Implementing Expedited Partner Therapy: Legal and Policy Issues

1. Implementing Expedited Partner Therapy: Legal and Policy Issues Amy Pulver, MBA, MA Associate Director for Policy, Planning and External Relations Division of STD Prevention Region II Infertility Prevention Project Advisory Committee Meeting New York, New York May 16, 2007 The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of the Centers for Disease Control and Prevention.

2. Overview • CDC guidance • Annual screening recommendations • Expedited Partner Therapy (EPT) • Legal barriers/facilitators project • Other policy efforts

3. CDC Guidance • Annual chlamydia screening recommended for sexually-active women ≤ 25 years of age • Infertility Prevention Program • Partnership with HHS Office of Population Affairs • Screen low-income, sexually-active women in publicly-funded clinics

4. Partner Services • Treating partners of patients with STD is critical • Halt spread of infection • Prevent re-infection of those treated • Provider or provider-assisted referral is optimal strategy • Not available to most with chlamydia or gonorrhea diagnoses because of resources • Usual alternative is advising patients to refer partners for treatment

5. Expedited Partner Therapy • Partners are treated without an intervening clinical assessment • Patients deliver either medications or prescriptions to their partners • 2005 CDC supports EPT as a useful option to facilitate partner management for treatment of male partners of female patients with chlamydial or gonorrheal infection • 2006 CDC’s STD Treatment Guidelines include guidance on EPT

6. http://www.cdc.gov/std/ept/default.htm

7. Guidance “The evidence indicates that EPT should be available to clinicians as an option for partner management… EPT represents an additional strategy for partner management that does not replace other strategies, such as standard patient referral or provider-assisted referral, when available. Along with medication, EPT should be accompanied by information that advises recipients to seek personal health care in addition to EPT. This is particularly important when EPT is provided to male patients for their female partners, and for male partners with symptoms.” Centers for Disease Control and Prevention. Expedited partner therapy in the management of sexually transmitted diseases. Atlanta, GA: US Department of Health and Human Services, 2006

8. http://www.cdc.gov/std/treatment/default.htm

9. Guidance “When medical evaluation, counseling, and treatment of partners cannot be done because of the particular circumstances of a patient or partner or because of resource limitations, other partner management options can be considered…. Patient-delivered therapy (i.e., via medications or prescriptions) can prevent reinfection of index case and has been associated with a higher likelihood of partner notification, compared with unassisted patient referral of partners. Medications and prescriptions for patient-delivered therapy should be accompanied by treatment instructions, appropriate warnings about taking medications if pregnant, general health counseling, and advice that partners should seek personal medical evaluations, particularly women with symptoms of STDs or PID.” Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006;55 (no. RR-11):6

10. Legal Status • Uncertainty about legal status consistently identified as barrier to implementation • Published papers • CDC guidance and reports • AMA statements • Perceived legal status is as important as actual legal status

11. Legal Status • “The legal status of EPT, whether real or perceived, will affect implementation.” * • “Most of the EPT implementation issues carry their own implications for research. For example, the only available data on the legality of EPT is based on the personal opinions of survey respondents, and refinement is desirable.” * • “Currently, EPT is not feasible in many settings because of operational barriers, including the lack of clear legal status of EPT in some states.” ** * Centers for Disease Control and Prevention. Expedited partner therapy in the management of sexually transmitted diseases. Atlanta, GA: US Department of Health and Human Services, 2006. ** Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines, 2006. MMWR 2006;55 (no. RR-11

12. Partners • James G. Hodge, Jr., JD, LLM, Executive Director • Erin Fusé Brown, JD, MPH, Senior Researcher • Dhrubajyoti Bhattacharya, JD, MPH, Senior Researcher

13. Project Goals • Joint effort of the Center for Law and the Public’s Health and CDC • Assess the legal environment underlying the practice of EPT • identify major legal issues • clarify relevant laws, ethics, and policies that facilitate or impede EPT • offer legal interpretations, strategies, or proposals for reform to accomplish EPT across jurisdictions consistent with public health laws and policies

14. Project Outcomes • Comprehensive table of legal authorities at the state and territorial levels • Web posting of comprehensive table • National input from federal, state, local, and tribal partners • Publishable paper submitted

15. Methodology • Develop relevant questions addressing 4 key areas: • Laws concerning the ability of physicians to provide a prescription to a patient’s partner without prior evaluation of the partner • Laws concerning the ability of other health care personnel (nurses, physicians’ assistants, pharmacists) to provide a prescription to a patient’s partner without prior evaluation of the partner • Laws concerning prescription requirements (e.g., patient-specific information requirements) • Laws concerning public health authorization for EPT

16. Outcome of Analysis • Assessment of the various laws and policies across the 50 states and other jurisdictions is categorized into three conclusions: • EPT is permissible for certain practitioners and conditions • EPT is likely prohibited • EPT is potentially allowable subject to additional actions or policies

17. Online Tool http://www.cdc.gov/std/ept/legal/default.htm

18. EPT Legal Status Summary WA VT NH HI AK MT ME ND MN OR MA ID SD WI NY RI MI WY CT PA IA NJ NE NV DE OH IN IL UT CA MD CO WV VA KS MO KY DC NC TN OK AZ NM AR SC GA AL MS TX LA EPT is Permissible FL EPT is Likely Prohibited EPT is Potentially Allowable PR - (Puerto Rico)

19. Conclusions • The assessment challenges the perception that laws may be impede the practice of EPT • In states where EPT is assessed as prohibited or possible, simple legislative, regulatory, or administrative fixes could permit its practice • Specific legal reforms may include statutory bills (in a few jurisdictions), administrative regulations, incorporation by reference of CDC STD Treatment Guidelines (2006), or favorable medical or pharmaceutical board interpretations

20. Limitations • Reviews are systematic and comprehensive, but not exhaustive • Interpreting non-binding legal sources, such as policy guidance documents or administrative decisions, is complicated • Comparative snapshot of legal provisions that may highlight laws concerning EPT in a given jurisdiction based on currently available information • Research is ongoing with additional opportunities for jurisdiction-specific feedback

21. AMA Policy Support • The following statements, recommended by the Council on Science and Public Health, were adopted as by the AMA House of Delegates as AMA policy and directive at the 2006 AMA Annual Meeting: 1. The AMA supports the Centers for Disease Control and Prevention’s (CDC) guidance on expedited partner therapy (EPT) that was published in its 2006 white paper, Expedited Partner Therapy in the Management of Sexually Transmitted Diseases. (Policy) 2. The AMA will continue to work with the CDC as it implements EPT, such as through the development of tools for local health departments and health care professionals to facilitate the appropriate use of this therapy. (Directive) http://www.ama-assn.org/ama/pub/category/16410.html

22. ABA Policy Support • Work with ABA professional staff and Public Health Law Section to develop resolution for ABA consideration • Assistance from CDC Public Health Law Office and The Center for Law and the Public’s Health • Consideration by ABA House of Delegates August 2007 • Support removal of legal impediments to implementation of practice recommended by CDC

23. Other Policy Activity • HRSA Office of Pharmacy Affairs • 340B Drug Pricing • Other professional boards and associations • Nursing • Pharmacy

24. Acknowledgements • Hunter Handsfield, MD, University of Washington • CDC Colleagues • Susan Bradley • Matthew Hogben, PhD • Karen McKie, JD, MLS • Steven Shapiro, BS • Jill Wasserman, MPH • Rachel Wynn, MPH • Center for Law and the Public’s Health Colleagues • James L. Hodge, JD • Erin Fusé Brown, JD, MPH • Dhrubajyoti Bhattacharya, JD, MPH