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...]

FDA Watch

First Warning Letters Issued for Improper Marketing of SARS-CoV-2 Antibody Tests

No more Mr. Nice Guy. For the first time, the FDA has exercised its enforcement powers to crack down on makers of unproven serologic SARS-CoV-2 antibody tests. A 180⁰ Pivot When the public … [Read more...]

Emerging Tests

Employers Show Signs of Hesitation on COVID-19 Return to Work Testing

Business reopening and return to work was expected to create a massive new market for employer point-of-care COVID-19 workplace screening tests. However, there are troubling new indications that … [Read more...]

Tool

Model COVID-19 Contact Log Sheet

Maintaining social distancing will be the price that labs and other businesses will have to pay to reopen and remain open until the COVID-19 threat goes away. But for social distancing to work, there … [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...]

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...]

Reimbursement

Feds Say Insurers Not Required to Pay for Employer Return to Work COVID-19 Testing

Since the public health emergency began, the US government has taken the position that insurers shouldn’t be allowed to make consumers pay for COVID-19 lab tests. But now comes news that insurers will … [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...]

FDA Watch

First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests

After initially allowing producers of serologic SARS-CoV-2 antibodies tests free access to the market, the US Food and Drug Administration (FDA) is now cracking down on unproven and inaccurate … [Read more...]


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