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Submitting LAS exception requests for candidates diagnosed with PH

Audience

We are providing this information to all lung transplant physicians, lung transplant surgeons, lung transplant coordinators, UNetSM Site Administrators, transplant program directors, and data coordinators at lung and heart/lung transplant programs. Please share this notice with anyone in your organization who would benefit from this information. This information is also posted monthly on our member website, Transplant Pro.

 Reminder: LAS Revisions were implemented on February 19, 2015

Revisions to the Lung Allocation Score (LAS) were implemented on February 19, 2015. The revisions include policy changes and changes to UNetSM. Visit the toolkit on the OPTN website for resources to help with this transition.

 Submitting Lung Allocation Score Exception Requests for Candidates Diagnosed with Pulmonary Hypertension

 Guideline

Lung transplant candidates diagnosed with pulmonary hypertension (PH) and who meet the following criteria may qualify for an increase in their Lung Allocation Score (LAS):

  1. Patient is deteriorating on optimal therapy, and
  2. Patient has a right atrial pressure greater than 15 mm Hg or a cardiac index less than 1.8 L/min/m2.

To request an increase in a PH candidate’s LAS, transplant programs must submit an exception request to the Lung Review Board (LRB); this request should include sufficient clinical detail to support that the patient meets the above criteria.

If the transplant program believes that its patient has similar waiting list mortality and potential transplant benefit as a PH patient meeting the criteria listed above, then it should provide a detailed narrative on that assertion, referencing literature supporting the request for a higher LAS. When submitting an exception request, transplant programs must provide a clinical justification for the exception. Please refer to Policy 10.2.B (Lung Candidates with Exceptional Cases) for additional information about the exception review process.

Policy 10.2.B allows a transplant program to submit an exception request for an LAS, an estimated value for one of the tests that is used to calculate the LAS, or assignment to a diagnosis group for a disease that is not listed in WaitlistSM.

 Note:  The LRB will render clinical judgment on exception requests for higher LAS, diagnosis, or estimated value.

Transplant programs may wish to submit to the LRB an exception request for the candidate’s LAS to be at the national 90th percentile (see table below).

The LAS for all active candidates greater than or equal to 12 years of age waiting for lung transplants as of June 22, 2018 are as follows:

Number waiting 25th percentile Median 75th percentile 90th percentile 95th percentile 99th percentile
1239 33.5 36.0 40.9 49.1 58.1 86.1

If you have questions, please contact the UNetSM Help Desk at 1-800-978-4334 or unethelpdesk@unos.org. You may also contact your review board staff member:

Aaron McKoy (804) 782-6575

Webinars provide information about public comment proposals

We will offer several webinar opportunities to help you learn more about policy and bylaws proposals that will be available for public comment in early August.

Non-discussion Webinars

Non-discussion webinars will be held to provide members an opportunity to learn about the proposals on the non-discussion agenda and ask questions of the presenters.

The non-discussion webinar will be held on the following date and time:

Monday, August 6, 2:00-3:30 pm EDT

Proposals presented:

  • Change to Hospital-Based OPO Voting Privileges
  • Changes to Islet Bylaws
  • Tracking Pediatric Transplant Outcomes Following Transition to Adult Care

Registration Link: https://attendee.gotowebinar.com/register/8903292499424812035

Discussion Webinars

The purpose of these webinars is to provide members, especially those who do not normally attend their regional meeting, an opportunity to learn about the proposals on the discussion agenda. Attendees will be permitted to ask questions during the webinars, but the regional meetings will still be the formal avenue for regional discussion and voting.

The discussion webinars will be held on the following dates and times:

Tuesday, August 14, 2:00-3:00 pm EDT

Proposals Presented:

  • Addressing HLA Typing Errors
  • Pancreas Program Functional Inactivity

Registration Link: https://attendee.gotowebinar.com/register/5922247096175594755

Tuesday, August 21, 2:00-3:00 pm EDT

Proposal Presented:

  • Proposed Frameworks of Distribution

Registration Link: https://attendee.gotowebinar.com/register/1707429799793984259

Recently published white paper explores ethical aspects of manipulating waitlist priority

At its June 2018 meeting, the OPTN/UNOS Board of Directors approved the publication of an Ethics committee white paper titled Manipulation of the Organ Allocation System Waitlist Priority through the Escalation of Medical Therapies. You can access this paper from the OPTN website.

Some physicians escalate the amount of care they provide to their patients on the waiting list in order to increase the chances of their patient receiving an organ. Many in the transplant community feel that this practice of unnecessarily escalating a patients’ care may be widespread.1,2 They also believe that other physicians may feel compelled to similarly escalate their own patients’ care so that their transplant candidates are not disadvantaged by the unethical practices of others.

