HHS Delays Effective Date of HIPAA Final Rule Implementing Modified Retail Pharmacy Standard
In December 2024, the Department of Health and Human Services published a final rule in the Federal Register modifying the National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards and the Medicaid Pharmacy Subrogation Standard. The effective date for those modifications was initially set as February 11, 2025; however, the HHS has now delayed the effective date until April 14, 2025.
The final rule adopted updated versions of the retail pharmacy standards for electronic transactions for health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits, and the adoption of a modified standard for the Medicaid pharmacy subrogation transaction.
The delay to the effective and compliance dates is due to President Trump’s January 20, 2025, Presidential memorandum, titled “Regulatory Freeze Pending Review.” Dorothy A. Fink, Acting Secretary of the Department of Health and Human Services, said the 60-day postponement of the effective date was made “for the purpose of reviewing any questions of fact, law, and policy.”
Fink said that initiating notice and comment procedures for the final rule is unnecessary and contrary to the public interest, and the HHS has found good cause to waive the notice and comment requirements and the 30-day delay in the effective date, with the rule effective immediately on publication in the Federal Register.
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The delay to the effective date will naturally delay the compliance date. Since the effective date was February 11, 2025, full compliance with the modified standards would have been February 11, 2028, with a transition period commencing 8 months before the full compliance date. An error was made when calculating the start of the transition period, which was incorrectly set as August 11, 2027, in the December 2024 final rule, when it should have been June 11, 2027. A technical correction therefore must be made and published in the Federal Register, and the delay will give the HHS more time to make the necessary corrections.
