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The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have released a draft policy Local Coverage Determination (LCD) for Lower Limb Prostheses for public comments from physicians, manufacturers, suppliers, and other professionals involved in the ordering or provision of the items. The LCD requires a 45-day public comment period, which will take place from July 16 through close of business on August 31.

It is requested that disagreement with any aspect of a policy be addressed very specifically in the comments and, if possible, an alternative should be offered. Clinical rationale should also be included, with references from the published clinical literature (e.g., standard textbooks, peer-reviewed journals, etc.). A written response for agreement with the policy is also encouraged.

The comment process also requires a public meeting, which will be held as a joint DME MAC meeting on August 26 in Linthicum, Maryland; interested parties from any DME MAC jurisdiction may attend. Registration for the public meeting must be completed by close of business on August 21. The meeting will provide opportunities for brief oral presentations only; there will be no question-and-answer or discussion period. In order for oral presentation comments to be considered, they must be presented through the formal comment process.

The draft LCD includes the following points:

• Revises coverage for the provision of definitive prosthetic components in lieu of an immediate or preparatory prosthesis
• Implements a requirement for an independent medical exam to determine functional status
• Implements a requirement for a new amputee to participate in a rehabilitation program prior to the provision of a definitive prosthesis
• Revises functional level modifiers (K-level modifiers)
• Revises codes for prosthetic feet

An Össur reimbursement and regulatory blog post addressed this draft LCD, and said that the “ramifications are potentially far reaching.” While the blog post said here were “too many changes to easily address in a single post,” it outlined a preliminary “top ten” concerns, including new definitions for many terms, such as for different types of prostheses and “Licensed or Certified Medical Professional”; socket code restrictions; two L-Codes for elevated vacuum systems are declared “not reasonable and necessary” due to lack of sufficient clinical evidence; K1 and K2 patients are restricted to fixed-ankle fee only; and prosthetic cover restrictions.

For details about the comment and meeting process and for copies of the draft LCDs, access the following links: