Lower Limb ProsthesesLower Limb Prostheses Form

A lower limb prosthesis is a device designed to replace the function of a missing lower limb.

A microprocessor is a prosthetic component which includes an internal computer and sensors. The microprocessor monitors each phase of an individual’s gait pattern and makes real-time adjustments, allowing for a more efficient gait at various speeds, and increased control on varying terrain and/or increased control on slopes, ramps, and stairs.

The microprocessor knee (MPK) component specifically enables rapid adjustments in knee resistance during swing and/or stance phase control to provide real-time adjustment of resistance within the MPK unit and facilitate optimal walking patterns on all surfaces, including uneven terrain, stairs, and inclines/declines.

The microprocessor foot/ankle (MPFA) unit specifically adjusts and controls ankle/foot movement in real time in response to sensor feedback, allowing optimization of plantarflexion and dorsiflexion during stance and swing phases and adaptation to underlying terrain, inclines/declines, and stairs. Additional potential benefit of a microprocessor unit includes reduced energy expenditure during ambulation.

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) and MassHealth for coverage determinations for its Dual Product Eligible plan members.

CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCas), and documentation included in the Medicare manuals and MassHealth Medical Necessity Determinations are the basis for coverage determinations. LCD - Lower Limb Prostheses (L33787) (cms.gov) is being supplemented to provide additional detail regarding medical necessity for Tufts Health One Point32Health companies2105789Lower Limb Prostheses1Care.

For the service of lower limb prostheses, evidence is sufficient for coverage. In addition to the criteria in the LCD, evidence also supports additional criteria for microprocessors of the knee and ankle/foot to be approved for the appropriate Member. For the appropriate member, a highly complex microprocessor can allow for a better quality of life, including decreased fall risk, and increased stability, control, and speed on uneven surfaces and slopes.

The use of this supplemented criteria in the utilization management process will ensure access to evidence based clinically appropriate care. See References section below for all evidence accessed in the development of these criteria.

Clinical Guideline Coverage Criteria

The Plan requires prior authorization for all new and replacement lower limb prostheses, or part thereof. The Plan will use the following as a guideline for determining the Member’s level of function as part of the process to determine medical necessity. It is the expectation provider will conform to manufacture’s product-specific recommendations.

According to Medicare Functional Classification Level (MFCL), an individual’s functional level is a measurement of the capacity and potential of the individual to accomplish his/her expected post- rehabilitation, daily function. The functional classification is used by The Plan to establish the medical necessity of prosthetic knee, feet, and ankle components. The clinical assessments of the Member’s rehabilitation potential should be based on the following classification levels:

• K Level
• IAMPnoPRO iscore
• I[AMPPro Iscore
• Description

1. Level K-0
2. 0-8
4. Does not have the ability or potential to ambulate or transfer safely with lor without assistance, and prosthesis does not enhance the quality of life lor mobility.
5. Level K-1
6. 9-20
7. 15-26
8. Has the ability or potential to use prosthesis for transfers or ambulation ion level services at fixed cadence.

2. Level K-2
   

   21-28

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

3. Level K-3
   

   29-36

   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 activities that demand prosthetic utilization beyond simple locomotion.

4. Level K-4
   

   37-43

   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 a child, active adult, or athlete.

Note: For all initial and replacement lower limb prosthetic requests, the score from the applicable functional mobility prediction tool (e.g., AMPPro, PROMIS 29) must be submitted to verify Member's K functional level

Initial Lower Limb Prostheses Authorization

The Plan may authorize coverage of initial lower limb prostheses as reasonable and medically necessary, safe and effective for the intended purpose(s) and prescribed by the attending physician (based on recommendations from an American Board for Certification (ABC) or Board of Certification (BOCP) certified prosthetic clinician) when ALL of the following criteria are met:

