FDA approval and mechanical traction


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Is FDA approval required for mechanical traction devices in order to bill 97012?
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Individual Payer Issue...

I think the coverage of that code is going to be based on your individual 3rd party payer policies. If you cannot find anything in your coding manual or with an organization like the AMA I would check your individual payer policies. I did a quick google search and found a few sample policies that address 97012, I have quoted them below...

Optum Policy "Nonsurgical spinal decompression therapy refers to the use of a device granted FDA 510(k) approval as “equipment, powered traction” to administer a treatment protocol that is centered around a form of
intermittent mechanical traction, which consists of a specialized table and computer designed to apply
variable force, variable traction/relaxation times, and variable angles of pull (in some devices), to produce
distractive tension along the axis of the spine.[2,3]"

AmeriHealth Policy "Although the FDA has approved several devices that are used for non-surgical spinal decompression therapy, the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature. Therefore, non-surgical spinal decompression therapy is considered experimental/investigational by the Company and is not covered."