Fraud and Abuse

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On August 5, President Biden signed two bills into law that extend to ten years the statute of limitations for civil and criminal enforcement actions for fraud on the Paycheck Protection Program (“PPP”) and Economic Injury Disaster Loans (“EIDL”). These two bills—the PPP and Bank Fraud Enforcement Harmonization Act of 2022 and the COVID-19 EIDL Fraud Statute of Limitations Act of 2022—were both passed by Congress with bipartisan support. Continue Reading Statute of Limitations for PPP and EIDL Fraud Extended to Ten Years

The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to…
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022

On July 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) released a Proposed Rule that proposes to amend certain regulations implementing the Physician Self-Referral Law, otherwise known as the “Stark Law”. The Proposed Rule proposes to revise once again the definition of “indirect compensation arrangement” (ICA), effectively to revert the meaning of the definition back – for the vast majority of indirect financial relationships between DHS entities and referring physicians – to the definition of that term as it was in place prior to the latest Stark Law rulemaking, “Modernizing and Clarifying the Physician Self-Referral Regulations” (the “MCR Final Rule”), published on December 2, 2020.[1]  The Proposed Rule also proposes to define the term “unit” and the phrase “services that are personally performed”, both for purposes of the ICA definition.
Continue Reading CMS Proposes to Revise, Again, the Stark Law’s Definition of “Indirect Compensation Arrangement”: What Was Old is New Again

As reported by the New York Times in an article dated July 13, 2017, in an effort to crack down on fraud and abuse, and with a particular focus on opioids, the Department of Justice (“DOJ”) is charging 412 individuals for collectively defrauding the government of around $1.3 billion. Of the individuals implicated, approximately one-third are being accused of opioid-related crimes. These crimes include billing Medicare and Medicaid for drugs that were never purchased, collecting money for fake treatments and tests, and exchanging prescription drugs for money. The fraud and abuse prosecutions are spread across more than 20 states, which include California, New York, Florida, and Texas.
Continue Reading Recent Department of Justice Crackdown on Fraud and Abuse