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The author discusses the need for a national quality improvement initiative to reduce the costs of liver transplantation in children in the United States. The author cites a University of Michigan study which reported on the financial implications of surgical complications in pediatric liver transplant recipients. The Michigan researchers have re-confirmed that surgical complications are expensive and lead to a financial burden to payers, medical centers and the government.

Background: Gabapentinoids, commonly used for treating neuropathic pain, may be misused and coprescribed with opioid and benzodiazepine, increasing the risk of mortality and dependency among kidney transplant recipients., Methods: We identified adult kidney transplant recipients who enrolled in Medicare Part D in 2006-2017 using the United States Renal Data System/Medicare claims database. We characterized recipients' post-transplant concomitant prescription of gabapentinoids, opioids, and benzodiazepine stratified by transplant year and recipient factors (age, sex, race, and diabetes). We investigated whether concomitant prescriptions were associated with postkidney transplant mortality using Cox regression. Models incorporated inverse probability weighting to adjust for confounders., Results: Among 63,359 eligible recipients, 13% of recipients filled at least one gabapentinoid prescription within 1 year after kidney transplant. The prevalence of gabapentinoid prescriptions increased by 70% over the study period (16% in 2017 versus 10% in 2006). Compared with nonusers, gabapentinoids users were more likely to have diabetes (55% versus 37%) and obesity (46% versus 34%). Of the 8509 recipients with gabapentinoid prescriptions, 45% were coprescribed opioids, 7% were coprescribed benzodiazepines, and 3% were coprescribed both opioids and benzodiazepines. Compared with no study prescriptions, gabapentinoid monotherapy (adjusted hazard ratio [aHR]=1.25; 95% confidence interval [CI], 1.16 to 1.32) and combination therapy (gabapentinoids and opioids [aHR=1.49; 95% CI, 1.39 to 1.60], gabapentinoids and benzodiazepines [aHR=1.46; 95% CI, 1.03 to 2.08], and coprescribing all three [aHR=1.88; 95% CI, 1.18 to 2.98]) were all associated with a higher risk of postkidney transplant mortality., Conclusions: Gabapentinoid coprescription with both benzodiazepines and opioids among kidney transplant recipients increased over time. Kidney transplant recipients prescribed gabapentinoids had a higher risk of post-transplant mortality, and the risk was higher with opioids or benzodiazepine coprescription., (Copyright © 2023 by the American Society of Nephrology.)

An electronic survey canvassing current policies of transplant centers regarding a COVID-19 vaccine mandate for transplant candidates and living donors was distributed to clinicians at US solid organ transplant centers performing transplants from October 14, 2021-November 15, 2021. Responses were received from staff at 141 unique transplant centers. These respondents represented 56.4% of US transplant centers, and responding centers performed 78.5% of kidney transplants and 82.4% of liver transplants in the year prior to survey administration. Only 35.7% of centers reported implementing a vaccine mandate, while 60.7% reported that vaccination was not required. A minority (42%) of responding centers with a vaccine mandate for transplant candidates also mandated vaccination for living organ donors. Centers with a vaccine mandate most frequently cited clinical evidence supporting the efficacy of pre-transplant vaccination (82%) and stewardship obligations to ensure organs were transplanted into the lowest risk patients (64%). Centers without a vaccine mandate cited a variety of reasons including administrative, equity, and legal considerations for their decision. Transplant centers in the United States exhibit significant heterogeneity in COVID-19 vaccination mandate policies for transplant candidates. While all centers encourage vaccination, most centers have not mandated COVID-19 vaccination for candidates and living donors, citing administrative opposition, legal prohibitions, and concern about equity in access to transplants., (© 2022 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Relationships between renal function and medical costs for deceased donor kidney transplant recipients are not fully quantified post-transplant. We describe these relationships with renal function measured by estimated glomerular filtration rate (eGFR) and graft failure. The United States Renal Data System identified adults receiving single-organ deceased donor kidneys 2012-2015. Inpatient, outpatient, other facility costs and eGFRs at discharge, 6 and 12 months were included. A time-history of costs was constructed for graft failures and monthly costs in the first year post-transplant were compared to those without failure. The cohort of 24,021 deceased donor recipients had a 2.4% graft failure rate in the first year. Total medical costs exhibit strong trends with eGFR. Recipients with 6-month eGFRs of 30-59 ml/min/1.73m 2 have total costs 48% lower than those <30 ml/min/1.73m 2 . For recipients with graft failure monthly costs begin to rise 3-4 months prior to failure, with incremental costs of over $38,000 during the month of failure. Mean annual total incremental costs of graft failure are over $150,000. Total costs post-transplant are strongly correlated with eGFR. Graft failure in the first year is an expensive, months-long process. Further reductions in early graft failures could yield significant human and economic benefits., Competing Interests: Authors ZW and WW are employed by company Genesis Research LLC; RJN is employed by Beta6 Consulting Group, LLC. MC received research funding and/or consultancy fees unrelated to this study from Angion Biomedica. RJN was an employee of Angion Biomedica at the time of writing. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that Angion Biomedica provided funding for the analysis supporting this research. Genesis Research performed the data analysis under contract to Angion Biomedica. Funding for open access fees has not been provided., (Copyright © 2022 Cooper, Schnitzler, Nilubol, Wang, Wu and Nordyke.)

