In January 2008, the HHS Office of the Assistant Secretary for Planning and Evaluation (ASPE) convened an expert panel to discuss outcomes measurement issues related to DM for populations with chronic conditions. The panel included researchers and clinicians, and the discussion noted that the inconsistency in methodologies used to evaluate DM programs makes it difficult to compare evaluations of program effectiveness. Based on the current state of DM outcomes measurement, increased standardization in evaluation methodologies is needed to more accurately estimate DM programs’ impact. In addition, there is wide variation in program designs and characteristics of the populations served in the programs, which presents a challenge for comparing the effectiveness of different DM models. For many Medicare and Medicaid patients who face a host of social service needs as well as medical needs, certain DM models (such as telephone-based health coaching) may not adequately address all of the patient’s needs. More study is needed to determine which models best respond to populations with special needs. The expert panel did not reach a conclusion about whether DM is the solution to getting health care costs under control, but they agreed that we need a better understanding of disease management’s impact on clinical outcomes and utilization. The panel noted that measures need to go beyond processes (e.g., number of tests or services provided) and reflect the specific outcomes that the DM program is attempting to achieve for the patients. For individuals with multiple chronic conditions, DM may have the potential to minimize hospitalizations or other acute complications associated with those conditions by improving care coordination and facilitating patient compliance with treatment plans.
One example of a population with special needs is individuals living with HIV. CDC estimates that more than 1.1 million people in the U.S. are living with HIV, and one-fifth of them are unaware of their infection. There are no known current estimates of the insurance status of Americans with HIV. A 1997 study found that, among a sample of HIV patients in 10 U.S. cities with high HIV prevalence, about one-third had private health insurance, 40 percent had public insurance, and 27 percent were uninsured (Fleishman, 1997). Their insurance coverage depended on factors like employment status, the extent of disability due to the disease, and the public benefits available in their geographic location. In many cases, an individual might utilize more than one type of coverage, for example, Medicaid or private insurance plus Ryan White program services for certain benefits not covered by the insurance.
After the discovery of antiretroviral medications in the 1990s, treatment became widely available and significantly extended the average lifespan for HIV-infected individuals. HIV disease was the eighth leading cause of death in 1996, but no longer ranks among the top fifteen causes of death. CDC data indicate that from 1987 through 2005, the proportion of deaths due to HIV disease among people under age 35 decreased from 43 percent to 12 percent. In contrast to the early days of the AIDS epidemic in the U.S., HIV disease is now generally considered to be a chronic condition rather than a death sentence. The highly active antiretroviral therapy (HAART) “drug cocktails” used for HIV/AIDS treatment require strict adherence to prevent resistance of the virus to therapy. Adherence to antiretroviral therapy can be difficult for some because of the number of pills involved in the regimen and unpleasant side effects caused by HIV medications, such as fatigue, nausea, skin rashes, and high cholesterol.
Because of the need for ongoing treatment and the potential for acquiring co-occurring illnesses, HIV patients seem appropriate for targeted intervention through DM to prevent complications associated with the disease. HIV infection disproportionately affects individuals of lower socioeconomic status, and many with the disease are uninsured or underinsured and may have other special needs like substance abuse treatment or mental health services.
The Medicaid program is the largest federal payer of HIV/AIDS medical care in the U.S. The Centers for Medicare and Medicaid Services (CMS) estimates that there are 266,000 Medicaid beneficiaries with AIDS, or advanced HIV disease. Low-income individuals with AIDS are often automatically eligible for Medicaid if they receive Supplemental Security Income disability payments. According to the Kaiser Family Foundation, annual federal Medicaid spending on HIV/AIDS between 2000 and 2007 increased from $3 billion to roughly $7 billion, which is equal to half of total annual federal spending on HIV/AIDS in the U.S. In general, prescription drug expenditures are a large part of the cost of HIV/AIDS treatment.
Several states use Medicaid waiver authority under sections 1115, 1915(b), and 1915(c) of the Social Security Act to implement special programs or services for individuals with HIV infection. These waiver authorities permit research and demonstration projects, and allow states to modify health care delivery systems and care settings in their Medicaid programs. Waivers are not needed to implement disease management in Medicaid, but some states have incorporated elements of DM in their waiver programs. Considering the growing prevalence of HIV/AIDS in the U.S. and the high proportion of Medicaid enrollees with multiple chronic illnesses, additional research is needed to help determine how DM might be used to improve health outcomes, treatment compliance, cost effectiveness and overall quality of care for people living with HIV/AIDS.
CMS estimates that there are approximately 100,000 Medicare beneficiaries with HIV/AIDS, and approximately 65,000 are also covered by Medicaid (“dual eligibles”). The availability of Medicare prescription drug coverage is important for beneficiaries with HIV/AIDS due to the need for medications to manage the disease. Data on the costs associated with the prescription drug benefit among Medicare enrollees with HIV/AIDS have not yet been published; however, Medicaid programs’ prescription volume decreased by almost 50 percent when drug coverage for dual eligibles moved to Medicare Part D (Bruen & Miller, 2008).
In addition to Medicaid and Medicare, HHS funds primary health care services, supportive services, and prescription medication coverage for individuals with HIV/AIDS through the Ryan White HIV/AIDS Program. The Ryan White HIV/AIDS Program administered by the Health Resources and Services Administration (HRSA) is the largest federal program specifically dedicated to providing HIV/AIDS care and treatment in the U.S., funded at $2.1 billion annually. The Ryan White Program is a safety net grant program and the payer of last resort for HIV/AIDS care. The grants to states for the AIDS Drug Assistance Program represent 40 percent of Ryan White funding each year. Other Ryan White funds pay for primary care, dental care, supportive services (e.g., nutrition assistance), provider education, quality assurance and program evaluation, and demonstration projects targeting hard-to-reach populations affected by HIV/AIDS.