EKRA Now Used to Combat Fraudulent COVID-19 Testing, Too

The Department of Justice steps beyond the law’s original focus on opioid-related lab testing fraud An interesting aspect with enforcement of the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is the government’s willingness to go after charges tied to fraudulent COVID-19 testing.  The case U.S. vs. Malena Badon Lepetich provides a good example of this approach. A grand jury indicted Lepetich on various healthcare fraud charges last year, including that she allegedly offered to pay...

Private Labs in South Africa Voluntarily Agree to Lower Prices for COVID-19 PCR Tests following Investigation by Country’s Competition Commission

In an out-of-court settlement, two commercial clinical laboratory companies also agreed to reduce their prices for rapid antigen tests as well How clinical laboratory companies were pricing their COVID-19 tests caught the attention of government authorities in South Africa. Government agencies in that country are establishing what they view as fair clinical laboratory pricing for private COVID-19 PCR (polymerase chain reaction) and rapid antigen tests without turning to litigation or fines....

Former Wall Street Journal Reporter John Carreyrou Reveals Ex-Theranos CLIA Laboratory Director and Pathologist Was Main Source for 2015 Investigation into Theranos

WSJ reporter affirms that the pathologist was his “first and most important source” in confirming the problems at the now-defunct medical lab testing company During the federal fraud trial of Theranos Founder and former-CEO Elizabeth Holmes, no one has spent more days on the witness stand than ex-Theranos Laboratory Director Adam Rosendorff, MD, the pathologist who testified for the prosecution that he repeatedly warned Holmes about problems with Theranos’ flawed Edison blood-testing device....

Forbes Ranks Epic’s Judith Faulkner the Richest Woman in Healthcare in Its 2021 List of 100 Richest Self-Made Women in US

Within the in vitro diagnostics and clinical laboratory space, Bio-Rad’s Alice Schwartz and 23andMe’s Anne Wojcicki also were recognized by Forbes At $6.5 billion net worth, Forbes, in its 2021 list of the 100 richest self-made women in the US, ranked Judith Faulkner, Chief Executive Officer and founder of Epic Systems Corp., in second place overall. But in the industry of healthcare, she tops the list by far. The next nearest healthcare-related “richest woman” is Alice Schwartz, co-founder of...

South Korean Telecommunications Partner with Direct-to-Consumer Genetic Testing Companies to Send Test Results to Consumers’ Mobile Devices

As consumer demand increases for medical laboratory testing services that bypass the supervision of primary care doctors, clinical laboratories may be affected Direct-to-consumer (DTC) genetic testing organizations and telecommunications companies in South Korea are collaborating to help consumers stay informed of their health status by sending lab test results directly to their mobile devices without requiring physician involvement. What can labs in the West learn from these developments? One...

Walmart to Open 4,000 Healthcare ‘Supercenters’ by 2029 That Include ‘Comprehensive’ Clinical Laboratory Services

With the majority of Americans living just a few miles from a Walmart, how might independent clinical laboratories compete? Retail giant Walmart (NYSE:WMT) plans to install 4,000 primary care “supercenters” in stores by 2029 that will include clinical laboratory testing services. This is on top of the dozens of Walmart Health locations already in operation in Georgia, Florida, Arkansas, Illinois, and Texas. Clinical laboratories already have growing competition in the healthcare marketplace...
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