The Patient Costs Involved with Clinical Trials



July 31, 2020

As you think about taking part in a clinical trial, you will need to think about how to cover its cost. Fortunately, under the Affordable Care Act (ACA), many health insurance plans cover at least part of the costs associated with these trials. From the potential costs to what could be covered by insurance, here is everything you need to know about paying for clinical trials. 

What costs are involved in cancer clinical trials?

There are two different costs associated with a cancer clinical trial: the patient care cost and research cost.

Patient care costs 

The routine costs related to treating your cancer, whether you are in a trial or receiving standard treatment, are called ‘patient care costs.’ Most of the time, these costs will be covered by your health insurance plan. Patient care costs include:

  • Doctor visits

  • Hospital stays

  • Standard cancer treatments

  • Treatments to alleviate symptoms of your cancer or the side effects from treatment

  • Lab tests

  • X-rays and other imaging tests

When you take part in a trial, you may have extra doctor visits so your doctor can closely monitor you for side effects after the study. Out-of-pocket costs like childcare, transportation or copays could add up for any extra visits.

Research costs 

Research costs are those related to taking part in the trial. Often these costs are not covered by health insurance, but they may be covered by the clinical trial’s sponsor. These costs may include:

  • The treatment, device, or service that’s being studied

  • Lab tests (like a blood test) performed for research purposes of the trial

  • Any additional X-rays and imaging tests for research purposes of the trial

In most cases, when you enrol in a clinical trial, the study sponsor provides the new treatment at no cost and pays for any special tests, procedures, or extra doctor visits. Some sponsors may pay for more; for example, some may offer to pay you back for travel time and mileage. It’s important to find out what will be paid for before you enter the study.

What clinical trial costs are covered by my insurance?

The Affordable Care Act is a federal law that regulates health plans and insurance coverage. Specifically, the ACA states that health plans and insurers cannot:

  • Keep you from joining a clinical trial

  • Limit or deny coverage of routine care costs associated with an approved clinical trial

  • Increase costs because you joined a clinical trial

Most health insurance plans are required by the Affordable Care Act to cover routine patient care costs in clinical trials. However, this coverage is based on certain criteria. In order to be eligible for coverage, you may need to meet the following requirements:

  • You are eligible for the trial

  • The trial has been approved, meaning it has been funded or approved by the federal government, there has been an IND application submitted to the FDA, or it is exempt from the Investigational New Drug (IND) requirements. In most cases, a new drug must have an IND application submitted to the FDA in order to be given to people in a clinical trial.

  • The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan

However, grandfathered insurance plans may not cover your participation. Health plans that existed on or before 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. But if a grandfathered plan changes in ways such as reducing benefits or raising costs, it is no longer considered to be a grandfathered plan and must follow ACA requirements. 

Costs paid by Medicare

The ACA does not affect Medicare coverage of cancer clinical trial costs. If you have Medicare, it pays for many of the routine medical costs for people with cancer who are in approved clinical trials. This is true no matter where in the United States you live. Medicare normally covers any cancer care when it’s part of either:

  • A clinical trial for the diagnosis and treatment of cancer; or

  • A clinical trial funded by the National Cancer Institute (NCI), NCI-Designated Cancer Centers, NCI-Sponsored Clinical Trials Cooperative Groups, or another federal agency that funds cancer research

Similar to traditional health insurance plans, Medicare does not cover research-related costs. If you’re not sure whether your trial meets all of the requirements, discuss these concerns with your doctor, call Medicare (1-800-633-4227), or connect with a Caribou Healthcare Advisor.

Remember, for clinical trials, both health insurance companies and Medicare are not required to cover:

  • The cost of the treatment or procedure the clinical trial is studying

  • Any procedure or lab testing only needed to collect data for the study

It is important to collect as much information as you can about the study and to know which costs you will be responsible for before joining a clinical trial. It would also be helpful to contact your insurance provider to learn more about your coverage.