Does Medicare Cover Experimental Procedures?

In this article...
  • New drugs and medical devices can offer options to people with medical challenges. Find out when Medicare may cover experimental procedures and treatments.

If you're a Medicare beneficiary seeking treatment for a serious condition, you may be wondering whether Medicare covers experimental procedures. Medicare doesn't consider most experimental treatments to be medically necessary and, therefore, won't provide coverage. However, Medicare may provide some coverage for costs of care associated with official medical research. 

Does Medicare Cover Experimental Procedures? 

Medicare plans only cover medically necessary treatments. These plans generally exclude experimental treatments from the definition of medically necessary. 

Therefore, beneficiaries can't get coverage for experimental medications, vaccines and medical procedures. In most cases, if the FDA hasn't approved a treatment, Medicare won't cover it. However, there are some exceptions, and Medicare beneficiaries may be able to get coverage for some costs associated with investigational devices and clinical research. 

Medicare Investigational Device Exemptions 

Medicare does offer coverage for routine costs and care for beneficiaries participating in Investigational Device Exemption (IDE) studies. IDE clinical studies determine whether a new medical device is safe and effective. Available coverage depends on the category of device. 

Category A Devices

Falling into Category A means that a device hasn't been proven safe or effective yet. The device may be new, or it may be a device that is being used for a new purpose. Medicare will not cover the cost of the device but will cover routine care that is part of the study.

Category B Devices 

Category B devices may not have full FDA approval but are known to be safe and effective. Examples of Category B devices include:

  • A device that is only slightly different from a previous version or use
  • A similar device made by another manufacturer was already approved 

Medicare covers Category B devices and associated care. 

Medicare Covers Some Clinical Trial Expenses 

Medicare does cover some routine care costs associated with clinical trials. There may be coverage under Medicare Parts A and B. Medicare beneficiaries can often get coverage for hospital stays, operations and treatments for complications. However, studies may include services or treatments that Medicare won't cover. Medicare drug plans don't always cover the cost of experimental drugs, even when they're part of a clinical trial. 

Joining a clinical trial can offer many benefits, including access to treatments that wouldn't otherwise be available. Since at least some clinical trial costs are covered, they can be a more affordable way to get new treatments. However, participants may face out-of-pocket costs and risk being in the placebo group that doesn't receive the experimental treatment. 

Who Pays for Experimental Treatment? 

There are several potential sources of funding for experimental procedures and treatments: 

  • Medicare or private insurance 
  • Charitable organizations 
  • Research organizations or trial sponsor
  • The person receiving the treatment 

Medicare, insurance and research groups may cover some costs associated with experimental treatments that are part of studies. For example, if you're part of a drug study, Medicare may cover routine appointments to monitor your condition or treat side effects. Although Medicare may not cover the drug itself, the trial sponsor or drug company usually offers the drug to study participants for free. 

If you're seeking a treatment that hasn't been approved by the FDA but isn't part of a research study, you may have to cover the costs. For example, while many people believe stem cell injections may be effective for many conditions, the FDA has approved them for use in limited circumstances. If you want to have stem cell treatment for a non-approved purpose, like arthritis, you may have to pay out of pocket or seek funding from a third party. 

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