6

Process for Regularly Updating the Recommendations

In this report, the Committee on Preventive Services for Women identifies a supplemental set of preventive health care services for women that should be considered by the U.S. Department of Health and Human Services (HHS). This task meets the first portion of the committee’s charge, which was to identify services and screenings that could fill the identified gaps in women’s preventive care not otherwise included in existing preventive services covered under the Patient Protection and Affordable Care Act of 2010 (ACA).

The second part of the committee’s charge was to provide guidance on a process for updating the preventive services and screenings to be considered. Developing and maintaining a comprehensive list of covered preventive services for women is not currently under the specific purview of any advisory group, task force, committee, or agency within HHS. Thus, the committee believes that it will be necessary to develop structures, accountability, and processes to ensure that preventive services meeting evidence standards are considered for coverage in the context of the general approach taken to identify and update preventive services for women. Here, the committee recommends a process supported by guiding principles that separates assessment and coverage decisions. The co-mingling of evidence reviews and coverage decision making in one body could result in skewing scientific results and a decrease in transparency in the rationale for the coverage decision. Components for a comprehensive structure are discussed below.



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6 Process for Regularly Updating the Recommendations In this report, the Committee on Preventive Services for Women identi- fies a supplemental set of preventive health care services for women that should be considered by the U.S. Department of Health and Human Ser- vices (HHS). This task meets the first portion of the committee’s charge, which was to identify services and screenings that could fill the identified gaps in women’s preventive care not otherwise included in existing preven- tive services covered under the Patient Protection and Affordable Care Act of 2010 (ACA). The second part of the committee’s charge was to provide guidance on a process for updating the preventive services and screenings to be consid- ered. Developing and maintaining a comprehensive list of covered preven- tive services for women is not currently under the specific purview of any advisory group, task force, committee, or agency within HHS. Thus, the committee believes that it will be necessary to develop structures, account- ability, and processes to ensure that preventive services meeting evidence standards are considered for coverage in the context of the general ap- proach taken to identify and update preventive services for women. Here, the committee recommends a process supported by guiding principles that separates assessment and coverage decisions. The co-mingling of evidence reviews and coverage decision making in one body could result in skew- ing scientific results and a decrease in transparency in the rationale for the coverage decision. Components for a comprehensive structure are discussed below. 157

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158 CLINICAL PREVENTIVE SERVICES FOR WOMEN GUIDING PRINCIPLES AND RECOMMENDATIONS Recommendation 6.1: The committee recommends that the process for updating the preventive services for women covered under the ACA be: • I ndependent; • F ree of conflict of interest; • E vidence-based; • G ender specific; • L ife-course oriented; • T ransparent; • I nformed by systematic surveillance and monitoring; • C ognizant of the need to integrate clinical preventive services with effective interventions in public health, the community, the work- place, and the environment; and • A ppropriately resourced to meet its mandate. A PREVENTIVE SERVICES COVERAGE COMMISSION The committee notes that coverage decisions must take into consid- eration a more extensive list of factors—including medicolegal consider- ations, ethical considerations, patient and provider preferences, cost, and cost-effectiveness—and that these decisions must be made in the context of the coverage decisions made in other clinical domains. Existing evidence review bodies (such as the United States Preventive Services Task Force [USPSTF]) focus on clinical evidence; and other bodies that develop clinical guidelines (professional organizations) do not have the methods, the exper- tise, or the independence to make coverage recommendations. The com- mittee believes that the review of the evidence and decision making about coverage are two separate activities and that there is value in preserving the separation. Thus, the committee does not recommend adding coverage decision making to the scope of work of existing evidence review bodies or bodies that develop clinical guidelines. Recommendation 6.2: The committee recommends that the Secretary of HHS establish a commission to recommend coverage of new preven- tive services for women to be covered under the ACA. In carrying out its work, the commission should: • B e independent from bodies conducting evidence reviews, free of conflict of interest, and transparent; • S et goals for prevention (it may use available HHS reports and products or commission its own at its discretion);

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159 PROCESS FOR REGULARLY UPDATING THE RECOMMENDATIONS • D esign and implement a methodology for making coverage de- cisions that considers information from bodies that review the available clinical evidence (and other bodies that establish clinical guidelines) and coverage factors (e.g., cost, cost-effectiveness, and legal and ethical factors); • C onduct horizon scanning or examine priority goals and/or per- sistent trends relating to women’s health and well-being to identify new information on significant health conditions; preventive inter- ventions; and new evidence on efficacy, effectiveness, periodicity, and safety; • F ocus on the general population but also search for conditions that may differentially affect women and high-risk subpopulations of women; • A ssign topics and set priorities for evidence-based reviews for the bodies reviewing clinical effectiveness; • S et timetables and processes for updating clinical practice guide- lines and coverage recommendations; and • S ubmit its coverage recommendations to the Secretary of HHS. As noted in the guiding principles, suggested priorities are systematic surveillance and monitoring, as well as horizon scanning for new informa- tion on significant health conditions, preventive interventions, and new evidence on efficacy, effectiveness, periodicity, and safety. Similarly, setting agendas, timetables, and resources for developing the evidence reviews and guidelines will need to be recommended to the Secretary of HHS. A commis- sion would not conduct its own systematic reviews of clinical effectiveness, relying instead on reviews completed by evidence review bodies under its direction. Recommendations will also need to be made by the commission regarding updates of evidence reviews and coverage decisions. Five years is a common benchmark for reevaluation of clinical practice guidelines and is the benchmark used by the National Guidelines Clearinghouse, but the committee notes that the process of scanning for new developments often uncovers issues that may require updates at other times. ROLE OF EVIDENCE-BASED REVIEW BODIES The committee believes that bodies that review the evidence, such as USPSTF, Bright Futures, and the Advisory Committee on Immunization Practices (ACIP), should continue to focus on evidence of efficacy and effec- tiveness. These bodies have an important role to perform and to contribute to this process in responding to direction from the Secretary of HHS and addressing topics requested. If necessary, systematic reviews will be com- missioned, meeting established standards (e.g., the standards outlined in

