Data / Federal rules / 2026-07205
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges
The Centers for Medicare & Medicaid Services published this proposed rule in the Federal Register on April 14, 2026. Comments closed on June 15, 2026.
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What the agency says
These proposals are intended to improve the electronic exchange of health care data and streamline processes related to prior authorization by increasing the interoperability of systems used across the health care industry. We are proposing new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs), including issuers that offer small group market QHPs on the Federally-facilitated Small Business Health Options Program (FF- SHOP) Exchanges (hereinafter referred to as "small group market QHP issuers on the FF-SHOPs") (collectively "impacted payers"), to make available electronic prior authorization for drugs. We are also proposing to extend many existing interoperability requirements for the prior authorization of non-drug items and services to include prior authorizations for drugs to further reduce patient and provider burden. We are also proposing to require impacted payers to report their application programming interfaces (API) endpoints and related information for the Patient Access, Provider Directory, Provider Access, Payer-to-Payer, and Prior Authorization APIs to CMS. To help assess the impact of our policies, we are proposing to collect API usage metrics. In addition, we are proposing to apply the existing interoperability requirements to small group market QHP issuers on the FF-SHOPs as impacted payers. To improve impacted payers' ability to exchange health information while continuing CMS's drive toward interoperability, we are proposing to require certain Health Level Seven (HL7[supreg]) Fast Healthcare Interoperability Resources (FHIR[supreg]) implementation guides (IGs) that are currently recommended. In addition, HHS is proposing to adopt the HL7 FHIR base standard and certain associated specifications and IGs as the Health Insurance Portability and Accountability Act of 1996 (hereinafter referred to as "HIPAA") (Pub. L. 104-191, enacted Aug. 21, 1996) standards for dental, professional, and institutional "referral certification and authorization" transactions and "eligibility for a health plan" transactions associated with prior authorization. We are proposing to add a definition for "failure to report," which would allow CMS to impose a civil monetary penalty (CMP) on applicable manufacturers or applicable group purchasing organizations (GPOs) if those entities fail to grant CMS timely access to documents for the purposes of an audit. Finally, ONC is using this rulemaking to propose to adopt updated versions of certain health information technology (health IT) standards and specifications for HHS use, such as CMS's interoperability requirements, to support a more robust health IT infrastructure.
Key facts
- Document number
- 2026-07205
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Centers for Medicare & Medicaid Services
- Published
- April 14, 2026
- Comments due
- June 15, 2026
- Dates
- To be assured consideration, comments must be received at one of the addresses provided below, by June 15, 2026.
- Docket
- CMS-0062-P
- Regulation ID (RIN)
- 0938-AV44
- Code of Federal Regulations
- 42 CFR 403; 42 CFR 422; 42 CFR 431; 42 CFR 438; 42 CFR 440; 42 CFR 457; 45 CFR 156; 45 CFR 162; 45 CFR 170
- Topics
- Administrative practice and procedure; Advertising; Brokers; Computer technology; Consumer protection; Grant programs-health; Health; Health care; Health facilities; Health insurance; Health maintenance organizations (HMO); Health records; Hospitals; Incorporation by reference; Indians; Individuals with disabilities; Intergovernmental relations; Laboratories; Loan programs-health; Medicaid; Medicare; Organization and functions (Government agencies); Penalties; Prescription drugs; Privacy; Public assistance programs; Public health; Reporting and recordkeeping requirements; Technical assistance; Women; Youth
- Significant
- Yes, under Executive Order 12866
- Pages
- 173
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