Nearly a dozen at-home COVID-19 antigen test kits have received Emergency Use Authorization (EUA) from the US Food and Drug Administration. And that begs a crucial question: Just how user-friendly are … [Read more...]
COVID-19 Testing
Just How User-Friendly Are Current Rapid At-Home COVID-19 Test Kits?
January 20, 2022
FDA Watch
Agency Continues Crack Down on Unauthorized COVID-19 Tests
January 19, 2022
COVID-19 tests from LuSys Laboratories pose a high risk of false results and should not be used. That was the message the US Food and Drug Administration (FDA) delivered to consumers and laboratories … [Read more...]
COVID-19 Testing
FDA Points the Way to Transition EUA SARS-CoV-2 Tests to Full Approval
January 19, 2022
As Omicron ravages the planet, it seems like Dr. Anthony Fauci is right in suggesting that the coronavirus will never completely go away. Even so, the current COVID-19 public health emergency (PHE) … [Read more...]
REIMBURSEMENT
COVID-19 Testing Drives Increase in Part B Medicare Lab Spending
January 14, 2022
Medicare Part B spending on lab testing isn’t following the Protecting Access to Medicare Act (PAMA) script. In FY 2018 and 2019, the first two years under the PAMA system, Medicare payments under the … [Read more...]
ENFORCEMENT
Omicron Forces FDA to Temporarily Shut Down Inspections
January 12, 2022
It’s déjà vu all over again. With new COVID-19 cases surpassing record highs, the FDA announced on Jan. 5 that it is once more calling a temporary halt to domestic and foreign inspections. It’s the … [Read more...]
COVID-19
White House Ups Effort to Resolve Rapid, At-Home COVID-19 Test Shortages
January 11, 2022
While it has been far more active in promoting the use of rapid COVID-19 antigen testing than its predecessor, the Biden administration has been playing catchup on this issue from the moment it took … [Read more...]
FDA WATCH
Agency Unveils Guidance for Full Approval of SARS-CoV-2 Tests
January 7, 2022
Even though the COVID-19 public health emergency (PHE) can’t last forever, according to US chief medical advisor Dr. Anthony Fauci, coronavirus may never completely disappear from the face of the … [Read more...]
COVID TESTING
Omicron Surge Creates Nationwide Shortage of COVID-19 Tests
January 5, 2022
Even before Omicron, demand for COVID-19 tests was on a major rise. The emergence of the new highly transmissible variant has now stretched testing supplies and capabilities to the breaking point. … [Read more...]
COMPLIANCE BRIEFING
The Year in Lab Compliance: The Biggest Stories of 2021
December 21, 2021
The ongoing COVID-19 public health emergency (PHE) has clearly had an impact on compliance. Enforcement funds have been sequestered, federal fraud recoveries are down and temporary waivers of … [Read more...]
TELEMEDICINE
63-Fold Increase in Utilization Adds Momentum to Drive to Make Telehealth Access Changes Permanent
December 16, 2021
When it comes to the future of telehealth, there are three undisputable facts: Fact 1: Unprecedented numbers of Americans tried it during the pandemic. Fact 2: Most of the people that utilized … [Read more...]
