Retired - Correct Coding - Inserts Used with Therapeutic Shoes for Persons with Diabetes (A5512, A5513, K0903)

Inserts used with therapeutic shoes for persons with diabetes coded as A5512, A5513, and K0903 must meet certain specifications outlined in the Therapeutic Shoes for Persons with Diabetes Local Coverage Determination (LCD) and related Policy Article, as well as the requirements for custom fabrication set out in the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Quality Standards, Appendix C. Custom fabrication requirements are applicable to A5513 and K0903. This article consolidates several older articles addressing correct Healthcare Common Procedure Coding System (HCPCS) coding for therapeutic shoe inserts, announces new HCPCS code K0903, and introduces a new coding guideline for K0903. In addition, revised information about the A5513 Coding Verification Review project, currently underway, is included.

New HCPCS Code K0903

A new HCPCS code has been created to describe a custom fabricated therapeutic shoe insert directly carved from a rectified model of an individual beneficiary’s foot. The new code is:

K0903
FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, MADE BY DIRECT CARVING WITH CAM TECHNOLOGY FROM A RECTIFIED CAD MODEL CREATED FROM A DIGITIZED SCAN OF THE PATIENT, TOTAL CONTACT WITH PATIENT’S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 3/16 INCH MATERIAL OF SHORE A 35 DUROMETER (OR HIGHER), INCLUDES ARCH FILLER AND OTHER SHAPING MATERIAL, CUSTOM FABRICATED, EACH

The required rectified model is created by computer-assisted design (CAD) software from a digitized scan of the individual beneficiary’s foot. The scan source may be any one of the following:

• A direct scan of the beneficiary’s foot
• A scan of a mold made from the beneficiary’s foot, e.g., such as from a "foam or crush box impression" (not all-inclusive)
• A scan of a model directly made from a mold made from the beneficiary’s foot

The rectified model of an individual beneficiary’s foot is then used by computer-aided manufacturing (CAM) equipment to directly create (carve or mill) a unique insert. K0903 does not describe therapeutic shoe inserts created using manufacturing techniques such as 3-D printing or similar processes.

Effective for claims with dates of service (DOS) on or after April 1, 2018, K0903 must be used for Medicare billing of all manufactured/centrally fabricated custom fabricated inserts that are produced by direct milling (carving) manufacturing. For direct-carved inserts currently coded as A5513, K0903 must be used for claims submitted to Medicare with DOS on or after April 1, 2018, regardless of their current listing on the A5513 Pricing, Data Analysis, and Coding (PDAC) contractor’s Product Classification List. For claims with DOS on or after April 1, 2018, and before August 1, 2018, the requirement for product listing on the PDAC Product Classification List for HCPCS code K0903 is waived for all manufacturers/central fabricators only if a completed coding review application has been submitted to the PDAC. The waiver is effective from the date of application through July 31, 2018. For claims with DOS on or after August 1, 2018, only therapeutic shoe inserts listed on the PDAC Product Classification List for K0903 may be billed to Medicare using HCPCS code K0903. Claims billed using K0903 for unlisted products after August 1, 2018, are incorrectly coded. HCPCS code A9270 (NON-COVERED ITEM OR SERVICE) must be used to bill for unlisted custom fabricated therapeutic shoe inserts.

See below for detailed coding guidelines and product coding review requirements.

Coding Guidelines and PDAC Coding Application

The Therapeutic Shoes for Persons with Diabetes LCD Related Policy Article CODING GUIDELINES section provides information about correct coding for inserts. A new coding guideline for HCPCS code K0903 is introduced below. The new guideline for K0903 will be included in a future revision to the policy article.

Additional guidance regarding the information to be included with an HCPCS coding application submitted to the PDAC contractor is included below.

