L11517-LCD

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Automated World Health

Local Coverage Determination (LCD) for Ankle-Foot/Knee-Ankle- Foot Orthosis (L11517)

Contractor Information

Contractor Name CGS Administrators, LLC

Contractor Number 18003

Contractor Type DME MAC

Jurisdiction J - G

LCD Information

Document Information

LCD ID Number L11517

LCD Title Ankle-Foot/Knee-Ankle-Foot Orthosis

Contractor's Determination Number AFO

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Alabama Arkansas Colorado Florida Georgia Louisiana Mississippi North Carolina New Mexico Oklahoma Puerto Rico

South Carolina Tennessee Texas

Virginia

Virgin Islands West Virginia

Oversight Region Region IV

DME Region LCD Covers Jurisdiction C

Original Determination Effective Date

For services performed on or after 10/01/1993 Original Determination Ending Date

Revision Effective Date

For services performed on or after 07/01/2012

Revision Ending Date

CMS National Coverage Policy None

Indications and Limitations of Coverage and/or Medical Necessity

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. For the items addressed in this local coverage determination, the criteria for "reasonable and necessary", based on Social Security Act §1862(a)(1)(A) provisions, are defined by the following indications and limitations of coverage and/or medical necessity.

For an item to be covered by Medicare, a detailed written order (DWO) must be received by the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving the completed DWO, the item will be denied as not reasonable and necessary.

AFOs NOT USED DURING AMBULATION:

An L4396 (Static or dynamic positioning ankle-foot orthosis) is covered if either all of criteria 1 - 4 or criterion 5 is met:

1. Plantar flexion contracture of the ankle (ICD-9 diagnosis code 718.47) with dorsiflexion on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture); and,

2. Reasonable expectation of the ability to correct the contracture; and,

3. Contracture is interfering or expected to interfere significantly with the beneficiary's functional abilities; and,

4. Used as a component of a therapy program which includes active stretching of the involved muscles and/or tendons.

5. The beneficiary has plantar fasciitis (ICD-9 diagnosis code 728.71)

If an L4396 is used for the treatment of a plantar flexion contracture, the pre-treatment passive range of motion must be measured with a goniometer and documented in the medical record. There must be documentation of an appropriate stretching program carried out by professional staff (in a nursing facility) or caregiver (at home).

An L4396 and replacement interface (L4392) will be denied as not reasonable and necessary if the contracture is fixed. Codes L4396 and L4392 will be denied as not reasonable and necessary for a beneficiary with a foot drop but without an ankle flexion contracture. A component of a static/dynamic AFO that is used to address positioning of the knee or hip will be denied as not reasonable and necessary because the effectiveness of this type of component is not established.

If code L4396 is covered, a replacement interface (L4392) is covered as long as the beneficiary continues to meet indications and other coverage rules for the splint. Coverage of a replacement interface is limited to a maximum of one (1) per 6 months. Additional interfaces will be denied as not reasonable and necessary.

Medicare does not reimburse for a foot drop splint/recumbent positioning device (L4398) or replacement interface (L4394). A foot drop splint/recumbent positioning device and replacement interface will be denied as not reasonable and necessary in a beneficiary with foot drop who is nonambulatory because there are other more appropriate treatment modalities.

AFOs AND KAFOs USED DURING AMBULATION:

Ankle-foot orthoses (AFO) described by codes L1900, L1902-L1990, L2106-L2116, L4350, L4360, L4386 and L4631 are covered for ambulatory beneficiaries with weakness or deformity of the foot and ankle, who require stabilization for medical reasons, and have the potential to benefit functionally.

Knee-ankle-foot orthoses (KAFO) described by codes L2000-L2038, L2126-L2136, and L4370 are covered for ambulatory beneficiaries for whom an ankle-foot orthosis is covered and for whom additional knee stability is required.

If the basic coverage criteria for an AFO or KAFO are not met, the orthosis will be denied as not reasonable and necessary.

AFOs and KAFOs that are custom-fabricated are covered for ambulatory beneficiaries when the basic coverage criteria listed above and one of the following criteria are met:

1. The beneficiary could not be fit with a prefabricated AFO; or,

2. The condition necessitating the orthosis is expected to be permanent or of longstanding duration (more than 6 months); or,

3. There is a need to control the knee, ankle or foot in more than one plane; or,

4. The beneficiary has a documented neurological, circulatory, or orthopedic status that requires custom fabricating over a model to prevent tissue injury; or,

5. The beneficiary has a healing fracture which lacks normal anatomical integrity or anthropometric proportions.

If a custom fabricated orthosis is provided but basic coverage criteria above and the additional criteria 1-5 for a custom fabricated orthosis are not met, the custom fabricated orthosis will be denied as not reasonable and necessary.

L coded additions to AFOs and KAFOs (L2180-L2550, L2750-L2768, L2780-L2830) will be denied as not reasonable and necessary if either the base orthosis is not reasonable and necessary or the specific addition is not reasonable and necessary.

Concentric adjustable torsion style mechanisms used to assist knee joint extension are coded as L2999 and are covered for beneficiaries who require knee extension assist in the absence of any co-existing joint contracture.

