Health Care Enforcement & Investigations

A recent Massachusetts Federal District Court decision adds to divergent opinions deciding an important health care enforcement question: what causation standard applies to a False Claims Act (FCA) case based on a violation of the Anti-Kickback Statute (AKS)? The AKS states that a claim that includes items or services “resulting from” a violation of the AKS constitutes a “false or fraudulent claim” under the FCA. 42 U.S.C. § 1320a-7b(g). On September 27, 2023, Chief Judge Saylor of the District of Massachusetts issued a decision in United States v. Regeneron Pharmaceuticals, Inc., C.A No. 20-11217-FDS, which adopted a “but-for” standard of causation applicable to the AKS’s “resulting from” language.

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider of intraoperative neuromonitoring (IONM) services. In reaching its determination, the OIG stated that Newco and its arrangements with the IONM Company would present a significant risk under the federal Anti-Kickback Statute (AKS) primarily because it exhibits many indicia of a suspect contractual joint venture.

A little over a year after the Dobbs v. Jackson Women’s Health Organization decision, the Food and Drug Administration (FDA) continues to be at the forefront of addressing reproductive health concerns. An example of this activity came just a few days after the FDA approved the first nonprescription daily oral contraceptive for marketing in the U.S. when the agency sent a warning letter to Wise Women’s Choice (WISE) in connection with the marketing and sale of its “birth control cream.” Among other things, this warning letter highlights for consumers the importance of confirming that birth control methods are safe, effective, and FDA-approved for their intended uses.

Do the qui tam provisions of the False Claims Act (FCA), see 31 U.S.C. § 3730(b)(1), violate the Executive Branch’s exclusive grant of authority under Article II of the United States Constitution? This long-dormant question has been revived in a surprising context. In its recent decision in United States ex rel. Polansky v. Exec. Health Resources, No. 21-1052 (S. Ct. June. 16, 2023), the Supreme Court affirmed the government’s authority to intervene to dismiss a whistleblower action, even after initially declining to intervene in the case. Knowledgeable FCA practitioners expected this result. Less expected was Justice Thomas’s dissent, which argued that the case should have been remanded to allow the parties to brief and argue whether Article II forbids allowing private citizens to maintain FCA claims on behalf of the government. A concurrence by Justice Kavanagh (joined by Justice Barrett), while rejecting Justice Thomas’s call for a remand, nonetheless stated that “the Court should consider the competing arguments on the Article II issue in an appropriate case.” With three justices expressing interest in this question—and only four justices being required to grant certiorari—health care enforcement defense attorneys should now consider whether to raise the constitutionality of the FCA’s qui tam provisions when relators move forward to litigate cases that the government declines to pursue.

Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun enforcing statutory penalties associated with violations of the Information Blocking Rules. On July 3, 2023, OIG and Department of Health and Human Services (HHS) took a significant step toward enforcement of these penalties when they published long-awaited civil monetary penalty (CMP) final rule (CMP Final Rule) for certain Information Blocking Actors in the Federal Register.

In a resounding unanimous 9-0 decision, the Supreme Court rejected the argument that a defendant’s subjective belief is irrelevant under the False Claims Act (FCA) when evaluating whether a defendant “knowingly” submitted a false claim to the government for payment. On June 1, 2023, the Court issued its highly anticipated opinion in the consolidated cases U.S. ex rel. Schutte v. SuperValu, Inc. and U.S. ex rel. Proctor v. Safeway, Inc. (SuperValu) and addressed the question of whether a defendant is liable under the FCA if its conduct is consistent with an “objectively reasonable” interpretation of ambiguous statutory or regulatory language. Justice Thomas, writing for the Court, held that an “objectively reasonable” interpretation does not provide a complete legal defense to liability under the FCA. Rather, a defendant meets the FCA’s intent (scienter) requirement if the defendant’s subjective beliefs indicate it had knowledge that its submission of claims was “false or fraudulent,” regardless of whether the defendant’s conduct could be supported by a later “objectively reasonable” interpretation of the ambiguous legal or regulatory issue. Further, the Court articulated new standards for what might constitute “deliberate ignorance” or “reckless disregard” under the “knowledge” prong of the FCA.

As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s authority to dismiss an FCA whistleblower case after declining to intervene, the Court has now granted certiorari to hear two cases addressing what constitutes a “knowing” violation of the FCA. Hanging in the balance is the fate of two lower court decisions that endorsed a powerful defense to FCA liability.

As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA Privacy Rule. Given the significant reputational harm that negative reviews on Yelp and other social media and public platforms (Platforms) can create, providers may be tempted to respond to such negative comments with patient specifics in an attempt to mitigate harm to their businesses.

The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act (FCA). The heightened pleading requirements of Federal Rule of Civil Procedure 9(b) require that, for allegations of fraud (which include FCA claims), “a party must state with particularity the circumstances constituting fraud or mistake.” Among other things, a cause of action for “false claims” must allege the defendants submitted false claims, or caused false claims to be submitted, to the government. The crux of the issue petitioners asked the Court to address is whether, to meet Rule 9(b)’s requirements for FCA causes of action, relators must allege in the complaint specific details of false claims allegedly submitted to the government for payment. This issue typically arises in qui tam cases under the FCA after the government declines to intervene.  

On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA).  Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement. 

In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth Circuit adopted a stricter but-for causation standard for FCA claims based on AKS violations, holding that, in order to prevail on these claims, the government must prove that FCA defendants would not have submitted claims for particular items or services to Medicare or Medicaid absent the illegal kickbacks.