Where Do We Stand on Well Woman Visits?

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ObGyn Update: What Does the Evidence Tell Us? October 25, 2013 Where Do We Stand on Well Woman Visits? No commercial disclosures for this lecture Michael S.

1 ObGyn Update: What Does the Evidence Tell Us? October 25, 2013 Where Do We Stand on Well Woman Visits? No commercial disclosures for this lecture Michael S. Policar, MD, MPH Clinical Professor of Ob,Gyn, & RS UCSF School of Medicine The Health Screening Visit Major health objectives Optimize health status through anticipatory guidance and screening for asymptomatic conditions Increase the client s sense of well-being Promote the clinician-client relationship Positive action toward self-maintenance of health In a reproductive health context Clarify the client s reproductive life plan Support correct and consistent use of her contraceptive, or Counsel regarding fertility and preconception health Advice to protect health and reproductive capacity Who Defines Well Woman Services? US Preventive Services Taskforce Primary care specialty societies (ACP, AAFP) Most health plan guidelines American College of Obstetricians and Gynecologists Primary and Preventive Care American Academy of Pediatrics (AAP) Bright Futures guidelines Advocacy groups ACS, AHA, and ADA joint guideline ACA: Women s Preventive Services Benefits without cost-sharing; not practice guidelines

2 USPSTF 2007: Strength of Recommendation Comment Intervention A Recommend Net benefit is substantial Offer or provide B Recommend Net benefit is moderate Offer or provide C Recommend against providing routinely D Recommend against I Evidence is insufficient May be considerations that support the service in an individual patient No net benefit (or) harms outweigh benefits Evidence is lacking, poor quality, or conflicting Offer only if other considerations to support Discourage the use of this service Benefits/harms can not be determined New web site: USPSTF: Age Band Anticipatory Guidance (counseling) Tobacco cessation; avoid tobacco use Avoid alcohol use while driving, boating, swimming Diet: limit fat and cholesterol; adequate calcium intake Regular physical activity and exercise Injury prevention: seat belts, helmets, smoke detector Sexual behavior: contraception, STD prevention Dental health Regular visits to dental provider Floss, brush with fluoride toothpaste daily Chemoprophylaxis Folic acid (women planning pregnancy) USPSTF: Age Band Physical exam, lab, and imaging tests Height and weight Physical Blood pressure exam Cervical cytology HIV screening (once, individuals y.o.) Targeted STD screening (GC, Ct, syphilis, HIV) Mammography (starting at 50 yo) Colorectal cancer screening (starting at 50 yo) Rubella serology or vaccination hx(childbearing age) ACOG Primary and Preventive Care ACOG Committee Opinion #483 Obstet Gynecol 2011;117:1008 More aggressive than other screening guidelines Retrogressive, compared to evidence based guidelines Assumes that the ObGyn is functioning as primary care provider; no mention of coordination with PCP Updated with Opinion #534 (Well Woman Visit) and Practice Bulletin #131 (Screening for Cervical Cancer)

ACOG Primary and Preventive Care Interventions Beyond USPSTF Annualwell woman visit starting @ 13-15 years of age Physical examination Neck, breasts, abdomen, pelvic exam @ >21 years of age >40 years

3 ACOG Primary and Preventive Care Interventions Beyond USPSTF Annualwell woman visit years of age Physical examination Neck, breasts, abdomen, pelvic >21 years of age >40 years old: oral cavity, axillae Lab and imaging TSH (Q5 50 years old Fasting glucose (Q 3 45 years old Lipid profile (Q5 45 years old Mammography 40 years old BMD screening: definition of high <65 years old Well Woman Health Screening Visits Is a physical exam necessary with every screening visit? As needed for scheduled screening tests Diagnostic exam when symptoms or signs present Some visits will consist solely of counseling and education without an exam beyond a BP check Is a yearlyhealth screening visit advised if no tests are due? USPSTF: visits can be every 1-3 years, depending upon health status and risk behaviors of the client ACOG: perform annually MMWR 62(5):1-60 June 21, 2013 Focus on efficacy in women and men using contraceptives U.S. SPR: Exams And Tests Needed Before Contraceptive Method Initiation Examination Blood pressure Clinical breast examination Weight (BMI) (weight [kg]/ height [m]2 Needed for OC, patch, ring Hormonal methods Bimanual examination, cervical inspection IUC, cap, diaphragm Glucose, Lipids Liver enzymes Thrombogenic mutations Cervical cytology (Papanicolaou smear) STD screening with laboratory tests HIV screening with laboratory tests

