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NON-MEDICAL
NECESSITY COVERAGE AND PAYMENT RULES
For an item addressed in this policy to be covered by Medicare, a written
signed and dated order must be received by the supplier prior to claim
submission. If the supplier bills for an item without first receiving the
completed order, the item will be denied as noncovered.
Therapeutic shoes, inserts and/or modifications to therapeutic shoes are
covered if the following criteria are met:
1) The patient has diabetes mellitus (ICD-9 diagnosis codes 250.00-250.93);
and
2) The patient has one or more of the following conditions:
- Previous amputation of the other foot, or
part of either foot, or
- History of previous foot ulceration of
either foot, or
- History of pre-ulcerative calluses of
either foot, or
- Peripheral neuropathy with evidence of
callus formation of either foot, or
- Foot deformity of either foot, or
- Poor circulation in either foot; and
3) The certifying physician who is managing the patient's systemic diabetes
condition has certified that indications (1) and (2) are met and that
he/she is treating the patient under a comprehensive plan of care for
his/her diabetes and that the patient needs diabetic shoes.
If criteria 1, 2 or 3 are not met, the therapeutic shoes, inserts and/or
modifications to therapeutic shoes will be denied as noncovered. When codes
are billed without a KX modifier (see Documentation section of accompanying
Local Coverage Determination), they will be denied as noncovered.
For patients meeting the coverage criteria, coverage is limited to one of
the following within one calendar year (January – December):
1) One pair of custom molded shoes (A5501) (which includes inserts provided
with these shoes) and 2 additional pairs of inserts (A5512 or A5513); or
2) One pair of depth shoes (A5500) and 3 pairs of inserts (A5512 or A5513)
(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
patient'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 physician are processed by the local carrier.
The particular type of footwear (shoes, inserts, modifications) which is
necessary must be prescribed by a podiatrist or other qualified physician,
knowledgeable in the fitting of diabetic shoes and inserts. The footwear
must be fitted and furnished by a podiatrist, or other qualified individual
such as a pedorthist, orthotist or prosthetist.
The Certifying Physician provides the medical care for and manages the
beneficiary’s systemic diabetic condition. The certifying physician must be
an M.D. or D.O. and may not be a podiatrist, physician assistant, nurse
practitioner, or clinical nurse specialist. The certifying physician may
not furnish the footwear unless he/she practices in a defined rural area or
a defined health professional shortage area.
The Prescribing Physician actually writes the order for the therapeutic
shoe, modifications and inserts. The prescribing physician may be a
podiatrist, M.D., D.O., physician assistant, nurse practitioner, or
clinical nurse specialist The prescribing physician can 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 Physician 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.
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.
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; 2) is made from leather
or other suitable material of equal quality; 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.) This
includes a shoe with or without an internally seamless toe.
A custom-molded shoe (A5501) is one that 1) is constructed over a positive
model of the patient's foot; 2) is made from leather or other suitable
material of equal quality; 3) has removable inserts that can be altered or
replaced as the patient's condition warrants; and 4) has some form of shoe
closure. This includes a shoe with or without an internally seamless toe.
Code A5512 describes a total contact, multiple density, prefabricated
removable inlay that is directly molded to the patient’s foot. Direct
molded means it has been conformed by molding directly to match the plantar
surface of the individual patient’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 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 patient’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 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 patient’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 patient’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 – A5508, A5510, A5512, A5513) 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 - L3253.
Inserts and modifications used with L coded footwear must be coded using L
codes (L3000 - L3649).
When a single shoe, insert or modification is provided, the appropriate
modifier, right (RT) or left (LT), must be used. If a pair is provided,
report as two (2) units of service on the claim – the RT or LT modifiers
should not be used.
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 or A5513 are those
that are specified in the Product Classification List on the SADMERC web
site. If an insert is not on the list, it must be billed with code A5510 or
A9270 (noncovered item). Information concerning the documentation that must
be submitted to the SADMERC for a Coding Verification Review can be found
on the SADMERC web site or by contacting the SADMERC.
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