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Code Verification Request Application Instructions

If required information is missed or not completed, the application may be rejected and a new application must be submitted with all required information.

See required column to verify if item is required.

Application is being submitted for:

Requested Information Completion Instructions Required Indicator
For a new product, not previously coded by PDAC Check box for a new product, not previously coded by PDAC 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*
For a previously reviewed product that has been modified since initial review 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*
For product previously reviewed by PDAC in which 45-day timeframe for submitting a reconsideration has lapsed. Note: This application will now be considered a new initial application for this product 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*

*One of the reasons for application submission must be selected to process the application.

Section A – Manufacturer Information

Requested Information Completion Instructions Required Indicator
Manufacturer Name Enter Manufacturer name. Name will be posted on Product Classification List (PCL) on Durable Medical Equipment (DME) Coding System (DMECS) YES
Manufacturer Point of Contact Enter manufacturer contact person name. PDAC will contact this person, if needed. This contact will be emailed all correspondence. YES
Email Address Enter manufacturer point of contact email address YES
Telephone Number Enter manufacturer point of contact valid telephone number YES
Mailing Address (City, State, Zip) Enter manufacturer mailing address (address, city, state, and zip code) YES
Website Enter manufacturer website address YES
Representative’s Name 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
NO
Email Address Enter designated representative email address NO
Telephone Number Enter designated representative telephone number NO

Section B – Product Information

Requested Information Completion Instructions Required Indicator
Product Name 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
YES
Model Number 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
YES
Does product need a DMECS Comment for Model Number Explanation to clarify size, color, or height? 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 No
If yes, provide comment to be entered in 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)
NO

Product Description and Details

Requested Information Completion Instructions Required Indicator
Is this product Pre-Market? Check appropriate box yes/no if product is currently pre-market and is not available for sale YES
Is this product for home use? 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
YES
Provide a detailed and complete description of the product. Include all functional information and any manufacturing information that supports requested code(s) 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
YES
List all component(s) that are standard that are included in base product (i.e. power cords, batteries, arm rests, leg rests, etc.), if applicable 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
NO*

HCPCS Code(s)

Requested Information Completion Instructions Required Indicator
List HCPCS Code(s) requested for product(s) and a detailed justification for code(s) being selected 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
YES
If previously coded by other insurers or agencies, provide code(s) assigned Enter product(s) has been coded by another payer, provide code assigned NO

Food and Drug Administration (FDA) Information

Requested Information Completion Instructions Required Indicator
Most Current Year of Registration 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
YES*
Establishment Registration Number 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
YES*
510K Number 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.
YES*

Additional Space for information in Section B

Space available for information in Section B. If additional space is needed attach document and indicate in the space.

Section C – Product Specific Information

Prior to completing Section C and submitting the coding verification application, review all appropriate DME MAC policy related material (DME MAC LCD, coding and policy articles, etc.).

Locate, complete and attach Section C for the product type being submitted. This is located dmepdac.com. Section C MUST be attached or the application will be rejected.

Prosthesis applications are not required to submit a Section C. Attach any additional documentation and/or photographs to support your requested code.

For Power Mobility Devices and Power Wheelchairs attach the RESNA testing results form. This is located at dmepdac.com. The form is required. The application will be rejected if not attached.

Be sure to complete and include applicable Section C.

Durable Medical Equipment and Supplies

Requested Information Completion Instructions Required Indicator
Does this product meet three-year Minimum Lifetime Requirement? 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 YES
MUST include a copy of Underwriters Laboratory Certification If submitting an application for a Heating Pad or Lamp only

*REQUIRED only for Applications for Heating Pads or Lamps
YES*
Does this heating pad/lamp include a timing device for automatic shut off? 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
YES*
List all accessories and/or supplies to be assigned a HCPCS code(s) with base product Enter in product name, model number, HCPCS code(s) requested and justification for add-on code with base product, if applicable NO

