Geographically Isolated Transplant Program Applicants

(Resolution 10)

Membership & Professional Standards Committee (MPSC)

Jonathan Chen, MD, ChairNovember 12-13, 2014

MPSC cannot designate and approve an applicant that does not satisfy qualifying requirements

MPSC may want to recommend an applicant to the Board that doesn’t meet all, but satisfies most, qualifying requirements

No process exists to do so

The Problem

#2 – Increase Access to Transplants

• Reduce geographic disparities in access to transplantation

Strategic Plan

Create a process for MPSC to recommend the Board consider approving a program not meeting all qualification criteria

Set exact circumstances when such a recommendation can be made

Establish that transplant program designation and approval is effective only upon approval of the Board of Directors (no interim approval)

Goal of the Proposal

The proposed changes will help to maximize the number of donors and transplants by approving capable transplant program applicants who serve a defined geographically isolated area.

The designation and approval of capable transplant programs in geographically isolated areas provides an opportunity for the patients to seek transplant treatment for end stage organ disease which might not be available due to their place of residence.

How will the Proposal Achieve its Goal

Product Bylaw Addition

Target Population Impact:

Transplant Hospitals

Total IT Implementation Hours

0/10,680

Total Overall Implementation Hours

65/17,885

Overall Project Impact

0 1000 2000 3000 4000 5000

Series1

0 1000 2000 3000 4000 5000 6000

Se-ries1

No action required

Affects a very small number of select hospitals and their programs

Application submission and review process continues by the MPSC

If MPSC recommends an exception consideration to the Board, applicant will be notified

What Members Will Need to Do

Public Comment Response Tally

Type of Response

Response Total

In Favor In Favor as amended

Opposed

No Vote/No Comment/Did not consider

Individual 18 13 (93%)

0 1 (7%) 4

Regional 11* 10 (91%)

0 0 0

Committee 19* 0 0 1 (50%)

17

*Region 2 & Pancreas Transplantation Committee both had equal votes of support and opposition.

Exceptions for program approval undermine the importance of, and established Bylaws requirements for, the program approval process.

Define what constitutes “geographic isolation” to accommodate future scenarios instead of simply listing Alaska, Hawaii, and Puerto Rico as the only areas where this exception could apply.

Public Comment Themes

RESOLVED, that section A.3.F. (Geographically Isolated Transplant Program Applicants) is added to the OPTN Bylaws, as set forth in Resolution 10, effective February 1, 2015.

Resolution 10 (page 19)

A.3.F. Geographically Isolated Transplant Program Applicants

The MPSC may recommend to the Board of Directors the approval of a designated transplant program if the prospective program cannot satisfy the current key personnel requirements due to its geographical isolation. Geographically isolated applicants must demonstrate to the MPSC that the proposed key personnel have both a satisfactory level of transplant experience and an established history of transplant success for the specific organ type indicated in the application for designated transplant program status.

A.3.F. Geographically Isolated Transplant Program Applicants cont…

MPSC recommendation of approval of a geographically isolated program that is not otherwise qualified does not give interim approval to the prospective program. The designated transplant program status of a geographically isolated program that is not otherwise qualified is effective only upon approval of the Board of Directors.

For purposes of this provision, “geographically isolated” is defined as a program located entirely within a state or commonwealth noncontiguous with the mainland United States. This includes Alaska, Hawaii, and Puerto Rico.