the Act and adjusted
(on a budget neutral basis for payments under section 1834(r) of the
Act) by any other adjustment factor under section 1881(b)(14)(D) of the
Act that the Secretary elects.
In the CY 2017 ESRD PPS final rule, we finalized several coverage
and payment policies in order to implement subsection (r) of section
1834 of the Act and the amendments to section 1881(s)(2)(F) of the Act,
including the payment rate for AKI dialysis (81 FR 77866 through 77872,
and 77965). We interpret section 1834(r)(1) of the Act as requiring the
amount of payment for AKI dialysis services to be the base rate for
renal dialysis services determined for a year under the ESRD PPS base
rate as set forth in Sec. 413.220, updated by the ESRD bundled market
basket percentage increase factor minus a productivity adjustment as
set forth in Sec. 413.196(d)(1), adjusted for wages as set forth in
Sec. 413.231, and adjusted by any other amounts deemed appropriate by
the Secretary under Sec. 413.373. We codified this policy in Sec.
413.372 (81 FR 77965).
B. Proposed Annual Payment Rate Update for CY 2021
1. CY 2021 AKI Dialysis Payment Rate
The payment rate for AKI dialysis is the ESRD PPS base rate
determined for a year under section 1881(b)(14) of the Act, which is
the finalized ESRD PPS base rate, including the applicable annual
market basket payment update, geographic wage adjustments and any other
discretionary adjustments, for such year. We note that ESRD facilities
have the ability to bill Medicare for non-renal dialysis items and
services and receive separate payment in addition to the payment rate
for AKI dialysis.
As discussed in section II.B.4.d of this proposed rule, the CY 2021
proposed ESRD PPS base rate is $255.59, which reflects the application
of the proposed CY 2021 wage index budget-neutrality adjustment factor
of .998652, a proposed addition to the ESRD PPS base rate to include
calcimimetics, and the CY 2021 proposed ESRDB market basket increase of
2.2 percent reduced by the multifactor productivity adjustment of 0.4
percentage points, that is, 1.8 percent. Accordingly, we are proposing
a CY 2021 per treatment payment rate of $255.59 for renal dialysis
services furnished by ESRD facilities to individuals with AKI. This
payment rate is further adjusted by the wage index as discussed below.
2. Geographic Adjustment Factor
Under section 1834(r)(1) of the Act and Sec. 413.372, the amount
of payment for AKI dialysis services is the base rate for renal
dialysis services determined for a year under section 1881(b)(14) of
the Act (updated by the ESRD bundled market basket and multifactor
productivity adjustment), as adjusted by any applicable geographic
adjustment factor applied under section 1881(b)(14)(D)(iv)(II) of the
Act. Accordingly, we apply the same wage index under Sec. 413.231 that
is used under the ESRD PPS and discussed in section II.B.4.b of this
proposed rule. The AKI dialysis payment rate is adjusted by the wage
index for a
[[Page 42184]]
particular ESRD facility in the same way that the ESRD PPS base rate is
adjusted by the wage index for that facility (81 FR 77868).
Specifically, we apply the wage index to the labor-related share of the
ESRD PPS base rate that we utilize for AKI dialysis to compute the wage
adjusted per-treatment AKI dialysis payment rate. As stated previously,
we are proposing a CY 2021 AKI dialysis payment rate of $255.59,
adjusted by the ESRD facility's wage index.
IV. End-Stage Renal Disease Quality Incentive Program (ESRD QIP)
A. Background
For a detailed discussion of the End-Stage Renal Disease Quality
Incentive Program's (ESRD QIP's) background and history, including a
description of the Program's authorizing statute and the policies that
we have adopted in previous final rules, we refer readers to the
following final rules:
CY 2011 ESRD PPS final rule (75 FR 49030),
CY 2012 ESRD PPS final rule (76 FR 628),
CY 2012 ESRD PPS final rule (76 FR 70228),
CY 2013 ESRD PPS final rule (77 FR 67450),
CY 2014 ESRD PPS final rule (78 FR 72156),
CY 2015 ESRD PPS final rule (79 FR 66120),
CY 2016 ESRD PPS final rule (80 FR 68968),
CY 2017 ESRD PPS final rule (81 FR 77834),
CY 2018 ESRD PPS final rule (82 FR 50738),
CY 2019 ESRD PPS final rule (83 FR 56922), and
CY 2020 ESRD PPS final rule (84 FR 60713).
We have also codified many of our policies for the ESRD QIP at 42
CFR 413.177 and 413.178.
B. Proposed Updates to Requirements Beginning With the PY 2023 ESRD QIP
1. PY 2023 ESRD QIP Measure Set
Under our current policy, we retain all ESRD QIP measures from year
to year unless we propose through rulemaking to remove them or
otherwise provide notification of immediate removal if a measure raises
potential safety issues (77 FR 67475). Accordingly, the PY 2023 ESRD
QIP measure set will include the same 14 measures as the PY 2022 ESRD
QIP measure set. These measures are described in Table 6.
BILLING CODE 4120-01-P
[[Page 42185]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.008
BILLING CODE 4120-01-C
2. Estimated Performance Standards for the PY 2023 ESRD QIP
Section 1881(h)(4)(A) of the Social Security Act (the Act) requires
the Secretary to establish performance standards with respect to the
measures selected for the ESRD QIP for a performance period with
respect to a year. The performance standards must include levels of
achievement and improvement, as required by section 1881(h)(4)(B) of
the Act, and must be established prior to the beginning of the
performance period for the year involved, as required by section
1881(h)(4)(C) of the Act. We refer readers to the CY 2013 ESRD PPS
final rule (76 FR 70277) for a discussion of the achievement and
improvement standards that we have established for clinical measures
used in the ESRD QIP. We recently codified definitions for the terms
``achievement threshold,'' ``benchmark,'' ``improvement threshold,''
and ``performance standard'' in our regulations at Sec. 413.178(a)(1),
(3), (7), and (12), respectively.
In the CY 2020 ESRD PPS final rule (84 FR 60728), we set the
performance period for the PY 2023 ESRD QIP as CY 2021 and the baseline
period as CY
[[Page 42186]]
2019. In this proposed rule, we are estimating the achievement
thresholds, 50th percentiles of the national performance, and
benchmarks for the PY 2023 clinical measures in Table 7 using data from
2018. We intend to update these standards, using CY 2019 data, in the
CY 2021 ESRD PPS final rule.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP13JY20.009
BILLING CODE 4120-01-C
3. Proposed Update to the Scoring Methodology for the Ultrafiltration
Rate Reporting Measure
In the CY 2017 ESRD PPS final rule, we adopted the Ultrafiltration
Rate reporting measure under the authority of section 1881(h)(2)(B)(ii)
of the Act (81 FR 77912). The measure assesses the number of months for
which a facility reports all data elements required to calculate
ultrafiltration rates (UFR) for each qualifying patient. It is based
upon the NQF-endorsed Avoidance of Utilization of High Ultrafiltration
Rate (>/= 13 ml/kg/hr) (NQF #2701), which assesses the percentage of
patient-months for patients with a UFR greater than or equal to 13 ml/
kg/hr.
In the CY 2017 ESRD PPS final rule (81 FR 77917), we also finalized
a policy to score the Ultrafiltration Rate reporting measure using the
following equation, beginning in PY 2020 (81 FR 77917):
[[Page 42187]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.010
In this proposed rule, we are proposing to replace the current
Ultrafiltration Rate reporting measure scoring equation with the
following equation, beginning with PY 2023:
[GRAPHIC] [TIFF OMITTED] TP13JY20.011
This proposal would modify the scoring methodology for the
Ultrafiltration Rate reporting measure so that facilities would be
scored based on the number of eligible patient-months, as opposed to
facility-months. The facility-month scoring methodology requires
facilities to report every data element necessary to calculate a UFR
reporting rate for 100 percent of its eligible patients each month in
order to receive any credit for successfully reporting the measure for
that month. The facility-month scoring approach then counts the number
of months in the performance period that the facility received credit
for reporting over the course of the performance period. For example,
under the facility-scoring methodology, if a facility has 10 eligible
patients in January, the facility must report all required UFR data
elements for each of those 10 patients in order to receive any credit
for January reporting. If the facility only reports the required UFR
data elements for 9 of those 10 patients, the facility receives a zero
for January. Our concern with this approach is that there may be
circumstances, such as when an eligible patient is hospitalized, when
facilities cannot obtain UFR data for a single patient, and as a
consequence, cannot receive any credit for the data it did report that
month. When we finalized the Ultrafiltration Rate reporting measure in
the CY 2017 ESRD PPS final rule, stakeholders raised their concern
regarding this issue (81 FR 77914). At the time, we responded that
because we defined the population for this reporting measure by
assignment to a facility for a full month, the facility is still
required to provide data even in cases where a patient may spend part
of that month hospitalized since the data elements are products of
ongoing dialysis treatment. We stated that since we do not restrict
facilities from coordinating with hospitals to obtain relevant data, we
believed that such coordination is appropriate. However, our rationale
for this was based on the reporting requirements prescribed by a
facility-month definition. Furthermore, coordinating with hospitals to
obtain relevant data continues to be a stakeholder concern in reporting
UFR data. We believe that the proposed patient-month scoring
methodology is more objective because it scores facilities based on the
percentage of eligible patients across the entire performance period
for which they report all UFR data elements. Thus, if a facility has
100 eligible patients in CY 2020 and reports all data elements
necessary to calculate a UFR rate for 90 of them, the facility will
receive a rounded score based on a 90 percent reporting rate. We
believe that this methodology will give facilities more flexibility to
receive credit for UFR reporting throughout the 12-month performance
period.