Examinations and Tests Needed Before Initiation of a Cu-IUD or an LNG-IUD Bimanual exam and cervical inspection are necessary Screen for CT + GC according to national STI guidelines only If no prior

4 Examinations and Tests Needed Before Initiation of a Cu-IUD or an LNG-IUD Bimanual exam and cervical inspection are necessary Screen for CT + GC according to national STI guidelines only If no prior screening, perform at time of IUD insertion Women with purulent cervicitis or current GC or CT should not undergo IUD insertion (U.S. MEC 4) If a very high individual likelihood of STD exposure generally should not have IUD insertion (U.S. MEC 3) Reproductive Life Plan Questions Do you hope to have any (more) children? How many children do you hope to have? How long do you plan to wait until you next become pregnant? How much space do you plan to have between your pregnancies? What do you plan to do until you are ready to become pregnant? What can I do today to help you achieve your plan? One Key Question Do you plan to become pregnant in the next year? Yes Unsure No Recommend Folic Acid 400mcg daily Glucose control in diabetics Avoid use of teratogenic medications Screen for health concerns that could impact pregnancy and treat as indicated Yes If using a Tier 2,3 method, use EC as a backup method Are you currently using a method that you are satisfied with? No Contraceptive counseling Recommend EC as needed

5 Unsure About Pregnancy Intentions (aka it s OK either way ) Questions to ask yourself Is right now the right time for me to be pregnant? Am I in good health and able to focus on my health to support a pregnancy? Do I have the resources I need to support a child? Is my partner supportive of a pregnancy at this time? How would a child affect my work, my education, my family, my future plans? Female cancer deaths % Deaths Screening Test Lung 27 % Breast 15% Yes Bowel, Rectum 10% Yes Lymphoma/Leukemia 7% Pancreas 6% Ovary 6% (low risk) Uterus 3% Cervix 1% Yes Screening tests available to prevent 26% of cancer deaths Breast Self-Examination (BSE) Two very large RCTs (Shanghai, Russia) Mortality, survival equal in treatment and controls SBE no better than coincidental discovery of mass USPSTF 2009:[ D] recommends against teaching BSE American Cancer Society 2003 At >20 years old, inform of benefits, limitations If BSE chosen, provide instruction in use Acceptable not to do BSE or to do irregularly Goal of BSE is increased breast awareness Breast Self-Awareness (BSA) BSA is defined as women s awareness of the normal appearance and feel of their breasts Endorsed by ACOG, ACS, PPFA, and the NCCN The effect of BSA education has not been studied Rationale ½ of breast cancer cases >50 y.o. and 70% of cases in younger women detected incidentally by themselves New cases can arise during screening intervals, and BSA may prompt women not to delay in reporting breast changes based on a recent negative screening result ACOG Practice Bulletin No

6 Clinical Breast Exam (CBE) Most studies evaluate MG + CBE, not CBE alone Accuracy of CBE Sensitivity: 54%, specificity: 93-94% 10% of breast cancers detected on CBE alone, especially in younger women Most recommendations: start CBE at 40; perform annually (concurrent with mammogram) Exceptions USPSTF 2009: [ I ] recommendation ACS 2012: every 1-3 years ACOG 2011: every 1-3 years USPSTF: Screening Mammography November 2009 The USPSTF recommends Biennial mammography years [ B ] Against routine mammography years [ C ] Evidence is insufficient to assess benefits, harms of Mammography in women >75 years old [ I ] Digital mammography or MRI (vsfilm) [ I ] USPSTF: Screening Mammography December 2009 The USPSTF recommends against routine screening mammography in women aged 40 to 49 years [C] The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms Even with 15% mortality reduction, there is moderate certainty that the net benefit is small Efficacy of Mammography By Screening Interval in RCTs Screening Interval years old Mortality Reduction 1 year 23% 2 years 23% years old 1 year 11% 2 years 17% Kerlikowske, JAMA 1996, Nelson, Ann Int Med 2009

