Medical Policy



Subject: Autologous and Allogeneic Pancreatic Islet Cell Transplantation
Document #: TRANS.00010 Current Effective Date:    03/29/2017
Status: Reviewed Last Review Date:    02/02/2017

Description/Scope

This document addresses autologous and allogeneic pancreatic islet cell transplantation. Islet cell transplantation involves the collection and infusion of isolated pancreatic islet cells into the portal vein of the liver. The goals of islet cell transplantation are to preserve endocrine function, glycemic control and to improve quality of life.

Note: For information on whole pancreas organ transplantation, please see:

Position Statement

Medically Necessary:

Autologous pancreatic islet cell transplantation is considered medically necessary as an adjunct to a total or near total pancreatectomy for individuals with chronic pancreatitis.

Investigational and Not Medically Necessary:

Autologous pancreatic islet cell transplantation is considered investigational and not medically necessary when the above criteria are not met and for all other indications.

Allogeneic pancreatic islet cell transplantation is considered investigational and not medically necessary for all indications.

Note: For multi-organ transplant requests, criteria must be met for each organ requested. In those situations, an individual may present with a concurrent medical condition which would be considered an exclusion or a comorbidity that would preclude a successful outcome, but would be treated with the other organ transplant. Such cases will be reviewed on an individual basis for coverage determination to assess the member's candidacy for transplantation.

Rationale

Islet cells are obtained from the resected pancreas by injecting a collagenase solution into the pancreas, which frees the cells from acinar tissue. The resultant dispersed pancreatic islet tissue is collected, washed and diluted in plasma. Most often the plasma is then injected slowly into the portal vein of the liver. In some cases, islet cells are transplanted elsewhere in the peritoneal cavity, for example, beneath the kidney capsule.

Chronic Pancreatitis

A total or near-total pancreatectomy can relieve pain from chronic pancreatitis, but also results in insulin dependent diabetes. Autologous islet cell transplantation as an adjunct to a total or near-total pancreatectomy is a technique used to salvage and transplant beta cells which may prevent complications of chronic diabetes. Bellin and colleagues (2012) noted "Because some acinar and ductal tissue is co-transplanted with the islets, islet autotransplant should be avoided if pancreatectomy is performed for malignancy of the pancreas."

Gruessner and colleagues (2004) performed 64 islet autotransplants (IATs) as an adjunct to total pancreatectomy (TP). Results indicated that islet autotransplants performed at the time of total pancreatectomy in individuals who had not previously received operations on the body and tail of the pancreas were associated with a high islet yield. Greater than 70% of these recipients achieved complete insulin independence.  In contrast, individuals with a history of a previous distal pancreatectomy or Puestow drainage procedure (lengthwise attachment of cleared pancreatic duct to the small intestine) had a low islet yield.  Less than 20% of these recipients achieved complete insulin independence. The authors noted there was no data available regarding the use of allogeneic islet cell transplantation to treat individuals who had a previous pancreatectomy for chronic pancreatitis.

In 2008, Sutherland and colleagues studied outcomes for 173 autologous islet cell recipients after complete pancreatectomy compared with those of allogeneic islet cell recipients in the Collaborative Islet Transplant Registry (CITR). The authors concluded that islet cell function is more resilient in autografts than allografts. They noted that the 5-year insulin-independence persistence rate for autografts is similar to the 2-year rate for allografts. Several factors unique to allograft cases are likely responsible for the outcome differences, including longer cold ischemia time, diabetogenic immunosuppression, and auto- and alloimmunity.

Dong and colleagues (2011) published a systematic review and meta-analysis of studies on IAT after TP or partial pancreatectomy (PP) with a focus on assessing insulin independence, mortality and metabolic outcomes. A total of 99 studies were eligible and 15 observational studies met inclusion criteria. A total of 10 studies involved IAT after TP, 2 studies involved IAT after PP, and 2 studies involved IAT after either TP or PP. From 13 of these studies, a total of 354 individuals with IAT post-TP for chronic pancreatitis were included. In an analysis of the pooled data, the rate of insulin dependence at last follow-up was 4.6 per 100 person-years (95% confidence interval [CI], 1.53-7.62). Ten studies reported transient insulin independence during studies at a rate of 8.34 per 100 person-years (95% CI, 3.32-13.37) with a duration of 15–57 months (95% CI, 10.35-20.79 months). Pooled data from 5 studies reported a 1-year rate of insulin independence was 27% (95% CI, 21-33%) and at 2 years was 21% (95% CI, 16-27%) based on 3 studies. The mortality rate at 30 days was 5% (95% CI, 2-10%) and at last follow-up the rate was 1.38 per 100 person-years (95% CI, 0.66-2.11). The cumulative mortality at 1 year (based on 10 studies) was 4.9% (95% CI, 2.6-7.3%) and at 2 years it was 6.2% (95% CI, 3.3-9.2%) which was based on 5 studies. Three studies reported mean or median HbA1c levels of 7%, 6.9% and 6.4% at 1 year. However, the data for C-peptide levels were insufficient for meta-analysis. For IAT after PP, the rate of insulin independence at last follow-up was 24.28 per 100 person-years (95% CI, 0.00-48.96). There were no events in 30 individuals at 30 days, resulting in a 30-day mortality rate of 0. At last follow-up, the cumulative mortality rate of IAT after PP was 0.70 per 100 person-years (95% CI, 0.00-1.80). The authors note this is the first systematic review and meta-analysis regarding IAT after pancreatectomy and the effect on insulin independence and mortality. The limitations of the analysis include heterogeneous methods, techniques, length of follow-up, lack of controls and the small number of events. Additional prospective trials with comprehensive data collection were recommended to further assess the risk and benefits of IAT as to improve the risk and benefit ratios.