Evolving literature suggests that the epidemic of prescription opioid use affects the transplant population. We examined a novel database wherein national U.S. transplant registry records were linked to a large pharmaceutical claims warehouse (2007-2015) to characterize prescription opioid use before and after kidney transplant, and associations (adjusted hazard ratio, 95% LCL aHR 95% UCL ) with death and graft loss. Among 75 430 eligible patients, 43.1% filled opioids in the year before transplant. Use was more common among recipients who were women, white, unemployed, publicly insured, and with longer pretransplant dialysis. Of those with the highest level of pretransplant opioid use, 60% continued high-level use posttransplant. Pretransplant opioid use had graded associations with one-year posttransplant outcomes; the highest-level use predicted 46% increased risk of death (aHR 1.28 1.46 1.66 ) and 28% increased risk of all-cause graft failure (aHR 1.17 1.28 1.41 ). Effects of high-level opioid use in the first year after transplant were stronger, predicting twice the risk of death (aHR 1.93 2.24 2.60 ) and 68% higher all-cause graft failure risk (aHR 1.50 1.68 1.89 ) over the subsequent year; increased risk persisted over five years. While associations may, in part, reflect underlying conditions or behaviors, opioid use history is relevant in assessing and providing care to transplant candidates and recipients., (© 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.)

While guidelines support metformin as a therapeutic option for diabetic patients with mild-to-moderate renal insufficiency, the frequency and outcomes of metformin use in kidney transplant recipients are not well described. We integrated national U.S. transplant registry data with records from a large pharmaceutical claims clearinghouse (2008-2015). Associations (adjusted hazard ratio, 95% LCL aHR 95% UCL ) of diabetes regimens (with and excluding metformin) in the first year post-transplant with patient and graft survival over the subsequent year were quantified by multivariate Cox regression, adjusted for recipient, donor, and transplant factors and propensity for metformin use. Among 14 144 recipients with pretransplant type 2 diabetes mellitus, 4.7% filled metformin in the first year post-transplant; most also received diabetes comedications. Compared to those who received insulin-based regimens without metformin, patients who received metformin were more likely to be female, have higher estimated glomerular filtration rates, and have undergone transplant more recently. Metformin-based regimens were associated with significantly lower adjusted all-cause (aHR 0.18 0.41 0.91 ), malignancy-related (aHR 0.45 0.45 0.99 ), and infection-related (aHR 0.12 0.32 0.85 ) mortality, and nonsignificant trends toward lower cardiovascular mortality, graft failure, and acute rejection. No evidence of increased adverse graft or patient outcomes was noted. Use of metformin-based diabetes treatment regimens may be safe in carefully selected kidney transplant recipients., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Medicare costs vary for solid organ transplant recipients by outcome: survival with graft function, survival with graft failure, and death. Average per-person per-year reimbursement was $75 thousand for kidney recipients who survived the first year posttransplant with a functioning graft, $171 thousand for those who required a return to dialysis or retransplant, and $350 thousand for those who died with function. For pancreas recipients: $105 thousand for those who survived the first year with a functioning graft, $120 thousand for those who survived pancreas failure, and $443 thousand for those who died with function. For liver recipients: $154 thousand for those who survived with a functioning graft, $388 thousand for those who required retransplant, and $740 thousand who died with function. For intestine recipients: $301 thousand for those who survived with a functioning graft and $1 million for those who died with function. For heart recipients: $272 thousand for those who survived with a functioning graft and $1.2 million for those who died with function. For lung recipients: $196 thousand for those who survived with a functioning graft, $642 thousand for those who required retransplant, and $761 thousand for those who died with function., (.)

Although biliary complications (BCs) have a significant impact on the outcome of liver transplantation (LT), variation in BC rates among transplant centers has not been previously analyzed. BC rate, LT outcome and spending were assessed using linked Scientific Registry of Transplant Recipients and Medicare claims (n = 16,286 LTs). Transplant centers were assigned to BC quartiles based upon risk-adjusted observed to expected (O:E) ratio of BC separately for donation after brain death (DBD) and donation after cardiac death (DCD) donors. The median incidence of BC was 300% greater in the highest versus lowest DBD quartiles (19.0% vs. 5.9%) and varied 250% between DCD quartiles (20.3%-8.4%). Donor and recipient characteristics suggest that high BC centers actually used lower donor risk index organs, fewer split livers and fewer imports (p < 0.001 for all). Transplant at a center in the highest O:E quartile was associated with increased posttransplant mortality (adjusted hazard ratio [aHR] 2.53, p = 0.007) in DCD transplant and increased graft loss (aHR 1.21, p = 0.02) in DBD transplant. Medicare spending was $22,895 (p < 0.0001) higher at centers in highest versus lowest BC quartile. In summary, BC rates vary widely among transplant centers and higher rates are a marker for an increased risk of death, graft failure and health-care spending., (© Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.)

