Access to Claims Data Act
- Sponsor
- Rep. Joyce, John [R-PA-13]
- Committees
- Ways and Means Committee (primary)
- Last action
- Jul 10, 2025
Bottom line
The bill aims to enhance healthcare research and quality improvement by providing specific clinical data registries with direct, streamlined access to federal health program claims data, while requiring a cost-recovery fee.
What it actually does
This bill mandates the Secretary of Health and Human Services to establish a process by January 1, 2026, allowing qualified clinical data registries and clinician-led clinical data registries to access claims data from the Medicare program, with the option to include Medicaid and CHIP data. This access is intended for linking with clinical outcomes data, conducting quality assessments, and publishing research to improve patient safety and healthcare quality. The bill also specifies that these registries will not need to be 'qualified entities' to gain access and will pay a reasonable, cost-recovery fee.
Proponents argue
Proponents argue that expanding access to claims data for clinical data registries will accelerate vital research, improve patient safety, and enhance the overall quality of care by enabling more robust analysis of clinical outcomes linked with claims information. They contend it removes unnecessary bureaucratic hurdles for entities already focused on quality improvement, fostering a more data-driven approach to healthcare advancements.
Opponents contend
Opponents might raise concerns about potential privacy risks associated with broader data sharing, even if the data is deidentified, and the administrative burden on the Department of Health and Human Services to establish and manage this new data access process within the specified timeframe. Some may argue that existing mechanisms for data access are sufficient or that this new pathway could create an uneven playing field for other research entities not covered by the exemption.
The bill is short and clear, making it accessible for a quick read and evaluation.
Section 2(a)
Mandate for Expanded Claims Data Access
This provision requires the Secretary of Health and Human Services to create a system by January 1, 2026, that allows specific types of clinical data registries (qualified clinical data registries and clinician-led clinical data registries) to request and receive claims data. The purpose is to combine this claims data with clinical outcomes data for research, quality assessment, and improvement activities, including publishing findings to enhance patient safety and quality of care.
Supporters argue
Supporters argue this provision is crucial for advancing medical research and improving healthcare quality by enabling a more comprehensive understanding of patient outcomes and provider performance. It leverages existing data for significant public health benefits and fosters innovation in care delivery.
Critics contend
Critics might raise concerns about the administrative burden on HHS to implement this new process and ensure robust data security, or argue that existing data access mechanisms are sufficient and this new pathway introduces unnecessary complexity or risk.
Tradeoffs
This provision balances the desire for robust research and quality improvement against concerns about data privacy, security, and the administrative overhead required to establish and manage a new data access framework.
Section 2(b)
Scope of Accessible Claims Data
This section specifies that the claims data to be made available primarily includes data from the Medicare program. It also grants the Secretary of HHS the discretion to include claims data from the Medicaid program and the State Children's Health Insurance Program (CHIP). The data can be provided at various levels of aggregation, including provider-specific, clinical specialty-specific, State-specific, or nationwide claims data.
Section 2(c)
Exemption from Qualified Entity Requirements
This provision clarifies that qualified clinical data registries and clinician-led clinical data registries will not be required to meet the existing definitions and requirements of being 'qualified entities' or 'quasi-qualified entities' under the Social Security Act to access claims data through this new process. This exemption is designed to streamline and expedite data access for these specific types of registries.
Section 2(d)
Cost-Recovery Fee for Data Access
This section establishes that the claims data will be made available to eligible qualified clinical data registries and clinician-led clinical data registries for a 'reasonable fee' that is equal to the cost incurred by HHS in making such data available. Any fees collected through this mechanism will be deposited into the Centers for Medicare & Medicaid Services Program Management Account.
The bill relies on external statutory definitions for 'qualified clinical data registry' (from section 1848(m)(3)(E) of the Social Security Act) and 'clinician-led clinical data registry' (from section 4005 of the 21st Century Cures Act) to specify which entities are eligible for expanded data access.
Section 2(a)
Why it matters:This is standard legislative practice to avoid reprinting lengthy definitions already codified in law, making the bill text more concise.
Case for: Streamlines legislative drafting and avoids redundancy, assuming readers have access to the referenced statutes or are familiar with their content.
Case against: Requires external research for a full understanding of the bill's precise scope and the characteristics of the entities it aims to benefit, which a casual reader might miss.
Estimated impact: These references are fundamental, as they precisely define the universe of entities eligible for data access, thereby determining the reach and impact of the entire bill.