Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 1
Summary
BACKGROUND
The Patient Protection and Affordable Care Act of 2010 (ACA) holds
much promise—beyond the expansion of health care coverage—for mil-
lions of Americans. The preventive health care services and screenings
specified in the legislation will be fully covered without requiring a patient
copayment. These include the services with Grade A and B recommenda-
tions made by the United States Preventive Services Task Force (USPSTF),
the Bright Futures recommendations for adolescents from the American
Academy of Pediatrics (AAP) in cooperation with the U.S. Department of
Health and Human Services (HHS), and vaccinations specified by the Cen-
ters for Disease Control and Prevention’s (CDC’s) Advisory Committee on
Immunization Practices (ACIP). These three sets of guidelines provide a list
of preventive services, such as blood pressure measurement, diabetes and
cholesterol tests, and mammography and colonoscopy screenings. As part
of the ACA, the list of preventive services specific to women’s health was
requested to be reviewed.
CHARGE TO THE COMMITTEE
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE) of HHS provided funds for the Institute of Medicine (IOM) to
conduct a review of effective preventive services to ensure women’s health
and well-being. The charge to the committee for the project is presented
in Box S-1.
1
OCR for page 2
2 CLINICAL PREVENTIVE SERVICES FOR WOMEN
BOX S-1
Statement of Task to the Committee on
Preventive Services for Women
The Institute of Medicine will convene an expert committee to review what pre-
ventive services are necessary for women’s health and well-being and should
be considered in the development of comprehensive guidelines for preventive
services for women. The committee will also provide guidance on a process for
regularly updating the preventive screenings and services to be considered. In
conducting its work, the committee will: conduct a series of meetings to examine
existing prevention guidelines, obtain input from stakeholders, identify gaps that
may exist in recommended preventive services for USPSTF Grade A and B pre-
ventive services guidelines for women and in Bright Futures and USPSTF Grade
A and B guidelines for adolescents, and highlight specific services and screenings
that could supplement currently recommended preventive services for women.
Specifically, the committee will consider the following questions:
• hat is the scope of preventive services for women not included in those
W
graded A and B by the USPSTF?
• hat additional screenings and preventive services have been shown to be
W
effective for women? Consideration may be given to those services shown to
be effective but not well utilized among women disproportionately affected by
preventable chronic illnesses.
• hat services and screenings are needed to fill gaps in recommended preven-
W
tive services for women?
• hat models could HHS and its agencies use to coordinate regular updates
W
of the comprehensive guidelines for preventive services and screenings for
women and adolescent girls?
The Office of the Assistant Secretary for Planning and Evaluation (ASPE) on
behalf of the U.S. Department of Health and Human Services (HHS) has been
charged to examine recommendations for women’s preventive services. ASPE will
use the information and recommendations from the committee’s report to guide
policy and program development related to provisions in the Affordable Care Act
addressing preventive services for women.
In response, the IOM convened a committee of 16 members—including
specialists in disease prevention, women’s health issues, adolescent health
issues, and evidence-based guidelines—to develop a set of recommendations
for consideration by the ASPE of HHS.
The committee sought clarification from ASPE on a number of issues
regarding its charge. In summary:
Preventive services were specified to be applicable to females aged
•
10 to 65 years;
OCR for page 3
3
SUMMARY
The mammography screenings specified in the ACA legislation
•
used USPSTF guidelines from 2002, which specify that such screen-
ings be performed every one to two years for women aged 40 years
and older;
The cost-effectiveness of screenings or services could not be a
•
factor for the committee to consider in its analyses leading to its
recommendations;
The committee was not intended to duplicate the processes used
•
by the USPSTF and thus should look to other bodies of evidence
beyond systematic evidence-based reviews; and
Preventive services were specified for clinical settings, and thus
•
community-based prevention activities were considered beyond the
scope of committee consideration.
COMMITTEE’S APPROACH TO ITS CHARGE
The committee met five times within six months. The committee held
three open information-gathering sessions at which the members heard
from a diverse group of stakeholders, researchers, members of advocacy
organizations, and the public. Box S-2 provides the committee definition
of preventive health services.
BOX S-2
Definition of Preventive Health Services
For the purposes of this study, the Committee on Preventive Services for Women
defines preventive health services to be measures—including medications,
procedures, devices, tests, education and counseling—shown to improve well-
being, and/or decrease the likelihood or delay the onset of a targeted disease
or condition.
COMMITTEE’S METHODOLOGY
The committee’s methodology to identify preventive services necessary
for women’s health and well-being and to identify specific services that
could supplement the current list of recommended preventive services for
women under the ACA follows.
