ADDENDUM A TO PATIENT SELECTION CRITERIA

Screening Criteria for Patients Presenting with Significant Histories of Substance Dependence

Evaluation Process

Individuals presenting with histories suggestive of alcohol or substance abuse or dependency shall be evaluated by an interdisciplinary team including at least the following: a chemical dependency specialist (may be a social worker, psychologist, psychiatrist, or addictionologist), an internist, and a surgeon. The evaluating committee will determine the patient's suitability for transplantation and will make recommendations regarding rehabilitation or counseling prior to listing or as a condition of listing.

Standard Criteria

For patients with a diagnosis of alcohol or substance dependence as defined by DSM-IVTR at the time of evaluation, the patient must sign a contract pledging not to use alcohol or any illicit or addictive substances (unless under a doctor's order) in the future and agreeing to unlimited, random drug and/or alcohol screening both while awaiting as well as following transplantation. All patients must satisfy the following requirements prior to listing:

1. Patients must demonstrate complete abstinence from all addictive substances (unless under a doctor's order) throughout the pre-transplant period and must meet one of the three determining factors:
   • a. Abstinence for more than two years prior to listing and confirmed by collateral information;
   • b. At least three months abstinence prior to listing and three months current participation in an active recovery program (structured treatment program; and/or documented 12-Step meeting attendance with sponsor selection/contact) AND random toxicology screens prior to listing and confirmed by collateral information; or
   • c. Meets criteria as a medically urgent patient (see following section on: Criteria for Medically Urgent Patients Unable to Meet Condition 1a or 1b).
2. Patients must also have demonstrated to the transplant treatment team:
   • a. Insight into their past substance dependency;
   • b. A good understanding of how substance dependency has had an impact on their current health; and
   • c. Adequate coping skills for dealing with stressors; or
   • d. Meets criteria as a medically urgent patient (see following section on: Criteria for Medically Urgent Patients Unable to Meet Condition 1a or 1b).
     
     
     Current and consistent participation in an active recovery program, corroborated by the transplant team could satisfy these requirements. (Patients are expected to continue active participation in a recovery program after listing.)
3. Additionally, other prognostic factors for abstinence will be taken into consideration, such as:
   • a. The presence of a sober, stable social network which will be available both pre- and post-transplant to offer ongoing support;
   • b. A stable work history; and
   • c. The presence of a family unit which acknowledges the issues posed by substance dependency and will support the patient's commitment to abstinence.

Even if the patient satisfies all the above standard criteria, the transplant center does not necessarily have to accept the patient as a transplant candidate. The rationale for why the patient should not be a transplant candidate shall be included in the patient's medical summary or medical record.

Medically Urgent Patients Unable to Meet Conditions 1a or 1b of the
Standard Criteria

Any transplant candidate with a diagnosis of alcohol or substance dependency who has not been abstinent at least 2 years and though committed to maintaining sobriety is too ill (as defined below) to actively work a recovery program for 3 months, may qualify for listing through one of the following mechanisms:

Low Risk

Patients who are low-risk for recidivism as defined below and confirmed by the treatment team are eligible for statewide review and listing with at least 1 month confirmed abstinence, a signed contract and commitment to begin a rehabilitation program pre-transplant if patient’s health will permit, and continue to actively working the recovery program post transplant.

• a) No previous failure with substance rehabilitation;
• b) Never been told that substance was affecting health; and
• c) Good social support

Medium Risk

Patients who are at medium risk for recidivism as defined below and confirmed by the treatment team are eligible for statewide review with at least 3 months confirmed abstinence, a signed contract and commitment to begin a rehabilitation program pre-transplant if the patient’s health permits, and to continue actively working the recovery program post transplant.

• a) One or more failures with rehabilitation; and
• b) Minimal support system

High Risk

Patients who are at high risk for recidivism as defined below and confirmed by the treatment team are eligible for listing based on the recommendation of the treatment team and only if they meet the criteria as specified in section 1b of the standard criteria.

• a) Two or more failures to remain abstinent despite medical complication;
• b) Refusal to sign contract; and
• c) Minimal to poor social support

For all patients who do not actively work a recovery program for 3 months pre-transplant, each transplant program agrees to closely monitor post-transplant compliance with ongoing active participation in a recovery program. Failure to follow treatment recommendations will be reported to the OSOTC for future use in modifying the CD criteria.

Even if the patient satisfies all of the above medically urgent criteria, the transplant center does not necessarily have to accept the patient as a transplant candidate. The rationale for why the patient should not be a transplant candidate shall be included in the patient's medically summary or medical record.

Chemical Dependency Committee Evaluation

The CD representatives from the Consortium programs shall review the patient's medical history and forward their advisory recommendations to the organ specific Patient Selection Committee. This review process will be conducted before or simultaneously with the medical review. The organ specific Patient Selection Committee will take the recommendations of the CD Committee under consideration as they determine whether the patient is appropriate to list for transplantation.

In so far as it reasonably practical, based on first person and/or collateral resources, medically urgent criteria patients will be evaluated regarding:

• a) Insight into their past substance dependency;
• b) A good understanding of how substance dependency has had an impact on their current health; and
• c) Adequate coping skills for dealing with stressors

Additionally, other prognostic factors for abstinence will be taken into consideration, such as:

• a) The presence of a sober, stable social network which will be available both pre and post-transplant to offer ongoing support;
• b) A stable work history; and
• c) The presence of a family unit which acknowledges the issues posed by substance dependency and will support the patient's commitment to abstinence.

Medically Urgent CD Patient Listing Prior to Review

Should it be necessary to list a medically urgent CD candidate (MELD>22 and too ill to actively work a recovery program for 3 months and meets criteria for low, medium or high risk) with UNOS prior the review by the CD Committee or the organs specific Patient Selection Committee, the transplant center must notify the OSOTC immediately by phone and/or email and submit the patient's clinical summary with chemical dependency history to the OSOTC office the next business day.

Exception

If a patient is unable to actively participate in a recovery program as determined by the medical team and does not fulfill the definition of medical urgency but the referring team determines that the patient should be an acceptable candidate for transplantation, a conference call with the Chemical Dependency (CD) Committee to facilitate a full and complete assessment of the patient’s situation will be required. The CD representatives from the Consortium programs along with the medical specialists shall review the patient’s medical history and forward their advisory recommendations to the organ specific Patient Selection Committee. This review process will be conducted before or simultaneously with the medical review. The organ specific Patient Selection Committee will take the recommendations of the CD Committee under consideration as they determine whether the patient is appropriate to list for transplantation. (The previous mechanism for exceptions will no longer be used.)

Patient Non-Compliance

If evidence arises that the patient has failed to maintain complete abstinence during the evaluation process or after listing, the patient is immediately made inactive or removed from the list. The evaluating team will reconsider the patient and recommend appropriate chemical dependency treatment. The evaluating team will have the discretion to reevaluate the patient or refer the patient on to another center for reevaluation. To be listed at a program in Ohio the patient must requalify for listing by 3 months active participation in a recovery program and 3-6 months confirmed abstinence. Confirmation of the patient’s participation in an ongoing recovery program must be presented to the Consortium and will require a conference call with the CD Committee prior to re-listing or reactivating the patient on the waiting list.

Patients who have a second relapse while awaiting a transplant will not be eligible for relisting. Failure to submit to random blood or urine screening is considered to be evidence of a relapse.

Patients who are non-compliant with following treatment recommendations will not be eligible for transplant.