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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act Executive Summary In 1981, clusters of cases of unusual pneumonia and cancer in otherwise healthy gay men led to the identification and first reports in the United States of what we now know as Acquired Immune Deficiency Syndrome (AIDS) (CDC, 1981). Epidemiologic studies showed that the virus was transmitted by sexual contact with an infected person, exposure to infected blood and blood products, sharing of contaminated syringes and needles, and from infected mothers to infants during pregnancy, at the time of delivery or via breastfeeding (IOM/NAS, 1988). Three years later, the cause of AIDS, a newly recognized retrovirus now known as Human Immunodeficiency Virus or HIV, was identified (Barre-Sinoussi et al., 1983; Gallo et al., 1984). HIV infection causes progressive damage to the immune system by destroying white blood cells called CD4+ T-lymphocytes. Initial infection with HIV causes a flu-like illness in some individuals. Others have no symptoms at all until 10 or more years later when they experience symptoms of infections or other diseases that take hold due to their lowered immunocompetence. These conditions can range all the way from dementia, to cancer, to chronic diarrhea (Pantaleo et al., 1993; Fauci et al., 1996). Testing the blood for antibodies against HIV infection indicates whether the individual is infected with the virus, but does not allow one to determine the stage of the infection. This is done by measuring viral replication, or the amount of virus in the blood (HIV RNA), and the state of the immune system (CD4+ cell count). AIDS is a term used to define those persons with HIV infection that have a CD4+ count < 200 cells/µL
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act or a specific opportunistic infection and represents the advanced stage of HIV disease (CDC, 1992; Pantaleo et al., 1993; Fauci et al., 1996). Recent advances in treatment of HIV disease have resulted in slowing the progression of the disease, and often temporary restoration of immune functioning, in infected individuals. Early detection of HIV infection, before the infected person develops AIDS, can allow the individual to enter care and thus receive treatment and preventive services that could limit the spread of infection and prevent the morbidity and mortality of AIDS. The Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, enacted in 1990 and reauthorized and amended in 1996 and 2000, provides funding to cities, states, and other public and private entities to provide care and support services to individuals with HIV and AIDS who have low incomes and little or no insurance (Ryan White CARE Act. 42 U.S.C. § 300ff ). The CARE Act was named after Ryan White, a teenager from Indiana whose struggle with HIV/AIDS and AIDS-related discrimination helped raise awareness of the disease. The CARE Act is a discretionary program that relies on annual appropriations from Congress. Since its original authorization, CARE Act funding has increased from $220 million in fiscal year (FY) 1991 to $2.0 billion in FY2003 (HRSA, 2003). The Health Resources and Services Administration’s HIV/AIDS Bureau (HRSA/HAB) has lead responsibility for implementation of the CARE Act. The CARE Act is composed of four major program titles and several other components. Title I provides grants to Eligible Metropolitan Areas (EMAs—currently 51) that have been disproportionately affected by the HIV/AIDS epidemic (HRSA, 2002a). Title II provides grants to U.S. states and territories to improve the quality, availability, and delivery of health care and support services for individuals with HIV disease, and provides access to medications through the AIDS Drug Assistance Program (ADAP) (HRSA, 2002b). Title III provides direct grants to nonprofit entities for primary care and early intervention services, and capacity building and planning grants (HRSA, 2002c). Title IV provides grants for family-centered care for infants, children, youth, and women living with HIV disease and their families (HRSA, 2002d). Other components of the CARE Act include the AIDS Education Training Centers, the Dental Reimbursement Program, and the Special Projects of National Significance. The CARE Act operates against a backdrop of significant inequalities in access to health care in the United States. More than 43 million Americans are uninsured (Mills and Bandhari, 2003), and millions more hold insurance policies that do not cover basic medications or treatments (IOM,
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act 2001a). Congress enacted the CARE Act in 1990 at least in part to address this challenge regarding people with HIV infection. Uninsured and underinsured HIV-infected individuals rely on a variety of safety-net programs, including CARE Act–funded providers, community and migrant health centers, private free clinics, and public hospitals (Kaiser Family Foundation, 2000). Some individuals with private or other sources of insurance also rely on programs funded under the CARE Act because other sources of coverage are poorly coordinated and gaps often remain (Kaiser Family Foundation, 2000). Congress established the CARE Act, also referred to as RWCA, as the “payer of last resort”; the RWCA funds care for low-income, uninsured, or underinsured individuals who have no other resources to pay for care (Ryan White CARE Act. 42 U.S.C. § 300ff-11 ). Funding for the CARE Act, however, has been insufficient to redress all of the inequalities and gaps in coverage for people with HIV. CHARGE TO THE COMMITTEE In response to a congressional mandate in the Ryan White CARE Act Amendments of 2000, HRSA and the Centers for Disease Control and Prevention (CDC) commissioned the Institute of Medicine (IOM) to conduct this study. The Committee’s charge has three components (Box ES-1): To assess whether reported HIV cases are adequate, reliable, and sufficiently accurate for inclusion in formula grants under Titles I and II of RWCA and to make recommendations for the improvement of HIV reporting systems (discussed in Chapter 4). To identify data and tools for assessing a community’s severity of need and how that information can be used in allocation decisions (discussed in Chapter 5). To identify available health outcome and other data that can be used to measure the quality of and access to RWCA-funded services (discussed in Chapter 6). Each of the three components of the Committee’s charge is discussed below. USE OF HIV DATA IN THE TITLE I AND II ALLOCATION FORMULAS Formulas are used to allocate 70 percent of RWCA funds through Title I and II ($1.3 billion in FY2002) (HRSA, 2003). These formula alloca-
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act BOX ES-1 Charge to the Committee In the Ryan White CARE Amendments of 2000, Congress directed the IOM to examine the following issues (Ryan White CARE Act. 42 U.S.C. § 300ff-11 ): Use of HIV Data in the Title I and II Allocation Formulas “whether the surveillance system of each of the States regarding [HIV] provides for the reporting of cases of infection with the virus in a manner that is sufficient to provide adequate and reliable information on the number of such cases and the demographic characteristics of such cases, both for the State in general and for specific geographic areas in the State.” “whether such information is sufficiently accurate for purposes of formula grants under parts A and B of title XXVI of the Public Health Service Act” [i.e., Title I and II of the RWCA]. “With respect to any State whose surveillance system does not provide adequate and reliable information on cases of infection with the virus, [provide] recommendations regarding the manner in which the State can improve the system.” Information for Estimating Severity of Need for Resources “Existing and needed epidemiological data and other analytic tools for resource planning and allocation decisions, specifically for estimating severity of need of a community and the relationship to the allocations process.” Quality-of-Care Measures “The availability and utility of health outcome measures and data for HIV primary care and support services and the extent to which those measures and data could be used to measure the quality of such funded services“; and “other factors determined to be relevant to assessing an individual’s or community’s ability to gain and sustain access to quality HIV services.” NOTE: The Ryan White CARE Act Amendments of 2000 also directed the IOM to study the public financing and delivery of HIV care. HRSA commissioned a separate IOM study to address those issues.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act tions are based on estimated living AIDS cases (ELCs),1 using data from the AIDS case reporting system2 (HRSA, 2001). Many have raised concerns that such allocations are not equitable because the epidemic is not adequately reflected by AIDS cases alone, and that areas with emerging HIV epidemics are underfunded because all cases of HIV disease are not included (U.S. Congress, 2000a,b). A related concern with basing allocations on AIDS cases is that jurisdictions are not compensated for providing early access to care and treatment (U.S. Congress, 2000b). There is a widely held perception that incorporating HIV data in the formulas would increase the equity of RWCA allocations by targeting funds according to need (U.S. Congress, 2000a,b). Prompted by these concerns, Congress specified in the 2000 reauthorization of the CARE Act that reported cases of HIV disease should be incorporated into RWCA Title I and II formulas as early as FY2005—provided that the Secretary of Health and Human Services determines that such data are available from all eligible areas, and that they are “sufficiently accurate and reliable” (Ryan White CARE Act. 42 U.S.C. § 300ff-13 ). Cases of HIV disease are to be incorporated in the formulas no later than the beginning of FY2007 (Ryan White CARE Act. 42 U.S.C. § 300ff-13 ). The legislation authorized the IOM to assist the Secretary in assessing the readiness of states to produce adequate and reliable HIV case-reporting data, determine the accuracy of using HIV cases within the existing allocation formulas, and establish recommendations regarding how states could improve their HIV case-reporting systems (Ryan White CARE Act. 42 U.S.C. § 300ff-11 ). At the outset, the Committee recognized the difficulty of defining such terms as “sufficiently accurate,” “adequate,” and “reliable” to char- 1 ELCs are calculated by applying annual survival weights to the most recent 10 years of reported AIDS cases and summing the totals. CDC updates the survival weights every two years. CDC provides both the survival weights and the most recent 10 years of reported AIDS cases to HRSA, which performs the award calculations (HRSA, 2001). 2 Legal authority to require reporting of diseases resides primarily at the state level (Thacker, 2000). All U.S. states and territories have laws requiring health care providers and laboratories to report cases of AIDS using a standardized name-based reporting system. As a result of changes in the natural history of the disease due primarily to improvements in therapy, data from the AIDS case-reporting system have become less informative about current trends in the HIV epidemic. Many states also have passed laws, some as early as the mid-1980s, requiring the reporting of cases of HIV (non-AIDS) disease in an effort to obtain more recent information about trends in HIV epidemic and to assist in program planning, evaluation, and targeting of prevention resources. Unlike AIDS case reporting, which relies on a standardized name-based reporting system, HIV reporting practices vary substantially by state (see Chapters 3 and 4).
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act acterize the quality of HIV surveillance data. No absolute standards of accuracy, adequacy, or reliability exist for assessing HIV reporting data; these standards vary according to the purposes and tasks for which the data are used. Evaluating HIV reporting systems for use in resource allocation formulas requires a different set of performance criteria than evaluating these data for public health purposes (e.g., epidemic surveillance, contact tracing, and partner notification). While CDC (1999) has established performance criteria3 for evaluating the latter function, it was not the purpose of this Committee to assess these standards. Rather, the Committee defined criteria for “sufficiency,” “adequacy,” and “reliability” in terms of over- and underfunding errors to RWCA grantees. Congress specified that allocation formulas should incorporate information about HIV cases based on the belief that such information would better characterize the HIV/AIDS epidemic and areas’ needs for resources than AIDS cases alone (U.S. Congress, 2000b,d). Thus, the Committee focused on whether incorporating HIV reporting into the RWCA formulas would provide a better representation of HIV disease-related resource needs across jurisdictions and more fairly channel scarce RWCA resources. The Committee concluded that four conditions need to be met for this to occur: Every state would need to be capable of providing data on HIV cases for the formulas. The quality of HIV data across states and EMAs would have to be comparable. This means that if there are biases in HIV reporting, those biases should be of similar direction and magnitude across areas. Incorporating HIV case-reporting data into the formula would need to produce different and more accurate assessments of the “relative disease burden” among states and jurisdictions and their resource needs than AIDS data alone. 3 CDC issued surveillance guidelines in December 1999 (CDC, 1999) outlining the performance criteria for states’ HIV/AIDS surveillance systems. Several of the performance measurements had specific quantitative measurements. The criteria outlined in the document stated that the system had to be timely (66 percent of HIV/AIDS cases reported to the health department within 6 months of diagnoses), provide accurate case counts (≤5 percent mis-matched reports and ≤5 percent duplicate cases in the database), have complete ascertainment of mode of exposure to HIV (≥85 percent of reported cases, or representative sample, must have reported transmission mode after complete epidemiologic follow-up), and have complete case reporting (≥85 percent of diagnosed cases reported to the health department). In addition, states must show that they can match to other databases of public health importance, follow up on cases of public health importance, collect valid and reliable data for key data elements, and use data for public health planning (CDC, 2003).
