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Medicare reimbursement policy change fails to meet objective
Allowing reimbursement for routine care expenses did not increase participation in clinical trials by people over the age of 65 years.
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Recruiting older patients with cancer for clinical trials is difficult for physicians due to multiple impediments, according to Cary P. Gross, MD, of the Yale University School of Medicine. Dr. Gross said that people over the age of 65 years constitute 61% of all new cancer cases, but they represent less than one-third of all research participants.
Dr. Gross said a “lack of insurance coverage for routine care costs” is cited as a common barrier to participation. Neither patients nor physicians can be certain that these costs will be repaid due to the “experimental nature of the treatments, the uncertainty of potential benefits and the possible risks,” he said.
In 2000, the Medicare reimbursement policy was changed based on studies that found that the lack of assured reimbursement was discouraging seniors from participating in clinical trials. Dr. Gross’ study was designed to determine if the policy change has increased participation in clinical trials by elderly patients.
Two approaches
Dr. Gross and the research team analyzed enrollment in clinical trials from 1996 through 2003 in order to compare participation before and after the policy change.
Two analytical approaches were employed, according to Dr. Gross. In the first approach, a specific group of trials was considered. Trials must have had 20% to 80% of patients enrolled prior to the Medicare policy change. Trials with fewer than 100 participants were excluded. Trials with an elderly enrollment of less than 5% were excluded because the researchers assumed these trials were designed to exclude patients over 65 years.
The second approach considered all participants in cooperative group trials before and after 2000. Data from 2000 was excluded since the Medicare policy changed during that year. The data from this analysis provided an overview of elderly participation in clinical trials. It also provided a basis of comparison between the restricted sample in the first approach and the full sample in the second approach, Dr. Gross said.
Twenty-three studies with a total of 16,135 patients met the inclusion criteria in the first sample. Before the policy change, 39.3% of participants were 65 or over. After the change, 33.5% were 65 or over. According to Dr. Gross, across all study strata, “participation of elderly patients was noted to be either stable or decreased” after the Medicare revision.
Policy falls short
Dr. Gross said that “this policy remedy has failed to increase the representation of older patients who participate in clinical trials.” He added that although the policy change has a “high face validity,” its results do not stand up to scientific empiricism.
According to Dr. Gross, there are a number of reasons why this administrative change did not produce the intended benefits.
Trial exclusion criteria is a barrier to participation, although Dr. Gross said that the study design factored out this reason. He added that “if trials are designed to implicitly or explicitly exclude older persons, the reimbursement policies are unlikely to enhance enrollment.”
A related factor is that many oncologists exclude patients from trials based on age alone. He said that some oncologists doubt an older patient’s ability to complete the trial or assume that aggressive therapy is unnecessary in an older patient.
Lack of awareness of both the option to join a clinical trial and of the Medicare change is another factor affecting enrollment. Dr. Gross said that few institutions provide sufficient information regarding the policy change on their Web sites.
He also suggested that some trial investigators were submitting bills to Medicare prior to the policy change, and the revision simply legalized an ongoing practice, resulting in few enrollment changes.
The last factor Dr. Gross offered is that it is too soon to see an increase in participation, since only 3 years of data since the change were available.
A note from the editors:
This article originally appeared in Hem/Onc Today, a SLACK Incorporated publication.
For Your Information:
- Janet F. Mays is an OSN Correspondent who writes primarily for OSN’s sister publication Hem/Onc Today.