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

After considering and assessing the current situation regarding care and treatment of low-income people living with HIV/AIDS in the US, and in light of the current provisions of the Ryan White CARE Act, The AIDS Institute proposes that a reauthorized CARE Act adhere to the principles noted below:

Keep Current With Epidemiological Trends Together With Medical and Technological Advancements

In order to offer proper medical care, Ryan White CARE Act grantees and providers must be kept current in epidemiological trends, together with medical and technological advancements. If there is an outbreak in a certain population subgroup, providers should be made aware of this and be on the outlook for it so that it can be properly treated.

In addition to offering competent and well trained medical providers (see discussion below), the care and treatment that Ryan White CARE Act providers offer must be current. Given that there are changes and rapid advancements in the treatment of HIV/AIDS, CARE Act providers should have access to the most current life-saving treatments. There are recognized standards of care that establish the selection of treatments from all FDA-approved anti-HIV medications. Each of the federal HIV treatment guidelines is a living document developed by experts in the field, supported by the latest clinical research and clinical practice experience, as well as responsive to the arrival of newly approved medications within each class.

The Public Health Service (PHS) HIV Treatment Guidelines are widely accepted as the standard of care for HIV and AIDS. The world's best HIV research doctors, who also have real life experience in treating patients, develop these guidelines. This distinguished panel reviews and updates the guidelines periodically and they, in our view, are the best qualified to develop the drug formularies.

The AIDS Institute supports that in the administration of Ryan White CARE Act services, medical providers must follow the PHS HIV Treatment Guidelines.

Provide Access to Cutting Edge Clinical Trials

One way to provide cutting edge medical care to those living with HIV/AIDS is through participation in clinical trials. HIV/AIDS clinical trials are necessary in determining the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. They can be used as a mechanism for making promising new treatments available for those who are faced with no other treatment options. Treatment options can be limited both by personal fiscal constraints and viral resistance. Clinical trials also allow those individuals that have resistance to all FDA-approved therapies to attempt a therapy before it is available to the general public, while it is still in the trial phases. The costs for these trials frequently are shared by pharmaceutical manufacturers and the government. Compassionate use programs are a product of pharmaceutical companies which make investigational new pharmaceuticals available for the same group. Pharmaceutical companies sponsor both expanded access and compassionate use programs.

The Ryan White CARE Act already calls for coordination of clinical trials between the National Institutes of Health (NIH) and Ryan White CARE Act grantees. The AIDS Institute supports this cooperation and wishes that this cooperation be expanded. The 2000 reauthorization called for enhancing and expanding voluntary access to these trials, "especially in communities that are not reasonably served by such projects". Efforts should be undertaken to ensure that this cooperation is occurring and arrangements between the NIH and Ryan White CARE Act grantees are being carried out. Further, groups who are not usually provided access to clinical trials should be included in them on a priority basis.

Recruit and Retain Competent, Specialized, Certified, Healthcare Practitioners as Well as Service Staff

According to the American Academy of HIV Medicine (AAHIVM), with the advent of HAART, HIV disease might now be considered a manageable lifelong illness for many individuals. Since HIV-positive patients can now live longer, healthier lives, they require less hospital and late-stage care and more long-term care that involves assistance in many aspects of living with HIV/AIDS and working with multidisciplinary healthcare teams. New technology, increased drug options, and changing treatment guidelines are making treatment and care increasingly complex. Additionally, HIV-positive patients can develop many noninfectious complications from their disease and the medicines used to treat the virus.⁹

In this environment, identifying experienced HIV healthcare providers with up-to-date knowledge of HIV medicine has become crucial to improving the quality of, and access to, effective HIV medical care.¹⁰

The Academy also reports that patients living with HIV/AIDS have better outcomes when they receive their healthcare from providers and facilities with more experience in treating HIV positive patients. Because of reduced morbidity, mortality, and inpatient costs as a result of state-of-the-art outpatient treatment, such care models are cost-effective compared with the alternatives.¹¹

