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CENTERS FOR MEDICARE & MEDICAID SERVICES

Medicare and Clinical

Research Studies
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You have the choice to join a clinical research study

to diagnose and 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 do any of the following:

• 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 the following:

• Your health care will be provided by top doctors.

• You will 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.

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Should I join a clinical research study?

(continued)

• You may be among the first to benefit if the

approach being studied is found to be helpful.

• You will have the chance to make an important

contribution to research that may help other

people who have the same illness.

Risks may include the following:

• New drugs and treatments may have side

effects or risks that your doctors may not

know about.

• New drugs and treatments may not be 

effective, or may be less effective, than current

approaches.

• Even if a new approach has benefits, it may not

work for you.

Before you agree to take part in a study, someone

involved in the study will explain it to you. Then

you will be asked to sign an informed consent

form. This form describes the clinical research

study and what’s being tested. It will also explain

any possible risks. 

Before you sign the form, ask questions so you

understand and are comfortable with what will

happen during the study. You should feel free to

ask any questions or bring up any issues you have

about the study at any time.

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What is a placebo, and will I be

given 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 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 will

be told if you might be given a placebo before you

decide whether to take part in the study.

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 the following:

• 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 following:

• The new item or service that the study is testing

(except for certain medical devices) 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 given only to collect data and not

used in your direct health care (such as monthly

CT scans for a condition that usually requires only

an annual scan)

• 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

and explain what you will have to pay for 

copayments, coinsurance, and deductibles. 
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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 following: 

• 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 pays first, visit

www.medicare.gov/Publications/Pubs/pdf/02179.pdf

to view the publication “Medicare and Other Health

Benefits: Your Guide to Who Pays First.” You can also

call 1-800-MEDICARE (1-800-633-4227). TTY users

should call 1-877-486-2048.

Will my Medigap (Medicare

Supplement Insurance) 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. You should contact the 

insurance company that provides your Medigap

policy for more information. 
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I'm in a Medicare drug plan (Part D).

If I join a clinical research study that

tests a prescription drug, will my

plan cover the cost of the drug? 

Medicare Part B (Medical Insurance) covers a limited

number of drugs such as injections you get in a 

doctor’s office, certain oral cancer drugs, drugs used

with some types of durable medical equipment (like a

nebulizer or infusion pump), and under very limited

circumstances, certain drugs you get in a hospital

outpatient setting. If the drug isn’t covered by

Medicare Part B, your Medicare drug plan may cover

it. If the drug isn’t on your plan's formulary, you can

ask your plan for an exception to cover it. However,

in most cases, your plan can only cover drugs that

have already been approved by the Food and Drug

Administration (FDA). Call your plan for more

information.

Where can I get more information?

Here’s how to find out more about clinical

research studies:

• Talk to your doctor. 

• Visit www.clinicaltrials.gov. This Web site is a 

service of 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. If you don’t have a computer,

your local library or senior center may be able to

help you find this information.
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Where can I get more information?

(continued)

To find out about cancer research studies, use the 

following resources through the National Cancer

Institute:

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

free cancer information and help finding cancer

clinical research studies. TTY users should call 

1-800-332-8615. 

• Visit www.cancer.gov/clinicaltrials. This Web site

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. 

CMS Product No. 02226

Revised March 2010