Regulatory Realities Redefining Benefit of Lung Transplant in the Current Era

Regulatory Realities Redefining Benefit of Lung Transplant in the Current Era Gundeep S Dhillon, MD, MPH Associate Professor of Medicine Medical Director, Lung & Heart-Lung Transplantation Program Stanford University School of Medicine

Disclosure I have no conflicts of interest to declare

Background Organ Allocation Principles Based upon medical urgency Avoid futile transplants Minimize the effect of waiting time Broader geographic sharing DHHS. OPTN Final Rule. 42 CFR-Part 121. 1999 IOM Report 2000

Background Lung Allocation Score (LAS) Development Developed by the lung allocation subcommittee of the OPTN & the SRTR Transplant candidates > 12 years of age Allocation based on a lung allocation score, rather than waiting time Implemented in May 2005 JHLT 2016;35:433-439.

LAS Calculation 1. Waitlist urgency measure (WL i ): Expected days lived in next year on waiting list 2. Post-transplant survival measure (PT i ): Expected days lived during 1 st year post-transplant 3. Benefit i = PT i WL i 4. Raw score = Benefit i WL i = PT i 2* WL i (Range 730 to 365) 5. LAS is obtained by normalizing the raw score (Range 0 to 100)

LAS Calculation 1. Waitlist urgency measure (WL i ): Expected days lived in next year on waiting list 2. Post-transplant survival measure (PT i ): Expected days lived during 1 st year post-transplant 3. Benefit i = PT i Wl i 4. Raw score = Benefit i WL i = PT i 2* WL i (Range 730 to 365) 5. LAS is obtained by normalizing the raw score (Range 0 to 100)

Effects of LAS on Waitlist

Number of Candidates Awaiting Lung Transplant American Journal of Transplantation pages 363-433, 2 JAN 2018 DOI: 10.1111/ajt.14562

Waitlist Mortality JHLT 2016;35:433-439.

Distribution of Lung Candidates by Diagnosis & Age A: Emphysema B: PH C: CF & bronchiectasis D: ILD American Journal of Transplantation pages 357-424, 3 JAN 2017 DOI: 10.1111/ajt.14129

Effects on Transplant Rates & Survival

Lung Transplant Trends Over Time within United States OPTN/SRTR 2016 Annual Data Report: Lung American Journal of Transplantation pages 363-433, 2 JAN 2018 DOI: 10.1111/ajt.14562

Effect of LAS Implementation on Short-term Survival US Experience Early Survival One-Year Survival No difference in 90 day mortality or PGD 2008 No difference in hospital or 1 year survival Higher PGD, ICU LOS Decreased waiting list # 2008 No difference in 1 year survival No change in lung transplant candidates but significant change in recipient diagnosis 2007

Effect of LAS Implementation on Short-term Survival European Experience No difference in LOS, 90, 180 & 1 year mortality or PGD 2015 Introduction of the Lung Allocation Score in Germany AJT 2014; 14: 1318-1327 No difference in 90-day mortality Decreased waiting list time

LAS and Survival No difference in 1 year survival compared to historic cohorts Significantly increased risk of death (HR 1.46) in quintile 5 (LAS > 46) 5331 UNOS Recipients into LAS Quartiles: <46, 47-59, 60-79, >80 OPTN/SRTR 2012 Annual Data Report: Lung

Lung Transplant Recipients Over Time OPTN/SRTR 2012 Annual Data Report: Lung

Concurrent Increase in Regulatory Oversight SRTR 1-year and 3-year mortality reports Centers for Medicare and Medicaid Services (CMS) conditions for participation Proposed in 2005 Final rule implemented in 2007 Proposed Rule. In: Federal Register 42 CFR Parts 405, 482, and 488; February 4, 2005; 6140 6182. Final Rule. In: Federal Register 42 CFR Parts 405, 482, 488 and 498; March 30, 2007; 15198 15280.

