Ankle-Foot/Knee-Ankle-Foot Orthoses - 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").  
  
For a beneficiary's orthosis 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.  
  
Ankle-foot orthoses (AFO) and knee-ankle-foot orthoses (KAFO) are covered
under the Medicare braces benefit (Social Security Act 1861(s)(9)). For
coverage under this benefit, the orthosis must be a rigid or semi-rigid
device, which is used for the purpose of supporting a weak or deformed body
member or restricting or eliminating motion in a diseased or injured part of
the body. Items that are not sufficiently rigid to be capable of providing the
necessary immobilization or support to the body part for which it is designed
do not meet the statutory definition of the braces benefit. Items that do not
meet the definition of a brace are statutorily noncovered, no benefit.  
  
Both "off-the-shelf" (OTS) and custom-fit items are considered prefabricated
braces for Medicare coding purposes. 42 CFR 414.402 establishes that correct
coding of AFO and KAFO items is dependent upon whether there is a need for
"minimal self-adjustment" during the final fitting at the time of delivery.
(See definitions below in CODING GUIDELINES.) If a custom fit code is billed
when minimal self-adjustment was provided at the final delivery, or if an OTS
code is billed when more than minimal self-adjustments were made at the final
delivery, the claims will be denied as incorrect coding.

A static/dynamic ankle-foot orthosis (AFO) (L4396, L4397) and replacement
interface (L4392) are denied as noncovered (no Medicare benefit) when they are
used solely for the prevention or treatment of a heel pressure ulcer because
for these indications they are not used to support a weak or deformed body
member or to restrict or eliminate motion in a diseased or injured part of the
body (i.e., it does not meet the definition of a brace).  
  
A foot drop splint/recumbent positioning device (L4398) and replacement
interface (L4394) are denied as noncovered (no Medicare benefit) when they are
used solely for the prevention or treatment of a pressure ulcer because for
these indications they are not used to support a weak or deformed body member
or to restrict or eliminate motion in a diseased or injured part of the body
(i.e., it does not meet the definition of a brace).  
  
Elastic or other fabric support garments (A4467 (BELT, STRAP, SLEEVE, GARMENT,
OR COVERING, ANY TYPE)) with or without stays or panels do not meet the
statutory definition of a brace because they are not rigid or semi-rigid
devices. Code A4467 is denied as noncovered (no Medicare benefit). Refer to
the CODING GUIDELINES section below for additional information.  
  
A foot pressure off-loading/supportive device (A9283) is denied as noncovered
(no Medicare benefit), because it does not support a weak or deformed body
member or restrict or eliminate motion in a diseased or injured part of the
body.  
  
An inversion/eversion correction device (A9285) is denied as noncovered (no
Medicare benefit), because it does not act as a brace; that is, it does not
support a weak or deformed body member or restrict or eliminate motion in a
diseased or injured part of the body.  
  
Socks (L2840, L2850) used in conjunction with orthoses are denied as
noncovered (no Medicare benefit).  
  
Refer to the Orthopedic Footwear policy for information on coverage of shoes
and related items which are an integral part of a brace.  
  
There is no separate payment for computer-aided design/computer-aided
manufacturing (CAD/CAM) technology when it is used to fabricate an orthosis.
Reimbursement, of the CAD/CAM technology utilized in the fabrication of an
orthosis, is included in the allowance of the orthosis HCPCS code.  
  
Evaluation of the beneficiary, measurement and/or casting, and
fitting/adjustments of the orthosis are included in the allowance for the
orthosis. There is no separate payment for these services.  
  
Payment for ankle-foot orthoses or knee-ankle foot orthoses are included in
the payment to a hospital or skilled nursing facility (SNF) if:

  1. The orthosis is provided to a beneficiary prior to an inpatient hospital admission or Part A covered SNF stay; and,

  2. The medical necessity for the orthosis begins during the hospital or SNF stay (e.g., after ankle, foot, or knee surgery).

A claim should not be submitted to the DME MAC in this situation.  
  
Payment for ankle-foot orthoses or knee-ankle foot orthoses are also included
in the payment to a hospital or a Part A covered SNF stay if:

  1. The orthosis is provided to a beneficiary during an inpatient hospital or Part A covered SNF stay prior to the day of discharge; and,

  2. The beneficiary uses the item for medically necessary inpatient treatment or rehabilitation.

A claim must not be submitted to the DME MAC in this situation.  
  
Payment for ankle-foot orthoses or knee-ankle foot orthoses delivered to a
beneficiary in a hospital or a Part A covered SNF stay is eligible for
coverage by the DME MAC if:

  1. The orthosis is medically necessary for a beneficiary after discharge from a hospital or Part A covered SNF stay; and,

  2. The orthosis is provided to the beneficiary within two days prior to discharge to home; and,

  3. The orthosis is not needed for inpatient treatment or rehabilitation but is left in the room for the beneficiary to take home.

  
**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.  
  
 **General Requirements**  
  
The supplier must include on the claim line the diagnosis code(s) for HCPCS
codes L4396, L4397, L4392 and L4631.  
  
For a custom-fabricated orthosis, there must be documentation in the
supplier's records to support the medical necessity of that type of device
rather than a prefabricated orthosis. This information must be available upon
request.  
  
When providing orthoses suppliers must:

  * Provide the product that is specified by the treating practitioner

  * Be sure that the treating practitioner's medical record justifies the need for the type of product (i.e., prefabricated versus custom fabricated)

  * Only bill for the HCPCS code that accurately reflects both the type of orthosis and the appropriate level of fitting

  * Have detailed documentation in the supplier's record that justifies the code selected

For prefabricated orthoses (L1902, L1906, L1910, L1930, L1932, L1951, L1971,
L2035, L2112, L2114, L2116, L2132, L2134, L2136, L4350, L4360, L4361, L4370,
L4386, L4387, L4396, L4397, L4398), there is no physical difference between
orthoses coded as custom fitted versus those coded as OTS. The differentiating
factor for proper coding (see definitions in CODING GUIDELINES section below)
is the need for "minimal self-adjustment" at the time of fitting by the
beneficiary, caretaker for the beneficiary, or supplier. This minimal self-
adjustment does not require the services of a certified orthotist or an
individual who has specialized training (as defined in the CODING GUIDELINES
section). Items requiring minimal self-adjustment are coded as OTS orthoses.
For example, adjustment of straps and closures, bending or trimming for final
fit or comfort (not all-inclusive) fall into this category.  
  