7 Screening Mammography Guidelines USPSTF 2009 Age (years) Recommendation Screen if specified high risk factors Discuss pros and cons of screening* Encourage screening* Strongly encourage screening* Discuss pros and cons of screening* >75 Little data *When done, perform routine mammography biennially Other Screening Mammography Guidelines American College of Ob-Gyn (ACOG) American College of Radiology (ACR) American Cancer Society (ACS) Annual screening starting at 40 years of age American College of Physicians years old based on individual risks Every 1-2 years starting at 50 years old World Health Organization Every 1-2 years between USPSTF 2012 Triple A 2012 ACOG 2012 hrhpv test Summary of 2012 Cervical Cancer Guidelines Under 21 years old [D] years old Years old Every 3 y Co-test: Q5 Cytology: Q3 Every 3 y Co-test: Q5* Cytology: Q3 Avoid Every 3 y Co-test: Q5* Cytology: Q3 Never Reflex only Co-test or reflex >65 years old Hyst, benign ** ** ** * Preferred ** If adequate prior screening with negative results Co-test: Cytology: cervical cytology plus hrhpv test cervical cytology (Pap smear) alone [D] When Is a Shorter Cytology Interval Justified? For women who Are in a surveillance pathway Previously abnormal cytology result Post-treatment for a pre-invasive cervical lesion Had an insufficient or unsatisfactory test result Have HIV infection, a major organ transplant with the use of an anti-rejection drug, or long term corticosteroid use Are newly enrolled in a practice and have no documented history of prior cytology results

end sooner Not too often Every 3 or 5 years What doesn t matter for screening intervals Age of sexual debut

8 Take it Home Take it Home Michael Pollan: Healthy eating Eat food Not too much Mostly plants Michael Pollan: Healthy eating Eat food Not too much Mostly plants Healthy Cervical Cancer Screening Start later, end sooner Not too often Every 3 or 5 years What doesn t matter for screening intervals Age of sexual debut Prior HPV vaccination New sexual partners or practices Hormonal contraceptives or hormone therapy choosingwisely.org

Ovarian Cancer Screening Options for screening (Bimanual) Pelvic examination Transvaginal pelvic ultrasound (TVS) Serum Tumor Marker: CA-125 Not recommended for low risk asymptomatic women Low

is not recommended [D] Insufficient evidence to recommend for or against in asymptomatic women at increased risk [I] Pelvic Exam at the Well-Woman Visit ACOG Committee Opinion 534; August 2012 Women

9 Ovarian Cancer Screening Options for screening (Bimanual) Pelvic examination Transvaginal pelvic ultrasound (TVS) Serum Tumor Marker: CA-125 Not recommended for low risk asymptomatic women Low sensitivity, specificity for early disease Low prevalence of disease High cost of evaluation USPSTF(2012) Ovarian Cancer Screening Screening asymptomatic women with ultrasound, tumor markers, or exam is not recommended [D] Insufficient evidence to recommend for or against in asymptomatic women at increased risk [I] Pelvic Exam at the Well-Woman Visit ACOG Committee Opinion 534; August 2012 Women younger than 21 years Pelvic exam only when indicated by medical history Screen for GC, chlamydia with vaginal swab or urine Women aged 21 years or older ACOG recommends an annual pelvic examination No evidence supports or refutes routine exam if low risk If asymptomatic, pelvic exam should be a shared decision Individual risk factors, patient expectations, and medicolegal concerns may influence these decisions If TAH-BSO, decision left to the patient if asymptomatic

