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to be submitted to the PDAC for the coding verification process .
The labeling requirements are as follows :
1 . Labeling must be permanently affixed and / or printed on the actual product ( please note the exceptions in the listing below identified by an asterisk (*) where product labeling can be on the package in which the product is sold and dispensed );
2 . Labeling must contain the manufacturers name , product name and model number ; and
3 . Labeling must be identical to labeling on the corresponding product dispensed to beneficiaries .
While complete and permanent labeling is advised for all DMEPOS , it is required
for the products listed below . All additional product labeling requirements as described in DME MAC Local Coverage Determinations and / or policy articles must also be met .
1 . Pneumatic compression sleeves / garments ;
2 . Compression stockings ;
3 . Continuous positive airway pressure ( CPAP ) headgear and facemasks *;
4 . Diabetic shoes ( labels should be on both items of the pair );
5 . Diabetic shoe inserts , includes custom fabricated in a central facility ( labels must be on both items of the pair );
6 . All support mattresses ( gel and foam ); 7 . Nebulizer machines ; 8 . Nebulizers ( mouth piece and supplies *);
9 . Orthotics , including prefabricated and custom fabricated by a manufacturer / central fabrication facility and then sent to someone other than the patient ;
10 . Ostomy / urological supplies * ( not accessories );
11 . Prosthetics , including prefabricated components ( e . g ., feet , knees );
12 . Surgical dressings *; and
13 . Wheelchair cushions and backs ( prefabricated ).
HCPCS review is the process that allows manufacturers , distributors and other parties to request a coding decision on a DMEPOS item . A Coding Verification Request form and supporting documentation is submitted to the PDAC staff for review and a decision .
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38 Pedorthic Footcare Association www . pedorthics . org