While the costs to Medicare of solid organ transplant are varied and considerable, the total Medicare expenditure of $4.4 billion for solid organ transplant recipients was less than 1 remains one of the most cost-effective surgical interventions in medicine. Heart transplant, the most expensive of the major transplants, is likely cost-effective; SRTR has released an Excel-based tool for investigators to use in exploring this question further. It is likely that most solid organ transplants are cost-effective, given the results presented here and the relatively high cost of heart transplant. However, this must be verified with further study., (© Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Despite improvement in surgical technique and medical management of liver transplant recipients, biliary complications remain a frequent cause of posttransplant morbidity and graft loss. Biliary complications require potentially expensive interventions including radiologic procedures and surgical revisions., Methods: A national data set linking transplant registry and Medicare claims data for 12,803 liver transplant recipients was developed to capture information on complications, treatments, and associated direct medical costs up to 3 years after transplantation., Results: Biliary complications were more common in recipients of donation after cardiac death compared to donation after brain death allografts (23% vs. 19% P<0.001). Among donation after brain death recipients, biliary complications were associated with $54,699 (95% confidence interval [CI], $49,102 to $60,295) of incremental spending in the first year after transplantation and $7,327 in years 2 and 3 (95% CI, $4,419-$10,236). Biliary complications in donation after cardiac death recipients independently increased spending by $94,093 (95% CI, $64,643-$124,542) in the first year and $12,012 (95% CI, $-1,991 to $26,016) in years 2 and 3., Conclusion: This national study of biliary complications demonstrates the significant economic impact of this common perioperative complication and suggests a potential target for quality of care improvements.

Despite improved overall liver transplant outcomes, biliary complications remain a significant cause of morbidity. A national data set linking transplant registry and Medicare claims data for 17,012 liver transplant recipients was used to identify all recipients with a posttransplant biliary diagnosis code within the first 6 months after transplantation. Patients were further categorized as follows: a diagnosis without a procedure, a diagnosis and an associated radiological or endoscopic procedure, or a diagnosis treated with surgery. Overall, 15.0% had a biliary diagnosis, 11.2% required a procedure, and 2.2% had a surgical revision. Factors independently associated with biliary complications included donation after cardiac death (DCD), donor age, recipient age, split grafts, and long cold ischemia times. Graft loss was significantly more common for patients with biliary diagnoses [adjusted hazard ratio (aHR) = 1.89, confidence interval (CI) = 1.63-2.19], interventions (aHR = 2.08, CI = 1.77-2.44), and surgical procedures (aHR = 1.80, CI = 1.31-2.49). Mortality after transplantation was also markedly increased for patients with biliary diagnoses (aHR = 2.18, CI = 1.97-2.40), procedures (aHR = 2.21, CI = 1.99-2.46), and surgeries (aHR = 1.77, CI = 1.41-2.23). In stratified analyses, the impact of early biliary complications was greater for DCD liver recipients, but they remained highly significant for recipients of allografts from brain-dead donors as well. Reducing biliary complications should improve posttransplant survival and reduce graft loss., (© 2014 American Association for the Study of Liver Diseases.)

Liver transplant in the us remains a successful life-saving procedure for patients with irreversible liver disease. In 2012, 6256 adult liver transplants were performed, and more than 65,000 people were living with a transplanted liver. The number of adults who registered on the liver transplant waiting list decreased for the first time since 2002; 10,143 candidates were added, compared with 10,359 in 2011. However, the median waiting time for active wait-listed adult candidates increased, as did the number of candidates removed from the list because they were too sick to undergo transplant. The overall deceased donor transplant rate decreased to 42.3 per 100 patient-years, and varied geographically from 18.9 to 228.0 per 100 patient-years. Graft survival continues to improve, especially for donation after circulatory death livers. The number of new active pediatric candidates added to the waiting list also decreased. Almost 75% of pediatric candidates listed in 2009 underwent transplant within 3 years; the 2012 rate of deceased donor transplants among active pediatric wait-listed candidates was 136 per 100 patient-years. Graft survival for deceased donor pediatric transplants was 92.8% at 30 days. Medicare paid for some or all of the care for more than 30% of liver transplants in 2010., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The number of heart transplants performed annually continues to increase gradually, and the number of adult candidates on the waiting list increased by 25% from 2004 to 2012. The heart transplant rate among active adult candidates peaked at 149 per 100 wait-list years in 2007 and has been declining since; in 2012, the rate was 93 heart transplants per 100 active wait-list years. Increased waiting times do not appear to be correlated with an overall increase in wait-list mortality. Since 2007, the proportion of patients on life support before transplant increased from 48.6% to 62.7% in 2012. Medical urgency categories have become less distinct, with most patients listed in higher urgency categories. Approximately 500 pediatric candidates are added to the waiting list each year; the number of transplants performed each year increased from 274 in 1998 to 372 in 2012. Graft survival in pediatric recipients continues to improve; 5-year graft survival for transplants performed in 2007 was 78.5%. Medicare paid for some or all of the care for nearly 40% of heart transplant recipients in 2010. Heart transplant appears to be more expensive than ventricular assist devices for managing end-stage heart failure, but is more effective and likely more cost-effective., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

