Week 8 - Signature Assignment: Design a System to Manage Administrative Policies
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Policy Framework for Covering Preventive Services Without Cost Sharing Saving Lives and Saving Money? Stephanie C. Chen, BA; Steven D. Pearson, MD, MSc, FRCP
P rior to The Patient Protection and Affordable Care Act (ACA),most preventive services covered by insurance required pa-tient cost sharing because many do not save money when delivered broadly to an entire population and because of the ad- ministrative complexity of exempting services from standard co- payment levels only for specific individuals.1 The preventive care pro- visions of the ACA, however, introduced major changes that were touted by President Obama as “saving lives and saving money.”2 The ACA mandates that all private, nongrandfathered, insurance plans cover without any patient cost sharing the preventive services en- dorsed by 4 expert committees: the US Preventive Services Task Force (USPSTF), the Advisory Committee on Immunization Prac- tices (ACIP), the Health Resources and Services Administration (HRSA) Bright Futures Project, and the Institute of Medicine (IOM) committee on women’s clinical preventive services.3 The tests and treatments recommended by these groups now represent a growing list of over 100 preventive services that are free for most Americans.
Notably, the ACA neither provides guidance nor mandates the development of a specific set of criteria by which preventive ser- vices should be selected, evaluated, and prioritized for free cover- age. Instead, each committee named under the ACA has devel- oped its own criteria for evaluating and recommending preventive services. This has led to important variations in their approach, but even their common elements have come under criticism. Some com- mentators have raised concerns that all the expert committees ex- clude entire categories of preventive services that have significant potential to improve health and reduce future health care costs.4 For example, diagnostic tests are not even eligible for consideration. Thus a 50-year-old woman can receive biennial screening mammo- grams for free, but only if she has no signs or symptoms of breast
cancer. A woman who has noticed a lump in her breast would not be able to receive a free screening mammogram but would have to pay a copayment for a diagnostic mammogram. As commentators have noted, in terms of saving both lives and money, diagnostic mam- mography is far more effective than screening mammography, yet it is only screening mammography that is free.5
Another category of excluded services are those that prevent adverse consequences associated with established disease.4
Treatment of hypertension prevents strokes, and insulin treat- ment of diabetes prevents coma and death, but these kinds of services are currently excluded even from consideration for free coverage. If the goals of the ACA preventive services provi- sions were to reduce barriers to a prioritized list of preventive services that would have the largest effect on improving health and reducing future costs, the current approach appears inconsis- tent, potentially incomplete, and open to being perceived as capricious.
Herein, we analyze the criteria used by each expert committee for developing its recommendations. Then, we propose a new, com- prehensive framework and associated criteria to help policy mak- ers in the future develop a more evidence-based, consistent, and ethically sound approach.
Current Methods Used to Develop the List of Free Preventive Services The current set of free preventive services totals 114, including 54 from the USPSTF, 27 from the ACIP, 25 from Bright Futures, and 8 from the IOM committee on women’s health. Forty-nine of these ser- vices are screening tests, and 28 are immunizations. The rest in- clude a wide range of services, from iron supplements for children to skin cancer behavioral counseling. Five recommendations are for
The US Affordable Care Act mandates that private insurers cover a list of preventive services without cost sharing. The list is determined by 4 expert committees that evaluate the overall health effect of preventive services. We analyzed the process by which the expert committees develop their recommendations. Each committee uses different criteria to evaluate preventive services and none of the committees consider cost systematically. We propose that the existing committees adopt consistent evidence review methodologies and expand the scope of preventive services reviewed and that a separate advisory committee be established to integrate economic considerations into the final selection of free preventive services. The comprehensive framework and associated criteria are intended to help policy makers in the future develop a more evidence-based, consistent, and ethically sound approach.
JAMA Intern Med. 2016;176(8):1185-1189. doi:10.1001/jamainternmed.2016.3052 Published online June 27, 2016.
Author Affiliations: Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland (Chen, Pearson); Institute for Clinical and Economic Review, Boston, Massachusetts (Pearson).
Corresponding Author: Steven D. Pearson, MD, MSc, FRCP, Department of Bioethics, 10 Center Drive, 1C118, Bethesda, MD 20892-1156 (pearsonsd@cc.nih.gov).
