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Appendix D Dissent and Response This appendix has two parts. The first is a dissent statement from com- mittee member Anthony Lo Sasso, and the second is a response from the chair and the other 14 members of the Committee on Preventive Services for Women. DISSENTING OPINION Anthony Lo Sasso Summary Given the combination of the unacceptably short time frame for the PSW committee to conduct or solicit meaningful reviews of the evidence associated with the preventive nature of the services considered, this dis- sent advocates that no additional preventive services beyond those ex- plicitly stated in the Affordable Care Act (ACA) be recommended for consideration by the Secretary for first dollar coverage until such time as the evidence can be objectively and systematically evaluated and an appropriate framework can be developed. The long-run risks associated with making poorly informed decisions, and their likely irreversibility once codified, outweigh the ACA-mandated rapidity with which the committee was confronted. 231

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232 CLINICAL PREVENTIVE SERVICES FOR WOMEN Rationale The ACA provided the impetus for the IOM to form a panel to make recommendations about screening and preventive services that “have been shown to be effective for women” that in turn will be considered by the Secretary for coverage on a first-dollar basis by all new private plans in operation in 2014. However, a remarkably short time frame was provided for the task of reviewing all evidence for preventive services beyond the services encompassed by the USPSTF, Bright Futures and ACIP: the final report from the committee was needed barely six months from the time the group was empanelled. As the Report acknowledges, the lack of time prevented a serious and systematic review of evidence for preventive services. This should in no way reflect poorly on the tireless work of the committee and staff; it instead merely reflects the fact that the process set forth in the law was unrealistic in the time allocated to such an important and time-intensive undertaking. Where I believe the committee erred was with their zeal to recommend something despite the time constraints and a far from perfect methodology. The Report posits four categories as the basis for the recommendations ranging from “high quality systematic evidence reviews” (Category I) to potentially self-serving guidelines put forth by professional organizations (Category IV). The categories alone on their face provide little basis to exclude many preventive services. For example, Category II asks whether there are any “quality” supportive peer-reviewed studies, but there is no clear benchmark for what quality means in this context; many studies published in peer-reviewed journals (even very well respected journals) are of low quality and are not generalizable. The problematic nature of the categories aside, the relative weights applied to each category vis-à-vis the recommendations were not specified, making it impossible to discern what factors were most important in the decision to recommend one ser- vice versus another. The categories were combined with expert judgment from members of the committee and supplemented with committee debate to arrive at the recommendations put forth in the Report. Readers of the Report should be clear on the fact that the recommendations were made without high quality, systematic evidence of the preventive nature of the services considered. Put differently, evidence that use of the services in question leads to lower rates of disability or disease and increased rates of well-being is generally absent. The view of this dissent is that the committee process for evaluation of the evidence lacked transparency and was largely subject to the preferences of the committee’s composition. Troublingly, the process tended to result in a mix of objective and subjective determinations filtered through a lens of advocacy. An abiding principle in the evaluation of the evidence and the

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233 APPENDIX D recommendations put forth as a consequence should be transparency and strict objectivity, but the committee failed to demonstrate these principles in the Report. This dissent views the evidence evaluation process as a fatal flaw of the Report particularly in light of the importance of the recom- mendations for public policy and the number of individuals, both men and women, that will be affected. Other Considerations Another concerning aspect of the Report is the lack of a coherent framework to evaluate coverage apart from the evidence regarding clini- cal efficacy. Although coverage determinations were not explicitly part of the committee’s charge, it is nevertheless difficult to ignore the fact that the committee’s recommendations will have important implications for coverage considerations. Thus while the lack of a theoretical or concep- tual framework to examine coverage decisions can perhaps be forgiven, it is clear that the “life course” model put forth in the Report does not lend itself to the consideration of coverage decisions. I describe one po- tential framework below that could inform such thinking around coverage determinations. The ACA law requires coverage by private insurers of all USPSTF A and B recommendations. The USPSTF process of evidence review represents a “gold standard” based on a critical and scholarly review of all extant literature and therefore is the bar the committee should have aspired to in basing its recommendations to the Secretary. That said, the clinical recom- mendations from the USPSTF were never intended to provide a basis for insurance coverage determinations; they are intended as guides to physician practice. Given the previous role of the USPSTF it is worth noting that bas- ing coverage decisions categorically on USPSTF recommendations has the potential to jeopardize the objectivity and scientific integrity of the USPSTF review process. In contrast, while Bright Futures is a body aimed at influencing clinical practice, the evidence bar for its recommendations is considerably lower than that of the USPSTF. Recommendations are considered “evidence- informed” and rely heavily on expert opinion rather than systemic, critical reviews of the literature. This is troubling given the important public policy consequences that will now result from Bright Futures recommendations. Additions to the Update Recommendations There are reasons to support the framework for future evaluation of preventive services in the Report (Chapter 6). The proposed framework crucially recognizes the importance of separating the scientific objective

