Article
Evaluation of a Renal Transplant Program for Incarcerated ESRD Patients
Journal of Correctional Health Care 2014, Vol. 20(3) 220-227 ª The Author(s) 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1078345814531726 jcx.sagepub.com
Mandip Panesar, MD1,2, Harpreet Bhutani, MD2, Nancy Blizniak, RN1, Aijaz Gundroo, MD1,2, Mareena Zachariah, MD1,2, William Pelley, MHA1, and Rocco Venuto, MD1,2
Abstract Renal transplantation (Tx) improves mortality and morbidity but is limited by availability of suitable organs. Clinical and economic impact of a Tx program for end-stage renal disease (ESRD) prisoners was evaluated. Wait list time and patient and organ survival rates were assessed. Twelve of the 104 ESRD prisoners at a prison dialysis unit were activated; 9 transplanted, 2 released active on the United Network for Organ Sharing list, and 1 died after listing. Kidneys from antibody-positive hepatitis C (HepC) donors were given to consenting HepC antibody-positive recipients. The average waiting period was 6.6 months for HepC-positive kidney recipients and 49.6 months for others. Compared with costs of continuing dialysis, Tx resulted in substantial savings. Patients with HepC experienced good graft and survival rates when given grafts from HepC donors, suggesting that transplantation is a viable, cost-effective option for the incarcerated patient with ESRD including those who have chronic HepC infection. Keywords end-stage renal disease, hepatitis C, incarcerated, renal transplantation, economics
Introduction Renal transplant is considered the best treatment option for patients with end-stage renal disease (ESRD) as it improves the quality and extends the life of recipients (Schnuelle, Lorenz, Trede, & Van Der Woude, 1998). According to the latest U.S. Renal Data System (USRDS) report, the first-year patient survival rate with a functioning graft ranges from 96% to 99%, depending on whether the allograft was from a deceased or living donor. Furthermore, transplant patient 5-year survival rate is 85% and 93%, while the 10-year survival is 62% and 78%, respectively (USRDS,
1 2
Transplant Unit, Erie County Medical Center, Buffalo, NY, USA School of Medicine and Biomedical Sciences, Nephrology Division, New York State University at Buffalo, Buffalo, NY, USA
Corresponding Author: Rocco C. Venuto, MD, Nephrology Unit, Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215 USA. Email: [email protected]
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2011). In contrast, for patients receiving maintenance dialysis the 5-year survival rate is about 30% to 50% in nondiabetics and only 25% in diabetics (USRDS, 2011). Renal transplantation is limited by the availability of suitable kidneys as reflected in the increasing nationwide median wait list times. The latest Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Annual Report shows the median time to transplant for new kidney waiting list registrations was 1,297 days (U.S. Department of Health and Human Services, Health Resources and Services Administration [HHS/HRSA], 2009). Consequently, extended donor criteria have been developed to expand the donor pool and many organ procurement organizations accept kidneys from HepC-positive donors to be transplanted into HepC-positive recipients. There are approximately 400,000 patients on dialysis in the United States, but this relatively small patient population consumes $23.9 billion per year or 5.8% of the annual Medicare budget (USRDS, 2011). The number of patients on dialysis is projected to increase to 533,800 by the year 2020 (Collins, Foley, Gilbertson, & Chen, 2009). Dialysis continues to be an economic burden to the U.S. health care budget and there is a strong impetus for transplantation, a cost-effective as well as a life-extending alternative (Wong et al., 2012). The Supreme Court interpreted the Eighth Amendment to the Constitution to imply that prisoners have equal rights to health care; consequently, prisoners in New York State and elsewhere with ESRD routinely receive chronic dialysis. The cost of providing dialysis care to the incarcerated is often greater than for the general population because of security issues. We established a transplant program at a maximum security state correctional facility. The objective of this study was to assess graft and patient survival rates, wait list times, donor sources, and projected cost differences between the patients remaining on dialysis and those who were transplanted. The economic and social implications of this transplant program are discussed.
Methods This retrospective chart review was approved by the Institutional Review Board at the State University of New York at Buffalo. In 2003, a protocol was implemented at a maximum security state prison for males to select incarcerated ESRD patients suitable for transplantation based on compliance and medical/psychiatric suitability (Figure 1). Compliance was determined by observation of their adherence to dialysis treatments and medications for 6 months by the dialysis interdisciplinary team and prison medical staff. The 6-month compliance was chosen to allow for the patients to adjust to the dialysis unit policies and regulations and for the interdisciplinary team members to conduct their independent assessments of the patient. The algorithm was divided into two arms: HepC-positive ESRD patients and HepC-negative ESRD patients. All prisoners with ESRD, regardless of hepatitis status, who were transferred to the correctional facility to begin dialysis were initially screened by the prison medical staff for HIV and immigration status. Social Security Act 1903(v)(2)(c)42usc1936(v) bars federal reimbursement for care and services related to transplant procedure for any alien who is not lawfully admitted for permanent residence or otherwise permanently residing in the United States (Schnuelle et al., 1998). If the patient was HIV positive, an illegal immigrant, or noncompliant, he was not considered for further evaluation for transplantation and remained on hemodialysis. Upon satisfactory completion of the 6-month observation period, the standard pre-Tx evaluation was initiated by the primary care physician for those patients who had negative hepatitis and serology. Once that testing was undertaken successfully, these compliant patients were referred to the transplant center to complete their evaluation (Table 1). Factors not considered for eligibility for transplantation were the length of the sentence or the type of crime committed. All patients were male, and their average age was 45 years. Data analyzed were collected from January 2003 through December 2009.
