September 24, 2008 — Members of Medicare's Health Maintenance Organization (HMO) plans might not be able to participate in cancer clinical trials because the federal health insurance does not adequately cover patients' costs, according to a new study presented at the American Society for Therapeutic Radiology and Oncology (ASTRO) 50th Annual Meeting, in Boston, Massachusetts.
"Out-of-pocket payment [required by Medicare's HMO plans] is a financial barrier to participation," said Chyongchiou Lin, PhD, lead author of the study and associate professor of health economics at the University of Pittsburgh Cancer Institute, in Pennsylvania. She called for a re-examination of Medicare's policies.
Under Medicare's HMO plans, which cover people 65 years and older, patients are required to pay both a deductible and 20% of all allowable costs, Dr. Lin explained to reporters at a press briefing.
In the new study, researchers at a University of Pittsburgh regional cancer center noticed a trend among patients who were screened for Medicare-qualifying clinical trials and informed of their potential anticipated costs. In 2007 alone, 103 patients at the 1 center declined participation because of anticipated financial burden.
The researchers evaluated the monthly out-of-pocket costs of 4 clinical trials offered to cancer patients at the university's cancer centers. The monthly costs ranged from $112.80 to $3082.80, which included treatment and drug charges, she said.
"It is devastating enough to get a diagnosis of cancer. That impact is likely to be compounded if you cannot participate in a clinical trial for financial reasons. I believe many people have a sense of great personal failure in these circumstances," Louis Harrison, MD, chair of the department of radiation oncology at Beth Israel Medical Center in New York City, New York, and chair of the ASTRO board of directors, told Medscape Oncology.
Patients 65 and Older are Underrepresented in Cancer Clinical Trials
The Medicare policy is at odds with other federal initiatives, said Dr. Lin. "The National Cancer Institute has made clinical-trial participation a national priority, yet current Medicare reimbursement policies present a participation barrier for a large number of patients, cutting them off from cutting-edge treatments."
Dr. Lin suggested that Medicare's HMO payment policy contributes to the underrepresentation of older Americans in clinical trials. "Two thirds of cancer patients are age 65 or older, with 60% of new cancers and 70% of cancer-related deaths occurring in this age group. At the same time, less than one third of [cancer] clinical-trial enrollees fall into this age group," she told reporters.
In the new study, the percentage of patients insured by Medicare HMOs increased annually.
The overall proportion of newly diagnosed cancer patients who had consultations and were insured by Medicare HMOs increased from 21% in 2003 to 27% in 2007 at 5 hospitals in an oncology outreach program affiliated with the University of Pittsburgh Medical Center. Ironically, the 5 hospitals are participating in the National Cancer Institute's Radiation Research Program and the Cancer Disparities Research Partnership, focusing on improving access and outcomes for underserved populations with cancer.
A second phase of the study is now being implemented at the University of Pittsburgh Cancer Institute and will track the number of patients offered and the number of patients turning down clinical trials.
Medicare Policy Hurts the Most Vulnerable
Dr. Lin also noted that Medicare reimbursement policies differ between its fee-for-service plans and its HMOs. Medicare fee-for-service plans fully reimburse the costs for all services included in the clinical research protocol.
In effect, access to state-of-the-art care is limited for some of society's most vulnerable members, Dr. Lin told reporters.
The researchers have disclosed no relevant financial relationships.
American Society for Therapeutic Radiology and Oncology (ASTRO) 50th Annual Meeting: Abstract 1055. Presented September 23, 2008.
Medscape Medical News © 2008 Medscape
Cite this: Nick Mulcahy. Expenses May Cause Cancer Patients to Decline Clinical Trial Enrollment - Medscape - Sep 24, 2008.
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