Article - Therapeutic Shoes for Persons with Diabetes - Policy Article (A52501)

There must be information in the medical records of the certifying physician that:Documents management of the beneficiarys diabetes; andDocuments detailed information about the condition (2a-2f listed above) that qualifies the beneficiary for coverage.The Certification Statement by itself does not meet this requirement for documentation in the medical records.The in-person evaluation of the beneficiary by the supplier at the time of selecting the items that will be provided (refer to Non-Medical Necessity Coverage and Payment Rules, criterion 4) must include at least the following:An examination of the beneficiarys feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.For all shoes, taking measurements of the beneficiarys feet.For custom molded shoes (A5501) and inserts (A5513 and A5514), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiarys feet that will be used in creating positive models of the feet.The in-person evaluation of the beneficiary by the supplier at the time of delivery (refer to Non-Medical Necessity Coverage and Payment Rules, criterion 5) must be conducted with the beneficiary wearing the shoes and inserts and must document that the shoes/inserts/modifications fit properly.The diagnosis code that justifies the need for these items must be included on the claim.MODIFIERSKX, GA, GY AND GZ MODIFIERS:Suppliers must add a KX modifier to codes for shoes, inserts, and modification only if criteria 1-5 in the Non-Medical Necessity Coverage and Payment Rules section have been met. This documentation must be available upon request. The Statement of Certifying Physician form is not sufficient to meet this requirement.If criteria 1-5 in the Non-Medical Necessity Coverage and Payment Rules section have not been met, the GY modifier must be added to each code.If a KX or appropriate GA, GY or GZ modifier is not included on the claim line, the claim line will be rejected as missing information.CODING GUIDELINESA depth shoe (A5500) is one that:Has a full length, heel-to-toe filler that when removed provides a minimum of 3/16" of additional depth used to accommodate custom-molded or customized inserts; andIs made from leather or other suitable material of equal quality; andHas some form of shoe closure; andIs available in full and half sizes with a minimum of three widths so that the sole is graded to the size and width of the upper portions of the shoe according to the American standard last sizing schedule or its equivalent. (The American last sizing schedule is the numerical shoe sizing system used for shoes in the United States.)The shoe may or may not have an internally seamless toe.A custom-molded shoe (A5501) is one that:Is constructed over a positive model of the beneficiary's foot; andIs made from leather or other suitable material of equal quality; andHas removable inserts that can be altered or replaced as the beneficiary's condition warrants; andHas some form of shoe closure.The shoe may or may not have an internally seamless toe.Code A5512 describes a total contact, multiple density, prefabricated removable inlay that is directly molded to the beneficiarys foot. Direct molded means it has been conformed by molding directly to match the plantar surface of the individual beneficiarys 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  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.Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a model of the beneficiarys 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 beneficiarys 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 beneficiarys condition.CodeA5514 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.TheA5514 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.Rigid rocker bottoms (A5503) are exterior elevations with apex position for 51 percent to 75 percent distance measured from the back end of the heel. The apex is a narrowed or pointed end of an anatomical structure. The apex must be positioned behind the metatarsal heads and tapering off sharply to the front tip of the sole. Apex height helps to eliminate pressure at the metatarsal heads. Rigidity is ensured by the steel in the shoe. The heel of the shoe tapers off in the back in order to cause the heel to strike in the middle of the heel.Roller bottoms (sole or bar) (A5503) are the same as rocker bottoms, but the heel is tapered from the apex to the front tip of the sole.Wedges (posting) (A5504) are either of hind foot, fore foot, or both and may be in the middle or to the side. The function is to shift or transfer weight bearing upon standing or during ambulation to the opposite side for added support, stabilization, equalized weight distribution, or balance.Metatarsal bars (A5505) are exterior bars which are placed behind the metatarsal heads in order to remove pressure from the metatarsal heads. The bars are of various shapes, heights, and construction depending on the exact purpose.Offset heel (A5506) is a heel flanged at its base either in the middle, to the side, or a combination, that is then extended upward to the shoe in order to stabilize extreme positions of the hind foot.A deluxe feature (A5508) does not contribute to the therapeutic function of the shoe. It may include, but is not limited to style, color, or type of leather.Code A5507 is only to be used for not otherwise specified therapeutic modifications to the shoe or for repairs to a diabetic shoe(s).Deluxe features must be coded using code A5508.Codes for inserts or modifications (A5503, A5504, A5505, A5506, A5507, A5508, A5510, A5512, A5513, A5514) may only be used for items related to diabetic shoes (A5500, A5501). They must not be used for items related to footwear coded with codes L3215, L3216, L3217, L3219, L3221, L3222, L3224, L3225, L3230, L3250, L3251, L3252, L3253. Inserts and modifications used with L-coded footwear must be coded using L codes (refer to the Orthopedic Footwear LCD and LCD-related Policy Article for more information).The right (RT) and/or left (LT) modifiers must be used when billing shoes, inserts, or modifications. Effective for claims with dates of service (DOS) on or after 3/1/2019, if bilateral items arebilled on the same date of service, billeach item on two separate claim lines using the RT and LT modifiers and 1 unit of service (UOS) on each claim line. Do not use the RTLT modifier on the same claim line and billed with 2 UOS. Claims billed without modifiers RT and/or LT,or with RTLT on the same claim line and 2 UOS,will be rejected as incorrect coding.Inserts for missing toes or partial foot amputation should be coded L5000 or L5999, whichever is applicable. When seeking coverage for devices for missing toes and partial foot amputations under the prosthetic devices benefit category, refer to the Lower Limb Prostheses LCD and LCD-related Policy Article for the applicable coding, coverage, and payment requirements.The only products that may be billed using codes A5512 are those that are specified in the Product Classification List (PCL) on the Pricing, Data Analysis, and Coding (PDAC) contractor web site.There are two categories of products that are billed with code 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 web site.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 web site 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 codes A5514 are those that are specified in the PCL on the PDAC contractor web site.If an insert is not included in one of these categories of items (A5512, A5513, A5514), it must be billed with code A5510 or A9270 (noncovered item).If a product is billed to Medicare using a HCPCS code that requires written coding verification review, but the product is not on the PCL for that particular HCPCS code, then the claim line will be denied as incorrect coding.Suppliers should contact the PDAC contractor for guidance on the correct coding of these items.