Amid increasing spending on genetic testing, there are more opportunities for bad actors to implement interstate, fraudulent billing schemes, according to OIG.
The owner of Specialty Drug Testing, a Monroe, Louisiana-based laboratory, appeared in United States District Court accused of violating the Anti-Kickback Statute.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
Under the LCD, pharmacogenomic tests are covered when medications are being considered for use that are known to have a clinically actionable gene-drug interaction.
The available data suggests PGx may be useful in managing medications for COVID-19 patients and in helping people struggling with the mental health impact of the pandemic.