The State of Health Care: Affordable Care Act and Clinical Trials

A common reason cancer patients do not take part in clinical trials is concern with insurance denial. To address that concern, the Patient Protection and Affordable Care Act (PPACA) of 2010 contains a provision that requires individual or group health insurance plans to cover routine costs associated with approved clinical trials. This federal requirement will apply to plans implemented after 2013.

In a study published in 2012 in the Journal of Clinical Oncology, researchers examined state laws regarding coverage of patient costs in clinical trials and found 17 states and the District of Columbia had existing mandates that meet the PPACA provision. These states include Alaska, Arizona, California, Colorado, Georgia, Indiana, Iowa, Kentucky, Maine, Massachusetts, Nevada, New Jersey, Ohio, Oregon, Tennessee, Texas and Vermont.

Researchers found that, of the remaining 33 states, 15 did not have any clinical trial provisions and 18 had coverage that did not meet PPACA guidelines. In the states with inadequate coverage, the most common deficiency was lack of support for phase 1 trials. The lack of coverage for trials not focused on cancer therapies, such as prevention trials, was the second most common deficiency.

The study authors noted that the PPACA requirements do not apply to “grandfathered” health plans, that is, insurance coverage for individuals enrolled before the enactment of the PPACA (March 23, 2010). “Given that, initially, the vast majority of group health plans and health insurance coverage will be grandfathered, it may be some time before most Americans benefit from the clinical trial coverage requirement,” researchers concluded in the study.