REDWOOD CITY, Calif.,
Sept. 28, 2015 /PRNewswire/ -- On
Friday, September 25, 2015, the
Centers for Medicare and Medicaid Services (CMS), which administers
the Medicare program, released a final payment determination,
subject to reconsideration, for the Clinical Laboratory Fee
Schedule (CLFS) for the Oncotype DX® breast cancer test,
representing a 15 percent reduction from its well-established
Medicare payment rate that has been in effect since 2006.
This rate is based upon a flawed methodology that does not take
into account the established $3,416
rate paid by Noridian Healthcare Solutions, the Medicare
Administrative Contractor (MAC) who processes Genomic Health's
claims. In addition, the methodology does not take into
account the factors set forth in Medicare law to establish payment
amounts, such as market rates and resources. These factors
were considered when the local MAC originally established the
payment rate for the Oncotype DX breast cancer test in 2006,
which has been revalidated on multiple occasions by numerous MACs
paying Oncotype DX claims over the past nine years.
"CMS can and should adopt the MAC-established rate for the
Oncotype DX breast cancer test, the only test validated to predict
chemotherapy benefit as evidenced by multiple studies including one
of the largest-ever adjuvant breast cancer trials published today
in The New England Journal of Medicine," said
Kim Popovits, Chairman of the Board,
Chief Executive Officer and President of Genomic Health. "We
will begin working immediately with CMS to ensure our currently
established rate extends into 2016."
Additionally, CMS issued a preliminary determination for the
Oncotype DX colon cancer test, representing a 79 percent
reduction from the well-established Medicare payment rate that has
been in effect since 2011. This proposed rate departs from
CMS's own precedent over the past several years to delegate
rate-setting for these complex tests to the MACs. The
MAC-established rates for Genomic Health's Oncotype DX tests are
consistent with the market-based rate-setting policies and
procedures enacted by Congress under the Protecting Access to
Medicare Act (PAMA), which are scheduled to go into effect in
2017. The CMS proposed rates are not consistent with CMS' own
policies about rate-setting for new tests and are inconsistent with
recommendations from nearly all stakeholders, as well as CMS'
recently established Advisory Panel on Clinical Diagnostic
Laboratory Tests.
The company will be working closely with the Coalition for
21st Century Medicine and other stakeholders to convince
CMS to adopt previously established MAC rates for these tests
through the CMS established reconsideration process before final
rates take effect in January
2016.
About Oncotype DX®
The Oncotype
DX® portfolio of breast, colon and prostate cancer
tests applies advanced genomic science to reveal the unique biology
of a tumor in order to optimize cancer treatment decisions. The
company's flagship product, the Oncotype DX breast cancer test, has
been shown to predict the likelihood of chemotherapy benefit as
well as recurrence in invasive breast cancer. Additionally, the
test predicts the likelihood of recurrence in a pre-invasive form
of breast cancer called DCIS. With half a million patients tested
in more than 90 countries, the Oncotype DX tests have redefined
personalized medicine by making genomics a critical part of cancer
diagnosis and treatment. To learn more about Oncotype DX breast
cancer tests,
visit: www.OncotypeDX.com or www.mybreastcancertreatment.org.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading
provider of genomic-based diagnostic tests that address both the
overtreatment and optimal treatment of early-stage cancer, one of
the greatest issues in healthcare today. The company is applying
its world-class scientific and commercial expertise and
infrastructure to lead the translation of massive amounts of
genomic data into clinically-actionable results for treatment
planning throughout the cancer patient's journey, from diagnosis to
treatment selection and monitoring. The company is based
in Redwood City, California,
with international headquarters in Geneva, Switzerland. For more information, please
visit, www.GenomicHealth.com and follow the company on
Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the benefits of the test to
physicians, patients and payors. Forward-looking statements are
subject to risks and uncertainties that 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 company's
ability to successfully achieve increases to reimbursement levels
in a reconsideration process with CMS, the ability of test results
to change treatment decisions; the risks and uncertainties
associated with the regulation of the company's tests; the results
of clinical studies; the applicability of clinical study results to
actual outcomes; the risk that the company may not obtain or
maintain sufficient levels of reimbursement, domestically or
abroad, for its existing tests and any future tests it may develop;
the risks of competition; unanticipated costs or delays in research
and development efforts; and the 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 year ended June 30, 2015. These
forward-looking statements speak only as of the date
hereof. Genomic Health disclaims any obligation to update
these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype
DX, Recurrence Score, and DCIS Score are trademarks or registered
trademarks of Genomic Health, Inc. All other trademarks
and service marks are the property of their respective
owners.
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SOURCE Genomic Health, Inc.