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1
Introduction
The passage of the Patient Protection and Affordable Care Act of
2010 (ACA) provides the United States with an opportunity to offer an
unprecedented level of population health care coverage and dramatically
reduce existing health disparities. The expansion of coverage to millions
of uninsured Americans and the new standards for coverage of preventive
services that are included in the ACA have the potential to increase the use
of preventive health care services and screenings and in turn improve the
health and well-being of individuals across the United States.
SPECIFICS OF THE LEGISLATION
The approaches to prevention and wellness offered within the Act are
broad based and range from new coverage requirements and incentives
to expand workplace wellness activities to new investments. Among these
are prohibition of the imposition of cost-sharing requirements for recom-
mended preventive services (an overview of the Act is provided in Box 1-1,
and the preventive services are listed and described in detail in Chapter 2),
the requirement to link health insurance premiums to participation in
health promotion programs, public health workforce development (the
ACA authorizes new training and placement programs for public health
workers), and community-based prevention activities.
This report focuses on the preventive services for women specified in
Section 2713 of the Public Health Service Act. These services were added by
the ACA and are detailed in the last bulleted item in Box 1-1 (HHS, 2010;
Federal Register, 2010).
15
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16 CLINICAL PREVENTIVE SERVICES FOR WOMEN
BOX 1-1
Overview of Regulations in Section 2713
of the Public Health Service Act
Section 2713 of the Public Health Service Act, Coverage of Preventive Health Ser-
vices, which was added by the Affordable Care Act, and the interim final regula-
tions (26 CFR 54.9815–2713T, 29 CFR 2590.715–2713, 45 CFR 147.130) require
that group health plans and health insurance issuers offering health insurance
coverage for groups or individuals provide benefits and prohibit the imposition of
cost-sharing requirements for
• edical devices or services that are evidence based and that have, in effect,
M
a rating of Grade A or B in the current recommendations of the United States
Preventive Services Task Force (USPSTF) for the individual involved.
• mmunizations for routine use in children, adolescents, and adults that have,
I
in effect, a recommendation from the Advisory Committee on Immunization
Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) for
the individual involved. A recommended ACIP immunization is considered to
be “in effect” after it has been adopted by the CDC director. A recommended
immunization is considered to be for routine use if it appears on the immuniza-
tion schedules of the Centers for Disease Control and Prevention.
• reventive health care and screenings for infants, children, and adolescents
P
informed by scientific evidence and provided for in the comprehensive guide-
lines supported by the Health Resources and Services Administration (HRSA).
• reventive health care and screenings for women informed by scientific evi-
P
dence and provided for in comprehensive guidelines supported by HRSA
(not otherwise addressed by the recommendations of the USPSTF). The U.S.
Department of Health and Human Services is developing these guidelines and
expects to issue them no later than August 1, 2011.
The complete list of recommendations and guidelines that these interim final regu-
lations are required to cover can be found at http://www.HealthCare.gov/center/
regulations/prevention.html.
ROLE OF PREVENTION IN ADDRESSING
HEALTH AND WELL-BEING
Prevention is a well-recognized, effective tool in improving health and
well-being and has been shown to be cost-effective in addressing many
conditions early (Maciosek et al., 2010). Prevention goes beyond the use of
disease prevention measures. For example, interventions to prevent injuries
and binge drinking can increase positive health outcomes and reduce harm.
Historically, the many disparate components of the U.S. health care
system have relied more on responding to acute problems and the urgent
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17
INTRODUCTION
needs of patients than on prevention. Although these functions are appro-
priate for acute and episodic health problems, a notable disparity occurs
when this model of care is applied to the prevention and management of
chronic conditions. The provision of preventive health care services is thus
inherently different from the treatment of acute problems, but the U.S.
health care system has fallen short in the provision of such services. Com-
pared with a system that prevents avoidable conditions early, a system that
responds to the acute health care needs of patients can be inefficient and
costly, and a focus on response instead of prevention is a major barrier to
the achievement of optimal health and well-being by Americans.
