Clinical Trials

A clinical trial is a research study that tests new medical treatments, drugs, procedures, or devices in human volunteers to determine whether they're safe and effective. Under the ACA, health plans must cover routine patient costs associated with participating in an approved clinical trial, even though the experimental treatment itself may be provided free by the trial sponsor.

The ACA's clinical trial protection means your plan cannot drop you, limit your benefits, or raise your premiums because you participate in a trial. It also means your plan must cover routine costs, like doctor visits, lab work, imaging, and hospitalization, that would be covered regardless of whether you're in a trial. What's experimental (the study drug or procedure itself) is typically provided by the trial sponsor at no cost.

This protection applies to clinical trials for cancer, life-threatening conditions, and other serious diseases. Your plan must allow participation in an approved trial, and you can't be denied routine care coverage just because that care is being delivered as part of a research study.

Before joining a trial, understand which costs your plan covers and which the trial sponsor covers. The trial's informed consent documents should outline this clearly. If your plan denies coverage for routine costs during a trial, you have the right to appeal, and this is one area where plans are clearly required to provide coverage under the ACA.

Clinical trials can provide access to advanced treatments that aren't yet available to the general public. If you're facing a serious health condition, ask your doctor whether any relevant clinical trials are enrolling. The National Institutes of Health maintains a searchable database at clinicaltrials.gov.