LAS and Long-Term Survival Impact of the Lung Allocation Score on Survival Beyond 1 Year AJT 2014; 14: 2288-2294

LAS and Long-Term Survival Kaplan-Meier survival curves conditioned on survival to one year post transplantation for the three cohorts: historical control (1995-2000) (red line), pre-las (2001-5/2005) (blue line), and post-las (6/2005-6/2010) (green line). AJT 2014

LAS effect on the oneyear threshold AJT 2014

At what cost?

ORIGINAL CLINICAL SCIENCE KEYWORDS: lung transplantation; organ utilization; lung allocation score; health care economics; resource utilization BACKGROUND: The United States lung allocation score (LAS) allows rapid organ allocation to higher acuity patients. Although, wait-list time and wait-list mortality have improved, the costs of lung transplantation (LTx) in these higher acuity patients are largely unknown. We hypothesize that LTx in high LAS recipients is associated with increased charges and resource utilization. METHODS: Clinical and financial data for LTx patients at our institution in the post-las era (May 2005 to 2009) were reviewed with follow-up through December 2009. Patients were stratified by LAS quartiles (Q). Total hospital charges for index admission and all admissions within 1 year of LTx were compared between Q4 vs Q1 3 using rank-sum and Kruskal Wallis tests, as charge data were not Impact of the lung allocation score on resource normally distributed. RESULTS: utilization after lung transplantation in the United States Eighty-four LTxs were performed during the study period. Sixty-three (75%) patients survived 1 year; 10 (11.9%) died during the index admission. Median LAS was 37.5 (interquartile range [IQR] 34.3 to 44.8). LAS quartiles were: Q1, 30.1 to 34.3, n 21; Q2, 34.4 to 37.5, n 21; Q3, 37.6 to 44.8, n 21; and Q4, 44.9 to 94.3, n 21. Charges for index admission were: Q4, $276,668 (IQR 191,301 to 300,156) vs Q1 3, $153,995 (IQR 129,796 to 176,849) (p 0.001). Index admission median length of stay was greater in Q4 (Q4: 35-day IQR 23 to 46 vs Q1 3: 15-day IQR 11 to 22, p George J. Arnaoutakis, MD, a Jeremiah G. Allen, MD, a Christian A. Merlo, MD, MPH, b Brigitte E. Sullivan, MBA, a William A. Baumgartner, MD, a to 252,045) (p John V. Conte, MD, a and Ashish S. Shah, MD a when examined individually. CONCLUSIONS: 0.003). For 1-year charges: Q4, $292,247 (IQR 229,192 to 421,597) vs Q1 3, $188,342 (IQR 153,455 0.002). Index admission and 1-year charges in Q4 were higher than for other quartiles This is the first study to show increased charges in high LAS patients. Charges for the index admission and hospital care in the year post-ltx were higher in the highest LAS quartile compared with patients in the lowest 75% of LAS. J Heart Lung Transplant 2011;30:14-21 From the a Division of Cardiac Surgery and b Division of Pulmonary and Critical Care Medicine, The Johns Hopkins Medical Institutions, Baltimore, Maryland. 2011 International Society for Heart and Lung Transplantation. All rights reserved. KEYWORDS: lung transplantation; organ utilization; lung allocation score; health care economics; resource utilization The lung allocation score (LAS) has shifted the demographics of United States (US) lung transplantation (LTx), with increased numbers of critically ill patients receiving LTx. Several studies have examined the impact of high LAS designed for this purpose. High LAS is known to negatively impact short-term mortality in IPF patients, and predicts decreased 1-year survival and increased post-operative complications in all LTx patients. 1 3 LTx is a resourceintensive surgical therapy requiring careful follow-up. 4 6 BACKGROUND: The United States lung on post-ltx allocation survival, score although (LAS) the system allows was not rapid initiallyorgan allocation to higher acuity patients. Although, wait-list time and wait-list mortality have improved, the costs of lung Reprints requests: Ashish S. Shah, MD, Division of Cardiac Surgery, transplantation (LTx) in these higher acuity patients are largely unknown. We hypothesize that LTx in The Johns Hopkins Hospital, Blalock 618, 600 North Wolfe Street, Balti- increased MD 21287. Telephone: charges 410-502-3900. and Fax: resource 410-955-3809. utilization. high LAS recipients is associated withmore, E-mail address: ashah29@jhmi.edu utilization. METHODS: Clinical and financial data for LTx patients at our institution in the post-las era (May 1053-2498/$ -see front matter 2011 International Society for Heart and Lung Transplantation. All rights reserved. 2005 to 2009) were reviewed with follow-up doi:10.1016/j.healun.2010.06.018 through December 2009. Patients were stratified by LAS quartiles (Q). Total hospital charges for index admission and all admissions within 1 year of LTx were compared between Q4 vs Q1 3 using rank-sum and Kruskal Wallis tests, as charge data were not normally distributed. However, the effects of high LAS on actual resource utilization are unknown. Therefore, we used an institutional cohort of patients to test the hypothesis that high LAS is associated with increased hospital charges and resource RESULTS: Eighty-four LTxs were performed during the study period. Sixty-three (75%) patients survived 1 year; 10 (11.9%) died during the index admission. Median LAS was 37.5 (interquartile range [IQR] 34.3 to 44.8). LAS quartiles were: Q1, 30.1 to 34.3, n 21; Q2, 34.4 to 37.5, n 21; Q3, 37.6 to 44.8, n 21; and Q4, 44.9 to 94.3, n 21. Charges for index admission were: Q4, $276,668 (IQR 191,301 to 300,156) vs Q1 3, $153,995 (IQR 129,796 to 176,849) (p 0.001). Index admission median length of stay was greater in Q4 (Q4: 35-day IQR 23 to 46 vs Q1 3: 15-day IQR 11 to 22, p 0.003). For 1-year charges: Q4, $292,247 (IQR 229,192 to 421,597) vs Q1 3, $188,342 (IQR 153,455 to 252,045) (p 0.002). Index admission and 1-year charges in Q4 were higher than for other quartiles when examined individually.

