42 CFR § 512.100 - Basis and scope.

---
identifier: "/us/cfr/t42/s512.100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 512.100 - Basis and scope."
title_number: 42
title_name: "Public Health"
section_number: "512.100"
section_name: "Basis and scope."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS"
part_number: "512"
part_name: "STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR CERTAIN MODELS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1302, 1315a, and 1395hh."
regulatory_source: "85 FR 61362, Sept. 29, 2020, unless otherwise noted."
cfr_part: "512"
---


# 512.100 Basis and scope.

(a) *Basis.* This subpart implements standard provisions for certain Innovation Center models, as that term is defined in this subpart.

(b) *Scope.* (1) The regulations in this subpart apply to the Radiation Oncology Model implemented under subpart B, the End-Stage Renal Disease (ESRD) Treatment Choices Model implemented under subpart C, and each Innovation Center model for which participation by Model participants is mandatory that begins its first performance period on or after January 1, 2025.

(2) This subpart sets forth the following:

(i) Basis and scope.

(ii) Definitions.

(iii) Beneficiary protections.

(iv) Cooperation in model evaluation and monitoring.

(v) Audits and record retention.

(vi) Rights in data and intellectual property.

(vii) Monitoring and compliance.

(viii) Remedial action.

(ix) Innovation Center model termination by CMS.

(x) Limitations on review.

(xi) Miscellaneous provisions on bankruptcy and other notifications.

(xii) Reconsideration review processes.

(3) Except as specifically noted in this subpart, these regulations do not affect the applicability of other provisions affecting providers and suppliers under Medicare FFS, including provisions regarding payment, coverage, or program integrity.

[89 FR 96444, Dec. 4, 2024]