Concentric adjustable torsion style mechanisms used to assist ankle joint plantarflexion or dorsiflexion are coded as L2999 and are covered for beneficiaries who require ankle plantar or dorsiflexion assist in the absence of any co-existing joint contracture.

Concentric adjustable torsion style mechanisms used for the treatment of contractures, regardless of any co- existing condition(s), are coded as E1810 and/or E1815 and are covered under the Durable Medical Equipment benefit (see related Policy Article Coding Guidelines for additional information).

Claims for devices incorporating concentric adjustable torsion style mechanisms used for the treatment of any joint contracture and coded as L2999 will be denied as incorrect coding.

Refer to the Orthopedic Footwear policy for information on coverage of shoes and related items which are an integral part of a brace.

MISCELLANEOUS:

Replacement of a complete orthosis or component of an orthosis due to loss, significant change in the beneficiary’s condition, or irreparable accidental damage is covered if the device is still reasonable and necessary. The reason for the replacement must be documented in the supplier's record.

Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out, are denied as not reasonable and necessary.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

The appearance of a code in this section does not necessarily indicate coverage.

HCPCS MODIFIERS:

EY - No physician or other licensed health care provider order for this item or service. GA – Waiver of liability statement issued as required by payer policy, individual case GZ – Item or service expected to be denied as not reasonable and necessary

KX - Requirements specified in the medical policy have been met LT - Left Side

RT - Right Side

HCPCS CODES:

A4466 GARMENT, BELT, SLEEVE OR OTHER COVERING, ELASTIC OR SIMILAR STRETCHABLE MATERIAL, ANY TYPE, EACH

A9283 FOOT PRESSURE OFF LOADING/SUPPORTIVE DEVICE, ANY TYPE, EACH

L1900 ANKLE FOOT ORTHOSIS, SPRING WIRE, DORSIFLEXION ASSIST CALF BAND, CUSTOM-FABRICATED L1902 ANKLE FOOT ORTHOSIS, ANKLE GAUNTLET, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT L1904 ANKLE FOOT ORTHOSIS, MOLDED ANKLE GAUNTLET, CUSTOM-FABRICATED

L1906 ANKLE FOOT ORTHOSIS, MULTILIGAMENTUS ANKLE SUPPORT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1907 AFO, SUPRAMALLEOLAR WITH STRAPS, WITH OR WITHOUT INTERFACE/PADS, CUSTOM FABRICATED

L1910 ANKLE FOOT ORTHOSIS, POSTERIOR, SINGLE BAR, CLASP ATTACHMENT TO SHOE COUNTER, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1920 ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT WITH STATIC OR ADJUSTABLE STOP (PHELPS OR PERLSTEIN TYPE), CUSTOM-FABRICATED

L1930 ANKLE FOOT ORTHOSIS, PLASTIC OR OTHER MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1932 AFO, RIGID ANTERIOR TIBIAL SECTION, TOTAL CARBON FIBER OR EQUAL MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1940 ANKLE FOOT ORTHOSIS, PLASTIC OR OTHER MATERIAL, CUSTOM-FABRICATED

L1945 ANKLE FOOT ORTHOSIS, PLASTIC, RIGID ANTERIOR TIBIAL SECTION (FLOOR REACTION), CUSTOM- FABRICATED

L1950 ANKLE FOOT ORTHOSIS, SPIRAL, (INSTITUTE OF REHABILITATIVE MEDICINE TYPE), PLASTIC, CUSTOM- FABRICATED

L1951 ANKLE FOOT ORTHOSIS, SPIRAL, (INSTITUTE OF REHABILITATIVE MEDICINE TYPE), PLASTIC OR OTHER MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1960 ANKLE FOOT ORTHOSIS, POSTERIOR SOLID ANKLE, PLASTIC, CUSTOM-FABRICATED L1970 ANKLE FOOT ORTHOSIS, PLASTIC WITH ANKLE JOINT, CUSTOM-FABRICATED

L1971

ANKLE FOOT ORTHOSIS, PLASTIC OR OTHER MATERIAL WITH ANKLE JOINT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1980 ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT FREE PLANTAR DORSIFLEXION, SOLID STIRRUP, CALF BAND/CUFF (SINGLE BAR 'BK' ORTHOSIS), CUSTOM-FABRICATED

L1990 ANKLE FOOT ORTHOSIS, DOUBLE UPRIGHT FREE PLANTAR DORSIFLEXION, SOLID STIRRUP, CALF BAND/CUFF (DOUBLE BAR 'BK' ORTHOSIS), CUSTOM-FABRICATED

L2000 KNEE ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT, FREE KNEE, FREE ANKLE, SOLID STIRRUP, THIGH AND CALF BANDS/CUFFS (SINGLE BAR 'AK' ORTHOSIS), CUSTOM-FABRICATED

KNEE ANKLE FOOT ORTHOSIS, ANY MATERIAL, SINGLE OR DOUBLE UPRIGHT, STANCE CONTROL, L2005 AUTOMATIC LOCK AND SWING PHASE RELEASE, ANY TYPE ACTIVATION, INCLUDES ANKLE JOINT, ANY

