What's Been Happening with ADAP?
Trends in Clients Served and Expenditures

Who Is Served by ADAP?
Race/Ethnicity
Gender/Age
Client Health Status/CD4 Counts
Economic Status/Income Levels
Medicaid/Insurance Status
HIV Primary Care Sites and Prescribing Physicians

How Is ADAP Funded?
Federal Funding for ADAP
State Funding for ADAP
Program Administrative Changes
Cost-Saving Strategies
ADAP Restrictions, Budget Shortages and Unexpended Funds

Eligibility Criteria
ADAP Formularies
Federal HIV Treatment Guidelines Dissemination

I. Total Clients Served, Expenditures and Prescriptions Filled in July 1997 and June 1998
II. Antiretroviral Expenditures and Per Capita Spending in July 1997 and June 1998
III. Opportunistic Infection/Other Drug Expenditures and Per Capita Spending in July 1997 and June 1998
IV. Protease Inhibitor Prescriptions Filled in July 1997 and June 1998
V. Race/Ethnicity of June 1998 ADAP Clients by State
VI. Gender/Age of June 1998 ADAP Clients
VII. CD4 Counts of June 1998 ADAP Clients
VIII. Client Income Levels and Medicaid/Insurance Status
IX. Primary Care Sites and Prescribing Physicians
X. FY 1998 ADAP Budget: Federal and State Sources
XI. FY 1998 ADAP Federal/State Budget Compared with FY 1997
XII. State Contributions to FY 1997 and FY 1998 ADAP Budgets
XIII. FY 1998 ADAP Budget: Cost Recovery Sources
XIV. State ADAP Formularies

Acknowledgments
This report, and the series of reports produced by the ADAP Monitoring Project, would not have been possible without the generous financial support of the Henry J. Kaiser Family Foundation and its continuing role as catalyst for informed dialogue on HIV/AIDS policy issues. The authors would especially like to thank Dr. Sophia Chang, Jennifer Kates, Tim Westmoreland and the staff of the Kaiser Family Foundation for their support and guidance in shaping our project reports.

We are indebted to the members of the National Alliance of State and Territorial AIDS Directors (NASTAD) and the AIDS drug assistance program (ADAP) coordinators in every state for volunteering their time to complete this national ADAP survey. Once again they proved to be extraordinarily helpful in responding to the survey and follow-up telephone calls.

We benefited greatly from the advice and suggestions provided by a group of state AIDS directors and AIDS drug assistance program managers who had the opportunity to review a draft of this report. They are: Wendy Craytor (AK), Lanny Cross (NY), Thera Meehan (MA), Randall Pope (MI) and Raleigh Watts (WA). Our thanks to them for devoting extra time providing us with important feedback.

The principal authors of this report are Arnold Doyle, Richard Jefferys, Joseph Kelly and Sasha Schamber. Antonie Auguste provided research assistance and technical support.

Executive Summary
State AIDS Drug Assistance Programs (ADAPs) provide access to HIV/AIDS treatments to low-income, uninsured and under-insured people living with HIV/AIDS. ADAPs, authorized under Title II of the federal Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, are administered by each state and territory that receives federal Ryan White Title II ADAP funds. Each state determines program financial and medical eligibility criteria and the number of treatments provided on its ADAP drug formulary. Each ADAP operates within a unique state delivery and financing environment. Consequently, these programs vary greatly by jurisdiction.

Since the introduction of combination antiretroviral therapy in late 1996, many ADAPs have been challenged to meet the demands of a rapidly growing client population and increased monthly expenditures within the context of finite program resources. While some states supplement federal Ryan White ADAP monies with state general revenue funds, other states do not provide any non-federal financing of their programs. In addition, ADAPs in states with relatively limited Medicaid programs may be shouldering an increased burden of low-income individuals living with HIV/AIDS who do not meet restrictive Medicaid eligibility criteria.

In an effort to track the response of ADAPs to the rapidly changing HIV/AIDS treatment environment, shifts in the demographics of the HIV/AIDS epidemic, changes in funding sources, and to document program variations across jurisdictions, the Henry J. Kaiser Family Foundation commissioned the National Alliance of State and Territorial AIDS Directors (NASTAD) and the AIDS Treatment Data Network (ATDN) to produce a series of national ADAP status reports. The reports produced through this effort, known as the National ADAP Monitoring Project, provide the most up-to-date information on the fiscal, administrative and programmatic status of the fifty-two state ADAPs.

The current report-the third in the series-is based on information gathered from state AIDS program directors and ADAP coordinators through a national ADAP survey. The survey was distributed to all ADAPs in August 1998, and requested data on numerous aspects of each state ADAP from the time period January 1, 1998 through June 30, 1998.

Data on number of clients served, program expenditures and number of prescriptions filled were collected for January 1998 and June 1998. In order to provide a picture of ADAP growth over a year, data from June 1998 were compared with data from July 1997 (presented in the March 1998 Interim Technical Report). While these data sets represent two discrete points in time, it is important to note that ADAPs are constantly evolving in an attempt to adapt to changes in the availability of program resources, client demand and changes in HIV/AIDS treatment. Fifty-one of the 52 jurisdictions responded by the survey deadline. The major findings are as follows:

Clients Served
The overall number of clients served by ADAPs continues to increase nationally, with most states experiencing increases and some states seeing declines in the number of clients served between July 1997 and June 1998:

• State ADAPs served 53,765 clients nationally in June of 1998.
• The number of clients served by ADAPs increased by 22% nationally among the 45 states reporting client and expenditure data in both June 1998 and July 1997 (47,814 compared to 39,106). When averaged out over the eleven-month period, this represents an increase of 792 clients per month nationally.
• Forty states reported increases in the number of clients served in June 1998 compared with July 1997. Ten of these states reported increases of 50% or more in the number of clients served during this time period. Nine states reported decreases in the number of clients served.

Expenditures
Overall ADAP program expenditures are growing at a fast rate, with large increases in national spending on antiretroviral treatments and decreases in national spending on drugs for the prevention and treatment of opportunistic infections (OIs) and other formulary drugs. Since July 1997, program expenditures have increased at a higher rate than the growth in the number of clients served, largely reflecting an increase in the costs and use of combination antiretroviral therapies recommended by Department of Health and Human Services' guidelines:

• Overall ADAP expenditures in June 1998 were $40.8 million.
• National ADAP expenditures grew by 37% among the 45 states reporting client and expenditure data in both periods ($35.7 million in June 1998 compared to $26 million in July 1997).
• Forty-one states reported increases in monthly program expenditures between July 1997 and June 1998. Eighteen of these states reported expenditure increases of 50% or more between these two time periods. Five states reported decreases in monthly expenditures between these two periods.
• In June 1998, national per client ADAP expenditures (for the 45 states reporting client and expenditure data in both periods) were $747 per client, compared to $665 in July 1997-a 12% increase.
• Antiretroviral (ARV) expenditures increased by 54% between June 1998 and July 1997 ($30.1 million compared to $19.6 million in the 38 states reporting data in both periods). Expenditures on antiretroviral drugs, including protease inhibitors, comprised a growing proportion of overall ADAP expenditures (88% in June 1998 compared to 78% in July 1997 for those states reporting data in both periods).
• Notably, national ADAP expenditures on OI and other formulary drugs decreased by 31%, from $5.6 million in July 1997 to $3.8 million in June 1998 (in the 33 states that cover OI drugs and reported data for both periods). In addition, expenditures on OI/other drugs comprised a decreasing proportion of overall ADAP expenditures (11% in June 1998 compared to 22% in July 1997 among these 33 states).
• In June 1998, the number of prescriptions filled by ADAPs nationally totaled 150,078.
• There was a 28% increase in the number of monthly prescriptions filled by ADAPs nationally (147,563 in June 1998 compared to 115,419 in July 1997 among the 41 states that reported prescription and client data for both periods). The number of protease inhibitor prescriptions filled rose by 71% among the 38 states reporting these data in both periods (34,708 in June 1998 compared to 20,247 in July 1997).

