Lower Limb Prostheses - Medical Clinical Policy Bulletins

Recent studies and guidelines highlight the significance of medical clinical policy bulletins (CPB) regarding lower limb prostheses, particularly those using advanced materials and robotic technologies. Comprehensive resources detailing these policies can be found online, emphasizing the need for standardized care and adherence to clinical classifications to ensure optimal patient outcomes.

Policy

Scope of Policy

This Clinical Policy Bulletin addresses lower limb prostheses.

1. Medical Necessity

   1. Criteria for Lower Limb Prostheses

      Aetna considers an orthosis (orthopedic brace) and/or prosthesis medically necessary when:

      1. Care is prescribed by a qualified health professional according to State law; and
      2. The orthosis or prosthesis significantly improves or restores mobility for daily living activities; and
      3. The member's healthcare provider determines it will enable them to perform activities of daily living; and
      4. The orthosis or prosthesis is provided within six months of the prescription date; and
      5. The services are performed by a licensed orthotic and/or prosthetic provider; and
      6. The complexity of the provided services necessitates a licensed or certified orthotist/prosthetist's involvement; and
      7. The orthotist or prosthetist is certified and in good standing with relevant boards or licensed by the state.

   Aetna considers lower limb prostheses medically necessary for normal activities when:

   1. The individual is motivated to ambulate; and
   2. The individual meets the specified criteria; and
   3. A defined functional state is achievable within a reasonable timeframe.

   Clinical assessments for rehabilitation potential should follow classification levels:

   Level	Clinical Assessments of Member Rehabilitation Potential
   Level 0	No ability to ambulate; prosthesis does not enhance quality of life.
   Level 1	Potential for ambulation on level surfaces at fixed cadence.
   Level 2	Ability to traverse low environmental barriers.
   Level 3	Variable cadence ambulation, traversing most barriers.
   Level 4	Exceeds basic ambulation skills, such as for active adults or athletes.

   Documentation of expected functional ability must be retained in the prosthetist's records, with specific evaluations required for higher functional levels.

   Medically Necessary Prostheses and Accessories

   Aetna considers the following medically necessary:

   1. Foot Prosthesis

      1. Solid ankle-cushion heel foot for functional level 1 or above;
      2. Multi-axial ankle/foot for functional level 2 or above;
      3. Energy-storing foot, multi-axial ankle/foot for functional level 3 or above.

      Repair or replacement of foot covers is typically included in the reimbursement of prosthetic foot components.

   2. Knee Prosthesis

      1. Pneumatic knee for level 3 or above;
      2. Single axis knee systems for level 1 or above;
      3. High-activity knee control frame for level 4 members.

   3. Sockets

      1. Two test sockets per individual are medically necessary;
      2. Socket replacement documentation must demonstrate physiological needs.

   Additional components such as protective outer surface covering systems are typically also medically necessary under specific circumstances.

   Experimental and Investigational

   Aetna assesses certain devices as experimental and investigational, including adjustable click systems and lower limb prostheses lacking peer-reviewed substantiation.

   Plan Limitations and Exclusions

   Evaluation, measurement, and prosthesis fittings are included in the overall allowance and do not warrant separate payment.

   Background

   Lower limb prostheses serve as essential tools for rehabilitation, aiming to restore mobility and enhance quality of life for users. These devices can vary significantly in design, material, and technological features, impacting user experience and functionality. For example, microprocessor-controlled prostheses offer advanced features that adjust to the user's gait and walking conditions, demonstrating improved biomechanical performance and user satisfaction.

   Adoption of innovative prosthesis technologies continues to evolve. Durability, function, and user comfort significantly influence patient outcomes, while integration of osseointegration techniques addresses longstanding problems with traditional socket designs. Continuous research in the field remains vital to ensure the ongoing development and optimization of prosthetic solutions.

   For more detailed information, including available lower limb prostheses, potential users can contact great resources available.