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Preventive Services Defined by the ACA

The Patient Protection and Affordable Care Act of 2010 (ACA) defined covered preventive health services for all patient populations to be those with Grade A and B recommendations made by the United States Preventive Services Task Force (USPSTF or the Task Force); for adolescents, the Bright Futures recommendations from the American Academy of Pediatrics (AAP) in cooperation with the U.S. Department of Health and Human Services (HHS), and for all patient populations, recommendations from the Advisory Committee on Immunization Practices (ACIP). The USPSTF, AAP, and ACIP are national authorities on health with defined processes for generating clinical recommendations. A summary of the methods that these entities use to arrive at recommendations and the actual recommendations follows.

UNITED STATES PREVENTIVE SERVICES TASK FORCE

The Task Force is an independent panel composed of nonfederal primary care clinicians, health behavior specialists, and methodologists. Its mission is twofold: (1) assess the benefits and harms of preventive services for people asymptomatic for the target condition on the basis of age, gender, and risk factors for disease; and (2) make recommendations about which preventive services should be incorporated into routine primary care practice. The USPSTF is now entering its 27th year of existence, and the medical community considers its methodologies and resulting recommendations to be the “gold standard” for evidence-based clinical practice in preventive services (USPSTF, 2008b).



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2 Preventive Services Defined by the ACA The Patient Protection and Affordable Care Act of 2010 (ACA) de- fined covered preventive health services for all patient populations to be those with Grade A and B recommendations made by the United States Preventive Services Task Force (USPSTF or the Task Force); for adoles- cents, the Bright Futures recommendations from the American Academy of Pediatrics (AAP) in cooperation with the U.S. Department of Health and Human Services (HHS), and for all patient populations, recommendations from the Advisory Committee on Immunization Practices (ACIP). The USPSTF, AAP, and ACIP are national authorities on health with defined processes for generating clinical recommendations. A summary of the methods that these entities use to arrive at recommendations and the actual recommendations follows. UNITED STATES PREVENTIVE SERVICES TASK FORCE The Task Force is an independent panel composed of nonfederal pri- mary care clinicians, health behavior specialists, and methodologists. Its mission is twofold: (1) assess the benefits and harms of preventive services for people asymptomatic for the target condition on the basis of age, gen- der, and risk factors for disease; and (2) make recommendations about which preventive services should be incorporated into routine primary care practice. The USPSTF is now entering its 27th year of existence, and the medical community considers its methodologies and resulting recom- mendations to be the “gold standard” for evidence-based clinical practice in preventive services (USPSTF, 2008b). 29

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30 CLINICAL PREVENTIVE SERVICES FOR WOMEN TABLE 2-1 USPSTF Grade Definitions Grade Definition Suggestions for Practice A The USPSTF recommends the service. There is Offer or provide this high certainty that the net benefit is substantial. service. B The USPSTF recommends the service. There is Offer or provide this high certainty that the net benefit is moderate service. or there is moderate degree of certainty that the net benefit is moderate to substantial. C The USPSTF recommends against routinely Offer or provide this providing the service. There may be service only if other considerations that support providing the considerations support the service in an individual patient. There is at offering or providing the least moderate certainty that the net benefit is service in an individual small. patient. D The USPSTF recommends against the service. Discourage the use of this There is moderate or high certainty that the service. service has no net benefit or that the harms outweigh the benefits. I Statement The USPSTF concludes that the current Read the clinical evidence is insufficient to assess the balance considerations section of of benefits and harms of the service. Evidence USPSTF Recommendation is lacking, of poor quality, or conflicting; and Statement. If the service the balance of benefits and harms cannot be is offered, patients should determined. understand the uncertainty about the balance of benefits and harms. SOURCE: USPSTF, 2008a. The charge of the Task Force is limited in scope: “its recommendations address primary or secondary preventive services targeting conditions that represent a substantial burden in the United States and that are provided in primary care settings or available through primary care referral” (USPSTF, 2008b). These recommendations are intended to inform primary care pro- viders as they care for individual patients in primary care practice. They are not intended to determine which preventive health care services health insurers should be required to cover. The methodology used in developing Task Force clinical recommendations does not take into consideration many nonclinical issues related to health care coverage (USPSTF, 2011). USPSTF uses a grade system, which is described in Table 2-1. USPSTF Methodology Task Force recommendations and their accompanying evidence reports are produced through the collaborative efforts of the USPSTF, the Agency

