The Affordable Care Act and Clinical Trials

Posted on: Wednesday, September 25, 2013


Have you or someone close to you ever thought about participating in a clinical trial? Most clinical trials involve drugs or devices, and those drugs or devices are generally provided without cost during the trial period. This allows the trial member to use treatments that, due to lack of FDA approval, aren't yet available to the general public. It also provides an opportunity to help others.

Effective January 1, the ACA requires that if anyone qualifies for an approved clinical trial, their health plan cannot deny or limit your regular benefits if you participate in a clinical trial. You'll keep your coverage if you participate in any type of clinical trial, including those for cancer and other serious conditions. This new provision doesn't apply to people with grandfathered health plans. 

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, such as federally funded trials, trials conducted under an investigational new drug application reviewed by the 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.

To participate in a clinical trial (and keep your coverage), there are a few requirements:

  • First, you have to qualify. This means your doctor has to agree that you're a good candidate for the study. It's best to call your health insurance company first. A customer service representative will explain your benefits to you. Then, talk to your doctor about how you can join a clinical trial, but also stay within your coverage requirements. Your doctor will look at the purpose of the study, as well as your health condition, to determine the best course of action. 
  • Coverage applies to your normal health care and expenses, based on your medical condition. Additional expenditures for investigational devices, costs of data collection, or specialized care unrelated to your condition do not apply. Plans are not required to provide benefits for routine patient care services provided outside of the plan’s network area unless out-of network benefits are otherwise provided under the plan.
  • Trials must be federally funded, as part of FDA research, or part of a drug trial that is exempt from FDA oversight.
  • You need to see an in-network doctor. However, this isn't a requirement if you need to travel out of state for the study. The costs of seeing an out-of-network doctor, or travel costs related to the trial, aren't covered under your plan. Hospitalization or monitoring in connection with the trial will be covered. 


As always in cases of health care, careful consideration of the risks and benefits, as well as the costs, should be thoroughly discussed with your doctor. Trials conducted far from home also can be a burden to family members. The upside can be tremendous simply from knowing that you have furthered the cause of science, but take the time to weigh everything. 

Do you have questions about the Affordable Care Act? We have a call center which is ready to help you navigate through the maze of complexities in the new world of health coverage.

Please call 1-877-214-2969. We’re ready to assist you.

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