Are Clinical Trial Prescriptions Covered By Medicare?

I am concerned about what to do when I enroll in Medicare and if I will be in Medicare’s “donut hole” since this is a clinical trial. I am not planning on enrolling in Medicare until my wife, Sarah, retires when she turns 65 in 2 years.

Are clinical trial prescriptions covered under Medicare’s drug plans? What are my options?

Thanks!   Lee from Jackson, Miss.

Hello Lee: What a smart decision you made to stay on Sarah’s employer benefits, because both you and Sarah can enroll in Medicare Parts A and B when she retires in 2 years at 65. At that time, you will be eligible for a Special Enrollment Period (SEP), avoiding the famous Medicare Part B penalty, and will be able to enroll in a Medicare Part D prescription drug plan. She will be enrolling in Medicare during her Initial Enrollment Period (IEP).

I have good news for you!  Medicare’s “donut hole” went away in 2025, and now there is a specific drug plan maximum out of pocket every year.

Lee, Medicare’s Part D maximum out of pocket for 2026 which is $2,100, and you would qualify for that when you order the cancer drug costing over $12,000 per month if that prescription is in the formulary for the Medicare Part D plan you enroll in when you are no longer covered by Sarah’s employer health insurance. If that specific cancer drug is not approved for clinical trial and not covered by the Part D plan you enroll in, then you may have to pay the $12,000 per month.

Enroll in the Medicare Part D plan that covers all of your prescriptions, even though the most expensive prescriptions are those covered by a clinical trial program and currently costs you nothing. There may be a time when those expensive prescriptions are no longer covered by the clinical trial, and without the right plan you will experience paying that year’s Part D maximum out of pocket. Each year, Medicare changes the Part D prescription drug deductible, copays, and maximum out of pocket.

Whether your Part D prescription drug plan will pay for a medication used in a clinical trial depends on whether it is covered in the plan’s formulary or can be classified as a highest-tier prescription drug, which costs more. Then you will go into that year’s Medicare Part D’s maximum out of pocket.

*Beware: If you are not enrolled in a Part D plan that covers the expensive clinical trial prescriptions, then you will pay 100% out of your pocket for the expensive prescriptions that are not covered when the clinical trial ends.*

For those enrolled in a Medicare Advantage plan seeking clinical trial, page 35 of the 2026 Medicare & You handbook under “Clinical Research Studies” states, “If you’re in a Medicare Advantage plan, Original Medicare may cover some costs along with your Medicare Advantage plans. Contact your plan for details about coverage for Clinical Research Studies.  This short section also explains how different types of medical care are covered under Medicare Parts A and B.

Lee, enrolling in Medicare Part B when your wife retires is a good option. Both you and Sarah will qualify for a Medicare Supplement/Medigap Plan during your 6-month Medigap Open Enrollment Period without having to answer one health question. This period starts the month your Medicare Part B is effective.

Take your time and research which Medicare options meet your needs because with Medicare what you don’t know WILL hurt you! Exploring Medicare Part D and prescription drugs is one of the most important topics during a Toni Says Medicare consultation.

Email info@tonisays.com or call 832-519-8664 with your Medicare question or to schedule a Medicare consultation.  Sign up for the Toni Says newsletter at www.tonisays.com to keep up to date on Medicare changes.