Medicare to Cover Care in Clinical Trials

Elderly and disabled Americans who want to participate in clinical trials of new drugs or medical treatments can now be certain Medicare will help pay the bill, after a change ordered Wednesday by President Clinton.

“Simply put, the more seniors we enroll in trials, the faster we’ll be able to use these advances to save American lives,” Clinton said, making the announcement before leaving the White House for Japan.

Clinton said he is ordering the Health and Human Services Department to instruct contractors who process Medicare claims to approve bills submitted for routine medical care during clinical trials.

That will include doctor’s office visits, lab tests and other care needed by a patient participating in a trial that normally Medicare would cover if it were part of traditional treatment.

The expanded coverage will not include care required only because of the trial, such as extra lab tests needed solely to help researchers collect data or the cost of the experimental devices or drugs. Often these costs are paid by the sponsors of clinical trials.

Clinton said that the Medicare change will take effect within a week and that HHS will track use of the benefits and evaluate the need for broader coverage.

It has been estimated that 265,000 Americans participate in clinical trials each year and that about 61% of them, or 161,000, are Medicare beneficiaries.

Among cancer patients, the White House said that 63% are age 65 or older--the Medicare eligibility age. But older people make up just 33% of participants in cancer clinical trials.

“Today America’s seniors are badly underrepresented in clinical trials, yet they bear the heaviest share of illness,” Clinton said.

A report from the Institute of Medicine, which is part of the National Academy of Sciences, recommended the Medicare change. The December report said uncertainty about whether the program would pay bills discouraged elderly and disabled Americans from participating in clinical trials.

“If the physician is giving a patient full information . . . he has to say he can’t guarantee they will be paid,” said Henry J. Aaron, one of the report’s authors.

The institute estimated that Medicare already paid 50% to 90% of health care costs for older people who take part in clinical trials. That is because claims submitted by doctors and hospitals do not normally indicate whether a patient is participating in a trial.

Medicare has generally deemed such bills improper when audits have uncovered them.

No Medicare law explicitly disallowed the coverage; rather, it was only a long-standing interpretation of law, the lawyers advised.

The White House did not say what the cost to Medicare would be. The Institute of Medicine had predicted it would be small because Medicare already paid many of the bills in question and because accompanying care often was the same whether someone had experimental or traditional treatment.

What goes for Medicare’s 39 million beneficiaries often influences health coverage available for other Americans. “One of the more interesting things will be to see how the insurance industry responds to the change in Medicare policy,” Aaron said.

Most private health insurance now does not cover care associated with experimental treatment. But there is evidence that, like Medicare, private insurance companies unwittingly have paid for much of it.