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EDITORIAL SUPPLEMENT ARTICLE Opt-Out Testing: Who Can Afford to Take Care of Patients with Newly Diagnosed HIV Infection? Michael S. Saag Center for AIDS Research, University of Alabama at Birmingham, Birmingham The appropriate adoption of a policy of opt-out universal testing for human immunodeficiency virus (HIV) will likely increase the number of new HIV-infected patients seeking care by at least 25% over the next several years. On the basis of recent analyses, this policy will save lives and reduce medical care costs. However, the majority of clinics are currently operating at maximum capacity and cannot absorb the influx of newly identified patients. Therefore, the implementation of the policy of opt-out testing will expose deficiencies in clinic capacity and will likely precipitate a crisis in health care access and delivery for patients seeking care at these clinics. A comprehensive assessment of the funding requirements of existing HIV clinics is urgently needed, and sufficient resources must be appropriated to ensure that existing clinics can expand their capacity to absorb the onslaught of HIV-infected patients newly identified via the opt-out testing policy. With the widespread adoption of modern antiretroviral therapy, the mortality rate and life span for patients infected with HIV have improved dramatically [1–3]. Data from multiple cohorts demonstrate that the benefits of antiretroviral therapy are dramatically better for persons who start treatment earlier during the course of disease [3, 4]. At the University of Alabama at Birmingham (UAB) (1917) outpatient HIV clinic (Birmingham, AL), the mortality rates after 8 years for patients with a CD4 cell count of 50–199 cells/mL or !50 cells/mL were 30% and 50%, respectively, during the modern HAART era, compared with !10% for patients with CD4 cell counts of ⭓200 cells/mL (figure 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: Dr. Michael S. Saag, Center for AIDS Research, University of Alabama at Birmingham, BBRB #256, 845 19th St. South, Birmingham, AL 35294 ([email protected]). Clinical Infectious Diseases 2007; 45:S261–5 2007 by the Infectious Diseases Society of America. All rights reserved. 1058-4838/2007/4512S4-0011$15.00 DOI: 10.1086/522548 1). Therefore, antiretroviral therapy initiated after the CD4 cell count has decreased to !200 cells/mL is too late to be fully effective; all recent guidelines have adopted this position [3, 5]. The critical question, therefore, is when do patients first present for care? At the UAB HIV clinic, patients show up very late during the HIV disease course. During the past decade, the median CD4 cell count at the first clinic visit among patients with newly diagnosed HIV infection has consistently been !200 cells/mL (table 1), which is much too low to receive the maximum benefits from antiretroviral therapy [3–5]. Despite the publicity about HIV/AIDS during the past 25 years, many HIV-infected individuals do not know they are infected until they show up at physicians’ offices and emergency departments with symptoms of advanced HIV disease or AIDS-defining conditions. Educational messages appear to have had very little effect in encouraging at-risk individuals to seek testing and start treatment. There is one exception to this rule: pregnant women. The median CD4 cell count of pregnant women presenting to our clinic is 400 cells/mL. Why? Opt-out testing has been universally implemented for all pregnant women who present for prenatal care. For individual patients, therefore, universal application of opt-out testing will get more patients into care and will save lives. How many HIV-infected patients with undiagnosed infection will be identified through opt-out testing policies? The answer to this question will depend on the region of the country or the world under investigation, but for my region of the country—the rural southeastern United States—I estimate that at least 25% and perhaps as many as 50% of infected individuals do not know their HIV serostatus and are not receiving care. This estimate is based on the natural history of HIV infection, in which progression to symptomatic disease occurs an average of 10–12 years after infection. Therefore, a large proportion of asymptomatic HIVinfected individuals are living daily in rural areas of the southeastern United States without knowledge of their infection. Treating Patients with Newly Diagnosed Infection • CID 2007:45 (Suppl 4) • S261 substantially reduce costs, providing another compelling reason for universal opt-out testing. Further examination of the drivers of the cost of care reveals that medication expenditures comprise 75%–80% of the total cost of medical care, regardless of the CD4 cell count stratum (figure 2) [6]. For patients with higher CD4 cell counts, the majority of the medication-associated cost comes from antiretroviral therapy. In contrast, for patients with lower CD4 cell counts, the cost of nonantiretroviral medications constitutes the bulk of the cost of medical care. Even hospitalization costs among the sickest patients are dwarfed by the cost of medications. However, we were able to demonstrate that patients whose CD4 cell counts increased during the year