Evaluating the New York State 2010 HIV testing law amendments: context, challenges, and conclusions.

Abstract

INTRODUCTION As the benefits of knowing one's HIV status early in infection have become increasingly well established, the Centers for Disease Control and Prevention (CDC) has issued progressively comprehensive screening recommendations.1 In 2006, the CDC recommended that testing be offered routinely in medical care settings to persons aged 13–64 years with an “opt-out” approach consistent with that of most other laboratory testing.1 In July 2010, the Office of National AIDS Policy released the National HIV/AIDS Strategy (NHAS) with goals of decreasing new HIV infections, improving access to HIV care and health outcomes, and decreasing HIV-related health disparities.2 National concerns addressed by the NHAS included the approximately 21% of infected persons in the United States unaware of their status, and the 35% of persons newly diagnosed who were not promptly linked to care. New York State (NYS) is home to 15% of the US residents living with diagnosed HIV infection and 10% of recently diagnosed cases.3 In the last decade, notable success has become evident, including marked and continuing declines in persons infected through injection drug use and near elimination of mother-to-child transmission. With aggressive prevention, care, and policy measures, new HIV diagnoses have been decreasing since HIV reporting began in 2000, with a 45% decrease in new diagnoses between 2002 and 2012 (New York State Department of Health; AIDS Institute, Bureau of HIV/AIDS Epidemiology, unpublished data, 2014). However, the fact that 29% of persons newly diagnosed with HIV in 2012 had AIDS within a year of HIV diagnosis is stark evidence that many New Yorkers remain unaware of their diagnosis until immune damage and many potential opportunities for HIV transmission have occurred.4 Moreover, the 59% increase in annual new diagnoses among adolescents and young adult men who have sex with men aged 13–29 years from 2002 to 2012 is a sobering reminder that HIV transmission has not decreased in some high-risk groups (New York State Department of Health; AIDS Institute, Bureau of HIV/AIDS Epidemiology, unpublished data, 2014). Concurrent with national efforts over the last decade, NYS has sought to routinize HIV screening and thus decrease the number of persons unaware of their HIV infection and facilitate early care and treatment for those with HIV infection. One obvious barrier to routine “opt-out” testing in medical settings as recommended by the CDC has been the NYS legal requirement for written informed consent before HIV testing. To address this and other barriers to routine HIV testing, Chapter 308 of the Laws of 2010, commonly referred to as the HIV Testing Law, authorized significant changes in HIV testing in NYS as of September 1, 2010.5 The publication of this supplement, “New York State HIV Testing Law,” provides an opportunity to examine the context and the impact of the law. This introductory article presents the elements of the law, summarizes the multicomponent evaluation reports in the supplement, and discusses the many challenges of evaluating the law. Key provisions of the legislation and accompanying regulations6 were as follows: HIV testing must be offered to all persons aged 13–64 years receiving hospital or primary care services, with limited exceptions. The offering must be made to inpatients, patients in emergency departments and to persons receiving primary care as an outpatient at a clinic or from a physician, physician assistant, nurse practitioner, or midwife. Specific consent for HIV testing was required. Specific consent for HIV testing could be included as part of a general consent to medical care, though specific opt-out language for HIV testing was required. Consent for rapid HIV testing could be oral but had to be noted in the medical record. Written consent was required for testing of incarcerated persons. Consent was durable, in that it could remain in effect for a period of time stipulated by the patient or until revoked by the patient. Components of informed consent and posttest counseling were specified. Patients had to be provided specific information about HIV, which could be in the form of written or audio/visual materials. Posttest counseling for those testing HIV negative had to provide information on risk behaviors; information could be conveyed in person, by mail, or by telephone as long as confidentiality was reasonably protected. Posttest counseling for those testing HIV positive included discussion of coping with the diagnosis, discrimination, transmission precautions, confidentiality, contact notification, domestic violence risk assessment, and medical and other HIV-related services. Providers authorizing HIV testing must arrange, with the consent of the patient, an appointment for medical care for those confirmed as HIV infected. Of note, 2 additional changes in the HIV Testing Law occurred as of April 1, 2014, with the amendments to Public Health Law Sections 2781 and 2135.7 These changes are expected to further facilitate HIV testing and linkage to care. The requirement for written informed consent for HIV testing was eliminated, except in correctional facilities, and state and local health departments are now allowed to share surveillance data with medical providers to promote linkage and retention. Regulations to implement the 