Does Medicare Cover Clinical Trials?
Medicare pays for routine costs in certain qualifying clinical research studies. However, a clinical trial may include services Medicare doesn’t cover, such as a new drug or additional tests conducted solely for data collecting purposes.
What Is a Clinical Research Study?
A clinical research study, also known as a clinical trial, helps doctors find better ways to treat and prevent certain diseases, such as cancer.
The goal of clinical trials is to evaluate if a new test or treatment works and is safe.
Clinical trials also help medical professionals learn how to prevent disease, treat symptoms and minimize side effects.
People participate in clinical trials for various reasons.
Patients with a serious illness or disease may join a research study to potentially receive the latest available treatment, as well as personalized care from the research staff.
Before you join a clinical trial, a doctor, nurse or other professional on the research team will explain the study’s purpose and what to expect during the trial.
You will be given a consent form to read. Make sure to ask questions about any aspect of the clinical trial or consent form that you don’t understand.
Even if you decide to participate in a clinical trial and sign the consent form, you can always change your mind and stop participating.
Medicare Coverage of Clinical Trials
Original Medicare (Part A and Part B) pays for routine costs in certain qualifying clinical research studies.
- Drugs, procedures and hospital stays that Medicare would cover even if you weren’t participating in a clinical trial
- 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
Sometimes a clinical research study includes services Medicare doesn’t cover. For example, Medicare will not cover research-related costs.
Medicare will not cover the new item or service being tested unless it’s normally covered by Medicare outside of clinical trials.
For example, Medicare would pay for chemotherapy-related medical care — but not the new chemotherapy drug itself.
However, according to the Medicare & Clinical Research Studies booklet, the new treatment being tested is often provided for free by the study sponsor.
Finally, Medicare will not cover additional tests and services conducted only for data collecting purposes.
For example, if Medicare usually only covers a yearly EKG test but the clinical trial conducts monthly EKGs, Medicare will not pay for these extra tests.
If you’re in a Medicare Advantage plan, you can get the same coverage for clinical research studies as someone in Original Medicare.
If you’re worried about paying for services not covered by Medicare, talk to the clinical trial research staff and see if they can help.
Which Clinical Trials Will Medicare Cover and How Do I Find One?
Your routine care costs are generally covered by Medicare if the clinical trial is funded at least in part by the federal government.
- Trials are funded by the Agency for Healthcare Research and Quality, National Institutes of Health, Centers for Disease Control and Prevention, Centers for Medicare & Medicaid Services, the Department of Defense or the Department of Veterans Affairs.
- Trials are supported by centers or cooperative groups that are funded by any of the organizations listed above.
- Trials are conducted under an investigational new drug application reviewed by the Food and Drug Administration.
You can visit ClinicalTrials.gov to see a list of government and private studies across the country. The website provides details about a trial’s purpose, who can participate, locations and contact information.
You can also join the National Registry of Research Volunteers at ResearchMatch.org.
This initiative is funded by the National Institutes of Health to connect people who are searching for research studies with researchers looking for people to participate in their studies.
It is a free, secure registry.
11 Cited Research Articles
- National Institutes of Health. (2019, November 6). Finding a Clinical Trial. Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/finding-clinical-trial
- Centers for Medicare & Medicaid Services. (2019, September). Medicare & Clinical Research Studies. Retrieved from https://www.medicare.gov/Pubs/pdf/02226-medicare-and-clinical-research-studies.pdf
- National Institutes of Health. (2019, May 30). Why Should I Participate in a Clinical Trial? Retrieved from https://www.nih.gov/health-information/nih-clinical-research-trials-you/why-should-i-participate-clinical-trial
- Goldfarb, N. (2018, November 8). It’s About Time That Medicare Advantage Stops Being A Disadvantage For Clinical Research Participants. Retrieved from https://www.clinicalresearchnewsonline.com/news/2018/11/07/it-s-about-time-that-medicare-advantage-stops-being-a-disadvantage-for-clinical-research-participants
- Cancer.net Editorial Board. (2018, October). Health Insurance Coverage of Clinical Trials. Retrieved from https://www.cancer.net/research-and-advocacy/clinical-trials/health-insurance-coverage-clinical-trials
- Alliance for Clinical Trials in Oncology. (n.d.). Medicare Coverage of Clinical Trials. Retrieved from https://www.allianceforclinicaltrialsinoncology.org/main/cmsfile?cmsPath=/Public/Annual%20Meeting/files/Medicare%20Coverage%20for%20Clinical%20Trials.pdf
- American Cancer Society. (n.d.). Clinical Trials: What You Need to Know. Retrieved from https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/what-you-need-to-know.html
- Centers for Medicare & Medicaid Services. (n.d.). Medicare Coverage - Clinical Trials: Final National Coverage Decision. Retrieved from https://www.cms.gov/medicare/coverage/clinicaltrialpolicies/downloads/finalnationalcoverage.pdf
- Centers for Medicare & Medicaid Services. (n.d.). Medicare Clinical Trial Policies. Retrieved from https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies
- Medicare.gov. (n.d.). Clinical research studies. Retrieved from https://www.medicare.gov/coverage/clinical-research-studies
- Public Health Service National Institutes of Health. (n.d.). If You Have Cancer and Have Medicare You Should Know About Clinical Trials. Retrieved from https://www.nh.gov/insurance/consumers/documents/cancer_med.pdf