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Organ Transplant Interpretive Guidelines Update

MCN Question of the Week

Organ Transplant Interpretive Guidelines Update


Where can I find CMS’ update for the Organ Transplant Interpretive Guidelines?


CMS published an advance copy of the Interpretive Guidelines for the Organ Transplant Conditions of Participation (CoPs) at 42 Code of Federal Regulations (CFR) § 482.68 through 482.104 on March 11, 2016.

CMS updated the Organ Transplant Interpretive Guidelines to incorporate previously-published changes, clarify certain areas, and address feedback received based on previously-released drafts. These Interpretive Guidelines supersede all previous versions and will be published in a new Appendix X of the State Operations Manual (SOM). The update was effective immediately.

The Interpretive Guidelines have additions, substantial clarifications and deletions in several areas, including but not limited to the following:

  • Abbreviations were added.
  • Definitions for the phases of transplant and living donor care were added.
  • X011: Guidelines regarding notification to CMS were updated and examples of the required information were added.
  • X013: Removed, as the requirement to notify CMS of a decrease in the number of transplants and potential non-compliance was removed, and other changes were made as needed to conform with amendments to the regulations that became effective on July 11, 2014.
  • X021: Clarification was provided on the relationship of the pediatric to adult programs.
  • X072: Removed, as the requirement for blood type (ABO) verification prior to organ recovery was removed to conform with amendments to the regulations that became effective on July 16, 2012.
  • X073 and X074: A verification requirement prior to administration of anesthesia to a living donor was added to X074, consistent with United Network for Organ Sharing/Organ Procurement and Transplantation Network (UNOS/OPTN) policy.
  • X082, X090 and X091: The phases of transplant and living donation were added and the language was clarified.
  • X092 and X093: The Social Work requirements and examples were clarified.
  • X099 through X104: Previously published content, “Five Aspects of Transplant Quality Assessment and Performance Improvement (QAPI),” was added to the guidelines for clarification, and the examples were updated.


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