Sponsors (3)
Introduced July 10, 2025 by John Joyce · Last progress July 10, 2025
The bill expands valuable links between claims and clinical registry data to improve care, research, and system-level insights, but does so in ways that materially raise patient privacy risks, reduce some oversight protections, and may limit equitable access for smaller researchers.
Millions of Medicare (and optionally Medicaid/CHIP) beneficiaries: hospitals and clinical registries can link claims to clinical outcomes so providers can identify care gaps and run targeted quality-improvement programs that improve patient care.
Clinicians and provider organizations: receive risk-adjusted feedback and benchmarking from registry analyses, supporting improved provider performance and better patient outcomes.
Researchers and policymakers: gain access to deidentified combined claims/clinical data enabling scientifically valid studies that can inform treatments, policy decisions, and system-level improvements.
Medicare beneficiaries and patients with chronic conditions: providing provider-level claims linked to clinical data increases reidentification risk even if deidentified, creating privacy harms and potential misuse of sensitive health information.
Patients and state governments: removing the 'qualified entity' requirement reduces existing oversight and safeguards for who can access linked claims/clinical data, increasing the chance of misuse or inadequate privacy protections.
Medicaid beneficiaries and children: allowing optional access to Medicaid/CHIP data risks exposing sensitive information about low-income families and children if privacy controls are insufficient.
Based on analysis of 2 sections of legislative text.
Requires HHS to establish by Jan 1, 2026 a process allowing certain clinical registries to request Medicare (and optionally Medicaid/CHIP) claims data for linking to clinical data, research, and quality assessment with cost‑based fees.
Requires the HHS Secretary to set up, by January 1, 2026, a process that lets qualified clinical data registries and clinician‑led clinical data registries request Medicare claims data (and, if appropriate, Medicaid and CHIP claims data) in a form determined by the Secretary for linking with clinical outcomes, provider quality assessment/improvement, risk‑adjusted research, and publishing analyses, including deidentified combined claims/clinical data. The bill waives the need for registries to be "qualified" or "quasi‑qualified" entities to access the data, allows HHS to charge a reasonable fee to recover costs, and directs that fees be deposited into the CMS Program Management Account.