L22664-LCD

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Automated World Health

Local Coverage Determination (LCD) for Knee Orthoses (L22664)

Contractor Information

Contractor Name

CGS Administrators, LLC opens in new window

Contractor Number

18003

Contractor Type

DME MAC

Jurisdiction

J - G

LCD Information

Document Information

LCD ID Number L22664

LCD Title

Knee Orthoses

Contractor's Determination Number KO

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.

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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 07/01/2008 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.

PREFABRICATED KNEE ORTHOSES (L1810, L1820, L1830 - L1832, L1836, L1843, L1845, L1847, L1850):

A knee flexion contracture is a condition in which there is shortening of the muscles and/or tendons with the resulting inability to bring the knee to 0 degrees extension or greater (i.e., hyperextension) by passive range of motion. (0 degrees knee extension is when the femur and tibia are in alignment in a horizontal plane). A knee extension contracture is a condition in which there is shortening of the muscles and/or tendons with the resulting inability to bring the knee to 80 degrees flexion or greater by passive range of motion. A contracture is distinguished from the temporary loss of range of motion of a joint following injury, surgery, casting, or other immobilization.

A knee orthosis with joints (L1810) or knee orthosis with condylar pads and joints with or without patellar control (L1820) are covered for ambulatory beneficiaries who have weakness or deformity of the knee and require stabilization.

If an L1810 or L1820 is provided but the criteria above are not met, the orthosis will be denied as not reasonable and necessary.

A knee orthosis with a locking knee joint (L1831) or a rigid knee orthosis (L1836) is covered for beneficiaries with flexion or extension contractures of the knee (ICD-9 diagnosis code 718.46) with movement on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture).

If an L1831 or L1836 orthosis is provided but the criterion above is not met, the orthosis will be denied as not reasonable and necessary.

There is no proven clinical benefit to the inflatable air bladder incorporated into the design of code L1847; therefore, claims for code L1847 will be denied as not reasonable and necessary.

A knee immobilizer without joints (L1830), or a knee orthosis with adjustable knee joints (L1832), or a knee orthosis, with an adjustable flexion and extension joint that provides both medial-lateral and rotation control (L1843, L1845), are covered if the beneficiary has had recent injury to or a surgical procedure on the knee(s) and has one of the following diagnoses:

Diagnosis ICD-9

Rheumatoid arthritis 714.0 – 714.4

Osteoarthritis 715.16, 715.26, 715.36, 715.96

Meniscal cartilage derangement 717.0 – 717.5

Chondromalacia of patella 717.7

Knee ligamentous disruption 717.81 – 717.9

Rupture of tendon, nontraumatic - quadriceps tendon 727.65

Pathologic fracture of femur 733.15

Pathologic fracture of tibia or fibula 733.16

Aseptic necrosis of tibia or fibula 733.49

Malunion of fracture – nonunion of fracture 733.81-733.82

Stress fracture of tibia or fibula 733.93

Congenital deformity of knee 755.64

Fracture of femur - lower end 821.20 – 821.39

Fracture of patella 822.0, 822.1

Fracture of tibia and/or fibula - upper end 823.00 – 823.42

Dislocation of knee 836.0 – 836.69

Sprains and strains of knee 844.0 – 844.2, 844.8

Late effect of fracture of lower extremities 905.4

Failed total knee arthroplasty 996.40 – 996.49, 996.66, 996.77, V43.65

Knee orthoses L1832, L1843 and L1845 are also covered for a beneficiary who is ambulatory and has knee instability due to a condition specified in any diagnosis listed above; or one of the following diagnoses:

Diagnosis ICD-9

Multiple sclerosis 340

Hemiplegia, unspecified; dominant side; nondominant side 342.90, 342.91, 342.92

Infantile cerebral palsy, unspecified 343.9

Paraplegia of both lower limbs 344.1

Mononeuritis of lower limb, unspecified 355.0, 355.2

A knee orthosis, Swedish type, prefabricated (L1850) is covered for a beneficiary who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee (736.5).

For codes L1832, L1843, L1845 and L1850, knee instability must be documented by examination of the beneficiary and objective description of joint laxity (e.g., varus/valgus instability, anterior/posterior Drawer test).

