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.
That’s why the Prevent Cancer Foundation urges Congress to pass the Multi-Cancer Early Detection Screening Coverage Act.
Advocacy organizations support the bill
The Multi-Cancer Early Detection Screening Coverage Act has the support of more than 500 leading health care and advocacy organizations across the United States, demonstrating the significant impact that it would have on a diverse set of communities throughout the U.S.
View sign on letter of supportWhat 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 would modernize the Medicare program and create a benefit category for MCED tests, which would 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. 2407) was introduced with bipartisan support on March 30, 2023, and its Senate companion (S. 2085) was introduced on June 22, 2023.
Read the full text of H.R. 2407
Read the full text of S. 2085
How does the MCED legislation work in practice if passed by Congress?
The Multi-Cancer Early Detection Screening Coverage Act would modernize the Medicare program and create 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 introducing legislation before FDA approval of these tests?
Passing legislation can be a lengthy process. By starting now, it is possible to have legislation enacted by the time these new tests are approved by the FDA and prevent significant delays to patient access. If Congress waits to introduce legislation until tests are approved by the FDA, patients could be waiting several years before they can access the tests while the legislative process moves forward.
What supporters of the bill are saying
