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Kidney/Pancreas Transplantation 1

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Kidney/Pancreas Transplantation 1

  1. 1. Kidney/Pancreas Transplantation Pancreas transplantation is the only known treatment that restores continuous euglycemic control in Type I diabetics. The incidence of kidney/pancreas and pancreas alone transplantation is 4.8/1,000,000 population. 1,387 patients underwent kidney/pancreas or pancreas alone transplantation at 124 centers in the United States in 2006. Kidney/pancreas (SPK) and pancreas transplantation (PAK & PTA) accounted for 5.5% of the solid organ transplants performed in the United States in 2004. As of November 13th, 2007 there were 3,982 patients awaiting kidney/pancreas or pancreas transplantation. There are two types of kidney/pancreas transplants: simultaneous pancreas kidney (SPK) and pancreas after kidney (PAK). They differ in the timing. With SPK, both organs are transplanted at the same time. With PAK, the pancreas is transplanted as a planned separate procedure that is usually done several months following a successful kidney transplant. Different centers have different philosophies on how kidney/pancreas transplantation is best managed. Historically, graft survival following SPK has been superior to PAK. But, with current immunosuppression and surgical techniques, this advantage may no longer be present. Thus, many centers will determine whether they will do an SPK or PAK based on organ availability. Typically, SPK is done using a deceased donor kidney and pancreas from the same donor. Frequently, PAK is done using a living donor kidney. This has the advantage that it can be a scheduled procedure. A deceased donor pancreas is used for the pancreas transplant. The timing of the pancreas transplant is dependent on the availability of the deceased donor pancreas. Pancreas transplant alone (PTA) is typically done for brittle diabetics without renal failure. (See “Indications for Pancreas Transplantation Alone (PTA)” later in this discussion.). UNOS and OPTN report PAK along with PTA as “pancreas” transplants. They reserve the term “kidney/pancreas” for SPK. This is important to remember when looking at center specific data on graft and patient survival, wait times, etc. Islet cell transplantation is considered to be an investigational procedure. It is confined to a relatively small number of centers. Islet cell transplantation is not typically reimbursed by most, if not all, insurance carriers. The indications for islet cell transplantation are the same as the other types of pancreas transplantation. What’s New? 1. Updated first year billed charges from Milliman: See tables at the end of this Quick Reference Guide. We have included the 2006 estimated billed charges for kidney/pancreas (SPK) and pancreas (PTA & PAK) transplants. 1
  2. 2. Kidney/Pancreas Transplantation 2. New Medicare National Coverage Determination (NCD) for Islet Cell Transplantation: NCD for Islet Cell Transplantation in the Context of a Clinical Trial (260.3.1), October 1, 20041: “Medicare will pay for the routine costs, as well as transplantation and appropriate related items and services, for Medicare beneficiaries participating in a National Institutes of Health (NIH)-sponsored clinical trial(s). The term `routine costs' means reasonable and necessary routine patient care costs, including immunosuppressive drugs and other follow- up care, as defined in section 310.1 of the NCD Manual.” “Specifically, Medicare will cover transplantation of pancreatic islet cells, the insulin producing cells of the pancreas. Coverage will include the costs of acquisition and delivery of the pancreatic islet cells, as well as clinically necessary inpatient and outpatient medical care and immunosuppressants.” For the complete information on Medicare coverage for SPK, PAK, PTA and islet cell transplantation please refer to CMS Manual System, Publication 100-3, Medicare National Coverage Determinations, Transmittal 18, July 30, 2004 at http://www.cms.hhs.gov/manuals/pm_trans/R18NCD.pdf. This reference contains the complete and updated text of Section 260.3.1 of the Medicare National Coverage Determinations Manual pertaining to pancreas and islet cell transplantation. Many payers use Medicare NCDs for guidance when making their own coverage determinations for unusual conditions or procedures. Diseases That Are Associated with Kidney/Pancreas and Pancreas Alone Transplantation Adults: Condition Type of Transplant Type I diabetes mellitus Pancreas transplant alone (PTA) ICD9: 250.xx but 250.x3 Islet cell transplant in particular indicating poor control Type I diabetes with end stage Simultaneous pancreas/kidney transplant (SPK) renal disease (ESRD) Pancreas transplant after kidney transplant (PAK) 1 http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=260.3.1&ncd_version=1&basket=ncd%3A260%2E3% 2E1%3A1%3AIslet+Cell+Transplantation+in+the+Context+of+a+Clinical+Trial. October 1, 2004. Accessed 21 July 2005 2
