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.

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
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.

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.

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.

# # #

• National Cancer Institute Fact Sheet 2.11, Clinical Trials: Questions and Answers ¹
  (http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials)
• If You Have Cancer and Have Medicare...You Should Know About Clinical Trials ²
  (http://www.cancer.gov/clinicaltrials/resources/medicare-and-cancer-trials)
• Taking Part in Cancer Treatment Research Studies ³
  (http://www.cancer.gov/clinicaltrials/Taking-Part-in-Cancer-Treatment-Research-Studies)

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

Glossary Terms

A term for diseases in which abnormal cells divide without control. Cancer cells can invade nearby tissues and can spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

The Cancer Information Service is the National Cancer Institute's link to the public, interpreting and explaining research findings in a clear and understandable manner, and providing personalized responses to specific questions about cancer. Access the CIS by calling 1-800-4-CANCER (1-800-422-6237), or by using the LiveHelp instant-messaging service at https://cissecure.nci.nih.gov/livehelp/welcome.asp. Also called CIS.

A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.

The process of identifying a disease, such as cancer, from its signs and symptoms.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered experimental in other diseases or conditions. Also called investigational.

A process in which a person is given important facts about a medical procedure or treatment, a clinical trial, or genetic testing before deciding whether or not to participate. It also includes informing the patient when there is new information that may affect his or her decision to continue. Informed consent includes information about the possible risks, benefits, and limits of the procedure, treatment, trial, or genetic testing.

In clinical trials, refers to a drug (including a new drug, dose, combination, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the U.S. Food and Drug Administration (FDA) to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but be considered investigational in other diseases or conditions. Also called experimental.

The National Cancer Institute, part of the National Institutes of Health of the United States Department of Health and Human Services, is the Federal Government's principal agency for cancer research. The National Cancer Institute conducts, coordinates, and funds cancer research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer. Access the National Cancer Institute Web site at http://www.cancer.gov. Also called NCI.

In medicine, action taken to decrease the chance of getting a disease or condition. For example, cancer prevention includes avoiding risk factors (such as smoking, obesity, lack of exercise, and radiation exposure) and increasing protective factors (such as getting regular physical activity, staying at a healthy weight, and having a healthy diet).

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.