The Ultrafiltration Rate reporting measure is intended to guard
against risks associated with high ultrafiltration (that is, rapid
fluid removal) rates for adult dialysis patients undergoing HD, because
of indications that high ultrafiltration is an independent predictor of
mortality. Faster ultrafiltration may lead to a number of health risks
resulting from large volumes of fluid removed rapidly during each
dialysis session, with deleterious consequences for the patient both in
the short and longer term. The outcome of this reporting measure is the
documentation of the ultrafiltration measurements, which ultimately
contributes to the quality of the patient's ESRD treatment. We believe
that calculating the measure rates using the patient-month scoring
methodology better supports our goal of assessing performance on
whether the facility is documenting UFR for its eligible patients,
which we believe will lead to better patient-level outcomes.
We also believe that this change is consistent with our plan to re-
evaluate our reporting measures for opportunities to more closely align
them with NQF measure specifications (see 84 FR 60724). We believe that
this proposed change would make the Ultrafiltration Rate reporting
measure more consistent with the NQF measure upon which it is based,
Avoidance of Utilization of High Ultrafiltration Rate (>/= 13 ml/kg/hr)
(NQF #2701), which reports results using a ``patient-month''
construction. Although we recognize that both the Anemia Management
reporting measure and the Serum Phosphorus reporting measure are also
calculated using a facility-month construction, we are not proposing to
change the scoring methodology used for either of those measures
because both measures are finalized for removal beginning with the PY
2021 ESRD QIP (83 FR 56986 through 56989). The proposed update to the
UFR reporting measure scoring methodology will make the scoring
methodology for that measure consistent with the scoring methodology we
are using to calculate the Medication Reconciliation (MedRec) reporting
measure (83 FR 57011). We also believe that the utilization of this
patient-month scoring methodology for both the MedRec and the
Ultrafiltration Rate reporting measures better reflects our intent to
score facilities based on actions taken by the facility that impact
patient experiences. .
We seek comment on this proposal.
4. Eligibility Requirements for the PY 2023 ESRD QIP
Our current minimum eligibility requirements for scoring the ESRD
QIP measures are described in Table 8. We are not proposing any changes
to these eligibility requirements for the PY 2023 ESRD QIP in this
proposed rule.
[[Page 42188]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.012
5. Clarification of the Timeline for Facilities To Make Changes To
Their NHSN Bloodstream Infection (BSI) Clinical Measure and NHSN
Dialysis Event Reporting Measure Data for Purposes of the ESRD QIP
Under our current policy for the NHSN BSI clinical measure and NHSN
Dialysis Event reporting measure, facilities are required to submit
monthly data on a quarterly basis, and each quarter's data is due 3
months after the end of the quarter (81 FR 77879 through 77881). For
example, data collected by facilities between January 1 and March 31,
2021 is due to NHSN by June 30, 2021, data collected between April 1
and June 30, 2021 is due to NHSN by September 30, 2021, and data
collected between July 1 and September 30, 2021 is due to NHSN by
December 31, 2021. After each quarterly data submission deadline, the
Centers for Disease Control and Prevention (CDC) takes a snapshot of
the facility's data for the quarter and creates a permanent data file.
Each quarterly permanent data file is aggregated together to create the
annual CMS ESRD QIP Final Compliance File, which the CDC transmits to
CMS for purposes of determining whether the facility has met the
reporting requirements for these measures. Facilities may make changes
to their quarterly NHSN data for purposes of the ESRD QIP at any point
up until the applicable quarterly submission data deadline.
We have become aware that the NHSN system does not prevent
facilities from making changes to their data for purposes of CDC
surveillance after the applicable ESRD QIP quarterly submission
deadline has passed. However, we are clarifying that any changes that a
facility makes to its data after the ESRD QIP deadline that applies to
those data will not be included in the quarterly permanent data file
that the CDC generates for purposes of creating the annual CMS ESRD QIP
Final Compliance File. Rather, as noted above, each quarterly permanent
data file captures a snapshot of the facility's data as of the
quarterly submission deadline, and that file cannot be updated for
purposes of the ESRD QIP because of operational and timing issues.
6. Estimated Payment Reduction for the PY 2023 ESRD QIP
Under our current policy, a facility will not receive a payment
reduction for a payment year in connection with its performance for the
ESRD QIP if it achieves a total performance score (TPS) that is at or
above the minimum TPS (mTPS) that we establish for the payment year. We
have defined the
[[Page 42189]]
mTPS in our regulations at Sec. 413.178(a)(8) as, with respect to a
payment year, the TPS that an ESRD facility would receive if, during
the baseline period it performed at the 50th percentile of national
performance on all clinical measures and the median of national ESRD
facility performance on all reporting measures.
Our current policy, which is codified at Sec. 413.177 of our
regulations, is also to implement the payment reductions on a sliding
scale using ranges that reflect payment reduction differentials of 0.5
percent for each 10 points that the facility's TPS falls below the
minimum TPS (76 FR 634 through 635).
For PY 2023, we estimate based on available data that a facility
must meet or exceed a mTPS of 57 in order to avoid a payment reduction.
We note that the mTPS estimated in this proposed rule is based on data
from CY 2018 instead of the PY 2023 baseline period (CY 2019) because
CY 2019 data are not yet available.
We refer readers to Table 7 for the estimated values of the 50th
percentile of national performance for each clinical measure. Under our
current policy, a facility that achieves a TPS below 57 would receive a
payment reduction based on the TPS ranges indicated in Table 9.
[GRAPHIC] [TIFF OMITTED] TP13JY20.013
We intend to update the mTPS for PY 2023, as well as the payment
reduction ranges for that payment year, in the CY 2021 ESRD PPS final
rule.
7. Proposal To Reduce the Number of Records That a Facility Selected
for NHSN Validation Must Submit
One of the critical elements of the ESRD QIP's success is ensuring
that the data submitted to calculate measure scores and TPSs are
accurate. The ESRD QIP currently includes two validation studies for
this purpose: the Consolidated Renal Operations in a Web-Enabled
Network (CROWNWeb) data validation study (OMB Control Number 0938-1289)
and the NHSN validation study (OMB Control Number 0938-1340). In the CY
2019 ESRD PPS final rule, we adopted the CROWNWeb data validation study
as a permanent feature of the Program (83 FR 57003). Under that policy,
we will continue validating CROWNWeb data in PY 2023 and subsequent
payment years, and we will deduct 10 points from a facility's TPS if it
is selected for validation but does not submit the requested records.
We also adopted a methodology for the PY 2022 NHSN validation
study, which targets facilities for NHSN validation by identifying
facilities that are at risk for under-reporting. For additional
information on this methodology, we refer readers to the CY 2018 ESRD
PPS final rule (82 FR 50766 through 50767). In the CY 2020 ESRD PPS
final rule, we finalized our proposal to continue using this
methodology for the NHSN validation study for PY 2023 and subsequent
years (84 FR 60727). In that rule, we concluded that to achieve the
most reliable results for a payment year, we would need to review
approximately 6,072 charts submitted by 303 facilities, and that this
sample size would produce results with a 95 percent confidence level
and a 1 percent margin of error. Based on those results and our desire
to ensure that dialysis event data reported to the NHSN for purposes of
the ESRD QIP are accurate, we finalized our proposal to continue use of
this methodology in the PY 2023 NHSN validation study and for
subsequent years.
Additionally, as we had previously finalized for CROWNWeb
validation, we finalized our proposal to adopt NHSN validation as a
permanent feature of the ESRD QIP with the methodology we first
finalized for PY 2022 and are continuing for PY 2023 and subsequent
years. We continue to believe that the purpose of our validation
programs is to ensure the accuracy and completeness of data that are
scored under the ESRD QIP, and we believe that validating NHSN data
using this methodology achieves that goal.
In the CY 2019 ESRD PPS final rule, we finalized that a sample of
300 facilities will be selected for the NHSN validation study each
year, and that each facility will be required to submit 20 patient
records per quarter for each of the first two quarters of the calendar
year (83 FR 57001), for a total of 40 records. In this proposed rule,
we are proposing to change this requirement and allow facilities
selected to participate in the NHSN validation study to submit a total
of 20 patient records for the applicable calendar year. We are also
proposing to allow facilities to submit patient records from any two
quarters during the year, as long as all of the records are from no
more than two quarters. For example, a facility could choose to submit
2 records from Q1 and 18 records from Q4, or 6 records from Q2 and 14
records from Q3, but it could not submit 4 records from Q1, 8 records
from Q2, and 8 records from Q3.
We have concluded that this revised approach would reduce facility
burden by decreasing the required number of patient records and
allowing more flexibility for facilities to choose what records to
submit, while continuing to maintain a sample size that is adequate for
our validation analysis. In reaching this conclusion, we were informed
by the CDC's recommendations. Based on the sample estimation analysis,
the CDC recommended the following factors to
[[Page 42190]]
improve the precision of estimation of accuracy of dialysis events
reported to NHSN: An expected 80 percent of dialysis events reporting
accuracy from facilities and setting the precision of the NHSN
validation study to a 95 percent confidence level and 1 percent margin
of error, which would require a total of 6,072 chart reviews. Beginning
with the CY 2017 and CY 2018 NHSN dialysis validation, we have
gradually increased the number of facilities randomly selected for
validation, as well as the number of charts for review, in order to
achieve the 6,000 chart threshold necessary for an accurate review.
Initially, 35 facilities were randomly selected and 10 charts per
facility were reviewed. For CY 2019, 150 facilities were randomly
selected and each facility submitted a total of 20 records, to achieve
the total of 3,000 charts available for review. For CY 2020, the goal
was to increase from 150 to 300 facilities, where each facility would
submit a total of 20 records thereby achieving the total of 6,000
charts available for review, as we previously finalized (83 FR 57001).