The committee’s first step was to review and reach an understanding of
existing guidelines. The second step was to assemble and assess additional
evidence, including reviews of the literature, federal health priority goals
OCR for page 4
4 CLINICAL PREVENTIVE SERVICES FOR WOMEN
and objectives, federal reimbursement policies, and the clinical guidelines of
health care professional organizations. The committee also considered the
public comments that it received. Finally, the committee formulated a list of
recommendations to be considered by the Secretary of HHS in developing
a comprehensive package of preventive services for women to be included
under the ACA.
USPSTF Recommendations
The USPSTF process for developing recommendations is a disease-
focused one. The intent of its recommendations has been to provide
guidance to primary care providers. The IOM committee’s approach to
identifying gaps in existing services accounts for contextual issues beyond
traditional research evidence used by the USPSTF. The committee looked
at women’s preventive service needs more broadly to account for women’s
health and well-being. The committee found that its interpretation of the
Grade A and B recommendations was important in those cases in which
ambiguity was found regarding periodicity of screenings. Furthermore, the
committee compared USPSTF guidelines with those of numerous health
care professional organizations to identify potential gaps.
The committee recognized that USPSTF Grade C recommendations
and I statements warranted further analysis because the USPSTF did not
develop and has not used these grades as support to offer or deny coverage
of a preventive service. The USPSTF Grade C recommendations are made
when the balance of potential benefits and harms does not strongly favor
the clinician recommending the preventive service to all patients, although
it may be appropriate in some cases.
The USPSTF I statements identify services for which the evidence is
insufficient to suggest the effectiveness of a service because evidence is
lacking, of lower quality, or conflicting. The committee notes that from a
coverage perspective, the evidence supporting many clinical interventions
in common use, whether in prevention or in general medical practice, is
insufficient or unclear, and coverage decisions may be or have been made
on the basis of other factors.
For example, although physician knowledge of the evidence of the ben-
efits associated with a counseling service will inform a physician’s decision
for each patient, in many instances, it is difficult for researchers to show or
conclude that outcomes are positive. Many preventive interventions that are
intended to be conducted early in the life span (e.g., skin cancer prevention)
require decades to demonstrate effectiveness.
Thus, each of the USPSTF Grade C and I statement recommenda-
tions and the evidence supporting them were collected and reviewed. The
committee’s evaluation included reviewing relevant supporting USPSTF
OCR for page 5
5
SUMMARY
publications, other peer-reviewed research and clinical articles, and clini-
cian fact sheets. Additional literature searches were conducted to identify
randomized control trials published after the USPSTF recommendation was
released. Furthermore, the committee compared the Grade C and I state-
ment guidelines with guidelines from other professional organizations. The
committee did not reexamine the services with Grade D recommendations,
because the USPSTF recommends against providing these services.
Bright Futures Recommendations
The committee reviewed all Bright Futures guidelines and compared
them with the USPSTF guidelines for adolescents. The committee noted that
the methodology that Bright Futures uses is quite different from that which
the USPSTF uses. Bright Futures makes decisions through a consensus-
driven process; thus, expert opinion is at the core of its development of
recommendations.
The committee interpreted the sample questions and advice suggested
in the anticipatory guidance section of the Bright Futures report (AAP,
2008) to describe topics to be covered as preventive services under the ACA
and addressed in an annual health care visit of sufficient length to cover
age- and sex-appropriate topics in the health domain. The committee as-
sumes that physicians will identify priorities from this section of the Bright
Futures report on the basis of the unique circumstances of each patient.
ACIP Recommendations
The committee reviewed ACIP General Recommendations on Immuni-
zations, which include all of the Food and Drug Administration-approved
immunizations recommended for the general population of adolescent and
adult women. Although literature searches were conducted to identify areas
where supplemental immunization recommendations might be warranted,
the committee identified little evidence to clearly indicate deficiencies in
existing ACIP recommendations.
Further Committee Considerations
The committee reviewed oral and written comments submitted through-
out the course of the study. The committee also invited researchers and
leaders of organizations to deliver presentations in areas in which the com-
mittee believed that it could benefit from their expertise. In addition, the
committee reviewed HHS documents relating to prevention priorities and
reimbursement policies. It also reviewed the existing coverage practices of
national, state, and private health plans. In some cases, current practice
OCR for page 6
6 CLINICAL PREVENTIVE SERVICES FOR WOMEN
in clinical care was also identified. Finally, the committee used the 2011
IOM report Leading Health Indicators for Healthy People 2020 as a tool
to perform horizon scanning or examine priority goals and/or persistent
trends relating to women’s health and well-being to identify potential gaps
(IOM, 2011).
