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Does Medicaid Cover Clinical Trials?

If you have been diagnosed with cancer, a clinical trial might be an appropriate treatment option for you. Clinical trials are research studies that find and test new treatments or procedures.

If you have Medicaid, you may be wondering if your care will be covered if you decide to participate in a clinical trial. This blog will explain the costs of a clinical trial, how the new Clinical Treatment Act helps patients, and whether Medicaid covers an out-of-network or out-of-state clinical trial.

What are the costs of a clinical trial?

If you participate in a clinical trial, the trial’s sponsor (e.g., a cancer center) typically pays for research costs. Research costs include the cost of the new drug or treatment being tested and tests performed solely for research purposes.

But the trial sponsor does not usually pay for routine costs of your cancer care, including doctor’s visits, hospital stays, and lab tests. Patients are responsible for these routine costs, but depending on the type of health insurance that a patient has, some or all routine costs may be covered.

How does the Clinical Treatment Act help?

In late 2020, Congress passed the Clinical Treatment Act (CTA). As of January 1, 2022, the CTA requires all state Medicaid programs to cover all routine costs of participating in a clinical trial. The trial must be approved by the National Institutes of Health, the Centers for Disease Control and Prevention, or the Centers for Medicare & Medicaid Services (CMS).

The CTA defines routine costs as any item or service provided to the clinical trial participant, such as those used to prevent, diagnose, monitor, or treat complications resulting from participation in the clinical trial.

The CTA does not require Medicaid to cover any investigational item or service that is the subject of the clinical trial, if it is not already covered by Medicaid outside of the clinical trial setting. These are costs usually covered by a clinical trial’s sponsor.

The CTA also does not require Medicaid to cover the cost of any item or service provided solely to satisfy data collection and analysis, if it is not used in the direct clinical management of the clinical trial participant. These are also costs usually covered by a clinical trial’s sponsor.

Does Medicaid cover an out-of-network or out-of-state clinical trial?

Under the Clinical Treatment Act, Medicaid cannot deny coverage of routine costs just because the clinical trial is out-of-state or because the health care provider is not in a patient’s Medicaid managed care plan’s network.

What can I do if I have a problem?

Despite the new law, people with Medicaid may still be denied coverage for routine costs, especially while participating in out-of-state clinical trials, or in clinical trials overseen by out-of-network health care providers.

Here are some practical steps you can take:

  • If Medicaid, or your Medicaid managed care plan, has told you they won’t pay a claim, but has not officially issued a denial, ask for them to issue the denial in writing. Without an official denial, you won’t be able to appeal.
  • Ask Medicaid, or your Medicaid managed care plan, why the claim was denied and request that information in writing.
  • Appeal the denial with Medicaid or your Medicaid managed care plan. For more information about how to appeal a denial, visit Cancer Finances.
  • If Medicaid tells you that you are being denied because your clinical trial is out-of-network or out-of-state, remind them that the Clinical Treatment Act (CMS Letter SMD #21-005, an April 2022 letter from CMS to state Medicaid directors), requires that “a state or territory may not deny coverage of routine patient costs based on where the clinical trial is conducted, including out of state, or based on whether the principal investigator or provider treating the beneficiary in connection with the clinical trial is outside of the network of the beneficiary’s Medicaid managed care plan.”
  • Contact your elected officials. Your state legislators may be able to help you if you are having issues with your state Medicaid office. Your U.S. Senators and Representatives have local district offices that may be able to help you if you are having issues with the Centers for Medicare and Medicaid Services (CMS). Common Cause has a tool to help you find your elected official's contact information.

We want to hear from you!

We understand that it can be incredibly frustrating to receive a denial for an item or service that you believe should be covered by your insurance.

If you have experienced problems with getting Medicaid to cover routine costs of care for clinical trials, please send us an email at info@triagecancer.org to let us know.

About Triage Cancer

Triage Cancer is a national, nonprofit providing free education to people diagnosed with cancer, caregivers, and health care professionals on cancer-related legal and practical issues. Through eventsmaterials, and resources, Triage Cancer is dedicated to helping people move beyond diagnosis.

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