Meaningful Access to Federal Health Plan Claims Data Act of 2021
The source supplies the latest action, but no lifecycle stage.
Latest action (29 Sep 2021): Referred to the Subcommittee on Health.
What this bill does
H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act of 2021, would direct the Secretary of Health and Human Services to create a new program giving clinician-led clinical data registries broader, faster, and more continuous access to federal claims data, separate from existing mechanisms such as the Medicare Qualified Entity Program and the Research Data Assistance Center process. The bill sets deadlines for approving or denying registry applications, establishes an appeals process, and requires access within 30 days of approval. It specifies allowable uses of the data (research, quality reporting, linking with clinical data), permits registries to charge fees for certain analyses, sets cost-based fees for data access, and outlines privacy protections, penalties for data-use breaches, and limits on using the data in legal proceedings. It also requires periodic reports to Congress and directs HHS to issue implementing regulations within a year. A separate section would amend Medicare law to allow coverage of certain new medical items/services with "promising but not definitive" evidence, contingent on data collection through registries or studies.
The bill primarily affects clinician-led clinical data registries, which support medical research and quality-of-care measurement; healthcare providers and suppliers whose data may be included; and federal agencies (HHS, CMS) responsible for administering claims data access and Medicare coverage decisions. It could also affect entities such as researchers, government agencies, and FDA-related data users who obtain data through these registries.
The bill was introduced on September 28, 2021, in the 117th Congress and referred to the House Committees on Energy and Commerce and Ways and Means. It did not receive a vote and did not become law; under congressional rules, it expired at the end of that Congress.
Plain-English summary generated by Bill100 AI from the official record. Always verify against the source below.
Official summary
Meaningful Access to Federal Health Plan Claims Data Act of 2021
This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish a program that allows clinician-led clinical data registries to access Medicare claims data for purposes of research, quality of care measurement, and reporting. (Clinician-led clinical data registries are data repositories operated by clinician organizations and that collect information about particular diseases and related medical procedures and therapies.)
The new program must allow for various types of data queries, including provider, state, and nationwide claims data. Such data may be used for public reports about provider performance, specified nonpublic analyses (e.g., medical research), and fee-based data services. Registries must apply to the CMS for access. Additionally, registries and their authorized users must enter into data use agreements and are subject to monetary penalties for breaching such agreements.
The bill also allows for Medicare coverage of new and emerging items and services for purposes of evidence collection in relation to such items and services.
Timeline
29 Sep 2021
Referred to the Subcommittee on Health.
Common questions
- What does H.R. 5394 do?
- H.R. 5394, the Meaningful Access to Federal Health Plan Claims Data Act of 2021, would direct the Secretary of Health and Human Services to create a new program giving clinician-led clinical data registries broader, faster, and more continuous access to federal claims data, separate from existing mechanisms such as the Medicare Qualified Entity Program and the Research Data Assistance Center process. The bill sets deadlines for approving or denying registry applications, establishes an appeals process, and requires access within 30 days of approval. It specifies allowable uses of the data (research, quality reporting, linking with clinical data), permits registries to charge fees for certain analyses, sets cost-based fees for data access, and outlines privacy protections, penalties for data-use breaches, and limits on using the data in legal proceedings. It also requires periodic reports to Congress and directs HHS to issue implementing regulations within a year. A separate section would amend Medicare law to allow coverage of certain new medical items/services with "promising but not definitive" evidence, contingent on data collection through registries or studies. The bill primarily affects clinician-led clinical data registries, which support medical research and quality-of-care measurement; healthcare providers and suppliers whose data may be included; and federal agencies (HHS, CMS) responsible for administering claims data access and Medicare coverage decisions. It could also affect entities such as researchers, government agencies, and FDA-related data users who obtain data through these registries. The bill was introduced on September 28, 2021, in the 117th Congress and referred to the House Committees on Energy and Commerce and Ways and Means. It did not receive a vote and did not become law; under congressional rules, it expired at the end of that Congress.
- Has H.R. 5394 become law?
- The source does not supply a confirmed lifecycle stage for H.R. 5394. Check the latest action and official source below.
- Who sponsored H.R. 5394?
- H.R. 5394 was sponsored by Rep. Bucshon, Larry [R-IN-8] (R-IN), with 6 cosponsors.
- What's the latest action on H.R. 5394?
- Referred to the Subcommittee on Health. (29 Sep 2021).
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