New CMS Proposed Rule Encourages Value-Based Reimbursement Based on Patient Outcomes When Payers and Drug Manufacturers Negotiate Payment for Pricey Therapies

Clinical laboratories and anatomic pathology groups should consider this another example of how CMS is taking forward steps to encourage value-based payment arrangements throughout the health system With the sky-high cost of many prescription drugs and gene therapies, it was only a matter of time before the Centers for Medicare and Medicaid Services (CMS) would seek to link reimbursement for them to patient outcomes. A recent CMS proposed rule (CMS-2842-P) concerning value-based purchasing...

COVID-19 is Mutating and A Scripps Research Study Reveals the Coronavirus May Become Even More Infectious

Researchers found evidence indicating that the virus has—under selection pressure—made itself more stable, giving it a “significant boost in infectivity” While the COVID-19 pandemic continues to spread across the United States and throughout the world, new research suggests that a coming genetic mutation within the SARS-CoV-2 coronavirus may make it much more dangerous than it already is. This finding has significant implications for clinical laboratories that perform COVID-19 testing and the...

With Consumer Demand for Ancestry and Genealogy Genetic Tests Waning, Leading Genomics Companies are Investigating Ways to Commercialize the Aggregated Genetics Data They Have Collected

Genomics experts say this is a sign that clinical laboratory genetics testing is maturing into a powerful tool for population health Faced with lagging sales and employee layoffs, genomics companies in the genealogy DNA testing market are shifting their focus to the healthcare aspects of the consumer genomics data they’ve compiled and aggregated. Recent analysis of the sales of genetic tests from Ancestry and 23andMe show the market is definitely cooling, and the analysts speculate...

Federal Prosecutors Charge a California Executive with Misleading Investors and Payers about Company’s Clinical Laboratory COVID-19 Test

Charges against this life science company executive include healthcare fraud as well as the first COVID-19 related securities fraud In the first securities fraud prosecution involving clinical laboratory COVID-19 testing, the US federal Department of Justice (DOJ) charged the president of a Sunnyvale, Calif., life sciences biotechnology company with participating in a scheme to mislead investors and also to commit healthcare fraud, stated a DOJ press release. The DOJ charged Mark Schena, PhD,...

Federal Prosecutors Add a 12th Felony Fraud Charge in Latest Criminal Indictment Against Theranos Founder Elizabeth Holmes

Holmes’ lawyers maintain the former CEO of Theranos has not waived right to be charged by indictment and therefore argue the added charge is ‘unconstitutional’ and should be dismissed Clinical laboratory leaders needing a break from nonstop coronavirus pandemic news will be interested to learn a familiar name is again making headlines. Disgraced Theranos founder Elizabeth Holmes—who went from paper billionaire to criminal defendant—is now facing a 12th felony fraud charge, with the additional...

Australia Spent $200 Million (AUD) on Chinese COVID-19 Diagnostic Testing Kits That Went into The Country’s Strategic Reserve Rather than Being Used

Australian government heralded April purchase of 10 million clinical laboratory diagnostics tests from BGI, but most of the nation’s states and territories say kits are unneeded or unable to be used by their health departments While the United States and other nations attempt to bring the COVID-19 outbreak under control, many countries have turned to China to offset shortages of clinical laboratory SARS-CoV-2 test kits needed to diagnose the coronavirus. This did not work out well for the...