SOUTH SAN FRANCISCO, Calif.,
Sept. 30, 2016 /PRNewswire/
-- Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics
company focused on reducing diagnostic uncertainty, today issued
the statement below on the Centers for Medicare and Medicaid
Services' (CMS) final 2017 "gapfill" Medicare reimbursement rate
for the Afirma Gene Expression Classifier (GEC), which the agency
released this afternoon. The rate is intended to be in effect for
one year before new Medicare rates based on private-payer
reimbursement amounts are instated on January 1, 2018.
Medicare has covered the Afirma GEC since 2012 at a rate of
$3,200. To date, the genomic test has
helped an estimated more than 25,000 patients avoid unnecessary
thyroid surgery and the often-resulting lifelong need for daily
hormone replacement therapy. The final 2017 gapfill rate for the
Afirma GEC as published is $2,864.45,
which is based on the median rate submitted by all Medicare
Administrative Contractors (MACs), regardless of whether they have
experience with the genomic test or not. Medicare represents
approximately 20 percent of Afirma GEC test volume.
"We are pleased that the final Afirma GEC rate is higher than
the preliminary rate announced by CMS in June," said Bonnie Anderson, Veracyte's president and chief
executive officer. "However, we believe this new rate is still
based on a flawed application of the CMS gapfill criteria. We plan
to file a reconsideration request with CMS because we believe the
data that we provided to the MACs support a higher rate, based on
CMS's gapfill criteria. We are hopeful that CMS will override this
misguided result and uphold its commitment to bring more
transparency to its rate-setting processes, which is at the heart
of PAMA (the Protecting Access to Medicare Act)."
Through the current gapfill process, the price of a test is
determined by the median price submitted by each of the MACs. The
MAC (Noridian) that currently processes Medicare claims for the
Afirma GEC submitted a rate that matches the test's current rate of
$3,200; other MACs, which have no
experience with the test, submitted lower rates.
Beginning January 1, 2018, through
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 rates will override any prior rates.
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 the fourth quarter of 2016, Veracyte plans to
launch 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
Afirma, our expectations with respect to the success of our entry
into the pulmonology market, our expectations regarding full-year
2016 guidance and forecast for annual GEC test volume, 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 increase usage of and reimbursement for
Afirma and to obtain reimbursement for 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 of commercialization; the size of the market
opportunity for our products; our ability to successfully achieve
adoption of and adequate reimbursement for our products; the amount
by which use of our products are 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;
our inclusion in clinical practice guidelines; the continued
application of clinical guidelines to our products; 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 June 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