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CMS Issues Proposed Rule to Revise Medicare Parts C and D Regulations

Client Alert | 1 min read | 10.07.11

On October 3, 2011, the Centers for Medicare & Medicaid Services (CMS) released on the Federal Register's Electronic Public Inspection Desk a new proposed rule designed to implement revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) regulations. The revisions address a number of goals, namely: "to implement new statutory requirements; strengthen beneficiary protections; exclude plan participants that perform poorly; improve program efficiencies; and clarify program requirements." In addition, CMS is considering revisions to the long term care facility conditions of participation requirements for pharmacy services. Comments on the proposed rule will be due 60 days after publication in the Federal Register, which has been slated for Tuesday, Oct. 11. Among the revisions considered, highlights include:

  • Implementation of Affordable Care Act with regard to the consolidation of prior guidance on the Coverage Gap Discount Program and implementation of Pharmacy Benefit Manager reporting requirements under Part D;
  • Implementation of MIPPA provision related to benzodiazepines and barbiturates as Part D drugs;
  • Provisions for beneficiary reinstatement into cost plans when good cause for failure to pay premiums can be established;
  • Provision of uniform ID cards for MA plan enrollees and guidance related to the determination of creditable coverage for the retiree drug subsidy;
  • A process for Independent Review Entity (IRE) reconsideration of Part D coverage determinations;
  • Procedures and standards for the exclusion of poor performers in the Parts C and D programs;
  • Measures to reduce costs, including the elimination of the requirement to purchase print advertising announcing non-renewal of cost contractors, implementation of hospital-acquired conditions and present-on-admission indicator policy for MA plans, changes to rules regarding agent/broker compensation, and cost-sharing associated with trial fills of prescription drugs;
  • And further codification and clarification of prior guidance under Parts C and D.

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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....