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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.