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
Compliance Corner: Must Employee Notify Lab of DUI?
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OIG Work Plan: Agency to Focus on Vaccine Adverse Event Reporting
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A roundup of recent cases and enforcement actions involving the diagnostics industry
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Industry Buzz: Supreme Court Declines Chance to End Agony of ACA Uncertainty
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HIPAA Compliance: Quest Pays $195K to Settle Class Action for HIV Data Breach
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Managing Lab Staff: Supervisor Liability for Subordinate Misconduct Under Civil Rights Law
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EKRA: More than a Year Out, Major Questions Remain Unresolved
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Compliance Tool: Model In-Office Phlebotomist Agreement
The following Model Agreement between a testing lab and a referring physician was created by Savannah, GA, lab compliance attorney Adam Walters and structured to minimize kickback liability risks to each party in
Finding the “Backdoor” into Payer Networks
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