Do Patients Have to Pay for Clinical Trials?
Clinical trials and health insurance
Under the Affordable Care Act, insurance companies must cover medically necessary routine patient care costs in clinical trials. The plan coverage works the same way it covers routine care costs outside of a clinical trial. In other words, if you pay a copay or need to meet a deductible before payments kick in for your regular care, the same rules most likely apply if you take part in a trial.
A few restrictions apply:
The trial must be "approved." To qualify, the trail must have a written protocol already approved by an Institutional Review Board (IRB). Trials listed on ClinicalTrials.gov or Antidote already meet this requirement.
Care providers and hospitals must be in network, if you don't have out-of-network coverage. If you don't have out-of-network coverage as part of your regular plan, the same rules apply for clinical trial participation.
For some plans, the trial must be for a "life-threatening" condition. The definition of this term can vary, so talk with your insurance provider and the trial team if you're concerned about coverage.
"Grandfathered in" insurance plans may not cover participation. Health plans that existed in March 2010, when the Affordable Care Act became law, are considered "grandfathered" plans and are not required to cover routine patient care costs in clinical trials. Once a grandfathered plan changes in certain ways, such as reducing benefits or increasing costs, it's no longer considered such a plan, and must follow federal law.
What insurance may not cover
Even if your insurance plan does cover your care while you're enrolled in a clinical trial, there are additional costs that may not be included in your coverage. These can include:
Lab tests. Insurance companies are not required to cover lab tests that are conducted for the sake of the trial, rather than for normal care. For example, if the study team conducts a blood test to collect data, rather than to check on your health, that test may not be covered by your insurance. However, these tests are typically covered by the sponsor.
Travel costs and other expenses. In addition to the cost of receiving care as part of a trial, patients may also spend money getting to the research site and paying for meals. While insurance will not typically cover these costs, the trial may offer reimbursement for travel and meals.
Your copays and deductible. If copays and deductibles are part of your insurance plan, you may need to continue to pay them for your routine site visits.
The trial sponsor may cover these costs – if you're considering taking part in a trial, ask the study team what costs you'll be responsible for.
What about paid clinical trials?
Some clinical trials offer payment to participants. This is more common for earlier trials, particularly Phase 1. These trials are for potential treatments that are less understood than those in later phases.
Paid clinical trials have their pros and cons. While you may like the idea of being paid for your time, early-stage clinical trials typically involve more risk than later-stage trials. The treatment may not have been tested in humans yet, or tested in very few volunteers. Before joining a paid clinical trial, you will have all potential risks explained to you during the informed consent process.
Later-stage clinical trials sometimes offer reimbursement for your trial or, more often, for travel or childcare. Reimbursements aren't always advertised and can vary from site to site, so ask the study team if you're interested in learning more.
By law, clinical trials cannot coerce patients into taking part. When Institutional Review Boards review study protocol and outreach materials, they may approve payment for participation, but it's important that payment not be positioned as a benefit of participating or a reason to participate.
Questions to ask the research team
Before joining a clinical trial, you'll have the opportunity to ask the study team all of the questions you may have. In terms of insurance coverage and other costs, you may ask:
- What costs will be covered by the sponsor? For example, my insurance company may not cover data collection, such as blood tests, that aren't part of my regular care.
- Will all visits be at this site? What is the name of the site so I can confirm it's within my insurance network?
- Will I be reimbursed for travel or meals?
- Have other patients had issues with getting insurance coverage?
If the study team says that other patients have had issues with insurance coverage, or if you're concerned about your own coverage, consider creating a packet of materials to submit to your insurance provider in support of the trial. The clinical trial coordinator of the study may be able to help you put together a packet that demonstrates why the trial is right for you. Your packet may include:
- Medical journal articles from prior studies that explain the potential benefit of the treatment
- A letter from your doctor that explains the trial or why the trial is medically necessary
- A letter from other outside supporters of the trial, such as a patient advocacy group.
It's important to understand the costs you'll be responsible for when participating in a trial, but don't feel overwhelmed: the trial team is there to help. Interested in finding a clinical trial near you? Start your search below.