Sep 25, 2015 | Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
Researchers are concerned about the lesser-known genes included in the test and also point out that little published research exists to support use of these genes for clinical laboratory testing
Gene-panel tests for inherited cancers were scrutinized by a group of 17 prominent international genetic researchers in a study published by the New England Journal of Medicine (NEJM) this summer titled “Gene-Panel Sequencing and the Prediction of Breast-Cancer Risk.” These experts pointed out that, for many of the genes included in these test panels, there remains much uncertainty about their role in various cancers and other diseases.
What will be of greatest interest to pathologist, Ph.D.s, and medical laboratory professionals currently performing molecular diagnostics assays and genetics is that these experts proposed greater regulation of unvalidated gene-panel tests for inherited cancers. In the NEJM, the authors provided some examples of genetic tests, such as those offered by Myriad Genetics, Inc. (NASDAQ:MYGN), Ambry Genetics, Invitae (NYSE:NVTA), and Illumina, Inc. (NASDAQ:ILMN) and noted that risks posed by many mutations occurring on these panels are unknown.
These panel tests can include more than 100 genes, 21 of which are an indication of breast cancer, including BRCA1 and BRCA2, stated the paper. (more…)
Jan 5, 2015 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Health plan sets no new date for BeaconLBS claims-payment decisions but promises 30-days’ notice before making decisions on claims payment
Physicians, pathologists, and clinical laboratories in Florida got a late Christmas present last week. UnitedHealthcare (UHC) (NYSE:UNH) postponed the date when its medical laboratory benefit-management pilot program in Florida, administered by BeaconLBS, would affect claims payments.
This was welcome news, because, beginning January 1, if physicians serving UHC patients had failed to use the BeaconLBS system to obtain pre-notification or pre-authorization for 82 medical laboratory tests, the physicians or labs performing the tests would not be paid by UHC—nor could clinical labs and pathology groups in the UHC provider network bill patients for these tests. (more…)
Dec 8, 2014 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
College of American Pathologists and associations for family physicians and ob-gyns in Florida have asked UnitedHealthcare to discontinue implementation of BeaconLBS system
Medical laboratory testing is at the center of a contest of wills in Florida. On one side is a health insurer that wants to require physicians to obtain pre-notification or preauthorization for a list of clinical laboratory tests. On the other side are the physicians who question the clinical basis for these requirements and the time and resources required to comply with the health insurer’s program.
This rancorous dispute is in reaction to the laboratory benefit management program created by UnitedHealthcare (NYSE: UNH) (UHC) administered by BeaconLBS, a business division of Laboratory Corporation of America (NYSE: LH) (LapCorp). (more…)
Jul 1, 2013 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Pathologists and clinical laboratory managers can expect to see an expansion of genetic testing in the wake of the Supreme Court’s decision in the Myriad case
Pathologists and clinical laboratory professionals got a major victory on June 13. That’s when the United States Supreme Court (SCOTUS) ruled 9-0 to end the 30-year-old practice of awarding patents on human genes. The unanimous decision invalidates certain hotly contested patents held by Myriad Genetics, Inc., (NASDAQ: MYGN) on the BRCA1 and BRCA2 genes.
Moreover, this Supreme Court decision also opens the doors to other medical laboratories to develop their own diagnostics around the BRCA genes and compete for breast-cancer testing market share. (more…)
Jan 21, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory News, Laboratory Pathology
Pathologists and clinical laboratory managers will likely learn next year whether Myriad’s gene patents will stand
In the ongoing debate about gene patents, the nation’s highest legal authority is about to weigh in on the question. The Supreme Court has agreed to hear the Myriad Genetics patent case in the upcoming term. The case turns on whether human genes can be patented.
Will Clinical Labs Need to Pay Royalties for Using Human Gene Patents?
How the high court rules on this matter has significant implications for clinical laboratories and pathology groups throughout the United States. That’s because holders of patents on human genes require medical laboratories to pay royalties for the clinical testing they perform. (more…)