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ESRD patient on dialysis
Exclusion criteria: 1. Medically unsuitable 2. Documented noncompliance 3. Failed psychiatric clearance 4. Illegal immigrant status
Check HepC status
HepC antibody positive
HepC antibody negative
Check HepC viral load
Follow figure 2
Granted viral load undetectable
Continue dialysis detectable viral load
Dialysis unit monitors monthly labs Follow figure 2
Primary Care at correctional facility orders tests Gastroenterology consult for liver biopsy
Advanced cirrhosis
Work up completed Minimal/No cirrhosis
Patient referred for liver transplant
Satisfactory Placed on transplant list Offer treatment for HepC
Successful liver transplant
Not a candidate for liver transplant
Follow figure 2
No further evaluation
Follow figure 2
Figure 1. Transplant evaluation algorithm. (Figure 1. continued)
The second arm of the algorithm consisted of evaluating ESRD patients with HepC. Viral load was measured in all ESRD HepC antibody–positive patients. Those who had an undetectable level were considered for a transplant workup after the mandatory 6-month evaluation period. If viral replication
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Approval given by nephrologist
Department of Corrections physician agrees
Request for transplant evaluation sent to review board for approval
Granted
Denied
Primary Care at correctional facility orders tests
Continue dialysis
Work up completed
Final med/surg clearence at Transplant Center
Not satisfactory; not a candidate for transplant
Satisfactory; placed on transplant list DOC notified: Patient listed on transplant list
Approval for transplant given
Dialysis unit monitors monthly labs
Return to dialysis unit Continue to monitor for changes in transplant candidacy
DOC notified when kidney available
Figure 1. Continued.
was detectable, patients were referred to the gastroenterology service for a liver biopsy. If the liver biopsy was normal or showed changes up to early cirrhosis, patients were offered treatment for HepC. Treated patients and those who refused treatment because of expected limited benefit were considered eligible for further transplant evaluation. Patients with advanced cirrhosis were considered for possible liver transplant but not primary renal transplant. Patients with persistent HepC and otherwise eligible for transplant were offered the opportunity to receive an organ from HepC-positive donors. To measure the outcome of this transplant program, we performed a retrospective chart analysis of incarcerated hemodialysis patients to identify those patients who were referred to our transplant
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Table 1. Transplant Workup on Initial Visit. Basic transplant testing panel to include: ABO, HLA, serologies, immunology Second ABO to be drawn on a different day C-peptide, Coag Profile, Protein C, Protein S, Cardiolipin A, antiphospholipid antibody EKG/echocardiogram Abdominal ultrasound, PVR Chest X-ray (PA and lateral) Urine (C/S and UA) KUB PSA for male patients Mammogram/pelvic exam/Pap smear for female patients (yearly updates) Bowel examination Age 45 or less, stool cards 3 Barium enema (age > 45 or history) Flexible endoscopy (age > 45 or history) Colonoscopy (age > 50 or history) Cardiac clearance Stress test (treadmill/cardiolyte/persantine) PET scan (if indicated) Cardiac catheterization (required in all diabetic patients) Urologic clearance VCUG/urodynamics Bladder scan Pulmonary clearance PFT CT chest Note. ABO ¼ standard ABO blood typing; HLA ¼ human leukocyte antigen; PVR ¼ post voiding residual; KUB ¼ abdominal X-ray: kidney, ureters, bladder; PSA ¼ prostate specific antigen; PA ¼ posterior to anterior; C/S ¼ culture and sensitivity; UA ¼ urine analysis; PET ¼ positron emission tomography; VCUG ¼ voiding cystourethrogram; PFT ¼ pulmonary function tests; CT ¼ computerized tomography.
center for further analysis. Of the 104 patients who were on dialysis at any time during that period, 12 were referred to the transplant team and their charts were further analyzed for time accumulated on the United Network for Organ Sharing (UNOS) waiting list, recipient HepC status, compliance, and patient and organ survival rates. This represented approximately one third of the potentially eligible patients since more than 50 failed to meet the criteria to be considered for transplant. The cost of continued dialysis versus transplant was projected using the USRDS database.
