Summary Of Evidence

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Analysis of Evidence

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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 Ankle-Foot Orthoses (AFO) and Knee-Ankle-Foot Orthoses (KAFO) definitions of off-the-shelf and custom fitted, refer to the CODING GUIDELINES section in the LCD-related Policy Article.

AFOs NOT USED DURING AMBULATION:

An L4396 or L4397 (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 (refer to the Group 1 Codes in the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses) 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 (refer to the Group 1 Codes in the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses).

If an L4396 or L4397 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 or L4397 and replacement interface (L4392) will be denied as not reasonable and necessary if the contracture is fixed. Codes L4396, L4397 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 or L4397 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, L1904, L1906, L1907, L1910, L1920, L1930, L1932, L1940, L1945, L1950, L1951, L1960, L1970, L1971, L1980, L1990, L2106, L2108, L2112, L2114, L2116, L4350, L4360, L4361, L4386, L4387 and L4631 are covered for ambulatory beneficiaries with weakness or deformity of the foot and ankle, who:

1. Require stabilization for medical reasons, and,

2. Have the potential to benefit functionally.

Knee-ankle-foot orthoses (KAFO) described by codes L2000, L2005, L2010, L2020, L2030, L2034, L2035, L2036, L2037, L2038, L2126, L2128, L2132, L2134, 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, L2182, L2184, L2186, L2188, L2190, L2192, L2200, L2210, L2220, L2230, L2232, L2240, L2250, L2260, L2265, L2270, L2275, L2280, L2300, L2310, L2320, L2330, L2335, L2340, L2350, L2360, L2370, L2375, L2380, L2385, L2387, L2390, L2395, L2397, L2405, L2415, L2425, L2430, L2492, L2500, L2510, L2520, L2525, L2526, L2530, L2540, L2550, L2750, L2755, L2760, L2768, L2780, L2785, L2795, L2800, L2810, L2820, 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 (refer to the CODING GUIDELINES section in the LCD-related Policy Article).

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.

Replacement components (e.g., soft interfaces) that are provided on a routine basis, without regard to whether the original item is worn out, are covered under the refill requirements.

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.