This post is all about the Medicare billing of oral appliaces and it does not pertain to commercial insurance billing, i.s Blue Criss, United, etc.
The Pricing Data and Anaylis Coding Contractor (PDAC) for CMS has recently gone through a reclassification of all oral appliances which were code verified E0486.
The PDAC function is to code verify each device for manufacturers and providers to ensure that the correct billing code is associated with each product. Manaufacturers are responsible to send through a code verification request for their products. This application contains a product description, intended use, pictures, an FDA 510K number and the recommended HCPCS code.
Since the announcement of the LCD for custom Oral Appliances January 3, 2011 several manufacturers and dental labs have acheived PDAC status for E0486. This would include the following devices: Dorsal, GL Herbst, Klearway, PM Positioner, Respire, SomnoMed, Suad and TAP.
As of Friday, September 28, 2012 the list of PDAC approved appliances for E0486 has been narrowed down to two Herbst devices. These Herbst designs are made by Gergens Ortho Lab and Space Maintainers Laboratory. A third Herbst from Great Lakes Ortho and the remainder of the above devices have been recoded as A9270 (non covered item or service).
The DMERCs added verbiage in a policy update (July 2012) which leads us to believe that they used the Herbst (a dental appliance from 1909) as a predicate device. Since coding is all about description of an item or service, this would not be unlike saying a car is not a car unless it is a Model T.
Moving Forward: many manufacturers will be either appealing this ruling or modifying their device to meet the current description. As of today you cannot bill Medicare under E0486 for any device but the two approved Herbst designs.
Providers are held responsible for what they bill to Medicare. Ask your manufacturer/lab two questions:
1. Do you have a PDAC letter stating that your device is coded verified to E0486?
2. Do you have an FDA 510K clearance letter for your particular device with your company name on it?
Please note that many of the Herbst designs do not of regulatory approval. This device has been around so long that anyone can make it. The dental community does not pay as close attention to the FDA requirements as the medical community and you should make sure that your code verified product has it’s own 510K number.