Although the OPTN Board had not publically commented on this issue, they requested that the committee conduct an ethical analysis of the issue, particularly pertaining to the escalation of medically unnecessary treatments provided for the sole purpose of increasing a candidate’s waitlist priority.

This paper can guide physicians who may be confronted with this issue by:

  • Offering them ways to advocate for their patients while also maintaining ethical responsibilities of stewardship of organs in the overall system
  • Giving them a model for how to engage in ethical clinical practice, and
  • Clarifying safeguards with the transplant system designed to protect justice and utility in organ allocation.

This paper does NOT propose that we enforce, monitor, or police the way any transplant hospital uses  therapeutic interventions. It also does not Intend to dictate how clinicians should provide care to their patients, or suggest what indications for using specific therapeutic interventions should be.

Constituent Council initiative tests options to improve committee structure

The Executive Committee is sponsoring a proof of concept project to test options to improve the OPTN/UNOS Committee structure through enhanced communication and engagement.

In spring 2018 public comment, feedback to the concept paper entitled “Improving the OPTN/UNOS committee structure” indicated significant concerns about specific recommendations, but general support for the overarching goals of broadening committee engagement, improving intra-Committee communication, and increasing engagement between the Board and committees.  The Executive Committee carefully considered feedback. They discussed forging ahead with a formal proposal based on the concept paper, abandoning the project, or testing a modified version of the proposed structure that addresses concerns raised during public comment. Ultimately, they decided to pursue this latter option.

The proof of concept, which will be tested during the fall public comment cycle, maintains the original structure and purpose of all committees.  It also maintains the ability for any committees to sponsor policy projects.

Two committees, Patient Affairs and Transplant Coordinators, are testing a “Constituent Council” structure: a constituency’s official representatives on other committees (e.g. the patient representative on the Kidney Committee) as well as that constituency’s representatives on the Board of Directors will merge with the current roster of members for that committee.  This proof of concept also invites other members of the constituency who self-identify as having a patient or clinical transplant coordinator perspective, but do not serve in that official capacity on their home committee (e.g. an OPO representative on the Liver Committee who is also a recipient).

The proof of concept will last from July 1, 2018-December 30, 2018.  Lessons learned will be used to determine future expansions of the proof of concept.

 

PDF versions of status justification forms now available in UNet

Start preparing now for the first implementation phase of the new heart policy.

Important Update:

You will notice two changes to the status justification forms we posted on UNet in May. We replaced the adult heart status 3 criteria 2 extension with a corrected version and we added a new adult heart status 3 criteria 5 extension form. If you previously printed out the PDFs, make sure you replace your printed copy with the updated versions.

  1. What changed on the adult heart status 3 criteria 2 extension form? To correct a typo and make sure the language on the form matched the language in policy, we changed “Cardiac index less than 2.2L/min/m2 during dose reduction” to “Cardiac index less than 2.2 L/min/m2 on the current medical regimen.” That language is one of the responses to this statement on the form: C. Within 48 hours prior to the status expiring, either of the following are true:
  2. Why did we add the adult heart status 3 criteria 5 extension form? A clarification of policy language for Status 3, Criterion 5 went to the Board in June. Because of that clarification, we’re collecting new inotrope data on the extension form for Status 3 Criterion 5, which will be consistent with the other forms where inotrope data is collected. Read policy notice for more information (this will be a link to the policy notice).

Phase one of the new heart allocation policy will be implemented in September 2018. At that time we’ll release the new status justification forms for adult heart and heart-lung candidates. This will allow you to submit the new forms for your candidates on the waiting list and be fully prepared when the second phase is implemented in October.

After listening to feedback from the community, we made PDFs of the justification forms available in UNet under Resources>Reference Docs (see screen shot below). Accessing these PDFs will make you familiar with the new required data so that you can effectively plan and prepare.

Additional resources:

A heart allocation toolkit is available to help you prepare for the upcoming changes. We will continue to add information to this resource as it becomes available. You can also learn more from these articles on Transplant Pro:

If you have any questions, please contact your UNOS regional administrator at 804-782-4800.

Updated resources for geographic distribution

At its June 11-12 meeting, the OPTN/UNOS Board of Directors approved a statement of principles to guide future policy relating to organ distribution.

These principles were recommended by the Ad Hoc Geography Committee, which the Board formed in December 2017 to accomplish three things:

  • Establish defined guiding principles for the use of geographic constraints in organ allocation
  • Review and recommend frameworks/models for incorporating geographic principles into allocation policies
  • Identify uniform concepts for organ specific allocation policies in light of the requirements of the OPTN Final Rule

The recommended frameworks will be available for public comment in August.

The following resources will help inform you about the geographic distribution discussion and actions. We will continue to provide resources and update the transplant community with the latest information on a regular basis.

Current resources include:

Look for additional updates on this initiative through additional periodic e-mails and the Transplant Pro e-newsletter.