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
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
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
On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national health priorities and potentially marking a significant shift in
Since the 2022 overhaul of Colorado’s restrictive covenant statute, C.R.S. § 8-2-113, the Colorado legislature has made ongoing amendments to the law which continue the trend of limiting the effectiveness of restrictive covenants in the state. Most recently, the 2025
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key personnel on current regulations and any changes, and involve them
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
Artificial intelligence (AI) continues to dominate headlines—not just for its technological leaps, but also for the policies shaping its future. In a major development, a new Republican-backed tax bill, released by the House Energy and Commerce Committee on May 11
On March 19, 2025, Wyoming passed a new law, SF 107, broadly circumscribing employers’ use of noncompete agreements. Generally, SF 107 broadly prohibits covenants that restrict the right of “any person” to receive compensation for performance of skilled or unskilled
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,