Results Among the 12 ESRD patients who successfully completed the transplantation evaluation, 9 received kidneys. Of those who remained on the UNOS waiting list, two were released from prison and one expired. Of the nine transplanted patients, three received kidneys from a HepC-positive donor. Three patients were released from prison with a functioning allograft and no deaths posttransplant have been reported in our patient population. The 1-year posttransplant patient and organ survival rate was 100%. Three allografts failed before the completion of the fifth posttransplant year but none were due to noncompliance. Of the three grafts that failed, only one was from a HepC-positive donor and that graft had survived for more than 4 years (50 months). The other two grafts that failed had survived for 13 and 17 months, respectively. The average serum creatinine of the remaining functioning allografts was 1.43 mg/dl.
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The average waiting period on the UNOS list for the nine transplanted patients was 35.3 months. More specifically, the waiting period for HepC-positive kidney recipients was 6.6 months versus 49.6 months for those who received a non-HepC kidney. The average national annual cost for maintaining a patient (age group: 40 to 49) on chronic hemodialysis is $65,628 (Domı´nguez-Gil, Esforzado, Andre´s, Campistol, & Morales, 2012). The cost of care for the first-year posttransplant is $103,831 and subsequently averages $14,984 annually (Dom´ınguez-Gil et al., 2012). The expenditure calculated for a patient whose organ survival is 2 years is $118,815 versus $131,256 if the patient remained on dialysis. This represents an approximate overall cost reduction of $12,441 2 years posttransplant and $50,644 every year thereafter. In our patient population, already there had been 7 patient years survival beyond the first 2 years for an estimated savings of $354,508 when the study ended.
Discussion Chronic kidney disease has become a health issue of epidemic proportions. The economic impact has been equally dramatic. There has been enormous growth in the Medicare-funded dialysis program. The number of patients has increased from approximately 215,000 in 1991 to 362,000 in 2009 and is expected to reach 562,000 in 2020 (Collins et al., 2009). This growth is a consequence of the number of new patients beginning dialysis and to a lesser extent a reflection of an increase in the survival of patients. The overall survival rate of dialysis patients has not changed and remains approximately 34% at 5 years (USRDS, 2011). The annual cost of ESRD management is in excess of $23.9 billion, and this represents 5.8% of the Medicare budget (USRDS, 2011) even though these patients comprise only 2% of the Medicare population. It is predicted that dialysis will continue to strain already limited financial resources. Renal transplantation has shown to improve both the mortality and morbidity of ESRD patients (Goldberg, Simmerling, & Frader, 2007; Wong et al., 2012); however, there is a serious shortage of transplantable kidneys. To increase the availability of organs, donor criteria have been extended. These criteria include donors over 60 years of age or between 50 and 59 years of age who have died of a stroke, had a history of hypertension, or at the time of death had a creatinine of greater than 1.5 mg/dl. Furthermore, many centers in the United States allow for the transplantation of kidneys from HepC-positive donors to HepC-positive recipients. This practice has enhanced the possibility of HepC-positive patients who fail treatment for hepatitis to undergo renal transplantation. Studies in the recent past support the notion that renal transplantation in HepC-positive ESRD patients should be considered as the treatment of choice after appropriate counseling (Shrestha et al., 2010). Approximately 5.2 million people or 1.6% of the U.S. general population are infected with HepC. Surveys conducted in correctional facilities show a 23% to 39% prevalence of this infection in incarcerated people (Chak, Talal, Sherman, Schiff, & Saab, 2011). Patients who are HepC positive comprise about 12% of the general population with ESRD and these people have an annual increased risk of death between 10% and 18% when compared to HepC-negative patients on dialysis. Since there is a shortage of organs and the wait list is long, the advantage of timelier transplant may outweigh the risk of waiting the usual several years that elapses before a HepC-negative kidney becomes available. Transplanting HepC-positive kidney to HepC-positive recipient had no effect on survival or liver disease during the follow-up of about 10 years. In contrast, transplanting HepC-positive kidney to HepCnegative donor is unacceptable because of poor graft and patient survival (Domı´nguez-Gil et al., 2012). The benefit of implementing a transplant program for incarcerated ESRD patients was assessed. Specifically, we evaluated the functionality of the transplant program, its impact on patient survival, and its effect on patient compliance, and tabulated its economic advantage. First, over 10% of the ESRD patients evaluated were referred for a renal transplant and of these, 75% were transplanted. Of the remaining 25%, two patients were released from prison who were active on the UNOS list. Of the patients transplanted, 33% (three patients) received a HepC-positive kidney. The protocol