2014 law are under development. The 2010 HIV Testing Law requirements for mandatory offer of HIV testing and for linking HIV positive persons to care did not change, and the evaluations reported here were completed before the 2014 law changes were made. IMPLEMENTATION CHALLENGES The HIV testing bill was signed into law 1 month before its effective date of September 1, 2010. Virtually all of the education and technical assistance for implementation occurred after the effective date. The New York State Department of Health (NYSDOH) had extensive dialog with a wide variety of health care providers and community advocates, facilitated by webcasts, webinars, regional stakeholder meetings, informational sessions for hospitals, and informational mailings, before releasing draft regulations for public comment in November 2011. Few comments were received, and the regulations were adopted without change in February 2012. Although the NYSDOH encouraged hospitals to implement the offer for HIV testing from the time of the effective date of the law, some hospitals may have waited to change their policies and procedures until after regulations were finalized in February 2012, to ensure that any decisions they made would conform to the regulatory requirements. With the postlaw timeline for implementation of the law and the lag inherent in most data collection and analysis, the short timeframe for evaluation was a key limitation of the legislative report. Implementation and evaluation of the law were also affected by the fact that the law requires a single offer of an HIV test to each person. Thus, as some facilities prepared to make ongoing recurrent offers to all patients, others may have been completing a one-time offer to their existing patients without provision for recurrent offers in the absence of identified behavioral risks. Given the staggered implementation, investigators reporting evaluation outcomes in this supplement chose varied timeframes as preimplementation and postimplementation periods. Continuing anecdotal reports suggest that some hospitals and primary care providers are not offering HIV testing as required by the law or that the offer made is not conducive to acceptance. Two evaluations of facility implementation conducted in 2012 supported the anecdotal reports that implementation was incomplete 2 years after the law went into effect, even in facilities in which administrative structures exist to support and monitor compliance with the law. A brief survey of all hospitals in NYS was conducted by the NYSDOH in July 2012, and 89% of hospitals reported that they had adapted their consent and medical practice to implement the law (New York State Department of Health; AIDS Institute, Office of Program Evaluation and Research, unpublished data, 2014). However, only 43% reported that “all” eligible patients were offered a test, whereas 38% said “more than half” of eligible patients were offered a test. Similarly, Egan et al8 reported results from a survey of New York Emergency Department (ED) Directors in 2012. Implementation in EDs was reported as high (86%), but only 65% reported offering HIV testing to all patients aged 13–64 years. The vast majority of EDs (94%) had a protocol for linkage of persons testing positive to care, but only 29% conducted follow-up to document linkage. EVALUATION STRUCTURE AND OUTCOMES The CDC has recommended routine testing of persons aged 13–64 years in medical settings since 2006,1 but no national or state-specific evaluation has looked at the impact of adopting routine testing on the number of persons screened or persons linked to care. Hence, there was no preexisting framework on which to model the evaluation or baseline of expectations in terms of impact. No single data set was available to directly measure the total number of New Yorkers tested for HIV or the number of newly diagnosed persons linked to care and treatment. After review of existing and potential data sources, the NYSDOH undertook 14 separate evaluation projects to examine various facets of the 2 questions the law posed. Additional evaluative work was done by the New York City Department of Health and Mental Hygiene (NYCDOHMH), an active partner in the implementation of the law. These projects are summarized in the required legislative report of September 1, 2012, which is available through the NYSDOH website.9 Reports incorporated here feature additional context and expanded analyses and/or data collection. In the first article, “The Evolution of Human Immunodeficiency Virus Testing Requirements in New York State, 1989–2013,” O'Connell et al trace the evolution of the new law, inclusive of social context and a content analysis of the 17 related bills introduced in the NYS Assembly and Senate from 2005 to 2010. Next, in “New York State 2010 HIV Testing Law: An Evaluation of Testing Rates Using Laboratory Data,” Lazariu et al assess an early impact of the law by examining the volume of HIV test specimens originating in NYS from 166 laboratories over a 26-month period. Modest increases were seen, consistent with the expectation that the law would result in increased testing. In “Evaluating the 2010 New York State HIV Testing Law in NYC Ambulatory Practices using Electronic Health Records,” Newton-Dame et al assess changes in HIV testing volume from providers participating in the NYCDOHMH's Primary Care Information Project, a system serving 650 practices and 1.6 million patients as of 2012. Although testing increased in the first year after the law, the overall level of testing was low, and a lesser increase in the second year prompts the question of whether the law's impact will include sustained increases in HIV testing. Two articles explore reactions of medical practitioners to the law and self-reported barriers to routine HIV testing. In “Correlates of Routine HIV Testing Practices: A Survey of New York State Primary Care Physicians, 2011,” Zielinski et al present survey data from physicians in 5 specialties obtained approximately 18 months after the passage of the law. The second article by Ortega-Peluso et al, “Routine HIV Testing Capacity, Practices and Perceptions among School-Based Health Center Providers,” uses survey data from medical providers serving adolescents through school-based health centers. Implementation of the law was far from complete among medical providers surveyed, but in both studies, a moderate percentage reported frequently or always offering testing to persons aged 13–64 years. Consumer-reported experience with HIV testing was assessed. In “HIV Testing Experience in New York City: Offer of and Willingness to Test in the Context of New Legal Support of Routine Testing,” Edelstein et al report on a 2011 telephone survey of 1,846 noninstitutionalized adults in New York City. Leung et al report on “HIV Test Offers and Acceptance: New York State Findings from the Behavioral Risk Factor Surveillance System and the National HIV Behavioral Surveillance, 2011–2012” through an assessment of local questions added to 2 established national CDC-sponsored survey projects. In these 3 studies, consistent themes emerged, including incomplete implementation of the routine test offer and participants' self-reported willingness to accept testing in medical settings. In “Timing of Entry to Care by Newly Diagnosed HIV Cases Before and After the 2010 New York State HIV Testing Law,” Gordon et al use viral load and CD4 lymphocyte data from the state's surveillance program as a proxy for linkage to care within 3 months of diagnosis. Progressive increases in the proportion of persons linked to care are seen from 2007 to 2012, with a greater increase in the percentage entering care within 3 months after diagnosis, consistent with a positive effect of the law on entry to care. Finally, the longer term impact of the law is investigated in “Mandating the Offer of HIV Testing in New York: Simulating the Epidemic Impact and Resource Needs” by Martin et al. A systems dynamics model of HIV testing and care was developed, where disease progression and transmission differ by awareness of HIV status, engagement in care, and disease stage. The model projected how alternate law implementation scenarios would change new infections, diagnoses, linkage to care, and living HIV cases over 10 years. Beneficial outcomes were consistent across scenarios but, not surprisingly, differed according to the level of implementation. IMPLICATIONS AND CONCLUSIONS This Supplement presents the first systematic evaluation of the impact of the NYS HIV Testing Law. The law may take several years to be fully implemented, and its impact may evolve over a much longer period. A review of available information from several public health projects and datasets, including Medicaid billing data, indicates that HIV testing in New York State was increasing before the law change and that this increase seems to have accelerated after the law was enacted (New York State Department of Health; AIDS Institute, Office of Medicaid Policy and Programs, unpublished data, 2014). This increase in testing may represent repeat testing in individuals with ongoing risk or an increase in the number of persons tested irrespective of risk assessment, both of which are worthy public health goals. Evaluation of the law's impact has focused on the latter. Given the evaluation limitations previously outlined, the fact that findings from different sources including reports contained here show that increased testing provides some assurance that the observed increases are a fair approximation of HIV testing in NYS, where linkage to HIV care is above the national average.3 Through Medicaid and the HIV Uninsured Care Program, NYS continues its strong commitment to ensuring the availability of care and antiretroviral treatment for all its HIV-infected residents. Although the legal approach to emphasizing public health testing goals in HIV can eliminate selected barriers, subsequent needed changes in approach may not occur in a timely manner. Carefully hewed legislative compromises may not have the impact of a demonstration of a decisive medical benefit or the cumulative impact of many small but timely tweaks in approach, either of which may occur with medical practice or public health policy evolution that is not constrained by preexisting legislation. Also, laws may not be effective in aligning overall fiscal, medical, and personal health care goals and thus may not realize their potential (Waxman M, Personal communication, 2014). The law evaluation has several limitations: Traditional quantitative research methods may not adequately address complexities in the system of HIV testing and care involving multiple public and private payers, facilities, providers, and social services. As noted, the law was implemented in the context of concurrent policies that may affect outcomes. Some of these related