Aspira Women’s Health Receives Final Crosswalk Pricing Determination from the Centers for Medicare & Medicaid Services (CMS)
28 November 2023 - 1:47AM
Aspira Women’s Health Inc. (“Aspira” or “the
Company”) (Nasdaq: AWH), a bio-analytical company focused on
the development and commercialization of women’s health diagnostic
tools for gynecologic diseases, today announced that
during the 2024 Clinical Laboratory Fee Schedule (CLFS) rate
setting process, the Centers for Medicare & Medicaid Services
(CMS) has approved the crosswalk of the fee to be paid to the
company for OvaWatch to the fee paid historically for Ova1. Aspira
will be reimbursed at a rate of $897 for all OvaWatch and Ova1
tests processed for Medicare patients meeting applicable coverage
requirements beginning on January 1, 2024.
“Crosswalking” refers to a process for setting the
Medicare reimbursement rate for a new laboratory test by assigning
the new code the same rate as a comparable existing test.
“Nothing is more important than reliable clinical
data when a patient is facing a possible ovarian cancer diagnosis.
With CMS’s approval of OvaWatch's price on the 2024 laboratory fee
schedule, we are closer than ever to ensuring that our
ground-breaking technology is available to all women with an
adnexal mass," said Nicole Sandford, President and Chief Executive
Officer of Aspira.
About Aspira Women’s Health Inc. Aspira
Women’s Health Inc. is transforming women’s gynecological health
with the discovery, development, and commercialization of
innovative testing options for women of all races and ethnicities,
starting with ovarian cancer.
Our ovarian cancer risk assessment portfolio is
marketed to healthcare providers as OvaSuiteSM, which includes
OvaWatch, a non-invasive, blood-based test intended for use in the
initial clinical assessment of ovarian cancer risk in women with
benign or indeterminate adnexal masses for which surgical
intervention may be either premature or unnecessary. With a
negative predictive value (NPV) of 99%, OvaWatch allows physicians
to confidently rule out ovarian cancer malignancy and choose the
appropriate clinical management for the right patient at the right
time. Ova1Plus® combines our FDA-cleared products,
Ova1 and Overa®, to detect risk of ovarian malignancy in women
with adnexal masses planned for surgery.
EndoCheckSM, Aspira’s first-of-its-kind
non-invasive diagnostic test for endometriosis, is currently in
development. Visit our website for more information
at www.aspirawh.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, as defined in the Private
Securities Litigation Reform Act of 1995, including statements
regarding the potential effects of widespread use of OvaWatch and
the availability of OvaWatch in New York. Forward-looking
statements involve a number of risks and uncertainties.
Words such as “may,” “expects,” “intends,” “anticipates,”
“believes,” “estimates,” “plans,” “seeks,” “could,” “should,”
“continue,” “will,” “potential,” “projects” and similar expressions
are intended to identify forward-looking statements. These
forward-looking statements speak only as of the date of this press
release and are subject to a number of risks,
uncertainties, and assumptions, including those described in the
section entitled “Risk Factors” in Aspira’s Annual Report on Form
10-K for the year ended December 31, 2022, as amended by Form
10-K/A filed on October 26, 2023, and as supplemented in Aspira’s
10-Q filings for the quarter ended March
31, 2023, June 30, 2023, and September 30, 2023. These
risks include, but are not limited to: our ability to continue as a
going concern; our ability to comply with Nasdaq’s continued
listing requirements; impacts resulting from potential changes to
coverage of Ova1 through our Medicare Administrative Carrier for
Ova1; impacts resulting from or relating to the COVID-19 pandemic
and actions taken to contain it; anticipated use of capital and its
effects; our ability to increase the volume of our product sales;
failures by third-party payers to reimburse for our products and
services or changes to reimbursement rates; our ability to continue
developing existing technologies and to develop, protect and
promote our proprietary technologies; plans to develop and perform
laboratory developed tests; our ability to comply with Food and
Drug Administration (“FDA”) regulations that relate to our products
and to obtain any FDA clearance or approval required to develop and
commercialize medical devices; our ability to develop and
commercialize additional diagnostic products and achieve market
acceptance with respect to these products; our ability to compete
successfully; our ability to obtain any regulatory approval
required for our future diagnostic products; or our suppliers’
ability to comply with FDA requirements for production, marketing
and post-market monitoring of our products; our ability to maintain
sufficient or acceptable supplies of immunoassay kits from our
suppliers; in the event that we succeed in commercializing our
products outside the United States, the political, economic and
other conditions affecting other countries; changes in healthcare
policy; our ability to comply with the additional laws and
regulations that apply to us in connection with the operation of
Aspira Labs; our ability to use our net operating loss
carryforwards; our ability to use intellectual property; our
ability to successfully defend our proprietary technology against
third parties; our ability to obtain licenses in the event a third
party successfully asserts proprietary rights; the liquidity and
trading volume of our common stock; the concentration of ownership
of our common stock; our ability to retain key employees; our
ability to secure additional capital on acceptable terms to execute
our business plan; business interruptions; the effectiveness and
availability of our information systems; our ability to integrate
and achieve anticipated results from any acquisitions or strategic
alliances; future litigation against us, including infringement of
intellectual property and product liability exposure; and
additional costs that may be required to make further improvements
to our laboratory operations. The events and circumstances
reflected in Aspira’s forward-looking statements may not be
achieved or occur, and actual results could differ materially from
those projected in the forward-looking statements. Aspira
expressly disclaims any obligation to update, amend or
clarify any forward-looking statements whether as a result
of new information, future events or otherwise, except as
required by law.
Investor Relations Contact:Jamie
SullivanDirector of Corporate CommunicationsAspira Women’s
HealthJsullivan@aspirawh.com
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