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STARK II PHASE III: A Detailed Section-By-Section Analysis of the Long-Awaited “Final” Rule

Client Alert | 11 min read | 10.02.07

 The Crowell & Moring Health Care Group is pleased to provide our clients, colleagues, and friends with our legal analysis of the Stark II Phase III Regulations, recently published in the September 5, 2007 Federal Register. These new regulations present both welcome relief and unanticipated future challenges in the manner in which physician financial relationships with DHS entities are structured. Our goal in preparing this analysis was to create a thoughtful, practical, and "user-friendly" Stark Law resource that incorporates references to prior rulemaking as well as to the proposed 2008 Medicare Physician Fee Schedule Rule. We hope you'll agree that we have accomplished this goal. As always, please feel free to contact your regular Crowell & Moring attorney if you have any questions regarding the analysis, which can be accessed by clicking on the image or link below.




www.crowell.com/pdf/expertise/healthcare/StarkLaw_2007.pdf


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Client Alert | 5 min read | 12.12.25

Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument....