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The Women’s Preventive Services Report And The Role Of Evidence



July 21st, 2011

Section 1001 of the Affordable Care Act establishes women’s preventive health benefits as a new mandatory coverage class for all insurance products sold in the individual and group markets, self insured employer-sponsored health plans, and benchmark plans enrolling newly eligible Medicaid beneficiaries.  In implementing the Act in accordance with the tight deadlines established under the law, the Secretary of Health and Human Services (HHS) tasked the Institute of Medicine (IOM) to “review what preventive services are necessary for women’s health and well-being and should be considered in the development of comprehensive guidelines for preventive services for women.” The IOM’s recommendations will guide agency decision-making in the development of the guidelines, which in turn will set the baseline for health plan coverage of women’s preventive health services.

The IOM’s Family Planning Coverage Recommendations Are Solidly Supported By Evidence

The centerpiece of this long-awaited report – released on July 19 to a flood of news articles – is a collection of recommendations focusing on preventive services linked to family planning, recognized by the CDC as one of the great public health advances of the 20th century.  The cluster of IOM-recommended services falling within what can be thought of as a family planning benefit subclass of the overall women’s preventive benefit category consists of well women visits; screening and counseling for sexually transmitted infections and HIV; HPV testing; and contraceptive methods and counseling. It also includes additional recommendations — on screening for gestational diabetes; domestic violence screening; and lactation counseling, support, and supplies,– which were found to be “Gaps” in preventive services for women in the ACA’s otherwise-applicable coverage requirements.

Although the IOM Committee worked with great speed in accordance with HHS’ legislative mandate, its recommendations on contraception undeniably rest on a strong body of evidence regarding its effectiveness.  Indeed, so robust is the evidence of effectiveness for these recommended family planning services that at least some level of coverage appears to be common in employer-sponsored health plans, although coverage varies, as do state coverage laws, according to research from both the Kaiser Family Foundation and the Guttmacher Institute. Public insurance is similar in its embrace of these services: family planning services and supplies are a required Medicaid benefit and have been since 1970, and state options for expanding coverage are part of the Affordable Care Act.

A Misguided Dissent

In his dissent to the report, Committee member Anthony  Lo Sasso protests the  “unacceptably short time frame” in which the Committee was given to work, a matter obviously not of the Committee’s choosing and a point that seems to completely ignore the legal timeframes under which HHS is working. He also points to the failure to conduct a cost-benefit analysis, a decision obviously reserved to the Secretary’s discretion since it was not included in the charge to the Committee.

The dissent’s observation that gives the most pause, however, concerns the insistence on having “gold standard” evidence and a “coherent framework” before any recommendations be made to HHS.  (Lo Sasso’s proffered “coherent framework” concerns cost-benefit, which is precisely what the Committee was not tasked to do). The Committee, as charged by HHS, in fact, proposed a framework for future evaluation for any updates to the recommended prevention services for women “meeting the requisite criteria…as the science emerges.”  This approach seems both reasonable and appropriate.

Dr. Lo Sasso does not identify any particular clinical preventive service for criticism, thus ignoring the available evidence on cost-benefit for family planning services.  Regardless, all are tarred with the same brush. He also criticizes the use (directed by Congress) of other guidelines for other preventive services – the US Preventive Services Task Force Clinical Services categories A and B, and the Bright Futures for Children guidelines,– since they were not developed with insurance coverage in mind.  Where women’s preventive health services are concerned, Dr. Lo Sasso apparently would simply have had the Committee return a blank sheet of paper to the Secretary.

Thinking through the implications of Lo Sasso’s dissent. Let’s play the Lo Sasso position all the way out to the endgame, in a way that academics (and we can say this since we are both members of the club) tend never to do.   Option 1 would be for HHS simply to do nothing (in health policy analysis, we always tell our students to think about this option).  The value of such an option is that it refrains from making any decisions in the absence of “Gold Standard” evidence.  However, Dr. Lo Sasso neglects to point out that the vast majority of insurance coverage for standard clinical treatment necessarily rests on numerous classes of evidence, precisely because there is such a limited body of “Gold Standard” evidence, except in the area of emerging clinical technologies.  To rely only on “Gold Standard” evidence would mean no coverage at all, an absurd result.  Another downside to Option 1 is that it would violate an Act of Congress. Not much of an option.

Option #2 is to punt the decision to the industry.  That is, HHS could issue a guideline that states, “We lack “Gold Standard’ evidence, therefore, we leave the definition of women’s preventive health benefits up to industry practice and custom, as well as to whatever legal standards states might want to adopt.”  Putting aside the fact that this position amounts to its own violation of the Act (Congress could have taken this tack just as easily but chose instead to delegate responsibility to a Cabinet agency with expertise in the matter), Dr. Lo Sasso offers absolutely no explanation as to why leaving matters to the insurance industry is preferable to acting on less than “Gold Standard” evidence.

His failure to come to grips with his own position – to play the chess match out to the final move – overlooks the fact that were matters to be left up to insurers, companies would have no more evidence than the Committee does, but would be obligated to cover something, since they would need to respond to the Congressional command to add a new benefit class. As a result, the same type of wild variation in coverage that exists today would continue to persist, with random differences from plan to plan, market to market, and state to state.

Maybe at some point an enterprising researcher will design an elegant multi-year, multi-million-dollar study of the health effects of variation in women’s preventive services; although even if funded, such a study still would not meet Dr. Lo Sasso’s “Gold Standard” test, as it would not be a randomized controlled trial. In the meantime, millions of women would be at risk from inadequate access to treatments whose effectiveness is readily understood.  Worse, insurers could use a “fully loaded” women’s prevention package as a come-on to attract the youngest, healthiest risks, who want first-dollar coverage of birth control pills and health clubs, and who think less about having good coverage for MS or cancer or the health effects of a major auto accident.  The potential spillover market effects of leaving matters to the industry could be quite serious.

Dr. Lo Sasso never explains why it is better for society to defer to the insurance industry, leaving women exposed to a lack of coverage for benefits of proven value, as opposed to having the Secretary adopt a reasoned policy based on substantial evidence.   Indeed, he never even acknowledges the practical implications of his arguments, a classic problem with academicians who fail to analyze the real effects of their own assertions. Simply kicking the can down the road to the insurance industry, as Dr. Lo Sasso apparently would have HHS do, leaves women in precisely the same position they have endured for decades, while creating yet a new adverse selection strategy. Millions of women would continue to face the same financial and access uncertainties about preventive health benefits that they face today in a highly industry-driven market.

Decisions On Established Treatments Must Utilize The Best Available Evidence, Even If It’s Less Than the “Gold Standard”

Dr. Lo Sasso’s dissent should serve as a reminder to health policymakers:  Although it is always critical to strive for the highest grade of evidence, important decisions involving established treatments (as opposed to emerging treatments, such as new drugs or vaccines) typically are made using the best evidence available.  If HHS were to defer a decision until perfect evidence materializes, it would abdicate its responsibility under law and would allow perverse market incentives to blossom. If we were the Secretary, and our choice lay between relying on the Committee’s remarkable efforts or punting to the insurance industry, we would pick the IOM every time.

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1 Response to “The Women’s Preventive Services Report And The Role Of Evidence”

  1. _Aaron_ Says:

    I’d urge anyone reading this post to actually read Dr. Lo Sasso’s dissent and the report. I think you would find that the facts are indeed in Dr. Lo Sasso’s favor.

    A rational framework for evaluating the effects of coverage decisions is largely lacking in the report. Emphatically, just because a treatment is effective on average does not mean it should necessarily be covered without copays. Everyone knows contraception works. This is not news. However, cost-sharing decisions are not only about medical effectiveness, but patient knowledge, risk, price-responsiveness and the possibility of over-consumption. See the rich literature on value-based insurance design or the papers Lo Sasso cites. A coherent argument in favor of doing away with copays for a service must not only demonstrate that the service is effective, but that the service is underutilized even at a cheap copay level, that copay elimination would increase use, and that eliminating the copay would not yield perverse results like encouraging patients to over-consume or to upgrade to needlessly expensive versions of the item. Since premiums will go up to pay for the coverage, the change recommended by the committee could actually make women’s lives worse.

    Apparently, the committee was not in a position to conduct such a detailed investigation, since time and data were limited. Still, the committee members should have at least acknowledged the paltry evidence base regarding the welfare effects of a move to zero copays for contraception. Lo Sasso seems to have been the only one brave and intellectually honest enough to do this, and to pillory him for it is unreasonable.

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