Code Verification Request Application Instructions

     If applicable*

For a product previously submitted for review in which application was rejected

Check box for a product previously submitted for review in which application was rejected

NOTE: If product sample was submitted with a previously submitted application for review and application was rejected, an Xref Number must be submitted
PDAC will keep product samples for 30 days after rejection notice date

     If applicable*

Check box for a previously reviewed product that has been modified since initial review

Provide original Xref Number from previous application and product listing on DMECS (Manufacturer name, product name and model number)

     If applicable*

Check box for a product previously reviewed by PDAC in which 45-day timeframe for submitting a reconsideration has lapsed.

Provide original Xref Number from previous application and product listing on DMECS (Manufacturer name, product name and model number)

     If applicable*

Enter Manufacturer name. Name will be posted on Product Classification List (PCL) on Durable Medical Equipment (DME) Coding System (DMECS)

     YES

Enter manufacturer contact person name. PDAC will contact this person, if needed. This contact will be emailed all correspondence.

     YES

Enter manufacturer point of contact email address

Enter manufacturer point of contact valid telephone number

Enter manufacturer mailing address (address, city, state, and zip code)

Enter manufacturer website address

Enter designated representative name, if different from manufacturer point of contact

Example: A consultant submitting on behalf of manufacturer. If filled in, all correspondence will be sent to designated representative rather than manufacturer point of contact

Enter designated representative email address

Enter designated representative telephone number

Enter name of product submitted for coding. This is name that will be listed on DMECS

NOTE: Verify accuracy of product name as it will be listed on DMECS

To ensure accuracy when product is listed any errors in submitted name will require a DMECS Update

Enter model number of product submitted for coding. This is model number that will be listed on DMECS. Enter ‘None’ if there is no model number

For example, if multiple model/part numbers, provide a base model number to be listed on DMECS. Place holders can be used for size, color, etc. options

Example of a base model number: SAMPLEXX-TESTYY

NOTE: Verify accuracy of product name as it will be listed on DMECS

To ensure accuracy when product is listed any errors in submitted name will require a DMECS Update

Often manufacturers request clarifying comments be posted to DMECS to clarify model number format and differences between model numbers. Indicate if your product needs a Comment for Model Number loaded to DMECS

Enter comment to be posted on DMECS providing product number explanation for product submitted

Example of comment: XX AND YY WITHIN THE MODEL NUMBER ARE PLACEHOLDERS FOR HEIGHT (XX) AND WIDTH (YY)

Check appropriate box yes/no if product is currently pre-market and is not available for sale

Check appropriate box yes/no if product is for home use

Per Social Security Act Title XVIII Section 1861(n), all products must be able to be used in home to qualify for payment by Medicare

Enter a detailed and complete description of product including all functional and manufacturing information that supports requested code(s)

NOTE: Referring to a manual, guide or attached documents without providing a written narrative on application will not be accepted for a detailed and complete description of product

If product submitted is considered a base code and includes additional components, list all items included with base product when provided to beneficiary

*Required if submitting an application for DME Supplies and Manual Wheelchairs

List HCPCS code(s) for product(s) submitted for review and provide a justification for each requested HCPCS code

If unsure what HCPCS code(s) to request, enter ‘UNSURE’ in HCPCS Code Field and leave justification blank. If additional room is needed attach documentation and indicate in box

Enter product(s) has been coded by another payer, provide code assigned

Enter most current year of registration for product from FDA correspondence. It must be current year of submission of Code Verification Review Application

*Not required for enteral nutrition formula

Enter Establishment Registration Number for product

A copy of email or letter confirmation provided from FDA including manufacturer name, product name, registration number and current registration year or a screen shot from FDA's website showing manufacturer name, product name, registration number, and current registration year MUST be included with application

View information on US FDA Establishment Registration & Devise Listing webpage

*Not required for enteral nutrition formula

Enter 510K Number if product requires a 510K from the FDA and is registered as a Class II product

A copy of 510K letter or a screen shot from FDA’s 510K database MUST be submitted with application. See the US FDA 510(k) Premarket Notification webpage

Important Note: If 510K product and/or manufacturer name do not match current manufacturer and product name listed on application, attach an explanation of relationship when submitting coding verification application

*Not required for enteral nutrition formula or Class I products.

