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
Lab Compliance Advisor
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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
FISH Testing Case Yields $3.8 Million Settlement
From - G2 Compliance Advisor
A Florida-based urologist is the latest 21st Century Oncology defendant to fork over seven figures to settle charges of false billing for…
Fraud and Abuse Enforcement Efforts Face Declining ROI
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Arizona Fraud Suit Opens New Front in the Legal War against Theranos
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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The 6 Things Labs Need to Know About the Trump Travel Ban
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Yates Is Gone But Her Memo Remains
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FISH Test Crackdown against 21st Century Oncology Nets Nearly $25 Million… and Counting
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HHS Blocked from Enforcing Gender Identity Antidiscrimination Rule
From - G2 Compliance Advisor
Section 1557 of the Affordable Care Act bans Medicare participants from committing discrimination on the basis of…
Brief Your CEO about Individual Liability
From - G2 Compliance Advisor
False Claims Act (FCA) and Anti-Kickback (AKS) prosecutions against labs are just two ways the US Justice Department cracks down on…
Five Things Labs Need to Know About the Trump Travel Ban
From - G2 Compliance Advisor
We'll leave it to others to argue whether it's legal, moral or wise. What we can tell you is that President Trump issued an Executive Order Jan. 27, 2017, establishing a…
