U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 42Chapter IVPart 512Subpart D - Subpart D—Increasing Organ Transplant Access (IOTA) Model

INCREASING ORGAN TRANSPLANT ACCESS MODEL SCOPE AND PARTICIPATION
§ 512.412 - Participant eligibility and selection.
§ 512.414 - Patient population.
§ 512.400 - Basis and scope.
§ 512.402 - Definitions.

PERFORMANCE ASSESSMENT AND SCORING
§ 512.422 - Overview of performance assessment and scoring.
§ 512.424 - Achievement domain.
§ 512.426 - Efficiency domain.
§ 512.428 - Quality domain.

PAYMENT
§ 512.430 - Upside risk payment, downside risk payment, and neutral zone.
§ 512.434 - Targeted review.
§ 512.436 - Extreme and uncontrollable circumstances.

DATA SHARING
§ 512.440 - Data sharing.
§ 512.442 - Transparency requirements.
§ 512.446 - Health equity plans.

BENEFICIARY PROTECTIONS AND FINANCIAL ARRANGEMENTS, BENEFICIARY INCENTIVES, AND COMPLIANCE
§ 512.450 - Required beneficiary notifications.
§ 512.452 - Financial sharing arrangements and attributed patient engagement incentives.
§ 512.454 - Distribution arrangements.
§ 512.455 - Enforcement authority.
§ 512.456 - Beneficiary incentive: Part B and Part D immunosuppressive drug cost sharing support.
§ 512.458 - Attributed patient engagement incentives.
§ 512.459 - Application of the CMS-sponsored model arrangements and patient incentives safe harbor.
§ 512.460 - Audit rights and records retention.
§ 512.462 - Compliance and monitoring.
§ 512.464 - Remedial action.
§ 512.466 - Termination.
§ 512.468 - Bankruptcy and other notifications.

WAIVERS
§ 512.470 - Waivers.
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