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act Including HIV data in the RWCA allocation formulas would result in significant variation in the relative size of awards to states and EMAs and more equitable allocations. If, in contrast, HIV data dampen variations in awards among jurisdictions, then the formulas may not result in more equitable allocations. Capability of States to Provide Data for the Formula To evaluate the capability of states to provide data for the formulas the Committee asked three questions: (1) Does each state have an HIV reporting system? (coverage); (2) Has the HIV reporting system of each state had sufficient time for full implementation? (maturity); (3) Are the data from every state with a system of HIV reporting reliable enough to be used in the formulas? (full use of reported data). The Committee found that (as of October 2003) all U.S. states, territories, and cities, except Georgia and Philadelphia,4 had implemented HIV reporting systems, but that states are not equally capable of providing high-quality data. Some have only recently implemented such systems and need time to fully implement or refine them. Furthermore, CDC does not accept data from states that use codes rather than names to report their cases, owing to a lack of methods for unduplicating those coded cases. Comparability of HIV Reporting Data Even if all states were capable of providing data on HIV cases, data should be of comparable quality across jurisdictions before they are used in the RWCA formulas, or the differential errors should be such that incorporating the data increases—rather than decreases—the equity of the resulting RWCA allocations. Differential rates of completeness and timeliness of HIV reporting, and the migration of people living with HIV across jurisdictions, have the potential to create significant biases in allocations. Methodological inconsistencies in the finding or reporting of HIV cases across jurisdictions, such as variations in policies on laboratory reporting and the aggressiveness of case finding, can also lead to differential biases in underlying HIV data. Due to lack of data, the Committee could not fully investigate the potential influence of possible patterns of underreporting, reporting delays, migration of people with HIV disease, or variation in laboratory reporting policies and the aggressiveness of 4 Since the release of this report, Georgia implemented name-based reporting and Philadelphia adopted code-based reporting. All areas of the United States now have HIV reporting.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act case finding on resulting formula allocations. CDC is currently conducting an evaluation that would provide information about several of these issues in selected regions, but additional studies are needed to examine the comparability of data from the HIV case-reporting system across jurisdictions for the purpose of allocating resources. Relative Disease Burden and Ranking of Need Across Jurisdictions Including data on HIV cases in allocation formulas would not increase the overall amount of RWCA allocations, but it could potentially shift the amounts provided to different jurisdictions. One premise underlying this possibility is that the HIV epidemic is in different stages of maturity in different areas of the country. Here maturity refers to the length of time that the epidemic of HIV infection has been established in at-risk populations. Because the risk of AIDS is low in the first years after infection and then rises over time, one would expect the ratio of reported HIV to AIDS cases to be higher in more recently infected populations than in populations where the epidemic had been established for a longer period of time, and most infected individuals acquired the HIV virus many years ago. Thus, assuming very different stages of maturity of the epidemic would lead one to expect significant variation in this ratio across jurisdictions. States that believe that their HIV epidemic was established relatively recently suspect that the current measure (based on AIDS cases alone) places them at a disadvantage in RWCA formula allocations. If, however, the epidemic is at similar levels of maturity across jurisdictions, and therefore the ratio of reported AIDS cases to reported HIV cases is relatively constant, including data on HIV cases in the formula will, in fact, have little influence on the relative measure of disease burden, and hence little influence on the resulting awards. Although it seems reasonable to assume that the epidemic is in various stages of maturity in different jurisdictions, it is difficult to confirm this belief. Some data do suggest the possibility of regional variation—specifically that the epidemic may be growing more quickly in the southern region of the United States than elsewhere. Between 1994 and 2001, the number of reported AIDS cases appeared to increase faster in southeastern states than in other parts of the country (Kates and Ruiz, 2002). Inspection of the cumulative distribution of AIDS cases suggests that the AIDS incidence curves have fairly similar—though not identical—shape across states over time (Chapter 4, Figures 4-1 and 4-2); similarity in shape implies roughly similar epidemic dynamics. These figures also illustrate shifts over time in these curves, implying that the stage of epidemic maturity differs somewhat from state to state (and from EMA to EMA). The conclusion is that while we might expect a higher ratio of HIV to AIDS
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act cases in some jurisdictions than others, this effect is not likely to be particularly large. The assumptions regarding regional variability in epidemic maturity need further assessment. Sensitivity of Formula Allocations to Changes in the Underlying Input Data For HIV reporting data to more fairly channel resources, allocation formulas need to be sensitive to changes in the underlying data. The Committee could not examine the impact of including HIV data in the formula because data on HIV cases were not available from all states, including several key states with a high disease burden. Since data from those states could have a large influence on results, any analyses based on partial data could be very misleading. Instead, using a combination of data from states for which reported HIV cases are available and estimated HIV cases in others, the Committee examined what the current allocation is using the ELCs (the measure now used for RWCA resource allocation) and combined estimates of HIV prevalence and AIDS prevalence (see Appendix C).5 