Clinical Trials

The Affordable Care Act (ACA) requires all self-funded nongrandfathered health plans to provide benefit coverage to “qualified individuals” for routine patient costs incurred during an “approved clinical trial.”

With this provision, items and services provided as part of an approved clinical trial must be covered by an employer-sponsored health plan consistent with typical coverage for a member not participating in a clinical trial. This requirement does not apply to grandfathered plans.

The coverage does not apply to the actual device, equipment or drug that is typically given to participating patients free of charge by the medical device or pharmaceutical company sponsoring the trial.

Ths mandate became effective for plan years on or after Jan. 1, 2014.