Check appropriate box yes or no if product meets three-year minimum lifetime requirement. The DME definition in CRF 414.202 requires all DME to have a three-year minimum lifetime

If submitting an application for a Heating Pad or Lamp only

*Required only for Applications for Heating Pads or Lamps

Check appropriate box yes or no if product has a timing device for automatic shut off

*REQUIRED only for Applications for Heating Pads or Lamps

Enter in product name, model number, HCPCS code(s) requested and justification for add-on code with base product, if applicable

Enter all medical conditions for which formula is used

Check appropriate box of how formula is administered. Oral Only, Tube Only, or Both Oral and Tube

Check appropriate box to whom formula is administered: Pediatric, Adult, or Both Pediatric and Adult

Check appropriate box yes/no if formula includes carbohydrates

Check appropriate box yes/no if formula includes fats

Check appropriate box yes/no if formula includes proteins

Check appropriate box yes/no if formula includes minerals

Check appropriate box yes/no if formula includes vitamins

Check appropriate box yes/no if formula includes blenderized natural foods

Check appropriate box yes/no if product is calorically dense

Enter number of KCAL/ML in formula

Check appropriate box yes/no if this product carries a warranty

Enter amount of time for warranty

Check appropriate box yes/no if product meets three-year minimum lifetime requirement. The DME definition in CRF 414.202 requires all DME to have a three-year minimum lifetime

Check appropriate box yes/no if wheelchair comes with a back and a seat

Enter measurement for seat width, depth and height in inches

Enter measurement for back height in inches

Check appropriate description of back if it is Fixed, Adjustable, High, or Standard

Enter weight of chair in pounds, without front riggings

Enter patient weight capacity if requesting a transport chair (HCPCS E1038 or E1039)

Enter weight capacity of wheelchair in pounds, if requesting a code other than HCPCS E1038 or E1039

Enter degree of tilt, if requesting a code for a wheelchair with tilt

Check appropriate box how product is supplied, Off-the-Shelf, Custom Fitted, Both Off-the-Shelf or Custom Fabricated

Important Note: If choosing both Off-The-Shelf and Custom Fitted both codes must be requested in Section B of application

List all material used in product and provide a detailed description of orthosis

As stated for custom fabricated products, provide a detailed step-by-step description of custom fabrication process. Include color photographs of each step within fabrication process

*Required only if product is custom fabricated

Check appropriate box yes/no if product meets three-year minimum lifetime requirement. The DME definition in CRF 414.202 requires all DME to have a three-year minimum lifetime

Check appropriate box yes/no if product has a durable, waterproof cover

Check appropriate box yes/no if product can be placed on a hospital bed frame

Check appropriate box yes/no if product can be placed on top of a mattress

Check appropriate box yes/no if product is designed to reduce friction and sheer

Check appropriate box yes/no if product prevents patient from bottoming out

Enter product length, width and height in inches in appropriate box

Check appropriate box for type of support surface: Foam, Gel, Water, Air, Other (provide description if other is marked)

Enter cycle time for product in minutes

*Required for Air Support Surface Only

Enter height of air cells in inches when fully inflated

Enter height of gel bladders in support surface

*Required for Gel Support Surface Only

Enter all components in dressing. Include weight and percentage of composition for each listed component. Total percentage of all components MUST equal 100%. Do not include packaging in list of components

Check appropriate box yes/no if insert is molded directly to patient’s foot immediately following use of an external heat source. This is only for off-the-shelf inserts/prefabricated

If no, proceed to next question

*Only Required for Prefabricated Therapeutic Inserts

Check appropriate box yes/no if insert is molded using compression molding. This is only for off-the-shelf inserts/prefabricated

*Required if previous question is no and for Prefabricated Therapeutic Inserts

Enter shore A durometer measurement of base material for requested HCPCS A5512

*Only Required for Prefabricated Therapeutic Inserts

Check appropriate box yes/no if insert is molded directly to a physical positive model of beneficiary’s foot

*Only Required for Custom Therapeutic Inserts

Check appropriate box yes/no if is insert a direct carved/milled carved from an electronic positive beneficiary’s foot?