To help persons living with HIV/AIDS receive quality medical care, many organizations have created various ways to identify those with sufficient experience and expertise in delivering HIV healthcare. The American Academy of HIV Medicine, to improve both quality of, and access to, HIV medicine for persons living with HIV/AIDS, has established a definition of an HIV Specialist that is based on specific evidence and maintenance of continuing competency in key aspects of HIV medicine. With its definition of the AAHIVM HIV Specialist^TM, the Academy (a) defines the specific skills and qualifications that HIV healthcare providers should possess to be credentialed as an HIV Specialist, (b) obtains evidence of these skills and qualifications from a broad range of practiced HIV healthcare providers, and (c) does so on a continual basis as clinically relevant information continues to change.¹²

The AIDS Institute supports the effort of the Academy and other HIV medical provider groups in ensuring there are HIV specialists who can offer expert care and supports that Ryan White CARE Act medical providers meet a minimum level of competency. An HIV-diagnosis in the family doctors' office or by a primary care doctor should immediately trigger a referral to specialized care. Primary care doctors need to be trained to recognize symptoms, recommend testing, and become a part of a referral network so that newly diagnosed patients can be linked to specialized care immediately. Further, healthcare professionals in emergency departments and emergency medical personal should be effectively trained and have access to the same network. This will not only benefit those living with HIV/AIDS, but ensure the government is buying cost effective services and the care they are funding is sufficient.

In order to recruit competent medical providers, Ryan White CARE Act medical providers, including doctors, nurses, and other practitioners, must be adequately compensated. In order to retain them, compensation levels must remain competitive.

The Ryan White CARE Act should continue its system of educating and training HIV medical practitioners and providing Technical Assistance to grantees so that they can offer the most cutting edge healthcare.

Underlying the medical support that the Ryan White CARE Act provides are the attendant support services that assist CARE Act clients in accessing and adhering to their medical care. That staff, as well, must be adequately trained and sensitive to those living with HIV/AIDS.

Care Must Be Made Available to All Low-Income People Infected With HIV/AIDS, No Matter Where They Reside

The Ryan White CARE Act must meet the needs of all low-income people with HIV/AIDS, no matter where they reside. Not only does this mean the care and treatment offered by Ryan White CARE Act providers should be comparable across the country, but that if a client moves from one area to another, that client should still be able to easily access services. As a predominately federal funded healthcare program, the Ryan White CARE Act is meant to fill in the gaps left by Medicaid, Medicare, state programs, and private insurance programs for low-income people with HIV/AIDS. The end result of all these programs should be comparable services for every client, no matter where they reside. In reality, the current public healthcare system for people with HIV/AIDS is a patchwork of care, with where you reside being one of the significant factors in determining the quality of your healthcare.

A low-income patient's quality of healthcare is determined by a number of factors, including 1) Medicaid benefits offered by the states; 2) Medicare benefits; 3) Ryan White CARE Act benefits; and 4) Private Health Insurance.

Medicaid currently provides the largest source of public funding for HIV/AIDS care in the U.S. In FY2005, it is estimated that federal Medicaid spending on AIDS will total $5.7 billion.¹³ If past indicators hold true in FY2005, an additional $4.3 billion will be spent by the state s on Medicaid AIDS care. To be eligible for Medicaid, beneficiaries must be low-income and meet certain other eligibility requirements, including being disabled. According to the IOM's report, Public Financing and Delivery of HIV/AIDS Care, the federal government provides matching funds to states that meet certain minimum federal standards in operating their Medicaid programs. States have broad flexibility in designing their Medicaid programs and, consequently, there is significant variation in eligibility, benefits, provider payments, and other aspects of the program at the state level.¹⁴

The IOM report continues:

Within broad national guidelines established by federal statutes, regulations and policies, states have broad flexibility standards, the type, amount, duration and scope of services provided, provider payments and other aspects of the program at the state level. ... State Medicaid policies vary considerably even among similar-sized and or adjacent states, thus, a person who is eligible for Medicaid in one state might not be eligible in another state; and the services provided by one state may differ from those of another state.¹⁵

Medicare is the second largest source of federal financing of HIV/AIDS care, accounting for $2.9 billion in FY2005.¹⁶ In order to be eligible to receive Medicare, one must be disabled, have sufficient work history to qualify for disability insurance, and live long enough to qualify for Medicare.¹⁷ Although Medicare currently does not provide prescription drug coverage, it will do so beginning January 1, 2006.

