Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [Read more...]


Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

The pattern of high volume and relatively low impact continued with strategic alliances outnumbering acquisitions at rate of roughly 3:1. M&A Following the trio of mega-deal closings, … [Read more...]


CMS Finalizes Controversial PAMA Fee Schedule

It's official. CMS is going forward with its controversial 2018 PAMA Clinical Laboratory Fee Schedule (CLFS). Regrettably, the final version closely tracks the preliminary one (See GCA, Oct. 24, 2017, … [Read more...]


Dx Earnings Report: Strong Q3 Adds to Robust 2017 as PAMA Looms for 2018

Big labs continue to post impressive earnings. But the positive Q3 numbers may prove to be the calm before the PAMA storm—at least for major reference labs that generate significant revenues from … [Read more...]


FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction … [Read more...]


CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times

By Kyle Fetter  bio The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA … [Read more...]


High-Deductible Plans Tied to Reduced Use of Health Care, Including Diagnostic Testing

People enrolled in high-deductible health plans (HDHPs) cut their use of health services, including laboratory testing, according to a study published in the October issue of Health Affairs. HDHPs … [Read more...]


Safety lapses continue with select agents

By Dan Scungio, MT (ASCP), SLS, CQA (ASQ)  bio The approach of the holiday season signals the end of another year. Was this just another year in a long line of them for you in lab safety, … [Read more...]


OPPS 2018: Revised Payment Rates & a New ADLT Date of Service Exemption

With all of the PAMA commotion, CMS's publication of the 2018 Medicare Hospital and Ambulatory Surgical Outpatient Prospective Payment System (OPPS) final rule has flown under the radar. In case you … [Read more...]


Employment Law Update: The Weinstein Edition

By Mike O'Brien  bio Harvey Weinstein all over our news feeds Your news feed, like mine, has exploded with references to someone named Harvey Weinstein for the past few weeks. What's up? … [Read more...]