[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Rules and Regulations]
[Pages 5020-5022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00805]
[[Page 5020]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 400, 410, 414, 415, 423, 424, and 425
[CMS-1734-F, CMS-1734-IFC, CMS-1744-F, CMS-5531-F and CMS-3401-IFC] CN
RIN 0938-AU10, 0938-AU31, 0938-AU32, and 0938-AU33
Medicare Program; CY 2021 Payment Policies Under the Physician
Fee Schedule and Other Changes to Part B Payment Policies; Medicare
Shared Savings Program Requirements; Medicaid Promoting
Interoperability Program Requirements for Eligible Professionals;
Quality Payment Program; Coverage of Opioid Use Disorder Services
Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid
Treatment Programs; Electronic Prescribing for Controlled Substances
for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and
Management Services; Hospital IQR Program; Establish New Code
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model
Emergency Policy; Coding and Payment for Virtual Check-In Services
Interim Final Rule Policy; Coding and Payment for Personal Protective
Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in
Response to the Public Health Emergency (PHE) for COVID-19; and
Finalization of Certain Provisions From the March 31st, May 8th and
September 2nd Interim Final Rules in Response to the PHE for COVID-19;
Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule and interim final rule; Correction.
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SUMMARY: This document corrects technical errors in the final rule that
appeared in the December 28, 2020, Federal Register under the same as
title above. Hereinafter, the December 28 rule is referred to as the CY
2021 PFS final rule.
DATES: This correction is effective January 19, 2021, and is applicable
beginning January 1, 2021.
FOR FURTHER INFORMATION CONTACT: Cynthia Lambert-Lawson, (410) 786-
1366, Gaysha Brooks, (410) 786-9649, or Annette Brewer (410) 786-6580.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2020-26815 of December 28, 2020, the CY 2021 PFS final
rule (85 FR 84472), there were technical errors that are identified and
corrected in this correcting document. These corrections are effective
and applicable beginning January 1, 2021.
II. Summary of Errors
A. Summary of Errors in the Preamble
On page 84545 of the CY 2021 PFS final rule, third column, prior to
the first full paragraph, in our discussion of clarifications and
proposals related to digitally stored data services/remote physiologic
monitoring/treatment management services, we inadvertently deleted,
before publication, language summarizing and responding to two sets of
public comments. We also inadvertently included language on page 84545
of the CY 2021 PFS final rule, third column, the first partial
paragraph at the top of the column.
B. Summary of Errors in the Addenda
On page 85057, in Table B.2. Audiology, second column, second row,
the entry NQF #/eCQM NQF # contains a typographical error.
On page 85069, in Table B.5. Clinical Social Work, second column,
second row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85076, in Table B.8. Diagnostic Radiology, ninth column
entry Measure Steward, third row, we inadvertently misidentified the
measure steward.
On page 85083, in Table B.10. Endocrinology, second column, third
row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85089, in Table B.11. Family Medicine, second column, sixth
row, the entry NQF #/eCQM NQF # contains typographical errors.
On page 85110, in Table B.16. Infectious Disease, ninth column
entry Measure Steward, fourth row, we inadvertently misidentified the
measure steward.
On page 85114, in Table B.17. Internal Medicine, second column,
first row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85124, in Table B.19. Mental/Behavioral Health, second
column, fifth row, the entry NQF #/eCQM NQF # contains a typographical
error.
On page 85130, in Table B.21. Neurology, second column, third row,
the entry NQF #/eCQM NQF # contains a typographical error.
On page 85141, in Table B.24. Obstetrics/Gynecology, third column
entry Quality # sixth row, we inadvertently omitted the Quality number.
On page 85146, in Table B.25a. Oncology/Hematology, third column
entry Quality #, fifth row, we inadvertently omitted the Quality
number.
On page 85157, in Table B.27. Orthopedic Surgery, second column,
third row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85171, in Table B.30. Pediatrics, second column, fifth row,
the entry NQF #/eCQM NQF # contains typographical errors.
On page 85171, in Table B.30. Pediatrics, ninth column entry
Measure Steward, sixth row, we inadvertently misidentified the measure
steward.
On page 85173, in Table B.30. Pediatrics, second column, sixth row,
the entry NQF #/eCQM NQF # contains typographical errors.
On page 85179, in Table B.32. Physical Therapy/Occupational
Therapy, second column, fifth row, the entry NQF #/eCQM NQF # contains
a typographical error.
On page 85190, in Table B.35. Preventive Medicine, second column,
third row, the entry NQF #/eCQM NQF # contains a typographical error.
On page 85199, in Table B.38. Skilled Nursing Facility, third
column entry Quality #, fifth row, we inadvertently omitted the Quality
number.
On page 85203, in Table B.39. Speech Language Pathology, second
column, first row, the entry NQF #/eCQM NQF # contains a typographical
error.
On page 85268, in Table D.26. Preventive Care and Screening:
Screening for Depression and Follow-Up Plan, second column, first row,
the entry NQF #/eCQM NQF # contains a typographical error.
On page 85333, in Table D.82. Immunizations for Adolescents, second
column, first row, the entry NQF #/eCQM NQF # contains a typographical
error.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (the
APA), the agency is required to publish a notice of the proposed rule
in the Federal Register before the provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Social Security Act (the Act)
requires the Secretary to provide for notice of the proposed rule in
the Federal Register and provide a period of not less than 60 days for
public comment. In addition, section 553(d) of the APA and section
1871(e)(1)(B)(i) of the Act mandate a 30-day delay in effective date
after issuance
[[Page 5021]]
or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the APA notice and comment, and delay in
effective date requirements; in cases in which these exceptions apply,
sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide
exceptions from the notice and 60-day comment period and delay in
effective date requirements of the Act as well. Section 553(b)(B) of
the APA and section 1871(b)(2)(C) of the Act authorize an agency to
dispense with normal notice and comment rulemaking procedures for good
cause if the agency makes a finding that the notice and comment process
is impracticable, unnecessary, or contrary to the public interest, and
includes a statement of the finding and the reasons for it in the rule.
In addition, section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii)
allow the agency to avoid the 30-day delay in effective date where such
delay is contrary to the public interest and the agency includes in the
rule a statement of the finding and the reasons for it.
In our view, this correcting document does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects technical errors in the CY 2021 PFS final rule. The
corrections contained in this document are consistent with, and do not
make substantive changes to, the policies and payment methodologies
that were proposed, subject to notice and comment procedures, and
adopted in the CY 2021 PFS final rule. As a result, the corrections
made through this correcting document are intended to resolve
inadvertent errors so that the CY 2021 PFS final rule accurately
reflects the policies adopted in the final rule. Even if this were a
rulemaking to which the notice and comment and delayed effective date
requirements applied, we find that there is good cause to waive such
requirements. Undertaking further notice and comment procedures to
incorporate the corrections in this document into the CY 2021 PFS final
rule or delaying the effective date of the corrections would be
contrary to the public interest because it is in the public interest to
ensure that the rule accurately reflects our policies as of the date
they take effect. Further, such procedures would be unnecessary because
we are not making any substantive revisions to the final rule, but
rather, we are simply correcting the Federal Register document to
reflect the policies that we previously proposed, received public
comment on, and subsequently finalized in the CY 2021 PFS final rule.
For these reasons, we believe there is good cause to waive the
requirements for notice and comment and delay in effective date.
IV. Correction of Errors
In FR Doc. 2020-26815 (85 FR 84472), published December 28, 2020,
make the following corrections:
A. Correction of Errors in the Preamble
1. On page 84545 of the CY 2021 PFS final rule, third column, the
first partial paragraph at the top of the column is corrected by
removing the following language:
The medically necessary services associated with all the medical
devices for a single patient can be billed by only one practitioner,
only once per patient per 30 day period, and only when at least 16 days
of data have been collected.
2. On page 84545 of the CY 2021 PFS final rule, third column, prior
to the first full paragraph, is corrected by adding the following
language:
Comment: Commenters stated that for CPT codes 99457 and 99458, we
interpreted ``interactive communication'' to mean ``real-time
synchronous, two-way audio interaction that is capable of being
enhanced with video or other kinds of data transmission'' and suggested
that the required 20 minutes of time associated with CPT codes 99457
and 99458 should be only synchronous time, real-time between a
practitioner and a patient. Commenters stated that these two codes
include non-face-to-face time as well as real-time two-way audio
interactions.
Response: We agree with commenters that our description of the
required 20 minutes of time associated with CPT codes 99457 and 99458
should include care management services, as well as synchronous, real-
time interactions. That is, we agree that ``interactive communication''
as we defined it in the CY 2021 PFS proposed rule contributes to the
total time, but is not the only activity that should be included in the
total time.
After considering comments, we are clarifying for purposes of this
final rule, that the 20-minutes of intra-service work associated with
CPT codes 99457 and 99458 includes a practitioner's time engaged in
``interactive communication'' as well as time engaged in non-face-to-
face care management services during a calendar month.
Comment: Commenters disagreed with our statement that the services
associated with CPT codes 99453 and 99454 should be billed only once
per patient, per 30-day period, and wrote that CMS should clarify that
CPT codes 99453 and 99454 can be billed once per provider, per patient,
per 30-day period.
Response: We thank commenters for their insights related to billing
CPT codes 99453 and 99454. As we stated in the proposed rule, we
believe these two codes should be reported for a patient only once
during a 30-day period and only when reasonable and necessary. In
response to public commenters, we are clarifying that only one
practitioner can bill CPT codes 99453 and 99454 during a 30-day period
and only when at least 16 days of data have been collected on at least
one medical device as defined in section 201(h) of the FFDCA. CPT
language suggests that even when multiple medical devices are provided
to a patient, the services associated with all the medical devices can
be billed only once per patient per 30-day period and only when at
least 16 days of data have been collected. We also note that when a
more specific code is available to describe a service, CPT indicates
that the more specific code should be billed. We believe that there are
additional, more specific codes available for billing that allow remote
monitoring (for example, CPT code 95250 for continuous glucose
monitoring and CPT codes 99473 and 99474 for self-measured blood
pressure monitoring). In summary, we are clarifying that CPT codes
99453 and 99454 should be reported only once during a 30-day period;
that even when multiple medical devices are provided to a patient, the
services associated with all the medical devices can be billed by only
one practitioner, only once per patient, per 30-day period, and only
when at least 16 days of data have been collected; and that the
services must be reasonable and necessary.
B. Correction of Errors in the Addenda
1. On page 85057, in Table B.2. Audiology, second column, second
row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read
``N/A/0418e''.
2. On page 85069, in Table B.5. Clinical Social Work, second
column, second row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
3. On page 85076, in Table B.8. Diagnostic Radiology, ninth column,
third row, the Measure Steward entry ``American College of Radiology/
American Medical Association-Physician Consortium for Performance
Improvement/National Committee for Quality Assurance'' is corrected to
read ``American College of Radiology/National Committee for Quality
Assurance''.
[[Page 5022]]
4. On page 85083, in Table B.10. Endocrinology, second column,
third row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to
read ``N/A/0418e''.
5. On page 85089, in Table B.11. Family Medicine, second column,
sixth row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to
read ``N/A/0418e'', and in the second column, sixth row, the NQF #/eCQM
NQF # entry ``1407/N/A'' is corrected to read ``N/A/N/A''.
6. On page 85110, in Table B.16. Infectious Disease, the ninth
column, fourth row, the Measure Steward entry ``Health Resources and
Services Administration'' is corrected to read ``National Committee for
Quality Assurance''.
7. On page 85114, in Table B.17. Internal Medicine, second column,
first row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to
read ``N/A/0418e''.
8. On page 85124, in Table B.19. Mental/Behavioral Health, second
column, fifth row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
9. On page 85130, in Table B.21. Neurology, second column, third
row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read
``N/A/0418e''.
10. On page 85141, in Table B.24. Obstetrics/Gynecology, third
column, fifth row, the blank Quality # entry is corrected to read
``111''.
11. On page 85146, in Table B.25a. Oncology/Hematology, third
column, fifth row, the blank Quality # entry is corrected to read
``110''.
12. On page 85157, in Table B.27. Orthopedic Surgery, second
column, third row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
13. On page 85171, in Table B.30. Pediatrics, second column, fifth
row, the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read
``N/A/0418e''.
14. On page 85171, in Table B.30. Pediatrics, ninth column, sixth
row, the Measure Steward entry ``Health Resources and Services
Administration'' is corrected to read ``National Committee for Quality
Assurance''.
15. On page 85173, in Table B.30. Pediatrics, second column, sixth
row, the NQF #/eCQM NQF # entry ``1407/N/A'' is corrected to read ``N/
A/N/A''.
16. On page 85179, in Table B.32. Physical Therapy/Occupational
Therapy, second column, fifth row, the NQF #/eCQM NQF # entry ``0418/
0418e'' is corrected to read ``N/A/0418e''.
17. On page 85190, in Table B.35. Preventive Medicine, second
column, third row, the NQF #/eCQM NQF # ``entry 0418/0418e'' is
corrected to read ``N/A/0418e''.
18. On page 85199, in Table B.38. Skilled Nursing Facility, third
column, fifth row, the blank Quality # entry is corrected to read
``110''.
19. On page 85203, in Table B.39. Speech Language Pathology, second
column, first row, the NQF #/eCQM NQF # entry ``0418/0418e'' is
corrected to read ``N/A/0418e''.
20. On page 85268, in Table D.26. Preventive Care and Screening:
Screening for Depression and Follow-Up Plan, second column, first row,
the NQF #/eCQM NQF # entry ``0418/0418e'' is corrected to read ``N/A/
0418e''.
21. On page 85333, in Table D.82. Immunizations for Adolescents,
second column, first row, the NQF #/eCQM NQF # entry ``1407/N/A'' is
corrected to read ``N/A/N/A''.
Dated: January 11, 2021.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and
Human Services.
[FR Doc. 2021-00805 Filed 1-14-21; 8:45 am]
BILLING CODE 4120-01-P