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Genetic Testing: New Medicare Early NGS Cancer Test Coverage Policy Is Less than Meets the Eye
For Myriad Genetics, Foundation Medicine and other manufacturers of next-generation sequencing (NGS)-based test panels for early-stage cancer risk assessment, the recent announcement of CMS’ decision to provide limited Medicare coverage
Enforcement Trends: Increase in OIG Fraud Recoveries Belies Continued Decline in Enforcement Actions
OIG fraud recovery has been a solid growth business for nearly two decades. So, when the agency announced a decline in FY 2018 recovery figures, it was more than a bit surprising. But things got back to normal this year, as far as
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2019 after issuing just one such warning letter in all of 2018.
Utilization: Study Finds that Distribution of Free Self-Tests Increases HIV Testing & Awareness
Internet distribution of free HIV self-tests can boost testing, promote awareness among high-risk individuals resulting in less incidence of transmitting the disease. These are the key findings of a newly published Centers for Disease Control and Prevention (CDC) study.