HHS Delays Effective and Compliance Dates of Final Rule Modifying HIPAA Retail Pharmacy Standards

Dorothy A. Fink, Acting Secretary of the Department of Health and Human Services (HHS), has delayed the effective and compliance dates of the final rule modifying the HIPAA National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards and the Medicaid Pharmacy Subrogation Standard.

The final rule modified the HIPAA administrative simplification provisions, specifically updating the NCPDP Telecommunication Standard Implementation Guide, the NCPDP Batch Standard Implementation Guide, and the NCPDP Batch Standard Medicaid Subrogation Implementation Guide. The modifications apply to 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, as well as broadening the scope of the Medicaid pharmacy subrogation transaction.

A final rule was published in the Federal Register in December 2024 which set the effective date for the final rule as February 11, 2025, and the compliance date as February 11, 2028. The HHS has temporarily delayed the effective date by 60 days, which will now be April 14, 2025, and the full compliance date will now be April 14, 2028.

The final rule established a transition period of 8 months before the full compliance date when the old and new versions of the standards can be used, the start date of which was erroneously set as August 11, 2027, in the December 2024 final rule – 6 months before the full compliance date – when it should have been June 11, 2027. Fink said this technical error needs to be corrected and published in the Federal Register, although that date, like the full compliance date, will be 60 days later, so there will be little difference to the previously stated start date.

The reason for the delay is the Presidential memorandum, titled Regulatory Freeze Pending Review, issued by President Trump on January 20, 2025. As a result of the memorandum, Fink said the delay was necessary for the purpose of reviewing any questions of fact, law, and policy. While there would normally be a notice and comment period, Fink said the HHS found good cause to waive the notice and comment period as it would be unnecessary and contrary to the public interest. She also said the delay will give the HHS more time to make technical corrections, such as changing the start date of the transition period.