3. RWCA 2000 Reauthorization Guidance
This chapter contains guidance related to the Ryan White CARE Act Reauthorization of 2000, AIDS Drug Assistance Programs (ADAPs). These materials were developed by the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB) Division of Service Systems (DSS).
Supplemental Treatment Drug Grant Guidance TOP
Supplemental Treatment Drug Grants are for the purchase of medications by States and Territories with demonstrated severe need to increase access to HIV/AIDS related medications. These grants are to help State and Territory ADAPs expand their ADAP formularies, target resources to reflect the changes in the epidemic, and enhance the State's/Territory's ability to remove eligibility restrictions. Funding for this grant award is authorized under section 2618 (a)(2)(I)(ii) of the Public Health Service Act, as amended by the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act Amendments of 2000. This new grant program represents 3 per cent of the total ADAP earmark appropriation. In FY 2002, $19.17 million of the $639 million Federal ADAP earmark was awarded to 15 severe need States.
As required by statute, HAB/DSS/ADAP established criteria for severe need States and territories based on eligibility standards, formulary composition and individuals at or below 200 percent of the Federal Poverty Level (FPL). States meeting one of the following elements of severe need are eligible to apply for this supplemental funding:
The legislative language of the CARE Act 2000 places several requirements on States and territories that receive supplemental funding. These requirements include: 1) States match the Federal funds received from the Supplemental Treatment Drug Grants at a rate of $1 in non-Federal funds to every $4 of Federal funds received through the grant; 2) States' eligibility requirements will not be more restrictive than those in place as of January 1, 2000; and 3) Supplemental Treatment Drug Grants can only be used to purchase HIV related medications.
HRSA's short-term expectation requires that States/territories meet the eligibility criteria for severe need, as referenced above, to be eligible to receive one of the Supplemental Treatment Drug Grants. HRSA's long term expectations requires that Supplemental Treatment Drug Grants will improve the State's ability to remove income eligibility restrictions, remove medical eligibility restrictions, and allow the State/Territory to provide a full range of HIV-related medications according to the Public Health Service Treatment Guidelines.
Guidance on the Flexible Use of ADAP Funds for Access, Adherence and Monitoring TOP
The core purpose of the AIDS Drug Assistance Program (ADAP) is to provide medications for the treatment of HIV disease and to prevent the serious deterioration of health, including medications for the prevention and/or treatment of opportunistic infections (OI). Congress, in its Appropriations Committee reports for HRSA's FY 2000 budget, requested that HRSA "consider allowing States to redirect a reasonable portion of ADAP funds, as determined in collaboration with the States, to such services that enhance the ability of eligible people with HIV/AIDS to gain access to, adhere to, and monitor their progress in taking HIV-related medications."
The Associate Administrator for the HIV/AIDS Bureau (HAB) originally signed the ADAP Flexibility Policy on July 26, 2000. The policy was amended on April 26, 2001, pursuant to changes in the legislative language of the Reauthorized Ryan White CARE Act regarding the amount of ADAP funds a State/Territory could request to use in a flexible manner. The ADAP Flexibility Policy allows States and territories that have met all conditions of grant awards and have no limitations to clients accessing services, to request to redirect a reasonable portion of ADAP funding.
The legislative language of the CARE Act 2000 affirms the critical relationship between support service provision and positive health outcomes and modified the amount of funding States and territories can redirect under this policy. Eligible States and territories can request to redirect 5 per cent of ADAP dollars (previously 10%) to pay for flexible services if such services are essential and do not diminish access to therapeutics. States and territories can request up to 10 percent under extraordinary circumstances, providing these services do not diminish the core purpose of ADAP. Examples of extraordinary circumstances include:
The State/Territory must redirect ADAP funds back to purchase medications if the State finds that it is unable to meet the demand of its clients.
HRSA is not prescriptive in imposing a specific list of services that can be funded under the ADAP Flexibility Policy. However, each service that is funded must enhance the ability of eligible clients with HIV disease to gain access to ADAP, adhere to their HIV medication regimens, and monitor client's progress in taking HIV related medications using tools recommended in the Public Health Service (PHS) Guidelines For the Use of Antiretroviral Agents in HIV-infected Adults and Adolescents. Additionally, ADAP clients must be the direct recipients of the funded service(s).
To participate in this program option, the ADAP Flexibility Policy requires that the grantee has met all conditions of award and has no limitations on clients accessing the ADAP including: (1) no client waiting list or limits on client enrollment; (2) no restrictions or limitations on HIV medications, such as caps on the number of prescriptions or cost to the client (such as co-pays), except for purposes of clinical quality assurance or the prevention of fraud and abuse; and (3) administrative support is maintained (e.g., administrative support and eligibility staff). States/territories must also ensure an ADAP Formulary that includes a full complement of PHS recommended antiretroviral medications, and medication necessary for the prophylaxis and treatment of OIs. States with alternative methods of providing comprehensive pharmacy coverage (e.g., health insurance, or State-funded pharmacy assistance programs) will be considered compliant with the requirement regarding formulary coverage.
