HSS Issues Updates to the Final Rule on HIPAA, NCPDP Standards, and the Medicaid Pharmacy Subrogation Standard

• On August 20, 2025, the U.S. Department of Health and Human Services (HHS) issued updates (the Interim Final Rule) which amends 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,” (the December 2024 Final Rule). 
• On February 11, 2025, the effective date of the December 2024 Final Rule was delayed to April 14, 2025 and the compliance date to April 14, 2028, with an 8-month transition period from August 14, 2027 to April 14, 2028 (Notice of Delay of Effective Date). This delay was intended to comply with the requirements of the administration’s Executive Order titled Regulatory Freeze Pending Review. 
• The December 2024 Final Rule adopted updated versions of the retail pharmacy standards for electronic transactions. The following updated standards were adopted:  
  • NCPDP Telecommunication Standard Implementation Guide Version F6 (Version F6), and 
  • Equivalent Batch Standard Implementation Guide, Version 15 (Version 15) 
• Beginning August 14, 2027, all covered entities can utilize either Version D.0 and Version 1.2 or Version F6 and Version 15 for an 8-month transition period leading up to full compliance with the requirements of the December 2024 Final Rule. 

More on This Topic: 

• December 2024 Final Rule
• December 2024 Regulatory NewsBREAK
• Notice of Delay of Effective Date
• Interim Final Rule
• Executive Order - Regulatory Freeze Pending Review 

For questions, please reach out to Vicky Jucelin.