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
Prenatal cfDNA screening, often called NIPT, has given rise to many differences of opinion among professional societies. Recommendations about using cfDNA for prenatal screening have evolved slowly as studies have validated these tests – and, of course, as the tests themselves have changed and expanded over time. ACMG, representing medical genetics and laboratories, has tended to make the most expansive recommendations in favor of cfDNA screening, while ACOG, representing the bulk of obstetricians, has tended to be the most conservative group. Others, like ISPD, have usually fallen between the two extremes.
Commercial cfDNA labs, for their part, have grumbled about what they see as an overly slow pace of accepting this new technology (although, by historical medical standards, it’s actually been quite fast). One of their long-standing complaints has been revived in a just-published commentary in Prenatal Diagnosis. Adam Wolfberg, formerly employed by Ariosa (the makers of the Harmony™ cfDNA screen), argues in this new commentary that professional bodies have an inherent conflict of interest that has led them to resist more enthusiastic recommendation for prenatal cfDNA screening. Maternal-fetal medicine (MFM) specialists, he argues, see their livelihood endangered by this new technology, which threatens to undermine the fetal ultrasounds that are their bread and butter. Continue reading Are professional societies conflicted about cfDNA?
Megan Allyse is representing PIRC at the 2017 annual meeting of the American Congress of Obstetrics and Gynecology (ACOG) in San Diego, with a poster presenting preliminary findings from the ERRORS (Errors in Reading and Reporting On Results of Screening) study. She presented the ERRORS poster, titled “Decisional Regret in Women Receiving High-risk or Inconclusive Results from Non-invasive Prenatal Genetic Screening,” in ePoster Session B on Saturday (Poster 24B).
She is also presenting a poster on ethical considerations in uterine transplantation surgery, in ePoster Session P on Tuesday (Poster 30P). Congratulations Megan!
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