SetPoint Medical announced that the Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for its SetPoint system, a neuroimmune modulation device.

The approval provides incremental payment procedures involving use of the SetPoint system in hospital outpatient and ambulatory surgery center (ASC) settings. The TPT becomes effective on Jan 1, 2026 and will last for up to three years.

Thanks to this approval, CMS created a new category to describe the SetPoint system (C1607) in the Healthcare Common Procedure Coding System (HCPCS). The category acknowledges it as the first FDA-approved, non-pharmacologic treatment option for adults living with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to—or are intolerant of—biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).

“We are truly grateful to CMS for their dedication to the health of Medicare beneficiaries,” said Spencer Bailey, MBA, CPC, VP of market access at SetPoint Medical. “Following this TPT approval, we plan to engage with providers to implement referral pathways and establish reimbursement infrastructure to support broader launch of the SetPoint System in 2026.”

The SetPoint system was approved by the U.S. Food and Drug Administration (FDA) in July 2025 as part of the Breakthrough Devices Program. It’s a fully integrated neuroimmune modulator designed to restore the immunologic balance by electrically stimulating the vagus nerve for one minute daily.

Once activated, integrated telemetry and a rechargeable battery in the implant are designed to automatically deliver therapy for up to 10 years.

“Receiving TPT is an important milestone for the SetPoint System, as it will enable broader access to our breakthrough therapy by reducing cost barriers for healthcare systems,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “We are committed to advancing care for people living with RA and are proud that CMS, the nation’s largest payer for healthcare, recognizes the value of our therapy to its beneficiaries.”