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U.S. Department of Health and Human Services
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 …
Attorney Advises Labs to Track Genetic Test LCDs
CEO SUMMARY: Skyrocketing numbers of genetic test referrals and telehealth claims since 2016 are getting the full attention of both federal prosecutors and auditors from Medicare and private health insurers. The DOJ has filed criminal cases against a growing number of telehealth pro…
On Appeal, ACLA Gains PAMA Victory in Court
CEO SUMMARY: Last month, a U.S. Court of Appeals issued a ruling that criticized how the Department of Health and Human Services originally implemented the Protecting Access to Medicare Act of 2014 (PAMA). This ruling was a win for the American Clinical Laboratory Association in its…
CURRENT ISSUE
Volume XXXI, No. 16 – November 25, 2024
Two different federal lawsuits that challenge the authority of the federal Food and Drug Administration (FDA) to regulate laboratory developed tests (LDTs) will be combined. Plaintiffs and the government in both cases agreed to move forward on this basis.
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