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employed appeared to drive a high transplant rate, identified potential candidates early, and enhanced the use HepC-positive kidneys that otherwise would likely have been discarded. Second, we measured the effect of having a systematic renal transplant program on survival of incarcerated ESRD patients. Cumulatively, 7 years of patient survival with functioning grafts beyond the initial costly 2-year period was already achieved in this 7-year study. Although three allografts had failed by the fifth year posttransplant, none of them were due to noncompliance. This algorithm, which helped identify compliant incarcerated ESRD patients early, was designed to predict the probability of future compliance. The average wait time in our study was 35 months, which was significantly lower than the average projected 2009 UNOS waiting period of 43.2 months (HHS/HRSA, 2009). The driving force behind the lower waiting period was the use of HepC-positive kidneys. The waiting period for HepC-positive kidney recipients was only 6.6 months, which substantially lowered our overall waiting time. Our results strengthen the notion that HepC-positive kidneys should be considered for HepC-positive recipients. Lastly, our program has resulted in a significant cost benefit. When the cost of maintaining a prisoner on hemodialysis was compared to the cost of transplantation, there was only a cost savings if the patient survived at least 2 years. If the kidney is rejected in the first year and the prisoner had to return to dialysis, the cost of transplantation would outweigh hemodialysis costs by about $38,000. However, if the organ was functional 2 years posttransplant, there was a $50,000 per year savings. These data suggest that if more incarcerated ESRD patients were transplanted, a substantial savings would result for the responsible government. We also speculate that the probability of recidivism would be reduced in those released from prison since they would be more employable. In summary, four major outcomes were achieved through the implementation of this systematic program: (1) patients gained a potential survival benefit via transplantation, (2) it reduced the wait list time, (3) patient compliance was achieved, and (4) there appeared to be a substantial economic benefit. To our knowledge, this is the first published triage algorithm designed for incarcerated ESRD patients to assess eligibility for renal transplantation that incorporated HepC-positive patients. In conclusion, we recognize the ongoing debate of transplanting incarcerated patients. Proponents for transplanting incarcerated patients argue that prisoners have not only a constitutional right according to the Eighth Amendment of the U.S. Constitution but also a moral right to this treatment modality. The counterargument is that transplanting prisoners is unfair since prisoners have been removed from society because of their criminal behavior and therefore should not be permitted to use this scarce resource. Our study neither supports nor refutes either premise; rather, it is an analysis of outcomes from a 7-year experience of a renal transplant program for incarcerated patients. Declaration of Conflicting Interests The authors disclosed the following potential conflict of interest with respect to the research, authorship, and/or publication of this article. Author Venuto has received consulting fees from NaphCare, Inc. For information about JCHC’s disclosure policy, please see the Self-Study Exam.
Funding The authors received no financial support for the research, authorship, and/or publication of this article.
References Chak, E., Talal, A. H., Sherman, K. E., Schiff, E. R., & Saab, S. (2011). Hepatitis C virus infection in USA: An estimate of true prevalence. Liver International, 31, 1090–1101. Collins, A. J., Foley, R. N., Gilbertson, D. T., & Chen, S. C. (2009). The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis. Clinical Journal of the American Society of Nephrology, 4, S5–S11. doi:10.2215/CJN.05980809
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Domı´nguez-Gil, B., Esforzado, N., Andre´s, A., Campistol, J. M., & Morales, J. M. (2012). Renal transplantation from donors with a positive serology for hepatitis C. Contributions to Nephrology, 176, 117–129. doi:10. 1159/000332392 Goldberg, A. M., Simmerling, M., & Frader, J. E. (2007). Why nondocumented residents should have access to kidney transplantation: Arguments for lifting the federal ban on reimbursement. Transplantation, 83, 17–20. Schnuelle, P., Lorenz, D., Trede, M., & Van Der Woude, F. J. (1998). Impact of renal cadaveric transplantation on survival in end-stage renal failure: Evidence for reduced mortality risk compared with hemodialysis during long-term follow-up. Journal of the American Society of Nephrology, 9, 2135–2141. Shrestha, Alice, Shrestha, Anne, Basarab-Horwath, C., McKane, W., Shrestha, B., & Raftery, A. (2010). Quality of life following live donor renal transplantation: A single centre experience. Annals of Transplantation, 15, 5–10. U.S. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation. (2009). 2009 annual report of the U.S. organ procurement and transplantation network and the scientific registry of transplant recipients: Transplant data 19992008. Rockville, MD: Author. U.S. Renal Data System. (2011). USRDS 2011 Annual data report: Atlas of chronic kidney disease and endstage renal disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Wong, G., Howard, K., Chapman, J. R., Chadban, S., Cross, N., Tong, A., . . . Craig, J. C. (2012). Comparative survival and economic benefits of deceased donor kidney transplantation and dialysis in people with varying ages and co-morbidities. PLoS One, 7, e29591. doi:10.1371/journal.pone.0029591
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Evaluation of a Renal Transplant Program for Incarcerated ESRD Patients
Journal of Correctional Health Care 2014, Vol. 20(3) 220-227 ª The Author(s) 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1078345814531726 jcx.sagepub.com
Mandip Panesar, MD1,2, Harpreet Bhutani, MD2, Nancy Blizniak, RN1, Aijaz Gundroo, MD1,2, Mareena Zachariah, MD1,2, William Pelley, MHA1, and Rocco Venuto, MD1,2
