T2 Biosystems Announces CMS Approval of a New Technology Add-On Payment for the T2Bacteria® Panel for a Second Year
September 04 2020 - 7:00AM
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
T2ResistanceTM 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 T2CaurisTM 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
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