In 2012, Sutherland and colleagues reported data from a large single center series of 409 individuals with chronic pancreatitis who were treated between 1977 and 2011 with TP and IAT to relieve pain and preserve β-cell mass. Fifty-three of the 409 participants (13%) were children between the ages of 5 and 18 years. Post TP and IAT actuarial survival at 1 year was 96% in adults and 98% in children, and 5-year survival was 89% in adults and 98% in children. Overall, at 15 years post-surgery, two-thirds (66%) of the individuals were reported alive. Insulin independence at 3 years was noted in 30% of individuals (25% of adults and 55% of children), while partial function was reported in 33%. Surgical complications requiring reoperation during the initial admission occurred in a total of 15.9% of the individuals, with bleeding as the most common reason for reoperation experienced in 9.5%. There were a total of 5 (1.2%) in-hospital deaths, and 53 deaths following initial discharge with 3 of those deaths related to chronic pancreatitis disease processes.  Insulin independence at 6 months was observed in 25% of individuals, 33% had partial islet function and less than one-fifth were dependent on insulin. Narcotic use for pain control declined after TPIAT with the number of individuals requiring narcotics, 91%, 61%, 54% and 51% at 3, 6, 12 and 24 months, respectively. A survey of integrated quality-of-life (QOL) outcomes, initiated in October 2008, had 219 participants eligible to participate and 193 completed the survey. At 1 year, 85% of the participants reported improvement compared to the prior year. The authors concluded TP alleviates pain caused by CP and IAT can help to preserve glycemic control in most individuals.

A systematic review of studies on IAT and TP treatment for individuals with chronic pancreatitis was published by Bramis (2012). Published articles from 1950 until 2012 were searched, and case series with a minimum of 5 consecutive subjects and a minimum of 1 year follow-up were considered for inclusion. A total of 72 full-text articles were reviewed, and 5 studies with 296 participants met inclusion criteria. Concurrent IAT with TP resulted in a reduction of insulin requirements. The rate of insulin independence was 46% at the 5-year mean follow-up and 10% at the 8-year mean follow-up. Two of the five studies reported preoperative morphine requirement and subsequent reduction of pain post IAT and TP. In one study with a mean follow-up of 1.5 years, the mean morphine use from baseline decreased by 116 mg. With a mean follow-up of 8 years, the second study had a mean decrease in morphine of 55 mg.

Wu and colleagues (2015) performed a systematic review and meta-analysis in order to evaluate outcomes of IAT after TP. A total of 12 studies involving 677 subjects were included. The insulin independent rate for IAT after TP at last follow-up was 3.72 per 100 person-years (95% CI: 1.00-6.44). The 30-day mortality was 2.1% (95% CI: 1.2-3.8%). The mortality at last follow-up was 1.09 per 100 person-years (95% CI: 0.21-1.97). Factors associated with incidence density of insulin independence in univariate meta-regression analyses included islet equivalents per kg body weight. The authors concluded that IAT is a safe modality for individuals with chronic pancreatitis who undergo TP.

Autologous pancreatic islet cell transplantation appears to significantly decrease the incidence of diabetes and pain after total or near-total pancreatectomy for chronic pancreatitis. Additionally, this procedure is not associated with serious complications and is performed as an adjunct to the pancreatectomy procedure.

Type 1 Diabetes

Type I diabetes mellitus is a result of cell-mediated autoimmune destruction of insulin producing pancreatic beta cells. Pancreatic islet cell transplantation is currently under investigation as a therapy option proposed to restore normal glycemia levels in labile type 1 diabetes.