Nearly half of all deaths in the United States are caused by modifiable
health behaviors (McGinnis and Foege, 1993). Maciosek and colleagues
found that an increase in the use of clinical preventive services in the United
States could result in the saving of more than 2 million life-years annually
(Maciosek et al., 2010). Because of the numbers of diseases and conditions
that are preventable, inclusion of support for prevention has become more
routine during clinical health care visits (Sussman et al., 2006). When
patients are systematically provided with the tools and information that
they need to reduce their health risks, the likelihood that they will take steps
to, for example, reduce substance use, stop using tobacco products, prac-
tice safe sex, eat healthful foods, and engage in physical activity increases
(WHO, 2002). Therefore, physicians who routinely educate patients on
risk-reducing behaviors may reduce the long-term burden and health care
demands of chronic conditions. Stimulating the commitment and action
of patients, families, and health care teams is also necessary to promote
prevention and improve overall population well-being.
Evidence-based testing, diagnosis, and relief of symptoms are also
hallmarks of contemporary health care, but these services are often under-
utilized. A well-cited reason for this underutilization is, for example, the
high cost of prescription copayments, with the result being that patients
do not fill their prescribed medications, resulting in the loss of lives and
dollars (Shrank et al., 2010). Moreover, a recent study by The Common-
wealth Fund that analyzed the responses of U.S. adults to a questionnaire
indicated that U.S. adults were significantly less likely than adults in all
other countries studied to have confidence in their ability to afford health
care (Schoen et al., 2009).
About 51 million Americans lacked health insurance in 2009
(DeNavas-Walt et al., 2010). This is in addition to the millions of under-
insured Americans who lack access to the appropriate screenings and services
needed to detect and address preventable health conditions and diseases.
Furthermore, health care workers have often failed to seize patient inter-
actions as opportunities to promote health and well-being and to inform
patients about disease prevention strategies (WHO, 2002). This failure to
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18 CLINICAL PREVENTIVE SERVICES FOR WOMEN
inform patients has been found to be due to time constraints in the clinical
setting, a lack of reimbursement for provision of these services, and a lack of
consensus and provider knowledge about what services to prioritize for their
patients. The ACA intends to mitigate these issues.
WHY WOMEN?
The ACA has the potential to transform the way in which the U.S.
health care system addresses women’s health issues in many ways. It ex-
pands access to coverage to millions of uninsured women, ends discrimi-
natory practices such as gender rating in the insurance market, eliminates
exclusions for preexisting conditions, and improves women’s access to
affordable, necessary care. The Women’s Health Amendment (Federal Reg-
ister, 2010), which was introduced by Senator Barbara Mikulski and which
was added to the ACA, expands on these improvements by requiring that
all private health plans cover—with no cost-sharing requirements—a newly
identified set of preventive health care services for women. Defining appro-
priate preventive services for women and ensuring that those services can be
accessed without cost sharing are important strategies to improve women’s
health and well-being (Bernstein et al., 2010; Blustein, 1995).
Many reasons exist for expanding the list of preventive care and screen-
ing services for women beyond those included in the guidelines of the
United States Preventive Services Task Force (USPSTF) Grade A and B
guidelines, the Advisory Committee on Immunization Practices (ACIP), and
Bright Futures (for adolescents) stipulated in the ACA (USPSTF, ACIP,
and Bright Futures and their guidelines are described in detail in Chapter 2).
Even though women have longer life expectancies than men, women suf-
fer from chronic disease and disability at rates disproportionate to those
of men, with consequences for their own health and the health of their
families (Wood et al., 2010). Furthermore, mounting evidence suggests
that women not only have different health care needs than men (because
of reproductive differences) but also manifest different symptoms and re-
sponses to treatment modalities (IOM, 2010). Behavioral factors that are
shown to contribute to morbidity and mortality in women, include smok-
ing, eating habits, physical activity, sexual risk-taking, and alcohol use
(IOM, 2010). Pregnancy and childbirth also carry risks to women’s health
including maternal mortality (CDC, 2008). Figure 1-1 illustrates prevent-
able mortality in women.
Health outcomes occur because of multiple factors including biology,
behavior, and the social, cultural, and environmental contexts in which
women live. Smoking, eating habits, physical activity, and other health-
related behaviors are shaped by cultural and social contexts, including
factors associated with social disadvantage. The marked differences in
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19
INTRODUCTION
Deaths attributable to individual risks
(thousands) in women
–50 50 150 250
High blood pressure
Smoking
Physical inactivity
Overweight-obesity (high BMI)
High blood glucose
Cardiovascular
High dietary sodium (salt)
Cancer
High LDL cholesterol
Low dietary omega-3 fatty acids (seafood) Diabetes
High dietary trans fatty acids
Respiratory
Low intake of fruits and vegetables
Other NCDs
Alcohol use
Low PUFA (in place of SFA) Injury
FIGURE 1-1 Deaths in women attributable to total effects of individual risk factors
(in thousands), by disease.
