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FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Our Role & Impact > Advocacy > Current Actions > Updated Response to USPSTF Guidelines on BRCA Testing

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USPSTF Guidelines on BRCA Risk Assessment, Genetic Counseling and Testing

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Read the 2016 USPSTF Breast Cancer: Screening recommendations

Read the May 2015 commentsFORCE 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 its new Breast Cancer: Screening recommendations on January 12, 2016. These recommendations would have replaced the current guidelines, published in 2009. However, a bill signed into law in December 2015 places at two-year moratorium on the new breast cancer screening guidelines, maintaining free annual mammogram screenings for women aged 40 to 74 while the impact of the proposed USPSTF guidelines and the its recommendations process are examined more closely.  FORCE was instrumental in efforts to curtail the proposed guidelines via the “Stop the Guidelines” campaign and support of the Protecting Access to Lifesaving Screenings (PALS) Act. The recommendations are specifically to guide decision-making about breast cancer screening for women of average breast cancer risk.

FORCE opposes many aspects of the new guidelines because we believe they will worsen existing disparities, lead to confusion, and cost the lives of women in the community that FORCE serves.  Read our letter to the USPSTF outlining our concerns with the guidelines when they were still in their draft form.

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."

The guidelines issued in January 2016 include the following recommendations:

  • For women ages 40–49: informed, individualized decision-making regarding screening mammography based on a woman’s values, preferences, and health history, but only gave this recommendation a “C” letter grade. The USPSTF points out that screening mammography in this age group “may reduce the risk of dying of breast cancer, but the number of deaths averted is much smaller than in older women…”
    This represents a modification and expansion of current/2009 USPSTF Recommendations, which concluded that evidence was insufficient to assess the balance of benefits and harms of mammography in this age group.
  • For women ages 50-74: screening mammography every two years rather than annually (grade B recommendation).
    This is consistent with current/2009 USPSTF Recommendations.
  • For women 75 and older: no concrete guidelines, indicating that current science is inadequate to recommend for or against screening mammography.
    This is consistent with the current/2009 USPSTF Recommendations.
  • On Breast Self-Exam (BSE): omission of any reference to this early detection modality
    This change from current/2009 USPSTF Recommendations that gave a grade D to teaching BSE indicates a “moderate or high certainty that the service has no net benefit or that harms outweigh the benefits.”
  • For women with dense breasts: indication that current evidence is insufficient to assess the balance of benefits and harms of screening for breast cancer using breast ultrasound, magnetic resonance imaging (MRI), tomosynthesis, or other modalities in women whom an otherwise negative screening mammograms identifies as having dense breasts.
    This is a new language that was not present in prior USPSTF recommendation statements.

FORCE's Concerns with the USPSTF Breast Cancer Screening Recommendations

Concern 1:

The guidelines will disproportionately harm women with Hereditary Breast and Ovarian Cancer (HBOC) and women with a BRCA mutation:

The USPSTF recommendations specifically apply to women of average risk, but these guidelines detrimentally affect members of the high-risk community we serve, for whom breast cancer before age 50 is particularly common. Because genetics experts and risk-assessment tools are underutilized, many high-risk women with an inherited predisposition to cancer learn about their high-risk status only after they have been diagnosed with cancer—often detected by breast self-exam or mammogram. For this population, access to screening is important and can lower the risk of breast cancer mortality. Giving a “C” grade to mammography in women ages 40-49 creates significant barriers to access to care because insurers will no longer cover the screenings at no cost.  Delaying screening until age 50 also misses the opportunity to diagnose breast cancer in high-risk women (who may not know of their increased risk) at earlier stages. 

Concern 2:

The guidelines discriminate against high-risk women:

The guidelines create a gap in screening recommendations and access to preventive services for women at high risk for breast cancer, thus discriminating against this vulnerable group. Although the Task Force’s stated goal is to improve the health of all Americans, women who are most at risk for breast cancer are omitted from breast cancer screening guidelines.

