Effective Jan. 1, 2014, The Affordable Care Act (ACA) requires all self-funded and fully insured non-grandfathered health plans to provide benefit coverage for certain routine patient costs for qualified individuals who participate in an approved clinical trial. Approved clinical trials must be covered for the treatment of cancer and other life-threatening diseases or conditions. The requirement does not apply to grandfathered plans.
The requirement mandates coverage of all medically necessary charges associated with the clinical trial, such as physician charges, labs, X-rays, professional fees and other routine medical costs. The coverage does not apply for 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.