HR 4331

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IN THE HOUSE OF REPRESENTATIVES

July 10, 2025

Mr. Joyce of Pennsylvania (for himself and Ms. Schrier) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

A BILL

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Access to Claims Data Act”.

SEC. 2. EXPANDED ACCESS TO CLAIMS DATA TO FACILITATE RESEARCH AND QUALITY IMPROVEMENT.

(a) In General.—Not later than January 1, 2026, the Secretary of Health and Human Services shall establish a process to allow a qualified clinical data registry under section 1848(m)(3)(E) of the Social Security Act (42 U.S.C. 1395w-4(m)(3)(E)) or a clinician-led clinical data registry under section 4005 of the 21st Century Cures Act (P.L. 114-255) to request claims data described in subsection (b) (in a form and manner determined to be appropriate by the Secretary) for the purposes of—

(1) linking such data with clinical outcomes data;

(2) conducting quality assessments and quality improvement activities of providers of services (as defined in subsection

(u) of section 1861 of the Social Security Act (42 U.S.C. 1395x) and suppliers (as defined in subsection (d) of such section)), reporting the results of such assessments and activities to such providers and suppliers, and performing risk-adjusted, scientifically valid analyses and research to support quality improvement or patient safety; and

(3) publishing research and quality improvement analyses, which may include deidentified combined claims and clinical outcomes data.

(b) Claims Data Described.—For purposes of subsection (a), the claims data described in this subsection—

(1) are—

(A) claims data under the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.); and

(B) if the Secretary determines appropriate, claims data under the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.) and the State Children’s Health Insurance Program under title XXI of such Act (42 U.S.C. 1397aa et seq.); and

(2) may include provider-specific claims data, clinical specialty-specific claims data, State-specific claims data, or nationwide claims data.

(c) Treatment of Qualified Clinical Data Registries and Clinician- Led Clinical Data Registries.—For the purposes of this section, qualified clinical data registries and clinician-led clinical data registries shall not be required to be qualified entities, as defined in section 1874(e)(2) of the Social Security Act (42 U.S.C. 1395kk(e)(2)), or quasi-qualified entities, to access claims data pursuant to subsection (a).

(d) Fee.—Data described in subsection (b) shall be made available to a qualified clinical data registry or clinician-led clinical data registry under this section at a reasonable fee equal to the cost of making such data available. Any fee collected pursuant to the preceding sentence shall be deposited into the Centers for Medicare & Medicaid Services Program Management Account. <all>