ABBREVIATIONS: BMI, body-mass index; 1-1.eps
now Figure LDL, low-density lipoproteins; NCD,
redrawn and colorized
non-communicable disease; PUFA, polyunsaturated fatty acid; SFA, saturated fatty
acid.
SOURCE: Danaei et al. (2009).
condition prevalence and mortality in women who experience social disad-
vantage are associated with minority race/ethnicity, lower education, low
income, and differential exposure to stressors such as domestic violence.
Such exposures are related to outcomes as varied as injury and trauma,
depression, asthma, heart disease, human immunodeficiency virus (HIV)
infection, and other sexually transmitted infections (Campbell et al., 2002;
Coker et al., 2000; Ozer and Weinstein, 2004; Tjaden and Thoennes, 1998).
On average, women need to use more preventive care than men (Asch
et al., 2006; HHS, 2001), owing to reproductive and gender-specific condi-
tions, causing significant out-of-pocket expenditures for women (Bertakis
et al., 2000; Kjerulff et al., 2007). This creates a particular challenge to
women, who typically earn less than men and who disproportionately have
low incomes. Indeed, women are consistently more likely than men to re-
port a wide range of cost-related barriers to receiving or delaying medical
tests and treatments and to filling prescriptions for themselves and their
families (KFF, 2010). For example, women have been shown to be more
likely than men to forgo preventive services such as cancer screenings and
dental examinations because of cost (Rustgi et al., 2009). Studies have
also shown that even moderate copayments for preventive services such as
mammograms and Pap smears deter patients from receiving those services
(Solanki et al., 2000; Trivedi et al., 2010). A 2010 Commonwealth Fund
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20 CLINICAL PREVENTIVE SERVICES FOR WOMEN
survey found that 44 percent of adult women (compared with 35 percent
of adult men) either reported that they had a problem paying medical bills
or indicated that they were paying off medical debt over time, an increase
from 38 percent in 2005 (Robertson and Collins, 2011). The same survey
indicated that less than half of women are up to date with recommended
preventive care screenings and services (Robertson and Collins, 2011).
Most women and men in the United States are covered by insurance
obtained through the workplace. However, women with employer-based
insurance are almost twice as likely as men to be covered as dependents,
increasing their vulnerability to losing their insurance if they divorce, their
partners lose their jobs, or they become widowed (KFF, 2010). Even though
results of studies indicate that evidence-based preventive care services lower
the burden of disease, are often cost-effective, increase the efficiency of
health care spending, and contribute to the creation of a more productive
and prosperous America, many financial barriers exist that prevent women
from achieving health and well-being for themselves and their families.
PREVENTIVE SERVICES FOR WOMEN
Preventive services for women are services that prevent conditions
harmful to women’s health and well-being. “Conditions” are considered
diseases, disabilities, injuries, behaviors, and functional states that have
direct implications for women’s health and well-being. These conditions
may be specific to women, such as gynecologic infections and unintended
pregnancy; they may be more common or more serious in women, such
as autoimmune diseases and depression; they may have distinct causes or
manifestations in women, such as alcohol abuse, obesity, and interpersonal
violence-related posttraumatic stress disorder; or they may have different
outcomes in women or different treatments, such as cardiovascular disease
and diabetes (IOM, 2010). To “prevent” is to forestall the onset of a condi-
tion; detect a condition at an early stage, when it is more treatable; or slow
the progress of a condition that may worsen or result in additional harm.
Preventive services may therefore include the provision of immunizations,
screening tests, counseling and education, Food and Drug Administration-
approved medications and devices, procedures, and over-the-counter medi-
cations and devices.
COMMITTEE ON PREVENTIVE SERVICES FOR WOMEN
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE) of the U.S. Department of Health and Human Services (HHS)
asked the Institute of Medicine to convene a diverse committee of experts
in disease prevention, women’s health issues, adolescent health issues, and
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21
INTRODUCTION
evidence-based guidelines to review existing guidelines, identify existing
coverage gaps, and recommend services and screenings for HHS to consider
in order to fill those gaps (Box 1-2). A 16-member committee was selected
to complete the statement of task.
