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S. 339: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

The bill known as the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act proposes amendments to the Social Security Act to allow for Medicare coverage of multi-cancer early detection screening tests. Here are the key points of the bill:

Coverage for Multi-Cancer Screening Tests

The bill adds provisions to Medicare that will cover specific multi-cancer early detection screening tests starting from January 1, 2028. These tests are aimed at detecting multiple types of cancer across different organs at once, and they must meet certain regulatory criteria set by the Food and Drug Administration (FDA).

Definition of Multi-Cancer Early Detection Screening Tests

A "multi-cancer early detection screening test" is defined in the bill as follows:

  • Tests must be approved or cleared by the FDA.
  • Tests may involve genomic sequencing of blood samples or similar biological materials.
  • Tests must be deemed reasonable and necessary for early illness detection by the Secretary of Health and Human Services.

National Coverage Determination Process

The Secretary of Health and Human Services is required to use a specific process to make national coverage determinations for these new tests, ensuring that they meet the necessary criteria for coverage.

Payment Structure and Standards

The bill outlines a payment structure for the multi-cancer early detection screening tests:

  • For tests provided before January 1, 2031, the payment would equal the current payment amount for certain existing cancer screening tests.
  • For tests provided on or after January 1, 2031, the payment will be based on specific calculations that may take current test payments into account.

Limitations on Payment

There are specific limitations on payment for these tests:

  • Payments will not be made if the individual has reached a certain age or if they received a similar test within the past 11 months.
  • Starting from 2028, the age limit is set at 68 years, increasing by one year each subsequent year.

Coverage for Other Cancer Screening Tests

The bill makes it clear that receiving a multi-cancer early detection screening test does not eliminate coverage for other individual cancer screening tests like breast, cervical, colorectal, lung, or prostate cancer tests.

Conforming Amendments

The legislation includes various conforming amendments to other sections of the Social Security Act to align the current provisions with the newly introduced coverage for multi-cancer early detection screening tests.

Effective Date

The proposed changes to Medicare coverage begin with a planned implementation date of January 1, 2028.

Relevant Companies

  • ILMN - Illumina, Inc.: A company that specializes in genomic sequencing technology, which could see an increase in business due to the demand for multi-cancer early detection screening tests.
  • NVTA - Invitae Corporation: Focuses on genetic testing and could benefit from an increase in usage of genomic tests covered under this bill.

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

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Sponsors

69 bill sponsors

Actions

2 actions

Date Action
Jan. 30, 2025 Introduced in Senate
Jan. 30, 2025 Read twice and referred to the Committee on Finance.

Corporate Lobbying

0 companies lobbying

None found.

* Note that there can be significant delays in lobbying disclosures, and our data may be incomplete.

Potentially Relevant Congressional Stock Trades

Estimated excess return of the underlying stock since the transaction
Politician Stock Transaction Filed Traded
Congress pfp
Gilbert Ray Cisneros, Jr. D / House
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ILMN ILLUMINA, INC. - COMMON STOCK
Purchase $1,001 - $15,000
Mar 09, 2026 Feb 10, 2026 +11.85%
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Ro Khanna D / House
ILMN logo
ILMN _ILLUMINA, INC CMN
Sale $1,001 - $15,000
Feb 06, 2026 Jan 29, 2026 -11.97%
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Lisa C. McClain R / House
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ILMN ILLUMINA, INC. - COMMON STOCK
Sale $1,001 - $15,000
Nov 21, 2025 Oct 31, 2025 +6.18%
Congress pfp
Lisa C. McClain R / House
ILMN logo
ILMN ILLUMINA, INC. - COMMON STOCK
Purchase $1,001 - $15,000
Nov 21, 2025 Oct 30, 2025 +34.33%
Congress pfp
Lisa C. McClain R / House
ILMN logo
ILMN ILLUMINA, INC. - COMMON STOCK
Sale $1,001 - $15,000
Nov 21, 2025 Oct 30, 2025 +34.33%
Congress pfp
Lisa C. McClain R / House
ILMN logo
ILMN ILLUMINA, INC. - COMMON STOCK
Purchase $1,001 - $15,000
Aug 13, 2025 Jun 09, 2025 +43.36%
Congress pfp
Thomas H. Kean, Jr. R / House
ILMN logo
ILMN ILLUMINA, INC. - COMMON STOCK
Purchase $1,001 - $15,000
Apr 18, 2025 Apr 01, 2025 +48.91%
Congress pfp
Thomas H. Kean, Jr. R / House
ILMN logo
ILMN ILLUMINA, INC. - COMMON STOCK
Purchase $1,001 - $15,000
May 15, 2025 Apr 01, 2025 +48.91%
Congress pfp
Ro Khanna D / House
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ILMN ILLUMINA, INC CMN
Sale $1,001 - $15,000
Mar 06, 2025 Feb 25, 2025 +23.47%
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Michael C. Burgess R / House
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ILMN ILLUMINA, INC. - COMMON STOCK
Sale $15,001 - $50,000
Sep 24, 2024 Sep 03, 2024 -25.33%
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Michael C. Burgess R / House
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ILMN ILLUMINA, INC. - COMMON STOCK
Sale $15,001 - $50,000
Oct 01, 2024 Aug 30, 2024 -23.56%
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Ro Khanna D / House
ILMN logo
ILMN ILLUMINA, INC CMN
Sale $1,001 - $15,000
Aug 07, 2024 Jul 02, 2024 -0.58%
Congress pfp
Ro Khanna D / House
ILMN logo
ILMN ILLUMINA, INC CMN
Purchase $1,001 - $15,000
Jun 05, 2024 May 29, 2024 -1.45%
Congress pfp
Ro Khanna D / House
ILMN logo
ILMN ILLUMINA, INC CMN
Sale $1,001 - $15,000
Jun 05, 2024 May 28, 2024 -4.79%