Sexually Transmitted Diseases:
The Real World of STD Prevention
The Legal Aspects of Expedited Partner Therapy Practice: Do State Laws and Policies Really Matter?
Cramer, Ryan JD, MPH; Leichliter, Jami S. PhD; Stenger, Mark R. MA; Loosier, Penny S. PhD, MPH; Slive, Lauren JD, MPH ; SSuN Working Group
From the Centers for Disease Control and Prevention, Atlanta, GA.
Supported by the Centers for Disease Control and Prevention (Cooperative Agreement No. PS08-865; data collection in Washington State also supported, in part, by National Institutes of Health, National Institute of Allergy and Infectious Diseases R01A068107).
This research was supported, in part, by an appointment to the Research Participation Program at the Centers for Disease Control and Prevention administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the US Department of Energy and the Centers for Disease Control and Prevention.
SSuN Working Group includes Lenore Asbel, MD (STD Control Program, Philadelphia Department of Public Health, Philadelphia, PA); Kyle T. Bernstein, PhD, ScM (STD Prevention and Control Services, San Francisco Department of Public Health, San Francisco, CA); Margaret Eaglin, MPH (City of Chicago Department of Public Health, Chicago, IL); Megan Jespersen, MPH (STD/HIV Program, Louisiana Office of Public Health, New Orleans, LA); Mukhtar Mohamed, MPH, MA (STD Control Program, Connecticut Department of Public Health, Hartford, CT); Preeti Pathela, PhD (Bureau of STD Control and Prevention, The New York City Department of Health and Mental Hygiene, Long Island City, NY); Mary Reed, MPH (Colorado Department of Public Health and Environment, Denver, CO); Michael C. Samuel, DrPH (STD Control Branch, California Department of Public Health, Richmond, CA); Christina Schumacher, PhD (Bureau of HIV/STD Services, Baltimore City Health Department, Baltimore, MD); Jane Schwebke, MD (University of Alabama at Birmingham, Birmingham, AL); Julie Simon, MSPH (Infectious Disease Assessment Unit, Washington State Department of Health, Olympia, WA); and Jeff Stover, MPH (Health informatics and Integrated Surveillance Systems, Virginia Department of Health–Division of Disease Prevention, Richmond, VA).
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Conflict of interest: None declared.
Correspondence: Ryan Cramer, JD, MPH, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS E-02, Atlanta, GA 30333. E-mail: firstname.lastname@example.org.
Received for publication January 14, 2013, and accepted March 11, 2013.
Expedited partner therapy (EPT) is a potential partner treatment strategy. Significant efforts have been devoted to policies intended to facilitate its practice. However, few studies have attempted to evaluate these policies.
We used data on interviewed gonorrhea cases from 12 sites in the STD Surveillance Network in 2010 (n = 3404). Patients reported whether they had received EPT. We coded state laws relevant to EPT for gonorrhea using Westlaw legal research database and the general legal status of EPT in STD Surveillance Network sites from Centers for Disease Control and Prevention’s Web site in 2010. We also coded policy statements by medical and other boards. We used χ2 tests to compare receipt of EPT by legal/policy variables, patient characteristics, and provider type. Variables significant at P < 0.10 in bivariate analyses were included in a logistic regression model.
Overall, 9.5% of 2564 interviewed patients with gonorrhea reported receiving EPT for their partners. Receipt of EPT was significantly higher where laws and policies authorizing EPT existed. Where EPT laws for gonorrhea existed and EPT was permissible, 13.3% of patients reported receiving EPT as compared with 5.4% where there were no EPT laws and EPT was permissible, and 1.0% where there were no EPT laws and EPT was potentially allowable (P < 0.01). Expedited partner therapy was higher where professional boards had policy statements supporting EPT (P < 0.01). Receipt of EPT did not differ by most patient characteristics or provider type. Policy-related findings were similar in adjusted analyses.
Expedited partner therapy laws and policies were associated with higher reports of receipt of EPT among interviewed gonorrhea cases.
