I'm participating in a clinical trial for a new cancer treatment that uses personalized medicine based on my genetic profile. How does Medicare coverage work in this situation?

Question

Larry Dalton · Accepted Answer

Medicare covers specific genetic tests if they are medically necessary and meet particular criteria. The cost of these procedures will be handled through expected Medicare benefits in payment. However, specialized clinics and procedures should always be verified for Medicare coverage before using them, and the medical necessity of such procedures must be demonstrated.

Answered by Larry Dalton on April 10, 2025

Broker Licensed in OK & TX

Answered by Larry Dalton Medicare Insurance Agent

Bruce Kern · Answer

It will either be covered by Part D Drugs or perhaps by Part B drugs. Or you can apply for a formulary exception to have either you Part D or Part B cover your medication

Gary Henderson · Answer

First of all, since you're doing it for a drug company, I would expect them to cover that 

In general, Medicare does not directly cover the cost of the medications themselves used in clinical trials. However, Medicare may cover certain routine costs and complications related to participation in qualifying clinical trials if they are otherwise covered services.

Robert Baez · Answer

Clinical research studies test how well different types of medical care work and 
if they’re safe, like how well a cancer drug works. For certain clinical research 
studies, Medicare covers some costs, like office visits and tests. You may pay 
20% of the Medicare-approved amount, depending on the treatment you get.  Check with your plan.

Mary Salmon · Answer

Medicare covers medically necessary and approved treatments. ACA requires that health insurance cover routine patient care costs for people who are in approved clinical trials. However, Medicare does not cover experimental treatments that are not part of the clinical trial. So there could be gaps in your Medicare coverage. Having a supplemental cancer policy is helpful in this situation.

Answered by Mary Salmon on April 15, 2025

Broker Licensed in TX & OK

Answered by Mary Salmon Medicare Insurance Agent

Tracy Brown · Answer

Medicare Part B does cover certain costs related to qualifying clinical trials, especially for treatments like yours that involve cancer and personalized medicine.  Here’s what’s typically covered:

1. Routine costs – These are things you’d get even if you weren’t in a trial, like: Doctor visits,
hospital stays (100 days per calendar year), lab tests, imaging (like MRIs or CTs), standard cancer treatments you’re receiving in conjunction with the trial

2. Any side effects treatment – If something unexpected happens as a result of the trial and you need care, Medicare generally covers it.

3. Medicare doesn’t cover: The actual drug or treatment being tested.  Most of these are likely not FDA-approved. Sometimes it is covered by the trial sponsor (such as a drug company, research institution, or cancer center) but no guarantees.   Also, Medicare doesn't cover the extra procedures for research that are not part of routine care.

Good news!  There is a personalized Medicine Twist:
If your trial involves genetic testing or biomarker analysis, Medicare may cover this if it's part of your standard care plan (if it's not solely for research). Coverage for precision medicine is growing, especially in cancer care.  Please be aware, I cannot make any personal guarantees.  It does look good for a genetic cancer in your health or family history.

Tony Evangelista · Answer

What Medicare Does NOT Cover
❌ The Investigational Item or Service Itself
Medicare usually doesn't cover the actual experimental drug or treatment (the personalized genetic therapy in this case), unless it's already approved by the FDA for your condition.

However, the clinical trial sponsor typically covers the cost of the experimental drug or genetic therapy being tested.

I'm participating in a clinical trial for a new cancer treatment that uses personalized medicine based on my genetic profile. How does Medicare coverage work in this situation?

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I'm participating in a clinical trial for a new cancer treatment that uses personalized medicine based on my genetic profile. How does Medicare coverage work in this situation?

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