Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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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
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
FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
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Ensure Compliant Hiring and Firing Strategies
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News at a Glance – July 2016
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Theranos Adds Compliance Focused Executives and Board Committee
From - G2 Compliance Advisor
While still facing serious sanctions from CMS, Theranos has been taking steps to rehabilitate its compliance image. The company announced the appointment of…
Penalties for False Claims Aren’t the Only FCA Risk to Avoid
From - G2 Compliance Advisor
In the last two issues of Lab & Pathology Insider we highlighted new developments concerning the False Claims Act (FCA): the U.S. Supreme Court decision recognizing the…
Democratic Committee Leaders and CMS Present Latest Challenges to Theranos
From - G2 Compliance Advisor
Both the Centers for Medicare & Medicaid Services (CMS) and some high ranking Democratic Committee members had some bad news for…
Data Analytics Fuels Billions of Dollars in Fraud Recoveries Says OIG, CMS
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Largest Takedown in Strike Force History Alleges $900 Million in False Medicare Billing
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Biodiagnostic Laboratory Services LLC Pleads Guilty
From - G2 Compliance Advisor
Amidst the guilty pleas and sentencing of dozens of individuals, the laboratory company Biodiagnostic Laboratory Services LLC (BLS) entered a…
Largest Takedown in Strike Force History Alleges $900 Million in False Medicare Billing
From - G2 Compliance Advisor
Nearly a year to the day after another nationwide Strike Force takedown, the Department of Justice announced last week what it says is a…