We are a bit late in reporting this ruling, but in March Natera settled with the US government for over $11 million to resolve claims of fraudulent billing for its Panorama prenatal cfDNA screening test. The government held that from 2013 through 2016, Natera knowingly submitted improper claims for payment from TRICARE (the insurance program for the US military), the Federal Employees Health Benefits Program, and Medicaid. By using improper billing codes, Natera misrepresented the services for which they were billing, causing these agencies to pay for testing that they would not otherwise cover – such as cfDNA screening for low-risk pregnancies and for microdeletion syndromes. Continue reading Natera pays $11M for fraudulent billing
We’re thrilled to announce the publication of our article summarizing insights from our Brocher Foundation workshop! In December 2015, we held a workshop at the Brocher Foundation in Geneva, Switzerland, on “Non-Invasive Prenatal Testing in the Non-Western Context.” With the participation of experts from around the world, we spent four days learning about the diverse social, economic, political, and cultural contexts in which prenatal cfDNA screening is being introduced globally, and discussed approaches to promote equitable and socially appropriate implementation. Our new article, published in the Hastings Center Report, shares 8 key insights emerging from that workshop.
The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” to clinicians, and providing direct patient care. Although the communication skills and genetics expertise of the genetic counselor prepare them well for these roles, they also raise concerns about conflicts of interest (COI).
Five laboratories have banded together to raise awareness about cell free DNA screening and lobby for its coverage by insurers for greater access by expectant mothers. Continue reading Coalition for Access to Prenatal Screening: Labs Advocate for Coverage of cfDNA Screening
Stories have been circulating for a while now that anomalous non-invasive prenatal genetic screening (NIPGS) results may sometimes indicate maternal cancer. Recently, however, these anecdotes have given way to more rigorous data, from a group of researchers at University of Leuven in Belgium, and from US companies Sequenom and Illumina.
For many this new discovery is not all that surprising. For several years now, researchers have been pursuing a test, based on cell-free DNA, that would provide a reliable “liquid biopsy.” Indeed, such tests are already being used clinically in limited circumstances, though–as with NIPGS–the rapid translation of this technology has left important questions about reliability and actionability as yet unanswered. Even more promising, sequencing cell-free DNA may circumvent some of the problems recently proposed with sequencing tumor DNA without matched controls from normal tissue–because both kinds of DNA will be present in serum, and can be distinguished by their relative frequency, much as NIPGS does with fetal and maternal cell-free DNA. Continue reading How do we deal with NIPGS and ‘The Big C’?