In the CY 2026 Medicare Physician Fee Schedule proposed rule (PFS Proposed Rule), released on July 14, 2025, the Center for Medicare and Medicaid Innovation (CMMI) introduced the Ambulatory Specialty Model (ASM), a new payment…
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/ Health, Insurance
The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare Part…
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/ Commercial Law & Contracts, Health
The Rhode Island Medical Spas Safety Act (RI MSSA) was signed into law by Governor Daniel McKee on June 30, 2025, and is the latest example of the increasing regulation of medical spas. Despite their growth in popularity across…
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/ Administrative Law, Health
On July 21, 2025, the U.S. District Court for the Southern District of Iowa issued a comprehensive preliminary injunction blocking enforcement of key provisions of Iowa Senate File 383 (the Act), a sweeping law aimed at…
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/ Constitutional Law, Health, Labor & Employment Law
The Center for Medicare and Medicaid Innovation (CMMI) recently announced a six-year payment model for 2026-2031 called the Wasteful and Inappropriate Service Reduction (WISeR) Model. WISeR will test the use of artificial…
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/ Health, Insurance, Science, Computers, & Technology
A July 14, 2025 U.S. Food & Drug Administration (FDA) warning letter to a prominent wellness product and services company offers a blunt reminder that medical device requirements cannot be waived or overlooked merely because a…
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/ Administrative Law, Health, Science, Computers, & Technology
On July 11, 2025, the Ninth Circuit Court of Appeals affirmed the criminal conviction of laboratory operator Mark Schena for violations of the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220 (EKRA) based on compensation…
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/ Civil Procedure, Criminal Law, Health
Within the first six months of President Trump’s second term, his Administration and the GOP have already implemented significant policies that are reshaping health care in the United States. Through his Administration’s…
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/ Health, Insurance, Taxation
Since April 2024, the California Department of Health Care Access and Information (HCAI), Office of Health Care Affordability (OHCA) has received twenty-six Material Change Transaction Notices (Notices) as part of its authority…
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/ Antitrust & Trade Regulation, Health, Mergers & Acquisitions
In a brief press release published on July 9, 2025, the Department of Justice (DOJ) announced the issuance of more than 20 subpoenas to doctors and clinics as part of investigations into health care fraud, false statements, and…
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/ Civil Procedure, Criminal Law, 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…
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/ 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…
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/ 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…
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/ 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…
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/ 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…
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/ Business Organizations, Commercial Law & Contracts, Health