In its analyses, the Committee examined allocations per case (using Title I and II funds) across states and EMAs as a point of departure. The Committee acknowledges that there are many reasons why an equitable system would depart from this standard, including unequal costs of care, unequal need, differences in the efficiency with which jurisdictions apply funds, differences in the quality and comprehensiveness of the existing resource base from one jurisdiction to another, and differences in economies of scale. Similar to the findings from a previous General Accounting Office (GAO) study (2000), the Committee found substantial variations in the amount of Title I and II funds received per ELC across states and EMAs. This appeared to stem primarily from the Title II formulas, which give an advantage to states with EMAs. Such variations persist regardless of the measure of disease burden used. The Committee also found that except for San Francisco, Title I formula allocations per ELC are uniform across EMAs. The large allocation to San Francisco reflects the influence of the hold-harmless provision; removal of this provision would reduce San Francisco’s allocation to within the reported range for other EMAs, but would have a small impact 5 The Committee also examined current allocations using AIDS prevalence alone. The differences in allocations using estimated AIDS prevalence and ELCs were not informative, suggesting that any methodological differences between the calculation of ELCs and the calculation of AIDS prevalence is not important for the purposes of identifying allocation variations.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act on other EMAs, which would observe a 2.6 percent increase in their allocation if San Francisco’s dropped. As noted by the GAO (2000), the hold-harmless provision has a small overall effect on allocations to EMAs, except for San Francisco. The Committee identified a number of structural features of the Title I and Title II funding formulas (including hold-harmless provisions, set-asides, minimum funding thresholds, and the eligibility criteria for EMAs) that have a large influence on resulting allocations. These features may dampen the influence of and obviate the potential benefits of adding HIV data to the RWCA formulas. The Committee also used multiple regression analysis to examine cross-state variations in Title I and Title II RWCA funding allocations. Similar to previous GAO findings (GAO, 2000), these analyses indicated that the presence of an EMA was a significant factor in determining funding allocations. States whose reported AIDS cases were concentrated within EMAs received greater combined RWCA funding per case than did other jurisdictions. Appendix C provides further details. The Committee notes with concern that southeastern states appear to receive the smallest allocations, per estimated living AIDS case, under the current formulas. While southeastern states might benefit more than other states from a measure that includes reported HIV cases, the structure of RWCA formulas, which favors states with EMAs, is more important in explaining the relative disadvantage of southeastern states. RWCA funds are intended for individuals who are low income and uninsured or underinsured. Insofar as the current RWCA case reporting–based formula counts patients that have other sources of insurance or funding, it overestimates the number of cases that qualify for RWCA services, just as it may underestimate the needs of a particular jurisdiction with greater proportions of patients with HIV. In addition, the current formulas do not account for variations in costs of care or fiscal capacity across Title I and II jurisdictions (GAO, 1995). The Committee makes several recommendations for improving the quality and completeness of HIV case-reporting systems for the purposes of allocating RWCA resources. Greater use of electronic laboratory reporting, and potentially the use of data from pharmacies, could enhance the comparability of HIV reporting data across states in terms of completeness and timeliness. Name-based reporting is cited as one way to facilitate elimination of duplicate reports (CDC, 1999). However, it is unclear if name-based reporting is intrinsically superior to code-based reporting for eliminating duplicate reports. Due to name variations, even name-based systems do not permit complete unduplication. In addition, code-based reporting systems were developed by some states after substantial political debate,
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act and altering those systems would require significant legislative changes, time, and effort. For this reason, and because name-based reporting is not clearly superior to code-based reporting for the specific goal of accurately estimating the number of known cases for determining RWCA allocations, better methods for unduplicating reports for both code- and name-based reporting states need to be developed and implemented so allocation formulas can include data from all states. At the same time, the Committee recognizes that there are strong feelings, both pro and con, about the use of name-based reporting for other surveillance functions (Colfax and Bindman, 1998; Osmond et al., 1999; Hecht et al., 2000). The Committee did not take a position on these issues because its charge limits its scope of activity to reporting for allocation purposes. Other techniques for estimating the prevalence of HIV infection and the differential disease burden among states and EMAs, such as modeling and survey-based approaches, should also be explored. Such approaches have the potential of providing estimates that are more accurate, more timely, and more consistent across jurisdictions than complete enumeration. The Committee further emphasizes knowing the size and distribution of the undiagnosed HIV-infected population is an important marker of our success in providing care for all patients with HIV. The Committee makes the following recommendations to address these issues.6 The Committee targets these and subsequent recommendations to several different entities including Congress, the Secretary of Health and Human Services (HHS), HRSA and CDC, and independent bodies. The Committee directs several recommendations (4.5, 5.2, 6.2c) to Congress that are related to the intent of the Ryan White CARE Act program. Many of the recommendations (4.2a, 4.2c, 4.4, 5.4, 6.2, and 6.3) are targeted to the Secretary of HHS, who has broad oversight responsibilities for the implementation of the CARE Act. The Committee also targeted recommendations to the Secretary of HHS when the recommendations involved coordination among multiple agencies. Several recommendations involving specific technical issues are targeted to HRSA (4.1, 5.1, 5.3, 6.1, 6.2a, 6.2b) and CDC (4.2a, 4.2b, 4.2c, 4.3, 6.2b). In a few instances, the Committee makes recommendations that assessments be undertaken, or reviewed, by an independent body (4.3, 4.4). An independent body was specified when the recommendations required a broad assessment of the science base or when the Committee thought that an independent entity could protect the federal entities from any appearance of vested or conflict of interest, since those agencies would be applying 6 All recommendations (4-1 through 6-3) found in the Executive Summary are identified by chapter number and recommendation number within that chapter.