Organ Transplantation Program Update

August 28, 2012

Christopher J. McLaughlinChief, Organ Transplantation Branch

Division of TransplantationDepartment of Health and Human Services

Health Resources and Services AdministrationHealthcare Systems Bureau

Policy UpdatesOPTN Liver Allocation Policy

OPTN approved “National Share 15” policy Adult deceased donor livers to be offered to all

candidates with MELD/PELD scores of 15 or higher locally, regionally, and nationally before being offered to candidates with lower MELD/PELD scores.

OPTN also approved “Regional Share 35” policy Adult deceased donor livers would be offered to

combined local and regional candidates with MELD/PELD scores of 35 or higher (“tiered regional sharing”).

Policy Updates SRTR Liver Region Redesign Project

HRSA provided $500,000 additional funding to SRTR to conduct analyses supporting OPTN developing evidence-based approaches for geographic distribution of livers.

Approach is to design allocation policies using a principles-based framework and mathematical optimization.

Liver community finds consensus on a few simple principles – a primary metric for evaluating any proposed allocation system--design the liver distribution units to meet the specified goal (subject to a priori specified constraints)

Mathematical optimization - aggregate geographical areas into larger units to maximize a numerical objective function (goal of the redesign) while satisfying stated constraints (allowable number of units would be one of the constraint).

Much of the modeling complete—SRTR will now ask OPTN Board and Liver Committee to establish liver policy goals and requirements that will guide the process.

Policy UpdatesOPTN Living Donor Policy Status

OPTN released three Living Kidney Donor policies for public comment Medical and Psychosocial Evaluation Informed Consent Follow-up

Policies were not reviewed by OPTN Board in June due to procedural issues

Expected to return to OPTN Board for review in November

Process to develop analogous Living Liver Donor policies has begun Joint Society recommendation development OPTN Living Donor Committee policy

development

Policy UpdatesOPTN Kidney Allocation Policy

OPTN Kidney Committee planning to release public comment proposal on September 21, 2012

Proposal intended to enhance post-transplant survival benefit, increase utilization of donated kidneys and increase transplant access for biologically disadvantaged candidates.

Proposal to incorporate new features: expanded definition of waiting time based in part on

the date of initiation of renal dialysis, a sliding scale for assigning points to sensitized

patients, expanded access for blood type B candidates who

can accept kidneys from subtypes of blood type A donors,

broader sharing for extremely highly sensitized candidates,

longevity matching of some kidneys, and regional sharing for kidneys with the highest risk of

discard.

Policy UpdatesStatus of VCA Rule/PHS High Risk

Guidelines

Vascularized Composite Allografts (VCA) NPRM Published December 17, 2011 Closed February 14, 2012 28 comments received – favorable Draft Final Rule undergoing internal HHS

review US Public Health Service/CDC Organ Donor

Screening Guidelines Internal/external review work group met in

June

Operational Updates OPTN Contract

Extension/Recompetition

OPTN contract in place since 2005 has been extended for 6 months until March 30, 2013

HRSA published RFI Jan. 6th, closed Feb. 17th seeking input on: Use of subcontracting OPTN National KPD program Ways to enhance public participation OPTN role in educating members Expansion of compliance on monitoring function

particularly for living donors Expanding OPTN’s research capacity Enhancing IT capacity and responsiveness

Request for Proposals will be posted as soon as possible

Operational Updates OPTN Deceased Donor Potential

Study

HRSA provided $1.6 million direct funding to UNOS (Center for Transplant System Excellence) to conduct a study evaluating donor potential in the U.S.

Findings to serve as basis for evidence-based goal setting

Rigorous methods

Demographic and epidemiological approaches

Systems dynamics modeling

Measure variables affecting donor potential

Address full range of donor potential

Operational Updates SRTR PSR Conference Follow-up

OPTN and SRTR consensus conference on Transplant Program Quality and Surveillance took place February 13-15, 2012.

Short- and Long-Term Action Items have been developed and placed on the SRTR web site and will be updated as work progresses.

SRTR produced a PSR Manual of Operations detailing the SRTR process for risk model development and oversight.

Moving towards a 3-year cycle of model development with formal input and involvement from the OPTN committees. Initial kidney model building steps are underway.

Operational Updates SRTR PSR and OPO Report

Improvements

July 2012 transplant program PSR has a new format using color and enhanced visual display to depict the same content in the traditional program-specific report.

OPO-specific PSRs now contain measures of expected donor yield using the models approved by the OPTN/UNOS Board in 2011. The SRTR released a Donor Yield Calculator tool

available for download on the secure websites that OPOs can use to track observed and expected donor yield using the new models.

Operational Updates HRSA/CMS Alignment Activities

HRSA, CMS, and the OPTN contractor have been working to identify areas of compliance overlap as a first step in the process of better aligning CMS and OPTN requirements.

First product will be a crosswalk of requirements from the CMS transplant center Conditions of Participation and the OPTN Bylaws and Policies.

Possible release of the crosswalk and educational webinar in November

Crosswalk will enhance efforts underway to modify OPTN and CMS requirements and survey processes to address areas that are similar but not identical.

It is hoped that these changes will provide clarity and make it easier for transplant centers to comply with both CMS and OPTN requirements.

Operational UpdatesCommunity of Practice

Organ Donation and Transplantation Community of Practice Sustain and improve upon the gains made

from the Collaboratives 7th National Learning Congress: October 4-5,

2012 Grapevine, Texas Theme: Intentional Integration of Quality Processes Tracks:

Donor Designation Advocacy Donor Management Pediatrics Transplantation Leadership

Operational Updates Public & Professional Education

50+ Campaign launched Print PSAs appearing in major National

magazines Workplace Hospital Campaign Donate Life Month – November 2012 Social Media Working with Dr. Howard Koh, Assistant

Secretary for Health, to help promote donation

Operational Updates National Living Donor Assistance

Center

Cooperative Agreement awarded to University of Michigan in 2006. Michigan subcontracted with the American Society of Transplant Surgeons to operate the system. System became operational in October 2007

Since becoming operational in October 2007, the NLDAC received 2,271 applications of which 2,012 were approved for funding and 1,123 living donation have been completed. The average reimbursement to donors and companions is $2,539. The NLDAC, since its inception, has paid out $3.57 million to donors

Operational UpdatesHHS Innovation Fellowship Program

DoT chosen to participate in a new HHS program designed to increase innovative thinking and problem solving in the Department.

Innovation Fellow will join us for one year to help us work with the OPTN to develop a new system for electronic identification and tracking of organs.

Questions?

Contact Information

Chris McLaughlinChief, Organ Transplantation Branch

Division of Transplantation301-443-0036

cmclaughlin@hrsa.gov