As part of expanded efforts against cancer, the President's budget proposal for FY 1999 will include a proposal for a three-year demonstration project related to cancer clinical trials. The demonstration would involve an agreement between two HHS agencies, the National Institutes of Health and the Health Care Financing Administration, which runs the Medicare program. The following questions and answers provide some details and background information about the proposal.

1. What is the President's proposal?

The President is proposing a three-year demonstration project that will provide Medicare coverage of patient care costs associated with cancer treatment clinical trials (research studies with patients) sponsored by the NIH. Under an arrangement between NIH and HCFA, Medicare would cover cancer clinical trials that are sponsored by the National Institutes of Health. In addition, the Secretary would report to Congress at the end of the demonstration on what is learned in the demonstration and what policy directions are suggested by those findings.

Studies in both the National Cancer Institute as well as other NIH institutes would be covered. As proposed, the new coverage would begin in October 1998, the beginning of the new fiscal year.

(In particular, the categories of treatment trials included would be: trials approved by NCI programs that oversee and coordinate extramural clinical cancer research;

• trials conducted by Cooperative Groups programs;
• NCI-sponsored trials at NCI-designated cancer centers;
• NCI grants supporting clinical investigators; and
• clinical trials for cancer conducted by other NIH institutes.)

2. Why is this proposal important?

Most of the major advances in cancer treatment have been made through clinical trials. The treatments that have improved cancer survival rates in childhood leukemia, Hodgkin's disease, breast cancer, and other cancers over the last few decades have all been developed through clinical trials. To continue this progress, it is critical that patients have access to clinical trial participation.

Under current Medicare policy, there is no coverage for patient costs if a beneficiary chooses to enroll in clinical trial. Without this coverage, beneficiaries are required either to pay for their own care or to forego the clinical trial as a treatment option. Providing coverage of high quality clinical trials for cancer assures that Medicare beneficiaries have access to the most advanced and promising approaches to cancer treatment.

So the primary object of this demonstration would be to help make clinical trials for cancer more accessible to the older population, which is the population most affected by cancer. 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, non-experimental care - which can help guide policy-making in the future.

3. Is this initiative intended to change current law regarding Medicare coverage of clinical trials?

No. Under current law, section 1862(a)(1)(A) of the Social Security Act prohibits Medicare coverage of any service that is not reasonable and necessary for the treatment of illness or injury. In defining this provision, Medicare has required that, in order to be covered, services must be demonstrated to be safe, effective, and appropriately provided. Under this policy, Medicare has not covered experimental services such as clinical trials or the routine services required in preparation for, monitoring of, or aftercare related to experimental noncovered services. FDA drug approval for marketing has been a longstanding prerequisite for coverage.

Everyone knows these rules, and we do not intend to change them.

4. How much is the demonstration project expected to cost?

Under the proposal, $750 million would be authorized in capped mandatory funds over three years, including evaluation.

5. How will it be funded?

Funds for the project would come from the Comprehensive Tobacco Legislation. Money would not be taken from the Medicare trust fund to finance this demonstration project.

6. What costs would be covered?

The proposal would cover patient care costs for participants in clinical trials. Patient care costs are those costs not directly linked to research, such as the costs of routine services including blood tests, X-rays, or other services required in preparation for and monitoring of treatment, and aftercare.

7. Does the proposal cover the cost of experimental drugs?

No. The cost of investigational drugs and other direct research costs are borne by the sponsor of the research. Medicare will not cover costs of an investigational drug (unless the Secretary of Health and Human Services has authorized the manufacturer to charge for the drug) or any item or service supplied without charge by the sponsor of the trial.

8. Is treatment in a clinical trial more expensive than treatment outside a study?

There has been intense debate about whether the cost of care provided in a clinical trial is greater than, equal to, or less than the cost of conventional treatment. Under the demonstration project, this issue will be studied using data from coverage of NIH clinical trials, and the Secretary will report to the Congress on this issue.

9. How will the demonstration project be evaluated?

The Secretary of HHS, in consultation with the National Cancer Policy Board (a freestanding body established to address issues that arise in the prevention, control, diagnosis, and treatment of cancer) will evaluate the program. The Board is under the auspices of the National Academy of Sciences. The demonstration program will be given an initial thorough review after its first year.

10. How many Americans are covered by Medicare?

Medicare in fiscal year 1996 provided health care coverage for more than 38 million people. This included 33 million people aged 65 and over, 5 million younger people with disabilities, and persons who need dialysis or kidney transplants for treatment of end-stage kidney disease.

11. What is the burden of cancer in people age 65 and over?

The chance of developing cancer increases with age. For all cancers combined, the median age at diagnosis is 68. About 60 percent of all cancers are diagnosed in people age 65 and above. In addition, about 70 percent of all cancer deaths are among people age 65 and over. The median age of cancer patients at death is 71.

12. Does NIH have this kind of arrangement with any other federal agencies?

Through the National Cancer Institute, NIH has established agreements with two other federal programs for the coverage of patient care costs in NCI-sponsored clinical trials. Under one arrangement, the Department of Defense (DOD) is conducting a demonstration program in which the patient care costs of cancer treatment trials are covered for people enrolled in the DOD's TRICARE/CHAMPUS health care program. The second NCI arrangement is with the Veteran's Administration which is providing coverage for eligible veterans to participate in a broad range of NCI-sponsored clinical trials across the country.

The President's proposal would cover all NIH-sponsored cancer clinical trials, including those sponsored by NCI. These arrangements are part of an ongoing effort at NIH to assure continued and expanded access to clinical trials by eliminating barriers to patient enrollment. The NIH is discussing similar agreements with major health plans, self-insured corporations, and other groups.

13. How do patients and physicians find out what trials are enrolling patients and where they are located?

NCI maintains a database of clinical trials as part of its Physician Data Query (PDQ) system. PDQ provides comprehensive information on NCI-sponsored trials enrolling patients throughout the country. The database is updated monthly and provides the latest information on eligibility for clinical trials as well as physicians and hospitals participating in the trials.

Patients and the general public can call the NCI's Cancer Information Service at 1-800-422-6237 (1-800-4-CANCER) to request a customized search of PDQ. Callers can ask, for example, for a search specific to a geographic location or a certain mode of treatment, as well as to the type of cancer and stage of the tumor. PDQ also contains searchable information on study sponsors. Health professionals can call the PDQ Search Service at 1-800-345-3300 to request a customized search or they can send an e-mail to pdqsearch@icic.nci.nih.gov/. In addition, NCI has developed a World Wide Web page on the Internet that allows users to search the PDQ database directly (http://cancernet.nci.nih.gov/).

14. What will NIH and the Medicare program do to publicize the new opportunity for Medicare patients to enroll in cancer studies?

The two groups will work together to publicize the agreement through the media, patient advocacy organizations, professional groups, and other organizations that work in the interests of cancer patients.

15. How many Medicare beneficiaries will take part in these trials with the proposed coverage?

It's too early to make that estimate at this time. But the number will certainly be in thousands.