In subsequent guidance to the committee, HHS sponsors at ASPE
directed the committee to limit its focus to females between the ages of 10
and 65 years.
BOX 1-2
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.
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22 CLINICAL PREVENTIVE SERVICES FOR WOMEN
The ACA defines the current USPSTF recommendations regarding
breast cancer screening, mammography, and breast cancer prevention to be
“the most current other than those issued in or around November 2009.”
Thus, coverage for screening mammography is guided by the 2002 USPSTF
guideline, which specifies that such screenings be performed every one to
two years for women aged 40 years and older.
Furthermore, for consistency in approach with the other three guide-
lines used by the ACA and given the time limitations for this study, the
committee was restricted from considering cost-effectiveness in its process
for identifying gaps in current recommendations. Finally, despite the po-
tential health and well-being benefits to some women, abortion services
were considered to be outside of the project’s scope, given the restrictions
contained in the ACA.
The committee received clarification from ASPE that its work was not
intended to duplicate the processes used by the USPSTF or Bright Futures.
Thus, the committee interpreted this guidance to indicate that evidence
ranging from systematic reviews of the evidence to other bodies of evidence
could be considered. This appears to be consistent with the process that led
to the current preventive services within the ACA.
The committee was also directed to limit its work to identifying clinical
preventive service coverage gaps and not to make recommendations regard-
ing community-based prevention activities.
The committee recognizes that many factors that shape the health
and well-being of women fall outside the realm of clinical services. These
include, for example, changes to the environment and the workplace to pro-
mote health, changes in women’s concept of self-efficacy to promote health,
and changes in women’s self-empowerment to address their own health and
wellness. These factors and determinants of health are elements of models
such as the Whitehead and Dahlgren (1991) determinants-of-health model
and encompass biological, behavioral, and social factors. Nevertheless,
evaluation of these factors and determinants of health were outside of the
committee’s purview.
HHS will consider the committee’s recommendations as it develops
guidelines to support the delivery of effective preventive services for women.
If they are enacted, the recommendations from this study, along with the
other coverage requirements in the ACA, will provide a comprehensive
package of clinical preventive services for women.
COMMITTEE PROCESS
To meet its charge, the committee held three information-gathering
meetings on preventive services for women and reviewed the relevant lit-
erature. Before the first meeting and throughout the committee’s delibera-
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23
INTRODUCTION
tions, the committee gathered extensive information on numerous topics
related to health and health care services for women, including chronic
and mental health conditions, cancers, sexually transmitted infections,
bone diseases, breastfeeding, interpersonal violence, unintended pregnancy,
and a variety of behavioral health issues. During the public forums, rep-
resentatives from women’s health organizations, national health interest
groups, health coverage providers, employer interest groups, and other
experts presented statements to the committee on the latest status and
developments in their respective fields (see Appendix B for the meeting
agendas). Committee members questioned the speakers to address addi-
tional concerns that they did not cover in their statements. The committee
also invited comments (both written and oral) from the general public and
representatives from numerous organizations with interest in women’s
preventive services.
The committee first met in November 2010 and held its last meeting in
May 2011. Within that time frame, it should be noted that the committee
did not have adequate time or resources to conduct its own meta-analyses
or comprehensive systematic review for each preventive service or for every
special population group that may have different health needs or benefit
from different preventive services, such as minority populations, disabled
women, recent immigrants, lesbians, prisoners, and those employed in high-
risk environments.
Box 1-3 details the committee’s definition of preventive health services,
which was used as a starting point for the study.
This definition of preventive health services is primarily derived from
a blend of definitions from multiple health care organizations and agen-
cies, including the USPSTF and the World Health Organization, with the
text regarding well-being possessing the most original phrasing by the
committee and stems from the statement of task. In addition, other key
definitions are included in Box 1-4. These definitions were adapted from
the Five Major Steps to Intervention of the Agency for Healthcare Research
BOX 1-3
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.
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24 CLINICAL PREVENTIVE SERVICES FOR WOMEN
BOX 1-4
Key Definitions: Preventive Interventions
Preventive interventions come in several forms: screening, testing, counseling,
immunization, preventive medication, and preventive treatment.
• Screening is best described as tests that assess the likelihood of the presence
of a disease or condition in an apparently healthy individual. Screening meth-
ods use, for example, laboratory analyses and X rays and similar technologies.
