PDAC - 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
Medium, regular or universal sized models should be submitted, when applicable

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 Samples Required for Formal Code Verification.