Medicare Policy and Elderly Trial Enrollment

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	Search for Clinical Trials NCI's PDQ® registry of cancer clinical trials. Medicare Coverage of Clinical Trials A collection of material about Medicare's policy of covering routine patient care costs associated with clinical trials. State Initiatives and Legislation A collection of material on states' efforts to address the question of whether insurance companies ought to cover the costs associated with patients' participation in clinical trials.

Key Words

Clinical trial enrollment, Medicare, elderly. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Since the federal Medicare program revised its policy and began paying for the routine patient care costs of clinical trials, the percentage of patients using Medicare plus supplemental insurance to pay for their care during a clinical trial has increased. However, the number of patients using Medicare alone to pay for their care during a trial has not changed. These findings are from a study conducted by researchers in a National Cancer Institute (NCI)-supported clinical trials cooperative group

Source

Journal of Clinical Oncology, published online ahead of print, December 5, 2005 (see the journal abstract).

Background

Only about one third of patients who enroll in cancer clinical trials are aged 65 and over, although two thirds of new cases of cancer occur in this age group. One barrier to older patients’ participation in trials has been cost. Until fairly recently, many insurers - including Medicare - did not cover care provided in a clinical trial.

Medicare changed its policy in the year 2000 and began reimbursing doctors for the routine patient care costs of clinical trials. Routine care costs include such things as doctor visits, hospital stays, clinical laboratory tests, x-rays, etc., that patients would receive whether or not they were participating in a clinical trial.

The Southwest Oncology Group (SWOG) published a study in 1999 that highlighted the underrepresentation of older patients in cancer clinical trials. SWOG researchers decided to update that study to see what impact Medicare’s policy change had on trial enrollment by older patients. The current study reports their updated findings. (SWOG is one of nine research groups supported by NCI to conduct large, multicenter cancer trials.)

The Study

Researchers compared the numbers of older patients enrolled in SWOG trials before and after Medicare’s policy change. They also studied information on how older patients’ treatment was paid for to determine whether Medicare was picking up the costs for more trial enrollees and and to see what other means (in addition to or instead of Medicare) older patients were using to cover the cost of their care when enrolled in a trial.

The study’s principal investigator was Joseph M. Unger, Ph.D., of the SWOG Statistical Center in Seattle, Washington.

Results

From 1993 to 1996 (the period covered by the first SWOG study), 25 percent of patients enrolled in SWOG trials were aged 65 or older. From 1997 to 2000, that proportion increased to 31 percent and from 2001 to 2003 it increased again, to 38 percent. The absolute number of older patients enrolled increased from 1,040 per year between 1993 and 1999 to 1,268 per year between 2000 and 2003.

From 1993 to 1999, despite the fact that Medicare’s policy was not to pay for patient care costs in clinical trials, 9.9 percent of older trial enrollees paid for their care with Medicare alone and 8.3 percent of older trial enrollees paid with Medicare plus private insurance. (Before its policy change, Medicare sometimes paid for trial enrollees’ care costs because the program was unaware that treatment was being provided in a trial, says Ted Trimble, M.D., of NCI’s Cancer Therapy Evaluation Program.)

Beginning in 2000 (the year Medicare changed its policy) the proportion of older patients paying for their care with Medicare plus private insurance increased to an average of 15.2 percent. However, the proportion of patients paying with Medicare alone remained about the same, 9.7 percent.

Most older patients enrolling in trials used either Medicare alone or, more often, Medicare plus private insurance to pay for their care. Some patients used private insurance alone and others used insurance offered to retired military personnel through the federal Department of Veterans Affairs.

Comments

“These results show the importance of third-party payer support of clinical trials - in this case, Medicare and supplemental insurance - in enabling more patients to participate in trials of new cancer treatments,” says Trimble.

Yet the findings also show that the Medicare policy change alone has not been enough to increase trial enrollment by older patients who do not have supplemental private insurance, the study authors write. Supplemental insurance often covers the 20 percent of care costs not covered by Medicare, which patients must otherwise pay out of pocket.

Limitations

The study’s findings relate only to trials run by SWOG, says Trimble. A study of trials run by other NCI-sponsored cooperative groups or by other funding entities might reach different conclusions.