Centers for Medicare and Medicaid Services Accepts Myomo’s Application to Classify the MyoPro® as a Brace

BOSTON--(BUSINESS WIRE)-- Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, announces that its request to the Centers for Medicare & 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, 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,” stated 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 announces that 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.

About Myomo, Inc.

Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury. It is currently the only marketed device that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Boston, Massachusetts, with sales and clinical professionals across the U.S. and Germany, and other representatives internationally. For more information, please visit www.myomo.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding the Company’s future business expectations, including expectations for finalization of the proposed rule codifying the change in the benefit category to a brace and timing for the DME MACs to make a determination on our initial claims, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors.

These factors include, among others:

• We have a history of operating losses and our financial statements for the period ended March 31, 2023 include disclosure regarding there being substantial doubt about our ability to continue as a going concern;
• the after-effects of the novel coronavirus (COVID-19) pandemic on our business and operations, including fabrication and delivery, sales, patient consultations, supply chain constraints, manufacturing, insurance reimbursements and employees;
• our ability to continue normal operations and patient interactions in order to deliver and fit our custom-fabricated device;
• our marketing and commercialization efforts;
• our ability to achieve reimbursement from third-party payers for our products, including CMS for Medicare Part B patients;
• our dependence upon external sources for the financing of our operations, to the extent that we do not achieve or maintain cash flow breakeven;
• our ability to effectively execute our business plan and scale up our operations;
• our expectations as to our product development programs; and
• general market, economic, environmental and social factors that may affect the evaluation, fitting, delivery and sale of our products to patients.

More information about these and other factors that potentially could affect our financial results is included in Myomo’s filings with the Securities and Exchange Commission, including those contained in the risk factors section of the Company’s annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. Although the forward-looking statements in this release of financial information are based on our beliefs, assumptions and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements or outcomes. No assurance can be made to any investor by anyone that the expectations reflected in our forward-looking statements will be attained, or that deviations from them will not be material and adverse. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

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