Federal Register #2026-07205

Proposed Rule: Interoperability Standards and Electronic Prior Authorization for Medicare, Medicaid, CHIP, and QHPs

This proposed rule from the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) aims to modernize electronic prior authorization for drugs in Medicare, Medicaid, CHIP, and Qualified Health Plans on Federally-facilitated Exchanges. - Government Buyer: - Department of Health and Human Services (HHS) - Centers for Medicare & Medicaid Services (CMS) - Office of the National Coordinator for Health Information Technology (ONC) - Impacted entities: Medicare Advantage organizations, state Medicaid fee-for-service programs, state CHIP FFS programs, Medicaid managed care plans, CHIP managed care entities, Qualified Health Plan (QHP) issuers on Federally-facilitated Exchanges (including small group market QHP issuers on FFSHOPs) - OEMs and Vendors: - HL7 (Health Level Seven International) – developer of FHIR interoperability standard - NCPDP (National Council for Prescription Drug Programs) – developer of SCRIPT, Formulary & Benefit, and Real-Time Prescription Benefit standards - Products/Services Requested: - Implementation of HL7 FHIR and NCPDP standards for electronic prior authorization of drugs - Includes support for API endpoint reporting, usage metrics, and adoption of recommended implementation guides - Applies to both medical and pharmacy benefit drugs - Reporting of API endpoints and prior authorization metrics to CMS - Unique or Notable Requirements: - Mandatory adoption of HL7 FHIR and NCPDP standards for all impacted payers - Public reporting of prior authorization metrics to enhance transparency - Civil monetary penalties for non-compliance - Compliance extensions available for state Medicaid and CHIP FFS programs; exceptions process for QHP issuers unable to meet requirements - Compliance dates: October 1, 2027 for most payers; January 1, 2028 for small group market QHP issuers on FFSHOPs; HIPAA Administrative Simplification proposals have 24-36 month compliance periods - Place of Performance/Delivery: - CMS and HHS offices in Baltimore, MD and Washington, DC

Description

This proposed rule by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) aims to improve electronic health data exchange and streamline prior authorization processes for drugs. It proposes new interoperability standards and requirements for Medicare Advantage organizations, Medicaid and CHIP programs, and Qualified Health Plan issuers on Federally-facilitated Exchanges. The rule includes adoption of HL7 FHIR and NCPDP standards for electronic prior authorization, reporting API endpoints, and penalties for non-compliance, with a compliance date proposed for October 1, 2027.

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