Claims for L1832, L1843, L1845 or L1850 will be denied as not reasonable and necessary when the beneficiary does not meet the above criteria for coverage. For example, they will be denied if only pain or a subjective description of joint instability is documented.

“Addition” codes are grouped into four (4) categories in relation to knee orthosis base codes.

• Eligible for separate payment

• Not reasonable and necessary

• Not separately payable

• Incompatible

The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified prefabricated base orthosis. Addition codes may be separately payable if:

• They are provided with the related base code orthosis; and

• The base orthosis is reasonable and necessary; and

• The addition is reasonable and necessary.

Addition codes will be denied as not reasonable and necessary if the base orthosis is not reasonable and necessary or the addition is not reasonable and necessary.

Base Code Addition Codes – Eligible for Separate Payment

L1810 None

L1820 None

L1830 None

L1831 None

L1832 L2397, L2795, L2810

L1836 None

L1843 L2385, L2395, L2397

L1845 L2385, L2395, L2397, L2795

L1847 None

L1850 L2397

The following table lists addition codes which describe components or features that can be physically incorporated in the specified prefabricated base orthosis but are considered not reasonable and necessary. These addition codes, if they are billed with the related base code, will be denied as not reasonable and necessary.

Base Code Addition Codes – Not Reasonable and Necessary

L1810 L2397

L1820 L2397

L1830 L2397

L1831 L2397, L2795

L1832 L2405, L2415, L2492, L2785

L1836 L2397

L1843 L2405, L2492, L2785

L1845 L2405, L2415, L2492, L2785

L1847 L2397, L2795

L1850 L2275

Refer to the related Policy Article for information on addition codes that are considered not separately payable or incompatible with prefabricated knee orthosis base codes.

CUSTOM FABRICATED KNEE ORTHOSES (L1834, L1840, L1844, L1846, L1860):

A custom fabricated orthosis is covered when there is a documented physical characteristic which requires the use of a custom fabricated orthosis instead of a prefabricated orthosis. Examples of situations which meet the criterion for a custom fabricated orthosis include, but are not limited to:

1. Deformity of the leg or knee;

2. Size of thigh and calf;

3. Minimal muscle mass upon which to suspend an orthosis.

Although these are examples of potential situations where a custom fabricated orthosis may be appropriate, suppliers must consider prefabricated alternatives such as pediatric knee orthoses in beneficiaries with small limbs, straps with additional length for large limbs, etc.

If a custom fabricated orthosis is provided but the medical record does not document why that item is medically necessary instead of a prefabricated orthosis, the custom fabricated orthosis will be denied as not reasonable and necessary.

Custom fabricated orthoses (L1834, L1840, L1844, L1846, L1860) are not reasonable and necessary in the treatment of knee contractures in cases where the beneficiary is nonambulatory.

A custom fabricated knee immobilizer without joints (L1834) is covered if criteria 1 and 2 are met:

1. The coverage criteria for the prefabricated orthosis code L1830 are met; and

2. The general criterion defined above for a custom fabricated orthosis is met.

If an L1834 orthosis is provided and both criteria 1 and 2 are not met, the orthosis will be denied as not reasonable and necessary.

A custom fabricated derotation knee orthosis (L1840) is covered for instability due to internal ligamentous disruption of the knee (717.81 – 717.9).

A custom fabricated knee orthosis with an adjustable flexion and extension joint (L1844, L1846) is covered if criteria 1 and 2 are met:

1. The coverage criteria for the prefabricated orthosis codes L1843 and L1845 are met; and

2. The general criterion defined above for a custom fabricated orthosis is met.

If an L1844 or L1846 orthosis is provided and both criteria 1 and 2 are not met the orthosis will be denied as not reasonable and necessary.

A custom fabricated knee orthosis with a modified supracondylar prosthetic socket (L1860) is covered for a beneficiary who is ambulatory and has knee instability due to genu recurvatum - hyperextended knee (736.5).

