Code Verification Request


The PDAC Code Verification Review process provides a mechanism for a product’s manufacturer or designated representative to request a HCPCS code be assigned to a Durable Medical Equipment, Prosthetic, Orthotic or Supply (DMEPOS) product. Review the appropriate DME MACs Local Coverage Determination (LCD) and related Policy Article to determine if a product being submitted qualifies for the code being requested.

The Items that Require Coding Verification Reviews webpage contains a current list of HCPCS codes that require coding verification review, the applicable LCD or Advisory Article for each code, and the code verification requirement effective date. Such information may also be found on each DME Medicare Administrative Contractor Jurisdiction (J) website.

JA: Noridian | JB: CGS, LLC | JC: CGS, LLC | JD: Noridian
 

Request Guidelines and Requirements

A valid request submission must include:

  • New Code Verification Review Application completed by a valid submitter. A valid submitter is defined as product manufacturer/distributor point of contact or designated representative (independent entity the manufacturer has assigned to represent their company)
  • Copy or screen shot of manufacturer’s Food and Drug Administration (FDA) Registration from FDA website and a copy of 510K letter, if applicable
    • All product coding applications to the PDAC require evidence applicable FDA requirements are met. Coding applications missing required FDA information will be rejected as incomplete
  • Only one product per application will be accepted. Exception: Surgical Dressings containing same composition but in multiple sizes. A sample for each size and requested HCPCS code must be submitted for review
  • Sample of product, if required. See Product Sample Requirements
    • Samples must be labeled with Manufacturer, Model Number, and Product Name as listed in Section B of application
    • PDAC may request a sample beyond those required, if necessary for coding verification
    • Product samples will not be returned. If you want your sample back, include a paid return label with it. Samples will be returned after the CMS required retention period
  • Detailed product information. Product information must explain structure and function of item. Examples of detailed product information included (not all inclusive)
    • Marketing Literature
    • Model Number and Product Name
    • Technical Information
    • User Manuals
    • Testing Results
    • Engineering Drawings
  • Variations of a product are considered one product for purposes of coding verification review. Examples of variations (not all inclusive):
    • Individual sizes (excludes surgical dressings)
    • Colors
    • Side specification (i.e. right and left)
    • Wheelchair Options
  • Accessories and supplies associated with a product may be included as part of application for base product

As of October 1, 2013, the PDAC is unable to process any coding applications or DMECS updates without receiving confirmation of the FDA establishment registration and device listing and/or 510k letter. All items must comply with FDA requirements applicable to device category. The FDA provides extensive resources to assist with device classification. See the FDA's How to Study and Market Your Device webpage as a useful starting point for information about FDA device requirements.

Application Deemed Invalid and Rejected

  • Application is not submitted by a valid submitter
  • Required submission material is incomplete
  • Application is illegible
  • Application is to change product coding assigned by CMS HCPCS Workgroup
  • Application is to create or revise DME MAC or CMS coding guidelines
  • Application conflicts with existing DME MAC benefit category and coding instructions
  • Application conflicts with existing CMS benefit category and coding instructions

Application Resubmission

  • If an application has been rejected for any reason, a new application is required
  • Requestor may choose to submit a new application for the same product. It must include the Document Control Number (DCN) from the rejection notification letter. If assistance is required to locate the DCN in question, call the PDAC Contact Center
  • Product Samples will be kept for 60 days on all rejected applications

Application Acknowledgement and Completion Timeframe

  • The PDAC will review submitted documentation and determine the validity of application within 15 days of its receipt
  • An acknowledgement notification will be emailed to submitter. It will indicate application was received, deemed valid and will be processed OR that application was considered invalid and must be resubmitted
  • A PDAC Coding Verification Review will be completed within 90 days of valid application receipt
  • Submitter is notified via email of review results along with decision rationale
  • If review results in an update to DMEPOS Code Product Classification List, PDAC will make necessary updates reflecting coding decisions


Last Updated: 09/21/2021