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.

A lower limb prosthesis is covered when the beneficiary:

1. Will reach or maintain a defined functional state within a reasonable period of time; and

2. Is motivated to ambulate.

FUNCTIONAL LEVELS:

A determination of the medical necessity for certain components/additions to the prosthesis is based on the beneficiary’s potential functional abilities. Potential functional ability is based on the reasonable expectations of the prosthetist, and treating practitioner, considering factors including, but not limited to:

1. The beneficiary’s past history (including prior prosthetic use if applicable); and

2. The beneficiary’s current condition including the status of the residual limb and the nature of other medical problems; and

3. The beneficiary’s desire to ambulate.

Clinical assessments of beneficiary rehabilitation potential must be based on the following classification levels:

Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility.

Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator.

Level 2: Has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs or uneven surfaces. Typical of the limited community ambulator.

Level 3: Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

Level 4: Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

The records must document the beneficiary’s current functional capabilities and his/her expected functional potential, including an explanation for the difference, if that is the case. It is recognized, within the functional classification hierarchy, that bilateral amputees often cannot be strictly bound by functional level classifications.

GENERAL:

If a prosthesis is denied as not reasonable and necessary, related additions will also be denied as not reasonable and necessary.

When an initial below knee prosthesis (L5500) or a preparatory below knee prosthesis (L5510, L5520,L5530, L5540) is provided, prosthetic substitutions and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5629, L5638, L5639, L5646, L5647, L5704, L5785, L5962, and L5980 which will be denied as not reasonable and necessary. When a below knee preparatory prefabricated prosthesis (L5535) is provided, prosthetic substitutions and/or additions of procedures are covered in accordance with the functional level assessment except for codes L5620, L5629, L5645, L5646, L5670, L5676, L5704, and L5962 which will be denied as not reasonable and necessary.

When an above knee initial prosthesis (L5505) or an above knee preparatory (L5560, L5570, L5580, L5590, L5595, L5600) prosthesis is provided, prosthetic substitution and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5610, L5631, L5640, L5642, L5644, L5648, L5705, L5706, L5964, L5980, and L5710, L5711, L5712, L5714, L5716, L5718, L5722, L5724, L5726, L5728, L5780, L5790, L5795 which will be denied as not reasonable and necessary. When an above knee preparatory prefabricated prosthesis (L5585) is provided, prosthetic substitution and/or additions of procedures and components are covered in accordance with the functional level assessment except for codes L5624, L5631, L5648, L5651, L5652, L5705, L5706, L5964, and L5966 which will be denied as not reasonable and necessary.

In the following sections, the determination of coverage for selected prostheses and components with respect to potential functional levels represents the usual case. Exceptions will be considered in an individual case if additional documentation is included which justifies the medical necessity. Prostheses will be denied as not reasonable and necessary if the beneficiary’s potential functional level is 0.

FEET:

A determination of the type of foot for the prosthesis will be made by the treating practitioner and/or the prosthetist based upon the functional needs of the beneficiary. Basic lower extremity prostheses include a SACH foot. Other prosthetic feet are considered for coverage based upon functional classification.

An external keel SACH foot (L5970) or single axis ankle/foot (L5974) is covered for beneficiaries whose functional level is 1 or above.

A flexible-keel foot (L5972) or multiaxial ankle/foot (L5978) is covered for beneficiaries whose functional level is 2 or above.

A microprocessor controlled ankle foot system (L5973), energy storing foot (L5976), dynamic response foot with multi-axial ankle (L5979), flex foot system (L5980), flex-walk system or equal (L5981), or shank foot system with vertical loading pylon (L5987) is covered for beneficiaries whose functional level is 3 or above.

The microprocessor foot or ankle system addition with power assist which includes any type motor (L5969) is not covered because there is insufficient information to demonstrate that the item meets the Medicare standard to be considered reasonable and necessary as per PIM Chapter 13. Claims for L5969 will be denied as not reasonable and necessary.

Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of foot. This information must be retained in the treating practitioner's or prosthetist's files.

A user-adjustable heel height feature (L5990) will be denied as not reasonable and necessary.

KNEES:

A determination of the type of knee for the prosthesis will be made by the treating practitioner and/or the prosthetist based upon the functional needs of the beneficiary. Basic lower extremity prostheses include a single axis, constant friction knee. Other prosthetic knees are considered for coverage based upon functional classification.

A high activity knee control frame (L5930) is covered for beneficiaries whose functional level is 4.

A fluid, pneumatic, or electronic/microprocessor knee (L5610, L5613, L5614, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840, L5848, L5856, L5857, L5858) is covered for beneficiaries whose functional level is 3 or above.

L5859 (ADDITION TO LOWER EXTREMITY PROSTHESIS, ENDOSKELETAL KNEE-SHIN SYSTEM, POWERED AND PROGRAMMABLE FLEXION/EXTENSION ASSIST CONTROL, INCLUDES ANY TYPE MOTOR(S)) is only covered when the beneficiary meets all of the criteria below:

1. Has a microprocessor (swing and stance phase type (L5856)) controlled (electronic) knee

2. K3 functional level only

3. Has a documented comorbidity of the spine and/or sound limb affecting hip extension and/or quadriceps function that impairs K-3 level function with the use of a microprocessor-controlled knee alone

4. Is able to make use of a product that requires daily charging

5. Is able to understand and respond to error alerts and alarms indicating problems with the function of the unit

If these coverage criteria for the knee component are not met, L5859 will be denied as not reasonable and necessary.

Other knee systems (L5611, L5616, L5710, L5711, L5712, L5714, L5716, L5718, L5810, L5811, L5812, L5816, L5818) are covered for beneficiaries whose functional level is 1 or above.

Coverage is extended only if there is sufficient clinical documentation of functional need for the technologic or design feature of a given type of knee. This information must be retained in the treating practitioner's or prosthetist's files.

ANKLES:

An axial rotation unit (L5982, L5984, L5985, L5986) is covered for beneficiaries whose functional level is 2 or above.

HIPS:

A pneumatic or hydraulic polycentric hip joint (L5961) is covered for beneficiaries whose functional level is 3 or above.

SOCKETS:

More than 2 test (diagnostic) sockets (L5618, L5620, L5622, L5624, L5626, L5628) for an individual prosthesis are not reasonable and necessary unless there is documentation in the medical record which justifies the need. Exception: A test socket is not reasonable and necessary for an immediate prosthesis (L5400, L5410, L5420, L5430, L5450, L5460).

No more than two of the same socket inserts (L5654, L5655, L5656, L5658, L5661, L5665, L5673, L5679, L5681, L5683) are allowed per individual prosthesis at the same time.

Socket replacements are considered reasonable and necessary if there is adequate documentation of functional and/or physiological need. It is recognized that there are situations where the explanation includes but is not limited to: changes in the residual limb; functional need changes; or irreparable damage or wear/tear due to excessive beneficiary weight or prosthetic demands of very active amputees.

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.