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.

**Base Code** | **Addition Codes - Eligible for Separate Payment**  
---|---  
L1810 | None  
L1812 | None  
L1820 | 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  
L1830 | L2397  
L1831 | L2397, L2795  
L1832 | L2405, L2415, L2492, L2785  
L1833 | L2405, L2415, L2492, L2785  
L1836 | L2397  
L1843 | L2405, L2492, L2785  
L1845 | L2405, L2415, L2492, L2785  
L1847 | L2397, L2795  
L1848 | L2397, L2795  
L1850 | L2275  
L1851 | L2405, L2492, L2785  
L1852 | L2405, L2415, L2492, L2785  
  
  
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.

**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 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.