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Application for Code Verification Review

Introduction

Welcome to the online Application for Code Verification Review (CVR).

The online form will guide you through the necessary steps to enter all required information and submit a valid Code Verification Review Request for a Durable Medical Equipment, Prosthetic, Orthotic or Supply (DMEPOS) product to the Pricing, Data Analysis and Coding (PDAC) contractor.

Before attempting to complete the application, be sure to read the Application Instructions and all DME MAC policy related material (DME MAC LCD, coding and policy articles, etc.) appropriate to your product.

Upon starting the application, you will want to have ready all required documentation necessary for PDAC to conduct a thorough review of the product. If applicable for the product type being submitted, locate, complete, and have ready the appropriate Section C - Product Specific Form. For Power Mobility Devices, have ready a completed PDAC Test Report for Performance Testing form.

Other commonly submitted documentation include:

  • Detailed and Complete Product Description & Functional Information
  • Product Manuals & Beneficiary Instruction
  • Manufacturing Process Information
  • FDA Establishment Registration & Device Listing screenshots
  • FDA 510K Letter or Exemption Letter
  • Warranty Information
  • Product Specific Test Information
  • Business Relationship Documentation

Note: PDF format is preferred. Individual file size must not exceed 40 MB.

Notice:

To complete this form, you must be authorized to submit proprietary product information on behalf of the manufacturer or distributor. An electronic signature by an authorized official will be required to finalize the application for submission.

Get Started

Fields marked with a red asterisk (*) are required.

Need assistance locating an FDA Establishment Registration Number? Find it Here.


Contact Information

Provide the requested information for the entity below.

Fields marked with a red asterisk (*) are required.

Manufacturer Information

Distributor Information

Consultant

If completed, all correspondence will be sent to the representative below:


Product Information

Fields marked with a red asterisk (*) are required.

Code Review History

Please select all statements that apply to the product being submitted. At least one statement is required. If selecting statement 2, 3, 4, or 5, provide Document Control Numbers (DCNs) from previous application(s).

If selected statements 2, 3, 4, or 5 above provide Document Control Number(s) (DCN) from previous application(s)

Product Description and Details

Provide product information as it should appear on the Product Classification List (PCL). Only one product (including accessories and supplies) should be submitted per application. If the product was previously coded by other insurers or agencies, provide the code(s) assigned.

The company name provided here will be displayed on the product classification list. If the name provided is neither the Manufacturer or Distributor as entered in the Contact Information section of this application, documentation supporting the business association (e.g. Private Label Agreement, etc.) is required before submitting the application. Failure to upload this information may result in rejection of the application.

For additional information reference Product Sample Requirements.

If exempt, enter FDA Exemption Regulation Number.

Note: Must submit a copy of the 510K letter

Provide a detailed and complete description of the product. Include all functional information, beneficiary information, and any manufacturing information that supports the requested code. You may also upload this information.

List all standard component(s) included in the base product (i.e. power cords, batteries, arm rest, etc.), if applicable.

For additional information reference Warranty vs. Minimal Lifetime Requirement.

For durable medical equipment (DME), specify the minimum expected lifetime for the equipment in months and/or years. When available, upload life cycle testing information as supporting documentation. Important: This does not apply to supplies or accessories necessary for the effective use of DME.

Product Model and Requested HCPCS

Detail all product model information and provide rationale for all requested Level II HCPCS codes. If product was previously coded by other insurers include the information within rationale. Up to 50 models may be added per application.


+ Add HCPCS Code

Accessories and Supplies

List any DME accessories or supplies necessary for the function of the product that require individual code review.


+ Add HCPCS Code

Document Upload

Upload copies of all required and supportive documentation. Suitable file types include PDF, Word, Excel and TXT. All images should be embedded in a Word or PDF document with adequate description. The max acceptable size for any single document is 40 MB. Documents larger than 40 MB will fail to upload. To accommodate a large volume of information up to 25 documents may be uploaded.

Fields marked with a red asterisk (*) are required.

Select an appropriate Document Type and choose the applicable file from your machine. Upload additional documents by clicking Add Another Document.

   

eSignature

The electronic signature MUST be certified by an authorized official or contracted representative of the company whose name is associated with the product listed in this application. This person should hold one of the following offices: owner, general partner, chief executive officer, president, chief financial officer, chief operating officer, executive vice-president, or a similar title that clearly shows that the signer holds a position of status and authority within the organization comparable to those offices. In the case of a signature by someone lacking any of the foregoing, the signature MUST be accompanied by a copy of a resolution of the organization's board of directors, certified by the organization's secretary, that the organization has authorized the signer to execute the electronic signature. If the electronic signature is not provided by a signer of status and authority within the organization the application will not be accepted.

Fields marked with a red asterisk (*) are required.

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Review

Please confirm that the information you are about to submit is complete, contains no errors, and that all required documents have been uploaded. Utilize the edit links to re-open any section where corrections need to be made or additional information should be added. Once you are satisfied with the application click submit. Upon submission you will not be able to make any further changes

Introduction Edit

Contact Information Edit

Manufacturer Information

Distributor Information

Consultant Information

Product Information Edit

Code Review History

Product Description and Details

Product Models and HCPCS Codes

Accessory / Supplies Models and HCPCS Codes

Document Upload Edit

eSignature Edit

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Version: 1.0-317-2024-11-08 18:02:14