A panel of the Ninth Circuit recently issued a 2-1 opinion reversing, in part, a district court’s dismissal of a False Claims Act case premised on a radiology facility’s use of non-medical grade computer monitors for diagnostic readings. In reviving the case, the majority concluded that the relator sufficiently pled a false certification theory of fraud from which the court drew a “strong inference” that the radiology facility’s use of the computer monitors did not meet Medicare’s “reasonable and necessary” requirement because the allegedly technologically inferior monitors the radiologists used undermined the efficacy of their diagnostic readings. The decision is notable because the majority relied on tenuous inferences to establish falsity, as detailed by the dissent, and a watered-down materiality analysis to establish materiality.
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. Jones2024-05-16 10:37:542024-05-16 10:37:54Ninth Circuit Reboots FCA Suit Based on Radiologist Use of Certain Computer Monitors
It is becoming increasingly common for private litigants to sue over conduct that was previously the subject of FCA actions. In one such recent case, the defendants successfully defeated such a collateral suit, demonstrating that it was time-barred under the statutes of limitations.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Scott D. Steinhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngScott D. Stein2024-05-14 11:09:492024-05-14 11:09:49Court Dismisses Commercial Insurer’s Claims Premised on Conduct Covered by FCA Settlements
In a recent decision, the Seventh Circuit acknowledged—but declined to pick sides in—a circuit split regarding the degree of causation required to establish FCA claims premised on AKS violations. In the same opinion, the Seventh Circuit rejected an Eighth Amendment challenge to the amount of an FCA judgment.
https://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.png00Scott D. Steinhttps://fcablog.sidley.com/wp-content/uploads/sites/5/2022/08/sidleyLogo-e1643922598198.pngScott D. Stein2024-05-08 09:04:582024-05-08 09:37:38Seventh Circuit Rejects Constitutional Challenge to FCA Judgment, Recognizes Circuit Split on Causation Requirement for AKS-Based Claims
Last week, DOJ and the State of California reached a $7,084,000 settlement with a California-based nursing home chain and two executives for allegedly misusing a pandemic-era waiver program by routinely submitting claims to Medicare for nursing home residents that did not have a qualifying prior hospital stay. This settlement is noteworthy because it is one of the first FCA settlements involving alleged abuse of this particular Centers for Medicare & Medicaid Services (“CMS”) COVID-19 waiver. See United States and State of California ex rel. Bay Area Whistleblower Partners v. Renew Health Group, LLC, No. 2:20-cv-09472-CBM-AS (C.D. Cal. Oct. 14, 2020).
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. Jones2024-05-03 09:06:212024-05-03 09:06:21DOJ Reaches Settlement with Nursing Home Provider Based on Alleged Abuse of COVID-19 Waiver
The Sixth Circuit recently confirmed that there is no per se bar on relators releasing previously filed FCA claims as part of a settlement agreement, although the government must still subsequently consent to the dismissal of such claims. See State Farm Mut. Auto. Ins. Co. v. Angelo, 95 F.4th 419 (6th Cir. 2024).
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. Jones2024-04-15 10:18:032024-04-15 10:26:51Sixth Circuit Affirms Orders Compelling Relator to Seek Government Consent to Dismiss Qui Tam Pursuant to Settlement Agreement
A recent decision from the Central District of California held that a qui tam relator cannot bring a False Claims Act (FCA) case against pharmaceutical manufacturers to enforce the 340B Drug Pricing Program’s (“340B Program”) statutory requirements. See United States ex rel. Adventist Health System/West v. AbbVie, No. 21-cv-04249 (C.D. Cal. Mar. 18, 2024). The 340B Program is a federal program that requires pharmaceutical manufacturers to offer discounted prices, called a “ceiling price,” on applicable drugs to certain hospitals and clinics, referred to as 340B “covered entities.” The relator, Adventist Health System/West, a covered entity under the 340B Program, alleged that the defendant pharmaceutical manufacturers failed to comply with the 340B Program’s requirements related to the “penny pricing” policy, which requires manufacturers to offer drugs at a penny if the ceiling price calculation results in a number at or less than a penny.
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. Jones2024-03-22 14:32:022024-03-22 16:03:01Court Finds That Qui Tam Relator Cannot Enforce 340B Program Statute
A recent opinion from the Northern District of Georgia reminds False Claims Act defendants about a potentially powerful tool at their disposal—counterclaims. In United States ex rel. Cooley v. ERMI, LLC, the court permitted several counterclaims to proceed over the relator’s argument that they were against public policy, demonstrating how defendants can go on offense to hold relators accountable for their own misconduct. (more…)
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 Koehler2024-03-18 12:38:142024-03-18 13:10:01When the Best Defense May Be a Good Offense: False Claims Act Counterclaims
On February 22, 2024, Acting Associate Attorney General Benjamin C. Mizer and Civil Division Principal Deputy Assistant Attorney General Brian M. Boynton announced that settlements and judgments under the FCA exceeded $2.68 billion in fiscal year (“FY”) 2023. DOJ and whistleblowers, further, were party to 543 FCA settlements and judgments, the most ever in a single year. Detailed statistics on FCA recoveries from 1986 through FY 2023 are available here.
