compliance programs Archives

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compliance programs

Pathology Firm Pays $63M to Settle Qui Tam Case

By Joseph Burns | From the Volume XXVI No. 3 – February 25, 2019 Issue

CEO SUMMARY: Inform Diagnostics, formerly Miraca Life Sciences, settled the federal qui tam case while denying wrongdoing. The $63.5 million settlement will by paid by the former owner, Miraca Holdings, a Japanese company. The federal Department of Justice alleged that the company—then …

Health insurance fraud cases take new turn with HDL-BlueWave outcome

By Mary Van Doren | From the Volume XXV No. 3 – February 12, 2018 Issue

This is an excerpt from a 2,700-word article in the February 12, 2018, 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:…

Use of ‘1099 Marketers’ and Lab Compliance Risk

By Jon Stone | From the Volume XXV No. 3 – February 12, 2018 Issue

CEO SUMMARY: Experts in lab compliance predict that clinical laboratories and anatomic pathology groups must anticipate tougher enforcement of federal and state laws this year. One source of increased compliance risk for lab companies is the rising use of third-party marketing agreements….

In Massachusetts, AG Targets Drug Testing Labs

By Robert Michel | From the Volume XVIII No. 14 – October 17, 2011 Issue

CEO SUMMARY: Since taking office in 2007, Massachusetts Attorney General Martha Coakley has aggressively pursued civil charges against drug testing labs. Last month, Coakley announced a criminal arrest in one ongoing investigation after a grand jury indicted a physician in a kick…

Will Lawsuits Re-shape Current Lab Practices?

By Robert Michel | From the Volume XVIII No. 9 – July 5, 2011 Issue

CEO SUMMARY: Recent events in California, triggered by a lab whistleblower lawsuit filed in 2005 and unsealed in 2009, provide the latest example of how these lawsuits and related government enforcement actions can cause fundamental changes in the pricing and marketing p…

How Could So Many Labs Violate California Law?

By Robert Michel | From the Volume XVII No. 18 – December 27, 2010 Issue

CEO SUMMARY: If a 40-year-old state law on Medi-Cal pricing was known to regulators and clinical laboratories alike, how did the legal and compliance departments of so many laboratories—staffed by some of the smartest legal minds in California and nationally—interpret the law…

New Privacy Breach Law Requires Labs to Respond

By Robert Michel | From the Volume XVI No. 15 – November 02, 2009 Issue

CEO SUMMARY: There were plenty of headlines about the passage of HITECH last February because of how it expanded funding for electronic medical records. But lesser known are new requirements that providers, including labs and pathology groups, must now take specific compliance ac…

Defense Attorneys Discuss Details Of UroCor Jury Trial

By Robert Michel | From the Volume XIII No. 10 – July 24, 2006 Issue

CEO SUMMARY: This was the first criminal case involving anti-kickback violations brought against executives of a public laboratory company. Federal prosecutors charged the defendants with offering inducements to referring physicians in several ways. Defense counsel rebutted the prosecutio…

Privacy Officer Shares Lessons on ID Theft

By Robert Michel | From the Volume XII No. 5 – March 28, 2005 Issue

CEO SUMMARY: “Nothing teaches like experience.” That adage aptly describes the lessons learned at a Seattle hospital after a case of patient identity theft surfaced. Laboratories and pathology groups must be just as alert to the potential for patient identity theft as they are to inap…

Change Beneath Surface Marks 2004 Lab Stories

By Robert Michel | From the Volume XI No. 17 – December 13, 2004 Issue

CEO SUMMARY: Presented here are THE DARK REPORT’S “Ten Biggest Lab Stories of 2004.” These are the events we consider most important to the lab industry during the year. However, in contrast to past years, 2004 lacked the types of blockbuster events which radically change and reshap…

Volume XXXII, No. 7 – May 12, 2025

Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.

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