SUPPLEMENT ARTICLE. Jennifer Kates 1 and Jeffrey Levi 2,3

SUPPLEMENT ARTICLE Insurance Coverage and Access to HIV Testing and Treatment: Considerations for Individuals at Risk for Infection and for Those with Undiagnosed Infection Jennifer Kates 1 and Jeffrey Levi 2,3 1 Kaiser Family Foundation, 2 Trust for America s Health, and 3 School of Public Health and Health Services, George Washington University, Washington, D.C. The Centers for Disease Control and Prevention estimates that of the 1.2 million people with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome in the United States, 500,000 are not receiving care for their disease, including 250,000 who do not know they are HIV positive. Although little is known about these 2 subgroups of HIV-infected people, they are likely to be reflective of the larger population of people with HIV infection; that is, they are predominantly racial minorities, more likely to be unemployed and/or poor, and much more likely to be uninsured or dependent on public insurance programs such as Medicaid, compared with the US population overall. In addition, many persons receive a diagnosis of HIV infection late during the course of the disease, and those who are difficult to reach are less likely to receive standard-of-care antiretroviral therapy. New testing initiatives attempting to diagnose infection in persons who do not know their HIV infection status have raised important questions about the funding and program capacity of the current system to handle new patients. Given these challenges and questions, measuring the success of new testing initiatives will be critical but difficult. A large proportion of HIV-infected people in the United States are currently unaware of their infection or are untreated despite having received a diagnosis. The Centers for Disease Control and Prevention (CDC) estimates that there are 1.2 million people with HIV/ AIDS in the United States, 500,000 of whom are not receiving care for their disease, including 250,000 who do not know they are HIV positive [1]. The recent CDC recommendations to expand HIV testing in health care settings are the latest in a series of efforts to diagnose HIV infection in people who are currently unaware of their serostatus and to ensure that a greater percentage of people with HIV are receiving appropriate care [2]. Presented in part: Opportunities for Improving HIV Diagnosis, Prevention & Access to Care in the U.S., Washington, D.C., 29 30 November 2006. Reprints or correspondence: Ms. Jennifer Kates, Kaiser Family Foundation, 1330 G St. NW, Washington, DC 20005 (jkates@kff.org). Clinical Infectious Diseases 2007; 45:S255 60 2007 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2007/4512S4-0010$15.00 DOI: 10.1086/522547 For these efforts to succeed, several important issues must be considered, and several barriers need to be addressed. First, expanded HIV testing and outreach efforts will occur within the general context of a growing number of uninsured individuals in the United States and an increased dependence on the public sector for financing and/or provision of health care. The latter is particularly true for individuals at risk for or living with HIV infection. Second, current data on HIV testing are limited in their ability to inform us about untested persons and thus provide only sparse information on how best to reach them. Similarly, we have few data on persons who have already received a diagnosis of HIV infection but are not yet in the health care system. Finally, there are also questions concerning whether, given current resources, the health care system has the capacity to accommodate additional individuals with HIV/AIDS. This article provides an overview of these issues and highlights existing data that may be helpful in informing efforts to expand HIV testing. Specifically, it reviews data on insurance coverage and Access to Treatment for HIV Infection CID 2007:45 (Suppl 4) S255

for care and may inform strategies for reaching them and enhancing their access to treatment. HIV TESTING Figure 1. Insurance coverage among patients with HIV/AIDS receiving medical care during 1996. Data are from [4] and J. A. Fleishman (personal communication). access to HIV testing and treatment, with a particular focus on individuals who are at risk for HIV infection and those whose infection is undiagnosed. HIV AND INSURANCE COVERAGE Approximately two-thirds of the US population are privately insured, either through employer-sponsored coverage or private (i.e., nongroup) health insurance. The remaining third rely on publicly funded coverage, including Medicaid, Medicare, and the State Children s Health Insurance Program, or are uninsured [3]. Conversely, a nationally representative survey of HIVinfected people receiving care in 1996 found that the reverse was true, with only one-third having private insurance (figure 1) [4] (J. A. Fleishman, personal communication). A 2002 analysis of HIV-infected patients in the HIV Research Network found that only 