Enteral Nutrition Formula

Requested Information Completion Instructions Required Indicator
List all indications Enter all medical conditions for which formula is used YES
Method of Administration Check appropriate box of how formula is administered. Oral Only, Tube Only, or Both Oral and Tube YES
Administered to Check appropriate box to whom formula is administered: Pediatric, Adult, or Both Pediatric and Adult YES
Does formula include carbohydrates? Check appropriate box yes/no if formula includes carbohydrates YES
Does formula include fats? Check appropriate box yes/no if formula includes fats YES
Does formula include proteins? Check appropriate box yes/no if formula includes proteins YES
Does formula include minerals? Check appropriate box yes/no if formula includes minerals YES
Does formula include vitamins? Check appropriate box yes/no if formula includes vitamins YES
Is product a blenderized natural food? Check appropriate box yes/no if formula includes blenderized natural foods YES
Is product calorically dense? Check appropriate box yes/no if product is calorically dense YES
Provide KCAL/ML for calorically dense formula Enter number of KCAL/ML in formula YES

Manual Wheelchairs

Requested Information Completion Instructions Required Indicator
Does this product carry a warranty? Check appropriate box yes/no if this product carries a warranty YES
If Yes, provide duration of warranty? Enter amount of time for warranty NO
Does this product meet 3-year Minimum Lifetime Requirement? Check appropriate box yes/no if product meets 3-year minimum lifetime requirement. The DME definition in CRF 414.202 requires all DME to have a 3-year minimum lifetime YES
Does this chair come with a back and seat? Check appropriate box yes/no if wheelchair comes with a back and a seat YES
Provide following product measurements and unit measure for each Enter measurement for seat width, depth and height in inches

Enter measurement for back height in inches
YES
Description of back Check appropriate description of back if it is Fixed, Adjustable, High, or Standard YES
Weight of manual wheelchair without front riggings Enter weight of chair in pounds, without front riggings YES
For transport chair (E1038, E1039), provide patient weight capacity Enter patient weight capacity if requesting a transport chair (HCPCS E1038 or E1039) NO
For all other manual wheelchairs, provide weight capacity Enter weight capacity of wheelchair in pounds, if requesting a code other than HCPCS E1038 or E1039 NO
Provide degree of tilt Enter degree of tilt, if requesting a code for a wheelchair with tilt NO

Orthosis

Requested Information Completion Instructions Required Indicator
How is this product supplied? 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
YES
Provide a list of materials and a description of orthosis List all material used in product and provide a detailed description of orthosis YES
If product is custom fabricated, a step by step description of fabrication process MUST be provided. Include color photographs of each step within fabrication process 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
YES*

Support Surfaces

Requested Information Completion Instructions Required Indicator
Does this product meet 3-year Minimum Lifetime Requirement? Check appropriate box yes/no if product meets 3-year minimum lifetime requirement. The DME definition in CRF 414.202 requires all DME to have a 3-year minimum lifetime YES
Does support surface have a durable, waterproof cover? Check appropriate box yes/no if product has a durable, waterproof cover YES
Can support surface be placed directly on a hospital bed frame? Check appropriate box yes/no if product can be placed on a hospital bed frame YES
Can support surface be placed on top of a mattress? Check appropriate box yes/no if product can be placed on top of a mattress YES
Is surface designed to reduce friction and shear? Check appropriate box yes/no if product is designed to reduce friction and sheer YES
Is there adequate patient lift to prevent bottoming out? Check appropriate box yes/no if product prevents patient from bottoming out YES
Provide measurement of overall product Enter product length, width and height in inches in appropriate box YES
Provide type of Support Surface Check appropriate box for type of support surface: Foam, Gel, Water, Air, Other (provide description if other is marked) YES
Provide cycle time for product Enter cycle time for product in minutes

*Required for Air Support Surface Only
NO*
Provide height of the air cells when inflated Enter height of air cells in inches when fully inflated NO
Provide height of gel bladders Enter height of gel bladders in support surface

*Required for Gel Support Surface Only
NO*

Surgical Dressings

Requested Information Completion Instructions Required Indicator
List all components in dressings along with weight and percentage of each component 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 YES

