1. Home
  2. |Insights
  3. |CMS Extends Deadline For Publication of Final Stark II, Phase III Rule

CMS Extends Deadline For Publication of Final Stark II, Phase III Rule

Client Alert | 1 min read | 03.21.07

As expected, CMS announced today that it is extending the timeline for publication of the final rule implementing the Stark Law (the “Phase III Rule”) for one year. With this extension, the interim final rule issued on March 26, 2004 (the “Phase II Rule”) will remain in effect until March 26, 2008, at which time CMS will publish the Phase III Rule.

The timeline for publishing a final regulation cannot exceed three years from the date of publication of the proposed interim final rule, unless there are “exceptional circumstances.” CMS attributes the “numerous and varied” public comments received following publication of the Phase II Rule, as well as the substantial “interagency coordination” among CMS, the Office of the Inspector General, and the Department of Justice, (resulting from their joint authority to enforce the Stark Law), as the justification for the one-year extension.

This leaves unanswered for at least one more year critical and outstanding issues under the Stark Law, including: 1) the Law’s applicability to Medicaid referrals and claims; 2) the potential for expansion of the physician recruitment exception to accommodate certain practical considerations; and 3) the potential narrowing of the in-office ancillary services exception to preclude certain referral practices that are understood to be deemed questionable by CMS.

Insights

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....

View All Insights