42 CFR § 512.400 - Basis and scope.

---
identifier: "/us/cfr/t42/s512.400"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 512.400 - Basis and scope."
title_number: 42
title_name: "Public Health"
section_number: "512.400"
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"
---


# 512.400 Basis and scope.

(a) *Basis.* This subpart implements the test of the Increasing Organ Transplant Access (IOTA) Model under section 1115A(b) of the Act.

(b) *Scope.* This subpart sets forth the following:

(1) The method for selecting IOTA participants.

(2) The patient population.

(3) The methodology for IOTA participant performance assessment and scoring for purposes of the achievement domain, efficiency domain, and quality domain, including beneficiary attribution and transplant target calculation.

(4) The schedule and methodologies for the upside risk payment and downside risk payment.

(5) Data sharing.

(6) Other IOTA Model requirements.

(7) Beneficiary protections.

(8) Financial arrangements.

(9) Monitoring.

(10) Evaluation.

(11) Termination.

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

(c) *Applicability.* IOTA participants are subject to the standard provisions for Innovation Center models specified in subpart A of this part 512 and in subpart K of part 403 of this chapter.