Therapeutic Shoes and Inserts

Requested Information Completion Instructions Required Indicator
Is insert molded directly to beneficiary’s foot immediately following use of an external heat source (excluding heat sources commonly used as commercial hand-held hair dryers) that can produce heat at temperatures of 230° or greater? 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
YES*
Is insert molded by use of “compression molding” (molding via beneficiary’s weight and body heat) without use of an external heat source? 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
YES*
Provide shore A durometer measurement of base material (for requested HCPCS A5512) Enter shore A durometer measurement of base material for requested HCPCS A5512

*Only Required for Prefabricated Therapeutic Inserts
YES*
Is insert molded directly to a physical positive model of beneficiary’s foot? 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
YES*
Is insert a direct carved/milled carved from an electronic positive beneficiary’s foot? 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
YES*
Provide shore A durometer measurement of base material (for requested HCPCS A5513 and K0903) Enter shore A durometer measurement of base material for requested HCPCS A5513 and K0903

*Only Required for Custom Therapeutic Inserts
YES*
Step-by-step description of fabrication process MUST be provided. Include color photographs of each step within fabrication process 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
YES*
Are there 3 or more widths available for each product line? 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
YES*
Do shoes come in half sizes? 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
YES*
Is shoe molded directly to a positive model of beneficiary’s foot? Check appropriate box yes/no if shoe molded directly to a positive model of beneficiary’s foot

*Only Required for Custom Modeled Therapeutic Shoes
YES*
Is shoe made from leather or other suitable material of equal quality? Check appropriate box yes/no if shoe made from leather or other suitable material of equal quality

*Only Required for Custom Modeled Therapeutic Shoes
YES*
Does shoe have removable inserts that can be altered or replaced as beneficiary’s condition warrants? 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
YES*
Does shoe have some form of closure? Check appropriate box yes/no if shoe has some form of closure

*Only Required for Custom Modeled Therapeutic Shoes
YES*
Step-by-step description of fabrication process MUST be provided. Include color photographs of each step within fabrication process 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
YES*

Wheelchair Backs and Cushions

Requested Information Completion Instructions Required Indicator
Does product have a permanent label with manufacturer name and model number and/or product name? Check appropriate box yes/no if product has a permanent label with manufacturer name and model number and/or product name listed YES
Does this product have a warranty for repair or a full replacement of manufacturer defects? Check appropriate box yes/no if product has a warranty for repair or a full replacement if the defects YES
If Yes, provide length of warranty 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 NO
Does this product have one of the following surface or cover types?
  • removable vapor permeable
  • waterproof cover
  • waterproof surface
Check appropriate box yes/no if product has one of surface types listed YES
Does cushion and cover meet California Bulletin 117 or 133 for fire retardant properties? 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
YES
Indicate type of testing methodology performed on product 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 YES
Provide type of wheelchair cushion or back Check appropriate box Foam, Gel, Water, Air, or Other for type of cushion or back. If other is checked, enter a description of type YES
Is wheelchair cushion adjustable based on requirements? Check appropriate box yes/no if product is adjustable based on requirements YES
If Yes, describe how cushion meets requirements If ‘yes’ was checked on previous box, a description on how cushion meets requirements in policy NO
List all components and accessories included in base product Enter all items that are included with wheelchair cushion or back when provided to beneficiary YES
Is cushion fabricated for a specific beneficiary starting with basic materials? Check appropriate box yes/no if cushion is fabricated for a specific beneficiary starting with basic materials

*Only required for Custom Fabricated Cushions.
YES*
Is it 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? 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.
YES*
Does cushion have structural features that significantly exceed the minimum requirements for a seat or back positioning cushion? 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.
YES*
Step-by-step description of fabrication process MUST be provided. Include color photographs of each step within fabrication process Provide a step-by-step description of fabrication process. Include color photographs of each step within fabrication process

*Only required for Custom Fabricated Cushions.
YES*

Section D – Authorized Signature

Requested Information Completion Instructions Required Indicator
Authorized Official Name Print authorized official’s name YES
Authorized Official Title Enter authorized official’s title YES
Signature Signature of authorized official YES
Date Enter date form was signed YES

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