DOJ Outlines Enforcement Priorities Under Biden Administration
Acting head of the Department of Justice’s (DOJ) civil division, Brian Boynton, predicts the False Claims Act (FCA) will provide a tool to bring “significant cases” over alleged healthcare fraud. In public comments last week, he outlined six priorities for the new administration’s FCA enforcement, including fraud claims related to:
- COVID-19 public health emergency
- Exploitation of senior citizens
- Electronic health records
- Telehealth, and
- Technology-influenced issues.
Chief among these priorities is fraud relating to the current public health emergency. Given the explosion of telehealth services during the pandemic, it comes as no surprise the topic will also be of renewed interest to DOJ. Together, the wide adoption of telehealth and the pandemic-related billing flexibility provided by the Centers for Medicare and Medicaid Services (CMS), appear to be fertile ground for investigation.
Not unlike the increasing focus on telehealth, it would seem that technology-related fraud will glean increased attention from the Department as well. Manufacturers would be well-advised to have appropriate safeguards in place related to their own internal data analytics. Conducting a proactive risk assessment could be an important step in identifying and addressing potential technology-related issues before they rise to a level of significant concern.
For life sciences manufacturers, FCA liability may arise pursuant to a line of cases based on implied false certification of claims for government reimbursement of products. Common issues giving rise to these allegations can relate to any number of compliance failures, like misleading advertising and promotional campaigns or suspect payments to healthcare providers in the form of consulting fees or research funding.
Check back for developments in False Claims Act enforcement, or contact Razor Legal Solutions here to discuss strategies to mitigate your risk.
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