Medicare to Cover Clinical Trial Costs

June 7, 2000 (Washington) -- Medicare will immediately begin covering the routine care costs for seniors and the disabled in clinical trials, President Clinton announced Wednesday in a special executive memorandum. Clinton's move is intended to encourage senior enrollment in clinical trials, which may speed progress toward disease treatments and cures.

Only about 1% of the nation's seniors participates in clinical trials, even though they suffer the brunt of the nation's diseases, according to administration documents.

This week, the Health Care Financing Administration (HCFA) will inform physicians, hospitals, and other providers that it will reimburse standard costs, including hospital and physician visits and routine lab tests, as well as those costs that are due to medical complications associated with participation in trials.

Although the sponsors of clinical studies usually pick up the costs of experimental agents and therapies, Medicare policies on the coverage of standard care delivered to patients while in trials have been unclear. That has presented potential trial enrollees with the unattractive option of paying out-of-pocket for expenses that would otherwise be covered.

The cost question is a barrier to enrollment in clinical trials, according to a survey discussed at the annual meeting of the American Society of Clinical Oncology held in May.

Some 63% of cancer patients are older than 65, but they constitute only 33% of those enrolled in clinical trials. For breast cancer patients, the statistics are even worse. Women over 65 make up 44% of breast cancer patients, but less than 2% of elderly women are in clinical trials for the condition.

According to the White House, the low participation in clinical trials means "scientists often need between three and five years to enroll enough participants in a clinical trial to generate ? meaningful results" that could lead to improvements in diagnosing and treating diseases.

Robert Comis, MD, president of the Coalition of National Cancer Cooperative Groups, calls Clinton's announcement "tremendous news." He tells WebMD, "We've been making a lot of progress on the private side, but HCFA has been the last frontier -- probably the greatest threat to the clinical trials process."

Alzheimer's Association official Stephen McConnell says, "Large-scale clinical trials are the only way we are going to discover effective means to delay, prevent, and treat Alzheimer's disease. It is essential that we remove any ... barriers to participation." And cost can be a huge barrier.

The Medicare clinical trials issue has drawn intense interest for years. A bipartisan group of House and Senate lawmakers had been pressing for legislation requiring coverage of costs for those in cancer studies, with the Institute of Medicine in December backing coverage for patients in all manner of clinical trials.

There are still other hurdles to getting seniors more involved in research, though. Comis tells WebMD that researchers and disease advocates need to assure older people that their age will not work against them in a trial. "When we've looked at the impact of age on response in clinical trials, the elderly patients do just as well," he says. "We have to get that word out and assure people that age ... is not a negative factor in response to treatment."

Comis concedes that another roadblock to higher trial enrollment is public perceptions of safety issues with being in a trial. News accounts of safety problems with gene therapy trials have dominated headlines in recent months.

As part of his announcement Wednesday, Clinton emphasized that private-sector health plans also should cover the costs of those in trials. The new Medicare policy likely will heighten the pressure on these plans, but many already have taken some steps. Most New Jersey plans, for example, announced last year that they would cover routine clinical trial costs. UnitedHealth Group and Aetna/U.S. Healthcare also have stepped up their national coverage.

The health insurance industry, however, opposes any mandate that plans must cover the costs. Health plans have been concerned that those in clinical trials may have higher expenses for standard doctor visits and lab tests than those patients not in trials. Plans also are worried that not all trials are well structured or legitimate.

That concern extends to the Medicare announcement. Karen Ignagni, president of the American Association of Health Plans, says, "We hope that the Administration will ... ensure that only the highest quality of clinical trials will be encouraged."

Clinical trials provisions are featured in the "Patients' Bill of Rights" on which Congress is struggling to reach final agreement. Senate legislation would require plans to cover costs for cancer trials, but the broader House bill would require coverage for patients in all clinical studies.