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31 PREVENTIVE SERVICES DEFINED BY THE ACA for Healthcare Research and Quality (AHRQ), Evidence-based Practice Centers (EPCs), and partner organizations. AHRQ provides methodologi- cal, technical, scientific, and administrative support to the Task Force. EPCs aid the USPSTF by developing technical reports, evidence summaries and reports, and systematic reviews that target new topics under consideration by the Task Force or that update ones addressed previously. The USPSTF uses systematic evidence reviews produced primarily by the Oregon EPC (under contract by AHRQ) and occasionally uses reviews and other analy- ses conducted by other groups, depending on the topic under consideration. Partner organizations consist of federal partners (examples include the Centers for Disease Control and Prevention [CDC], the U.S. Department of Defense, Centers for Medicare and Medicaid Services, and the Food and Drug Administration [FDA]) and organizations representing primary care professionals (examples include the American Academy of Family Physicians [AAFP], the American College of Obstetricians and Gynecolo- gists [ACOG], the American Medical Association [AMA], and AAP). They contribute expertise to the evaluation process and comment on preliminary drafts of Task Force recommendation statements and the accompanying evidence reports. A step-by-step overview of the process of recommenda- tion development, from topic selection to recommendation dissemination, follows. The average amount of time required to complete this process is 21 months (USPSTF, 2011). 1. Topic Selection—USPSTF EPCs, Task Force members, organizations, and individuals can nomi- nate topics through a publicly accessible website, as well as through solicitations to partner organizations and the Federal Register. On the basis of these submissions, the Task Force Topic Prioritization Work Group periodically updates a prioritized list of topics to be addressed either for the first time or for updating during the year. 2. Work Plan Development—AHRQ, EPCs, USPSTF Prioritized topics are appointed to “topic teams,” consisting of USPSTF “leads,” AHRQ staff (including a Medical Officer), and EPC members. The topic team develops preliminary work plans from the work assignment that AHRQ has issued to the team. The work plan includes the analytic framework, key questions, the literature search strategy, and a timeline for recommendation dissemination.

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32 CLINICAL PREVENTIVE SERVICES FOR WOMEN 3. External Work Plan Peer Review—Outside Experts Work plans for new topics are sent to a limited number of outside ex- perts in appropriate fields for their comments and review. 4. Approval of Work Plan—USPSTF The topic team presents work plans for new topics to the entire Task Force. The Task Force then evaluates and requests any revisions to the work plan that it deems necessary. The work plan is then edited by the EPC in accordance with the Task Force’s requests and is finalized. 5. Draft Evidence Report—EPC The EPC next conducts a systematic evidence review addressing the key questions posed by the Task Force in the work plan, and generates a draft evidence report. 6. Peer-Review of Draft Evidence Report—USPSTF, Content Area Experts, Federal Partners Draft evidence reports are sent to Task Force leads, content area ex- perts, federal partners, and other partner organizations for review and comment. 7. Development of Draft Recommendation Statement—USPSTF, AHRQ Concomitant with the draft evidence report review process, Task Force leads collaborate with the AHRQ Medical Officer to discuss and draft a preliminary recommendation statement. 8. Vote on Draft Recommendation Statement—USPSTF The Task Force is presented with the peer-reviewed evidence report findings by the EPC and the preliminary recommendation statement by the Task Force leads at one of three annual meetings that include the USPSTF, AHRQ, the EPC, and representatives from the partner organizations. The entire Task Force, including the leads, discusses the evidence and debates the language of the recommendation statement until a consensus is reached and the statement passes a vote. The revised recommendation statement is then sent to Task Force leads for completion and editing prior to external review.

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33 PREVENTIVE SERVICES DEFINED BY THE ACA 9. Final Evidence Report—EPC The EPC revises the evidence report in response to comments from the federal partners, content area experts, and Task Force leads. The EPC then sends a summary of the comments and how the comments were addressed to AHRQ. AHRQ staff then review, approve, and finalize the revised evidence report. The EPC then prepares the finalized evidence report for submission to a peer-reviewed journal for publication. The final technical report is also made available on the AHRQ website. 10. Review of Draft Recommendation Statement—Federal and Primary Care Professional Organization Partners and the Public The newly revised and approved recommendation statement is sent to relevant federal and primary care professional organization partners for review and comment. The statement is also posted on the AHRQ website for one month for public comment. 11. Approval of Final Recommendation Statement—USPSTF Task Force leads edit the recommendation statement on the basis of the comments received from the federal and primary care professional organi- zation partners and the public after discussion with the AHRQ Medical Officer. 12. Release of Recommendation Statement and Evidence Report—Peer-Reviewed Journals Recommendation statements and the accompanying EPC evidence report-derived manuscript are often published simultaneously in the pro- fessional journals Annals of Internal Medicine (adult topics) or Pediatrics (child/adolescent topics) and must go through the respective journal’s peer- review process before publication. They are occasionally published in other journals (USPSTF, 2008b). Preventive services relevant to women that have a grade of A or B from the USPSTF are listed in Table 2-2.

