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Jan 22, 2025 | 
mondaq.com | Eoin P. Beirne |Eóin Beirne |Grady Campion
In past years we have discussed how opioid-related enforcementefforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcementefforts continued across the entire opioid supply chain, and twothemes dominated the most significant opioid cases and resolutionsof 2024. First, two major settlements from the past year highlightexamples of allegations that crossed a line, prompting thegovernment to pursue criminal charges.
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Jan 22, 2025 | 
mondaq.com | Grady Campion |Laurence J. Freedman |Kevin M. McGinty
In 2024, federal courts issued a number of important decisionsin False Claims Act (FCA) cases that are particularly noteworthyfor the health care and life sciences industries. We focus here ondecisions that further develop the FCA scienter standard addressedin 2023 by the Supreme Court in its important SuperValudecision. We also look at decisions that have accepted theinvitation of three Supreme Court justices to reexamine theconstitutionality of the FCA's qui tam provisions.
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Jan 17, 2025 | 
jdsupra.com | Grady Campion |Karen S. Lovitch
Value-based care (VBC) is a health care delivery model that has grown increasingly common in recent years. Perhaps unsurprisingly, this growth seems to have attracted the attention of government enforcement agencies. In September 2024, the Department of Justice (DOJ) announced a large False Claims Act (FCA) settlement with a VBC primary care practice.
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Jan 17, 2025 | 
jdsupra.com | Eoin P. Beirne |Eóin Beirne |Grady Campion
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid supply chain, and two themes dominated the most significant opioid cases and resolutions of 2024. First, two major settlements from the past year highlight examples of allegations that crossed a line, prompting the government to pursue criminal charges.
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Oct 9, 2024 | 
today.westlaw.com | Grady Campion |Jane Haviland |Karen S. Lovitch
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Oct 7, 2024 | 
jdsupra.com | Grady Campion |Jane Haviland |Karen S. Lovitch
On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution.U.S. ex rel. Zafirov v. Fla. Med. Assocs., LLC, C.A. No. 8:19-cv-01236-KKM, 2024 U.S. Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024) (“Zafirov”).While Zafirov’s holding is novel, the constitutional issue raised in that decision is not. Last summer, in U.S. ex rel. Polansky v.
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Oct 4, 2024 | 
natlawreview.com | Grady Campion
On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution. U.S. ex rel. Zafirov v. Fla. Med. Assocs., LLC, C.A. No. 8:19-cv-01236-KKM, 2024 U.S. Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024) (“Zafirov”). While Zafirov’s holding is novel, the constitutional issue raised in that decision is not. Last summer, in U.S. ex rel. Polansky v.
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Feb 12, 2024 | 
natlawreview.com | Grady Campion
The Physician Self-Referral Law — known as the “Stark Law” — broadly prohibits physicians from profiting from self-referrals for “designated health services” (DHS) payable by Medicare or Medicaid. For example, the Stark Law prohibits referrals when a physician refers a patient for DHS to a medical facility in which the physician has a financial interest, either through ownership or compensation.
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Feb 12, 2024 | 
natlawreview.com | Grady Campion
In January 2023, the Criminal Division of the Department of Justice (DOJ) announced revisions to its Corporate Enforcement Policy (CEP), which we previously summarized here and discussed in further detail as part of EnforceMintz. The CEP defines the criteria that DOJ uses to decide whether to decline to prosecute a criminal case.
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Feb 9, 2024 | 
jdsupra.com | Grady Campion |Karen S. Lovitch
Private equity (PE) investment in the health care industry has grown significantly over the last decade. This past year was no exception. While total deal volume lagged behind 2021 record highs, PE health care deal activity nevertheless remained robust, with an estimated deal volume of about $29 billion in North America. By some accounts, nearly 400 hospitals are owned by private equity firms, representing approximately 9% of all private hospitals nationwide.
