PDAC Process to re-classify orthotic products as Off-The-Shelf

Noridian Healthcare Services reports that effective January 1, 2014, the Centers for Medicare & Medicaid Services (CMS) established 23 new HCPCS codes to describe Pre-Fabricated Off-The-Shelf (OTS) orthoses and revised the HCPCS code description for 29 existing codes describing Pre-Fabricated Custom-Fitted orthoses. These changes were outlined in the Advisory Article titled HCPCS Code Update (2014) which was posted to the PDAC website on January 3, 2014. The link is provided here for your convenience: www.dmepdac.com/resources/articles/2014/01_03_14.html

Products that are currently listed on the Durable Medical Equipment Coding System (DMECS) with any of the 29 HCPCS codes that were revised, can no longer be considered fully “code verified” by the PDAC under the new definitions. While the product(s) fits the general category of its currently designated HCPCS code, the PDAC needs to further differentiate if products are only OTS, only custom-fitted, or possibly both.

PDAC is undertaking the task of reviewing all products currently on DMECS affected by these coding changes to ensure DMECS is updated with the correct coding assignments. We are currently in the process of contacting the manufacturers of products listed on DMECS and asking them to identify which product(s) they consider as being only OTS. As we receive these responses, we will update DMECS. A coding verification application will not be required to re-classify an existing product listed on DMECS to the appropriate OTS HCPCS code.

Off-the-Shelf orthotics under Medicare are statutorily defined by law in Title 18 of the Social Security Act [section 1847(a)(2)(C)], and also in Federal Regulations at 42 CFR §414.402 asorthotics described in section 1861(s)(9) of the Act that require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling or customizing to fit a beneficiary.

Minimal Self-Adjustment is defined at 42 CFR §414.402 Subpart F: Minimal self-adjustment means an adjustment that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform and does not require the services of a certified orthotist (that is, an individual certified by either the American Board for Certification in Orthotics and Prosthetics, Inc., or the Board for Orthotist/Prosthetist Certification) or an individual who has specialized training.

Due to the high volume of products currently listed on DMECS with these revised codes, we are contacting manufacturers in segments. If you haven’t received a notice from the PDAC yet, it will be forthcoming over the next several months. If you have products currently listed on DMECS that you consider only OTS under the new codes, PDAC is requesting that you please wait to be contacted by us before taking any action or submitting a coding verification application. As noted above, submission of a coding verification application to the PDAC is not necessary for products currently listed on DMECS to be classified as OTS.

For further questions about this process, please contact the PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or email the PDAC by completing the DME PDAC Contact Form located on the PDAC website: www.dmepdac.com/


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