Expedited Partner Therapy: A Legal Tool to Advance Women’s Health Amy Pulver, MBA, MA Division of STD Prevention Healthy States Forum for State Legislators

Expedited Partner Therapy:A Legal Tool to Advance Women’s Health

Amy Pulver, MBA, MADivision of STD Prevention

Healthy States Forum for State LegislatorsBoston, Massachusetts

August 25, 2006

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

Women’s health issue: STI-related infertility Chlamydia and gonorrhea Impact on women

CDC guidance Annual screening recommendations Expedited Partner Therapy (EPT)

Legal barriers/facilitators project

STI-related Infertility

Chlamydia Most commonly-reported infectious disease in U.S. Bacterial infection, easily treated, asymptomatic 929,462 cases reported to CDC in 2004

Gonorrhea Second most commonly-reported infectious disease Bacterial infection, easily treated, asymptomatic 330,132 cases reported to CDC in 2004

Chlamydia — Age- and sex-specific rates: United States, 2004*

Men Rate (per 100,000 population) Women

Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14 10.8


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

458.3


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

744.7


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

402.9


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

185.2


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

99.3


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

56.1


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

23.0


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

7.4


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

2.2


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

147.5


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14 132.0


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

2,761.5


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

2,630.7


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

1,039.5


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

364.8


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

148.3


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

62.6


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

22.4


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

6.2


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

2.0


Age3,000 2,400 1,800 1,200 600 0 0 600 1,200 1,800 2,400 3,000

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

486.2

* 2004 STD Surveillance Report

Gonorrhea — Age- and sex-specific ratesUnited States, 2004*


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-145.8


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

252.9


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

430.6


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

302.1


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

178.6


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

124.5


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

89.6


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

48.1


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

17.0


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

4.1


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

110.2


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14 36.9


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

610.9


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

569.1


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

269.7


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

114.2


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

60.3


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

32.9


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

11.7


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

2.5


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

0.6


Age750 600 450 300 150 0 0 150 300 450 600 750

Total 65+55-6445-5440-4435-3930-3425-2920-2415-1910-14

116.7

* 2004 STD Surveillance Report

Women’s Health Consequences

•Infectious complications–Neonatal pneumonia (CT) or eye infections (CT & GC) in 60-

70% of infants born to untreated mothers–At least 2-5 fold increased risk of HIV infection

chlamydia

gonorrhea

pelvicinflammatory

disease

infertility

ectopicpregnancy

chronicpelvicpain

20-50%

10-40%

20%

9%

18%

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/treatment/EPTFinalReport2006.pdf

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

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

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

Assessing Legal and Policy Issues Concerning Expedited Partner Therapies

for Sexually Transmitted Diseases

James G. Hodge, Jr., J.D., LL.M.,Associate Professor, Johns Hopkins Bloomberg School of Public Health

Executive Director, Center for Law and the Public’s Health

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

Health and CDC’s National Center for HIV, STD, and TB Prevention (NCHSTP), Division of STD Prevention

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

The Center for Law & the Public’s Healthat Georgetown& Johns Hopkins Universities

CDC Collaborating Center Promoting Health through LawWHO/PAHO Collaborating Center on Public Health Law and Human Rights



Project OutcomesComprehensive table of legal authorities at the state

and territorial levels to assist law- and policy-makers, STD prevention professionals, and health care workers assess the legality of EPT (but not to provide specific legal advice)

Web posting of comprehensive table is forthcomingNational input from federal, state, local, and tribal

partners is anticipatedAssessment report and scholarship analyzing results of

comprehensive table is in development





Methodology Examine statutes, bills, regulations, cases, opinions, and other

laws and policies in each jurisdiction in 4 key areas:

1. Laws concerning the ability of physicians to provide a prescription to a patient’s partner without prior evaluation of the partner

2. 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

3. Laws concerning prescription requirements (e.g., patient-specific information requirements)

4. Laws concerning public health authorization for EPT (via incorporation by reference or other techniques)





Table of Key Legal Provisions Implicating EPT Juris-diction

I. Statutes/ regs on health care providers authority to prescribe for STDs to a patient’s partner(s) w/out prior evaluation

II. Speci-fic

judicial decisions concern-ing EPT (or like practi-ces)

III. Specific administra-tive opinions by the AG, or medical or pharmacy boards concerning EPT (or like practices)

IV. Legis-lative bills or prospec-tive regs concerning EPT (or like practices)

V. Laws that incorporate via reference guidelines as acceptable practices (including EPT)

VI. Pre-scription require-ments

VII. Assess-ment of EPT’s legal status with brief comm-ents

Alabama

↓Wyoming

Results with hot links to citations

Summary

Totals





Select Example - CaliforniaJurisdiction I. Existing

statutes/regsII. Specific judicial decisions

III. Specific administrative opinions

IV. Legislative bills or prospective regulations

V. Legal provisions that incorporate via reference guidelines

VI. Prescription law requirements

VII. Assessment of EPT’s legal status

California (+) EPT authorized for Chlamydia. May be conducted by physicians, nurse practitioners, certified nurse midwives and physicians assistants.

Cal. Health & Safety Code § 120582.

(-) EPT not allowed for all diseases or conditions except Chlamydia.

Cal. Bus. & Prof. Code §§ 2242(4), 4170.

(-) Suspens-ion of physician’s license upheld because the Board established that physician prescribed to persons who were not his patients. Leslie v. Bd. of Medical Quality Assurance, 234 Cal. App. 3d 117

(+) AB 2280 allows medical providers to offer patient-delivered therapy to partners of individuals diagnosed with gonorrhea or other STDs. (introduced June 21, 2006).

(-) Prescription label must bear patient’s name. Cal. Bus. & Prof. Code § 4076.

EPT is permiss-ible.

Statutory authority expressly authorizes EPT for the treatment of chlamydia.





Preliminary Conclusions

As of August 16, 2006, our initial 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 possible subject to additional actions or policies

3. EPT is likely prohibited





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

Jurisdictions Where EPT is Permissible





EPT is Permissible

RI

MA

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


HIHIAKAK

Jurisdictions Where EPT is Possible





EPT is Possible

RI

MA

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


HIHIAKAK

Jurisdictions Where EPT is Likely Prohibited





EPT is Likely Prohibited

RI

MA

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


HIHIAKAK

Comprehensive Assessment of EPT’s Legal Status





EPT is Likely Prohibited

EPT is Possible

EPT is Permissible

RI

MA

The Legality of EPT Across Jurisdictions

- EPT is permissible for certain practitioners and conditions in 10 jurisdictions (CA, CO, MN, MS, NV, PA, TN, UT, WA, WY).

~ - EPT is possible subject to additional actions or policies in 29 jurisdictions.

- EPT is likely prohibited in 13 jurisdictions (AZ, AR, FL, IL, LA, KY, MI, ND, OH, OK, SC, VT, WV).





The Legality of EPT Across Jurisdictions





10

29

13

0

5

10

15

20

25

30

Ju

ris

dic

tio

ns

Permissible Possible Prohibited

Conclusions

These initial assessments challenge 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





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 Erin Fusé Brown, J.D., M.P.H. Dhrubajyoti Bhattacharya, J.D., M.P.H.

Documents

Expedited Partner Therapy: A Legal Tool to Advance Women’s Health Amy Pulver, MBA, MA Division of STD Prevention Healthy States Forum for State Legislators