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UPDATE: CMS Issues Positive Draft LCD for Genomic Health's Oncotype DX Prostate

This article has been updated with additional details on the coverage criteria of the LCD.

NEW YORK (GenomeWeb) – Genomic Health today announced that Medicare contractor Palmetto GBA has issued a draft local coverage determination for its Oncotype DX prostate cancer test.

The draft LCD recommends coverage of the test for qualified Medicare patients "to help determine which patients with early-stage, needle biopsy proven prostate cancer can be conservatively managed rather than treated with definitive surgery or radiation therapy."

Oncotype DX prostate provides a genomic assessment of a tumor's aggressiveness and is intended to help doctors decide which patients are at low enough risk that they can be more conservatively managed, avoiding costly medical interventions.

According to the LCD draft, coverage for the test is subject to several criteria, including that testing must be performed only by physicians who are enrolled in a Palmetto MolDX-approved Certification and Training Registry program for the test.

In addition, for the test to be covered, patients must have biopsy-confirmed localized disease only, as well as a number of other clinical factors indicating low or very-low risk of disease.

Tested patients also must be monitored for disease progression according to active surveillance guidelines, and physicians must then report any cases of metastasis or prostate cancer deaths in patients who were deemed low risk by the assay and were not treated definitively.

Genomic Health said the Palmetto announcement follows several research presentations at the American Urological Association's annual meeting this month demonstrating the test's value in managing healthcare costs associated with treatment decisions in low-risk patients.

During a call discussing its first quarter earnings earlier this month, Genomic Health said that while more than 1,800 physicians have used its prostate test in their treatment decision-making to date, Medicare reimbursement remains a "critical near-term step," essential to the company's ability to deliver a profit by the end of the year.

In a statement, Genomic Health President and CEO Kim Popovits called the Palmetto draft LCD an "important step toward ensuring that all prostate cancer patients covered by Medicare, which represents 50 percent of the population eligible for our test, have access to the unique biological information provided by Oncotype DX … for their physicians to determine the optimal treatment."

The draft will now go through Medicare's review process, which includes a public comment period, before finalization and notification.

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