Product Sample Requirements
A sample product must be included with the Code Verification Review Application for certain DMEPOS products. For applications submitted on/after July 9, 2018, the product sample requirements are as follows:
- Product samples submitted must be identical to products that are dispensed to Medicare beneficiaries
- Manufacturer name, product name, and model number must be on sample or sealed packaging that the product comes in
- Manufacturer name, product name, and model number on sample must match product name and model number listed in Section B of application and in product literature
Coding verification applications with product samples that do not meet these requirements are considered incomplete and cannot be reviewed by the PDAC. Incomplete applications will not be processed. Manufacturers may resubmit the application with an appropriate sample.
NOTE: Product labeling requirements specified in a DME MAC Local Coverage Determination (LCD) or article, supersede these product sample requirements.
Unless otherwise noted in the Code Verification Review Application, send only one sample.
Product samples are not routinely returned. To request the return of a product sample, include a written request and a paid return label with your application. Samples will be returned after the CMS required retention period expires.
View the below related information on this page.
Required Product Samples
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):
- For HCPCS A5510 and A5512
- One sample pair of therapeutic inserts for diabetics. Each insert must be labeled as specified under product sample requirements
- For HCPCS A5513 and K0903
- One 4” x 4” x ½” sample of base layer material used in custom fabricating process. Base layer must be one solid piece and be labeled with type of material (e.g., 55 Shore A EVA, etc.)
- One sample pair of finished inserts. Each insert must be labeled as specified under product sample requirements
- Enteral Nutrition – Product label with nutrition information and ingredients list
- Nebulizers – E0574 only
- Oral appliances for obstructive sleep apnea
- Orthotics – pre-fabricated (off-the-shelf and custom-fit), and custom fabricated by a manufacturer/central fabrication facility
- LSO and TLSO – samples must be either a size medium or considered universal size.
- Ostomy appliances and barriers
- Pneumatic compression sleeves/garments
- Prosthetics – prefabricated components, e.g. feet, knees
- Support surfaces – excludes HCPCS E0181, E0193, E0194, and E0277
- Surgical dressings – one sample of each size listed on application
- Wheelchair back cushions (prefabricated)
- Wheelchair seat cushions (prefabricated)
Not Required Product Samples
Product samples are not required for the following products.
- Bath and toilet aids
- Commodes and accessories
- CPAP machine – headgear and facemasks
- Custom wheelchair seat and back cushions (prefabricated are required as noted above)
- Enteral nutrition – formula, nutritional supplements and related supply samples
- Exercise equipment
- Glucose monitor, lancets, test strips and control solution
- Hospital beds and accessories
- Infusion pumps
- IV poles
- Nebulizers – mouth pieces and supplies
- Ostomy supplies and accessories
- Patient lifts
- Support Surfaces - Powered pressure-reducing air overlay/mattress – HCPCS E0181, E0193, E0194, and E0277
- Trapeze bar
- Urological supplies and accessories
- Wheelchairs (any type)
Do not send samples of these items unless specifically requested by the PDAC.
Updated September 2018