The Medicare Pricing, Data Analysis, and Coding contractor (PDAC) has announced that effective February 1, 2012, any product that is subject to a PDAC coding review and identification by the Centers for Medicare & Medicaid Services (CMS) and its contractors, including the PDAC, Durable Medical Equipment Medicare Administrative Contractors (DME MACs), DME Program SafeGuard Contractors, and Zone Program Integrity Contractors (ZPICs), must be permanently labeled. According to the PDAC, the label must contain the manufacturer’s name, product name, and model number. The label on any product delivered to the beneficiary must be identical to the label on the product submitted for coding verification and must be permanent in nature.
While the PDAC advises complete and permanent labeling for all durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), the O&P-specific products that must be labeled at this time include:
- Pneumatic compression sleeves/garments.
- Compression stockings.
- Diabetic shoes: Labels should be on both items of the pair.
- Diabetic shoe inserts: Includes custom fabricated in a central facility. Labels must be on both items of the pair.
- Orthotics: Prefabricated and custom fabricated by a manufacturer/central fabrication facility and then sent to someone other than the patient.
- Prosthetics: Prefabricated components (e.g. feet, knees).
All additional product labeling requirements as described in DME MAC Local Coverage Determinations (LCDs) and/or policy articles must also be met.
PDAC also advises that the list is subject to change.
