Transcript Slide 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.
Overview
 CDC guidance
Annual screening recommendations
 Expedited Partner Therapy (EPT)
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 Legal barriers/facilitators project
 Other 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
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Partner Services
 Treating partners of patients with STD is critical
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Halt spread of infection
Prevent re-infection of those treated
 Provider or provider-assisted referral is optimal
strategy
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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 patientdelivered 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
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 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
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James G. Hodge, Jr., JD, LLM, Executive Director
Erin Fusé Brown, JD, MPH, Senior Researcher
Dhrubajyoti Bhattacharya, JD, MPH, Senior Researcher
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
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
Methodology
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Develop relevant questions addressing 4 key areas:
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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.
2.
3.
EPT is permissible for certain practitioners
and conditions
EPT is likely prohibited
EPT is potentially allowable subject to
additional actions or policies
Online Tool
http://www.cdc.gov/std/ept/legal/default.htm
EPT Legal Status Summary
WA
HI
VT NH
AK
MT
ME
ND
MN
OR
MA
ID
SD
WI
WY
NE
NV
UT
CA
AZ
NM
KS
OK
KY
EPT is Likely Prohibited
EPT is Potentially Allowable
TX
RI
CT
PA
NJ
DE
WV VA
MD
DC
OH
IN
MO
NC
TN
AR
SC
MS
EPT is Permissible
MI
IA
IL
CO
NY
AL
GA
LA
FL
PR - (Puerto Rico)
Conclusions
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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
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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 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
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
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340B Drug Pricing
 Other professional boards and associations
Nursing
 Pharmacy
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Acknowledgements
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Hunter Handsfield, MD, University of Washington
CDC Colleagues
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Susan Bradley
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Matthew Hogben, PhD
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Karen McKie, JD, MLS
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Steven Shapiro, BS
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Jill Wasserman, MPH
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Rachel Wynn, MPH
Center for Law and the Public’s Health Colleagues
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James L. Hodge, JD
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Erin Fusé Brown, JD, MPH
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Dhrubajyoti Bhattacharya, JD, MPH