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Open for Comment: 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

Health and Human Services Department — 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. (61 days remaining)

Open for Comment: Air Plan Approval; Ohio; Redesignation of the Cleveland, OH Area to Attainment of the 2015 Ozone Standards

Environmental Protection Agency — The Environmental Protection Agency (EPA) is proposing to act in accordance with a request from the Ohio Environmental Protection Agency (Ohio EPA) to redesignate the Cleveland, Ohio area to attainment for the 2015 ozone National Ambient Air Quality Standards (NAAQS) because the request meets the statutory requirements for redesignation under the Clean Air Act (CAA). The Cleveland area includes Cuyahoga, Geauga, Lake, Lorain, Medina, Portage, and Summit Counties. Ohio EPA submitted this request on December 8, 2025. The EPA is also proposing to approve, as a revision to the Ohio State Implementation Plan (SIP), the State's plan for maintaining the 2015 ozone NAAQS through 2038 in the Cleveland area. The EPA is also initiating the adequacy process and proposing to approve Ohio's 2032 and 2038 volatile organic compound (VOC) and oxides of nitrogen (NO<INF>X</INF>) motor vehicle emissions budgets (budgets) for the Cleveland area. Additionally, the EPA is proposing to adjust the deadline for Ohio to submit Serious SIP revisions for the Cleveland area. Finally, the EPA is proposing to approve the Enhanced motor vehicle inspection and maintenance (I/M) program certification, clean fuel vehicle program (CFVP) certification, and enhanced monitoring plan (EMP) certification SIP revisions submitted by Ohio EPA on December 19, 2025, and January 12, 2026, pursuant to section 110 and part D of the CAA, because they satisfy Serious SIP requirements for the Cleveland area under the 2015 ozone NAAQS. (30 days remaining)