The following table lists addition codes which describe components or features that can be and frequently are physically incorporated in the specified custom fabricated base orthosis. Addition codes may be separately payable if:

• They are provided with the related base code orthosis; and

• The base orthosis is reasonable and necessary; and

• The addition is reasonable and necessary.

Addition codes will be denied as not reasonable and necessary if the base orthosis is not reasonable and necessary or the addition is not reasonable and necessary.

Base Code Addition Codes – Eligible for Separate Payment

L1834 L2795

L1840 L2385, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2492, L2755, L2785, L2795

L1844 L2385, L2390, L2395, L2397, L2405, L2492, L2755, L2785

L1846 L2385, L2390, L2395, L2397, L2405, L2415, L2492, L2755, L2785, L2795, L2800

L1860 None

The following table lists addition codes which describe components or features that can be physically incorporated in the specified custom fabricated base orthosis but are considered not reasonable and necessary. These addition codes, if they are billed with the related base code, will be denied as not reasonable and necessary.

Base Code Addition Codes – Not Reasonable and Necessary

L1834 L2397, L2800

L1840 L2275, L2800

L1844 None

L1846 None

L1860 L2397

Refer to the related Policy Article for information on addition codes that are considered not separately payable or incompatible with custom fabricated knee orthosis base codes.

MISCELLANEOUS:

Heavy duty knee joint codes (L2385, L2395) are covered only for beneficiaries who weigh more than 300 pounds.

Coverage of a removable soft interface (K0672) is limited to a maximum of two (2) per year beginning one (1) year after the date of service for initial issuance of the orthosis. Additional replacement interfaces will be denied as not reasonable and necessary. Refer to the Coding Guidelines section of the related Policy Article for information on denial of removable soft interfaces that are billed separately at the time of initial issue of the orthosis.

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 for the treatment of contractures are coded as E1810 and 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.

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 MODIFIER

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

A9270 NON-COVERED ITEM OR SERVICE

K0672 ADDITION TO LOWER EXTREMITY ORTHOSIS, REMOVABLE SOFT INTERFACE, ALL COMPONENTS, REPLACEMENT ONLY, EACH

L1810 KNEE ORTHOSIS, ELASTIC WITH JOINTS, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1820 KNEE ORTHOSIS, ELASTIC WITH CONDYLAR PADS AND JOINTS, WITH OR WITHOUT PATELLAR CONTROL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1830 KNEE ORTHOSIS, IMMOBILIZER, CANVAS LONGITUDINAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1831 KNEE ORTHOSIS, LOCKING KNEE JOINT(S), POSITIONAL ORTHOSIS, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1832 KNEE ORTHOSIS, ADJUSTABLE KNEE JOINTS (UNICENTRIC OR POLYCENTRIC), POSITIONAL ORTHOSIS, RIGID SUPPORT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1834 KNEE ORTHOSIS, WITHOUT KNEE JOINT, RIGID, CUSTOM-FABRICATED

L1836 KNEE ORTHOSIS, RIGID, WITHOUT JOINT(S), INCLUDES SOFT INTERFACE MATERIAL, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1840 KNEE ORTHOSIS, DEROTATION, MEDIAL-LATERAL, ANTERIOR CRUCIATE LIGAMENT, CUSTOM FABRICATED

KNEE ORTHOSIS, SINGLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION L1843 JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT

VARUS/VALGUS ADJUSTMENT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

KNEE ORTHOSIS, SINGLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION L1844 JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT

VARUS/VALGUS ADJUSTMENT, CUSTOM FABRICATED

KNEE ORTHOSIS, DOUBLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION L1845 JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT

VARUS/VALGUS ADJUSTMENT, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

KNEE ORTHOSIS, DOUBLE UPRIGHT, THIGH AND CALF, WITH ADJUSTABLE FLEXION AND EXTENSION L1846 JOINT (UNICENTRIC OR POLYCENTRIC), MEDIAL-LATERAL AND ROTATION CONTROL, WITH OR WITHOUT