COMMITTEE ANALYSIS
The product of these reviews was an array of potential areas where
supplemental preventive measures might be warranted. Some of these areas
were identified on the basis of traditional indicators, such as morbidity and
mortality, whereas others were identified as being more generally supportive
of a woman’s well-being. The committee focused on conditions unique to
women or that affected women in some specific or disproportionate way.
The committee moved forward using criteria adapted from the USPSTF that
considered frequency, severity, morbidity, mortality, and quality of life to
bring consistency to the analyses.
For each potential supplemental preventive measure considered, the
committee conducted an extensive comparison of the guidelines of profes-
sional organizations to understand the development of the guidelines and
the evidence that the organizations used to reach their conclusions. The
committee also performed targeted literature searches. However, it should
be noted that the committee did not have adequate time or resources to
conduct its own meta-analyses or comprehensive systematic review of each
preventive service.
Supplemental Preventive Measures
The committee attempted to identify preventive measures that were
aimed at filling the gaps that it had identified. In most cases, the commit-
tee found that measures had already been proposed in the guidelines of
other professional organizations. The committee also eliminated preven-
tive measures that, even at this early stage in the analysis, were clearly not
developed, tested, or known well enough to have a measurable impact. The
resulting product of this step was a series of preventive service areas with
gaps in coverage and the accompanying preventive measure or measures
that could be considered by HHS. The core of the committee’s task was to
assemble the evidence that would allow it to recommend consideration of
a preventive service.
Coverage Decisions
As noted above, the USPSTF, Bright Futures, and ACIP guidelines focus
on guidance for primary care providers and patients. Coverage decisions
OCR for page 7
7
SUMMARY
often consider a host of other issues, such as established practice; patient
and clinician preferences; availability; ethical, legal, and social issues; and
availability of alternatives. Further complicating matters, special population
groups such as minority populations, disabled women, recent immigrants,
lesbians, prisoners, and those employed in high-risk environments, may
have different health needs or benefit from different preventive services.
High-risk groups, population subsets, and special populations are unevenly
identified and addressed to varying degrees in current guidelines. Finally,
cost-effectiveness was explicitly excluded as a factor that the committee
could use in developing recommendations, and so the committee process
could not evaluate preventive services on this basis.
Committee Approach
The committee developed a hybrid approach that collected relevant
evidence for each measure. Four categories of evidence—posed in the form
of questions—to be examined for each potential preventive measure were
developed. The committee did not formally rank or assign weights to the
categories, nor did it stipulate that evidence in any one category would
automatically result in a recommendation for a measure or service to be
considered. Instead, the queries and categories were used to consider the
range of evidence and to ensure consistency in the committee’s analysis and
deliberations. Many of the recommendations are supported by more than
one category of evidence.
Category I. Are high-quality systematic evidence reviews available in-
dicating that the service is effective in women?
Category II. Are quality peer-reviewed studies available demonstrating
effectiveness of the service in women?
Category III. Has the measure been identified as a federal priority to
address in women’s preventive services?
Category IV. Are there existing federal, state, or international practices,
professional guidelines, or federal reimbursement policies that support the
use of the measure?
RECOMMENDATIONS
Subcommittees were formed, and each subcommittee reviewed the
available evidence applicable to its identified potential preventive measure(s)
and assigned the evidence to one or more of the above categories. Each
subcommittee then brought its analysis of the range of evidence before the
full committee for deliberation. The committee then combined the burden
of the condition and its potential impact on health and well-being with
the array of available evidence and support to reach a consensus regarding
OCR for page 8
8 CLINICAL PREVENTIVE SERVICES FOR WOMEN
whether to recommend a specific preventive measure for that condition. As
is true in most analytical processes in decision making, evidence and expert
judgment are inextricably linked; thus, the expert judgments of the commit-
tee members also played a role in decision making.
In general, the preventive measures recommended by the committee for
consideration of coverage (see Table S-1) met the following criteria:
The condition to be prevented affects a broad population;
•
The condition to be prevented has a large potential impact on
•
health and well-being; and
The quality and strength of the evidence is supportive.
•
Ultimately, the decision to develop a recommendation for a preventive
service to be considered was made after a thoughtful review and debate
of each of the subcommittee reports and when the committee found the
evidence to be compelling.
TABLE S-1 Summary of the Committee’s Recommendations on
Preventive Services for Women
Preventive USPSTF
Service Grade Supporting Evidence Recommendations
Recommendation 5.1
Screening for I The evidence provided to
gestational support a recommendation The committee
diabetes for screening for gestational recommends for
diabetes is based on current consideration as a
federal practice policy from preventive service for
the U.S. Indian Health women: screening for
Service, the U.S. Department gestational diabetes in
of Veterans Affairs, as well as pregnant women between
current practice and clinical 24 and 28 weeks of
professional guidelines such gestation and at the first
as those set forth by the prenatal visit for pregnant
American Academy of Family women identified to be at
Physicians and the American high risk for diabetes.
Congress of Obstetricians and
Gynecologists.
OCR for page 9
9
SUMMARY
TABLE S-1 Continued
Preventive USPSTF
Service Grade Supporting Evidence Recommendations
Recommendation 5.2
Human I The evidence provided to
papillomavirus support a recommendation The committee
testing (HPV) to support testing for recommends for
HPV is based on federal consideration as a
practice policy from the U.S. preventive service for
Department of Defense. Peer- women: the addition
reviewed studies demonstrate of high-risk human
that improved testing papillomavirus DNA
technologies, particularly testing in addition to
combined screening using cytology testing in women
both conventional cytology with normal cytology
and high-risk HPV DNA results. Screening should
testing, may significantly begin at 30 years of age
improve the rate of detection and should occur no more
of cervical cancer precursors frequently than every 3
and facilitate the safe years.
lengthening of the interval for
screening.
Recommendation 5.3
Counseling I The evidence provided to
for sexually support a recommendation The committee
transmitted related to STI counseling recommends for
infections is based on federal goals consideration as a
(STIs) from the Centers for Disease preventive service for
Control and Prevention and women: annual counseling
Healthy People 2020, as on sexually transmitted
well as recommendations infections for sexually
from the American Medical active women.
Association and the American
College of Obstetricians and
Gynecologists.
continued
OCR for page 10
10 CLINICAL PREVENTIVE SERVICES FOR WOMEN
TABLE S-1 Continued
Preventive USPSTF
Service Grade Supporting Evidence Recommendations
Recommendation 5.4
Counseling C The evidence provided to
and screening support a recommendation The committee
for human for expanding screening recommends for
immuno- for HIV is based on federal consideration as a
deficiency virus goals from the Centers preventive service for
(HIV) for Disease Control and women: counseling and
Prevention, as well as clinical screening for human
professional guidelines, such immunodeficiency virus
as those from the American infection on an annual
College of Physicians, the basis for sexually active
Infectious Diseases Society women.
of America, the American
Medical Association, and
the American College
of Obstetricians and
Gynecologists.
Recommendation 5.5
Contraceptive Not The evidence provided to
methods and Addressed support a recommendation The committee
counseling related to unintended recommends for
pregnancy is based on consideration as a
systematic evidence preventive service for
reviews and other peer- women: the full range
reviewed studies, which of Food and Drug
indicate that contraception Administration-approved
and contraceptive contraceptive methods,
counseling are effective sterilization procedures,
at reducing unintended and patient education and
pregnancies. Current counseling for women
federal reimbursement with reproductive capacity.
policies provide coverage
for contraception and
contraceptive counseling,
and most private insurers
also cover contraception
in their health plans.
Numerous health professional
associations recommend
family planning services
as part of preventive care
for women. Furthermore,
a reduction in unintended
pregnancies has been
identified as a specific goal
in Healthy People 2010 and
Healthy People 2020.
OCR for page 11
11
SUMMARY
TABLE S-1 Continued
Preventive USPSTF
Service Grade Supporting Evidence Recommendations
Recommendation 5.6
Breastfeeding B The evidence provided to
support, support a recommendation The committee
supplies, and regarding the inclusion recommends for
counseling of breastfeeding services consideration as a
is based on systematic preventive service for
evidence reviews, federal and women: comprehensive
international goals (such as lactation support and
the U.S. Surgeon General, counseling and costs of
Health Resources and Services renting breastfeeding
Administration [HRSA], equipment. A trained
Healthy People 2020, provider should provide
World Health Organization counseling services to all
and UNICEF) and clinical pregnant women and to
professional guidelines those in the postpartum
such as those set forth by period to ensure the
the American Academy successful initiation and
of Family Physicians, the duration of breastfeeding.
American Academy of (The ACA ensures that
Pediatrics, and the American breastfeeding counseling
College of Obstetricians and is covered; however, the
Gynecologists. committee recognizes
that interpretation of this
varies.)
