5020 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

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. 

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 FollowUp 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 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 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, realtime 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 selfmeasured 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 AssociationPhysician 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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5022 Federal Register / Vol. 86, No. 11 / Tuesday, January 19, 2021 / Rules and Regulations 

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 FollowUp 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Part 67 

[Docket No. USCG–2020–0215] 

RIN 1625–AC26 

Certificate of Documentation—5 Year 

Renewal Fees 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is issuing a 

final rule extending the validity of a 

recreational vessel endorsement on a 

Certificate of Documentation (COD) 

from 1 to 5 years. Congress passed and 

the President signed the Frank 

LoBiondo Coast Guard Authorization 

Act of 2018, which requires the Coast 

Guard to issue recreational vessel CODs 

for 5 years. By updating the Code of 

Federal Regulations to reflect this 

change, the Coast Guard anticipates this 

final rule to harmonize with the 

requirements of the 2018 Act that 

decreased the burden on recreational 

vessel owners by requiring COD 

renewals every 5 years rather than 

annually. 

DATES: This final rule is effective 

February 18, 2021. 

ADDRESSES: To view documents 

mentioned in this preamble as being 

available in the docket, go to https://

www.regulations.gov, type USCG–2020– 

0215 in the ‘‘SEARCH’’ box and click 

‘‘SEARCH.’’ Click on Open Docket 

Folder on the line associated with this 

rule. 

FOR FURTHER INFORMATION CONTACT: For 

information about this document, call or 

email Mr. Ronald Teague, Department of 

Homeland Security, U.S. Coast Guard, 

National Vessel Documentation Center, 

792 T J Jackson Drive, Falling Waters, 

WV 25419; telephone 304 271–2506; 

email ronald.s.teague@uscg.mil. 

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble 

I. Abbreviations 

II. Basis and Purpose, and Regulatory History 

III. Background 

IV. Discussion of the Rule 

V. Regulatory Analyses 

A. Regulatory Planning and Review 

B. Small Entities 

C. Assistance for Small Entities 

D. Collection of Information 

E. Federalism 

F. Unfunded Mandates 

G. Taking of Private Property 

H. Civil Justice Reform 

I. Protection of Children 

J. Indian Tribal Governments 

K. Energy Effects 

L. Technical Standards 

M. Environment 

I. Abbreviations 

2018 Act Frank LoBiondo Coast Guard 

Authorization Act of 2018 (Pub. L. 115– 

282, 132 Stat. 4192) 

BLS Bureau of Labor Statistics 

CFR Code of Federal Regulations 

COD Certificate of Documentation 

DHS Department of Homeland Security 

FR Federal Register 

NPRM Notice of proposed rulemaking 

NVDC U.S. Coast Guard National Vessel 

Documentation Center 

OMB Office of Management and Budget 

§ Section 

SME Subject matter expert 

U.S.C. United States Code 

II. Basis and Purpose, and Regulatory 

History 

The legal basis for this final rule is 

found in Section 512 of the Frank 

LoBiondo Coast Guard Authorization 

Act of 2018 (2018 Act) (Pub. L. 115–282, 

132 Stat. 4192) (the 2018 Act), which 

the President signed on December 4, 

2018. The 2018 Act directed the Coast 

Guard to do the following: (1) Make 

Certificates of Documentation (CODs) 

for recreational vessels of at least five 


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