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...]

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 June … [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...]

LDTs

FDA Sets the Bar on Specimen Pooling & Asymptomatic Screening for SARS-CoV-2 Test Development

On June 16, the US Food and Drug Administration (FDA) issued new guidance addressing two key issues related to SARS-CoV-2 testing: validation processes for test pooling of samples for test development … [Read more...]

Labs In Court

Florida Lab, Execs Settle False Billing of Urine Drug Test Charges for $41 Million

Case: Prosecutors accused a Tampa reference lab, pain clinic and two former executives of billing Medicare, Medicaid and TRICARE for medically unnecessary presumptive and definitive Urine Drug Testing … [Read more...]

Focus On

The Next Round of COVID-19 Legislation: What It Will Take to Prevent a Second Outbreak?

The next wave of federal COVID-19 relief legislation is in the works and the lab industry is doing its level best to ensure that it includes the necessary support for lab testing that the previously … [Read more...]

OIG Watch

Agency to Review First Two Years of PAMA-Based Medicare Reimbursements for Lab Tests

As we pass the midpoint of the third year of the PAMA experiment—if that’s what it is—the OIG announced plans to review what happened in years one and two. One of the new items on the agency’s Work … [Read more...]

New Products

First SARS-CoV-2 Antigen Test Gets EUA Clearance from the FDA

First came the molecular and then the serologic assays. And last month, the FDA granted emergency use authorization (EUA) for a COVID-19 assay based on a third kind of testing methodology: antigen … [Read more...]


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