CMS Releases Final 2016 Clinical Lab Fee Schedule (CLFS) Including Gap-fill Pricing for Oncotype DX® Colon Cancer Test

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November 18, 2015 at 8:00 AM EST

CMS Releases Final 2016 Clinical Lab Fee Schedule (CLFS) Including Gap-fill Pricing for Oncotype DX® Colon Cancer Test

REDWOOD CITY, Calif., Nov. 18, 2015 /PRNewswire/ -- On Tuesday, November 17, 2015, the Centers for Medicare and Medicaid Services (CMS), which administers the Medicare program, issued its final Clinical Laboratory Fee Schedule (CLFS) for 2016, which will allow the Medicare Administrative Contractor (MAC) to continue to set payment for the Oncotype DX® colon cancer test through 2016, as has been done since initiation of coverage in 2011. 

"We are pleased that the final 2016 CLFS reflects CMS's precedent over the past several years to delegate rate-setting for these complex tests to the MACs," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health.  "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 currently scheduled to go into effect in 2017."

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. With over 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 tests, visit: and

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, and follow the company on Twitter:@GenomicHealthFacebook,  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 maintain reimbursement levels, the ability of test results to change treatment decisions; the risks and uncertainties associated with the regulation of the company's tests; 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; 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 September 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.

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