Data

Genomic Testing Utilization Is Low & Geographically Inconsistent but Not Just Due to Payor Coverage

Genomic testing is inconsistently utilized in the U.S., even in states with favorable coverage policies. Those are the findings of a report from the Personalized Medicine Coalition (PMC) released in … [Read more...]

Labs in Court

OSHA Fines New Jersey Hospital for Coronavirus Respiratory Protection Violations

Case: OSHA is proposing to fine the hospital $9,639 for two serious violations: i. Failure to fit test tight-fitting respirators face piece respirators on employees required to use them; and ii. Not … [Read more...]

FDA Watch

Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season

The robust COVID-19 testing EUA pipeline has opened up a new opportunity for companies that produce multi-analyte panels capable of detecting not only the SARS-CoV-2 virus but other respiratory viral … [Read more...]

Compliance Perspectives

Using Waivers to Avoid Getting Sued for COVID-19 Infections

PLEASE READ NOTICE TO ALL ENTRANTS AND USERS OF THESE LABORATORY FACILITIES EXCLUSION OF LIABILITY – ASSUMPTION OF RISK THESE CONDITIONS WILL AFFECT YOUR LEGAL RIGHTS INCLUDING THE RIGHT TO … [Read more...]

Economic Trends

Labs Lost Less & Will Recover More than Other Healthcare Sectors, Says New Report

Although it’s not exactly “Happy Days Are Here Again,” a new S&P report is predicting that the healthcare sector has seen the worst of the COVID-19 pandemic and won’t have to go through “a return … [Read more...]

Quiz

Lab’s Duty to Protect Returning Employees from COVID-19 Discrimination and Harassment

SITUATION Fully recovered from his bout with COVID-19, Max is thrilled and excited to return to his custodian job after 14 days of mandatory home isolation. But almost immediately, he senses that … [Read more...]

Labs in Court

BioReference Labs Shells Out $11.5 Million to Settle Kickback and False Billing Charges

Case: The feds claimed that from 2009 to 2012, BioReference Laboratories billed Medicare TRICARE for hospital inpatient tests listed on the Part B Clinical Lab Fee Schedule even though those tests … [Read more...]

Labs in Court

Referral Arrangement Violates Kickback Laws Even If Only Purpose Is to Generate Illegal Referrals

Case: The U.S. Attorney accused a Kentucky physician of taking a $105 per beneficiary payment from a lab company in exchange for ordering its pharmacogenetic tests in violation of the Anti-Kickback … [Read more...]

M&A Report

One Blockbuster Dies and Another Arises as Sluggish Deal Making Continues

The decline in diagnostic M&A activity is reflective of what’s been happening across the entire healthcare industry, with deals from down 20% during Q2, as compared to Q1 2020, according to … [Read more...]

FDA Watch

Agency to Provide Emergency Clearance for Multi-Analyte Respiratory Panels

We are now seven months into the COVID-19 public health emergency and flu season is rapidly approaching. Several diagnostics test producers have responded to this convergence by creating new … [Read more...]


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