Abstract Renal transplantation (Tx) improves mortality and morbidity but is limited by availability of suitable organs. Clinical and economic impact of a Tx program for end-stage renal disease (ESRD) prisoners was evaluated. Wait list time and patient and organ survival rates were assessed. Twelve of the 104 ESRD prisoners at a prison dialysis unit were activated; 9 transplanted, 2 released active on the United Network for Organ Sharing list, and 1 died after listing. Kidneys from antibody-positive hepatitis C (HepC) donors were given to consenting HepC antibody-positive recipients. The average waiting period was 6.6 months for HepC-positive kidney recipients and 49.6 months for others. Compared with costs of continuing dialysis, Tx resulted in substantial savings. Patients with HepC experienced good graft and survival rates when given grafts from HepC donors, suggesting that transplantation is a viable, cost-effective option for the incarcerated patient with ESRD including those who have chronic HepC infection. Keywords end-stage renal disease, hepatitis C, incarcerated, renal transplantation, economics
Introduction Renal transplant is considered the best treatment option for patients with end-stage renal disease (ESRD) as it improves the quality and extends the life of recipients (Schnuelle, Lorenz, Trede, & Van Der Woude, 1998). According to the latest U.S. Renal Data System (USRDS) report, the first-year patient survival rate with a functioning graft ranges from 96% to 99%, depending on whether the allograft was from a deceased or living donor. Furthermore, transplant patient 5-year survival rate is 85% and 93%, while the 10-year survival is 62% and 78%, respectively (USRDS,
1 2
Transplant Unit, Erie County Medical Center, Buffalo, NY, USA School of Medicine and Biomedical Sciences, Nephrology Division, New York State University at Buffalo, Buffalo, NY, USA
Corresponding Author: Rocco C. Venuto, MD, Nephrology Unit, Erie County Medical Center, 462 Grider Street, Buffalo, NY 14215 USA. Email: [email protected]
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2011). In contrast, for patients receiving maintenance dialysis the 5-year survival rate is about 30% to 50% in nondiabetics and only 25% in diabetics (USRDS, 2011). Renal transplantation is limited by the availability of suitable kidneys as reflected in the increasing nationwide median wait list times. The latest Organ Procurement and Transplantation Network (OPTN)/Scientific Registry of Transplant Recipients (SRTR) Annual Report shows the median time to transplant for new kidney waiting list registrations was 1,297 days (U.S. Department of Health and Human Services, Health Resources and Services Administration [HHS/HRSA], 2009). Consequently, extended donor criteria have been developed to expand the donor pool and many organ procurement organizations accept kidneys from HepC-positive donors to be transplanted into HepC-positive recipients. There are approximately 400,000 patients on dialysis in the United States, but this relatively small patient population consumes $23.9 billion per year or 5.8% of the annual Medicare budget (USRDS, 2011). The number of patients on dialysis is projected to increase to 533,800 by the year 2020 (Collins, Foley, Gilbertson, & Chen, 2009). Dialysis continues to be an economic burden to the U.S. health care budget and there is a strong impetus for transplantation, a cost-effective as well as a life-extending alternative (Wong et al., 2012). The Supreme Court interpreted the Eighth Amendment to the Constitution to imply that prisoners have equal rights to health care; consequently, prisoners in New York State and elsewhere with ESRD routinely receive chronic dialysis. The cost of providing dialysis care to the incarcerated is often greater than for the general population because of security issues. We established a transplant program at a maximum security state correctional facility. The objective of this study was to assess graft and patient survival rates, wait list times, donor sources, and projected cost differences between the patients remaining on dialysis and those who were transplanted. The economic and social implications of this transplant program are discussed.
Methods This retrospective chart review was approved by the Institutional Review Board at the State University of New York at Buffalo. In 2003, a protocol was implemented at a maximum security state prison for males to select incarcerated ESRD patients suitable for transplantation based on compliance and medical/psychiatric suitability (Figure 1). Compliance was determined by observation of their adherence to dialysis treatments and medications for 6 months by the dialysis interdisciplinary team and prison medical staff. The 6-month compliance was chosen to allow for the patients to adjust to the dialysis unit policies and regulations and for the interdisciplinary team members to conduct their independent assessments of the patient. The algorithm was divided into two arms: HepC-positive ESRD patients and HepC-negative ESRD patients. All prisoners with ESRD, regardless of hepatitis status, who were transferred to the correctional facility to begin dialysis were initially screened by the prison medical staff for HIV and immigration status. Social Security Act 1903(v)(2)(c)42usc1936(v) bars federal reimbursement for care and services related to transplant procedure for any alien who is not lawfully admitted for permanent residence or otherwise permanently residing in the United States (Schnuelle et al., 1998). If the patient was HIV positive, an illegal immigrant, or noncompliant, he was not considered for further evaluation for transplantation and remained on hemodialysis. Upon satisfactory completion of the 6-month observation period, the standard pre-Tx evaluation was initiated by the primary care physician for those patients who had negative hepatitis and serology. Once that testing was undertaken successfully, these compliant patients were referred to the transplant center to complete their evaluation (Table 1). Factors not considered for eligibility for transplantation were the length of the sentence or the type of crime committed. All patients were male, and their average age was 45 years. Data analyzed were collected from January 2003 through December 2009.