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234 CLINICAL PREVENTIVE SERVICES FOR WOMEN of establishing the effectiveness and potentially the cost effectiveness of preventive services from the policy decision regarding coverage of services. This dissent advocates for a more concrete structure based on sound public policy principles to frame both the evidence review and coverage decision for specific preventive services for women. A highly regarded framework to examine coverage decisions of pre- ventive services in an insurance context was developed more than twenty years ago by Pauly and Held (1990). The authors consider coverage deci- sions for a hypothetical preventive service that is presumed to reduce the probability of a covered and potential costly healthcare treatment episode (for example, inpatient treatment of a preventable disease outcome). More formally, if one assumes a preventive service, S, that costs P is available that when administered changes the probability from pn to py of experiencing an inpatient event with cost E, the following can be observed: 1. If pn > py the service is effective in prevention as the treatment S reduces the probability of experiencing the negative outcome; this represents the minimum necessary threshold for which “preven- tive” needs to be defined. 2. If (pn – py)E > P the service is “cost effective”1 in that the cost asso- ciated with the relative reduction in the probability of the negative outcome exceeds the cost of the treatment S; this is a potentially high bar but an important one for a preventive service. However, it is important to understand that point (1) and even point (2) do not necessarily imply that first-dollar coverage of preventive services leads to an overall reduction in insurer payments (and hence insurance premiums) as many might assume. Whether coverage of preventive service leads to a reduction in healthcare expenditure depends on the fraction of enrollees using the service before the service becomes covered and the magnitude of the response among enrollees who experience the reduction in out-of-pocket price. This latter point is what Pauly and Held term “be- nign moral hazard” and it points to a critical parameter of interest as the elasticity or responsiveness of preventive service utilization to the user price for the service. Knowing how elastic patient demand is to preventive ser- vices is a critical element to a coverage decision even if one already has good estimates of the effectiveness and cost-effectiveness. This is self-evidently a useful parameter to know for any preventive service because it highlights 1 It is important to note that the statute rules out cost as a consideration by the committee. Cost is included in the example only to demonstrate that the hypothetical preventive service meets a high bar beyond effectiveness.

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235 APPENDIX D the impact that first-dollar coverage of the service will have, perhaps in relation to other forms of outreach. More recently, Pauly and Blavin (2008) incorporate some additional considerations in the wake of research on so-called value-based health insurance designs. First dollar coverage can be justified if enrollees lack information about the benefits of preventive services in order to make cor- rect (or at least fully informed) decisions. Such a determination, however, would depend on the relative efficacy of information provision about the benefits of preventive services versus reducing (or eliminating) cost sharing. REFERENCES Pauly, M. V., and F. E. Blavin. 2008. Moral hazard in insurance, value-based cost sharing, and the benefits of blissful ignorance. Journal of Health Economics 27:1407–1417. Pauly, M. V., and P. J. Held. 1990. Benign moral hazard and the cost-effectiveness analysis of insurance coverage. Journal of Health Economics 9:447–461. RESPONSE TO DISSENTING STATEMENT Linda Rosenstock (Chair), Alfred O. Berg, Claire D. Brindis, Angela Diaz, Francisco Garcia, Kimberly Gregory, Paula A. Johnson, Jeanette H. Magnus, Heidi D. Nelson, Roberta B. Ness, Magda G. Peck, E. Albert Reece, Alina Salganicoff, Sally W. Vernon, and Carol S. Weisman The dissenting committee member wanted more time and the opportu- nity to incorporate cost-benefit analysis. At the first committee meeting, it was agreed that cost considerations were outside the scope of the charge, and that the committee should not attempt to duplicate the disparate re- view processes used by other bodies, such as the USPSTF, ACIP, and Bright Futures. HHS, with input from this committee, may consider other factors including cost in its development of coverage decisions. The dissent also includes inaccurate statements regarding the committee process and its approach to the committee charge. The committee members’ expertise is diverse and while many have different perspectives, no other member shares the opinion that report recommendations were not soundly evidence based.

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