On May 13, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a press release and a Federal Register notice announcing a nationwide moratorium on the enrollment of new home health agencies (HHAs) and hospices,…
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/ Administrative Law, Health, Mergers & Acquisitions
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, Health, Science, Computers, & Technology
As previously reported, the Department of Labor (DOL) released a proposed rule (Proposed Rule) on January 30, 2026, targeting ERISA disclosure obligations applicable to PBMs. The public comment period closed on April 15,…
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/ Administrative Law, Health, Labor & Employment Law
What Happened: On April 13, 2026, Maine enacted two significant pieces of legislation affecting health care transactions. Chapter 661 (H.P. 1481), effective July 14, 2026, requires health care entities with a threshold presence…
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/ Antitrust & Trade Regulation, Health, Mergers & Acquisitions
On April 8, 2026, the Department of Health and Human Services’ Office for Civil Rights (OCR) released an educational video, Risk Management Under the HIPAA Security Rule, detailing the risk management requirements under HIPAA as…
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/ Health, Privacy, Science, Computers, & Technology
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, Health, Science, Computers, & Technology
What Happened: In McKee Foods Corp. v. BFP Inc., decided April 7, 2026, the Sixth Circuit affirmed that ERISA preempts two Tennessee laws intended to prevent pharmacy benefit managers (PBMs) from steering patients to affiliated…
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/ Health, Labor & Employment Law
While federal and state legislators contemplate the next wave of PBM and drug pricing reform, legislatures in Virginia and Ohio have already sent significant legislation addressing prescription drug pricing and pharmacy benefit…
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/ Health, Insurance
What Happened: Washington’s Governor signed House Bill 2548 (Chapter 222, Laws of 2026) into law on March 25, 2026, to take effect June 11, 2026, to amend the state’s health care transaction review law at Chapter 19.390. The…
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/ Antitrust & Trade Regulation, Health, Mergers & Acquisitions
Despite the flurry of reform activity throughout the first quarter of 2026, the pace of new PBM regulation and drug pricing reforms shows no sign of tapering off. Instead, both federal and state legislatures continue to target…
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/ Antitrust & Trade Regulation, Health, International Law & Trade
Federal Trade Commission (FTC) Chairman Andrew Ferguson announced the launch of a Healthcare Task Force on March 20, 2026, signaling a significant escalation in the FTC’s approach to healthcare oversight. The directive aligns…
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/ Antitrust & Trade Regulation, Consumer Protection, Health
The first week of March 2026 brought coordinated congressional oversight targeting the Trump administration's most-favored-nation (MFN) drug pricing initiative. Congressional leaders sent several letters to President Trump and…
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/ Administrative Law, Commercial Law & Contracts, 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
Substance use disorder (SUD) providers who are subject to the federal Confidentiality of Substance Use Disorder Patient Records regulations, commonly referred to as the “Part 2 Regulations,” are officially subject to a new civil…
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/ Administrative Law, Consumer Protection, Health, Privacy, Science, Computers, & Technology
The Federal Bar Association’s 2026 Qui Tam Conference featured two sets of remarks from Deputy Assistant Attorney General of the U.S. Department of Justice’s (DOJ) Commercial Litigation Branch, Brenna Jenny (DAAG Jenny). In her…
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/ Civil Rights, Constitutional Law, Government Contracting