VARUS/VALGUS ADJUSTMENT, CUSTOM FABRICATED

L1847 KNEE ORTHOSIS, DOUBLE UPRIGHT WITH ADJUSTABLE JOINT, WITH INFLATABLE AIR SUPPORT CHAMBER(S), PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1850 KNEE ORTHOSIS, SWEDISH TYPE, PREFABRICATED, INCLUDES FITTING AND ADJUSTMENT

L1860 KNEE ORTHOSIS, MODIFICATION OF SUPRACONDYLAR PROSTHETIC SOCKET, CUSTOM-FABRICATED (SK)

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

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

L2385 ADDITION TO LOWER EXTREMITY, STRAIGHT KNEE JOINT, HEAVY DUTY, 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

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

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

L2999 LOWER EXTREMITY ORTHOSES, NOT OTHERWISE SPECIFIED

L4002 REPLACEMENT STRAP, ANY ORTHOSIS, INCLUDES ALL COMPONENTS, ANY LENGTH, ANY TYPE L4205 REPAIR OF ORTHOTIC DEVICE, LABOR COMPONENT, PER 15 MINUTES

L4210 REPAIR OF ORTHOTIC DEVICE, REPAIR OR REPLACE MINOR PARTS

L9900 ORTHOTIC AND PROSTHETIC SUPPLY, ACCESSORY, AND/OR SERVICE COMPONENT OF ANOTHER HCPCS "L" CODE

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 L1831, and L1836:

718.46 CONTRACTURE OF LOWER LEG JOINT

For HCPCS Codes L1830, L1834

714.0 - 714.4 opens in

new window RHEUMATOID ARTHRITIS - CHRONIC POSTRHEUMATIC ARTHROPATHY

715.16 OSTEOARTHROSIS LOCALIZED PRIMARY INVOLVING LOWER LEG

715.26 OSTEOARTHROSIS LOCALIZED SECONDARY INVOLVING LOWER LEG

715.36 OSTEOARTHROSIS LOCALIZED NOT SPECIFIED WHETHER PRIMARY OR SECONDARY INVOLVING LOWER LEG

715.96 OSTEOARTHROSIS UNSPECIFIED WHETHER GENERALIZED OR LOCALIZED INVOLVING LOWER LEG

717.0 - 717.5 opens in OLD BUCKET HANDLE TEAR OF MEDIAL MENISCUS - DERANGEMENT OF MENISCUS NOT

new window

ELSEWHERE CLASSIFIED

717.7 CHONDROMALACIA OF PATELLA

717.81 - 717.9 opens in new window

OLD DISRUPTION OF LATERAL COLLATERAL LIGAMENT - UNSPECIFIED INTERNAL DERANGEMENT OF KNEE

727.65 NONTRAUMATIC RUPTURE OF QUADRICEPS TENDON

733.15 PATHOLOGICAL FRACTURE OF OTHER SPECIFIED PART OF FEMUR

733.16 PATHOLOGICAL FRACTURE OF TIBIA OR FIBULA

733.49 ASEPTIC NECROSIS OF OTHER BONE SITES 733.81 - 733.82 opens

in new window MALUNION OF FRACTURE - NONUNION OF FRACTURE

733.93 STRESS FRACTURE OF TIBIA OR FIBULA

755.64 CONGENITAL DEFORMITY OF KNEE (JOINT)

821.20 - 821.39 opens FRACTURE OF LOWER END OF FEMUR UNSPECIFIED PART CLOSED - OTHER FRACTURE

in new window

822.0 - 822.1 opens in

OF LOWER END OF FEMUR OPEN

new window CLOSED FRACTURE OF PATELLA - OPEN FRACTURE OF PATELLA

823.00 - 823.42 opens

in new window CLOSED FRACTURE OF UPPER END OF TIBIA - TORUS FRACTURE OF FIBULA WITH TIBIA

836.0 - 836.69 opens in new window

TEAR OF MEDIAL CARTILAGE OR MENISCUS OF KNEE CURRENT - OTHER DISLOCATION OF KNEE OPEN

844.0 - 844.2 opens in SPRAIN OF LATERAL COLLATERAL LIGAMENT OF KNEE - SPRAIN OF CRUCIATE LIGAMENT

new window

OF KNEE

844.8 SPRAIN OF OTHER SPECIFIED SITES OF KNEE AND LEG

905.4 LATE EFFECT OF FRACTURE OF LOWER EXTREMITIES

996.40 - 996.49 opens UNSPECIFIED MECHANICAL COMPLICATION OF INTERNAL ORTHOPEDIC DEVICE,

in new window

IMPLANT, AND GRAFT - OTHER MECHANICAL COMPLICATION OF OTHER INTERNAL

ORTHOPEDIC DEVICE, IMPLANT, AND GRAFT

996.66 INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS

996.77 OTHER COMPLICATIONS DUE TO INTERNAL JOINT PROSTHESIS V43.65 KNEE JOINT REPLACEMENT

For HCPCS Code L1840

717.81 - 717.9 opens in new window

OLD DISRUPTION OF LATERAL COLLATERAL LIGAMENT - UNSPECIFIED INTERNAL DERANGEMENT OF KNEE

For HCPCS Codes L1832, L1843, L1844, L1845, and L1846

340 MULTIPLE SCLEROSIS

342.90 UNSPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING UNSPECIFIED SIDE

342.91 UNSPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING DOMINANT SIDE

342.92 UNSPECIFIED HEMIPLEGIA AND HEMIPARESIS AFFECTING NONDOMINANT SIDE

343.9 INFANTILE CEREBRAL PALSY UNSPECIFIED

344.1 PARAPLEGIA

355.0 LESION OF SCIATIC NERVE

355.2 OTHER LESION OF FEMORAL NERVE 714.0 - 714.4 opens in

new window RHEUMATOID ARTHRITIS - CHRONIC POSTRHEUMATIC ARTHROPATHY

715.16 OSTEOARTHROSIS LOCALIZED PRIMARY INVOLVING LOWER LEG

715.26 OSTEOARTHROSIS LOCALIZED SECONDARY INVOLVING LOWER LEG

715.36 OSTEOARTHROSIS LOCALIZED NOT SPECIFIED WHETHER PRIMARY OR SECONDARY INVOLVING LOWER LEG

715.96 OSTEOARTHROSIS UNSPECIFIED WHETHER GENERALIZED OR LOCALIZED INVOLVING LOWER LEG

717.0 - 717.5 OLD BUCKET HANDLE TEAR OF MEDIAL MENISCUS - DERANGEMENT OF MENISCUS NOT ELSEWHERE CLASSIFIED

717.7 CHONDROMALACIA OF PATELLA

717.81 - 717.9 opens in new window

OLD DISRUPTION OF LATERAL COLLATERAL LIGAMENT - UNSPECIFIED INTERNAL DERANGEMENT OF KNEE

727.65 NONTRAUMATIC RUPTURE OF QUADRICEPS TENDON

733.15 PATHOLOGICAL FRACTURE OF OTHER SPECIFIED PART OF FEMUR

733.16 PATHOLOGICAL FRACTURE OF TIBIA OR FIBULA

733.49 ASEPTIC NECROSIS OF OTHER BONE SITES 733.81 - 733.82 opens

in new window MALUNION OF FRACTURE - NONUNION OF FRACTURE

733.93 STRESS FRACTURE OF TIBIA OR FIBULA

755.64 CONGENITAL DEFORMITY OF KNEE (JOINT)

821.20 - 821.39 opens FRACTURE OF LOWER END OF FEMUR UNSPECIFIED PART CLOSED - OTHER FRACTURE

in new window

822.0 - 822.1 opens in

OF LOWER END OF FEMUR OPEN

new window CLOSED FRACTURE OF PATELLA - OPEN FRACTURE OF PATELLA

823.00 - 823.42 opens

in new window CLOSED FRACTURE OF UPPER END OF TIBIA - TORUS FRACTURE OF FIBULA WITH TIBIA

836.0 - 836.69 opens in new window

TEAR OF MEDIAL CARTILAGE OR MENISCUS OF KNEE CURRENT - OTHER DISLOCATION OF KNEE OPEN

844.0 - 844.2 SPRAIN OF LATERAL COLLATERAL LIGAMENT OF KNEE - SPRAIN OF CRUCIATE LIGAMENT OF KNEE

844.8 SPRAIN OF OTHER SPECIFIED SITES OF KNEE AND LEG

905.4 LATE EFFECT OF FRACTURE OF LOWER EXTREMITIES

996.40 - 996.49 opens UNSPECIFIED MECHANICAL COMPLICATION OF INTERNAL ORTHOPEDIC DEVICE,

in new window

IMPLANT, AND GRAFT - OTHER MECHANICAL COMPLICATION OF OTHER INTERNAL

ORTHOPEDIC DEVICE, IMPLANT, AND GRAFT

