Volume XXVIII, No. 4 - March 22, 2021 Archives

Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs

This is an excerpt of a 1,385-word article in the March 22, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: The Dark Report explains how changes to the Stark Law and Anti-Kickback Statute will benefit labs, according to attorneys representing clinical labs and pathology …

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Despite COVID-19, Regular Lab Testing Expands

TIMES ARE GOOD FOR THE REGULAR RANGE of clinical laboratory and anatomic pathology testing services. Despite the COVID-19 pandemic, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are showing substantial growth this year, compared to 2019. It may surprise many clinical …

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Revised Stark and AKS Rules Are Good News for Labs

Laboratory Compliance / By Robert Michel

CEO SUMMARY: It must be rewarding for federal rulemakers at the Centers for Medicare and Medicaid Services and the Office of the Inspector General to hear that attorneys representing clinical labs and pathology groups consider the new final rules for the Stark Law and the Anti-Kickback Statute to be helpful for clarifying how labs and …

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Understanding Key Parts of New AKS, Stark Law Rules

Laboratory Compliance / By Robert Michel

CEO SUMMARY: Both the federal Stark Law and Anti-Kickback Statute have been revised and the final rules became effective on Jan. 19. The good news for clinical laboratories and anatomic pathology groups is that federal regulators from the Centers for Medicare and Medicaid Services and the Office of the Inspector General made it a goal …

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Roche to Acquire GenMark, Ovation.io Raises $21.5M

In Vitro Diagnostics / By Robert Michel

Roche to Pay $1.8 Billion for GenMark THERE’S MORE CONSOLIDATION in the in vitro diagnostics (IVD) industry. It was announced on Mar. 15 that Roche Diagnostics would acquire GenMark Diagnostics of Carlsbad, Calif., for a purchase price of $1.8 billion. With access to GenMark’s technology, which enables rapid testing of many pathogens from one sample, …

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What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22

Clinical Laboratory Trends / By Robert Michel

CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They need to make accurate predictions about the demand for tests in coming …

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Truvian Sciences Raises $105M for Near-Patient Lab Test System

In Vitro Diagnostics, IVD/Lab Informatics / By Robert Michel

DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accurate results in just minutes. That would describe the …

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March 22, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By Robert Michel

This may be the nation’s first federal case of fraud and abuse involving a clinical laboratory company specializing in microbiome testing. In San Francisco last week, federal prosecutors filed multiple criminal charges against bankrupt uBiome, formerly based in San Francisco, Jessica Richman, uBiome’s former CEO, and Zachary Apte, its former chief scientific officer. The company …

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