The U.S. Department of Health and Human Services (HHS) has ordered labs that perform COVID-19 testing to report test data to state and local public health agencies by August 1, 2020. What makes the … [Read more...]
Case of the Month
Feds Launch First COVID-19 Testing Fraud Prosecution
July 3, 2020
Stop me if you’ve heard this one before. The DOJ has charged a publicly traded Silicon Valley med tech firm and its CEO with touting a sham finger stick blood test to defraud payors and rip off … [Read more...]
GAO Report
Federal COVID-19 Testing Data Collection Effort Has Been Ineffective
July 3, 2020
The federal government has done a poor job of collecting and reporting COVID-19 testing data to the CDC since the pandemic began. That’s the conclusion of a U.S. Government and Accountability Office … [Read more...]
Labs In Court
A roundup of recent cases and enforcement actions involving the diagnostics industry
July 2, 2020
Case: CMS revoked an Arizona lab’s CLIA certification in 2000. Three unsuccessful appeals and one failed petition to the U.S. Supreme Court later—eight years in total—the seven CLIA deficiencies, … [Read more...]
The Business of Testing
Pandemic Energizes Search for Genomics-Based Early PTSD Detection Diagnostics
June 23, 2020
COVID-19 is destroying not only lives and the economy but also mental health. The global pandemic is widely expected to result in a dramatic increase in post-traumatic syndrome disorder (PTSD) cases. … [Read more...]
