Health Care Reform:

New Administration May Not Be Enough to Save the ACA

Patients, payors and health exchanges await nervously as the drama over the Affordable Care Act (ACA, aka Obamacare) continues to play out. It looked like the U.S. Supreme Court had settled the issue … [Read more...]

Labs In Court

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

Massachusetts Drug Testing Lab Shells Out $84K to Settle SVT False Billing Charges Case: A urine drug testing lab in Massachusetts is the latest to settle self-disclosed charges of falsely billing … [Read more...]

DX Deals

Global Collaboration Seeks to Develop Game-Changing Handheld COVID-19 Breathalyzer Test

A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a breakthrough in the effort to contain the spread of the virus. That vision … [Read more...]

FDA

FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits

Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, nearly 30 have received clearance for at-home collection; a … [Read more...]

Labs In Court

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

$4.3 Million Is Too High a Penalty for HIPAA Violation, Says Federal Court  Case: A federal appeals court has shot down what had been the fourth largest OCR penalty for a HIPAA violation as having … [Read more...]

DX Deals

Siemens, California Health Network and Biopharm Research Company Partner for Enhanced Liver Fibrosis Testing

Although COVID-19 remains the driving force, non-pandemic-related strategic deal making continues. Among the most impactful deals announced in December is the partnership among Renown Institute for … [Read more...]

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

LabCorp Can Sue Physician to Collect $117K Worth of “Pass-Through” Charges for Uninsured Patients Case: Labs like LabCorp typically enter “pass-through” arrangements with physicians covering … [Read more...]

Consumer Fraud

OIG Warns Medicare Beneficiaries Not to Fall for COVID-19 Scams

Pharma companies, diagnostics manufacturers, labs and other parts of the healthcare industry have done a commendable job in pivoting in response to the current public health industry. Sadly, it seems … [Read more...]

Special Report: Long-Awaited Kickback Relief Rules Leave Labs Out in the Cold

The final rule for value-based care kickback relief that HHS and the OIG published on Nov. 20 is slightly more favorable to labs than the proposed rule published in October 2019. But with a limited … [Read more...]

FOCUS ON

The Year in Labs Regulation: The 9 Biggest Stories of 2020

When 2020 started, COVID-19 was just a news story unfolding on the other side of the globe in China. The novelty of the pathogen meant that there were no tests specifically targeting the virus on the … [Read more...]


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