In United States v. Regeneron, the District of Massachusetts Court recently joined the Sixth and Eighth Circuits in requiring the government to show a direct tie between kickbacks and referrals that proximately caused claims to federal healthcare programs to prevail in Anti-Kickback Statute (AKS) and False Claims Act (FCA) actions. The District Court’s ruling contributes to the growing split between the Third Circuit, which requires a mere causal connection between kickbacks and referrals, and the Sixth and Eighth Circuits, which require but-for causation between the kickback and the federal claim. This split relates to the per se fraud clause added to the AKS in 2010, which provides “a claim that includes items or services resulting from a violation of this section constitutes a false or fraudulent claim” for purposes of the FCA. The specific causal connotation of the language “resulting from” is the core of the debate between circuits.

In light of a significant rise in cyberattacks against hospitals and health systems, the U.S. Department of Homeland Security Cybersecurity and Infrastructure Security Agency and the U.S. Department of Health and Human Services recently released a cybersecurity toolkit. Read on for details about the toolkit and how the federal government is prioritizing cybersecurity in healthcare.…

In late August, the Department of Health and Human Services recommended rescheduling marijuana from a Schedule I substance to a Schedule III substance under the Controlled Substance Act. Meanwhile Congress is weighing a bill that would create federal safe harbors for financial institutions to accept deposits from state-sanctioned marijuana business operators. Read on for details…

On Oct. 26, 2023, the National Labor Relations Board issued a final rule that significantly broadens the definition of “joint employment” under the National Labor Relations Act, marking the fifth change to the board’s joint employer standard since 2015. Read on to learn more about how this rule affects employers.

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The regulatory landscape for telehealth prescribing of controlled substances is evolving.

In episode 13 of Complications: Health Policy Unraveled, host Stephanie Kennan covers the DEA’s recent extension of pandemic-era telehealth prescribing flexibilities for controlled substances through 2024, marking the second extension. Originally set to expire in May, these extensions followed extensive public input, including…

Corporate Transparency Act Beneficial Ownership Reporting Requirements to Take Effect

In 2021, the Corporate Transparency Act (“CTA”) was enacted as part of the Anti-Money Laundering Act of 2020, requiring certain business entities (“Reporting Companies”) to report beneficial ownership information (“BOI”) to the U.S. Department of Treasury’s Financial Crimes Enforcement Network (“FinCEN”).  FinCEN issued the final…

At McGuireWoods’ 16th annual Healthcare Finance & Growth (HCFG) Conference, a panel of dental industry leaders shared insights with attendees about the market. Panelists included Smiles Ahead COO Sean Barnard, SGA Dental Partners Vice President of M&A Jonathan Mikailonis, Polaris Healthcare Partners Co-founder and Partner Diwakar Sinha, and Edgemont Partners Managing Director Brett Skolnik. The…