Health Law Daily Wrap Up, REGULATION TRACKER—Information on pending or recently adopted regulations and regulation amendments, (May 20, 2024)

By WK Editorial Staff

This Health Law Regulation Tracker includes a Proposed Rules Comment Calendar and a Table of Final Rule Effective Dates.

New proposed rules. On May 17, 2024, CMS issued a proposed rule that describes a new mandatory Medicare payment model, the Increasing Organ Transplant Access Model (IOTA Model), that would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals increase access to kidney transplants for patients with end-stage renal disease (ESRD) while preserving or enhancing the quality of care and reducing Medicare expenditures. This proposed rule also includes standard provisions that would apply to Innovation Center models whose first performance period begins on or after January 1, 2025, and also would apply, in whole or part, to any Innovation Center model whose first performance period begins prior to January 1, 2025 should such model’s governing documentation incorporate the provisions by reference in whole or in part. The proposed standard provisions relate to beneficiary protections; cooperation in model evaluation and monitoring; audits and records retention; rights in data and intellectual property; monitoring and compliance; remedial action; model termination by CMS; limitations on review; miscellaneous provisions on bankruptcy and other notifications; and the reconsideration review process.

See the Regulation Tracker for details.

New final rules. No new final rules have been issued since May 10, 2024.

See the Regulation Tracker for details.

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