New Medicare Orthotics Regulation Final Rule

CMS released this week the CY 2024 Home Health Prospective Payment final rule (“Final Rule”), which contains a section codifying the definition of a “brace” or “orthosis” in the federal regulations. This constitutes a significant win for NAAOP, working in conjunction with its O&P Alliance partners, as well as the broader rehabilitation and disability communities.

The final rule largely tracks the proposed rule but offers some clarifications on topics raised by NAAOP in its comment letter and in other communications with CMS over the past few months.

Definition of a Brace: CMS finalized its proposal to amend the federal Medicare regulations to add the definition of a “brace.” Currently, the term “brace” is defined in the Medicare Benefit Policy Manual (MBPM) which is guidance and does not carry the weight of regulations. The final rule defines braces as “rigid and semi-rigid devices which are used for the purpose of supporting a weak or deformed body member or restricting or eliminating motion in a diseased or injured part of the body.” This solidifies the definition of an orthosis so that future administrations cannot easily restrict the definition through guidance documents.

Rigid or Semi-Rigid: CMS states in the Final Rule that “[r]igid materials are used to eliminate motion but also to support underload,” and “semi-rigid materials … intentionally allow some amount of motion as compared to materials that completely immobilize a part of the body.” These definitions are consistent with the proposed rule. CMS also will consider expansion of the brace definition in future rulemaking if there is evidence that more elastic devices still meet this definition.

Powered Features: CMS clarified that devices with power features designed to assist with traditional bracing functions are considered braces. Specifically, powered upper extremity devices and powered lower extremity exoskeleton devices will be classified as orthotics effective on January 1, 2024. This is a major victory for O&P patients and providers and is expected to lead to Medicare coverage of a new generation of powered orthoses.

Shoes as Integral Part of Leg Brace: CMS also clarified that a brace may include a shoe if it is an integral part of a leg brace and its expense is included as part of the cost of the brace. HCPCS codes L3224 (orthopedic footware; woman’s shoe) and L3225 (orthopedic footware; man’s shoe) are available to submit claims for orthopedic shoes that are an integral part of a brace. This clarifies that orthopedic shoes used as an integral part of a leg brace are covered by Medicare and a separate billing code can be added to the orthotic claim to cover the cost of providing the patient with a shoe that is integral to the brace’s function. This is consistent with NAAOP’s position expressed in our comment letter to the proposed rule and should be considered a win for orthotic patients and providers.

NAAOP thanks our membership for its support of our efforts to improve O&P policies that will lead to better O&P care, greater access to care, and appropriate reimbursement.