Systems and Regulatory Issues

ACA and Clinical Trials Coverage: Helpful resources for providers and patients

Last Updated: Feb 12, 2014

We are 6 weeks into the new ACA requirements for clinical trial coverage. How's it going so far?

Linda Parreco's Image

The Affordable Care Act's provision for insurance coverage of routine costs for patients on clinical trials became effective on January 1, 2014, for new and renewing health plans. The ACA states that if a group health plan or health insurance issuer provides coverage to a qualified individual, they may not:

  1. Deny the qualified individual participation in an approved clinical trial with respect to the treatment of cancer or another life-threatening disease or condition;
  2. May not deny the coverage of routine patient costs for items and services furnished in connection with participation in the trial; and
  3. May not discriminate against the individual on the basis of the individual's participation in the trial. 

No doubt, care delivery organizations, professional organizations and advocacy groups are all learning the fine details of implementation. Health and Human Services states that the law is 'self-implementing' and the Department does not expect to issue regulations in the near future. All are expected to implement PHS Act 2709 using 'a good faith, reasonable interpretation of the law' (

The American Society of Clinical Oncology (ASCO) and their patient education website Cancer.Net have resources that you may find useful. You can see a collection of their useful resources for research team members here, including a form to demonstrate that a trial meets statutory requirements. In addition, here are links to ACA education materials designed for patients who are participating on or considering participation in a clinical trial. 

How has your experience been so far? Do you have any helpful tips or resources to share with your clinical trial colleagues? Just post a quick comment below and we'll get a conversation started.

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