AJRCCM 2015

In post-las era: Length of stay have increased Tracheostomy & ECMO rates post-transplant have increased Disposition to SNFs & rehab hospitals have increased

Since LAS implementation Decreased number of wait list patients and waiting list time per patient Decreased waiting list mortality, initially, now increasing Recipient Characteristics Shift Older patients Sicker Patients Group D / ILD recipient favored High LAS scores associated with increased posttransplant mortality But, No change in overall survival at 1 year

But Long-term survival appears to have worsened Increased resource utilization Indirect evidence of increased morbidity

Is there a pullback?

Candidates waiting for lung transplant by LAS American Journal of Transplantation pages 363-433, 2 JAN 2018 DOI: 10.1111/ajt.14562

Pre-transplant Mortality by LAS American Journal of Transplantation pages 363-433, 2 JAN 2018 DOI: 10.1111/ajt.14562

Total Lung Transplants by LAS American Journal of Transplantation pages 363-433, 2 JAN 2018 DOI: 10.1111/ajt.14562

Since 2014 The percentage of candidates with LAS > 50 is decreasing The waitlist mortality for patients with LAS > 50 is rising The total number of transplants for LAS > 50 is decreasing

Vock et al. Ann Am Thorac Soc Vol 14, No 2, pp 172 181, Feb 2017

Vock et al. Ann Am Thorac Soc Vol 14, No 2, pp 172 181, Feb 2017

Summary Implementation of LAS shifted the organs towards older & sicker patients Concurrent increase in regulatory pressures, probably led to: Increased focus on 1-year survival Worsening long term outcomes Increased resource utilization to maintain 1-year outcomes Risk aversion leading to decreased number of transplants in the higher LAS groups

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