[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]



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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

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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''.

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    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