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act awards, the effort required for grantees to complete the application seems unjustified. Accordingly, the Committee recommends the following: Recommendation 5-1 HRSA should modify the Title I supplemental application process. The severity-of-need component of the Title I supplemental award should be based on two components: Quantitatively defined need, based on a small number of measures that can be calculated by HRSA/HAB. Locally defined need described in a short narrative by the applicant. Recommendation 5-2 A predominance of the weight for determining Title I awards should be given to the quantitative measure of resource needs that reflect variations in costs of care and fiscal capacity across EMAs. Proposed New Approach The Committee notes that either direct or indirect measures of resource needs could be developed. The Committee also describes a way to develop indirect indicators. This approach—sometimes referred to as social-area analysis—attempts to relate the characteristics of geographically defined populations to variations in disease or the use of services (Shevky and Bell, 1955; Pittman et al., 1986; Kessler, 1998). The first step in the latter approach would be to identify direct measures or predictors of resource needs that meet acceptable standards of scientific importance, soundness, and feasibility. The second step is to develop a more explicit definition of the factors that are considered when defining resource needs. Once useful predictors of need have been identified, it will be necessary to assess the extent to which that information predicts variations in resource needs among areas. (Details of this analysis are presented in Chapter 5 and Appendix D.) Accordingly, the Committee recommends the following: Recommendation 5-3 HRSA/HAB should evaluate the feasibility and usefulness of using social-area indicator models that are based on publicly available data that are collected in standardized ways across jurisdictions, to estimate EMA-level resource needs for the Title I supplemental award. This approach also might be useful in assessing resource needs for other RWCA discretionary grant programs. Recommendation 5-4 The Secretary of HHS should evaluate the cost and utility of redesigning and coordinating studies conducted by HRSA/HAB and CDC to assess the specific needs and circumstances
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act of people living with HIV. These data can be used to estimate resource needs and as part of quality assessment activities. The Secretary of HHS should also assess the cost and utility of the indirect modeling approach described in Recommendation 5-3 for assessing regional variations in resource requirements. MEASURING QUALITY OF CARE HRSA/HAB and RWCA grantees have undertaken a variety of quality-improvement initiatives. The 2000 reauthorization placed more emphasis on quality by requiring that all RWCA grantees establish a quality-management program. Although Titles III and IV grantees already had such programs in place, the new provision required Titles I and II grantees to implement them. The focus on quality in the most recent reauthorization reflects two national trends in quality improvement and accountability. First, the health sector has seen growing interest in measuring and improving quality (IOM, 2000, 2001b). Second, federal policy and funding decisions are increasingly being based on demonstrable performance indicators. Progress on this broad agenda cannot be adequately measured by outcomes alone. Considering this context, the Committee interpreted this charge as a request to examine and make recommendations regarding the availability and usefulness of not only outcomes, but a broad continuum of measures for assessing and improving the quality of both primary care and support services funded through the CARE Act. Knowledge about what constitutes the best possible HIV/AIDS care is constantly changing, and the applicability of specific measures is limited by the evolving nature of the epidemic, including changes in the affected populations, the course and outcomes of infection, treatment standards, and policies and programs for financing and delivering care. Accordingly, while the Committee makes recommendations regarding measures that HRSA and grantees can use to monitor quality of care (see Recommendation 6-1), the Committee felt it could best contribute by providing a framework, criteria, and process for selecting measures that can evolve with the epidemic. Conceptual Framework HIV quality assessment can be thought of as having four key dimensions: the population of interest, the level assessed, the type of measures employed, and the spectrum of services to be evaluated. Population: The HIV-infected population consists of three groups: (1) those who are not yet diagnosed (and thus are not in care), (2) those who
