The government should stop forcing insurers to provide first-dollar coverage of services endorsed by the U.S. Preventive Services Task Force (USPSTF), say several former task force chairs.
"The American public is best served by an independent scientific process free from advocacy and political pressure," wrote , of the Texas Children's Hospital in Houston, and colleagues. "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. Perhaps it is time for the USPSTF to inform, but not determine, coverage." The appeared online Monday in the Annals of Internal Medicine.
ACA Mandates Coverage
The Affordable Care Act (ACA) currently requires that any preventive service given an A or B rating by the task force must be covered 100% by insurers, with no copays or deductibles, the authors explained. Such ratings are given when evidence shows that a service "provides asymptomatic persons more benefit than harm."
"All health care services should accomplish one or more of three goals: to relieve suffering, to prevent future suffering, or to prolong life," they further noted, adding that "Preventive services by definition are targeted at asymptomatic people and thus address only the latter two goals."
However, because of the requirement that preventive services rated A or B by the task force must be entirely covered by insurers, Mylan, the company that makes the EpiPen epinephrine auto-injector -- used to prevent anaphylaxis in patients having an allergic reaction -- is trying to twist the definition of "preventive" to include its product, according to the authors. The EpiPen has been the subject of controversy recently because of Mylan's steep increases in the price of the product.
"These [above] 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," they wrote.
"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 people who are suffering from various acute, life-threatening events."
"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," the authors concluded. "The linkage also encourages those with a significant financial interest to attempt to influence the direction and decisions of the task force."
Mixed Reactions
Responses to the commentary were mixed.
, dean of the John A. Burns School of Medicine at the University of Hawaii, in Manoa, cautioned against throwing out the baby with the bath water. "Is it necessary to decouple mandated payment for sound preventive services (as included in the [ACA]) to prevent such a calamity? We should hope not," he wrote in an email.
"We simply need the resolve to sustain the purpose of this provision in the [ACA]. If we cannot hold fast and limit the role of the USPSTF to preventive services for asymptomatic individuals, we will soon have mandated insurance coverage for all services that potentially can benefit symptomatic patients -- once the service is recommended by the USPSTF. Relative benefit, cost, safety, alternative societal needs, alternative treatments options and many other factors must be reviewed when looking at national policy for specific interventions. Having all future health insurance coverage decisions made by the USPSTF is a bridge too far."
, of the University of Colorado Denver, agreed with Hedges, writing in an email that the recommendations shouldn’t be decoupled from insurance coverage. “This is manipulative and only serves to make health care more expensive and difficult for consumers (patients and insurance),†Eckel wrote.
Others contacted by ľֱ sided with the former USPSTF chairs.
"Though the EpiPen case is egregious, there have been other examples of political brouhahas over USPSTF recommendations (such as mammography) and, as the authors note, broader access to preventive services may increase out-of-pocket costs for other care," , of the University of North Carolina in Chapel Hill, wrote in an email to ľֱ.
"My view is that the current zero-sum game of covering preventive and treatment costs might be better addressed through rational and transformational reform of our broken health financing system, rather than by backing away from the important premise of removing financial barriers to access to evidence-based preventive services."
, of the University of Louisville, in Kentucky, agreed with Kirkman. "The egregious misconstruction of the Mylan executives to create EpiPen as a preventive measure has polluted the the concept of 'preventive services,'" she said in an email.
Similarly, said , of Yale University, in an email, "I find the authors' case very persuasive, and have had related concerns of my own for quite some time ... I am not overly concerned about the attempt by Mylan to influence the task force, knowing well the integrity of those involved. I think they will resist any such attempt at undue influence. But there are other, related problems not so readily overcome.
"The right response to this is just what the authors suggest: using the extremely valuable work of the Task Force to guide reimbursement decisions, but not being held hostage by a standard of evidence often not met due to timing, or cost," Katz continued. "Science and sense tend to work best in one another's company, and this situation is no exception."
New Form of 'Orwellian Doublespeak'
, of Mercy Medical Center in Baltimore, also said he thought the rule should be changed. "While the language of medicine that I studied some 50 years ago was concerned with precise descriptions of states of health and illness, pathological processes and diseases, the introduction of the world of politics into the universe of medicine has provided a new form of Orwellian doublespeak, in which treatment becomes prevention, and advice becomes policy," he wrote in an email.
"Guidelines are just that, guidelines," he concluded. "They should not be morphed into policy or mandates that force physicians to lock step into a government-mandated cookbook of medicine, devoid of any consideration of patient individuality, practice variables, population needs, or physician specifics."
, professor of epidemiology at the University of Georgia, in Athens, and a former task force member, also reviewed the commentary favorably. "The authors make a strong case for separating the decision-making about the science behind a preventive service from the decision-making about coverage," he wrote in an email.
"The potential benefit is encouraging parity between the coverage of needed preventive services with that of needed diagnostic and treatment services. The potential harm, especially for people with a high-deductible plan, is that it may lead them to forgo preventive services that otherwise would be covered without a co-pay."
But Harper noted that USPSF recommendations do have an advantage over other systems used to determine insurance coverage. "As the new screening tests are developed and evaluated with a grade A or B by USPSTF, it is vitally important that they replace old measures of insurance company payment. The payment for screening services is inextricably linked to the USPSTF grade," she said.
"The encumbrance to primary care physicians is that HEDIS and other 'quality' measures do not keep current with the USPSTF- or FDA-approved screening tests, prohibiting physicians from providing the best care to their populations just so that an old HEDIS measure can be checked off a list and payment made," she continued. "We have to stop paying for old lists of quality measures that are outdated and harmful to our patients."
For more on Mylan's effort to have the EpiPen deemed a preventive medication, see this video by ľֱ reviewer F. Perry Wilson, MD.