1. Modifications to Approved Lung Allocation Policy (Resolution 25) OPTN/UNOS Thoracic Organ Transplantation Committee Dr. Joe Rogers

2. Multiple modifications to LAS system scheduled to be implemented in February 2015 During implementation, UNOS staff identified unclear policy language Background

3. Unclear policy language lead to programming questions and calculation errors The Problem

4. #6: Promote the Efficient Management of the OPTN Simplify policies and procedures for efficient and effective implementation Strategic Plan

5. Modify policy to reflect original intent Ensure smooth and timely implementation of LAS modifications Goals

6. Proposed clarifications to policy fall into 3 categories: Non-substantive clarificationsSubstantive changesPolicy rewrite transition errors How the Proposal Will Achieve Its Goal

7. Product Policy Modification Target Population Impact: Lung candidates at least 12 years old Total IT Implementation Hours 0/10,680 Total Overall Implementation Hours 10/17,885 Overall Project Impact

8. Scheduled implementation date: February 19, 2015 These changes will not delay implementation Changes do not impose additional burden on members Changes do not change monitoring and compliance Implementation

9.  RESOLVED, that additions and modifications to Policies 10.1.C (Priority and Clinical Data Update Schedule for Candidates less than 12 Years Old), 10.1.E (LAS Values and Clinical Data Update Schedule for Candidates at Least 12 Years Old), 10.1.F (The LAS Calculation), 10.1.F.i (Lung Disease Diagnosis Groups), 10.1.F.ii (PCO 2 in the LAS), 10.1.F.iii (Bilirubin in the LAS), 10.1.F.iv (Creatinine in the LAS), 10.2.B.iv (LAS Values and Diagnoses Approved by the LRB), 10.3 (Waiting Time), and 10.5 (Probability Data Used in the LAS Calculation, as set forth in Exhibit B, are hereby approved, effective pending programming and notice to OPTN membership. Resolution 25 (page 89)

10. Non-substantive Clarifications IssueProposed Solution The organization of Table 10-1: Values Substituted for Missing or Expired Actual Values in Calculating the LAS may lead to multiple interpretations. Reorganize Table 10-1 by adding a column and changing the column titles When the value “continuous mechanical ventilation” (CMV) is programmed, transplant programs will have the option of selecting CMV “while hospitalized” or CMV without a qualifier. The default value will only apply if the candidate is hospitalized, but the description in Table 10-1 does not explicitly explain this. Add “while hospitalized” to the description of CMV in the substituted value column of Table 10-1. The description of the coefficient for creatinine increase of at least 150% in Table 10-4: Post-Transplant Survival Calculation: Covariates and Their Coefficients is misleading as written. Remove “or creatinine decreases” from the description of the coefficient for creatinine increase of less than 150%. The coefficient for six-minute-walk-distance in Table 10- 4: Post-Transplant Survival Calculation: Covariates and Their Coefficients is not clear because it is not spelled out. Change “6mw” to six-minute-walk-distance for clarity. The diagnosis for BAC is misspelled in Diagnosis Group DChange the spelling to bronchioloalveolar carcinoma (BAC) The diagnosis Pulmonary lymphangiectasia (PL) is missing from the lists of diagnoses in Diagnosis Group D. It was added as a result of the “other diagnosis” project approved in November 2009. Add Pulmonary lymphangiectasia (PL) to the list of Group D diagnoses.

11. Substantive Changes IssueProposed Solution The coefficient for oxygen needed to maintain minimum oxygen saturation at rest, in both Table 10-3: Waiting List Mortality Calculation: Covariates and their Coefficients, and Table 10-4: Post-Transplant Survival Calculation: Covariates and Their Coefficients, is missing the multiplier that is necessary to make the calculation operable. Add “*O 2 ” to this covariate in Tables 10-3 and 10-4. The definition of Current PCO 2 is missing the time component. Current PCO 2 was programmed in 2010, and uses most recent date only; if there are multiple tests from the same date, it will choose an “arterial” test over a “venous” or “capillary test.” Current bilirubin and current serum creatinine, on the other hand, use the most value with the most recent date and time. Add “and time” to the definition of current PCO 2 so that it is consistent with the definitions for current bilirubin and current serum creatinine, and delete the section of policy that indicates arterial values should be chosen over other test types if the dates are the same. The description of Current Bilirubin, which states that a current bilirubin value of at least 1.0 mg/dL will impact a candidate’s LAS, is mathematically incorrect. The current bilirubin value must be greater than 1.0 mg/dL to impact the LAS. Change the description from “at least 1.0 mg/dL” to “greater than 1.0 mg/dL.” For both serum creatinine and bilirubin, the least beneficial values provided in Table 10-1: Values Substituted for Missing or Expired Actual Values in Calculating are both less than 1. However, in the threshold change calculation for both bilirubin and serum creatinine, the high value must be at least 1. Threshold change maintenance is awarded if the high value for serum creatinine is 150% greater than low value used in the threshold change calculation (and 50% greater than low value used in the threshold change calculation for bilirubin). If 0.1 is the low value used in the threshold change calculation for serum creatinine, the high value used in the threshold change could be 150% higher than 0.1 but still not be 1 – which is the requirement for the threshold change calculation. The same holds true for bilirubin; if 0.7 is the low value used in the threshold change calculation, the high value used in the threshold change could be 50% higher than 0.7 but still not be 1. In the description of the threshold change maintenance calculation in both the bilirubin and serum creatinine sections, modify the description to require the current bilirubin and current serum creatinine values to be at least 1.0 mg/dL, in addition to meeting the respective percentage increase to maintain the impact of the threshold change calculation.

12. IssueProposed Solution The description of the coefficient for functional status in Table 10-4: Post-Transplant Survival Calculation: Covariates and Their Coefficients uses incorrect phrasing for “activities of daily living.” Change “or” to “of” for the phrase activities of daily living. During the plain language rewrite, the term for the threshold change calculation was replaced with “increase in…” for PCO 2, bilirubin and creatinine. Describing the calculation as a threshold change is more accurate than describing it as an “increase,” because the values for PCO 2, creatinine and bilirubin could increase but the calculation would still not apply unless the threshold was met. Change the title of the calculation back to “threshold change.” The section title for 10.2.B.iv: LAS Values and Diagnoses Approved by the LRB is misleading, because the section only discusses diagnoses approved by the LRB. Remove “Values and” from the section title. Policy 10.3: Waiting Time does not correctly describe the waiting time policies for lung candidates less than 12 years old. These candidates do accrue waiting time while inactive. Add the waiting time accrual policy for candidates less than 12 years old in this section. Policy Rewrite Transition Errors