Fabrication of an orthosis using CAD/CAM or similar technology without the
creation of a positive model with minimal self-adjustment at delivery is
considered as OTS.  
  
Items requiring more than minimal self-adjustment by a qualified practitioner
(as defined in the CODING GUIDELINES below) are coded as custom fitted (L1910,
L1930, L1932, L1951, L1971, L2035, L2112, L2114, L2116, L2132, L2134, L2136,
L4360, L4386, L4396). Documentation must be sufficiently detailed to include,
but is not limited to, a detailed description of the modifications necessary
at the time of fitting the orthosis to the beneficiary. This information must
be available upon request.  
  
For a custom fabricated orthosis (L1900, L1904, L1907, L1920, L1940, L1945,
L1950, L1960, L1970, L1980, L1990, L2000, L2005, L2006, L2010, L2020, L2030,
L2034, L2036, L2037, L2038, L2106, L2108, L2126, L2128, L4631), there must be
detailed documentation in the treating practitioner's records to support the
medical necessity of the custom fabricated orthosis rather than a
prefabricated orthosis as described in the Coverage Indications, Limitations,
and/or Medical Necessity section of the related LCD. This information will be
corroborated by the functional evaluation in the orthotist's records and the
method of custom fabrication should adhere to the DMEPOS Quality Standards,
Appendix C. This information must be available upon request.  
  
MODIFIERS  
  
GA, GZ, KX, LT, and RT MODIFIERS:  
  
Suppliers must add a KX modifier to the AFO/KAFO base and addition codes only
if all of the coverage criteria in the "Coverage Indications, Limitations,
and/or Medical Necessity" section in the related LCD have been met and
evidence of such is retained in the supplier's files and available to the DME
MAC upon request.  
  
If all of the criteria in the "Coverage Indications, Limitations, and/or
Medical Necessity" section of the related LCD have not been met, the GA or GZ
modifier must be added to the code. When there is an expectation of a medical
necessity denial, suppliers must enter the GA modifier on the claim line if
they have obtained a properly executed Advance Beneficiary Notice (ABN) or the
GZ modifier if they have not obtained a valid ABN.  
  
Claim lines billed with codes without a KX, GA or GZ modifier will be rejected
as missing information.

The right (RT) and left (LT) modifiers must be used with orthosis base codes,
additions, and replacement parts. Effective for claims with dates of service
(DOS) on or after 3/1/2019, when the same code for bilateral items (left and
right) is 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.  
  
MISCELLANEOUS  
  
If the item is custom fabricated and does not have a specific HCPCS code, a
complete and clear description of the item, including what makes this item
unique, and a breakdown of charges (material and labor used in fabrication)
should be entered in the narrative field of an electronic claim or on Item 19
of a paper claim. (Refer to the LCD-related Standard Documentation
Requirements article (A55426) for more information regarding billing of items
with HCPCS codes that include miscellaneous, NOC, unlisted, or non-specified
in their narrative descriptions.)  
  
A claim for code L4205 must include an explanation of what is being repaired.
A claim for code L4210 must include a description of each item that is billed.
This information should be entered in the narrative field of an electronic
claim. (Refer to the REPAIR/REPLACEMENT section for more information regarding
billing of L4205 and L4210 HCPCS codes.)  
  
All codes for orthoses or repairs of orthoses billed with the same date of
service must be submitted on the same claim.  
  
Refer to the Orthopedic Footwear policy for information on documentation
requirements for shoes and related items which are an integral part of a
brace.  
  
 **CODING GUIDELINES**

CUSTOM FABRICATED

A custom fabricated item is one that is individually made for a specific
patient. No other patient would be able to use this item. A custom fabricated
item is a device which is fabricated based on clinically derived and rectified
castings, tracings, measurements, and/or other images (such as X-rays) of the
body part.

The fabrication may involve using calculations, templates, and components.
This process requires the use of basic materials including, but not limited
to, plastic, metal, leather, or cloth in the form of uncut or unshaped sheets,
bars, or other basic forms and involves substantial work such as vacuum
forming, cutting, bending, molding, sewing, drilling, and finishing prior to
fitting on the patient. Custom-fabricated additions are appropriate only for
custom-fabricated base orthotics and should not be billed with prefabricated
base orthotics.

Molded-to-Patient-Model

A particular type of custom fabricated device in which either:

  * An impression (usually by means of a plaster or fiberglass cast) of the specific body part is made directly on the patient, and this impression is then used to make a positive model of the body part from which the final product is crafted; or,
  * A digital image of the patient's body part is made using CAD/CAM systems software. This technology includes specialized probes/digitizers and scanners that create a computerized positive model, and then direct milling equipment to carve a positive model. The device is then individually fabricated and molded over the positive model of the patient.

Positive Model of the Patient

A positive model is an exact replica of the actual body part for which the
custom fabricated item is being constructed. A positive model can be produced
by any of these methods:

  * Molded-to-patient-model, which is a negative impression taken of the patient's body member and which is used to make a positive model rectification.
  * CAD/CAM software, which uses digitizers to send surface contour data the practitioner uses to rectify or modify the model on the computer screen. The data showing the modified shape goes to a commercial milling machine that carves the rectified model.
  * Direct formed model, in which the patient serves as the positive model. The device is constructed over the patient's model, and is then fabricated to the patient. The completed custom fabrication is checked and all necessary adjustments are made.

An orthosis that is fabricated from a mold, CAD/CAM, or similar technology but
without the creation of a positive model is considered a prefabricated
orthosis.

Specialized Training

Specialized training is defined as training that provides knowledge, skills,
and experience in the provision of orthotics in compliance with all applicable
Federal and State licensure and regulatory requirements.

PREFABRICATED

A prefabricated orthosis is an item that is manufactured in quantity without a
specific beneficiary in mind. A prefabricated orthosis may be considered an
OTS or a custom fitted device that may be trimmed, bent, molded (with or
without heat), or otherwise modified for use by a specific beneficiary. An
orthosis that is assembled from prefabricated components is considered
prefabricated. It is inherent in the definition of prefabricated that a
particular item is complete.

