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, today reported 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).
As background, 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. The information on CMS’ decision is available 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 payers – 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.
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 the impact on the Company’s business from a change in the benefit category to a brace and the timing and impact of the publication of additional research on the MyoPro 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 September 30, 2022 include disclosure regarding there being substantial doubt about our ability to continue as a going concern;
- the direct and indirect impact of the novel coronavirus (COVID-19) on our business and operations, including fabrication and delivery, sales, patient consultations, supply chain, 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.
