The COVID-19 Crisis

Easy & Rapid Testing Remains Unavailable to Most Physicians

New laboratory tests to detect COVID-19 are clearing the Food and Drug Administration and reaching the US market faster and in volumes greater than anybody would have ever dared to expect. But so far … [Read more...]

FDA Watch

Agency Clears Dozens of New COVID-19 Diagnostic Tests in Record Time

The US Food and Drug Administration (FDA) has taken a lot of heat for wasting precious time in responding to the COVID-19 emergency. While this criticism is fair, it is also true that the agency has … [Read more...]

The Business of Testing

New COVID-19 Revenues Not Enough to Offset Declines in Elective & Screening Tests

That line from Charles Dickens’ A Tale of Two Cities about the best of times and the worst of times is especially apt with what testing laboratories in the US and around the world are experiencing. … [Read more...]

Pandemic & Progress

First Saliva COVID-19 Test Secures FDA Approval

One of the toughest parts of COVID-19 laboratory testing is the sample collection process. A swab must be inserted into each nostril, one at a time, to the nasopharynx at the back of the nasal cavity, … [Read more...]

Focus On

Nearly 3 in 4 Physicians Say They Can’t Provide Easy & Rapid COVID-19 Testing

Development of new lab tests to detect the SARS-CoV-2 virus that causes COVID-19 coronavirus has been faster and more prolific than anybody could dare expect for a pathogen that was unknown just a few … [Read more...]

The Coronavirus Crisis

Test-Now, Regulate-Later Strategy Generates Robust Dx Test Pipeline in Record Time

Historically, the lag between Public Health Emergency (PHE) declaration and FDA approval of a lab test to diagnose the pathogen has been a minimum of eight weeks. Eight weeks into the coronavirus PHE, … [Read more...]

Cybersecurity

OCR Temporarily Eases HIPAA Privacy Restrictions for Telehealth Practice

In furtherance of its social distancing strategy, the federal government is temporarily allowing labs and other health care providers to use communication technologies like Facetime or Skype for any … [Read more...]

Coronavirus

OIG Temporarily Waives Anti-Kickback Restrictions for Certain COVID-19 Physician Arrangements

As it previously did with the Stark Law (See National Intelligence Report, NIR, March 25, 2020), the OIG is temporarily loosening Antikickback Statute (AKS) restrictions to clear the way for health … [Read more...]

Billing & Coding

New HCPCS Codes for COVID-19 Specimen Collection

CMS has established two new Level II HCPCS codes for COVID-19 specimen collection: G2023 - Specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus … [Read more...]

PAMA

COVID-19 Relief Bill Defers 2021 Medicare Part B Lab Test Price Cuts for One Year

The $2 trillion COVID-19 relief bill, CARES (Coronavirus Aid, Relief and Economic Security Act), provides for free coronavirus testing without adequately compensating the labs who perform the tests. … [Read more...]


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