Bayesian wins Medicare NTAP for sepsis

Bayesian Health said on September 2 that its FDA-cleared sepsis flagging device won Medicare new-technology add-on payment status under the Centers for Medicare & Medicaid Services’ fiscal 2027 inpatient payment rule. The decision gives the New York company a temporary add-on reimbursement pathway for eligible inpatient use on top of the standard Medicare severity diagnosis-related group payment, according to Bayesian and CMS. The company said the billing pathway starts October 1, 2026, when the fiscal 2027 inpatient rule takes effect. (prnewswire.com) Bayesian said the device is a continuous AI sepsis monitor used in hospitals to flag patients at risk of sepsis. (cms.gov) ### What did Medicare approve here? CMS’s new-technology add-on payment, or NTAP, is a hospital reimbursement mechanism inside the Medicare inpatient prospective payment system. CMS says NTAP applications are posted publicly through its MEARIS system, and Bayesian Health’s Sepsis Flagging Device appears there as a fiscal 2027 alternative-pathway application. Bayesian said the approval means hospitals can seek extra Medicare payment when the technology is used in qualifying inpatient cases and costs exceed what the bundled payment already covers. October 1, 2026, is the operative date. CMS said the fiscal 2027 IPPS final rule was issued July 31, 2026, published in the Federal Register on August 4, 2026, and is effective October 1, 2026. (prnewswire.com) Bayesian said that is when hospitals using its sepsis monitor will have a way to bill for eligible adult Medicare fee-for-service inpatient admissions monitored by the system. ### What exactly is Bayesian Health’s device? The FDA cleared the Bayesian Health Sepsis Flagging Device on April 30, 2026, under 510(k) number K250680. The clearance letter identifies it as a Class II software device to aid in the prediction or diagnosis of sepsis under 21 CFR 880.6316, with product code SAK. (mearis.cms.gov) The letter says FDA found the device substantially equivalent to a legally marketed predicate device. May 12, 2026, was the date Bayesian publicly announced the clearance. Trade publications at the time described it as the first continuous AI sepsis monitor to receive FDA clearance, and Bayesian said the sepsis module is part of its broader real-time clinical intelligence platform. (cms.gov) ### Why does NTAP matter to hospitals? Medicare’s inpatient payment system generally pays hospitals a bundled amount tied to the diagnosis-related group, not a separate line item for each technology. Bayesian said NTAP “closes that gap” by providing a temporary add-on payment above the standard MS-DRG payment when a qualifying technology is used and hospital costs exceed the bundled amount. (accessdata.fda.gov) That matters because hospitals often weigh new software purchases against whether they can recover part of the cost through reimbursement. Bayesian said the billing opportunity spans an estimated 739 MS-DRGs. (medicaldevice-network.com) The company did not disclose the dollar amount of the add-on payment in its announcement, and CMS’s general NTAP materials describe the program structure rather than a single uniform payment amount across products. ### How much evidence is behind the sepsis monitor? Bayesian said its device was validated in a prospective study published in *Nature Medicine*. The company described that study as one of the largest evaluations of AI in clinical care, and outside coverage of the FDA clearance cited the same study as part of the evidence base behind the 510(k) decision. (prnewswire.com) Sepsis remains a closely watched condition for hospital payment and quality programs. CMS said in the same fiscal 2027 inpatient final rule that it is finalizing a hospital 30-day, all-cause, risk-standardized readmission rate following sepsis hospitalization measure, with modifications. (prnewswire.com) ### What happens next for hospitals and Bayesian? October 1, 2026, is the next practical milestone because that is when the fiscal 2027 IPPS rule becomes effective and hospitals can begin billing eligible use under the NTAP pathway, according to Bayesian and CMS. Hospitals that want to use the technology will still need to contract for the software and document qualifying inpatient use under Medicare billing rules. (prnewswire.com) Bayesian’s NTAP application remains listed in CMS’s MEARIS public summaries database for fiscal 2027. (cms.gov)