Insurance Denial of Coverage for Patients Enrolled in Cancer Clinical Trials Is Still a Problem in the Affordable Care Act Era.

Abstract

Improved understanding of cancer biology has led to important advances in cancer therapeutics. The three pillars of twentiethcentury cancer treatment—surgery, radiotherapy, andcytotoxic chemotherapy—have been augmented bymore effective and less toxic pathway-targeted systemic therapies and by various forms of immunotherapy. As a result of recent advances, more patients with cancer are achieving better outcomes and living longer. For certain cancer types, such as chronic myeloid leukemia, chronic lymphocytic leukemia, multiple myeloma, epidermal growth factor receptor-mutant lung cancer, and melanoma, drug therapies that were Food and Drug Administration-approved in recent years have changed the natural history of disease. None of this exciting progress would have been possible without patient participation in clinical trials. The National Comprehensive Cancer Network guidelines appropriately state that “the bestmanagement of any cancer patient is in a clinical trial,” yet, interventional clinical trial participation rates for adult patients remain dismal, with less than 3% of adult patients diagnosed with cancer enrolling in clinical trials. This disturbingly low rate of participation has been attributed to multiple factors. Barriers to trial participation include a prevailing perception that patients enrolled in clinical trials are “guinea pigs” subject to the experimental whims of research teams and trial sponsors; fear of being assigned to an ineffective treatment or a placebo; socioeconomic obstacles (eg, long distance to centers that conduct clinical research, with the associated costs of travel, lodging, and food); narrowly restrictive protocol eligibility criteria that exclude a high proportion of potential trial candidates (eg, performance status, organ function, comorbid conditions); and the need for frequent blood and imaging tests, with adherence to a rigid protocol schedule. Among the economic barriers to clinical trials in the United States have been insurance denials of payment for care of patients enrolled in trials. The Affordable Care Act (ACA) and precursor legislation was supposed to have eliminated the insurance barrier. Efforts to overcome this obstacle have been ongoing for more than 15 years. In 2000, the Clinton administration mandated that Medicare programs reimburse providers for the cost of routine patient care associated with participation in clinical trials and called for additional actions to promote the participation ofMedicare beneficiaries in clinical trials foralldiseases.A June 7, 2000,White House press release noted, “clinical trials serve as the first step towards providing new clinical innovations to the forefront of medical practice.” This directive followed an Institute of Medicine report recommending policies to encourage greater use of clinical trials.