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act are diagnosed but are not currently in care,7 and (3) those who are diagnosed and are receiving care. The CARE Act traditionally has focused on individuals who are diagnosed and currently in care. The Committee believes that quality assessment in HIV disease should extend to the entire HIV-infected population. Although quality assessment typically evaluates the care provided to those already receiving services, the number of persons not in treatment in an area can be an important indicator of access to care. Level of Assessment: Quality can be assessed at the individual patient level, at the clinic/provider level, or at the population level. When assessing the quality of a clinic or provider, analysts aggregate individual levels of quality to the program level. For example, a measure of the quality of care provided by clinics is the proportion of patients with indications for treatment who are receiving appropriate highly active antiretroviral therapy (HAART). Provider organizations, including HRSA and its grantees, now commonly employ a variety of such provider-level measures. Little attention has been paid to assessing quality for whole communities, metropolitan areas, or states.8 Type of Measure: The Committee adopted the widely accepted taxonomy that classifies measures into three domains: structure, process, and outcome (Donabedian, 1966). Structure measures assess the characteristics and resources of an organization, such as staffing, supplies, equipment, and training. Process measures usually focus on the actions of a provider or organization to improve care, such as promoting self-care, conducting diagnostic tests, and offering appropriate therapies. Outcome measures assess the changes in a patient’s health status. The three elements are interrelated and theoretically causally linked; that is, structure affects the probability of good processes of care, which can in turn affect outcomes such as health status and quality of life. Despite compelling arguments for analyzing outcomes as ultimate indicators of quality, such measures are often only weakly related to the quality of care provided by specific clinics. For this reason, process measures are often used in lieu of outcome measures at the program or clinic level, while the monitoring of outcomes is both a simpler and more compelling way of assessing the impact of all care provided in an area. Spectrum of Services: Both primary care and support services are essential components of high-quality care. Quality measurement to date has focused almost exclusively on clinical care. 7 The category of those who are “not in care” also includes those who are not in regular care. 8 HRSA, however, has recently initiated some work focused on developing quality measures at the EMA level.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act Review of Existing Measures The Committee reviewed the quality measures used by key organizations and frequently cited studies (see Table 6-2 for a list), and the measures used in RWCA programs. While there is some consistency in the measures used across sources, there is also a great deal of variation in how the measures are defined and implemented. This review also shows that many sources use numerous process measures and, to a lesser extent, outcomes measures. Process measures, almost all of which were closely related to well-accepted clinical guidelines,9 were over 10 times more frequent than outcome measures. Comparable attention has not been devoted to measures of structure, such as the availability of clinicians with the appropriate expertise and experience, despite studies linking increased provider expertise, capacity, and number of HIV-specific services to longer patient survival and prevention of opportunistic conditions (Bennett et al., 1989; Ball and Turner, 1991; Kitahata et al., 1996; Turner et al., 1998). The Committee identified relatively few measures of support services, and no systematic efforts to assess patient experiences with care. Finally, the Committee found that all measures focused on the provider level, and that no population-level process or outcome measures of quality were in routine use, despite their importance as an indicator of the overall impact of an area’s epidemic and prevention/treatment/support programs. Based on its review of selected quality-of-care measure sets, the Committee recommends a standardized set of structure, process, and outcome quality measures for assessing and facilitating quality improvement at the clinic level and at the EMA/state levels (See Recommendation 6-1). For the well-developed process of clinical care measures, measures were selected if at least four of the nine groups included them. Other measures were identified using expert judgment. A detailed review of measures used by these sources is included in Appendix E. The Committee also recommends several population-level measures be included in RWCA quality assessments at the EMA and state level. The Committee notes that RWCA grantees do not bear the entire responsibility for outcomes among their patients; private and public insurers and others do as well. However, population-based measures are essential in monitoring HIV care in a region and identifying areas for improvement. Rather than being interpreted as direct measures of the quality of care 9 See Department of HHS guidelines (http://www.aidsinfo.nih.gov/guidelines/) and International AIDS Society-USA guidelines (Yeni et al., 2002; http://www.iasusa.org/).
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act provided by specific clinics, they could be interpreted as reflecting the cumulative effects of many influences on case quality and outcomes. Overall, HRSA and RWCA-funded clinics and programs are doing an admirable job of defining, assessing, and attempting to improve the quality of care received by HIV-infected individuals. In many ways, RWCA-funded programs have a more advanced approach to measuring and improving quality of care than most general medical facilities. However, HRSA, RWCA grantees, and providers could still do much more to measure and improve quality of care by adopting a common framework and starting to standardize the assessment of quality. A critical step in moving from the current situation of uncoordinated data collection to a more standardized approach would entail reaching a consensus on how different indicators should be defined and implemented, and then putting into place a mechanism for ensuring the quality of the ensuing data. Although there are many ways of doing this, the National Committee on Quality Assurance (NCQA) and the National Quality Forum have developed procedures and policies that could be emulated or modified. For example, NCQA has technical advisory groups that provide advice on the importance, scientific soundness, and feasibility of different measures, and maintains a standing Committee on Performance Measurement that evaluates recommendations from technical experts and staff. A comparable set of procedures should be established by HRSA. The Committee summarizes these recommendations below. Recommendation 6-1 Quality measures: HRSA should adopt quality measures that are comprehensive with respect to populations (diagnosed in care; diagnosed but not in care; not diagnosed, not in care), level of assessment (provider and population levels), types of measures (structure, process, and outcome), and spectrum of services (clinical and supportive services). At a minimum, HRSA and grantees should strongly consider inclusion of the following standard set of measures to assess the quality of care provided by RWCA-funded providers and EMA and state-level programs. Standard definitions and detailed criteria for these measures need to be developed by HRSA in collaboration with grantees, affected communities, and other stakeholders after a rigorous examination of the importance, scientific soundness, and feasibility of potential measures. I. CLINIC LEVEL MEASURES A. Structure 1. Proportion of providers with appropriate expertise and experience in treating patients with HIV* 2. Availability of case management services
