Science Policy For All

Because science policy affects everyone.

Challenges in the Translation of Science into Policy: The Case of Breast Cancer Screening Coverage

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By: Felisa Gonzales, Ph.D.

The appropriate role of science in policy making has been debated for centuries. Most theories of decision-making posit that decisions, including policy decisions, are based on beliefs and values. How best to incorporate scientific knowledge into policymakers’ beliefs and values is unclear, and doing so is particularly difficult when the science is not definitively conclusive. The challenges inherent to the use of science to inform policy were clearly demonstrated when the Patient Protection and Affordable Care Act (ACA) mandated free health insurance coverage for certain preventive services based on the science-based recommendations of the United States Preventive Services Task Force (USPSTF). The USPSTF is an independent, volunteer panel of experts and clinicians from the fields of preventive medicine and primary care charged with evaluating the scientific evidence regarding the benefits and harms of clinical preventive services. The target audience for the USPSTF recommendations is primary care clinicians, not policymakers. Because the use of their recommendations has been codified into law, the scientifically and clinically oriented USPSTF is now occupying a policy role for which it was neither designed nor intended. The scientific conclusions of the USPSTF may not match the beliefs and values of democratically elected policymakers, raising the question: Is USPSTF the appropriate body to be put in the position of determining coverage policy?

The direct linkage of the USPSTF’s science-based recommendations to health insurance coverage came to public attention in 2009 when the panel changed its breast cancer screening recommendation. Based on data from randomized trials of mammography screening, the USPSTF made age-specific recommendations that advised against routine breast cancer screening for women between the ages of 40-49 and called for women to weigh “the potential benefit against the potential harms” before deciding to initiate mammography before the age of 50. Although women older than 40 have long heard messages such as “screening saves lives” and “take the test, not the chance”, researchers had been expressing their uncertainty about the benefits of mammography for women in their 40s since at least 1993. Nevertheless, the 2009 recommendation was criticized as “gender genocide”, “incredibly flawed”, “disastrous for women’s health”, and “callous and poorly conceived”. Despite the backlash, the USPSTF reiterated the same recommendation in January of 2016.

A review of the available evidence in 2016 indicated that for every 10,000 women ages 40-49 screened for breast cancer, approximately 1,212 false-positives will result, 164 biopsies will be conducted, 10 cancers will be missed. With repeat screening over 10 years, only 4 breast cancer deaths among women ages 40-49 will be avoided. Based on this information, the USPSTF gave mammography for women ages 40-49 a grade of “C”, which indicates that “there is at least moderate certainty that the net benefit [i.e., the degree to which the benefits outweigh the harms] is small”. Only clinical preventive services with “A” or “B” grades, which indicate a moderate to high degree of certainty that the benefits outweigh the harms of a procedure by a moderate to substantial margin, are required to be completely covered by health insurers under ACA. The USPSTF grade definitions include assessments of certainty because science is not often absolutely conclusive. Commenting on the role and responsibility of expert bodies, the Organisation for Economic Co-Operation and Development Committee for Scientific and Technological Policy notes, “the policy and societal context for scientific advice is challenging, not only because the stakes are high, but also because the general expectation is that science can provide clear and unambiguous answers. The reality is that the results of scientific research are often provisional and sometimes heavily contested…” The fact that the USPSTF recommendations are based on the best available science and are of superior quality was not enough to convince policymakers that they were sufficient to be the sole determinant of coverage for mammography.

The “C” rating for mammography among women ages 40-49 was not a recommendation against screening or against coverage, but because the ACA linked the USPSTF recommendations to coverage decisions, some incorrectly interpreted it this way. As a “C” rating would result in mammography not being covered as a preventive service under ACA, Senators Barbara Mikulski (D-MD) and David Vitter (R-LA) drafted amendments requiring insurance plans to pay for annual mammograms for women ages 40 and older and not restrict mammography based on USPSTF recommendations. Mikulski’s amendment also included screenings for ovarian and lung cancer screening despite a lack of evidence of any benefit, and concerns about substantial harms, associated with these procedures. Members of the House and Senate have proposed additional actions including eliminating funding for future USPSTF recommendations and requiring people who are not experts in prevention or evidence-based medicine to serve on the panel (for example representatives from patient groups, specialty physicians, and relevant stakeholders from the medical products manufacturing community). Experts are wary of these efforts, noting that “political interference with science can discourage shared decision-making, increase harms from screening, and foster public doubt about the value and integrity of science.” These tensions highlight differences in scientists’ and policymakers’ beliefs and values despite a shared commitment to improved public health.

The USPSTF “is committed to using the best science to identify the most effective preventive services to improve the health of the public,” but carrying out this mission is much more complicated now that their recommendations are used to dictate health insurance coverage. One proposed solution, favored by the USPSTF and its critics, is the creation of a separate independent panel to be charged with reviewing the USPSTF screening recommendations as well as other considerations important for public policy, such as cost, context, and feasibility. As the current chair and members of the USPSTF have noted, “the science on effectiveness – although foundational – is only one factor that needs to be considered in developing policy coverage.” Others closely associated with the USPSTF have warned that “limiting first-dollar coverage to services supported by strong evidence of effectiveness, as determined by one panel, is potentially harmful for public policy and threatens the USPSTF and other independent panels like it.” The linkage of the USPSTF recommendations to health insurance coverage policy reminds us that scientists are not policymakers, and policymakers are not scientists. The development of evidence-based policy requires scientific advice that is “scientifically sound and politically suitable and legitimate at the same time.” In the absence of an independent, intermediate body that can consider both scientific beliefs and prevailing societal values in health insurance coverage decisions, we risk building walls rather than bridges between science and policy.

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Written by sciencepolicyforall

May 12, 2016 at 11:00 am

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