Hoping to overcome seniors' lack of participation in clinical trials, President Clinton last week directed Medicare to begin covering medical expenses commonly incurred by beneficiaries testing a new drug or treatment.
Citing findings that 63% of cancer patients are older than 65 but constitute only 33% of clinical trials enrollees, the White House instructed HCFA to revise Medicare guidelines to make the new coverage effective this week.
Medicare's new coverage is an "important step forward" for clinical trials research, said Robert Dickler, senior vice president for healthcare affairs at the Association of American Medical Colleges, a Washington-based group representing the nation's medical schools and teaching hospitals.
Specifying the types of trials that qualify for Medicare reimbursement is an issue still to be resolved, Dickler said.
"I think this will give clinical trials a major boost in the United States," added Robert Califf, M.D., professor of medicine at Duke University and director of Duke's Clinical Research Institute, which is conducting some 300 clinical trials.
In connection with the policy change, the White House also asked HCFA to educate Medicare beneficiaries about the new coverage and to implement a system that tracks spending in Medicare-assisted trials.
"Because Medicare's policies on payment for clinical trials have been unclear, seniors cannot be sure of coverage if they volunteer for experimental care," Clinton said last week, adding that he expects private insurers to follow Medicare's lead.
Dickler agreed that nongovernment payers should also provide clinical trials coverage.
President Clinton's directives are fueled at least in part by a recent Institute of Medicine study recommending that physicians treating Medicare patients in clinical trials be permitted to submit claims for medical services in the same way they would for patients not in a trial.
HCFA officials said they believe they are ready to carry out the president's plan.
"We will move quickly to implement this new policy by formally and explicitly instructing our contractors to provide such coverage," Jeffrey Kang, M.D., director of HCFA's Office of Clinical Standards and Quality, said in a written statement.
The Clinton administration is not ready to forecast how much the new coverage will cost, but policy advisers do not expect rising expenses to prevent them from carrying out the plan.
"We believe the cost factor appears to be relatively small," said Chris Jennings, deputy health policy assistant to the president.
Many of the seniors who are likely to benefit from participating in a clinical trial are already receiving Medicare-subsidized treatment, Jennings said. As a result, the cost of including those seniors in a clinical trial may be comparable to the course of treatment that would otherwise be prescribed.
Even prior to the new coverage announcement, Jennings added, some providers were submitting claims and receiving reimbursement for care they delivered that was related to clinical trials. That leaves open the question, he said, of whether or not costs will rise as more seniors become aware of being able to join a trial.