Liver and Intestinal Organ Transplantation Committee Spring 2014 Proposed Membership and Personnel Requirements for OPTN Designation & Approval of Intestine Transplant Programs Liver and Intestinal Organ Transplantation Committee Spring 2014

Problem Statement No OPTN/UNOS requirements exist regarding who may perform intestine transplants and care for intestine transplant recipients Currently, any transplant program that is approved to perform liver transplants can perform intestinal transplants upon submitting a written request to UNOS membership department At present, there are no OPTN requirements regarding who may perform intestine transplants or take care of intestine patients, other than the requirement that the transplant program be approved to perform liver transplants. Several previous attempts have been made to develop qualification criteria for OPTN designation and approval of intestinal transplant programs. For various reasons these attempts were unsuccessful. HRSA has expressed the desire to have codified intestine transplant program qualification criteria and this proposal hopefully will result in that.

Define a designated intestine transplant program Goals of the Proposal Define a designated intestine transplant program Establish minimum qualifications for primary intestine transplant surgeons and physicians Done without compromising quality or restricting new program formation The goals of this proposal are to define a designated intestine transplant program and to establish minimum qualifications for the primary intestine transplant surgeon and physician. The proposed bylaw is structured in the same way as other organ transplant program designation and approval requirements. As the number of transplant hospitals performing intestine transplants is small, as is the number of procedures performed (and those are declining), it is not possible to establish statistically significant thresholds or criteria. Regardless, this proposal is sound and will accomplish the need for some minimum set of requirements to designate and approve intestinal transplant programs.

Additional Background Prior Proposal: August 2006 Not well-supported, withdrawn Concerns from 2006: Many well-qualified programs would not meet requirements Did not contain a transition plan for existing programs The Liver Committee and MPSC submitted a proposal for these requirements in 2006, but that proposal was not well supported and was withdrawn. The primary concerns were that the proposed thresholds for the number of transplants performed (surgeon) and the number of patients cared for (physician) would exclude well-qualified programs. Further, there was no transition plan for existing programs.

Additional Background Current Proposal Lower thresholds Full approval and conditional approval pathways The current proposal addresses these concerns. Recognizing that the number of intestine transplants and fellowship training opportunities are decreasing, lower thresholds are proposed. In addition, multiple pathways for primary surgeon and physician qualification are proposed.

Supporting Evidence Low-volume procedure with most programs performing fewer than 5 IN or LI-IN transplants in 2012 Thresholds not derived from statistical analyses Represent level of experience to set minimal standards without restricting access or new program development Similar to initial thresholds for other organs Due to the low volume of intestine transplant performed annually, it was not possible to determine thresholds based on statistical analysis. However, the Committee felt that the thresholds proposed represent a level of experience necessary to provide appropriate care to these patients without restricting access to transplant by closing programs or preventing new program development. This is how the initial thresholds were set when transplant volumes were low.

Summary of Proposed Bylaws I will provide you a summary of the highlights of the proposed bylaws. These were patterned closely after the existing bylaws for liver surgeons and physicians, although tailored to include lower requirement thresholds for intestine programs. The requirements for a designated intestine transplant program mirror those for other organs (i.e., must identify a Program Director and qualified primary transplant surgeon and physician). The primary surgeon must meet the usual criteria (i.e., MD or DO, in good standing at the hospital, licensed, Board-certified. etc.). The primary liver surgeon may also be intestine surgeon if all other criteria are met. The proposal also includes a detailed program personnel coverage plan consistent with the bylaws for other organs. Please review the proposal for all the details.

Primary Surgeon Experience Pathways Full Approval Conditional Approval Direct involved in primary care of at least 7 newly transplanted intestine recipients, followed for a minimum of 3 months Direct involvement in intestine transplant patient care within the last 2 years Observed at least 1 isolated intestine transplant and 1 combined liver-intestine or multi-visceral Directly involved in primary care of at least 5 newly transplanted IN recipients, followed for a minimum of 3 months Directly involved in IN transplant patient care within last 2 years Observed at least 1 isolated intestine transplant & 1 combined liver-intestine or multi-visceral transplant 12 months experience (active intestine transplant service) as primary intestine transplant physician or under direct supervision of a qualified intestine Transplant physician within a 24-month period Demonstrate progress towards meeting full requirement (care of 7 intestine transplant recipients The surgeon must meet one of these pathways: If the surgeon does not meet the currency requirements, approval may be granted if the surgeon develops a formal mentor/proctor relationship with a primary intestine transplant surgeon at another fully approved intestine transplant program.

Provision for Combined Adult/Ped Programs Primary pediatric IN transplant physician can function as primary adult IN transplant physician if an adult gastroenterologist is also involved in the care (if in same program) If no qualified pediatrician on staff: Adult IN transplant physician can function as primary Pediatric IN transplant physician pediatric if a gastroenterologist involved in the care Programs serving predominantly pediatric patients should have a board certified pediatrician who meets the criteria for primary IN transplant physician (read)

Centers Performing at Least One Intestine Transplant 2009-2013 (n = 26 “active” out of 41 registered IN programs) Center N A 125 B 97 C 89 D 57 E 54 F 46 G 40 H I 27 J 18 K 14 L 13 M 11 9 Center N O 6 P Q 5 R 4 S T 2 U V W 1 X Y Z Total # 675 These data show the number of intestine transplants performed over a recent 5-year period by blinded center. While this does NOT tell you how many transplants the surgeon has performed, this is intended to give you some idea of the number of centers doing intestine transplants and their volumes.

What Members will Need to Do On a given date ALL current intestine transplant program designations will terminate At least 120 days before the termination date an intestinal transplant program application will be available Members must submit an application and receive approval by the termination date in order to perform intestine transplants Many of the “inactive” programs have either done 1 or less since their start up date. The intent is to eliminate all currently approved intestine transplant programs (no grandfathering) and start the approval process anew with all programs having to meet the qualification requirements set forth in this proposal, if approved.

Questions? David C. Mulligan, MD Committee Chair david.mulligan@yale.edu Name Region # Representative Email Ann Harper Committee Liaison ann.harper@unos.org