What's a medical device maker to do when prices skyrocket?
If you're Mylan, the maker of EpiPen, you lobby the U.S. Preventive Services Task Force. You lobby the task force to deem your product "preventive," so the Affordable Care Act requires insurance companies to cover the cost. At first blush, this action seems benevolent — it helps consumers access an important product that can treat life-threatening conditions.
However, in a recent article for Annals of Internal Medicine, three physicians argue that Mylan's actions are not completely altruistic. Instead, they argue Mylan is making a "blatant attempt to twist the notion of prevention to get first-dollar coverage."
At issue is part of the ACA that requires insurance companies to cover preventive services, or services the USPSTF gives an A or B recommendation. These services must be used or referred from the primary care setting, according to the article's authors, and must be used for primary prevention — to prevent disease — or secondary prevention — to treat symptoms of a disease before they appear, but after diagnosis of the condition. The EpiPen does not serve a primary or secondary preventive purpose, as it treats symptoms after they occur, according to the report's authors.
As Mylan continues to raise the price of the EpiPen, consumers can no longer afford to pay for it. Rather than reduce the price, the makers have chosen to lobby USPSTF to deem the device preventive so payers are responsible for the complete cost, according to the opinion article. In fact, its CEO considers this strategy part of its "unconventional approach to growing this franchise," according to the authors.
The authors argue Mylan's actions demonstrate that the ties between USPSTF decisions and insurance coverage are too strong. This link puts undue emphasis on preventive procedures, when nonpreventive care is equally important and should receive parity in coverage. It also invites companies to attempt to sway the task force's decisions and "distracts from the mission" of making evidence-based recommendations for preventive services that improve Americans' health. The authors recommend USPSTF make recommendations, but not decide what insurance should cover.
Virginia Moyer, MD, section head of academic general pediatrics at Houston-based Texas Children's Hospital; Michael LeFevre, MD, director of clinical services at University of Missouri School of Medicine in Columbia; and Ned Calonge, MD, president and CEO of The Colorado Trust, a health equity foundation, contributed to the opinion article. Read the full article here.
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