TYPE, CUSTOM FABRICATED

L2010 KNEE ANKLE FOOT ORTHOSIS, SINGLE UPRIGHT, FREE ANKLE, SOLID STIRRUP, THIGH AND CALF BANDS/CUFFS (SINGLE BAR 'AK' ORTHOSIS), WITHOUT KNEE JOINT, CUSTOM-FABRICATED

L2020 KNEE ANKLE FOOT ORTHOSIS, DOUBLE UPRIGHT, FREE ANKLE, SOLID STIRRUP, THIGH AND CALF BANDS/CUFFS (DOUBLE BAR 'AK' ORTHOSIS), CUSTOM-FABRICATED

L2030 KNEE ANKLE FOOT ORTHOSIS, DOUBLE UPRIGHT, FREE ANKLE, SOLID STIRRUP, THIGH AND CALF BANDS/CUFFS, (DOUBLE BAR 'AK' ORTHOSIS), WITHOUT KNEE JOINT, CUSTOM FABRICATED

KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, SINGLE UPRIGHT, WITH OR WITHOUT FREE MOTION L2034 KNEE, MEDIAL LATERAL ROTATION CONTROL, WITH OR WITHOUT FREE MOTION ANKLE, CUSTOM

FABRICATED

L2035 KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, STATIC (PEDIATRIC SIZE), WITHOUT FREE MOTION ANKLE, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2036 KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, DOUBLE UPRIGHT, WITH OR WITHOUT FREE MOTION KNEE, WITH OR WITHOUT FREE MOTION ANKLE, CUSTOM FABRICATED

L2037 KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, SINGLE UPRIGHT, WITH OR WITHOUT FREE MOTION KNEE, WITH OR WITHOUT FREE MOTION ANKLE, CUSTOM FABRICATED

L2038 KNEE ANKLE FOOT ORTHOSIS, FULL PLASTIC, WITH OR WITHOUT FREE MOTION KNEE, MULTI-AXIS ANKLE, CUSTOM FABRICATED

L2106 ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, TIBIAL FRACTURE CAST ORTHOSIS, THERMOPLASTIC TYPE CASTING MATERIAL, CUSTOM-FABRICATED

L2108 ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, TIBIAL FRACTURE CAST ORTHOSIS, CUSTOM- FABRICATED

L2112 ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, TIBIAL FRACTURE ORTHOSIS, SOFT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2114 ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, TIBIAL FRACTURE ORTHOSIS, SEMI-RIGID, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2116 ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, TIBIAL FRACTURE ORTHOSIS, RIGID, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2126 KNEE ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, FEMORAL FRACTURE CAST ORTHOSIS, THERMOPLASTIC TYPE CASTING MATERIAL, CUSTOM-FABRICATED

L2128 KNEE ANKLE FOOT ORTHOSIS, FRACTURE ORTHOSIS, FEMORAL FRACTURE CAST ORTHOSIS, CUSTOM- FABRICATED

L2132 KAFO, FRACTURE ORTHOSIS, FEMORAL FRACTURE CAST ORTHOSIS, SOFT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2134 KAFO, FRACTURE ORTHOSIS, FEMORAL FRACTURE CAST ORTHOSIS, SEMI-RIGID, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2136 KAFO, FRACTURE ORTHOSIS, FEMORAL FRACTURE CAST ORTHOSIS, RIGID, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L2180 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, PLASTIC SHOE INSERT WITH ANKLE JOINTS L2182 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, DROP LOCK KNEE JOINT

L2184 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, LIMITED MOTION KNEE JOINT

L2186 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, ADJUSTABLE MOTION KNEE JOINT, LERMAN TYPE

L2188 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, QUADRILATERAL BRIM L2190 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, WAIST BELT

L2192 ADDITION TO LOWER EXTREMITY FRACTURE ORTHOSIS, HIP JOINT, PELVIC BAND, THIGH FLANGE, AND PELVIC BELT

L2200 ADDITION TO LOWER EXTREMITY, LIMITED ANKLE MOTION, EACH JOINT

L2210 ADDITION TO LOWER EXTREMITY, DORSIFLEXION ASSIST (PLANTAR FLEXION RESIST), EACH JOINT L2220 ADDITION TO LOWER EXTREMITY, DORSIFLEXION AND PLANTAR FLEXION ASSIST/RESIST, EACH JOINT L2230 ADDITION TO LOWER EXTREMITY, SPLIT FLAT CALIPER STIRRUPS AND PLATE ATTACHMENT

L2232 ADDITION TO LOWER EXTREMITY ORTHOSIS, ROCKER BOTTOM FOR TOTAL CONTACT ANKLE FOOT ORTHOSIS, FOR CUSTOM FABRICATED ORTHOSIS ONLY

L2240 ADDITION TO LOWER EXTREMITY, ROUND CALIPER AND PLATE ATTACHMENT

L2250 ADDITION TO LOWER EXTREMITY, FOOT PLATE, MOLDED TO PATIENT MODEL, STIRRUP ATTACHMENT L2260 ADDITION TO LOWER EXTREMITY, REINFORCED SOLID STIRRUP (SCOTT-CRAIG TYPE)