For most end-stage renal disease patients, successful kidney transplant provides substantially longer survival and better quality of life than dialysis, and preemptive transplant is associated with better outcomes than transplants occurring after dialysis initiation. However, kidney transplant numbers in the us have not changed for a decade. Since 2004, the total number of candidates on the waiting list has increased annually. Median time to transplant for wait-listed adult patients increased from 2.7 years in 1998 to 4.2 years in 2008. The discard rate of deceased donor kidneys has also increased, and the annual number of living donor transplants has decreased. The number of pediatric transplants peaked at 899 in 2005, and has remained steady at approximately 750 over the past 3 years; 40.9% of pediatric candidates undergo transplant within 1 year of wait-listing. Graft survival continues to improve for both adult and pediatric recipients. Kidney transplant is one of the most cost-effective surgical interventions; however, average reimbursement for recipients with primary Medicare coverage from transplant through 1 year posttransplant was comparable to the 1-year cost of care for a dialysis patient. Rates of rehospitalization are high in the first year posttransplant; annual costs after the first year are lower., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The number of pancreas transplants has decreased over the past decade, most notably numbers of pancreas after kidney (pak) and pancreas transplant alone (pta) procedures. This decrease may be mitigated in the future when changes to national pancreas allocation policy approved by the Organ Procurement and Transplantation Network Board of Directors in 2010 are implemented. The new policy will combine waiting lists for pak, pta, and simultaneous pancreas-kidney (spk) transplants), and give equal priority to candidates for all three procedures. This policy change may also eliminate geographic variation in waiting times caused by geographic differences in allocation policy. Deceased donor pancreas donation rates have been declining since 2005, and the donation rate remains low. The outcomes of pancreas grafts are difficult to describe due to lack of a uniform definition of graft failure in the transplant community. However long-term survival is better for spk versus pak and pta transplants. This may represent the difficulty of detecting rejection in the absence of a simultaneously transplanted kidney. The challenges of pancreas transplant are reflected in high rates of rehospitalization, most occurring within the first 6 months posttransplant. Pancreas transplant is associated with higher incidence of rejection compared with kidney transplant., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Previous economic analyses of liver transplantation have focused on the cost of the transplant and subsequent care. Accurate characterization of the pretransplant costs, indexed to severity of illness, is needed to assess the economic burden of liver disease. A novel data set linking Medicare claims with transplant registry data for 15,710 liver transplant recipients was used to determine average monthly waitlist spending (N = 249,434 waitlist months) using multivariable linear regression models to adjust for recipient characteristics including Model for End-Stage Liver Disease (MELD) score. Characteristics associated with higher spending included older age, female gender, hepatocellular carcinoma, diabetes, hypertension and increasing MELD score (p < 0.05 for all). Spending increased exponentially with severity of illness: expected monthly spending at a MELD score of 30 was 10 times higher than at MELD of 20 ($22,685 vs. $2030). Monthly spending within MELD strata also varied geographically. For candidates with a MELD score of 35, spending varied from $19,548 (region 10) to $36,099 (region 7). Regional variation in waitlist costs may reflect the impact of longer waiting times on greater pretransplant hospitalization rates among high MELD score patients. Reducing the number of high MELD waitlist patients through improved medical management and novel organ allocation systems could decrease total spending for end-stage liver care., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Lung transplants are increasingly used as treatment for end-stage lung diseases not amenable to other medical and surgical therapies. Lungs are allocated to adult and adolescent transplant candidates on the basis of age, geography, blood type compatibility, and the Lung Allocation Score, which reflects risk of wait-list mortality and probability of posttransplant survival. The overall median waiting time in 2012 was 4 months, and 65.3% of candidates underwent transplant within 1 year of listing; however, this proportion varied greatly by donation service area. Unadjusted median survival of lung transplant recipients was 5.3 years in 2012, and median survival conditional on living for 1 year posttransplant was 6.7 years. Among pediatric lung candidates in 2012, 32.1% were wait-listed for less than 1 year, 17.9% for 1 to less than 2 years, 16.7% for 2 to less than 4 years, and 33.3% for 4 or more years. Both graft and patient survival have continued to improve; survival rates for recipients aged 6-11 years are better than for younger recipients. Compared with recipients of other solid organ transplants, lung transplant recipients experienced the highest rates of rehospitalization for transplant complications: 43.7 per 100 patients in year 1 and 36.0 in year 2., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: The complement-dependent microcytotoxicity crossmatch (CDCXM) is a standard method for evaluating the presence of preformed antibodies before transplantation. The flow cytometry crossmatch (FCXM) is more sensitive, but there is controversy regarding translation of its increased sensitivity to clinically relevant graft outcomes., Methods: We analyzed Organ Procurement and Transplant Network registry data for living and deceased donor kidney transplants performed in 1995 to 2009 after both CDCXM and FCXM testing. Transplants with negative CDCXM (CDCXM(-)) and with T-cell positive (T(+)), T-cell negative/B-cell positive (T(-)B(+)), or T- and B-cell negative (T(-)B(-)) FCXM results were included. Graft survival according to crossmatch results was compared by survival analysis., Results: Among patients transplanted with negative CDCXM (CDCXM(-)), deceased and living donor graft recipients with T(+) FXCM experienced significant absolute reductions in 5-year graft survival of 11.5% and 8.8% compared to those with T(-) FCXM (P < .0001). Compared to patients with FCXM(-)/CDCXM(-) deceased and living donor recipients with T(-)B(+) FCXM/CDCXM(-) had absolute reductions in 5-year graft survival of 9.6% and 7.6%, respectively (P < .0001). Upon multivariate adjustment with Cox regression, T(+) FCXM/CDCXM(-) deceased donor transplantation was associated with 51% higher adjusted relative risk of 1-year graft loss than FCXM(-)/CDCXM(-). Relative risks were more marked at 1 year for the T(+) groups but stronger in the 1- to 5-year interval for the T(-)B(+) groups., Conclusion: Positive FCXM has important prognostic implications even when CDCXM is negative. Thus, positive FCXM should not routinely be dismissed as "overly sensitive" when CDCXM is negative., (Copyright © 2010 Elsevier Inc. All rights reserved.)

