NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES

For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).

Therapeutic Shoes and inserts are covered under the Therapeutic Shoes for Individuals with Diabetes benefit (Social Security Act §1861(s)(12)). In order for a beneficiary’s equipment to be eligible for reimbursement the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.

For an item addressed in this policy to be covered by Medicare, a Standard Written Order (SWO) must be communicated to the supplier prior to claim submission. If the supplier bills for an item without first receiving the SWO, the item will be denied as statutorily noncovered.

The Certifying Physician is defined as a doctor of medicine (M.D.) or a doctor of osteopathy (D.O.) who is responsible for diagnosing and treating the beneficiary’s diabetic systemic condition through a comprehensive plan of care. The certifying physician may not be a podiatrist or clinical nurse specialist. Consequent to the M.D. or D.O. restriction, a nurse practitioner (NP) and a physician assistant (PA) may not serve in the role of the certifying physician, unless practicing “incident to” the supervising physician’s authority, as described below.

NPs or PAs providing ancillary services as auxiliary personnel could meet the “incident to” requirements in their provision of therapeutic shoes to beneficiaries with diabetes if all of the following criteria are met:

1. The supervising physician has documented in the medical record that the patient is diabetic and has been, and continues to provide, the patient follow-up under a comprehensive management program of that condition; and,
2. The NP or PA certifies that the provision of the therapeutic shoes is part of the comprehensive treatment plan being provided to the patient; and,
3. The supervising physician must review and verify (sign and date) all of the NP or PA notes in the medical record pertaining to the provision of the therapeutic shoes, acknowledging their agreement with the actions of the NP or PA.

In states where the NP may practice independently, the NP’s employment situation would require compliance with Medicare “incident to” rules in order to serve as the certifying physician. Please refer to the applicable A/B MAC for further information.

The Prescribing Practitioner is the person who actually writes the order for the therapeutic shoe, modifications and inserts. This practitioner must be knowledgeable in the fitting of diabetic shoes and inserts. The prescribing practitioner may be a podiatrist, M.D., D.O., physician assistant, nurse practitioner, or clinical nurse specialist. The prescribing practitioner may be the supplier (i.e., the one who furnishes the footwear).

The Supplier is the person or entity that actually furnishes the shoe, modification, and/or insert to the beneficiary and that bills Medicare. The supplier may be a podiatrist, pedorthist, orthotist, prosthetist or other qualified individual. The Prescribing Practitioner may be the supplier. The Certifying Physician may only be the supplier if the certifying physician is practicing in a defined rural area or a defined health professional shortage area.

Therapeutic shoes, inserts and/or modifications to therapeutic shoes are covered if all of the following criteria are met:

1. The beneficiary has diabetes mellitus (Reference diagnosis code section below); and
2. The certifying physician has documented in the beneficiary's medical record one or more of the following conditions: 
   1. Previous amputation of the other foot, or part of either foot, or
   2. History of previous foot ulceration of either foot, or
   3. History of pre-ulcerative calluses of either foot, or
   4. Peripheral neuropathy with evidence of callus formation of either foot, or
   5. Foot deformity of either foot, or
   6. Poor circulation in either foot; and
3. The certifying physician has certified that indications (1) and (2) are met and that he/she is treating the beneficiary under a comprehensive plan of care for his/her diabetes and that the beneficiary needs diabetic shoes. For claims with dates of service on or after 01/01/2011, the certifying physician must:
   • Have an in-person visit with the beneficiary during which diabetes management is addressed within 6 months prior to delivery of the shoes/inserts; and
   • Sign the certification statement (refer to the Policy Specific Documentation Requirements section below) on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts.
4. Prior to selecting the specific items that will be provided, the supplier must conduct and document an in-person evaluation of the beneficiary. (Refer to the Policy Specific Documentation Requirements section below.)
5. At the time of in-person delivery to the beneficiary of the items selected, the supplier must conduct an objective assessment of the fit of the shoe and inserts and document the results. A beneficiary’s subjective statements regarding fit as the sole documentation of the in-person delivery does not meet this criterion.

If criteria 1-5 are not met, the therapeutic shoes, inserts and/or modifications will be denied as noncovered. When codes are billed without a KX modifier (see Policy Specific Documentation Requirements section below), they will be denied as noncovered.

In order to meet criterion 2, the certifying physician must either:

1. Personally document one or more of criteria a – f in the medical record of an in-person visit within 6 months prior to delivery of the shoes/inserts and prior to or on the same day as signing the certification statement; or
2. Obtain, initial, date (prior to signing the certification statement), and indicate agreement with information from the medical records of an in-person visit with a podiatrist, other M.D or D.O., physician assistant, nurse practitioner, or clinical nurse specialist that is within 6 months prior to delivery of the shoes/inserts, and that documents one of more of criteria a – f.

The requirement that the in-person visit(s) be within 6 months prior to delivery of the shoes/inserts is effective for claims with dates of service on or after 1/1/2011.

Note: The certification statement is not sufficient to meet the requirement for documentation in the medical record.

Depending on the items ordered, both the evaluation and delivery could occur on the same day if the supplier had both a sufficient array of sizes and types of shoes/inserts and adequate equipment on site to provide the items that meet the beneficiary’s needs. Both components of the visit (criteria 4 and 5 above) must be clearly documented.

For claims with dates of service on or after 1/1/2011, there must be an in-person visit with the prescribing practitioner within 6 months prior to delivery of the shoes/inserts.

For beneficiaries meeting the coverage criteria, coverage is limited to one of the following within one calendar year (January – December):

• One pair of custom molded shoes (A5501) (which includes inserts provided with these shoes) and 2 additional pairs of inserts (A5512, A5513, or A5514); or
• One pair of depth shoes (A5500) and 3 pairs of inserts (A5512, A5513, or A5514) (not including the non-customized removable inserts provided with such shoes).

A modification of a custom molded or depth shoe may be covered as a substitute for an insert. Although not intended as a comprehensive list, the following are the most common shoe modifications: rigid rocker bottoms (A5503), roller bottoms (A5503), wedges (A5504), metatarsal bars (A5505), or offset heels (A5506). Other modifications to diabetic shoes (A5507) include, but are not limited to flared heels.

Quantities of shoes, inserts, and/or modifications greater than those listed above will be denied as noncovered.

Items represented by code A5510 reflect compression molding to the beneficiary's foot over time through the heat and pressure generated by wearing a shoe with the insert present. Since these inserts are not considered total contact at the time of dispensing, they do not meet the requirements of the benefit category and will be denied as noncovered.

Inserts used in noncovered shoes are noncovered.

Deluxe features of diabetic shoes (A5508) will be denied as noncovered.

There is no separate payment for the fitting of the shoes, inserts or modifications or for the certification of need or prescription of the footwear. Claims for unrelated evaluation and management services provided by the practitioner are processed by the local carrier.

Shoes are also covered if they are an integral part of a covered leg brace. However, different codes are used for footwear provided under this benefit. See the medical policy on Orthopedic Footwear for details.

REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)

Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The link will be located here once it is available.

Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.

If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD, it will be eligible for coverage.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.

Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.

An order for each item billed must be signed and dated by the prescribing practitioner, kept on file by the supplier, and made available upon request. Items billed before a signed and dated order has been received by the supplier must be submitted with an EY modifier added to each affected HCPCS code.

If the prescribing practitioner is the supplier, a separate order is not required, but the item provided must be clearly noted in the beneficiary's record.

A new order is not required for the replacement of an insert or modification within one year of the order on file. However, the supplier's records should document the reason for the replacement. A new order is required for the replacement of any shoe. A new order is also required for the replacement of an insert or modification more than one year from the most recent order on file. The SWO must be signed on or after the date of the visit with the Prescribing Practitioner.

The supplier must obtain a signed statement from the practitioner who is personally managing the beneficiary’s systemic diabetes condition (i.e., the certifying physician) specifying that the beneficiary has diabetes mellitus, has one of conditions 2a-2f above, is being treated under a comprehensive plan of care for his/her diabetes, and needs diabetic shoes. The certifying physician must be an M.D. or D.O and may not be a podiatrist or clinical nurse specialist. An NP or PA may not serve in the role of the certifying physician, unless practicing “incident to” the supervising physician’s authority.

The "Statement of Certifying Physician for Therapeutic Shoes" form (see related LCD Attachments section) is recommended. Whatever form is used must contain all of the elements contained on the recommended form attached to the related LCD. This statement must be completed, signed, and dated by the certifying physician. If an NP or PA is practicing “incident to” a supervising physician, the NP or PA completes, signs, and dates the statement; however, the supervising physician (M.D. or D.O.) must review and verify (sign and date), acknowledging agreement with the NP or PA. A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file.

There must be information in the medical records of the certifying physician that:

1. Documents management of the beneficiary’s diabetes; and
2. Documents 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:

1. An examination of the beneficiary’s feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications.
2. For all shoes, taking measurements of the beneficiary’s feet.
3. For custom molded shoes (A5501) and inserts (A5513 and A5514), taking impressions, making casts, or obtaining CAD-CAM images of the beneficiary’s 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.


MODIFIERS

KX, 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 GUIDELINES

A depth shoe (A5500) is one that:

1. 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; and
2. Is made from leather or other suitable material of equal quality; and
3. Has some form of shoe closure; and
4. Is 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:

1. Is constructed over a positive model of the beneficiary's foot; and
2. Is made from leather or other suitable material of equal quality; and
3. Has removable inserts that can be altered or replaced as the beneficiary's condition warrants; and
4. Has 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 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.

Code A5513 describes a total contact, custom fabricated, multiple density, removable inlay that is molded to a 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.

Code A5514 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 A5514 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 (L3000, L3001, L3002, L3003, L3010, L3020, L3030, L3031, L3040, L3050, L3060, L3070, L3080, L3090, L3100, L3140, L3150, L3160, L3170, L3201, L3202, L3203, L3204, L3206, L3207, L3208, L3209, L3211, L3212, L3213, L3214, L3215, L3216, L3217, L3219, L3221, L3222, L3224, L3225, L3230, L3250, L3251, L3252, L3253, L3254, L3255, L3257, L3260, L3265, L3300, L3310, L3320, L3330, L3332, L3334, L3340, L3350, L3360, L3370, L3380, L3390, L3400, L3410, L3420, L3430, L3440, L3450, L3455, L3460, L3465, L3470, L3480, L3485, L3500, L3510, L3520, L3530, L3540, L3550, L3560, L3570, L3580, L3590, L3595, L3600, L3610, L3620, L3630, L3640, L3649).

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 are billed on the same date of service, bill each 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.

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.