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34 CLINICAL PREVENTIVE SERVICES FOR WOMEN TABLE 2-2 USPSTF Preventive Services Relevant to Women That Have a Grade of A or B Topic Description Grade Alcohol misuse counseling The USPSTF recommends screening and B behavioral counseling interventions to reduce alcohol misuse by adults, including pregnant women, in primary care settings. Anemia screening: pregnant The USPSTF recommends routine B women screening for iron deficiency anemia in asymptomatic pregnant women. Aspirin to prevent The USPSTF recommends the use of A cardiovascular disease aspirin for women age 55 to 79 (CVD): women years when the potential benefit of a reduction in ischemic strokes outweighs the potential harm of an increase in gastrointestinal hemorrhage. Bacteriuria screening: The USPSTF recommends screening for A pregnant women asymptomatic bacteriuria with urine culture for pregnant women at 12 to 16 weeks’ gestation or at the first prenatal visit, if later. Blood pressure screening The USPSTF recommends screening for A high blood pressure in adults aged 18 and older. BRCA screening, counseling The USPSTF recommends that women B about whose family history is associated with an increased risk for deleterious mutations in BRCA1 or BRCA2 genes be referred for genetic counseling and evaluation for BRCA testing. Breast cancer preventive The USPSTF recommends that clinicians B medication discuss chemoprevention with women at high risk for breast cancer and at low risk for adverse effects of chemoprevention. Clinicians should inform patients of the potential benefits and harms of chemoprevention. Breast cancer screeninga The USPSTF recommends screening B mammography for women, with or without clinical breast examination, every 1–2 years for women aged 40 and older. Breastfeeding counseling The USPSTF recommends interventions B during pregnancy and after birth to promote and support breastfeeding.

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35 PREVENTIVE SERVICES DEFINED BY THE ACA TABLE 2-2 Continued Topic Description Grade Cervical cancer screening The USPSTF strongly recommends A screening for cervical cancer in women who have been sexually active and have a cervix. Chlamydial infection The USPSTF recommends screening for A screening: non-pregnant chlamydial infection for all sexually women active non-pregnant young women aged 24 and younger and for older non-pregnant women who are at increased risk. Chlamydial infection The USPSTF recommends screening for B screening: pregnant women chlamydial infection for all pregnant women aged 24 and younger and for older pregnant women who are at increased risk. Cholesterol abnormalities The USPSTF strongly recommends A screening: women 45 and screening women aged 45 and older older for lipid disorders if they are at increased risk for coronary heart disease. Cholesterol abnormalities The USPSTF recommends screening B screening: women younger women aged 20 to 45 for lipid than 45 disorders if they are at increased risk for coronary heart disease. Colorectal cancer screening The USPSTF recommends screening for A colorectal cancer using fecal occult blood testing, sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and continuing until age 75 years. The risks and benefits of these screening methods vary. Depression screening: The USPSTF recommends screening of B adolescents adolescents (12–18 years of age) for major depressive disorder when systems are in place to ensure accurate diagnosis, psychotherapy (cognitive- behavioral or interpersonal), and follow-up. Depression screening: adults The USPSTF recommends screening adults B for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment, and follow-up. Diabetes screening The USPSTF recommends screening for B type 2 diabetes in asymptomatic adults with sustained blood pressure (either treated or untreated) greater than 135/80 mm Hg. continued

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36 CLINICAL PREVENTIVE SERVICES FOR WOMEN TABLE 2-2 Continued Topic Description Grade Folic acid supplementation The USPSTF recommends that all women A planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 µg) of folic acid. Gonorrhea screening: The USPSTF recommends that clinicians B women screen all sexually active women, including those who are pregnant, for gonorrhea infection if they are at increased risk for infection (that is, if they are young or have other individual or population risk factors). Healthy diet counseling The USPSTF recommends intensive B behavioral dietary counseling for adult patients with hyperlipidemia and other known risk factors for cardiovascular and diet-related chronic disease. Intensive counseling can be delivered by primary care clinicians or by referral to other specialists, such as nutritionists or dietitians. Hepatitis B screening: The USPSTF strongly recommends A pregnant women screening for hepatitis B virus infection in pregnant women at their first prenatal visit. Human immunodeficiency The USPSTF strongly recommends A virus (HIV) screening that clinicians screen for HIV all adolescents and adults at increased risk for HIV infection. Obesity screening and The USPSTF recommends that clinicians B counseling: adults screen all adult patients for obesity and offer intensive counseling and behavioral interventions to promote sustained weight loss for obese adults. Osteoporosis screening: The USPSTF recommends screening for B women osteoporosis in women aged 65 years or older and in younger women whose fracture risk is equal to or greater than that of a 65-year-old white woman who has no additional risk factors. Rh incompatibility screening: The USPSTF strongly recommends Rh (D) A first pregnancy visit blood typing and antibody testing for all pregnant women during their first visit for pregnancy-related care.

