The Next Wave in AIDS Care: Reauthorization of the Ryan White CARE Act 2005-2010

Summary of the IOM Report "Public Financing and Delivery of HIV/AIDS Care"

In May of 2004, the Institute of Medicine (IOM) produced a report, mandated by the 2000 Ryan White CARE Act reauthorization, on the public financing structures of HIV/AIDS programs for low-income individuals (Public Financing and Delivery of HIV Care, Securing the Legacy of Ryan White). The results of the report are to be used to help guide the HHS, who commissioned the study, and other decision makers in the 2005 reauthorization of the CARE Act to meet current and future challenges of the HIV/AIDS epidemic. The IOM Committee on Financing and Delivery of HIV Care, comprised of experts in program provision and finance, was convened to develop a framework for a system of public financing and delivery of primary care and health-related support services for low-income, uninsured, and underinsured individuals with HIV.

After several years of work, the committee recommended the establishment of a new federally funded program for low-income HIV infected persons that provides early access, continuous coverage, and uniform benefits to best meet the needs of those with HIV/AIDS. The new entitlement program, administered by the states and financed by the federal government, would allow for access to essential service provision to all HIV-positive individuals, from the point of HIV diagnosis through all acuity levels and stages of disease progression.

The IOM report also recommended that the CARE Act be preserved, in part, to meet additional, unique needs of people living with HIV/AIDS. The new program would provide enormous benefits in lives saved, health maintained, and medical and socioeconomic costs deferred or avoided. The report and its recommendations are supported by The AIDS Institute and should serve as the philosophical basis for the work of advocates and government officials alike as they focus on the 2005 reauthorization of the Ryan White CARE Act.

Specifically, the IOM recommends ensuring continuous and equitable access to high quality healthcare from the point of diagnosis of HIV infection for all people in need of public assistance regardless of where they live. The IOM report is instructive in the sense that the proposed system would go far in addressing the current state of quality of HIV/AIDS care and access to that care, while rectifying many of the funding problems related to the discretionary nature of the CARE Act.

Analysis of a Current Broken System

In order to reach its recommendations, the IOM committee first studied and analyzed the current financing and delivery of publicly provided HIV/AIDS services. They concluded that the current system is:

complex and undermines the significant advances made in the development of new technologies to treat HIV/AIDS, such as highly active antiretroviral therapy (HAART). Many individuals experience delays in treatment access or are provided only limited options for specific drugs or important laboratory monitoring. As a result, each year there are missed opportunities to reduce mortality, morbidity, and disability among individuals with HIV infection. It is not uncommon for patients to receive care for the first time with advanced disease stages. The fact that about 40,000 new AIDS diagnoses and 16,000 deaths occur each year further indicates that our current system is failing to ensure adequate health care for persons living with HIV infection (CDC, 2002). A similar number of new infections each year indicated that the threat to the public's health from HIV continues (Fleming et al., 2000).¹

While the report identifies numerous successes of HIV/AIDS care in the US, mainly the dramatic drop in the number of deaths from AIDS, the IOM identified new and difficult challenges including:

the central role of adherence to the therapeutic regimen and the attendant risk of drug resistance to HAART; the changing demographics of the epidemic and the challenges presented by those changes; and, the increasing incidence of both medical and social comorbid conditions among people living with HIV/AIDS. Most importantly, the course of the illness has changed. Individuals with HIV are living longer and require care that is more suited to that for a chronic illness rather than an acute terminal illness.²

The Ryan White CARE Act, when initially written in 1990, addressed the acute needs of those living and, unfortunately, dying of an acute illness. With the advent of HAART, therapy today for most consists of a number of prescription drugs delivered in outpatient settings and requires access to high-quality primary care. In addition, many individuals require a variety of other services including substance abuse and mental health treatment, case management, and prevention services. The care delivery system, and the financing that supports it, has struggled to adapt to the shift in the locus of service delivery and to integrate HIV care among numerous and multidisciplinary providers.³

The IOM identified other problems as well, mainly that there are significant inequities in access to the standard of care for HIV across geographic and demographic populations. According to IOM Committee Chair Lauren LeRoy,

Much of this disparity is related to the patchwork of financing mechanisms across the country and the programs' widely disparate eligibility requirements and benefit packages, all of which result in fragmentation of coverage and significant variations in the type of services available to people with HIV in each state. For many people, the current system does not allow for sustained access to highly active antiretroviral therapy, or HAART, and services that support adherence to treatment. The lack of sustained access to HAART is a clear indicator of poor quality care. Without this treatment, individuals face increased illness, disability, and death. Furthermore, the committee noted that the current federal-state partnership for financing HIV care is unresponsive to the fact that HIV/AIDS is a national epidemic with consequences that spill across state borders.⁴

