• Contents
• Introduction
• Study 1: Factors Contributing to Variations in Per Capita State AIDS Drug Assistance Program Expenditures
• Study 2: ADAP Supplemental Funds
• Study 3: The Role of Title I-Funded AIDS Pharmacy Assistance Programs in Ensuring Access to HIV Therapeutics
• Study 4: Issues Associated With Capped Enrollment and Waiting Lists

Study 3
THE ROLE OF TITLE I–FUNDED AIDS PHARMACY ASSISTANCE PROGRAMS IN ENSURING ACCESS TO HIV THERAPEUTICS

Jeffrey Levi, Julia Hidalgo, John Palen, E. Blaine Parrish, Kendra Williams, and Anthony S. Lara

Background

Many communities are encountering constrained public funding due to decreased tax revenue and increased expenditures for Medicaid and other entitlement programs. As a result, Medicaid and State-funded health insurance pools and pharmacy programs have reduced or eliminated benefits for medically needy adults, including people living with HIV (PLWH). At the same time, many State ADAPs have narrowed their eligibility criteria and decreased benefits to contain costs.

Changes in indigent care programs and the growing number of newly identified HIV-infected individuals have resulted in significant growth in the number of uninsured and underinsured PLWH in many communities. Concurrently, new HIV medications continue to be approved by the Food and Drug Administration (FDA), and new combinations of therapeutics are being introduced into HIV medical practice. These forces are likely to prompt either steady or increased demand for HIV medications in the near future.

These factors make the role of Title I–funded AIDS Pharmacy Assistance (APA) programs increasingly important in ensuring that HIV medications are accessible and affordable. In FY 2002 alone, Title I Eligible Metropolitan Areas (EMAs) allocated almost $40 million to APAs. APA expenditures represented 6 percent of total Title I funds in FYs 1999 and 2000; 9 percent in FY 2001; and 6 percent in FY 2002. Despite the large financial outlays made by Title I APAs, little is known about their design. Moreover, it is unclear how APAs coordinate eligibility and benefits with State ADAPs, Medicaid, the Department of Veterans Affairs (VA), and other payers to ensure optimal use of public funds.

The goal of this study was to help HAB identify and maximize resources available to support HIV medication costs by

• Gaining a better understanding of the role of APAs in ensuring access to HIV medications;
• Identifying the distinction and overlap between APAs and ADAPs;
• Evaluating the extent to which APAs coordinate benefits with ADAPs, Medicaid, and other payers; and
• Assessing the extent to which APAs maximize their resources.

Methodology

GWU staff conducted a voluntary, email-based survey of Title I grantees that fund APAs. Before conducting the survey, an institutional review board (IRB) package was prepared and submitted to the GWU IRB for review. Approval was granted, and a copy of the survey and accompanying IRB materials were sent to the Title I grantees that HAB had identified as having an APA. The survey was in the field from February 2004 through March 2004, and a total of 21 Title I grantees with APAs were contacted. The Title I grantees received an initial email requesting that they complete the survey. Nonresponding grantees received several email reminders and one telephone reminder call. One Title I grantee (Denver) reported that it no longer operated an APA. Of the remaining 20 Title I grantees listed in Table 3, 17 (85 percent) responded. The three nonresponding APAs were located in moderate-size EMAs in California, Puerto Rico, and Texas.

Limitations

Three EMAs did not respond to the survey. It is unclear to what extent the characteristics of their APAs differ from APAs of responding EMAs. Several EMAs did not provide a copy of their formularies.

Major Findings

APA Eligibility Requirements

Less than one-third (29 percent) of the responding APAs reported using centralized eligibility determination, whereas two APAs (12 percent) use decentralized eligibility through community-based case managers. The remaining APAs did not provide data on their processes for determining eligibility. Seventy-one percent of the APAs have a county residency requirement. Of the 12 APAs with a residency requirement, 4 (23 percent) require that an applicant reside in the county for at least 1 month; 1 (6 percent) require a 12-month residency; and the remainder did not report the length of their residency requirement. Only two APAs (12 percent) reported having a clinical requirement, such as CD4 count or viral load, to be enrolled in the program.

Redetermination of APA eligibility varies among APAs. Of the 17 APAs responding to the survey, 1 (6 percent) requires quarterly redetermination; 7 (42 percent) require redetermination every 6 months; 8 (47 percent) require annual redetermination, and 1 (6 percent) requires redetermination in the event of a significant change in income or other eligibility criterion.

Income and documentation requirements of APAs also vary. Most of the APAs surveyed (88 percent) require proof of income; only two (12 percent) reported that proof of income is not required. Five APAs (29 percent) reported having no income requirement. One APA (6 percent) has a maximum allowable income of 199 percent of the FPL; 7 (41 percent) set the ceiling at 299 percent of FPL; 2 (12 percent) set the ceiling at 399 percent of FPL; and 2 (12 percent) set the ceiling at 499 percent of FPL. In a separate survey item, however, 10 APAs (59 percent) reported that they do not have an income ceiling. More than one-half of the APAs (59 percent) require that applicants apply for Medicaid concurrently with the application for assistance from the APA. Only about one-quarter of the APAs (23 percent), however, require that applicants show proof of Medicaid denial to be eligible for APA enrollment. Veterans are eligible to enroll in slightly more than one-half of the responding APAs (59 percent). In most APAs (88 percent), clients also are allowed to enroll in a State ADAP.