Demographic Characteristics of ADAP Clients
Most of the clients served by ADAPs are people of color, are poor, and are uninsured. More focused studies need to be conducted in order to determine whether ADAPs-and other publicly-funded HIV care programs-are serving the populations most in need in their jurisdictions:

• Forty percent of clients with HIV disease served by ADAPs nationally are white, 30% African American, and 26% Hispanic. Asian/Pacific Islanders and American Indians/Alaskan Natives each comprise about 1% of the ADAP client population.
• Eighty percent of clients with HIV disease served by ADAPs have reported incomes below 200% of the Federal Poverty Level. Forty-eight percent of ADAP clients have reported incomes below 100% of the Federal Poverty Level, including ten states in which two-thirds or more of the ADAP client population earn less than 100% of the Federal Poverty Level.
• The majority of ADAP clients lack other public or private health insurance. Almost 6% of national ADAP clients are also Medicaid beneficiaries, and 9% of national ADAP clients have private insurance that provides some level of prescription drug coverage.
• For the first time, state ADAPs identified where clients receive primary care services and the number of physicians prescribing medications for ADAP clients. ADAP clients most often receive primary care from public clinics/local health departments (38% of all clients) and hospital-based clinics (33%). The number of physicians prescribing medications for ADAP clients ranged from a low of seven physicians to a high of 3,339 physicians among states. Notably, 40 states were able to report this information which provides additional base data for further assessments of quality of HIV care.

ADAP Budget
The national budget for ADAP in fiscal year (FY) 1998 is expected to total $510.2 million in federal and state funding-an increase of $139.4 million (or 38%) over the FY 1997 national ADAP budget.

• ADAP supplemental funding under Title II of the federal Ryan White CARE Act increased by 71%, from $167 million in 1997 to $285.5 million in 1998. The amount of federal Title II base funding allocated by states to their ADAPs increased by 6%, to $71.9 million nationally.
• Forty states provided state general revenue support for their ADAPs in FY 1998, for a total of $119.4 million nationally; this represents a 22% increase over FY 1997 state general revenue contributions to ADAPs. Twelve states do not provide funds specifically for ADAP and therefore rely solely on federal funding to provide ADAP services.

Administrative Changes/Cost-Savings Strategies
In an effort to more effectively manage program costs, several states reported making changes in the administrative structures of their ADAPs, and taking a more active role in negotiating drug discounts:

• Three states modified their ADAPs' drug purchasing/distribution systems in order to take advantage of a federal drug discount program. Significant changes went into effect since the March 1998 Interim Report in the administration of this federal discount program that will allow more ADAPs to receive drug discounts.
• Recently, several ADAPs delayed adding a newly approved antiretroviral drug to their formularies pending the outcome of negotiations with the drug's manufacturer over the relatively high cost of the product. The ADAPs were successful in negotiating an additional discount/rebate on the drug for all ADAPs nationally.

ADAP Restrictions, Budget Shortages and Unexpended Funds
Notwithstanding increased federal and, in some cases, state funding for ADAPs, 26 states reported that they are facing special ADAP program restrictions and/or budget shortages due to client demand and inadequate resources. Several other states reported that they expect to have unexpended ADAP funds remaining at the end of FY 1998:

• Eleven states reported capped program enrollments, i.e., limiting the number of clients that can be served at one time. All eleven maintain active waiting lists for clients to enter the program. The number of individuals on these waiting lists totals over 2,500. Five states reported monthly or yearly per capita expenditure caps.
• Six states have capped or restricted access to protease inhibitors or other antiretrovirals and two states continue not to provide any protease inhibitors due to budget constraints.
• Fourteen states reported that, based on budget projections, they expected to exhaust their current ADAP operating budget prior to the end of Ryan White FY 1998 (March 31, 1999).
• Eighteen states reported that they had unexpended ADAP funds remaining in their ADAP budgets at the end of Ryan White FY 1997; eleven of these states carried these funds over into their FY 1998 ADAP operating budgets. Nine states reported that they expect to have unexpended funds-totaling an estimated $8.6 million nationally-remaining in their ADAP budgets at the end of Ryan White FY 1998.

• Five states expanded their ADAP income eligibility since the last annual report, including three states that raised their income eligibility since the March 1998 Interim Technical Report. On the other hand, two states reported lowering their financial eligibility ceiling since the last annual report.
• When the first NASTAD/ATDN report was published in July 1997, only two ADAPs reported covering all approved antiretroviral drugs. By October 1998, 46 ADAPs provided coverage for all approved antiretroviral treatments.
• Twenty-two states reported adding antiretroviral drugs to their ADAP formularies since July 1997. Twenty-three states reported adding drugs for the prevention and treatment of opportunistic infections and other non-antiretroviral drugs to their formularies.
• While 21 states now cover ten or more of the 14 drugs strongly recommended by the U.S. Public Health Service/Infectious Disease Society of America (USPHS/IDSA) "Guidelines for the Prevention of Opportunistic Infections for Persons Infected with HIV," the remaining 31 state ADAPs do not provide this level of coverage.
• Almost all states reported efforts to disseminate federal HIV treatment guidelines to providers and consumers and to provide some type of ongoing HIV treatment education, such as mailings to providers and clients and instituting Drug Utilization Review (DUR) procedures.

The ADAP State by State Profile Table that begins on the next page includes a synopsis of each ADAP's financial and medical eligibility criteria, coverage of specific classes of drugs, FY 1998 federal/state ADAP budget information, the recent number of clients served and a listing of special ADAP program restrictions in place as of October 1998.

Introduction
State ADAPs continue to play a vital role in providing access to life sustaining treatments for an increasing number of low-income, uninsured and under-insured people living with HIV/AIDS. While ADAPs initially were intended to provide a temporary safety net of medication coverage, they are now being called upon-within the context of the broader Ryan White care system and the state public health system-to be conduits into ongoing primary care, a means of access to more comprehensive and longer-term health care reimbursement options such as Medicaid and private insurance, purveyors of clinical education to health care providers and consumers, and coordinators of outreach to underserved populations. 1999 may continue to see an expansion of ADAPs' role, with significant new investment in these critical programs by the federal government and increased attention to program achievements and outcomes.

For the remainder of Ryan White FY 1998 and through FY 1999, the variations and disparities among ADAPs will likely continue to be evident. While ADAPs operate within broad federal guidelines and receive the bulk of their funding from the federal government, states have significant discretion in determining client eligibility, the scope of the ADAP drug formulary and how treatments are purchased and delivered to clients. The varying fiscal, political, geographical and economic environments particular to each jurisdiction add to the heterogeneity of state ADAPs-similar to the impact these factors have on state Medicaid programs. Significant additional federal ADAP funds expected in FY 1999 are unlikely to ameliorate the existing variations and disparities among ADAPs.

The past year has been a time of fiscal stability and even expansion for some ADAPs, while others implemented or continued program restrictions due to resource constraints. This year has also seen continued rapid advances in the treatment of HIV/AIDS with new and costly antiretroviral medications entering the market. ADAPs have been challenged to keep pace with this rapidly changing treatment environment, including efforts to expand their formularies, expand eligibility/client access and provide ongoing provider and consumer education. While most ADAPs now provide all approved anti-HIV drugs, there continues to be significant variation among these programs in their coverage of drugs for the prevention and treatment of opportunistic infections.

National attention has focused on disparities in health outcomes among racial/ethnic groups in the United States, especially African Americans and Latinos. While AIDS death rates have declined among all affected communities, African Americans and Latinos have not experienced as great a decline in AIDS-related mortality as whites. While there is some evidence that the disparities in death rate declines among these populations are lessening in some areas of the United States, disparities persist in other areas of the country. State and federal public health programs, including Ryan White programs and ADAP, are being called to greater accountability for their efforts to reach and serve these communities.

This report-the third in a series produced under the National ADAP Monitoring Project-provides updated information on the number of clients served through ADAPs, program expenditures and an analysis of utilization and expenditure trends. The report will also analyze current program budgets and changes in ADAP funding categories. Modifications in ADAP eligibility and drug formularies, and program responsiveness to changing clinical standards of care will be presented. Given national attention on disparities in health outcomes for minority populations, this report will also include a discussion of the demographic make-up of state ADAPs, including the race/ethnicity, gender, age, health status, and economic status of the ADAP client population.

The ADAP Update Survey
In August 1998, a national ADAP update survey was distributed to the fifty-two jurisdictions receiving Ryan White CARE Act Title II ADAP funds. Survey responses were collected and analyzed throughout September and October, with significant follow-up conducted by phone. Fifty-one jurisdictions responded to the survey; the state of Wyoming was unable to respond by the survey deadline.