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37 PREVENTIVE SERVICES DEFINED BY THE ACA TABLE 2-2 Continued Topic Description Grade Rh incompatibility screening: The USPSTF recommends repeated Rh (D) B 24–28 weeks gestation antibody testing for all unsensitized Rh (D)-negative women at 24–28 weeks’ gestation, unless the biological father is known to be Rh (D)-negative. Sexually transmitted The USPSTF recommends high-intensity B infections (STIs) counseling behavioral counseling to prevent STIs for all sexually active adolescents and for adults at increased risk for STIs. Tobacco use counseling and The USPSTF recommends that clinicians A interventions: non-pregnant ask all adults about tobacco use and adults provide tobacco cessation interventions for those who use tobacco products. Tobacco use counseling: The USPSTF recommends that clinicians A pregnant women ask all pregnant women about tobacco use and provide augmented, pregnancy-tailored counseling to those who smoke. Syphilis screening: non- The USPSTF strongly recommends that A pregnant persons clinicians screen persons at increased risk for syphilis infection. Syphilis screening: pregnant The USPSTF recommends that clinicians A women screen all pregnant women for syphilis infection. aHHS, in implementing ACA under the standard that it sets out in revised Section 2713(a)(5) of the Public Health Service Act, uses the 2002 recommendation on breast cancer screening of the USPSTF. SOURCE: USPSTF, 2010b. BRIGHT FUTURES—AMERICAN ACADEMY OF PEDIATRICS The HHS Health Resources and Services Administration’s Maternal and Child Health Bureau established the Bright Futures project in 1990 with the mission to “promote and improve the health, education, and well- being of infants, children, adolescents, families, and communities” (AAP, 2008). It is a “set of principles, strategies, and tools that are theory based and system oriented that can be used to improve the health and well-being of all children through culturally appropriate interventions that address the

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38 CLINICAL PREVENTIVE SERVICES FOR WOMEN current and emerging health promotion needs at the family, clinical prac- tice, community, health system, and policy levels” (AAP, 2008). The most recent report, published in 2008, was developed through the collaborative efforts of four multidisciplinary panels consisting of experts in health dur- ing infancy, early childhood, middle childhood, and adolescence and was then reviewed by more than 1,000 educators, public health and health care professionals, child health advocates, and parents. Bright Futures Methodology The Bright Futures Steering Committee used three approaches to de- velop its guidance and recommendations and described these approaches as follows: 1. “Multidisciplinary Expert Panels were convened to write recom- mendations for Bright Futures visit priorities, the physical exami- nation, anticipatory guidance, immunizations, and universal and selective screening topics for each age and stage of development. In carrying out this task, the Expert Panels were charged with ex- amining the evidence for each recommendation, and evidence was an important consideration in the guidance they provided. How- ever, lack of evidence was sometimes problematic for the physical examination (the elements of which can be considered screening interventions) and for counseling interventions. For these compo- nents, the Expert Panels relied on an indirect approach buttressed by their expertise and clinical experience” (AAP, 2008). 2. A Bright Futures Evidence Panel, composed of consultants who are experts in finding and evaluating evidence from clinical studies, was convened to examine studies and systematic evidence reviews and to develop a method of informing readers about the strength of the evidence. The Evidence Panel conducted literature searches for key ques- tions using the MEDLINE® database of the National Library of Medicine. Key themes were searched in the Medical Subject Headings (MeSH) database to determine the most appropri - ate search terms. Searches were limited to clinical trials, meta- analyses, and randomized controlled trials. Other limits included English language and designations for age, when appropriate. Standardized terms were used for counseling (i.e., counseling, primary prevention, health promotion, health education, and patient education) and for screening (i.e., mass screening and risk assessment). The Evidence Panel also used the systematic