In 2013, the USPSTF published Guidelines on BRCA Risk Assessment, Genetic Counseling and Testing that assigned a letter grade of “B” for identification of women at high risk for breast and ovarian cancer through genetic counseling and BRCA testing. However, the clinical utility of genetic counseling and testing for BRCA lies in the high-risk individual accessing preventive services to lower their risk for breast or ovarian cancer, or to detect these cancers at an earlier stage. During the review phase of the draft guidelines in 2013, FORCE urged the USPSTF to review the evidence and assign a letter grade to expert-recommended interventions for high-risk women, including risk-reducing salpingo-oophorectomy and breast MRI. The USPSTF did not implement these suggestions. Without a letter grade assigned to screening and prevention interventions, these services are not covered under the PPACA.  Without a USPSTF grade “A” or “B” recommendation, some insurers refuse to cover breast MRI and/or preventive surgeries.  Ultimately, this means that high-risk women may have less access to recommended interventions than average risk women.

The USPSTF also notes that women in their 40s who have a mother, sister, or daughter with breast cancer may benefit more than average-risk women by initial breast cancer screening before age 50. The new breast cancer screening guidelines, however, assign this service a grade “C” recommendation, which will make insurance reimbursement for screening mammography before age 50 difficult for millions of women who have increased risk for breast cancer due to family history.

Dense breast tissue is linked to an increased risk of breast cancer. Mammography is less effective in screening dense breasts for cancer, so other screening tools such as MRI or ultrasound may provide crucial early detection for these women. Several states have laws requiring that women be informed if they have dense breasts. Unfortunately, without a USPSTF grade “A” or “B” recommendation, insurers are not required to pay for supplemental screenings in these high-risk women. This may place an unnecessary financial burden on this population.

Concern 3:

The guidelines miss an opportunity to find aggressive breast cancers and cancers in younger women:

The Task Force acknowledges that screening mammography is likely to save lives, but claims that it saves fewer lives in women ages 40-49 as compared to older women. Nevertheless, we have a moral obligation to applyall means at our disposal to save as many lives as possible. By delaying screening mammography until age 50 we miss opportunities to identify breast cancers in high-risk women. Limiting mammography to biennial screenings after age 50 means many aggressive, rapid developing, interval breast cancers (cancers that develop between screenings) will go undetected until they are advanced and much harder to treat. These recommendations may also disproportionately burden and increase disparities for African American women, who are more likely to develop aggressive triple-negative breast cancer, and who are more likely to die of their breast cancer than women of other races. If implemented, these recommendations will cost lives.

Concern 4

The guidelines emphasize risks for overdiagnosis and treatment, while minimizing risks of misdiagnosis, and ignoring clinical tools that can help minimize overdiagnosis:

The guidelines state, “All women undergoing regular screening mammography are at risk for the diagnosis and treatment of noninvasive and invasive breast cancer that would otherwise not have become a threat to her health, or even apparent, during her lifetime (known as “overdiagnosis”). This risk is predicted to be increased when beginning regular mammography before age 50 years.”  Unfortunately, the guidelines fail to acknowledge the existence of valuable decision-support tools such as Oncotype DX and Mammaprint, technologies that can help prevent overtreatment by determining which early-stage cancers, when found, are more likely to behave aggressively.

Conclusion

The Task Force review of risk and the cost/benefit ratio for breast cancer screening highlights the need for:

  • a better system for determining which screening and preventive services should be covered at no cost under PPACA,
  • more effective breast cancer screening,
  • better utilization of risk-assessment tools, and
  • more research on breast cancer risk factors, screening, and outcomes.

To make breast cancer preventive services accessible to all Americans we must provide guidelines for breast cancer screening that take high-risk women into account, as well as women at average risk. Under the current system, we must also assure coverage for preventive services without cost-sharing for people at increased risk for breast cancer with a USPSTF review and letter grade for recommended services such as risk-reducing salpingo-oophorectomy for women with a BRCA mutation and breast MRI for women at high risk for breast cancer due to inherited risk factors. At a time when our elected leaders are focusing on personalized and precision medicine, we should strive to replace sweeping one-size-fits-all recommendations with more appropriate guidelines that support individualized risk assessment and screening. Until risk assessment becomes an exact science, all women should have access to credible and balanced information, and with guidance from their physician, be allowed to decide and have insurance coverage for the breast screening most appropriate for them.

Page updated 1/15/16

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