of observation had a significantly lower annual cost of care than patients whose CD4 cell counts stayed the same or decreased. Therefore, it is likely that use of antiretroviral therapy, which increases CD4 cell counts over time, would ultimately result in reduced overall health care expenditures. Only a formal cost-benefit analysis could demonstrate the actual degree of cost savings, but it is clear that costs for patients with higher CD4 cell counts are much lower than costs for patients with lower CD4 cell counts. The most striking finding in this study was the paucity of funds available to sup- Figure 1. Kaplan-Meier analysis of the time to death among patients at the University of Alabama at Birmingham (1917) outpatient HIV clinic (Birmingham, AL) during the HAART era, according to CD4 cell count at the time of HAART initiation. Only with a policy of universal opt-out testing can these individuals be identified and linked to medical care. This policy is essential to the welfare and survival of these individuals. COSTS OF CARE Once patients with newly diagnosed infection are identified and linked to medical care, how much does it cost to treat them? We recently published data on the annual cost of health care services at our clinic [6]. Using data from our electronic medical record system, we described medical care expenditures according to the CD4 cell count and the following expenditure categories: medication costs, hospitalization costs, outpatient costs (including the costs of radiological examinations, laboratory tests, procedures, and home health care), referral costs, and physician and/or clinic fees. We assumed every patient had Medicare insurance, and standard reimbursement schedules were used to calculate the cost of each service or encounter with the health care system. Medication costs were obtained by determining the drug type, the dose administered, and the dates on which treatment was started and stopped. Drug price was calculated using the S262 • CID 2007:45 (Suppl 4) • Saag drug’s average wholesale price. Collection rates for expenditures were assumed to be 100%. Using this approach, we determined that the overall cost of care was approximately $18,600 per patient per year (table 2). But costs for patients who presented with a CD4 cell count of !50 cells/mL were 2.5 times those for patients who presented early during the course of disease (i.e., when the CD4 cell count was ⭓350 cells/mL). These data demonstrate that early diagnosis and treatment not only improve mortality rates but also Table 1. CD4 cell count at initial presentation among patients at the University of Alabama at Birmingham (1917) outpatient HIV clinic (Birmingham, AL) for whom HIV infection was diagnosed during the past decade. CD4 cell count, % of patients Year Median CD4 cell count, cells/mL !50 cells/mL 50–199 cells/mL 200–349 cells/mL ⭓350 cells/mL 1996 115 32.6 30.2 24.4 12.8 1997 1998 1999 180 221 212 21.4 16.1 23.9 31.8 31.3 25.4 16.9 26.3 21.1 29.9 26.3 29.6 2000 2001 144 202 34.7 25.0 23.5 23.9 20.4 23.9 21.4 27.3 2002 2003 2004 166 98 170 30.3 36.5 31.3 23.3 23.5 23.4 24.4 24.7 28.1 22.1 15.3 17.2 Table 2. Annual expenditures per patient at the University of Alabama at Birmingham (1917) outpatient HIV clinic (Birmingham, AL), according to CD4 cell count. Mean expenditures in US$ per patient per year (%), by cost component Total Antiretroviral medication costs Nonantiretroviral medication costs Hospitalization costs Other outpatient costsa Physician and/or clinic fees 50–199 36,532 (100) 23,864 (100) 10,855 (30) 11,862 (50) 14,882 (41) 6685 (28) 8353 (23) 3369 (14) 1909 (5) 1416 (6) 533 (1) 532 (2) 200–349 ⭓350 Overall 18,274 (100) 13,885 (100) 18,640 (100) 11,935 (65) 9407 (68) 10,500 (56) 3452 (19) 1855 (13) 4240 (23) 1186 (7) 1408 (10) 2342 (13) 1365 (7) 930 (7) 1199 (6) 336 (2) 285 (2) 359 (2) CD4 cell count, cells/mL !50 NOTE. Adapted from [6]. a Includes the costs of outpatient radiological examinations, laboratory tests, procedures, and home health care. port the work of health care professionals and clinics. Reimbursement dollars allocated to pay the fees of clinics and health care professionals amounted to only $359 per patient per year, or !2% of the total costs of medical care, and this reimbursement figure assumes that every patient has Medicare insurance and that the collection rate is 100%! Even with this generous assumption, for a 1000-patient clinic, the maximum reimbursement that could be collected is less than $360,000 annually. This is the amount available to cover all of the costs of operating the clinic, including rent, physicians’ salaries, nurses’ salaries, utilities, ancillary personnel costs, and malpractice expenses. Given these circumstances, how do clinics survive in this reimbursement environment? In the United States, the answer to this question comes in the form of funding from the Ryan White Comprehensive AIDS Resources Emergency Act, now referred to as the Ryan White Program. The Ryan White Program was created in the early 1990s and is the primary reason patients are able to access care today in the United States. Over the past 5 years, however, funding through the Ryan White Program has not increased for most clinics, despite dramatic increases in patient volume. The only increases in federal funding of the Ryan White Program has targeted the AIDS Drug Assistance Program (ADAP), which is funded through Part B. No new dollars have been allocated for direct medical services. And although the provision of antiretroviral medications is an important component of HIV care, the provision of drugs without the provision of care is meaningless [7]. What good is access to high-powered medicine if there are no health care professionals available to provide care? The situation in our clinic demonstrates the emerging crisis in accessing medical care. We have 1500 active patients, and our operating budget is $2.1 million per year. Our third-party payment overall is $500,000, and we receive $500,000 through Part C of the Ryan White Program. What is remarkable is that our allocation of Ryan White funding has not increased for 7 years, despite a 75%–80% increase in patient volume. This implies that, 7 years ago, we were not optimally using our Ryan White allocation or that, currently, we are desperately underfunded. In fact, our annual deficit is $1.1 million. We absorb this deficit because we are part of an institution that has embraced the fight against the AIDS epidemic and will not allow the clinic to close. Clinics and physician practices that do not have such a benefactor are in trouble. IMPACT OF HEALTH CARE PROFESSIONAL SHORTAGES ON ACCESS TO MEDICAL CARE Taking all of these points together, it is clear that patients who start therapy late during the course of HIV infection have a much higher mortality rate and incur a higher cost of medical care, universal optout testing will identify up to 50% more patients who will need care, and HIV clinics are underfunded in the current reimbursement environment. This raises the following question: as universal opt-out testing is appropriately implemented in the United States, who will take care of the patients with newly diagnosed infection? The moral assumption of early testing is that once HIV-infected patients are identified, they will have access to care. But will they? In a collaborative effort between the HIV Medicine Association and the American Academy of HIV Medicine, a survey of 1800 HIV clinics was conducted to assess current clinic capacity. The overwhelming majority of respondents were internists or infectious diseases specialists 40–50 years of age who have been practicing HIV medicine for 110 years and work in clinics that provide care for ⭓500 patients. A plurality of respondents indicated that they had significant difficulty recruiting and retaining health care professionals and that it was more difficult to retain quality professionals than it was 5 years ago. However, most respondents indicated that the issue was moot because, in their words, they “didn’t have funding to hire a new person anyway.” Unlike the early years, when burnout among HIV health care professionals was due to the emotional drain of watching large numbers of young people die, today’s Treating Patients with Newly Diagnosed Infection • CID 2007:45 (Suppl 4) • S263 inability to hire new staff, increased burnout among health care professionals, and disincentives for young health care professionals to choose a career path in HIV medicine. SUMMARY Figure 2. Annual expenditures for patients at the University of Alabama at Birmingham (1917) outpatient HIV clinic (Birmingham, AL) who had a baseline CD4 cell count of 50–199 cells/mL, according to whether the CD4 cell count measured 6 months after baseline had increased, decreased, or stayed the same. ART, antiretroviral therapy. Adapted from [6]. HIV health care professionals are burning out from being overworked. The majority of responding clinics indicated they have experienced a 30%–70% increase in patient volume, yet these same clinics have not had the resources to add new staff to accommodate the explosion in the number of patients. Staff members reported that they are tired of working 12–14-h days, filling out paperwork, filing prior authorizations for medications and radiologic procedures, and answering telephone calls. In addition, no primary care clinics receive reimbursement for these indirect patient-care activities, although this situation is not unique to HIV care. The primary beneficiaries of these efforts are the third-party payers and insurance companies, who benefit from the “cost reductions” accrued by erecting barriers to care in the form of piles of paperwork that must be completed by health care professionals before they can deliver medical care. The most important question in the survey was “How much increase in patient capacity can your clinic environment currently, right now, absorb?” Only 15% of responding clinics felt they could absorb S264 • CID 2007:45 (Suppl 4) • Saag 25% more new patients. Therefore, 85% of the responding clinics could at most absorb 25% more new patients over the next year, and 50% could absorb only 10% or fewer new patients. Further evidence of the lack of current capacity is demonstrated by the estimated waiting time for appointments for new patients, which is up to 4 weeks at most clinics. Any increase in patient referral will likely further increase the waiting time for a new appointment. Can patients with advanced HIV disease wait 8–12 