What are the Affordable Care Act’s coverage requirements relating to clinical trials?

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Plans that are not grandfathered provide coverage for routine patient costs received by a member who is participating in an approved clinical trial. Coverage includes phase I clinical trials and expands the types of conditions beyond cancer. 

Plans cover routine costs associated with a phase I, phase II, phase III, or phase IV clinical trial that is being done to prevent, detect, or treat cancer or a life-threatening disease or condition (a disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted). Routine patient costs are considered the medically necessary services that would be otherwise covered by a health plan if the member was not a part of a clinical trial.

To qualify, a clinical trial must be at least one of the following:

  • Federally funded
  • Conducted under an investigational new drug application reviewed by the Food and Drug Administration
  • A drug trial that is exempt from having such an investigational new drug application

This information is subject to change based on new or revised laws or regulations, and additional coverage rules and limitations may apply. For more information on how these benefits may apply to your coverage, please check your subscriber agreement or call Customer Service.