(a) Basis. This subpart implements certain general provisions for the Radiation Oncology Model implemented under subpart B (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model implemented under subpart C (ETC Model), collectively referred to in this subpart as Innovation Center models. Except as specifically noted in this part, the regulations do not affect the applicability of other provisions affecting providers and suppliers under Medicare Fee-For-Service (FFS), including provisions regarding payment, coverage, or program integrity.

(b) Scope. The regulations in this subpart apply to model participants in the RO Model (except as otherwise noted in § 512.160(b)(6)) and to model participants in the ETC Model. This subpart sets forth the following:

(1) Basis and scope.

(2) Beneficiary protections.

(3) Model participant requirements for participation in model evaluation and monitoring, and record retention.

(4) Rights in data and intellectual property.

(5) Monitoring and compliance.

(6) Remedial action and termination by CMS.

(7) Limitations on review.

(8) Miscellaneous provisions on bankruptcy and notification.