Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations 7813 

Accordingly, the Department is not 

required either to certify that the final 

rule would not have a significant 

economic impact on a substantial 

number of small entities or to conduct 

a regulatory flexibility analysis. 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance number and title for the 

program affected by this document is 

64.114, Veterans Housing Guaranteed 

and Insured Loans. 

Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), the Office of 

Information and Regulatory Affairs 

designated this rule as not a major rule, 

as defined by 5 U.S.C. 804(2). 

List of Subjects 

38 CFR Part 36 

Condominiums, Housing, Individuals 

with disabilities, Loan programs— 

housing and community development, 

Loan programs—veterans, Manufactured 

homes, Mortgage insurance, Reporting 

and recordkeeping requirements, 

Veterans. 

38 CFR Part 42 

Administrative practice and 

procedure, Claims, Fraud, Penalties. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. 

Brooks D. Tucker, Assistant Secretary 

for Congressional and Legislative 

Affairs, Performing the Delegable Duties 

of the Chief of Staff, Department of 

Veterans Affairs, approved this 

document on January 14, 2021, for 

publication. 

Luvenia Potts, 

Regulations Development Coordinator, Office 

of Regulation Policy & Management, Office 

of the Secretary, Department of Veterans 

Affairs. 

Editorial note: This document was 

received for publication by the Office of the 

Federal Register on January 15, 2021. 

For the reasons stated in the 

preamble, the Department of Veterans 

Affairs amends 38 CFR parts 36 and 42 

as set forth below: 

PART 36—LOAN GUARANTY 

■ 1. The authority citation for part 36 

continues to read as follows: 

Authority: 38 U.S.C. 501 and 3720. 

§ 36.4340 [Amended] 

■ 2. In § 36.4340, amend paragraphs 

(k)(1)(i) introductory text and (k)(3) by 

removing ‘‘$23,331’’ and adding in its 

place ‘‘$23,607’’. 

PART 42—STANDARDS 

IMPLEMENTING THE PROGRAM 

FRAUD CIVIL REMEDIES ACT 

■ 3. The authority citation for part 42 

continues to read as follows: 

Authority: Pub. L. 99–509, secs. 6101– 

6104, 100 Stat. 1874, codified at 31 U.S.C. 

3801–3812. 

§ 42.3 [Amended] 

■ 4. In § 42.3, amend paragraphs 

(a)(1)(iv) and (b)(1)(ii) by removing 

‘‘$11,665’’ and adding in its place 

‘‘$11,803’’. 

[FR Doc. 2021–01335 Filed 2–1–21; 8:45 am] 

BILLING CODE 8320–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 423 

[CMS–4189–F2] 

RIN 0938–AT94 

Medicare Program; Secure Electronic 

Prior Authorization for Medicare Part D 

Program; Delay in Effective Date 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Final rule; delay in effective 

date. 

SUMMARY: In accordance with the 

memorandum of January 20, 2021 from 

the Assistant to the President and the 

Chief of Staff, entitled ‘‘Regulatory 

Review,’’ this action temporarily delays 

for 60 days the effective date of the 

December 31, 2020 final rule entitled, 

‘‘Medicare Program; Secure Electronic 

Prior Authorization For Medicare Part 

D’’, which published on December 31, 

2020. 

DATES: The effective date of the final 

rule amending 42 CFR part 423 

published at 85 FR 86824 on December 

31, 2020, is delayed from February 1, 

2021, to March 30, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Joella Roland, (410) 786–7638. 

SUPPLEMENTARY INFORMATION: 

Background and Provisions of the Final 

Rule 

The January 20, 2021 memorandum 

from the Assistant to the President and 

Chief of Staff, entitled ‘‘Regulatory 

Freeze Pending Review,’’ instructed 

Federal agencies to delay the effective 

date of rules published in the Federal 

Register, but which have not yet taken 

effect, for a period of 60 days from the 

date of the memorandum. 

