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T2 Biosystems Sepsis Test to Get New Technology Add-on Payment From CMS

NEW YORK — T2 Biosystems said today that the US Centers for Medicare & Medicaid Services (CMS) has approved a New Technology Add-on Payment (NTAP) for the company's T2Bacteria sepsis panel.

The T2Bacteria panel, which runs on the T2Dx magnetic resonance-based instrument, detects five common sepsis-causing species of bacteria in whole blood samples from patients with potential bloodstream infections in roughly five hours. It received US Food and Drug Administration clearance in mid-2018.

Lexington, Massachusetts-based T2 said that, starting October 1, US hospitals treating Medicare in-patients with sepsis will now be eligible for a maximum NTAP of $97.50 for T2Bacteria, on top of the diagnosis-related group-based reimbursement that hospitals receive under the Medicare Hospital Inpatient Prospective Payment System.

"By approving NTAP for the T2Bacteria panel, CMS has confirmed that the [test] represents a substantial clinical improvement over existing technologies," T2 Chairman and CEO John McDonough said in a statement.

Earlier this year, T2 published data from a pivotal clinical trial demonstrating strong performance of T2Bacteria, including its ability to detect bloodstream pathogens missed by blood culture.