The Centers for Medicare and Medicaid Services (CMS), the Office of the National Coordinator for Health Information Technology (ONC), and the Department of Health and Human Services (HHS) have issued 89 FR 51238 (final rule) amending the Medicare Prescription Drug Benefit (Part D) and ONC regulations to implement changes related to the adoption of mandatory standards for electronic prescribing and health information technology (IT) standards for use by HHS.
The final rule addresses proposed changes that were not finalized to the November 2023 proposed rule on IT standards for Medicare programs. The final rule requires sponsors, prescribers, and dispensers of Part D covered drugs to Part D recipients to comply with standards that CMS has adopted directly or that it requires by cross-referencing standards that ONC has adopted for the electronic transmission of prescriptions and prescription-related information.
The finalized Part D standards for electronic prescribing regulations require prescriptions, medication histories, and electronic prior authorizations to comply with standards adopted by ONC. After January 1, 2028, entities must use only National Council of Prescription Drug Programs (NCPDP) SCRIPT standard version 2023011. Until then, they may use SCRIPT standard versions 2017071 or 2023011. Additionally, after January 1, 2027, Part D sponsors, prescribers, and dispensers of Part D-covered drugs for Part D recipients must use only NCPDP Formulary and Benefits (F&B) Standard version 60 for electronic submission of formulary and benefit information.
The final rule also provides that by January 1, 2027, Part D sponsors' real-time benefit tools (RTBTs) must comply with standards adopted by ONC, including the adoption of the NCPDP Real-Time Prescription Benefit (RTPB) Standard Version 13, finalized in the final rule. Finally, the final rule finalizes provisions that cross-reference to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) regulations on eligible transactions, ensuring that Part D requirements will automatically align with any future updates to the standards required for eligible transactions.
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