How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Billing Medically Unnecessary Nuclear Stress Tests Costs Urgent Care Practice $1.25 Million
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OIG Revises Self-Disclosure Protocol
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Failure to Prevent Ransomware Attacks Exposes Your Lab to Costly Negligence Lawsuits
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What to Do If a Lab Employee Defies Your Mandatory Vaccination Policy
Two key actions you should take if one of your employees refuses to comply with your mandatory vaccination policy.
Did Commission Agreement based on Lab Client Revenues Violate EKRA?
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Texas MDs Pay $3.9 Million to Settle Claims of Falsely Billing Urine Drug Tests
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Company Must Prove Bona Fide Employment Relationship AKS Safe Harbor at Trial
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Florida Lab Owner Gets 82-Month Jail Sentence for Telemedicine Genetic Test Ripoff
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A roundup of recent cases and enforcement actions involving the diagnostics industry
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Ex-CEO of NWPL Settles Urine Drug Test Kickback Claims for $1.1 Million
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