16% had private insurance coverage; a similar result was seen in 2004 (figure 2) [5] (J. A. Fleishman, personal communication). Nationally the percentages of black persons and Hispanic persons with private insurance were lower than the percentage of white persons with private insurance, with correspondingly higher reliance on public funding [3]. This difference is more pronounced among people with HIV/AIDS. Among HIV-infected patients receiving care, more black patients, Hispanic patients, and women relied on public-sector coverage, particularly Medicaid, than did white patients and men (figure 3) [4] (J. A. Fleishman, personal communication). Large differences in income and employment levels exist between persons with and persons without HIV infection. The majority (62%) of HIV-infected individuals receiving care are unemployed, and nearly half (45%) have annual incomes less than $10,000, compared with rates of 5% and 8%, respectively, in the general population [4, 6, 7]. Although limited, these data provide critical information on the barriers people with HIV/AIDS face in accessing or paying Data on HIV testing rates for the entire US population and for those at particular risk for HIV infection provide an important context for understanding the current reach of testing efforts. According to a nationally representative survey conducted by the Kaiser Family Foundation in 2006, more than half (55%) of Americans reported having been tested for HIV at some time, with 21% having been tested in the last 12 months [8]. Self-reported testing rates were higher among black individuals, with 70% saying they had been tested at some point; 41% reported having been tested in the last 12 months. Fifty-seven percent of Hispanic individuals reported having been tested, with 28% reporting they had been tested in the last 12 months. The public seems to support the move toward routine HIV screening, with 65% saying that HIV testing should be treated similarly to routine screening for any other disease and should be included as part of regular check-ups and examinations; however, 27% said HIV screening should be treated differently. A concern facing expanded HIV testing is the perceived or actual relationship between HIV testing and HIV-related stigmatization. The Kaiser survey found that 62% of persons in the United States did not think getting tested for HIV would make others think less of them, although 21% did express this concern. Nine percent felt that being tested would engender more respect for them. In addition, there is evidence that stigmatization against people infected with HIV remains. Most people reported believing that there is prejudice and discrimination against HIV-infected persons in the United States, with 81% saying there is a lot or some discrimination, including 45% who say a lot [8]. Moreover, only 71% of respondents indicated they would be very comfortable or somewhat comfortable working with someone infected with HIV; 52%, with having a roommate Figure 2. Insurance coverage among patients with HIV/AIDS receiving medical care during 2002. Data are from [5] and J. A. Fleishman (personal communication). S256 CID 2007:45 (Suppl 4) Kates and Levi

Figure 3. Insurance coverage among patients with HIV/AIDS receiving medical care during 1996, by race, ethnicity, and sex. Data are from [4] and J. A. Fleishman (personal communication). Medicaid data include individuals with Medicaid and other forms of coverage, primarily Medicare. Medicare data include individuals with Medicare only. Because of rounding, data in some columns do not sum to 100%. who was infected with HIV; and 62%, with having an HIVpositive schoolteacher for their child, even though there is no risk of HIV transmission in any of these circumstances [8]. Nevertheless, the survey gives some indication that people are generally open to the concept of routine screening for HIV, that most people do not believe HIV testing would be associated with stigmatization, and that a significant number of people have already been tested. REACHING PERSONS AT RISK FOR HIV INFECTION AND THOSE WITH UNDIAGNOSED HIV INFECTION Despite the relatively large percentage of persons who have been tested and the expressed receptivity to expanded screening, individuals at high risk for HIV infection face particular and unique challenges with regard to testing. Studies show that a large number of persons at high risk for HIV infection who undergo testing do not return to obtain their test results, although the increasing availability of a rapid 20-min test should ameliorate this somewhat [9]. For example, a CDC study in 2002 found that 10% of men who have sex with men (MSM), 20% of heterosexual individuals at high risk for HIV infection (i.e., persons who reported having had heterosexual sex with a person with or at high risk for HIV infection, such as an injection drug user), and 27% of injection drug users did not return for their results (figure 4) [10]. A study of MSM in 5 US cities (Baltimore, Los Angeles, Miami, New