Off-the-shelf (OTS) orthotics are:

  * Items that are prefabricated.
  * They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
  * OTS items require minimal self-adjustment for fitting at the time of delivery for appropriate use and do not require expertise in trimming, bending, and molding, assembling, or customizing to fit an individual.
  * This fitting does not require expertise of a certified orthotist or an individual who has specialized training in the provision of orthoses to fit the item to the individual beneficiary.

The term "minimal self-adjustment" is defined at 42 CFR 414.402 as an
adjustment the beneficiary, caregiver for the beneficiary, or supplier of the
device can perform and that does not require the services of a certified
orthotist (that is, an individual who is certified by the American Board for
Certification in Orthotics and Prosthetics, Inc., or by the Board for
Orthotist/Prosthetist Certification) or an individual who has specialized
training. For example, adjustment of straps and closures, bending or trimming
for final fit or comfort (not all-inclusive) fall into this category. See
"more than minimal self-adjustment" definition below for additional
information.  
  
Use of CAD/CAM or similar technology to create an orthosis without a positive
model of the patient is considered as OTS if the final fitting upon delivery
to the patient requires minimal self-adjustment not requiring expertise as
described in this section.  
  
Custom fitted orthotics are:

  * Devices that are prefabricated.
  * They may or may not be supplied as a kit that requires some assembly. Assembly of the item and/or installation of add-on components and/or the use of some basic materials in preparation of the item does not change classification from OTS to custom fitted.
  * Classification as custom fitted requires more than minimal self-adjustment for fitting at the time of delivery in order to provide an individualized fit, i.e., the item must be trimmed, bent, molded (with or without heat), or otherwise modified resulting in alterations beyond minimal self-adjustment.
  * This fitting at delivery does require expertise of a certified orthotist or an individual who has specialized training in the provision of the orthosis to fit the item to the individual beneficiary.

In contrast to "minimal self-adjustment," "more than minimal self-adjustment"
is defined as changes made to achieve an individualized fit during the final
fitting at the time of delivery of the item that requires the expertise of a
certified orthotist or an individual who has equivalent specialized training
in the provision of orthotics in compliance with all applicable Federal and
State licensure and regulatory requirements. A certified orthotist is defined
as an individual who is certified by the American Board for Certification in
Orthotics and Prosthetics, Inc., or by the Board for Orthotist/Prosthetist
Certification.  
  
Correct coding of prefabricated orthoses is dictated by actions that take
place at the time of fitting to the beneficiary, either custom-fitted
(requiring expertise) or OTS (requiring minimal self-adjustment).

Use of CAD/CAM or similar technology to create an orthosis without a positive
model of the patient is considered as custom fitted if the final fitting at
the time of delivery to the patient requires more than minimal self-adjustment
requiring expertise as described in this section.

Corresponding HCPCS Code Sets

For many prefabricated orthoses, corresponding sets of HCPCS codes are
available which describe the identical types of items. The corresponding code
sets, when available for identical products, are only differentiated by the
nature of the final fitting performed at the time of delivery. The
corresponding HCPCS code types are:

  * HCPCS codes which describe "PREFABRICATED, OFF-THE-SHELF." These HCPCS codes must be used when minimal self-adjustment is the extent of the fitting performed at delivery.
  * HCPCS codes which describe "PREFABRICATED ITEM THAT HAS BEEN TRIMMED, BENT, MOLDED, ASSEMBLED, OR OTHERWISE CUSTOMIZED TO FIT A SPECIFIC PATIENT BY AN INDIVIDUAL WITH EXPERTISE." These HCPCS codes must be used when more than minimal self-adjustment is necessary and performed at delivery.

In the following table, the HCPCS codes located in Column I and Column II
within the same row are considered a corresponding HCPCS code set. These codes
represent identical products which are only differentiated by the nature of
the final fitting performed at the time of delivery.

**Column I** | **Column II**  
---|---  
L4360 | L4361  
L4386 | L4387  
L4396 | L4397  
  
  
For some prefabricated orthoses, corresponding sets of HCPCS codes (which
describe the identical types of items) are not available. HCPCS codes with
long descriptions of "PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT" describe
custom fitted items. For these HCPCS codes there are no corresponding OTS
codes. When the unique HCPCS code that most closely describes the product
includes "PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT" in the HCPCS long
description, the supplier must:

  * Code the product using the unique HCPCS code, if the product was custom fitted at the time of delivery to the beneficiary; or,
  * Code the product using a miscellaneous HCPCS code, if the product was not custom fitted at delivery to the beneficiary and, instead, was provided as OTS to the beneficiary. The miscellaneous HCPCS code for billing of AFOs and KAFOs is HCPCS code L2999.

Kits are:

  * A collection of components, materials, and parts that require further assembly before delivery of the final product.
  * The elements of a kit may be packaged and complete from a single source or may be an assemblage of separate components from multiple sources by the supplier.

ELASTIC AND SIMILAR STRETCHABLE MATERIALS

For items where the HCPCS code specifies "elastic" or other similar
terminology for stretchable material, use the code that is most applicable to
the item. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must
not be used instead of the specific code. Refer to the long code narrative and
any relevant coding guideline for the criteria applicable for each HCPCS code.  
  
For items where the HCPCS code does not specify elastic or other similar
terminology for stretchable material, the following guidelines apply:

  * Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra) (not all-inclusive)) must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).
  * Items that are primarily constructed of elastic or other stretchable materials (e.g. support items made of material such as neoprene or spandex (elastane, Lycra]) (not all-inclusive)) that contain stays and/or panels must be coded as A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).
  * Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).
  * Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) that are incapable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using A4467 (BELT, STRAP, SLEEVE, GARMENT, OR COVERING, ANY TYPE).
  * Items that are primarily constructed of inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and any relevant coding guideline for the criteria applicable for each HCPCS code.
  * Items that are primarily of constructed inelastic material (e.g., canvas, cotton or nylon (not all-inclusive)) capable of providing the necessary immobilization or support to the body part for which it is designed and that have stays and/or panels capable of providing the required immobilization or support to the body part for which it is designed, must be coded using the applicable specific HCPCS code for the type of product. A NOC (Not Otherwise Classified) or miscellaneous HCPCS code must not be used instead of the specific code. Refer to the long code narrative and relevant coding guideline for the criteria applicable for each HCPCS code.
  * Items that are not capable of providing the necessary immobilization or support to the body part for which it is designed (regardless of materials) must be coded using A9270 (NONCOVERED ITEM OR SERVICE).