L2265 ADDITION TO LOWER EXTREMITY, LONG TONGUE STIRRUP

L2270 ADDITION TO LOWER EXTREMITY, VARUS/VALGUS CORRECTION ('T') STRAP, PADDED/LINED OR MALLEOLUS PAD

L2275 ADDITION TO LOWER EXTREMITY, VARUS/VALGUS CORRECTION, PLASTIC MODIFICATION, PADDED/LINED

L2280 ADDITION TO LOWER EXTREMITY, MOLDED INNER BOOT

L2300 ADDITION TO LOWER EXTREMITY, ABDUCTION BAR (BILATERAL HIP INVOLVEMENT), JOINTED, ADJUSTABLE

L2310 ADDITION TO LOWER EXTREMITY, ABDUCTION BAR-STRAIGHT

L2320 ADDITION TO LOWER EXTREMITY, NON-MOLDED LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY

L2330 ADDITION TO LOWER EXTREMITY, LACER MOLDED TO PATIENT MODEL, FOR CUSTOM FABRICATED ORTHOSIS ONLY

L2335 ADDITION TO LOWER EXTREMITY, ANTERIOR SWING BAND

L2340 ADDITION TO LOWER EXTREMITY, PRE-TIBIAL SHELL, MOLDED TO PATIENT MODEL

L2350 ADDITION TO LOWER EXTREMITY, PROSTHETIC TYPE, (BK) SOCKET, MOLDED TO PATIENT MODEL, (USED FOR 'PTB' 'AFO' ORTHOSES)

L2360 ADDITION TO LOWER EXTREMITY, EXTENDED STEEL SHANK L2370 ADDITION TO LOWER EXTREMITY, PATTEN BOTTOM

L2375 ADDITION TO LOWER EXTREMITY, TORSION CONTROL, ANKLE JOINT AND HALF SOLID STIRRUP L2380 ADDITION TO LOWER EXTREMITY, TORSION CONTROL, STRAIGHT KNEE JOINT, EACH JOINT L2385 ADDITION TO LOWER EXTREMITY, STRAIGHT KNEE JOINT, HEAVY DUTY, EACH JOINT

L2387 ADDITION TO LOWER EXTREMITY, POLYCENTRIC KNEE JOINT, FOR CUSTOM FABRICATED KNEE ANKLE FOOT ORTHOSIS, EACH JOINT

L2390 ADDITION TO LOWER EXTREMITY, OFFSET KNEE JOINT, EACH JOINT

L2395 ADDITION TO LOWER EXTREMITY, OFFSET KNEE JOINT, HEAVY DUTY, EACH JOINT L2397 ADDITION TO LOWER EXTREMITY ORTHOSIS, SUSPENSION SLEEVE

L2405 ADDITION TO KNEE JOINT, DROP LOCK, EACH

L2415 ADDITION TO KNEE LOCK WITH INTEGRATED RELEASE MECHANISM ( BAIL, CABLE, OR EQUAL), ANY MATERIAL, EACH JOINT

L2425 ADDITION TO KNEE JOINT, DISC OR DIAL LOCK FOR ADJUSTABLE KNEE FLEXION, EACH JOINT

L2430 ADDITION TO KNEE JOINT, RATCHET LOCK FOR ACTIVE AND PROGRESSIVE KNEE EXTENSION, EACH JOINT

L2492 ADDITION TO KNEE JOINT, LIFT LOOP FOR DROP LOCK RING

L2500 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, GLUTEAL/ ISCHIAL WEIGHT BEARING, RING

L2510 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, QUADRI- LATERAL BRIM, MOLDED TO PATIENT MODEL

L2520 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, QUADRI- LATERAL BRIM, CUSTOM FITTED

L2525 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, ISCHIAL CONTAINMENT/NARROW M-L BRIM MOLDED TO PATIENT MODEL

L2526 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, ISCHIAL CONTAINMENT/NARROW M-L BRIM, CUSTOM FITTED

L2530 ADDITION TO LOWER EXTREMITY, THIGH-WEIGHT BEARING, LACER, NON-MOLDED

L2540 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, LACER, MOLDED TO PATIENT MODEL L2550 ADDITION TO LOWER EXTREMITY, THIGH/WEIGHT BEARING, HIGH ROLL CUFF

L2750 ADDITION TO LOWER EXTREMITY ORTHOSIS, PLATING CHROME OR NICKEL, PER BAR

L2755 ADDITION TO LOWER EXTREMITY ORTHOSIS, HIGH STRENGTH, LIGHTWEIGHT MATERIAL, ALL HYBRID LAMINATION/PREPREG COMPOSITE, PER SEGMENT, FOR CUSTOM FABRICATED ORTHOSIS ONLY

L2760 ADDITION TO LOWER EXTREMITY ORTHOSIS, EXTENSION, PER EXTENSION, PER BAR (FOR LINEAL ADJUSTMENT FOR GROWTH)

L2768 ORTHOTIC SIDE BAR DISCONNECT DEVICE, PER BAR

L2780 ADDITION TO LOWER EXTREMITY ORTHOSIS, NON-CORROSIVE FINISH, PER BAR L2785 ADDITION TO LOWER EXTREMITY ORTHOSIS, DROP LOCK RETAINER, EACH L2795 ADDITION TO LOWER EXTREMITY ORTHOSIS, KNEE CONTROL, FULL KNEECAP