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39 PREVENTIVE SERVICES DEFINED BY THE ACA evidence reviews performed for the USPSTF and the Cochrane Collaboration [the publisher of Cochrane Reviews of primary research in human health care and health policy]. This approach was by no means exhaustive, but it did provide an assessment of the most relevant literature. (AAP, 2008) 3. “Throughout the Guidelines development process, the Project Ad- visory Committee and Expert Panels consulted with individuals and organizations with expertise and experience in a wide range of topic areas. The entire Guidelines document also underwent public review twice in 2004 and once in 2006. More than 1,000 reviewers, representing national organizations concerned with infant, child, and adolescent health and welfare, provided nearly 3,500 com- ments. The contributions of these reviewers provided an opportu- nity to refine the guidelines and strengthen the scientific base for the guidance provided” (AAP, 2008). Bright Futures describes its guidelines as “evidence informed rather than fully evidence driven” (AAP, 2008) and takes a broader view of prevention that is less focused on specific conditions and more on general health guidance (e.g., aggregating services into health supervision visits and extensive anticipatory guidance). Like the USPSTF, Bright Futures does not directly comment on insurance coverage, but unlike the USPSTF, Bright Futures does not have categories regarding services comparable to “C” or “I” grades that do not definitively recommend for or against a particular service. Bright Futures intends to leave no gaps in its recommendations, supplementing the evidence where needed with experience and expert opin- ion so that clinical guidance is always provided. Figures 2-1, 2-2, and 2-3 present the Bright Futures recommendations for adolescents and outline the preventive services that are covered for adolescent women in the ACA. In addition to the information in the tables shown in Figures 2-1 to 2-3, Bright Futures also provides extensive anticipatory guidance on a range of health matters in the context of discussing health issues with adolescents. These measures do not provide action steps and are not suitable for summary in a structured format.

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40 CLINICAL PREVENTIVE SERVICES FOR WOMEN Physical Examination A complete physical examination is included as ■ Breast part of every health supervision visit. Female • Assess sexual maturity rating When performing a physical examination, the health Male care professional’s attention is directed to the following • Observe for gynecomastia components of the exam that are important for 11- to ■ Genitalia 14-year-olds: Female ■ Measure: • Perform visual inspection for sexual maturity • Blood pressure rating and observation for signs of STIs (eg, ■ Measure and plot: warts, vesicles, vaginal discharge) • Height • Perform pelvic exam, if clinically warranted, • Weight based on sexual activity (eg, for Pap smear ■ Calculate and plot: within 3 years of onset of sexual activity) and/or • BMI specific problems (eg, pubertal aberrancy, ■ Skin abnormal bleeding, abdominal or pelvic pain) Male • Inspect for acne, acanthosis nigricans, atypical nevi, tattoos, piercings, and signs of abuse or • Perform visual inspection for sexual maturity self-inflicted injury rating and observations for signs of STIs (ie, ■ Spine warts, vesicles) • Examine back • Examine testicles for hydrocele, hernias, varicocele, or masses Screening UNIVERSAL SCREENING ACTION Snellen test Vision (once in early adolescence) SELECTIVE SCREENING RISK ASSESSMENT* ACTION IF RA + Vision at other ages + on risk screening questions Snellen test Hearing + on risk screening questions Audiometry Anemia + on risk screening questions Hemoglobin or hematocrit Tuberculosis + on risk screening questions Tuberculin skin test + on risk screening questions and not Lipid screen Dyslipidemia previously screened with normal results STIs Sexually active Screen for chlamydia and gonorrhea; use tests appropriate to the patient population and clinical setting Sexually active and + on risk questions Syphilis blood test HIV† Sexually active without contraception, Urine hCG Pregnancy late menses, or amenorrhea Sexually active, within 3 years of Pap smear, conventional slide Cervical dysplasia onset of sexual activity or liquid-based Alcohol or drug use + on risk screening questions Administer alcohol and drug screening tool *See Rationale and Evidence chapter for the criteria on which risk screening questions are based. The CDC has recently recommended universal voluntary HIV screening for all sexually active people, beginning at age 13. At the time of † publication, the AAP and other groups had not yet commented on the CDC recommendation, nor recommended screening criteria or techniques. The health care professional’s attention is drawn to the voluntary nature of screening and that the CDC allows an opt out in communities where the HIV rate is <0.1%. The management of positives and false positives must be considered before testing. FIGURE 2-1 Adolescence 11–14 year visits. ABBREVIATIONS: AAP = American Academy of Pediatrics; BMI = body mass in- Figure 2-1.eps dex; CDC = Centers for Disease Control and Prevention; hCG = human chorionic gonadotropin; HIV = human immunodeficiency virus; RA = risk assessment; STI = sexually transmitted infection. SOURCE: AAP, 2008. Used with permission of the American Academy of Pediat- rics, Bright Futures—Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition, American Academy of Pediatrics, 2008.

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41 PREVENTIVE SERVICES DEFINED BY THE ACA Physical Examination A complete physical examination is included as ■ Breast part of every health supervision visit. Female • Assess sexual maturity rating When performing a physical examination, the health Male care professional’s attention is directed to the following • Observe for gynecomastia components of the exam that are important for 15- to ■ Genitalia 17-year-olds: Female ■ Measure: • Perform visual inspection for sexual maturity • Blood pressure rating and observation for signs of STIs (eg, ■ Measure and plot: warts, vesicles, vaginal discharge) • Height • Perform pelvic exam, if clinically warranted, • Weight based on sexual activity (eg, for Pap smear ■ Calculate and plot: within 3 years of onset of sexual activity) and/or • BMI specific problems (eg, pubertal aberrancy, ■ Skin abnormal bleeding, abdominal or pelvic pain) Male • Inspect for acne, acanthosis nigricans, atypical nevi, tattoos, piercings, and signs of abuse or • Perform visual inspection for sexual maturity self-inflicted injury rating and observations for signs of STIs (ie, ■ Spine warts, vesicles) • Examine back • Examine testicles for hydrocele, hernias, varicocele, or masses Screening UNIVERSAL SCREENING ACTION Vision (once in middle adolescence) Snellen test SELECTIVE SCREENING RISK ASSESSMENT* ACTION IF RA + Vision at other ages + on risk screening questions Snellen test Hearing + on risk screening questions Audiometry Anemia + on risk screening questions Hemoglobin or hematocrit Tuberculosis + on risk screening questions Tuberculin skin test + on risk screening questions and not Lipid screen Dyslipidemia previously screened with normal results STIs Sexually active Screen for chlamydia and gonorrhea; use tests appropriate to the patient population and clinical setting Sexually active and + on risk questions Syphilis blood test HIV† Sexually active without contraception, Urine hCG Pregnancy late menses, or amenorrhea Sexually active, within 3 years of Pap smear, conventional slide Cervical dysplasia onset of sexual activity or liquid-based Alcohol or drug use + on risk screening questions Administer alcohol and drug screening tool *See Rationale and Evidence chapter for the criteria on which risk screening questions are based. The CDC has recently recommended universal voluntary HIV screening for all sexually active people, beginning at age 13. At the time of † publication, the AAP and other groups had not yet commented on the CDC recommendation, nor recommended screening criteria or techniques. The health care professional’s attention is drawn to the voluntary nature of screening and that the CDC allows an opt out in communities where the HIV rate is <0.1%. The management of positives and false positives must be considered before testing. Figure 2-2.eps FIGURE 2-2 Adolescence 15–17 year visits. ABBREVIATIONS: AAP = American Academy of Pediatrics; BMI = body mass in- dex; CDC = Centers for Disease Control and Prevention; hCG = human chorionic gonadotropin; HIV = human immunodeficiency virus; RA = risk assessment; STI = sexually transmitted infection. SOURCE: AAP, 2008. Used with permission of the American Academy of Pediat- rics, Bright Futures—Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition, American Academy of Pediatrics, 2008.

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42 CLINICAL PREVENTIVE SERVICES FOR WOMEN Physical Examination A complete physical examination is included as ■ Breast part of every health supervision visit. Female • Clinical Breast Examination is considered When performing a physical examination, the health routine after age 20. care professional’s attention is directed to the following ■ Genitalia components of the exam that are important for 18- to Female 21-year-olds: • Inspect for signs of STIs (eg, warts, vesicles, ■ Measure: vaginal discharge) • Blood pressure • Perform pelvic exam by age 21 or if clinically ■ Measure and plot: warranted, based on sexual activity (eg, for Pap • Height smear within 3 years of onset of sexual activity) • Weight and/or specific problems (eg, pubertal aber- ■ Calculate and plot: rancy, abnormal bleeding, abdominal or pelvic • BMI pain) ■ Skin Male • Inspect for acne, acanthosis nigricans, atypical • Perform visual inspection for sexual maturity nevi, tattoos, piercings, and signs of abuse or rating and observations for signs of STIs (ie, self-inflicted injury warts, vesicles) • Examine testicles for hydrocele, hernias, varicocele, or masses Screening UNIVERSAL SCREENING ACTION Snellen test Vision (once in late adolescence) A fasting lipoprotein profile (total cholesterol, LDL choesterol, high density Dyslipidemia (once in late adolescence) lipoprotein (HCL), cholesterol, and triglyceride). If the testing opportunity is non-fasting, only total cholesterol and HDL cholesterol will be usable. SELECTIVE SCREENING RISK ASSESSMENT* ACTION IF RA + Vision at other ages + on risk screening questions Snellen test Hearing + on risk screening questions Audiometry Anemia + on risk screening questions Hemoglobin or hematocrit Tuberculosis + on risk screening questions Tuberculin skin test If not age 20, + on risk screening Lipid screen Dyslipidemia questions and not previously screeened with normal resaults STIs Sexually active Screen for chlamydia and gonorrhea; use tests appropriate to the patient population and clinical setting Sexually active and + on risk questions Syphilis blood test HIV† Sexually active without contraception, Urine hCG Pregnancy late or absent menses, or heavy or irregular bleeding Sexually active, within 3 years of Pap smear, conventional slide Cervical dysplasia onset of sexual activity or liquid-based Alcohol or drug use + on risk screening questions Administer alcohol and drug screening tool *See Rationale and Evidence chapter for the criteria on which risk screening questions are based. The CDC has recently recommended universal voluntary HIV screening for all sexually active people, beginning at age 13. At the time of † publication, the AAP and other groups had not yet commented on the CDC recommendation, nor recommended screening criteria or techniques. The health care professional’s attention is drawn to the voluntary nature of screening and that the CDC allows an opt out in communities where the HIV rate is <0.1%. The management of positives and false positives must be considered before testing. Figure 2-3.eps FIGURE 2-3 Adolescence 18–21 year visits. ABBREVIATIONS: AAP = American Academy of Pediatrics; BMI = body mass in- dex; CDC = Centers for Disease Control and Prevention; hCG = human chorionic gonadotropin; HDL = high-density lipoprotein; HIV = human immunodeficiency virus; LDL = low-density lipoprotein; RA = risk assessment; STI = sexually trans- mitted infection. SOURCE: AAP, 2008. Used with permission of the American Academy of Pediat- rics, Bright Futures—Guidelines for Health Supervision of Infants, Children, and Adolescents, Third Edition, American Academy of Pediatrics, 2008.