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160 CLINICAL PREVENTIVE SERVICES FOR WOMEN Finding What Works in Health Care: Standards for Systematic Reviews [IOM, 2011b]). The evidence-review bodies should review the evidence with a primary focus on efficacy and effectiveness and develop clinical prac- tice guidelines meeting established standards (e.g., the standards outlined in Clinical Practice Guidelines We Can Trust [IOM, 2011a]). If the Secretary of HHS determines that existing evidence-review bodies cannot support these activities, new bodies that review the evidence should be created. Such bodies would best be populated with experts from within and outside government who are free of conflicts of interest and who rep- resent a wide range of health and related disciplines. These experts should use standard, transparent, and accountable approaches to identify, assess, and synthesize the relevant evidence. Recommendation 6.3. The committee recommends that the Secretary of HHS identify existing bodies or appoint new ones as needed to review the evidence and develop clinical practice guidelines to be re- viewed by a preventive services coverage commission. DISCUSSION Bringing coverage for clinical preventive health care services into rational alignment with coverage for other health care services provided under the ACA will be a major task. The committee notes that many of the individual components are already managed within HHS but currently lack effective coordination for the purposes outlined in the ACA and that some functions are entirely new. The structure might be effectively built over time by using some current bodies and adding new ones as resources permit. The committee does not believe that it has enough information to specifically recommend which unit in HHS should implement the recommendations. Figure 6-1 illus- trates the committee’s suggested structure for updating preventive services under the ACA. Additionally, the 2011 Institute of Medicine (IOM) study Finding What Works in Health Care: Standards for Systematic Reviews examines differ- ent grading systems in use. One review mentioned in the study found that there were more than 50 evidence-grading systems and 230 quality assess- ment instruments in current use. The variation, complexity, and lack of transparency in existing systems were identified (IOM, 2011b). In light of this, the Preventive Services for Women Committee chose not to identify a recommendation for HHS to consider for use in grading evidence. However, many of these models may warrant consideration. The committee is aware that the IOM Determination of Essential Health Benefits Committee is developing recommendations regarding the criteria and methods for determining and updating the essential health

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161 PROCESS FOR REGULARLY UPDATING THE RECOMMENDATIONS Secretary HHS ns atio Dir nduct to c ect nd o me s a review com gen cie s Re s A Preventive Services Coverage Commission • Sets prevention goals • Scans horizon Evidence-Developing • Asks for the development of evidence reviews • Sets priorities and timetables for reviews Bodies • Receives evidence reviews USPSTF Transfer of information • Develops weights for other factors: Bright Futures Medicolegal ACIP Cost Others to be developed Cost-effectiveness (if needed) • Makes recommendations to Secretary FIGURE 6-1 Suggested structure for updating preventive services under the ACA. Figure S-1 and 6-1.eps benefits package. That committee is reviewing how insurers determine covered benefits and medical necessity and will provide guidance on the policy principles and criteria for the Secretary to take into account when examining qualified health plans for appropriate balance among categories of care and limits on patient cost sharing. The committee’s recommenda- tions are forthcoming. Although the ACA’s preventive coverage rules are clearly directed at clinical services, the committee recognizes that in view of the critical impor- tance of community-based preventive services and the public health system in achieving clinical aims, the committee thus encourages the Secretary to consider widening the scope of authority to include public health efforts to more comprehensively address prevention (e.g., as discussed in Healthy People 2020: Topics & Objectives [HHS, 2011]). It will be critical for the proposed preventive services coverage commission to coordinate with the new and existing bodies that are involved with other elements of the ACA. Finally, the committee notes that it would make the most sense to con- sider preventive services for women, men, children, and adolescents in the same way. Thus, although the committee’s recommendations presented here address women’s preventive services, the process could be equally useful for

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162 CLINICAL PREVENTIVE SERVICES FOR WOMEN determining preventive services for men, children, and male adolescents that should be covered by the ACA. REFERENCES HHS (U.S. Department of Health and Human Services). 2011. Healthy People 2020: Topics & objectives. http://www.healthypeople.gov/2020/topicsobjectives2020/default.aspx (ac- cessed April 19, 2011). IOM. 2011a. Clinical practice guidelines we can trust. Washington, DC: The National Acad- emies Press. IOM. 2011b. Finding what works in health care: Standards for systematic reviews. Washing- ton, DC: The National Academies Press.