  3. 3. Kidney/Pancreas Transplantation Condition Type of Transplant ICD9: 250.xx and 585 in any order Other S/P pancreas transplant ICD9: V42.83, 996.86 Pancreas graft failure Pediatrics: Pancreas transplants are not typically performed in children under the age of 18. Of the 1,387 pancreas transplants performed in the US in 2006, only 40 were performed in children. Three centers have performed most of the pancreas transplants in children: Jackson Memorial Hospital, Clarian Health Partners in Indiana and Children’s Hospital of Pittsburgh. • Jackson Memorial performed 21 pancreas transplants in children, including 2 kidney/pancreas transplants. • Clarian Health Partners of Indiana performed 5 pancreas transplants in children. • Children’s Hospital of Pittsburgh performed 8 pancreas transplants in children, including 1 kidney/pancreas transplant. Jackson Memorial, Clarian Health Partners of Indiana, and Children’s Hospital of Pittsburgh are participating providers for pediatric pancreas transplantation in the INTERLINK Transplant Network. Children’s Hospital of Pittsburgh and Jackson Memorial are participating providers for pediatric small intestine/multivisceral transplantation. (Jackson Memorial is also a participating provider for adult small intestine/multivisceral transplantation.) Patient Selection Criteria There is a high degree of variability among centers in the application of selection criteria for patients undergoing kidney/pancreas transplantation. Each center may evaluate the same patient and make different recommendations. This is due to the fact that this is a relatively newly accepted treatment, even though the procedure has been done for a number of years in a small number of centers. The surgical techniques have evolved rapidly over the past several years, as has the immunosuppression. Each center will have a different level of experience. Many have active research protocols looking into different facets of pancreas transplantation, including islet cell transplantation. All of this will influence how any given center evaluates a patient and the treatment recommendations that are made. Absolute or relative contraindications at one center may be acceptable at another, more experienced center. 3
  4. 4. Kidney/Pancreas Transplantation Indications for Kidney/Pancreas Transplantation (SPK and PAK) Since kidney/pancreas and pancreas transplantation are the only known treatments that can restore euglycemia in Type I diabetics and slow the progression of diabetic complications, pancreas transplantation is indicated in all patients in whom the risks of transplantation and of chronic immunosuppression are less than the risk of continued diabetic complications. Indications for Pancreas Transplantation Alone (PTA) The principal indication for PTA is uncontrolled/brittle diabetes in a patient with Type I diabetes who does not have kidney failure. This is typically a younger person who has not been diabetic long enough to develop significant kidney disease. These patients will have difficultly controlling diabetes, demonstrated by frequent episodes of hypoglycemia severe enough to require medical attention and hypoglycemic unawareness. These patients should demonstrate that they are compliant with a strict control regimen, and that in spite of their efforts, the dosage of exogenous insulin sufficient to control their diabetes produces frequent hypoglycemia. Hypoglycemic unawareness is a particular concern. In these patients, the benefits of enhanced glycemic control and freedom from hypoglycemic episodes needs to outweigh the risks of the procedure and chronic immunosuppression. Contraindications for Kidney/Pancreas and Pancreas Transplantation Solid Organ Transplantation: General Contraindications2 • Active infection • Malignant disease - patients should be tumor-free for at least three years prior to consideration for transplantation (this may vary by center) • HIV (this may vary by center) • Active peptic ulcer disease • Active drug, tobacco or alcohol abuse • Severe, irreversible organ system damage other than organ to be transplanted • Evidence of psychopathology • Inability to understand the procedure or the risks involved or comply with follow-up care • History of failure to comply with medical regimen • Lack of functional psychosocial support system 2 Cowan PA, Wicks MN, Rutland TC, Ammons J and Hathaway DK. “Pancreas Transplantation.” Organ Transplantation 2002 17 June 2002. 20 June 2003 http://www.medscape.com/viewarticle/436542. 4