Expedited partner therapy (EPT) is a partner management technique where medications or prescriptions are provided to the partner of a patient who tests positive for chlamydia or gonorrhea without physical examination of the partner. EPT can reduce chlamydia and gonorrhea reinfection1–4 and is recommended by the Centers for Disease Control and Prevention (CDC) and other medical and legal organizations.5–8 Given the effectiveness of EPT in reducing sexually transmitted disease (STD) reinfections and the low risk of adverse effects associated with its use,9 policy efforts have focused on facilitating its practice. To serve as a resource for providers, Hodge and colleagues analyzed state laws and policies relevant to EPT, categorizing the probable legal status of EPT for treating any STD in each state as: permissible, potentially allowable, or prohibited.10 The primary factors considered were state statutes (laws passed by the legislature), regulations (promulgated by state departments of health or professional licensure boards), and policy statements by state professional licensure boards supporting its practice. This resulted in a “comparative snapshot of legal provisions that may highlight legislative, regulatory, judicial laws and policies concerning EPT.”11
Research has evaluated various aspects of EPT. One study found that EPT is routinely used by family planning providers in California, and most of these providers feel that it improves care.12 In addition, rates of partner treatment are higher for both concurrent treatment visits (patient and partner treated concurrently) and EPT as compared with standard patient referral.13 EPT is cost-effective in certain situations,14 and changes to clinic policies requiring documentation of EPT have been shown to increase EPT’s acceptance.15 Lastly, provider knowledge of EPT is associated with higher rates of practice, yet practice is inhibited by concern for legal liability.16 Concern for liability exists because EPT involves prescribing and dispensing medications to individuals who have not been physically examined by a health care provider. Potential legal actions include medical malpractice lawsuits from individuals or censure from state professional licensure boards.10
Concern for legal liability is considered one of the primary impediments to the practice of EPT,10 and despite policy initiatives intended to clarify its legal status, the effect of these laws and policies on the provision of EPT has not been evaluated. Therefore, this study investigates the relationship between laws and policies and the practice of EPT by comparing the receipt of EPT by patients with gonorrhea in Sexually Transmitted Disease Surveillance Network (SSuN) participating sites across states of varying legal environments.
MATERIALS AND METHODS
We used several sources to assess the relationship between legal and policy aspects of EPT and receipt of EPT among reported cases of gonorrhea in the United States. For the legal and policy variables, we used the Westlaw legal research database (Thompson Reuters, New York, NY) and the probable legal status for each state as listed on CDC’s Web site to categorize states.11 These data were merged with data collected in 2010 from the 12-site SSuN, which includes STD programs in health departments in the 4 US Census regions (Fig. 1). Each site interviewed a random sample of individuals diagnosed as having gonorrhea from cases reported to the health department. Cases were randomly assigned into the sample when entered into the surveillance system or were randomly selected from the reported cases weekly or biweekly. All sites include at least one county (refer to Fig. 1 for a list of counties), and cases were eligible for sampling if reported within 30 days of diagnosis. Interviews were conducted by telephone, and respondents were asked a series of questions about their gonorrhea diagnosis.
We used 3 measures to assess the legal and policy aspects of EPT as of January 1, 2010: (1) a combined variable of the general determination of state legal status for EPT as shown on CDC’s Web site (based on legal research conducted by Hodge and colleagues10) and state laws that explicitly authorize EPT for gonorrhea (law-legal status), (2) state medical board statements relevant to EPT, and (3) state nonmedical board (eg, pharmacy board) statements relevant to EPT. Using EPT laws specific to gonorrhea from Westlaw and the probable legal status of EPT as displayed on CDC’s Web site, we coded the primary legal variable, law-legal status, into the following categories: (1) has law authorizing EPT for gonorrhea and is listed as permissible on CDC Web site (gonorrhea [GC] EPT law and CDC permissible), (2) does not have law authorizing EPT for gonorrhea but is listed as permissible on CDC’s Web site (no GC EPT law and CDC permissible), and (3) does not have law authorizing EPT for gonorrhea and is listed as potentially allowable on CDC’s Web site (no GC EPT law and CDC potentially allowable; Fig. 2). We used the legal status of EPT as shown on CDC’s Web site as a measure of the general legal context of EPT for each state. We considered only those authorities that carry the force of law (eg, statutes and regulations) to be “laws” for this variable.
