Last week a court in the District of Massachusetts took the rare step of allowing an FCA defendant to pursue an interlocutory appeal arising from the summary judgment stage of an FCA case in which DOJ is seeking $10 billion in damages and penalties. The question on appeal asks the First Circuit to take a side in an expanding circuit split on the requisite causation requirement for AKS violations to trigger FCA liability.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Jaime L.M. Joneshttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngJaime L.M. Jones2023-08-23 14:35:552023-09-11 10:06:00Court Certifies Interlocutory Appeal to First Circuit on Causation Standard Connecting AKS Violations and the FCA
In a recent decision, United States ex rel. Silbersher v. Valeant Pharmaceuticals Int’l Inc., 2023 WL 4940429 (9th Cir. Aug. 3, 2023) (“Valeant”), the Ninth Circuit ruled that the False Claims Act’s (“FCA”) public disclosure bar does not apply to inter partes review (“IPR”) proceedings—holding that, unlike patent prosecutions, IPRs are not a qualifying channel for disclosures under the bar. The panel also ruled that the qualifying disclosures the Valeant defendants did identify did “not disclose a combination of facts sufficient to permit a reasonable inference of fraud.” The panel’s decision reversed a district court’s conclusion that the bar did apply, greenlighting the relator’s lawsuit to proceed to its merits.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Gordon D. Toddhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngGordon D. Todd2023-08-22 10:10:202023-09-11 09:52:33Ninth Circuit Excludes Inter Partes Review Proceedings from Public Disclosure Bar and Greenlights Relator’s Qui Tam Claims Based on Patent Activity
The Eleventh Circuit recently became the first Court of Appeals to apply the Supreme Court’s decision in United States ex rel. Polansky v. Executive Health Resources, Inc., 143 S. Ct. 1720 (2023), when it affirmed a district court’s decision to grant DOJ’s motion to dismiss a qui tam suit over a relator’s objections. In Polansky, which we analyzed in detail here, the Supreme Court held that the United States may move to dismiss under 31 U.S.C. § 3730(c)(2)(A) regardless of when it intervened in the case and that courts should review any such motion under Federal Rule of Civil Procedure 41(a). The Eleventh Circuit’s decision underscores the United States’ broad dismissal power in False Claims Act cases.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Brenna E. Jennyhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngBrenna E. Jenny2023-08-08 10:01:452023-09-11 09:53:31First Court of Appeals to Apply Polansky Upholds DOJ’s Dismissal
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.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Brenna E. Jennyhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngBrenna E. Jenny2023-07-26 11:20:022023-09-11 09:53:53Data Analytics Firm Files Qui Tam Based on Billing Outliers
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.
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.
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.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Jaime L.M. Joneshttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngJaime L.M. Jones2023-04-13 15:24:442023-09-11 09:54:48DOJ Reaches Settlement with Laboratory Over Commission-Based Compensation Arrangements with Independent Contractors, Medical Necessity
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.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Kristin Graham Koehlerhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngKristin Graham Koehler2023-04-03 10:18:312023-09-11 09:55:06Sixth Circuit Adopts Limited Definition of AKS “Remuneration,” Robust Standard for Causation in AKS Qui Tams
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Court Certifies Interlocutory Appeal to First Circuit on Causation Standard Connecting AKS Violations and the FCA
Last week a court in the District of Massachusetts took the rare step of allowing an FCA defendant to pursue an interlocutory appeal arising from the summary judgment stage of an FCA case in which DOJ is seeking $10 billion in damages and penalties. The question on appeal asks the First Circuit to take a side in an expanding circuit split on the requisite causation requirement for AKS violations to trigger FCA liability.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
Ninth Circuit Excludes Inter Partes Review Proceedings from Public Disclosure Bar and Greenlights Relator’s Qui Tam Claims Based on Patent Activity
In a recent decision, United States ex rel. Silbersher v. Valeant Pharmaceuticals Int’l Inc., 2023 WL 4940429 (9th Cir. Aug. 3, 2023) (“Valeant”), the Ninth Circuit ruled that the False Claims Act’s (“FCA”) public disclosure bar does not apply to inter partes review (“IPR”) proceedings—holding that, unlike patent prosecutions, IPRs are not a qualifying channel for disclosures under the bar. The panel also ruled that the qualifying disclosures the Valeant defendants did identify did “not disclose a combination of facts sufficient to permit a reasonable inference of fraud.” The panel’s decision reversed a district court’s conclusion that the bar did apply, greenlighting the relator’s lawsuit to proceed to its merits.
(more…)
Gordon D. Todd
Washington, D.C.
gtodd@sidley.com
Kamila Rivas
Washington, D.C.
krivas@sidley.com
Kimberly Leaman
First Court of Appeals to Apply Polansky Upholds DOJ’s Dismissal
The Eleventh Circuit recently became the first Court of Appeals to apply the Supreme Court’s decision in United States ex rel. Polansky v. Executive Health Resources, Inc., 143 S. Ct. 1720 (2023), when it affirmed a district court’s decision to grant DOJ’s motion to dismiss a qui tam suit over a relator’s objections. In Polansky, which we analyzed in detail here, the Supreme Court held that the United States may move to dismiss under 31 U.S.C. § 3730(c)(2)(A) regardless of when it intervened in the case and that courts should review any such motion under Federal Rule of Civil Procedure 41(a). The Eleventh Circuit’s decision underscores the United States’ broad dismissal power in False Claims Act cases.
(more…)
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Matt Bergs
Chicago
mbergs@sidley.com
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.
(more…)
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Joseph T. McNally
Chicago
jmcnally@sidley.com
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.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Matthew Guillod
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.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Francesca R. Ozinal
Washington, D.C.
fozinal@sidley.com
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.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Ahsin Azim
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.
(more…)
Kristin Graham Koehler
Washington, D.C.
kkoehler@sidley.com
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Joshua J. Fougere
Washington, D.C.
jfougere@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
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