Susan F. Wood, PhD Jacobs Institute of Women‘s Health Milken Institute School of Public Health The George Washington University

GEORGE WASHINGTON UNIVERSITY MILKEN INSTITUTE SCHOOL OF PUBLIC HEALTH 950 New Hampshire Ave, NW Washington, DC Website: publichealth.gwu.edu

What my Postdoc Advisor told me: Wait until you are a Full Professor Maybe wait until you are a member of the NAS or IOM What can you really do at this stage in your career? ….I didn’t follow this advice So I accepted a AAAS Congressional Fellowship, sponsored by the Biophysical Society

Different parts of policy world: Congress Federal Agencies Individual Elected officials Think Tanks (IOM, Brookings) State level policy and practice Local level policy and practice Now for some examples (focused on Federal level)….

Working on Federal Policy: from the inside or from the outside From inside as Congressional Fellow and staff ( ) Women’s Health Equity Act Inclusion of Women in clinical research studies Expanded research on key women’s health issues Breast and Cervical Cancer screening program Infertility Prevention program From the inside at HHS and FDA ( ) Developed new programs on women’s health Funded research on medications and pregnancy as a model to industry Provided advice to policy leaders From the outside as advocate and Academic faculty (2005 – present) Provide data on ACA FDA Prescription Drug User Fee legislation Data on conflicts of interest Medication Abortion (Bridging the Divide)

US Department of Health and Human Services

Agencies you may be familiar with: National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Food and Drug Administration (FDA) Centers for Medicare and Medicaid (CMS) Less familiar with? Health Resources and Services Administration (HRSA) Substance Abuse and Mental Health Services Administration (SAMHSA) Agency for Health Care Research and Quality (AHRQ) Indian Health Service (IHS)

Congress authorizes and appropriates funds NIH, CDC, HRSA, HIS, SAMHSA, AHRQ, most other parts of HHS, are funded through annual appropriations FDA is funded through a combination of user fees (from regulated industry) and annual appropriations CMS funded through mandatory spending (if you are eligible for Medicare or Medicaid, the funds are made available, thus the term “Entitlements”)

The Federal Government does not regulate the Practice of Medicine It may regulate medical products and marketing by industry It may regulate safety and laboratory quality It may greatly influence through Medicare and Medicaid payment policy It may greatly influence the research priorities through NIH funding May influence the training of providers through residency funding Other ways? But state governments and professional boards and organizations determine who is a provider and scope of practice, etc.

However, Congress and the Federal Government treats women’s health differently than anything else! Examples: Battles over Preventive Services guidelines on mammography screening frequency Coverage of contraception under the Affordable Care Act (particular focus on IUDs, emergency contraception) Funding bans on abortion, special requirements for abortion covered under private insurance Fetal tissue research eg Planned Parenthood tissue donation Approval (or non approval) of “controversial products” like Plan B by FDA

Example 1 Plan B Science and data didn’t win this one Both FDA Advisory Committee AND the professional staff recommended full approval of Plan B emergency contraception in 2003/2004 Not approved with an age restriction (18) until 2006 Not fully approved until 2013 (after multiple court decisions) I resigned in 2005 after ongoing delays in FDA approval. The Federal Court made the final decisions not the medical and scientific experts.

Example 2 Mixed result, but data and expertise played a big role Coverage of women’s preventive services in the Affordable Care act

Figure 1 Women's Health Issues , e273-e280DOI: ( /j.whi ) Copyright © 2013 Jacobs Institute of Women's Health Terms and Conditions Terms and Conditions

Gender rating not allowed under ACA (as previously allowed in many states demonstrated by study by NWLC) Premiums can only be adjusted based on: Family size Geographic Area Age (limited to 3X premium) Tobacco use

Insurance Reforms Ban on Gender Rating Greater transparency and premium rate review Requirements on Medical Loss Ratio Guarantee issue Ban on pre-existing conditions Ban on caps and lifetime limits Remain on parents coverage until 26 Standard Summary of Benefits Extends Mental Health Parity