Screening also includes questions from clinicians. Screening may be targeted
to people at increased risk because of age, gender, family or personal his-
tory, and other factors. Each screening tool is different in design and method,
affecting the sensitivity (ability to correctly identify those with the disease),
specificity (ability to correctly identify those without the disease), and positive
and negative predictive values of the tool. Ideally, screening tests are rapid,
simple, and safe. Screening is not a definitive diagnostic test, and a positive
result on a screening test merely indicates that the screened individual has
a higher likelihood of having the disease or condition for which the individual
is being screened. Individuals who screen positive on such tests should have
confirmatory diagnostic tests to ensure an accurate diagnosis.
• Testing refers to any process used to determine whether a condition is present
or to assess the status of a condition. Testing may involve questioning patients
(e.g., asking a patient about tobacco use), physical examination (e.g., mam-
mography screening to detect potential breast cancers), or examining blood,
body fluids, or tissues (e.g., to see if a cancer is present in a biopsy sample).
Testing may also require the use of sophisticated technology, such as com-
puted tomography and magnetic resonance imaging scans and other X rays,
or invasive procedures, such as heart catheterization to detect blockage of
coronary arteries. Tests may be used to
1. Screen individuals who have risk factors but no indication of having the
condition,
2. Diagnose a disease or condition in individuals who have symptoms and
signs but for whom a test will add certainty about the diagnosis, or
3. Monitor the progress of an individual who is being treated or being
considered for treatment, such as monitoring blood pressure over time.
• Counseling refers to a discussion between a clinician and patient about ways
that changes in personal behavior can reduce the risk of illness or injury. The
goal of counseling is for clinicians to educate patients about their health risks
as well as to provide them with the skills, motivation, and knowledge that they
need to address their risk behaviors (e.g., the “5 A” framework for tobacco
cessation: ask, advise, assess, assist, arrange). A special kind of counseling,
informed decision making, recognizes that different people will make differ-
ent decisions, even though their situations may seem to be similar. Informed
decision making is structured to give an individual all the information needed
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25
INTRODUCTION
BOX 1-4 Continued
to choose from among different clinical options, such as whether to undergo
genetic testing.
• Immunization protects an individual from a specific communicable disease
(e.g., hepatitis) by exposing the individual to an antigen or a trace amount of
an inactivated disease-causing agent, spurring the development of natural
immunity.
• reventive medications are used to prevent the onset of a disease or a
P
condition (e.g., aspirin therapy to prevent cardiovascular events).
• Preventive treatment involves a procedure intended to prevent the occur-
rence of a disease or condition or to prevent the progression of a disease
from one stage to another. Preventive treatments usually refer to the use of
prescription or nonprescription (over-the-counter) medications, but they may
also involve the use of prescriptions for lifestyle changes (e.g., exercise or diet
change) or other interventions. Some surgical procedures may be considered
preventive treatment, such as removal of polyps in the colon identified during
a screening colonoscopy to prevent their progression to cancer lesions.
SOURCES: AHRQ, 2011; NBGH, 2005.
and Quality (AHRQ, 2011) and the National Business Group on Health’s
Purchaser’s Guide to Clinical Preventive Services: Moving Science into
Coverage (NBGH, 2005).
The report that follows is organized into seven chapters, summarized
below.
• In Chapter 2, the report reviews the three existing guidelines used
in the ACA to determine coverage.
• Chapter 3 details the existing practices of national, state, and se-
lected private health plans.
• In Chapter 4, the committee discusses its framework for identifying
gaps in existing preventive services and its process for selecting how
to fill those gaps.
• Chapter 5 provides a description of the gaps identified through the
committee’s work.
• The committee’s recommendations for updating guidelines for pre-
ventive services are proposed in Chapter 6.
• Chapter 7 includes committee conclusions and summarizes com-
mittee recommendations while identifying the limitations under
which the committee performed its work.
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26 CLINICAL PREVENTIVE SERVICES FOR WOMEN
• Appendix A includes a review of the conditions that the committee
considered as part of its deliberations. Although no new recom-
mendations were developed, the committee made clarifying state-
ments or suggestions of ways to use preventive services to address
these conditions.
• Appendix B provides agendas for the committee’s three public
meetings.
• Appendix C includes condensed biographies of committee members.
• Appendix D contains one committee member’s statement of dissent
and a response from all other committee members.
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