The Long and Winding Road From the Origins of an HIV Policy to the Development of the MELD System Gloria Taylor, RN, MA, CPTC

United Network for Organ Sharing (UNOS) National not for profit 501 C Membership organization Government contractor

Organ Procurement and Transplantation Network (OPTN) Elect board & set committees Create membership criteria & policies Collect & report data Provide secure computer system Maintain waiting list & match run system Assist with organ placement Conduct professional education

OPTN Committees Communications Ethics Finance Histocompatibility International Relations Membership & Professional Standards Minority Affairs OPO Organ Availability Organ Specific (K/P, Liver & Intestine, etc.) Patient Affairs Pediatrics Transplant Administrators

General Policy Process National committee proposal Public comment Regional meetings Final committee proposal Board action

UNOS Regional Map

Evolution of HIV Policy

Precipitous Event August 1986 First report of the transmission of HIV by an organ transplanted from a screened donor

Original Policy - May 31, 1988 Potential Donor Test all potential donors with an FDA licensed screening test Perform a donor history to determine if the potential donor is in a “high risk” group UNOS would not share organs or tissues that repeatedly tested positive

Original Policy - May 31, 1988 Potential Donor (continued) An exception existed for extra renal organs in extreme medical emergencies, & the transplant surgeons had to notify the recipient or next of kin Donor consent forms were encouraged to include language stating potential donors would be screened for medical acceptability and these tests could prevent donation

Original Policy - May 31, 1988 Potential Recipient HIV-Ab testing should be a condition for candidacy An asympotomatic HIV-Ab sero-positive recipient, should not be excluded from transplant candidacy An HIV-Ab sero-positive with AIDS or AIDS-related complex should be excluded from candidacy

Original Policy - May 31, 1988 Additional Issues Healthcare personnel caring for an AIDS antibody positive patient should be informed Treatment of AIDS antibody positive patients should not be optional or discretionary Disclosure of information comply with statutes UNOS members were requested to adopt an overall policy to address special HIV-related problems

Policy Amended - June 20, UNOS members shall not knowingly participate in the transplantation or sharing of organs from donors who are confirmed reactive for HIV-Ab by an FDA licensed screening test. 4.2 Testing for HIV-Ab shall be a condition of candidacy… Patients confirmed positive should undergo appropriate counseling.

Policy Amended - June 20, 1989 (continued) (added)...but should be advised that they may be at increased risk because of immunosuppressive therapy. The last sentence was deleted. 4.6 (added) HTLV-I Screening

Next Amendments December 1, 1991 Brought to the UNOS Board by the Ad Hoc Committee on Donor Testing at the November 6-7, 1991 meeting Policy proposal 4.7 was recommended for distribution for public comment

Next Amendments December 1, 1991 (continued) 4.7 Transplant Recipient HIV Reporting was implemented December 1, 1991 concurrent with public comment submission Transplant centers shall immediately notify the procuring OPO and UNOS when recipients test positive for HIV or die from HIV-related causes

Present Policy At the June 1992 UNOS Board meeting public comment was reviewed and the modified policy accepted

Organ Allocation and Transplant Candidate Criteria

A long, long time ago… B.U. Allocation & transplant candidate listing criteria were handled by the programs Allocation progressed to a network-type mechanism Candidate criteria remained the purview of transplant programs

NOTA Created a task force April 1986 reported its recommendations

Task Force Recommendations Establish a single national network for organ sharing Participants will agree on & adopt uniform policies and standards Each donated organ is a national resource to be used for public good Public must participate in the decisions of how this resource can be used to best serve the public interest

Task Force Recommendations (Continued) Selection of patients for waiting lists and allocation of organs be based on publicly stated medical criteria and be fairly applied Develop criteria for prioritization through a broadly representative group taking into account both need & probability of success Selection of patients otherwise equally medically qualified should be based on length of time on the waiting list

Task Force Recommendations (Continued) Selection of patients for transplant not be subject to favoritism, discrimination on the basis of race, gender, or ability to pay Organ sharing concepts that are designed to improve the probability of success be implemented in the interests of justice and effective use of organs Ongoing assessment of mandated organ sharing to identify & rectify imbalances that may reduce access by any group

Creation of the OPTN UNOS was awarded a contract to establish the OPTN UNOS was awarded a contract to operate the OPTN Reauthorization of NOTA OPTN shall establish membership criteria & medical criteria for organ allocation

OPTN Policy Development Allocation policies historically balanced justice and medical utility Candidate listing criteria continued largely to be a program-specific function

A Bump in the Road April 2, 1998 Department of Health and Human Services (HHS) Organ Procurement and Transplantation Network; Final Rule 60-day public comment

Public Discussion Ensued Resulting in a moratorium in 1999 Commissioned an IOM study

Results of the OPTN Final Rule The OPTN will develop: Criteria aimed at allocating organs first to those in the highest medical urgency status, with reduced reliance on geographical factors This should reduce disparities in waiting times

Results of the OPTN Final Rule (Continued) Criteria to be followed in deciding when to place patients on the waiting list Medically objective criteria to be used by all transplant centers

Results of the OPTN Final Rule (Continued) Criteria for determining the status of patients who are listed Medically objective, uniform criteria would help ensure a “level playing field” in selecting patients & determining greatest medical need

Organ Specific Criteria Minimum listing criteria were already being developed Pediatric and adult liver criteria are policy Heart, Lung & Heart- Lung criteria are presently guidelines

Determining Highest Medical Urgency Status Public forums were held Liver Disease Severity Scale Committee Liver Committee Public comment X 2 Regional Meetings

Result: MELD System Model for End Stage Liver Disease Based on short term risk of death without a liver transplant (3 months) Formula that is calculated based on medically objective, uniform criteria

Suggested Elements of the Liver Disease Severity Score Bilirubin cholestatic, INR, Albumin, & Creatinine Hepatocellular Carcinoma Spontaneous Bacterial Peritonitis TIPS (contraindications were noted) Intubated Chronic bleeding (  3 days over 7 days)

Additional Suggestions The scale be tested & refined Other predictors of mortality (i.e., cholangitis, hepatopulmonary syndrome, and non-liver comorbidities) eventually be included in the scale to improve its predictive accuracy There should be an inclusive national forum held

Questions, Comments & Concerns

OPTN/UNOS Ethics Committee Supports the basic concept demonstrated by the MELD ideology Believes identifying patients at greatest risk of dying is well founded in the ethical principle of justice However, the use of organs for critically ill patients for transplant may not demonstrate the ethical principle of medical utility

OPTN/UNOS Ethics Committee (Continued) Recommends continued evaluation in the realm of medical utility Recommends periodic reviews of the outcomes to ensure that no specific group is disadvantaged (i.e., the use of serum creatine vs. creatine clearance as an element of the MELD system may disadvantage women)

Next Steps Liver Disease Severity Scale Committee met July 25, 2001 Liver Committee met July 26, 2001 HIV+ candidate concerns were on the agenda Modifications are still occurring

Concluding Remarks Policy-making regarding organ transplantation has never suffered from inertia Use the existing mechanisms to allow your voice to be heard Offer to present to the appropriate committees