Tag: genetic testing labs

Medicare Affiliation Rule Targets Criminal Behavior

CEO SUMMARY: Under a new federal rule in effect this month, all healthcare providers—including clinical laboratories and pathology groups—will need to scour the records of all officers, directors, and affiliates to identify any that have had negative dealings with CMS or other federal enforcement agencies. Under the rule, the Medicare program is likely to target

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PGx Labs Concerned by FDA’s Statements, Actions

CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions

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Theranos News Gets Worse for the Former Silicon Valley Hero

CEO SUMMARY: In a tale of two fraudsters, the Department of Justice has filed a warning shot to all technology startups: Criminal indictments against Elizabeth Holmes and Ramesh “Sunny” Balwani could mean prison time and massive fines. In this latest Theranos news, The DOJ cited harm to investors, doctors and patients by the two company

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