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Lab Industry Fallout from CLIAC Termination

CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…

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Federal Court Reverses Conviction in AKS Case

CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed t…

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UnitedHealth Group Heads into Difficult Waters Mid-Year

WITH THE NEWS THAT THE FORMER HEAD OF UNITEDHEALTH GROUP (UHG) has returned after the sudden resignation of the company’s CEO, it is apparent that pressure on the healthcare company continues to mount. This latest twist comes on top of a bad…

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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…

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With LDT Rule Vacated, Labs Await FDA Retort

CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…

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OPKO Settles Allegations of Fraudulent Billing

DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….

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April 21, 2025, Intelligence: Late-Breaking Lab News

The administration of President Donald Trump is calling for a $40 billion cut in funding to the U.S. Department of Health and Human Services (HHS), according to a report in The Washington Post on April 16. This amount would come from HHS discretionary spending,…

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Trump Signs Executive Order on Price Transparency

ON FEBRUARY 25, PRESIDENT DONALD TRUMP SIGNED AN EXECUTIVE ORDER targeted at driving price transparency requirements for hospitals and insurers. The order aims to strictly enforce a previous rule, signed during his first term, intended to provide patients with cl…

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OIG Issues New Report on Medicare 2023 Lab Spend

CEO SUMMARY: When the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) issued its latest report on Medicare spending in 2023 for clinical laboratory tests, it attracted relatively little attention from the lab industry. Maybe other issues—such a…

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HHS Revises HIPAA Privacy, Security Rule

CEO SUMMARY: Officials at the Department of Health and Human Services (HHS) are proposing significant changes in what observers are calling a major revision to HIPAA’s requirements for protected health information (PHI) and cybersecurity. HHS issued a statement that the objective of the…

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