We also coded policy variables indicating whether a state medical board or other nonmedical board had released a policy statement that would influence the provision of EPT. Although these policy statements do not carry the force of law, they are, nonetheless, presumptive of the legal status of EPT in a state and provide a strong indication of the likelihood that a board would censure a licensee for practicing EPT. For our purposes, “nonmedical board” meant any professional board or organization other than the entity responsible for licensing physicians, including entities such as boards of pharmacy and state medical associations. The policy statement variables were coded as (1) yes, statement prohibits EPT; (2) yes, statement permits EPT; and (3) no statement influencing EPT. EPT laws and policies did not change during the study period in any SSuN site.
Our outcome of interest was receipt of EPT. As part of the SSuN interviews, patients with gonorrhea were asked if they were given medication or a prescription for their sex partners using the following response options: (1) no; (2) no, partner(s) was already treated; and (3) yes. Respondents who reported that their partner(s) was already treated were considered ineligible for EPT; therefore, our final outcome measure was dichotomous (yes/no). One site (San Francisco) used different coding (yes/missing) for this variable that we recoded as yes/no; therefore, our estimate of EPT in this site should be interpreted as a minimum estimate.
In addition, SSuN interviews with patients with gonorrhea collected information on patient characteristics and provider type. Demographics examined in our analysis included patient age (limited to those 15–59 years old), race/ethnicity, education, sex/sexual behavior (women; men who have sex with men, or MSM; men who have sex with women, or MSW), and recent incarceration history (past 12 months). Although EPT is not routinely recommended for MSM because it might inhibit diagnosis and treatment of coexisting infections,5 our purpose was to examine the actual implementation of EPT in areas with different legal environments rather than evaluating adherence to CDC guidelines. Therefore, we included MSM in our analyses. In addition, respondents were asked about other STDs (previous gonorrhea diagnosis in the past 12 months and coinfection with chlamydia during current gonorrhea diagnosis) and were asked if they had used crack cocaine or methamphetamines in the past 12 months. Respondents reported their number of sex partners in the past 3 months and were asked several questions about sexual risk in the past 12 months, including the following: had anonymous sex partner, met sex partner on internet, exchanged sex for money/drugs, and had partner who had been in jail/prison recently. Type of health care provider where gonorrhea was diagnosed was also included in the analyses.
We used SAS (Release 9.2; SAS Institute, Cary, NC) for analyses. Specifically, the SURVEY procedures were used to (1) adjust and account for the complex sample design (eg, clustering by county) and (2) weight data for site sampling fraction and nonresponse (by age, sex, provider type). Our law-legal status variable was highly correlated with our 2 policy variables (policies were included in the general legal status displayed on CDC’s Web site); therefore, we assessed the relationship between these variables and our outcome separately. We used χ2 tests for bivariate analyses. Variables significant at P < 0.10 in bivariates were included in an adjusted logistic regression model. We conducted 2 post hoc analyses excluding MSM and Washington (statewide effort to promote EPT) separately, to see if our findings were the same without either group. Finally, in the 7 SSuN sites that did not have a law authorizing EPT for gonorrhea, we used the χ2 test of independence to assess the relationship of each policy variable (state medical board and other nonmedical board policy statement) to the receipt of EPT. These estimates were unstable (relative standard errors were >30%); therefore, we did not include these variables in adjusted models.