Recommendation 5.7
Screening and I The evidence provided to
counseling for support a recommendation The committee
interpersonal related to increasing recommends for
and domestic detection of and counseling consideration as a
violence for domestic violence and preventive service for
abuse is based on peer- women: screening
review studies and federal and counseling for
and international policies, interpersonal and
in addition to clinical domestic violence.
professional guidelines Screening and counseling
from organizations, such involve elicitation of
as the American Medical information from women
Association and the American and adolescents about
College of Obstetricians and current and past violence
Gynecologists. and abuse in a culturally
sensitive and supportive
manner to address current
health concerns about
safety and other current or
future health problems.
continued
OCR for page 12
12 CLINICAL PREVENTIVE SERVICES FOR WOMEN
TABLE S-1 Continued
Preventive USPSTF
Service Grade Supporting Evidence Recommendations
Recommendation 5.8
Well-woman Not The evidence provided to
visits Addressed support a recommendation The committee
for including well-woman recommends for
visits is based on federal consideration as a
and state policies (such preventive service for
as included in Medicaid, women: at least one
Medicare and the state of well-woman preventive
Massachusetts), clinical care visit annually for
professional guidelines (such adult women to obtain
as those of the American the recommended
Medical Association and the preventive services,
American Academy of Family including preconception
Practitioners), and private and prenatal care. The
health plan policies (such as committee also recognizes
those of Kaiser Permanente). that several visits may
be needed to obtain all
necessary recommended
preventive services,
depending on a woman’s
health status, health needs,
and other risk factors.
UPDATING GUIDELINES
Developing and maintaining a comprehensive list of covered preventive
services for women is not currently under the specific purview of any HHS
entity. Thus, the committee believes that it will be necessary to develop
structures, accountability, and processes to ensure that preventive services
meeting evidence-based standards are considered in the context of the gen-
eral approach taken to identify and update preventive services for women.
The committee recommends a process supported by guiding principles
that separates evidence assessment and coverage decisions.
Recommendation 6.1: The committee recommends that the process for
updating the preventive services for women be:
Independent;
•
Free of conflict of interest;
•
Evidence-based;
•
Gender-specific;
•
Life-course oriented;
•
Transparent;
•
Informed by systematic surveillance and monitoring;
•
OCR for page 13
13
SUMMARY
C
ognizant of the need to integrate clinical preventive services with
•
effective interventions in public health, the community, work place,
and environment; and
Appropriately resourced to meet its mandate.
•
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 of 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);
D
esign and implement a coverage decision making methodology
•
to consider information from evidence review bodies (and other
clinical guideline bodies) and coverage factors (e.g., cost, cost-
effectiveness, legal, ethical);
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, new evidence regarding 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 evidence review topics and set review priorities for the bod-
•
ies 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.
•
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.
Bringing clinical preventive services into rational alignment with the
coverage for other health care services under the ACA will be a major task.
The committee notes that many of the individual components for review of
the evidence 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
OCR for page 14
14 CLINICAL PREVENTIVE SERVICES FOR WOMEN
Secretary HHS
ns
atio
Dir nduct
to c
ect
end
o
s a review
mm
gen
co
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 S-1 and 6-1.eps
FIGURE S-1 Suggested structure for updating preventive services under the ACA.
some current bodies and adding new ones as resources permit. The com-
mittee does not believe that it has enough information to recommend which
unit in HHS should implement the recommendations. Figure S-1 illustrates
the committee’s suggested structure.
In view of the critical importance of community-based preventive ser-
vices in achieving clinical aims, the committee encourages the Secretary to
consider widening the scope of authority to include public health efforts to
more comprehensively address prevention. It will be critical for a preven-
tive services coverage commission to coordinate with the new and existing
committees that are charged with overseeing other elements of the ACA.
Finally, the committee notes that it would make the most sense to
consider preventive services for women, men, children, and adolescents in
the same way. Thus, although the committee’s recommendations address
women’s preventive services, a parallel approach could be equally useful
for determining covered preventive services for men, children, and male
adolescents.
REFERENCES
AAP (American Academy of Pediatrics). 2008. Bright Futures: Guidelines for health super-
vision of infants, children and adolescents, 3rd ed. (J. F. Hagan, J. S. Shaw, and P. M.
Duncan, eds.). Elk Grove Village, IL: American Academy of Pediatrics.
IOM (Institute of Medicine). 2011. Leading health indicators for Healthy People 2020 Report.
Washington, DC: The National Academies Press.
