Does Medicare Part D cover prescriptions for clinical trials?

on May 23, 2024

I turn 65 in September, am covered under my wife’s employer’s health insurance and fighting liver cancer. I am participating in a clinical trial for a cancer medication which costs over $12,000 per month and pay $0 for a medication which is curing my cancer.

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, Toni.

--Lincoln from Tampa, Fla.

Hello Lincoln:

What a smart decision you made to stay on Sarah’s employer benefits, because you both 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 be able to enroll in a Medicare Part D prescription drug plan. She will be enrolling in Medicare during her Initial Enrollment Period (IEP).

Exploring Medicare Part D and prescription drugs is one of the most important topics during a Toni Says Medicare consultation. Lincoln, you would go into the famous “donut hole” the second you order the prescription which costs over $12,000 per month if you were not in a clinical trial.

In 2024, the donut hole begins once the actual cost of a person’s prescriptions reaches $5,030 and ends when one has spent $8,000 out of pocket; then the Catastrophic Coverage phase begins. As of January 1, 2024, the new Catastrophic Coverage cost is $0 out of pocket for the Medicare beneficiary and the Part D plan, with Medicare picking up all the costs.

The Toni Says team will search the Medicare.gov Part D prescription drug website for the Medicare Part D plan that best meets the beneficiary’s Medicare and financial needs. Readers, you should always enroll in the Medicare Part D plan which covers ALL your prescriptions, even though the most expensive prescription is covered by a clinical trial program and currently costs you nothing. There may be a time when that expensive prescription is no longer covered by the clinical trial, and without the right plan you will experience paying the donut-hole cost.

Whether your Part D prescription drug plan will pay for a medication used in a clinical trial depends on if it is covered in the plan’s formulary or can be classified as a Tier 5 prescription that costs more. Then you will be leaving the donut hole and go into Medicare Part D’s Catastrophic coverage immediately.

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 trials, page 34 of the 2024 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.”

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.

Lincoln, take your time and research which Medicare options meet your needs.

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Toni King is an author and columnist on Medicare and health insurance issues. She has spent nearly 30 years as a top sales leader in the field. If you have a Medicare question, email info@tonisays.com or call 832-519-8664. The “Medicare Survival Guide Advanced” edition and her new “Confused about Medicare” video series are available at www.tonisays.com.