Issue: Volume XXVIII, No. 8 - June 14, 2021

Whistleblower Lab Manager Files Response to PerkinElmer Lawsuit

IN A DAVID-VERSUS-GOLIATH-LIKE BATTLE, perhaps the most unusual lawsuit in decades involving clinical laboratory operations and compliance is unfolding in a federal courthouse in California. In this case, a multi-billion-dollar in vitro diagnostics (IVD) company is suing a laboratory manager who was once in a leadership position at a lab the plaintiff company operated, and …

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MedPAC Advises Congress on Lab-Data Reporting

CEO SUMMARY: For years, the clinical lab industry has sought unsuccessfully to get the federal Centers for Medicare and Medicaid Services to address the inequities in the payment formula CMS adopted after Congress passed the Protecting Access to Medicare Act (PAMA). In April, the lab industry received good news when the Medicare Payment Advisory Commission …

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Getting Payer Coverage for New Tests Continues to Be Difficult

EVERY YEAR, IT BECOMES TOUGHER FOR CLINICAL LABORATORIES WITH NEW GENETIC AND OTHER TESTS to obtain favorable coverage decisions by government and private payers.  Not only does it take longer to get a decision from a payer, but payers today want to see more complete data on the analytical and clinical validity of the test …

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June 14, 2021 Intelligence: Late-Breaking Lab News

Is it possible to use a genetic test to predict an individual’s risk of severe infection requiring hospitalization or death from SARS-CoV-2? That is the claim of Australian-based molecular diagnostics company Genetic Technologies Limited. It recently announced an agreement with U.S.-based Infinity BiologiX LLC (IBX) to sell its “COVID-19 Severe Disease Risk Test” to consumers …

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