More Choices in Cancer Care: 

Information for Beneficiaries on Medicare Coverage of Cancer Clinical Trials

Key Points 

• A clinical trial is a research study conducted with people (see Question 1). 

• Clinical trials are conducted with patients to find out whether promising 

treatments are safe and more effective than those already available 

(see Question 2). 

• Any cancer care normally covered by Medicare is also covered when it is 

part of a clinical trial (see Question 6). 

Medicare1 now offers beneficiaries more choices in their cancer care by reimbursing 

patient care costs in clinical trials. Although beneficiaries have Medicare coverage for standard 

cancer care, they now also have coverage for participating in clinical trials for the diagnosis and 

treatment of cancer. 

1. What is a clinical trial? 

A clinical trial is a research study conducted with people. Treatment trials answer 

specific questions about new ways to improve medical care. The result of such research 

is that many people with cancer are surviving and living longer, more comfortable lives. 

 

1

 Medicare is a Federal health insurance program administered by the Centers for Medicare & Medicaid Services 

(CMS). Eligible individuals include those who are age 65 and older, people of any age with permanent kidney 

failure, and some disabled people under age 65. 

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2. Why are clinical trials conducted? 

Clinical trials are conducted with patients to find out whether promising treatments are 

safe and more effective than those already available. Cancer clinical trials help doctors 

and researchers find better ways to prevent, diagnose, and treat cancer. 

3. Why do people consider participating in a clinical trial? 

Reasons to consider a cancer clinical trial include the following: 

• To be among the first to benefit from new treatments 

• To gain access to promising, new treatments that are not widely available 

• To obtain high-quality care from doctors who are cancer specialists 

• To help future patients with the same type of cancer 

4. Why don’t people participate in clinical trials? 

• New drugs or procedures may have unknown side effects or risks. 

• Even if a new cancer treatment looks promising, it may be less effective than standard 

care. 

• The trial may require more visits to the doctor than standard care. 

• People may not be aware that Medicare provides coverage for clinical trials. 

• Patients or their doctors may not be aware that a cancer trial might be a treatment 

option for their type of cancer. 

5. Should I take part in a clinical trial?

Only you can make this decision after your doctor has given you all of the facts. An 

informed consent process is required, which can provide you with information to help 

you make educated decisions about whether or not to begin or continue participating in a 

trial. 

Medicare Coverage of Clinical Trials

6. If I am in a clinical trial, what will Medicare pay? 

Any cancer care normally covered by Medicare is also covered when it is part of a 

clinical trial. This care may include the following: 

• Routine tests, procedures, and doctor visits 

• Services or items usually associated with the experimental treatment, such as costs to 

 administer investigational drugs 

• Health care associated with being in a clinical trial, such as a test or hospitalization 

 due to an unanticipated side effect 

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7. What costs are not covered? 

• Investigational drugs, items, or services being tested in a trial 

• Items or services used solely for the data collection needs of the trial 

• Anything being provided free by the sponsor of the trial 

• Any coinsurance and deductibles 

8. What kinds of clinical trials are covered? 

Cancer clinical trials are covered if: 

• They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer 

Centers, NCI-Sponsored Clinical Trials Cooperative Groups, or another Federal 

agency that funds cancer research. 

• They are designed to treat or diagnose cancer. 

• The purpose or subject of the trial is within a Medicare benefit category. For 

 example, cancer diagnosis and treatment are Medicare benefits, so these trials are 

 covered. Cancer prevention trials are not currently covered. 

If your trial is not described above, or if you are not sure whether your trial meets all of 

the requirements, discuss these concerns with your doctor or call the Medicare 

information number. Other trials may be covered, so ask about these trials before you 

begin participating in a clinical trial that is not covered. 

How To Learn More

9. How can I learn more about cancer clinical trials?

Discuss this option with your doctor and refer to these resources from the NCI: 

Over the Internet: 

• NCI’s Web site (http://www.cancer.gov) provides information on most types of 

cancer. The Web site’s content is reviewed and updated by expert cancer specialists. 

• The clinical trials page of the NCI’s Web site 

(http://www.cancer.gov/clinicaltrials) lists trials for patients with cancer and includes 

in-depth information about cancer clinical trials. 

• If you do not have access to a personal computer, your local library or senior center 

 may be able to help you find this information. 

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Over the phone: 

• Call the NCI’s toll-free Cancer Information Service at 1–800–4–CANCER 

(1–800–422–6237) for cancer information and help locating cancer clinical trials. If 

you are deaf or hard of hearing, call the TTY number toll-free at 1–800–332–8615.

10. How can I learn more about what Medicare covers? 

Over the Internet: 

• The Medicare and Clinical Research Studies publication 

(http://www.medicare.gov/Publications/Pubs/pdf/02226.pdf) has answers to 

frequently asked questions. 

• The official U.S. Government Web site for Medicare (http://www.medicare.gov) 

 contains enrollment and general information. 

Over the phone: 

• 1–800–MEDICARE (1–800–633–4227), Medicare’s toll-free number for 

beneficiaries, offers information about benefits. If you are hearing or speech 

impaired, call the TTY/TDD line toll-free at 1–877–486–2048. 

# # # 

Related NCI materials and Web pages: 

• National Cancer Institute Fact Sheet 2.11, Clinical Trials: Questions and Answers

(http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials) 

• If You Have Cancer and Have Medicare...You Should Know About Clinical Trials

(http://www.cancer.gov/clinicaltrials/resources/medicare-and-cancer-trials)

• Taking Part in Cancer Treatment Research Studies

(http://www.cancer.gov/clinicaltrials/Taking-Part-in-Cancer-Treatment-ResearchStudies)

For more help, contact: 

NCI’s Cancer Information Service 

Telephone (toll-free): 1–800–4–CANCER (1–800–422–6237) 

TTY (toll-free): 1–800–332–8615

LiveHelp® online chat: https://cissecure.nci.nih.gov/livehelp/welcome.asp

This fact sheet was reviewed on 2/15/06 

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