Data Analytics Firm Files Qui Tam Based on Billing Outliers

Earlier this month, a federal court unsealed a declined qui tam complaint filed by a data analytics firm based on identification of Medicare billing outliers.  See United States ex rel. Lincoln Analytics, Inc. v. Global Integrated Medical Group, Inc., No. 2:22-cv-06501 (C.D. Cal.).  Despite asserting a claim as an original source, the relator, Lincoln Analytics, Inc., appears to have assembled its allegations through its own analysis of Medicare data and a single interview.  DOJ has increasingly been deploying data analytics to develop FCA cases (as discussed here and here) and this unsealed complaint demonstrates that relators are also beginning to use data analytics in a similar manner.

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Supreme Court Affirms Broad DOJ Dismissal Authority

On June 16, 2023, the Supreme Court issued its opinion in United States ex rel. Polansky v. Executive Health Resources, affirming that courts should grant DOJ motions to dismiss over relator objections “in all but the most exceptional cases.”  Prior coverage of this case is here and here.

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Qui Tam Alleges Hospital Fraud Relating to Provider Relief Fund “High Impact” Payment

Earlier this month, a federal court unsealed a qui tam complaint against several New Jersey hospitals, management services organizations, and the hospitals’ Chief Executive Officer and Chief Financial Officer for allegedly refusing to return CARES Act Provider Relief Fund (“PRF”) money for which the hospitals knew they were not eligible, and for allegedly using PRF money for impermissible purposes.  See United States ex rel. Singh v. Hudson Hospital OPCO, LLC, No 21-cv-19788 (D.N.J. Nov. 5, 2021).  This case is noteworthy because it is one of the first unsealed qui tam complaints raising allegations about ineligibility for, and misuse of, PRF payments.

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DOJ Reaches Settlement with Laboratory Over Commission-Based Compensation Arrangements with Independent Contractors, Medical Necessity

Earlier this month, the U.S. Department of Justice (“DOJ”) announced a $5.9 million FCA settlement resolving allegations that Genotox Laboratories Ltd., a toxicology and pharmacogenetics testing laboratory: 1) violated the Anti-Kickback Statute (“AKS”), and thereby caused the submission of false claims, through commission-based compensation arrangements with its independent contractors, and 2) submitted claims to federal healthcare programs for unnecessary drug tests.  In parallel proceedings, the U.S. Attorney’s Office for the Western District of Texas and Genotox entered into an eighteen-month Deferred Prosecution Agreement to resolve a criminal investigation into the same conduct.  The settlement highlights DOJ’s ongoing interest in pursuing independent contractor arrangements that do not fit within a safe harbor to the AKS, where such relationships are also accompanied by conduct that traditionally attracts enforcement scrutiny, such as submission of claims for medically unnecessary services.

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Sixth Circuit Adopts Limited Definition of AKS “Remuneration,” Robust Standard for Causation in AKS Qui Tams

On March 28, 2023, the Sixth Circuit issued a notable decision rejecting broad theories from DOJ and relators about (1) the definition of remuneration under the Anti-Kickback Statute (AKS) and (2) the causation requirement for AKS violations that trigger FCA liability.  See United States ex rel. Martin v. Hathaway, No. 22-1463 (6th Cir. 2023).  On the first, the court held that “remuneration” under the AKS “covers just payments and other transfers of value,” not “any act that may be valuable to another.”  On the second, the court held that FCA liability attaches only if the claim would not have been submitted but for the AKS violation.

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Court Finds That Qui Tam Relator Who Built Case From Patent Records Is Not an Original Source

A relator who scours public patent filings to “uncover” an alleged fraud against the government cannot avoid the False Claims Act’s public disclosure bar by claiming to be an original source, the Northern District of California held this week.

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Second Circuit Leaves Open Novel Legal Theory that Flawed AI is a “Worthless Service”

In a decision issued last week, the Second Circuit was faced with the novel legal theory that use of flawed artificial intelligence systems can constitute a “worthless service” for purposes of FCA liability.  See Doe v. eviCore Healthcare MSI, LLC, No. 22-530-CV, 2023 WL 2249577 (2d Cir. Feb. 28, 2023).  The Second Circuit affirmed the district court’s dismissal for failure to satisfy the heightened Rule 9(b) pleading standard but did not reach the merits, leaving open the question of whether such a theory is viable under the FCA.

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DOJ Reaches Settlement with OraPharma, Inc., Pushing Novel AKS Theory

Earlier this month the U.S. Attorney’s Office for the District of Massachusetts announced a $100,000 FCA settlement resolving novel allegations that a pharmaceutical company violated the Anti-Kickback Statute (“AKS”), and thereby caused the submission of false claims, through incentive compensation payments to its employees for conduct outside the scope of the employee relationship.

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