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act B. Process Screening for: 3. Cervical cancer* 4. Hepatitis B a. And administration of hepatitis B vaccine if negative 5. Hepatitis C* 6. Syphilis* 7. Toxoplasmosis 8. Tuberculosis* Performance of the following clinical monitoring tests: 9. CD4+ cell count and HIV viral load (process)* Antiretroviral treatment: 10. Provision of indicated antiretroviral treatment* 11. Provision of adherence counseling and monitoring Vaccinations and prophylaxis for opportunistic infections: 12. Influenza vaccination 13. Pneumoccocal pneumonia vaccination 14. Hepatitis B vaccination if patient not immune 15. If indicated, Mycobacterium avium complex (MAC) 16. If indicated, Pneumocystis carinii pneumonia (PCP)* C. Outcomes 17. Monitoring of CD4+ and viral load values* 18. Proportion of patients with a history of an AIDS-defining opportunistic condition* 19. Proportion of patients who have >2 missed scheduled clinic appointments per year 20. Hospitalizations and emergency room visits without hospital admission* 21. Proportion of patients with unmet need for support services (e.g., assistance with obtaining housing)^ II. AREA-LEVEL MEASURES (E.G., EMA OR STATE) Outcome measures related to access and care: 22. Proportion of HIV-infected persons in an area who are not diagnosed^ 23. Proportion of diagnosed persons in area who are receiving regular care^ 24. Proportion of people with HIV who died within 12 months of an HIV diagnosis* 25. Proportion of people with HIV who progressed to AIDS within 12 months of initial HIV diagnosis* Key: * indicates high priority; ^ indicates high priority, but may require further development. Other measures are important, but of lower priority. Recommendation 6-2 Infrastructure development: The Secretary of HHS should provide additional resources to HRSA and CDC to develop infrastructure for monitoring quality at the patient, clinic, and population levels. This infrastructure development strategy has three major components:
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act HRSA should enhance support for information technology and personnel to enable clinics to collect, aggregate, and report a focused set of clinical and patient-reported data. HRSA should collaborate with CDC and other agencies to develop innovative population-based measures that can be captured using existing data sources or other community-based information gathering activities, such as surveys of unmet needs. Congress should enhance flexibility in the administrative caps at the grantee level to promote infrastructure development. Recommendation 6-3 Collaborative quality activities: The Secretary of HHS should convene a working group, not restricted to, but including the NCQA; state insurance commissioners; state Medicaid officials; and representatives from HRSA, CDC, the Centers for Medicare & Medicaid Services; providers of community, outpatient, and inpatient care; and members of the relevant research communities to consider strategies for promoting greater collaboration between public health departments and public- and private-sector providers in order to establish tools and methods to assess systems of care and quality, building on the successful collaborative models developed by the CDC for immunization (e.g., Clinic Assessment Software Application and Assessment Feedback Incentives Exchange). SUMMARY RWCA is a program that has provided lifesaving care to millions of persons who otherwise would not have access to adequate services, and that has helped develop an infrastructure for providing high-quality care that would not exist in its absence. Despite this success, it is critical to periodically reevaluate whether allocation strategies are an equitable and efficient way of distributing resources to jurisdictions with the greatest needs. Furthermore, it is important that activities for assessing and improving the quality of care be refined and expanded. With the advent of HAART and the availability of a wide array of other support services and prevention efforts for HIV-infected individuals, it is essential to promote efforts to make individuals aware of their status and to facilitate their entry into care. Significant and continued improvements in long-term morbidity and mortality related to HIV will not occur unless these individuals are under appropriate care. The Committee recognizes that the last frontier to eliminate morbidity and mortality from HIV disease will be primary prevention.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act The Committee proposes that overarching principles of equity be used to guide the development of a refined and more explicit framework for evaluating the distribution of RWCA resources. It proposes several specific types of analyses that could be used to guide the evaluation and improvement of allocation formulas. Similarly, it proposes a framework for assessing quality of care provided to HIV-infected persons, and several specific steps that could be taken to build on existing work and develop a national, standardized approach to quality assessment. Such refinements in the approach to distributing and evaluating the impact of RWCA resources could help the CARE Act remain a pathbreaking approach to providing care to some of the nation’s most vulnerable citizens. REFERENCES Ball JK, Turner BJ. 1991. AIDS in U.S. Hospitals in 1986–1987: A National Perspective. Rockville, MD: Agency for Health Care Policy and Research. DHHS publication (PH) 91–0015. Barre-Sinoussi F, Chermann JC, Rey F, Nugeyre MT, Chamaret S, Gruest J, Dauguet C, Axler-Blin C, Vezinet-Brun F, Rouzioux C, Rozenbaum W, Montagnier L. 1983. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Science 220:868–71. Bennett CL, Garfinkle JB, Greenfield S, Draper D, Rogers W, Mathews C, Kanouse DE. 1989. The relation between hospital experience and in-hospital mortality for patients with AIDS-related PCP. Journal of the American Medical Association 261:2975–9. CDC (Centers for Disease Control and Prevention). 