The purpose of the final rule is to 

adopt a new standard for certain 

transactions concerning Part D-covered 

drugs prescribed to Part D-eligible 

individuals under the Part D eprescribing program. Under this final 

rule, Part D plan sponsors will be 

required to support version 2017071 of 

the National Council for Prescription 

Drug Programs (NCPDP) SCRIPT 

standard for four electronic Prior 

Authorization (ePA) transactions, and 

prescribers will be required to use that 

standard when performing ePA 

transactions for Part D-covered drugs 

they wish to prescribe to Part D-eligible 

individuals. Part D plans, as defined in 

42 CFR 423.4, include Prescription Drug 

Plans (PDPs) and Medicare Advantage 

Prescription Drug Plans (MA–PDs); Part 

D sponsor, as defined in 42 CFR 423.4, 

means the entity sponsoring a Part D 

plan, MA organization offering a MA– 

PD plan, a Programs of All-Inclusive 

Care for the Elderly (PACE) organization 

sponsoring a PACE plan offering 

qualified prescription drug coverage, 

and a cost plan offering qualified 

prescription drug coverage. The ePA 

transaction standard will provide for the 

electronic transmission of information 

between the prescribing health care 

professional and Part D plan sponsor to 

inform the sponsor’s determination as to 

whether or not a prior authorization 

(PA) should be granted. The NCPDP 

SCRIPT standard version 2017071 was 

adopted as a Part D e-prescribing 

program standard for certain defined 

transactions in the April 16, 2018 final 

rule (83 FR 16440) titled Medicare 

Program; Contract Year 2019 Policy and 

Technical Changes to the Medicare 

Advantage, Medicare Cost Plan, 

Medicare Fee-for-Service, the Medicare 

Prescription Drug Benefit Programs, and 

the PACE Program that became effective 

June 15, 2018. 

The effective date of that rule, which 

would have been February 1, 2021, is 

now effective on March 30, 2021. 

The temporary delay in the effective 

date of this final rule is necessary to 

give Department officials the 

opportunity for further review and 

consideration of new regulations, 

consistent with the memorandum of 


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7814 Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations 

January 20, 2021, from the Assistant to 

the President and Chief of Staff, entitled 

‘‘Regulatory Freeze Pending Review.’’ 

Norris Cochran, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2021–02181 Filed 1–29–21; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 486 

[CMS–3380–F2] 

RIN 0938–AU02 

Medicare and Medicaid Programs; 

Organ Procurement Organizations 

Conditions for Coverage: Revisions to 

the Outcome Measure Requirements 

for Organ Procurement Organizations; 

Public Comment Period; Delay of 

Effective Date 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Health and 

Human Services (HHS). 

ACTION: Final rule; public comment 

period; delay of effective date. 

SUMMARY: In accordance with the 

memorandum of January 20, 2021, from 

the Assistant to the President and Chief 

of Staff, entitled ‘‘Regulatory Freeze 

Pending Review,’’ this action 

temporarily delays for 60 days the 

effective date of part of the final rule 

entitled, ‘‘Medicare and Medicaid 

Programs; Organ Procurement 

Organizations Conditions for Coverage: 

Revisions to the Outcome Measure 

Requirements for Organ Procurement 

Organizations; Final rule’’ published in 

the Federal Register on December 2, 

2020. We are also providing an 

additional 30-day public comment 

period. 

DATES: The February 1, 2021, effective 

date of the rule amending 42 CFR part 

486, published at 85 FR 77898 on 

December 2, 2020, is delayed to March 

30, 2021. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, by March 4, 2021. 

ADDRESSES: In commenting, please refer 

to file code CMS–3380–F2. 

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-3380–F2, 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-3380–F2, 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: 

Diane Corning, (410) 786–8486; Jesse 

Roach, (410) 786–1000; Kristin Shifflett, 

(410) 786–4133; CAPT James Cowher, 

(410) 786–1948; or Alpha-Banu Wilson, 

(410) 786–8687. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

The January 20, 2021 memorandum 

from the Assistant to the President and 

Chief of Staff, entitled ‘‘Regulatory 

Freeze Pending Review,’’ instructed 

Federal agencies to delay the effective 

date of rules published in the Federal 

Register, but which have not yet taken 

effect, for a period of 60 days. On 

December 2, 2020, we published a final 

rule in the Federal Register entitled 

‘‘Medicare and Medicaid Programs; 

Organ Procurement Organizations 

Conditions for Coverage: Revisions to 

the Outcome Measure Requirements for 

Organ Procurement Organizations; Final 

rule’’ (85 FR 77898). The December 

2020 final rule revises the Organ 

Procurement Organizations Conditions 

for Coverage to increase donation rates 

and organ transplantation rates by 

replacing the current outcome measures 

with new transparent, reliable, and 

objective outcome measures and 

increasing competition for open 

donation service areas. The effective 

date of that rule, except for amendment 

number 3, which would have been 

February 1, 2021, is now March 30, 

2021. We are also providing a 30-day 

public comment period. The 60-day 

delay in effective date is necessary to 

give Department officials the 

opportunity for further review of the 

issues of fact, law, and policy raised by 

this rule. In addition, this action 

provides a comment period on the 

policies set out in the December 2, 2020 

final rule to allow interested parties to 

provide comments about issues of fact, 

law and policy raised by the rule. 

II. 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. 

Norris Cochran, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2021–02180 Filed 1–29–21; 11:15 am] 

BILLING CODE 4120–01–P 


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