L2800 ADDITION TO LOWER EXTREMITY ORTHOSIS, KNEE CONTROL, KNEE CAP, MEDIAL OR LATERAL PULL, FOR USE WITH CUSTOM FABRICATED ORTHOSIS ONLY

L2810 ADDITION TO LOWER EXTREMITY ORTHOSIS, KNEE CONTROL, CONDYLAR PAD

L2820 ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, BELOW KNEE SECTION

L2830 ADDITION TO LOWER EXTREMITY ORTHOSIS, SOFT INTERFACE FOR MOLDED PLASTIC, ABOVE KNEE SECTION

L2840 ADDITION TO LOWER EXTREMITY ORTHOSIS, TIBIAL LENGTH SOCK, FRACTURE OR EQUAL, EACH L2850 ADDITION TO LOWER EXTREMITY ORTHOSIS, FEMORAL LENGTH SOCK, FRACTURE OR EQUAL, EACH L2999 LOWER EXTREMITY ORTHOSES, NOT OTHERWISE SPECIFIED

L4002 REPLACEMENT STRAP, ANY ORTHOSIS, INCLUDES ALL COMPONENTS, ANY LENGTH, ANY TYPE L4010 REPLACE TRILATERAL SOCKET BRIM

L4020 REPLACE QUADRILATERAL SOCKET BRIM, MOLDED TO PATIENT MODEL L4030 REPLACE QUADRILATERAL SOCKET BRIM, CUSTOM FITTED

L4040 REPLACE MOLDED THIGH LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY L4045 REPLACE NON-MOLDED THIGH LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY L4050 REPLACE MOLDED CALF LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY

L4055 REPLACE NON-MOLDED CALF LACER, FOR CUSTOM FABRICATED ORTHOSIS ONLY L4060 REPLACE HIGH ROLL CUFF

L4070 REPLACE PROXIMAL AND DISTAL UPRIGHT FOR KAFO L4080 REPLACE METAL BANDS KAFO, PROXIMAL THIGH

L4090 REPLACE METAL BANDS KAFO-AFO, CALF OR DISTAL THIGH L4100 REPLACE LEATHER CUFF KAFO, PROXIMAL THIGH

L4110 REPLACE LEATHER CUFF KAFO-AFO, CALF OR DISTAL THIGH L4130 REPLACE PRETIBIAL SHELL

L4205 REPAIR OF ORTHOTIC DEVICE, LABOR COMPONENT, PER 15 MINUTES L4210 REPAIR OF ORTHOTIC DEVICE, REPAIR OR REPLACE MINOR PARTS

L4350 ANKLE CONTROL ORTHOSIS, STIRRUP STYLE, RIGID, INCLUDES ANY TYPE INTERFACE (E.G., PNEUMATIC, GEL), PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L4360 WALKING BOOT, PNEUMATIC AND/OR VACUUM, WITH OR WITHOUT JOINTS, WITH OR WITHOUT INTERFACE MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L4370 PNEUMATIC FULL LEG SPLINT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L4386 WALKING BOOT, NON-PNEUMATIC, WITH OR WITHOUT JOINTS, WITH OR WITHOUT INTERFACE MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L4392 REPLACEMENT, SOFT INTERFACE MATERIAL, STATIC AFO L4394 REPLACE SOFT INTERFACE MATERIAL, FOOT DROP SPLINT

STATIC OR DYNAMIC ANKLE FOOT ORTHOSIS, INCLUDING SOFT INTERFACE MATERIAL, ADJUSTABLE L4396 FOR FIT, FOR POSITIONING, MAY BE USED FOR MINIMAL AMBULATION, PREFABRICATED, INCLUDES

FITTING AND ADJUSTMENT

L4398 FOOT DROP SPLINT, RECUMBENT POSITIONING DEVICE, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

ANKLE FOOT ORTHOSIS, WALKING BOOT TYPE, VARUS/VALGUS CORRECTION, ROCKER BOTTOM, L4631 ANTERIOR TIBIAL SHELL, SOFT INTERFACE, CUSTOM ARCH SUPPORT, PLASTIC OR OTHER MATERIAL,

INCLUDES STRAPS AND CLOSURES, CUSTOM FABRICATED

ICD-9 Codes that Support Medical Necessity

The presence of an ICD-9 code listed in this section is not sufficient by itself to assure coverage. Refer to the section on “Indications and Limitations of Coverage and/or Medical Necessity” for other coverage criteria and payment information.

For HCPCS codes L4392 and L4396:

718.47 CONTRACTURE OF ANKLE AND FOOT JOINT

728.71 PLANTAR FASCIAL FIBROMATOSIS

For HCPCS code L4631:

713.5 ARTHROPATHY ASSOCIATED WITH NEUROLOGICAL DISORDERS

Diagnoses that Support Medical Necessity

For the specific HCPCS codes indicated above, refer to previous section. For all other HCPCS codes, diagnoses are not specified.

ICD-9 Codes that DO NOT Support Medical Necessity

For the specific HCPCS code indicated above, all ICD-9 codes that are not specified in the preceding section. For all other HCPCS codes, diagnoses are not specified.