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services addressing men’s health, while 28 are related to women’s health. The composition and methods of the 4 committees are de- scribed in further detail below.
The US Preventive Services Task Force Established by Congress in 1984, the USPSTF has contributed the largest number of services to the free coverage list. The Task Force makes recommendations exclusively for “persons without recog- nized symptoms or signs of the target conditions” and it has “de- cided not to make recommendations concerning services to pre- vent complications in patients with established disease (eg, coronary artery disease and diabetes).”6 When deciding whether to recom- mend a service, the USPSTF balances health benefits against po- tential harms and recommends the service based on the strength of evidence and magnitude of net benefit. It explicitly excludes con- sideration of the cost or cost-effectiveness of a service in its deci- sions about whether to recommend a service.7
The Advisory Committee on Immunization Practices Established by federal legislation in 1964, the ACIP develops na- tional policies on the use of vaccines. The ACIP lists many factors, including the cost of interventions, that are taken into consider- ation in prioritizing candidate vaccines for review and is the only com- mittee whose methods explicitly acknowledge a role for cost con- siderations. However, the ACIP states that “there is no consensus on the weight that should be given to economic data. In practice, vaccine recommendations are made primarily on the basis of the bur- den of disease, vaccine effectiveness, and safety.”8
Bright Futures A partnership between multiple federal health agencies that began over 25 years ago, and now a partnership between the American Academy of Pediatrics (AAP) and the federal Health Resources and Services Administration (HRSA), Bright Futures makes recommen- dations regarding services provided in pediatric primary care. Throughout its methodology statement there is little information on how the committee defines the scope of pediatric prevention, pri- oritizes potential services for review, or evaluates individual ser- vices. The Bright Future Guidelines state that “evidence for effec- tiveness is a core criterion”9 and cites professional guidelines and clinical studies as the primary source of evidence. Whether cost is considered at any point of the recommendation development pro- cess is not addressed.
Institute of Medicine Committee on Women’s Preventive Services The ACA mandated that insurers cover “with respect to women, such additional preventive care and screenings…as provided for in com- prehensive guidelines supported by the Health Resources and Ser- vices Administration (HRSA) for purposes of this paragraph.”3 Sub- sequently, the HHS convened an IOM committee to draft such “comprehensive guidelines,” a committee that saw itself as focus- ing on “conditions unique to women or that affected women in some specific or disproportionate way.”10 Like the USPSTF, the IOM Com- mittee excludes cost and cost-effectiveness analyses from consid- eration, and also excludes services that address existing illnesses be- cause they believed services involving treatment decisions are viewed as “outside of its scope.”10
A Framework for Recommending Preventive Services for Free Coverage The 4 expert committees have similar goals, but they lack a com- mon overarching conceptual framework to guide the work that ul- timately produces a national list of free preventive services. The com- mittees have different processes and criteria for identifying services, evaluating them, and prioritizing them for recommendation. Meth- ods for evaluating the relative clinical benefits of different preven- tive services vary across committees. The ACIP is the sole commit- tee that considers costs but does so in an ad hoc fashion. It is not therefore surprising that the relative cost-effectiveness of the pre- ventive services currently recommended varies widely.11,12 In an in- dependent review of 25 recommendations by the USPSTF and ACIP, only 5 services were judged to be cost saving; all other services were estimated to add costs to the health care system, even over the long-term.13
We propose that all of the current committees should adopt a clear and uniform framework for recommending free preventive ser- vices. They should use a consistent methodology to measure the health effect of preventive services for individuals and the entire population. This methodology must be transparent and, given the linkage between committee recommendations and mandated cov- erage, it must be rigorous and resistant to external lobbying. With this foundation in place, we believe the committees should broaden the scope of their reviews to include diagnostic services and ser- vices that can prevent serious adverse outcomes for patients with established conditions. Finally, we propose a new committee be cre- ated and charged with the important task of adopting an explicit methodology for considering the cost effect of recommended pre- ventive services. This new committee would also be responsible for integrating the clinical recommendations of all four existing com- mittees with cost considerations as part of a uniform final pathway for determining which preventive services will be provided free.
