Special Report: The 2024 Lab Enforcement Landscape
Lab leaders should be wary of telemedicine arrangements, certain marketing firms, and unnecessary PGx and CGx testing
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Articles and Reports
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
LDTs Around the World
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Here’s my latest Employment Law update prepared for many HR professionals
By Mike O'Brien bio
Lots of ADA Facility Lawsuits in Utah: Here is an interesting legal news update from my partner Mike Judd: Title III of the Americans with Disabilities Act (ADA) requires places of…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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OIG Switches from Semi-Annual to Monthly Work Plan Strategy
From - G2 Compliance Advisor
New OIG Work Plans every six months are a thing of the past. In June, the agency announced plans to update its Work Plan website monthly. The self-proclaimed…
Theranos and Walgreens Bury the Hatchet—For Now
From - G2 Compliance Advisor
It all looked so promising back in 2015. Privately-held Theranos was poised to usher in a new era of diagnostics with its revolutionary fingerprick technology for…
Employment Law Update for August 2017
By Mike O'Brien bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
Clinical Laboratories Continue to Figure Less Prominently in New OIG Enforcement Report
From - G2 Compliance Advisor
The Office of Inspector General just published its most recent Semiannual Report to Congress. To the untrained eye, the newest OIG Report, which covers Oct. 1, 2016 through March 31, 2017, is not substantially different from…
Avoid Liability for Commission-Based Marketing Arrangements
From - G2 Compliance Advisor
Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on…
CMS Exercises Enforcement Discretion for PAMA Reporting
From - G2 Compliance Advisor
As we previously reported, the Centers for Medicare & Medicaid Services (CMS) has indicated that laboratories had sought relief from the March 31 deadline for reporting applicable information under the…
CMS, OIG Reps Address Attendees at ACLA Annual Meeting
From - G2 Compliance Advisor
At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the…
Dealing with the FDA: 12 Best Practices for Responding to a Form 483
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