Medicare to expand clinical trial coverage

Clinton orders change to enable elderly to take part without cost worries

June 7, 2000
Web posted at: 10:51 a.m. EDT (1451 GMT)

WASHINGTON (CNN) -- Medicare will soon begin covering the cost of routine patient care associated with clinical tests of new drugs and medical treatments for millions of elderly and disabled people.

President Bill Clinton said Wednesday he has ordered the Department of Health and Human Services to revise the program so that it pays for tests related to Medicare-covered services.

"Today, thousands of important clinical trials don't have enough patients because so few seniors are able to take part and that means slower progress toward curing or treating illness," Clinton said.

"One major factor keeping seniors out of clinical trials is patients' lack of certainty that their expenses will be covered by insurance," he said.

Listen to President Clinton talk about the services needed for senior citizens 391K/35 sec. AIFF or WAV sound 353K/32 sec. AIFF or WAV sound

Clinton, who issued the order in an executive memorandum, announced the change on the South Lawn of the White House before leaving for a 36-hour trip to Japan to attend memorial services for Prime Minister Keizo Obuchi.

"As America ages, we must provide all our seniors affordable, quality health care and we should be using our cutting edge science to meet that challenge," the president said. "The more seniors we enroll in (clinical) trials, the faster we'll be able to use these advances to save American lives."

Only about 1 percent of elderly Americans participate in clinical trials of drugs and treatments even though the elderly are more severely affected by disease than are younger people.

The White House cited findings that 73 percent of cancer patients are older than 65 but people that age make up only 33 percent of those enrolled in clinical trials.

The disparity is greater for breast cancer patients. Elderly women make up 44 percent of breast cancer patients, but only 1.6 percent of women over 65 are in clinical trials for the disease.

The administration said the current Medicare reimbursement policy could discourage older people from taking part in clinical trials because the investigators running the tests cannot be sure that Medicare will pay for the care.

As a result, older women considering whether to enter the trials may be responsible for costs simply because they are taking part in a test and investigators and research centers often are reluctant to recruit older people because of the uncertainty of Medicare reimbursement.

Medicare covers nearly 40 million elderly and disabled Americans. Many private insurers follow its example in deciding what to cover.

The White House cited progress in treating the youngest patients as evidence that greater participation in clinical trials by older people is worthwhile.

For decades, more than 50 percent of pediatric cancer patients have been enrolled in clinical trials, the White House said, and today 75 percent of cancers in children are curable.

As part of the policy change, the Health Care Financing Administration -- the government agency that administers Medicare -- will put out word to Medicare contractors that these costs are reimbursable.

Clinton also wants a tracking system for Medicare payment for test costs.

The underlying Medicare law has been interpreted to bar reimbursement for routine medical care needed when beneficiaries participate in clinical trials. Many private insurers also deny coverage on grounds the treatments were experimental.

Vice President Al Gore, who is campaigning for the presidency, has been advocating Medicare coverage of such clinical trials.

Senior White House Correspondent John King and The Associated Press contributed to this report.