1981. Pneumocycstis Pneumonia–Los Angeles. Morbidity and Mortality Weekly Report 30:250–2. Atlanta, GA: CDC. CDC. 1992. 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. Morbidity and Mortality Weekly Report 41(RR–17):1–19. Atlanta, GA: CDC. CDC. 1999. Guidelines for national human immunodeficiency virus case surveillance, including monitoring for human immunodeficiency virus infection and acquired immunodeficiency syndrome. Morbidity and Mortality Weekly Report 48(13):1–28. Atlanta, GA: CDC. CDC. 2003. Update on the Evaluation of the Performance of Integrated Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) Surveillance Systems. (Email communication, Patricia Sweeney, CDC, March 4, 2003). Colfax GN, Bindman AB. 1998. Health benefits and risks of reporting HIV-infected individuals by name. American Journal of Public Health 88(6):876–9. Donabedian A. 1966. Evaluating the quality of medical care. Milbank Memorial Fund Quarterly 44(3 (Supp)):166–206. Fauci AS, Pantaleo G, Stanley S, Weissman D. 1996. Immunopathogenic mechanisms of HIV infection. Annals of Internal Medicine 124(7):654–63.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act Gallo RC, Salahuddin SZ, Popovic M, Shearer GM, Kaplan M, Haynes BF, Palker TJ, Redfield R, Oleske J, Safai B, et al. 1984. Frequent detection and isolation of cytopathic retroviruses (HTLV-III) from patients with AIDS and at risk for AIDS. Science 224:500–3. Georgia Division of Public Health, Epidemiology Branch, HIV/STD Epidemiology Section. 2003. Proposal for HIV Infection Reporting in Georgia. [Online]. Available: http://www.ph.dhr.state.ga.us/epi/hivreporting.shtml [accessed September 25, 2003]. GAO (General Accounting Office). 1995. Ryan White CARE Act of 1990: Opportunities Are Available to Improve Funding Equity. GAO/T-HEHS-95-91. Washington, DC: GAO. GAO. 2000. Ryan White CARE Act: Opportunities to Enhance Funding Equity. GAO/ T-HEHS-00-150 . Washington, DC: GAO. Hecht FM, Chesney MA, Lehman JS, Osmond D, Vranizan K, Colman S, Keane D, Reingold A, Bindman AB. 2000. Does HIV reporting by name deter testing? MESH Study Group. AIDS 14(12):1801–8. HRSA (Health Resources and Services Administration). 2001. A Primer on Title I and Title II Formula Allocation Calculations. Unpublished document. (Email communication, Steven Young, HRSA, November 21, 2001). HRSA. 2002a. Title I: Grants to Eligible Metropolitan Areas. [Online]. Available: http://ftp.hrsa.gov/hab/titleifact.pdf [accessed May 22, 2003]. HRSA. 2002b. Title II: AIDS Drug Assistance Program. [Online]. Available: ftp://ftp.hrsa.gov/hab/adap1.pdf [accessed May 22, 2003]. HRSA. 2002c. Title III: Early Intervention Services. [Online]. Available: ftp://ftp.hrsa.gov/hab/titleiiifact.pdf [accessed May 22, 2003]. HRSA. 2002d. Title IV: Services for Women, Infants, Children, Youth, and Their Families. [Online]. Available: ftp://ftp.hrsa.gov/hab/titleiv.htm [accessed May 22, 2003]. HRSA. 2003. CARE Act Overview and Funding History. [Online]. Available: ftp://ftp.hrsa.gov/hab/fundinghis03.xls [accessed October 9, 2003]. IOM (Institute of Medicine). 2000. To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press. IOM. 2001a. Coverage Matters: Insurance and Health Care. Washington, DC: National Academy Press. IOM. 2001b. Envisioning the National Health Care Quality Report. Hurtado MP, Swift EK, Corrigan JM, Eds. Washington, DC: National Academy Press. IOM/NAS (Institute of Medicine and the National Academy of Sciences). 1988. Confronting AIDS, Update 1988. Washington, DC: National Academy Press. Kaiser Family Foundation. 2000. Financing HIV/AIDS Care: A Quilt with Many Holes. Capital Hill Briefing Series on HIV/AIDS. Kates J, Ruiz S. 2002. Sources of Coverage and Care for People with HIV/AIDS in the United States: Assessing Coverage in Southern States. Southern States Summit on HIV/AIDS and STDs. Menlo Park, CA: Kaiser Family Foundation. Kessler RC. 1998. A methodology for estimating 12-month prevalence of serious mental illness. Mental Health, United States 1998. DHHS Pub. No. (SMA) 99-3285 ed. Washington, DC: Government Printing Office.
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Measuring What Matters: Allocation, Planning, and Quality Assessment for the Ryan White CARE Act Kitahata MM, Koepsell TD, Deyo RA, Maxwell CL, Dodge WT, Wagner EH. 1996. Physicians’ experience with the acquired immunodeficiency syndrome as a factor in patients’ survival. New England Journal of Medicine 334(11):701–6. Mills R, Bhandari S. 2003. Health insurance coverage, 2002. Current Population Reports. Washington, DC: U.S. Census Bureau. Pp. 60–223. Osmond DH, Bindman AB, Vranizan K, Lehman JS, Hecht FM, Keane D, Reingold A. 1999. Name-based surveillance and public health interventions for persons with HIV infection. Multistate Evaluation of Surveillance for HIV Study Group. Annals of Internal Medicine 131(10):775–9. Pantaleo G, Graziosi C, Fauci AS. 1993. New concepts in the immunopathogenesis of human immunodeficiency virus infection. New England Journal of Medicine 328(5):327–35. Pittman J, Andrews H, Struening E. 1986. The use of zip-coded population data in social area studies of service utilization. Evaluation and Program Planning 9(4):309–17. Shevky E, Bell W. 1955. Social Area Analysis. Stanford, CA: Stanford University Press. Thacker SB. 2000. Historical development. Principles and Practice of Public Health Surveillance . 2nd ed. Teutsch SM, Churchill RE, eds. New York: Oxford University Press. Turner B, Markson L, Cocroft J, Cosler L, Hauck WW. 1998. Clinic HIV-focused features and prevention of Pneumocystis carinii pneumonia. Journal of General Internal Medicine 13(1):16–23. U.S. Congress, House of Representatives. Committee on Commerce. 2000a. Report on Ryan White CARE Act Amendments of 2000 (106-788). 106th Cong., 2d Sess. July 25, 2000. Pp. 24–6. U.S. Congress, House of Representatives. Committee on Commerce. 2000b. Report on Ryan White CARE Act Amendments of 2000 (106-788). 106th Cong., 2d Sess. July 25, 2000. P. 30. U.S. Congress. 2000c. Congressional Record. 146(123): S10032. U.S. Congress, Senate. 2000d. Ryan White CARE Act Amendments of 2000—Managers’ Statement of Explanation. October 5, 2000. Yeni P, Hammer SM, Carpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Volberding PA. 2002. Antiretroviral treatment for adult HIV infection in 2002: Updated recommendations of the International AIDS Society-USA Panel. The Journal of the American Medical Association 288(2):222–35.
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