Comment on CMS-2026-1256-0002

Dear Dr. Oz: On behalf of SpinaFx, manufacturer of the Triojection system a novel Breakthrough Device indicated for treatment of contained herniated lumbar disks, 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.”) Triojection is a minimally invasive, image-guided procedure that leverages a proprietary oxygen-ozone delivery system to reduce pressure within the herniated disc and alleviate nerve compression. Triojection offers a targeted, outpatient solution that can be performed in a variety of healthcare settings from hospitals and ambulatory surgical centers to clinics in emerging markets. Triojection received FDA Breakthrough Device Designation (BDD) on August 15, 2025 and is currently undergoing clinical trials under an FDA approved Investigational Device Exemption. Our primary concern with the Proposed Rule is the CMS proposal to dissolve the Alternative Pathway for BDD devices under the hospital outpatient Transitional Pass Through (TPT), effective for all applications received after September 30, 2026. Though Triojection is undergoing a robust randomized clinical trial, the very subjective nature of CMS’ “substantial clinical improvement” threshold under the traditional TPT pathway creates significant uncertainties for this promising new technology, which was duly recognized as eligible for BDD status by the FDA. Hernia treatments today, such as microdiscectomy have failure rates of 10% to 25% and steroidal injections provide pain relief of relatively short duration. Triojection promises to deliver a safe, effective solution for contained herniated discs with longer duration than steroids but with far fewer safety issues than existing treatment options. Though we anticipate clinical superiority in our clinical trial, anticipating CMS views on the meaning of “substantial clinical improvement” is relatively unpredictable. SpinaFx opposes the CMS proposal to eliminate the alternative pathway for NTAP and outpatient Transitional Pass Through pathways for FDA Designated Breakthrough Devices. These pathways are vital to ensuring a predictable pathway for rapid reimbursement for life saving devices and diagnostics. The proposal by CMS for sudden dissolution of these pathways is both disruptive to innovations in the pipeline and would diminish access to vital therapies for Medicare patients. At a minimum, we would propose a two-year delay in any change to the Alternative pathway, such that devices that have planned on this submission process can have adequate time to pursue their submissions. We appreciate the opportunity to comment on proposed IPPS rule and your consideration of these issues. Sincerely, Kieran Murphy, MD Chief Executive Officer SpinaFx Medical