The survey was intended to collect updated information on ADAP client utilization and monthly utilization trends, ADAP budgets, program shortfalls and restrictions, changes in ADAP formularies and efforts to respond to changing clinical practice standards. In addition to updating the information contained in previous National Monitoring Project reports, states were asked to provide detailed ADAP client demographic information, client health status/CD4 measurements and an assessment of where their ADAP clients were receiving primary care services.

The findings from this survey represent one point in time and comparisons reflect data reported between two to three points in time. ADAPs are dynamic programs and continue to change on a daily basis. Up-to-date state-by-state ADAP information is available on the Monitoring Project's website at: http://www.aidsinfonyc.org/adap/index.html.

Client Utilization and Drug Expenditures:
What's Been Happening With ADAP?
Over the past year, ADAPs have continued to experience growth in the number of clients served and in monthly pharmaceutical expenditures. Between July 1997 and June 1998, program expenditures increased at a higher rate than the growth in clients served. This higher growth in expenditures largely reflects increases in the cost and use of combination antiretroviral therapies. While overall ADAP program expenditures on formulary drugs continued to increase, expenditures on drugs for the treatment and prevention of opportunistic infections and other formulary drugs decreased.

This section will discuss trends in the number of clients served per month by ADAPs and trends in monthly expenditures on pharmaceuticals, including comparing current utilization and expenditure data with similar data from one year ago. This section will also highlight trends in ADAP expenditures on antiretroviral drugs and drugs for the prevention and treatment of opportunistic infections.

Trends in Clients Served and Expenditures
Nationally, states reported that ADAPs served 53,765 clients during June 1998. When compared to July 1997, the number of clients served by ADAPs increased by 22% among the 45 states reporting client and expenditure data in both periods (47,814 in June 1998 compared to 39,106 in July 1997), as shown in Figure 1. When averaged out over the eleven-month period between July 1997 and June 1998, ADAPs experienced an increase of approximately 792 clients per month nationally. Over the two-year period, since July 1996, client utilization has increased by 71% (47,109 in June 1998 compared to 27,531 in July 1996 among those 43 states reporting expenditure and client data in June 1998 and July 1996).

Forty states reported increases in the number of clients served between July 1997 and June 1998 (among the 49 states reporting client data in both time periods). Ten states reported increases of 50% or more. Of those ten states, four (Alaska, Delaware, the District of Columbia and Oregon) reported greater than 100% increases in the number of clients served during the same time period. Nine states (Alabama, Idaho, Mississippi, New Jersey, North Dakota, Rhode Island, South Dakota, Vermont and Virginia) reported decreases in the number of clients served during this same time period.

Overall, ADAP program expenditures in June 1998 were $40.8 million. Monthly ADAP expenditures grew by 37% nationally among the 45 states reporting client and expenditure data in both time periods ($35.7 million in June 1998 compared to $26 million in July 1997), as illustrated above in Figure 2. Over the two-year period, ADAPs experienced a 163% growth in monthly expenditures nationally among those 43 states reporting expenditure and client data in both June 1998 and July 1996 ($35.3 million in June 1998 compared to $13.4 million in July 1996).

Forty-one states reported increases in monthly program expenditures between July 1997 and June 1998 (among the 46 states reporting expenditure data in both time periods). Eighteen states reported increases in monthly program expenditures of 50% or more between these two time periods; of these, seven states (Alaska, Delaware, Nevada, North Carolina, Oregon, Vermont and West Virginia) reported increases of more than 100%. Five states (Alabama, Idaho, Iowa, Montana and New Mexico) reported decreases in ADAP expenditures during this same time period.

Nationally, per client ADAP expenditures were $747 in June 1998 and $665 in July 1997, an increase of 12%. The average per capita expenditure among ADAPs nationally during the same time period was $706 per month, or $8,472 annualized.

The primary component driving the increase in overall ADAP expenditures is the significant rise in HIV antiretroviral expenses: an increase of 54% between June 1998 ($30.1 million) and July 1997 ($19.6 million) among the 38 states reporting data in both periods. ADAP expenditures for antiretroviral drugs (ARVs), including protease inhibitors, comprised approximately 88% of June 1998 national ADAP expenditures, compared with 78% of overall ADAP expenditures in July 1997. Per capita spending on ARVs increased by 26% during this time period ($659 in June 1998 and $524 in July 1997) among these 38 states.

National ADAP expenditures on drugs for the treatment and prevention of opportunistic infections and other formulary drugs decreased by 31%, from $5.6 million in July 1997 to $3.8 million in June 1998, among the 33 states that cover OI drugs and reported data in both periods. In July 1997, OI/other drug expenditures comprised 22% of overall ADAP expenses nationally; in June 1998, OI/other drugs accounted for approximately 11% of overall ADAP expenditures (among these 33 states). Per capita spending on OI/other drugs also decreased from $152 per ADAP client in July 1997 to $86 in June 1998-a decrease of 43%. The decreases in expenditures on OI/other drugs occurred despite the fact that many ADAPs increased their coverage of these drugs over the past year. Further research is needed to determine the exact reason(s) for the decline in expenditures; however the decline may be due to increasing numbers of ADAP clients utilizing combination antiretroviral therapy and subsequent improvement in and/or maintenance of client health status.

The total number of prescriptions filled for all drugs on ADAP formularies in June 1998 was 150,078. There was a 28% increase in prescriptions filled among the 41 states that reported prescription and client data in both June 1998 and July 1997 (from 115,419 in July 1997 to 147,563 in June 1998). The average number of prescriptions filled per client remained relatively constant between July 1997 and June 1998-from an average of 3.19 to 3.28 prescriptions per ADAP client. The number of protease inhibitor (PI) prescriptions filled nationally between June 1998 (34,708) and July 1997 (20,247) increased by 71%. The percentage of PI prescriptions filled by ADAPs nationally increased as well, with PIs accounting for 24% of ADAP prescriptions filled in June 1998 compared to 18% of ADAP prescriptions filled in July 1997. The increase in PI prescriptions may be the primary component of prescription expenditure growth nationally among state ADAPs.

Appendix I contains a state-by-state breakout of ADAP expenditures and prescriptions filled. Expenditures and per capita spending on antiretrovirals and OI/other drugs are delineated in Appendices II and III. Appendix IV contains information on the number of protease inhibitor prescriptions filled by state ADAPs. Each of these appendices contains totals of all data reported by ADAPs as well as national comparison totals that reflect data from only those states reporting in both time periods.

Client Demographics: Who Is Served by ADAP?
Each year, federal, state and local governments spend significant dollars to provide medical care to people living with HIV/AIDS through publicly funded HIV care programs. While the recent national decline in death rates may attest to the success of these programs, an important-and as yet unanswered-question remains: To what extent are publicly financed HIV care programs serving the populations most in need? Persisting disparities in health outcomes for racial/ethnic minorities-especially African Americans-demand that ADAPs and other publicly funded HIV care programs carefully assess how and whether they are meeting the needs of traditionally underserved populations in their jurisdictions. This question should be posed not only to ADAPs but also to state Medicaid programs, community health centers and other publicly-funded sources of HIV care since, together, they form the fractured continuum of care for the majority of people living with HIV/AIDS in the U.S.

Answering this question at this time is methodologically complex. First, there are currently no reliable estimates of the number of people living with HIV at the national or state level-particularly by racial and ethnic categories. While all states track AIDS cases, only 28 states currently track adult HIV cases. Some of the states with the largest ADAP populations and largest AIDS caseloads (e.g., California, New York) are among those that do not have HIV case reporting systems. Yet ADAPs serve both people with HIV without an AIDS diagnosis and those with AIDS. In fact, these programs may be more likely to serve people with HIV because those with an AIDS diagnosis are more likely to be eligible for Medicaid. Therefore, the only available national data set against which to compare ADAP demographic data-AIDS prevalence (reported living AIDS case) data-provides an incomplete frame of reference.

Recently released data from the HIV Cost and Services Utilization Study (HCSUS) provide detailed demographic information on a nationally representative probability sample of people living with HIV, including those with AIDS, in care. While these data may also be used as a point of comparison, they too are limited in that they represent only individuals living with HIV/AIDS that are in care, i.e., not all of the HIV-infected population.

Secondly, ADAP is only one piece of a much larger financing puzzle-one part of a health care payer system that includes Medicaid, Medicare, other public health programs, private insurance and pharmaceutical manufacturer-sponsored "charity" programs. An individual who is not served by ADAP may be securing a portion or all of his/her HIV treatments through any one of these other payers, or through a combination of payers. Without looking at all pieces of this puzzle together, it is impossible to draw conclusions about which demographic groups may not have adequate access to needed services through any one of these payers.

