[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]


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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.

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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