Congress Moves to Expand Medicare Coverage of Genetic Cancer Screening

Current Medicare policies limiting coverage of genetic cancer testing to already diagnosed cases is out of step with current science and medical practice, which recognizes the importance of early detection in preventing cancer deaths as well as costly, often unnecessary, medical interventions. With that in mind, on Feb. 16, Senators from each party introduced a bill called the Reducing Hereditary Cancer Act of 2022 (RHCA) that would require Medicare to cover genomic cancer testing and follow-up screening for individuals with a family history of hereditary cancer.

The Diagnostic Challenge

Genetic cancer testing enables early cancer detection at relatively low costs. However, Medicare does not pay for genetic cancer tests unless the person has “signs, symptoms, complaints, or personal histories of disease.” This leaves out persons who have not been diagnosed but are at high risk of cancer due to family history or a known genetic mutation in the family. As a result, those at genetically high risk must decide between forgoing screenings recommended by the National Comprehensive Cancer Network (NCCN) or pay for the tests out of their own pocket. In addition to medical practice guidelines, including, but not providing for screening those at genetically high risk runs counter to private insurance. But because they are part of the Medicare statute, the existing cancer testing coverage rules must be modified via legislation. In fact, Congress has recently passed legislation providing for coverage of mammograms, colonoscopies, prostate-specific antigen (PSA) tests, and other cancer screenings for “average risk” populations, along with specific screenings like colonoscopies every two years for those considered high-risk. However, legislation to this effect has yet to be passed for genetic cancer testing.

The RHCA

Proposed by a pair of US senators from each side of the aisle (Ben Cardin (D-Md) and Lisa Murkowski (R-Alaska)), the RHCA would fix the coverage gap by amending the current Medicare coverage law, Title XVIII of the Social Security Act, to include germline mutation testing in individuals with a known, hereditary cancer gene mutation in their family or a history otherwise suspicious for hereditary cancer. Specifically, it would mandate Medicare coverage of:

• Genetic testing for germline mutations for individuals with a known, hereditary cancer gene mutation in their family or a history otherwise suspicious for hereditary cancer, subject to a limit of one per individual;
• Risk-reducing surgeries for patients found to have a hereditary cancer mutation, coverage where such procedures are endorsed by evidence-based guidelines from groups; and
• Increased preventive screening frequencywhere genetic testing determines that an individual has a hereditary cancer gene mutation, increased frequency for evidence-based screenings, at least once a year or at greater frequencies determined in accordance with NCCN guidelines or the Secretary of Health and Human Services.

The provision providing for more frequent preventive screening covers cases where an individual tests positive for a genetic predisposition to cancer but elects not to undergo preventive surgery.

The House of Representatives Bill

The RHCA is not the only current legislative effort to extend Medicare coverage of preventive genetic testing for high-risk individuals. Last June, a group of lawmakers in the House of Representatives led by Rep. Debbie Wasserman Schultz (D-Fla) introduced a parallel bill, also called the Reducing Hereditary Cancer Act, 2021 (H.R. 4110), to cover hereditary cancer genetic testing for individuals with a history of a hereditary cancer gene mutation in a blood relative or a personal or ancestral history suspicious for hereditary cancer, as well as certain cancer screenings or preventive surgeries to reduce the risk for individuals with a germline mutation associated with a high risk of developing a preventable cancer.

Takeaway

Passage of the RHCA bills would likely increase the percentage of high-risk persons who are 65 or older who get the cancer screening tests and services recommended by the NCCN. In addition to saving lives and preventing costly and difficult medical interventions, mandatory Medicare coverage would be welcome news for manufacturers of genetic screening assays and genetic testing laboratories. While both bills have bipartisan support, their prospects of passage remain unclear, at least for now.