Essential Health Benefits Ambulatory patient services Emergency services Hospitalization Laboratory services Maternity and newborn care Mental health and substance use disorder services, including behavioral health treatment Pediatric services, including oral and vision care Prescription drugs Preventive and wellness services and chronic disease management without copay or deductible Rehabilitative and habilitative services and devices

Senator Barbara Mikulski, (D-MD) offered a Women's Health Amendment which was adopted and includes: Coverage by group and individual plans for basic women’s preventive care and screenings such as mammograms and Pap smears and Services provided by community health centers and women’s clinics. Direct HRSA and HHS to develop a list of preventive services for women to be included in addition to the USPSTF list. 17

Figure 1: Preventative Screening and Counseling Services for Women Source: United States Preventive Services Task Force ( and HHS, Office of Women’s Health ( * Counseling

Preventive Services for Women U.S. Preventive Services Task Force charged with making recommendations for men, women, and children The USPSTF list includes many services for women, but does not include several key services for women

IOM Definition of Preventive Service 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 wellbeing and/or decrease the likelihood or delay the onset of a targeted disease or condition.

ServiceRecommendation Screening for gestational diabetesPregnant women between 24 and 28 weeks of gestation and at first prenatal visit for high risk pregnant women HPV TestingAdd high-risk HPV DNA testing to cytology testing in women with normal results. Every 3 yrs after 30 Counseling for STIsAnnual counseling on STIs for sexually active women Counseling and screening for HIVCounseling and screening HIV annually for sexually active women Contraceptive Methods and CounselingFDA-approved contraceptive methods, sterilization procedures, and patient education and counseling for women with reproductive capacity Breastfeeding support, supplies, and counseling Comprehensive lactation support and counseling and costs of renting breastfeeding equipment. Screening and counseling for Interpersonal and domestic violence Screening and counseling for interpersonal and domestic violence Well-women visitsAt least one well-woman preventive care visit annually for adult women to obtain recommended preventive services, including preconception and prenatal care

Religious Employers and Contraception “Exemption” Religious employers expressed opposition about covering contraception as a preventive service Obama administration crafted a narrow exemption: Churches, houses of worship are exempt and are not required to offer coverage to employees

Religious Employers and Contraception – “Accommodation” Religious affiliated orgs such as schools or hospitals can use an additional transition period No subsidization of contraception is required To ensure women still have access to contraception Insurance plans will be required to offer the service directly to women free of charge Final “Accommodation” regulation released Challenged in court by some organizations Both for-profit companies and not profit organizations

Non Sectarion, Private For Profit Employers Coverage Rule went into effect Several Lawsuits filed under Religious Freedom Restoration Act Supreme Court Ruled in Hobby Lobby Case that closely held for-profit companies do have religious freedom rights and should have relief from coverage requirement Cases for Non-Profit religiously-affiliated organizations who don’t want to use the “accommodation”are pending before the Supreme Court now

Coverage of Contraception in Employer based health insurance Is this an employee compensation question? Is this sex discrimination? Is this impinging on employer’s religious freedom? Isn’t insurance about coverage of individual health needs- everyone differently?

Another strategy: Bridging the Divide Connect Researchers with Advocates and Policymakers Provide in-depth information for educated lay audience on specific topics Technically complex Good research base Relevant to many policies Provide basic research methods training – to help them be more critical readers of data

Topics: 1)Medication Abortion October 2015 Activities: Day long Roundtable with Researchers Hill meetings and briefings White Paper 2) LARCs, May 2016 Activities: Day Long Roundtable with Researchers Meetings with HHS agencies, and separate one with CMS White Paper

What’s Next? Women’s reproductive health remains controversial inside the DC Beltway Education of Members of Congress, the media, and the public remains a key strategy to inform them of data and clinical knowledge BUT it is not necessarily going to drive policy debates Advances may be more likely at the local, state and regional level YOUR EXPERTISE IS NEEDED- and might make a big difference!