Beginning January 1, 2000, Medicare extended coverage of immunosuppression medications from 3 years to lifetime based on age >65 years or disability. Using United States Renal Data System (USRDS) data for Medicare-insured recipients of kidney transplants between July 1995 and December 2000, we identified four cohorts of Medicare-insured kidney transplant recipients. Patients in cohort 1 were individuals who were both eligible and received lifetime coverage. Patients in cohort 2 would have been eligible, but their 3-year coverage expired before lifetime coverage was available. Patients in cohort 3 were ineligible for lifetime coverage because of youth or lack of disability. Patients in cohort 4 were transplanted between 1995 and 1996 and were ineligible for lifetime coverage. Incomes were categorized by ZIP code median household income from census data. Lifetime extension of Medicare immunosuppression was associated with improved allograft survival among low-income transplant recipients in the sense that the previously existing income-related disparities in graft survival in cohort 2 were not apparent in cohort 1. Ineligible individuals served as a control group; the income-related disparities in graft survival observed in the early cohort 4 persisted in more recent cohort 3. Multivariate proportional hazards models confirmed these findings. Future work should evaluate the cost effectiveness of these coverage increases, as well as that of benefits extensions to broader patient groups.

Pulsatile machine perfusion (PMP) has been shown to reduce delayed graft function (DGF) in expanded criteria donor (ECD) kidneys. Here, we investigate whether there is a cost benefit associated with PMP utilization in ECD kidney transplants. We analyzed United States Renal Data System (USRDS) data describing Medicare-insured ECD kidney transplant recipients in 1995-2004 (N = 5840). We examined total Medicare payments for transplant hospitalization and annually for 3 years posttransplant according to PMP utilization. After adjusting for other recipient, donor and transplant factors, PMP utilization was associated with a $2130 reduction (p = 0.007) in hospitalization costs. PMP utilization was also associated with lower DGF risk (p < 0.0001). PMP utilization did not predict differences in rejection, graft survival, patient survival, or costs at 1, 2 and 3 years posttransplant. PMP utilization is correlated with lower costs for the transplant hospitalization, which is likely due to the associated reduction in DGF among recipients of PMP kidneys. However, there is no difference in long-term Medicare costs for ECD recipients by PMP utilization. A prospective trial is necessary as it will help determine if the associations seen here are due to PMP utilization and not differences in the population studied.

We investigated graft and patient survival implications of simultaneous pancreas kidney (SPK) transplant from old donors. Data describing patients with type 1 diabetes mellitus listed for an SPK transplant from 1994 to 2005 were drawn from Organ Procurement and Transplant Network registries. Allograft survival, patient survival and long-term survival expectations among SPK recipients from young (age <45 years) and old (age >/=45 years) donors were modeled by multivariate regression. We also examined predictors of reduced early access to young donor transplants. Of 16 496 eligible SPK candidates, 8850 patients (53.6%) received an SPK transplant and 776 (8.8%) of these transplants were from old donors. Reasonable 5-year, death-censored kidney (77.8 %) and pancreas (71.3%) survivals were achieved with old donors. SPK transplantation from both young and old donors predicted lower mortality compared to continued waiting. An additional expected wait of 1.5 years for a young donor equalized long-term survival expectations to that achieved with use of old donors. Early allocation of young donor transplants declined in the more recent era and varied by region, candidate age, blood type and sensitization. We conclude that old SPK donors should be considered for patients with decreased access to young donor transplants. Prospective evaluation of this practice is needed.