The Ryan White CARE Act is a discretionary federal program, with some state contributions, meant to provide coverage for low-income people with HIV/AIDS after other sources of public and private healthcare programs are exhausted. Most of the more than $2 billion of Ryan White CARE Act funding is distributed to the states and cities disproportionately affected by AIDS through a formula based on a weighted average of cumulative AIDS cases. Consortium and planning councils in the states and cities are responsible for setting priorities as to how and where the funds should be allocated within each state and city.

The amount each state or city receives through formula under the Ryan White CARE Act is based primarily on the number of AIDS cases. It does not take into account the number of people who have HIV, but who have not yet developed AIDS, the poverty rate or unemployment rate in the area, the number of people who have health insurance, the generosity of a state's Medicaid program, or state and local contributions to HIV/AIDS healthcare programs. Nor does the formula allocation take into account the cost of care in an area, the availability of services, and other special needs such as the level of substance abuse. In the awarding of Ryan White CARE Act supplemental awards, some of these factors are considered. [Note: In the IOM report, Measuring What Matters: Allocation, Planning and Quality Assessment for the Ryan White CARE Act, many of these issues were discussed and analyzed.

Due to variations in each state and locality that are not factored into the formula distribution and other awards of the Ryan White CARE Act, a client in one jurisdiction will receive far different care and treatment than a client in another jurisdiction. An examination of the AIDS Drug Assistance Program (ADAP) of the Ryan White CARE Act, which provides critically important life-saving drugs to low-income people with HIV/AIDS, exemplifies the variation from one state to another.

According to the National ADAP Monitoring Project, resource constraints and state discretion have resulted in significant variations in access to the range of drugs offered across the country. Some examples of the variation include:

• Client eligibility ranges from 125 percent of the Federal Poverty Level (FPL) in North Carolina to 500 percent FPL or higher in Delaware, Maryland, Massachusetts, New Jersey, and Ohio.

• The number of drugs on ADAP formularies ranges from 25 in Louisiana to nearly 500 in New York. Three jurisdictions reported that they had an open formulary (Massachusetts, New Hampshire and New Jersey).

• Seventeen states do not provide all FDA-approved antiretroviral medications, including one state (South Dakota) that does not provide any protease inhibitors.

• Fifteen states provide less than ten of the full set of 16 drugs highly recommended by the Public Health Service/Infectious Disease Society of America (PHS/IDSA) Guidelines for the prevention and treatment of opportunistic infections. One state (Louisiana) does not provide any of these drugs or drugs for other HIV-related conditions.

• Ten states do not cover Fuzeon, the first FDA-approved drug in a new class (fusion inhibitors).

• Twenty-four states report coverage of drugs for the treatment of hepatitis C (HCV), a major co-morbidity for people with HIV. Twenty-two states offer hepatitis A and B vaccines, recommended for those at risk and living with HIV.¹⁸

Due to a growing case load, minor federal funding increases, state budget constraints, along with the existing Ryan White CARE Act formula system, states have had to institute waiting lists, capped enrollments, and additional cost containment measures such as limiting drug formularies, tightening eligibility requirements, or limiting the quantity of prescriptions a client can receive per month.

Variation between jurisdictions, even within the same state, occurs in other Ryan White CARE Act programs as well. For example, access to and the quality of healthcare services can be determined by whether the client lives in a Title I Eligible Metropolitan Area (EMA) or not.

Whether an area has Title III or IV grantees, Ryan White CARE funded Dental Clinics, or received Title I or II Supplemental awards will also directly impact a client's healthcare. Allocation decisions recommended by a community's planning council or a state's consortium are additional factors that determine a client's healthcare in a jurisdiction.

While private health insurance covers a significant share of HIV/AIDS healthcare, most low-income people with HIV/AIDS are not insured or are under-insured, and therefore, must rely on publicly funded healthcare programs. In any event, private healthcare insurance benefits vary from one jurisdiction to the other, sometimes in response to state laws.

Taken together, Medicaid, Medicare, Ryan White CARE Act, and private insurance, all of which provide healthcare to low-income people with HIV/AIDS, as described above, offer varying degrees of coverage depending on where you live. The AIDS Institute finds this unacceptable and supports a program that offers coverage and benefits to all low-income people with HIV/AIDS, no matter where they live.