Rating the Magnitude of Health Impact and Level of Confidence in the Evidence Only the USPSTF and the ACIP have clearly defined methodologies for evidence rating, and each committee uses a different approach. The home-grown USPSTF system assigns a letter grade, such as “A,” “B” or “C” that reflects a joint judgment of two factors: (1) the net health benefit, determined by assessing the balance of benefits and potential harms; and (2) the level of certainty in the net health ben- efit that the existing evidence can provide.14 The ACIP had fol- lowed USPSTF methodology until 2011 when it switched to an- other evidence rating system developed by an international consortium known as GRADE.15 GRADE also assigns letter grades re- flecting the strength of evidence, but the methodology uses differ- ent terminology and is structured differently than that of the USPSTF, so that the meaning of the letter grades and the criteria by which the evidence is judged do not match between the 2 committees.
We believe that either the USPSTF or the ACIP (GRADE) meth- odology should be used as a common approach for all 4 commit- tees. A common framework, terminology, and grading system would bring greater transparency and consistency to the recommenda- tions across the committees. Both the USPSTF and ACIP favor di- rect evidence from high-quality randomized clinical trials (RCTs) on key outcomes such as disease-specific or overall mortality. Only rarely, however, have such data been available: cervical cancer screening
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and lung cancer screening are the only 2 USPSTF recommenda- tions based, in part, on RCT evidence of improvement in overall sur- vival. Many other recommendations are based on RCT evidence for improvement in other patient-centered outcomes, including disease- specific mortality (colorectal cancer screening), HIV transmission (HIV screening for pregnant women), or prevention of neural tube defects (folic acid supplementation).
However, because long-term RCTs on the outcomes of screen- ing interventions and vaccination programs in general populations have generally not been done, the USPSTF and ACIP also consider studies of intermediate or surrogate outcome measures, or what is sometimes termed indirect evidence, that can nonetheless pro- vide moderate certainty that patient-centered outcomes are improved.14,15 The USPSTF definition of moderate certainty is when the available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the esti- mate of the magnitude of improvement is constrained by such fac- tors as: (1) the number, size, or quality of individual studies; (2) in- consistency of findings across individual studies; (3) limited generalizability of findings to routine primary care practice; and (4) lack of coherence in the chain of evidence.14
Recommendations that have been based on moderate cer- tainty arising from indirect evidence tend to be more controversial and include those by the ACIP for immunization against human pap- illoma virus (HPV)16 and by the USPSTF for age-based screening for hepatitis C virus.17 Our point is not to question the evidentiary judg- ments for these specific recommendations but to note that the lack of a consistent evidence grading approach raises important con- cerns regarding the consistency of the evidentiary rigor applied both within and across all 4 existing committees. Using a single uniform approach to rating evidence should reinforce across all commit- tees that services supported by strong evidence of a substantial net health benefit should be prioritized above services with either in- direct or otherwise more limited evidence and/or a lower esti- mated net health benefit.
Including Additional Types of Preventive Services It is understandable that the USPSTF decided to focus its energies by limiting the types of preventive services it would consider. One reason to do so was to avoid overlap with the topics covered in clinical guidelines developed by professional specialty societies. In addition, unlike population-based screening and immunization programs, some diagnostic tests and treatments prevent sub- stantial clinical harms only for certain patients and may be over- prescribed. Nonetheless, we believe that careful consideration should now be given to including some of these secondary prevention services, such as treatments for diabetes and hyper- tension among high-risk populations, in the scope of the expert committees.
Including secondary prevention within the scope of consider- ation has become more feasible now that advances in billing and cod- ing mechanisms allow insurers to link patient diagnoses and other clinical characteristics with prescriptions to identify high-risk popu- lations and assign differential cost-sharing amounts as part of value- based insurance designs (VBID).18 In addition, the evidence base for secondary prevention can be very strong, arising from high-quality RCTs, and many of these effective services, such as those listed in the Box,19-25 have also been estimated to produce cost savings, al-
though the evidence on long-term cost-savings is almost always less certain than that on clinical benefits.
