Medicare Program; Secure Electronic Prior Authorization for Medicare Part D Program; Delay in Effective Date, 7813-7814 [2021-02181]

Download as PDF Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations 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. § 36.4340 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. PART 42—STANDARDS IMPLEMENTING THE PROGRAM FRAUD CIVIL REMEDIES ACT 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. Luvenia Potts, Regulations Development Coordinator, Office of Regulation Policy & Management, Office of the Secretary, Department of Veterans Affairs. jbell on DSKJLSW7X2PROD with RULES 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: 1. The authority citation for part 36 continues to read as follows: ■ Authority: 38 U.S.C. 501 and 3720. VerDate Sep<11>2014 15:58 Feb 01, 2021 Jkt 253001 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’’. ■ 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 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. PART 36—LOAN GUARANTY [Amended] [CMS–4189–F2] RIN 0938–AT94 Medicare Program; Secure Electronic Prior Authorization for Medicare Part D Program; Delay in Effective Date Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Final rule; delay in effective date. AGENCY: 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. 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: DATES: PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 7813 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 E:\FR\FM\02FER1.SGM 02FER1 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 Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS). ACTION: Final rule; public comment period; delay of effective date. jbell on DSKJLSW7X2PROD with RULES AGENCY: 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 VerDate Sep<11>2014 15:58 Feb 01, 2021 Jkt 253001 to https://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: https:// 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. 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 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; PO 00000 Frm 00018 Fmt 4700 Sfmt 9990 E:\FR\FM\02FER1.SGM 02FER1

Agencies

[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Rules and Regulations]
[Pages 7813-7814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02181]


=======================================================================
-----------------------------------------------------------------------

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 e-prescribing 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

[[Page 7814]]

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
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.