The disparity between the organ supply and the demand for liver transplantation (LT) has resulted in the growing utilization of 'marginal donor' organs. While economic outcomes for subsets of 'marginal' organs have been described for renal transplantation, similar analyses have not been performed for LT. Using UNOS data for 17 710 LTs performed between 2002 and 2005, we assessed the relationship between recipient model for end-stage liver disease (MELD) score, organ quality as defined by donor risk index (DRI, Feng et al. 2005) and hospital length of stay (LOS). Single-center cost-accounting data for 338 liver transplants were then analyzed with a multivariate linear regression model to determine the estimated cost associated with a day of LOS. Overall, 8.4% of donor organs were classified as high risk (DRI > 2-2.5) and 1.9% as very high risk (DRI > 2.5). In the lowest MELD group (0-10), the LOS difference between 'ideal' donors (DRI < 1.0) and very high risk (DRI > 2.5) was 10.6 days which was associated with an estimated incremental cost of $47 986. For patients with MELD >35, the average LOS increased from 23.2 to 41.8 days when very high DRI donors were used, resulting in an estimated increase in cost of nearly $84 000. We conclude that the use of marginal liver grafts results in increased hospital costs independent of recipient risk factors.

Background: Comorbidity is an important prognostic factor for elderly patients with head and neck cancer. Investigators are faced with the dilemma of selecting the appropriate comorbidity instrument for outcomes research in cancer. The goal of this study was to compare 2 general comorbidity indices with 2 disease-specific indices., Methods: The Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked database was used to identify 15,493 patients with incident squamous cell carcinomas of the oral cavity, pharynx, and larynx first diagnosed between December 1983 and December 1994. Comorbid ailments were identified through the use of the International Classification of Diseases, 9th edition codes in the Medicare inpatient and outpatient claims for 7131 patients. The overall severity of comorbidity was classified according to 2 general comorbidity indices: the Charlson Comorbidity Index and the Klabunde Index, and 2 disease-specific indices: the Washington University Head and Neck Index and the Head and Neck Cancer Index. Overall survival was the primary end point. Cox proportional hazards analysis was used to assess the performance and discrimination of the comorbidity indices., Results: For each of the 4 comorbidity indices, there was a weak trend of worse survival with higher levels of comorbidity. The 2 general indices performed as well as the 2 disease-specific indices and no instrument clearly performed better than the others., Conclusion: Both the general and disease-specific comorbidity indices provided important prognostic information. The disease-specific indices did not perform better than the general indices. In this claims-based analysis, there was no apparent advantage to using a disease-specific index when attempting to predict overall survival.

The supply of kidneys does not meet the demand. As a consequence, the waiting time for a cadaver kidney continues to lengthen, and there is renewed debate about payment for living donors. To facilitate this debate, we studied what amount of payment would be cost-effective for society, i.e. what costs would be saved (if any) by removing a patient from the waiting list using a paid (living unrelated: LURD) donor-vendor. A Markov model was developed to calculate the expected average cost and outcome benefits of increasing the organ supply and reducing waiting times by adding paid LURD organs to the available pool. We found that a LURD transplant saved $94,579 (US dollars, 2002), and 3.5 quality-adjusted life years (QALYs) were gained. Adding the value of QALYs, a LURD transplant saved $269 319, assuming society values additional QALYs from transplantation at the rate paid per QALY while on dialysis. At a minimum, a vendor program would save society >$90,000 per transplant and provides QALYs for the ESRD population. Thus, society could break even while paying $90,000/kidney vendor.

There has been considerable recent debate concerning the reconfiguration of the cadaveric liver allocation system with the intent to allocate livers to more severely ill patients over greater distances. We sought to assess the economic implications of longer preservation times in cadaveric liver transplantation that may be seen in a restructured allocation system. A total of 683 patients with nonfulminant liver disease, aged 16 years or older, receiving a cadaveric donor liver as their only transplant, were drawn from a prospective cohort of patients who received transplants between January 1991 and July 1994 at the University of California, San Francisco, the Mayo Clinic, Rochester, Minnesota, or the University of Nebraska, Omaha. The primary outcome measure was standardized hospitalization resource utilization from the day of transplantation through discharge. Secondary outcome measures included 2-year patient survival, and 2-year retransplantation rates. Results indicated that each 1-h increase in preservation time was associated with a 1.4% increase in standardized hospital resource utilization (p = 0.014). The effects on 2-year patient survival and retransplantation rates were not measurably affected by an increase in preservation time. We conclude that policies that increase preservation time may be expected to increase the cost of liver transplantation.

Between 1993 and 1995, Medicare extended its coverage of maintenance immunosuppression medications following renal transplantation from 1 to 3 years. We hypothesized that Medicare's extension of immunosuppressive coverage would improve graft survival among low-income transplant recipients. We merged patient-level clinical data from the USRDS-distributed UNOS registry of kidney transplants throughout the USA with median family income for each patient's ZIP code from the 1990 Census. We were able to merge median incomes to 10,837 first cadaveric renal transplants performed in 1992-93 and 16,732 performed in 1995-97. Each of these chronological cohorts was divided into two groups, those with family incomes above (high-income group) and those below (low-income group) $36,033. There were no differences in graft survival at 1 year based on income in either chronological era. However, when Medicare covered immunosuppression medications for just 1 year, the low-income group of 1-year graft survivors had a 4.5% lower graft survival at the end of 3 years post-transplant (p < 0.001). During the 1995-97 period, during which Medicare provided 3 years' immunosuppression coverage, the low-income and high-income groups had equivalent graft survival at 3 years post-transplant.