To manage the potential overlap and conflict with recommenda- tions on these topics from specialty societies, we propose that the USPSTF and other committees use the clinical guidelines from spe- cialty societies as a starting point. Clinical services recommended by specialty societies could be evaluated by the preventive services ex- pert committees, using the uniform and rigorous evidence rating ap- proach discussed above. Requiring that secondary preventive ser- vices pass through the same evidentiary gauntlet as other services would ensure consistency across the evaluation of primary and sec- ondary prevention services and help manage external pressures to have many treatments added to the free coverage list.
Integrating Consideration of Cost-effectiveness and Budget Impact Given limited resources available for health care, not all preventive services with a net positive health effect should be provided for free
Box. Examples of Effective and Cost-Saving Services Not Covered by the ACA
Preventive Services • Multicomponent interventions for diabetic risk factor control and
early detection of complications compared with conventional insulin therapy for persons with type 1 diabetes19a
• Multicomponent interventions for diabetic risk factor control and early detection of complications compared with standard glycemic control for persons with type 2 diabetes19b
• Preemptive virology screening in the pediatric hematopoietic stem cell transplant population20
Treatment • Cochlear implants in profoundly deaf children21
• Angiotensin converting enzyme inhibitors (ACEI) therapy for intensive hypertension control, as in the UK Prospective Diabetes Study, in persons with type 2 diabetes compared with standard hypertension control19
• ACEI or angiotensin receptor blocker (ARB) therapy to prevent end-stage renal disease (ESRD) for type 2 diabetes compared with no ACEI or ARB therapy19
• Early irbesartan therapy at the stage of microalbuminuria to prevent ESRD in people with type 2 diabetes compared with treatment at the stage of macroalbuminuria19
• Comprehensive foot care to prevent ulcers in mixed population with either type 1 or type 2 diabetes compared with usual care19
• Treatment of patients with existing cardiovascular disease or stage 2 hypertension22
Other • Cognitive behavioral family intervention for patients with
Alzheimer disease24
• Providing combination pharmacotherapy without cost sharing after a myocardial infarction compared with standard coverage25
a The components include ACEI treatment, eye screening and treatment in addition to conventional insulin control. Eye screening is preventive while other components are not.
b Components include education, nephropathy screening, ACEI treatment, retinopathy screening in addition to conventional antidiabetic care. Nephropathy and retinopathy screenings and education are preventive while other components are not.
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if doing so would add significant new costs to the health care sys- tem. But how should costs be considered? The most important per- spective is long-term cost-effectiveness. Cost-effectiveness analy- ses can estimate whether making a preventive service free will produce clinical gains while breaking even or reducing overall health care costs in the long-term. If a preventive service is found to offer that long-term win-win scenario, then it would be an excellent can- didate for free coverage.
However, many services, such as colorectal cancer and hyper- tension screening, offer substantial health benefits but are esti- mated to add costs to the health care system, even over the long-term. 1 3 Signif icant uncer tainty about long-term cost- effectiveness is also quite common. At some threshold, if the added cost associated with making a preventive service free is judged to be too high or too uncertain in relation to the amount of health gain, it would be reasonable to maintain a recommendation for the service on clinical grounds but not to require free coverage. As ex- amples, tetanus-diphtheria boosters, diet counseling, and diabe- tes screening—all services currently mandated for free coverage— are estimated to offer very modest health gains at high added cost.13
In addition to long-term cost-effectiveness, policy makers con- templating the addition of a preventive service to the free cover- age list should also consider the potential short-term budget im- pact on Medicare and private insurer plans. The short-term financial effects may not be insignificant: based on the cumulative effect of the set of currently recommended preventive services, United Health Care projected that free coverage would increase short-term insur- ance premiums by as much as 3.6%.26 Long-term cost-effective- ness should still dominate the considerations related to mandating free coverage for a preventive service, but if estimates suggest that short-term effects on health care budgets and insurance costs may be extreme, policy makers should have the option to delay or defer making the service free. What is the best mechanism for integrat- ing analyses of cost-effectiveness and short-term budget impact into the work of the expert committees? Each of the existing 4 commit- tees could develop an internal apparatus or commission analyses ex- ternally. This is the approach that the ACIP currently uses, although in an ad hoc fashion. Instead, we believe that there are several rea- sons to centralize this function in a new, separate expert commit- tee, that we suggest could be named the Free Coverage Advisory Committee (Figure).
