This post is the first in our three-part series, Gearing Up for HTLH USA 2025, where our team of attorneys will share insights on intellectual property, equity, and exit strategies and how these issues intersect in the transactional context.
Physicians are driving much of today’s health innovation. From new devices and digital tools to
In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a range of actors including alleged transnational criminal organizations, providers of allegedly fraudulent wound care, alleged prescription opioid traffickers, alleged telemedicine, and genetic testing fraudsters, among others. DOJ also introduced the creation of a Health Care Fraud Data Fusion Center, designed to enhance the detection, investigation, and prosecution of healthcare fraud.
In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review, mandated by the Protecting Access to Medicare Act of 2014 (PAMA), focuses on analyzing the top 25 laboratory tests by Medicare expenditures for the previous calendar year. For clinical laboratories and healthcare providers, this announcement signals the need to pay close attention to billing practices, compliance programs, and potential audit risks.
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at strengthening the government’s civil enforcement of the False Claims Act (FCA) in the healthcare space. While the DOJ and HHS have long worked together to combat fraud, this Working Group marks a formalized, tightly coordinated effort focused on high-impact enforcement areas.
Recently, Attorney General Pam Bondi purportedly issued an internal memorandum in response to Executive Order 14187 (“Protecting Children from Chemical and Surgical Mutilation”) concerning the treatment of transgender minors by medical practitioners, hospitals, clinics, and pharmaceutical companies. The memo set forth guidance for all Department of Justice (DOJ) employees to investigate individuals and entities who provide gender-affirming care to minor patients. To be clear, the memorandum—which has been posted in various locations on the internet and widely reported on by various media outlets but has not been verified as authentic by Husch Blackwell—is an internal policy statement directed to DOJ personnel and is not law. While it purports to issue “guidelines” pursuant to an executive order from the President, that executive order is itself under scrutiny (and has been partially enjoined).
A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure adherence to federal regulations governing medical necessity, lab requisition practices, and the Anti-Kickback Statute (AKS).
On February 20, 2025, the ERISA Industry Committee (ERIC) announced that its legal counsel submitted a letter to the U.S. Departments of Labor (DOL), Health and Human Services (HHS) and Treasury, requesting a stay of enforcement of the September 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule. In the letter, ERIC urged the Departments to exercise their authority under 5 U.S.C. § 705 to postpone the effective date of the Final Rule while litigation challenging its validity is ongoing. This request marks a significant development in the legal landscape surrounding mental health parity laws and could have far-reaching implications for employers, health plans, and other stakeholders in the health insurance industry.
On January 17, 2025, the ERISA Industry Committee (ERIC) filed a lawsuit in the U.S. District Court for the District of Columbia, claiming that the 2024 Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule oversteps legal bounds, breaches the Administrative Procedure Act (APA), improperly delegates the Departments of Labor, Health and Human Services and Treasury’s (Departments) executive power to private entities, and violates the Due Process Clause. ERIC argues that under the Mental Health Parity Act of 1996, the plan was not obligated to assess any disparate impact that a term, applicable to both medical/surgical (M/S) and mental health and substance use disorder (MH/SUD) benefits, might have had on access to MH/SUD benefits. The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) similarly maintained the disparate treatment standard of liability, rather than the disparate impact standard. Moreover, the Departments acknowledged in the 2013 regulations that “disparate results alone” did not constitute a parity violation.
On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), issued proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule (the Proposed Rule) to strengthen the cybersecurity protections that HIPAA-regulated entities are required to maintain for electronic protected health information (ePHI).
On January 8, 2025, a federal grand jury in Virginia returned an indictment against a hospital. This rare criminal event in healthcare alleges that Chesapeake Regional Medical Center conspired to defraud the United States and committed healthcare fraud. Hospitals are almost never criminally charged, as federal investigations into hospitals are nearly always civil proceedings under the False Claims Act. This post explains how this hospital’s alleged actions rose to the level that merited criminal indictment.