policies, such as national recommendations for HIV testing frequency, have similar goals to the state law, and thereby make it harder to distinguish each policy's unique impact. Other actions with policy implications, such as funding cuts from the federal government for supportive services that may improve testing and entry into care, may counteract some of the law's potential positive effects. Also, upcoming changes in health care reform may have additional impacts on testing, entry to care, and medical services received. Our evaluation does not answer certain key questions. For example, even though the percentage of the newly diagnosed with concurrent HIV and AIDS diagnoses has decreased slightly in recent years, we do not know if infected persons are being diagnosed earlier in their infection than would have occurred in the absence of the law. Similarly, because our evaluation focused on linkage at 1 point in time (3 months) after diagnosis, we do not know if people are otherwise experiencing more timely and sustained linkage to care than would have occurred without the law. The good news is that with the increased awareness and the increase in testing generated by the new law and concurrent ongoing efforts to increase HIV testing, new diagnoses continue to decline. These declines are occurring in men and women, all large race/ethnicity groups, most geographic areas, and most age and risk groups (New York State Department of Health; AIDS Institute, Bureau of HIV/AIDS Epidemiology, unpublished data, 2014). Additional evidence that the decline in new diagnoses represents fewer newly infected persons rather than inadequate testing strategies is seen in the NYS incidence estimates generated through National HIV Incidence Surveillance. Annual NYS incidence estimates have shown a statistically significant decline of 41% between 2006 and 2012, from 5,030 to 2,990 (New York State Department of Health; AIDS Institute, Bureau of HIV/AIDS Epidemiology, unpublished data, 2014). These encouraging findings have prompted New York to expand its focus. On June 29, 2014, Governor Andrew M. Cuomo announced a 3-point plan that involves “(1) Identifying persons with HIV who remain undiagnosed and linking them to health care; (2) Linking and retaining persons diagnosed with HIV to health care and getting them on anti-HIV therapy to maximize HIV virus suppression, so they remain healthy and prevent further transmission; and (3) Providing access to preexposure prophylaxis (PrEP) for high-risk persons to keep them HIV negative.”10 “Ending the Epidemic” goals have been established that include decreasing the new transmissions of HIV to <750 annually by 2020 and decreasing the percentage of persons who develop AIDS after HIV diagnosis. Multiple prevention, treatment, and policy initiatives are being pursued in an effort to achieve this dramatic decrease in HIV infection and AIDS in NYS by 2020. NYS is implementing additional strategies specifically related to HIV testing and linkage to care, which include (1) Development of regulations to implement the 2014 testing law amendments that further simplify consent requirements, align them as much as possible with the CDC-recommended “opt-out” approach1 and enable state surveillance data to be shared with medical providers to promote linkage and retention; (2) Promotion of the “fourth-generation” screening assays in HIV testing, which enables detection of acute HIV infection; (3) Multiple interventions supporting linkage and retention, including field services provided by partner services staff and NYSDOH-sponsored collaboratives that involve medical and community providers; (4) Intensive monitoring of linkage and retention through NYSDOH and NYCDOHMH surveillance data and NYSDOH-sponsored Quality of Care data. To provide a strong foundation for these efforts, additional work remains to ensure facilities and practitioners mandated to offer HIV testing and link newly diagnosed persons to care do so. Of particular note in the evaluation data are several studies that indicate people will accept HIV testing if it is offered. Providing technical assistance and other interventions that prompt practitioners and facilities to make the offer has the potential to significantly reduce the number of undiagnosed persons. This supplement highlights the challenges of continually rethinking HIV testing in the face of a changing epidemic and increased opportunities for implementing routine HIV testing. It is our hope that lessons learned from NYS's efforts to promote the offer of HIV testing as part of routine care and the subsequent linkage to care will resonate with our readers and find broader application in other parts of the country. ACKNOWLEDGMENTS The Editor wishes to acknowledge and thank Winnie Yu of the New York State Department of Health Public Affairs Group for editorial assistance with this Supplement, and Sharon Winters for verifying the references for several articles in this Supplement. Special thanks go to the following individuals who took precious time in their busy schedules to review the manuscripts and provide invaluable comments and constructive criticisms on improving the manuscripts—Haven Battles, Ian Brissette, James Clancy, Greg DiRienzo, Zoe Edelstein, Daniel Gordon, Marilyn Kacica, Daniel Kuhles, Victoria Lazariu, Rachel Malloy, Erika Martin, Louise-Anne McNutt, Maria Schymura, Perry Smith, Rosalind Thomas, Benjamin Tsoi, and Michael Waxman.