COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]
Billing & Collections
OIG Targets Pandemic’s Impact on Billing of Medicare Part B Lab Testing
February 22, 2021
Looking upon Medicare billing and payment of lab services with suspicion is and has always been part of the OIG’s organizational DNA. So, the fact that audits of Medicare Part B lab services during … [Read more...]
FDA Watch
2020 Was a Record Year for New Medical Device Approvals—And Not Just for COVID-19
February 21, 2021
They say that necessity is the mother of invention. But, historically, invention has never been the problem for creators of novel medical devices; the real challenge for these inventors has been more … [Read more...]
LDTs
FDA Clears Neutralizing Antibodies Detection Test for COVID-19
February 21, 2021
Innovative new COVID-19 tests continue to emerge from the pipeline. One of the novel diagnostic products that has flown slightly under the radar is the cPass SARS-CoV-2 Neutralization Antibody … [Read more...]
Testing Strategy
The Biden Administration Initiates New Plan for National COVID-19 Testing
February 21, 2021
As with any other aspect of public life, the philosophy and views of the individual occupying the White House ultimately impact the direction of healthcare and diagnostics in the U.S. However, when a … [Read more...]
Enforcement Alert
OIG to Audit Medicare Part B Lab Testing During the Pandemic
February 20, 2021
Fraudulent and abusive billing of lab services has long been a favorite target of OIG enforcers. And with the unprecedented surge of COVID-19 testing during the public health emergency, it’s hardly … [Read more...]
Special Report
The 5 Things Labs Need to Know about the Biden COVID-19 Testing Plan
February 20, 2021
Special Report: The 5 Things Labs Need to Know about the Biden COVID-19 Testing Plan Testing labs on the front lines of the COVID-19 battlefield are getting federal reinforcements. And it’s not … [Read more...]
SUPPLY CHAIN
Federal Agencies Reach Out to Manufacturers to Ramp Up COVID-19 Testing Supply Chain
February 20, 2021
Supply chain and logistics have bedeviled COVID-19 testing efforts on a national basis since the pandemic began. On Feb. 5, the federal government took steps to address the supply chain challenge via … [Read more...]
DX Deals
Global Collaboration Seeks to Develop Game-Changing Handheld COVID-19 Breathalyzer Test
February 19, 2021
A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a breakthrough in the effort to contain the spread of the virus. That vision … [Read more...]
FDA
FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
February 19, 2021
Since the pandemic began, the FDA has granted Emergency Use Authorization (EUA) for more than 250 COVID-19 diagnostic tests. Among these, nearly 30 have received clearance for at-home collection; a … [Read more...]