In 2010, 3404 interviews with selected patients with gonorrhea were completed with a response rate of 39%. Among the sample, 2564 patients responded to the receipt of EPT question and were considered eligible to receive EPT. Overall, 9.5% of eligible patients with gonorrhea reported receiving EPT for their sex partners. Receipt of EPT was highest in Washington state where 43.8% of eligible patients with gonorrhea reported receipt of EPT and lowest in Connecticut where no eligible patients with gonorrhea reported receipt of EPT. Five sites reported receipt of EPT by less than 5% of patients with gonorrhea; the remaining 5 reported receipt by 10% to 20% of patients with gonorrhea (Fig. 1).
The law-legal status variable was significantly associated with the receipt of EPT (P < 0.01) (Table 1). EPT was received by patients with gonorrhea more often in jurisdictions that have a GC EPT law and where EPT is considered permissible (13.3%) than in jurisdictions that do not have an EPT law and where EPT is considered permissible (5.4%), as well as in jurisdictions that do not have an EPT law and where EPT is considered potentially allowable (1.0%). Several demographic variables also met our criteria for inclusion in our adjusted model. In terms of race/ethnicity, white patients with gonorrhea had the highest reported receipt of EPT (12.4%), followed by blacks (9.7%), Hispanics (5.9%), and other racial/ethnic groups (14.4%; P = 0.06). The receipt of EPT also differed based on the sex of the patient’s sex partner, with MSM receiving EPT 7.5% of the time, MSW receiving EPT 5.8% of the time, and women receiving EPT 13.7% of the time (P < 0.01). Lastly, patients who had a recently incarcerated sex partner (past 12 months) had higher reports of receiving EPT (13.7%) did than those not having such a partner (8.7%; P = 0.07).
Among states that do not have a law authorizing EPT for gonorrhea, the receipt of EPT differed based on state medical board or other nonmedical board policy statements relevant to EPT (Table 2). In states with medical board policy statements permitting EPT, patients with gonorrhea received EPT at a significantly higher rate (24.4%) than in states with medical board policy statements prohibiting EPT (0%) and states without a medical board policy statement (1.1%; P < 0.01). Similar results were found for nonmedical board policy statements. In states with nonmedical board policy statements permitting EPT, patients with gonorrhea received EPT at a significantly higher rate (24.4%) than in states with nonmedical board policy statements prohibiting EPT (3.8%) and states without a nonmedical board policy statement (1.0%; P < 0.1). Washington implemented an extensive statewide effort to increase EPT uptake among providers; therefore, we also examined policy variables excluding this site. The significant differences remained (P < 0.01), but the percentage who received EPT dropped to 4.5% where state medical and nonmedical boards had statements permitting EPT.
Multiple Logistic Regression Models
In adjusted analyses, patients with gonorrhea in states that have an EPT law and where EPT is considered permissible (adjusted odds ratio [AOR], 23.2 [95% confidence interval [CI], 6.0–89.8]) and states that do not have an EPT law but where EPT is considered permissible (AOR, 7.3 [95% CI, 1.7–30.7]) were more likely to have received EPT than patients with gonorrhea in states without a law and where EPT is potentially allowable (Table 1). Of the demographic variables included in the model, sex of sex partners was the only variable that remained statistically significant in adjusted analysis. MSW were less likely to receive EPT than women (AOR, 0.4 [95% CI, 0.2–0.8]), as were MSM (AOR, 0.3 [95% CI, 0.2–0.70]). Race/ethnicity and having a recently incarcerated partner (past 12 months) were not significant in adjusted analyses.
Finally, we conducted 2 additional analyses to determine if findings were the same when separately excluding 1) MSM and 2) Washington (data not shown in tables). When excluding MSM, the findings for the law-legal status variable, sex of sex partners, and having an incarcerated partner in the past 12 months were similar to results from the overall model; however, we found one difference in that non-Hispanic whites (AOR, 2.1 [95% CI, 1.1–4.1]) were significantly more likely than non-Hispanic blacks to have received EPT. When excluding Washington, the only finding that was not similar to the overall model was that patients with gonorrhea in states that do not have an EPT law but where EPT is considered permissible (AOR, 1.9; 95% CI, 0.5–7.6]) did not differ from patients in sites without a law and where EPT is considered potentially allowable.
