MADISON, Wis., Oct. 3, 2016 /PRNewswire/ -- Exact Sciences
Corp. (Nasdaq: EXAS) today announced that Cologuard® is
now included in the 2017 Healthcare Effectiveness Data and
Information Set (HEDIS) quality measures for colorectal cancer
screening. The new quality measures were published by the National
Committee for Quality Assurance (NCQA). More than 90 percent of
America's health plans measure quality based on HEDIS.
"Cologuard's inclusion in the preeminent quality measures and
its standing as an A-graded service in a leading screening
guideline are critical steps toward becoming a standard of care for
colon cancer screening," said Kevin
Conroy, chairman and CEO of Exact Sciences. "Quality
measures rate health care providers, systems and payers on metrics,
including colon cancer screening compliance and patient
satisfaction. These quality scores influence the level of
reimbursement providers receive under value-based health care
structures. Providers can now receive quality credit when their
patients are screened using Cologuard, and Exact Sciences'
comprehensive compliance program encourages completion of screening
following a physician's prescription."
The HEDIS quality measures promote evidence-based health care
and quality service to patients by assessing the performance of
health plans on multiple measures. Colorectal cancer screening
compliance and patient satisfaction are two measures that are
evaluated to generate an overall quality score. Cologuard
continues to achieve a nearly 70-percent compliance
rate1 and survey data shows that 88 percent of patients
have a very positive experience2 using Cologuard and
engaging Exact Sciences' compliance program. Conversely,
colonoscopy and fecal blood testing compliance rates are typically
much lower.
"Including Cologuard in HEDIS creates incentives for health
plans and providers to adopt the test by helping them achieve
compensation goals and establish marketing opportunities," Conroy
said. "We also believe that because patients like using Cologuard,
they are more likely to rate their experience with their
prescribing health care provider favorably."
Cologuard's inclusion in HEDIS with a three-year interval
provides payers, health systems, and providers quality credit for a
three-year lookback period during HEDIS audits. The 2016 HEDIS
audit will give credit for Cologuard tests completed beginning in
2014, when Cologuard received FDA approval and was made available
to patients.
"The fact that Cologuard is now accounted for in your HEDIS
measures is huge for health plans," said Troy Caraway, chief executive officer of
Physicians Plus Insurance Corporation. "If one or two early-stage
cancers are detected because more people have a Cologuard test, we
are far ahead as a health plan."
"With Cologuard, the scientific evidence is there, the
compliance service is there, and now it counts toward our colon
cancer screening quality credit," said Anas
Daghestani, M.D., CEO of Austin Regional Clinic (ARC) and
medical director for ARC's Population Health and Clinical
Quality. "Adopting a test like Cologuard allows me to push my
screening rate for colon cancer very high, very quickly without
investing a lot of internal resources."
The HEDIS measures directly impact the CMS Star Ratings, which
use HEDIS as the primary data source to guide quality measures for
Medicare Advantage plans. The public comment period for the 2018
Star Ratings is expected to be announced in November 2016.
The updated Star Ratings are expected to be published in
February 2017.
NCQA's update to the colorectal cancer screening measure aligns
HEDIS with the preeminent colorectal cancer screening guidelines,
including those of the U.S. Preventive Services Task Force,
American Cancer Society, National Comprehensive Cancer Network and
the American College of Gastroenterology.
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
recommendations of the U.S. Preventive Services Task Force (2016)
and the American Cancer Society's (2014) colorectal cancer
screening guidelines. Stool DNA is included in the combined
screening guidelines of the American Cancer Society/U.S.
Multi-Society Task Force/American College of Radiology (2008), the
American College of Gastroenterology guidelines (2009) and the
National Comprehensive Cancer Network (2016). 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 the deadliest forms of cancer. The company has
exclusive intellectual property protecting its non-invasive,
molecular screening technology for the detection of colorectal
cancer. For more information, please visit the company's website
at www.exactsciences.com, follow Exact Sciences on Twitter
@ExactSciences or find Exact Sciences on Facebook.
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities 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. All statements other than
statements of historical facts included in this news 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 the potential inclusion of
Cologuard in CMS's Five-Star Quality Rating System, or other
quality measures, the potential impact of using Cologuard on a
given HEDIS score, expected future operating results, anticipated
results of our sales and marketing efforts, expectations concerning
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 and services; the acceptance of
our products and services by patients and healthcare providers; the
willingness of health insurance companies and other payors to cover
Cologuard and reimburse us for our performance of the Cologuard
test; the amount and nature of competition from other cancer
screening products and services; the effects of any healthcare
reforms, including the Affordable Care Act, or changes in
healthcare pricing, coverage and reimbursement; recommendations,
guidelines and/or quality metrics issued by various organizations
such as the U.S. Preventive Services Task Force, the American
Cancer Society and the National Committee for Quality Assurance
regarding cancer screening or our products and services; our
ability to successfully develop new products and services; our
success establishing and maintaining collaborative, licensing and
supplier arrangements; our ability to maintain regulatory approvals
and comply with applicable regulations; 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 Report(s) 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.
1Cologuard's patient compliance rate is derived from
the number of valid tests reported divided by the number of
collection kits shipped to patients during the 12-month period
ending 60 days prior to June 30,
2016.
2 Exact Sciences Laboratories patient satisfaction
survey data is cumulative; n = 2,799
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CONTACT: JP Fielder, jpfielder@exactsciences.com,
608-210-5220
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SOURCE EXACT SCIENCES CORP