Healthcare Law Requires Clinical Trial Coverage

CURESpring 2012
Volume 11
Issue 1

The new healthcare law requires clinical trial coverage after 2013.

Often, cancer patients decide not to take part in a clinical trial because they’re concerned insurance won’t cover it. To address this concern, the Patient Protection and Affordable Care Act (PPACA) of 2010 requires individual or group health insurance plans to cover routine costs associated with approved clinical trials. This requirement applies to plans implemented after 2013.

In a study published 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 have 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.

[Read the JCO study]

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, 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 trials coverage requirement,” the researchers concluded.