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Medicare Part D is creating major drug access problems for people with HIV/AIDS, according to a new informal survey by two leading organizations of HIV medical providers. Bureaucratic roadblocks, exorbitant co-pays, and plans that fail to cover key drugs mean that this new program is failing an especially vulnerable population.
Eighty-three percent of respondents to the survey said their patients had experienced problems having prescriptions filledincluding prescriptions for antiretroviralssince joining a Medicare Part D drug plan. Of these, 75 percent had patients who went without medications.
"People with HIV/AIDS face serious health problems when forced to miss doses of their anti-retroviral medications," said Aimee Wilkin, MD, MPH, of Wake Forest University Health Sciences.Â "The virus develops resistance and becomes harder and more expensiveor even impossibleto treat. Medicare Part D is supposed to help patients get access to life-saving drugs, but for many of my patients, it has been a huge barrier to treatment."
The HIV Medicine Association (HIVMA) and the AmericanAcademy of HIV Medicine (AAHIVM), whose combined membership represents nearly all the nation's HIV medical providers, surveyed their members in November 2006 about their experiences and their patients' experiences with Medicare Part D. While limitations in the survey mean its conclusions can't be generalized to all HIV medical providers, the summary provides an illuminating snapshot of serious problems in the system.
In addition to antiretrovirals, patients in Part D drug plans had problems with access to medications for infections brought on by their weakened immune systems, mental health, and cholesterol and hypertension control.
One roadblock coming between patients and the medications they need is a pre-approval process called "prior authorization." It requires a provider to submit a request for a medication and wait for the drug plan's approval before a patient can have a prescription filled.
Four out of five providers whose patients had problems getting prescriptions filled said prior authorization was the cause. Nearly half of those with Part D problems said they had requested prior authorization for antiretroviralsdespite the fact that the Centers for Medicare and Medicaid Services (CMS) specifically exempts all but one antiretroviral, enfuvirtide (Fuzeon), from prior authorization.
"We're currently processing at least 25 prior authorizations per week. That consumes more than half of a nurse's time," said HIVMA board member Michael S. Saag, MD, director of the 1917 Clinic at the University of Alabama at Birmingham.Â "That's valuable time that could be spent providing care for other patients."
"The net effect of prior authorization is that it makes providers think twice about each prescription they write, even if it is genuinely the best medicine for the patient," Dr. Saag said. "This is not the proper way to practice medicine. And the only ones who benefit are the insurance companies."
HIVMA and AAHIVM are also concerned that some plans may not cover two new promising antiretrovirals that are expected to be approved by the Food and Drug Administration later this year.Â These new drugs, however, may be precisely what a person with HIV/AIDS in a Part D plan needs. That's because people with HIV/AIDS don't qualify for Medicare until they're disabled, which often happens after their antiretroviral therapy fails.
"These new medications literally may be lifesavers for patients whose HIV drugs have stopped working," Wilkin said, "but not if the drug plan won't cover it, or charges such an enormous co-payment that the patient can't afford it."
Three out of four respondents cared for patients whose Part D drug plan did not cover one or more of their medications. Also, three out of four reported having patients who could not afford the co-payments they were required to pay for their necessary medications.
HIV medical providers reported their own problems with Medicare Part D as well. Two-thirds of respondents said dealing with Part D drug plans was a greater burden than other insurance plans. Seventy-nine percent said they are spending more time now than before making sure Medicare patients get the drugs they need.
"These survey results are unfortunately not very surprising to any HIV care provider," said Michael Wong, MD, at Harvard Medical School's Beth Israel Deaconess Medical Center. "Doctors across the country are buried under paperwork and phone calls related to Part D, trying to get medications (both antiretroviral agents and those needed to treat the complications of these life-saving medications) to patients whose health and access to care are both very fragile. CMS and Congress need to think quickly about better ways to handle their needs and how this impacts those providing care and services to these individuals."
HIVMA and AAHIVM are calling for changes in Medicare Part D to accommodate the special needs of people with HIV. CMS must do a better job to stop Part D drug plans from requiring prior authorization for antiretroviralsa practice that violates CMS policy. The prior authorization process for other drugs should be streamlined or eliminated. "We're being strangled by prior authorization," Saag said, "and it's our patients who ultimately suffer."
HIVMA and AAHIVM assert that people with HIV/AIDS should also have access to all the medications they need to treat their complex medical needs, including drugs to treat infections brought on by their weakened immune systems, lipid control and antihypertensive medications, and antidepressants and other psychiatric medicines. Furthermore, co-pays and other cost-sharing should be capped at a nominal amount. "People with HIV/AIDS often live on very low incomes," Wilkin noted. "They should not have to choose between medications, housing, and food."