Medicare has opened a payment path for continuous sepsis monitoring. Bayesian Health announced on September 2, 2026, that its FDA-cleared sepsis flagging device received approval for a New Technology Add-on Payment. Beginning October 1, 2026, hospitals using the continuous AI sepsis monitor can receive additional Medicare payment for eligible inpatient cases.
The approval came through the Centers for Medicare and Medicaid Services’ fiscal year 2027 Inpatient Prospective Payment System final rule. The rule was displayed on July 31, 2026, and published on August 4, 2026, setting the framework for the reimbursement pathway.
A payment pathway built into inpatient claims
Eligible discharges qualify for an add-on payment of up to $61.84 per case. The payment is claim by claim, with no separate authorization required, giving hospitals a defined route to seek reimbursement when the technology is used for eligible inpatient cases.
The pathway covers 739 diagnosis-related groups, representing roughly 97 percent of all diagnosis-related groups in the inpatient prospective payment system. It remains in place for up to three years, creating a fixed reimbursement window rather than an open-ended promise that hospitals must decode later.
CMS determines which technologies receive add-on payments through an annual application process tied to its rulemaking cycle. That process places the decision inside the agency’s broader payment rules, rather than treating reimbursement as a separate arrangement for each hospital or case.
From FDA clearance to Medicare approval
Bayesian Health’s device received FDA 510(k) clearance on April 30, 2026. The Medicare decision follows that clearance and makes the product the first continuous sepsis monitoring technology with both FDA clearance and a dedicated Medicare reimbursement pathway.
Those two approvals address different parts of the same problem: FDA clearance establishes the device’s regulatory status, while the New Technology Add-on Payment creates a route for eligible Medicare cases to receive additional payment. Hospitals now have a stated payment mechanism that begins October 1, 2026, with the case-by-case limit set at up to $61.84.
The timing gives Bayesian Health a defined transition from cleared technology to reimbursed hospital use. The company’s sepsis flagging device entered the Medicare payment framework less than six months after its April 30 FDA clearance — a tidy sequence by healthcare technology standards, where regulatory approval and payment often travel on separate calendars.
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