CG-OR-PR-08 Microprocessor Controlled Lower Limb Prosthesis Form

This document addresses the use of microprocessor controlled lower limb prostheses including, but not limited to, knee prostheses (such as the Otto-Bock C-Leg^® device, the Genium^™ Bionic Prosthetic System, the Genium^™ X2^® and X₃^® devices, the Ossur Rheo Knee^®, and the Endolite Intelligent Prosthesis^®) and foot-ankle prostheses (such as the Proprio Foot^®, the PowerFoot BiOM, and the Endolite élan foot).

Note: For additional information regarding lower limb prosthesis, please see:

• CG-DME-13 Lower Limb Prosthesis

Clinical Indications

Medically Necessary:

1. Microprocessor controlled lower limb prostheses (for example, Otto-Bock C-Leg device, Otto-Bock Genium Bionic Prosthetic System, the Ossur Rheo Knee or the Endolite Intelligent Prosthesis) are considered medically necessary for individuals with transfemoral (above knee) and knee disarticulation amputations when all of the criteria set forth in (A) and (B) below have been met:
   1. Selection criteria:
      1. Individual has adequate cardiovascular reserve and cognitive learning ability to master the higher level technology; and
      2. Individual has a functional K-Level 3 or above; and
      3. The provider has documented that there is a reasonable likelihood of better mobility or stability with the device instead of a mechanical knee prosthesis; and
      4. There is documented need for ambulation in situations where the device will provide benefit (for example, regular need to ascend/descend stairs, traverse uneven surfaces or ambulate for long distances [generally 400 yards or greater cumulatively])
         and
   2. Documentation and performance criteria:
      1. Complete multidisciplinary assessment of individual including an evaluation by a trained prosthetic clinician. The assessment must objectively document that all of the above selection criteria have been evaluated and met.
2. Microprocessor controlled foot or ankle systems (such as the Propio Foot or Endolite élan foot) are considered medically necessary for individuals with transtibial amputation when all of the criteria set forth in (A) and (B) below have been met:
   1. Selection criteria:
      1. Individual has adequate cardiovascular reserve and cognitive learning ability to master the higher level technology; and
      2. Individual has a functional K-Level 3 or above; and
      3. The provider has documented that there is a reasonable likelihood of better mobility or stability with the device instead of a mechanical foot or ankle prosthesis; and
      4. There is documented need for ambulation in situations where the device will provide benefit (for example, regular need to ascend/descend stairs, traverse uneven surfaces or ambulate for long distances [generally 400 yards or greater cumulatively]);
         and
   2. Documentation and performance criteria:
      1. Complete multidisciplinary assessment of individual including an evaluation by a trained prosthetic clinician. The assessment must objectively document that all of the above selection criteria have been evaluated and met.

Use of both a microprocessor controlled knee prosthesis and microprocessor controlled foot-ankle prosthesis simultaneously for the same individual, either for the same limb or for different limbs, is considered medically necessary when the applicable criteria for knee prosthesis and foot-ankle prosthesis above have both been met.

Repairs and replacements of a myoelectric lower extremity prosthetic devices are considered medically necessary when:

1. Needed for normal wear or accidental damage; or
2. The changes in the individual’s condition warrant additional or different equipment, based on clinical documentation.

Not Medically Necessary:

Microprocessor controlled lower limb (knee/foot/ankle) prostheses are considered not medically necessary in all other cases, including when the criteria above have not been met, including for individuals with a functional K-Level 2 or below.

Repairs and replacements of a myoelectric lower extremity prosthetic devices are considered not medically necessary when the criteria above have not been met

Microprocessor controlled foot-ankle prostheses with power assistance, which includes any type of motor, (for example, the PowerFoot BiOM) are considered not medically necessary for all indications.