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. Jones2024-02-23 08:28:292024-02-23 08:31:33FY 2023 Saw the Most FCA Settlements and Judgments Ever in a Single Year, with the Majority of Recovered Funds Paid by the Healthcare Industry
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Ninth Circuit Reboots FCA Suit Based on Radiologist Use of Certain Computer Monitors
A panel of the Ninth Circuit recently issued a 2-1 opinion reversing, in part, a district court’s dismissal of a False Claims Act case premised on a radiology facility’s use of non-medical grade computer monitors for diagnostic readings. In reviving the case, the majority concluded that the relator sufficiently pled a false certification theory of fraud from which the court drew a “strong inference” that the radiology facility’s use of the computer monitors did not meet Medicare’s “reasonable and necessary” requirement because the allegedly technologically inferior monitors the radiologists used undermined the efficacy of their diagnostic readings. The decision is notable because the majority relied on tenuous inferences to establish falsity, as detailed by the dissent, and a watered-down materiality analysis to establish materiality.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Matt Bergs
Chicago
mbergs@sidley.com
Court Dismisses Commercial Insurer’s Claims Premised on Conduct Covered by FCA Settlements
It is becoming increasingly common for private litigants to sue over conduct that was previously the subject of FCA actions. In one such recent case, the defendants successfully defeated such a collateral suit, demonstrating that it was time-barred under the statutes of limitations.
(more…)
Scott D. Stein
Chicago
sstein@sidley.com
Joseph R. LoCascio
Chicago
joseph.locascio@sidley.com
Seventh Circuit Rejects Constitutional Challenge to FCA Judgment, Recognizes Circuit Split on Causation Requirement for AKS-Based Claims
In a recent decision, the Seventh Circuit acknowledged—but declined to pick sides in—a circuit split regarding the degree of causation required to establish FCA claims premised on AKS violations. In the same opinion, the Seventh Circuit rejected an Eighth Amendment challenge to the amount of an FCA judgment.
(more…)
Scott D. Stein
Chicago
sstein@sidley.com
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
DOJ Reaches Settlement with Nursing Home Provider Based on Alleged Abuse of COVID-19 Waiver
Last week, DOJ and the State of California reached a $7,084,000 settlement with a California-based nursing home chain and two executives for allegedly misusing a pandemic-era waiver program by routinely submitting claims to Medicare for nursing home residents that did not have a qualifying prior hospital stay. This settlement is noteworthy because it is one of the first FCA settlements involving alleged abuse of this particular Centers for Medicare & Medicaid Services (“CMS”) COVID-19 waiver. See United States and State of California ex rel. Bay Area Whistleblower Partners v. Renew Health Group, LLC, No. 2:20-cv-09472-CBM-AS (C.D. Cal. Oct. 14, 2020).
(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
Sixth Circuit Affirms Orders Compelling Relator to Seek Government Consent to Dismiss Qui Tam Pursuant to Settlement Agreement
The Sixth Circuit recently confirmed that there is no per se bar on relators releasing previously filed FCA claims as part of a settlement agreement, although the government must still subsequently consent to the dismissal of such claims. See State Farm Mut. Auto. Ins. Co. v. Angelo, 95 F.4th 419 (6th Cir. 2024).
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Jane E. Fisher
Chicago
jane.fisher@sidley.com
Court Finds That Qui Tam Relator Cannot Enforce 340B Program Statute
A recent decision from the Central District of California held that a qui tam relator cannot bring a False Claims Act (FCA) case against pharmaceutical manufacturers to enforce the 340B Drug Pricing Program’s (“340B Program”) statutory requirements. See United States ex rel. Adventist Health System/West v. AbbVie, No. 21-cv-04249 (C.D. Cal. Mar. 18, 2024). The 340B Program is a federal program that requires pharmaceutical manufacturers to offer discounted prices, called a “ceiling price,” on applicable drugs to certain hospitals and clinics, referred to as 340B “covered entities.” The relator, Adventist Health System/West, a covered entity under the 340B Program, alleged that the defendant pharmaceutical manufacturers failed to comply with the 340B Program’s requirements related to the “penny pricing” policy, which requires manufacturers to offer drugs at a penny if the ceiling price calculation results in a number at or less than a penny.
(more…)
Jaime L.M. Jones
Chicago
jaimejones@sidley.com
Brenna E. Jenny
Washington, D.C.
bjenny@sidley.com
Elizabeth Hardcastle
Washington, D.C.
ehardcastle@sidley.com
Joseph T. McNally
Chicago
jmcnally@sidley.com
When the Best Defense May Be a Good Offense: False Claims Act Counterclaims
A recent opinion from the Northern District of Georgia reminds False Claims Act defendants about a potentially powerful tool at their disposal—counterclaims. In United States ex rel. Cooley v. ERMI, LLC, the court permitted several counterclaims to proceed over the relator’s argument that they were against public policy, demonstrating how defendants can go on offense to hold relators accountable for their own misconduct. (more…)
Kristin Graham Koehler
Washington, D.C.
kkoehler@sidley.com
Joshua J. Fougere
Washington, D.C.
jfougere@sidley.com
Tyler J. Domino
New York
tdomino@sidley.com
FY 2023 Saw the Most FCA Settlements and Judgments Ever in a Single Year, with the Majority of Recovered Funds Paid by the Healthcare Industry
On February 22, 2024, Acting Associate Attorney General Benjamin C. Mizer and Civil Division Principal Deputy Assistant Attorney General Brian M. Boynton announced that settlements and judgments under the FCA exceeded $2.68 billion in fiscal year (“FY”) 2023. DOJ and whistleblowers, further, were party to 543 FCA settlements and judgments, the most ever in a single year. Detailed statistics on FCA recoveries from 1986 through FY 2023 are available here.
(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
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