Benzinga | Jun 8, 2021 08:08AM EDT

Myomo Gives Update On Application For Healthcare Common Procedure Coding System Level 2 Code Change: Finalization Of Proposed Rules Has Been Delayed, Co. Withdrew Its Code Change Application

Myomo, Inc. (NYSE:MYO) ("Myomo" or the "Company"), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, today provided an update regarding its application for a Healthcare Common Procedure Coding System ("HCPCS") Level II code change and benefit category redetermination for HCPCS codes L8701 and L8702 submitted in January 2021. The Centers for Medicare & Medicaid Services ("CMS") proposed several changes to the benefit category determination process in its proposed rule (the "Proposed Rule") CMS-1738-P, "Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics and Supplies ("DMEPOS") Policy Issues and Level II of the Healthcare Common Procedure Coding System (HCPCS)" (85 Fed. Reg. 70358, November 4, 2020). With the change in CMS leadership and continued COVID mitigation planning, finalization of the Proposed Rule has been delayed. As a result, Myomo withdrew its HCPCS code change application and intends to meet with CMS to continue discussions for finalizing the appropriate Medicare benefit category, coverage and fee publications for HCPCS codes L8701 and L8702. The Company intends to continue with its current business strategy of serving patients with certain Medicare Advantage, commercial and government health insurance plans.

Paul R. Gudonis, Chief Executive Officer of Myomo commented, "Since a new CMS Administrator was only recently confirmed, we decided that it was in the Company's best interest to withdraw our application until the Proposed Rule is finalized. We intend to resubmit our coding application at that time. Due to recent actions by the new Administration, over 800,000 more Americans now have access to health insurance and we are pleased to see this broader access. We look forward to working with new CMS leadership and staff to enable more individuals with dysfunctional arms to gain access to a MyoPro brace to restore their arm and hand function and reduce their overall cost of care."