Natera (NTRA) Announces CMS 2017 CLFS for Aneuploidy And Microdeletion Testing; Sees Impact

December 1, 2016 8:02 AM EST

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Natera (Nasdaq: NTRA) announced that the Centers for Medicare & Medicaid Services (CMS) released final determinations for the 2017 Clinical Lab Fee Schedule (CLFS), which included determinations for both aneuploidy and microdeletion testing described by Current Procedure Terminology (CPT) codes. CMS decided to cross-walk the aneuploidy (81420) and microdeletion (81422) CPT codes to the hereditary colon cancer disorder codes (81435 and 81436, respectively) "based on similarities in function and resource utilization." Both CPT codes will be priced at $796.75, effective January 1, 2017.

Although aneuploidy and microdeletion testing is not typically performed within the Medicare population, this has significance for Natera's Panorama® non-invasive prenatal test (NIPT) for two reasons:

  • Some Medicaid programs set their rates for aneuploidy and microdeletion testing based on CLFS; since several Medicaid programs haven't yet priced aneuploidy testing, we expect the pricing of aneuploidy in the CLFS will increase the number of Medicaid programs that price the test and may result in Medicaid plans pricing microdeletions testing at a faster pace, and
  • Although most commercial insurances have already priced aneuploidy testing, the price established by CMS for microdeletions testing can serve as a relevant benchmark for pricing discussions with commercial insurance plans to begin reimbursement for microdeletions testing.

"We are very pleased that the CMS has decided to provide a price benchmark for both aneuploidy and microdeletion testing. We believe that the aneuploidy testing price may help drive price changes by Medicaid over the long term, and the microdeletion price is a relevant benchmark for supporting the new test code for microdeletions," said Matt Rabinowitz, Ph.D., CEO and Founder of Natera. "This is an important step in establishing physician confidence that our Panorama test may over the long term be increasingly reimbursed for a broader group of patients."

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