BOSTON—Myomo, Inc. (NYSE American: MYO), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, announced that its request to the Centers for Medicare and Medicaid Services (CMS) to classify the company’s MyoPro as a brace has been published for public comment.
Currently, the MyoPro is assigned Healthcare Common Procedure Coding System (“HCPCS”) billing codes L8701 and L8702, with coverage based on consideration of each patient’s medical necessity for the powered arm brace. In June 2022, Myomo presented its appeal to CMS to change the benefit category of the MyoPro from durable medical equipment (DME), which is reimbursed as a rental, to a brace, which has historically been reimbursed in a lump-sum payment. On June 30, 2023, in conjunction with new proposed rules covering home health services, CMS issued a proposal that clarifies the definition of a brace to include newer technologies, including the MyoPro.
The proposed rule states that the L8701 and L8702 HCPCS codes are to be classified as a brace. Should the proposed rule be finalized and should there be no change to how braces are reimbursed, the MyoPro will be reimbursed on a lump-sum basis by CMS, which is consistent with the payment approach by private health insurers. A 60-day public comment period is required before the proposed rule is finalized. In addition, CMS stated that it intends to publish a fee for the MyoPro HCPCS codes at an upcoming public meeting. The next public meeting is expected to be held in late 2023 or early 2024.
The proposed rule as published in the Federal Register is available here, and the discussion of the changes to the brace definition begins on page 289.
“This proposed rule represents the culmination of a multi-year effort to obtain the proper classification for the MyoPro as a brace,” said Myomo’s Chief Executive Officer Paul R. Gudonis. “We are pleased with this outcome and intend to work with CMS and others in the orthotics and prosthetics industry to support the proposed rule, which, if enacted, is expected to support health equity by providing access to the MyoPro for medically-qualified Medicare Part B beneficiaries.”
Myomo also announced its initial claims filed with CMS’ billing contractors, referred to as the DME MACs, are currently under detailed review by the DME MACs as part of the process of individual consideration. The Company cannot predict whether the review of these initial claims will be impacted by the publication of this proposed rule by CMS.