Background: Recently the United Network for Organ Sharing (UNOS) began a pilot study to evaluate prospectively the merits of an allocation of cadaveric kidneys based on broader classes of HLA antigens, called cross-reactive groups (CREG). The objectives of the pilot study consider patient outcomes, but not the potential economic impact of a CREG-based allocation. This study predicts the impact of a CREG-based local allocation of cadaveric kidneys on 3-year Medicare payments and graft survival., Methods: The UNOS renal transplant registry was merged to Medicare claims data for 1991-1997 by the United States Renal Data System. Average accumulated Medicare payments and graft survival up to 3 years posttransplant for first cadaveric renal transplant recipients were stratified by cross-reactive group mismatch categories. The economic impact was defined as the difference in average 3-year costs per transplant between the current and proposed allocation algorithms. Average 3-year costs were computed as a weighted average of costs, where the weights were the actual and predicted distributions of transplants across cross-reactive group categories., Results: Results suggest that an organ allocation based on cross-reactive group matching criteria would result in a 3-year cost savings of $1,231 (2%) per transplant, and an average 3-year graft survival improvement of 0.6%., Conclusions: Cost savings and graft survival improvements can be expected if CREG criteria were to replace current criteria in the current allocation policy for cadaveric kidneys, although the savings appear to be smaller than may be achievable through expanded HLA matching.

Background: We found previously that the clinical advantages of living donor (LD) renal transplantation lead to financial cost savings compared to either cadaveric donation (CAD) or dialysis. Here, we analyze the sources of the cost savings of LD versus CAD kidney transplantation., Methods: We used United States Renal Data System data to merge United Network for Organ Sharing registry information with Medicare claims data for 1991-1996. Information was available for 42,868 CAD and 13,754 LD transplants. More than 5 million Medicare payment records were analyzed. We calculated the difference in average payments made by Medicare for CAD and LD for services provided during the first posttransplant year., Results: Average total payments were $39,534 and $24,652 for CAD and LD, respectively (P<0.0001) during the first posttransplant year. The largest source of the difference in payments was in inpatient hospitals, representing $10,653.67 (P<0.0001). For patients who had Medicare as the primary payer, average transplant charges were significantly higher for CAD donation ($79,730 vs. $69,547, P<0.0001); average transplant payments demonstrated no statistical differences ($28,483 vs. $28,447, P = 0.858). Therefore, inferred profitability was significantly higher for LD., Conclusions: Medicare payments are remarkably lower for LD compared to CAD in every category. The single largest cost saving comes from inpatient hospital services. A portion of the savings from LD could be invested in programs to expand living kidney donation.

Background: The potential economic effects of the allocation of cadaveric kidneys on the basis of tissue-matching criteria is controversial. We analyzed the economic costs associated with the transplantation of cadaveric kidneys with various numbers of HLA mismatches and examined the potential economic benefits of a local, as compared with a national, system designed to minimize HLA mismatches between donor and recipient in first cadaveric renal transplantations., Methods: All data were supplied by the U.S. Renal Data System. Data on all payments made by Medicare from 1991 through 1997 for the care of recipients of a first cadaveric renal transplant were analyzed according to the number of HLA-A, B, and DR mismatches between donor and recipient and the duration of cold ischemia before transplantation., Results: Average Medicare payments for renal transplant recipients in the three years after transplantation increased from 60,436 dollars per patient for fully HLA-matched kidneys (those with no HLA-A, B, or DR mismatches) to 80,807 dollars for kidneys with six HLA mismatches between donor and recipient, a difference of 34 percent (P<0.001). By three years after transplantation, the average Medicare payments were 64,119 dollars for transplantations of kidneys with less than 12 hours of cold ischemia time and 74,997 dollars for those with more than 36 hours (P<0.001). In simulations, the assignment of cadaveric kidneys to recipients by a method that minimized HLA mismatching within a local geographic area (i.e., within one of the approximately 50 organ-procurement organizations, which cover widely varying geographic areas) produced the largest cost savings (4,290 dollars per patient over a period of three years) and the largest improvements in the graft-survival rate (2.3 percent) when the potential costs of longer cold ischemia time were considered., Conclusions: Transplantation of better-matched cadaveric kidneys could have substantial economic advantages. In our simulations, HLA-based allocation of kidneys at the local level produced the largest estimated cost savings, when the duration of cold ischemia was taken into account. No additional savings were estimated to result from a national allocation program, because the additional costs of longer cold ischemia time were greater than the advantages of optimizing HLA matching.