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity

For the specific HCPCS code indicated above, all diagnoses that are not specified in the preceding section. For all other HCPCS codes, diagnoses are not specified.

General Information

Documentations Requirements

Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider.” It is expected that the beneficiary's medical records will reflect the need for the care provided. The beneficiary's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available upon request.

PRESCRIPTION (ORDER) REQUIREMENTS

GENERAL (PIM 5.2.1)

All items billed to Medicare require a prescription. An order for each new or full replacement item billed must be signed and dated by the treating physician, kept on file by the supplier, and made available upon request. Items dispensed and/or billed that do not meet these prescription requirements and those below must be submitted with an EY modifier added to each affected HCPCS code.

DISPENSING ORDERS (PIM 5.2.2)

Equipment and supplies may be delivered upon receipt of a dispensing order except for those items that require a written order prior to delivery. A dispensing order may be verbal or written. The supplier must keep a record of the dispensing order on file. It must contain:

• Description of the item

• Beneficiary's name

• Prescribing Physician's name

• Date of the order and the start date, if the start date is different from the date of the order

• Physician signature (if a written order) or supplier signature (if verbal order)

For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The dispensing order must be available upon request.

For items that are provided based on a dispensing order, the supplier must obtain a detailed written order before submitting a claim.

DETAILED WRITTEN ORDERS (PIM 5.2.3)

A detailed written order (DWO) is required before billing. Someone other than the ordering physician may produce the DWO. However, the ordering physician must review the content and sign and date the document. It must contain:

• Beneficiary's name

• Physician's name

• Date of the order and the start date, if start date is different from the date of the order

• Detailed description of the item(s) (see below for specific requirements for selected items)

• Physician signature and signature date

The order must list the unique features of the base code that is billed plus every addition that will be billed on a separate claim line.

For the “Date of the order” described above, use the date the supplier is contacted by the physician (for verbal orders) or the date entered by the physician (for written dispensing orders).

The detailed description in the written order may be either a narrative description or a brand name/model number.

Signature and date stamps are not allowed. Signatures must comply with the CMS signature requirements outlined in PIM 3.3.2.4.

The DWO must be available upon request.

A prescription is not considered as part of the medical record. Medical information intended to demonstrate compliance with coverage criteria may be included on the prescription but must be corroborated by information contained in the medical record.

MEDICAL RECORD INFORMATION

GENERAL (PIM 5.7 -5.9)

The Indications and Limitations of Coverage and/or Medical Necessity section of this LCD contains numerous reasonable and necessary (R&N) requirements. The Nonmedical Necessity Coverage and Payment Rules section of the related Policy Article contains numerous non-reasonable and necessary, benefit category and statutory requirements that must be met in order for payment to be justified. Suppliers are reminded that:

• Supplier-produced records, even if signed by the ordering physician, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes.

• Templates and forms, including CMS Certificates of Medical Necessity, are subject to corroboration with information in the medical record.

Information contained directly in the contemporaneous medical record is the source required to justify payment except as noted elsewhere for prescriptions and CMNs. The medical record is not limited to physician’s office records but may include records from hospitals, nursing facilities, home health agencies, other healthcare professionals, etc. (not all-inclusive). Records from suppliers or healthcare professionals with a financial interest in the claim outcome are not considered sufficient by themselves for the purpose of determining that an item is reasonable and necessary.

The supplier must include on the claim the ICD-9 diagnosis code for the underlying condition for a static or dynamic positioning AFO (L4396) or replacement interface material (L4392).

For a custom-fabricated orthosis, there must be documentation in the supplier's records to support the medical necessity of that type device rather than a prefabricated orthosis. This information must be available upon request.

PROOF OF DELIVERY (PIM 4.26, 5.8)

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. For medical review purposes, POD serves to assist in determining correct coding and billing information for claims submitted for Medicare reimbursement. Regardless of the method of delivery, the contractor must be able to determine from delivery documentation that the supplier properly coded the item(s), that the item(s) delivered are the same item(s) submitted for Medicare reimbursement and that the item(s) are intended for, and received by, a specific Medicare beneficiary.

Suppliers, their employees, or anyone else having a financial interest in the delivery of the item are prohibited from signing and accepting an item on behalf of a beneficiary (i.e., acting as a designee on behalf of the beneficiary). The signature and date the beneficiary or designee accepted delivery must be legible.

For the purpose of the delivery methods noted below, designee is defined as "Any person who can sign and accept the delivery of DMEPOS on behalf of the beneficiary."

Proof of delivery documentation must be available to the Medicare contractor on request. All services that do not have appropriate proof of delivery from the supplier will be denied and overpayments will be requested. Suppliers who consistently fail to provide documentation to support their services may be referred to the OIG for imposition of Civil Monetary Penalties or other administrative sanctions.