If this was attained, the issue of portability of services from one jurisdiction to another within a state or from one state to another would also be more easily addressed. The current Ryan White CARE Act "counts" the client at the place of diagnosis. But, reality is that clients do not always stay in that place and frequently move for a variety of reasons. Someone with HIV/AIDS may move back to where they grew up to be with their family, who can help provide for them, while someone else may wish to move to a different climate or to take on a new job.

Unfortunately, to further illustrate the geographic disparities in care, some individuals decide to move their residences to locations with more expansive service offerings. Whatever the circumstances, The AIDS Institute believes that not only should every low-income person with HIV/AIDS be able to access the same type of healthcare no matter where they live, the services that are offered to them should be portable so that they can access that care with relatively ease when they move into another jurisdiction.

Be Culturally and Linguistically Appropriate

For CARE Act providers to offer proper medical attention and care it is essential that it be offered in a culturally and linguistically appropriate manner. Given the varied and distinct populations affected by HIV/AIDS in the United States, this may pose more of a challenge than the treatment of other diseases and medical conditions. These added challenges must be taken into account in the development and administration of CARE Act programs. If done properly, the results will not only pay off in more people who are healthy, but in healthier and happier families. Additionally, it should help serve as a prevention tool, and reduce the transmission of HIV to others. Consider these facts:

• According to the CDC, at the end of 2003, nearly 50 percent of people living with HIV/AIDS in the United States were African American and approximately 12 percent were Hispanic. Thus, approximately 62 percent were racial or ethnic minorities.¹⁹

• From 1998-2002, a growing number of AIDS cases occurred in African Americans, Asian/Pacific Islanders, and American Indian/Alaska Natives.²⁰

• When examining the impact of AIDS on racial and ethnic minority women, the disproportionate share is even more pronounced.

• African Americans accounted for 67 percent of female cases in 2003; Hispanics accounted for another 15.6 percent.²¹

• Among males, 66.2 percent of reported AIDS cases in 2003 were among racial and ethnic minorities, 44 percent among African Americans and 19.76 percent among Hispanics.²²

According to HRSA, approximately one-half of the current CARE Act clients live at or below the Federal Poverty Level.²³ CARE Act clients commonly live in more dire circumstances than do other people living with HIV disease, and HIV-infected people in general are more likely than the non-infected population to be economically disadvantaged.²⁴

While the vast majority of people with AIDS live in large cities, there is growing evidence that the incidence of AIDS is growing in rural America. This is best exemplified by the increased incidence of AIDS in the South. The South now has the greatest number of people estimated to be living with AIDS in the U.S. While the South represents a little more than one-third of the U.S. population (34 percent), it accounts for 41 percent of the people estimated to be living with AIDS. While the prevalence rate is going down in other regions of the country, the reverse is happening in the South, rising from 35 percent in 1993 to 40 percent in 2001.²⁵

People with HIV/AIDS also experience other problems as well. Since about a quarter of all new AIDS cases were contracted through intravenous drug use (IDU)²⁶, it is clear that many people with AIDS have substance abuse issues. Many experience severe mental illness. In the US and Europe, it is estimated that severe mental illness occurs in 20 to 50 percent of the people living with HIV.²⁷ An added problem for many people with AIDS is homelessness or poor housing conditions. The U.S. Department of Housing and Urban Development (HUD) estimates that one-third to one-half of all people living with AIDS "are either homeless or in imminent danger of losing their homes."²⁸ Additionally, approximately one-third of people living with AIDS also carry the hepatitis C virus, which further complicates their treatment and health outcomes.

With an understanding and acceptance of these co-morbidities, medical and social service providers can better deliver proper medical care under the Ryan White CARE Act. In order for that to happen, CARE Act programs must provide for the proper training, planning, and financial resources. Given the varied populations affected, this is no small feat.

The actual medical providers working for a grantee must also be cognizant of their patients' characteristics and be respectful of them when offering and suggesting care and treatment. This can best be accomplished by first having a competent intake system and competent case workers. The Ryan White CARE Act system should ensure that medical providers can be made aware of their patients' cultural and linguistic needs.

If the CARE Act ensures that medical care is offered in a culturally and linguistically appropriate manner, the health of the patients is apt to improve. This should assist in adherence to medication and services, and additionally serve as a tool towards better prevention.