Chapter 6
AIDS Drug Assistance Program  TOP

Introduction

AIDS Drug Assistance Programs (ADAPs) are authorized under Title II of the CARE Act. ADAPs are State-administered programs that provide HIV/AIDS medications to low-income individuals living with HIV disease who have little or no coverage from private or third party insurance. All 50 States, Puerto Rico, the Virgin Islands, Guam, and the District of Columbia operate ADAPs. United States Territories including American Somoa, the Commonwealth of the Northern Mariana Islands, Palou, the Federated States of Micronesia and the Republic of the Marshall Islands are eligible to establish ADAPs.

Title II grantees are required to use a portion of their Title II funds for ADAPs to provide medications to treat HIV disease, including measures for the prevention and treatment of opportunistic infections.

ADAP managers must keep abreast of multiple HIV/AIDS treatment issues, such as:

• Eligibility criteria to maximize access to ADAP in relation to funding and other Federal programs
• Approval of new HIV medications and changing their drug formularies
• Evolving Federal treatment guidelines in response to new understanding of treatment of HIV disease
• Maximizing use of ADAP funds through drug purchasing programs and cost-containment strategies, and
• Coordination with other funding sources.

Legislative Background  TOP

Title II of the CARE Act provides for the provision of treatments to eligible individuals with HIV disease in a State under Section 2616, as follows:

(a) In General. —A State shall use a portion of the amounts provided under a grant awarded under this part to establish a program under section 2612(a)(5) to provide therapeutics to treat HIV disease or prevent the serious deterioration of health arising from HIV disease in eligible individuals, including measures for the prevention and treatment of opportunistic infections.

(b) Eligible Individual. —To be eligible to receive assistance from a State under this section an individual shall—

(1) have a medical diagnosis of HIV disease; and

(2) be a low-income individual, as defined by the State.

(c) State Duties. —In carrying out this section the State shall—

(1) determine, in accordance with guidelines issued by the Secretary, which treatments are eligible to be included under the program established under this section;

(2) provide assistance for the purchase of treatments determined to be eligible under paragraph (1), and the provision of such ancillary devices that are essential to administer such treatments;

(3) provide outreach to individuals with HIV disease, and as appropriate to the families of such individuals;

(4) facilitate access to treatments for such individuals;

(5) document the progress made in making therapeutics described in subsection (a) available to individuals eligible for assistance under this section; and

(6) encourage, support, and enhance adherence to and compliance with treatment regimens, including related medical monitoring.

Of the amount reserved by a State for a fiscal year for use under this section, the State may not use more than 5 percent to carry out services under paragraph (6), except that the percentage applicable with respect to such paragraph is 10 percent if the State demonstrates to the Secretary that such additional services are essential and in no way diminish access to the therapeutics described in subsection (a).

(d) Duties of the Secretary. —In carrying out this section, the Secretary shall review the current status of State drug reimbursement programs established under section 2612(2) and assess barriers to the expanded availability of the treatments described in subsection (a). The Secretary shall also examine the extent to which States coordinate with other grantees under this title to reduce barriers to the expanded availability of the treatments described in subsection (a).

(e) Use of Health Insurance and Plans.—

(1) In General. —In carrying out subsection (a), a State may expend a grant under this part to provide the therapeutics described in such subsection by paying on behalf of individuals with HIV disease the costs of purchasing or maintaining health insurance or plans whose coverage includes a full range of such therapeutics and appropriate primary care services.

(2) Limitation. —The authority established in paragraph (1) applies only to the extent that, for the fiscal year involved, the costs of the health insurance or plans to be purchased or maintained under such paragraph do not exceed the costs of otherwise providing therapeutics described in subsection (a).

History of ADAPs  TOP

ADAP started as a HRSA demonstration project to provide zidovudine (AZT), the first drug approved by the Food and Drug Administration (FDA) to treat HIV disease, to low-income persons living with HIV disease. The annual cost of this drug-about $10,000 per year per person-placed it out of reach for many people. Congress responded by approving $30 million in funding under a public health emergency provision, and later enacted Public Law 100-71 authorizing the establishment of an ADAP program nationwide.