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43 PREVENTIVE SERVICES DEFINED BY THE ACA ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES ACIP is the sole federal government entity that provides written rec- ommendations for delivering vaccines to children and adults in the general population. It provides guidance and recommendations to HHS and the CDC on matters regarding the approval, administration, and safety of vaccines. Its goal is to reduce the prevalence of vaccine-preventable diseases in the United States and bolster the safe use of vaccines and other related biological products. ACIP is comprised of 15 voting immunization-related experts and 34 other representatives from liaison organizations and federal agencies that oversee national immunizations programs (CDC, 2011a). ACIP Methodology The ACIP General Recommendations Work Group (GRWG) revises the General Recommendations on Immunization every 3 to 5 years. Relevant topics are those identified by ACIP to be topics that relate to all vaccines, including timing and spacing of doses, vaccine administration procedures, and vaccine storage and handling. New topics are often added when ACIP decides that previous ACIP statements on general issues, such as combina- tion vaccines, adolescent vaccination, and adult vaccination, should be revised and combined with the General Recommendations on Immuniza- tion (CDC, 2011b). The recommendations in the 2011 GRWG report are based not only on available scientific evidence but also on expertise that comes directly from a diverse group of health care providers and public health officials. GRWG includes “professionals from academic medicine (pediatrics, family practice, and pharmacy); international (Canada), federal, and state public health professionals; and a member of the nongovernmental Immunization Action Coalition” (CDC, 2011b). ACIP committee work groups comprising an ACIP member chair, a CDC subject-matter expert, and at least two ACIP members meet during the year to perform analyses of vaccine-related data and generate potential policy recommendations to be presented to the committee. These analyses include review of the available scientific literature on the immunizing agent, morbidity and mortality from the disease in the U.S. population, recom- mendation statements issued by other professional organizations, results of clinical trials with the immunizing agent, cost-effectiveness projections, and the feasibility of incorporating the vaccine into preexisting U.S. immuniza- tion programs. Draft recommendations are then subjected to further review by the FDA, CDC, ACIP members, external expert consultants, and other relevant federal agencies. Work group findings and potential recommen- dations are presented to ACIP at one of three annual open meetings and

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44 CLINICAL PREVENTIVE SERVICES FOR WOMEN are deliberated upon by the committee. Public comments are heard at the meetings and taken into consideration during the deliberations. A majority vote is then conducted to pass a recommendation that includes guidance re- garding the route of administration and dosing intervals, contraindications and precautions, and target groups for immunization. Recommendations are published on the ACIP website and in Morbidity and Mortality Weekly Report (Smith et al., 2009). ACIP functions in a unique position because its recommendations are relevant to the general population and to some quite specific subpopula- tions, but its recommendations focus on efficacy and safety for intended populations. Some of its recommendations are not intended for general clin- ical use (e.g., recommendations for international travelers), are not intended for the entire population (e.g., recommendations for high-risk groups such as health care workers), or require specific guidance in footnotes for special circumstances (e.g., allergies and immunosuppression). Table 2-3 lists the FDA-Licensed Combination Vaccines, and Table 2-4 lists ACIP-recommended vaccines that are covered without cost sharing as part of the ACA. TABLE 2-3 FDA-Licensed Combination Vaccines Trade Name Vaccine (Year Licensed) Age Range Routinely Recommended Ages ≥18 years HepA-HepB Twinrix (2001) Three doses on a schedule of 0, 1, and 6 months MMRV ProQuad (2005) 12 months– Two doses, the first at 12–15 months, 12 years the second at 4–6 years ABBREVIATIONS: HepA = hepatitis A; HepB = hepatitis B; MMRV = measles, mumps, rubella, and varicella. SOURCES: AAP, 2009; CDC, 2011.

