Sponsors (3)
Requires HHS to create a process for qualified clinical registries to request Medicare (and optionally Medicaid/CHIP) claims data for linkage, quality assessment, research, and publication, with cost‑based access fees.
Official title: To require the Secretary of Health and Human Services to establish a process to expand access to claims data under certain Federal health plans in order to facilitate research and quality improvement.
Introduced July 10, 2025 by John Joyce · Last progress July 10, 2025
The bill expands registry and researcher access to linked claims and clinical data to accelerate quality measurement and evidence-based care while reducing administrative barriers and providing predictable, cost-based fees — but it raises significant patient privacy risks, potential misuse or misinterpretation of provider data, costs for smaller organizations, and state-level implementation complications.
Hospitals, health systems, clinician-led registries, and researchers gain direct access to claims linked with clinical outcomes, enabling risk-adjusted quality assessments, improved provider reporting, and evidence-based care improvements for Medicare beneficiaries and patients with chronic conditions.
Clinical data registries and clinician-led registries can obtain claims data without needing 'qualified entity' status, reducing administrative barriers and accelerating timely research and registry activities.
A clear fee structure limited to reasonable cost makes access costs predictable and helps cover CMS processing expenses, supporting registry operations and planning.
Medicare, Medicaid, and other patients — particularly those with chronic conditions — face increased privacy and reidentification risks if identifiable or linkable claims data are shared and deidentification or controls fail.
Smaller registries and nonprofit organizations may be financially burdened by access fees (even if limited to cost), which could limit participation and reduce the diversity of research and oversight activities.
Broad access to provider-, specialty-, or State-specific claims data could enable disclosure risks or lead to misinterpretation of provider performance without robust risk adjustment and safeguards, potentially harming providers and misleading patients.
Based on analysis of 2 sections of legislative text.
Requires HHS to create a process by January 1, 2026 allowing qualified clinical data registries and clinician-led registries to request Medicare claims data (and, at the Secretary’s discretion, Medicaid and CHIP claims data) for linking with clinical outcomes, quality assessment, risk-adjusted research, and publication (including deidentified combined analyses). The bill exempts those registries from being treated as 'qualified' or 'quasi‑qualified' entities under an existing statute and permits HHS to charge access fees limited to the reasonable cost of providing the data, with fees deposited into the CMS Program Management Account.