CMS Knee Orthoses Form

Summary Of Evidence

N/A

Analysis of Evidence

N/A

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.

The purpose of a Local Coverage Determination (LCD) is to provide information regarding “reasonable and necessary” criteria based on Social Security Act § 1862(a)(1)(A) provisions.

In addition to the “reasonable and necessary” criteria contained in this LCD there are other payment rules, which are discussed in the following documents, that must also be met prior to Medicare reimbursement:

• The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

• Refer to the Supplier Manual for additional information on documentation requirements.

• Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

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

For knee orthoses definitions of off-the-shelf and custom fitted, refer to the CODING GUIDELINES section in the LCD-related Policy Article.

PREFABRICATED KNEE ORTHOSES (L1810, L1812, L1820, L1830, L1831, L1832, L1833, L1836, L1843, L1845, L1847, L1848, L1850, L1851, L1852):

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, L1812) 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, L1812 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 with movement on passive range of motion testing of at least 10 degrees (i.e., a nonfixed contracture) (refer to the Group 1 ICD-10 Codes in the LCD-related Policy Article).

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 or L1848; therefore, claims for code L1847 or L1848 will be denied as not reasonable and necessary.

A knee immobilizer without joints (L1830), or a knee orthosis with adjustable knee joints (L1832, L1833), or a knee orthosis, with an adjustable flexion and extension joint that provides both medial-lateral and rotation control (L1843, L1845, L1851, L1852), are covered if the beneficiary has had recent injury to or a surgical procedure on the knee(s). Refer to the diagnoses listed in the Groups 2 or 4 ICD-10 Codes in the LCD-related Policy Article.

Knee orthoses L1832, L1833, L1843, L1845, L1851 and L1852 are also covered for a beneficiary who is ambulatory and has knee instability due to a condition specified in the Group 4 ICD-10 Codes in the LCD-related Policy Article.

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, congenital or acquired (refer to the Group 5 ICD-10 Codes in the LCD-related Policy Article).

For codes L1832, L1833, L1843, L1845, L1850, L1851 and L1852, 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, L1833, L1843, L1845, L1850, L1851 or L1852 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.

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.

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 (refer to the Group 3 ICD-10 Codes in the LCD-related Policy Article).

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, L1845, L1851 and L1852 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 (refer to the Group 5 ICD-10 Codes in the LCD-related Policy Article).

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.

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.

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 in the LCD 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.

GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a claim is submitted. If the supplier bills for an item addressed in this policy without first receiving a completed SWO, the claim shall be denied as not reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) base items that require a Written Order Prior to Delivery (WOPD), the supplier must have received a signed SWO before the DMEPOS item is delivered to a beneficiary. If a supplier delivers a DMEPOS item without first receiving a WOPD, the claim shall be denied as not reasonable and necessary. Refer to the LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed associated options, accessories, and/or supplies, the supplier must have received a WOPD which lists the base item and which may list all the associated options, accessories, and/or supplies that are separately billed prior to the delivery of the items. In this scenario, if the supplier separately bills for associated options, accessories, and/or supplies without first receiving a completed and signed WOPD of the base item prior to delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC articles. Claims that do not meet coding guidelines shall be denied as not reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are required to maintain POD documentation in their files. Proof of delivery documentation must be made available to the Medicare contractor upon request. All services that do not have appropriate proof of delivery from the supplier shall be denied as not reasonable and necessary.