DX Earnings Report

Q2 Revenues Slide but By Less than Wall Street Expected

As expected, the COVID-19 pandemic took a tremendous bite out of lab company earnings in the second quarter. However, the losses were largely below expectations, significantly below in many cases. And … [Read more...]

False Claims Act

Federal Appeals Court Tosses Cold Water on DOJ’s Crackdown on Weak Whistleblower Suits

It’s fair to say that when it comes to False Claims Act (FCA) whistleblower qui tam lawsuits, the current U.S. Department of Justice (DOJ) is less enthusiastic than its predecessor. In fact, the DOJ … [Read more...]

Reimbursement

OIG Medicare Lab Spending Report May Warn of Greater Scrutiny of Genetic and Automated Chemistry Tests

PAMA and market-based rate reductions for lab testing was supposed to save Medicare bundles of money. But according to a new OIG report, Medicare Part B spending on lab spending for 2018, the first … [Read more...]

Market Trends

COVID-19 Fuels Massive & Sustainable Growth in Molecular Diagnostics

While it may be decimating demand for most lab tests, COVID-19 is driving incredible growth in molecular testing. The global market for molecular diagnostics will top $13 billion in 2020, about $5 … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Magnolia Wins Round One of False Advertising Suit against Rival Collection Device Maker Case: Score one, maybe two, for Magnolia Medical Technologies, Inc. in its ongoing litigation war with rival … [Read more...]

FDA Watch

FDA Warns of False-Positives from Becton Dickinson SARS-CoV-2 Test & Reagents

July 6 was a tough day for Becton Dickinson (BD) when the FDA issued a warning letter alerting clinical lab staff and providers of the increased risk of false-positive results from the New … [Read more...]

Reimbursement

Not Making Insurers Pay for Back-to-Work COVID-19 Testing May Leave Labs Holding the Bag

Who should pay for desperately needed COVID-19 testing? In the first stage of the public health crisis, the federal government’s answer was that insurers should pay the bills and not pass along the … [Read more...]

Labs In Court

Failure to Redo “Error” Message A1c Test on Diabetic Patient ≠ No-Brainer Medical Malpractice

 Case: A patient with Type 2 diabetes presented to a federal health clinic with normal heart function, clear lungs and no swelling. And since he didn’t complaint about light-headedness or dizziness, … [Read more...]

Emerging Tests

Employers Show Signs of Hesitation on COVID-19 Return to Work Testing

Business reopening and return to work was expected to create a massive new market for employer point-of-care COVID-19 workplace screening tests. However, there are troubling new indications that … [Read more...]

Labs In Court

Taking Job at Genetic Lab Doesn’t Violate Oncologist’s Non-Compete with Health Data Firm

Case: Three years after becoming Senior Medical Director of Research Oncology for healthcare technology and data services company Flatiron Health, an accomplished oncologist accepted the position of … [Read more...]


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