A5512
FOR DIABETICS, ONLY, MULTIPLE DENSITY INSERT, DIRECT FORMED, MOLDED TO FOOT AFTER EXTERNAL HEAT SOURCE OF 230 DEGREES FAHRENHEIT OR HIGHER, TOTAL CONTACT WITH PATIENT'S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 1/4 INCH MATERIAL OF SHORE A 35 DUROMETER OR 3/16 INCH MATERIAL OF SHORE A 40 DUROMETER (OR HIGHER), PREFABRICATED, EACH

This HCPCS code describes a prefabricated therapeutic shoe insert that is heat-molded directly to the beneficiary’s foot. The current Coding Guidelines for A5512 are:

Code A5512 describes a total contact, multiple density, prefabricated removable inlay that is directly molded to the beneficiary's foot. Direct molded means it has been conformed by molding directly to match the plantar surface of the individual beneficiary's foot. Total contact means it makes and retains actual and continuous physical contact with the weight-bearing portions of the foot, including the arch throughout the standing and walking phases of gait.

The A5512 insert must retain its shape during use for the life of the insert. The layer responsible for shape retention is called the "base layer" in the code descriptor. This material usually constitutes the bottom layer of the device and must be of a sufficient thickness and durometer to maintain its shape during use (i.e., at least ¼ inch of 35 Shore A or higher or at least 3/16 inch of 40 Shore A or higher). The material responsible for maintaining the shape of the device must be heat moldable. The specified thickness of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes.

For an insert to be coded as A5512, the criteria described in the HCPCS code narrative and in the coding guidelines must be met. A PDAC coding application must include sufficient and clear information to demonstrate that all criteria are met. To assist applicants, PDAC has reformatted the coding requirements into a list to aid manufacturers and practitioners in verifying that each criterion has been addressed in their coding application. To be assigned to HCPCS code A5512, information must be included showing that the product:

• Is a prefabricated insert
• Is a multiple density insert
• Is direct formed by molding to the beneficiary's foot with an external heat source of 230 degrees Fahrenheit or higher
• Has total contact with beneficiary's foot, including the arch
• Has a base layer that has a minimum:
  • 1/4-inch material of Shore A 35 durometer or
  • 3/16-inch material of Shore A 40 durometer (or higher)
• Has the specified thickness of the base layer extending from the heel through the distal metatarsals (May be absent at the toes)
• Retains its shape during use for the life of the insert

A5513
FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, CUSTOM MOLDED FROM MODEL OF PATIENT'S FOOT, TOTAL CONTACT WITH PATIENT'S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 3/16 INCH MATERIAL OF SHORE A 35 DUROMETER OR HIGHER, INCLUDES ARCH FILLER AND OTHER SHAPING MATERIAL, CUSTOM FABRICATED, EACH

This HCPCS code describes a custom fabricated therapeutic shoe insert created on a physical model of the individual beneficiary’s foot. The current Coding Guidelines for A5513 are:

Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a physical model of the beneficiary's foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height, and length, or toe shape.

The A5513 insert must retain its shape during use for the life of the insert. The base layer of the device must be at least 3/16 inch of 35 Shore A or higher material. The base layer is allowed to be thinner in the custom fabricated device because appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact and accommodate each beneficiary's specific needs. The central portion of the base layer of the heel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be of a lower durometer and must also be heat moldable. The materials used should be suitable with regards to the beneficiary's condition.

For an insert to be coded as A5513, the criteria described in the HCPCS code narrative and in the coding guidelines must be met. Also, the custom fabrication criteria set out in the DMEPOS Quality Standards, Appendix C, must be met. A PDAC coding application must include sufficient and clear information to demonstrate that all criteria are met. To assist applicants, PDAC has reformatted the requirements into a list to aid manufacturers and practitioners in verifying that each criterion has been addressed in their coding application. To be assigned to HCPCS code A5513, information must be included showing that the product:

• Is a custom fabricated insert
• Is a multiple density insert
• Is molded to a beneficiary-specific, physical model
• Is made from basic materials
• Has total contact with beneficiary's foot, including the arch
• Has a base layer that has a minimum 3/16-inch material of Shore A 35 durometer (The central portion of the heel may not be less than 1/16 inch thick)
• Has the specified thickness of the base layer extending from the heel through the distal metatarsals (May be absent at the toes)
• Has a heat-moldable top layer
• Retains its shape during use for the life of the insert

