T2 Biosystems Announces CMS Approval of a New Technology Add-On Payment for the T2Bacteria® Panel for a Second Year

Rhea-AI Summary

T2 Biosystems (NASDAQ:TTOO) announced the continuation of the New Technology Add-on Payment (NTAP) for its T2Bacteria® Panel for Fiscal Year 2021 by the U.S. Centers for Medicare & Medicaid Services (CMS). This payment of $97.50 covers 65% of the average price of the panel, enhancing hospital reimbursement for treating sepsis. The T2Bacteria Panel is the first diagnostic test to receive NTAP approval, allowing rapid identification of sepsis-causing pathogens from whole blood within 3 to 5 hours. This technology aims to improve patient outcomes and reduce sepsis mortality rates.

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• NTAP extension of $97.50 for T2Bacteria Panel enhances hospital reimbursement.
• T2Bacteria Panel facilitates rapid identification of pathogens, improving treatment speed.

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• None.

LEXINGTON, Mass., Sept. 04, 2020 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) continued the New Technology Add-on Payment (NTAP) for the Company’s T2Bacteria® Panel for Fiscal Year 2021.

With this extension, U.S. hospitals treating Medicare inpatients with sepsis continue to be eligible for a NTAP of $97.50 for the T2Bacteria Panel. This accounts for an additional 65 percent of the average price of the T2Bacteria Panel, to be paid along with the diagnosis-related group (MS-DRG) reimbursement that hospitals receive under the Medicare Hospital Inpatient Prospective Payment System (IPPS) for cases exceeding the MS-DRG payment.

“We are pleased with CMS’s decision to extend the NTAP for the T2Bacteria Panel as it allows greater access and continued favorable reimbursement to healthcare providers for use of this life-saving technology,” said John Sperzel, President and Chief Executive Officer of T2 Biosystems. “According to the Centers for Disease Control and Prevention, each year at least 1.7 million adults in the United States develop sepsis and nearly 270,000 die as a result. With rapid diagnosis and treatment, which our T2Bacteria helps facilitate, we can help reduce these numbers for patients with bloodstream infections by targeting appropriate antibiotics, and improving patient outcomes.”  

The T2Bacteria Panel became the first in-vitro diagnostic test to ever receive approval for a NTAP in 2019, and is the only FDA-cleared test able to identify sepsis-causing bacterial pathogens directly from whole blood, in 3 to 5 hours, without the need to wait for a positive blood culture. The T2Bacteria Panel runs on the Company’s FDA-cleared T2Dx® Instrument.

In 2019, CMS stated, “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.”

About T2 Biosystems
T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens, is dedicated to improving patient care and reducing the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx® Instrument, T2Candida® Panel, the T2Bacteria® Panel, the T2Resistance^TM Panel, and the T2SARS-CoV-2™ Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including the T2Cauris^TM Panel, and T2Lyme ^TM Panel, as well as additional products for the detection of bacterial and fungal pathogens and associated antimicrobial resistance markers, and biothreat pathogens.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the benefits of the T2Bacteria Panel  and its adoption by U.S. hospitals, the benefit of early identification of bacterial or fungal infections, as well as statements that include the words “expect,” “intend,” “plan”, “believe”, “project”, “forecast”, “estimate,” “may,” “should,” “anticipate,” and similar statements of a future or forward looking nature. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, (i) any inability to (a) realize anticipated benefits from commitments, contracts or products; (b) successfully execute strategic priorities; (c) bring products to market; (d) expand product usage or adoption; (e) obtain customer testimonials;  (f) accurately predict growth assumptions; (g) realize anticipated revenues; (h) incur expected levels of operating expenses; or (i) increase the number of high-risk patients at customer facilities; (ii) failure of early data to predict eventual outcomes;  (iii) failure to make or obtain anticipated FDA filings or clearances within expected time frames or at all; or (iv) the factors discussed under Item 1A. "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission, or SEC, on March 16, 2020, and other filings the Company makes with the SEC from time to time.  These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, unless required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. Thus, no one should assume that the Company’s silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements.  These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this press release.

Media Contact:
Gina Kent, Vault Communications
gkent@vaultcommunications.com  
610-455-2763

Investor Contact:
Philip Trip Taylor, Gilmartin Group
philip@gilmartinIR.com
415-937-5406

FAQ

What is the NTAP extension for T2Bacteria Panel?

The NTAP extension allows U.S. hospitals to receive an additional $97.50 for the T2Bacteria Panel, covering 65% of its average price.

How does the T2Bacteria Panel improve patient outcomes?

The T2Bacteria Panel enables rapid identification of sepsis-causing pathogens, allowing for quicker and more appropriate antibiotic treatment.

When does the NTAP for T2Bacteria Panel take effect?

The NTAP for the T2Bacteria Panel is applicable for Fiscal Year 2021.

What is the significance of the T2Bacteria Panel approval in 2019?

The T2Bacteria Panel was the first in-vitro diagnostic test to gain NTAP approval, marking a significant advancement in sepsis diagnostics.

What impact does the T2Bacteria Panel have on healthcare costs?

By reducing the length of hospital stays and inappropriate therapies, the T2Bacteria Panel can lower overall healthcare costs associated with sepsis treatment.