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ESRD patient on dialysis
Exclusion criteria: 1. Medically unsuitable 2. Documented noncompliance 3. Failed psychiatric clearance 4. Illegal immigrant status
Check HepC status
HepC antibody positive
HepC antibody negative
Check HepC viral load
Follow figure 2
Granted viral load undetectable
Continue dialysis detectable viral load
Dialysis unit monitors monthly labs Follow figure 2
Primary Care at correctional facility orders tests Gastroenterology consult for liver biopsy
Advanced cirrhosis
Work up completed Minimal/No cirrhosis
Patient referred for liver transplant
Satisfactory Placed on transplant list Offer treatment for HepC
Successful liver transplant
Not a candidate for liver transplant
Follow figure 2
No further evaluation
Follow figure 2
Figure 1. Transplant evaluation algorithm. (Figure 1. continued)
The second arm of the algorithm consisted of evaluating ESRD patients with HepC. Viral load was measured in all ESRD HepC antibody–positive patients. Those who had an undetectable level were considered for a transplant workup after the mandatory 6-month evaluation period. If viral replication
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Approval given by nephrologist
Department of Corrections physician agrees
Request for transplant evaluation sent to review board for approval
Granted
Denied
Primary Care at correctional facility orders tests
Continue dialysis
Work up completed
Final med/surg clearence at Transplant Center
Not satisfactory; not a candidate for transplant
Satisfactory; placed on transplant list DOC notified: Patient listed on transplant list
Approval for transplant given
Dialysis unit monitors monthly labs
Return to dialysis unit Continue to monitor for changes in transplant candidacy
DOC notified when kidney available
Figure 1. Continued.
was detectable, patients were referred to the gastroenterology service for a liver biopsy. If the liver biopsy was normal or showed changes up to early cirrhosis, patients were offered treatment for HepC. Treated patients and those who refused treatment because of expected limited benefit were considered eligible for further transplant evaluation. Patients with advanced cirrhosis were considered for possible liver transplant but not primary renal transplant. Patients with persistent HepC and otherwise eligible for transplant were offered the opportunity to receive an organ from HepC-positive donors. To measure the outcome of this transplant program, we performed a retrospective chart analysis of incarcerated hemodialysis patients to identify those patients who were referred to our transplant
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Table 1. Transplant Workup on Initial Visit. Basic transplant testing panel to include: ABO, HLA, serologies, immunology Second ABO to be drawn on a different day C-peptide, Coag Profile, Protein C, Protein S, Cardiolipin A, antiphospholipid antibody EKG/echocardiogram Abdominal ultrasound, PVR Chest X-ray (PA and lateral) Urine (C/S and UA) KUB PSA for male patients Mammogram/pelvic exam/Pap smear for female patients (yearly updates) Bowel examination Age 45 or less, stool cards 3 Barium enema (age > 45 or history) Flexible endoscopy (age > 45 or history) Colonoscopy (age > 50 or history) Cardiac clearance Stress test (treadmill/cardiolyte/persantine) PET scan (if indicated) Cardiac catheterization (required in all diabetic patients) Urologic clearance VCUG/urodynamics Bladder scan Pulmonary clearance PFT CT chest Note. ABO ¼ standard ABO blood typing; HLA ¼ human leukocyte antigen; PVR ¼ post voiding residual; KUB ¼ abdominal X-ray: kidney, ureters, bladder; PSA ¼ prostate specific antigen; PA ¼ posterior to anterior; C/S ¼ culture and sensitivity; UA ¼ urine analysis; PET ¼ positron emission tomography; VCUG ¼ voiding cystourethrogram; PFT ¼ pulmonary function tests; CT ¼ computerized tomography.
center for further analysis. Of the 104 patients who were on dialysis at any time during that period, 12 were referred to the transplant team and their charts were further analyzed for time accumulated on the United Network for Organ Sharing (UNOS) waiting list, recipient HepC status, compliance, and patient and organ survival rates. This represented approximately one third of the potentially eligible patients since more than 50 failed to meet the criteria to be considered for transplant. The cost of continued dialysis versus transplant was projected using the USRDS database.