Because a total of 20 records would achieve the 6,000 chart threshold
necessary for an accurate review, we concluded that we could reduce the
sample size from 40 records to 20 records. We believe a total of 20
medical records across a 6-month validation study time frame for a
calendar year, rather than 20 records per quarter, would provide a
sufficiently accurate sample size.
We believe the reduction in patient records still provides an
adequate sample size for the validation and reduces overall facility
burden. A recent estimation analysis conducted by the CDC supports our
belief that a review of 20 charts per facility across a specified
validation timeline that are acquired by randomly selecting
approximately 300 facilities would continue to meet the medical record
selection criteria outlined in the NHSN Dialysis Validation
methodology. This would meet the CDC's recommended sample estimate to
achieve the 95 percent confidence level precision and 1 percent margin
of error, while also reducing facility burden.
We seek comment on this proposal.
We are not proposing any changes to the CROWNWeb validation study
methodology.
C. Proposals for the PY 2024 ESRD QIP
1. Continuing Measures for the PY 2024 ESRD QIP
Under our previously adopted policy, the PY 2023 ESRD QIP measure
set will also be used for PY 2024.
2. Performance Period for the PY 2023 ESRD QIP and Subsequent Years
We continue to believe that 12-month performance and baseline
periods provide us sufficiently reliable quality measure data for the
ESRD QIP. In the CY 2020 ESRD PPS final rule, we finalized the
performance and baseline periods for the PY 2023 ESRD QIP (84 FR
60728). We also finalized our proposal to adopt automatically a
performance and baseline period for each year that is 1 year advanced
from those specified for the previous payment year. For example, under
this policy, we would automatically adopt CY 2022 as the performance
period and CY 2020 as the baseline period for the PY 2024 ESRD QIP.
In this proposed rule, we are not proposing any changes to this
policy.
3. Performance Standards for the PY 2024 ESRD QIP and Subsequent Years
Section 1881(h)(4)(A) of the Act requires the Secretary to
establish performance standards with respect to the measures selected
for the ESRD QIP for a performance period with respect to a year. The
performance standards must include levels of achievement and
improvement, as required by section 1881(h)(4)(B) of the Act, and must
be established prior to the beginning of the performance period for the
year involved, as required by section 1881(h)(4)(C) of the Act. We
refer readers to the CY 2012 ESRD PPS final rule (76 FR 70277) for a
discussion of the achievement and improvement standards that we have
established for clinical measures used in the ESRD QIP. We recently
codified definitions for the terms ``achievement threshold,''
``benchmark,'' ``improvement threshold,'' and ``performance standard''
in our regulations at Sec. 413.178(a)(1), (3), (7), and (12),
respectively.
a. Performance Standards for Clinical Measures in the PY 2024 ESRD QIP
At this time, we do not have the necessary data to assign numerical
values to the achievement thresholds, benchmarks, and 50th percentiles
of national performance for the clinical measures because we do not
have CY 2020 data. We intend to publish these numerical values, using
CY 2020 data, in the CY 2022 ESRD PPS final rule.
b. Performance Standards for the Reporting Measures in the PY 2024 ESRD
QIP
In the CY 2019 ESRD PPS final rule, we finalized the continued use
of existing performance standards for the Screening for Clinical
Depression and Follow-Up reporting measure, the Ultrafiltration Rate
reporting measure, the NHSN Dialysis Event reporting measure, and the
MedRec reporting measure (83 FR 57010 through 57011). We will continue
use of these performance standards in PY 2024.
4. Scoring the PY 2024 ESRD QIP
a. Scoring Facility Performance on Clinical Measures
In the CY 2014 ESRD PPS final rule, we finalized policies for
scoring performance on clinical measures based on achievement and
improvement (78 FR 72215 through 72216). In the CY 2019 ESRD PPS final
rule, we finalized a policy to continue use of this methodology for
future payment years (83 FR 57011) and we codified these scoring
policies at Sec. 413.178(e).
We are not proposing to change our scoring policies in this
proposed rule.
b. Scoring Facility Performance on Reporting Measures
Our policy for scoring performance on reporting measures is
codified at Sec. 413.178(e), and more information on our scoring
policy for reporting measures can be found in the CY 2020 ESRD PPS
final rule (84 FR 60728). We previously finalized policies for scoring
performance on the NHSN Dialysis Event reporting measure in the CY 2018
ESRD PPS final rule (82 FR 50780 through 50781), as well as policies
for scoring the Ultrafiltration Rate reporting measure, MedRec
reporting measure, and Clinical Depression Screening and Follow-up
reporting measure in the CY 2019 ESRD PPS final rule (83 FR 57011). We
also previously finalized the scoring policy for the STrR reporting
measure in the CY 2020 ESRD PPS final rule (84 FR 60721 through 60723).
We refer the reader to section IV.B.3 of this proposed rule for
proposed changes to the scoring methodology for the Ultrafiltration
Rate reporting measure.
5. Weighting the Measure Domains and the TPS for PY 2024
Under our current policy, we assign the Patient & Family Engagement
Measure Domain a weight of 15 percent of the TPS, the Care Coordination
Measure Domain a weight of 30 percent of the TPS, the Clinical Care
Measure Domain a weight of 40 percent of the TPS, and the Safety
Measure domain a weight of 15 percent of the TPS.
In the CY 2019 ESRD PPS final rule, we finalized a policy to assign
weights to individual measures and a policy to redistribute the weight
of unscored measures (83 FR 57011 through 57012). In the CY 2020 ESRD
PPS final rule, we finalized a policy to use the measure weights we
finalized for PY 2022 for the
[[Page 42191]]
PY 2023 ESRD QIP and subsequent payment years, and also to use the PY
2022 measure weight redistribution policy for the PY 2023 ESRD QIP and
subsequent payment years (84 FR 60728 through 60729). We are not
proposing any updates to these policies. Under our current policy, a
facility must be eligible to be scored on at least one measure in two
of the four measures domains in order to be eligible to receive a TPS
(83 FR 57012).
V. Collection of Information Requirements
A. Legislative Requirement for Solicitation of Comments
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection requirement
should be approved by OMB, the Paperwork Reduction Act of 1995 (44
U.S.C. 3506(c)(2)(A)) requires that we solicit comment on the following
issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs):
Using the following format describe the information collection
requirements that are in each section.
B. Requirements in Regulation Text
In sections II.B.1 through II.B.3 and II.B.5 of this proposed rule,
we are proposing changes to regulatory text for the ESRD PPS for CY
2021. However, the changes that are being proposed do not impose any
new information collection requirements.
C. Additional Information Collection Requirements
This proposed rule does not impose any new information collection
requirements in the regulation text, as specified above. However, there
are changes in some currently approved information collections. The
following is a discussion of these information collections.
1. ESRD QIP--Wage Estimates
To derive wages estimates, we used data from the U.S. Bureau of
Labor Statistics' May 2019 National Occupational Employment and Wage
Estimates. In the CY 2016 ESRD PPS final rule (80 FR 69069), we stated
that it was reasonable to assume that Medical Records and Health
Information Technicians, who are responsible for organizing and
managing health information data, are the individuals tasked with
submitting measure data to CROWNWeb and NHSN, as well as compiling and
submitting patient records for purpose of the data validation studies,
rather than a Registered Nurse, whose duties are centered on providing
and coordinating care for patients. The median hourly wage of a Medical
Records and Health Information Technician is $20.50 per hour.\199\
Fringe benefit and overhead are calculated at 100 percent. Therefore,
using these assumptions, we estimate an hourly labor cost of $41.00 as
the basis of the wage estimates for all collections of information
calculations in the ESRD QIP. We have adjusted these employee hourly
wage estimates by a factor of 100 percent to reflect current HHS
department-wide guidance on estimating the cost of fringe benefits and
overhead. These are necessarily rough adjustments, both because fringe
benefits and overhead costs vary significantly from employer to
employer and because methods of estimating these costs vary widely from
study to study. Nonetheless, there is no practical alternative and we
believe that these are reasonable estimation methods.
---------------------------------------------------------------------------
\199\ https://www.bls.gov/oes/current/oes292098.htm.
---------------------------------------------------------------------------
We used this updated wage estimate, along with updated facility and
patient counts to re-estimate the total information collection burden
in the ESRD QIP for PY 2023 that we discussed in the CY 2020 ESRD QIP
final rule (84 FR 60787 through 60788) and to estimate the total
information collection burden in the ESRD QIP for PY 2024. We provide
the re-estimated information collection burden associated with the PY
2023 ESRD QIP and the newly estimated information collection burden
associated with the PY 2024 ESRD QIP in sections IV.C.2 and IV.C.3 of
this proposed rule.
2. Estimated Burden Associated With the Data Validation Requirements
for PY 2023 and PY 2024
In the CY 2020 ESRD PPS final rule, we finalized a policy to adopt
the CROWNWeb data validation methodology that we previously adopted for
the PY 2016 ESRD QIP as the methodology we would use to validate
CROWNWeb data for all payment years, beginning with PY 2021 (83 FR
57001 through 57002). Under this methodology, 300 facilities are
selected each year to submit 10 records to CMS, and we reimburse these
facilities for the costs associated with copying and mailing the
requested records. The burden associated with these validation
requirements is the time and effort necessary to submit the requested
records to a CMS contractor. In this proposed rule, we are updating
these estimates using a newly available wage estimate of a Medical
Records and Health Information Technician. We estimate that it will
take each facility approximately 2.5 hours to comply with this
requirement. If 300 facilities are asked to submit records, we estimate
that the total combined annual burden for these facilities will be 750
hours (300 facilities x 2.5 hours). Since we anticipate that Medical
Records and Health Information Technicians or similar administrative
staff will submit these data, we estimate that the aggregate cost of
the CROWNWeb data validation each year will be approximately $30,750
(750 hours x $41.00), or an annual total of approximately $102.50
($30,750/300 facilities) per facility in the sample. The decrease in
our burden estimate is due to using the median hourly wage instead of
the mean hourly wage for Medical Records and Health Information
Technicians or similar staff and is not the result of any policies
proposed in this proposed rule. The burden associated with these
requirements is captured in an information collection request (OMB
control number 0938-1289).
In section IV.B.7 of this proposed rule, we proposed to reduce the
number of records that a facility selected to participate in the NHSN
data validation study must submit to a CMS contractor, beginning with
PY 2023. Under the proposal, a facility would be required to submit
records for 20 patients across any two quarters of the year, instead of
20 records for each of the first two quarters of the year. The burden
associated with this proposal is the time and effort necessary to
submit the requested records to a CMS contractor. Applying our proposal
to reduce the
[[Page 42192]]
number of records required from each facility participating in the NHSN
validation study, we estimate that it would take each facility
approximately 5 hours to comply with this requirement. If 300
facilities are asked to submit records each year, we estimate that the
total combined annual burden hours for these facilities per year would
be 1,500 hours (300 facilities x 5 hours). Since we anticipate that
Medical Records and Health Information Technicians or similar staff
would submit these data, using the newly available wage estimate of a
Medical Records and Health Information Technician, we estimate that the
aggregate cost of the NHSN data validation each year would be
approximately $61,500 (1,500 hours x $41), or a total of approximately
$205 ($61,500/300 facilities) per facility in the sample. The reduction
in our burden estimate is due to a reduction in the number of medical
records collected and the utilization of the median hourly wage instead
of the mean hourly wage. The burden associated with these requirements
is captured in an information collection request (OMB control number
0938-1340).
3. CROWNWeb Reporting Requirements for PY 2023 and PY 2024
To determine the burden associated with the CROWNWeb reporting
requirements, we look at the total number of patients nationally, the
number of data elements per patient-year that the facility would be
required to submit to CROWNWeb for each measure, the amount of time
required for data entry, the estimated wage plus benefits applicable to
the individuals within facilities who are most likely to be entering
data into CROWNWeb, and the number of facilities submitting data to
CROWNWeb. In the CY 2020 ESRD PPS final rule, we estimated that the
burden associated CROWNWeb reporting requirements for the PY 2023 ESRD
QIP was approximately $211 million.
We are not proposing any changes that would affect the burden
associated with CROWNWeb reporting requirements for PY 2023 or PY 2024.
However, we have re-calculated the burden estimate for PY 2023 using
updated estimates of the total number of dialysis facilities, the total
number of patients nationally, and wages for Medical Records and Health
Information Technicians or similar staff as well as a refined estimate
of the number of hours needed to complete data entry for CROWNWeb
reporting. In the CY 2020 ESRD PPS final rule, we estimated that the
amount of time required to submit measure data to CROWNWeb was 2.5
minutes per element and used a rounded estimate of 0.042 hours in our
calculations. In this proposed rule, we did not use a rounded estimate
of the time needed to complete data entry for CROWNWeb reporting. There
are 229 data elements for 523,314 patients across 7,386 facilities. At
2.5 minutes per element, this yields approximately 676.05 hours per
facility. Therefore, the PY 2023 burden is 4,993,288 hours (676.05
hours x 7,386 facilities). (Using the wage estimate of a Medical
Records and Health Information Technician, we estimate that the PY 2023
total burden cost is $205 million (4,993,288 hours x $41). There is no
net incremental burden change from PY 2023 to PY 2024 because we are
not proposing to change the reporting requirements for PY 2024.
VI. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
VII. Economic Analyses
A. Regulatory Impact Analysis
1. Introduction
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review, Executive Order 13563 on
Improving Regulation and Regulatory Review, the Regulatory Flexibility
Act (RFA) (Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4), Executive Order 13132 on Federalism, the Congressional Review Act
(5 U.S.C. 801 et seq.), and Executive Order 13771 on Reducing
Regulation and Controlling Regulatory Costs.
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. Accordingly, we have prepared a RIA
that to the best of our ability presents the costs and benefits of the
rulemaking.
We solicit comments on the regulatory impact analysis provided.
2. Statement of Need
a. ESRD PPS
This rule proposes a number of routine updates and several policy
changes to the ESRD PPS for CY 2021. The proposed routine updates
include the CY 2021 wage index values, the wage index budget-neutrality
adjustment factor, and outlier payment threshold amounts. Failure to
publish this proposed rule would result in ESRD facilities not
receiving appropriate payments in CY 2021 for renal dialysis services
furnished to ESRD beneficiaries.
b. AKI
This rule also proposes routine updates to the payment for renal
dialysis services furnished by ESRD facilities to individuals with AKI.
Failure to publish this proposed rule would result in ESRD facilities
not receiving appropriate payments in CY 2021 for renal dialysis
services furnished to patients with AKI in accordance with section
1834(r) of the Act.
c. ESRD QIP
This rule proposes to implement requirements for the ESRD QIP,
including a proposal to modify the scoring methodology for the
Ultrafiltration Rate reporting measure
[[Page 42193]]
beginning with the PY 2023 ESRD QIP and a proposal to update the
reporting requirements for facilities selected for NHSN data
validation. The rule also clarifies the review and correction timeline
for the NHSN BSI clinical measure and NHSN Dialysis Event reporting
measure.
3. Overall Impact
a. ESRD PPS
We estimate that the proposed revisions to the ESRD PPS would
result in an increase of approximately $190 million in payments to ESRD
facilities in CY 2021, which includes the amount associated with
updates to the outlier thresholds, payment rate update, updates to the
wage index, the proposal to adopt the new OMB delineations with a
transition period, and the proposal to include calcimimetics in the
ESRD PPS base rate. These figures do not reflect estimated increases or
decreases in expenditures based on our proposal to expand eligibility
for the TPNIES to certain new and innovative home dialysis machines
when used in the home. The fiscal impact of this proposal cannot be
determined due to the uniqueness of each new and innovative home
dialysis machine and its cost.
b. AKI
We estimate that the proposed updates to the AKI payment rate would
result in an increase of approximately $5 million in payments to ESRD
facilities in CY 2021.
c. ESRD QIP
For PY 2023, we have re-estimated the costs associated with the
information collection requirements under the ESRD QIP with updated
estimates of the total number of dialysis facilities, the total number
of patients nationally, wages for Medical Records and Health
Information Technicians or similar staff, and a refined estimate of the
number of hours needed to complete data entry for CROWNWeb reporting.
We have made no changes to our methodology for calculating the annual
burden associated with the information collection requirements for the
CROWNWeb validation study and CROWNWeb reporting. We updated the annual
burden associated with the NHSN validation study to reflect our
proposal to reduce the total number of records collected. This proposed
update would reduce the collection of information requirements
associated with the NHSN validation study by $65,460 per year across
the facilities selected for validation that year.
We also updated the payment reduction estimates using more recent
data for the measures in the ESRD QIP measure set and applying our
proposal to modify the scoring methodology for the Ultrafiltration Rate
reporting measure beginning with the PY 2023 ESRD QIP. We estimate $205
million in information collection burden, which includes the cost of
complying with this rule, and an additional $16 million in estimated
payment reductions across all facilities for PY 2023.
For PY 2024, we estimate that the proposed revisions to the ESRD
QIP would result in $205 million in information collection burden and
$16 million in estimated payment reductions across all facilities
impact of $221 million as a result of the policies we have previously
finalized and the policies we have proposed in this proposed rule.
4. Regulatory Review Cost Estimation
If regulations impose administrative costs on private entities,
such as the time needed to read and interpret this proposed rule, we
should estimate the cost associated with regulatory review. Due to the
uncertainty involved with accurately quantifying the number of entities
that will review the rule, we assume that the total number of unique
commenters on last year's proposed rule will be the number of reviewers
of this proposed rule. We acknowledge that this assumption may
understate or overstate the costs of reviewing this rule. It is
possible that not all commenters reviewed last year's rule in detail,
and it is also possible that some reviewers chose not to comment on the
proposed rule. For these reasons we thought that the number of past
commenters would be a fair estimate of the number of reviewers of this
rule. We welcome any comments on the approach in estimating the number
of entities which will review this proposed rule. We also recognize
that different types of entities are in many cases affected by mutually
exclusive sections of this proposed rule, and therefore for the
purposes of our estimate we assume that each reviewer reads
approximately 50 percent of the rule. We seek comments on this
assumption.
Using the wage information from the Bureau of Labor Statistics
(BLS) for medical and health service managers (Code 11-9111), we
estimate that the cost of reviewing this rule is $109.36 per hour,
including overhead and fringe benefits https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average reading speed, we estimate that it
would take approximately 6.25 hours for the staff to review half of
this proposed rule. For each entity that reviews the rule, the
estimated cost is $683.50 (6.25 hours x $109.36). Therefore, we
estimate that the total cost of reviewing this regulation rounds to
$62,882. ($683.50 x 92 reviewers).
B. Detailed Economic Analysis
1. CY 2021 End-Stage Renal Disease Prospective Payment System
a. Effects on ESRD Facilities
To understand the impact of the changes affecting payments to
different categories of ESRD facilities, it is necessary to compare
estimated payments in CY 2020 to estimated payments in CY 2021. To
estimate the impact among various types of ESRD facilities, it is
imperative that the estimates of payments in CY 2020 and CY 2021
contain similar inputs. Therefore, we simulated payments only for those
ESRD facilities for which we are able to calculate both current
payments and new payments.
For this proposed rule, we used CY 2019 data from the Part A and
Part B Common Working Files as of April 3, 2020, as a basis for
Medicare dialysis treatments and payments under the ESRD PPS. We
updated the 2019 claims to 2020 and 2021 using various updates. The
updates to the ESRD PPS base rate are described in section II.B.4.d of
this proposed rule. Table 10 shows the impact of the estimated CY 2021
ESRD PPS payments compared to estimated payments to ESRD facilities in
CY 2020.
BILLING CODE 4120-01-P
[[Page 42194]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.014
[[Page 42195]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.015
BILLING CODE 4120-01-C
Column A of the impact table indicates the number of ESRD
facilities for each impact category and column B indicates the number
of dialysis treatments (in millions). The overall effect of the
proposed changes to the outlier payment policy described in section
II.B.4.c of this proposed rule is shown in column C. For CY 2021, the
impact on all ESRD facilities as a result of the changes to the outlier
payment policy would be a 0.3 percent increase in estimated payments.
All ESRD facilities are anticipated to experience a positive effect in
their estimated CY 2021 payments as a result of the proposed outlier
policy changes.
Column D shows the effect of the annual update to the wage index,
as described in section II.B.4.b of this proposed rule. That is, this
column reflects the update from the CY 2020 ESRD PPS wage index using
CY 2020 OMB delineations with a basis of the FY 2021 pre-floor, pre-
reclassified IPPS hospital wage index data in a budget neutral manner.
The total impact of this change is 0.0 percent, however, there are
distributional effects of the change among different categories of ESRD
facilities. The categories of types of facilities in the impact table
show changes in estimated payments ranging from a 0.8 percent decrease
to a 0.4 percent increase due to the annual update to the ESRD PPS wage
index.
Column E shows the effect of adopting the proposed new OMB
delineations and the transition policy as described in sections
II.B.4.b.(2) and II.B.4.b.(3), respectively, of this proposed rule.
That is, the impact represented in this column reflects the change from
using the CY 2020 OMB delineations and basing the CY 2021 ESRD PPS wage
index on the FY 2021 pre-floor, pre-reclassified IPPS hospital wage
index data to the new OMB delineations and a 5 percent cap on wage
index decreases in CY 2021, in a budget neutral manner. The total
impact of this change is 0.0 percent, however, there are distributional
effects of the change among different categories of ESRD facilities.
The categories of types of facilities in the impact table show changes
in estimated payments ranging from a 1.2 percent decrease to a 0.3
percent increase due to these proposals to the ESRD PPS wage index.
Column F shows the effect of the proposed addition to the ESRD PPS
base rate to include calcimimetics as described in section II.B.1 of
this proposed rule. That is, the impact represented in this column
reflects the change, under the ESRD PPS, proposed for payment to ESRD
facilities for furnishing calcimimetics. Beginning January 1, 2018,
ESRD facilities received payment for calcimimetics under the TDAPA
policy in Sec. 413.234(c). Under our proposal, beginning January 1,
2021, we would modify the ESRD PPS base rate by adding $12.06 to
include calcimimetics and no longer pay for calcimimetics using the
TDAPA. In addition, calcimimetics would become outlier eligible
services under Sec. 413.237. The categories of types of facilities in
the impact table show changes in estimated payments ranging from a 3.9
percent decrease to a 4.5 percent increase due to this proposal.
Column G shows the effect of the proposed CY 2021 ESRD PPS payment
rate update as described in section II.B.4.a of this proposed rule. The
proposed ESRD PPS payment rate update is 1.8 percent, which reflects
the proposed ESRDB market basket percentage increase factor for CY 2021
of 2.2 percent and the proposed MFP adjustment of 0.4 percent.
Column H reflects the overall impact, that is, the effects of the
proposed outlier policy changes, the proposed updated wage index and
transition policy, the payment rate update, and the proposed addition
to the ESRD PPS base rate to include calcimimetics. We expect that
overall ESRD facilities would experience a 1.6 percent increase in
estimated payments in CY 2021. The categories of types of facilities in
the impact table show impacts ranging from a 2.0 percent decrease to a
6.5 percent increase in their CY 2021 estimated payments.
b. Effects on Other Providers
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled
payment for renal dialysis services, which may have been separately
paid to other providers (for example, laboratories, durable medical
equipment suppliers, and pharmacies) by Medicare prior to the
implementation of the ESRD PPS. Therefore, in CY 2021, we estimate that
the proposed ESRD PPS would have zero impact on these other providers.
c. Effects on the Medicare Program
We estimate that Medicare spending (total Medicare program
payments) for ESRD facilities in CY 2021 would be approximately $9.3
billion. This estimate takes into account a projected decrease in fee-
for-service Medicare dialysis beneficiary enrollment of 8.6 percent in
CY 2021.
d. Effects on Medicare Beneficiaries
Under the ESRD PPS, beneficiaries are responsible for paying 20
percent of the ESRD PPS payment amount. As a result of the projected
1.6 percent overall increase in the proposed CY 2021 ESRD PPS payment
amounts, we estimate that there would be an increase in beneficiary co-
insurance payments of 1.6 percent in CY 2021, which translates to
approximately $40 million.
e. Alternatives Considered
(1) Inclusion of Calcimimetics Into the ESRD PPS Bundled Payment
In section II.B.1 of this proposed rule, we propose that beginning
January 1, 2021, we would modify the ESRD PPS base rate by adding
$12.06 to include calcimimetics and no longer pay for calcimimetics
using the TDAPA. In addition, calcimimetics would become ESRD outlier
services eligible for outlier payments under Sec. 413.237. With regard
to the methodology proposed to calculate the amount to be added the
ESRD PPS base rate, we considered using the Medicare expenditures
reflecting payments made for the calcimimetics in CYs 2018 and 2019,
that is, approximately $2.3 billion and dividing by total treatments
furnished in both years to arrive at an amount of $27.08. However,
using the most recent calendar quarter of ASP data available to
calculate the ASP-based values as the proxy rate incorporates the lower
priced generic calcimimetics into the
[[Page 42196]]
calculation of the amount added for oral calcimimetics. We believe it
is appropriate for the ESRD PPS base rate to reflect generic drug
manufacturer ASP data since we believe that this aligns with how ESRD
facilities would purchase and furnish the oral calcimimetics in the
future.
(2) Expansion of the TPNIES to Capital-Related Assets That are Home
Dialysis Machines When Used in the Home for a Single Patient
In section II.B.3 of this proposed rule, we propose to expand the
TPNIES policy and allow capital-related assets that are home dialysis
machines when used in the home for a single patient to be eligible for
the add-on payment adjustment when used in the home. Then, consistent
with the policies finalized last year for other renal dialysis
equipment and supplies eligible for the TPNIES, we would pay 65 percent
of the pre-adjusted per treatment amount for a period of 2 years. With
regard to the duration of applying the TPNIES for capital-related
assets that are home dialysis machines when used in the home for a
single patient, we considered paying the TPNIES for 3 years. However,
we believe that the proposal is consistent with the TDAPA and other
Medicare fee-for-service add-on payment programs (for example, the IPPS
NTAP), and supports innovation for dialysis in the home setting, the
President's Executive Order on Advancing American Kidney Health, and
current HHS initiatives to support home dialysis, while taking into
account the potential increase in ESRD PPS expenditures.
(3) CY 2021 ESRD PPS Wage index
In section II.B.4.b of this proposed rule, we propose to adopt the
new OMB delineations with a transition policy. That is, we are
proposing to adopt the OMB delineations based on the September 14, 2018
OMB Bulletin No. 18-04 and, to mitigate any potential negative impacts,
we would apply a 5 percent cap on any decrease in an ESRD facility's
wage index from the ESRD facility's wage index from the prior calendar
year. This transition would be phased in over 2 years, such that the
estimated reduction in an ESRD facility's wage index would be capped at
5 percent in CY 2021 and no cap would be applied to the reduction in
the wage index for the second year, CY 2022. With regard to the
transition policy, we considered doing a 2-year 50/50 blended wage
index approach consistent with the adoption of OMB delineations in the
CY 2015 ESRD PPS final rule (79 FR 66142). However, we determined that
the proposed 5 percent cap on any decrease policy would be an
appropriate transition for CY 2021 as it provides predictability in
payment levels from CY 2020 to the upcoming CY 2021 and additional
transparency because it is administratively simpler than the 50/50
blended approach.
2. Proposed Payment for Renal Dialysis Services Furnished to
Individuals With AKI
a. Effects on ESRD Facilities
To understand the impact of the changes affecting payments to
different categories of ESRD facilities for renal dialysis services
furnished to individuals with AKI, it is necessary to compare estimated
payments in CY 2020 to estimated payments in CY 2021. To estimate the
impact among various types of ESRD facilities for renal dialysis
services furnished to individuals with AKI, it is imperative that the
estimates of payments in CY 2020 and CY 2021 contain similar inputs.
Therefore, we simulated payments only for those ESRD facilities for
which we are able to calculate both current payments and new payments.
For this proposed rule, we used CY 2019 data from the Part A and
Part B Common Working Files as of April 3, 2020, as a basis for
Medicare for renal dialysis services furnished to individuals with AKI.
We updated the 2019 claims to 2020 and 2021 using various updates. The
updates to the AKI payment amount are described in section III.B of
this proposed rule. Table 11 shows the impact of the estimated CY 2021
payments for renal dialysis services furnished to individuals with AKI
compared to estimated payments for renal dialysis services furnished to
individuals with AKI in CY 2020.
