Ideas and Opinions20 December 2016

Is It Time for the USPSTF to Inform—But Not Determine—Coverage?

    Author, Article, and Disclosure Information

    Appendectomy is not a preventive service; neither is an EpiPen.

    Mylan, the maker of the EpiPen, has heavily and successfully marketed this medical device with a resultant increase in demand. At the same time, the company has increased its price more than 5-fold over the past 9 years, resulting in stunning increases in revenue, as reported by The New York Times (1). The higher price, in concert with falling pharmacy benefits for many people, will inevitably limit sales and has courted the attention and disdain of national policymakers. While reducing the price is one answer to Mylan's current predicament, another approach—one that would protect profits—would be to enhance insurance coverage, increasing sales of the device and minimizing complaints about the price. However, insurance companies are also balking at the costs, and this approach faces significant challenges. Under provisions of the Patient Protection and Affordable Care Act, insurers must cover preventive services without copay if the services are declared by the U.S. Preventive Services Task Force (USPSTF) as meeting the criteria to warrant an A or B recommendation. A preventive service receives an A or B recommendation on the basis of evidence that it provides asymptomatic persons more benefit than harm. These criteria (preventive service, asymptomatic persons) are only distantly related to Mylan's product, but the company is nonetheless attempting to lobby the USPSTF by claiming that its product meets the stated criteria. To legitimize this goal, the company has written an article, found a willing physician to attach his name to it, and published it in a medical journal. The physician, listed as the sole author of the article, did not write it; as stated in the publication, it was drafted and revised by a paid consultant, “based on input from the author” (2). The sole—and openly acknowledged—purpose of calling the EpiPen a preventive service would be to trigger first-dollar insurance coverage for the device. Mylan is attempting to make a case that when used for the acute treatment (not prevention) of one specific and very symptomatic condition, a medication should be relabeled as a preventive medication—when that medication is in a device that they make (the EpiPen). Otherwise the medication remains what it is: a pharmacologic intervention used to treat persons who are suffering from various acute, life-threatening events.

    All health care services should accomplish at least 1 of 3 goals: to relieve suffering, to prevent future suffering, or to prolong life. Preventive services by definition are targeted at asymptomatic people and thus address only the latter 2 goals. Prevention is typically classified into 3 categories: primary prevention, the prevention of disease before it occurs; secondary prevention, the detection and treatment of disease before symptoms occur; and tertiary prevention, the use of services after disease develops that are targeted at preventing future complications rather than relieving current symptoms.

    It can be argued that many services used to relieve suffering also prevent future suffering or prolong life. In the context of acute appendicitis, a timely appendectomy not only relieves suffering but prevents future suffering by preventing rupture and in some circumstances prolongs life. Few people would argue on that basis that an appendectomy is a preventive service. But now we are in a circumstance where patients' out-of-pocket expenses are eliminated if the USPSTF gives an A or B grade to a preventive service, and as a result the drug company that markets a medication delivery device (EpiPen) that would never be used in an asymptomatic person is advocating calling it a preventive medication. As stated by the chief executive officer of Mylan, influencing government policies is part of their “unconventional approach to growing this franchise” (1). That is perhaps an understatement. Indeed, it 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.

    The USPSTF is an independent, volunteer panel of 16 national experts in prevention and evidence-based medicine whose mission is to improve the health of all Americans by making evidence-based recommendations on screening, counseling, and preventive medications. The scope of services considered by the USPSTF includes only those considered primary or secondary prevention that can be used in or referred from the primary care setting. The Task Force uses highly structured methods to ensure that its recommendations are of consistently high quality and methodologically sound, scientifically defensible, reproducible, unbiased, and well-documented. The USPSTF does not consider costs or coverage when making recommendations about preventive services, only the scientific assessment of the benefits and harms. The Task Force uses rigorous assessments of conflict of interest to ensure unbiased decisions, and members may not receive remuneration for services with respect to transactions involving parties with a financial interest in the outcome of a USPSTF decision (3).

    The Affordable Care Act linkage of USPSTF decisions to insurance coverage has brought both benefit and harm. 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 (4). 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. Parity in coverage of preventive and nonpreventive services should be expected, but preventive services cannot be assumed to be of greater value than other services. The linkage also encourages those with a significant financial interest to attempt to influence the direction and decisions of the Task Force. 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. The American public is best served by an independent scientific process free from advocacy and political pressure. If the only way to ensure such independence is to sever the direct link to coverage, then it may be time to consider that option. Perhaps it is time for the USPSTF to inform, but not determine, coverage.



    Kirsten Bibbins-Domingo, David C. Grossman, Susan J. Curry31 October 2016
    USPSTF Chair and Vice Chairs Response to Drs. Moyer, LeFevre, and Calonge
    On October 11, the Annals of Internal Medicine published a commentary by Drs. Virginia Moyer, Michael LeFevre, and Ned Calonge, entitled, “Is It Time for the USPSTF to Inform—But Not Determine—Coverage?” (1). In this commentary, our esteemed colleagues warn of undue external pressure on the U.S. Preventive Services Task Force, specifically related to recent calls for the Task Force to review the EpiPen as a preventive service.

    The EpiPen, an epinephrine auto-injection device, delivers life-saving treatment of anaphylaxis but is generally prescribed to people who already have severe allergies. The EpiPen is not a preventive service for asymptomatic people and thus does not fall within the scope of the Task Force. We have not received any nominations for use of the EpiPen to be considered by the Task Force, and if we did, this is not an area where we would undertake making a recommendation.

    In making their public statements regarding the Task Force, the makers of EpiPen (Mylan; Canonsburg, PA) are hoping to secure no-cost insurance coverage for their device. The Task Force does not make coverage decisions. These decisions are the domain of payers, regulators, and legislators, whereas our independent scientific process remains focused solely on evaluating the evidence about which preventive services have a net benefit.

    Although the authors raise concerns about external pressure, outside interests affect neither the domain nor the decision making process of the Task Force. We have clear policies and procedures that protect the Task Force from outside influence. We follow the National Academy of Medicine’s widely-accepted standards for developing rigorous and trustworthy clinical practice guidelines (2), as articulated in 2011. The USPSTF has transparent processes in place to avoid or minimize any possible outside influence that could create potential conflicts of interest (see the Task Force’s policies on conflict of interest [3] and standards for guideline development [4]).

    We are deeply committed to improving the health of all Americans and helping ensure access to preventive care. Our role is to evaluate the science on the benefits and harms of a given preventive service so people can make informed decisions with their clinicians about their health care.

    Our focus on the evidence, along with our open and transparent policies and procedures, are the best safeguard against outside influence.

    Kirsten Bibbins-Domingo, PhD MD, MAS, Chair, USPSTF
    David C. Grossman, MD, MPH, Vice Chair, USPSTF
    Susan J. Curry, PhD, Vice Chair, USPSTF

    1. Moyer VA, LeFevre M, Calonge N. Is it time for the USPSTF to inform—but not determine—coverage? Ann Intern Med. 2016. doi: 10.7326/M16-2304
    2. Institute of Medicine. Clinical Practice Guidelines We Can Trust: Standards for Developing Trustworthy Clinical Practice Guidelines. Washington, DC: National Academies Press; 2011.
    3. U.S. Preventive Services Task Force. Conflict of Interest Disclosures. 2016. Accessed October 31, 2016.
    4. U.S. Preventive Services Task Force. Standards for Guideline Development. 2016. Accessed October 31, 2016.