ANKLE-FOOT-ORTHOSES

Ankle-foot orthoses described by codes L1900, L1910, L1920, L1930, L1932,
L1940, L1945, L1950, L1951, L1960, L1970, L1971, L1980, L1990, extend well
above the ankle (usually to near the top of the calf) and are fastened around
the lower leg above the ankle. These features distinguish them from foot
orthotics which are shoe inserts that do not extend above the ankle and ankle
gauntlets described by codes L1902, L1904, L1906, L1907.

L1900 (ANKLE FOOT ORTHOSIS, SPRING WIRE, DORSIFLEXION ASSIST CALF BAND, CUSTOM
FABRICATED) describes a custom fabricated AFO designed to control inversion,
eversion, dorsiflexion, and plantarflexion motions of the ankle foot complex.
Primary construction is of two springwire uprights, which are joined to a
rigid calf band/cuff, and a component for attaching the orthosis to the sole
of an orthopedic shoe. The springwire is contoured into a coiled spring below
the ankle and above the shoe sole. The height of the rigid calf band/cuff
terminates well-above the ankle (usually near the top of the calf) and the
band/cuff is fastened around the lower leg above the ankle. The coiled
springwire applies a spring force to resist plantarflexion motion and provide
dorsiflexion assist. Included in the code are closure components, and
attaching spring wire to the footwear. This AFO is custom fabricated per the
DMEPOS quality standards, Appendix C.

L1902 (ANKLE ORTHOSIS, ANKLE GAUNTLET OR SIMILAR, WITH OR WITHOUT JOINTS,
PREFABRICATED, OFF-THE-SHELF) describes a prefabricated ankle orthosis (AO)
designed to provide compression and resist motion of the ankle foot complex.
Primary construction is a sleeve type device (gauntlet) with or without
joints. The gauntlet encloses the foot and ankle from the longitudinal arch to
at least just above the malleoli. Gauntlet closure may be straps, hook and
loop, laces or equal. The orthosis may or may not include joints or hinges for
additional support. There are no additional HCPCS codes for this type of
prefabricated ankle orthosis.

L1904 (ANKLE ORTHOSIS, ANKLE GAUNTLET OR SIMILAR, WITH OR WITHOUT JOINTS,
CUSTOM FABRICATED) describes a custom fabricated AO designed to provide
compression and resist motion of the ankle foot complex. Primary construction
is a sleeve type device (gauntlet) with or without joints. The gauntlet
encloses the foot and ankle from the longitudinal arch to at least just above
the malleoli. Gauntlet closure may be straps, hook and loop, laces or equal.
The orthosis may or may not include joints or hinges for additional support.
This AO is custom fabricated per the DMEPOS quality standards, Appendix C.

L1906 (ANKLE FOOT ORTHOSIS, MULTILIGAMENTOUS, ANKLE SUPPORT, PREFABRICATED,
OFF-THE-SHELF) describes a prefabricated AFO which provides multi-directional
support to the ankle ligaments while allowing free dorsiflexion and
plantarflexion motion. Primary construction contains a rigid footplate with
integral ankle joints and uprights extending above and below the ankle joints.
Proximal uprights provide surface area contact for stabilization of the
footplate and ankle joints. Additional support is from wraparound straps.
Included in the code are closures from lacing, webbing, hook and loop, or
equal, and additional support strapping. There are no additional HCPCS codes
for this type of prefabricated ankle foot orthosis.

L1907 (ANKLE ORTHOSIS, SUPRAMALLEOLAR WITH STRAPS, WITH OR WITHOUT
INTERFACE/PADS, CUSTOM FABRICATED) describes a custom fabricated AO designed
to control motion of the ankle and mid-foot. Primary construction is of molded
plastic designed to control inversion and eversion, and horizontal rotation
motions while allowing dorsiflexion and plantarflexion motion of the ankle
joint. Included in the code are closure components, soft interface and
padding. Trim lines extend from tips of toes to just above the malleoli. This
AO is custom fabricated per the DMEPOS quality standards, Appendix C.

L1910 (ANKLE FOOT ORTHOSIS, POSTERIOR, SINGLE BAR, CLASP ATTACHMENT TO SHOE
COUNTER, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT) describes a
prefabricated AFO designed to control dorsiflexion and plantarflexion motions
of the ankle foot complex. Primary construction is a single flexible upright
utilizing a removable clasp-type component attached to the heel portion of a
shoe and a rigid calf band/cuff. Height of the rigid calf band/cuff terminates
well above the ankle (usually near the top of the calf) and is fastened around
the lower leg above the ankle. Included in the code are closure and clasp
components. There are no additional HCPCS codes for this type of prefabricated
ankle foot orthosis.

L1920 (ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT WITH STATIC OR ADJUSTABLE STOP
(PHELPS OR PERLSTEIN TYPE), CUSTOM FABRICATED) describes a custom fabricated
AFO designed to control only the plantarflexion motion of the ankle foot
complex. Primary construction is a single metal upright which has a pivoting
attachment into a sole component attached to an orthopedic shoe. The single
rigid upright is joined to a rigid calf band/cuff which terminates well-above
the ankle (usually near the top of the calf) and is fastened around the lower
leg above the ankle. The pivoting attachment has an integrated component(s) to
stop plantarflexion ankle motion while always allowing free dorsiflexion
motion. Included in the code are components for closures and attaching the
footwear. This AFO is custom fabricated per the DMEPOS quality standards,
Appendix C.