K0903
FOR DIABETICS ONLY, MULTIPLE DENSITY INSERT, MADE BY DIRECT CARVING WITH CAM TECHNOLOGY FROM A RECTIFIED CAD MODEL CREATED FROM A DIGITIZED SCAN OF THE PATIENT, TOTAL CONTACT WITH PATIENT’S FOOT, INCLUDING ARCH, BASE LAYER MINIMUM OF 3/16 INCH MATERIAL OF SHORE A 35 DUROMETER (OR HIGHER), INCLUDES ARCH FILLER AND OTHER SHAPING MATERIAL, CUSTOM FABRICATED, EACH

This HCPCS code describes a custom fabricated therapeutic shoe insert directly milled (carved) using digitized scanning and CAD technology to create a rectified, virtual model of the individual beneficiary’s foot. The new Coding Guidelines for K0903 are:

Code K0903 describes a total contact, custom fabricated, multiple density, removable inlay that is directly milled from a rectified virtual model of the beneficiary's foot so that it conforms to the plantar surface and makes total contact with the foot, including the arch. A custom fabricated device is made from materials that do not have predefined trim lines for heel cup height, arch height and length, or toe shape.

The K0903 insert must retain its shape during use for the life of the insert. The base layer of the device must be at least 3/16 inch of 35 Shore A or higher material. The base layer is allowed to be thinner in the custom fabricated device because appropriate arch fill or other additional material will be layered up individually to maintain shape and achieve total contact and accommodate each beneficiary's specific needs. The central portion of the base layer of the heel may be thinner (but at least 1/16 inch) to allow for greater pressure reduction. The specified thickness of the lateral portions of the base layer must extend from the heel through the distal metatarsals and may be absent at the toes. The top layer of the device may be of a lower durometer and must also be heat moldable. The materials used should be suitable with regards to the beneficiary's condition.

For an insert to be coded as K0903, the criteria described in the HCPCS code narrative and in the coding guidelines must be met. Also, the custom fabrication criteria set out in the DMEPOS Quality Standards, Appendix C, must be met. A PDAC coding application must include sufficient and clear information to demonstrate that all criteria are met. To assist applicants, PDAC has reformatted the requirements into a list to aid manufacturers and practitioners in verifying that each criterion has been addressed in their coding application. To be assigned to HCPCS code K0903, information must be included showing that the product:

• Is a custom fabricated insert
• Is a multiple density insert
• Is directly milled from a beneficiary-specific, rectified digital (virtual) model
• Is made from basic materials
• Has total contact with beneficiary's foot, including the arch
• Has a base layer that has a minimum 3/16-inch material of Shore A 35 durometer (The central portion of the heel may not be less than 1/16 inch thick)
• Has the specified thickness of the base layer extending from the heel through the distal metatarsals (May be absent at the toes)
• Has a heat-moldable top layer
• Retains its shape during use for the life of the insert

With each PDAC Coding Verification Application, manufacturers/central fabrication facilities must submit all the following:

1. A 4 x 4 x ½ inch sample of base layer material(s)
2. A sample pair of inserts
3. A complete narrative description of the production process from receipt of the request to shipping of the finished insert
4. Photographs and/or videos showing compliance with the process specifications applicable to each code

The CODING GUIDELINES are also updated to specify:

The only products that may be billed using code A5512 are those that are specified in the Product Classification List on the PDAC contractor’s website.

There are two categories of products that are billed with codes A5513:

• Inserts that are custom fabricated by a manufacturer/central fabrication facility and then sent to someone other than the beneficiary. These items may be billed using code A5513 only if they are listed on the PDAC website.
• Inserts that are custom fabricated from raw materials that are dispensed directly to the beneficiary by the entity that fabricated the insert. These items do not have to be listed on the PDAC website in order to be billed using code A5513. However, the supplier must provide a list of the materials that were used and a description of the custom fabrication process on request.

The only products that may be billed using code K0903 are those that are specified in the Product Classification List on the PDAC contractor’s website.

