AUSTIN, Texas, July 2, 2026
Mobia Medical, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) has proposed maintaining CPT® Code 64568, the procedure code used for the Vivistim® Paired VNS™ System, under New Technology Ambulatory Payment Classification (APC) 1580 in the Calendar Year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) proposed rule. Under the proposal, hospitals would continue to receive an outpatient reimbursement rate of approximately $45,000, unchanged from the 2026 payment level. The proposed decision represents an important reimbursement milestone for the commercial-stage medical device company, helping preserve financial stability for hospitals that offer the FDA-approved therapy while supporting broader patient access. CMS is expected to publish the final OPPS rule in November 2026, with any approved changes becoming effective on January 1, 2027.
Stable Reimbursement Supports Hospital Adoption of Vivistim Technology
The proposed continuation of New Technology APC 1580 is expected to provide hospitals with reimbursement certainty as they continue expanding Vivistim Programs for eligible Medicare beneficiaries recovering from stroke. According to Mobia Medical, maintaining the current outpatient payment level removes financial uncertainty for healthcare providers considering adoption of the technology and strengthens the commercial outlook for the company’s stroke rehabilitation platform. Company President and Chief Executive Officer Richard Foust stated that consistent reimbursement allows hospitals to confidently invest in Vivistim while improving access to advanced neurostimulation therapy for patients living with long-term upper limb impairment following ischemic stroke. Mobia believes the CMS proposal will support continued commercial growth and wider market adoption throughout 2027 and beyond as additional healthcare systems incorporate the therapy into stroke rehabilitation programs.
Vivistim Combines Vagus Nerve Stimulation with Rehabilitation Therapy
The Vivistim® Paired VNS™ System is the first and only FDA-approved implantable therapy specifically designed to improve upper extremity function in patients with chronic ischemic stroke who experience moderate to severe arm impairment. The system combines targeted vagus nerve stimulation (VNS) with structured rehabilitation exercises to promote neuroplasticity, enabling the brain to strengthen neural pathways associated with movement recovery. Unlike conventional rehabilitation alone, Vivistim delivers precisely timed stimulation during functional movement exercises, helping patients regain meaningful arm and hand function. Clinical validation supporting the technology has positioned Vivistim as an innovative treatment option for stroke survivors who continue to experience disability months or years after their initial stroke, addressing a significant unmet need in neurological rehabilitation.
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CMS Proposal Reinforces Mobia Medical’s Commercial Growth Strategy
The proposed 2027 CMS reimbursement decision represents an important step in Mobia Medical’s broader commercialization strategy as the company seeks to expand the availability of advanced stroke recovery technologies across the United States. Continued reimbursement under New Technology APC 1580 provides healthcare providers with greater confidence when establishing new treatment programs while ensuring Medicare beneficiaries retain access to an innovative FDA-approved rehabilitation option. As CMS moves toward publication of the final Hospital Outpatient Prospective Payment System (OPPS) rule later this year, Mobia Medical remains focused on increasing physician awareness, strengthening hospital partnerships, and expanding utilization of the Vivistim Paired VNS System. If finalized, the reimbursement proposal is expected to further support adoption of implantable neurostimulation technology designed to improve long-term functional recovery and quality of life for stroke survivors.
Source: Mobia Medical press release
