S. 339Senate119th Congress (2025-2027)In Committee

Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

A bill to amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

AI-Generated Summary

Updated November 24, 2025 at 3:11 AM UTC

The Nancy Gardner Sewell Medicare Multi‑Cancer Early Detection Screening Coverage Act would expand Medicare to pay for blood‑based genomic tests that can screen for several cancers at once. It defines which tests qualify, sets how the Department of Health and Human Services decides coverage, and establishes payment rates and usage limits. The bill also ensures that these new screenings do not interfere with existing Medicare coverage for single‑cancer tests.

Key Provisions

Adds a new Medicare coverage category for “multi‑cancer early detection screening tests,” defined as FDA‑cleared or approved blood‑based genomic tests that can detect several cancers at once, starting Jan. 1 2028.
The Secretary of HHS must decide if each test is reasonable, necessary, and appropriate for Medicare beneficiaries using the existing national coverage determination process.
Sets the payment rate for these tests equal to the current rate for multi‑target stool DNA screening until Jan. 1 2031; after that, payment is the lower of that rate or the amount set under section 1834A.
Limits coverage to one test per person every 11 months and restricts eligibility by age – beginning at 68 years in 2028 and increasing by one year each subsequent year.
If the United States Preventive Services Task Force gives the test an A or B rating, the age and frequency limits do not apply.
Clarifies that covering a multi‑cancer test does not affect Medicare coverage for other individual cancer screenings (e.g., breast, colorectal) and vice‑versa.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Finance.

Finance Committee

January 30, 2025

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SenateIntro Referral

Introduced in Senate

January 30, 2025

SenateIntro Referral

Read twice and referred to the Committee on Finance.

Finance Committee

January 30, 2025

Floor Debate

1 member

What members said about S. 339 on the floor

1 Democrat

Sen. Ron WydenD-OR · Sep 15, 2025

Mr. President, I come to the floor to recognize and honor an exceptional Oregonian. For 27 years, Kathy Ottele has served as a volunteer for the American Cancer Society and has been instrumental to…

The mission to eradicate cancer is deeply personal to Kathy. She is a seven-time skin care survivor, and she lost her dad, her mom, and her two younger sisters to this horrible disease. Kathy understands the importance of sharing her story.

From local community events to the halls of government in both Oregon and the Nation's Capital, she has made it her personal mission to connect with as many people as possible about the critical work at the American Cancer Society.

I have personally seen through my time with Kathy how her advocacy has helped families in a very positive way. Oregonians will long feel the positive impact of her tireless dedication to finding a cure for cancer. At home, we call it the Oregon Way.

She has also made it a personal priority to raise awareness and funding for the cause each year. I could stand here all day and announce a long list of things she has achieved during her 27 years of service. I will name just a few.

Through her efforts, she has consistently been one of the American Cancer Society's top fundraisers. Last year, she raised over $17,000 for this cause. In recognition of her steadfast volunteer and advocacy efforts to help make cancer a national priority, she was named the State Lead Ambassador by the American Cancer Society's Cancer Action Network in 2020.

She has also been a member of the American Cancer Society's organization in Oregon and Southwestern Washington. She has been on the board of directors for the last 7 years.

Part of the reason why she is so deserving of all these important honors and responsibilities has been because of her advocacy and fight for early cancer detection blood testing--hugely important--such as in the bipartisan bill that I sponsor with our colleagues Senators Crapo and Bennet. It is one of the best ways we know of to make sure people can stop cancer early and save lives.

For the last 5 years, Kathy aimed her advocacy efforts at promoting groundbreaking early cancer detection advances--known as Multi-Cancer Early Detection tests--to help more cancer victims learn their diagnosis far earlier and survive the disease at far higher rates. Kathy actually participated in a clinical trial of the new technology conducted at Oregon Health Sciences University, and she came away from that experience committed to winning broader access to this lifesaving, groundbreaking advance.

Kathy has played a critical role in educating community and policymakers in Oregon about the importance of access to multi-cancer early detection screening coverage, and I am proud to be a lead sponsor with Senators Crapo and Bennet, S. 339, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection--MCED--Screening Coverage Act that will help ensure access to screenings that can detect cancer at earlier, more treatable stages. As a testament to Kathy's advocacy, every single Member of the Oregon delegation serves as a cosponsor of our legislation.

As Kathy celebrates her 27th year as a Society volunteer, she shows absolutely no signs of slowing down. Her rigorous dedication in service continues to make a lasting impact on the mission to ending cancer as we know it, and she does that for everyone.

I know that I speak for Oregonians in every nook and cranny in our State as we express our gratitude for her commitment, her talent, her mentorship, her leadership, and particularly in the constant effort to better cancer research and treatment.

So on behalf of our whole State, this afternoon here on the floor of the U.S. Senate, I would like to thank Kathy Ottele for her tireless work and service. She has literally dedicated her life to this cause, and the people of Oregon are better for it. I look forward to our

continued partnership on these important efforts as I work as a senior member of the Senate Finance Committee, and she continues her incredible volunteering at home.