Results Among the 12 ESRD patients who successfully completed the transplantation evaluation, 9 received kidneys. Of those who remained on the UNOS waiting list, two were released from prison and one expired. Of the nine transplanted patients, three received kidneys from a HepC-positive donor. Three patients were released from prison with a functioning allograft and no deaths posttransplant have been reported in our patient population. The 1-year posttransplant patient and organ survival rate was 100%. Three allografts failed before the completion of the fifth posttransplant year but none were due to noncompliance. Of the three grafts that failed, only one was from a HepC-positive donor and that graft had survived for more than 4 years (50 months). The other two grafts that failed had survived for 13 and 17 months, respectively. The average serum creatinine of the remaining functioning allografts was 1.43 mg/dl.
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The average waiting period on the UNOS list for the nine transplanted patients was 35.3 months. More specifically, the waiting period for HepC-positive kidney recipients was 6.6 months versus 49.6 months for those who received a non-HepC kidney. The average national annual cost for maintaining a patient (age group: 40 to 49) on chronic hemodialysis is $65,628 (Domı´nguez-Gil, Esforzado, Andre´s, Campistol, & Morales, 2012). The cost of care for the first-year posttransplant is $103,831 and subsequently averages $14,984 annually (Dom´ınguez-Gil et al., 2012). The expenditure calculated for a patient whose organ survival is 2 years is $118,815 versus $131,256 if the patient remained on dialysis. This represents an approximate overall cost reduction of $12,441 2 years posttransplant and $50,644 every year thereafter. In our patient population, already there had been 7 patient years survival beyond the first 2 years for an estimated savings of $354,508 when the study ended.
Discussion Chronic kidney disease has become a health issue of epidemic proportions. The economic impact has been equally dramatic. There has been enormous growth in the Medicare-funded dialysis program. The number of patients has increased from approximately 215,000 in 1991 to 362,000 in 2009 and is expected to reach 562,000 in 2020 (Collins et al., 2009). This growth is a consequence of the number of new patients beginning dialysis and to a lesser extent a reflection of an increase in the survival of patients. The overall survival rate of dialysis patients has not changed and remains approximately 34% at 5 years (USRDS, 2011). The annual cost of ESRD management is in excess of $23.9 billion, and this represents 5.8% of the Medicare budget (USRDS, 2011) even though these patients comprise only 2% of the Medicare population. It is predicted that dialysis will continue to strain already limited financial resources. Renal transplantation has shown to improve both the mortality and morbidity of ESRD patients (Goldberg, Simmerling, & Frader, 2007; Wong et al., 2012); however, there is a serious shortage of transplantable kidneys. To increase the availability of organs, donor criteria have been extended. These criteria include donors over 60 years of age or between 50 and 59 years of age who have died of a stroke, had a history of hypertension, or at the time of death had a creatinine of greater than 1.5 mg/dl. Furthermore, many centers in the United States allow for the transplantation of kidneys from HepC-positive donors to HepC-positive recipients. This practice has enhanced the possibility of HepC-positive patients who fail treatment for hepatitis to undergo renal transplantation. Studies in the recent past support the notion that renal transplantation in HepC-positive ESRD patients should be considered as the treatment of choice after appropriate counseling (Shrestha et al., 2010). Approximately 5.2 million people or 1.6% of the U.S. general population are infected with HepC. Surveys conducted in correctional facilities show a 23% to 39% prevalence of this infection in incarcerated people (Chak, Talal, Sherman, Schiff, & Saab, 2011). Patients who are HepC positive comprise about 12% of the general population with ESRD and these people have an annual increased risk of death between 10% and 18% when compared to HepC-negative patients on dialysis. Since there is a shortage of organs and the wait list is long, the advantage of timelier transplant may outweigh the risk of waiting the usual several years that elapses before a HepC-negative kidney becomes available. Transplanting HepC-positive kidney to HepC-positive recipient had no effect on survival or liver disease during the follow-up of about 10 years. In contrast, transplanting HepC-positive kidney to HepCnegative donor is unacceptable because of poor graft and patient survival (Domı´nguez-Gil et al., 2012). The benefit of implementing a transplant program for incarcerated ESRD patients was assessed. Specifically, we evaluated the functionality of the transplant program, its impact on patient survival, and its effect on patient compliance, and tabulated its economic advantage. First, over 10% of the ESRD patients evaluated were referred for a renal transplant and of these, 75% were transplanted. Of the remaining 25%, two patients were released from prison who were active on the UNOS list. Of the patients transplanted, 33% (three patients) received a HepC-positive kidney. The protocol
