Lab Risk & Compliance
OIG: 25% of Medicare Inpatients ‘Harmed in Hospitals’ Pre-COVID
CEO SUMMARY: This year’s report to Congress on patient harm in hospitals—prepared by the Office of the Inspector General (OIG)—determined that one in four Medicare beneficiaries suffered harm while an inpatient in a hospital. The report garnered little attention outside the he…
Passage of FDA Regulation of LDTs Inches Closer in the Senate
CONGRESSIONAL LAWMAKERS ARE MOVING A BILL FORWARD that would give the federal Food and Drug Administration (FDA) the power to regulate laboratory-developed tests. There are many in the clinical laboratory profession who oppose any proposal to give the FDA regulatory oversight of LDTs. …
DOJ Charges Execs over Alleged Lab Kickbacks to Obtain Restitution
CEO SUMMARY: Multiple executives and sales representatives at True Health Diagnostics and Boston Heart Diagnostics have been named as defendants in a civil suit filed by the U.S. Department of Justice. The complaint centers on alleged kickbacks in return for clinical laboratory test…
Seven Doctors Settle Lab Test Fraud Case
CEO SUMMARY: In January, a U.S. Attorney from East Texas announced that seven physicians and a hospital CEO had agreed to settle allegations of fraud involving the payment of bribes in exchange for lab test orders. This is a positive development for the clinical laboratory profession because it…
Federal Prosecutors Describe Illegal Lab Bribes to Physicians
PATHOLOGISTS AND CLINICAL LAB MANAGERS SHOULD WELCOME every federal prosecution of a physician who accepts illegal bribes and inducements in exchange for laboratory test referrals. If physicians understood that federal prosecutors would file criminal charges against them for this behavior, fewer doct…
Restitution and Guilty Plea in Two Lab Fraud Cases
CEO SUMMARY: In one case, owners and a sales rep agreed to pay restitution totaling almost $10 million. In the second case, three defendants pled guilty to federal charges involving payment or receipt of kickbacks and illegal inducements. A fourth defendent in this second case, a ph…
CURRENT ISSUE
Volume XXIX, No. 11 – August 8, 2022
This issue examines the challenges facing the nation’s hospitals, health systems, and clinical labs: unprecedented shortages of lab staff, nurses, and other professionals with inflation-fueled cost increases and deteriorating hospital finances. Also, the issue delivers a case study showing how Bryan Health in Nebraska expanded its lab outreach program to include direct-to-consumer tests.
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