*Only Required for Custom Therapeutic Inserts

Enter shore A durometer measurement of base material for requested HCPCS A5513 and K0903

*Only Required for Custom Therapeutic Inserts

Provide a step- by-step description of fabrication process MUST be provided. Include color photographs of each step within fabrication process. Attach additional sheets if necessary

*Only Required for Custom Therapeutic Inserts

Check appropriate box yes/no if there are three or more widths. This is only for off-the-shelf or prefabricated shoes

*Only Required for Prefabricated Therapeutic Shoes

Check appropriate box yes/no if shoes come in half sizes. This is only for off-the-shelf or prefabricated shoes

*Only Required for Prefabricated Therapeutic Shoes

Check appropriate box yes/no if shoe molded directly to a positive model of beneficiary’s foot

*Only Required for Custom Modeled Therapeutic Shoes

Check appropriate box yes/no if shoe made from leather or other suitable material of equal quality

*Only Required for Custom Modeled Therapeutic Shoes

Check appropriate box yes/no if shoe has removable inserts that can be altered or replaced as beneficiary’s condition warrants

*Only Required for Custom Modeled Therapeutic Shoes

Check appropriate box yes/no if shoe has some form of closure

*Only Required for Custom Modeled Therapeutic Shoes

Provide a step-by-step description of fabrication process MUST be provided. Include color photographs of each step within fabrication process. Attach additional sheets, if necessary

*Only Required for Custom Modeled Therapeutic Shoes

Check appropriate box yes/no if product has a permanent label with manufacturer name and model number and/or product name listed

Check appropriate box yes/no if product has a warranty for repair or a full replacement if the defects

Check appropriate box 12 months, 18 months, or Other if product has a warranty. If ‘other’ is checked, enter amount of time for warranty, in months

• removable vapor permeable
• waterproof cover
• waterproof surface

Check appropriate box yes/no if product has one of surface types listed

Check appropriate box yes/no if product meets California Bulletin 117 or 133 for fire retardant properties

If ‘yes’ was checked on previous box, test report MUST be submitted

Check appropriate box if type of testing methodology was a Simulation Use Test or Human Subject. The test report for product on this application must be submitted. For testing requirements, see Wheelchair Seating Local Coverage Determination (LCD) and Policy Article

Check appropriate box Foam, Gel, Water, Air, or Other for type of cushion or back. If other is checked, enter a description of type

Check appropriate box yes/no if product is adjustable based on requirements

If ‘yes’ was checked on previous box, a description on how cushion meets requirements in policy

Enter all items that are included with wheelchair cushion or back when provided to beneficiary

Check appropriate box yes/no if cushion is fabricated for a specific beneficiary starting with basic materials

*Only required for Custom Fabricated Cushions.

Check appropriate box yes/no if cushion is fabricated using molded-to-beneficiary-model technique, direct molded-to-beneficiary technique, CAD-CAM technology, or detailed measurements of beneficiary used to create a configured cushion

*Only required for Custom Fabricated Cushions.

Check appropriate box yes/no if cushion has structural features that significantly exceed minimum requirements for a seat or back positioning cushion

*Only required for Custom Fabricated Cushions.

Provide a step-by-step description of fabrication process. Include color photographs of each step within fabrication process

*Only required for Custom Fabricated Cushions.

Print authorized official’s name

Enter authorized official’s title

Signature of authorized official

Enter date form was signed