York, and San Francisco) during 2004 2005 revealed that nearly 50% of MSM who tested positive for HIV were unaware of their HIV serostatus at the time of testing. This percentage was more pronounced (67%) among black MSM and much lower (18%) among white MSM (figure 5) [11]. Data indicate that the settings in which people are tested for HIV contrast with the settings in which they are more likely to receive a diagnosis of HIV infection, thus providing important context for current and future outreach efforts. Although most HIV tests (44%) are performed in the private setting, only 17% of tests conducted in these settings are positive. Positive results of HIV tests are most likely to be found in hospitals and emergency rooms (27% of tests) and community clinics (21% of tests), where only 22% and 9%, respectively, of the overall number of tests are performed. Up to 5% of HIV tests are performed in community clinics, correctional settings, sexually transmitted diseases clinics, and drug treatment clinics, where tests are also more likely to be positive [12]. These findings indicate that most HIV testing occurs when care is sought for other conditions, regardless of their association with HIV infection. This is a major impetus behind the CDC s new testing recommendations for health care settings. Some data are available on insurance coverage for and demographic characteristics of HIV-infected people at the time their infection is diagnosed, and these data provide an important background for informing outreach efforts. A CDC Kaiser Family Foundation study of data from 25 states revealed that 22% of patients with HIV infection diagnosed during 1994 2000 were covered by Medicaid at the time of diagnosis. An additional 19% were covered by other public-sector programs, and 27% were uninsured (CDC Kaiser Family Foundation, unpublished data). The large proportion of individuals covered by Medicaid at the time of diagnosis indicates that there is considerable potential to reach high-risk individuals through the Medicaid system. State Medicaid programs were used to good effect after the Pediatric AIDS Clinical Trials Group Protocol 076 Study Group reported the value of zidovudine therapy Figure 4. Percentage of persons at high risk for HIV infection who underwent HIV testing during 2000 but did not return to obtain their test results. Data are from [10]. Access to Treatment for HIV Infection CID 2007:45 (Suppl 4) S257

Figure 5. Percentage of HIV-positive men who have sex with men in 5 US cities who were unaware of their HIV serostatus at the time of testing during 2004 2005, by race. Data are from [11]. in preventing transmission of HIV from infected pregnant women to their children [13]. As with people living with HIV/AIDS overall, a majority of individuals for whom infection is newly diagnosed are estimated to be minorities, including 50% who are black [14]. In addition, compared with HIV infection in white individuals, HIV infection in black individuals and Hispanic individuals is more likely to be undiagnosed [1]. HIV infection in MSM and heterosexuals is also more likely to be undiagnosed, compared with HIV infection in injection drug users [1]. ACCESS TO TREATMENT AMONG PEOPLE INFECTED WITH HIV One indicator of access to treatment among people infected with HIV is the time between their initial HIV diagnosis and the onset of AIDS, the most advanced form of HIV disease. Data from the CDC indicate that 4 in 10 individuals develop AIDS 12 months after HIV infection is diagnosed. Clearly, HIV infection is being diagnosed much too late in the disease process for many people to fully benefit from available treatments (figure 6) [14]. Diagnosis is no guarantee that appropriate therapy will be received. Teshale et al. [15] estimated that, of persons who are eligible for antiretroviral therapy, 30% are not receiving medical care, whereas another 15% who are receiving medical care are not receiving ART. Studies of HIV-infected people who are considered hard to reach indicate that these individuals are less likely than the overall population of people with HIV/AIDS to receive antiretroviral therapy. For example, in a 16-site study of hard-to-reach HIV-infected people, 42% were not receiving antiretroviral therapy; even among individuals with CD4 cell counts of!350 cells/ml, 38% were not receiving antiretroviral therapy (figure 7) [16]. Comparatively, 18 in 10 of all people with HIV/AIDS who were receiving medical care were also receiving ART (figure 8) [16]. It is clear that a large number of people are currently not Figure 6. Interval between diagnosis of HIV infection and subsequent diagnosis of AIDS for persons in 37 US states and territories during 2004. Data are from [14]. receiving appropriate antiretroviral therapy, regardless of whether they are receiving other medical care. If this picture is to be improved, a key question is whether the current health care system has the capacity to provide care and services. The AIDS Drug Assistance Program (ADAP), part of the Ryan White HIV/AIDS Treatment Modernization Act (i.e., the Ryan White Program), is a federally funded, state-operated program that provides prescription medications to low-income uninsured or underinsured HIV-infected people in the United States. ADAP has struggled since its inception to provide medication to eligible individuals; as of March 2007, close to 600 people in 4 states were on waiting lists to receive therapy (table 1) [17]. In addition to waiting lists, other markers of restricted access to ADAP include stringent eligibility criteria and limits on per capita expenditures. MOVING FORWARD Moving forward, several questions face policy makers, public health practitioners, and others who seek to increase access to HIV testing and treatment. The CDC s recent testing recommendations are designed to routinize HIV screening in health care settings, with a goal of normalizing testing and increasing Figure 7. Percentage of hard-to-reach HIV-infected persons at 16 US sites during 2001 2003 who had access to antiretroviral drugs, by CD4 cell count. Data are from [16]. S258 CID 2007:45 (Suppl 4) Kates and Levi

Figure 8. Percentage of patients receiving medical care during 1998 who had access to antiretroviral drugs, by CD4 cell count. Data are from [16]. opportunities to reach persons whose infection has not been diagnosed [2]. As the foregoing data indicate, we know relatively little about people with undiagnosed HIV infection. Questions remaining include what barriers do they face, why are they disconnected from the system, who are they, and how do we best reach them? The studies presented here suggest that they are likely to have a disproportionately lower income, to be uninsured and/or reliant on public-sector health care coverage, and to be people of color, particularly black individuals. In addition, other data indicate that they are likely to have complex health care needs, often because of concomitant presence of hepatitis, mental illness, and drug dependence [18, 19]. Specific barriers to reaching the target population exist at the patient level, the payer and system levels, and the health care professional level. Patient-level barriers include challenges to accessing medical care, lack of or limits on insurance coverage, limits on knowledge about HIV testing and risk, and continued HIV-related stigmatization and perceptions of stigmatization. Payer-level and system-level barriers include limits on reimbursement for testing, constraints on resources, and more-specific barriers that may exist within programs in the private sector and those in the public sector, such as the Ryan White Program, Medicaid, and Medicare. Health care professional level barriers include lack of knowledge about HIV/AIDS, lack Table 1. State AIDS Drug Assistance Programs with waiting lists, March 2007. State No. of persons on waiting list Alaska 13 Montana 20 Puerto Rico 75 South Carolina 463 NOTE. Data are from [17]. of experience treating people infected with HIV, and time constraints. There are also important cost considerations and implications of expanding access to HIV testing. Because we have relatively little information on the major factors that are likely to affect national-level and state-level costs and resource needs of expanded access to testing and associated medical care and services for persons with newly diagnosed HIV infection, our ability to prepare for widespread testing is limited. For example, what proportion of the estimated 250,000 HIV-infected people who do not know their HIV serostatus is likely to be identified through increased testing efforts? The answer to this question will have significant implications for system capacity and resource needs. Also, how many people with newly diagnosed HIV infection will need medical care? Finally, what proportion of persons with newly diagnosed infection will need to rely on the Ryan White program, Medicaid, Medicare, and the private sector for medical care? Ultimately, given the annual per capita costs of antiretroviral therapy (estimated to range from $12,000 to $15,000, depending on the payer), these factors stand to significantly affect the level of demand on the health care system. SUMMARY Ultimately, the critical questions that need to be answered may become apparent only as increased testing and outreach efforts get under way. These questions include who are we trying to reach, how can we reach them, and how can we pay for their testing and care? Given the level of uncertainty and limited data, defining the success of such efforts is a difficult but critical task. Whether success is defined by the number of people tested, the time between HIV diagnosis and development of AIDS, and/or more-direct morbidity and mortality measures will itself affect the rollout and trajectory of this effort. Acknowledgments We thank Bruce Wilson for his assistance in preparing this manuscript. The Opportunities for Improving HIV Diagnosis, Prevention & Access to Care in the U.S. conference was