State/Territory ADAPs interested in requesting to use ADAP dollars under the ADAP Flexibility Policy should begin with an assessment of their financial resources to determine that they will be able to cover new and existing clients on their roles with medications should they request to redirect 5-10 per cent of ADAP funding to pay for flexible services. States/territories must then submit a request detailing:
An application to request to use ADAP funds under the ADAP Flexibility Policy must be submitted annually, and it may be included with the Title II Grant Application Guidance. It is important to note that the use of funds under the ADAP Flexibility Policy only applies to the ADAP earmark. It does not apply to funds under other titles that may use funding to purchase medications.
Quality Management Programs TOP
States are expected to develop strategies and implement Quality Management Programs beginning Fiscal Year (FY) 2001 to assess the extent to which HIV health services are provided to patients under the grant consistent with the most recent Public Health Service guidelines for the treatment of HIV disease and related opportunistic infections. The use of funds for Quality Management Programs are to be no more than 5 percent of amounts received under the Title II grant, or $3,000,000, whichever is less. Grantees may take less than this amount, but regardless of what amount is taken, Quality Management Programs MUST be implemented.
The HIV/AIDS Bureau has defined quality as "the degree to which a health or social service meets or exceeds established professional standards and user expectations. Evaluations of the quality of care should consider (1) the quality of the inputs, (2) the quality of the service delivery process, and (3) the quality of outcomes, in order to continuously improve systems of care for individuals and populations." HAB supports several activities to improve the quality of HIV/AIDS services. These include the Primary Care Assessment Tool, HIVQual, and a series of Technical Assistance Monographs on quality.
The Division of Service Systems (DSS) will monitor grantees to ensure compliance through questions in the application guidance, progress reports, and site visits. State Governors or their representatives will be asked to sign an assurance in the annual application attesting that quality management programs are in place.
The use of an additional 5 percent of funds is intended to assist grantees in evaluating and improving the quality of primary care and health-related supportive services provided under this act. In deciding what activities to undertake, quality management should be coordinated with program evaluation and quality assurance activities currently funded. While the focus and ultimate goal of quality management is improved health status for clients, the quality management program looks beyond clinical services to include consideration of both supportive services that link clients with health care and community/populations outcomes.
States are expected to perform quality monitoring on an individual provider basis. That is to say DSS/HAB expects that States will have monitoring systems in place to assure that:
ADAPs can assess quality by:
Additionally, money can be spent on programs to enhance patient adherence to antiretroviral medications, laboratory evaluation tools to measure how a client is progressing on their medication therapy, and systems to enhance access to ADAP services for patient populations in hard to reach areas.
Minority AIDS Initiative TOP
African-American members of the House of Representatives formally organized the Congressional Black Caucus (CBC) in January 1969. Their primary goal was, "to positively influence the course of events pertinent to African-Americans and others of similar experience, and to achieve greater equity for persons of African descent in the design and content of domestic and international programs and services." Today, the CBC has 38 members several ongoing health initiatives focused to eliminate health disparities as it relates to access, treatment, and availability of medical care in African-American and other communities of color.
In fiscal year (FY) 2001, Congress appropriated $7,000,000 in funds under Part B (Title II) of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act for the Congressional Black Caucus Minority AIDS Initiative (MAI). These funds are to support educational and outreach contracts to minority community-based organizations to increase the number of minorities participating in State AIDS Drug Assistance Programs (ADAPs). This was the first year since the MAI's establishment in 1999 that funds have been made available for Title II grantees to participate in this important initiative.
The MAI allocation among the 54 States and territories is predicated on the relative distribution of minority AIDS cases in accordance with criteria established by Congress. MAI funds are to be used to initiate, modify, or expand educational and outreach services for disproportionately impacted communities of color to improve ADAP participation. The FY 2001 DHHS Appropriations Conference Report for Title II MAI funds states:
"The continuing under representation of African Americans, Latinos, Native Americans, Asian Americans, Native Hawaiians and Pacific Islanders in State run ADAPs contributes to their persistently poor health outcomes in comparison to other communities."
The overarching purpose of the Minority AIDS Initiative is unchanged since its inception three years ago. Following Congressional intent, MAI funds must be used to expand or support new initiatives consistent with these goals. As with all Title II funds, MAI funds may NOT be used to supplant funding from other local, State, or Federal sources or existing programs.