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H.R. 842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

This bill, known as the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, proposes to amend the Social Security Act to include Medicare coverage for specific multi-cancer early detection screening tests. Here’s a structured breakdown of what the bill entails:

Medicare Coverage for Screening Tests

The bill aims to ensure that Medicare recognizes and covers multi-cancer early detection screening tests beginning January 1, 2028. These tests would allow for the simultaneous detection of several types of cancer across multiple organ sites.

Definition of Multi-Cancer Early Detection Screening Tests

A "multi-cancer early detection screening test" is defined as:

  • A test that is cleared, classified, or approved by the FDA under certain sections of the Federal Food, Drug, and Cosmetic Act.
  • A genomic sequencing blood test or a similar test based on biological materials that helps identify multiple cancers.
  • A test deemed reasonable and necessary for preventing or detecting illnesses by the Secretary of Health and Human Services.

Payment Standards

The bill establishes specific payment protocols for these screening tests:

  • For tests provided before January 1, 2031, the payment amount will match the current payments in effect for existing covered tests.
  • Starting January 1, 2031, payments will be determined based on regulations outlined for such tests, ensuring they remain accessible under Medicare.

Limitations on Coverage

The legislation introduces certain limitations:

  • A person may only receive payment for one multi-cancer screening test within an 11-month period.
  • The specifications for coverage will not apply if the test is provided to individuals who have reached an age threshold set in the bill, beginning with 68 years in 2028.

Standards for Coverage Decisions

The Secretary of Health and Human Services will use the national coverage determination process to assess new tests and whether they are reasonable and necessary for early detection.

Impact on Other Cancer Screenings

The bill clarifies that undergoing a multi-cancer early detection test will not affect coverage for other types of cancer screening tests such as those for breast, cervical, colorectal, lung, or prostate cancer. Similarly, testing for other types of cancer will not interfere with the use or coverage of multi-cancer tests.

Relevant Companies

  • EXAS (Exact Sciences Corporation) - A company that develops tests for cancer detection and early diagnosis may see an increase in demand for its multi-cancer tests due to this legislation.
  • GHDX (Genomic Health, Inc.) - As a provider of genomic tests for cancer, GHDX might benefit from Medicare coverage of multi-cancer early detection tests.
  • NVTA (Invitae Corporation) - With a focus on genetic information for disease prevention, Invitae may find its services in higher demand if more tests are covered under Medicare.

This is an AI-generated summary of the bill text. There may be mistakes.

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Sponsors

323 bill sponsors

Actions

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Date Action
Oct. 03, 2025 Reported (Amended) by the Committee on Ways and Means. H. Rept. 119-333, Part I.
Sep. 17, 2025 Committee Consideration and Mark-up Session Held
Sep. 17, 2025 Ordered to be Reported in the Nature of a Substitute (Amended) by the Yeas and Nays: 43 - 0.
Jan. 31, 2025 Introduced in House
Jan. 31, 2025 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.

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