Blue Cross and Blue Shield of Illinois

 

October 18, 2013

Legislative Update
Affordable Care Act Question of the Week: Clinical Trials

The Question of the Week provides you with answers to frequently asked questions regarding the Affordable Care Act (ACA). This week, we feature a question about clinical trials. The clinical trials provision of ACA goes into effect for plan years beginning on or after Jan. 1, 2014. It requires that if a “qualified individual” is in an “approved clinical trial,” then the Plan may not:

  1. Deny the individual participation in the clinical trial.
  2. Deny the coverage of routine patient costs for items and services furnished in connection with the trial.
  3. Discriminate against the individual on the basis of the individual’s participation in such trial.

This only applies to non-grandfathered plans.

Q:
What is an “approved clinical trial” according to ACA?

A: 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 (or other condition described in ACA). Examples include federally funded trials, trials conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration (FDA), or drug trials exempt from having an investigational new drug application. A life-threatening condition is any disease from which the likelihood of death is probable, unless the course of the disease is interrupted.

This communication is intended for informational purposes only. It is not intended to provide, does not constitute, and cannot be relied upon as legal, tax or compliance advice. The information contained in this communication is subject to change based on future regulation and guidance.



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an Independent Licensee of the Blue Cross and Blue Shield Association.