As HIV treatment advances occurred and as resources permitted, States expanded their programs to cover drugs in addition to AZT. States added therapeutics beneficial in the treatment of many of the opportunistic infections (OIs) that occur in persons living with HIV disease (PLWH). When ADAP became part of the newly enacted CARE Act, States had the option to cover any FDA-approved drug that treats HIV disease or prevents the deterioration of health due to HIV.

ADAPs have expanded considerably since 1991 (when Congress first appropriated funds for CARE Act programs), both in terms of numbers of enrolled clients and in program resources. As of 2001, there are four types of HIV antiretroviral medications approved by the FDA: nucleoside reverse transcriptase inhibitors (NRTIs), nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and protease inhibitors (PIs).

Combination therapy costs approximately $10,000 to $12,000/year, which is too expensive for many individuals. Moreover, prices for drugs continue to rise as new therapies are quickly introduced into the market. With these rising drug costs and increasing numbers of people seeking treatment, ADAPs are greatly challenged in providing services to all eligible clients.

Eligibility  TOP

Financial and medical eligibility for ADAP enrollment is determined at the State level and varies among States. Medical eligibility is most often a positive HIV diagnosis. Financial eligibility is usually determined as a percentage of Federal Poverty Level (FPL). Most ADAPs have set their financial eligibility criteria at 200 percent FPL or higher. However, in these States, at least 88 percent of enrolled clients have incomes below 200 percent FPL. All States require proof of HIV positive status for ADAP enrollment. Some States also require evidence of disease progression, including CD4 counts and viral load testing.

Making Decisions About ADAP Programs  TOP

Most States ADAP programs use a mix of mechanisms to decide such issues as eligibility criteria and drugs to add in their ADAP formulary.

• Most States have established advisory bodies to help with difficult decisions regarding eligibility criteria, the addition of drugs to the formulary, and other program matters.
• The CARE Act gives States the authority to determine which FDA-approved drugs to include on their formularies. Most States focus on antiretroviral medications to treat HIV infection while others also include medications to prevent and to treat opportunistic infections.
• HIV-related treatment guidelines have been crafted by DHHS to guide clinicians and other health care providers in the treatment of HIV-infected individuals. These guidelines are regularly updated to reflect emerging therapies, ongoing research, and newly approved HIV treatment medications. ADAPs and their advisory bodies use guidelines to help them decide about formulary coverage. The most recent guidelines may be obtained at the DHHS website.

Cost-Saving Strategies  TOP

Demand for HIV medications continues to grow as an increasing number of people seek treatment. ADAPs have taken many important steps to respond to the challenges of reducing their costs and stretching their limited resources. Some of the cost-containment strategies employed by ADAPs include restructuring their purchasing and dispensing systems, creating insurance programs, and coordinating with other agencies, such as other Ryan White Title programs and Medicaid.

Patient Assistance Programs  TOP

Patient Assistance Programs (PAPs), also called "compassionate use" programs, are sometimes available to clients who fail to qualify for the State ADAP or who are on the State ADAP waiting list. Funded and operated by HIV pharmaceutical manufacturers on a State-by-State basis, PAPs are short-term sources of treatment assistance, either free of charge or at a nominal charge. These programs are available to eligible, financially disadvantaged patients in order to help them receive necessary prescriptions or maintain an existing regimen until another option is available. Eligibility requirements vary, and it usually requires assistance from a doctor or patient advocate to apply.

ADAP Monthly Report  TOP

The ADAP Monthly Report (AMR) is a data collection system for State ADAPs to report on clients, expenditures, and any major changes to their State ADAP. The data allow HAB/DSS to:

• Monitor the rapid growth in client utilization, program costs, and changing patterns of enrollment and program use
• Compile information on prices paid by State ADAPs for common HIV pharmaceuticals, on a quarterly basis
• Generate reports highlighting individual programs, comparisons between ADAPs, and aggregate nationwide trend analyses.

ADAP Resourcess  TOP

The ADAP program at HAB/DSS produces an array of technical assistance documents to help ADAP programs operate more efficiently. Examples include ADAP Conference Call Reports, the ADAP Manual, and special reports and can be accessed via the TA Library or by calling the ADAP Branch at (301) 443-6745.