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Tuesday, April 25, 2023

Raising and lowering barriers to preventive services in the U.S.

The Affordable Care Act's guarantee of no cost-sharing for cancer screenings and other beneficial evidence-based preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) has been put in jeopardy by a district court decision favoring the plaintiffs in a lawsuit claiming that requiring insurance coverage of HIV pre-exposure prophylaxis violated their religious freedom. Judge Reed O'Connor ruled that because USPSTF members are not confirmed by the Senate and their recommendations are not subject to government oversight or approval, health insurers are no longer obligated to cover any preventive services recommended after the ACA was signed into law in March 2010. Mandatory coverage of services endorsed by other governmental bodies, such as the Advisory Committee on Immunization Practices (ACIP) and the Health Resources and Services Administration (HRSA), will remain in effect. In a previous blog post, I called this outcome "an exceedingly dumb and harmful proposition that would result in more preventable illness and poorer quality of life for millions of Americans," but now that it's happened, it is worth exploring why the ACA left the Task Force vulnerable and what can be done to repair the damage.

In 2013, family physicians Steven Woolf and Doug Campos-Outcalt wrote a prescient viewpoint in JAMA noting that the USPSTF's exclusive focus on the scientific evidence of clinical benefits and harms made it ill-equipped to implement insurance policy designs:

Coverage decisions, like other aspects of public policy, should not always be dictated solely by science. ... Just as clinicians must consider individual circumstances that transcend empirical data, the public should be allowed to influence policy choices, like paying for services, when factors other than science pertain. Laws should certainly adhere to the evidence in ensuring public access to a minimum set of services of proven benefit, but the latitude to build on this evidence-based “floor” should also be preserved. ... Placing the USPSTF in this position puts its analytic rigor at risk by preventing members from concentrating on the science. The inescapable reality that their conclusions dictate coverage guidelines may engender a subliminal pressure to reinterpret the evidence, knowing the ramifications, and to lower the threshold for A and B recommendations.

Drs. Woolf and Campos-Outcalt suggested severing the link between USPSTF recommendations and coverage policy "by naming a separate body to advise the secretary of Health and Human Services on appropriate preventive services for first-dollar coverage." This did not happen, of course, even after three former Task Force Chairs published a second commentary a few years later asking "Is It Time for the USPSTF to Inform—But Not Determine—Coverage?" Discussing an attempt by Mylan, the manufacturer of the EpiPen, to pressure the panel to declare its anaphylaxis drug a preventive service so that insurance companies would be forced the bear the full burden of future price increases, the authors noted that "the linkage ... encourages those with a significant financial interest to attempt to influence the direction and decisions of the Task Force."

In a recent Health Affairs Forefront article, Richard Hughes IV and colleagues discussed potential policy solutions that would save the ACA's preventive coverage provision and strengthen the USPSTF's position against inevitable future challenges. (As a physician who has cared for countless patients with this chronic infectious disease, it boggles my mind that 40 years after the discovery of the HIV virus as the cause of AIDS, at-risk and affected patients remain stigmatized for "immoral" behavior.) Although it is unlikely that Congress will act, administrative reforms are possible. For example, "the HHS Secretary could authorize the director of the Agency for Health Care Research and Quality or the CDC director to review and adopt the Task Force's recommendations." Or, echoing Woolf and Campos-Outcalt, "the Administration could establish an additional body within HHS to provide additional review, oversight and approval of recommendations. This group could be a vehicle for badly needed reforms to better align criteria, processes and recommendations across the various recommending bodies."
 
Even if this legal quandary is resolved, either by appeals to higher courts or executive actions such as those proposed above, the fact remains that "free" health care services, preventive or not, are not free if taking time off work to receive them results in lost income. Only 16 states and Washington, DC require employers to provide paid sick leave, and nearly 30% of workers lack it as a result, with higher proportions among people with low incomes, women, and underserved minority groups. An innovative study by Dr. Kevin Callison and colleagues examined the association between paid sick leave mandates and screening for colorectal and breast cancers using administrative claims data. Even though employees presumably use paid sick leave mostly for acute illnesses and non-preventive care, the researchers found that cancer screening rates were significantly higher in metropolitan statistical areas with paid sick leave mandates. Requiring that employers provide paid sick leave throughout the U.S. would not only lower a barrier to receiving beneficial preventive services, but as the COVID-19 pandemic demonstrated, likely drive overall population health improvement as well.