Does Medicare Cover Experimental and Investigational Procedures?
Medicare typically does not cover experimental and investigational procedures. An exemption for investigational devices, however, allows for coverage under some circumstances. Medicare also covers some of the costs associated with participating in clinical trials.
How Does Original Medicare Define Experimental and Investigational Procedures?
Original Medicare coverage includes treatments, conditions and items that are medically necessary. One of the requirements that Medicare lists for treatment to be reasonably necessary is that it is not experimental or investigational. As a result, those types of treatments and services will not be covered.
The definition of experimental or investigational can also include anything from a new drug or vaccine to a procedure that isn’t FDA-approved.
What Are Investigational Device Exemptions (IDEs) and How Does Medicare Cover Them?
Medicare coverage of investigational devices could be available through an exemption. The exemption details that an IDE clinical study can use an experimental device to determine safety and effectiveness.
Investigational devices fall into two groups: Category A or Category B.
Category A devices are types that are not cleared yet for safety or efficiency. A device would fall into this category and receive IDE approval if it’s studied for a new use, no clinical date is available or not enough data exists to answer safety questions.
Medicare will not cover Category A devices but will cover routine care and services that are part of the study on the device.
Category B devices are proven to be safe to use and effective. Devices fall into this category if clinical data is present to clear any safety concerns like any legally marked device.
Medicare will cover a Category B device, its routine care and any related services.
Clinical trials test new types of care, procedures and treatments to determine effectiveness.
Medicare will cover some of the costs associated with a clinical research study, including tests and office visits. Depending on the circumstances, both Medicare Part A and Part B could cover clinical trials.
You can expect to pay 20 percent of the Medicare-approved amount. If you are using Medicare Part B, there is a deductible that you must meet before coverage can begin.
- Accessing new drugs and treatments
- Having healthcare providers monitor you for side effects
- Receiving specialized care
The risks of taking part in a clinical trial include treatment that is not effective, receiving a placebo and potential side effects.
More coverage could be available through a Medicare Advantage plan provided by a private insurer. These plans include everything covered in Original Medicare as well as additional benefits.
If you have an Advantage plan, check with your plan provider to determine if clinical trials are covered differently.
7 Cited Research Articles
- U.S. Centers for Medicare & Medicaid Services. (2021, March 24). Medicare Coverage Related to Investigation Device Exemption (IDE) Studies. Retrieved from https://www.cms.gov/Medicare/Coverage/IDE
- U.S. Food & Drug Administration. (2019, December 13). Investigational Device Exemption (IDE). Retrieved from https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide
- U.S. Centers for Medicare & Medicaid Services. (2014, November 6). Medicare Coverage of Items and Services in Category A and B Investigational Device Exemption (IDE) Studies. Retrieved from https://www.cms.gov/Medicare/Coverage/IDE/Downloads/MM8921pdf.pdf
- U.S. Centers for Medicare & Medicaid Services. (n.d.). Clinical research studies. Retrieved from https://www.medicare.gov/coverage/clinical-research-studies
- U.S. Centers for Medicare & Medicaid Services. (n.d.). Medical Devices. Retrieved from https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c14.pdf
- U.S. Centers for Medicare & Medicaid Services. (n.d.). Medicare & Clinical Research Studies. Retrieved from https://www.medicare.gov/Pubs/pdf/02226-medicare-and-clinical-research-studies.pdf
- U.S. Food & Drug Administration. (n.d.). FDA/CDRH Webinar. Retrieved from https://www.fda.gov/media/99397/download