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CMS Restores Reimbursement Rate for Oncotype DX Breast Cancer Test

NEW YORK (GenomeWeb) – Genomic Health today announced that the Centers for Medicare and Medicaid Services has restored the reimbursement rate for the firm's Oncotype DX breast cancer test to $3,416, a week-and-a-half after the center had cut the rate to $2,900. 

CMS restored the rate on Tuesday in updated pricing determinations for the Clinical Laboratory Fee Schedule, ensuring that Genomic Health would get the same rate that Noridian Health Solutions — the Medicare administrative contractor for Genomic Health — has been reimbursing for the test. The payment rate for the Oncotype DX breast cancer test will remain at $3,416 through 2016, Genomic Health said. 

It added that in 2017, market-based rates under the Protecting Access to Medicare Act are expected to replace the current Medicare CLFS.

Late last month, CMS issued preliminary pricing determinations for 2016 that cut reimbursements for several multi-analyte algorithm-based assays, including the Oncotype DX breast cancer test, prompting an outcry from the molecular diagnostics industry. At the time, Genomic Health said that the new $2,900 reimbursement rate was based on "a flawed methodology" that ignored Noridian's $3,416 rate.

"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," the Redwood City, California-based firm added.

Today, Genomic Health Chairman, President, and CEO Kim Popovits said in a statement, "We are pleased that CMS quickly revised its final pricing determination for the Oncotype DX breast cancer test to reflect the MAC-established rate as well as the factors set forth by Medicare to establish payment amounts, such as market rates and resources."

CMS' pricing determination last month also cut reimbursement rates for the Oncotype DX colon cancer test by about 79 percent from a rate that had been in place since 2011. The agency has not yet addressed that rate cut. In a research note, Nicholas Jansen of Raymond James said that CMS is still considering the rate change during the 60-day comment period before pricing determinations are adjusted or finalized.