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2023 False Claims Act Enforcement in Health Care and Life Sciences, Part III

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Second Circuit Reinforces Anti-Kickback Statute's Demanding Willfulness Standard

The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral for an item or service reimbursable by a...more

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part I

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

In Short - The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more

Sixth Circuit Denies Rehearing in Important Anti-Kickback Statute Case

The decision should prove helpful for those in the health care and life sciences industries whose daily operations require compliance with the federal Anti-Kickback Statute ("AKS")....more

Sixth Circuit Narrows Scope of Anti-Kickback Statute

In Short - The Situation: The Anti-Kickback Statute ("AKS") prohibits a defendant from willfully paying or receiving "remuneration" in exchange for referrals—and, in addition, also specifies that any claims "resulting...more

Eighth Circuit Requires But-For Causation for False Claims Act Suits Alleging Kickbacks

In Short - The Situation: Under 42 U.S.C. § 1320a-7b(g), a claim that "includes items or services resulting from a violation" of the Anti-Kickback Statute ("AKS") is a false claim for purposes of the False Claims Act...more

DOJ Announces Second-Largest Annual Total Recoveries in False Claims Act History

DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. - The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more

Federal Enforcement Keeps Pace with the Expansion of Telemedicine Services

Federal government enforcement in the telemedicine space continues to escalate, with three separate announcements in just the last three weeks regarding criminal and civil telemedicine-related actions. These enforcement...more

CMS Finalizes New Limitations to the Isolated Transactions Exception to the Stark Law

The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value...more

Department of Justice Moves to Dismiss FCA Cases Involving Patient Support Services

Exercising the government's discretion to dismiss meritless FCA cases, DOJ argues patient support services are "appropriate and beneficial to federal healthcare programs and their beneficiaries." This week, the Department...more

Pharmaceutical Company Agrees to $625 Million False Claims Act Settlement

The civil settlement is one of the largest FCA settlements in recent years. The Department of Justice ("DOJ") recently announced that it agreed with AmerisourceBergen Corporation ("ABC") and several of its subsidiaries to...more

DOJ Pursues PE Firm Based on Portfolio Company's Alleged Payment of Kickbacks

The Situation: In what may indicate a sea change in terms of who the Department of Justice ("DOJ") is willing to pursue in False Claims Act cases, a private equity firm has been named as a co-defendant in a False Claims Act...more

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