I yield the floor.

Bill Text

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Introduced in SenateIssued January 30, 2025

119th CONGRESS

1st Session

S. 339

IN THE SENATE OF THE UNITED STATES

January 30, 2025

Mr. Crapo (for himself, Mr. Bennet, Mr. Scott of South Carolina, and Mr. Wyden) introduced the following bill; which was read twice and referred to the Committee on Finance

A BILL

To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.

Short title

This Act may be cited as the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act.

Medicare coverage of multi-cancer early detection screening tests

(a)

Coverage

Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—

(1)

in subsection (s)(2)—

(A)

by striking the semicolon at the end of subparagraph (JJ) and inserting ; and; and

(B)

by adding at the end the following new subparagraph:

(KK)

multi-cancer early detection screening tests (as defined in subsection (nnn));

; and

(2)

by adding at the end the following new subsection:

(nnn)

Multi-Cancer early detection screening tests

(1)

In general

The term multi-cancer early detection screening test means a test furnished to an individual for the concurrent detection of multiple cancer types across multiple organ sites on or after January 1, 2028, that—

(A)

is cleared under section 510(k), classified under section 513(f)(2), or approved under section 515 of the Federal Food, Drug, and Cosmetic Act;

(B)

is—

(i)

a genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids; or

(ii)

a test based on samples of biological material that provides results comparable to those obtained with a test described in clause (i), as determined by the Secretary; and

(C)

the Secretary determines is—

(i)

reasonable and necessary for the prevention or early detection of an illness or disability; and

(ii)

appropriate for individuals entitled to benefits under part A or enrolled under part B.

(2)

NCD process

In making determinations under paragraph (1)(C) regarding the coverage of a new test, the Secretary shall use the process for making national coverage determinations (as defined in section 1869(f)(1)(B)) under this title.

(b)

Payment and standards for multi-Cancer early detection screening tests

(1)

In general

Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:

(aa)

Payment and standards for multi-Cancer early detection screening tests

(1)

Payment amount

The payment amount for a multi-cancer early detection screening test (as defined in section 1861(nnn)) is—

(A)

with respect to such a test furnished before January 1, 2031, equal to the payment amount in effect on the date of the enactment of this subsection for a multi-target stool screening DNA test covered pursuant to section 1861(pp)(1)(D); and

(B)

with respect to such a test furnished on or after January 1, 2031, equal to the lesser of—

(i)

the amount described in subparagraph (A); or

(ii)

the payment amount determined for such test under section 1834A.

(2)

Limitations

(A)

In general

No payment may be made under this part for a multi-cancer early detection screening test furnished during a year to an individual if—

(i)

as of January 1 of such year, such individual has attained the age specified in subparagraph (B) for such year; or

(ii)

such a test was furnished to the individual during the previous 11 months.

(B)

Age specified

For purposes of subparagraph (A)(i), the age specified in this subparagraph is—

(i)

for 2028, 68 years of age; and

(ii)

for a succeeding year, the age specified in this subparagraph for the preceding year, increased by 1 year.

(3)

Standards following USPSTF rating

In the case of a multi-cancer early detection screening test that is recommended with a grade of A or B by the United States Preventive Services Task Force, beginning on the date on which coverage for such test is provided pursuant to section 1861(ddd)(1), the preceding provisions of this subsection shall not apply.

(2)

Conforming amendments

(A)

Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended—

(i)

in subsection (a)—

(I)

in paragraph (1)(D)(i)(I), by striking section 1834(d)(1) and inserting subsection (d)(1) or (aa) of section 1834; and

(II)

in paragraph (2)(D)(i)(I), by striking section 1834(d)(1) and inserting subsection (d)(1) or (aa) of section 1834; and

(ii)

in subsection (h), by striking section 1834(d)(1) and inserting subsections (d)(1) and (aa) of section 1834.

(B)

Section 1862(a) of the Social Security Act (42 U.S.C. 1395y(a)) is amended—

(i)

in paragraph (1)—

(I)

in subparagraph (O), by striking and at the end;

(II)

in subparagraph (P), by striking the semicolon at the end and inserting , and; and

(III)

by adding at the end the following new subparagraph:

(Q)

in the case of multi-cancer early detection screening tests (as defined in section 1861(nnn)), which are not reasonable and necessary for the concurrent detection of multiple cancer types across multiple organ sites;

; and

(ii)

in paragraph (7), by striking or (P) and inserting (P), or (Q).

(c)

Rule of construction relating to other cancer screening tests

Nothing in this section, including the amendments made by this section, shall be construed—

(1)

in the case of an individual who undergoes a multi-cancer early detection screening test, to affect coverage under part B of title XVIII of the Social Security Act for other cancer screening tests covered under such title, such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or

(2)

in the case of an individual who undergoes another cancer screening test, to affect coverage under such part for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test.