Guest Director's Update
Targeting Barriers, including Insurance Coverage, to Improve Clinical Trial Participation
Lack of health insurance coverage for the routine cost of care for patients taking part in clinical trials—including doctor visits, hospital stays, clinical laboratory tests, and other expenses—is a major barrier to participation. Some insurance companies have chosen to deny coverage for the routine medical care a patient would receive whether or not he or she is participating in a clinical trial, thereby creating an out-of-pocket expense burden for patients who want to participate in a research study.
Recognizing the threat that this burden poses to the individual care of patients, clinical trial participation, and in turn the improvement and advancement of cancer treatment, a number of state legislatures have worked with their regional insurance federations to draft laws or agreements that ensure standard care coverage, even when provided in a clinical trial, will not be denied.
The state legislatures of Texas, Oregon, and New Mexico recently passed laws that require this level of improved health care coverage for their residents. And in Nebraska, a voluntary agreement for insurance coverage was signed with the Nebraska Insurance Federation on November 6. Three Nebraska institutions in NCI’s Community Cancer Centers Program—Saint Francis Medical Center, Saint Elizabeth’s Regional Medical Center, and Good Samaritan Hospital—worked closely with many in the cancer advocacy community to help craft this agreement with insurers that will enable them to better serve their patients.
SCLD and Insurance Laws
Over half of states have added a routine health insurance provision for patients who are enrolled in clinical trials, as there is currently no federal legislation mandating such coverage. But that could soon change.
A clinical trials amendment was included in the health care reform bill passed late last month in the Senate. Senators Sherrod Brown (D-OH) and Kay Bailey Hutchison (R-TX) negotiated an agreement to include their amendment requiring insurers to cover routine care costs associated with clinical trials in the Senate health reform legislation (H.R. 3590). The provision covers cancer and other life-threatening diseases or conditions and applies to clinical trials funded or approved by the federal government, which includes NCI-funded and NCI-approved trials.
Cancer patients receiving health care coverage through federal programs—including the Department of Defense’s TRICARE, the Veterans Health Administration, and Medicare—have had their routine care covered when participating in federally sponsored cancer treatment trials for the past decade, and more private insurance companies are following the trend.
In addition to the routine coverage of care, the Centers for Medicare and Medicaid Services asked NCI to join in a pilot program several years ago that gave beneficiaries rapid access to promising new uses of technologies under controlled clinical trial conditions. The agency issued a National Coverage Determination (NCD) to cover the off-label use of certain anticancer drugs in nine specific NCI-sponsored clinical trials of colorectal cancer, as well as other cancer types.
This pilot has been successful because, as intended, it attracted more elderly patients to clinical trials; approximately one-third of the patients participating in these nine trials have been age 65 or older, representing a significantly larger proportion of older patients on trials than is typically seen. Inclusion of these older individuals in clinical trials is critical for developing evidence-based treatments for the large number of older Americans who suffer from cancer.
It has been challenging to recruit older adults to clinical trials, despite the increasing incidence of cancer with age, and the results from this pilot suggest that has been due in some part to lack of insurance coverage. The American Society of Clinical Oncology (ASCO) and geriatric oncology leaders have been actively encouraging oncologists to increase enrollment of older adults in clinical trials, and having Medicare explicitly provide details of the medical coverage for the nine trials appears to be a strategy to analyze for broader adoption.
To further heighten the critical component of recruitment issues such as these, NCI and ASCO are jointly sponsoring a scientific meeting on April 29–30 in Bethesda, MD, with special emphasis on strategies for targeting minority and underrepresented populations, including older adults, for enrollment in clinical trials. The “Cancer Trial Accrual Symposium: Science and Solutions” will feature key experts in the clinical trials arena who are actively conducting research and implementing strategies to improve physician and patient participation in clinical trials.
In addition to publishing the results of the symposium, NCI’s Office of Communications and Education plans to use the evidence presented at this meeting to help develop a new online resource, AccrualNet, to assist physicians and staff at clinical sites with trial recruitment.Results from clinical trials form the basis for the modern oncologic therapies that are prolonging survival for many with cancer. Future advances could come more quickly if more patients participate in research. We encourage individuals who are leading efforts to improve accrual to consider participating in this novel symposium. Abstracts are due February 19, and further information can be found online.
Andrea M. Denicoff
Nurse Consultant, Clinical Investigations Branch, Cancer Therapy Evaluation Program
NCI Division of Cancer Treatment and Diagnosis
Dr. Jeffrey S. Abrams
Associate Director, Cancer Therapy Evaluation Program
NCI Division of Cancer Treatment and Diagnosis