Patient Protections for Clinical Trials Under ACA

Under the Affordable Care Act, health plans or insurers cannot deny patients’ participation in a clinical trial, limit or deny coverage of routine costs to patients who choose to participate in an approved clinical trial, or increase costs because a patient chooses to participate in a clinical trial. This means that an insurer cannot limit benefits if the individual chooses to enroll in a clinical trial.

Health insurance companies are not required to cover the cost of the treatment or procedure being researched; however, the clinical trial’s sponsor may cover these costs.