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 Indicator column to verify if item is required.

Section A – Manufacturer Information
o   A.1 Manufacturer Information
o   A.2 Distributor Information
o   A.3 Consultant/Designated Representative Information
Section B – Product Information
o Product Description and Details
o HCPCS Codes
Section C – Product Specific Information
o   Enteral Nutrition Formula
o Gradient Compression Garments
o   Manual Wheelchairs
o   Power Wheelchairs and Power Operated Vehicles
o   Orthotics
o   Oral Appliances for Obstructive Sleep Apnea
o   Support Surfaces
o   Surgical Dressings
o   Therapeutic Shoes and Inserts for Diabetics
o   Wheelchair Cushions (Backs and Seats)
Section D – Authorized Signature
Submit an Application

Select all statements and options that apply to product being submitted:

Requested Information	Completion Instructions	Required Indicator
1. The product has never been code reviewed by the PDAC	Check box for a new product, not previously coded by PDAC.	If applicable*
2. The product was submitted for code review but the application was rejected	Check box for a product previously submitted for review in which application was rejected.	If applicable*
3. The product was code reviewed by the PDAC over 45 days ago	Check the box for a product previously reviewed by PDAC in which 45-day timeframe for submitting a reconsideration has lapsed. Provide DCN from previous application(s).	If applicable*
4. The Product has been modified in part or in whole since code reviewed by the PDAC	Check the box for a previously reviewed product that has been modified since initial review.	If applicable*
5. The product was code reviewed by the PDAC but the following has changed	Check appropriate boxes [CHANGE IN MANUFACTURER NAME, CHANGE IN PRODUCT NAME/CHANGE IN MODEL NUMBER(S)/ADDITION TO MODEL NUMBER(S)/PRIVATE LABEL AGREEMENT].	If applicable*
If selected statements 2, 3, 4, or 5 provide Document Control Number(s) (DCN) from previous application(s)	Provide DCN from previous application(s) if statements 2 through 5 are selected.	If applicable*

*One of the options listed above must be selected in order to process the application.

Section A – Manufacturer Information

A.1 Manufacturer Information

Requested Information	Completion Instructions	Required Indicator
Manufacturer Name	Enter the legal manufacturer's name.	YES
Manufacturer Point of Contact	Enter the manufacturer contact person's name. This contact will be sent all correspondence and contacted during the review process if needed.	YES
Email Address	Enter the manufacturer point of contact's email address.	YES
Telephone Number	Enter the manufacturer point of contact's telephone number.	YES
Mailing Address (City, State, Zip) (Country, if other than US)	Enter the manufacturer point of contact's mailing address.	YES
Website Address	Enter the manufacturer's website address.	YES
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.	YES
Establishment Registration Number	Enter Establishment Registration Number for product. A copy of email or letter confirmation provided from FDA or screen shot from FDA’s website containing manufacturer name, product name, registration number, and current registration year MUST be included with application. View information on US FDA Establishment Registration & Device Listing webpage.	YES

A.2 Distributor Information

Requested Information	Completion Instructions	Required Indicator
Distributor Name	Enter the legal distributor’s name.	If applicable*
Distributor Point of Contact	Enter the distributor contact person’s name. This contact will be sent all correspondence and contacted during the review process if needed.	If applicable*
Email Address	Enter the distributor point of contact’s email address.	If applicable*
Telephone Number	Enter the distributor point of contact’s telephone number.	If applicable*
Mailing Address (City, State, Zip) (Country, if other than US)	Enter the distributor point of contact’s mailing address.	If applicable*
Website Address	Enter the distributor’s website address.	If applicable*
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.	If applicable*
Establishment Registration Number	Enter Establishment Registration Number for product. A copy of email or letter confirmation provided from FDA or screen shot from FDA’s website containing distributor name, product name, registration number, and current registration year MUST be included with application. View information on US FDA Establishment Registration & Device Listing webpage for more information along with Who Must Register.	If applicable*

A.3 Consultant/Designated Representative Information

Requested Information	Completion Instructions	Required Indicator
Consultant/Representative Name	Enter the legal consultant or representative name.	If applicable*
Company Name	Enter the company name of the consultant or representative.	If applicable*
Email Address	Enter the consultant’s or representative’s email address.	If applicable*
Telephone Number	Enter the consultant’s or representative’s telephone number.	If applicable*
Mailing Address (City, State, Zip)	Enter the consultant’s or representative’s mailing address.	If applicable*
Website Address	Enter the consultant’s or representative’s website address.	If applicable*

