LCD L33318: Knee Orthoses

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, L1821, 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, L1821) are covered for ambulatory beneficiaries who have weakness or deformity of the knee and require stabilization.

If an L1810, L1812, L1820 or L1821 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) (r efer 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.

An immobilizer knee orthosis without joints (L1830) is covered for a beneficiary who has had a recent injury to or a surgical procedure on the knee(s) (refer to the Group 2 or Group 4 ICD-10 Codes in the LCD-related Policy Article).

A knee orthosis with adjustable knee joints (L1832, L1833) is covered if one of the following criteria is met:

• The beneficiary has had a recent injury to or a surgical procedure on the knee(s) (refer to the Groups 2 or Group 4 ICD-10 Codes in the LCD-related Policy Article); or,

• The beneficiary is ambulatory and has knee instability (refer to the Group 4 ICD-10 Codes in the LCD-related Policy Article).

A prefabricated Swedish type knee orthosis (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 a knee orthosis with adjustable knee joints or a prefabricated Swedish type knee orthosis (L1832, L1833, L1850), objective knee instability must be supported by documentation of the beneficiary’s physical examination including the joint laxity test(s) performed (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article).

A knee orthosis with single or double upright, adjustable flexion and extension joint, medial-lateral and rotation control, with or without varus/valgus adjustment (L1843, L1845, L1851, L1852) is covered if one of the following criteria (1-3) is met:

• The beneficiary is ambulatory and has objective knee instability that must be supported by documentation of a physical examination including the joint laxity test(s) performed (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article; refer to the Group 4 ICD-10 Codes in the LCD-related Policy Article); or,

• The beneficiary has had a recent injury to or a surgical procedure on the knee(s) (refer to the Groups 2 or Group 4 ICD-10 Codes in the LCD-related Policy Article); or,

• The beneficiary has a documented (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section in the LCD-related Policy Article) diagnosis of medial or lateral tibiofemoral osteoarthritis (refer to the Group 6 ICD-10 Codes in the LCD-related Policy Article), and meets all criteria (a-d):

a. The beneficiary is ambulatory; and,

b. The beneficiary is experiencing pain or reduction in their mobility and/or function secondary to the medial or lateral tibiofemoral osteoarthritis; and,

c. The knee orthosis provides either varus or valgus adjustment; and,

d. The beneficiary expresses a willingness to use the knee orthosis.

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.

“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

L1812

None

L1820

None

L1821

None

L1830

None

L1831

None

L1832

L2397, L2795, L2810

L1833

L2397, L2795, L2810

L1836

None

L1843

L2385, L2395, L2397

L1845

L2385, L2395, L2397, L2795

L1847

None

L1848

None

L1850

L2397

L1851

L2385, L2395, L2397

L1852

L2385, L2395, L2397, L2795

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

L1812

L2397

L1820

L2397

L1821

L2397

L1830

L2397

L1831

L2397, L2795

Clinical Background

Osteoarthritis (OA) is the most common form of arthritis and is a leading cause of disability. 1-4 The tibiofemoral joint is most often affected by OA, and within the knee joint, the medial compartment is the most frequently involved due to the mechanics and loading forces of ambulation. 5-10 The prevalence of knee osteoarthritis has increased in recent decades. 11 Using data from the National Health Interview Survey (NHIS), 12 it was estimated that 13.7 million people in the United States had symptomatic knee OA in 2007-2008, corresponding to 6.9% of the total US population ≥ 25 years of age. In 2011-2012, this estimate increased to 15.1 million, corresponding to 7.3% of the total US population ≥ 25 years of age. 7 The prevalence of knee OA increases with each decade of life, with an estimated 16% of the adult population > 65 years of age experiencing symptomatic knee OA. 7

Osteoarthritis of the knee can affect all structures within the joint, including the cartilage, synovium, ligaments, and bone. 4,13 Unicompartmental knee OA occurs when degenerative joint changes affect one part (e.g., the medial or lateral compartment) of the knee. Signs and symptoms of OA can include pain, stiffness, decreased range of motion, swelling and perceived instability. 2,4,7,14 Varus or valgus knee malalignment increases the risk of medial or lateral knee OA progression, respectively, and unicompartmental knee OA may lead to worsening of varus or valgus malalignment. 15-18 Additionally, an increase in varus-valgus laxity has been observed in patients with knee OA compared to individuals without knee OA. 19 The presence of knee laxity may represent a risk factor for the development of knee OA, and may also influence disease progression; 19-21 however, a correlation between knee laxity and self-reported joint function has not been consistently identified. 8,22-25

Recommended nonsurgical management options for knee OA include, but are not limited to, exercise programs, weight loss, self-management programs, topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular corticosteroids, and orthotics. 26-31 Several types of knee orthotics are available for the management of knee OA symptoms (e.g., compression sleeves, supportive braces, and unloader braces). Unloader, also known as offloader, knee braces use adjustable straps, condylar pads, or pneumatic bladders to apply either a valgus or varus external force on the knee joint for the management of medial or lateral unicompartmental OA, respectively. The therapeutic goal of an unloader knee brace is to reduce biomechanical forces on the degenerative compartment, realign the knee, and potentially relieve pain and improve function. 16,32,33