996.66 INFECTION AND INFLAMMATORY REACTION DUE TO INTERNAL JOINT PROSTHESIS

996.77 OTHER COMPLICATIONS DUE TO INTERNAL JOINT PROSTHESIS V43.65 KNEE JOINT REPLACEMENT

For HCPCS Codes L1850 and L1860

736.5 GENU RECURVATUM (ACQUIRED)

Diagnoses that Support Medical Necessity

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

ICD-9 Codes that DO NOT Support Medical Necessity

For the specific HCPCS codes indicated above, all ICD-9 codes that are not specified in the previous section.

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

Diagnoses that DO NOT Support Medical Necessity

For the specific HCPCS codes indicated above, all diagnoses that are not specified in the previous 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 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

For items provided on a periodic basis, including drugs, the written order must include:

• Item(s) to be dispensed

• Dosage or concentration, if applicable

• Route of Administration

• Frequency of use

• Duration of infusion, if applicable

• Quantity to be dispensed

• Number of refills

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).

Frequency of use information on orders must contain detailed instructions for use and specific amounts to be dispensed. Reimbursement shall be based on the specific utilization amount only. Orders that only state "PRN" or "as needed" utilization estimates for replacement frequency, use, or consumption are not acceptable. (PIM 5.9)

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.

CONTINUED USE

Continued use describes the ongoing utilization of supplies or a rental item by a beneficiary.

Suppliers are responsible for monitoring utilization of DMEPOS rental items and supplies. No monitoring of purchased items or capped rental items that have converted to a purchase is required. Suppliers must discontinue billing Medicare when rental items or ongoing supply items are no longer being used by the beneficiary.

Beneficiary medical records or supplier records may be used to confirm that a DMEPOS item continues to be used by the beneficiary. Any of the following may serve as documentation that an item submitted for reimbursement continues to be used by the beneficiary:

1. Timely documentation in the beneficiary's medical record showing usage of the item, related option/accessories and supplies.

2. Supplier records documenting the request for refill/replacement of supplies in compliance with the Refill Documentation Requirements This is deemed to be sufficient to document continued use for the base item, as well.

3. Supplier records documenting beneficiary confirmation of continued use of a rental item

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in this policy.

CONTINUED MEDICAL NEED

For all DMEPOS items, the initial justification for medical need is established at the time the item(s) is first ordered; therefore, beneficiary medical records demonstrating that the item is reasonable and necessary are created just prior to, or at the time of, the creation of the initial prescription. For purchased items, initial months of a rental item or for initial months of ongoing supplies or drugs, information justifying reimbursement will come from this initial time period. Entries in the beneficiary's medical record must have been created prior to, or at the time of, the initial DOS to establish whether the initial reimbursement was justified based upon the applicable coverage policy.

For ongoing supplies and rental DME items, in addition to information described above that justifies the initial provision of the item(s) and/or supplies, there must be information in the beneficiary's medical record to support that the item continues to be used by the beneficiary and remains reasonable and necessary. Information used to justify continued medical need must be timely for the DOS under review. Any of the following may serve as documentation justifying continued medical need:

A recent order by the treating physician for refills A recent change in prescription

A properly completed CMN or DIF with an appropriate length of need specified

Timely documentation in the beneficiary's medical record showing usage of the item.

Timely documentation is defined as a record in the preceding 12 months unless otherwise specified elsewhere in the policy.

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

REPAIR/REPLACEMENT (BPM Ch 15, §100.2)

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

An order is not necessary for the repair of an orthosis; however, claims for code L4210 must be accompanied by a description of the part that is being repaired or replaced. This information should be entered into the narrative field on an electronic claim.