Section B – Product Information

Requested Information	Completion Instructions	Required Indicator
Manufacturer/Distributor Name	Enter the Manufacturer or Distributor’s Name as it will be listed on the Product Classification List (PCL). If the Distributor’s name is to be associated with the product, provide documentation supporting the relationship with the manufacturer.	YES
Product Name	Enter the Product Name as it will appear on the PCL. Note: Verify accuracy of product name as it will be listed on the PCL. Any errors in the submitted name to be corrected will require submission of another code verification review application.	YES
Model Number(s)	Enter the model number(s) of product submitted for coding. This is the model number that will be listed on the PCL. Enter ‘None’ if there is no model number associated with the product. If there are multiple model/part numbers for the product, provide a base model number to be listed on the PCL. Place holders can be used for size, color, etc. options. Example: Base-XX where XX indicates size. Note: Verify accuracy of model number(s) product name as it will be listed on the PCL. Any errors in the submitted number(s) name to be corrected will require submission of another code verification review application.	YES
Does product need a PCL Comment for Model Number Explanation to clarify size, color, or height?	Check appropriate box [YES/NO] if product needs a PCL comment for the model number. Often manufacturers request clarifying comments be posted to the PCL to clarify model number format and differences between model numbers. Indicate if your product needs a Comment for Model Number loaded to the PCL.	YES
If yes, provide comment to be entered in DMECS	Enter the comment to be posted on the PCL providing additional information for product submitted. Example: XX AND YY WITHIN THE MODEL NUMBER ARE PLACEHOLDERS FOR HEIGHT (XX) AND WIDTH (YY)	NO
Is a product sample required to be submitted per instructions on the PDAC Website?	Check appropriate box [YES/NO] if product sample is required. List of product sample requirements can be found here.	YES
Is a product sample being submitted with this application?	Check appropriate box [YES/NO] if product sample is being submitted with application.	YES

Product Description and Details

Requested Information	Completion Instructions	Required Indicator
Product Status?	Check appropriate box [MARKET/PRE-MARKET] of current status of submitted product. Pre-Market indicates that the product is not available for sale.	YES
Is this product for home use?	Check appropriate box [YES/NO] if product is for home use. Per the 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
FDA Device Classification	Check appropriate box [CLASS I/CLASS II/CLASS III] of the classification of product	YES
FDA 510(K) Number or FDA Exemption Regulation Number if Exempt	Enter FDA 510(K) number or Exemption Regulation Number if 510(K) exempt. If 510(K) manufacturer does not match submitter, documentation must be provided explaining relationship. Note: Must submit a copy of letter	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, etc.), if applicable	If the 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*
Does this product carry a warranty?	Check appropriate box [YES/NO] if product comes with a warranty.	YES
Type/Duration	Enter type of warranty and duration (e.g. Service Life)	YESYES
Specify minimum expected lifetime for the equipment in months and/or years	Enter the minimum expected lifetime for the product in months and/or in years.	YES

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 the desired 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 it in the application.	YES
List HCPCS Code(s) requested for accessory/supply and detailed justification for code(s) being selected	List the desired HCPCS code(s) for accessories or supplies associated with product 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 it in the application.	If applicable*
If previously coded by other insurers or agencies, provide code(s) assigned	Enter if the product(s) has/have been coded by another payer and provide the code that was assigned.	NO

Requested Information

Completion Instructions

Required Indicator

List HCPCS Code(s) requested for product(s) and a detailed justification for code(s) being selected

List the desired 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 it in the application.

YES

List HCPCS Code(s) requested for accessory/supply and detailed justification for code(s) being selected

List the desired HCPCS code(s) for accessories or supplies associated with product 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 it in the application.

If applicable*

If previously coded by other insurers or agencies, provide code(s) assigned

Enter if the product(s) has/have been coded by another payer and provide the code that was assigned.

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 at dmepdac.com. Section C must be attached or the application will be rejected.

Prostheses, orthopedic footwear, and DME accessory 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 it is not attached.

Be sure to complete and include applicable Section C.

