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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

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

Recent Changes to the Anti-Kickback Statute’s Personal Services Safe Harbor

The Situation: The Office of Inspector General ("OIG") recently modified the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand protections to...more

OIG and CMS Modify AKS Safe Harbor and Stark Law Exception for EHR Donations

The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more

New Stark Law and Anti-Kickback Statute Protections for Cybersecurity Technology

The Situation: The adoption of new technologies has been a hallmark of the health care industry in the twenty-first century. While these technologies have helped to improve both industry efficiency and patient outcomes, the...more

New Limited Remuneration Exception and Additional Tools to Ensure Compliance with the Stark Law

The Situation: On November 20, 2020, the Centers for Medicare & Medicaid Services ("CMS") released the long-awaited final rule to modernize and clarify the Stark Law. As part of this final rule, CMS reviewed stakeholder...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

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