Medicare & Clinical 

Research Studies

CENTERS FOR MEDICARE & MEDICAID SERVICES
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You may have the choice to join a clinical research study to diagnose or treat an illness. If you join a covered 

clinical research study, Medicare will help pay for some of 

your costs. 

What are clinical research studies?

Clinical research studies (also called clinical trials) may 

involve diagnostic tests, surgical treatments, medicine, or 

new types of patient care. These studies may:

• Study how well new treatments and tests benefit patients. 

• Compare different treatments for the same condition to 

see which treatment is better. 

• Study new ways to use existing treatments.

These studies help doctors, researchers, and patients see if 

the new care improves patient health.

Should I join a clinical research study?

Before you decide to join a study, it’s important to think 

about the benefits and risks that might be involved.

Benefits may include: 

• Your health care may be provided by top doctors or 

facilities.

• You may have access to new drugs and treatments before 

they’re widely available.

• Your health care will be monitored closely for any side 

effects.

• You can take a more active role in your own health care.

• You may be among the first to benefit if the drug or 

treatment is found to be helpful.

• You can make an important contribution to research that 

may help other people who have the same illness.
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Should I join a clinical research study? 

(continued)

Risks may include: 

• You may experience serious side effects from new 

drugs and treatments that your doctors can’t reasonably 

anticipate.

• You may get drugs and/or treatments that aren’t 

effective, or are less effective than current approaches.

• You may not benefit from drugs or treatments that may 

benefit others.

• Studies may require a lot of your time and frequent trips 

to the study site.

Before you agree to take part in a study, someone involved 

in the study will explain it to you. Then, they’ll ask you to 

sign an informed consent form. This form describes the 

study and what’s being tested. The form also explains any 

anticipated risks. 

Before you sign the form, ask questions so you understand 

and are comfortable with what will happen during the 

study. Feel free to ask any questions or bring up any issues 

you have about the study at any time.
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What’s a placebo, and will I get one?

A placebo is an inactive substance (like a sugar pill) or 

treatment that looks the same as, and is given the same 

way as, an active drug or treatment being tested in a 

clinical research study. 

Many clinical research studies compare a new treatment 

with an existing treatment (a treatment currently known 

for a disease based on past research). In some of these 

studies, patients are randomly put in one group or 

another. If there isn’t an existing treatment, a study may 

compare a new treatment with a placebo to find out if 

the new treatment has any effect on the condition being 

studied. You’ll be told if you might be given a placebo 

before you decide whether to take part in the study. Once 

you’re in the study, you won’t know if you’re taking the 

placebo or the drug being tested.

Will I have to pay for any part of the study?

Medicare pays for routine costs of items and services in 

covered research studies. Examples of these items and 

services include:

• Room and board for a hospital stay that Medicare 

would pay for even if you weren’t in a study

• An operation to implant an item that’s being tested

• Treatment of side effects and complications that may 

occur as a result of the study
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Will I have to pay for any part of the study? 

(continued)

Medicare won’t pay for:

• The new item or service that the study is testing unless 

Medicare would cover the item or service even if you 

weren’t in a study 

• Items and services the study gives for free (many 

times the treatment will be provided free by the study 

sponsor)

• Items or services used only to collect data and not used 

in your direct health care (like monthly EKGs for a 

condition that usually requires only a yearly EKG)

• Coinsurance and deductibles

I’m in a Medicare health plan. Can I still be 

in a clinical research study?

Yes. If you’re in a Medicare Advantage Plan (like an HMO 

or PPO) or other Medicare health plan, you can get the 

same coverage for clinical research studies as a person in 

Original Medicare, as described in the previous section. 

Once you join a Medicare-covered clinical research study, 

Medicare will pay for your covered services as if you were 

in Original Medicare. This means that your Medicare 

health plan can’t keep you from joining a clinical research 

study. However, you should tell your plan before you start 

a study. That way, the plan can still keep track of your 

health care services.
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Will my employer group health plan 

cover the costs in a clinical research study?

Whether your employer plan covers all or some of the 

costs depends on: 

• The rules of your employer plan

• Whether the employer plan or Medicare pays your bills 

first 

Before you join a study, check with your employer plan 

or your benefits administrator to find out what will be 

covered. For more information on who should pay first, 

visit Medicare.gov/publications to view the publication 

“Medicare & Other Health Benefits: Your Guide to 

Who Pays First.” You can also call 1-800-MEDICARE 

(1-800-633-4227). TTY users can call 1-877-486-2048.

Will my Medicare Supplement Insurance 

(Medigap) policy pay for my costs if I’m in 

a clinical research study?

If Medicare covers the routine costs of your study, then 

your Medigap policy must pay the same as it would for 

any other Medicare-covered services. 

However, if Medicare doesn’t cover a certain cost of the 

study, in most cases, your Medigap policy won’t provide 

any benefits. Contact the insurance company that provides 

your Medigap policy for more information.
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I’m in a Medicare drug plan. If I join a 

clinical research study that tests a 

prescription drug, will my plan cover the 

cost of the drug?

Your drug plan may cover the drug under very limited 

circumstances. Contact your plan for more information. 

Where can I get more information?

To find out more about clinical research studies, you can: 

• Talk to your doctor. 

• Visit ClinicalTrials.gov. This website is run by the 

National Library of Medicine (NLM) at the National 

Institutes of Health (NIH), and it lists government 

and private studies across the country. It also has more 

information to help you understand clinical research 

studies. 

To find out about cancer research studies available 

through the National Cancer Institute: 

• Visit cancer.gov/clinicaltrials. This website lists studies 

for patients with cancer and detailed information about 

cancer clinical research studies. If you don’t have a 

computer, your local library or senior center may be 

able to help you find this information.

• Call 1-800-4-CANCER (1-800-422-6237) for free 

cancer information and help finding cancer clinical 

research studies. TTY users can call 1-800-332-8615.
CMS Product No. 02226

Revised April 2018

You have the right to get Medicare information in an 

accessible format, like large print, Braille, or audio. You also 

have the right to file a complaint if you feel you’ve been 

discriminated against. Visit Medicare.gov/about-us/nondiscrimination/accessibility-nondiscrimination.html, or call 

1-800-MEDICARE (1-800-633-4227) for more information. 

TTY users can call 1-877-486-2048.