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Long-Awaited Stark Law Phase III Final Rule Released By CMS

Client Alert | 1 min read | 08.28.07

On August 27, 2007, CMS released the final rule that constitutes the third phase (“Phase III”) of the long, drawn out rulemaking process relating to the Federal physician self-referral prohibition (the “Stark Law”). Phase III is scheduled for publication in the Federal Register on September 5, 2007, which would allow the rules to take effect on December 4, 2007. Although Phase III contains many technical changes and nuanced details, it also includes significant and substantive changes that will cause health care organizations, physicians, and their counsel to scramble to reevaluate and restructure longstanding relationships before the end of the year is out.

All existing hospital and physician group practice arrangements must be revisited and likely restructured before the current terms of the arrangements expire; scheduled amendments to space leases, equipment leases, and personal service arrangements must be reviewed for compliance (and likely scrapped); and group practices must reconsider and perhaps revise the manner in which they share profits with and distribute productivity bonuses to group physicians.

Phase III is a final rule wholly separate from the self-referral provisions contained in the recent, Proposed CY 2008 Medicare Physician Fee Schedule (the “Fee Schedule Rule”). See http://www.crowell.com/NewsEvents/Newsletter.aspx?id=477. In fact, certain Phase III requirements significantly differ and sometimes directly conflict with the Fee Schedule Rule, adding confusion and frustration as providers attempt to comply with a declaredly “strict liability” statute. In addition, Phase III commentary reveals that CMS may be considering yet another future rulemaking to address further issues raised by stakeholders.

Please click here for a brief summary and analysis of some of Phase III’s more important requirements.

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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....