Implementing Expedited Partner Therapy: Legal and Policy Issues

Amy Pulver, MBA, MAAssociate Director for Policy, Planning and External Relations

Division of STD Prevention

Region II Infertility Prevention Project Advisory Committee Meeting

New York, New YorkMay 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.

Overview

CDC guidance Annual screening recommendations Expedited Partner Therapy (EPT)

Legal barriers/facilitators projectOther policy efforts

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

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

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

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

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

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

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

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

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

Partners

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

Project GoalsJoint effort of the Center for Law and the Public’s

Health and CDCAssess 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

Project OutcomesComprehensive table of legal authorities at the

state and territorial levelsWeb posting of comprehensive tableNational input from federal, state, local, and

tribal partnersPublishable paper submitted

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

Outcome of Analysis

Assessment of the various laws and policies across the 50 states and other jurisdictions is categorized into three conclusions:

1. EPT is permissible for certain practitioners and conditions

2. EPT is likely prohibited

3. EPT is potentially allowable subject to additional actions or policies

Online Tool

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

CACA

OROR

WAWA

IDID

MTMT

TXTX

SDSDWYWY

NVNV

OKOK

KSKS

NENE

COCO

NMNMAZAZ

UTUT

NDND

SCSC

MNMN

WIWI

IAIA

MOMO

ARAR

LALA

VAVA

NCNC

GAGA

FLFL

ALALMSMS

ILILWVWV

KYKY

TNTN

NYNY

PAPA

ININ OHOH

MIMI

DEDENJNJ

CTCT

MEME

DCDC

MDMD

NHNHVTVT

PR - PR - (Puerto Rico)(Puerto Rico)

HIHIAKAK

EPT Legal Status Summary

EPT is Potentially Allowable

EPT is Likely Prohibited

EPT is Permissible

RI

MA

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

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

AMA Policy SupportThe 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

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

Other Policy Activity

HRSA Office of Pharmacy Affairs 340B Drug Pricing

Other professional boards and associations Nursing Pharmacy

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