Since 1995, Reliable Business Intelligence for Clinical Laboratories, Pathology Groups and Laboratory Diagnostics

Volume XXVI No. 12 - September 3, 2019

PGx Testing Labs Concerned by FDA’s Statements, Actions

TDR Insider / By Mary Van Doren

This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. …

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What Comes Next for the Pathology Profession?

Commentary and Opinion by R. Lewis Dark / By R. Lewis Dark

IT MAY NOT BE A COINCIDENCE THAT MANY RECENT NEWS CYCLES have more negative pathology news than positive pathology news. After all, laboratory medicine is at the core of most clinical care delivered to patients, so it’s no coincidence that pathology—both clinical and anatomic—is a prime target for government and private payers, along with federal investigators. …

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PGx Labs Concerned by FDA’s Statements, Actions

Genetic Testing / By Joseph Burns

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions …

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Concerns Raised Over Pharmacogenetic Tests

Genetic Testing / By Joseph Burns

CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory testing. One issue is how to educate physicians …

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Anthem’s Cuts in AP Fees Could Put Patients at Risk

Pathology Trends / By Joseph Burns

CEO SUMMARY: Consultants who work with anatomic pathologists have several theories about why Anthem is enacting deep cuts of 50% to 70% for the professional component of many anatomic pathology services. While they have different ideas about what motivates the nation’s second largest health insurer, they agree that such reductions in payments will have a …

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Few Options for Pathology Groups Facing Anthem’s Payment Cuts

Pathology Trends / By Joseph Burns

FACED WITH DEEP CUTS in payment for anatomic pathology professional component services from Anthem Inc., pathologist have only a few options in how they can respond, according to consultants who work with AP groups. “These are dire cuts to anatomic pathology reimbursement,” said one consultant who asked not to be named. He suggested that small …

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Arkansas Pathologist Faces 3 Manslaughter Charges

Pathology Trends / By Joseph Burns

CEO SUMMARY: Federal prosecutors in Arkansas charged a former Veterans Administration pathologist with three counts of involuntary manslaughter and 28 other criminal counts related to his work at the Veterans Health Care System of the Ozarks. In the indictment, officials charged that the pathologist’s misdiagnoses contributed to the deaths of 15 patients. The pathologist had …

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OIG Finds 120-Day Delays at Memphis VA Path Lab

Laboratory Management / By Joseph Burns

CEO SUMMARY: Last year, Veterans Administration officials received an anonymous complaint about delays in laboratory specimen processing and results at the Memphis VA Medical Center may have harmed patients and led to a patient death. Following an investigation, the VA’s Office of Inspector General issued a report last month. It determined that a staff shortage …

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September 3, 2019 Intelligence: Late Breaking Lab News

Late Breaking Lab News / By Robert Michel

Two more clinical laboratory organizations that used American Medical Collection Agency (AMCA) to handle their lab test claims announced in July that their patients’ data was breached. Inform Diagnostics of Irving, Texas, disclosed that the data of 173,716 patients was compromised. Within days of that announcement, CompuNet Clinical Laboratories of Moraine, Ohio, stated that about 110,000 …

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