Enteral Nutrition Formula
Gradient Compression Garments
Manual Wheelchairs
Orthotics
Oral Appliances for Obstructive Sleep Apnea
Support Surfaces
Surgical Dressings
Therapeutic Shoes and Inserts for Diabetics
Wheelchair Cushions (Backs and Seats)

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 [ORAL ONLY/TUBE ONLY/ BOTH ORAL AND TUBE] of how formula is administered.	YES
Administered to	Check appropriate box [PEDIATRIC/ADULT/BOTH PEDIATRIC AND ADULT] to whom formula is administered.	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 hydrolyzed proteins?	Check appropriate box [YES/NO] if formula includes hydrolyzed proteins.	YES
If yes, list all hydrolyzed proteins	List all hydrolyzed proteins included in formula.	NO
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 amount of formula in KCAL/ML.	YESYES

Gradient Compression Garments

Requested Information	Completion Instructions	Required Indicator
Garment Location	Check appropriate box [ARM/BRA/FOOT/GAUNTLET/GENITAL/GLOVE/LEG/SHOULDER/THIGH /TOE/TORSO/WAIST/OTHER] of location garment is applied. (Provide location if other is marked).	YES
Is the garment used to treat lymphedema?	Check appropriate box [YES/NO] if garment is used to treat lymphedema.	YES
Is the garment for nighttime use?	Check appropriate box [YES/NO] if garment is used at night.	YES
If a stocking or wrap, is the garment used as a surgical dressing?	Check appropriate box [YES/NO/NOT APPLICABLE] if garment can be used as a surgical dressing.	YES
Specify all available gradient compression ranges for the product line by providing the minimum and maximum values for each. Note: For both standard and custom garments, testing documentation must accompany the application to support the accuracy of the stated ranges.	List all available gradient ranges of this product line and the minimum and maximum pressures for each range (ex. 18-30 mmHg). Testing documentation validating the accuracy of the pressure ranges must be included with the application to confirm that the product can generate gradient compression.	YES
Is the garment custom?	Check appropriate box [YES/NO] if garment is custom.	YES
If custom, indicate the number of measurements which are taken for construction of the garment.	Enter the number of measurements that need to be taken in order to produce a custom final product.	YES
If custom, explain how the garment is custom fitted. Provide supporting documentation, including an order form, if available.	Describe how the garment is custom fitted. Supporting documentation, such as an order form, will assist with the review if it is available to be submitted with your application.	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 three-year Minimum Lifetime Requirement?	Check appropriate box [YES/NO] if product meets three-year minimum lifetime requirement. The DME definition in CFR 414.202 requires all DME to have a three-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 and depth in inches. Enter measurements for back width and height in inches.	YES
Description of back	Check appropriate description [FIXED/ADJUSTABLE/HIGH/STANDARD] of back.	YES
Weight of manual wheelchair without front riggings	Enter weight of chair without front riggings, in pounds.	YES
For transport chair (E1038, E1039), provide patient weight capacity	Enter patient weight capacity if requesting a transport chair (HCPCS E1038 or E1039), in pounds.	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, in pounds.	NO
Provide degree of tilt	Enter degree of tilt, if requesting a code for a wheelchair with tilt.	NO
Provide the degree of recline	Enter degree of recline, if requesting a code for a wheelchair with recline.	NO

Orthotics

Requested Information	Completion Instructions	Required Indicator
How is this product sampled? Important Note: If choosing both Off-The-Shelf and Custom Fitted both codes must be requested in Section B of application	Check appropriate box [OFF-THE-SHELF/CUSTOM FITTED/BOTH OFF-THE-SHELF AND CUSTOM FITTED/CUSTOM FABRICATED] how product is supplied.	YES
Provide a list of materials and a description of orthosis	List all material(s) 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 the fabrication process	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.	NO*

Requested Information

Completion Instructions

Required Indicator

How is this product sampled?

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

Check appropriate box [OFF-THE-SHELF/CUSTOM FITTED/BOTH OFF-THE-SHELF AND CUSTOM FITTED/CUSTOM FABRICATED] how product is supplied.

YES

Provide a list of materials and a description of orthosis

List all material(s) 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 the fabrication process

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.

NO*

Oral Appliances for Obstructive Sleep Apnea

Requested Information	Completion Instructions	Required Indicator
Is the product custom fabricated?	Check appropriate box [YES/NO] if product is custom fabricated.	YES
If Yes, provide information on how the impression of the beneficiary’s teeth is made and how the device is fabricated.	Provide detailed information how impression is made of beneficiary’s teeth and how the device is fabricated. Pictures of both processes are highly recommended.	NO
If product is custom fabricated, a step-by-step description of fabrication process must be provided. Include color photographs of each step within the fabrication process	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.	NO*

Requested Information

Completion Instructions

Required Indicator

Is the product custom fabricated?

