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98 results
Publication
September 2026 | Americas
Triage Health Law
In February 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released new Industry Segment-Specific Compliance Program Guidance (Guidance) for Medicare Advantage Organizations (MAOs). While the guidance is not legally binding, it provides a detailed roadmap for managing compliance risks and strengthening oversight across Medicare Advantage operations. The guidance is...... Continue Reading
September 2026 | Blog
Federal enforcement of fraud involving taxpayer-funded programs, like Medicare, is intensifying and businesses that work with the US government should be paying close attention. The US Department of Justice’s latest guidance is designed to accelerate qui tam investigations, increase the role of whistleblowers and strengthen coordination across government agencies. Combined with a record-breaking $6.8 billion...... Continue Reading
This May, the food and drug law community gathered at an annual conference hosted by the Food and Drug Law Institute (“FDLI”) in Washington DC. The agenda featured speakers across the agency, including former Commissioner Makary, current Acting FDA Commissioner Kyle Diamantas, Grace Graham, Sara Brenner, FDA Chief Counsel Sean R. Keveney and leaders from...... Continue Reading
May 2026 | Blog
In a joint motion filed February 5th with the U.S. District Court for the District of Maine, the U.S. Department of Health and Human Services (“HHS”) stated that it would terminate its current 340B Rebate Pilot Program (the “Program”), which we discussed previously on this blog. The Program’s termination follows the filing of a lawsuit...... Continue Reading
March 2026 | Blog
February 2026 | Americas
The U.S. Food and Drug Administration (FDA) recently updated two guidance documents applicable to wearable devices and guidance for clinical decision support tools, continuing the agency’s efforts to ease regulatory hurdles for digital health tools and potentially the use of artificial intelligence. The updates expand the type of digital health tools, including certain general wellness...... Continue Reading
February 2026 | Blog
The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week. The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse. The U.S. Food and Drug Administration (“FDA”), tasked with protecting public health by ensuring the safety,...... Continue Reading
October 2025 | Blog
What happened. On September 10, 2025, the FTC announced it sent warning letters to a number of healthcare employers and staffing firms about potentially unlawful non-compete provisions, signaling the agency’s renewed focus on labor restraints in healthcare. The letters urge recipients to reassess existing contracts and warn that the FTC may open investigations if provisions...... Continue Reading
September 2025 | Blog
On July 31, 2025, the U.S. Department of Health and Human Services Health Resources and Service Administration (HRSA) announced the availability of a new 340B Rebate Model Pilot Program (the Rebate Pilot Program). Under this Rebate Pilot Program, instead of receiving discounts on the purchase price for certain drugs, covered entities will receive a post-purchase...... Continue Reading
Amedisys, a major provider of home health and hospice care, has agreed to pay a $1.1 million civil penalty to settle allegations that it violated the Hart-Scott-Rodino (HSR) Act during the antitrust review of its pending $3.3 billion acquisition by UnitedHealth’s Optum division. What Happened In December 2023, while responding to a DOJ “Second Request”...... Continue Reading
August 2025 | Blog
On June 5, 2025, the FDA issued draft guidance addressing frequently asked questions regarding the transfer or sale of a 510(k) clearance from one 510(k) holder to another. As transfer of 510(k)s is a common issue during transactions involving medical devices, this guidance, if finalized as written, will provide helpful insight regarding the FDA’s position...... Continue Reading
June 2025 | Blog
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