After years of debate and failed legislation, President Clinton issued an executive memorandum last month directing the Medicare program to reimburse health care providers for the routine costs of patient care associated with participation in all clinical trials.
The action, which went into effect immediately, is a sweet victory for those who have rallied for more than a decade to get the government to take action on covering clinical trials under Medicare.
"It means that Medicare will no longer discriminate against clinical trial participants," said Robert Wittes, M.D., director of the Division of Cancer Treatment and Diagnosis at the National Cancer Institute. "In other words, if you are in a clinical trial being treated in a certain way, and if Medicare would have reimbursed for those services outside a clinical trial, [Medicare] will now do so within [a clinical trial]."
The Health Care Financing Administration, the agency that administers Medicare, has long maintained that it does not have the authority to cover clinical trials costs under the original Medicare legislation, which prohibits payment for anything that is not "reasonable and necessary for the diagnosis and treatment of illness or injury." However, the lack of an explicit policy left the door open for interpretation.
An Institute of Medicine report issued last December concluded that the HCFA does have such authority. The IOM also expanded to Medicare its decade-old recommendation that third-party payers "should reimburse routine care for patients in clinical trials in the same way it reimburses routine care for patients not in clinical trials."
Sen. Jay Rockefeller (D-W.V.), along with Sen. Connie Mack (R-Fla.), Rep. Nancy Johnson (R-Conn.), and Rep. Benjamin Cardin (D-Md.), has been working for years to pass legislation mandating Medicare coverage of clinical trials costs. All of the bills have stalled. He described the executive order as winning "an enormous legislative battle."
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Mack said that he wanted the president to include language that Medicare cover only "peer reviewed" trials, a point Clintons announcement did not address.
The executive order follows an agreement last year between NCI and TRICARE, the Department of Defense health benefit program and one of the nations largest health plans, which allowed beneficiaries to participate in NCIs prevention, early detection, and treatment trials. In addition, over the past 2 years, eight states have mandated third-party-payer coverage for some or all cancer clinical trials.
In his remarks, President Clinton cited the lack of participation in clinical trials by elderly Americans as the primary drive behind the order.
"Because Medicares policies on payment for clinical trials have been unclear, seniors cannot be sure of coverage if they volunteer for experimental care," Clinton said.
Edward L. Trimble, M.D., head of the surgery section of NCIs Cancer Therapy Evaluation Program, said he hopes that the order can change the percentage of older patients that participate.
"We certainly know that in our clinical cancer trials older patients are underrepresentedless than 1% participate in clinical trials," Trimble said. "We also know that more than 50% of cancers happen in people older than 65 years. This is a critical step for our treatment trials."
Mack emphasized that there is plenty more to be done to encourage clinical trials participation.
"Its a two-way street," he said. "Weve removed some of the barriers to participation, but theres also a responsibility on the side of the medical community to get the message out to patients that clinical trials are available."
Trimble agreed. "There are a number of other factors at play," he said. "Just having HCFA support clinical trials is not the only thing needed, but its a very important piece of the puzzle."
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