Myomo Inc, a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, reports progress and next steps in the process to obtain Medicare Part B reimbursement for the MyoPro as a brace from the Centers for Medicare & Medicaid Services (CMS).

Myomo was issued Healthcare Common Procedure Coding System (HCPCS) codes L8701 and L8702 by CMS, which became effective January 1, 2019. At that time, CMS classified the MyoPro as durable medical equipment, or DME, which is reimbursed on a 13-month capped rental basis. Since 2019, the Company has been in discussions with CMS to change the benefit category designation from DME to an orthosis, or brace, which for Medicare Part B patients would be reimbursed in a single payment. While these discussions have been taking place, no fee schedule rate has been set by CMS for the MyoPro.

After a new rule was issued by CMS in early 2022, which defined the process for requesting benefit category changes, the Company presented its request to change the benefit category at a CMS public meeting in June 2022. In September 2022, CMS announced that more time was required to evaluate this issue, stating that in the meantime coverage and payment for the MyoPro would be at the discretion of Medicare’s administrative billing contractors, referred to as the DME MACs. Read more about CMS’ decision here.

While a formal benefit category determination change is pending, the Company plans to request a meeting with the medical directors of the DME MACs and to begin submitting claims for Medicare Part B beneficiaries after these discussions in the first part of 2023.

“MyoPro’s are custom fabricated for long-term, individual patient use and, as such, do not fit the DME rental classification. We are committed to bringing the benefits of the MyoPro brace to clinically qualified Medicare Part B beneficiaries, to supporting health equity with broader access and to securing appropriate payment for Myomo,” said Paul R. Gudonis, Myomo’s Chairman and Chief Executive Officer. “We believe that obtaining designation for the MyoPro as a brace or orthosis will expand our addressable market, provide for a faster revenue cycle and allow us to more efficiently process inquiries from clinicians and patients who have Medicare Part B coverage.”

Myomo plans to submit for publication in peer-reviewed medical journals the findings from two research studies that are currently in process, which are expected to add to existing evidence that the MyoPro is effective, reasonable, necessary, and appropriate for Medicare beneficiaries. This research is expected to be published during the first quarter of 2023. Currently, many major payors – including certain Medicare Advantage and commercial insurers, the Veterans Health Administration, the Bureau of Workers Compensation and certain state Medicaid plans – cover the MyoPro and pay for the brace in a lump-sum payment.

At this time Myomo cannot provide any assurance that CMS will change the benefit category for the MyoPro to a brace, pay claims submitted for medically qualified patients or the timing of such payments.

[Source(s): Myomo Inc, Business Wire]