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
Emerging Tests
One-Step HCV RNA Tests Help Encourage Hepatitis C Screening
January 19, 2022
Viral hepatitis is responsible for 1.34 million worldwide deaths each year, as many as HIV/AIDS, tuberculosis, or malaria. The World Health Organization (WHO) has recognized the critical role played … [Read more...]
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...]
Game Changers
New Blood Test Enables Early Cancer Detection in “Low-Risk, but Not No-Risk” Patients
January 19, 2022
Scientists in the UK say they have developed a blood test that may help detect cancer in people with nonspecific signs and symptoms. The new blood test may enable early cancer detection of a low-risk … [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...]
IN THE NEWS
Theranos Wunderkind Elizabeth Holmes Convicted on Federal Fraud Charges
January 12, 2022
It looks like Elizabeth Holmes will be trading in her trademark black turtleneck for an orange jumpsuit. On Jan. 4, a federal jury convicted the former Theranos CEO and co-founder once hailed as the … [Read more...]
ENFORCEMENT
Federal Enforcers Crack Down on Fraudulent Billing of Genetic Tests
January 12, 2022
Genetic tests are becoming a favorite target for federal fraud enforcers. So, if your lab bills Medicare, Medicaid, and other federal health care programs for these tests, you need to pay especially … [Read more...]
Legislation
The Sun Is About to Set on the Controversial Trump Era “SUNSET” Rule
January 12, 2022
As part of its wider strategy to free business from cumbersome regulation, the Trump administration adopted a rule that would have imposed a Hobson’s choice on the Department of Health and Human … [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...]
