Blue Cross and Blue Shield of Illinois

 

September 13, 2013

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

The “Question of the Week” answers frequently asked questions regarding the Affordable Care Act (ACA). This week features 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 applies only to non-grandfathered plans.

Q: What is a qualified individual for clinical trials according to ACA?

A: A qualified individual is someone who is eligible to participate in an approved clinical trial based on either of the following:

  • The individual’s health care provider has concluded that participation is appropriate.
  • The participant provides medical and scientific information establishing that his or her participation is appropriate according to the trial protocol with respect to treatment of cancer or other life-threatening condition.

 

 
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