BILLING CODE 4120-01-P
BILLING CODE 4120-01-P
[[Page 42197]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.016
[[Page 42198]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.017
BILLING CODE 4120-01-C
Column A of the impact table indicates the number of ESRD
facilities for each impact category and column B indicates the number
of AKI dialysis treatments (in thousands).
Column C shows the effect of the proposed CY 2021 wage indices.
Column D shows the effect of the adjustment to the AKI dialysis
payment rate that reciprocates the adjustment proposed to the ESRD PPS
base rate for CY 2021, consistent with Sec. 413.372. As discussed in
section II.B.1 of this proposed rule, we propose to modify the ESRD PPS
base rate by adding $12.06 to include calcimimetics.
Column E shows the effect of the proposed CY 2021 ESRD PPS payment
rate update. The proposed ESRD PPS payment rate update is 1.8 percent,
which reflects the proposed ESRDB market basket percentage increase
factor for CY 2021 of 2.2 percent and the proposed MFP adjustment of
0.4 percent.
Column F reflects the overall impact, that is, the effects of the
updated wage index, the proposed addition to the ESRD PPS base rate,
and the payment rate update. We expect that overall ESRD facilities
would experience a 6.9 percent increase in estimated payments in CY
2021. The categories of types of facilities in the impact table show
impacts ranging from an increase of 0.0 percent to 7.3 percent in their
CY 2021 estimated payments.
b. Effects on Other Providers
Under section 1834(r) of the Act, as added by section 808(b) of
TPEA, we propose to update the payment rate for renal dialysis services
furnished by ESRD facilities to beneficiaries with AKI. The only two
Medicare providers and suppliers authorized to provide these outpatient
renal dialysis services are hospital outpatient departments and ESRD
facilities. The decision about where the renal dialysis services are
furnished is made by the patient and his or her physician. Therefore,
this proposal will have zero impact on other Medicare providers.
c. Effects on the Medicare Program
We estimate approximately $56 million would be paid to ESRD
facilities in CY 2021 as a result of AKI patients receiving renal
dialysis services in the ESRD facility at the lower ESRD PPS base rate
versus receiving those services only in the hospital outpatient setting
and paid under the outpatient prospective payment system, where
services were required to be administered prior to the TPEA.
d. Effects on Medicare Beneficiaries
Currently, beneficiaries have a 20 percent co-insurance obligation
when they receive AKI dialysis in the hospital outpatient setting. When
these services are furnished in an ESRD facility, the patients would
continue to be responsible for a 20 percent co-insurance. Because the
AKI dialysis payment rate paid to ESRD facilities is lower than the
outpatient hospital PPS's payment amount, we would expect beneficiaries
to pay less co-insurance when AKI dialysis is furnished by ESRD
facilities.
e. Alternatives Considered
As we discussed in the CY 2017 ESRD PPS proposed rule (81 FR
42870), we considered adjusting the AKI payment rate by including the
ESRD PPS case-mix adjustments, and other adjustments at section
1881(b)(14)(D) of the Act, as well as not paying separately for AKI
specific drugs and laboratory tests. We ultimately determined that
treatment for AKI is substantially different from treatment for ESRD
and the case-mix adjustments applied to ESRD patients may not be
applicable to AKI patients and as such, including those policies and
adjustment would be inappropriate. We continue to monitor utilization
and trends of items and services furnished to individuals with AKI for
purposes of refining the payment rate in the future. This monitoring
would assist us in developing knowledgeable, data-driven proposals.
3. ESRD QIP
a. Effects of the PY 2023 ESRD QIP on ESRD Facilities
The ESRD QIP is intended to prevent possible reductions in the
quality of ESRD dialysis facility services provided to beneficiaries.
The general methodology that we are using to determine a facility's TPS
is described in our regulations at Sec. 413.178(e).
Any reductions in the ESRD PPS payments as a result of a facility's
performance under the PY 2023 ESRD QIP would apply to the ESRD PPS
payments made to the facility for services furnished in CY 2023, as
codified in our regulations at Sec. 413.177.
For the PY 2023 ESRD QIP, we estimate that, of the 7,386 dialysis
facilities (including those not receiving a TPS) enrolled in Medicare,
approximately 23.2 percent or 1,657 of the facilities that have
sufficient data to calculate a TPS would receive a payment reduction
for PY 2023. We are presenting an estimate for the PY 2023 ESRD QIP to
update the estimated impact that was provided in the CY 2020 ESRD PPS
final rule (84 FR 60797). If our proposal to update the scoring
methodology for the Ultrafiltration Rate reporting measure is
finalized, the total estimated payment reductions for all the 1,657
facilities expected to receive a payment reduction in PY 2023 would
decrease from $18,247,083.76 to approximately $15,586,453.64.
Facilities that do not receive a TPS do not receive a payment
reduction.
Table 12 shows the overall estimated distribution of payment
reductions resulting from the PY 2023 ESRD QIP.
[[Page 42199]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.018
To estimate whether a facility would receive a payment reduction
for PY 2023, we scored each facility on achievement and improvement on
several clinical measures we have previously finalized and for which
there were available data from CROWNWeb and Medicare claims. Payment
reduction estimates are calculated using the most recent data available
(specified in Table 13) in accordance with the policies proposed in
this proposed rule. Measures used for the simulation are shown in Table
13. These estimates also incorporate the proposed update to the scoring
methodology for the Ultrafiltration Rate reporting measure.
[GRAPHIC] [TIFF OMITTED] TP13JY20.019
For all measures except SHR and SRR, clinical measures with less
than 11 patients for a facility were not included in that facility's
TPS. For SHR and STrR, facilities were required to have at least 5
patient-years at risk and 11 index discharges, respectively, in order
to be included in the facility's TPS. Each facility's TPS was compared
to an estimated mTPS and an estimated payment reduction table that were
consistent with the proposals outlined in sections IV.B and IV.C of
this proposed rule. Facility reporting measure scores were estimated
using available data from CY 2017 and CY 2018. Facilities were required
to have at least one measure in at least two domains to receive a TPS.
To estimate the total payment reductions in PY 2023 for each
facility resulting from this proposed rule, we multiplied the total
Medicare payments to the facility during the 1-year period between
January 2018 and December 2018 by the facility's estimated payment
reduction percentage expected under the ESRD QIP, yielding a total
payment reduction amount for each facility.
Table 14 shows the estimated impact of the finalized ESRD QIP
payment reductions to all ESRD facilities for PY 2023. The table also
details the distribution of ESRD facilities by size (both among
facilities considered to be small entities and by number of treatments
per facility), geography (both rural and urban and by region), and by
facility type (hospital based and freestanding facilities). Given that
the performance period used for these calculations differs from the
performance period we are using for the PY 2023 ESRD QIP, the actual
impact of the PY 2023 ESRD QIP may vary significantly from the values
provided here.
[[Page 42200]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.020
[[Page 42201]]
b. Effects of the PY 2024 ESRD QIP on ESRD Facilities
For the PY 2024 ESRD QIP, we estimate that, of the 7,386 dialysis
facilities (including those not receiving a TPS) enrolled in Medicare,
approximately 23.2 percent or 1,657 of the facilities that have
sufficient data to calculate a TPS would receive a payment reduction
for PY 2024. The total payment reductions for all the 1,657 facilities
expected to receive a payment reduction is approximately
$15,586,453.64. Facilities that do not receive a TPS do not receive a
payment reduction.
Table 15 shows the overall estimated distribution of payment
reductions resulting from the PY 2024 ESRD QIP.
[GRAPHIC] [TIFF OMITTED] TP13JY20.021
To estimate whether a facility would receive a payment reduction in
PY 2024, we scored each facility on achievement and improvement on
several clinical measures we have previously finalized and for which
there were available data from CROWNWeb and Medicare claims. Payment
reduction estimates were calculated using the most recent data
available (specified in Table 15) in accordance with the policies
proposed in this proposed rule. Measures used for the simulation are
shown in Table 16.
[GRAPHIC] [TIFF OMITTED] TP13JY20.022
For all measures except SHR, SRR, and STrR, measures with less than
11 patients for a facility were not included in that facility's TPS.
For SHR and SRR, facilities were required to have at least 5 patient-
years at risk and 11 index discharges, respectively, in order to be
included in the facility's TPS. For the STrR reporting measure,
facilities were required to have at least 10 patient-years at risk in
order to be included in the facility's TPS. Each facility's TPS was
compared to an estimated mTPS and an estimated payment reduction table
that incorporates the proposals outlined in section IV.B and IV.C of
this proposed rule. Facility reporting measure scores were estimated
using available data from CY 2018. Facilities were required to have at
least one measure in at least two domains to receive a TPS.
To estimate the total payment reductions in PY 2024 for each
facility resulting from this proposed rule, we multiplied the total
Medicare payments to the facility during the 1-year period between
January 2018 and December 2018 by the facility's estimated payment
reduction percentage expected under the ESRD QIP, yielding a total
payment reduction amount for each facility.
Table 17 shows the estimated impact of the finalized ESRD QIP
payment reductions to all ESRD facilities for PY 2024. The table
details the distribution of ESRD facilities by size (both among
facilities considered to be small entities and by number of treatments
per facility), geography (both rural and
[[Page 42202]]
urban and by region), and by facility type (hospital based and
freestanding facilities). Given that the performance period used for
these calculations differs from the performance period we are proposing
to use for the PY 2024 ESRD QIP, the actual impact of the PY 2024 ESRD
QIP may vary significantly from the values provided here.
