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Updated Response to USPSTF Guidelines on BRCA Testing

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Read the USPSTF's new guidelines on Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer.

Read the change.org petition submitted to the USPSTF.

The United States Preventive Services Task Force (USPSTF) is a government-supported independent panel of experts that reviews and develops recommendations on select preventive health services. The task force released their new guidelines on genetic counseling and testing for BRCA. As written, these guidelines have gaps that directly affect patient access to genetic counseling, BRCA testing, and preventive services.

Significance of These Guidelines

The USPSTF published guidelines are important to consumers for two reasons:

  1. Primary care clinicians and health systems follow these guidelines. The content of the guidelines can affect what information doctors convey to patients about hereditary cancer, genetic counseling, genetic testing, screening, and prevention.
  2. The panel's guidelines are incorporated into the Patient Protection and Affordable Care Act (PPACA), which states that health plans must provide benefits without imposing cost-sharing (i.e., without a deductible or co-pay) for services that have a rating from the task force of "A" or "B."

History of USPSTF Guidelines on Genetic Risk Assessment and BRCA Mutation Testing

In 2005, the USPSTF first issued guidelines for primary care providers on Genetic Risk Assessment and BRCA Mutation Testing for Breast and Ovarian Cancer Susceptibility. The task force assigned a grade "B" to the recommendation of genetic counseling and testing for women with a family history suggestive of a possible BRCA mutation.

After soliciting public commentary, the USPSTF issued their new guidelines in December, 2013. These new guidelines do not take into account many concerns affecting the HBOC community. Below is a review of the concerns and the response by the USPSTF. We are encouraging our constituents to become familiar with these issues so they can self-advocate and inform us about any problems with coverage of services. We are currently focusing our advocacy efforts on addressing the gaps in these guidelines.

FORCE's Concerns with the 2013 USPSTF Guidelines

In April 2013, the USPSTF released a new draft version of the guidelines and solicited public commentary; the update made few changes to the 2005 guidelines and grades. FORCE responded with a letter and voiced our concern about the serious guideline omissions. We submitted a second letter in October 2013 that focused on three important gaps in the guidelines that have the highest level of supporting evidence and are most inconsistent with USPSTF stated goals.stent with USPSTF stated goals.

FORCE received a response to our letter from the USPSTF. In our opinion, the USPSTF did not adequately address the concerns of the HBOC community. We submitted a sign-on letter and a change.org petition further explaining our lingering concerns to the USPSTF. Below is an outline of the issues we raised, the USPSTF response, and excerpts from our counter-response.

FORCE Concerns, Recommendations, and Counter-response

Concern 1:

The patient population covered by the guidelines does not include women with a known mutation in the family.

The USPSTF states: “These recommendations apply to women who have not received a diagnosis of breast or ovarian cancer but who have family members with breast or ovarian cancer whose BRCA status is unknown. Women presenting to their primary care providers who have a relative with a known potentially harmful mutation in the BRCA1 or BRCA2 genes should receive genetic counseling and consideration for testing.”

Initial FORCE Recommendation:

Extend the evaluation and letter grade to women with a known mutation in the family.

As written, the USPSTF acknowledges that women who have a relative with a known mutation in BRCA1 or BRCA2 should receive genetic counseling and consideration for testing, but the language of the current guidelines does not include these individuals in the "Patient Population Under Consideration."

USPSTF Response:

"This is a critical population that is very relevant to this recommendation. In response to your comments, the Task Force reorganized the 'Patient Population under Consideration' in the Clinical Considerations to increase the prominence of the statement that women who have one or more family members with a known potentially harmful mutation in the BRCA1 or BRCA2 genes should be offered genetic counseling and testing."

FORCE Counter-response

We are satisfied with this change as long as it states clearly that the "B grade" extends to this subset of the population, and feel that it will close the gap regarding genetic counseling and testing for women with a known mutation in the family.

Concern 2:

The patient population covered by the guidelines does not include women with a previous diagnosis of cancer.

The USPSTF states: “These recommendations apply to women who have not received a diagnosis of breast or ovarian cancer but who have family members with breast or ovarian cancer whose BRCA status is unknown.”

Recommendation:

Extend the evaluation and letter grade to women with a previous diagnosis of cancer.

Women with BRCA mutations and a cancer diagnosis are at high risk for a second primary cancer. Strong research evidence supports genetic risk assessment for preventive purposes in women who have been diagnosed with breast cancer and meet national guidelines; this evidence warrants a literature review and consideration by the task force. Omission of survivors from these guidelines will negatively impact their access to care and coverage for preventive services under the PPACA.

Further, genetic risk assessment is most likely to yield informative results when the family testing process begins with an individual who has already been diagnosed with cancer. Once a mutation is identified in the family, then other family members can be screened for that mutation. This cascade approach to genetic testing increases the likelihood of informative testing and minimizes wasted health care dollars on inconclusive tests.

We request that the USPSTF review the evidence for genetic counseling and testing in women with a diagnosis of breast cancer and history (both personal and family) that is suggestive of a mutation, and based on the strength of the evidence, include these women in the patient population under guidelines and the "B" letter grade.

USPSTF Response:

"Although the Task Force recognizes the importance of the further evaluation women who have the diagnosis of breast or ovarian cancer, that assessment is part of disease management and is beyond the scope of this recommendation. The Task Force recognizes that genetic counseling and testing may be an important part of disease management for women who have been diagnosed. However, the Task Force’s mission is to determine the evidence-base for preventive services in the general population who have no signs or symptoms of disease."

FORCE Counter-response

FORCE disagrees on this point. While BRCA test results can affect the surgical management of women newly diagnosed with breast cancer, it is important to recognize that BRCA testing has clinical utility for preventive services in women diagnosed with cancer, separate from and beyond their disease management. Consequently, genetic risk assessment is still recommended for women whose personal and/or family medical history indicates a possible mutation—even after they have completed their treatment for cancer and have no evidence of disease. These women meet the definition of having no signs or symptoms of disease.

Women with a BRCA mutation and a cancer diagnosis face a high risk for a second primary cancer that is unrelated to their initial diagnosis, and therefore outside of their disease management. We urge the USPSTF to include them in the population under consideration. Omission of breast and ovarian cancer survivors from these guidelines is inconsistent and will negatively impact access to care and coverage for preventive services under the PPACA.

Concern 3:

No letter grade is assigned to risk-management options.

Under the draft guidelines, BRCA counseling and testing are assigned a “B” letter grade. Awarding a grade to both services acknowledges their clinical utility. The clinical value of genetic counseling and testing for BRCA with regard to preventive medicine, however, lies in a high-risk individual’s access to appropriate evidence-based screening and preventive services that lower the risk for breast or ovarian cancer—or detect these cancers at an early stage. Without a letter grade, these preventive services are exempt from the PPACA, ultimately limiting patient access to needed services. In contrast, breast cancer screenings for average risk women are covered under the PPACA because they carry a "B" grade in USPSTF guidelines.

Recommendation:

Assign a letter grade to specific screening and preventive services for people with BRCA mutations

We request that the USPSTF review the evidence for risk-management services, including annual screening with breast MRI and mammogram for women found to have a BRCA mutation, and based on the strength of this evidence, provide a letter grade to these preventive services.

USPSTF Response:

"Although we appreciate that people with BRCA mutations are at high risk for breast and ovarian cancers, it is beyond the scope of this recommendation as this recommendation specifically targets BRCA counseling and screening in the general population. Individuals and populations who are at increased risk for certain cancers are addressed within the specific recommendations for those cancers."

FORCE Counter-response

The USPSTF statement, "Individuals and populations who are at increased risk for certain cancers are addressed within the specific recommendations for those cancers." is confusing because we could find no USPSTF breast cancer screening recommendations that include women with a BRCA mutation. We are asking the USPSTF to clarify where these guidelines exist. In light of the fact that the PPACA specifically cites the USPSTF guidelines for appropriate screening and preventive services, insurers may not recognize guidelines developed by entities other than the USPSTF.

These guidelines overlook preventive services for women who are at the highest risk for breast cancer even while similar services have been evaluated for the general population. It is inconsistent and confusing that the USPSTF offers guidelines for primary care providers to identify high-risk women, yet offers these practitioners no guidance for provision of preventive services to manage their risk. We urge the USPSTF to provide an evaluation of preventive services for this population that is comparable to the effort afforded to women of average risk. In the absence of such guidelines these women will face significant barriers to accessing preventive services, due to gaps in primary care provider knowledge about appropriate breast cancer screening and lack of guaranteed insurance coverage for these services without co-pay or deductible as provided within the PPACA.

Conclusion

The 2013 guidelines on Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer contain gaps that directly impede consumer access to preventive services. The guidelines dismiss the value of preventive medicine for cancer survivors, even those who have no signs or symptoms of disease. While recognizing the preventive benefit of identifying high-risk women who carry a BRCA mutation, the USPSTF does not evaluate nor offer a letter grade for cancer preventive services aimed at early detection or lowering risk, even as these services have been evaluated for average-risk women. Although the published guidelines are "final," FORCE is actively working to address these and related concerns.

Page updated 8/14/14

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