If a therapeutic shoe insert is not included in one of these categories of items (A5512, A5513, or K0903), it must be billed with code A5510 or A9270.

Applications are available on the PDAC website at https://www.dmepdac.com/.

A copy of the PDAC Coding Verification Letter to the manufacturer/central fabrication facility, approving the product as A5512, A5513, or K0903, must be kept on file and be available to distributors, suppliers, and CMS contractors upon request.

Coding Redetermination Review Project

In August 2017, a project to re-review inserts coded as HCPCS code A5513 was announced. This project required all manufacturers/central fabricators of custom fabricated therapeutic shoe inserts to submit an HCPCS coding review application to the PDAC so that compliance with the DMEPOS Quality Standards, Appendix C, requirements for custom fabrication could be assessed. The project required that all product reviews be completed by June 1, 2018, at which time an updated PDAC Product Classification List for HCPCS code A5513 would be published. Only listed therapeutic shoe insets would be eligible for Medicare billing of A5513.

With the creation of K0903 to describe an additional manufacturing technique for custom fabricated therapeutic shoe inserts, this project is revised to include therapeutic shoe inserts coded as A5513 and K0903. The project end date is extended to allow additional time for applications. The project specifics follow.

The Coding Guidelines section of the Therapeutic Shoes for Persons with Diabetes LCD-Related Policy Article requires manufacturers wishing to use A5513 or K0903 for their product(s) to submit a coding verification application to the PDAC. Therefore, all products must be submitted for this review. There is no carryover or "grandfathering" of prior coding determinations.

All products currently listed in the DMECS Product Classification List on the PDAC website as assigned to HCPCS code A5513 will be end-dated effective July 31, 2018. After this end-date, only products that have completed this current review and that have been verified as meeting all A5513 or K0903 code requirements will be listed. Effective for claims with dates of service on or after August 1, 2018, the only products which may be billed to Medicare using code A5513 or K0903 are the products that are listed in the Product Classification List in DMECS maintained on the PDAC website.

As discussed above:

Effective for claims with dates of service (DOS) on or after April 1, 2018, K0903 must be used for Medicare billing of all manufactured/centrally fabricated custom fabricated inserts that are produced by direct milling (carving) manufacturing. For direct-carved inserts currently coded as A5513, K0903 must be used for claims submitted to Medicare with DOS on or after April 1, 2018, regardless of their current listing on the A5513 PDAC Product Classification List. For claims with DOS on or after April 1, 2018, and before August 1, 2018, the requirement for product listing on the PDAC Product Classification List for HCPCS code K0903 is waived for all manufacturers/central fabricators only if a completed coding review application has been submitted to the PDAC. The waiver is effective from the date of application through July 31, 2018. For claims with DOS on or after August 1, 2018, only therapeutic shoe inserts listed on the PDAC Product Classification List for K0903 may be billed to Medicare using HCPCS code K0903. Claims billed using K0903 for unlisted products after August 1, 2018, are incorrectly coded. HCPCS code A9270 (NON-COVERED ITEM OR SERVICE) must be used to bill for unlisted custom fabricated therapeutic shoe inserts.

For dates of service on or before July 31, 2018, products that are presently listed in the Product Classification List in DMECS as A5513, other than those direct milled inserts that must be billed using K0903 (as described above), may continue to use code A5513 for Medicare billing.

Products which have not received coding verification review from the PDAC must be billed to Medicare with code A9270 (NON-COVERED ITEM OR SERVICE).

PDAC coding reviews can take up to 90 days to complete. PDAC strongly encourages applicants to submit coding verification applications well in advance of the July 31, 2018, end-date to avoid disruption to the billing of their products. Manufacturers are also encouraged to be sure that coding applications clearly and unambiguously show that all applicable coding requirements are met. The PDAC coding verification application required for these products is the Therapeutic Shoes and Inserts for Diabetics.

Refer to the Therapeutic Shoes for Persons with Diabetes LCD and related Policy Article for additional information about coverage, documentation and HCPCS coding.