CMS approves first sepsis in-vitro diagnostic test for NTAPs

Aug. 9, 2019
Designation granted only to new technologies that demonstrate substantial clinical improvement

T2 Biosystems, Inc., provider of medical diagnostic products, has announced the Centers for Medicare & Medicaid Services (CMS) has granted the company approval for a New Technology Add-on Payment (NTAP) for the T2Bacteria Panel for FY 2020.

T2 Biosystems asserts that the T2Bacteria Panel is the first and only FDA-cleared test to identify sepsis-causing bacterial pathogens directly from whole blood in 3 to 5 hours without the need to wait for blood culture. It is now also the first and only in-vitro diagnostic test to ever receive approval for NTAP.

In its FY 2020 inpatient prospective payments system final rule, CMS explained: “the T2Bacteria Test Panel represents a substantial clinical improvement over existing technologies because it reduces the proportion of patients on inappropriate therapy, thus reducing the rate of subsequent diagnostic or therapeutic intervention as well as length of stay and mortality rates caused by sepsis causing bacterial infections.”

With this designation, hospitals in the U.S. treating Medicare inpatients with sepsis will now be eligible for a NTAP, in addition to the standard payment amount. In the final rule, CMS determined a maximum NTAP amount of $97.50 for the T2Bacteria Panel in addition to the diagnosis-related group (MS-DRG)-based reimbursement that hospitals receive under the Medicare Hospital Inpatient Prospective Payment System (IPPS).

John McDonough, Chairman and Chief Executive Officer at T2 Biosystems stated, “The introduction of the T2Bacteria Panel has altered the course of clinical treatment in a number of ways, and this new designation will ensure increased access to this groundbreaking, direct-from-blood rapid diagnostic for patients suspected of a bloodstream infection or sepsis.”

Hospitals will be eligible for the NTAP for any in-patient T2Bacteria Panel tests performed on Medicare patients beginning October 1, 2019. The maximum NTAP reimbursement for a qualifying case involving the use of the T2Bacteria Panel is $97.50, (65 percent of the list price of one T2Bacteria Panel test) in addition to standard hospital payment under the appropriate sepsis MS-DRG codes.

The T2Bacteria Panel is one of several panels that are approved or in development that are run on the Company’s T2Dx Instrument, which is powered by miniaturized magnetic resonance (T2MR) technology.