Blase Polite, MD, MPP
A mandate enacted after the 2010 Patient Protection and Affordable Care Act (ACA) was supposed to improve health coverage for patients enrolled in clinical trials. However, nearly 63% of cancer centers and organizations that responded to a recent survey reported insurance denials of routine care costs associated with patient involvement in clinical trials during 2014 (Figure 1)
Figure 1: Sites Experiencing Clinical Trial Insurance Denials
“Patient coverage during trials has significantly improved since the implementation of the provision,” said Howard Burris, III, MD, chief medical officer and executive director of drug development at the Sarah Cannon Research Institute. Before the advent of the ACA, insurance approvals for clinical trials could be described as “all over the place,” he said. “Since the ACA, it’s just accepted that standard of care will be paid for within the clinical trials and there won’t be so much picking and choosing and asking questions about it. We have not had much in the way of denials.”
Prior to the ACA, 38 states and the District of Columbia had laws or agreements in place requiring insurance companies to cover routine costs for patients participating in clinical trials, including physician and hospital visits, imaging testing, laboratory tests, and approved medications. The clinical trial sponsor covered the costs of the experimental procedures, tests, and therapies specifically related to the research and data collection.
Loosely Written Law Makes Enforcement Difficult
The 2014 mandate broadened the scope of coverage by forcing payers to cover qualified individuals enrolled in approved phase I to IV clinical trials conducted in relation to prevention, detection, or treatment of cancer or other life-threatening diseases or conditions.