L1930 (ANKLE FOOT ORTHOSIS, PLASTIC OR OTHER MATERIAL, PREFABRICATED, INCLUDES
FITTING AND ADJUSTMENT) describes a prefabricated AFO designed to control
inversion, eversion, dorsiflexion, and plantarflexion motions of the ankle
foot complex. Primary construction is a rigid calf cuff and rigid foot plate
section joined by a flexible posterior strut. The foot plate must extend to
the metatarsal heads and may extend as far as the toe tips. Calf cuff height
terminates well-above the ankle (usually near the top of the calf) and is
fastened around the lower leg above the ankle and footplate may extend to toe
tip. This AFO is constructed from plastic or other materials. Included in the
code are closure components.

L1932 (AFO, RIGID ANTERIOR TIBIAL SECTION, TOTAL CARBON FIBER OR EQUAL
MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT) describes a
prefabricated AFO designed to control the dorsiflexion and plantarflexion, and
inversion and eversion, motions of the ankle foot complex. Primary
construction includes full length foot plate, rigid front shin shell that
extends from lower shin region to near tibial tubercle. Rigid strut connects
foot plate to shin shell. This AFO is constructed of carbon fiber or equal.
Included in the code are closure components and soft interface. There are no
additional HCPCS codes for this type of prefabricated ankle foot orthosis.

L1940 (ANKLE FOOT ORTHOSIS, PLASTIC OR OTHER MATERIAL, CUSTOM FABRICATED)
describes a custom fabricated AFO designed to control inversion, eversion,
dorsiflexion, and plantarflexion motions of the ankle foot complex. Primary
construction includes rigid foot plate, strut or equal component, which joins
footplate to a calf cuff. Calf cuff height terminates well above the ankle
(usually to near the top of the calf) and are fastened around the lower leg
above the ankle. This AFO can be constructed from flexible and strong
thermosetting materials, thermoplastics, or composite type materials. Included
in the code are closure components. This AFO is custom fabricated per the
DMEPOS quality standards, Appendix C.

L1945 (ANKLE-FOOT ORTHOSIS (AFO), PLASTIC, RIGID ANTERIOR TIBIAL SECTION
(FLOOR REACTION), CUSTOM FABRICATED) describes a custom fabricated AFO
designed to control inversion, eversion, dorsiflexion, plantarflexion, and
horizontal rotation motions of the ankle foot complex. Primary construction is
a plastic full-length rigid foot plate, rigid shell with Anterior calf cuff
typically extending from mid-shin region to tibial tubercle. Rigid strut
connects foot plate to shin shell. Shell cutouts are created to aid donning of
the AFO. This AFO is constructed of plastic materials. Included in the code
are closure components. This AFO is custom fabricated per the DMEPOS quality
standards, Appendix C.

L1950 (ANKLE FOOT ORTHOSIS, SPIRAL, (INSTITUTE OF REHABILITATIVE MEDICINE
TYPE), PLASTIC, CUSTOM FABRICATED) describes a custom fabricated AFO designed
to control inversion, eversion, dorsiflexion, plantarflexion, and horizontal
rotation motions of the ankle foot complex. Primary construction includes, at
minimum, a 90-degree spiral-shaped strut joining the rigid footplate to the
rigid calf cuff. Foot plate must extend to the metatarsal heads and may extend
as far as the toe tips. Calf cuff height terminates well above the ankle
(usually to near the top of the calf) and are fastened around the lower leg
above the ankle. This AFO can be constructed from flexible and strong
thermosetting materials, thermoplastics, or composite type materials. Included
in the code are closure components. This AFO is custom fabricated per the
DMEPOS quality standards, Appendix C.

L1951 (ANKLE FOOT ORTHOSIS, SPIRAL, (INSTITUTE OF REHABILITATIVE MEDICINE
TYPE), PLASTIC OR OTHER MATERIAL, PREFABRICATED, INCLUDES FITTING AND
ADJUSTMENT) describes a prefabricated AFO designed to control dorsiflexion and
plantarflexion motions of the ankle foot complex. Primary construction
includes, at minimum, a 90-degree spiral-shaped strut linking the footplate to
the rigid calf cuff. Foot plate must extend to the metatarsal heads and may
extend as far as the toe tips. Calf cuff height terminates well above the
ankle (usually to near the top of the calf) and are fastened around the lower
leg above the ankle. The AFO can be constructed from flexible and strong
thermosetting materials, thermoplastics, or composite type materials. Included
in the code are closure components. There are no additional HCPCS codes for
this type of prefabricated ankle foot orthosis.

L1960 (ANKLE FOOT ORTHOSIS, POSTERIOR SOLID ANKLE, PLASTIC, CUSTOM FABRICATED)
describes an AFO which provides ankle control for beneficiaries with
musculoskeletal or neuromuscular dysfunction. The AFO is designed to provide
rigid immobilization of the ankle-foot complex in the sagittal, coronal, and
transverse planes. The custom fabricated solid ankle AFO can be constructed
from thermosetting materials, thermoplastics, or composite type materials.
This AFO is custom fabricated per the DMEPOS quality standards, Appendix C.

L1970 (ANKLE FOOT ORTHOSIS, PLASTIC WITH ANKLE JOINT, CUSTOM FABRICATED **)**
describes a custom fabricated AFO designed to control inversion, eversion,
dorsiflexion, plantarflexion, and horizontal rotation motions of the ankle
foot complex. Primary construction is a rigid shell-like or equal structure
containing a hinge or joint mechanism. Structure contacts calf, lower leg, and
foot to provide control. Foot plate must extend to the metatarsal heads and
may extend as far as the toe tips. Calf cuff height terminates well above the
ankle (usually to near the top of the calf) and are fastened around the lower
leg above the ankle. This AFO can be constructed from thermosetting materials,
thermoplastics, or composite type materials. Included in the code are closure
components. This AFO is custom fabricated per the DMEPOS quality standards,
Appendix C.

L1971 (ANKLE FOOT ORTHOSIS, PLASTIC OR OTHER MATERIAL WITH ANKLE JOINT,
PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT) describes a prefabricated AFO
designed to control inversion, eversion, dorsiflexion, plantarflexion, and
horizontal rotation motions of the ankle foot complex. Primary construction is
a rigid shell-like or equal structure containing a hinge or joint mechanism.
Structure contacts calf, lower leg, and foot to provide control. Foot plate
must extend to the metatarsal heads and may extend as far as the toe tips.
Calf cuff height terminates well above the ankle. Included in the code are
closure components.  

