Health Insurance Coverage of Clinical Trials

Approved by the Cancer.Net Editorial Board, 10/2018

Understanding the costs covered by insurance

The Patient Protection and Affordable Care Act (ACA) is a federal law that regulates health plans and insurance coverage. It is a type of health care reform.

This law includes regulations regarding insurance coverage of clinical trials. Specifically, the ACA states that health plans or insurers cannot:

  • Keep patients from joining a clinical trial.

  • Limit or deny coverage of routine costs to patients who join an approved clinical trial.

  • Increase costs because a patient joins a clinical trial.

The clinical trials coverage provision does not apply to “grandfathered” health plans. These plans existed on or before March 23, 2010, the date that the ACA went into effect.

But if a plan has reduced benefits or raised costs since the ACA went into effect, the government may no longer consider it a grandfathered plan. 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 do not know if your plan is considered a grandfathered plan, contact your health insurance provider.

Approved clinical trials

The law applies to clinical trials designed to study new methods to prevent, detect, or treat cancer or another life-threatening illness. According to the law, an approved clinical trial must meet any of the following conditions:

Be federally approved or funded. This means 1 or more of the organizations listed below approved or funded the clinical trial.

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

  • Organizations funded by the NIH or NCI, including 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, if the trial is subject to unbiased, scientific review that is similar to NIH requirements

Have an investigational new drug application. Research regulated by the U.S. Food and Drug Administration (FDA) must include an investigational new drug 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 approval for an investigational new drug.

Be excused from investigational new drug application requirements. Sometimes, researchers do not need to ask the FDA for permission. This occurs when drug makers are not looking to include a new use of an existing drug in the labeling or advertising. But researchers still need the FDA to approve changes to a drug’s labeling or advertising. Researchers also need FDA approval to test changes in drug dose or ways to give a drug if it can increase risk for the people participating.

Your doctor can help determine if the ACA covers the clinical trial you are considering.

Routine costs and choice of provider

If you choose to join a clinical trial and the ACA requirements apply to your insurance plan, your insurer must cover routine costs. Examples of routine costs include:

  • Office visits
  • Lab tests
  • Supportive care drugs
  • Procedures and services you need while you are in the trial

These are costs your insurer would cover even if you were not in the trial. But your insurer does not need to cover the treatment being studied. (See "Costs not covered," below)

Additionally, your insurer may not cover health care providers outside your health plan’s network. The insurance materials should list the providers covered by your plan.

Sometimes an insurance plan includes coverage for out-of-network providers. These are doctors and hospitals that the insurer does not list as part of its network. If you have out-of-network coverage, the insurer must cover your routine costs of care for a clinical trial with a provider outside your network.

Medicare and Medicaid coverage

Medicare. The ACA does not affect Medicare coverage of clinical trial costs. Medicare has slightly different rules for covering clinical trials.

Medicare covers the following routine clinical trial costs:

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

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

  • Medical care related to health problems from the clinical trial. One example is the prevention and management of side effects.

Special rules apply for people enrolled in Medicare-managed care plans. These plans are also called Medicare Advantage plans.

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

Medicare does not cover research-related costs.

Medicaid. The ACA clinical trials coverage rule does not apply to Medicaid plans. Federal law does not require states to cover clinical trials through Medicaid. But some states have laws that require Medicaid to cover clinical trials. Learn more about insurance coverage of clinical trials by state. Please note that this link takes you to a different ASCO website.

Costs not covered by health insurance

It is important to know which costs you will need to pay before joining a clinical trial. Remember, health insurance companies and Medicare are not required to cover:

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

  • Any procedure only needed to collect data for the study

Talk with the clinical trial research team about what your insurance plan may cover. And check if your insurance plan must meet the ACA clinical trial coverage requirements. You will usually talk about this with the research team during the informed consent process.

Related Resources

ASCO Answers: Clinical Trials Coverage Through the Affordable Care Act (PDF)

Financial Considerations

Questions to Ask About Clinical Trials

More Information

HealthCare.gov

Centers for Medicare & Medicaid Services

Patient Advocate Foundation

CancerCare

Cancer Support Community