Helping research inform legislation

The following post is coauthored by Sarah Jane Reed, Sarah K. Emond, and Austin Frakt. Sarah Jane Reed serves as Program Director for the Institute for Clinical and Economic Review (ICER), where she oversees operations and strategic planning for the New England Comparative Effectiveness Public Advisory Council (CEPAC).  She holds a Masters of Science in International Health Policy from the London School of Economics. Sarah K. Emond is responsible for the strategic direction of ICER as its Chief Operating Officer, including the implementation of ICER’s research through its flagship initiatives, CEPAC and the California Technology Assessment Forum (CTAF).  Sarah has a Masters of Public Policy from the Heller School at Brandeis University.

Disclaimers: The views expressed here are the authors’ own and do not necessarily represent the views or opinions of ICER or CEPAC. Austin serves as a member of CEPAC.

Increasingly, lawmakers are influencing medical policy through patient notification laws and insurance coverage mandates. Such laws are intended to benefit patients, but their inflexibility can cause them to be out of step with sound interpretations of clinical research.

Consider breast cancer screening. Thirteen states have recently passed breast density notification legislation requiring radiologists to inform women when their mammogram results reveal they have dense breast tissue, which may mask abnormalities. (Approximately 50% of women have dense breasts.) Dozens more states have similar legislation pending. Some states have gone further, requiring insurance coverage of supplemental ultrasound screening for women with dense breasts.

The issue has also caught the attention of Congress, where similar breast density notification legislation has been introduced.

Notably, no states with laws such as these and none of the legislation introduced in Congress stratify their requirements by patient risk. Yet sensitivity to risk may, in fact, be what’s best for patients.

We often think more health information is better. However, notifying women at low risk of breast cancer of their density status may raise more questions than it helps answer. To make informed decisions about future screening options for women with dense breasts, patients and providers need to weigh the benefits and risks of additional screening. Does supplemental screening catch more cancers? Does it help save lives?

The New England Comparative Effectiveness Public Advisory Council (CEPAC) recently addressed these questions. CEPAC is an independently recruited Council of 18 practicing physicians, methodologists and public representatives from all six New England states who meet in public to discuss and vote on evidence reviews covering test and treatment options in high-impact clinical areas.

Through its process, CEPAC discusses how evidence can be interpreted on a regional basis, taking into consideration factors such as prevalence, workforce issues, and utilization patterns that are unique to New England but affect how evidence can best be applied in policy and practice. The body also accepts and considers public comments, thereby incorporating a diverse range of stakeholder views and concerns.

(CEPAC, and its sister organization, the California Technology Assessment Forum, are the flagship implementation initiatives of the independent non-profit, the Institute for Clinical and Economic Review.)

At its last meeting in December, CEPAC deliberated on the latest evidence on supplemental breast cancer screening for women with dense breasts. In weighing the benefits and risks of supplemental screening, CEPAC examined the evidence on additional cancers detected, reduced mortality rates and the risks of further testing, including the possibility of false alarms.

A majority of CEPAC voted that for women at low-risk for breast cancer, the evidence does not demonstrate a benefit of supplemental screening. During the deliberation, Council members highlighted the dearth of evidence on long-term outcomes, such as mortality, for these women. However, in women at a moderate- or high-risk for cancer, CEPAC voted that the benefits of supplemental screening outweigh the risks, with the strongest evidence supporting additional screening in women at higher risk for breast cancer. You can read the full report here.

A discussion at the December meeting of how the evidence should influence policy and practice focused on changes needed in guidelines, clinical practice workflow. A common refrain during this discussion was, “is the policy ahead of the science?” In other words, in light of CEPAC’s votes, are laws that mandate dense breast notification to low-risk women doing more harm than good? This touches on the divisive issue of just how much of medical care should be shaped by legislation. Though CEPAC cannot resolve that question, it is clearly relevant in the case of dense breast tissue notification, as well as others.

As states in New England, and nationally, contemplate legislation mandating that women be notified if they have dense breasts, more attention should be paid by policymakers to expert, fair, transparent, and publicly deliberative assessments of the current state of the relevant evidence. There is a real danger of laws getting ahead of science. And, all good intentions aside, that is not to the benefit of patients.

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