Check appropriate box [YES/NO] if product is custom fabricated.

YES

If Yes, provide information on how the impression of the beneficiary’s teeth is made and how the device is fabricated.

Provide detailed information how impression is made of beneficiary’s teeth and how the device is fabricated. Pictures of both processes are highly recommended.

If product is custom fabricated, a step-by-step description of fabrication process must be provided. Include color photographs of each step within the fabrication process

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.

NO*

Support Surfaces

Requested Information	Completion Instructions	Required Indicator
Does this product meet three-year Minimum Lifetime Requirement?	Check appropriate box [YES/NO] if product meets three-year minimum lifetime requirement. The DME definition in CFR 414.202 requires all DME to have a three-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 shear.	YES
Is there adequate patient lift to prevent bottoming out?	Check appropriate box [YES/NO] if product prevents patient from bottoming out.	YES
Provide the measurements of overall product	Enter product length, width and height in inches in appropriate box.	YES
Provide the type of Support Surface	Check appropriate box [FOAM/GEL/ AIR/OTHER] for type of support surface (provide description if other is marked).	YES
Provide the cycle time for product	Enter the cycle time for the product in minutes. *Required for Air Support Surface Only.	NO*
Provide height of the air cells when inflated	Enter the height of the air cells, in inches, when fully inflated. *Required for Air Support Surface Only.	NO*
Provide the number of cells	Enter the number of air cells in the support surface. *Required for Air Support Surface Only.	NO*
Provide height of gel bladders	Enter the height of the 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 for Diabetics

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. *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. *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 Fabricated Therapeutic Inserts.	YES*
Is insert a direct carved/milled from a rectified virtual model of the beneficiary’s foot?	Check appropriate box [YES/NO] if insert is directly carved/milled from a digital scan of the beneficiary’s foot? *Only Required for Custom Fabricated Therapeutic Inserts.	YES*
Provide shore A durometer measurement of base material (for requested HCPCS A5513 and A5514)	Enter shore A durometer measurement of base material for requested HCPCS A5513 and A5514. *Only Required for Custom Fabricated 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 Fabricated 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. *Only Required for Prefabricated Therapeutic Shoes.	YES*
Does the shoe come in half sizes?	Check appropriate box [YES/NO] if shoes come in half sizes. *Only Required for Prefabricated Therapeutic Shoes.	YES*
Is the 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 the 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 the 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 the 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 Cushions (Backs and Seats)

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 for the defects.	YES
If Yes, provide length of warranty	Check appropriate box [12 MONTHS/18 MONTHS/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?	Check appropriate box [YES/NO] if product has one of surface types listed: removable vapor permeable waterproof cover waterproof surface	YES
Does cushion and cover meet California Bulletin 117 or 133 for fire retardant properties or equivalent test?	Check appropriate box [YES/NO] if product meets California Bulletin 117 or 133 for fire retardant properties or equivalent test. If “YES”, test report MUST be submitted.	YES
Indicate type of testing methodology performed on product	Check appropriate box [SIMULATION TEST/HUMAN SUBJECT] for testing methodology. 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 seat or back cushion	Check appropriate box [FOAM/GEL/ AIR/OTHER] for type of seat or back cushion. If “OTHER” is checked, enter a description.	YES
Is wheelchair cushion adjustable based on the Local Coverage Determination Coding Guideline 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 in previous box, provide 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 seat 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 the 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
Company	Enter authorized company.	YES
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

Submit an Application

If no product sample is required, a completed application can be submitted via email to PDAC.APPLICATION@palmettogba.com, faxed, or mailed to the address below:

Fax Number: (803) 264-0648

Palmetto GBA
Attn: PDAC
PO Box 100320
Columbia, SC 29202-3320

If product samples are required, a completed application and product samples must be mailed to:

Palmetto GBA
Attn: PDAC
AG-440
2300 Springdale Drive, Building One
Camden, SC 29020-1728

See Product Sample Requirements webpage for a list of required product samples.
All product samples will be held for 60 days from date on rejection notice.
If new application is submitted after 45 days, a new product sample MUST be submitted.
Enter DCN number from rejection notice at the top of application form, if not entered, application processing may be delayed.

Last Updated: 09/21/2021