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
Beware of Backlash When Restructuring Commission Arrangements for EKRA Sales Commissions & EKRA Liability Risks
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Federal Court Dismisses Quidel’s False Advertising Claims against Siemens
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Failure to Reimburse Government for Overpayments Is a Reverse False Claim
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Whistleblower Industry Continues to Thrive During Pandemic
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Georgia Lab Shells Out $200K to Settle Genetic Testing Kickback Claims
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New Rules for CDLTs that Aren’t ADLTs Take Effect Jan. 1
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A roundup of recent cases and enforcement actions involving the diagnostics industry
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Not Following Government Guidance May Be Used Against You in False Claims Prosecutions
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Federal Court Upholds $46.7 Million Medicare PHPs Fraud Conviction
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Payor Can’t Use Alleged Co-Conspirator’s Settlement as Evidence Lab that Engaged in Pass-Through Billing Scheme
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