Despite these significant barriers, it is still critically important to begin framing a response to the question posed above and to develop a research agenda to explore this question more thoroughly. This section attempts to begin such an assessment of ADAPs by providing a first glance at the racial/ethnic, economic, gender and age characteristics of the national ADAP population. The report compares national ADAP client demographic data with the two data sets, albeit limited, mentioned above - national AIDS prevalence data from the Centers for Disease Control and Prevention (CDC) and HCSUS data. While the conclusions that can be drawn from these comparisons are limited, they may assist states and researchers in identifying areas for more detailed analysis.

Race/Ethnicity
As discussed in the introduction to this report, national attention has focused on racial/ethnic disparities in health outcomes among people living with HIV/AIDS and other chronic illnesses. ADAPs, other Ryan White programs, and public and private health care systems are being called to accountability for their efforts to reach and serve populations disproportionately affected by the HIV/AIDS epidemic, particularly African Americans.

States were asked to report the race/ethnicity of their ADAP clients served in June 1998. Three state ADAPs (Louisiana, Nevada, New Mexico) did not provide sufficient data to analyze the racial/ethnic make-up of their client populations. However, the client population in this analysis (N= 53,365) represents 99% of the total reported ADAP clients served in June 1998.

Figure 3
As shown in Figure 3, 40% of the June 1998 ADAP population was reported as white/non-Hispanic, 30% as African American (black/non-Hispanic), and 26% as Hispanic. Asian/Pacific Islanders and American Indians/Alaskan Natives each comprised 1% of the utilizing ADAP population, and 2% were reported as "other." When compared to data from the Health Resources and Services Administration (HRSA) 1996 Ryan White Title II Annual Administrative Report (AAR), there has been little change in the racial/ethnic distribution of clients served by ADAPs over the last two years. According to 1996 AAR data, whites comprised approximately 41% of the utilizing ADAP population, African Americans 28%, Hispanics 25%, and Asian/Pacific Islanders and American Indians/Alaskan Natives about 1% each. The racial/ethnic distribution of the ADAP client population in June 1998 varied significantly by state. A state-by-state breakout of June 1998 ADAP client race/ethnicity is included in Appendix V.

Figure 4
When comparing these data with AIDS prevalence data from the end of 1997 and with data from the HCSUS study, differences between the three data sets emerge, as shown in Figure 4. Whites account for 40% of reported living AIDS cases, 40% of the ADAP population and 49% of HIV-infected adults in care. African Americans comprise 39% of reported living AIDS cases, 30% of the ADAP population and 33% of adults in care. Hispanics represent 20% of reported living AIDS cases, 26% of ADAP clients and 15% of HIV infected adults in care. Asian/Pacific Islanders comprise 0.7% of reported living AIDS cases, 1% of ADAP clients and about 1% of adults in care. American Indians/Native Alaskans represent 0.3% of reported living AIDS cases, 0.6% of ADAP clients and 1% of adults in care.

Due to the limitations of the national data sets mentioned previously, and the lack of data on other payers, the conclusions that can be drawn from these comparisons are limited. This preliminary presentation of the racial/ethnic make-up of state ADAPs should serve to provide a starting point for further, more detailed research that takes into account jurisdictional variations in the availability and accessibility of other HIV care payers, the insurance status of affected populations and other social, political and economic factors unique to each jurisdiction.

Gender/Age
States were asked to provide data describing the gender and age characteristics of their ADAP populations. Eighty percent of clients served nationally by ADAPs in June 1998 were male, 20% were female. HRSA's 1996 Annual Administrative Report (AAR) shows that of the total population served by ADAP during calendar year 1996 (N=78,750), 79% of the clients were male and approximately 18% were female (3% were reported as "unknown/missing"). This indicates little change in the national percentage of male and female clients served through ADAPs in the past two years. AIDS prevalence (living AIDS case) data also indicate that, nationally, 80% of living AIDS cases are among males, 20% are among females. Seventy-seven percent of the HCSUS survey population (individuals living with HIV/AIDS in care) was male and 23% was female.

In 1997, the CDC reported that the number of AIDS deaths had fallen for most demographic groups, but not for women. There was actually a reported increase (3%) in the number of AIDS deaths among women during this same time period. More recently, however, there have been reports of decreases in the number of AIDS deaths among women. However, there have also been reports indicating that women-especially poor, African American women-comprise an increasing number of new HIV infections. These data highlight the need for states to assess the disproportionate impact that HIV may have on women in their jurisdictions, and-as with racial/ethnic minority populations-to study the level and quality of care that populations are receiving through ADAP and other publicly funded HIV programs.

The overwhelming majority of clients (99%) who utilized ADAP services during June 1998 were reported to be age 20 or above. The relative dearth of clients below the age of 20 who are served by ADAPs is likely attributable to the fact that infants and children with HIV/AIDS can generally access more comprehensive healthcare services through Medicaid. State-by-state information on ADAP client gender and age is included in Appendix VI.

Client Health Status/CD4 Counts
In order to make a preliminary assessment of the health status of the national ADAP population, states were asked to provide, within a given range, the CD4 counts of their currently utilizing ADAP population. Thirty states, representing 62% (N=33,067) of the June 1998 utilizing client population, provided CD4 data. Notably, only about half of the states reporting CD4 data also reported that these data were updated periodically, as opposed to being collected only at the time of client enrollment.

Figure 5
As shown in Figure 5, 38% of the clients were reported to have CD4 counts of less than 200, 42% were reported in the 200-500 CD4 range and approximately 20% of clients were reported to have CD4 counts above 500. There is some significant variation among states in terms of the reported CD4 distribution of their ADAP populations. However, due to the fact that much of these data may have been collected at an unspecified time in the past, it is difficult to draw any conclusions regarding the health status of the current ADAP population. Furthermore, since many ADAPs do not regularly collect and update CD4 count data, more focused studies-perhaps including studies of ADAP client medical records-are needed to determine the health status of this population. State-by-state ADAP client CD4 ranges are in Appendix VII.

Economic Status/Income Levels
States were asked to report the income levels, within a given range, of their June 1998 ADAP clients served. Income ranges were based upon percentages of the Federal Poverty Level (FPL) for 1998. Eight states did not provide sufficient data to analyze client income status. However, client income information was provided for 95% (N=50,927) of the reported June 1998 ADAP clients served. National ADAP client income level data are presented in Figure 6:

Figure 6
ADAP clients are relatively poor with 48% percent having reported incomes below 100% of FPL. Thirty-two percent of ADAP clients had reported incomes between 101-200% of FPL, indicating that 80% of June 1998 utilizing clients had incomes below 200% of FPL. Eleven percent of clients had reported incomes in the 201-300% FPL range, about 5% in the 301-400% FPL range, and less than 2% had reported incomes above 400% of FPL. A comparison with income level data from clients served by ADAPs nationally in July 1997 shows negligible changes in the reported income status of the national ADAP population over the past year.

Appendix VIII includes a state-by-state breakout of ADAP client income levels. This appendix also shows the upper ADAP financial eligibility and Medicaid eligibility limit for coverage under categorical disability. While the upper ADAP financial eligibility limit varies from a low of 100% of FPL to a high of over 400% of FPL, the Medicaid financial eligibility ceiling is 75% of FPL-around $503 per month (or lower) in every state. The question persists as to the degree of impact that state Medicaid coverage has on ADAPs. While Medicaid financial eligibility is relatively low in all states, 48% of ADAP clients nationally have reported incomes below 100% of FPL. Ten states reported that two thirds or more of their ADAP client populations had incomes below 100% of FPL. These states are: Alaska (93%), Arkansas (100%), Florida (75%), Georgia (73%), Kentucky (68%), Mississippi (80%), North Carolina (85%), South Carolina (75%), South Dakota (80%), and West Virginia (70%). Based on income criteria alone, many ADAP clients in these states-and nationally-could be eligible for Medicaid services if they also met the disability or other categorical eligibility requirements. However, all of these states have "limited" or less expansive Medicaid coverage, as described in an analysis of the impact of Medicaid coverage on state ADAPs presented in the March 1998 Interim Technical Report, perhaps limiting the ability of potential clients to enroll in the Medicaid program.

