The Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for the system This offers incremental payment for procedures involving the use of the SetPoint System in hospital outpatient and ambulatory surgery center (ASC) settings. The TPT becomes effective January 1, 2026, and lasts for up to three years.
SetPoint received FDA approval for its SetPoint neuroimmune modulation system for treating rheumatoid arthritis (RA) in July. It reported the first commercial cases a month later.
The first-of-its-kind device treats adults with moderate-to-severe RA not adequately managed by (or failing to tolerate) existing therapies. Those therapies include biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
Valencia, California-based SetPoint Medical designed the implantable, integrated neurostimulation system to deliver electrical stimulation. It stimulates the vagus nerve once per day. This activates the body’s innate anti-inflammatory and immune-restorative pathways to treat RA.
Approval created a new CMS device category for the SetPoint system, acknowledging its novelty, according to a news release. It’s the first FDA-approved, non-pharmacologic treatment option for adults with moderately to severely active RA who have had an inadequate response to—or are intolerant of—biological or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs).
Spencer Bailey, SetPoint’s VP of market access, said the approval enables the company to implement referral pathways and establish reimbursement infrastructure. It supports the broader launch of the system in 2026, Bailey said.
“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, 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.”