The Committee reached these conclusions after it examined two federal programs that provide services to HIV infected people -- Medicaid and Ryan White CARE Act. It concluded:

both allow for a tremendous amount of variability in the benefits an HIV-infected person can receive. Benefits in one area often fall well below those considered standard in others. The federal-state partnership, embodied in the Medicaid program, in particular, allows states to respond to the epidemic in significantly different ways that may not be the most efficient or effective in light of the nationwide epidemic. HIV-infected individuals living in one state may not be eligible for Medicaid services in another state because of differences in income thresholds or they may receive fewer or more services because the benefit packages vary in each state (e.g. limitations on prescription drugs or coverage of case management, hospice services).⁵

The Committee found similar inequities in the delivery of services under the Ryan White CARE Act, which is designed to fill the gaps in care left by Medicaid. They found:

Access to HAART and primary care, for example, varies significantly by state and city of residence, in part due to varying income eligibility requirements for the AIDS Drug Assistance Program (ADAP) under Title II of the Ryan White CARE Act and in part due to the varying resource allocation decisions made by localities. Substantial state variation also occurs in the types of drugs covered and number of prescriptions allowed (Morin et al, 2002). Budget shortfalls can also lead to further restrictions in the ADAP program, such as enrollment caps or benefit limitations, as they did in June of 2003.⁶

The IOM determined that an astonishing 233,000 people in the United States who know their HIV status do not have consistent access to HAART. As a locally controlled, discretionary program that relies on annual appropriations by Congress, CARE Act programs cannot ensure continuity of care from year to year, nor can they ensure that all eligible individuals infected with HIV will receive a minimum basic set of services. ...⁷

IOM Committee Recommendation

In order to improve the current broken system, and to address the needs of the future, the IOM committee recommended the establishment of a federally funded entitlement program called the HIV Comprehensive Care Program (HIV-CCP) that would treat low-income individuals with HIV and would be administered by the states.

To assist the states in implementing the program, the federal government would pay for costs directly attributable to efficient administration of the program. To receive federal funding, states must ensure compliance with federal standards and operate programs according to principles of accountability and transparency. Under the federally sponsored program, the federal government would relieve the states of the full cost of providing care to HIV infected individuals through their Medicaid programs.⁸

The program has several primary design features that are critical to achieving the goals of the program. They are: eligibility requirements; benefits; access to experienced providers and provider reimbursement; quality and program management efficiencies; and interaction with other programs.

Eligibility

• Open to individuals with HIV whose family income is under 250 percent of the federal poverty level (FPL), which is around $23,000.

• Individuals with HIV infection whose family income is above 250 percent of the FPL would be allowed to establish eligibility for coverage by spending-down or buying-in on a sliding scale basis.

Benefits

• Each eligible individual with HIV would be entitled to a uniform, federally defined benefit package that reflects the standard of care for HIV/AIDS.

• Benefits would include HAART and other drug therapies, primary care services, obstetrics and reproductive health services for HIV-infected women, case management, prevention services, mental health treatment, and substance abuse treatment.

Provider Reimbursement

• Provider reimbursement would be set at the Medicare reimbursement rates.

Cost Offsets

• Recommends that Congress implement measures that lower the cost of drugs, such as applying Federal Ceiling Price or the Federal Supply Schedule price currently used by some major federal programs.

• This would lead to an estimated discount off of Medicaid ARV prices of 9 to 25 percent.

Improving Quality and Programmatic Efficiencies

• To be determined by the state, e.g., some states may administer through their Medicaid agency.

• Create demonstration projects for Centers of Excellence as models of care -- the assembly of highly trained, experienced HIV providers and coordination of their activities to provide support for HAART adherence and access to medical and non-medical services. It is assumed that a wide range of providers, including community based providers who have experience and expertise working with the affected populations, will be a part of these Centers. Centers of Excellence would receive funding for data collection and program evaluation.

Coordination With Other Programs

• Ryan White CARE Act programs would be altered and would provide services to those not eligible for the new entitlement program.

• Ryan White CARE Act would provide ancillary services such as assisting individuals in enrolling in the new federal program, filling in any remaining service gaps, and supporting delivery system improvements.

• Title III would play an important role by funding community health centers, hospital or university-based medical centers by participating as Centers of Excellence, and/or would provide services to those in need not covered by the program.

The Potential Benefits

• In its first year of implementation, the recommended program would enroll approximately 285,000 individuals with HIV/AIDS.

• The majority of these people are currently receiving Medicaid, however, 58,697 individuals would gain access to Highly Active Antiretroviral Therapy.

• Premature deaths would decrease by 55.9 percent over 10 years, from 35,489 to 15,664 deaths.

• Through prevention counseling it is estimated that more than 3,000 new infections could be prevented annually.

Cost

• The Committee estimates that the incremental cost of providing HAART to 58,697 individuals for ten years in 2002 dollars is $2.65 billion.

• Adding the cost of the other elements that the committee recommends for comprehensive care is estimated to be $5.56 billion, discounted, over 10 years.

• The cost per quality-adjusted life-year gained by implementing the program is $42,972 in 2002 dollars; an amount that is comparable to other widely accepted healthcare investments.