Interpace Biosciences Announces Update of Previously Announced CMS Billing Policy Impacting its Thyroid Tests
February 22 2022 - 9:00AM
Interpace Biosciences, Inc. (OTCQX: IDXG) (“Interpace” or the
“Company”), a leader in enabling personalized medicine, announced
today that the National Correct Coding Initiative (NCCI) program
issued a response on behalf of the Centers for Medicare &
Medicaid Services (CMS) stating that the previously announced
billing policy reimbursement for its ThyGeNEXT (O245U) and ThyraMIR
(oo18U) tests, disclosed by it in a press release dated January 28,
2022, has been changed retroactive to January 1, 2022. As a result,
the Company will continue billing for both tests according to its
Laboratory Coverage Determination (LCD) as originally set by
Novitas. According to CMS, this updated policy will be posted on
its website and will be included in the July 1, 2022 edit file.
Tom Burnell, Interpace’s President and CEO
stated, “We appreciate the prompt consideration of our appeal by
NCCI and CMS to prevent any beneficiary access issues for our
Medicare covered thyroid testing. We believe this is the correct
policy based on the patient management for thyroid patients to
allow physicians to help improve care and treatment of their
patients.” Burnell added, “This decision removes a potential
adverse impact on our 2022 financial goals.”
About Interpace Biosciences
Interpace Biosciences is an emerging leader in
enabling personalized medicine, offering specialized services along
the therapeutic value chain from early diagnosis and prognostic
planning to targeted therapeutic applications.
Clinical services, through Interpace
Diagnostics, provides clinically useful molecular diagnostic tests,
bioinformatics and pathology services for evaluating risk of cancer
by leveraging the latest technology in personalized medicine for
improved patient diagnosis and management. Interpace has five
commercialized molecular tests and one test in a clinical
evaluation program (CEP): PancraGEN® for the diagnosis and
prognosis of pancreatic cancer from pancreatic cysts; PanDNA, a
“molecular only” version of PancraGEN® that provides
physicians a snapshot of a limited number of factors;
ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid
nodules utilizing a next generation sequencing assay;
ThyraMIR® for the diagnosis of thyroid cancer from thyroid
nodules utilizing a proprietary gene expression assay; and
RespriDX® that differentiates lung cancer of primary versus
metastatic origin. In addition, BarreGEN®, a molecular based assay
that helps resolve the risk of progression of Barrett’s Esophagus
to esophageal cancer, is currently in a clinical evaluation program
(CEP) whereby we gather information from physicians using
BarreGEN® to assist us in gathering clinical evidence relative
to the safety and performance of the test and also providing data
that will potentially support payer reimbursement.
Pharma services, through Interpace Pharma
Solutions, provides pharmacogenomics testing, genotyping,
biorepository and other customized services to the pharmaceutical
and biotech industries. Pharma services also advances personalized
medicine by partnering with pharmaceutical, academic, and
technology leaders to effectively integrate pharmacogenomics into
their drug development and clinical trial programs with the goals
of delivering safer, more effective drugs to market more quickly,
while also improving patient care.
For more information, please visit Interpace
Biosciences’ website at www.interpace.com.
Forward-looking Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, relating to the
Company's future financial and operating performance. The Company
has attempted to identify forward looking statements by terminology
including "believes," "estimates," "anticipates," "expects,"
"plans," "projects," "intends," "potential," "may," "could,"
"might," "will," "should," "approximately" or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are based on current
expectations, assumptions and uncertainties involving judgments
about, among other things, future economic, competitive and market
conditions and future business decisions, all of which are
difficult or impossible to predict accurately and many of which are
beyond the Company's control. These statements also involve known
and unknown risks, uncertainties and other factors that may cause
the Company's actual results to be materially different from those
expressed or implied by any forward-looking statements, including,
but not limited to, the reimbursement of the Company’s tests being
subject to review by CMS, the adverse impact of the COVID-19
pandemic on the Company’s operations and revenues, the substantial
doubt about the Company’s ability to continue as a going concern,
the possibility that the Company’s estimates of future revenue,
cash flows and adjusted EBITDA may prove to be materially
inaccurate, the Company’s history of operating losses, the
Company’s ability to adequately finance its business and seek
alternative sources of financing, the Company’s ability to repay
borrowings with Comerica Bank and BroadOak, the Company’s
dependence on sales and reimbursements from its clinical services,
the Company’s ability to retain or secure reimbursement including
its reliance on third parties to process and transmit claims to
payers and the adverse impact of any delay, data loss, or other
disruption in processing or transmitting such claims, and the
Company’s revenue recognition being based in part on estimates for
future collections which estimates may prove to be incorrect.
Additionally, all forward-looking statements are subject to the
“Risk Factors” detailed from time to time in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2020, as
amended, Current Reports on Form 8-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission. Because of
these and other risks, uncertainties and assumptions, undue
reliance should not be placed on these forward-looking statements.
In addition, these statements speak only as of the date of this
press release and, except as may be required by law, the Company
undertakes no obligation to revise or update publicly any
forward-looking statements for any reason.
Contacts:Investor RelationsInterpace Biosciences, Inc.(855)
776-6419Info@Interpace.com
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