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
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Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 27 (Tuesday, February 11, 2025)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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