Exact Sciences Corp. (NASDAQ: EXAS) today announced that the Centers for
Medicare and Medicaid Services (CMS) Advisory Panel on Clinical
Diagnostic Laboratory Tests voted unanimously to maintain Medicare’s
current crosswalk pricing ($492.72) for Cologuard. The 11-0 vote,
including one abstention, came after the Clinical Lab Fee Schedule’s
July 16, 2015 public meeting. Exact Sciences’ Chairman and CEO Kevin
Conroy presented a proposal at the July 16th meeting to
crosswalk Cologuard from its current G-code to a CPT code. Following
today’s vote, Conroy issued this statement:
“We’re very pleased with the panel’s unanimous vote in favor of
maintaining the current Medicare reimbursement for rate for Cologuard.
CMS will post a preliminary determination after considering the July
meeting comments, today’s panel vote, and other written comments. A
final determination is expected to be released in the November timeframe
and will be effective January 1, 2016.”
The Advisory Panel on Clinical Diagnostic Laboratory Tests is a new
panel established under the 2014 Protecting Access to Medicare Act
(PAMA), which directs the Secretary of Health and Human Services to
consult with an expert outside advisory panel on establishing payment
rates for new clinical diagnostic laboratory tests, including whether to
use crosswalking or gapfilling processes to determine payment for new
clinical laboratory tests and the factors used in determining coverage
and payment processes for new clinical diagnostic laboratory tests. PAMA
requires the panel to be established by the secretary and composed of an
appropriate selection of individuals with expertise in issues related to
clinical diagnostic laboratory tests. The panel may include
representatives of clinical laboratories, molecular pathologists,
clinical laboratory researchers and individuals with expertise in
clinical laboratory science or health economics. Today’s meeting was the
first for the panel.
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
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company
focused on the early detection and prevention of colorectal cancer. The
company has exclusive intellectual property protecting its noninvasive,
molecular screening technology for the detection of colorectal cancer.
For more information, please visit the company's website at www.exactsciences.com,
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 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. All statements other
than statements of historical facts included in this press release
regarding our strategies, prospects, financial condition, operations,
costs, plans and objectives are forward-looking statements. Examples of
forward-looking statements include, among others, statements we make
regarding future CMS actions regarding Cologuard pricing or
reimbursement, expected future operating results, anticipated results of
our sales and marketing efforts, expectations concerning other payor
reimbursement and the anticipated results of our product development
efforts. 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, projections, anticipated
events and trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject to
inherent uncertainties, risks and changes in circumstances that are
difficult to predict and many of which are outside of our control. Our
actual results and financial condition may differ materially from those
indicated in the forward-looking statements. Therefore, you should not
rely on any of these forward-looking statements. Important factors that
could cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: our ability to successfully and
profitably market our products; the acceptance of our products by
patients and health care providers; the amount and nature of competition
from other cancer screening products and procedures; our ability to
maintain regulatory approvals and comply with applicable regulations;
our success establishing and maintaining collaborative and licensing
arrangements; our ability to successfully develop new products; and the
other 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
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to time,
whether as a result of new information, future developments or otherwise.
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