OIG Switches from Semi-Annual to Monthly Work Plan Strategy

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 "dynamic," web-based strategy is … [Read more...]


Theranos and Walgreens Bury the Hatchet—For Now

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 performing a wide array of tests with … [Read more...]


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. In this update: REPEAL? REPAIR? REPLACE? … [Read more...]


Clinical Laboratories Continue to Figure Less Prominently in New OIG Enforcement Report

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 … [Read more...]


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) … [Read more...]


Avoid Liability for Commission-Based Marketing Arrangements

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 the volume or value … [Read more...]


CMS Exercises Enforcement Discretion for PAMA Reporting

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 … [Read more...]


CMS, OIG Reps Address Attendees at ACLA Annual Meeting

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 Office of Inspector … [Read more...]


Dealing with the FDA: 12 Best Practices for Responding to a Form 483

Laboratory diagnostic tests and affiliation with drug and device manufacturers have made labs a popular target for U.S. Food and Drug Administration (FDA) quality system inspection. Going through an … [Read more...]


FISH Testing Case Yields $3.8 Million Settlement

A Florida-based urologist is the latest 21st Century Oncology defendant to fork over seven figures to settle charges of false billing for fluorescence in situ hybridization (FISH) tests. The Original … [Read more...]