  5. 5. Kidney/Pancreas Transplantation • Lack of financial resources to pay for surgery, hospitalizations, medications and follow-up care SPK, PAK and PTA: Absolute Contraindications • Uncorrectable coronary artery disease • Advanced peripheral vascular disease • Refractory congestive heart failure • Active infection • HBV surface Ag positive • Irreversible hepatic or pulmonary disease • Severe systemic illness that threatens recovery or otherwise limit life-expectancy • Diabetes adequately controlled with insulin SPK, PAK and PTA: Relative Contraindications • Advanced vascular disease that is remedial • Advanced autonomic neuropathy • Extreme obesity (> 150 percent of ideal body weight) • Recent retinal hemorrhage • Active smoking • Age < 18 years or > 60 years • Blindness • Major amputation • CVA • Corrected coronary artery disease 5
  6. 6. Kidney/Pancreas Transplantation Time to Transplant New Kidney-Pancreas (SPK) Waiting List Registrations, 1996 to 2005 Blood Year of Waiting List Registration Type 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 All Number of Registrations 1,379 1,412 1,535 1,805 2,007 1,788 1,743 1,646 1,731 1,790 10th Percentile of TT (Days) 50 55 48 64 68 65 63 63 48 48 25th Percentile of TT (Days) 138 154 147 176 224 179 180 177 150 135 Median TT (Days) 375 380 404 448 543 492 471 454 428 + O Number of Registrations 682 689 770 859 975 851 872 803 817 876 10th Percentile of TT (Days) 40 57 52 79 91 76 73 75 60 66 25th Percentile of TT (Days) 127 147 157 206 296 215 222 215 180 192 Median TT (Days) 385 389 449 497 680 595 553 539 535 + A Number of Registrations 490 514 550 673 728 625 610 594 634 654 10th Percentile of TT (Days) 54 44 41 52 55 52 52 47 31 36 25th Percentile of TT (Days) 126 151 135 140 167 161 138 138 107 101 Median TT (Days) 298 338 329 389 418 360 355 366 323 351 B Number of Registrations 164 155 170 210 246 258 202 193 217 187 10th Percentile of TT (Days) 95 150 57 101 71 68 105 80 59 51 25th Percentile of TT (Days) 267 298 158 226 246 183 226 241 190 168 Median TT (Days) 921 797 484 511 607 552 801 712 520 + AB Number of Registrations 43 54 45 63 58 54 59 56 63 73 10th Percentile of TT (Days) 55 26 22 24 36 36 43 48 48 17 25th Percentile of TT (Days) 102 77 114 90 108 77 106 105 78 68 Median TT (Days) 474 310 259 195 287 309 210 208 214 264 Source: OPTN/SRTR Data as of May 1, 2006. (+) = Not determined due to insufficient follow-up; fewer than this percentile have transplanted. TT = Time to Transplant in days. a. This table takes a cohort of waiting list registrations and shows how long it takes for 10%, 25%, and 50% (the median) of those patients to be transplanted. b. These tables take the point of view of a patient who has just been registered on a waiting list and take into account all of the things that can happen to the patient after wait listing, including receiving a transplant, being removed from the waiting list, and dying. 6
  7. 7. Kidney/Pancreas Transplantation New Pancreas Transplant Alone (PTA) Waiting List Registrations, 1996 to 2005 Blood Year of Waiting List Registration Type 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 All Number of Registrations 154 187 217 219 266 336 301 322 360 371 10th Percentile of TT (Days) 35 25 24 15 8 24 17 13 18 18 25th Percentile of TT (Days) 165 105 87 55 49 108 58 57 85 83 Median TT (Days) 374 498 283 190 290 751 300 348 376 + O Number of Registrations 68 78 91 102 111 167 142 157 157 153 10th Percentile of TT (Days) 58 28 37 27 13 45 31 12 32 21 25th Percentile of TT (Days) 213 171 98 82 64 150 88 67 145 135 Median TT (Days) 526 602 450 241 327 621 501 418 507 + A Number of Registrations 62 83 88 89 116 129 115 122 149 167 10th Percentile of TT (Days) 19 25 21 7 4 18 3 11 6 18 25th Percentile of TT (Days) 162 88 76 45 38 62 49 44 55 76 Median TT (Days) 369 376 202 149 256 + 161 233 260 290 B Number of Registrations 18 20 27 23 27 30 33 31 42 32 10th Percentile of TT (Days) 48 49 26 18 11 45 31 49 15 32 25th Percentile of TT (Days) 99 109 112 52 49 143 91 86 60 72 Median TT (Days) + 735 231 169 293 751 524 583 311 281 AB Number of Registrations 6 6 11 5 12 10 11 12 12 19 10th Percentile of TT (Days) 9 1 18 3 10 1 23 30 82 9 25th Percentile of TT (Days) 15 1 50 14 11 44 32 39 102 32 Median TT (Days) 21 143 157 154 189 + 58 138 + 117 Source: OPTN/SRTR Data as of May 1, 2006. (+) = Not determined due to insufficient follow-up; fewer than this percentile have transplanted. TT = Time to Transplant in days. a. This table takes a cohort of waiting list registrations and shows how long it takes for 10%, 25%, and 50% (the median) of those patients to be transplanted. b. These tables take the point of view of a patient who has just been registered on a waiting list and take into account all of the things that can happen to the patient after wait listing, including receiving a transplant, being removed from the waiting list, and dying. 7
