How does Medicare handle coverage for experimental treatments or clinical trials?

Question

Nancy Suozzi-Vidal · Accepted Answer

Routine services that would normally be covered under Medicare may be covered for participation in a clinical trial. But, clinical trial services and experimental treatment will not be covered. Any covered services would most likely be subject to prior approval. Likewise, your OOP responsibility would apply for covered services. Your provider should work with Medicare or other Medicare plan coverage carrier regarding specific criteria to actually participate. I also recommend the patient discuss with a carrier nurse to determine any patient responsibilities.

Answered by Nancy Suozzi-Vidal on May 1, 2025

Broker Licensed in NY & CT

Answered by Nancy Suozzi-Vidal Medicare Insurance Agent

Norman Smith · Answer

Medicare does not typically cover experimental treatments. There may be coverage for some of the testing in the trials, but I would not bank on Medicare covering anything for you.

Charise Karjala · Answer

This answer is provided in a video format. Watch the agent's video response here: https://medicareagentshub.com/questions/how-does-medicare-handle-coverage-for-experimental-treatments-or-clinical-trials#charise-karjala

Sean Willingham · Answer

Experimental treatment or investigational device being tested in trial is typically not covered by Medicare. However, Medicare does cover routine costs associated with qualifying for clinical trials, but not the investigational treatment itself. These costs include doctor's visits, hospital stays, diagnostic texts, and medical care related to side effects. To know if Medicare will cover a specific service, it is best to communicate directly with the provider of that service. For example, to know if Medicare will cover a diagnostic test, it is best to ask the provider of that diagnostic test.

Answered by Sean Willingham on May 21, 2025

Broker Licensed in TX, AL, FL & 8 other states

Answered by Sean Willingham Medicare Insurance Agent

Steven Bleicher · Answer

You will have to pay out of pocket for anything of an experimental nature. However, should the CDC or the Center for Medicare and Medicaid Services (CMS) approve that treatment in the future, it would then be paid for.

Answered by Steven Bleicher on May 29, 2025

Broker Licensed in AZ

Answered by Steven Bleicher Medicare Insurance Agent

Diana Garner · Answer

Medicare usually does not cover experimental treatments or clinical trials. Medicare will typically only cover the routine costs associated with participating in certain approved clinical trials, including items and services that would normally be covered if not participating in the trial, such as standard medical care and treatment of trial-related side effects.

Answered by Diana Garner on May 6, 2025

Broker Licensed in KY, FL, IN, OH & TN

Answered by Diana Garner Medicare Insurance Agent

Tammy Stoner · Answer

Historically, Medicare will not cover experimental treatments. 

Medicare may cover clinical trials, labs, Dr. visits, and costs associated with the clinical trial. Medicare may not cover additional costs outside of the clinical trial. It is suggested that pre-approval may be best practice before beginning some clinical trials.

Deb Haley · Answer

Medicare typically doesn't cover experimental treatments, however it may cover certain testing required while the experimental treatment is going on but that would likely need prior authorization.

Brian Leichner · Answer

Medicare does not cover experimental treatments.  It covers Hospitals when inpatient using Part A and doctors using Part B.  Drugs are covered under Part D, but must be on the formulary, so you probably won't find coverage for experimental meds either.  

To talk to you about what could be covered; you can buy policies that pay directly to you.  Policies like this pay for being unable to take care of yourself, cancer, accidents, hospital and other plans that pay you cash and then you can use that cash to pay for experimental procedures that you seek.

Have questions about any of this?  Call me, Brian Leichner @ 402.708.6616. OR write to me at Brian@ProInsuranceResources.com

Fred Manas · Answer

Medicare generally covers routine costs associated with participation in qualifying clinical trials. This includes costs like hospitalization, outpatient services, & medical care for treatment-related side effects, if these are things Medicare would normally cover. However, Medicare doesn't typically cover the experimental treatment or drug itself, or costs specifically related to the clinical trial research. 
Here's a more detailed breakdown:
What Medicare Does Cover:
Routine costs:
This includes the costs of services & procedures that would be covered by Medicare if the patient weren't participating in a clinical trial. 
Medical care for treatment-related side effects:
Medicare will cover medical care needed to address complications or side effects arising from participating in the clinical trial. 
Some costs related to investigational devices:
Medicare may cover costs related to investigational devices if certain conditions are met. 
Coverage with conditions:
In specific instances, Medicare may reimburse for investigational treatments under certain conditions, notes the National Institutes of Health (NIH). 
What Medicare Does Not Cover:
Experimental treatment costs:
Medicare typically doesn't cover the cost of the experimental drug, device, or treatment itself, or the costs associated with the research aspect of the trial. 
Costs not covered by Medicare otherwise:
If a cost is not covered by Medicare outside of a clinical trial, it is unlikely to be covered as part of the trial. 
Important Considerations:
Clinical trial must meet requirements: The clinical trial must meet specific criteria & have therapeutic intent to be covered by Medicare. 
Prior authorization may be needed: Some Medicare plans may require prior authorization for certain clinical trial costs. 
Patient cost-sharing: Even with Medicare coverage, patients may still have out-of-pocket costs for co-insurance and deductibles. 
Discussions with plan administrator to understand what is & isn't covered.

Vachik Chakhbazian · Answer

Medicare generally covers the routine costs of clinical trials and may cover certain experimental treatments or services, especially those that are part of a "Coverage with Evidence Development" (CED) study. Routine costs include services that would normally be covered by Medicare if not part of a clinical trial.

Answered by Vachik Chakhbazian on April 12, 2025

Agent Licensed in CA, AL, AR & 22 other states

Answered by Vachik Chakhbazian Medicare Insurance Agent

Marcie Barnes · Answer

Medicare doesn't cover experimental treatment and clinical trials.  Typically any insurance providers would not cover this.  They're normally paid for by the clinical trial and manufacturer.

Suzanne Lamperti · Answer

These two procedures are not covered., unfortunately. Medicare will not consider these a viable treatments.

Jack Mayer · Answer

If Medicare covers it and these clinical trials are available in your area network then it's covered by your health plan, your chances of getting that covered are greater when you have the flexibility that a Medigap plan offers.

Answered by Jack Mayer on April 12, 2025

Agent Licensed in CA & NV

Answered by Jack Mayer Medicare Insurance Agent

Robert Baez · Answer

Medicare doesn’t cover clinical research itself; it may cover certain treatments or services you get as part of participating in the trial. You will need to check with your insurance carrier to ensure you can move forward with the clinical research.

Answered by Robert Baez on April 11, 2025

Agent Licensed in IL

Answered by Robert Baez Medicare Insurance Agent

Charles Mai · Answer

Health insurance including Medicare generally does not cover experimental treatments and clinical trials.  However, drugs used in these might be covered.

Marisol Torres · Answer

Medicare usually doesn’t cover experimental treatments, but it does cover some costs if you're in an approved clinical trial. You may still have to pay some out-of-pocket expenses.

How does Medicare handle coverage for experimental treatments or clinical trials?

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How does Medicare handle coverage for experimental treatments or clinical trials?

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