Rules and Regulations. Final rule; delay of effective date
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/register/2025/02/11/2025-02511·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4910-13-P 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. 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 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]
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