Despite the importance of medical research for improving the health of seniors, very few seniors take part because they are concerned that they may lose their Medicare coverage if they do. However, new Medicare rules approved in 2000 makes it easier for Medicare beneficiaries to participate in medical research.

Before you agree to participate in a research study, you should talk with the researchers to clarify what costs the study sponsor will cover, which will be covered by Medicare, and which, if any, are not covered. Here are some of the questions you should be asking:

What costs does Medicare pay if I'm in a research study?

Medicare pays for routine costs. These include costs for items and services that:

  • Medicare would pay, even if you weren't in a trial, like room and board for a hospital stay
  • You need to get the new care, like an operation to implant a device that is being studied
  • You need to treat any side effects or complications of the new treatment or device.

Will my supplemental (Medigap) plan pay for my coinsurance and deductibles if I am in a research study?

If the routing costs of your study are covered by Medicare, then your Medigap policy must pay coinsurance amounts for those costs. If your Medigap policy also covers deductibles and excess charges, it must also pay these amounts for routine services.

Will my employer group plan cover the routine costs in a research study?

Whether your employer plan covers all or some of the costs routine services depends on:

  • The terms of the employer plan, and
  • Whether or not the employer plan or Medicare pays your bills first (in other words, is the primary payer). Before you join a trial, check with you employer group plan or the benefits manager of the employer to find out what benefits are covered. You can also call 1-800-MEDICARE (1-800-633-4227) for more information.

I am in a Medicare + Choice Plan. Can I still be in a clinical trial?

Yes, if you are in a Medicare + Choice Plan, you will get the same coverage for research studies as a person in the original Medicare plan. This means that your Medicare managed care plan cannot keep you from joining a research study. However, he should tell your plan before you start a study. That way, the plan can still keep track of your health care services. In addition, because you have the same coverage as a person in the original Medicare, you will have to pay the original Medicare plan coinsurance for the research study services. However, you will not be responsible for the Part A or Part B deductible.

Are there any costs that Medicare won't pay?

Yes, Medicare will not pay for:

  • In most cases, the new treatment or device that the study is testing
  • Devices or treatments provided only to collect data, and not used in your direct health care (such as monthly CT scans for a condition that usually requires only one scan)
  • Devices and treatments that the study gives you or any other volunteer for no charge
  • Coinsurance and deductibles. Check with the study sponsor to make sure that the study will cover these costs.

I'm a research study now. Are the routine costs of my study covered by Medicare?

Check with the doctor or the steady coordinator to see if the study meets the following requirements for Medicare coverage.

The routine costs of services given on or after September 19, 2000 are covered by Medicare if the trial is:

  • Funded by, or the center conducting the study is funded by:
    • National Institutes of Health (NIH),
    • Centers for Disease Control and Prevention (CDC),
    • Agency for Healthcare Research and Quality (AHRQ),
    • Centers For Medicare and Medicaid Services (CMS),
    • Department of Defense (DoD), or
    • Department of Veterans Affairs (VA),

AND

  • The study should also be under an "investigational new drug" application (IND) reviewed by the FDA, or is exempt from having an IND.

AND

  • The trial studies a device or treatment that falls within a Medicare benefit category. The device or treatment must not be statutorily excluded from coverage. For example, studies of most prevention activities are excluded.

AND

  • The trial is designed to treat or diagnose a disease. Also, you must be diagnosed with the disease the study is about, unless your part of the control (healthy subjects) group in a diagnostic trial.

Other studies can ask Medicare to pay their Medicare patients' costs. If your study isn't described above, or if you're not sure whether your study meets all the requirements, ask your doctor or the study coordinator if Medicare covers its routine costs.

For more information about Medicare and research studies, please click here, to visit the Medicare website or call 1-800-MEDICARE (1-800-633-4227) for more information.