Veracyte Announces Release of 2018 Preliminary Reimbursement Rate for Afirma Genomic Classifier Under PAMA
September 25 2017 - 8:00AM
Business Wire
Veracyte, Inc. (NASDAQ: VCYT) today announced that the Centers
for Medicare & Medicaid Services (CMS) published preliminary
2018 rates for clinical diagnostic laboratory tests. The
reimbursement rate for the Afirma Genomic Classifier (code 81545)
is expected to increase from $3,220 to $3,600 for calendar year
2018. The preliminary rate is based on the median of private payer
payments submitted by Veracyte as part of the market-based payment
reforms mandated through the Protecting Access to Medicare Act of
2014 (PAMA). The CMS plans to finalize the rates in November 2017,
following a public comment period, and the new rates are scheduled
to become effective January 1, 2018.
“We believe this new rate for the Afirma classifier reflects the
value our test delivers to physicians and patients by reducing
unnecessary thyroid surgeries and associated healthcare costs,”
stated Bonnie Anderson, chairman and chief executive officer of
Veracyte. “We are pleased that CMS is moving forward with
implementation of PAMA following the original delays to ensure
smooth data submission.”
About PAMA
On June 17, 2016, CMS released a final rule implementing Section
216(a) of the Protecting Access to Medicare Act of 2014 (PAMA),
requiring laboratories performing clinical diagnostic laboratory
tests to report the amounts paid by private insurers for laboratory
tests. CMS indicated that it would calculate the weighted median of
these private insurer rates to determine Medicare payment rates for
laboratory tests paid under the Clinical Laboratory Fee Schedule
(CLFS) beginning January 1, 2018. (CMS extended the original date
of January 1, 2017 to provide time for laboratories to establish
necessary reporting infrastructure.) Laboratories were required to
collect private payer data from January 1, 2016 through June 30,
2016 and report it to CMS by May 30, 2017. These rates were used to
calculate Medicare payment rates for advanced laboratory diagnostic
tests (ADLTs). Preliminary rates were published on September 22,
2017. CMS plans to finalize the rates in November 2017, following a
public comment period, and the new rates are scheduled to become
effective January 1, 2018.
About Veracyte
Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company
that is fundamentally improving patient care by resolving
diagnostic uncertainty with evidence that is trustworthy and
actionable. The company’s products uniquely combine genomic
technology, clinical science and machine learning to provide
answers that give physicians and patients a clear path forward
without risky, costly surgery that is often unnecessary. Since its
founding in 2008, Veracyte has commercialized three genomic
classifiers, which are transforming the diagnosis of thyroid
cancer, lung cancer and idiopathic pulmonary fibrosis and
collectively target a $2 billion market opportunity. Veracyte is
based in South San Francisco, California. For more information,
please visit www.veracyte.com and follow the company on Twitter
(@veracyte).
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: “believe,” “plans,” “preliminary,” and similar references to
future periods. Forward-looking statements include, among others,
the amount of the rate, the timing of the proposed increase, and
the company’s belief that the new rates reflect the value of the
company’s test to physicians and payers. 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: the final reimbursement rate for
our test, our ability to successfully achieve and maintain adoption
of and reimbursement for our products; 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,
2017. These forward-looking statements speak only as of the date
hereof and Veracyte specifically disclaims any obligation
to update these forward-looking statements.
Veracyte, and the Veracyte logo are trademarks of Veracyte,
Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20170925005515/en/
Veracyte, Inc.Media:Tracy Morris,
650-380-4413tracy.morris@veracyte.comInvestors:Jackie
Cossmon, 650-243-6371jackie@veracyte.com
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