TAG:
clinical laboratory compliance
Understanding Key Parts of New AKS, Stark Law Rules
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 a…
Regulators Acted Slowly as Labs Developed Tests for Coronavirus
WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since…
First EKRA Guilty Plea Involves Lab Kickback
CEO SUMMARY: Federal investigators wasted little time in using the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) to prosecute fraud involving clinical laboratories and providers. The manager of an opioid treatment center in Kentucky pleaded guilty last month to three counts…
Digital Pathology Systems Will Create Opportunities
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administra…
Calloway Labs Settles with Feds, West Virginia
CEO SUMMARY: West Virginia is the second state in recent years to settle claims of Medicare and Medicaid fraud filed against Calloway Laboratories of Woburn, Massachusetts. Last month, the pain management lab company agreed to pay $4.675 million to resolve that case, while not admitting l…
FDA Wants Abbott Labs To Toe Regulatory Line
CEO SUMMARY: In the short term, it’s Abbott Laboratories which must deal with increasingly aggressive FDA regulators. But the real story behind the story is that the FDA is stepping up regulatory oversight of the entire diagnostics industry. Abbott faces serious consequences if it canno…
CURRENT ISSUE
Volume XXX No. 2 – January 23, 2023
The Dark Report explores the decision by The Joint Commission to no longer accept COLA-accredited facilities at its own accredited organizations, and reprints the letters sent by both TJC and COLA relative to the move. In other news, CLIA changes are coming and The Dark Report has an exclusive interview with a member of the committee studying those potential changes.
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