Labs and Payors Take Their COVID-19 Test Reimbursement Feud to Court

The very public feud between health insurers and labs over payment of COVID-19 tests has just entered a new stage: litigation. FFCRA, CARES & the Free Test Mandate  On March 18, 2020, at … [Read more...]

Industry Trends

Investors Sink Nearly $15 Billion into Digital Health Companies in First 6 Months of 2020

The pandemic has enabled developers of Electronic Health Record (EHR), Laboratory Information Systems, ePrescription software and other digital health technologies to attract investment capital at … [Read more...]

DX Deals

Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market

Will Amazon transform diagnostic lab testing the way it did the retail industry? Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of … [Read more...]

M&A Report

23andMe Goes Public While the Clock Ticks on Illumina’s Grail Acquisition

M&A deal making in the diagnostics space remained hot and heavy in June. Key deals included Danaher’s announced $9.6 billion acquisition of life sciences plasma DNA maker Aldevron and the closing … [Read more...]

FDA Watch

First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

The U.S. Food and Drug Administration (FDA) continues to step outside its traditional comfort zone in response to COVID-19 pandemic pressures. Among the most recent agency firsts is best seen as part … [Read more...]


Congress Reintroduces Rival VALID and VITAL Acts to Regulate New Lab Tests

VALID and VITAL are familiar acronyms to those of you who’ve been following the long-running effort to impose order on the FDA’s regulation of Laboratory Developed Tests (LDTs). Now both of those … [Read more...]


Labs Sue National Insurers for Not Reimbursing COVID-19 Testing Claims

Medical testing lab Genesis Laboratory Management is suing UnitedHealth Group for not paying claims for COVID-19 tests. The lawsuit, filed on June 2 in the U.S District Court for the district of New … [Read more...]

Increasing Revenue

Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

Makers of innovative medical devices makers will remain on pins and needles after CMS’s decision to once more delay a final rule that would automatically provide initial Medicare coverage for new … [Read more...]


ACLA Keeps the Pressure on CMS by Appealing Dismissal of PAMA Lawsuit

The American Clinical Laboratory Association (ACLA) is not backing down. For more than three years, the association has waged litigation warfare challenging the legality of CMS’s methodology for … [Read more...]

FDA Watch

Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be … [Read more...]