HIV experts gathering at the International AIDS Society conference in Sydney next week are sure to champion the need for greater treatment access in the developing world—and to point out that in the United States, by contrast, drugs have made HIV a manageable disease. But that is only partly true: Many HIV-positive people in this country confront financial barriers and a labyrinth of rules that keep life-saving medications beyond their reach. For them, HIV is not manageable at all.

In 2006, the U.S. government spent about $12.3 billion on HIV/AIDS treatment and care. But increased pressure on states to test and treat more people has resulted in many HIV-positive patients being turned away from services. “There are a lot of individuals in this country who don’t have access to treatments—just like in other countries,” says Murray Penner, deputy executive director of domestic programs at the National Alliance of State and Territorial AIDS Directors (NASTAD).

Positive Americans who don’t have insurance apply for drug assistance through Medicaid, Medicare or the Ryan White Care Act, which underwrites the states’ AIDS Drug Assistance Programs (ADAP). ADAP is the payer of last resort—it will only provide prescription drug assistance where none exists or bridge the gaps in coverage where Medicaid, Medicare or private insurance are lacking. To qualify for any of these programs, one has to meet certain income or “disease progression” requirements. Because federal and state governments share funding responsibility, these requirements vary widely from state to state.

ADAP has become seriously backed up lately. In mid-May, there were 529 positive Americans wait-listed for access to drug treatment through ADAP programs; 470 of them were in South Carolina alone. That state, which has the ninth highest rate of AIDS cases in the country, received about $13.5 million through the Ryan White Care Act for its ADAP program last year, a $325,000 decrease from the previous year. The state’s 2006 contribution was only $500,000, not enough to cover the gap in services for the people in need.

Late last month, after much lobbying by providers and advocates, the South Carolina state legislature approved $3 million in annual appropriations plus a one-time $1 million grant for the state’s ADAP program. This eliminated the state’s waiting list for the time being, but the amount was much less than the $8 million that advocates argued is needed.

South Carolina is not the only state or territory compelled to tinker with ADAP because of increasing demand, tight budgets and lack of political will. As of May of this year, Alaska, Montana and Puerto Rico also had people waiting for drug assistance, according to NASTAD’s June ADAP Watch Report.

The report also noted that several other states have used cost-cutting measures to avoid waiting lists such as capping enrollment in ADAP. Another technique has been removing certain drugs from a state formulary—the list of antiretrovirals (ARVs) that state drug assistance programs will pay for. The latest Ryan White Reauthorization Act demands that all states provide drugs from every class of ARVs, but that doesn’t mean every single drug from each class. 

Trimming formularies often isn’t the money-saver it promises to be, however, because of the potential risk to drug-experienced people living with HIV. Those who develop drug resistance or experience serious side effects need a range of options within each drug class to choose from. And now there’s concern that upcoming new medications—several representing entirely new HIV-drug classes, such as oral entry inhibitors and integrase inhibitors—may be expensive enough to force states to further restrict their formularies.

How did this happen? “I think this started with a chronic underfunding of ADAPs at the federal level in general over the last three years,” says Penner. “We saw a $2 million increase in 2006, and the program was flat-funded in fiscal year 2007.”

Ironically, ADAP’s funding problems stem at least in part from the success of HIV treatment. Since the introduction of combination drug therapy in 1996, people with HIV are living longer and tend to have much better health outcomes. As a result, fewer people with HIV claim disability status, which would qualify them for Medicare or Medicaid—and take the pressure off ADAP.

New prevention efforts have also had an impact on ADAP and treatment as a whole, especially last year’s decision by the Centers for Disease Control and Prevention (CDC)  to revamp its testing and treatment guidelines by calling for routine access to HIV antibody screening for all Americans, not just those perceived to be “at risk.”

The CDC’s goal is to find the estimated 250,000 Americans who are believed to be living with HIV but do not yet know it. But more positive test results will ultimately mean more people needing HIV care, and states have not yet figured out how to pay for the inevitable increase in demand. While the CDC in May announced a $35 million pot of money to help local health departments expand testing capacity, there has been no substantial funding increase for the care of those newly diagnosed with HIV.

Then there are the social factors that can affect whether people access treatment or are able to adhere to their drug regimens. Applying for ADAP, Medicaid or Medicare usually entails filling out such an intimidating stack of paperwork that many clients are overwhelmed, especially if they’re on more than one program. “We have to continue to be concerned about the way a person has to navigate these systems in order to get their benefits and treatments,” says Penner.

“I’ve experienced delays in getting patients on ARVs, anywhere from two to four months,” says David Malebranche, MD, MPH of Emory University School of Medicine, whose Atlanta practice includes many people living with HIV. In addition to patients’ frustration about facing piles of paperwork, he says, the emotional trauma of an HIV diagnosis can get in the way too.

Malebranche has also found that a lack of rapport with clinicians can keep patients from following up on applications for drug assistance—or even taking their pills on time once they do get into a program. “I’ve heard clients say that they will leave a clinic if the receptionist treats them like crap or the triage nurse talks down to them,” he says. In 2004, Malebranche published a study in the Journal of the National Medical Association in which black men who have sex with men described the ways that negative healthcare experiences affected their willingness to be tested, get care and adhere to their regimens.

There’s some help out there for clinicians facing these obstacles. Over the past year, for instance, Adrena Harrison, RN, MSN, ACRN, Director of Education with the South Carolina HIV/AIDS Clinical Training Center, has trained some 800 South Carolina doctors, nurses and other clinicians in the art of patient rapport and cultural competency, as well as the basic science of the HIV virus. She also helps doctors understand bread-and-butter economic survival concerns that affect positive people’s ability to adhere. “I’m not going to do what I need to do until I have housing or food,” Harrison says, voicing common patient concerns, “or until I have some drug treatment or my mental health issues are taken care of—and that’s where there’s no money.”

Others are lobbying Congress to help bridge gaps in treatment access caused by outdated eligibility rules. A group called the HIV Medicare and Medicaid Working Group is pushing for passage of the Early Treatment for HIV Act (ETHA). Under ETHA, states would be able to deem people Medicaid-eligible at a very early stage of HIV, rather than when they are disabled or have an AIDS diagnosis.

 “The Medicaid program’s eligibility rules are completely out of line with the United States’ own guidelines for treating HIV,” says Robert Greenwald, director of the Treatment Access Expansion Project (TAEP) and cochair of the HIV Medicare and Medicaid Working Group. “The [CDC] treatment guidelines call for early access. But Medicaid doesn’t grant people access until people are disabled with AIDS.”

The group is circulating a signed letter on behalf of dozens of HIV organizations nationwide. The letter, addressed to the House Energy and Commerce and Ways and Means Committees, urges Congress to approve ETHA and to strengthen access to ARVs drugs under Medicare Part D. Since the start of Part D in 2006, Greenwald explains, limited formularies, increased cost sharing and burdensome bureaucratic processes have left some Medicare beneficiaries with HIV with inadequate prescription drug coverage.

“The main thing to remember is that we are very supportive of the United States playing a role in addressing the needs of people with HIV around the world,” Greenwald says. “But that can never be confused with the fact that we still have significant problems here in terms of guaranteeing access to care.”