1. Covered devices must be fitted and programmed by a board-certified prosthetist [American Board of Certification (ABC) or Board of Certification (BOCP) certified prosthetic clinician]; and
2. The requested prosthesis or component(s) is the most appropriate, least intensive, medically necessary model that adequately meets the medical needs of the Member; and
3. Member will reach or maintain a predicted improved functional state (e.g. transfers, ambulation) with the use of the prescribed prosthesis within a reasonable and predictable period of time; and
4. Member is motivated and has adequate cardiovascular reserve and cognitive ability to utilize the device; and
5. There is clinical documentation and support for the functional need of the technology or design feature of a given Lower Limb Prosthesis type of foot and/or knee; and
6. The component(s) or prosthesis has been prescribed by a physician, and meets the specific criteria listed for each lower limb component described below:

• Foot Components
  • A solid ankle-cushion heel (SACH) foot is considered appropriate for persons whose functional level is 1 or above; or
  • An external keel SACH foot or single axis ankle/foot is considered appropriate for persons whose functional level is 1 or above; or
  • A flexible-keel foot or multi-axial ankle/foot is considered appropriate for persons whose functional level is 2 or above; or
  • A flex foot system, energy storing foot, multi-axial ankle/foot, dynamic response, or flex-walk system or equal is considered appropriate for persons whose functional level is 3 or above;
• Knee Components
  • A single axis constant friction knee and other basic knee systems are considered appropriate for persons whose functional level is 1 or above; or
  • A fluid, pneumatic, or electronic knee is considered appropriate for persons whose functional level is 3 or above;
• Ankle Components
  • An axial rotation unit is considered appropriate for persons whose functional level is 2 or above;
• Sockets
  • The Plan will cover up to two (2) test (diagnostic) sockets for an individual prosthesis. Additional documentation of medical necessity is required for more than two test sockets.

Documentation of a complete multidisciplinary assessment (e.g., medical record notes, Physical Therapy assessment, detailed written order completed by certified prosthetist and signed by the attending physician) including an evaluation by a certified prosthetic clinician with expertise in the evaluation and fitting for the requested device is required

Microprocessor Controlled Prosthetic Knee as Initial Prosthesis:

The Plan may authorize coverage of a microprocessor knee component as initial prosthesis when criteria for initial prosthesis are met and when ALL the following criteria are met:

1. Member is an active MFCL K3-K4 individual with a trans-femoral, knee-disarticulation or hip disarticulation amputation; and
2. Functional assessment indicates a member has the potential to ambulate independently with requested MPK in a reasonable and predictable period of time; and
3. Member has no contraindications which prevent immediate training with requested MPK. Contraindications may include but are not limited to pain, delay of wound healing of residual limb, inability to fit socket, co-morbidities; and
4. Documentation sufficiently demonstrates the reasonable likelihood of member meeting Microprocessor Controlled Prosthetic Knee criteria below

Microprocessor Controlled Prosthetic Knee

The Plan may authorize coverage of a microprocessor knee component when documentation confirms ALL of the following:

1. Member has no cardiovascular, neuromuscular, musculoskeletal, or cognitive conditions that could adversely affect the ability to successfully use requested prosthesis.
2. Member has undergone evaluation by a trained prosthetic clinician with expertise in the evaluation and fitting of members for this device.
3. Member has adequate strength and balance required to activate the knee unit.
4. Member has cognitive ability required to master control, operation, and maintenance of requested MPK
5. AND criteria for applicable MFCL is met:

MPK for MFCL K3-K4

The Plan may authorize coverage of a microprocessor knee component for MFCL K3-4 when ALL of the following criteria are met:

1. Member is an active MFCL K3-K4 adult with a trans-femoral, knee disarticulation or hip disarticulation amputation; and
2. Member has a documented need for and use of a microprocessor knee as the primary day to day prosthesis for ALL the following:

• Daily necessary long-distance ambulation (> 400 ft.) at variable speeds; and
• Daily necessary ambulation on outdoor uneven terrain; and
• Daily necessary repetitive use of stairs beyond usual routine limited home or workplace; and
• Daily necessary ambulatory speed greater than normal or usual speed

Documentation of ALL of the following:

• Member is in excellent physical condition, has a high exercise capacity; and
• Member has undergone a clinical gait analysis demonstrating the ability to ambulate at a rate faster than the member’s baseline rate using a standard prosthetic application swing and stance control; and
• Current non-MPK knee no longer fulfills ambulatory and functional needs of the member

