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Changes to Stark Law Special Compensation Rules for Group Practices Go into Effect on January 1, 2022

The final rules regarding special compensation under 42 U.S.C. § 1395nn, the Physician Self-Referral or Stark Law, go into effect on January 1, 2022 and will require many physician group practices to modify their compensation methodologies, specifically the pooling and distribution of profits for the provision designated health services (“DHS”)….

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DOJ Announces New Initiative to Use False Claims Act to Enforce Compliance with Data Privacy and Security Laws and Contract Requirements

The Department of Justice recently announced the launch of its new Civil Cyber-Fraud Initiative (the “Initiative”) which intends to use the False Claims Act to pursue “cybersecurity-related fraud by government contractors and grant recipients.” Specifically, the Initiative will target those who: knowingly provide deficient cybersecurity products or services, knowingly misrepresenting…

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Pharmaceutical Manufacturers Beware: New State Drug Transparency Laws and Enforcement Mechanisms Are Coming In 2022

In 2016, states began passing pharmaceutical price reporting laws.  These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and other information related to the cost, development, and sale of drugs.  By October 2021, approximately twenty states have passed…

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Five Emerging Concerns for the Health Care Industry as AI & Telehealth Converge

The use of telehealth continues to grow rapidly across the U.S.  Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely engaging with healthcare providers is here to stay.   In fact, the National Center for Health Statistics…

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Value-Based Arrangement Exceptions and Safe Harbors Have Narrow Utility for Medical Device and Pharmaceutical Companies

On December 2, 2020, the Department of Health & Human Services (HHS) published its long-awaited two final rules – one by the Office of Inspector General (OIG) and one by the Center for Medicare & Medicaid Services (CMS) – finalizing changes to regulations implementing the federal anti-kickback statute (AKS), the…

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