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[Federal Register Volume 90, Number 27 (Tuesday, February 11, 2025)]
[Rules and Regulations]
[Pages 9289-9290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-02511]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 162

[CMS-0056-F2]
RIN 0938-AU19

Administrative Simplification: Modifications of Health Insurance 
Portability and Accountability Act of 1996 (HIPAA) National Council for 
Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and 
Modification of the Medicaid Pharmacy Subrogation Standard; Delay of 
Effective Date

AGENCY: Office of the Secretary, Department of Health and Human 
Services (HHS).

ACTION: Final rule; delay of effective date.

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SUMMARY: In accordance with the Presidential memorandum of January 20, 
2025, titled ``Regulatory Freeze Pending Review,'' the effective date 
of the final rule titled ``Administrative Simplification: Modifications 
of Health Insurance Portability and Accountability Act of 1996 (HIPAA) 
National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy 
Standards; and Modification of the Medicaid Pharmacy Subrogation 
Standard'' is delayed until April 14, 2025. That final rule adopted 
updated versions of the retail pharmacy standards for electronic 
transactions adopted under the Administrative Simplification subtitle 
of HIPAA, which constitute modifications to the adopted standards for 
the following retail pharmacy transactions: health care claims or 
equivalent encounter information; eligibility for a health plan; 
referral certification and authorization; and coordination of benefits. 
It also adopted a modification to the standard for the Medicaid 
pharmacy subrogation transaction.

DATES: 
    Effective date: The final rule titled ``Administrative 
Simplification: Modifications of Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) National Council for Prescription 
Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of 
the Medicaid Pharmacy Subrogation Standard,'' which appeared in the 
December 13, 2024, Federal Register (89 FR 100763) is delayed to April 
14, 2025. The incorporation by reference of certain publications 
adopted in the rule and approved by the Director of the Federal 
Register is also delayed to April 14, 2025.
    Compliance Date: The compliance dates are extended to April 14, 
2028.

FOR FURTHER INFORMATION CONTACT: 
Geanelle G. Herring, (410) 786-4466.
Christopher S. Wilson, (410) 786-3178.

SUPPLEMENTARY INFORMATION: Under 5 U.S.C. 553(b) of the Administrative 
Procedure Act (APA), the agency is required to publish a notice of 
proposed rulemaking in the Federal Register before the provisions of a 
rule take effect. In addition, section 553(d) of the APA mandates a 30-
day delay in the effective date after issuance or publication of a 
rule. However, to the extent that 5 U.S.C. 553 applies to this action, 
it is exempt from such requirements because it constitutes a rule of 
procedure under 5 U.S.C. 553(b)(A).
    Alternatively, HHS's implementation of this action without 
opportunity for public comment, effective immediately, is based on the 
good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Seeking public 
comment is impracticable, unnecessary, and contrary to the public 
interest. The temporary delay in the effective date until April 14, 
2025, is necessary to give agency officials the opportunity for further 
review and consideration of the new regulation, consistent with the 
memorandum described previously. Given the imminence of the effective 
date and the brief length of the extension of the effective date, 
seeking prior public comment on this temporary delay would have been 
impracticable, as well as contrary to the public interest in the 
orderly promulgation and implementation of regulations. HHS also 
believes that affected entities need

[[Page 9290]]

to be informed as soon as possible of the extension and its length in 
order to plan and adjust their implementation process accordingly.
    Moreover, we are cognizant that the final rule that appeared in the 
December 13, 2024, Federal Register (89 FR 100763) requires publication 
in the Federal Register of a correction document as a technical error 
was made in the calculation of the date of the 8-month transition 
period prior to full compliance with the retail pharmacy and Medicaid 
pharmacy subrogation standards. References in that final rule to August 
11, 2027 should, instead, read June 11, 2027. The delay by virtue of 
this final rule will permit more time to publish those corrections, 
while also signaling the nature of those forthcoming corrections, 
thereby minimizing public confusion.
    Consistent with the Presidential memorandum of January 20, 2025, 
``Regulatory Freeze Pending Review'', we are postponing for 60 days the 
effective date of the final rule that appeared in the December 13, 
2024, Federal Register (89 FR 100763), for the purpose of reviewing any 
questions of fact, law, and policy. As a result, undertaking notice and 
comment procedures for this rule is unnecessary and contrary to the 
public interest, and we find good cause to waive the notice and comment 
requirements and the 30-day delay in the effective date. Based on these 
findings, this rule is effective immediately upon publication in the 
Federal Register.

Dorothy A. Fink,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2025-02511 Filed 2-10-25; 8:45 am]
BILLING CODE 4120-01-P
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