Health Insurance Coverage of Clinical Trials

Aprobado por la Junta Editorial de Cancer.Net, 03/2022

If you are in the United States, you may have concerns about whether or not your cancer care is covered by your health insurance if you join a clinical trial. Clinical trials are research studies that involve people who volunteer to take part in the research.

Clinical trials can focus on new cancer treatments, new ways of using existing treatments or combinations of treatments, and new techniques. They can also focus on supportive care and learning more about existing treatments. For some people with cancer, clinical trials are their best treatment option. Other people may choose to participate in a clinical trial because they know these studies are a way to contribute to progress in cancer treatment.

Recent changes to U.S. health care laws mean that most routine care costs from clinical trials are covered if you have health insurance, including Medicaid. Other costs are covered by the study's researchers or sponsor. Before joining a cancer clinical trial, talk with the researchers and your insurance company to confirm what costs are covered by who.

What will I have to pay for if I participate in a clinical trial?

There are 2 kinds of costs associated with clinical trials:

Patient care costs or routine costs are the costs of your cancer care you and your health insurance company will need to pay for. For most insurance plans, these costs are covered for both standard treatment and treatment received through a clinical trial. If you must pay personally for a medical service, it is called an "out of pocket" cost.

Patient care costs include:

  • Office visits and hospital stays

  • Lab tests

  • Standard cancer treatments

  • Medications that relieve symptoms and side effects

  • Imaging tests and scans

  • Other laboratory tests

Research costs are costs that are related to taking part in a specific clinical trial. These costs are usually not covered by health insurance. Instead, costs may be covered by the clinical trial's sponsor and/or you may need to cover certain costs. Some examples of research costs in clinical trials include:

  • The medication being studied in the clinical trial, if it is not a standard treatment

  • Tests or scans that are only being done to gather data for the clinical trial

Before enrolling in a clinical trial, be sure to ask the researchers what specific research costs they will be covering and there are any costs that enrolled participants must cover out of pocket. Also, you can ask your cancer care team for help in comparing total and out of pocket costs of standard treatment and the costs of a specific clinical trial.

Also, consider whether there will be additional costs that come with participating in a clinical trial compared to standard cancer treatment, and if so, ask the researchers about who pays for those costs. For example, if you need to travel to another cancer center for the clinical trial, there can be additional transportation costs and housing costs. Or if you have more frequent appointments, you may have additional childcare or other costs. If the clinical trial sponsor does not cover these costs, there are organizations that can help.

Are cancer clinical trials covered by health insurance?

In the United States, federal law requires that health plans and insurance companies cover routine costs when people receive care through clinical trials that meet certain conditions. These following conditions must be met to have your care in a clinical trial covered:

  • You must be eligible for the clinical trial

  • It must be an approved clinical trial

  • The doctors and the hospital where you will receive care must not be out-of-network, unless out-of-network coverage is a part of your health care plan

The U.S. law called the Patient Protection and Affordable Care Act (ACA) regulates some private health plans and insurance coverage. According to the ACA, health plans or insurers cannot:

  • Keep people from joining a clinical trial

  • Limit or deny coverage of routine costs to people who join approved clinical trials

  • Increase costs because a patient joins an approved clinical trial

Health care plans that existed on or before March 23, 2010, are exempt from these requirements. They are called "grandfathered" health plans. If a health care plan changes in any way – for example, raised costs or reduced benefits – then they are no longer considered "grandfathered" health plans. Losing grandfathered status means the plan must follow all ACA requirements. This includes covering routine clinical trial costs.

A grandfathered plan must note its grandfathered status in materials that describe the plan benefits. If you are unsure if your health care plan is grandfathered, contact your health insurance provider.

What types of clinical trials are approved?

The ACA applies to clinical trials that study new ways to prevent, detect, or treat life-threatening illnesses, like cancer. The law says an approved clinical trial must meet at least 1 of the following conditions:

Be federally approved or funded. This means that 1 or more of these organizations approved or funded the clinical trial:

  • National Institutes of Health (NIH). This includes organizations under NIH, such as the National Cancer Institute (NCI).

  • Organizations funded by the NIH or NCI. This includes academic institutions, designated cancer centers, and cooperative groups.

