Does Medicare cover clinical trials?

What does Medicare cover in a clinical trial?

Clinical research studies test different types of medical care, including new treatments, to find out how well they work and whether they're safe, for example how well a new cancer drug works. Medicare Part A and/or Part B cover some costs, like office visits and tests. Inpatient hospital care that Part A covers includes inpatient care you get as part of a qualifying clinical research study.

Under CMS's national coverage policy, Medicare covers the routine costs of qualifying clinical trials, plus reasonable and necessary items and services to diagnose and treat complications from taking part in any clinical trial. Routine costs include:

• Items and services you'd usually get without a clinical trial (conventional care).
• Items and services needed only to provide the investigational item or service, like giving a chemotherapy drug that Medicare doesn't cover, and the monitoring of its effects.
• Care needed for complications that come from the investigational item or service.

What doesn't Medicare cover in a clinical trial?

CMS's policy leaves these out of the routine costs Medicare pays for:

• The investigational item or service itself, unless Medicare covers it outside the trial.
• Items and services used only for data collection and analysis and not for your direct care, like monthly CT scans for a condition that usually needs only one scan.
• Items and services the research sponsor usually provides free to everyone in the trial.

Which clinical trials qualify for Medicare coverage?

A trial must study an item or service that falls within a Medicare benefit category and isn't excluded by law (like cosmetic surgery or hearing aids), must have therapeutic intent rather than test only toxicity or how a disease works, and, if it tests a treatment, must enroll patients who have the disease rather than healthy volunteers. CMS treats some trials as automatically qualified, including:

• Trials funded by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ), CMS, the Department of Defense or the Department of Veterans Affairs.
• Trials supported by centers or cooperative groups funded by those agencies.
• Trials conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA).

What will I pay in a clinical trial?

You may pay 20% of the Medicare-approved amount, depending on the treatment you get, and the Part B deductible ($283 in 2026) may apply. For inpatient care, Part A costs apply: in 2026, you pay the $1,736 Part A deductible for days 1 to 60 of each benefit period. Ask your doctor or other health care provider what Medicare will cover, since what you owe also depends on other insurance you have and where you get the care.

What if I'm in a Medicare Advantage plan?

Medicare says that if you're in a Medicare Advantage plan, Original Medicare may cover some costs of clinical research studies along with your plan. Medicare Advantage plans provide all Part A and Part B benefits with a few exclusions, such as certain aspects of clinical trials, which Original Medicare covers even though you're still in the plan. Contact your plan for details about its coverage for clinical research studies. See how Medicare Advantage differs from Original Medicare.