Neuspera Integrated Sacral Neuromodulation System (iSNM) to Receive Same Medicare Payment as Legacy Implantable SNM Devices Under Proposed 2027 CMS Rule

Reimbursement Parity Advances Patient Access and Will Help More Patients Avoid the Pain, Complications, and Repeat Surgeries Common in the $1 Billion Legacy Sacral Neuromodulation (SNM) Market Served by Boston Scientific and Medtronic

SAN JOSE, Calif., July 8, 2026 /PRNewswire/ -- Neuspera Medical today highlighted that the Centers for Medicare & Medicaid Services (CMS) has confirmed the assignment of the billing code for the Neuspera Sacral Neuromodulation System (SNM) to payment level APC 5464 in the proposed CY 2027 Outpatient Prospective Payment System Rule.¹ The assignment provides the externally powered integrated SNM (iSNM) system the same Medicare payment as all other neuromodulation implantable therapies for urinary urge incontinence. The rule also increases the payment rate for APC 5464 to $22,150 for CY 2027, an 11.8% increase from 2026. Combined with the addition of the iSNM's billing code to Medicare's existing National Coverage Determination (NCD) 230.18 for Sacral Nerve Stimulation for Urinary Incontinence effective last year, this provides broad and straightforward access for Medicare beneficiaries for this technology.

"We commend CMS for their thorough review and for making the decision to assign APC Level 4 to the Neuspera sacral neuromodulation system, with a strong proposed payment increase," said David Van Meter, CEO of Neuspera. "This puts us on equal footing and will allow many more patients to benefit from SNM without the complications of implanted batteries commonly associated with legacy systems. A testament to the importance of our therapy is the opposition it faced from those invested in the status quo.^2,3 Ultimately, what is best for patients prevailed."

This announcement comes at a time of accelerating activity in the FREEDOM registry, a study designed to demonstrate how the Neuspera iSNM system eliminates drawbacks related to traditional battery SNM systems while maintaining SNM-level effectiveness. This builds on the recent milestone case⁴ by Dr. Kellen Choi at the University of Louisville, with many more cases already completed and scheduled.

A newly published Cleveland Clinic study⁵ further quantifies the patient burden with legacy systems: 62% of patients can feel the device, 36% experience activity-related discomfort, and 18% report sleep or movement limitations. The Neuspera iSNM system was designed to completely eliminate these common issues.

Dr. Charles R. Powell, Professor of Urology at Indiana University, commented: "Neuspera's externally powered iSNM system is a major step forward that I'm excited to have in my armamentarium. For the many patients struggling with complications from implanted batteries, including pocket pain, infections, and repeated replacement surgeries, this finally solves those long-standing problems. Equally important, it offers an attractive option to the much larger number of patients who have avoided sacral neuromodulation because they simply don't want a bulky device implanted in their body. I believe this will rapidly become the preferred therapy for the majority of candidates."

About the Sacral Neuromodulation Market
Despite its gold-standard clinical efficacy (80-90% responder rates), the SNM market remains dramatically underpenetrated, with less than 5 in 100 potential patients pursuing this option.⁶  Conventional SNM requires creating a "pocket" in the buttock tissue to house the Oreo-sized metal battery, and surgically creating a "tunnel" from the upper buttock to connect the electrode array to its battery. With only marginal advancements in the past 30 years, legacy SNM systems carry notable downsides from implanted lithium-ion batteries that cause pocket pain, infections, plus the need for surgical battery replacement up to 2-3 times in a patient's lifetime. These complications drive substantial healthcare costs. Revisions and replacements account for up to 30% of all SNM procedures and over $300 million annually across the U.S. system.^7,8

About the FREEDOM Registry
The FREEDOM Registry is a prospective, multi-center observational study enrolling up to 100 patients across as many as 20 centers. It systematically captures quality-of-life, pain relief, satisfaction, and other patient-reported outcomes before and after iSNM implantation in patients who had previously had a traditional battery SNM system. By bringing the authentic "voice of the patient" to clinicians and stakeholders, the registry generates real-world evidence to guide adoption and optimize outcomes as the Neuspera iSNM system rolls out commercially — with particular emphasis on individuals transitioning from traditional SNM systems due to battery-related complications, such as those associated with weight-loss from GLP-1s, or routine replacements.

For more on the Neuspera iSNM system or the FREEDOM Registry, visit www.neuspera.com.

About Neuspera Medical
Neuspera® Medical, Inc. is a leader in advanced, directionally adaptive energy systems that power tiny medical implants deep within the body. The company is introducing a new class of neurostimulation technology, starting with the first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence (UUI), approved by the FDA in June 2025. Learn more at neuspera.com and on LinkedIn.

Media Contact 
[email protected]

References

1. Centers for Medicare & Medicaid Services. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems... (CY 2027 OPPS Proposed Rule). Federal Register. Available at: https://www.federalregister.gov/documents/2026/07/07/2026-13656/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
2. Public comment letter regarding CY 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems (CMS-2025-0306). Available at: https://downloads.regulations.gov/CMS-2025-0306-2605/attachment_1.pdf.
3. Public comment letter regarding CY 2026 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment Systems (CMS-2025-0306). Available at: https://downloads.regulations.gov/CMS-2025-0306-2965/attachment_1.pdf.
4. Neuspera Medical, Inc. Neuspera Medical Announces Milestone Case of Traditional Sacral Neuromodulation (SNM) System Removed and Replaced With the Company's Integrated SNM System for Urinary Urge Incontinence. PR Newswire. February 10, 2026. Available at: https://www.prnewswire.com/news-releases/neuspera-medical-announces-milestone-case-of-traditional-sacral-neuromodulation-snm-system-removed-and-replaced-with-the-companys-integrated-snm-system-for-urinary-urge-incontinence-302683335.html.
5. Mansour M, Trump T, Zeinab MA, et al. Patients' Perspectives and Challenges with Implantable Pulse Generator in Patients Undergoing Sacral Neuromodulation. Int Urogynecol J. Published online June 9, 2026.
6. Ball MAZ, Cheng MYZ, Mbassa R, Meeks W, Galen E, Van Kuiken ME. Trends in Utilization of Sacral Neuromodulation for Overactive Bladder: Insight From the AUA AQUA Registry. Urology Practice. 2026;13(2):189-197. doi:10.1097/UPJ.0000000000000916.
7. Bretschneider CE, et al. Device-Related Reoperations 8 Years Following Sacral Neuromodulation Implantation in Older Women. Int Urogynecol J. 2024;35(12):2349-2355.
8. Axonics Modulation Technologies, Inc. Form S-1 registration statement. October 5, 2018. U.S. Securities and Exchange Commission. Available at: https://www.sec.gov/Archives/edgar/data/1603756/000119312518294804/d609102ds1.htm#toc609102_9.

SOURCE Neuspera Medical