Why Falling Demand for COVID-19 Testing May Be a Mixed Blessing

We all understood that the massive spike in COVID-19 testing was unsustainable and bound to gradually peter out. But now it appears that the decline is coming steeper and faster than anybody expected. … [Read more...]

Emerging Tests

The Evolving COVID-19 Market: FDA Clears the Way for Asymptomatic Screening Products

A year after it came into being, the market for coronavirus diagnostics is dramatically evolving with the focus of growth inevitably shifting to products designed for serial screening of the … [Read more...]

Inside the Lab Industry

COVID-19 Surge Lifts Overall Molecular Point of Care Testing Market to $900 Million

To the uninitiated, the term molecular point-of-care (POC) testing might sound like an oxymoron. After all, the science of molecular microbiology is all about detecting targeted bits of microbial … [Read more...]

Compliance Perspectives

Medicare Medical Necessity Denials and How Your Lab Can Prevent Them

Ensuring that the lab services you bill for meet Medicare medical necessity requirements is one of the oldest challenges faced by lab compliance managers. And it doesn’t get any easier over time. The … [Read more...]


CMS Closes the Free COVID-19 Tests Coverage Loophole

Getting Republicans and Democrats to agree on anything these days is a Herculean task, even during a global pandemic. One of the rare points of consensus is with regard to the notion that all … [Read more...]


Model Lab Enhanced Cleaning and Disinfection Policy

Complying with the usual CLIA, accreditation and other hygiene standards and requirements may not be adequate to protect workers and others present at your lab facilities against risk of COVID-19 … [Read more...]

Health Reform

Will Transition to a New Administration Be Enough to Save the ACA?

The Affordable Care Act (ACA, aka Obamacare) has gained a powerful new ally in its bid to stave off legal extinction at the hands of the Supreme Court: the U.S. Department of Justice (DOJ). On Feb. … [Read more...]

Enforcement Alert

OIG to Audit Medicare Part B Lab Testing During the Pandemic

Fraudulent and abusive billing of lab services has long been a favorite target of OIG enforcers. And with the unprecedented surge of COVID-19 testing during the public health emergency, it’s hardly … [Read more...]

FDA Watch

FDA Watch: Molecular Tests May Miss New SARS-CoV-2 Strains, Agency Warns

Like many viruses, the SARS-CoV-2 is a shape-shifter. And that may make it harder to detect. With this in mind, the U.S. Food and Drug Administration (FDA) is warning clinical laboratories and health … [Read more...]

Genetic Testing

New Study Shows Viability of Using Ancestry to Compare Prostate Cancer Risk Across Populations

Ancestry has been shown to be a risk factor for prostate cancer. Unfortunately, we know very little about why men of certain races and ethnicities are more prone to get it, let alone how to use … [Read more...]