Neuros Medical Announces CMS Final Rule Granting Medicare Transitional Pass-Through Status for the ALTIUS® System in 2027 Calendar Year Rulemaking
Transitional Pass-Through Payment under the CY 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System expands Medicare patient access to the ALTIUS® System for adult lower limb amputees suffering from chronic post-amputation pain.
ARDEN HILLS, Minn., Nov. 5, 2026 /PRNewswire/ -- Neuros Medical, Inc., a commercial-stage medical device company and developer of the ALTIUS® System for the treatment of chronic post-amputation pain , today announced that the Centers for Medicare & Medicaid Services (CMS) has finalized Medicare Transitional Pass-Through (TPT) status for the ALTIUS® Direct Electrical Nerve Stimulation System in the Calendar Year (CY) 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule.
Effective January 1, 2027, this approval establishes separate incremental reimbursement for the ALTIUS System when implanted in both Hospital Outpatient Departments (HOPDs) and Ambulatory Surgical Centers (ASCs). The newly assigned Category C-code provides separate device reimbursement above the standard Ambulatory Payment Classification (APC) procedural payment rate.
FDA Indication & Unmet Need in Lower Limb Amputees
The ALTIUS® Direct Electrical Nerve Stimulation System is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees.
Chronic post-amputation pain—encompassing both phantom limb pain and residual limb (stump) pain—affects a vast majority of lower limb amputees, often leading to severe disability, impaired mobility, reduced prosthetic usage, and heavy reliance on systemic opioids. Prior to the introduction of ALTIUS, treatment options for managing intractable nerve pain after amputation were limited, and facility reimbursement constraints often hindered access to specialized high-frequency nerve block technologies designed to inhibit pain signals directly at the peripheral nerve source.
Transforming Patient Access and Removing Financial Barriers for ASCs and HOPDs
CMS grants Transitional Pass-Through status to foster Medicare beneficiary access to breakthrough technologies by ensuring that healthcare facilities do not incur financial losses while adopting innovative therapies.
Standard bundled Medicare payments often result in a significant financial gap for facilities purchasing high-cost, advanced neurostimulation implants. Under the CY 2027 final ruling, separate pass-through payment can be made to HOPDs and ASCs for the acquisition cost of the ALTIUS System.
- Unlocking ASC Access: The ruling eliminates historical financial disincentives for Ambulatory Surgical Centers to offer high-frequency neurostimulation, accelerating the migration of care into lower-cost, highly convenient outpatient settings.
- Ensuring Facility Viability: Outpatient providers can now offer this therapy without absorbing negative operating margins, providing clear financial predictability for hospital administration and surgical centers.
- Expanding Beneficiary Coverage: Medicare beneficiaries living with debilitating lower limb post-amputation pain will gain expanded, timely access to the ALTIUS technology without facility cost constraints restricting treatment availability.
"This landmark CMS ruling validates the significant clinical advancement and patient value that the ALTIUS System brings to individuals suffering from chronic post-amputation pain. Historically, technology acquisition costs presented a significant hurdle for outpatient facilities and ASCs, limiting access despite strong patient and provider demand. With transitional pass-through status starting in 2027, Medicare lower limb amputee patients across the country can access this life-changing therapy in the most appropriate care setting, while ensuring our hospital and ASC partners can cover their technology costs." |
Coding and Reimbursement Support
Transitional pass-through payment for the ALTIUS System will remain in effect for up to three years, starting January 1, 2027. Neuros Medical's dedicated Market Access and Reimbursement team will provide comprehensive coding, billing, and health economics support to assist clinicians, ASC managers, and hospital administrators through the transition.
Please email us at reimbursement@neurosmedical.com if you would like additional information.
About the ALTIUS® Direct Electrical Nerve Stimulation System
The ALTIUS System is a patient-controlled, on-demand system that uses Neuros' patented technology to address the underlying cause of post-amputation pain by inhibiting pain signal transmission from the damaged peripheral nerves near the site of amputation to the central nervous system. The system consists of a nerve cuff electrode placed around an affected nerve and an implantable pulse generator (IPG). Patients initiate an on-demand 30-minute treatment session as needed for targeted pain relief.
The ALTIUS System is FDA-approved and is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. The ALTIUS System is the only FDA-approved device that provides amputees with patient-controlled, on-demand relief by targeting the nerve pain directly.
Click here for important safety information.
About Neuros Medical, Inc.
There are nearly two million amputees in the U.S., with 300,000 new amputations occurring every year.1 Post-amputation pain includes both phantom limb pain and residual limb pain, and impacts up to 80% of amputees, representing a significant unmet medical need, as existing treatment options are limited and consist primarily of opioids and gabapentinoids.2 Neuros Medical is a privately held company and the maker of the ALTIUS Direct Electrical Nerve Stimulation System which is FDA-approved and is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees. Our mission is to relieve pain and restore life for people suffering with post-amputation pain. We are a passionate team guided by our core values and committed to our patients and the healthcare professionals who care for them.
Our Core Values: Patients First, Team Before Self, Humility, Accountable, Deliver Excellence.
References
1. Prevalence of Limb Loss and Limb Difference in the United States: Implications for Public Policy. Caruso and Harrington 2024 Avelere Report.
2. Erlenwein, J., Diers, M., Ernst, J., Schulz, F., & Petzke, F. (2021). Clinical updates on phantom limb pain. Pain reports, 6(1), e888.
Media & Market Access Contact:
Kimberly Konopa
Vice President Market Access and Reimbursement
Neuros Medical, Inc.
1212 Red Fox Rd, Arden Hills, MN 55112
kkonopa@neurosmedical.com
SOURCE Neuros Medical
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