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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.
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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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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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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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