L1980 (ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT FREE PLANTAR DORSIFLEXION, SOLID
STIRRUP, CALF BAND/CUFF (SINGLE BAR 'BK' ORTHOSIS), CUSTOM FABRICATED)
describes a custom fabricated AFO designed to control inversion and eversion
motions of the ankle foot complex. Primary construction is a single metal
upright (medial or lateral) joined to a rigid calf band, free motion ankle
joint, and stirrup component attached to an orthopedic shoe. Height of calf
cuff/band terminates well above the ankle (usually to near the top of the
calf) and is fastened around the lower leg above the ankle. Included in the
code are components for closures and attaching the footwear. This AFO is
custom fabricated per the DMEPOS quality standards, Appendix C.

L1990 (ANKLE FOOT ORTHOSIS, DOUBLE UPRIGHT FREE PLANTAR DORSIFLEXION, SOLID
STIRRUP, CALF BAND/CUFF (DOUBLE BAR 'BK' ORTHOSIS), CUSTOM FABRICATED)
describes a custom fabricated AFO designed to control inversion and eversion
motions of the ankle foot complex. Primary construction are two metal uprights
(medial and lateral) joined to a rigid calf band, free motion ankle joints,
and stirrup component attached to an orthopedic shoe. Height of calf cuff/band
terminates well above the ankle (usually to near the top of the calf) and is
fastened around the lower leg above the ankle. Included in the code are
components for closures and attaching the footwear. This AFO is custom
fabricated per the DMEPOS quality standards, Appendix C.

Code L4631 describes a Charcot's restraint orthotic walker (CROW) orthosis.
Code L4631 is a custom fabricated ankle-foot orthosis which has all of the
following characteristics:

  1. Designed to maintain the foot at a fixed position of 0 (i.e., perpendicular to the lower leg); and,

  2. Allows for varus or valgus deformity correction; and,

  3. Contains a rocker bottom sole with a custom arch support; and,

  4. Incorporates a rigid anterior tibial shell; and,

  5. Used by a beneficiary who is ambulatory; and,

  6. Has a soft interface

  7. Totally encapsulated.

Code L4631 includes all additions including straps and closures. No additional
codes may be billed with code L4631.

KNEE-ANKLE-FOOT ORTHOSES

L2005 (KNEE ANKLE FOOT ORTHOSIS, ANY MATERIAL, SINGLE OR DOUBLE UPRIGHT,
STANCE CONTROL, AUTOMATIC LOCK AND SWING PHASE RELEASE, ANY TYPE ACTIVATION,
INCLUDES ANKLE JOINT, ANY TYPE, CUSTOM FABRICATED) describes a custom
fabricated, single or double upright KAFO with an automatic lock and swing
phase release knee joint. Automatic knee lock is activated by any method such
as mechanical or electrical. The custom fabricated KAFO can be constructed
from thermosetting materials, thermoplastics, or composite type materials. It
includes any type ankle joint and closure components. There are no additional
add-on codes for L2005. This KAFO is custom fabricated per the DMEPOS Quality
Standards, Appendix C.

L2006 (KNEE ANKLE FOOT DEVICE, ANY MATERIAL, SINGLE OR DOUBLE UPRIGHT, SWING
AND STANCE PHASE MICROPROCESSOR CONTROL WITH ADJUSTABILITY, INCLUDES ALL
COMPONENTS (E.G., SENSORS, BATTERIES, CHARGER), ANY TYPE ACTIVATION, WITH OR
WITHOUT ANKLE JOINT(S), CUSTOM FABRICATED) describes a custom fabricated,
single or double upright KAFO with an adjustable microprocessor control
feature which provides resistance to stance and swing phase knee joint motion.
The custom fabricated KAFO can be constructed from thermosetting materials,
thermoplastics, or composite type materials. There are no additional add-on
codes for this KAFO. This KAFO is custom fabricated per the DMEPOS Quality
Standards, Appendix C.

L2034 (KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, SINGLE UPRIGHT, WITH OR WITHOUT
FREE MOTION KNEE, MEDIAL LATERAL ROTATION CONTROL, WITH OR WITHOUT FREE MOTION
ANKLE, CUSTOM FABRICATED) describes a custom fabricated, single upright KAFO
designed to control (1) knee flexion, extension, and rotation motions (2)
ankle inversion, eversion, dorsiflexion, plantarflexion, and rotation motions
of the ankle foot complex. Primary construction is a rigid shell-like or equal
structure which can be; (1) with or without free range of motion knee hinge or
joint mechanism; (2) with or without free range of motion ankle hinge(s).
Through a series of straps/supports that cross over and around the knee joint,
rotational control and varus or valgus force is exerted on the knee joint.
Structure contacts thigh, calf, lower leg, and foot to provide control. Foot
plate must extend to the metatarsal heads. The custom fabricated KAFO can be
constructed from thermosetting materials, thermoplastics, or composite type
materials. Included in the code are closure components. The predicate product
is the Generation II KAFO with hinged ankle manufactured by Generation II USA,
Inc. This KAFO is custom fabricated per the DMEPOS Quality Standards, Appendix
C.

L2036 (KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, DOUBLE UPRIGHT, WITH OR WITHOUT
FREE MOTION KNEE, WITH OR WITHOUT FREE MOTION ANKLE, CUSTOM FABRICATED)
describes a custom fabricated, double upright KAFO designed to control (1)
knee flexion, extension, rotation motions (2) ankle inversion, eversion,
dorsiflexion, plantarflexion, and rotation motions of the ankle foot complex.
Primary construction is a rigid shell-like or equal structure which can be
with or without free range of motion hinge or joint mechanisms at the knee
and/or ankle. Structure contacts thigh, calf, lower leg, and foot to provide
control. Foot plate must extend to the metatarsal heads. The custom fabricated
KAFO can be constructed from thermosetting materials, thermoplastics, or
composite type materials. Included in the code are closure components. This
KAFO is custom fabricated per the DMEPOS Quality Standards, Appendix C.

LOWER EXTREMITY ADDITIONS

Custom-fabricated additions are appropriate only for custom-fabricated base
orthotics and should not be billed with prefabricated base orthotics unless a
product has been previously assigned an addition code per PDAC/CMS prior to
1/1/2023. Correct coding with use of addition codes should not include, or
partially include, features or functions described by other codes billed for a
specific device.