  • Centers for Disease Control and Prevention (CDC)

  • Agency for Health Care Research and Quality (ARHQ)

  • Center for Medicare and Medicaid Services (CMS)

  • Department of Defense, Department of Veteran Affairs, or the Department of Energy

Have an investigational new drug (IND) application. Research regulated by the U.S. Food and Drug Administration (FDA) must include an IND application. Researchers need FDA approval to provide a drug that is still under development in a clinical trial. Your doctor or the clinical trial sponsor can tell you if the study has IND approval.

Be exempt from IND requirements. Sometimes, researchers do not need to get FDA permission. This happens when drug makers do not want to include new uses of an existing drug in labeling or advertising. But researchers still need the FDA to:

  • Approve changes to a drug's labeling or advertising

  • Test changes in drug dose

  • Test changes in ways to give a drug if the changes can increase risk for people participating

Your health care team can help find out if the ACA covers any clinical trials you are considering for your cancer treatment.

Do Medicare and Medicaid cover clinical trials?

Medicare and Medicaid are public insurance plans that cover certain people in the United States. Medicare is run by the U.S. federal government, and each state has its own Medicaid program.

Medicare is the federal health insurance program for people who are 65 and older. It also covers some people who are disabled.

Because Medicaid programs are run by each state, eligibility requirements depend on where you live. Medicaid usually covers people who are disabled, have a low income, and/or who are older. It may also cover certain people with dependent children.

The ACA does not affect Medicare or Medicaid. But both Medicare and Medicaid cover routine care costs associated with cancer clinical trials.

Medicare. Medicare covers these routine clinical trial costs:

  • Drugs, procedures, and services that Medicare would cover if you were not in the clinical trial.

  • Medical care needed for the treatment that the clinical trial is studying. For example, Medicare would cover related medical care related to chemotherapy. But it would not cover the new chemotherapy drug.

  • Medical care related to health problems for the clinical trial. One example is preventing and managing side effects.

Special rules apply for people in Medicare-managed care plans. Another name for these plans is Medicare Advantage plans.

If you are in one of these plans, traditional Medicare covers routine clinical trial costs. Then, the Medicare Advantage plan pays any difference in your out-of-pocket costs between traditional Medicare and Medicare Advantage plan.

Medicare does not cover costs related to research.

Medicaid. In 2020, the U.S. Congress passed the CLINICAL TREATMENT Act, which requires all state and territory Medicaid programs to cover routine costs associated with qualifying clinical trials. This act went into effect on January 1, 2022.

A Medicaid plan now has 72 hours to determine if you qualify for coverage of routine costs associated with a qualifying clinical trial. If you qualify:

  • Medicaid must cover routine costs associated with a qualifying clinical trial in any phase of development.

  • A state or territory Medicaid plan must cover routine costs for qualifying clinical trials located out of state.

  • Medicaid must cover routine patient costs even if the doctor or hospital connected to the clinical trial is outside of the network of the beneficiary’s Medicaid managed care plan.

Questions to Ask the Health Care Team

Before you join a clinical trial, your health care team and the research staff can help you understand a clinical trial. They will also give you printed information about what will happen in the clinical trial. This process is called informed consent.

During this meeting, you can ask questions about the costs you may have to pay during the clinical trial. Consider asking these questions:

  • What costs will be covered by the clinical trial sponsor?

  • What costs will my health insurance company cover?

  • What costs will I need to cover out of pocket?

  • How do the costs of the clinical trial compare with the costs of the recommended standard treatment? Does one cost more than another for me out of pocket?

  • Can I be reimbursed for any of my out of pocket costs of the clinical trial?

  • Are there other organizations that can help me with transportation or childcare costs if I participate in a clinical trial?

  • Who can I speak to if I am concerned about paying for my treatment in a clinical trial?

  • If I have Medicaid, when will my insurance cover routine costs?

  • Is there a financial counselor that I can speak to?

Related Resources

ASCO Answers: Cancer Clinical Trials

Financial Considerations

Questions to Ask About Clinical Trials

Questions to Ask About Cost

More Information

HealthCare.gov

Medicare.gov

Centers for Medicare & Medicaid Services

Triage Cancer

Patient Access Network Foundation