Medicare Part D has big impact on HIV treatment interruptions

Decreased access to meds, six-fold increase in interruptions

Some of the concerns and predictions HIV/AIDS advocates made two years ago about the impact of Medicare Part D—the prescription drug benefit—on HIV antiretroviral treatment appear to be coming true.

The drug benefit's emphasis on consumer cost-sharing is associated with HIV-infected patients having decreased access to medications and six-time greater treatment interruptions, a new study finds.1

The study found that about 11% (14 of 125 participants) reported having their antiretroviral therapy interrupted for more 48 hours or longer, and 71.4% of those with interruptions were covered by Medicare Part D.

Most of the respondents who had treatment interruptions said they were due to new co-payments after they became enrolled in Medicare Part D. Even co-payments of $1 to $3 per drug are a significant cost burden for Medicare/Medicaid-eligible patients who have high numbers of prescriptions, the study notes.1

There are a number of reasons why HIV patients might interrupt their antiretroviral treatment, including forgetfulness, travel, stressful life events, substance abuse, and transportation problems, says David Bangsberg, MD, MPH, a senior scientist with the Massachusetts General Hospital in Boston, MA, and the Harvard Initiative for Global Health at the Harvard Medical School in Cambridge, MA.

But the new study shows a significant impact from the Medicare Part D coverage, as well, says Bangsberg, who is a co-author of the study.

"The study found that people living with HIV were more likely to have interruptions because of Medicare Part D," Bangsberg says.

The five-day window

There's a new theory in HIV medicine that clinicians have a five-day window in which to do something about a patient's medication interruption, Bangsberg notes.

"You've got five days to figure out how to get the patient back on antiretrovirals, and the clock is ticking," Bangsberg says. "If you know that someone is interrupted on day one or two, then you have enough time to do something about it."

So the key is to detect interruption problems in real time and have creative case managers work to solve the problem, Bangsberg says.

The latest medical consensus also appears to be that clinicians do not have to worry about the patients who miss 5 % of their antiretroviral doses, but patients who miss 20 to 30 % of their doses are entering a danger zone, he adds.

This is why HIV clinicians who work with populations impacted by Medicare Part D and treatment interruptions due to the drug program's failures are up in arms.

"Medicare Part D is driving regular doctors out in the field nuts," says Moupali Das-Douglas, MD, MPH, an assistant clinical professor at the University of California - San Francisco (UCSF) and director of research in HIV in San Francisco, CA. Das-Douglas is a lead author of the study.

Das-Douglas and her physician colleagues have witnessed how the Medicare Part D program policies have had an adverse impact on patients' health.

"In my clinic at Ward 86, San Francisco General, one of my colleagues' patients had a Medicare Part D problem, and he couldn't get his medication," Das-Douglas recalls. "He is a long-time survivor of AIDS and had been on the same regimen for 12 to 15 years, doing really well."

The man's viral load was suppressed and his CD4 cell count was high because he was very regimented about taking his antiretroviral drugs, she notes.

"Then because of Medicare Part D, he couldn't get medication for a month and a half, and he asked for to have his CD4 cell count and viral load tested," Das-Douglas says. "He wanted to prove that because of the policy problem his viral load had become unsuppressed, and indeed it had."

The new study also suggests that some HIV patients are using their personal priorities to triage their medications, often short-changing their ARTs, Das-Douglas notes.

"We asked participants detailed questions about their treatment interruptions," she says. "Some said they were filling other drugs over ARTs due to co-payments, or they might prioritize methadone or some psychiatric drug because they don't want to be in pain."

HIV clinics and providers are finding that dealing with Medicare Part D is time-consuming and at times overwhelming for staff.

"Our social worker staff spends so much time dealing with Medicare Part D that it's ridiculous," Das-Douglas says. "It's really unfortunate that this is such a poorly-designed policy because of the influence of pharmaceutical company lobbyists."

The main problem with Medicare Part D is that it cannot do what even the U.S. Veterans Affairs administration can do, which is to negotiate drug contracts as one large entity, Das-Douglas says.

It's only through such negotiations that an economy of scale can be achieved, and this is the only way to obtain fair prices, she adds.

"Medicare doesn't have that ability to negotiate, and it's specifically written into the law that they can't do it," Das-Douglas says.

The second mistake made with the bill is that it's designed in terms of forcing consumers to have price sensitivity, she notes.

"It's like thinking consumers are buying widgets," Das-Douglas says.

"They wanted consumers to have price sensitivity, as though someone on antiretroviral therapy (ART) would have a choice," she adds. "HIV patients either take their medication or they don't and then they get opportunistic infections (OIs), and they die."

Medicine not a 'cell phone plan'

All of the recent literature shows that HIV patients who stop taking their ARTs have an adverse health impact, especially if they were co-infected with hepatitis B, Das-Douglas says.

"They're trying to put price sensitivity into health care and it's ridiculous," Das-Douglas says. "They treat it like a cell phone plan where if you use up your minutes in a month, then you have to stop making cell phone calls."

Another problem is that while the AIDS Drug Assistance Program (ADAP) as a payer of last result worked well enough for many HIV patients, now people are supposed to sign up for Medicare Part D if they're eligible for Medicare, says Christopher A. Douglas, JD, staff attorney with the Legal Aid Society of San Mateo County in California.

"The way the rules are written, any person who signs up for the Medicare Part D plan has to follow its rules," Douglas explains. "And there are different formularies, different premium payments, and so right at the outset, there is the potential for things to go wrong."

It's so confusing and complex for even the typical Medicare recipient that Douglas spends some of his spare time helping his friends' parents understand their Part D coverage, he says.

When there are problems with Medicare Part D coverage among HIV patients who have poverty-level incomes, it's up to HIV doctors and their clinics to straighten out medication coverage problems, Douglas says.

This includes both patients having their standard medications not covered by Medicare Part D and patients having problems with deductibles, co-pays, and the doughnut hole.

"Clinicians need to be really proactive and call in or fax in an appeal," Douglas says. "The standard appeal takes five days."

An expedited appeal has to be answered in 48 hours, he adds.

While most doctors want to help patients with their medication reimbursement issues, the problem is they also have little time to deal with these adherence barriers, he adds.

"The most important thing for HIV clinicians is to work collaboratively as a team," Das-Douglas says. "The team needs a health care worker, a doctor, social worker, pharmacist, and, if necessary, a legal or policy advocate because each state and jurisdiction has different laws."

It takes local expertise and everyone working together as a team to treat HIV patients, who are the most vulnerable of populations, Das-Douglas says.


  1. Das-Douglas M, Riley ED, Ragland K, et al. Implementation of the Medicare Part D Prescription Drug Benefit is associated with antiretroviral therapy interruptions. AIDS Behav. 2008; Epub ahead of print: s10461-008-9401-5.