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...]

Labs In Court

Whistleblower Lawsuit Can’t Start Until Criminal Investigation Ends

Case: Two former MedComp Laboratory Sciences employees filed a whistleblower lawsuit accusing the lab of concocting an elaborate scheme to pay kickbacks to a group of 61 physicians in exchange for … [Read more...]

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...]

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

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...]

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...]

Emerging Tests

New Study Supports Accuracy of COVID-19 Testing on Self-Collected Nasal Samples

At-home specimen collection for SARS-CoV-2 diagnostic testing requires a leap of faith, namely, that patients can do an adequate job of self-collecting the nasal and nasopharyngeal samples on which … [Read more...]


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