Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
FDA Speeding Approval Process, Continued User Fees Needed
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) is plagued with chronic understaffing, scrutiny over the length of time for approvals, and an expanding workload, while also…
FDA Speeding Approval Process, Continued User Fees Needed
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and…
Case of the Month: False Billing of Nuclear Stress Tests at Center of $50 Million Cardio Fraud Scheme
From - National Intelligence Report
The feds arrested a cardiologist, neurologist and four others for their role in an elaborate fraud scheme…
Potential Upcoming Shifts for Diabetes-Related Diagnostic Testing
From - Diagnostic Testing & Emerging Technologies
New research suggests that potential shifts might occur in diabetes-related testing, including potential increased use of…
Electronic Health Records: The eClinicalWorks False Claims Settlement—Big Fines & Unprecedented CIA Obligations
From - National Intelligence Report
False Claims Act actions targeting health care vendors have become more common. eClinicalWorks (ECW), one country's biggest…
Why Your Best Talent is Leaving and Four Ways to Win Them Back
By William A. Schiemann, Ph.D bio
Most leaders of companies today recognize the importance of having engaged people at work. Yet research from the Metrus Institute, Gallup, and others say that…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Reimbursement Trends: 5 More New Molecular Tests Get the Medicare Green Light from Palmetto
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Enforcement Trends: Labs Get Cameo, Rather than Starring Role in OIG’s New Enforcement Report
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New Laws: House Bans Firing Whistleblowers for Disobeying Orders to Break the Law
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