10 The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial Ovarian Cancers: PLCO Cancer Screening RCT Cases Deaths Randomized trial of 78,216 women aged Annual screening with CA-125 for 6 years + transvaginal U/S for 4 years (n=39,105) versus usual care (n=39,111) 10 US screening centers Followed a median of 12 years Bimanual examination originally part of the screening procedures but was discontinued JAMA. 2011;305(22): JAMA. 2011;305(22): Is The Screening Pelvic Exam Outdated? Screen for Preferred test GC, Ct NAAT: vaginal swab or urine sample Cervical cancer Not recommended until 21 years old Cytology every 3-5 years afterward, if total hyst for benign disease Ovarian cancer USPSTF rec. against bimanual exam Is The Screening Pelvic Exam Outdated? Screen for Preferred test GC, Ct NAAT: vaginal swab or urine sample Cervical cancer Not recommended until 21 years old Cytology every 3-5 years afterward, if total hyst for benign disease Ovarian cancer USPSTF rec. against bimanual exam Vulvar lesions Unnecessary if asymptomatic Vaginal infxn Myomas Unnecessary if asymptomatic Unnecessary if asymptomatic

11 Reproductive Health Cancer Healthy Behaviors Pregnancy related Immunizations Chronic conditions Specified preventive services must be covered with no cost-sharing for deductibles and co-payments Preventive services include USPSTF grade [A] or [B] recommendations AAP Bright Futures recommendations for adolescents CDC ACIP vaccination recommendations 2011: IOM recommended additionalwomen s preventive services not addressed by USPSTF to close the gaps STI and HIV counseling ; all sexually active F) Ct, GC, Syphilis screening HIV screening (adults at HR; all sexually active F) Contraception (women w/repro capacity Breast Cancer Mammography Alcohol S&C Alcohol S&C Genetic S&C Tobacco C&I Tobacco C&I Preventive medication counseling Cervix: Cytology HPV + cytology Colorectal: FOBT, Colonoscopy, Sigmoid Diet counseling if CVD risk Interpersonal and DV S&C Well woman visits Folic acid supplement GDM screen Rh screen Anemia screen STI screen Bacteruria screen Lactation Supports TdaP, Td booster, MMR, varicella Influenza Hepatitis A, B Meningococcal HPV (women 19 26) Pneumococcal Zoster CV: HTN, lipids T2DM screen Depression screen Osteoporosis screen Obesity screen; C&I if obese S&C: screening and counseling C&I: counseling and interventions Women's Preventive Services Women's Preventive Services HHS Guideline for Insurance Coverage Well-woman visits annually includingpreconception and prenatal care Frequency Several visits may be needed to obtain all recommended services, depending on health status, health needs, and other risks HHS Guideline for Insurance Coverage All FDA approved contraceptive methods, sterilization procedures, and patient education & counseling for women with reproductive capacity Frequency As prescribed All methods must be covered, but not all products Limited exclusion for religious institutions (e.g., churches) from providing contraceptive coverage for insured employees

Immediately Next new plan year ; mostly by 1/1/2013 Once plan changes; mostly in 2014 * Unless plan agrees to remove cost sharing earlier than deadline How Do You Know If You Have First Dollar

12 New Plan Costsharing? Nongrandfathered Grandfathered plan When Does the Contraception As Prevention Benefit Start? Definition Created after 8/1/2012 Created 3/23/10-8/1/12 Created before 3/23/2012 Yes* When is cost-sharing prohibited? Immediately Next new plan year ; mostly by 1/1/2013 Once plan changes; mostly in 2014 * Unless plan agrees to remove cost sharing earlier than deadline How Do You Know If You Have First Dollar Coverage for Contraceptives? Call Member Services at you health plan the number is on your insurance card If you feel you are not receiving benefits to which you are entitled, contact the National Women s Law Center PILL4US pill4us@nwlc.org National Women s Law Center: PILL4US How Can My Practice Prepare? Ask every patient if she also sees another provider for screening.if so, avoid duplication of interventions Determine the screening policies for your practice Make sure that all staff are aware of your policy Inform your patients of changes that apply to them During transition, discuss these decisions with patients Inform patients with a personal letter or newsletter Keep track of benefit changes made by your payers Few have changed screening benefits yet but they will! Enjoy SF and have a safe trip home

Paps & Pelvics: Where Do We Stand?

Women s Health Congress Washington DC, April 5, 2014 Paps & Pelvics: Where Do We Stand? There are no relevant financial relationships with any commercial interests to disclose Michael Policar, MD, MPH