Does Medicare Cover Clinical Trials?
- Explore the potential costs of participating in clinical trials. Find out what Medicare may cover and what you'll likely need to pay for out of pocket.
Clinical trials are an important stage of research and development for medications and treatments for acute illnesses and chronic conditions. Participating in one lets you potentially benefit from the latest innovations in medicine, but you must ensure you understand the potential risks and costs before you join a study. Medicare may cover certain expenses related to clinical trials, leaving you potentially responsible for the rest.
Does Medicare Cover Clinical Trials?
Original Medicare (Parts A and B) typically pays for clinical trial routine costs only. You may be responsible for all other costs associated with the clinical trial.
What Are Clinical Trial Routine Costs as Defined by Medicare?
Clinical trial routine costs are generally defined as regular care costs that would ordinarily be covered under Medicare Part A and B. Some examples include:
- Room and board for a hospital stay
- Expenses for operations to implant medical devices that are being tested
- Costs of treating any side effects or complications that happen because of the study
What Are Clinical Trials?
Clinical trials or clinical research studies involve using a carefully selected group of people with a new medication, a device or other technology to diagnose or treat an illness or disease. The purpose is to determine if the new treatment or diagnosis tool is safe and effective.
What Are the Benefits of Participating in Clinical Trials?
Some benefits of participating in clinical trials include:
- Accessing cutting-edge treatments that may not become available to the public for years
- Receiving specialty care and close monitoring
- Increasing your own involvement with your care
- Helping others by contributing to scientific research
Are There Any Risks of Participating in Clinical Trials?
Potential downsides of clinical trials include:
- Side effects
- Possibility that the treatment is ineffective
- Placement in a placebo group that does not receive the treatment
- Investment of time and money
Are Clinical Trials Safe?
Before any research project moves to the clinical trial phase, researchers must show that potential benefits of participation outweigh the risks and that the overall likelihood of complications and side effects is low. An Institutional Review Board assesses the information before letting a study proceed. The research protocol is also periodically reviewed after approval to ensure safety. This process helps make clinical trials as safe as possible; however, no one can guarantee that any clinical trial will be free of risks for all participants.
How Do I Sign Up for a Clinical Trial?
To sign up for a clinical trial:
- Visit gov to view a list of government and private studies that are currently accepting participants.
- Read the eligibility criteria for studies to see if you can participate.
- Review the information for any studies you are interested in with your doctor.
- Use the contact information to get in touch with the study's sponsor. Your doctor may offer to do this for you.
- Carefully review the informed consent form, which spells out the details of what's involved.
- Sign the form if you feel comfortable.
An informed consent form isn't a legally binding contract. You have the right to stop participating in a clinical trial at any time for any reason.
What's a Placebo?
Many clinical trials involve giving one group a treatment and the other an inactive substance called a placebo. The group that receives the placebo is called the control group. Researchers compare the health outcomes of the placebo group versus the group that received the active treatment. The expectation is that the control group won't see the same results as their counterparts.
Typically, study participants are assigned to the placebo group at random and not told which group they are in. In double-blind studies, even the researchers don't know which participants are receiving the placebo until the end of the data collection period.
The informed consent form will tell you if placebos are being used in a clinical trial. A placebo won't hurt you, but it won't treat your illness or condition either.
What Are the Potential Costs of Clinical Trials?
Depending on the study, a clinical trial may involve the following costs:
- Doctor visits
- Experimental drug
- Experimental durable medical equipment
- Lab tests
- Hospital stays
- Imaging tests like X-rays and MRIs
- Traditional treatments for an illness or disease
Non-medical costs of participating in research studies include:
- Child care
- Lost time at work
When Does Original Medicare Pay for Clinical Trials?
Medicare Part A typically pays for hospital stays related to clinical trials. Medicare Part B is likely to pay for doctor's visits, lab tests and imaging tests that would routinely be covered as a part of usual care. For these routine expenses, you will usually have to pay for 20% of the cost with Medicare Part B covering the remainder.
Original Medicare usually won't pay for:
- The item or service being researched unless it would usually be covered by Medicare
- Anything that the study provides for free
- Testing used only to gather data for the survey
For example, if you undergo an MRI before a study to assess your current condition, Medicare Part B is likely to cover it, and you would pay 20% of the cost of the test out of pocket. Additional MRIs performed only to track your response to the medication being tested aren't likely to be paid for. Keep in mind that studies often pay many costs that Medicare won't cover.
Do Medicare Advantage Plans Pay for Clinical Trials?
Medicare Advantage plans or Medicare Part C plans must pay for anything that Original Medicare would cover. Your Medicare Advantage plan can't prohibit you from joining a study, but they may require you to notify them in writing or by phone prior to the start of the research.
Do Medigap Plans Pay for Clinical Trials?
Medigap plans help you pay for the portion of your medical expenses that Medicare doesn't cover. When you participate in a clinical trial, your Medigap plan will typically cover all or some of the 20% of costs that you are responsible for under Medicare Part B. Medigap plans usually won't pay for anything that Medicare Parts A and B won't cover.
Do Medicare Drug Plans Pay for Clinical Trials?
Whether your Medicare Part D prescription drug plan will pay for a medication used in a clinical trial depends on their formulary. Often, experimental drugs aren't covered or are classified as Tier 5 drugs that cost more out of pocket. If the study isn't providing the drug for free, contact your insurance provider for information about potential costs.