By Mike O’Brien bio Employer law is rapidly changing amid the coronavirus pandemic. For one thing, Congress has passed another coronavirus related law. The United States Department of Labor (DOL) … [Read more...]
Reimbirsement
Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients
March 30, 2020
As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. … [Read more...]
Focus On
FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests
March 30, 2020
The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]
Daily Update
FDA Approved Coronavirus Tests
March 30, 2020
COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION (As of April 2, 2020) Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology … [Read more...]
Reimbursement
CDC Issues ICD-10-CM Coding Guidance for Coronavirus Encounters
March 28, 2020
The U.S. Centers for Disease Control and Prevention (CDC) issued official guidance to labs and other health care providers on which ICD-10-CM diagnosis codes to use for 2019 novel coronavirus … [Read more...]
ACA Update
SCOTUS Agrees to Rule on Obamacare for the Third Time
March 25, 2020
Before the coronavirus outbreak, the health care issue that kept millions of Americans up at night was the future of Obamacare, aka, the Affordable Care Act (ACA or Obamacare). Having already having … [Read more...]
Conflicts with US Guidelines
The Coronavirus Crisis: Is CT More Effective than Laboratory Testing in Detecting COVID-19?
March 23, 2020
Could it be that we are barking up the wrong tree in terms of how best to diagnose 2019 novel coronavirus COVID-19? Current U.S. guidelines prioritize laboratory testing over computed tomography (CT) … [Read more...]
Coronavirus
FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests
March 19, 2020
The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]
LDTs
Laboratory Developed Tests: The VALID Act is Back
March 18, 2020
With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has … [Read more...]
