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…
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/ 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…
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/ 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…
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/ 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…
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/ 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…
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/ 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…
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/ 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…
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/ 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…
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/ Administrative Law, Elections & Politics, Health
The first 120 days of the Trump administration have been characterized by dramatic changes in the realm of white-collar enforcement. However, in the midst of a period wrought with uncertainty over what the administration may do…
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/ Criminal Law, International Law & Trade, Securities Law
On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced significant changes in its risk adjustment data validation (RADV) audits. The changes focus on speed, the volume of targeted contracts, and process…
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/ Administrative Law, Health, Science, Computers, & Technology
California legislative activity focused upon private equity group and hedge fund health care transactions continues notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129 (AB-3129). As…
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/ Finance & Banking, Mergers & Acquisitions, Health
On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million (the Settlement Agreement) and…
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/ Administrative Law, Civil Remedies, Health
The pharmaceutical and medical device industries have long utilized speaker programs, which typically involve retaining health care professionals to speak or present on the companies’ products to educate their peers. Speaker…
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/ Administrative Law, Business Organizations, Health
Nineteen states plus the District of Columbia filed a federal Complaint in U.S. District Court for the District of Rhode Island on May 5, 2025 alleging that the Trump Administration’s recent activities to downsize and…
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/ Administrative Law, Constitutional Law, Health
A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program (Negotiation…
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/ Administrative Law, Civil Procedure, Constitutional Law, Health
