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Coverage for individuals participating in clinical trials

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clinical trials

Have you or a loved one ever thought about participating in a clinical trial? If you have a health condition, there could be a lot of benefits to such treatment. You can make use of new treatments that aren't yet available to everyone because they're not yet approved. Plus, you have an opportunity to help others.

There are a lot of risks too. The treatment might not work well for you. And, in the past, your health care plan might not have covered you during the clinical trial. With health care reform, this is changing. Starting in 2014, all people who participate in clinical trials will keep their health coverage.

Insurance companies can't 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 ones for cancer and other serious conditions.*

How does it work?

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. Your doctor will look at the purpose of the study, as well as your health condition.
  • You only get coverage for routine health costs. Your health plan isn't allowed to deny or limit your coverage for routine patient costs during the clinical trial. This is the care you'd normally get to manage your condition. It doesn't include extra costs for investigational devices, costs of data collection, or other care you wouldn't normally get.
  • The clinical trial has to be approved. This means it needs to be federally funded, part of an FDA investigation, or part of a drug trial that is exempt from FDA investigation.
  • 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 related to the treatment aren't covered under your plan.

Keep in mind: This provision doesn't apply to people with grandfathered heath plans.

How it impacts you

As of 2014, you now get to keep your health coverage when participating in clinical trials. It also encourages more people to participate in clinical trials and help advance medicine.

How much coverage do I get when participating in a clinical trial?

You get the same coverage that you'd normally have to manage your condition. The big change is that insurance companies can't limit or deny your coverage just because you're part of a clinical trial.

How do I know my coverage?

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.

*Have health insurance under a grandfathered plan? If so, you might not get these benefits. If there is any difference between the information on this website and your health plan, your policy's provisions will apply.

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