Tips For Completing Applications
To ensure legibility and accuracy, please complete all fields electronically before printing and signing the application.
Section A – Submitter Identification
If someone other than the person who signs the application in Section E needs to receive all correspondence related to the application, please put this person's name in the top part of Section A.
Section B – Marketing Information
All PDAC coding verification applications must contain either a copy of the FDA 510K Summary Letter or a copy of the Establishment Registration & Device Listing.
For information on obtaining a 510(K) number, please visit the FDA Web site at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
For information on the Establishment Registration & Device Listing, visit the FDA website at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm.
Section B asks for the HCPCS code that best meets the description of the product. This is not required information, but it is helpful to include. The following steps will assist in finding a HCPCS code for the product:
- Search the associated Local Coverage Determination (LCD) on the Centers for Medicare & Medicaid Services (CMS) web site to determine if the product that is being submitted qualifies for that code. Check both the LCD and the related Policy Article. The link to the related Policy Article is found at the bottom of the LCD. The LCDs are published on the CMS web site at http://www.cms.gov/center/coverage.asp. The LCDs can be searched by Contractor, State, or alphabetically.
- Review and select the HCPCS code in the policy that best meets the product description. If a code cannot be found that matches the product(s) being submitted, it is OK to leave this item blank on the HCPCS Coding Verification application.
- Search DMECS to determine if there is an existing code for the product. DMECS is the DME Coding System (DMECS) and is located on the PDAC web site at https://www.dmepdac.com/dmecs/index.html.
NOTE: Only one HCPCS code can be submitted on each HCPCS Coding Verification application, unless the additional HCPCS code(s) are the base code add-ons/accessory code(s).
Section D – Product Listing on DMECS
Please review this section carefully to ensure your product is listed correctly on the Product Classification List (PCL) within the Durable Medical Equipment Coding System (DMECS) after the code is assigned.
This section can be copied multiple times to allow the submission of more than 5 model numbers on one application.
Multiple model numbers can be submitted on the same application only if the request is for the same base HCPCS code and any respective add-on / accessory code(s).
- Product Name
The product name should be listed with the same name that is on your product packaging and/or marketing literature. Do not use abbreviations unless the product is legally represented that way.
- Manufacturer and/or Distributor Name
The legal company name of either the manufacturer or distributor should be listed. Please include all correct punctuation and spacing. If both the manufacturer and distributor names are listed, both companies need to sign Section E.
- Model Number
PDAC uses model numbers to specify each individual item/color, and/or size on the Durable Medical Equipment Coding Systems (DMECS).
- While a product may have many model numbers, the product name should remain consistent throughout Section D. The model number should not be a part of the product name.
- If the model number represents the color and/or size, there is no need to include the color and/or size with the model number.
Product Name: AFO
Model Number: 211-small (the word small is not needed)
Section E – Authorized Official Signature
There must be an original signature on the application. The additional signature is only required if the application is completed by a distributor for a manufacturer’s product, or if there are multiple company names listed in the Manufacturer and/or Distributor name field in Section D.
Information to submit with the application
Please include current and original marketing literature with each application. Copies will not be accepted. If the item product being submitted for coding verification is pre-market, please note the required information in Section B.