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.

Find more information about cancer clinical trials near you HERE.

Insurance Coverage and Clinical Trials

Insurance coverage for cancer clinical trials SCORFederal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions. Such conditions include:

  • You must be eligible for the trial
  • The trial must be an approved clinical trial
  • The trial does not involve out-of-network doctors or hospitals, if out-of-network care is not part of your plan

Also, if you do join an approved clinical trial, most health plans cannot refuse to let you take part or limit your benefits.

What are approved clinical trials?

Approved clinical trials are research studies that:

  • Test ways to prevent, detect or treat cancer or other life-threatening diseases
  • Are funded or approved by the federal government, have submitted an IND application to the FDA, or are exempt from the IND application.  IND stands for Investigational New Drug.  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.

Which costs are not covered?

Health plans are not required to cover the research costs of a clinical trial. Examples of these costs include extra blood tests or scans that are done purely for research purposes. Often, the trial sponsor will cover such costs.

Plans are also not required to cover the costs of out-of-network doctors or hospitals, if the plan does not usually do so. But if your plan does cover out-of-network doctors or hospitals, they are required to cover these costs if you take part in a clinical trial.

Which health plans are not required to cover clinical trials?

Grandfathered health plans are not required to cover routine patient care costs in clinical trials. These are health plans that existed in March 2010, when the Affordable Care Act became law. But, once such a plan changes in certain ways, such as reducing its benefits or raising its costs, it will no longer be a grandfathered plan. Then, it will be required to follow the federal law.

Federal law also does not require states to cover routine patient care costs in clinical trials through their Medicaid plans.

How do I figure out which costs, if any, my health plan will pay for if I take part in a clinical trial?

You, your doctor, or a member of the research team should check with your health plan to find out which costs it will cover.


Act Seeks to Expand Clinical Trial Access to Patients on Medicaid

By Brielle Benson, Feb 20, 2020

ASCO representatives visit Capitol HillClinical trial routine care costs (including X-Rays, lab work, doctor visits and more) are not covered for people who are insured by Medicaid, leading to certain groups being underrepresented in clinical trials. However, the Clinical Treatment Act (H.R. 913) is trying to change that.

“The Treatment Act is really about ensuring accessibility for Medicaid patients for participation,” Dr. Melissa Dillmon, the Chair of the Association for Clinical Oncology’s (ASCO) Government Relations Committee said.

ASCO is one of more than 100 organizations that urged Congress this week to include the act in the upcoming “must pass” health care extenders package that is expected to be passed on May 22, 2020.

The Clinical Treatment Act would ensure that all patients on Medicaid have coverage of routine procedures and checkups associated with clinical trials. This could potentially boost the participation of minorities, who tend to be overrepresented in the Medicaid population, but underrepresented in clinical trials.

“It’s important when we look at clinical trials – especially in cancer – that we have racial and socioeconomic diversity so that it can be used in the real-world setting,” Dillmon said.

Representative Ben Ray Luján (D-NM) and Representative Gus Bilirakis (R-FL) introduced the act, which currently has 28 cosponsors representing both parties. Additionally, organizations such as the American Medical Association and the American Cancer Society Cancer Action Network have also voiced their support for the bill.

While some may be apprehensive to support H.R. 913 because they think it could increase costs, Dillmon said that is not true.

“One of the concerns is the financial part, and I hope we’re able to dispel that myth,” Dillmon added, noting that some states in the U.S. already have Medicaid coverage for clinical trial care costs, and there have been no reported increased costs there. And since the pharmaceutical company usually pays for the drug being tested, costs could even go down.

“Logically, one may think costs of care may go down. If the patient is on a clinical trial, there is no bill to Medicaid for the drug, and that’s often one of the most expensive parts of treatment,” Dillmon said.

Clinical trials are crucial to moving the field of cancer – and other serious illnesses – forward. The more patient populations they can include, the better outcomes can be for more Americans.

“Oncology has seen unprecedented successes right now in our treatment for cancer. We’ve had the single biggest improvement in the reduction in mortality. Our goal as physicians is to continue that fight and have even more survivors,” Dillmon concluded.

Understanding Clinical Trials

It’s Pancreatic Cancer Clinical Trial Awareness Month, and this short video from the National Pancreas Foundation gives a great overview of what clinical trials are, how they are conducted, and why they are important for patients with diseases like pancreatic cancer. It provides a thorough overview of study design, eligibility criteria, informed consent, safeguards, different phases of clinical trials, and the potential benefits and potential risks of participation. Find out more about cancer clinical trials HERE.


Paying for Clinical Trials

As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. There are two types of costs associated with a clinical trial: patient care costs and research costs.

Patient Care Costs

Patient care costs are those costs related to treating your cancer, whether you are in a trial or receiving standard therapy. These costs are often covered by health insurance. They include:

  • Doctor visits
  • Hospital stays
  • Standard cancer treatments
  • Treatments to reduce or eliminate symptoms of cancer or side effects from treatment
  • Lab tests
  • X-rays and other imaging tests

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 trial’s sponsor. Examples include:

  • The study drug
  • Lab tests performed purely for research purposes
  • Additional x-rays and imaging tests performed solely for the trial

When you take part in a trial, you may have extra doctor visits that you would not have with standard treatment. During these visits your doctor carefully watches for side effects and your safety in the study. These extra visits can add costs for transportation and child care.