UK Continues to Use Innova’s SARS-CoV-2 Antigen Rapid Test Despite Recall and FDA Warning Letter

FDA cites ‘risk of false results’ and concerns about labeling and ‘performance claims’ in its official warning letter to Innova, a company with connections to Chinese firms By many standards, the US government’s response to the COVID-19 pandemic has been phenomenal. However, the many emergency use authorizations (EUAs) awarded by the US federal Food and Drug Administration (FDA) to bring as many COVID-19 tests to market as quickly as possible means some of those tests in use today at clinical...

Hospitals in Three States Offer Patients Free Medical Laboratory Tests Following Arrest of Surgical Technician for Allegedly Stealing Fentanyl from Operating Room

A 1999 case involving California phlebotomist charged with reusing needles resulted in similar widespread testing of thousands of patients Because of possible exposure to HIV, hepatitis B, and hepatitis C from a healthcare worker, thousands of patients treated in multiple hospitals in different states are being offered free clinical laboratory testing. This situation is attracting national media attention and is a reminder to pathologists and medical laboratory professionals of the increased...

CMS Begins the New Year by Instituting Fines for Insurance Payers That Issue Error-Filled Provider Directories

Increased accuracy in listings should benefit in-network medical laboratories and anatomic pathology groups Regional and smaller medical laboratories will welcome a new enforcement initiative by the Centers for Medicare & Medicaid Services (CMS). Health insurers now will face fines as high as $25,000 per beneficiary as a sanction from regulators in many states for errors in provider directories that can result in patients receiving surprise out-of-network bills. As the number of consumers...

CMS Says Obamacare Premiums to Increase by an Average of 7.5% in 2016, But Squeeze on Consumers’ Wallets Will Vary Depending on Where They Live

UnitedHealthcare announces it may exit the federal marketplace because of slow growth and higher-than-expected claims; clinical laboratories may see less reimbursement Health insurance premiums in 2016 for plans offered through federal Obamacare exchanges (more formally known as the Health Insurance Marketplace) will see an average rate hike on midrange plans of 7.5%. This amount may vary widely depending on which state a consumer lives. In 2016, 38 states will have healthcare consumers apply...

California Patient Gets Outrageous Clinical Pathology Laboratory Test Bill from Napa Hospital, Almost 10 Times Higher Than Similar Testing from Quest Diagnostics

A newspaper in San Francisco featured a story about the patient’s complaint about being overcharged thousands of dollars by the hospital for medical laboratory tests Here’s how a community hospital that charges inpatient prices for clinical laboratory testing to a walk-up customer find itself at the center of a media news storm. In California, a newspaper trumpeted the story of an unhappy consumer stuck with a $4,316.55 bill for a panel of medical lab tests that a national lab would have...
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