MULTI-CANCER EARLY DETECTION
Coverage and Legislation
Today, there are recommended routine screenings for only a few of more than 200 cancer types, leaving most cancers undetected until symptoms appear, often in later stages.
The Prevent Cancer Foundation supports legislation that recognizes emerging advances in our fight against cancer by ensuring the Centers for Medicare and Medicaid Services(CMS) can make a coverage decision for new, innovative tests that can detect multiple types of cancer.
The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act/Medicare Multi-Cancer Early Detection Screening Coverage Act was signed into law on February 3, 2026.
The law passed through both chambers of Congress as part of a bipartisan spending package that is funding multiple federal agencies through the remainder of FY 2026, including Labor, Health and Human Services (LLHS).
Over the last five years, the Prevent Cancer Foundation has proudly led more than 550 advocacy organizations to support the MCED Screening Coverage Act, reflecting widespread recognition of the urgent need for Medicare to have the ability to adopt innovative cancer detection technologies.
The MCED Screening Coverage Act has been championed by Representatives Jodey Arrington (R-Texas), Terri Sewell (D-Ala.), Richard Hudson (R-N.C.), Raul Ruiz (D-Calif.), Mariannette Miller-Meeks (R-Iowa) and Robin Kelly (D-Ill.), along with Senators Mike Crapo (R-Idaho), Michael Bennet (D-Colo.), Tim Scott (R-S.C.) and Ron Wyden (D-Ore.).
What are the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act and the Medicare Multi-Cancer Early Detection Screening Coverage Act?
The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act and the Medicare Multi-Cancer Early Detection Screening Coverage Act are bills that modernize the Medicare program and create a benefit category for MCED tests, which will allow the Centers for Medicare and Medicaid Services (CMS) to initiate an evidenced-based coverage process for multi-cancer tests upon approval of the tests by the Food and Drug Administration (FDA).
The House bill (H.R. 842) was introduced with bipartisan support on January 31, 2025, and its Senate companion (S. 339) was introduced on January 30, 2025.
Read the full text of H.R. 842
Read the full text of S. 339
How does the MCED legislation work in practice?
The Multi-Cancer Early Detection Screening Coverage Act modernizes the Medicare program and creates a benefit category for MCED tests, which allows the Centers for Medicare and Medicaid Services (CMS) to initiate an evidenced-based coverage process for multi-cancer tests upon FDA approval.
The legislation was drafted based on the colorectal and prostate cancer screening legislation from the Balanced Budget Act of 1997 that established a covered benefit for colorectal and prostate cancer screening tests and granted the Secretary of the Department of Health and Human Services (HHS) the authority to cover new screening technologies for these cancers.
Why is FDA approval required?
The Multi-Cancer Early Detection Screening Coverage Act is for screening tests, not diagnostics. Diagnostic tests are routinely covered by Medicare and do not require congressional action, but for screening tests to obtain Medicare coverage through a National Coverage Determination, it must fit within a “benefit” category. (Under the Affordable Care Act, Medicare is also required to cover routine cancer screening tests that are given an “A” or “B” grade by the U.S. Preventive Services Task Force.)
The Multi-Cancer Early Detection Screening Coverage Act is based on the precedent of Congress’ authorization of Medicare coverage of mammograms to screen for breast cancer, Pap tests to screen for cervical cancer and screening tests for colorectal and prostate cancers (all which required FDA approval).
CMS’ National Coverage Determinations for cancer screenings have only provided coverage to FDA-approved tests, including Cologuard (colorectal cancer screening), human papillomavirus (HPV) tests, and a recent blood-based biomarker test for colorectal cancer screening.
Based on this precedent, MCED tests need FDA approval to be considered for a National Coverage Determination.
Why not create coverage authority for all new cancer screenings?
The Multi-Cancer Early Detection Screening Coverage Act does not prevent any other efforts to create coverage for new single-cancer screening tests. The policy is focused on multi-cancer tests because it is where coverage barriers are most acute. New multi-cancer early detection tests could maximize cancer detection by adding an additional tool to our existing arsenal of cancer screenings. By creating coverage authority for MCED tests, Congress can fuel additional development of multi-cancer screenings.
Is coverage or cost-sharing for existing screenings impacted by MCED legislation or these tests?
No. Existing screenings save lives, and it is important that patients continue to follow existing screening recommendations and benefit from zero cost-sharing. For this reason, the legislation states that coverage of existing screenings should not be impacted.
What are the benefits of passing legislation before FDA approval of these tests?
Passing legislation can be a lengthy process. If Congress waited to introduce legislation until tests are approved by the FDA, patients would be waiting several years before they can access the tests while the legislative process moves forward. By passing legilation now, we hope CMS can be ready once tests are approved by the FDA to prevent significant delays to patient access.
What supporters of the bill are saying