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.

KX, GA, and GZ MODIFIERS

Suppliers must add a KX modifier to knee orthoses 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.

MISCELLANEOUS

For custom fabricated orthoses (L1834, L1840, L1844, L1846, L1855-L1880), 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.

When billing L2999, the following information should accompany the claim: manufacturer's name; product name; justification of patient's medical necessity for the item. In addition, if the item is custom fabricated, 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) must be included with the claim.

The beneficiary’s condition (ICD-9 diagnosis code) that necessitates the need for the knee orthosis must be included on the claim.

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 09/10/2004

End Date of Comment Period 10/25/2004

Start Date of Notice Period 03/20/2008

Revision History Number 001

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

Revised: Order requirements language to specify a “detailed written order” Added: Coverage for concentric adjustable torsion joints (Effective 3/13/2012) Added: Code L2755 to Addition Codes – Eligible for Separate Payment table

Added: ICD-9 codes 733.81-733.82 and 905.4 for L1830, L1832, L1843, L1845 to coverage table per request for reconsideration.

Changed: Word “Patient” to “Beneficiary” HCPCS CODES AND MODIFIERS

Added: Code L2755

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Added: ICD-9 codes 733.81-733.82 and 905.4 for L1830, L1832, L1834, L1843, L1844, L1845, L1846 per

request for reconsideration. DOCUMENTATION REQUIREMENTS:

(Note: The effective date above is not applicable to this section. These revised and added requirements are existing Medicare requirements which are now included in the LCD for easy reference)

Added: Refill requirements, general medical record information requirements, continued use and continued need requirements, and proof of delivery requirements

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: 07/01/2011

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Added: ICD-9 codes 342.91 and 342.92 for L1832, L1843 – L1846

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

Deleted: Least costly alternative for multiple HCPCS codes HCPCS CODES AND MODIFIERS:

Added: Code L4002 Revised: GA modifier

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Added: ICD-9 code 844.8 for codes L1830, L1832, L1834 and L1843-L1846

Revision Effective Date: 01/01/2010 INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: Coverage criteria for L1810, L1820 Added: Definition for knee instability Revised: Coverage criteria for L1832 HCPCS CODES AND MODIFIERS:

Deleted: L1800, L1815, L1825

Added: A4466

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Revised: Covered diagnoses for L1832

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

Added: GA/GZ modifiers Revised: RT/LT descriptors

DOCUMENTATION REQUIREMENTS:

Added: Instructions for GA/GZ modifier use

Revision Effective Date: 11/15/2009

CPT/HCPCS code L1800 was deleted from group 1 CPT/HCPCS code L1815 was deleted from group 1 CPT/HCPCS code L1825 was deleted from group 1

08/08/2009 - This policy was updated by the ICD-9 2009-2010 Annual Update. Revision Effective Date: 04/01/2009

INDICATIONS AND LIMITATIONS OF COVERAGE:

Added: ICD-9 diagnosis codes 844.0 – 844.2 and 996.40 – 996.49 to range of codes for L1830, L1832, L1834, L1843, L1844, L1845 and L1846 in response to request for reconsideration.

Deleted: Codes L1800, L1815, L1825 from prefabricated knee orthoses

Deleted: Codes L1800, L1815, L1825 from Base code & Addition Codes - Eligible for Separate Payment Deleted: Codes L1800, L1815, L1825 from Base code & Addition Codes - Not Medically Necessary HCPCS CODES AND MODIFIERS:

Revised: KX modifier

ICD-9 CODES THAT SUPPORT MEDICAL NECESSITY:

Added: ICD-9 diagnosis codes 844.0 – 844.2 and 996.40 – 996.49 to range of codes for L1830, L1832, L1834, L1843, L1844, L1845 and L1846

DOCUMENTATION:

Added: Clarified that use of KX modifier is applicable to both the base and addition codes. Revised: Changed DMERC to DME MAC

04/11/2008 Added Response to Comments document

Reason for Change HCPCS Addition/Deletion HCPCS/ICD9 Descriptor Change