OPINION: TONI SAYS: Does Medicare Part D cover prescriptions for clinical trials?

May 27—Dear Toni: 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.

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 [email protected] 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.