The Centers for Medicare & Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC), and thr Department of Health and Human Services (HHS) published 89 FR 51238 (the Final Rule), which revised the Medicare Prescription Drug Benefit (Part D) and ONC regulations to implement changes related to required standards for electronic prescribing and adoption of health information technology (IT) standards for HHS use.

The Final Rule addresses proposed changes to a November 2023 proposed rule regarding Medicare program IT standards that were not finalized. The Final Rule requires sponsors, prescribers, and dispensers of covered Part D drugs for Part D-eligible individuals to comply with standards CMS has either adopted directly or is requiring by cross-referencing standards that ONC adopts for electronically transmitting prescriptions and prescription-related information.

As finalized, Part D standards for electronic prescribing regulations will require that prescriptions, medication history, and electronic prior authorization comply with standards adopted by ONC. As of January 1, 2028, entities will be required to exclusively use National Council for Prescription Drug Programs (NCPDP) SCRIPT standard version 2023011. Up until that time, SCRIPT standard versions 2017071 or 2023011 can be used. Additionally, as of January 1, 2027, Part D sponsors, prescribers, and dispensers of covered Part D drugs for Part D eligible individuals will be required to exclusively use NCPDP Formulary and Benefit (F&B) standard version 60 for the electronic transmission of formulary and benefits information.

The Final Rule also states that by January 1, 2027, Part D sponsor real-time benefit tools (RTBTs) must comply with a standard adopted by ONC, including its adoption of NCPDP Real-Time Prescription Benefit (RTPB) standard version 13 finalized in the Final Rule. Lastly, the Final Rule finalizes a provision that will cross-reference Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations for eligibility transactions, making Part D requirements automatically align with any potential future updates to the required standards for eligibility transactions.

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