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
Genomics Giants Accused of Misappropriating Sequencing Technology
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Dissolution: The Final Act of the Theranos Tragedy
From - G2 Compliance Advisor
Just five years ago, Theranos was a Silicon Valley sensation with a valuation of over $9 billion. While black turtlenecked Elizabeth Holmes supplied the charisma, the heart of the Theranos phenomenon was…
Michigan Hospital System Pays $84.5 Million for Alleged Billing of Kickback-Induced Services
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Monthly Work Plan Review: September 2018
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Stark Relief: Change Seems Imminent but Less Dramatic than Industry Wants
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TOOL: Model Specimen Processing Fees Compliance Policy
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PAMA: OIG Backing of CMS Heats Up Market-Based Lab Rates Controversy
From - G2 Compliance Advisor
CMS did it right and saved Medicare a boatload of money in the process, concludes a new OIG report reviewing the methods CMS used to establish…
Shareholders Sue Missouri Hospitals for Alleged Lab Billing Ripoff
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Proposed 2019 Medicare PFS: The 5 Things Labs Need to Know
From - G2 Compliance Advisor
On July 12, CMS issued the proposed 2019 Medicare physician fee schedule (PFS), with comments scheduled to end on Sept. 10. Takeaways…