Therapeutic Shoes for Persons with Diabetes - Policy Article

**  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 required Face-to-Face Encounter and Written Order Prior to Delivery List
is available [here](https://www.cms.gov/Research-Statistics-Data-and-
Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-
Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment).  
  
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 14 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 (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 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. 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.