SetPoint Medical, a company focused on improving care for people with chronic autoimmune diseases, announced that the Centers for Medicare and Medicaid Services has approved Transitional Pass-Through payment for its neuroimmune modulation device, the SetPoint System. This approval allows hospitals and ambulatory surgery centers to receive incremental payment for procedures using the SetPoint System starting January 1, 2026, and lasting up to three years.
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CMS has created a new device category, C1607, in the Healthcare Common Procedure Coding System to recognize the SetPoint System. This category highlights the device’s uniqueness as the first FDA-approved, non-drug treatment for adults with moderately to severely active rheumatoid arthritis who have not responded to or cannot tolerate biological or targeted synthetic disease-modifying antirheumatic drugs.
Spencer Bailey, MBA, CPC, vice president of Market Access at SetPoint Medical, said the company is grateful to CMS for supporting Medicare patients. He added that following the approval, SetPoint Medical will work with healthcare providers to establish referral pathways and develop reimbursement processes to support the broader launch of the SetPoint System in 2026.
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Rheumatoid arthritis affects over 1.5 million Americans. This chronic autoimmune condition causes the immune system to attack healthy tissue, leading to joint pain, bone erosion, deformities, and long-term disability. The SetPoint System, approved by the U.S. Food and Drug Administration in July 2025 under the Breakthrough Devices Program, is an integrated neuroimmune modulator. It works by stimulating the vagus nerve for one minute each day. The device’s telemetry system and rechargeable battery are designed to deliver therapy automatically for up to ten years.
Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical, said that receiving TPT approval is a major milestone. He noted that this decision will help expand patient access to the therapy by reducing cost barriers for healthcare systems. He emphasized that the company is committed to advancing care for people with rheumatoid arthritis and is proud that CMS recognizes the value of the SetPoint System for its beneficiaries.
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