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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

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

OIG Issues Final Rule on New Exception for ESRD-Related Telehealth Technologies

The Situation: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while often demonstrating cost effective options for care. The Action: The Office...more

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more

2018 Budget Act Eases Stark Law Requirements, Increases AKS and CMP Penalties

The Bipartisan Budget Act of 2018, signed into law on February 9, 2018, imposes changes on health care fraud and abuse laws that appear to reflect Congress's desire to reduce the draconian threat of strict liability under the...more

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