SOUTH SAN FRANCISCO, Calif.,
Nov. 22, 2016 /PRNewswire/
-- Veracyte, Inc. (NASDAQ: VCYT) announced today that the
Centers for Medicare and Medicaid Services (CMS) has released its
revised final 2017 Medicare reimbursement rate for the company's
Afirma Gene Expression Classifier (GEC). As a result of Veracyte's
reconsideration request, the agency has determined the genomic
test's current rate of $3,200 will be
maintained in 2017. This final rate replaces the previously
released lower "gapfill" amount and will go into effect on
January 1, 2017.
"We are pleased with CMS's decision to uphold the Afirma GEC
Medicare reimbursement rate that the agency has been paying since
2012," said Bonnie Anderson,
Veracyte's president and chief executive officer. "Moreover, with
final Medicare rates in place for 2017 and market-based pricing to
begin in 2018 through the Protecting Access to Medicare Act, we
believe that Medicare reimbursement for the Afirma GEC will now
remain stable for the foreseeable future."
The rate announced today follows Veracyte's submission to CMS of
a reconsideration request expressing its concern that the
previously released lower gapfill rate was not supported by CMS's
own gapfill regulatory criteria. Through the gapfill process, the
price of a test is determined by the median price submitted by each
of CMS's Medicare Administrative Contractors (MACs).
Beginning January 1, 2018, through
the Protecting Access to Medicare Act (PAMA), Medicare
reimbursement for advanced genomic tests such as the Afirma GEC
will be based on the median price paid by commercial payers, which
Veracyte calculates as above $3,200
for the Afirma GEC. Under PAMA, the new market-based Medicare rate
will override any prior rate. Medicare represents approximately 20
percent of Afirma GEC test volume.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of
molecular cytology, offering genomic solutions that resolve
diagnostic ambiguity and enable physicians to make more informed
treatment decisions at an early stage in patient care. By improving
preoperative diagnostic accuracy, the company aims to help patients
avoid unnecessary invasive procedures while reducing healthcare
costs. Veracyte's Afirma® Thyroid FNA Analysis
centers on the proprietary Afirma Gene Expression Classifier (GEC)
and is becoming a new standard of care in thyroid nodule
assessment. The Afirma test is recommended in leading practice
guidelines and is covered for 185 million lives in the
United States, including
through Medicare and many commercial insurance
plans. Veracyte is expanding its molecular cytology
franchise to other clinical areas, beginning with
difficult-to-diagnose lung diseases. In 2015, the company
launched the Percepta® Bronchial Genomic
Classifier, a test to evaluate patients with lung nodules that are
suspicious for cancer, which has already received draft Medicare
coverage. In October 2016,
Veracyte launched its second pulmonology product, the Envisia™
Genomic Classifier, to improve diagnosis of interstitial lung
diseases, including idiopathic pulmonary fibrosis. For more
information, please visit www.veracyte.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements can be identified by words such
as: "anticipate," "intend," "plan," "expect," "believe," "should,"
"may," "will" and similar references to future periods. Examples of
forward-looking statements include, among others, statements we
make regarding our beliefs regarding the drivers of adoption of our
products, our belief as to the size of our addressable markets and
our financial foundation for growth, our expectations with respect
to the success of our entry into the pulmonology market, our
expectations regarding full-year 2016 revenue guidance and forecast
for annual GEC test volume, our expectation that Medicare
reimbursement for the Afirma GEC will remain stable, and the value
and potential of our technology and research and development
pipeline. Forward-looking statements are neither historical facts
nor assurances of future performance. Instead, they are based only
on our current beliefs, expectations and assumptions regarding the
future of our business, future plans and strategies, anticipated
events and trends, the economy and other future conditions.
Forward-looking statements involve risks and uncertainties, which
could cause actual results to differ materially, and reported
results should not be considered as an indication of future
performance. These risks and uncertainties include, but are not
limited to: our limited operating history and history of losses;
our ability to enhance the performance of our Afirma test; the
performance and acceptance of our Envisia test; our ability to
increase usage of and reimbursement for Afirma and to obtain
adequate reimbursement for our Percepta and Envisia tests, as well
as any future products we may develop or sell; our ability to
continue our momentum and growth; our dependence on a few payers
for a significant portion of our revenue; the complexity, time and
expense associated with billing and collecting from payers for our
tests; laws and regulations applicable to our business, including
potential regulation by the Food and Drug
Administration or other regulatory bodies; our ability to
develop and commercialize new products and the timing and speed of
commercialization; our ability to successfully launch our Envisia
test and achieve adoption of our Percepta and Envisia tests; the
amount by which use of our products is able to reduce invasive
procedures and reduce healthcare costs; our ability to achieve
sales penetration in complex commercial accounts; the occurrence
and outcome of clinical studies; the timing and publication of
study results; the applicability of clinical results to actual
outcomes; the continued application of clinical guidelines to our
products and their inclusion in such clinical practice guidelines;
our ability to compete; our ability to obtain capital when needed;
and other risks set forth in the company's filings with
the Securities and Exchange Commission, including the risks
set forth in the company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2016. These forward-looking
statements speak only as of the date hereof
and Veracyte specifically disclaims any obligation to
update these forward-looking statements.
Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the
Afirma logo are trademarks of Veracyte, Inc.
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SOURCE Veracyte