COVID-19

CDC Knowingly Shipped Flawed COVID-19 Test Kits to Public Labs in Early Days of Crisis, Says Report

Early missteps characterized the federal government’s initial efforts to ensure a supply of reliable COVID-19 diagnostic tests in response to the public health emergency. And now a new National Public … [Read more...]

LDTs

VITAL Act Would Eliminate FDA Regulation of New Tests During Health Emergencies

In standing aside and allowing test makers to validate and perform COVID-19 laboratory developed tests (LDTs) and not wait for Emergency Use Authorization (EUA), the FDA has actually acknowledged what … [Read more...]

Reimbirsement

Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients

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...]

Reimbursement

CDC Issues ICD-10-CM Coding Guidance for Coronavirus Encounters

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...]

Coronavirus

FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests

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...]

REIMBURSEMENT

Billing & Coding: CMS Sets Rules for Medicare Coronavirus Testing Reimbursement with Private Payors Expected to Follow Suit

Good news for labs that are testing Medicare patients for the SARS-CoV-2 virus that causes coronavirus using the Centers for Disease Control and Prevention (CDC) 2019 Real Time RT-PCR Diagnostic Test … [Read more...]

ACLA

Lab industry leaders meet with White House on COVID-19 testing

The American Clinical Laboratory Association (ACLA) has issued a statement following a meeting last week with the White House's Coronavirus Task Force. Here is a statement from ACLA President Julie … [Read more...]

Coronavirus

Two commercial labs testing now for COVID-19

Two commercial lab companies have announced they are moving into testing for COVID-19. LabCorp. said Thursday it was immediately offering testing for COVID-19 and Quest Diagnostics has announced it … [Read more...]

Coronavirus

CMS Develops Additional Code for Coronavirus Lab Tests 

On March 6, the Centers for Medicare & Medicaid Services (CMS) announced a  second Healthcare Common Procedure Coding System (HCPCS) code that can be used by laboratories to bill for certain … [Read more...]

Billing & Coding: Use New HCPCS Code U0001 to Bill Medicare for CDC Coronavirus Test

Good news for labs that are testing Medicare patients for SARS-CoV-2 using the newly approved Centers for Disease Control and Prevention (CDC) 2019 Real Time RT-PCR Diagnostic Test Panel (and … [Read more...]


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