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45 PREVENTIVE SERVICES DEFINED BY THE ACA TABLE 2-4 Recommended and Minimum Ages and Intervals Between Vaccine Doses Recommended Minimum Recommended Minimum Vaccine and Dose Age for This Age for This Interval to Interval to Number Dose Dose Next Dose Next Dose LAIV (intranasal)a 2–49 years 2 years 1 month 4 weeks MCV4-1b 11–12 years 2 years 5 years 8 weeks MCV4-2 16 years 11 years (+8 weeks) HPV-1c 11–12 years 9 years 2 months 4 weeks HPV-2 11–12 years 9 years 4 months 12 weeks (+2 months) (+4 weeks) HPV-3d 11–12 years 9 years (+6 months) (+24 weeks) Td 11–12 years 7 years 10 years 5 years Tdap 11–12 years 7 years NOTE: Combination vaccines are available. Use of licensed combination vaccines is generally preferred to separate injections of their equivalent component vaccines. When combination vaccines, the minimum age for administration is the oldest age for any of the individual components; the minimum interval between doses is equal to the greatest interval of any of the individual components. Information on traveler vaccines, including typhoid, Japanese encephalitis, and yellow fever, is available at http://www.cdc.gov/travel. Information on other vaccines that are licensed in the United States but not distributed, including anthrax and smallpox, is available at http://www.bt.cdc.gov. ABBREVIATIONS: LAIV = live, attenuated influenza vaccine; MCV4 = quadrivalent meningo- coccal conjugate vaccine; HPV-1 to HPV-3 = human papillomavirus doses 1 to 3, respectively; Td = adult tetanus and diphtheria toxoids; Tdap = tetanus and reduced diphtheria toxoids and acellular pertussis vaccine (for adolescents and adults). a One dose of influenza vaccine per season is recommended for most persons. Children aged < 9 years who are receiving influenza vaccine for the first time or who received only one dose the previous season (if it was their first vaccination season) should receive two doses this season. b Revaccination with meningococcal vaccine is recommended for previously vaccinated persons who remain at high risk for meningococcal disease (CDC, 2009). c Bivalent HPV vaccine is approved for females aged 10–25 years. Quadrivalent HPV vaccine is approved for males and females aged 9–26 years. d The minimum age for HPV-3 is based on the baseline minimum age for the first dose (i.e., 108 months) and the minimum interval of 24 weeks between the first and third doses. Dose 3 need not be repeated if it is administered at least 16 weeks after the first dose. SOURCES: AAP, 2009; CDC, 2011b.

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46 CLINICAL PREVENTIVE SERVICES FOR WOMEN 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. AAP. 2009. Passive immunization. In Red Book: 2009 Report of the Committee on Infectious Diseases, 28th ed. (L. K. Pickering, C. J. Baker, D. W. Kimberlin, and S. S. Long, eds.). Elk Grove Village, IL: American Academy of Pediatrics. CDC (Centers for Disease Control and Prevention). 2009. Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for revaccination of persons at prolonged increased risk for meningococcal disease. MMWR Morbidity and Mortality Weekly Report 58(37):1042–1043. CDC. 2011a. Advisory Committee on Immunization Practices. Atlanta, GA: Centers for Disease Control and Prevention. http://www.cdc.gov/vaccines/recs/acip/#about (accessed June 2, 2011). CDC. 2011b. General recommendations on immunization—recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations and Reports: Morbidity and Mortality Weekly Report 60(2):1–64. Smith, J. C., D. E. Snider, and L. K. Pickering. 2009. Immunization policy development in the United States: The role of the Advisory Committee on Immunization Practices. Annals of Internal Medicine 150(1):W45–W49. USPSTF (United States Preventive Services Task Force). 2008a. Grade definitions. Rockville, MD: United States Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/ uspstf/grades.htm (accessed May 31, 2011). USPSTF. 2008b. U.S. Preventive Services Task Force procedure manual. Rockville, MD: Agency for Healthcare Research and Quality. http://www.uspreventiveservicestaskforce. org/uspstf08/methods/procmanual.htm (accessed June 2, 2011). USPSTF. 2010b. USPSTF A and B recommendations. Rockville, MD: United States Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/uspstf/uspsabrecs.htm (accessed June 2, 2011). USPSTF. 2011. Methods and processes. Rockville, MD: United States Preventive Services Task Force. http://www.uspreventiveservicestaskforce.org/methods.htm (accessed May 21, 2011).