sponsored by the American Academy of HIV Medicine, amfar, the Centers for Disease Control and Prevention, the Forum for Collaborative HIV Research, the HIV Medicine Association of the Infectious Diseases Society of America, and the National Institute of Allergy and Infectious Diseases. Funding for the conference was supplied through an unrestricted educational grant from Gilead Sciences, amfar, GlaxoSmithKline, Pfizer, Abbott Virology, OraSure Technologies, Roche Diagnostics, and Trinity Biotech. Supplement sponsorship. This article was published as part of a supplement entitled Opportunities for Improving the Diagnosis of, Prevention of, and Access to Treatment for HIV Infection in the United States, sponsored by the American Academy of HIV Medicine, amfar, the Centers for Disease Control and Prevention, the Forum for Collaborative HIV Research, the HIV Medicine Association of the Infectious Diseases Society of America, and the National Institute of Allergy and Infectious Diseases. Potential conflicts of interest. J.K. and J.L.: no conflicts. Access to Treatment for HIV Infection CID 2007:45 (Suppl 4) S259

References 1. Glynn MK, Rhodes P, Kajese T. Changes in the estimated number of persons diagnosed and living with HIV from 2000 to 2003 in the United States [abstract 969]. In: Program and abstracts of the 12th Conference on Retroviruses and Opportunistic Infections (Boston, MA). 2005. Available at: http://www.retroconference.org/2005/cd/abstracts/24669.htm. Accessed 29 March 2007. 2. Centers for Disease Control and Prevention. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in healthcare settings. MMWR Recomm Rep 2006; 55(RR-14):1 17. 3. Urban Institute, Kaiser Commission on Medicaid and the Uninsured. Health insurance coverage of nonelderly 0 64 (2005 2006), US. 2006. Available at: http://statehealthfacts.org/comparebar.jsp?indp126&cat p3. Accessed 31 October 2007. 4. Bozette SA, Berry SH, Duan N, et al. The care of HIV-infected adults in the United States. N Engl J Med 1998; 339:1897 904. 5. Fleishman JA, Gebo KA, Reilly ED, et al. Hospital and outpatient health services utilization among HIV-infected adults in care 2000 2002. Med Care 2005; 43(9 Suppl):III40 52. 6. US Department of Labor Bureau of Labor Statistics. Labor force statistics from the current population survey: employment status of the civilian noninstitutional population, 1940 to date. 5 October 2007. Available at: http://www.bls.gov/cps/. Accessed 29 March 2007. 7. DeNavas-Walt C, Proctor BD, Lee CH, US Census Bureau. Current population reports: income, poverty, and health insurance coverage in the United States: 2005. No. P60-231. Washington, DC: US Government Printing Office, 2006. 8. Kaiser Family Foundation. Survey of Americans on HIV/AIDS. 8 May 2006. Available at: http://www.kff.org/kaiserpolls/pomr050806pkg.cfm. Accessed 29 March 2007. 9. Greenwald JL, Burstein GR, Pincus J, Branson B. A rapid review of rapid HIV antibody tests. Curr Infect Dis Rep 2006; 8:125 31. 10. Sullivan PS, Lansky A, Drake A. Failure to return for HIV test results among persons at high risk for HIV infection: results from a multistate interview project. J Acquir Immune Defic Syndr 2004; 35:511 8. 11. Centers for Disease Control and Prevention. HIV prevalence, unrecognized infection, and HIV testing among men who have sex with men five U.S. cities, June 2004 April 2005. MMWR Morb Mortal Wkly Rep 2005; 54:597 601. 12. Schiller JS, Bernadel L. Summary health statistics for the U.S. population: National Health Interview Survey, 2002. Vital Health Stat 10 2004; 220:1 101. 13. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med 1994; 331:1173 80. 14. Centers for Disease Control and Prevention (CDC). HIV/AIDS surveillance report, 2005. Rev. ed., Vol. 17. Atlanta, GA: US Department of Health and Human Services, CDC, 2007. Available at: http://www.cdc.gov/hiv/topics/surveillance/resources/reports/. Accessed 23 October 2007. 15. Teshale E, Kamimoto L, Harris N, et al. Estimated number of HIVinfected persons eligible for and receiving HIV antiretroviral therapy, 2003 United States [abstract 167]. In: Program and abstracts of the 12th Conference on Retroviruses and Opportunistic Infections (Boston, MA). 2005. Available at: http://www.retroconference.org/2005/cd/ab stracts/24468.htm. Accessed 29 March 2007. 16. Cunningham WE, Sohler N, Tobias C, et al. Health services utilization for people with HIV infection: comparison of a population targeted for outreach with the U.S. population in care. Med Care 2006; 44: 1038 47. 17. Kaiser Family Foundation, National Alliance of State and Territorial AIDS Directors. National ADAP monitoring report. Washington, DC: Kaiser Family Foundation, 2007. 18. Douaihy AB, Jou RJ, Gorske T, Salloum IM. Triple diagnosis: dual diagnosis and HIV disease, part 1. AIDS Read 2003; 13:331 2, 339 41. 19. Stoskopf CH, Kim YK, Glover SH. Dual diagnosis: HIV and mental illness, a population-based study. Community Ment Health J 2001; 37: 469 79. S260 CID 2007:45 (Suppl 4) Kates and Levi