Notably, all ten states referenced above also reported some type of ADAP limitation/shortfall. While additional focused analysis needs to be conducted in this area, research suggests that limited Medicaid coverage in a state may cause low-income clients with HIV disease to be more reliant on ADAP for accessing prescription drugs.

Medicaid/Insurance Status
What percentage of the national ADAP population has some level of prescription drug coverage through private insurance or is covered by Medicaid? Forty-eight states, representing 98% (N=52,775) of the June 1998 ADAP clients served provided data on client Medicaid/insurance status. These data indicate that approximately 6% of the national ADAP client population in June were also Medicaid beneficiaries, and over 9% of national ADAP clients had private insurance that provided some level of prescription drug coverage. Data from the March 1998 Interim Technical Report indicate that 7% of the July 1997 national utilizing ADAP population were on Medicaid and that 7% had private insurance.

In a few states, the reported percentage of clients with some level of drug coverage through commercial insurance is relatively high, including Minnesota (73%) and Oregon (70%). These states have well-established insurance continuation/purchasing programs that facilitate access to HIV primary care services in addition to HIV treatments. These states pay only a portion of the costs of drugs for large numbers of their ADAP clients who have prescription drug coverage through commercial or high-risk pool insurance plans.

HIV Primary Care Sites and ADAP Prescribing Physicians
A critical question that remains unanswered is exactly where ADAP clients receive their primary care. Access to prescriptions is clearly sufficient to drive the continuing growth in the ADAP client population, but access to prescriptions cannot be interpreted as a marker for access to regular, quality care. While this section provides a preliminary overview of care sites of ADAP clients, it cannot provide information about the quality of care received by clients.

The ideal way to comprehensively analyze the care received by ADAP clients would be to collect data on health outcomes. Washington State, for example, is conducting an ongoing review of ADAP client health records in order to determine whether individuals are receiving the standard of HIV care. As yet unpublished data from the HCSUS study may also permit a national analysis of the health status of individuals in HIV care, including ADAP clients.

In order to identify where ADAP clients receive primary care services, states were asked to estimate what percentage of their ADAP client populations receive primary care services at each of the following sites: hospital-based clinics, private community-based clinics, public clinics/local health departments, private physician/physician group, or other sites. There was notable diversity among ADAPs.

Figure 7
As shown in Figure 7, ADAP clients receive primary care from public clinics/local health departments (38%), followed by hospital-based clinics (33%), private physicians (13%), private community-based clinics (11%) and "other" sites (5%).

Colorado, Delaware, Michigan, Mississippi, Nebraska, New Jersey, North Dakota, Utah, and Vermont reported that more than 75% of their clients receive primary care at hospital-based clinics. Notably, in Colorado, Delaware, Nebraska and Utah, large university hospitals purchase and distribute treatments to ADAP clients on behalf of the state health department (the Ryan White Title II/ADAP grantee).

Arizona, Florida, Nevada, and Puerto Rico indicated that 75% or more of their ADAP clients receive primary care from public clinics. Montana reported that 75% of its ADAP clients receive primary medical care at private community-based clinics. Idaho reported that 75% of its clients receive primary medical care from private physicians.

To provide additional base data for further assessment of quality of care issues, states were also asked to estimate the number of physicians who currently prescribe treatments for their ADAP client population. Ten states did not provide these data; however, data were available for approximately 67% (N=35,945) of June 1998 utilizing ADAP clients. The number of physicians prescribing medications for ADAP clients ranged from a low of seven physicians in Montana to a high of 3,339 physicians in New York State. As expected, small states with relatively few ADAP clients reported a relatively small number of ADAP prescribing physicians, while larger ADAPs reported a relatively high number of prescribers. Complete state-by-state information on primary care sites and ADAP prescribing physicians is contained in Appendix IX.

ADAP Budget Update: How Is ADAP Funded?
The national ADAP budget continues to expand. In FY 1998, the national ADAP budget is expected to total $510.2 million in federal and state funding. This represents an increase of $139.4 million over the FY 1997 total of $370.8 million or a 38% increase. This section will present the components of the national ADAP budget and trends in budget growth over the past several years. The section will also describe ADAP programmatic changes and cost-saving strategies, and will present program limitations, projected budget shortfalls and projected unexpended funds.

The national ADAP budget in FY 1998 consists of $390.8 million (76.6%) in federal contributions and a state share of $119.4 million (23.4%). The proportion of federal to state funding remained relatively unchanged compared with FY 1997. However, Ryan White Title II ADAP supplemental funding represented a larger share in the national ADAP budget (45% in FY 1997 to 56% in FY 1998). Figure 8 shows the breakout of the 1998 ADAP budget:

Figure 8 : Federal Funding for ADAP
ADAP supplemental funding increased from $167 million in FY 1997 to $285.5 million in FY 1998 - a 71% increase. The growth in overall ADAP budgets since FY 1996 nationally is being driven primarily by growth in federal appropriations for ADAP supplemental funding. Federal ADAP supplemental funding is expected to remain the most critical component of ADAP budgets in FY 1999. Beginning in April 1999, the federal ADAP supplemental budget will be $461 million, a $175.5 million increase over FY 1998. Figure 9 illustrates the relative changes in ADAP budget categories between FY 1996 and FY 1998.

Figure 9
All but three states (Massachusetts, Nebraska and West Virginia) experienced increases in their federal/state ADAP budgets between FY 1997 and FY 1998. Fifteen states saw increases of greater than 50% in their federal/state ADAP budgets in the last year. These states were: Alabama, Arizona, Colorado, Georgia, Idaho, Illinois, Iowa, Kansas, Kentucky, Maryland, Michigan, Minnesota, Mississippi, New Mexico and Wisconsin. Nebraska and West Virginia reported significantly decreased contributions to ADAP from their states' Ryan White Title II base grants, likely due to the significant increase in ADAP supplemental dollars.

Aside from the ADAP supplemental funding, the other federal ADAP budget categories received only modest increases and one significant decrease in FY 1998. The funds states elect to devote to ADAP from their Ryan White Title II base funding increased by $4.3 million (6%) to $71.9 million nationally. Funding from Ryan White Title I Eligible Metropolitan Areas (EMAs) increased by $2.6 million (11%) to $26.8 million in FY 1998. The number of EMAs contributing funds directly to support their state's ADAP remained constant at 13, although the constellation changed slightly. The Title I EMA in Cleveland, OH was added to the list of contributing Title I areas in FY 1998, while Portland, OR fell from the list. The Title I EMAs in New York State - most significantly New York City - continued to account for the majority (69%) of the nation's Title I contributions to ADAP. Funds identified as "other federal funds" decreased by 53% to $7.3 million in FY 1998. These largely included prior year funds that were approved as carry-over funds into the FY 1998 fiscal year for state ADAPs.

State Funding for ADAP
Individual state contributions to ADAP represent the widest degree of change in FY 1998 with significant fluctuations in many areas. Forty states now supplement federal funds with state-specific financial support for ADAP - a net increase of four states since FY 1997. There was a 22% increase over FY 1997 in state general revenue contributions to ADAPs nationally. Five states provided contributions in FY 1998 that did not provide funds in FY 1997. These states were Idaho, Kansas, Mississippi, New Hampshire and North Dakota.

Twenty states provided increased general revenue support to their ADAPs. Most notably, six states more than doubled their state ADAP contributions in FY 1998 (Arizona, Colorado, Florida, Georgia, Indiana, Missouri and New Mexico). On the other hand, six jurisdictions reported reductions in ADAP funding from their state/locality in the last year (District of Columbia, Hawaii, Illinois, Massachusetts, New Jersey and Puerto Rico). Eight states provided level funding support to their ADAPs in FY 1998 (Connecticut, Maine, Maryland, Minnesota, Nevada, Texas, Utah and West Virginia). Twelve states do not provide funds specifically for ADAP and therefore rely solely on federal funding to provide ADAP services. These 12 states are: Alaska, Arkansas, Delaware, Iowa, Michigan, Montana, Nebraska, Oregon, Rhode Island, South Dakota, Tennessee and Wyoming.

Federal and state contributions to each state ADAP are listed in Appendix X, with comparisons between FY 1997 and FY 1998 funding listed in Appendix XI. State general revenue contributions to ADAP are contained in Appendix XII.

Half of all ADAPs (26 states) draw upon additional sources of funding to supplement their budgets, although these other sources are chiefly used to recover costs and are not uniformly used by all states. These additional cost recovery mechanisms include obtaining rebates from pharmaceutical companies and private health insurance recovery, and accounted for $46.8 million in FY 1998. The largest portion of this comes from drug rebates ($33.6 million or 71.8%). A state-by-state breakout of these other budget sources is in Appendix XIII.

