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U.S. Department of Health and Human Services
OPKO Settles Allegations of Fraudulent Billing
DEMONSTRATING THAT EVEN ROUTINE TESTS CAN CAUSE LEGAL HEADACHES for clinical laboratories, the U.S….
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,…
Change Healthcare Cyberattack Involved 100 Million Americans
AFTER EXPERIENCING WHAT MANY CYBERSECURITY EXPERTS consider to be one of the largest, most disruptive ransomware attacks ev…
How Is COVID-19 Evolving? It’s Not Like Flu or Colds
CEO SUMMARY: It’s been 53 months since the SARS-CoV-2 virus triggered the worst global pandemic since 1918’s influenza pandemic. The coronavirus continues to surprise public health officials as new variants are detected, along with a multi-year pattern of summer surges in new cases. T…
Final Rule on AI Transparency Can Benefit Clinical Labs
ARTIFICIAL INTELLIGENCE (AI) AND MACHINE LEARNING are becoming ubiquitous in today’s modern hospital systems and clinical laboratories. In response to these developments, federal officials issued a new rule that has major implications on how healthcare providers use artificial intelligence. T…
No Surprises Act Sparks a Slew of Court Decisions
CEO SUMMARY: Multiple lawsuits filed by the Texas Medical Association against the federal government have resulted in key decisions that affect provisions in the law. Qualifying payment amounts and …
Private Health Insurers Are Aware of Problems with CPT Code 81408
EDITOR’S NO…
Big Employers Sue Payers over Price Transparency
CEO SUMMARY: Feeling they’ve been denied access by insurance companies to price data about medical claim payments, self-funded employer plans and unions are taking their health insurance companies…
Cyberattack Victims Sue Enzo Biochem and Labcorp
CEO SUMMARY: It’s the latest reminder that clinical laboratories and anatomic pathology groups are at risk for two threats. One threat is a cyberattack that shuts down a lab’s IT system while stealing patient data. The other threat involves lawsui…
Proposed Electronic Signature Rule Has Compliance Risks
CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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