SAN CARLOS, Calif., Dec. 1, 2016 /PRNewswire/ -- Natera (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA announced today 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."
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system.
Tests include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier test to detect inherited mutations; and the Panorama® non-invasive prenatal test (NIPT) to identify common chromosomal anomalies in a fetus as early as nine weeks of gestation.
Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test.
These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration. For more information, visit http://www.natera.com and connect on Twitter and Facebook.
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release.
Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our ability to increase demand for our screening tests, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests to patients, providers and payers, or our ability to successfully implement, commercialize or scale our Constellation platform.
Additional risks and uncertainties are discussed in greater detail in the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's Form 10-Q for the quarter ended September 30, 2016. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company's website at www.natera.com under the Investor Relations section, and on the SEC's website at www.sec.gov.
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SOURCE Natera, Inc.