Including all sources (federal, state and cost recovery funds) the total national ADAP budget increased from $402 million in FY 1997 to $557 million in FY 1998.

Program Administrative Changes
During the past three years, ADAPs have attempted to adjust to a rapidly changing treatment environment. In some cases, states made significant structural changes in their ADAPs in order to provide treatments in a more cost-effective and efficient manner. Numerous states reported making administrative changes in their ADAPs during the past year. In most cases, these changes were intended to improve the operating efficiency, cost-effectiveness and data management capabilities of the programs to adjust to changing conditions. Specific state examples of program modifications include:

Program Administration
Although states can administer their ADAPs centrally or decentrally (i.e., contracting the administration of the program to an entity outside the state government system), the vast majority of states administer their programs centrally.

• California and Iowa completed the centralization of their ADAPs. Previously, day-to-day administration of the California ADAP occurred at the county level and Iowa ADAP was administered by the regional Title II consortia.
• Louisiana decentralized its ADAP; the program is now administered through ten regional medical centers that were part of the state charity hospital system.

Drug Purchasing/Distribution Systems
ADAPs use a variety of systems to purchase and distribute pharmaceuticals to clients. The type of drug purchasing/distribution system that an ADAP uses determines the type of drug-discounting strategy that the program can utilize.

• Iowa and Montana ADAPs began accessing the federal 340B (Public Health Service) drug discount program by contracting with one retail pharmacy outlet to provide ADAP services through the 340B contract pharmacy mechanism.
• Kentucky ADAP contracted most of its drug purchasing/distribution services to a local hospital that obtains federal 340B pricing.
• Connecticut, Vermont and West Virginia ADAPs converted from time-consuming manual pharmacy billing systems to electronic, point-of-sale (POS) billing systems.

Data Management
ADAPs must collect and manage significant amounts of data in order to track program expenditures, develop budget projections and fulfill reporting requirements.

• Connecticut, Louisiana, Michigan and Utah reported upgrading their ADAP data collection and management capabilities.

Coordination with the State Medicaid Program
The March 1998 Interim Technical Report highlighted the importance and cost-effectiveness of collaboration between state ADAPs and their respective Medicaid programs. The Health Resources and Services Administration (HRSA) and the Health Care Financing Administration (HCFA), the federal agency that oversees the Medicaid program, have encouraged cooperation and collaboration between Ryan White programs-especially ADAPs-and state Medicaid programs.

• Connecticut, Florida, Kansas and South Carolina ADAPs reported improved data-sharing and better overall coordination with their state Medicaid offices.
• New York and Virginia ADAPs have implemented "back-billing" systems with their Medicaid programs.
• Washington's ADAP has instituted a system whereby ADAP/Ryan White clients in the Medicaid spenddown process have their total spenddown liability reimbursed by the ADAP with state HIV dollars.

Cost-Saving Strategies

The 340B (PHS) Drug Discount Program
ADAPs have sought effective means of controlling program costs-especially since the advent of combination therapy and the subsequent increases in the number of clients served and monthly pharmaceutical expenditures. The most proactive vehicles for ADAPs to reduce monthly pharmaceutical costs are through participation in the federal 340B (PHS) drug discount program or by obtaining voluntary manufacturer rebates. Until recently, participation in the 340B drug discount program was viable only for those ADAPs that act as direct drug purchasers. However, on June 29, 1998, HRSA published new guidelines that allow reimbursement-type ADAPs to obtain rebates through the 340B program. Reimbursement-type ADAPs that elect to participate in the 340B program rebate option are eligible to receive the same unit rebate amount on purchased drugs as state Medicaid programs.

As of January 1999, 22 ADAPs had enrolled in the 340B program under the new rebate option. Twenty-three ADAPs are currently enrolled as direct purchasers. The remaining seven ADAPs are either planning to enroll after April 1, 1999 (e.g., Maine, Missouri and Ohio), already obtain rebates equal to or in excess of the 340B rebate percentage due to favorable voluntary manufacturer rebate agreements (e.g., Michigan and Minnesota) or ADAP rebate percentages are mandated by state law (e.g., Pennsylvania).

Negotiation With Drug Manufacturers
As purchasers of care for relatively large numbers of people with HIV/AIDS, state ADAPs have begun to play a more central role in negotiations with the pharmaceutical industry regarding drug cost/discount issues. Two examples highlight this trend:

• The 340B rebate option guidelines published by HRSA in June 1998 did not include specific steps for implementation of the rebate mechanism. A workgroup of ten ADAPs, in collaboration with HRSA and NASTAD, met and developed a set of implementation guidelines for the 340B rebate option called "Conditions of Participation." These Conditions were shared with representatives of the pharmaceutical industry-mainly major manufacturers of HIV/AIDS therapies-who provided comment and feedback. The Conditions of Participation were revised to address state and industry concerns.
• In September 1998, Dupont Pharmaceuticals received approval from the Food and Drug Administration (FDA) to market a new anti-HIV drug, efavirenz (Sustiva). The advertised wholesale cost of the new drug, however, was approximately 50% higher than the other two approved anti-HIV drugs in the same class (non-nucleoside reverse transcriptase inhibitors, or NNRTIs). With several new HIV drugs slated for approval in the coming year, some ADAPs became concerned about the comparatively high cost of Sustiva and the potential for other manufacturers to price their new products at the high end of the HIV antiretroviral drug pricing spectrum. Several higher-volume ADAPs, most in collaboration with local and national HIV community organizations, decided to delay adding Sustiva to the state ADAP formulary until Dupont Pharmaceuticals agreed to provide all ADAPs with a greater discount/rebate than already mandated under the 340B program. In response, Dupont did agree to offer all ADAPs an additional 5% discount/rebate over the 340B price. This level of involvement by a group of ADAPs to lower the final cost for a given drug for all ADAPs nationally was unprecedented and it is an action that is expected to continue.

Increasing Use of Insurance Continuation/Purchasing Programs
Several states have well-established insurance continuation/purchasing programs that allow them to more cost-effectively facilitate access to HIV care and treatment for clients. Recent developments at the federal level will likely increase the development and implementation of these programs:

• Since FY 1996, Congress has set aside an ADAP "earmark" within the Ryan White Title II allocation. HRSA has traditionally argued that these earmarked funds be used solely for the purchase of FDA-approved pharmaceuticals on the ADAP formulary. Several states have requested greater flexibility in the use of these funds, including using a portion to purchase and maintain insurance policies for ADAP clients, thereby providing clients with a reimbursement source for both pharmaceuticals and primary care services. During the FY 1999 federal appropriations cycle, House and Senate appropriations committees approved report language supporting the use of ADAP-earmarked funds for the purchase and maintenance of health insurance policies that provide adequate coverage for prescription drugs.

ADAP Restrictions, Budget Shortages and Unexpended Funds
Despite the growth in ADAP budgets nationally, and the increased level of expenditures discussed earlier in this report, there is substantial variation across state ADAPs in terms of demand, client accessibility and services offered. There are states with persistent program limitations, caps on new client enrollment, waiting lists, budget shortages, and notable lack of state contributions.

There are also a handful of states that are carrying unexpended federal funds and are not currently using the full ADAP allocation. Several of these states reported that they could more effectively use the ADAP money for other purposes like insurance purchasing, often a more cost-efficient means of providing client access to therapies and primary care. There are also states that currently do not have a high level of client demand. These states will likely be requesting permission from HRSA, the federal agency that administers Ryan White, to carry unexpended funds into the next fiscal year. These issues will be discussed in more detail later in this section.

