Koninklijke Philips N.V., a global medical technology manufacturer, recently agreed to pay over $62 million to resolve a Foreign Corrupt Practices Act (FCPA) enforcement action with the Securities and Exchange Commission (SEC). The enforcement action – the second for the Netherlands-based company – centered on alleged violations of the FCPA’s books-and-records and internal-accounting controls provisions
Last week, the Sixth Circuit closed two paths the government and relators have tried to take to expand liability for medical providers under the Anti-Kickback Statute (AKS) and False Claims Act (FCA): the meaning of “remuneration” under the AKS and the causation standard for AKS-based FCA claims.
The AKS, which prohibits referrals in
On December 6, 2022, the Supreme Court heard oral argument in United States ex rel. Polansky v. Executive Health Resources, Inc. As previously reported, this case raises whether the government has the authority to dismiss a False Claims Act (FCA) qui tam suit after it initially declined to proceed with its own action and
Continuing its focus on healthcare technology and electronic health records (EHR) companies, the Department of Justice announced last month a $45 million settlement to resolve a False Claims Act suit involving EHR provider Modernizing Medicine, Inc. (ModMed). The underlying complaint involved allegations in three areas that often draw government scrutiny — exclusive contracts, marketing agreements
As Medicare Advantage attracts more eligible beneficiaries, it is also drawing attention from False Claims Act (FCA) prosecutors. In 2022, enrollment in Medicare Advantage plans reached 28.7 million Medicare beneficiaries, or 49% of eligible beneficiaries. Recently, the United States intervened in a qui tam case against Cigna filed in the Southern District of New York and
The Eighth Circuit split with the Third Circuit over the appropriate causation standard in False Claims Act (FCA) cases involving alleged violations of the Anti-Kickback Statute (AKS), holding that the 2010 amendments to the AKS created a “but-for causal requirement” (United States ex rel. Cairns v. D.S. Medical, LLC).
In 2010, Congress amended
The U.S. Supreme Court’s decision in Ruan v. United States ups the ante for prosecutors who bring charges against doctors for unlawfully dispensing and distributing drugs under the Controlled Substances Act. Under the Supreme Court’s guidance, to secure a conviction, the government must now prove, beyond a reasonable doubt, that doctors knowingly and intentionally exceeded