In 2016, the Centers for Medicare & Medicaid Services (CMS) convened the multidisciplinary Lower Limb Prostheses Interagency Workgroup in response to negative feedback 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 issued its report to CMS as a consensus statement to inform Medicare coverage policy.
Based on the workgroup’s findings, CMS said it will take the following actions:
· Provide instruction to its Durable Medical Equipment Medicare Administrative Contractors (DME MACs) to remove the proposed/draft LCD. Coverage of lower-limb prostheses continues under the current LCD for lower-limb prostheses with no changes. If a new or revised LCD is required in the future, the LCD process established by the 21st Century Cures Act will be followed, which includes a summary of the evidence the CMS contractors considered during the development of the LCD, publication of a written explanation of the rationale for the LCD, and a public comment period.
· Collaborate with the National Center for Medical Rehabilitation Research of the National Institutes of Health to create a guidance document to promote research standards in the field of lower-limb prostheses.
· Consider opening a National Coverage Determination to evaluate the use of microprocessor knees in those individuals utilizing their prostheses as a limited community ambulator, meaning they utilize the prosthesis in the home and to traverse low-level community barriers such as curbs, stairs, and uneven surfaces. (These activities are consistent with the K2 level of function defined in the current LCD.)
CMS said it welcomes external requests on this topic submitted according to the process described at www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf