Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies…
more
/ Administrative Law, Health, International Law & Trade
In the latest episode of Health Law Diagnosed , Of Counsel Bridgette Keller hosts a discussion of best practices for interacting and communicating with the FDA…
more
/ Administrative Law, Health
On June 11, 2025, Iowa enacted Senate File 383 (the Act), a comprehensive bill aimed at regulating pharmacy benefit managers (PBMs) with the stated goals of increasing transparency, supporting independent pharmacies, and…
more
/ Administrative Law, Constitutional Law, Health
This year’s National Health Care Fraud Takedown (Takedown) announced recently by the Department of Justice was touted by the Department of Justice (DOJ) as the largest to date, involving over $14.6 billion in “intended loss” and…
more
/ Civil Remedies, Criminal Law, Health
On June 9, 2025, Oregon Governor Tina Kotek signed into law Oregon Senate Bill 951 (Oregon CPOM Law), further expanding Oregon’s prohibition on the corporate practice of medicine (CPOM) doctrine. The stated purpose of the Oregon…
more
/ Business Organizations, Commercial Law & Contracts, Health
In May 2025 the Department of Justice (DOJ) Criminal Division published its enforcement priorities, and the Civil Division has now followed suit with a memorandum of its own (the “Civil Division Memo”)…
more
/ Administrative Law, Civil Rights, Health
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on a proposed arrangement where a physician practice managed by a management services…
more
/ Administrative Law, Business Organizations, Health
Welcome to FDA in Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies…
more
/ Administrative Law, Consumer Protection, Health, Science, Computers, & Technology
[embedded content] Host, Bridgette Keller is joined by Associate, David Gilboa to break down the highlights from our Spring 2025 PBM Policy and Legislative Update. In just five minutes, we cover the most impactful federal and…
more
/ Administrative Law, Consumer Protection, Health
Mintz’s Managed Care Practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition breaks down the key federal and state legislative developments shaping the PBM landscape this spring…
more
/ Administrative Law, Antitrust & Trade Regulation, Health
On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s…
more
/ Business Organizations, Constitutional Law, Health
Shortly following its announcement of sweeping changes to RADV audits, CMS shared industry guidance last week regarding upcoming deadlines for the submission of risk adjustment data corrections in advance of RADV sampling. While…
more
/ Administrative Law, Health, Insurance
Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these…
more
/ Administrative Law, Commercial Law & Contracts, Health
In our February 14, 2025 blog post, we detailed a proposed expansion of Article 45-A of New York’s Public Health Law (hereinafter, the Disclosure of Material Transactions Law) included in the proposed Fiscal Year 2026 New York…
more
/ Administrative Law, Health, Mergers & Acquisitions
The Center for Medicare and Medicaid Innovation (CMMI) recently announced a new strategic direction during a public webinar and accompanying white paper, outlining its evolving priorities under the current administration. During…
more
/ Administrative Law, Elections & Politics, Health
