Compliance Briefing

How to Comply with the New HHS COVID-19 Test Data Reporting Rules

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

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

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...]

Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]

Compliance Perspectives

Use Contact Logging to Ensure Lab Employees Practice Social Distancing

Managing a lab compliance program in the age of COVID-19 poses new and unprecedented challenges. One of the biggest and most important is ensuring that lab employees and the persons they interact with … [Read more...]

Labs In Court

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

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...]

Labs In Court

Arizona Lab’s 20-Year Quest to Regain CLIA Certification Comes Up Empty

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...]

Current Issue of LCA

Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download LCA content: I agree that I am the the only person who is accessing my … [Read more...]

Billing & Coding

AMA Creates New CPT Code 87426 for COVID-19 Antigen Testing

On June 24, the American Medical Association Current Procedural Terminology (CPT) approved new CPT code 87426 to report COVID-19 antigen tests, which use immunofluorescent or immunochromatographic … [Read more...]

Billing & Coding

CMS Issues Reminders for Billing COVID-19 Specimen Collection & Symptom/Exposure Assessment

On June 18, CMS offered up some guidance on billing Medicare for COVID-19 symptom and exposure assessment and specimen collection performed on and after March 1, 2020: Use CPT code 99211 to bill … [Read more...]


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