Tag: DOJ

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Health Law Highlights

Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid

Summary of article from Woods Rogers, by Justin Lugar:

The Department of Justice (DOJ) announced a $408 million settlement with Rite Aid and its affiliates over allegations of violating the Controlled Substances Act (CSA) and the False Claims Act (FCA) by filling unnecessary opioid prescriptions. This settlement underscores the DOJ’s commitment to enforcing pharmacists’ responsibilities to ensure prescriptions are issued for legitimate medical purposes. Recent enforcement actions, including significant penalties against various pharmacies and individuals, highlight the increasing scrutiny and accountability faced by pharmacists and pharmacies. The DOJ, alongside the DEA, is utilizing predictive analytics and state monitoring programs to intensify these actions. Pharmacies must now be more vigilant in adhering to CSA regulations to avoid severe penalties and legal consequences.

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Health Law Highlights

DOJ Introduces Task Force on Health Care Monopolies and Collusion

Summary of article from King & Spalding, by Catherine Behnke:

The Department of Justice (DOJ) recently announced the establishment of a Health Care Monopolies and Collusion (HCMC) Task Force. This initiative is part of the Biden administration’s broader effort to enhance antitrust enforcement in the health care sector, including measures aimed at increasing transparency, promoting competition, and curbing corporate greed. The HCMC Task Force will identify and address monopolistic and collusive practices that contribute to rising health care costs and decreased quality of care. The Task Force will focus on issues such as payer-provider consolidation, serial acquisitions, labor and quality of care, medical billing, health care IT services, and misuse of health care data. The HCMC Task Force will include a multi-disciplinary team of civil and criminal prosecutors, economists, health care industry experts, technologists, data scientists, investigators, and policy advisors.

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Health Law Highlights

Is Your Compliance House In Order? Tips for Ensuring Private Equity and Portfolio Company Compliance

Summary of article from Bass, Berry & Sims PLC, by Angela Humphreys, Jennifer Michael:

The recent Request for Information by federal agencies highlights the need for private equity (PE) firms to have robust compliance programs for their healthcare sector investments. Such programs should align with the Office of Inspector General’s General Compliance Program Guidance, and include written policies, procedures, risk analyses, and audits. PE firms need to understand their role and risk profile in the portfolio company’s structure, including their involvement in executive hiring, business program implementation, and potential antitrust issues. Equity incentive awards should comply with both the Stark Law and the federal Anti-Kickback Statute. Lastly, PE firms should ensure attorney-client privilege is maintained in their interactions with both the portfolio company and outside counsel.

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Health Law Highlights

DOJ Releases 2024 COVID-19 Fraud Enforcement Task Force Report

Summary of article from Morrison Foerster, by Adam Braverman, Kate Driscoll, Kamran Jamil, Brian Kidd, Nathaniel Mendell:

The U.S. Department of Justice (DOJ) has released a comprehensive report on the COVID-19 Fraud Enforcement Task Force, calling for an extension of the statute of limitations for pandemic fraud-related offenses and increased funding for investigations and prosecutions. Since May 2021, the Task Force has charged over 3,500 defendants, recovered more than $1.4 billion in government funds, and filed over 400 civil suits. The report highlights cases involving False Claims Act liability, primarily related to the Small Business Administration’s Paycheck Protection Program (PPP), Economic Injury Disaster Loans (EIDL), and COVID-19 testing claims. The DOJ is seeking to establish a permanent interagency body to combat government benefits fraud. The report also calls for legislation to extend time limits for charging pandemic-related fraud cases and further resource fraud investigations.