Myomo's (MYO) MyoPro Seeks CMS Classification for Medicare Cover

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Myomo, Inc. MYO recently achieved a significant milestone with its MyoPro device. The company's request to the Centers for Medicare and Medicaid Services (CMS) to reclassify the MyoPro as a brace has been published for public comment. Myomo is a pioneering wearable medical robotics company catering to individuals with neurological disorders and upper-limb paralysis.

With this development, the company advances with its target to support health equity for medically-qualified Medicare Part B beneficiaries.

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At present, MyoPro is categorized as durable medical equipment, reimbursed through rental payments. However, Myomo has appealed to CMS to reclassify it as a brace, which historically receives lump-sum payments.

On Jun 30, 2023, CMS issued a proposal as part of its new rules governing home health services. The proposal, aiming to define a brace to include advanced technologies like the MyoPro, could potentially lead to a positive outcome for Myomo's classification request.

The proposed rule suggests that the existing Healthcare Common Procedure Coding System (HCPCS) codes, L8701 and L8702, be classified as a brace.If this rule is finalized without any changes to reimbursement practices, Myomo's MyoPro could be reimbursed in a lump-sum manner by CMS, aligning with the payment approach adopted by private health insurers.

Looking Ahead

Before the proposed rule becomes official, a 60-day public comment period is required. This period allows stakeholders, including patients, healthcare providers, and industry experts, to provide feedback and insights to CMS. Additionally, CMS plans to disclose the fee for the MyoPro HCPCS codes at an upcoming public meeting, expected to be held in late 2023 or early 2024.

A Long-Awaited Milestone

Myomo's CEO, Paul R. Gudonis, expressed his satisfaction with this progress, describing the proposed rule as the culmination of a multi-year endeavor to secure the appropriate classification for the MyoPro as a brace. The company intends to collaborate with CMS and other stakeholders in the orthotics and prosthetics industry to support the proposed rule's enactment, as it holds the promise of advancing health equity and enabling Medicare beneficiaries to access MyoPro.

Medical Robotics Market Prospects

According to a comprehensive research report by Market Research Future, the global market for medical robotics is poised for significant growth. It is projected to reach a value of $35.2 billion by 2030, with a CAGR of 21.3% between 2022 and 2030.

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Several factors contribute to the positive market prospects of medical robotics. An aging population, susceptible to injuries and medical conditions requiring surgical interventions, drives the demand for accurate and precise procedures. The increasing number of laparoscopic surgeries and trauma injuries further fuel market growth. Moreover, advancements in medical equipment technology, coupled with rising per capita healthcare expenditure in emerging economies, create attractive opportunities for market expansion.

Technological advancements, including robotic catheter control systems, motion sensors, data recorders, 3D imaging, high-definition surgical microscopic cameras, remote navigation and data analytics are also catalysts for market growth. Additionally, the growing number of FDA clearances for new products adds to the positive outlook for the global medical robotics market.

Price Performance

In the past year, MYO shares have plunged 63.6% compared with the industry’s decline of 21.4%.

Zacks Rank and Other Key Picks

Myomo currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the broader medical space are Zimmer Biomet ZBH, Penumbra PEN and Hologic, Inc. HOLX.

Zimmer Biomet has an earnings yield of 5.23% compared to the industry’s -3.14%. Zimmer Biomet’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average surprise being 7.38%. Its shares have rallied 34.8% against the industry’s 22.2% decline over the past year.

ZBH sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Penumbra, sporting a Zacks Rank #1 at present, has an estimated growth rate of 64.1% for 2024. Penumbra shares have surged 170.3% compared with the industry’s 9.8% rise over the past year.

PEN’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 109.4%.

Hologic, carrying a Zacks Rank #2 (Buy) at present, has an earnings yield of 4.87% compared to the industry’s -6.35%. Shares of HOLX have risen 12.7% compared with the industry’s 9.8% growth over the past year.

Hologic’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 27.3%.

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