[[Page 42203]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.023
[[Page 42204]]
c. Effects on Other Providers
The ESRD QIP is applicable to dialysis facilities. We are aware
that several of our measures impact other providers. For example, with
the introduction of the SRR clinical measure in PY 2017 and the SHR
clinical measure in PY 2020, we anticipate that hospitals may
experience financial savings as dialysis facilities work to reduce the
number of unplanned readmissions and hospitalizations. We are exploring
various methods to assess the impact these measures have on hospitals
and other facilities, such as through the impacts of the Hospital
Readmission Reduction Program and the Hospital-Acquired Conditions
Reduction Program, and we intend to continue examining the interactions
between our quality programs to the greatest extent feasible.
d. Effects on the Medicare Program
For PY 2024, we estimate that the ESRD QIP would contribute
approximately $15,586,453.64 in Medicare savings. For comparison, Table
18 shows the payment reductions that we estimate will be applied by the
ESRD QIP from PY 2018 through PY 2024.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP13JY20.024
e. Effects on Medicare Beneficiaries
The ESRD QIP is applicable to dialysis facilities. Since the
Program's inception, there is evidence on improved performance on ESRD
QIP measures. As we stated in the CY 2018 ESRD PPS final rule, one
objective measure we can examine to demonstrate the improved quality of
care over time is the improvement of performance standards (82 FR
50795). As the ESRD QIP has refined its measure set and as facilities
have gained experience with the measures included in the Program,
performance standards have generally continued to rise. We view this as
evidence that facility performance (and therefore the quality of care
provided to Medicare beneficiaries) is objectively improving. We are in
the process of monitoring and evaluating trends in the quality and cost
of care for patients under the ESRD QIP, incorporating both existing
measures and new measures as they are implemented in the Program. We
will provide additional information about the impact of the ESRD QIP on
beneficiaries as we learn more. However, in future years we are
interested in examining these impacts through the analysis of available
data from our existing measures.
f. Alternatives Considered
In section IV.B.7 of this proposed rule, we are proposing that
facilities selected to participate in the NHSN data validation study
can submit a total of 20 records across two quarters. We considered
retaining our current reporting requirement, under which facilities
must submit 20 records per quarter for each of the first two quarters
of the CY, for a total of 40 records. However, we concluded that the
reduction in patient records provides an adequate sample size for the
validation. This approach would lower administrative costs and would
reduce the burden on facilities.
C. Accounting Statement
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 19, we have prepared an accounting statement showing
the classification of the transfers and costs associated with the
various provisions of this proposed rule.
[[Page 42205]]
[GRAPHIC] [TIFF OMITTED] TP13JY20.025
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
D. Regulatory Flexibility Act Analysis (RFA)
The Regulatory Flexibility Act requires agencies to analyze options
for regulatory relief of small entities, if a rule has a significant
impact on a substantial number of small entities. For purposes of the
RFA, small entities include small businesses, nonprofit organizations,
and small governmental jurisdictions. Approximately 11 percent of ESRD
dialysis facilities are considered small entities according to the
Small Business Administration's (SBA) size standards, which classifies
small businesses as those dialysis facilities having total revenues of
less than $41.5 million in any 1 year. Individuals and states are not
included in the definitions of a small entity. For more information on
SBA's size standards, see the Small Business Administration's website
at http://www.sba.gov/content/small-business-size-standards (Kidney
Dialysis Centers are listed as 621492 with a size standard of $41.5
million).
We do not believe ESRD facilities are operated by small government
entities such as counties or towns with populations of 50,000 or less,
and therefore, they are not enumerated or included in this estimated
RFA analysis. Individuals and states are not included in the definition
of a small entity.
For purposes of the RFA, we estimate that approximately 11 percent
of ESRD facilities are small entities as that term is used in the RFA
(which includes small businesses, nonprofit organizations, and small
governmental jurisdictions). This amount is based on the number of ESRD
facilities shown in the ownership category in Table 10. Using the
definitions in this ownership category, we consider 534 facilities that
are independent and 299 facilities that are shown as hospital-based to
be small entities. The ESRD facilities that are owned and operated by
Large Dialysis Organizations (LDOs) and regional chains would have
total revenues of more than $41.5 million in any year when the total
revenues for all locations are combined for each business (individual
LDO or regional chain), and are not, therefore, included as small
entities.
For the ESRD PPS updates proposed in this rule, a hospital-based
ESRD facility (as defined by type of ownership, not by type of dialysis
facility) is estimated to receive a 0.1 percent increase in payments
for CY 2021. An independent facility (as defined by ownership type) is
estimated to have no change in payments for CY 2021.
For AKI dialysis, we are unable to estimate whether patients would
go to ESRD facilities, however, we have estimated there is a potential
for $56 million in payment for AKI dialysis treatments that could
potentially be furnished in ESRD facilities.
For the ESRD QIP, we estimate that of the 1,657 ESRD facilities
expected to receive a payment reduction as a result of their
performance on the PY 2024 ESRD QIP, 817 are ESRD small entity
facilities. We present these findings in Table 15 (``Estimated
Distribution of PY 2024 ESRD QIP Payment Reductions'') and Table 17
(``Impact of Proposed QIP Payment Reductions to ESRD Facilities for PY
2024''). We estimate that the payment reductions would average
approximately $9,406.43 per facility across the 1,657 facilities
receiving a payment reduction, and $8,698.69 for each small entity
facility. We also estimate that there are 817 small entity facilities
in total, and that the aggregate ESRD PPS payments to these facilities
would decrease 0.30 percent in CY 2022.
Therefore, the Secretary has determined that this proposed rule
would not have a significant economic impact on a substantial number of
small entities. The economic impact assessment is based on estimated
Medicare payments (revenues) and HHS's practice in interpreting the RFA
is to consider effects economically ``significant'' only if greater
than 5 percent of providers reach a threshold of 3 to 5 percent or more
of total revenue or total costs. We solicit comment on the RFA analysis
provided.
In addition, section 1102(b) of the Act requires us to prepare a
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 603 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a metropolitan statistical area and has fewer
than 100 beds. We do not believe this proposed rule would have a
significant impact on operations of a substantial number of
[[Page 42206]]
small rural hospitals because most dialysis facilities are
freestanding. While there are 127 rural hospital-based dialysis
facilities, we do not know how many of them are based at hospitals with
fewer than 100 beds. However, overall, the 127 rural hospital-based
dialysis facilities would experience an estimated 0.3 percent decrease
in payments.
Therefore, the Secretary has determined that this proposed rule
would not have a significant impact on the operations of a substantial
number of small rural hospitals.
E. Unfunded Mandates Reform Act Analysis (UMRA)
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2020, that
threshold is approximately $156 million. This proposed rule does not
mandate any requirements for state, local, or tribal governments in the
aggregate, or by the private sector. Moreover, HHS interprets UMRA as
applying only to unfunded mandates. We do not interpret Medicare
payment rules as being unfunded mandates, but simply as conditions for
the receipt of payments from the federal government for providing
services that meet federal standards. This interpretation applies
whether the facilities or providers are private, state, local, or
tribal.
F. Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has federalism
implications. We have reviewed this proposed rule under the threshold
criteria of Executive Order 13132, Federalism, and have determined that
it would not have substantial direct effects on the rights, roles, and
responsibilities of states, local or Tribal governments.
G. Regulatory Reform Analysis Under Executive Order 13771
Executive Order 13771, entitled Reducing Regulation and Controlling
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. It has
been determined that this is a transfer rule, which imposes no more
than de minimis costs. As a result, this rule is not considered a
regulatory or deregulatory action under Executive Order 13771.
VIII. Files Available to the Public via the internet
The Addenda for the annual ESRD PPS proposed and final rulemakings
will no longer appear in the Federal Register. Instead, the Addenda
will be available only through the internet and is posted on the CMS
website at http://www.cms.gov/ESRDPayment/PAY/list.asp. In addition to
the Addenda, limited data set files are available for purchase at
http://www.cms.gov/Research-Statistics-Data-and-Systems/Files-for-Order/LimitedDataSets/EndStageRenalDiseaseSystemFile.html. Readers who
experience any problems accessing the Addenda or LDS files, should
contact [email protected].
List of Subjects in 42 CFR Part 413
Diseases, Health facilities, Medicare, Reporting and recordkeeping
requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as follows:
PART 413--PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR
END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT
RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY
INJURY DIALYSIS
0
1. The authority citation for part 413 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a),
(i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww.
0
2. Section 413.232 is amended by--
0
a. Revising paragraphs (b) introductory text, (b)(1), (e), and (g)
introductory text; and
0
b. Adding paragraphs (g)(4) and (h).
The revisions and additions read as follows:
Sec. 413.232 Low-volume adjustment.
* * * * *
(b) A low-volume facility is an ESRD facility that, as determined
based on the documentation submitted pursuant to paragraph (g) of this
section:
(1) Furnished less than 4,000 treatments in each of the 3 cost
reporting years (based on as-filed or final settled 12-consecutive
month cost reports, whichever is most recent, except as specified in
paragraph (g)(4) of this section) preceding the payment year; and
* * * * *
(e) Except as provided in paragraph (f) of this section and unless
extraordinary circumstances justify an exception, to receive the low-
volume adjustment an ESRD facility must provide an attestation
statement, by November 1st of each year preceding the payment year, to
its Medicare Administrative Contractor (MAC) that the facility meets
all the criteria established in this section, except that:
(1) For payment year 2012, the attestation must be provided by
January 3, 2012;
(2) For payment year 2015, the attestation must be provided by
December 31, 2014;
(3) For payment year 2016, the attestation must be provided by
December 31, 2015; and
(4) For payment year 2021, the attestation must be provided by
December 31, 2020.
* * * * *
(g) To receive the low-volume adjustment, an ESRD facility must
include in their attestation provided pursuant to paragraph (e) of this
section a statement that the ESRD facility meets the definition of a
low-volume facility in paragraph (b) of this section. To determine
eligibility for the low-volume adjustment, the MAC on behalf of CMS
relies upon as filed or final settled 12-consecutive month cost
reports, except as specified in paragraph (g)(4) of this section, for
the 3 cost reporting years preceding the payment year to verify the
number of treatments, except that:
* * * * *
(4) For payment years 2021, 2022, and 2023, the attestation
specified in paragraph (e)(4) of this section must indicate that the
ESRD facility meets all the criteria specified in this section, except
that, for a facility that would not otherwise meet the number of
treatments criterion specified in paragraph (b)(1) of this section
because of the COVID-19 PHE, the facility may attest that it furnished
less than 2,000 treatments in any six months during the cost-reporting
period ending in 2020. For any facility that so attests--
(i) The facility must also attest that it furnished treatments
equal to or in excess of 4,000 in the payment year due to temporary
patient shifting as a result of the COVID-19 PHE; and
(ii) The MAC relies on the attestation and multiplies the total
number of treatments for the 6 months period by 2.
(h) When an ESRD facility provides an attestation in accordance
with paragraph (e) of this section, for the
[[Page 42207]]
third eligibility year, the MAC verifies the as-filed cost report and
takes one of the following actions:
(1) If the MAC determines an ESRD facility meets the definition of
a low-volume facility as described in paragraph (b) of this section,
CMS adjusts the low-volume facility's base rate for the entire payment
year; or
(2) If the MAC determines an ESRD facility does not meet the
definition of a low-volume facility as described in paragraph (b) of
this section, the MAC reprocesses claims and recoups low-volume
adjustments paid during the payment year.
0
3. Section 413.234 is amended by adding paragraph (f) to read as
follows:
Sec. 413.234 Drug designation process.
* * * * *
(f) Methodology for modifying the ESRD PPS base rate to account for
the costs of calcimimetics in the ESRD PPS bundled payment. Beginning
January 1, 2021, payment for calcimimetics are included in the ESRD PPS
base rate using the following data sources and methodology:
(1) The methodology specified in paragraph (f)(2) of this section
for determining the average per treatment payment amount for
calcimimetics that is added to the ESRD PPS base rate uses the
following data sources:
(i) Total units of oral and injectable calcimimetics and total
number of paid hemodialysis-equivalent dialysis treatments furnished,
as derived from Medicare ESRD facility claims, that is, the 837-
institutional form with bill type 072X, for calendar years 2018 and
2019.
(ii) The weighted average ASP based on the most recent
determinations by CMS.
(2) CMS uses the following methodology to calculate the average per
treatment payment amount for calcimimetics that is added to the ESRD
PPS base rate:
(i) Determines utilization of oral and injectable calcimimetics by
aggregating the total units of oral and injectable calcimimetics in
paragraph (f)(1) of this section.
(ii) Determines a price for each form of the drug by calculating
100 percent of the values from the most recent calendar quarter ASP
calculations available to the public for the oral and injectable
calcimimetic.
(iii) Calculates the total calcimimetic expenditure amount by
multiplying the utilization of the oral and injectable calcimimetics
determined in paragraph (f)(2)(i) of this section by their respective
prices determined in paragraph (f)(2)(ii) of this section and adding
the expenditure amount for both forms.
(iv) Calculates the average per treatment payment amount by
dividing the total calcimimetic expenditure amount determined in
paragraph (f)(2)(iii) of this section by the total number of paid
hemodialysis-equivalent dialysis treatments in calendar years 2018 and
2019.
(v) Calculates the amount added to the ESRD PPS base rate by
reducing the average per treatment payment amount determined in
paragraph (f)(2)(iv) of this section by 1 percent to account for the
outlier policy under Sec. 413.237.
0
4. Section 413.236 is amended by--
0
a. Revising paragraphs (a), (b) introductory text, (b)(2), (4) through
(6), (c), (d) introductory text, and (d)(2); and
0
b. Adding paragraph (f).
The revisions and addition read as follows:
Sec. 413.236 Transitional add-on payment adjustment for new and
innovative equipment and supplies.
(a) Basis and definitions. (1) Effective January 1, 2020, this
section establishes an add-on payment adjustment to support ESRD
facilities in the uptake of new and innovative renal dialysis equipment
and supplies under the ESRD prospective payment system under the
authority of section 1881(b)(14)(D)(iv) of the Social Security Act.
(2) For purposes of this section, the following definitions apply:
Capital-related asset. Asset that an ESRD facility has an economic
interest in through ownership (regardless of the manner in which it was
acquired) and is subject to depreciation. Equipment obtained by the
ESRD facility through operating leases are not considered capital-
related assets.
Depreciation. The amount that represents a portion of the capital-
related asset's cost and that is allocable to a period of operation.
Home dialysis machines. Hemodialysis machines and peritoneal
dialysis cyclers in their entirety, meaning that one new part of a
machine does not make the entire capital-related asset new, that
receive FDA marketing authorization for home use and when used in the
home for a single patient.
Particular calendar year. The year in which the payment adjustment
specified in paragraph (d) of this section would take effect.
Straight-line depreciation method. A method in accounting in which
the annual allowance is determined by dividing the cost of the capital-
related asset by the years of useful life.
Useful life. The estimated useful life of a capital-related asset
is its expected useful life to the ESRD facility, not necessarily the
inherent useful or physical life.
(b) Eligibility criteria. CMS provides for a transitional add-on
payment adjustment for new and innovative equipment and supplies (as
specified in paragraph (d) of this section) to an ESRD facility for
furnishing a covered equipment or supply only if the item:
* * * * *
(2) Is new, meaning within 3 years beginning on the date of the
Food and Drug Administration (FDA) marketing authorization;
* * * * *
(4) Has a complete Healthcare Common Procedure Coding System
(HCPCS) Level II code application submitted, in accordance with the
HCPCS Level II coding procedures on the CMS website, by the HCPCS Level
II code application deadline for biannual Coding Cycle 2 for durable
medical equipment, orthotics, prosthetics and supplies (DMEPOS) and
services as specified in the HCPCS Level II coding guidance on the CMS
website prior to the particular calendar year;
(5) Is innovative, meaning it meets the criteria specified in Sec.
412.87(b)(1) of this chapter; and
(6) Is not a capital-related asset, except for capital-related
assets that are home dialysis machines.
(c) Announcement of determinations and deadline for consideration
of new renal dialysis equipment or supply applications. CMS will
consider whether a new renal dialysis supply or equipment meets the
eligibility criteria specified in paragraph (b) of this section and
announce the results in the Federal Register as part of its annual
updates and changes to the ESRD prospective payment system. CMS will
only consider a complete application received by CMS by February 1
prior to the particular calendar year. FDA marketing authorization for
the equipment or supply must occur by the HCPCS Level II code
application deadline for biannual Coding Cycle 2 for DMEPOS items and
services as specified in the HCPCS Level II coding guidance on the CMS
website prior to the particular calendar year.
(d) Transitional add-on payment adjustment for new and innovative
equipment and supplies. A new and innovative renal dialysis equipment
or supply will be paid for using a transitional add-on payment
adjustment for new and innovative equipment and supplies based on 65
percent of the MAC-determined price, as specified in paragraph (e) of
this section. For capital-related assets that are home dialysis
[[Page 42208]]
machines, payment is based on 65 percent of the pre-adjusted per
treatment amount, as specified in paragraph (f)(1)(ii) of this section.
* * * * *
(2) Following payment of the transitional add-on payment adjustment
for new and innovative equipment and supplies, the ESRD PPS base rate
will not be modified and the new and innovative renal dialysis
equipment or supply will be an eligible outlier service as provided in
Sec. 413.237, except a capital-related asset that is a home dialysis
machine will not be an eligible outlier service as provided in Sec.
413.237.
* * * * *
(f) Pricing of new and innovative renal dialysis equipment and
supplies that are capital-related assets that are home dialysis
machines. (1) The MACs calculate a pre-adjusted per treatment amount,
using the prices they establish under paragraph (e) of this section for
a capital-related asset that is a home dialysis machine, as defined in
paragraph (a)(2) of this section, as follows:
(i) Calculate an annual allowance to determine the amount that
represents the portion of the cost allocable to 1 year for use in
calculating the pre-adjusted per treatment amount, using the straight-
line depreciation method, by dividing the MAC-determined price by its
useful life of 5 years.
(ii) Calculate a pre-adjusted per treatment amount to determine the
amount that is adjusted by the 65 percent under paragraph (d) of this
section, by dividing the annual allowance, as determined in paragraph
(f)(1)(i) of this section, by the expected number of treatments.
(2) [Reserved]
0
5. Section 413.237 is amended--
0
a. In paragraphs (a)(1)(i) through (iii) by removing the semicolon at
the end of the sentence and adding a period in its place;
0
b. In paragraph (a)(1)(iv) by removing ``; and'' and adding a period in
its place; and
0
c. By revising paragraph (a)(1)(v).
The revision reads as follows:
Sec. 413.237 Outliers.
(a) * * *
(1) * * *
(v) Renal dialysis equipment and supplies, except for capital-
related assets that are home dialysis machines (as defined in Sec.
413.236(a)(2)), that receive the transitional add-on payment adjustment
as specified in Sec. 413.236, after the payment period has ended.
* * * * *
Dated: June 12, 2020.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: June 19, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-14671 Filed 7-6-20; 4:15 pm]
BILLING CODE 4120-01-P