Top of the News

Major Insurer Claims It Has No Obligation to Pay for Pooled COVID-19 Testing

Free COVID-19 testing is a powerful and very compelling policy. The problem, of course, is that somebody has to pay for coronavirus testing. And the insurance companies have been designated as that … [Read more...]

Enforcement Trends

Granston Memo Whistleblower Dismissals May Be Tougher than DOJ Thought

In 2018, the Justice Department sent an internal memorandum ordering US Attorneys to aggressively seek to dismiss False Claims Act (FCA) whistleblower qui tam lawsuits that lack merit or don’t serve … [Read more...]

Emerging Tests

FDA Offers New Guidance on Validating SARS-CoV-2 Tests in “Non-Laboratory” Settings

SARS-CoV-2 testing in homes, workplaces, airports, schools, sports venues and other non-traditional diagnostic settings is likely to play an increasingly important role in the months ahead. The FDA … [Read more...]

Labs In Court

Rhode Island Health System Fined +$1 Million for Failure to Encrypt Laptops

Case: The trouble began when Lifespan Corporation, the parent company of a Rhode Island-based non-profit health system filed a breach report after a laptop containing medical record numbers, … [Read more...]

Enforcement Trends

After 5 Down Years, Federal Enforcement ROI Increases—But Just a Tad

Like any other business, federal health care fraud law enforcement has to account for its return on investment (ROI). And for the previous six years, that ROI had been in steady decline. But ROI … [Read more...]

LDTs

Battle of the SARS-CoV-2 Antibody Immunoassays: Only One Test Meets Both UK Sensitivity and Specificity Targets

Several of the world’s biggest testing companies have created and secured emergency regulatory clearance for immunoassays that detect antibodies to the SARS-CoV-2 virus. But how reliable are these … [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...]

Test Utilization

Rapid Testing the Linchpin of COVID-19 Contact Tracing Effectiveness

Without rapid testing and results, COVID-19 contact tracing will not work. That is the conclusion of a new study published in The Lancet. Even the most efficient contact tracing strategy will not … [Read more...]

Inside the Beltway

President Calls for Cutting NIH Budget but Congress Increases It Instead

The Trump administration wanted to slash the National Institutes of Health (NIH) budget but Congress wouldn’t allow it. It’s been the same narrative for the past four years. But even though it’s … [Read more...]


(-00000g2)