Reader Questions:
Tread Carefully With Non-FDA-Approved Devices
Published on Sun Apr 27, 2008
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Question:
I have a question regarding investigative studies: If a physician's office is using a device that has not been FDA-approved but performs an approved therapy (that is, the CPT codes are valid), can the center charge for the services when performed by a rehab professional, and can the practice bill Medicare for it?
Florida Subscriber
Answer:
You could always check with other insurance payers, but you cannot charge Medicare for this, regardless of who's doing the service and whether you're using a valid CPT code. Why: The CMS manual states that devices not approved by the FDA used in the treatment of patients should not be billed to the Medicare program.