1. Fall 2012 Public Comment Cycle
Proposal to Remove the OPTN Bylaw for the Combined Heart-Lung Transplant Program Designation
Co-Sponsors: MPSC and
Thoracic Committees
Fall 2012 Public Comment Cycle
This proposal to remove the OPTN bylaw for the combined heart-lung transplant program designation is cosponsored by the Membership and Professional Standards and the Thoracic Organ Transplantation Committees.

2. The Problems
Only combined transplant that requires separate program approval status
Inconsistent with other combined organ transplants
Computer system development and programming challenges
Simultaneous combined organ transplants (like heart-kidney or kidney-pancreas) are allowed as long as the hospital has OPTN designation and approval as transplant programs for each organ transplanted. The only exception to this practice is heart-lung transplantation. To perform a heart-lung transplant the hospital must apply for and then be approved as a heart-lung transplant program.
To achieve consistency and eliminate inefficiencies resulting from unlike program approval requirements for different combined organ groupings, we propose that the heart-lung transplant program designation be eliminated. Then, all simultaneous combined organ transplants would be treated the same way.
UNOS realized this was a problem when trying to develop a consistent way to handle combined transplants in the new Chrysalis computer system they are developing. Since in practice every other combined organ transplant could be done by any hospital with OPTN designation and approval as a transplant program for each organ being transplanted, then it would make sense to apply the same requirement for heart-lung transplant. This is especially true because in the bylaws there are NO unique heart/lung qualifications placed on the applicant for program approval.

3. Goals Align program requirements for all combined organ transplants
Reduce application burden
Simplify
Make more efficient
By eliminating the separate heart-lung transplant program status, we hope to:
Align the combined heart-lung program requirement with requirements for other combined organs
Reduce application burden for transplant hospitals with approved heart lung programs
Reduce the time spent by UNOS staff to process, seek and manage approval of a separate application for a heart-lung program; and
Simplify and make the combined organ transplant process more efficient for both members and OPTN contractor.

4. Remove bylaw = problems solved
Achieving These Goals
Remove bylaw = problems solved
It is simple to achieve these goals. If we remove the current bylaw language, any center that has an approved heart and approved lung transplant center will be able to perform heart-lung transplants.

5. Programs Impact 50 heart/lung programs Potential for 125 more
Patients
54 heart/lung transplant candidates
Candidates not affected
There should be no effect on a current patient’s ability to receive a heart-lung transplant.
As a matter of fact, more heart-lung transplants could be performed if qualifying hospitals elect to perform combined heart-lung transplants. This could mean less travel for some patients needing a heart-lung transplant.

6. Expected Implementation
Anticipated Board Consideration:
June 2013
Anticipated Effective Date:
September 1, 2013
Proposals that go out for public comment this fall are scheduled for board consideration next June. If approved in June, policies like this one that don’t need programming, would then take effect on September 1, 2013.
The full benefit of this change will not be realized until the Chrysalis system is fully deployed. This change will be critical in the development of processes and handling of simultaneous combined organ transplants in the new system.

7. Member Action
None!
The best part is that this change will be transparent and it will not require any action by transplant hospitals.
UNOS will communicate these and all other policy changes after the board approves them.

8. NOT Controversial Feedback Very few objections “makes sense”
This proposal has received nearly unanimous endorsement so far.
We have only received two objections and they were based on misconceptions.
The first commenter asked “aren’t there specific qualifications and competencies to qualify as a heart-lung transplant program”? The answer is no. Just concurrent OPTN approval as a heart and lung transplant program.
The second said “lost ability to collect and analyze combined heart-lung transplant data ”. Combined heart-lung transplant data will be collected and analyzed.
CMS was asked if they foresee “any issues with eliminating the heart/lung program status?” and an unofficial reply of no problems was received by staff.
The most frequent comment we’ve gotten has been some version of “this makes sense.” Hopefully, you agree.

9. Contacts
Thoracic Chair: Steven A. Webber, MD Thoracic Vice Chair: Joe Rogers, MD Staff Liaison Liz Robbins
Thoracic Committee Contacts
Thoracic Chair: Steven A. Webber, MD
Thoracic Vice Chair: Joe Rogers, MD
Staff Liaison
Liz Robbins

10. MPSC Chair: Kenneth Andreoni, MD
Contacts
MPSC Chair: Kenneth Andreoni, MD MPSC Vice Chair: Alan Reed, MD Staff Liaison Sally Aungier
Membership and Professional Standards Committee Contacts
MPSC Chair: Kenneth Andreoni, MD
MPSC Vice Chair: Alan Reed, MD
Staff Liaison
Sally Aungier