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employed appeared to drive a high transplant rate, identified potential candidates early, and enhanced the use HepC-positive kidneys that otherwise would likely have been discarded. Second, we measured the effect of having a systematic renal transplant program on survival of incarcerated ESRD patients. Cumulatively, 7 years of patient survival with functioning grafts beyond the initial costly 2-year period was already achieved in this 7-year study. Although three allografts had failed by the fifth year posttransplant, none of them were due to noncompliance. This algorithm, which helped identify compliant incarcerated ESRD patients early, was designed to predict the probability of future compliance. The average wait time in our study was 35 months, which was significantly lower than the average projected 2009 UNOS waiting period of 43.2 months (HHS/HRSA, 2009). The driving force behind the lower waiting period was the use of HepC-positive kidneys. The waiting period for HepC-positive kidney recipients was only 6.6 months, which substantially lowered our overall waiting time. Our results strengthen the notion that HepC-positive kidneys should be considered for HepC-positive recipients. Lastly, our program has resulted in a significant cost benefit. When the cost of maintaining a prisoner on hemodialysis was compared to the cost of transplantation, there was only a cost savings if the patient survived at least 2 years. If the kidney is rejected in the first year and the prisoner had to return to dialysis, the cost of transplantation would outweigh hemodialysis costs by about $38,000. However, if the organ was functional 2 years posttransplant, there was a $50,000 per year savings. These data suggest that if more incarcerated ESRD patients were transplanted, a substantial savings would result for the responsible government. We also speculate that the probability of recidivism would be reduced in those released from prison since they would be more employable. In summary, four major outcomes were achieved through the implementation of this systematic program: (1) patients gained a potential survival benefit via transplantation, (2) it reduced the wait list time, (3) patient compliance was achieved, and (4) there appeared to be a substantial economic benefit. To our knowledge, this is the first published triage algorithm designed for incarcerated ESRD patients to assess eligibility for renal transplantation that incorporated HepC-positive patients. In conclusion, we recognize the ongoing debate of transplanting incarcerated patients. Proponents for transplanting incarcerated patients argue that prisoners have not only a constitutional right according to the Eighth Amendment of the U.S. Constitution but also a moral right to this treatment modality. The counterargument is that transplanting prisoners is unfair since prisoners have been removed from society because of their criminal behavior and therefore should not be permitted to use this scarce resource. Our study neither supports nor refutes either premise; rather, it is an analysis of outcomes from a 7-year experience of a renal transplant program for incarcerated patients. Declaration of Conflicting Interests The authors disclosed the following potential conflict of interest with respect to the research, authorship, and/or publication of this article. Author Venuto has received consulting fees from NaphCare, Inc. For information about JCHC’s disclosure policy, please see the Self-Study Exam.
Funding The authors received no financial support for the research, authorship, and/or publication of this article.
References Chak, E., Talal, A. H., Sherman, K. E., Schiff, E. R., & Saab, S. (2011). Hepatitis C virus infection in USA: An estimate of true prevalence. Liver International, 31, 1090–1101. Collins, A. J., Foley, R. N., Gilbertson, D. T., & Chen, S. C. (2009). The state of chronic kidney disease, ESRD, and morbidity and mortality in the first year of dialysis. Clinical Journal of the American Society of Nephrology, 4, S5–S11. doi:10.2215/CJN.05980809
Downloaded from jcx.sagepub.com at UNIV OF NORTH DAKOTA on May 28, 2015
Panesar et al.
227
Domı´nguez-Gil, B., Esforzado, N., Andre´s, A., Campistol, J. M., & Morales, J. M. (2012). Renal transplantation from donors with a positive serology for hepatitis C. Contributions to Nephrology, 176, 117–129. doi:10. 1159/000332392 Goldberg, A. M., Simmerling, M., & Frader, J. E. (2007). Why nondocumented residents should have access to kidney transplantation: Arguments for lifting the federal ban on reimbursement. Transplantation, 83, 17–20. Schnuelle, P., Lorenz, D., Trede, M., & Van Der Woude, F. J. (1998). Impact of renal cadaveric transplantation on survival in end-stage renal failure: Evidence for reduced mortality risk compared with hemodialysis during long-term follow-up. Journal of the American Society of Nephrology, 9, 2135–2141. Shrestha, Alice, Shrestha, Anne, Basarab-Horwath, C., McKane, W., Shrestha, B., & Raftery, A. (2010). Quality of life following live donor renal transplantation: A single centre experience. Annals of Transplantation, 15, 5–10. U.S. Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation. (2009). 2009 annual report of the U.S. organ procurement and transplantation network and the scientific registry of transplant recipients: Transplant data 19992008. Rockville, MD: Author. U.S. Renal Data System. (2011). USRDS 2011 Annual data report: Atlas of chronic kidney disease and endstage renal disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases. Wong, G., Howard, K., Chapman, J. R., Chadban, S., Cross, N., Tong, A., . . . Craig, J. C. (2012). Comparative survival and economic benefits of deceased donor kidney transplantation and dialysis in people with varying ages and co-morbidities. PLoS One, 7, e29591. doi:10.1371/journal.pone.0029591
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