APA Covered Benefits

Among the 17 responding APAs, all purchase medications with Title I funds. Two of the 17 APAs also purchase insurance premiums, and 6 reported paying co-payments on behalf of clients. GWU asked Title I APAs to include a copy of their formulary with their completed survey form. Twelve APAs provided a copy of their current formulary. The submitted APA formularies vary substantially, and many APAs include HIV medications that are also covered by their State’s Medicaid program and ADAP. Additionally, the APAs tend to have formularies that are broader than their State ADAP to compensate for medications required to treat HIV and non-HIV-related conditions common among PLWH. In addition to prescribed medications, some APAs cover over-the-counter medications and medical supplies. APAs tended to report somewhat similar patterns of coverage of HIV antiretrovirals (ARVs). The number of ARVs covered by APAs ranged from 8 ARVs (Patterson, NJ) to 21 (Fort Lauderdale, FL); the modal number of ARVs covered was 20. Only 2 of the 12 APAs that submitted their formularies to GWU covered Fuzeon.

Relationship of APAs to ADAPs

The effective coordination of eligibility and coverage policies between APAs and ADAPs is important given the high number of APA clients that can also enroll in a State ADAP. While 88 percent of APAs allow their clients to enroll in a State ADAP, only 41 percent of the EMAs with APAs allocate funds to their State ADAPs. Two of the 17 APAs reported that their State ADAPs do not need Title I funds. Some APAs reported that their role is to provide benefits that wrap around those covered by the State ADAP. Almost all the APAs (94 percent) covered drugs not covered by ADAP. About one-third of APAs (35 percent) cover clients not eligible for ADAP, whereas almost one-quarter (23 percent) enroll ADAP-disenrolled clients. Despite the importance of coordination of benefits with ADAPs, only about one-third of APAs (35 percent) reported coordinating coverage of newly approved HIV drugs with their State ADAPs. Only 29 percent of APAs reported coordinating the benefits of individual clients.

Relationship of APAs to Medicaid

Reflecting the importance of coordinating APA eligibility with the Medicaid Program, almost three-quarters of APAs (71 percent) reported having access to electronic Medicaid eligibility records. It is unclear, however, how often those records are reviewed to identify newly enrolled or disenrolled Medicaid beneficiaries. Most APAs (82 percent) reported covering clients who are not Medicaid eligible, and more than one-half (59 percent) cover Medicaid beneficiaries. Reflecting the highly restrictive coverage of the Texas Medicaid Program, the APAs located in Texas reported enrolling Medicaid beneficiaries. As with State ADAPs, some APAs function as a wraparound for Medicaid benefits: almost one-third of APAs (29 percent) cover medications that are not on Medicaid’s formulary.

APA Cost-Containment Mechanisms

APAs reported using a variety of cost-containment strategies. As mentioned earlier, two APAs (12 percent) purchase health insurance premiums. About two-thirds of APAs (65 percent) have Section 340B direct purchase arrangements, whereas one APA (6 percent) participates in the 340B rebate program. Only three APAs (18 percent) reported having negotiated price reductions with manufacturers. It is unclear, however, how many of the drugs on these APAs’ formularies were purchased on a price-reduction basis. Only four APAs (23 percent) reported having negotiated dispensing fee or other price reductions from retail or mail-order pharmacies. Use of manufacturers’ patient assistance programs is uncommon among APAs: only six (35 percent) reported such referrals. Other cost-containment strategies that are used by APAs are likely to reduce access to HIV medications. Two APAs (12 percent) limit the number of clients that can enroll in the APA. Almost one-half of APAs (47 percent) reported limiting the number of drugs on their formulary, and 18 percent of APAs reported limiting the number of prescriptions per client. Forty-one percent limit the number of dispensing pharmacies with which they contract. It does not appear that APAs follow the CARE Act’s requirement that a sliding fee scale be used to determine the amount of co-payment required from the APA and other clients. No APA reported requiring clients to pay a co-payment. Because of limits on the number of clients that can enroll in an APA, one APA reported having had a waiting list for 12 months at the time the survey was conducted; another APA had had a waiting list for 4 months, and a third APA had had a waiting list for 2 months.

Benefits of APA Funding Reported by EMAs

GWU asked Title I grantees to comment on the benefits of APAs to their EMAs. Respondents reported the following benefits to funding an APA:

• APAs are viewed as a stopgap measure while clients await ADAP or Medicaid enrollment.
• In some EMAs, APAs purchase medications at specific points of care to ensure that they are immediately available. As a result, filling prescriptions is convenient to clients and the system ensures that prescriptions are filled on a timely basis.
• APA funds are used to reduce co-payments that would otherwise act as a barrier to access to pharmaceuticals.
• The APA formularies are broader than those available from some Medicaid programs (e.g., Texas) or State ADAPs.
• Several respondents indicated that APAs are cost-effective, although no formal studies of their cost-effectiveness were offered by APAs to support this claim.
• Several Title I grantees reported that the APAs in their EMAs function as the PLR because no other programs will provide pharmaceutical coverage to their clients.

Disadvantages of APA Funding Reported by EMAs

Title I grantees also commented on the following disadvantages of APAs to their EMAs:

• APAs are labor intensive and have burdensome administrative functions. As a result, Title I grantees must absorb the cost of administering the APAs.
• Several APAs commented that they have limited distribution systems that result in reduced access to retail pharmacies.
• APAs reported that it is difficult to coordinate benefits with other payers. Data-sharing issues related to client confidentiality are frequent because other payers will not accept APA patient-release forms.
• Despite the importance of recertification to ensure that APA clients are appropriately enrolled, frequent recertification was reported to be a burden for clients.
• Cost-containment was reported to be a challenge for many APAs because they lack the buying power of State ADAPs and the ability to negotiate pricing and rebate agreements.
• As resources decrease in other systems (e.g., ADAPs, the Health Insurance Continuation Program, Medicaid), additional demand for slots is growing. APAs reported that they are unable to meet demand for their services.

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