L2200 (ADDITION TO LOWER EXTREMITY, LIMITED ANKLE MOTION, EACH JOINT)
describes an ankle joint product which can control dorsiflexion and/or
plantarflexion of the ankle joint. The range of motion is set during
fabrication. Joints can be deployed as a pair (two UOS) or singly (one UOS)
with appropriate custom fabricated AFO or KAFO. Product will be distinctly
identifiable from other components of the orthosis.

L2210 (ADDITION TO LOWER EXTREMITY, DORSIFLEXION ASSIST (PLANTAR FLEXION
RESIST), EACH JOINT) describes an ankle joint product which can control
plantarflexion of the ankle joint. The range of motion is adjustable post-
delivery of the orthosis. Initial setting is set by the supplier during
fabrication. Joints can be deployed as a pair (two UOS) or singly (one UOS)
with appropriate custom fabricated AFO or KAFO. Product will be distinctly
identifiable from other components of the orthosis.

L2220 (ADDITION TO LOWER EXTREMITY, DORSIFLEXION AND PLANTAR FLEXION
ASSIST/RESIST, EACH JOINT) describes an ankle joint product which can control
dorsiflexion and/or plantarflexion of the ankle joint. The range of motion is
adjustable post-delivery of the orthosis. Initial setting is set by the
supplier during fabrication. Joints can be deployed as a pair (two UOS) or
singly (one UOS) with appropriate custom fabricated AFO or KAFO. Product will
be distinctly identifiable from other components of the orthosis.

L2280 (ADDITION TO LOWER EXTREMITY, MOLDED INNER BOOT) describes a custom
molded device which encircles the ankle and to at least the mid-foot to
provide multi-directional support to the ankle foot complex with compression
from semi-rigid or rigid material(s). Inner boot is fully circumferential with
closure components included such as lacing/eyelets or hook/loop. Lacer
material and construction must conform to DMEPOS Quality Standards, Appendix
C.

L2330 (ADDITION TO LOWER EXTREMITY, LACER MOLDED TO PATIENT MODEL, FOR CUSTOM
FABRICATED ORTHOSIS ONLY) describes an upgrade to the cuff (including
closures) to cover the rigid structures of the orthosis. Custom fabrication
would capture shapes and contours of the anatomy to improve function of the
included cuff/closure component. Lacer is fully circumferential with closure
components included such as lacing/eyelets or hook/loop. Lacer material and
construction must conform to DMEPOS Quality Standards, Appendix C.

L2340 (ADDITION TO LOWER EXTREMITY, PRE-TIBIAL SHELL, MOLDED TO PATIENT MODEL)
is a pre-tibial shell, custom fabricated, that provides a rigid overlapping
interlocking anterior tibial control between the tibial tuberosity to a point
no greater than 3 inches proximal to the medial malleolus. The pre-tibial
shell can be constructed from thermosetting materials, thermoplastics, or
composite type materials.  
  
Code L2755 (ADDITION TO LOWER EXTREMITY ORTHOSIS, HIGH STRENGTH, LIGHTWEIGHT
MATERIAL, ALL HYBRID LAMINATION/PREPREG COMPOSITE, PER SEGMENT, FOR CUSTOM
FABRICATED ORTHOSIS ONLY) describes an addition to a lower extremity orthosis
composed of high strength and/or lightweight material such as Kevlar, carbon
fiber or other laminated or impregnated composite material.

L2820 (ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED
PLASTIC, BELOW KNEE SECTION) describes a moldable and compliant material which
has been fabricated as an integral part of a custom fabricated orthosis. The
interface is designed to allow cushioning and contouring over pressure-
sensitive areas of the limb in greater capacity than what may be included in
the base orthosis that is constructed from thermosetting materials,
thermoplastics, or composite type materials. The soft interface material and
construction must conform to DMEPOS Quality Standards, Appendix C.

POSITIONING DEVICES

A non-ambulatory ankle-foot orthosis may be either an ankle contracture
splint, night splint or a foot drop splint.  
  
A static or dynamic positioning ankle-foot orthosis (L4396, L4397) is a
prefabricated ankle-foot orthosis which has all of the following
characteristics:

  1. Designed to accommodate either plantar fasciitis or an ankle with a plantar flexion contracture up to 45; and,

  2. Applies a dorsiflexion force to the ankle; and,

  3. Used by a beneficiary who is minimally ambulatory, or non-ambulatory; and,

  4. Has a soft interface.

A foot drop splint/recumbent positioning device (L4398) is a prefabricated
ankle-foot orthosis which has all of the following characteristics:

  1. Designed to maintain the foot at a fixed position of 0 (i.e., perpendicular to the lower leg); and,

  2. Not designed to accommodate an ankle with a plantar flexion contracture; and,

  3. Used by a beneficiary who is non-ambulatory; and,

  4. Has a soft interface.

SHOE INSERTS

Foot orthoses are shoe inserts that do not extend above the ankle. Shoes,
inserts, and shoe modifications that are integral components of a leg brace
are referred to as orthopedic footwear (ORF). These shoes, inserts, and shoe
modifications are only covered if they are an integral part of a covered leg
brace that is described by HCPCS code L1900, L1920, L1980, L1990, L2000,
L2005, L2010, L2020, L2030, L2050, L2060, L2080, or L2090. In addition to
being an integral component of the covered leg brace, these products must also
be medically necessary for the proper functioning of the leg brace. When
billing for ORF, the leg brace and ORF must be billed by the same supplier
(refer to the Orthopedic Footwear policy for more information).

Multiple density foot orthotics that are provisioned in the treatment of a
beneficiary's diabetes-related condition(s), must not be billed using L-codes
but rather must be billed using A-codes. The A-codes for billing of such foot
orthotics are A5512, A5513, and A5514 (code A5514 effective for DOS on or
after 01/01/2019) (refer to the Therapeutic Shoes for Persons with Diabetes
policy for more information).