Objective: This model introduces a unique and inexpensive technique to estimate profit increases that might be expected from: (i) an additional clinical trial to establish a drug's second clinical indication; and (ii) a survey of market demand., Design: Microsoft Excel spreadsheets are used to solicit selected expert opinions about the new product's annual market share under scenarios reflecting different pricing points, promotional expenditures and clinical advantage., Main Outcome Measures and Results: The preprogrammed model returns profit-maximising price, promotional expenditure and market differentiation for each expert and the group as a whole. The extent of disagreement among the experts is used to estimate the additional profits which might be expected from a clinical trial and a market survey. Results from an illustrative application indicated greater incremental profits could be expected from the survey of market demand. The clinical trial generated smaller expected incremental profits because several experts felt that the trial's potential results would not affect the drug's profit-maximising price., Conclusions: With a 1-day meeting between 6 experts, the model provided a recommendation about the new product's profit-maximising market price and promotional expenditure. Furthermore, it estimated profit increases that might be expected from additional clinical trials and a survey of market demand.

Objective: To examine differences in healthcare delivery by expected health insurance status for hospitalized patients in diagnosis-related group (DRG) 475, respiratory system diagnoses requiring intubation and continuous ventilator support., Design: A survey, derived from the Healthcare Cost and Utilization Project interstate database, of the care delivered to 21,149 adult patients in DRG 475 and hospitalized in one of 718 acute-care hospitals in nine states. Multivariate analysis was performed, controlling for demographic and hospital factors., Results: Patients insured by health maintenance organizations (HMOs) had significantly lower rates of inpatient mortality (odds ratio [OR], 0.84; 95% confidence interval [CI95], 0.73-0.96), 14.3 more procedures performed (CI95, 11.5-17.2), 7.0% shorter hospitalizations (CI95, 12.5-1.6), and 5.2% higher charges (CI95, 0.4-10.0) than those with traditional private insurance. In addition, patients insured by Medicaid had 3.5% more procedures performed (CI95, 1.6-5.4), 10.4% longer lengths of hospitalization (CI95, 6.7-14.0), and 13.8% higher charges (CI95, 10.6-17.0) than those with traditional private insurance. Finally, the uninsured had significantly lower rates of inpatient mortality (OR, 0.87; CI95, 0.77-0.99), 8.5% more procedures performed (CI95, 6.0-11.1), 16.5% shorter hospitalizations (CI95, 21.5-11.6), and 13.4% lower charges (CI95, 17.8-9.0) than those with traditional private insurance., Conclusion: Variations in healthcare measures by insurance status for this DRG emphasize the importance of more careful analyses of insurance categories as a determinant of healthcare access and outcomes. Expected insurance status was an independent predictor of cost. Private insurance and HMO populations differed significantly in outcome and cannot be considered equivalent.

Background: The total expense associated with acute myocardial infarction in the United States is substantial because of the combination of high volume and high cost per case. The aim of this study was to identify potential cost-saving strategies for the management of acute myocardial infarction., Methods: Information was gathered through professional interviews combined with an extensive literature review., Results: Numerous opportunities for cost savings were identified and classified into six categories: pharmaceuticals, changing the work within steps, corporate philosophy and clinical decision making, continuous physician education and involvement, preventive measures and systems of care, and additional resources., Conclusions: Although there are many possible areas healthcare providers could consider for cost saving in acute myocardial infarction, the situation at each site will need to be considered carefully before areas are selected. It is of vital importance that the quality of care not be compromised in the effort to reduce cost.

The potential benefits from allocating donated cadaveric kidneys based on donor and recipient cytomegalovirus (CMV) serology remain controversial. We estimated graft survival and recipient survival using bivariate Kaplan-Meier models and multivariate Cox proportional hazards models for 24,543 first cadaveric renal transplantations performed in the United States between 1989, coinciding with the introduction of ganciclovir, and 1994. The effects of donor and recipient CMV serology were estimated, and the implications of these estimates for CMV-based allocation of cadaveric kidneys were considered. From Kaplan-Meier estimates, the 3-year impact of CMV-seropositive donor kidneys was a 3.6% reduction in graft survival and a 2.4% reduction in recipient survival for CMV-seronegative recipients, and a 3.9% reduction in graft survival and a 3.0% reduction in recipient survival for CMV-seropositive recipients. Multivariate Cox analysis demonstrated an adverse impact of donor CMV seropositivity regardless of recipient CMV status. D-/R- CMV serologic pairs had the best 3-year outcomes, with 73.4% graft survival and 87.7% recipient survival. D+/R+ CMV serologic pairs were found to have the worst 3-year outcomes, with 68.4% graft survival and 83.1% recipient survival, and were significantly worse than D+/R- pairs in terms of recipient survival. The maximum estimated impact of a program allocating donor kidneys to maximize the number of D-/R- CMV serologic pairs, assuming no impact on HLA mismatches, was a 0.1% reduction in aggregate 3-year graft survival and a 0.2% reduction in aggregate recipient survival. An alternative program allocating donor kidneys to minimize the number of D+/R+ pairs had no estimated effect on either graft or recipient survival. We conclude that during the ganciclovir era, CMV continues to have an important impact on first cadaveric renal transplantation. However, even under ideal conditions, CMV-based kidney allocation to either maximize the number of D-/R- pairs or minimize the number of D+/R+ pairs is likely to provide little benefit to the population of cadaveric renal transplant recipients.