Suppliers are required to maintain POD documentation in their files. There are three methods of delivery:

1. Delivery directly to the beneficiary or authorized representative

2. Delivery via shipping or delivery service

3. Delivery of items to a nursing facility on behalf of the beneficiary

Method 1—Direct Delivery to the Beneficiary by the Supplier

Suppliers may deliver directly to the beneficiary or the designee. In this case, POD to a beneficiary must be a signed and dated delivery slip. The POD record must include:

• Beneficiary's name

• Delivery address

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Beneficiary (or designee) signature and date of signature

The date of signature on the delivery slip must be the date that the DMEPOS item was received by the beneficiary or designee. In instances where the supplies are delivered directly by the supplier, the date the beneficiary received the DMEPOS supply must be the date of service on the claim.

Method 2—Delivery via Shipping or Delivery Service Directly to a Beneficiary

If the supplier utilizes a shipping service or mail order, the POD documentation must be a complete record tracking the item(s) from the DMEPOS supplier to the beneficiary. An example of acceptable proof of delivery would include both the supplier's own detailed shipping invoice and the delivery service's tracking information. The supplier's record must be linked to the delivery service record by some clear method like the delivery service's package identification number or supplier's invoice number for the package sent to the beneficiary. The POD record must include:

• Beneficiary's name

• Delivery address

• Delivery service's package identification number, supplier invoice number or alternative method that links the supplier's delivery documents with the delivery service's records.

• Sufficiently detailed description to identify the item(s) being delivered (e.g., brand name, serial number, narrative description)

• Quantity delivered

• Date delivered

• Evidence of delivery

If a supplier utilizes a shipping service or mail order, suppliers must use the shipping date as the date of service on the claim.

Suppliers may also utilize a return postage-paid delivery invoice from the beneficiary or designee as a POD. This type of POD record must contain the information specified above.

Method 3—Delivery to Nursing Facility on Behalf of a Beneficiary

When a supplier delivers items directly to a nursing facility, the documentation described for Method 1 (see above) is required.

When a delivery service or mail order is used to deliver the item to a nursing facility, the documentation described for Method 2 (see above) is required.

Regardless the method of delivery, for those beneficiaries that are residents of a nursing facility, information from the nursing facility showing that the item(s) delivered for the beneficiary's use were actually provided to and used by the beneficiary must be available upon request.

POLICY SPECIFIC DOCUMENTATION REQUIREMENTS

KX, GA, and GZ MODIFIERS:

Suppliers must add a KX modifier to the AFO/KAFO base and addition codes only if all of the coverage criteria in the “Indications and Limitations of Coverage and or Medical Necessity” section of this policy 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 Indications and Limitations of Coverage and/or Medical Necessity section 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.

Claims lines billed with codes without a KX, GA or GZ modifier will be rejected as missing information.

REPAIR/REPLACEMENT (BPM Ch 15, §100.2)

A new Certificate of Medical Necessity (CMN) and/or physician's order is not needed for repairs.

The supplier must maintain detailed records describing the need for and nature of all repairs including a detailed explanation of the justification for any component or part replaced as well as the labor time.

A physician's order and/or new Certificate of Medical Necessity (CMN), when required, is needed to reaffirm the medical necessity of the item for replacement of an item.

MISCELLANEOUS

For custom fabricated orthoses, there must be detailed documentation in the treating physician’s records to support the medical necessity of custom fabricated rather than a prefabricated orthosis. This information will be corroborated by the functional evaluation in the orthotist or prosthetist’s records. This information must be available upon request.

A claim for code L2999 must include either a narrative description of the item (for custom fabricated items) or the manufacturer name and model name/number (for pre-fabricated items). For replacement components billed with code L2999, there must also be a HCPCS code or the manufacturer name and model name/number of the base orthosis. This information should be entered in the narrative field of an electronic claim.

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.

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.

Refer to the Supplier Manual for more information on documentation requirements.

Appendices PIM citations above denote references to CMS Program Integrity Manual, Internet Only Manual 100-8.

Utilization Guidelines Refer to Indications and Limitations of Coverage and/or Medical Necessity.

Sources of Information and Basis for Decision Advisory Committee Meeting Notes

Start Date of Comment Period 04/16/1993

End Date of Comment Period 05/31/1993

Start Date of Notice Period 08/01/1993

Revision History Number 016

Revision History Explanation Revision Effective Date: 07/01/2012 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Coverage of concentric adjustable torsion joints (Effective 3/13/2012) DOCUMENTATION REQUIREMENTS:

Added: Documentation of custom-fabricated items

Revision Effective Date: 01/01/2012 INDICATIONS AND LIMITATIONS OF COVERAGE:

Revised: Order requirements language to specify a “detailed written order” Changed: Word “Patient” to “Beneficiary”

DOCUMENTATION REQUIREMENTS:

(Note: The effective date above is not applicable to this section. These revised and added requirements are

Revised: Prescription requirements Added: Medical Record Information

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

L2005 descriptor was changed in Group 1

08/05/2011 - The Jurisdiction C contractor adopted a new business name. This LCD revision only includes the change from CIGNA Government Services to CGS Administrators, LLC. No coverage information was included in this revision and no provider action is needed regarding this revision.

