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Are these tests covered by insurance?

Currently, MCED tests are not covered by insurance. The Prevent Cancer Foundation and more than 300 advocacy organizations and cancer centers support the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021. This legislation would authorize the Centers for Medicare & Medicaid Services (CMS) to evaluate and cover blood-based multi-cancer early detection tests and future test methods (e.g., urine or hair tests), once approved by the Food and Drug Administration (FDA).

Under current law, Medicare coverage of preventive services is limited to circumstances in which Congress has explicitly authorized coverage or the U.S. Preventive Services Task Force (USPSTF) recommends the service with an “A” or “B” grade.

In the absence of this legislation, it could take several years after FDA approval before Medicare beneficiaries can receive coverage for MCED tests. This bill would greatly reduce such access delays for seniors while allowing CMS to use its evidence-based process to determine coverage.

What is the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021?

The Medicare Multi-Cancer Early Detection Screening Coverage Act is a bill that would authorize the Centers for Medicare & Medicaid Services (CMS) to evaluate and cover blood-based multi-cancer early detection tests and future test methods (e.g., urine or hair tests), once approved by the Food and Drug Administration (FDA).

The House bill (H.R. 1946) was introduced with bipartisan support on March 16, 2021, and its companion bill in the Senate is expected to be released soon.

Read the full text of the bill.

The Prevent Cancer Foundation leads more than 300 organizations in support of the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021.

The Prevent Cancer Foundation and more than 300 organizations from all 50 states joined together in a sign-on letter in support of the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021.

National advocacy organizations who support the legislation include the American Cancer Society – Cancer Action Network, the National Minority Quality Forum, Cancer Support Community, the Association of Community Cancer Centers, the Community Oncology Alliance and the Oncology Nursing Society. A diverse array of additional medical, community and public health focused organizations across the country joins with the Prevent Cancer Foundation in applauding the legislation and calling for action on this issue. These organizations provide essential services to cancer patients, offer resources to families, and raise awareness of the need to improve prevention and care for a range of different cancers.

Read the full letter.

How does the MCED legislation work in practice if passed by Congress?

The Medicare 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.

The Medicare Multi-Cancer Early Detection Screening Coverage Act does not establish coverage policy for MCED tests, but rather gives CMS the authority to create coverage parameters through the National Coverage Determination (NCD) process. During this process, CMS evaluates the evidence for available tests to establish patient criteria.  The NCD process includes multiple opportunities for stakeholder input through a comment period before finalizing coverage.

Why is FDA approval required?

The Medicare 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 cancer screening tests that are given an “A” or “B” grade by the U.S. Preventive Services Task Force.)

The Medicare Multi-Cancer Early Detection Screening Coverage Act is based on the precedent of Congress’ authorization of Medicare coverage of mammography for breast cancer, Pap test for cervical cancer and screening tests for colorectal and prostate cancers (all requiring FDA approval). Congressional action is necessary to pursue a National Coverage Determination after FDA approval.

CMS’ National Coverage Determinations for cancer screenings have only provided coverage to FDA approved tests, including Cologuard (colorectal cancer screening), HPV tests approved by the FDA, and a recent blood-based biomarker test for colorectal cancer screening.

What are the benefits of introducing legislation before FDA approval of MCED 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 patient access delays. If Congress decides not to introduce legislation until tests are approved by the FDA, patients could face several years of access delays as the legislative process moved forward. 

Why not create coverage authority for all new cancer screenings?

The Medicare 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 can help 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 maintain adherence to existing screenings and continue to benefit from zero cost-sharing.  For this reason, the legislation states that coverage of existing screenings should not be impacted.

How much does this policy score?

This policy has not been scored by the Congressional Budget Office (CBO). Historically, CBO has scored preventive services and cancer screening as impacting the federal budget, in part because CBO will attribute costs associated with lives saved from the benefits of early detection.

According to CBO, the agency is required by federal law to undertake a formal cost estimate for most legislative proposals (except appropriations measures) that are passed out of a House or Senate full committee. CBO cost estimates employ certain economic assumptions and require the agency to make projections over a period of time, usually 10 years. CBO scores use current federal law as a baseline for its assumptions and the agency does not presume any future modifications that might be made to federal laws, programs or spending.1  


1. The District Policy Group, “CBO Score,” Washington, D.C. Accessed April 2021. http://www.districtpolicygroup.com/dewonkify-detail/dewonkify-cbo-score#:~:text=Definition%3A%20%22Score%22%20or%20%22,Congressional%20Budget%20Office%20(CBO)

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