Post by icemandios on Dec 1, 2016 14:22:45 GMT
Natera partners with GeneDx on the Panorama non-invasive prenatal test (NIPT).
The Centers For Medicare And Medicaid Services Establishes 2017 Pricing For Aneuploidy And Microdeletion Testing
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."
About Natera
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 www.natera.com and connect on Twitter and Facebook.
The Centers For Medicare And Medicaid Services Establishes 2017 Pricing For Aneuploidy And Microdeletion Testing
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."
About Natera
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 www.natera.com and connect on Twitter and Facebook.