Ottobock Advocates for Expanded Access to Proven Prosthetic Technologies Under New Proposed LCD Changes

Our mission at Ottobock is to help people maintain and regain their freedom of movement. Our commitment includes advocacy that those with limb loss or limb difference have access to the safest and most appropriate prostheses as recommended by their clinician.

As a testimony to this commitment, we are pleased to share some exciting news. On January 18th, the DME MACs announced proposed changes to the Medicare Local Coverage Determination (LCD) for Lower Limb Prosthetics, including MPK coverage for K2 patients. This is the direct result of a LCD Reconsideration Request filed by Ottobock to the DME MACs on 03/31/2022 (read the application HERE). We started working on this policy change in 2005 with the initiation of the very first MPK study in K2 patients. Over the years, Ottobock has commissioned and supported a total of 11 clinical studies; resulting in 13 peer-reviewed publications, two peer-reviewed systematic reviews - including one meta-analysis of the study results of 704 patients that have all proved the benefits of MPK technology for K2 patients. Without this body of evidence built by Ottobock, this positive policy change would not have been possible.

Understanding the Proposed Changes:

The proposed LCD proposes coverage criteria for microprocessor-controlled prosthetic knees (MPKs) for K2 level patients which have traditionally been limited to K3 users and above. Additionally, the proposed LCD proposes that the coverage criteria for feet be modified to allow coverage of a compatible foot when coverage criteria for an MPK are met. These changes, if implemented, will have a profound impact on the accessibility and functionality of prosthetic knees and feet for individuals at different functional levels.

• Fluid, pneumatic, and microprocessor-controlled knees: Previously available only to K3 users, the draft proposes these could now be fitted to K2 users. This is contingent on (1) a comprehensive clinical evaluation to determine their functional level, (2) supporting medical documentation including the rationale for a fluid, pneumatic or microprocessor knee, and (3) a thorough consideration of other knee systems (knee systems that exclude use of fluid, pneumatic, or microprocessor control).
  • Knee codes eligible for consideration include: L5610, L5613, L5614, L5615, L5722, L5724, L5726, L5728, L5780, L5814, L5822, L5824, L5826, L5828, L5830, L5840, L5848, L5856, L5857, and L5858.
• Microprocessor-Controlled Knees (MPKs): Additional criteria for MPKs include (1) indicated for functional level K2, (2) integrated stumble recovery technology, (3) the user's ability to manage a product that requires daily charging and (4) the user’s ability to respond to error alerts or alarms.
  • Knee codes eligible for consideration include: L5856, L5857, or L5858.
• Revised Criteria for Foot Prosthetics: Certain foot codes, previously reserved for K3 transfemoral amputees, could be available for K2 users when a (1) the user satisfies the K2 level criteria above and (2) higher-level foot is necessary for the effective use of the prescribed knee system.
  • Foot codes eligible for consideration under these criteria include: L5973, L5976, L5979, L5980, L5981, and L5987.

To view the complete Proposed LCD, please CLICK HERE

What This Means for You: These proposed changes represent a significant advancement in making microprocessor prosthetic solutions more accessible to a broader range of patients. It addresses longstanding critiques of the K-level classification system, which has sometimes limited patient access to the most clinically appropriate prosthetic technologies and services.

Staying Engaged and Informed:

• Open Virtual Meeting: CMS will host a national virtual meeting on February 22, 2024, to discuss this draft LCD. We encourage you to register and participate. Advance registration is required. CLICK HERE.
• Public Comments: Additionally, you have until March 2, 2024, to submit your public comments on the draft LCD. We strongly recommend reviewing the full document and sharing your insights. To view the draft LCD, supporting information, and to submit your public comment, please CLICK HERE.

At Ottobock, we believe in empowering our community with the right information and tools to make informed decisions. We are closely monitoring these developments and will keep you updated on any new information regarding this draft LCD. Together, we strive to enhance patient outcomes and extend the boundaries of what's possible in prosthetics and orthotics.

Microprocessor Prosthetic Knee Technology currently available and PDAC-verified

Based on their technical principles and published evidence for benefits in individuals with TFA and KD, not all MPK currently available in the U.S. market and verified by PDAC for billing of L5856 may be suitable for use in subjects with MFCL-2 mobility [11, 20, 21]. The following table gives an overview on the 6 MPK that have currently been verified by PDAC. Disclaimer: For non-Ottobock MPK, all information listed here is based on publicly accessible resources, such as the peer-reviewed publications, manufacturers´ websites, marketing materials/brochures, and instructions for use (IFU), if accessible.