TAG:
lab risk & compliance
Accreditors Explain Changes to CLIA Supervisor Qualifications
In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussio…
Could AI Oversight in Labs Fall Under a CLIA Model?
CEO SUMMARY: Clinical AI is advancing faster than regulation, creating risk for medical labs. An expert discusses using CLIA to oversee development and ensure safety, performance, and accountability while complementing FDA oversight. Lab leaders face regulatory uncertainty…
Court: Percentage-Based Comp Is Not Illegal in Itself
OUR MEMBERS LEARNED IN THE PRIOR ISSUE ABOUT AN IMPORTANT COURT RULING that interpreted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA), a law that has long been maligned by clinical laboratories for its murkiness. The Dark Report has since talked in…
How Federal Court’s Decision Will Affect Lab Marketing
MOST MEDICAL PROVIDERS are buyers of healthcare services. But for clinical laboratories, that equation is turned on its head. Labs are medical providers, but since they rarely provide those services directly to patients, they must properly market them to providers to ensure steady sales…
JAMA Authors Warn LDT Legal Defeat Brings Risk for Labs
CLINICAL LABORATORY AND ANATOMIC PATHOLOGY LEADERS WILL WANT TO NOTE will a recent JAMA Health Forum article that strikes a cautionary tone about the future of laboratory developed test (LDT) regulation. The piece argued that the recent federal court decision…
Using Sophisticated Schemes, Fraudsters Hit the Next Level
Investigators and fraudsters appear to be upping their game as the government seeks to punish those filing unscrupulous Medicare claims. These aspects were clear in the US Department of Justice’s (DOJ) announcement last month of the largest healthcare fraud takedown reportedly in US history. Cli…
How Medicaid Cuts May Affect Clinical Labs
CEO Summary: As lawmakers debate the merits of President Donald Trump’s budget bill, it appears that Medicaid changes are on the horizon. For medical laboratories, three immediate areas to monitor include potentially decreased Medicaid recipients, federal cuts to Medicai…
Labs Beware: ‘Vishing’ Rises as Major Cybersecurity Threat
CYBERSECURITY SHOULD ALWAYS BE TOP OF MIND FOR CLINICAL LABORATORIES AND PATHLOGY groups, especially since the notorious data breach at Change Healthcare in February 2024. Often, such security breaches begin with phishing campaigns in which employees are enticed to click on malicious li…
LDT Oversight May Fall to Congress, CLIA
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
CURRENT ISSUE
Volume XXXII, No. 15 – October 27, 2025
The Dark Report examines the momentous decision by the VA to switch accreditors from The Joint Commission to CAP. Also, we analyze retractions in pathology journals to gain insight into scientific fraud.
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