Comment on CMS-2026-1256-0002

Dear Mr. Administrator: On behalf of Pulse Biosciences, manufacturer of the nPulse technology, I am pleased to submit these comments to the Centers for Medicare & Medicaid Services (CMS) in response to the Notice of Proposed Rulemaking for the Medicare Hospital Inpatient Prospective Payment System (IPPS) for FY 2027 (the Proposed Rule.) The patented nPulse technology is currently used for the ablation of soft tissue and related applications, such as the ablation of benign thyroid tumors and nodules as well as ablations to restore normal cardiac sinus rhythm such as atrial fibrillation. The nPulse platform using nsPFA energy is a novel technology that has the potential across many different therapy areas. Retaining the Alternative Pathways for Breakthrough Devices Pulse Biosciences finds the sudden proposal by CMS to dissolve the alternative pathway for Breakthrough Devices both ill considered and in sharp contrast to policy established in FY2020 for inpatient New Technology Add-on Payments (NTAP) and for calendar 2020 Transitional Pass Through (TPT) payments. Since that time, manufacturers such as Pulse Biosciences with FDA-designated Breakthrough Devices have structured multi-year development, evidence generation, and capital deployment plans in reliance on these alternative pathways. Pulse Biosciences supports industry comments in opposing the CMS proposal to eliminate the alternative pathway for NTAP and outpatient TPT pathways for FDA Designated Breakthrough Devices. We anticipate the CMS proposal for sudden dissolution of this pathway would significantly undermine the notion of rapid access to innovative technologies for Medicare patients. We appreciate your careful consideration of these issues. Sincerely, Paul LaViolette Chief Executive Officer & Cochairman of the Board