  8. 8. Kidney/Pancreas Transplantation New Pancreas After Kidney (PAK) Waiting List Registrations, 1996 to 2005 Blood Year of Waiting List Registration Type 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 All Number of Registrations 128 141 179 309 523 613 596 593 624 517 10th Percentile of TT (Days) 34 21 14 24 29 51 37 47 33 36 25th Percentile of TT (Days) 95 49 54 67 92 139 124 142 137 164 Median TT (Days) 299 219 218 219 463 551 594 500 575 + O Number of Registrations 38 70 72 132 220 275 273 270 285 254 10th Percentile of TT (Days) 53 39 37 37 50 84 77 66 56 74 25th Percentile of TT (Days) 156 115 137 85 130 189 213 212 184 264 Median TT (Days) 377 342 492 289 623 817 922 758 632 + A Number of Registrations 68 53 82 129 222 241 218 227 246 197 10th Percentile of TT (Days) 26 6 6 24 20 43 21 28 23 20 25th Percentile of TT (Days) 77 24 31 70 73 113 87 122 119 131 Median TT (Days) 194 145 134 197 4102 489 395 362 487 + B Number of Registrations 18 11 17 37 58 74 85 73 67 47 10th Percentile of TT (Days) 56 67 11 14 11 20 52 44 31 27 25th Percentile of TT (Days) 86 85 54 52 64 84 160 109 102 87 Median TT (Days) 173 354 198 369 197 334 752 346 + 217 AB Number of Registrations 4 7 8 11 23 23 20 23 26 19 10th Percentile of TT (Days) 2 3 4 14 38 15 6 47 7 10 25th Percentile of TT (Days) 2 23 20 21 53 66 42 110 66 65 Median TT (Days) 202 38 116 127 468 561 124 257 298 323 Source: OPTN/SRTR Data as of May 1, 2006. (+) = Not determined due to insufficient follow-up; fewer than this percentile have transplanted. TT = Time to Transplant in days. a. This table takes a cohort of waiting list registrations and shows how long it takes for 10%, 25%, and 50% (the median) of those patients to be transplanted. b. These tables take the point of view of a patient who has just been registered on a waiting list and take into account all of the things that can happen to the patient after wait listing, including receiving a transplant, being removed from the waiting list, and dying. 8
  9. 9. Kidney/Pancreas Transplantation Adjusted Patient and Graft Survival Following SPK, PAK and PTA (PTA) = Pancreas transplant alone (PAK) = Pancreas after kidney (SPK) = Simultaneous kidney pancreas 3 Months 1 Year 3 Years 5 Years N % Std. Err. N % Std. Err. N % Std. Err. N % Std. Err. Graft (PTA) 225 87.6% 2.20% 225 73.2% 3.00% 241 66.4% 3.20% 136 52.2% 4.80% Graft (PAK) 763 86.9% 1.20% 763 78.7% 1.50% 1,439 67.6% 1.50% 1,958 56.4% 1.60% Graft K (SPK) 1,746 95.5% 0.50% 1,746 91.8% 0.70% 3,534 85.1% 0.70% 5,372 76.4% 0.80% Graft P (SPK) 1,746 89.2% 0.70% 1,746 85.2% 0.90% 3,534 79.3% 0.80% 5,372 71.2% 0.80% Patient (PTA) 195 100.0% 18.30% 195 99.9% 46.80% 411 91.6% 1.60% 590 90.6% 1.60% Patient (PAK) 600 98.3% 0.50% 600 95.5% 0.80% 1,123 90.0% 1.10% 1,483 83.4% 1.40% Patient (SPK) 1,728 97.8% 0.40% 1,728 95.3% 0.50% 3,497 90.8% 0.60% 5,317 85.8% 0.60% Source: OPTN/SRTR Data as of May 1, 2006. a. (+) = Values not determined due to insufficient follow-up. b. (-) = Values not determined since there were no transplants in the category. c. Cohorts are transplants performed during 2001-2002 for 3 month and 1 year; 1999-2000 for 3 year; and 1997-1998 for 5 year survival. d. Graft survival follows individual transplants until graft failure. Counts for patient and graft survival are different because a patient may have more than one transplant fora type of organ. e. Center volume = Center's yearly transplants performed during the base period, based on lung and heart-lung transplants. f. Multi-organ transplants are excluded. g. Survival rates are adjusted to the characteristics of the 3 month and 1 year cohort. 9
  10. 10. Kidney/Pancreas Transplantation Average Billed Charges Estimated US average billed charges per kidney transplant as of June 2005, from evaluation through the first year following transplantation: 3 Kidney/Pancreas (SPK): Evaluation $ 13,700 Procurement 159,500 Hospital 95,100 Physician 23,000 Follow-up 45,100 Immunosuppressant 32,800 Total $369,200 Pancreas (PTA and PAK): Evaluation $ 13,700 Procurement 92,200 Hospital 135,600 Physician 23,000 Follow-up 45,100 Immunosuppressant 32,900 Total $342,500 3 2006 US Organ and Tissue Transplant Cost Estimates and Discussion. http://www.milliman.com. Milliman. April 19, 2006. 10

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