Insights on Government Investigations

For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.

In recent months, three federal courts have refused to enforce expansive US Department of Justice (DOJ) administrative subpoenas issued to providers of gender-affirming care, concluding the subpoenas were issued for an improper purpose or exceeded the government’s statutory authority. These rulings are significant.

Judge Kathryn Kimball Mizelle’s ground-breaking decision in Zafirov v. Florida Medical Associates LLC and Justice Clarence Thomas’ solo dissent in US ex rel. Polansky v. Executive Health Resources Inc. have revived what many had viewed as a settled constitutional question.

Last week’s jury convictions of Safe Chain Solutions’ co-owners in United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.) coupled with US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enforcement make one conclusion unavoidable: The DSCSA is both a regulatory mandate and a criminal risk boundary.

Health Care Partner David Greenberg will present in a BARBRI CLE course titled “Overpayment Recoveries by Health Insurers: Bringing and Defending Claims, Evaluating Merits, Scope of Recovery” on October 1, 2025.

Federal enforcement of information blocking rules has entered a new era.

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health care-related agency actions.

The US Supreme Court recently overturned its ruling in Chevron USA, Inc. v. Natural Resources Defense Council, Inc., changing the landscape for federal agency rulemaking and actions, particularly in the health care industry.

On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute.

With 2024 well underway, this article highlights some of the pressing legal issues impacting the long term care and senior housing industry this year, including trends affecting the industry and emerging issues industry participants likely will face throughout the rest of 2024 and beyond.

On March 5, the Federal Trade Commission (FTC), the US Department of Justice (DOJ) Antitrust Division, and the US Department of Health and Human Services (HHS) launched a cross-government inquiry into the role private equity firms, other alternative asset managers, health systems, and private payers play in health care transactions.

With 2024 underway, ArentFox Schiff highlights 10 of the most pressing legal issues facing the health care industry this year.

On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that have “suspect characteristics” of a fraud scheme.

Health Care Partner Hillary Stemple presented to eye and vision care providers about co-management compliance at the Kentucky Optometric Association’s Annual Meeting on April 21.

Health Care Partner David Greenberg will present in a Strafford CLE webinar about health insurer audits, overpayment demands, and recoveries on August 5.

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Practice Co-Leader Douglas Grimm will present about fraud and abuse investigations in the telehealth industry at Palmetto Care Connections’ Telehealth Summit of South Carolina on October 9.

Health Care partner Anne Murphy will present during the 2020 American Health Law Association’s (AHLA) In-House Counsel Program.

Rachel Hold-Weiss will present during the 2020 American Health Law Association’s (AHLA) Annual Meeting. Rachel’s presentation “Hindsight is 2020: A Look at Home Health and Hospice in the New Decade,” focuses on compliance and regulatory issues for home health and hospice providers.

Healthcare partner Stephanie Trunk has been selected by JD Supra to receive a 2020 Readers’ Choice Award in the healthcare category.

The health care industry continues to be a top priority of the Justice Department with respect to False Claims Act enforcement. In the meantime, investment in a robust compliance program may pay off in cooperation credits to mitigate a False Claims violation.

The Federal Trade Commission issued a decision last week illustrating that even sophisticated executives need reminding that emails and texts will be “Exhibit A” of an antitrust violation.

Please join Arent Fox in San Francisco for our annual Medical Staff Leaders and the Law Conference. This full day conference is designed to equip your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership.

Please join Arent Fox in Costa Mesa for our ninth annual Medical Staff Leaders and the Law Conference. This full day conference is designed to equip your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership.