MADISON, Wis.--(BUSINESS WIRE)--
On November 25, 2015, the Centers for Medicare and Medicaid Services
(CMS) posted the 2016 Clinical Diagnostic Laboratory Fee Schedule (CLFS)
on its website. The reimbursement national limitation amount (NLA) for
Cologuard within the 2016 CLFS appears to be inconsistent with what CMS
publicly communicated on November 17, 2015, when issuing a final
reimbursement decision for Cologuard using the crosswalk methodology to
CPT codes 81315, 81275, and 82274. Based on the 2016 CLFS as posted, the
sum of the NLAs for those three codes is $501.26.
Last year, the NLA for Cologuard in the 2015 CLFS, as initially posted
on the CMS website, was significantly lower than the sum of the NLAs for
the three codes to which Cologuard is cross-walked. CMS subsequently
issued a correction to the 2015 CLFS and ultimately established an NLA
for Cologuard of $492.72.
Exact Sciences requested that CMS clarify the 2016 reimbursement rate
for Cologuard. Exact Sciences will communicate more information as it
becomes available.
About Cologuard
Cologuard was approved by the FDA in August 2014 and results from Exact
Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal
trial were published in the New England Journal of Medicine in March
2014. Cologuard is included in the colorectal cancer screening
guidelines of the American Cancer Society and stool DNA is listed in the
screening guidelines of the U.S. Multi-Society Task Force on Colorectal
Cancer.
Cologuard is indicated to screen adults of either sex, 50 years or
older, who are at average risk for colorectal cancer. Cologuard is not
for everyone and is not a replacement for diagnostic colonoscopy or
surveillance colonoscopy in high-risk individuals. False positives and
false negatives do occur. Any positive test result should be followed by
a diagnostic colonoscopy. Following a negative result, patients should
continue participating in a screening program at an interval and with a
method appropriate for the individual patient. Cologuard performance
when used for repeat testing has not been evaluated or established. For
more information about Cologuard, visit www.CologuardTest.com.
Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the
early detection and prevention of some of the deadliest forms of cancer.
The company has exclusive intellectual property protecting its
noninvasive, molecular screening technology for the detection of
colorectal cancer. Cologuard is included in the colorectal cancer
screening guidelines of the American Cancer Society and stool DNA is
included in the guidelines of the U.S. Multi-Society Task Force on
Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or
find us on Facebook.
Certain statements made in this news release contain forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities and Exchange Act of
1934, as amended that are intended to be covered by the 'safe harbor'
created by those sections.
Forward-looking statements, which are
based on certain assumptions and describe our future plans, strategies
and expectations, can generally be identified by the use of
forward-looking terms such as 'believe,' 'expect,' 'may,' 'will,'
'should,' 'could,' 'seek,' 'intend,' 'plan,' 'estimate,' 'anticipate' or
other comparable terms.
Forward-looking statements in this news
release may address the following subjects among others: statements
regarding the sufficiency of our capital resources, our ability to
secure favorable reimbursement rates from Medicare and other third-party
payors, specifically including statements regarding the 2016 Medicare
reimbursement amount for Cologuard and statements regarding the 2016
CLFS, timing of our launch of a commercial product, our estimates of the
available market size and our potential penetration, expected research
and development expenses, expected general and administrative expenses
and our expectations concerning our business strategy.
Forward-looking
statements involve inherent risks and uncertainties which could cause
actual results to differ materially from those in the forward-looking
statements, as a result of various factors including those risks and
uncertainties described in the Risk Factors and in Management's
Discussion and Analysis of Financial Condition and Results of Operations
sections of our most recently filed Annual Report on Form 10-K and
our subsequently filed Quarterly Reports on Form 10-Q.
We
further caution that although the NLA for Cologuard initially posted by
CMS in the 2015 CLFS was erroneous and later corrected, we cannot
provide any assurance that the NLA currently posted in the 2016 CLFS is
erroneous or that CMS will change it.
We urge you to consider
those risks and uncertainties in evaluating our forward-looking
statements.
We caution readers not to place undue reliance upon
any such forward-looking statements, which speak only as of the date
made.
Except as otherwise required by the federal securities
laws, we disclaim any obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained herein
(or elsewhere) to reflect any change in our expectations with regard
thereto or any change in events, conditions or circumstances on which
any such statement is based.
View source version on businesswire.com : http://www.businesswire.com/news/home/20151127005035/en/
Exact Sciences Corp.
J.P. Fielder, 608-210-5220
jfielder@exactsciences.com
or
MSL
GROUPJayme Maniatis or Jane Hauser, 781-684-0770
exactsciences@mslgroup.com
Source: Exact Sciences Corp.
News Provided by Acquire Media