Product Sample Requirements
To prevent a delay in processing a coding verification application, a sample product must be submitted for certain DMEPOS products. Sample products submitted as part of this process should be identical to and exact examples of the product(s) that are dispensed to Medicare beneficiaries. For coding verification applications submitted on or after June 18, 2012, the product sample requirements are as follows:
Samples are REQUIRED for the following products:
- Compression stockings
- Diabetic shoes: Pair of shoes
- Diabetic shoe inserts (Includes custom fabricated by a central fabrication facility): Pair of inserts; each insert must be labeled as specified under Product Sample Provisions
- Support Surfaces – Gel and Foam (Excludes E0277)
- Nebulizer Machines – E0574 only
- Oral appliances for Obstructive Sleep Apnea
- Orthotics – Pre-fabricated (OTS and Custom-Fit), and custom fabricated by a manufacturer/central fabrication facility
- Ostomy appliances and barriers
- Pneumatic compression sleeves/garments
- Prosthetics – Prefabricated components, e.g. feet, knees
- Surgical Dressings
- Wheelchair Cushions and Backs (prefabricated)
NOTE: The above list is subject to change and may not be all-inclusive. If a product is not listed, please review the Coding Verification Application for instructions or call the PDAC Contact Center at (877) 735-1326, or email us using the PDAC Email Contact form located at www.dmepdac.com. The PDAC Contact Center hours of operation are Monday through Friday from 8:30 a.m. to 4:00 p.m. CT.
Please send only one sample unless otherwise noted in the Coding Verification Application.
Samples will not be returned.
Product Sample Provisions
Product samples submitted with coding verification applications should be identical to and exact examples of the products that are dispensed to Medicare beneficiaries.
Product samples must be identifiable as corresponding to the manufacturer, product name and model number information included on the coding verification application.
- The manufacturer name, product name and model number must be on the sample or the sealed packaging that the product comes in.
- The manufacturer name product name and model number on the sample must match how the product name and model number is listed on the coding verification application and the product literature.
Coding verification applications with product samples that do not meet these requirements cannot be reviewed by the PDAC.
NOTE: Product labeling requirements as outlined per policy (e.g. Wheelchair Cushions) supersede the PDAC product sample requirements.
Product samples are NOT REQUIRED for the following products. Please DO NOT send samples.
- Bath and Toilet Aids
- Catheters, Drainage Bags and Accessories
- Commodes and Accessories
- CPAP Machine – Headgear and Facemasks
- Custom Wheelchair Cushions and Backs (Prefabricated ARE Required as noted above)
- Enteral Nutrition – Nutritional Supplements – no formula, no supplies are needed
- Exercise Equipment
- Glucose Monitor, Lancets, Test Strips and Control Solution
- Hospital Beds and Accessories
- Infusion Pumps
- IV Poles
- Nebulizers-Mouth Pieces and Supplies
- Ostomy/Urological Accessories/Supplies
- Patient Lifts
- Powered Pressure-Reducing Air Mattress – E0277
- Trapeze Bar
- Wheelchairs (Any Type)
Updated February 2015