First, it would likely prove challenging to find adequate exper- tise to create parallel programs in each committee for the develop- ment and consideration of economic evidence. The Free Coverage Advisory Committee could centralize the needed expertise and be staffed from its inception by a mixture of experts in clinical epide- miology, health economics, and associated domains. Second, his-
tory has shown that the US public and political environment makes it difficult for public expert bodies to consider both clinical and cost- effectiveness information together without coming under fire for perceived rationing.27 Having a separate body for economic con- siderations would allow the 4 existing committees to continue their well-respected tradition of identifying preventive services that on clinical grounds should be recommended for regular use.
Lastly, creating a fifth committee offers the added benefit of im- proving the transparency and consistency of all future additions to the list of free preventive services. All services recommended on the basis of health benefits (graded through a common methodology) would enter a process of economic analysis to estimate the poten- tial short-term and long-term economic consequences of provid- ing the service for free. With that information in hand, the Free Cov- erage Advisory Committee would hold public hearings as part of a final step in prioritizing services for free coverage. Some of the pre- ventive services recommended by the expert committees would gain final approval for free coverage, particularly those that are deemed likely to be cost neutral or cost saving to the overall health system, while other services would fall short of the standard for final approval.
Policy Implications We believe that there are important advantages to be gained from our proposal to adopt more consistent evidence review method- ologies, increase the scope of preventive services considered by ex- isting expert committees, and create a separate new advisory com- mittee to integrate economic considerations as part of a common final pathway for selection of services that will be provided free.
Increasing the scope of preventive services to be considered for free coverage will raise important policy concerns. Doing so may open the floodgates to intrusive interest group advocacy seeking the ad- dition of ever more tests and treatments to the list. This is certainly a risk, but we believe it is worth taking under certain circum- stances. We believe that any expansion of the scope of preventive services to be considered must occur only after the evidentiary re- view and rating systems for all 4 expert committees are strength- ened as we have described to be more resistant to lobbying ef- forts. We also believe that any mandate for free coverage should not prevent insurers from exercising the full range of policy tools at their disposal, including the development of narrow or tiered networks and reference pricing, to counteract the pricing power of providers of these services.
Some policy makers have also called attention to the narrow fo- cus on primary preventive services that are eligible for coverage be- fore the deductible is met in High Deductible Health Plans.4 We agree with their calls for the Centers for Medicare and Medicaid Services
Figure. Proposed Mechanism for Implementing the Free Coverage Legislation
USPSTF
ACIP
IOM Women’s Committee
Bright Futures
Refer clinical recommendations (based on net health benefit and strength of evidence)
Assign cost- effectiveness ratings
Rank all eligible services
Final recommendation
Free Coverage Advisory Committee The figure illustrates the policy mechanism proposed in the manuscript. ACIP indicates Advisory Committee on Immunization Practices; IOM, Institute of Medicine; USPSTF, United States Preventive Services Task Force.
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to grant more flexibility to permit innovative plan designs based on actuarial value thresholds that would allow insurers to adjust co- payments and coinsurance to reflect inherent value across ser- vices, regardless of the type of service, clinical condition, or popu- lation affected.
Any proposal to establish a new committee as part of the pre- ventive services policy infrastructure is sure to face political chal- lenges, and any governmental body charged with considering cost- effectiveness will be attacked by some interest groups as a harbinger of rationing. But it must be remembered that this entire process is not geared to determine whether a service is covered or not by in- surers; instead, it is focused on determining which services merit free coverage. As a responsible exercise of public stewardship, it seems
reasonable for the government to consider costs when deciding when to mandate that public resources be provided to individuals for free.
Conclusions We believe that the spirit behind the preventive services provi- sions of the ACA has been imperfectly implemented through the ex- isting structure and methodologies of the 4 expert committees that have the power to require that services be provided for free. Fur- ther reform is needed to ensure that the goals of the legislation can be fully realized.
ARTICLE INFORMATION
Published Online: June 27, 2016. doi:10.1001/jamainternmed.2016.3052.
Conflict of Interest Disclosures: None reported.
Funding/Support: This research is supported by the Intramural Research Program at the National Institutes of Health (NIH).
Role of the Funder/Sponsor: The NIH had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: The views expressed are the authors’ and do not represent the views or policies of the NIH, DHHS, or the US government.
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