IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own request for summary judgment; and most recently ACLA filed its rebuttal to the
CEO SUMMARY: Discovery of multiple diagnostic errors occurring in an anatomic pathology department triggered a complaint investigation and a 54-page report from the federal Centers for Medicare and Medicaid Services. The report shows that Wake Forest Baptist Medical Center is reviewing more than 9,000 pathology cases to identify incorrect cancer diagnoses. Last month, the medical
CEO SUMMARY: In the midst of expanding their toxicology testing services nationally, DrugScan and DSI Medical Services (collectively Toxicology Holdings Inc.) hired a brokerage firm last year to pursue a sale of the two toxicology companies. Multiple potential buyers responded with interest. The buyer, ACM Global Laboratories—owned by a health system in Rochester, N.Y.—saw the
This is an excerpt from an 850-word article in the May 15, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: There are few places and times where a broad cross-section of
CEO SUMMARY: It’s almost a case of man bites dog. In malpractice cases involving genetic test results, labs are often assumed to be at fault. But in a lawsuit filed in Oregon, healthcare providers are alleged to have misinterpreted a genetic test. As a consequence, a patient underwent medically-unnecessary and life-changing surgery. This malpractice lawsuit
CEO SUMMARY: Miraca Life Sciences amended its merger agreement with Avista Capital Partners after the lab lost value in the two months since the agreement was signed in September. Factors precipitating the revision were a significant decline in reimbursement rates, stiff competition from physician-office labs (POLs), and a loss of specimen volume to POLs and
1. CMS Sticks by Decision to Deeply Cut Medicare Part B Lab Test Fees
SHORT OF A MIRACLE, the clinical laboratory industry is less than three weeks from the single most financially-disruptive event of the past 30 years. On Jan. 1, the federal Centers for Medicare and Medicaid Services will impose deep cuts to Part B
CEO SUMMARY: In hindsight, 2017 is likely to be remembered as a milestone year that launched several disruptive developments that will reshape the lab industry moving forward. For the clinical laboratory sector this year, CMS confirmed its intent to slash Part B clinical laboratory test prices aggressively, effective Jan. 1. For the anatomic pathology sector
Last Friday, Roche announced an agreement to acquire Viewics, Inc., of Sunnyvale, Calif., in a transaction that, subject to regulatory clearance, is expected to close on Nov. 21. Viewics sells a middleware analytics solution to clinical labs. Terms of the sale were not announced. Viewics was founded in 2010.
SUNQUEST IN DEAL WITH N-OF-ONE
Earlier this month,