MPK for MFCL K2

The Plan may authorize coverage of a microprocessor knee component for MFCL K2 when ALL of the following criteria are met:

1. Member is an MFCL K2 individual with a unilateral trans-femoral amputation; and
2. Member has received a non-MPK lower limb prosthesis and documentation, including Physical Therapy evaluation, support current prosthetic knee component does not meet member’s daily ambulatory and functional requirements; and
3. Member’s use of MPK will result in ONE of the following:

• Decreased risk of fall(s); or
• Increased indoor ambulation; or
• Increased independence in indoor ADLs; or
• Increased community ambulation, including uneven terrain, slopes and/or ramps

Member has completed a trial using MPK prosthesis; and

Documented peer-reviewed outcome measures from MPK trial (e.g., 2MWT, AMP, TUG, AMPPro, Basic Amputee Mobility Score (BAMS)), support member will achieve desired ambulatory and functional goals

Microprocessor Controlled Prosthetic Foot/Ankle (MPFA): Initial or Replacement

The Plan may authorize coverage of a microprocessor foot/ankle component when criteria for initial lower limb prosthesis are met and when ALL the following criteria are met:

1. Member is a transtibial amputee whose functional level is K3-K4; and
2. Member has undergone evaluation by a board-certified prosthetist [American Board of Certification (ABC) or Board of Certification (BOCP) certified prosthetic clinician] trained prosthetic with expertise in the evaluation and fitting of individuals for this device; and
3. Non-microprocessor ankle/foot prosthetic components (e.g., multi-axial ankle/foot, dynamic-response foot) have been trialed and submitted clinical documentation supports that trialed component will not meet member’s daily ambulatory and functional requirements, OR
4. a. Member currently utilizes a lower limb prosthesis with a foot/ankle component other than a microprocessor-controlled foot/ankle component, and documentation supports their current prosthetic foot/ankle component no longer meets member’s ambulatory daily functional requirements.
5. Daily necessary ambulation on outdoor uneven terrain; and
6. Daily necessary ambulation on inclines/declines (e.g., slopes, ramps); and
7. Daily necessary repetitive use of stairs beyond usual routine limited home or workplace; and
8. Member has cognitive ability required to master control, operation, and maintenance of requested foot/ankle microprocessor.

Prostheses and Prosthetic Components for Recreational Purposes Applicable to Harvard Pilgrim Health Care members Residing in Maine or with Maine Plans.

Please refer to the Member's plan documents for details. The Plan may authorize coverage of one additional prosthesis and/or prosthetic component for Members under 18 years of age for recreational purposes when the following criteria are met:

1. Documentation of a complete multidisciplinary assessment (e.g., medical record notes, Physical Therapy assessment, detailed written order completed by certified prosthetist and signed by the attending physician) including an evaluation by a certified prosthetic clinician with expertise in the evaluation and fitting for the requested device is required and includes ALL of the following:
2. a. Requested prosthesis/prosthetic component is the most appropriate and least intensive model that meets the medical needs of the Member to maximize the Member’s ability to perform recreational activity (e.g., ambulate, run, bike, swim) and allow developmentally appropriate experience; and
3. b. Physical therapy evaluation and assessment (e.g., musculoskeletal, endurance) supports the Member is able to tolerate the physical demands of desired recreational activity; and
4. c. Delivery of prosthesis by prosthetist will include education regarding any specialized maintenance and care of prosthesis/prosthetic components

Replacement Prosthesis Authorization (A replacement is the removal and substitution of a prosthesis or a component of a prosthesis)

The Plan may authorize the replacement of lower limb prosthesis or the replacement of any part of such device, if an ordering physician determines that the replacement device, or replacement part of such a device, is necessary when ALL the following criteria are met:

1. Documentation by Provider that Member has demonstrated continuous use of current prosthesis; and
2. There is a change in the physiological condition or functional level of the Member, which justifies a new prosthesis or replacement part(s); or
3. There is an irreparable change in the condition of the device, or in a part of the device; and

The component or prosthesis in need of replacement due to irreparable change in condition of device is not covered under warranty Additionally:

1. The Plan may cover the replacement of sockets when there is adequate documentation of functional and/or physiological need, including but not limited to: changes in the residual limb, functional need changes, or irreparable damage or wear/tear due to excessive weight or prosthetic demands of very active amputees.
2. Covered repairs must be performed by a certified prosthetist as described above, or technician working under the supervision of a certified prosthetist.

In addition to the above criteria, the following replacement criteria are applicable to Tufts Health Commercial, Tufts Health Direct, and Tufts Health RITogether products only:

1. The condition of the device, or the part of the device, requires repairs, and the cost of such repairs would be more than 60 percent of the cost of a replacement device, or, as the case may be, of the part being replaced.
2. The component or prosthesis is not in need of replacement as a result of improper use.

Limitations

1. The Plan will not authorize a prosthesis for a Member whose potential functional level is 0.
2. The Plan will not authorize prosthesis for a Member with intolerance to test socket fitting and/or wear due to residual limb issues, including but not limited to intractable pain, joint contractures, and skin/wound complications, as such intolerance will likely predict a poor outcome with a permanent prosthetic.
3. The Plan will not cover lower limb adjustable sockets.
4. The Plan will not cover upgrade or enhancement of member's current prosthesis or prosthetic component(s) when member’s current prosthesis or prosthetic component(s) meets their medical and ambulatory needs and allows the Member to perform activities of daily living.
5. The Plan will not cover additional or duplicate prosthesis or prosthetic component(s).
6. The Plan will not cover repair or replacement of a spare, backup or duplicate prosthesis or prosthetic component(s).

The Plan will not cover any of the following items, as they are not considered medically necessary:

• Swim prosthesis (Note: Unless covered per “Prostheses/prosthetic components for recreational purposes” criteria)
• Shower prosthesis
• Devices intended for sports, recreation and/or work-related purposes (Note: Unless covered per “Prostheses/prosthetic components for recreational purposes” criteria)
• Prosthetic device/component(s) intended for athletics (e.g., high-tech competitive models)
• Test (diagnostic) sockets for immediate prostheses
• More than two of the same socket inserts per individual prosthesis at the same time
• Vacuum-assisted socket system (VASS™)
• Artificial limbs or parts thereof for cosmetic purposes only, including, but not limited to, nonfunctional prosthetics, nonfunctional prosthetic covers and toe prostheses.5 Lower Limb Prostheses
• The Plan will not cover powered knee flexion/extension component (L5859) and power assist ankle-foot or ankle system (L5969) as they are considered experimental and investigational according to the Plan’s Evidence of Coverage definition. There is a lack of sufficient evidence in the published peer-reviewed medical literature substantiating their effectiveness in reducing disability and improving function over standard leg prostheses. Refer to Medical Necessity Guidelines: Noncovered Investigational Services.
• Hip flexion contracture >30
• Microprocessor-controlled prostheses for individuals who do not meet recommended weight or height guidelines of manufacturer
• Recreational prosthesis/prosthetic components for individuals who do not meet recommended weight or height guidelines of manufacturer
• 3D printed prostheses
• Osseointegrated prostheses

Targeted Muscle Reinnervation

Myoelectric sensors can be implanted beneath the skin to improve the prosthetic function and control.

Additional Limitations – Microprocessor Knee and Microprocessor Foot/Ankle

The Plan will not cover the following, as they relate to microprocessor knee and microprocessor foot/ankle prosthetic component requests, as they are not considered medically necessary:

1. Significant deformity of the remaining limb exists, impairing ability to transfer or ambulate stride.
2. Member is unable to tolerate the weight of the microprocessor unit.
3. Significant hip flexion contracture of affected residual limb preventing correct knee alignment and MPK activation as per manufacturer’s recommendations.
4. Prosthesis will be utilized in environment contraindicated for microprocessor components, including excessive sand, debris, water, and saltwater.
5. Genium X2 microprocessor-controlled knee prosthetic device and Genium X3 waterproof microprocessor- controlled knee prosthetic devices when there is a less intensive MPK device which can safely and effectively meet the Member’s ambulatory and functional needs.
6. Waterproof MPK devices