Memorandum on Increasing Participation of Medicare Beneficiaries in Clinical Trials

Memorandum for the Secretary of Health and Human Services

Subject: Increasing Participation of Medicare Beneficiaries in Clinical Trials

Promoting biomedical research and ensuring that Medicare beneficiaries receive the highest quality care possible are longstanding priorities of my Administration. Over the past 3 years, with the invaluable assistance of the Vice President, my Administration has advocated and secured funding for a budget proposal that explicitly provides for Medicare coverage of services associated with cancer clinical trials, assuring that seniors and disabled persons with cancer have access to cutting-edge treatments and helping promote the research necessary to find new treatments and cures.

Research shows that only about 1 percent of American seniors participate in clinical trials, although the elderly bear the majority of the disease burden in the United States. For example, although 63 percent of cancer patients are over 65, these older cancer patients constitute only 33 percent of all those enrolled in clinical trials. The disparity is greater for breast cancer patients—elderly women comprise 44 percent of breast cancer patients, but only 1.6 percent of women over the age of 65 are in clinical trials for the disease. These low participation rates hinder efforts to develop new therapies, because they mean that scientists often need between 3 and 5 years to enroll enough participants in a clinical trial to generate scientifically valid and statistically meaningful results.

Experts believe that coverage of all clinical trials—not just those for cancer—can lead to breakthroughs in diagnostics, treatments, and cures for many of the most devastating diseases afflicting millions of Americans of all ages. For example, we have made striking progress in treating and curing pediatric cancers, largely because of widespread participation in clinical trials. For decades now, well over 50 percent of pediatric cancer patients were enrolled in clinical trials, and today, 75 percent of cancers in children are curable.

One factor contributing to seniors' low participation rate in clinical trials is the Medicare program's failure to guarantee Medicare payment for the care associated with participation. This uncertainty regarding reimbursement often deters patients from participating in these trials, and deters physicians and other clinicians from recruiting patients, contributing to low participation rates and slowing the development of new medical treatments and diagnostic tests that could benefit the entire Medicare population.

Last December, the Institute of Medicine (IOM) issued a report entitled "Extending Medicare Reimbursement in Clinical Trials," which recommended that Medicare explicitly cover routine patient care costs for participants in clinical trials. This and other recommendations by IOM, combined with your ongoing efforts to modernize Medicare's process to ensure coverage of new technology, prompted a review of Medicare's administrative flexibility to independently remove barriers to participation in clinical trials. Following this review, you concluded that Medicare could exercise its administrative authority to provide reimbursement for routine patient care costs associated with clinical trials.

Based on the results of your Department's review and your recommendations, as well as our shared commitment to promoting critical biomedical research and to assuring that older Americans and millions of people with disabilities have access to cutting edge medical treatments, I hereby direct the Department of Health and Human Services (HHS) to:

• Revise Medicare program guidance to explicitly authorize payment for routine patient care costs associated with clinical trials. The HCFA should inform all claimsprocessing contractors that Medicare will immediately begin to reimburse routine patient care costs and costs due to medical complications associated with participation in clinical trials.
• Launch activities to increase beneficiary awareness of the new coverage option. The HHS should educate beneficiaries and providers about this policy change, including developing an easy-to-read brochure, adding information on clinical trial coverage to future Medicare handbooks, and posting information on the HHS website.
• Establish a tracking system for Medicare payments. The HCFA should implement a system to track clinical trial spending to which Medicare contributes financial support.
• Ensure that the information gained from important clinical trials is used to inform Medicare coverage decisions. The HCFA and the National Institutes of Health (NIH) should work with researchers prior to clinical trials designed to test the efficacy of devices or therapies that have significant implications for the Medicare program to structure those trials to produce information to inform subsequent Medicare coverage decisions.
• Review and report back to me within 90 days on the feasibility and advisability of additional actions to promote research on issues of importance to the Medicare population, including:

— as recommended by IOM, supporting certain clinical trials of particular importance to the Medicare population, including certain health care interventions unique to the Medicare population and clinical trials that could lead to more effective and/or less costly treatments. HHS should review IOM's recommendation to provide additional financial support for monitoring and evaluation, device implantation, and other non-covered costs for trials researching methods of care of particular importance to Medicare beneficiaries;

— increasing the participation of seniors in clinical trials. Specifically, the NIH should evaluate additional action to increase seniors' participation in clinical trials to ensure that researchers can determine the best therapies for older as well as younger patients; and

— developing a registry of all ongoing clinical trials receiving Medicare reimbursement, using the information contained in current NIH and FDA clinical trial registries. This new registry would provide a comprehensive picture of ongoing trials, participation rates, and ways patients can access the trials and facilitate the HCFA's ongoing review and oversight activities to ensure that only covered services are billed and reimbursed.

WILLIAM J. CLINTON