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: - Deny the individual participation in the clinical trial
- Deny the coverage of routine patient costs for items and services furnished in connection with the trial
- 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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