It’s hard to imagine a more mind-numbingly boring topic than billing codes for medical tests … and yet those codes mean the difference between profit and loss to commercial labs, and often the difference between whether patients can get the tests that their providers recommend. Continue reading Changing the way labs bill for genetic tests?
The Nuffield Council on Bioethics, a UK-based group that issues carefully considered (though not legally binding) reports on bioethics issues, made a number of important recommendations regarding prenatal testing in its 2017 report, Non-Invasive Prenatal Testing (NIPT). In a blog post nearly two years later, however, the Council expressed dismay that so little action had been taken to alleviate their concerns. Remarkably, that blog post and a troubling BBC report issued the same day have apparently led to some important changes in just a few months.
Continue reading Nuffield Council and BBC report spur change
One of the major selling points for prenatal cell-free DNA (cfDNA) screening has been that it will reduce the number of miscarriages resulting from invasive diagnostic tests–amniocentesis and CVS. However, a randomized controlled trial in France, just published (paywall) in the Journal of the American Medical Association, has found no evidence of this promised benefit.
The SAFE21 Study Group randomized “high risk” pregnant women in 57 French clinics to either go straight to invasive diagnosis or, alternately, to have cfDNA screening first. Those in the cfDNA arm of the trial received invasive testing only if the cfDNA screen returned positive results. There were just over 1000 women assigned to each arm of the trial. In the cfDNA arm, nearly all the women had cfDNA screening, and 84 women (8.3%) had follow-up invasive diagnosis. Yet the miscarriage rate for the cfDNA arm was identical to that for the invasive testing arm, in which 751 women (76.5%) had invasive diagnosis. In each arm 8 women (0.8%) experienced miscarriage. Furthermore, in the invasive testing arm, researchers discovered 11 chromosomal anomalies (1.5%) that would not have been found using cfDNA screening. Continue reading No safety differences between cfDNA screening and diagnostic testing?
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?
Many of us PIRCers came out of NIH-funded ELSI training programs, so we’re proud to have our individual and collaborative ELSI work represented at this year’s ELSI Congress at the Jackson Labs in Farmington, Connecticut.
Continue reading PIRC at the 2017 ELSI Congress
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!
Full program for the ACOG 2017 annual meeting.