Current and Projected Program Restrictions
Twenty states are listed in one or more current and/or projected ADAP program limitation categories:

• Eleven states currently have capped program enrollment for client entry (in other words, a set limit on the number of clients capable of being served at any one given time - typically if somebody leaves the program, a space opens up). Ten states reported capped enrollment in the March 1998 Interim Technical Report. The states currently reporting capped enrollment, followed by the date the cap was instituted (where available), are: Alabama (set 4/98), Alaska (3/98), Florida (4/97), Georgia (1991), Idaho (4/98), Mississippi (4/97), Montana (9/96), Nebraska (8/98), Nevada, (N/A), North Carolina (9/97) and South Carolina (N/A). Eight of these eleven states also reported ADAP waiting lists or capped enrollment in the March 1998 report. Alaska, Idaho and Nebraska instituted their waiting lists in 1998, after the release of the March 1998 interim report (Indiana and South Dakota dropped from the list). All eleven of these states have active waiting lists for clients to enter the program, lists that range in size from 5 individuals in Alaska to 944 individuals in Georgia. The total number of individuals on all eleven ADAP program waiting lists is over 2,500. In addition to these states with current enrollment caps, Iowa's ADAP also reported that it may need to implement a cap, based on current projections, before the end of FY 1998.
• Six states currently have capped or restricted access to protease inhibitors or antiretrovirals: Idaho (set 4/98), Kentucky (9/96), Maine (N/A), Nebraska (8/98), Oklahoma (1/97), and West Virginia (11/97); seven states reported capping PIs/other antiretrovirals in the March 1998 report. Of these states currently reporting this limitation, Idaho, Kentucky, Maine and Oklahoma reported that they have active waiting lists for individuals to access PIs or antiretrovirals - lists that range in size from eleven individuals in Idaho to 111 individuals in Oklahoma. Four states out of the six currently reporting PI/antiretroviral caps also reported this limitation in the March 1998 report. Nebraska and West Virginia instituted their caps after the March 1998 report (the District of Columbia, Mississippi and Nevada dropped from the list).
• Five states currently have monthly or yearly per capita expenditure caps (in other words clients may not exceed a pre-set spending limit for reimbursement of pharmaceuticals covered in a given month, or a given year). In Illinois the cap is $1,000 per month (set 7/98); Mississippi - $12,000 per year (4/97); Missouri - $16,000 per year (11/96); Oklahoma - $6,000 per year (4/96); and South Dakota - $5,000 per year (4/97).
• One state reported that it reduced its ADAP formulary: Nebraska (8/98).
• Two states reported that they have not restored previous actions which lowered the financial eligibility threshold for client entry into ADAP: Idaho (set 12/97) and West Virginia (11/97). In addition, Iowa reported that it may need to lower financial eligibility, based on current projections, before the end of FY 1998 (possibly by January 1999).
• Four states transferred funds to ADAP from other services such as local HIV care programs, HIV prevention or other public health programs: Idaho (set 12/97), Iowa (3/98), Kentucky (4/98), and Maine (9/98). In addition to these states, six additional ADAPs (Arkansas, Nebraska, North Carolina, Puerto Rico, Texas and West Virginia) reported that they may need to transfer funds from other services to ADAP, based on current projections, before the end of FY 1998 (in early 1999).
• Two states (Arkansas and South Dakota) do not currently offer protease inhibitors on their formularies. In addition to special program limits, 14 states reported that, based on current budget projections, their ADAPs are expected to exhaust their current operating budgets prior to the end of the Ryan White Fiscal Year 1998 (March 31, 1999). These states are: Arkansas, Colorado, Connecticut, Hawaii, Iowa, Louisiana, Maine, Nebraska, North Carolina, Oklahoma, Puerto Rico, South Dakota, Texas and West Virginia. Thirteen states projected potential budget shortages in FY 1997. The current projected shortages total nearly $20 million, with the largest estimated shortages reported by Puerto Rico ($4 million) and Texas ($6.9 million). In terms of percentage of states' overall ADAP budgets, the estimated shortages range from a low of 8% in Hawaii to 50% each in Connecticut and in Louisiana. Taken together, roughly half the state ADAPs (26 out of 52) have either special program limitations and/or projected budget shortages.

Unexpended ADAP Funds
Balanced against those states with ADAP program limits and budget shortages are those states that have reported ADAP budget surpluses in the last year.

Eighteen states reported that they had unexpended federal funds remaining in their budget at the end of Ryan White FY 1997 (March 31, 1998). The states were Alaska, Arkansas, Idaho, Indiana, Iowa, Maryland, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Utah and Washington. The majority of these states (eleven out of 18) indicated that they carried these funds over as part of the Ryan White FY 1998 ADAP budget (and these amounts are reflected in the state-by-state budget breakdowns as "Other Federal Funds," shown in Appendix X). Notably, Alaska, Arkansas, Idaho, Iowa, Nevada and South Dakota are among those states that reported one form or another of ADAP program limitation. Two of the states that had unexpended funds at the end of FY 1997 (Alaska and Idaho) had previously reported that they would potentially face ADAP budget shortages prior to the end of FY 1997. However, both Alaska and Idaho received low dollar allocations from the Ryan White CARE Act in FY 1997 (less than $400,000 each), and carried relatively small balances into FY 1998.

Nine states reported that they anticipate their ADAP will have unexpended funds in its operating budget at the end of Ryan White FY 1998 (March 31, 1999). These states are: Maryland, Minnesota, New Hampshire, New Jersey, North Dakota, Oregon, Rhode Island, Utah and Washington. These same states had reported unexpended ADAP funds for FY 1997. The estimated unexpended balances from the nine states total over $8.6 million.

States were not asked on the survey to explain the existence of unexpended funds. However, follow-up with several states indicates a number of reasons why some programs have unexpended ADAP funds at the end of the fiscal year. For example, Washington State maintained and carried-over unexpended funds from one Ryan White fiscal year to another as a means to manage program growth across different federal and state fiscal years. In many states, ADAPs may not overspend and must put limitations in place to prevent the program from doing so. This may result in small amounts of unexpended funds that can be carried over into the next fiscal year, even if the ADAP has an enrollment cap/waiting list.

The presence of unexpended funds may also point to lack of access to an ADAP, the need for more outreach to inform potential clients about the program, or a simple lack of need for the funds. More state-specific analysis should be conducted to draw clearer conclusions about the reasons for unexpended funds.

Trends in ADAP Eligibility, Drug Formulary Coverage, and Responsiveness to Evolving Clinical Practice
Clinical HIV practice continues to evolve at a rapid rate. Changes in ADAP eligibility criteria, drug formularies and clinical education/outreach programs often reflect state efforts to keep pace with the changing treatment environment. This section will describe changes in state ADAP financial and medical eligibility criteria, formulary additions/deletions, and state efforts to disseminate and implement federal HIV treatment guidelines.

Eligibility Criteria
State ADAPs establish both financial and medical eligibility criteria for access to their ADAPs leading to significant variation across the programs. Financial eligibility is usually expressed as a percentage of the Federal Poverty Level (FPL). Most states simply follow the basic federal statutory requirement in establishing medical eligibility for their ADAPs-that a recipient of Ryan White care services is HIV-positive. However a few states establish additional medical criteria for access to their ADAPs.

Six states reported that they altered their financial eligibility criteria since the March 1998 Interim Technical Report. Idaho and West Virginia both lowered their financial eligibility threshold: Idaho from 400% to 200% of the FPL, West Virginia from 300% to 250% of the FPL. Three states increased the maximum allowable income for ADAP clients: Illinois raised its eligibility threshold from 200% to 400% of the FPL, Oregon from 250% to 325% of FPL and Vermont, while preserving its income threshold at 200% of FPL, switched to counting net available income rather than gross income when making eligibility determinations. Maryland ADAP is unique in having a threshold for minimum income in addition to its upper limit, due to the existence of the Maryland Pharmacy Assistance Program (MPAP) which provides pharmaceutical benefits to all indigent Maryland residents. The Maryland ADAP's minimum income limit has been raised slightly, from $8,750 to $9,250, to reflect an increase in the eligibility ceiling for MPAP.

In terms of medical eligibility, Kentucky is the only state to report a change. The minimum CD4 count requirement of 550 cells was abandoned. Kentucky also amended viral load eligibility requirements for its protease inhibitor program (PIP), from a minimum of 5,000 copies to any detectable measurement. There are now only eight states with medical eligibility criteria for entry to ADAP that go beyond confirmation of HIV-positive status (these criteria are listed in the ADAP Summary Table).

Looking back to the first ADAP Monitoring Project Report (data from July 1997), there have been few changes in eligibility criteria beyond those outlined above. Alaska had raised its eligibility bar from 200% to 300% of the FPL after July 1997 and this remains in effect. Michigan's eligibility threshold increased from 185% to 362% during the same time period. In addition to Kentucky's recent medical eligibility change (detailed above), three other states - Georgia, Indiana and Michigan - have dropped CD4 count requirements since July 1997.

