H.R. 4331 — Access to Claims Data Act

This section directs the Secretary of HHS, not later than January 1, 2026, to establish a process allowing qualified clinical data registries (under SSA §1848(m)(3)(E), i.e., entities that submit quality measures data on behalf of eligible professionals under Medicare's Merit-based Incentive Payment System) and clinician-led clinical data registries (under Cures Act §4005) to request Medicare claims data—and, if determined appropriate by the Secretary, Medicaid and CHIP claims data—in a form and manner specified by the Secretary. The data, which may be provider-specific, clinical specialty-specific, state-specific, or nationwide, may be requested for (1) linking with clinical outcomes data; (2) conducting quality assessments and improvement activities for Medicare providers of services and suppliers, reporting results to them, and performing risk-adjusted analyses and research to support quality improvement or patient safety; or (3) publishing research and quality improvement analyses, including deidentified combined claims and clinical outcomes data. Such registries are exempt from the "qualified entity" requirements under current law (42 USC 1395kk(e)). (Thus, these registries gain streamlined access to claims data previously restricted to vetted entities evaluating provider/supplier performance.) Data must be provided at a reasonable fee equal to production costs, with fees deposited into the CMS Program Management Account.