weeks for their initial appointment? Although the policy of universal optout testing continues to move closer to the goal of identifying ⭓250,000 HIV-infected individuals, there is currently not enough clinic capacity to absorb the volume of new patients. Where are the health care professionals going to come from? Compounding the problem, the majority (50%) of patients with newly diagnosed infection at our clinic have no health insurance, compared with 25% of patients 10 years ago. This changing demographic statistic exacerbates all of the access issues highlighted above, including the lack of funding for medical care, the The policy of universal opt-out testing is the right policy: it will reduce the costs of medical care and HIV-related morbidity and mortality and will likely reduce HIV transmission, as recently described elsewhere [8]. All of these benefits, however, are predicated on the assumption that patients will have access to medical care. Right now in the United States the assumption of access to care is suspect at best and a genuine emerging crisis at worst. The heavy emphasis by members of Congress on eliminating the embarrassment of ADAP-associated waiting lists by allocating funds via Part B of the Ryan White Program has inadvertently ignored the question, what good are medications if there are no trained health care professionals available to prescribe them? The economic data indicate that health care professionals in private practice will not likely manage HIV-infected patients, even if the patients have health insurance. Moreover, available data strongly suggest that publicly funded HIV clinics are currently at capacity. What is urgently needed is a renewed focus on the provision of health care in general, not simply medications. Formal assessments of clinic capacity are required to accommodate newly identified HIV patients through the optout testing policy and to reconcile the needs of these patients with existing clinic capacity. Once this needs-based assessment is performed, resources must be targeted to expand existing clinics and create new clinics where appropriate. Finally, the extra burden placed on clinic staff (which saves money for third-party payers) needs to be compensated. Clinic staff have assumed responsibility for performing medical assessments and prescribing appropriate therapy, but they also have taken on the role of assuring that patients have ac- cess to prescribed therapies. There are few other business enterprises in which the purveyor of a service takes on the responsibility of ensuring that the client can access payment for the services rendered. Metaphorically, the safety net that exists in our country for the 140 million individuals who fall through the cracks of our health care delivery system is made solely of the fabric of health care professionals who give a damn. These professionals deserve our support, if we expect to sustain the improvements in HIV care that have manifested over the past 2 decades. Acknowledgments 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. Financial support. The Center for AIDS Research, University of Alabama at Birmingham(National Institutes of Health [NIH]/National Institute of Allergy and Infectious Diseases 5 P30-AI027767-17), and the Centers for AIDS Research–Network of Integrated Clinical Systems (NIH R24). 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. M.S.S. receives grant and/or research support from Achillion Pharmaceutical, Boehringer Ingelheim, Gilead Sciences, GlaxoSmithKline, Merck, Panacos, Pfizer/ Agouron, Progenics, Roche Laboratories, Serono, Tibotec, Trimeris, and Vertex and is a consultant for Achillion Pharmaceutical, Avexa, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck, Monogram Biosciences, Panacos, Pfizer/Agouron, Progenics, Roche Laboratories, Tanox, Tibotec/Virco, Trimeris, and Vertex. His outpatient HIV clinic is a recipient of Part B and Part C funding from the Ryan White Program via the Health Resources and Services Administration References 1. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998; 338:853–60. 2. Hammer SM. Clinical practice: management of newly diagnosed HIV infection. N Engl J Med 2005; 353:1702–10. 3. Hammer SM, Saag MS, Schechter M, et al. Treatment for adult HIV Infection: 2006 recommendations of the International AIDS Society–USA Panel. JAMA 2006; 296:827–43. 4. Egger M, May M, Chene G, et al. Prognosis of HIV-1 infected drug naive patients starting potent antiretroviral therapy: a collaborative analysis of prospective studies. Lancet 2002; 360: 119–29. 5. US Department of Health and Human Services. Guidelines for the use of antiretroviral therapy in adults and adolescents. 10 October 2006. Available at: http://www.aidsinfo.nih.gov/. Accessed 24 April 2007. 6. Chen RY, Accortt NA, Westfall AO, et al. Distribution of health care expenditures for HIVinfected patients. Clin Infect Dis 2006; 42: 1003–10. 7. Saag MS. Which policy to ADAP-T: waiting lists or waiting lines? Clin Infect Dis 2006; 43: 1365–7. 8. Cohen M, Gay C, Kashuba AD, Blower S, Paxton L. Narrative review: antiretroviral therapy to prevent the transmission of HIV-1. Ann Intern Med 2007; 146:591–601. Treating Patients with Newly Diagnosed Infection • CID 2007:45 (Suppl 4) • S265