Stay up to date on research and information
Sign Up for FORCE NewslettersCurrent Policy Priority
FORCE Provides Input on BRCA Screening Research Plan
February 2024 - U.S. Preventive Services Task Force (USPSTF) recommendations guide the use of many health screenings and determine which preventive services are available to patients at no cost under the Affordable Care Act (ACA). FORCE submitted comments in response to the recently published USPSTF draft BRCA screening research plan. Once finalized, the latest studies will be analyzed and the guidelines will be updated accordingly.
Typically reviewed and updated every 5-7 years, the Task Force published its current guidelines for “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing” in September 2019. At that time, the USPSTF slightly expanded the population eligible for BRCA counseling and testing but we believe the recommendations are significantly lacking. FORCE comments on the draft research plan for updated guidelines note that the proposed scope of the recommendations continues to fall short of meeting the needs of Americans who may be at increased risk of cancer due to hereditary factors.
Included Populations
The proposed research plan fails to include key populations including men, women with a personal or family history of cancers other than breast or ovarian, and patients currently in cancer treatment. There is a relationship between inherited genetic mutations such as BRCA and cancers including prostate, pancreatic, male breast and colorectal. A substantial portion of people with mutations that increase their risk of cancer are missed with the narrow population under consideration.
Mutations Beyond BRCA
The proposed research plan is limited to risk for BRCA1 and BRCA2 mutations. This fails to acknowledge that mutations in genes including ATM, BARD1, CDH1, CHEK2, MLH1, MSH2, PALB2, PTEN, TP53 and STK11 increase the risk of breast and/or ovarian as well as other cancers. For this reason, the current standard of care is multigene panel testing. The USPSTF must consider genetic mutations beyond BRCA1/2 to adequately address cancer risk and mortality. See our article on the development of USPSTF of Lynch Syndrome Screening Guidelines for related information.
Screenings & Interventions
The research and related recommendations should include interventions pertinent to the early detection of all cancers related to hereditary cancer mutations. In addition, the guideline letter grade should apply to the associated preventive screenings and risk-reducing surgeries for mutation carriers. Without this, medically necessary downstream services such as breast screening MRIs, colonoscopies before age 45, and risk-reducing surgeries may not be adequately covered by insurers. These interventions constitute "prevention" and should be included in the USPSTF recommendation to facilitate affordable access.
Timeline and Next Steps
After considering the draft research plan feedback, the USPSTF will finalize its research plan. Using this as a guide, the Task Force will develop and share draft recommendations on its website. Once again, there is a public comment period. The USPSTF will review the comments and make any changes it deems are needed. Then, the final recommendation statement, evidence review and evidence summary are posted on its website. This process may take up to two years. FORCE will weigh in every step of the way.
News Briefs
4/3/2024 - Submitted comments to Senator Cassidy and the HELP Committee in response to an RFI regarding oversight of clinical diagnostic tests, known as in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs).
3/15/2024 - Joined the Coalition to Increase Access to Cancer Care (CIACC) in comments to House leadership on efforts to strengthen the Employee Retirement Income Security Act (ERISA) and emphasize the need to pass the Cancer Drug Parity Act.
3/1/2024 - Provided feedback to CMS on the Medicare Advantage Advanced Notice and accompanying Part D Redesign Program provisions aimed at reducing and managing beneficiary out-of-pocket costs in the Medicare Part D program.
2/29/2024 - Wrote sponsors to endorse the BENEFIT Act, which would require the FDA to include in the benefit-risk assessment framework of a new drug application how patient experience data was considered in the review process.
Related Resources
The U.S. Preventive Services Task Force is an independent panel of national experts that makes evidence-based recommendations about preventive health services such as screenings, counseling services, and preventive medications. The Task Force publishes guidelines on screenings such as breast mammograms, colonoscopies, and PSA testing for prostate cancer. Any screening receiving a grade "A" or "B" is covered as an essential preventive service under the Affordable Care Act (ACA). These services must be provided at no cost under the ACA. Health insurers often look to the USPSTF to determine what preventive services to cover. As such, gaps in the Task Force guidelines often affect access to health care. For more information on this, see our article entitled, "High-Risk Individuals Often Struggle to Get Insurance Coverage of Health Services."
- Visit the How to Get Testing section of our website for criteria for genetic testing and information on finding a cancer genetics expert.
- FORCE's toll-free helpline: 866-288-RISK, ext. 704, can connect you with a volunteer board-certified genetic counselor who can answer general questions about genetic testing and hereditary cancer and help you find a genetic counselor near you.
- FORCE Peer Navigator Program will match you with a volunteer who has undergone genetic counseling and can help you navigate resources to find a genetic counselor near you.