Clinical Trials Q&A

What are the requirements under the ACA for patients in clinical trials?

For non-grandfathered health plans renewing on or after January 1, 2014, the ACA requires coverage of "routine patient costs" for "qualified individuals" in an "approved clinical trial." that if a “qualified individual” is in an “approved clinical trials.” Plans are also prohibited from discriminating against an individual on the basis of the individual's participation in a clinical trial.

What is a “qualified individual”?

A “qualified individual” is someone who is eligible to participate in an “approved clinical trial” and either the individual’s doctor has concluded that participation is appropriate or the participant provides medical and scientific information establishing that their participation is appropriate.

What is an “approved clinical trial”?

An “approved clinical trial” is defined as a Phase I, II, III or IV clinical trial for the prevention, detection or treatment of cancer or other life-threatening condition or disease including federally funded trials, trials conducted under an investigational new drug application reviewed by the FDA or drug trials exempt from having an investigational new drug application. A life-threatening condition is any disease or condition from which the likelihood of death is probable unless the course of the disease is interrupted.

What are “routine patient costs”?

“Routine patient costs” include all items and services consistent with the coverage provided in the plan that is typically covered for a qualified individual who is not enrolled in a clinical trial. Routine patient costs do not include 1) the investigational item, device or service itself; 2) items and services that are provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; and 3) a service that is clearly inconsistent with the widely accepted and established standards of care for a particular diagnosis. Plans are not required to provide benefits for routine patient care services provided outside of the plan’s network area unless out-of network benefits are otherwise provided under the plan.

Most clinical trials involve drugs or devices, and those drugs or devices are generally provided without cost during the trial period.

May a plan require a qualified individual to participate in a trial through a participating provider?

Yes. If a participating provider is participating in an approved clinical trial, the plan may require the individual to participate in the trial through that participating provider if the provider will accept the individual as a participant in the trial. Plan sponsors should review their process and procedures related to clinical trials to ensure that their practices comply with ACA, and consult with their own legal counsel.