This study suggests that laws and policies authorizing EPT are associated with higher reports of receipt of EPT among patients with gonorrhea, when adjusting for patient and provider variables associated with EPT. Although this is the first study to evaluate the relationship between laws and EPT by comparing uptake across states of varying legal environments, our findings are consistent with evaluations of EPT uptake within jurisdictions that have laws authorizing EPT.12 Potential explanations include the possibility that laws authorizing EPT may diminish provider concern for legal liability, as such laws explicitly make the practice of EPT legal within a jurisdiction. Uptake is also higher in jurisdictions where EPT is deemed permissible versus those in which it is potentially allowable, notwithstanding the existence of an EPT law. However, in adjusted analyses, these findings were only observed when the site with an intensive statewide effort to promote the use of EPT (Washington) was included.
This study found that having a law or a regulation authorizing EPT was associated with higher receipt of EPT. However, in states where such laws or regulations do not exist, our findings suggest that professional licensure board policy statements are related to an increase in the receipt of EPT because the receipt of EPT was significantly higher in states with policy statements endorsing EPT, even when excluding Washington. It should be noted, however, that board policy statements do not carry the force of law as do statutes and regulations; policy statements are, nevertheless, highly presumptive of boards’ priorities in terms of regulating health care professionals.
It is worth noting that receipt of EPT was low overall, with fewer than 1 in 10 patients with gonorrhea reporting that they received it. Although receipt of EPT for gonorrhea was higher within jurisdictions with laws authorizing EPT for gonorrhea, it was still relatively low in these areas. Thus, although laws may alleviate provider concerns with dispensing medication without a physical examination, other possible barriers to the use of EPT may remain. Among providers, awareness of EPT and reimbursement issues may inhibit EPT use even in supportive legal environments. Furthermore, technological advancements such as electronic health records may optimize the practice of EPT.15 Finally, it is possible that uptake of new strategies may take several years; therefore, future research should examine the time since a law took effect and health department and other organizations’ efforts to increase the use of EPT.
There are some limitations to our analysis. First, our findings may not be generalizable to patients with gonorrhea across the United States, given that only 12 sites participated in SSuN (accounting for approximately 20% of US gonorrhea cases) and the response rate was low (39%). In addition, the number of sites produced limited legal environment variation. The second limitation is that this study analyzes the receipt of EPT among patients with gonorrhea, yet it has been suggested that EPT is more commonly provided to patients with chlamydia. This limitation was caused by the lack of available data on the receipt of EPT for chlamydia; future studies should investigate this issue as such data become available. In addition, given increasing antimicrobial resistance, in 2012, the CDC amended its guidance concerning EPT for gonorrhea stating “if a heterosexual partner of a patient cannot be linked to evaluation and treatment in a timely fashion, then expedited partner therapy should be considered, using oral combination antimicrobial therapy for gonorrhea....”17 Thus, the receipt of EPT for gonorrhea may have changed since the time of data collection, and concerns regarding susceptibility to oral cephalosporins may limit the practice of EPT for gonorrhea moving forward. Third, this study is not a randomized controlled trial; causality cannot be inferred from our results. Lastly, it is possible that states with providers more receptive to EPT are more likely to pass a law. Thus, the receipt of EPT itself could cause a legal environment more amendable to EPT, rather than the legal environment facilitating its practice. In addition, it is possible that health departments may more actively promote the use of EPT in states that pass laws.
The results of this analysis show that, within our sample, individuals with gonorrhea in jurisdictions that have an EPT law and, to a lesser degree, jurisdictions where EPT is considered legally permissible are significantly more likely to receive EPT as a treatment option. Similarly, in those jurisdictions without an EPT law, EPT was practiced at a significantly higher rate in jurisdictions with a medical or nonmedical board that supports its practice. For jurisdictions wanting to increase the receipt of EPT, this study suggests that laws and policies may be effective options for doing so.
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