CONCENTRIC TORSION JOINTS

All claims for devices that contain a concentric adjustable torsion style
mechanism in the knee joint for any condition other than an assistive function
to joint extension motion must be coded as durable medical equipment using
code E1810 (DYNAMIC ADJUSTABLE KNEE EXTENSION / FLEXION DEVICE, INCLUDES SOFT
INTERFACE MATERIAL). If a concentric adjustable torsion style mechanism in the
knee joint is used solely to provide an assistive function for joint
extension, it must be coded as L2999 (See Coverage Indications, Limitations,
and/or Medical Necessity section of the related LCD).  
  
All claims for devices that contain a concentric adjustable torsion style
mechanism in the ankle joint for any condition other than an assistive
function to joint plantar- or dorsiflexion motion must be coded as durable
medical equipment using code E1815 (DYNAMIC ADJUSTABLE ANKLE EXTENSION/FLEXION
DEVICE, INCLUDES SOFT INTERFACE MATERIAL). If a concentric adjustable torsion
style mechanism in the ankle joint is used solely to provide an assistive
function for joint plantar or dorsiflexion, it must be coded as L2999 (See
Coverage Indications, Limitations, and/or Medical Necessity section of the
related LCD).  
  
Claims for devices that contain a concentric adjustable torsion style
mechanism in the knee or ankle joint and that are being used to treat any
condition other than an assistive function to joint extension motion are not
covered under the braces benefit and will be denied as incorrect coding when
billed using code L2999 (See Coverage Indications, Limitations, and/or Medical
Necessity section of the related LCD).  
  
WALKING BOOTS

Prefabricated walking boots are coded using codes L4360, L4361, L4386 or
L4387. These codes describe complete products. Claims for add-on codes used
with walking boots coded L4360, L4361, L4386 or L4387 will be denied as
unbundling.  

Certain products may have both covered and non-covered uses, as defined by the
braces benefit category, and must be coded based on the beneficiary's
condition. For example, when used as a brace for the treatment of an
orthopedic condition, walking boots are coded L4360, L4361, L4386, L4387 and
L4631. However, walking boots must be coded A9283 when used solely for the
prevention or treatment of a lower extremity ulcer or pressure reduction.



OTHER DEVICES



Code A9283 (FOOT PRESSURE OFF LOADING/SUPPORTIVE DEVICE, ANY TYPE, EACH) is
used for an item that is designed primarily to reduce pressure on the sole or
heel of the foot. It may be a shoe-like item, an item that is used inside a
shoe and may or may not extend outside the shoe, or an item that is attached
to a shoe. It may be prefabricated or custom fabricated. Code A9283 does not
include items that meet the definition of a therapeutic shoe for diabetes
(A5500, A5501).



When using code A9283, there is no separate billing using addition codes.
Replacement liners for devices billed with A9283 must be billed with code
A9270 (NON-COVERED ITEM OR SERVICE).  
  
Code A9285 (INVERSION/EVERSION CORRECTION DEVICE) is designed to provide off-
loading pressure to the knee for the treatment of knee osteoarthritis. The
device is applied at the foot and extends across the ankle to apply pressure
to the side of the leg below the knee. It does not provide any support at the
ankle.  
  
REPAIR/REPLACEMENT



Code L4205 (REPAIR OF ORTHOTIC DEVICE, LABOR COMPONENT, PER 15 MINUTES) may
only be billed for time involved with the actual repair of an orthosis or for
medically necessary adjustments made more than 90 days after delivery. Code
L4205 must not be used to bill for time involved with other professional
services including, but not limited to:  

  * Evaluating the beneficiary
  * Taking measurements, making a cast, making a model, use of CAD/CAM
  * Making modifications to a prefabricated item to fit it to the individual beneficiary
  * Follow-up visits
  * Making adjustments at the time of or within 90 days after delivery

Suppliers must distinguish between repair and replacement of an orthosis. When
an orthotic is replaced, there is no separate billing for the above services
because reimbursement for these services is included in the allowance for the
replacement item.  
  
Repairs to a covered orthosis due to wear or to accidental damage are covered
when they are necessary to make the orthosis functional. The reason for the
repair must be documented in the supplier's record. If the expense for repairs
exceeds the estimated expense of providing another entire orthosis, no payment
will be made for the amount in excess.  
  
The allowance for the labor involved in replacing an orthotic component that
is coded with a specific L-code is included in the allowance for that
component. The allowance for the labor involved in replacing an orthotic
component that is coded with the miscellaneous code L4210 is separately
payable in addition to the allowance for that component.  
  
Addition codes L4002, L4010, L4020, L4030, L4040, L4045, L4050, L4055, L4060,
L4070, L4080, L4090, L4100, L4110, L4130, and L4392 are for billing of
replacement components and are not payable at initial issue of a base
orthosis. When claims for code(s) L4002, L4010, L4020, L4030, L4040, L4045,
L4050, L4055, L4060, L4070, L4080, L4090, L4100, L4110, L4130, and L4392 are
billed at the time of initial issue of a base orthosis, the addition code(s)
will be rejected as incorrect coding.  
  
Suppliers should contact the Pricing, Data Analysis, and Coding (PDAC)
contractor for guidance on the correct coding of these items.

HCPCS codes L4050 and L4055 do not describe replacement soft interfaces used
with contracture orthoses.

Some replacement items have unique Healthcare Common Procedure Coding System
(HCPCS) codes. Replacement components that do not have a unique HCPCS code
must be billed with a "not otherwise specified" code - L2999. Items that have
unique codes must not be billed using a NOC code.

CODING VERIFICATION REVIEW  
The only products which may be billed using the following list of HCPCS codes
are those for which a written coding verification review (CVR) has been made
by the PDAC contractor and subsequently published on the Product
Classification List (PCL). Information concerning the documentation that must
be submitted to the PDAC for a CVR can be found on the PDAC web site or by
contacting the PDAC. A PCL with products which have received a coding
verification can be found on the PDAC web site. The effective date of the CVR
is included for each code.

Effective for claims with dates of service on or after April 1, 2012:  
L1906

Effective for claims with dates of service on or after January 1, 2020:  
L2006

If a product is billed to Medicare using a HCPCS code that requires written
CVR, but the product is not on the PCL for that particular HCPCS code, then
the claim line will be denied as incorrect coding.