Clinical Trials FAQ

Most clinical trials involve drugs or devices, generally provided without cost during the trial period. Effective January 1, 2014, the Affordable Care Act (ACA) requires the following provisions:

If a “qualified individual” is in an “approved clinical trial,” the plan may not:

  1. Deny the individual participation in an approved clinical trial.
  2. Deny or limit, or impose additional conditions on the coverage of routine patient costs for items or services furnished in connection with participation in the approved clinical trial.
  3. Discriminate against the individual on the basis of their participation in the approved clinical trial.

The term “approved clinical trial” is defined as a phase I, phase II, phase III, or phase IV clinical trial conducted in relation to the prevention, detection or treatment of cancer or other life-threatening disease or condition. In addition, an approved clinical trial must also be classed as one of the following:

  1. A federally funded or federally approved trial.
  2. A clinical trial conducted under a U.S. Food and Drug Administration (FDA) investigational new drug application.
  3. A drug trial that is exempt from the requirement of an FDA investigational new drug application.

A qualified individual is an individual eligible to take part in an approved clinical trial according to the trial protocol with respect to treatment of cancer or another life-threatening disease or condition. To be a qualified individual, there is an additional requirement that a determination be made by the individual’s doctor that participation in the approved clinical trial is appropriate to treat the individual’s disease or condition.

This determination must offer medical and scientific information establishing that the individual’s participation is appropriate.

A "life-threatening condition" means any disease or condition which is likely to result in death unless the course of the disease or condition is interrupted.

Routine patient costs include all items and services typically covered by the Plan for a member who is not enrolled in a clinical trial. This does not include the following:

  • Investigational items, devices or services;
  • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient; or
  • Any services clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

Yes. A member or their doctor must ask for approval, known as prior authorization, from the Plan before they take part in a clinical trial. The Plan will review the case to make sure the rules are followed.

If a member wishes to participate in an approved clinical trial, the Plan may require the member to participate through an in-network provider. This also requires that an in-network provider is holding an approved clinical trial and that they accept the member as a patient in the trial.

If the Plan already provides coverage for out-of-network services, then clinical trials may also be covered out-of-network. Some plans do not cover any services received out-of-network.

Out-of-state clinical trials may only be covered if there are no clinical trials available in the patient’s primary state of residence.

Yes. If a state law has requirements that are more generous or provide more protections to patients, health insurance plans in that state will need to comply with the state law as well as the ACA requirements.