Medicare Innovation At Risk? Patients And NTAP Breakthrough Technology

InnovationHealthcareMedicare Innovation At Risk? Patients And NTAP Breakthrough TechnologyByRichard Menger MD MPA,Contributor.Forbes contributors publish independent expert analyses and insights. Richard Menger is a neurosurgeon and a political scientist.Follow AuthorJun 09, 2026, 10:01am EDTCANADA - 2025/08/31: In this photo illustration, the United States Medicare logo is seen displayed on a smartphone screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty ImagesOn April 14, 2026, the Centers for Medicare & Medicaid Services (CMS) released the FY 2027 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. Among its notable provisions is a proposal to repeal the alternative New Technology Add-on Payment (NTAP) pathway tied to FDA Breakthrough Device designation, effective for applications beginning in FY 2028.This change warrants close scrutiny from spine surgeons, hospitals, device innovators, policymakers and most importantly, patients.What Is The NTAP Breakthrough Device Designation?The New Technology Add-on Payment (NTAP) program, established in 2001, provides supplemental Medicare payments to hospitals for certain new, high-cost technologies during their initial market years (typically up to three years). These payments help offset the gap between the technology’s cost and standard Medicare Severity-Diagnosis Related Group (MS-DRG) reimbursement to the hospital.To qualify under the traditional pathway, technologies must meet three criteria:Newness: Not substantially similar to existing options.Cost: The technology must be significantly more costly than the MS-DRG payment.Substantial Clinical Improvement (SCI): Demonstrated meaningful benefits in clinical outcomes for Medicare beneficiaries.In 2020 (finalized for FY 2021), CMS created an alternative pathway for devices with FDA Breakthrough Device designation. These transformative technologies—intended for life-threatening or irre...