Should USPSTF Inform Not Determine ACA Coverage?

Former chairs of the US Preventive Services Task Force (USPSTF) published an editorial in Annals of Internal Medicine questioning whether it may be time to alter the relationship between the USPSTF and determinations of preventive services coverage under the Patient Protection and Affordable Care Act.

The USPSTF publishes evidence-based recommendations on clinical preventive services such as screening, counseling, and preventive medications for various diseases including cancer, with some, such as breast and prostate cancers, sparking debate within the medical community in recent years. 

Virginia A. Moyer, MD, MPH, from the American Board of Pediatrics, Chapel Hill, North Carolina, Michael LeFevre, MD, MSPH, from the University of Missouri, Columbia, Missouri, and Ned Calonge, MD, MPH, from the Colorado Trust, Denver, highlight attempts by EpiPen manufacturer Mylan to lobby the USPSTF to develop guidelines that incorporate its EpiPen as a type of preventive service. Mylan has recently come under public scrutiny for increasing the price of its EpiPen fivefold over the last decade.

Current coverage under the Patient Protection and Affordable Care Act requires health insurance companies to cover preventive services without copay if the USPSTF declares the service as meeting criteria to warrant an A or B recommendation.

According to the editorial, Mylan has written an article, attached a physician name to it, and published it in a medical journal in an attempt to make a case that when the EpiPen is used for acute treatment of a “specific and very symptomatic condition” that it can be labeled as preventive medication. The article, “Prevention of anaphylaxis: the role of epinephrine auto-injector” was published in the American Journal of Medicine. “The first-line pharmacologic intervention for anaphylaxis is epinephrine, and guidelines uniformly agree that its prompt administration is vital to prevent progression, improve patient outcomes, and reduce hospitalizations and fatalities,” states the abstract of the article. “The recognition and classification of epinephrine as a preventive medicine by both the US Preventive Services Task Force and insurers could increase patient access, improve outcomes, and save lives.”

However, according to the former USPSTF chairs, “The sole-and openly acknowledged-purpose of calling the EpiPen a preventive service would be to trigger first-dollar insurance coverage for the device. This is a blatant attempt to twist the notion of prevention to get first-dollar coverage, specifically to deflect legitimate concerns about the dramatic and as of now indefensible increase in the cost of the device.”

Since signed into law, the link between the Affordable Care Act coverage and USPSTF recommendations has brought “benefit and harm,” the authors continued. “As advocates of preventive services, we are excited that many people who previously had no financial access to preventive services can now benefit from those services for which the balance of benefit and harm has been scientifically established to be favorable. But if such financial access comes at the cost of increased deductibles or copays for equally important services that are not preventive, then we must question whether the link inadvertently discourages other important care.”

In addition, the link provides incentive to those with significant financial interest to influence the decisions of the USPSTF.

“We doubt that Mylan will succeed with these current efforts, but it attempts to violate the integrity of the process and thus distracts from the mission,” they wrote. “The American public is best served by an independent scientific process free from advocacy and political pressure. If the only way to assure such independence is to sever the direct linkage to coverage, then it may be time to consider that option.”