Revision Effective Date: 02/04/2011 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Statement from policy article regarding routine replacement of components Deleted: Least costly alternative for custom fabricated orthoses

HCPCS CODES AND MODIFIERS (Effective 1/1/2011):

Added: Code L4631 Revised: GA modifier

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Added: Code L4631 and ICD-9 code 713.5

Revision Effective Date: 01/01/2010 HCPCS CODES AND MODIFIERS:

Added: A4466 Deleted: L1901

Revised: L4396 Description

Revision Effective Date: 12/01/2009 HCPCS CODES AND MODIFIERS:

Added: GA and GZ modifiers Deleted: GY modifier DOCUMENTATION REQUIREMENTS:

Added: Instructions for the use of GA and GZ modifiers

11/15/2009 - The description for CPT/HCPCS code L4396 was changed in group 1 11/15/2009 - CPT/HCPCS code L1901 was deleted from group 1

Revision Effective Date: 06/01/2009 HCPCS CODES AND MODIFIERS:

Added: KX modifier Deleted: L2770 DOCUMENTATION:

Added: Instructions for use of KX modifier with both the base and addition code(s)

Revision Effective Date: 04/01/2009 INDICATIONS AND LIMITATIONS OF COVERAGE:

Deleted: L1901 and L2770 from code range of AFO-KAFO used with ambulation (Note: Code L2770 invalid for claims with DOS on or after 07/01/2008

HCPCS CODES AND MODIFIERS:

Revised: Code L4360 descriptor Deleted: Code L2860

11/09/2008 - The description for CPT/HCPCS code L4360 was changed in group 1

03/01/2008 - In accordance with Section 911 of the Medicare Modernization Act, this policy was transitioned to DME MAC CIGNA Government Services (18003) LCD L11517 from DME PSC TrustSolutions (77012) LCD L11517.

Revision Effective Date: 01/01/2008 HCPCS CODES AND MODIFIERS:

Added: A9283

Revision Effective Date: 07/01/2007 INDICATIONS AND LIMITATIONS OF COVERAGE:

Removed: References to DMERC.

Printed on 1/26/2013. Page 13 of 15

DOCUMENTATION REQUIREMENTS:

Removed: References to DMERC.

06/01/2007 - In accordance with Section 911 of the Medicare Modernization Act of 2003, Virginia and West Virginia were transitioned from DME PSC TriCenturion (77011) to DME PSC TrustSolutions (77012).

03/01/2006 - In accordance with Section 911 of the Medicare Modernization Act of 2003, this policy was transitioned to DME PSC TrustSolutions (77012) from DMERC Palmetto GBA (00885).

Revision Effective Date: 01/01/2006 HCPCS CODES AND MODIFIERS:

Added: L2034 and L2387 Deleted L2039

DOCUMENTATION REQUIREMENTS:

Removed requirement for documentation to be attached to the claim.

Revision Effective Date: 04/01/2005 HCPCS CODES AND MODIFIERS: Added: L1932, L2005, L2232, L4002

Revised: L2035, L2036, L2037, L2038, L2039, L2320, L2330, L2755, L2800, L4040, L4045, L4050, L4055

Deleted: L2435

07/01/2004 - Indications and Limitations of Coverage: Added coverage of codes L4392 and L4396 for the treatment of plantar fasiitis (ICD-9 diagnosis code 728.71. LMRP converted to LCD and Policy Article.

Revision Effective Date: 04/01/2004 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added codes L4360 and L4386 to paragraph describing coverage of braces used for edema and pressure ulcers. HCPCS CODES AND MODIFIERS:

Added: L1907, L1951 and L1971 Revised: L1950, L4350, L4360, L4386 DOCUMENTATION REQUIREMENTS:

Added: L4360 and L4386 to list of codes requiring the use of modifier GY when used to treat pressure ulcers

Revision Effective Date: 07/01/2003 HCPCS CODES AND MODIFIERS:

Corrected HCPCS array to add L4350-L4370 which were inadvertently omitted from 04/01/2003 revision.

Revision Effective Date: 07/01/2003 HCPCS CODES AND MODIFIERS:

Corrected HCPCS array to add L4350 - L4370 which were inadvertently omitted from 04/01/2003 revision.

Revision Effective Date: 04/01/2003 HCPCS CODES AND MODIFIERS: Added: L1901, L4386, EY

INDICATIONS AND LIMITATIONS OF COVERAGE:

Adds standard language concerning coverage of items without an order.

Adds code L4350, L4360, L4370 and L4386 to range of codes used with ambulatory patients only. DOCUMENTATION REQUIREMENTS:

Adds standard language concerning use of EY modifier for items without an order.

Revised to allow either ICD-9 diagnosis code or narrative description on order for codes L4392 and L4396.

The revision dates listed below are the dates the revisions were published and not necessarily the effective dates for the revisions.

04/01/2002 – Added new HCPCS codes descriptors adding “prefabricated.” Added new descriptor for code L4396. Deleted splint codes now under local carrier jurisdiction-L2102, L2104, L2122, L2124. Added definition of custom- fabricated. Added RT and LT modifiers. Added new GY modifier.

06/01/1999 – Added HCPCS codes. Revised text for entire policy. 07/01/1996 – Corrected description for L1980.

04/01/1996 – Corrected description for L1990.

10/01/1995 – Revised Documentation section, removing Certificate of Medical Necessity requirement. 06/01/1994 – Corrected typo in Coverage and Payment Rules section from 1920 to L1920.

Reason for Change Other