CMS’ Lower Limb Prostheses Interagency Workgroup Releases a Consensus Statement


In 2016 the Center for Medicare & Medicaid Services (CMS) convened the Lower Limb Prostheses Interagency Workgroup in response to the comments received in regard to the 2015 Draft Local Coverage Determination (LCD) for Lower Limb Prostheses. The Workgroup’s purpose was to “develop a consensus statement that informs Medicare policy by reviewing the available clinical evidence that defines best practices in the care of beneficiaries who require lower limb prostheses.” The Workgroup has completed their review and released a consensus statement outlining their findings and suggestions.
Based on the findings and recommendations of the Workgroup CMS is taking the following immediate actions:

• Instructing the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) to remove the Draft LCD
• Instructing the DME MACs that coverage for lower limb prostheses will remain under the current LCD, with no changes
• Future LCD changes must follow procedures set forth in the 21st Century Cures Act
• Considering creating a National Coverage Determination (NCD) to evaluate the use of microprocessor knees (MPK) in those individuals utilizing their prostheses as a limited community ambulator (K2 functional level)

The removal of the Draft LCD has been an aim of AOPA and its lobbying efforts, since it was introduced in 2015, and the official directions from CMS to remove it is a major victory.

AOPA is currently reviewing the full findings of the Workgroup and the consensus document, and there are some areas/conclusions where AOPA will likely disagree and wish to provide additional comments. For example, it appears that the consensus document may have been written before the enactment in February, 2018 of Section 50402 of the Bipartisan Budget Act of 2018 which recognizes the legitimacy of orthotist’s and prosthetist’s notes in the medical record for the justification of medical necessity. Even in light of the recent letter from the CMS Deputy Administrator & Director of Program Integrity instructing the implementation of Section 50402, CMS has yet to revise the Program Integrity Manual to reflect the directions from the Deputy Director, the head of CMS’ own Program Integrity Center, and the current status of the prosthetist’s notes continues to be misstated.

In addition the recommendation that the potential for MPK devices for K2- limited community ambulators- be done by a NCD is an important step forward as it represent CMS taking back this authority from the DME MACs. LCDs are the province of the DME MACs, while a NCD is a strict Federal Register CMS-driven rulemaking process. CMS has consistently said that the only way they could take this matter out of the authority of the DME MACs would be to invoke a NCD. AOPA will also be submitting comments on the proposed NCD and potential for microprocessor knees to be used by K2 -limited community- ambulators in accordance with established guidelines.

Click here to access the document. Then click to go to the Lower Limb Prosthetic Workgroup Consensus Document link.

AOPA will keep you posted about any additional actions taken as a result of the Workgroup’s final findings. Questions? Contact Joe McTernan at jmcternan@AOPAnet.org or Devon Bernard at dbernard@AOPAnet.org.