WASHINGTON--Medicare patients who participate in most clinical cancer trials sponsored by the federal government would have their patient-care costs covered for the first time, under a proposal contained in President Clintons budget request for fiscal year 1999.
Vice President Al Gore announced the Administrations plans for the 3-year, $750 million demonstration project. "Right now, only 3% of cancer patients have access to clinical trials," he said. "And Americas seniors--who are 10 times more likely to get cancer but very rarely get the newest treatments--deserve more access to the latest weapons in the war against cancer."
Paying for the patient costs incurred by Medicare recipients during clinical trials, which the federal government does not now do, has become an issue of increasing import to cancer advocates, oncology groups, and within the NCI. If approved by Congress, the demonstration plan would take effect with the new fiscal year, which begins Oct. 1.
However, the Administrations plan carries what some consider a poison-pill proviso. Although administered by the Health Care Financing Administration (HCFA), which manages Medicare, money to pay the projects costs would come not from the Medicare Trust Fund but from funds derived from passage of a comprehensive tobacco settlement by Congress. On Capitol Hill and off, many question whether this legislation will win enactment by the current Congress.
The proposed program would focus on clinical cancer trials sponsored by the National Institutes of Health. The major categories of treatment trials would be those approved by NCI programs that oversee and coordinate extramural clinical research.
These include trials sponsored by cooperative group programs; NCI-sponsored trials at NCI-designated cancer centers; NCI grants supporting clinical investigators; and clinical cancer trials conducted by other NIH institutes.
The project plans also allows the Secretary of Health and Human Services the discretion to include other federally sponsored clinical cancer studies in the payment plan.
"The primary object of this demonstration would be to help make clinical trials for cancer more accessible to the older population," the NCI said in a statement. "In addition, we would learn more about this area--for example, the actual cost of providing care through clinical trials as compared with the costs of normal, nonex-perimental care--which can help guide policy making in the future."
The plan envisions that Medicare would cover patients costs not directly linked to research, such as those for blood tests, x-rays, and other services associated with monitoring treatment and a patients care afterward. Each trials sponsor will cover the cost of the drugs and any other research costs associated with the study.
As part of the demonstration project, researchers would investigate the issue of whether the cost of care provided in a clinical trial is greater than, equal to, or less than the cost of conventional cancer treatment.
Medicare beneficiaries include 33 million people age 65 and older and another 5 million below age 65 who are disabled or suffer serious kidney disease. The NCI said it is too early to estimate the number of Medicare patients who might choose to enroll in clinical cancer trials, but suggested that "the number will certainly be in the thousands."
The National Cancer Policy Board (NCPB), a committee of the National Academy of Sciences Institute of Medicine, would assess the program for the HHS Secretary, who would make the final evaluation of its results. The NCPB would make its initial review of the project after the first year.
Wooing Elderly Patients
As part of the project, both NIH and Medicare would publicize the new coverage in an effort to woo patient participation. Efforts would be made to reach the elderly through the media, patient advocacy groups, professional organizations, and others seeking to improve the care and quality of life of cancer patients.
Currently, Medicare does not cover patient costs resulting from clinical trials because of its requirement that any treatment given to its beneficiaries be demonstrated safe and effective, and appropriately provided.
Thus, Medicare has refused coverage of experimental services, such as clinical trials, because it requires that patients receive only drugs that have won FDA marketing approval. This policy would not be altered for clinical trials other than those specified in the proposed demonstration project.
Both ASCO and the American Cancer Society issued statements of support for the initiative. "By expanding access to clinical trials, well be offering new hope for every cancer patient," said ASCOs John R. Durant, MD.