Growth of Medicare HMOs could impact clinical trials

A study of Pittsburgh-area cancer patients suggests that many are opting out of clinical trials because, as members of Medicare HMO plans, they cannot afford the additional expense such trials entail.

Researchers from UPMC McKeesport Hospital ROCOG Program, an affiliate of the University of Pittsburgh Cancer Institute, found that those enrolled in Medicare HMOs accounted for 26.5% of the health system’s newly diagnosed cancer patients in 2007, up from 20.9% in 2003.

In 2007, many of those patients qualified for a clinical trial but decided not to participate because of the anticipated costs of treatment.

Those costs can range from $100 to more than $3,000 per month, according to Chyongchiou Lin, PhD, associate professor of health economics at the University of Pittsburgh Cancer Institute.

“The Medicare HMO policy requires additional out-of-pocket expense for participating in a clinical trial,” Dr. Lin said. “We would like to further examine whether this policy might be a barrier for participation.”

Once an HMO patient enrolls in a trial, his or her coverage reverts to what it would be under a fee-for-service (FFS) plan. This requires that the patient pay 20% of the costs associated with a clinical trial.

Whereas Medicare FFS patients typically have supplemental insurance to cover those out-of-pocket expenses, Medicare HMO patients do not. The same policy applies to costs associated with treating any adverse effects or complications that arise during the course of a trial, which were not included in the range cited by the Pittsburgh researchers (ASTRO 2008 abstract 1055).

“Th ere are two elements to the costs of clinical trials: the predictable and the unpredictable,” said Louis Harrison, MD, a radiation oncologist at the Continuum Medical Centers of New York, and president of the American Society of Therapeutic Radiology & Oncology (ASTRO) in commenting on the Pittsburgh study. “Patients can’t calculate the financial risk of the unpredictable costs.”

Complicating matters further is that physicians may not even inform Medicare HMO patients about trials for which they may be eligible, if the costs appear to be prohibitive, said Dwight E. Heron, MD, associate professor and vice chairman of radiation oncology at the University of Pittsburgh Cancer Institute and a co-author of the study.

“We know that patients who participate in clinical trials generally have better screening, better follow-up, and often better care,” Dr. Heron said. “Patients should become educated that Medicare HMO products could render them ineligible for state-of-the-art cancer care.

There also needs to be an understanding on the part of our government that there are unintended consequences of payment policies that pose significant barriers for patients.”

The trials themselves may be hurt by inadvertently excluding minorities, Dr. Lin said.

“The Medicare HMO population may be the most vulnerable population, so if they are not included in a clinical trial, it could bias the results,” she said.