2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS-0062-P)

The Centers for Medicare & Medicaid Services (CMS) has released the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule (CMS-0062-P), continuing its efforts to improve electronic prior authorization so patients and providers can benefit from a more expeditious, transparent and reliable process. This proposed rule builds on the 2020 CMS Interoperability and Patient Access final rule (CMS-9115-F) and the 2024 CMS Interoperability and Prior Authorization final rule (CMS-0057-F), which require Medicare Advantage (MA) organizations, state Medicaid and Children’s Health Insurance Program (CHIP) fee-for-service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) (collectively “impacted payers”) to implement Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization Application Programming Interfaces (APIs) (collectively “interoperability APIs”).

While the prior authorization requirements in the 2024 final rule focused on non-drug items and services, the 2026 CMS Interoperability Standards and Prior Authorization for Drugs proposed rule extends many of those requirements to cover prior authorizations for drugs. Specifically, CMS now proposes to require impacted payers to support electronic prior authorization, to make decisions on requests within shorter timeframes that align CMS programs, and to increase transparency for the prior authorization of drugs. In addition, CMS is proposing to require impacted payers to update health information technology (health IT) standards and to report interoperability API endpoints and API usage metrics to CMS.  

Furthermore, under the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Department of Health and Human Services (HHS) is proposing to adopt certain Health Level Seven® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) standards and implementation specifications for transactions related to prior authorizations.  These HHS proposals would apply to all HIPAA covered entities (health care providers, health plans, and health care clearinghouses) that electronically exchange prior authorization requests and decisions for item and services. information for dental, professional, and institutional transactions for health care. 

The proposed rule will be available for public comment until June 15, 2026.