ADAP Formularies
Twenty-two states added antiretroviral drugs to their formularies since July 1997. In some cases, states added antiretrovirals that had been approved by the FDA some time ago, e.g., the non-nucleoside reverse transcriptase inhibitors (NNRTIs) nevirapine (Viramune), approved in June 1996 and delavirdine (Rescriptor), approved in April 1997. Six states reported adding nevirapine to their formularies since July 1997: Alabama, Arkansas, Idaho, Louisiana, Pennsylvania and Tennessee. Three states - Iowa, Maine and Puerto Rico - have yet to add nevirapine to their formularies over two years after approval. Eight states reported the addition of delavirdine during 1998: Alabama, Idaho, Kentucky, Maryland, Missouri, Pennsylvania, South Dakota and Tennessee. Five states remain without delavirdine on their formularies: Arkansas, Iowa, Maine, Mississippi and Puerto Rico.

Two new versions of existing drugs faced few difficulties in attaining ADAP coverage: Combivir, a combination AZT/3TC pill that is priced as the sum of its constituent parts, and Fortovase, a better absorbed formulation of the protease inhibitor saquinavir, priced equivalent to the previous version, Invirase. All ADAPs are covering Combivir. The only ADAPs not covering Fortovase brand saquinavir are Arkansas and South Dakota, which do not cover any protease inhibitors on their formularies.

The NNRTI antiretroviral efavirenz (Sustiva), was cleared for marketing by the FDA on September 17, 1998. Most ADAP survey responses were submitted before that date or shortly thereafter, so complete data are lacking as to exactly how many programs have added this drug to their formularies. However, 12 states reported adding efavirenz: Arizona, Florida, Georgia, Hawaii, Kansas, Louisiana, Nevada, New Hampshire, New Mexico, Ohio, Vermont and West Virginia. As discussed earlier in this report, several states, including New York and California, decided to delay coverage of efavirenz due to its higher cost compared to other drugs in the NNRTI class.

At the time of the first ADAP Monitoring Project Report (July 1997 data), only two states-New York and North Carolina-reported covering all FDA-approved antiretrovirals. At the time of the production of this report the situation has improved dramatically, with 46 state ADAPs offering all 12 FDA-approved antiretroviral drugs. Abacavir (Ziagen), the thirteenth antiretroviral to receive FDA-approval, was approved after the survey completion deadline and is therefore not included in this analysis.

Thirteen states reported adding hydroxyurea, a longstanding cancer chemotherapy, to their formularies, bringing the total number of states covering this drug to 15. Hydroxyurea is not yet indicated for the treatment of HIV infection, but recent studies suggest it has a useful role to play. The fact that the drug is off-patent and inexpensive may also be a point in its favor from the perspective of ADAPs.

Twenty-three states added drugs for the prevention and treatment of opportunistic infections and other non-antiretroviral drugs to their formularies since July 1997. The most dramatic changes in OI/other drug coverage occurred in California and Oregon, where the ADAP formularies were greatly expanded. California added more than fifty drugs, including psychotropics and anabolic steroids. Oregon underwent a massive formulary expansion by increasing the number of OI-related treatments from seven to 180, approaching an "open" formulary model. This expansion was made possible by shifting eligible ADAP clients into an insurance-purchasing program, thereby reducing ADAP expenditures for these individuals. Oregon also became the first ADAP to include lipid-lowering agents on its formulary. Protease inhibitor-related hyperlipidemia has been an increasingly reported problem, and recent studies suggest that lipid-lowering agents may successfully control this side effect in some patients.

Other states have made relatively minor changes in their OI-related drug coverage. New York, like California, made its first foray in the coverage of anabolic steroids for the treatment of weight loss. Four states (Delaware, North Carolina, Ohio, South Carolina) added antimycobacterial drugs that they had not previously offered. Washington State, experiencing less utilization than previously predicted, was able to begin offering antidepressant medications. Overall, 21 states now cover ten or more of the 14 drugs strongly recommended in the USPHS/IDSA "Guidelines for the Prevention of Opportunistic Infections for Persons Infected with HIV," up from 19 since December 1996.

The only major deletion of formulary drugs occurred in Nebraska due to a rapid increase in utilization and the resulting fiscal crisis. All 17 non-antiretroviral drugs were removed from Nebraska's ADAP formulary in August of 1998 as a result of a severe budget shortfall.

An updated ADAP formulary chart that lists all drugs covered by each state is included in Appendix XIV, with new drugs added since July 1997 indicated in bold. Drugs that were added between the first Monitoring Project Report survey period (December 1996) and July 1997 are highlighted in italics.

Federal HIV Treatment Guidelines Dissemination
In April 1998, the federal government released its "Guidelines for the Use of Antiretroviral Agents on HIV-infected Adults and Adolescents." The March 1998 Interim Technical Report reported on state efforts to disseminate these guidelines to providers and, in some cases, consumers, while the Guidelines were in final draft form. The Guidelines are recognized as a definitive source of information on the standard of care for HIV-infected individuals and will be updated periodically to keep pace with advances in HIV therapeutics and clinical practice. When states were asked to report on HIV/AIDS program efforts (since March 1998) to disseminate the Guidelines to their provider and consumer communities, a number of common strategies emerged:

Mailings
Arguably one of the most straightforward methods of dissemination, 17 states reported mailing guidelines to ADAP clinicians and/or providers. In response to a separate survey question, 41 states were able to provide data on the number of medical providers prescribing for ADAP clients, suggesting that mailings could be targeted with a fair degree of accuracy.

Drug Utilization Review (DUR)
In the past few years, an increasing number of states have adopted computerized systems that allow detailed analysis of physician prescribing and pharmacy medication dispensing. In the context of the Guidelines, these systems can potentially be used to periodically review clients' antiretroviral regimens. Nine states reported using some type of DUR to monitor for compliance with the PHS Guidelines. California, Maryland, Pennsylvania and South Carolina all cite ongoing use of DUR with the potential for follow-up with the prescriber and/or client when combinations are notably divergent from those recommended. Massachusetts, Michigan, and New Jersey reported ongoing studies of DUR. These studies will be analyzed to provide an overview of how prescribing patterns of ADAP physicians compare to the PHS Guidelines. New York ADAP already conducts such analyses periodically. Maine is in the early stages of developing computerized utilization review in conjunction with the state Medicaid program.

AIDS Education and Training Centers (AETCs)
Twelve states specifically mentioned collaboration with their AETCs to facilitate Guidelines dissemination. The AETCs provide Continuing Medical Education (CME)-accredited training to providers, either on site or through conferences.

Consumer Education
Twelve states provided information on education initiatives for ADAP consumers. Treatment and adherence education and/or support are the main focus of these efforts. A brief summary of the states and their survey responses is included in Table A:

Table A
Examples of State ADAP Consumer Education Initiatives

Care Consortia
Care consortia are funded through Title II of the Ryan White CARE Act. The consortia are charged by the Act to assess the needs of all populations with HIV disease in the state, develop a plan for meeting identified needs through a continuum of outpatient medical and support services, promote the coordination of community resources, assure continuity of services through effective case management, and periodically evaluate their own effectiveness in responding to service needs and providing cost-effective alternatives to hospitalization. Eight states specifically reported utilizing regional consortia to assist in disseminating the PHS Guidelines.

Conferences, Videos and Other Initiatives
Fourteen states have co-sponsored HIV/AIDS conferences that included sessions on the PHS Guidelines. Alaska and Florida both reported regular use of video/teleconferences. South Dakota has taped copies of the PHS Guidelines Video Conference available for viewing free-of-charge. One state, Washington, reported creating its own Guidelines video, which was produced in collaboration with their AETC.

Novel mechanisms for assisting with Guidelines dissemination were cited by two states. Florida ADAP, in collaboration with its Medicaid program, offers computerized CD-ROM treatment protocols. Louisiana collaborated with the Pediatric AIDS Program at a local Children's Hospital to develop a physician's "Lab Coat Protocol Card." The card includes the Internet address for the PHS Guidelines and the toll-free number for the HIV Telephone Consultation Service at San Francisco General Hospital.

Conclusions
ADAP Monitoring Project data have been collected since July 1996, allowing this report to view the evolution of the programs through time. The picture is one of continuous growth, both in terms of clients served and escalating expenditures. It is also a picture of continuing variation among ADAPs. The heterogeneity of state ADAPs permits few other broad conclusions to be drawn. Based on the findings of this report and the previous Monitoring Project reports, there are several significant challenges that ADAPs face as they move into 1999: