Critical Medicare Update for Clinicians: Expanding Coverage for Lower Limb Prosthetics

Effective September 1, 2024, the Centers for Medicare & Medicaid Services (CMS) will implement expanded coverage for lower limb prosthetics, particularly affecting higher-functioning knee systems and K2 functional-level prosthetic users.

On July 18, 2024, CMS and the Durable Medical Equipment (DME) Medicare Administrative Contractors (MACs) released the finalized draft of the Lower Limb Prostheses LCD and Related Policy Article. This update introduces crucial modifications that will directly affect your clinical decision-making and documentation practices.

Key changes include:

1. Expanded coverage criteria for fluid, pneumatic, and electronic/microprocessor-controlled knee units for K2 level patients
2. Recognition of Orthotist and Prosthetist documentation as part of the official Medical Records
3. Updated functional level characteristics and documentation requirements

As clinicians, understanding these changes is vital for ensuring your patients receive appropriate care and that your practice remains compliant with Medicare guidelines. For a detailed breakdown of the new coverage criteria, documentation requirements, and implications for your clinical practice, keep reading.

Lower Limb Prostheses LCD Changes Effective September 1, 2024

What's New?

A fluid or pneumatic knee unit (L5610, L5613, L5614, L5615, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840, and L5841), or control addition, fluid (L5848), or electronic/microprocessor (L5856, L5857, L5858) is also covered under limited circumstances for beneficiaries whose functional level is 2, when all of the following criteria (1-3) are met:

1. The beneficiary has had a clinical evaluation to determine their functional level; and,
2. Supporting documentation in the medical record outlines, in the context of the beneficiary’s overall medical health, the rationale for selection of a fluid, pneumatic, or electronic/microprocessor-controlled knee, including (at minimum) how the selected knee will:
   1. Improve the beneficiary’s functional health outcomes (e.g., fall reduction, injury prevention, lower energy expenditure); and,
   2. Help the beneficiary accomplish their activities of daily living (ADLs); and,
3. Lower-level knee systems (e.g., knee systems that exclude the use of fluid, pneumatic, or microprocessor) have been considered and ruled out based on the beneficiary’s specific functional and medical needs.

In addition, for coverage of an electronic/microprocessor-controlled knee system (L5856, L5857, or L5858 plus associated components) for beneficiaries whose functional level is 2, all the following criteria (1-4) must also be met:

1. The electronic/microprocessor knee is indicated for functional level 2; and,
2. The electronic/microprocessor knee has integrated technology that allows the knee to detect when the user trips or stumbles and can automatically adjust to stabilize the knee unit (e.g., stumble recovery); and,
3. The beneficiary is able to make use of a product that requires daily charging; and,
4. The beneficiary is able to understand and respond to error alerts and alarms indicating problems with the function of the unit.

Lower Limb Prostheses Policy Article Effective September 1, 2024

Overview of Functional Level Charactersitics

Note: Not all traits listed for K levels must be realized by the patient to receive a K-level assignment. Generally, documentation should demonstrate that the prosthetic user can achieve equivalent activities.

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

1. The individual can, with or without an assistive device (which may include one or two handrails) and/or with or without the assistance/supervision of one person:
   1. Perform the Level 1 tasks designated above
   2. Ambulate on a flat, smooth surface (e.g., concrete, asphalt) such as might be found outside the home. (e.g., porch, deck, patio garage, driveway)
   3. Negotiate a curb
   4. Access public or private transportation
   5. Negotiate 1-2 stairs
   6. Negotiate a ramp built to ADA specifications.
2. The individual may require a wheelchair for distances that are beyond the perimeters of the yard/driveway, apartment building, etc.
3. The individual is only able to increase their generally observed speed of walking for short distances or with great effort.
4. The individual is generally not capable of accomplishing most of the tasks at Level 3 (or does so infrequently with great effort).

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

1. With or without an assistive device (which may include one or two handrails), the individual is independently capable (i.e. requires no personal assistance or supervision) of performing the Level 2 tasks above and can:
   1. Walk on terrain that varies in texture and level (e.g., grass, gravel, uneven concrete)
   2. Negotiate 3-7 consecutive stairs
   3. Walk up/down ramps built to ADA specifications
   4. Open and close door
   5. Ambulate through a crowded area (e.g., grocery store, big box store, restaurant)
   6. Cross a controlled intersection within their community within the time limit provided (varies by location)
   7. Access public or private transportation
   8. Perform dual ambulation tasks (e.g. carry an item or meaningfully converse while ambulating)
2. The individual does not perform the activities of Level 4.

New Policy Specific Documentation Requirements

Information which specifies that orthotist and prosthetist records are considered part of the medical record to support documentation created by the treating practitioner.

Based on Social Security Act §1834(h)(5), for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics, documentation created by an orthotist or prosthetist shall be considered part of the individual’s medical record to support documentation created by the treating practitioner.

Added: L5615 and L5841 to the HCPCS codes referenced in regard to claims for knee, foot, ankle, and hip components.

Information that must be included in the medical records for certain HCPCS codes (L5610, L5613, L5614, L5615, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840, L5841, L5848, L5856, L5857, L5858) for beneficiaries whose functional level is 2, the medical records must include all the following:

1. Documentation of a clinical evaluation of the beneficiary’s potential functional abilities by a treating practitioner or the prosthetist which designates a functional level of 2 (If completed by a prosthetist, the treating practitioner's medical records must support the functional level assigned); and,
2. Discussion of the beneficiary’s overall medical health and the rationale for selection of a fluid, pneumatic, or electronic/microprocessor-control addition to a prosthetic knee system. Taking into consideration potential safety concerns of the advanced knee technology, the following must be included (at minimum):
   1. Which functional health outcomes (e.g., fall reduction, injury prevention, lower energy expenditure) are expected to be improved with the selected knee; and,
   2. Specifically which activities of daily living (e.g., transferring, climbing stairs, grocery shopping, housekeeping, working) are expected to be improved with the use of the selected knee; and,
3. Documentation to support that lower-level knee systems (e.g., knee systems which exclude use of fluid, pneumatic, or microprocessor) have been considered and ruled out, including the rationale for why a lower-level knee system would not be sufficient to meet the beneficiary's specific functional and medical needs.

Additionally, for an electronic/microprocessor-controlled knee system (L5856, L5857, or L5858 plus associated components) for beneficiaries whose functional level is 2, the medical record must also include:

1. Documentation that the electronic/microprocessor knee is indicated for functional level 2 and has integrated technology that allows the knee to detect when the user trips or stumbles and can automatically adjust to stabilize the knee unit (e.g., stumble recovery); and,
2. Documentation indicating the beneficiary is able to make use of a product that requires daily charging and has the capacity to understand and respond to error alerts and alarms indicating problems with the function of the unit.

Resources & References

• LCD Lower Limb Prostheses (Effective Date September 1, 2024)
• Lower Limb Prostheses – Policy Article (Effective Date September 1, 2024)