The 2008 update from Collaborative Islet Transplant Registry (CITR; Close, 2007), which has collected and monitored data on allogeneic islet transplantation in North America, Europe, and Australia since 1999, reported that as of April 2008, its registry was comprised of 325 adult recipients and 649 islet infusions from 712 donors. Recipients of allogeneic islet transplants all had type 1 diabetes for more than 5 years, were between 18 and 65 years of age, and had poor diabetes control. It was noted that at 3 years post first infusion only 23% of islet-alone recipients were insulin independent (defined as insulin independent 2 or more weeks), 29% were insulin dependent with detectable C-peptide, 26% had lost function, and 22% had missing data. A total of 70% achieved insulin independence at least once, of which 71% were still insulin independent 1 year later and 52% at 2 years. There have been seven reported deaths among allograft recipients with causes ranging from unknown reasons to viral meningitis possibly related to immunosuppressant therapy, drug toxicity and stroke.

The 2012 report of clinical outcomes from the CITR database (Barton, 2012) focused on changes in outcomes over time. The number of individuals receiving islet transplants was 214 during 1999-2002, 255 between mid-2003 and 2006, and 208 from 2007 to 2010. A total of 575 of the 677 (85%) islet transplant recipients received islets only and the remainder underwent simultaneous kidney and islet transplants. In the 1999-2002 group, rates of insulin independence were 51% after 1 year, 36% after 2 years, and 27% after 3 years. Rates for the 2007-2010 group were 66%, 55% and 44%, respectively. The incidence of clinically reportable adverse events in the first year after infusion decreased from 50% to 53% in 1999-2006 to 38% in 2007-2010. The rates of peritoneal hemorrhage or gallbladder infusion were 5.4% in 1999-2003 and 3.1% in 2007-2010. Findings were not reported separately for the subset of individuals who underwent islet only transplantation. Limitations to the database updates were increasing levels of missing data from medical records and pending entry of data into the registry.

A systematic comparative review of quality of life and individual-reported outcomes after islet cell transplantation and pancreas transplantation in individuals with Type 1 diabetes noted mixed results (Speight, 2010). Sample sizes and the specific measures from the various studies did not clearly identify the impact of islet cell transplantation on quality of life. Additional studies are needed.

There are significant issues requiring further investigation before islet cell transplantation for treatment of diabetes could be considered outside of clinical trials. These issues include:

The U.S. Food and Drug Administration (FDA) provided industry guidance regarding investigational new drug development (IND) for allogeneic pancreatic islet cell products. However, to date, there is no FDA approved biologic license for allogeneic pancreatic islet cell products.

Published data from studies investigating tolerance and outcomes from allogeneic pancreatic islet cell transplants has been limited. Qi and colleagues (2014) reported a small single center 5-year follow-up of type 1 diabetics transplanted with allogeneic islets. A total of 10 individuals were enrolled in an open-label prospective trial. The first 4 subjects underwent islet transplantation with the Edmonton immunosuppressive regimen and the remaining 6 subjects received the Edmonton regimen plus etanercept and exenatide. All 10 individuals achieved insulin independence after 1-3 transplants. At 5 years of follow-up, 6 of the initial 10 subjects were free of exogenous insulin.

In 2015, LaBlanche and colleagues reported 5-year metabolic, functional and safety results of individuals with type 1 diabetes transplanted with allogeneic islet cells within a Swiss-French multicenter network between 2003 and 2010. A total of 44 subjects received islet cell transplantation of which 24 (54.5%) received islet transplantation alone (ITA) and 20 (45.5%) received islet after kidney (IAK). Thirty-four subjects completed the 5-year follow-up and 10 subjects completed the 4-year follow-up. At 1, 4, and 5 years post islet transplantation, respectively, 83%, 67%, and 58% of the ITA recipients and 80%, 70%, and 60% of the IAK transplant recipients reached HbA1c under 7% and were free of severe hypoglycemia, while none of the ITA recipients and only 10% of the IAK transplant recipients met this criterion at the preinfusion stage. Thirty-three of 44 subjects (75%) experienced insulin independence during the follow-up period, with a median duration of insulin independence of 19.25 months. A total of 55 adverse events occurred in 29 of 44 recipients. Of the adverse events, 14% were deemed mild, 9% were moderate, 67% were serious and 9% were life-threatening. Two individuals died due to a cardiovascular event at 55 and 48 months post-transplant; however, no deaths related to islet transplantation were reported during the follow-up period.

Studies supporting the use of allogeneic islet transplantation are limited by small numbers of recipients and significant adverse events. At this time, the level of evidence remains insufficient to substantiate the net benefit of allogeneic islet cell transplantation for type I diabetes and other indications.

Background/Overview

Three types of islet transplants have been reported: allogeneic transplants isolated from human adult islet tissue (including the use of multiple donors for one recipient in order to obtain a sufficient number of islet cells); transplants isolated from fetal human or animal tissue; and autologous transplants. A variety of tissue sources, methods of islet isolation and preservation, sites of cell implantation and immunosuppressive regimens continue to be investigated to identify improved islet cell procurement techniques, optimal selection criteria, and long-term durability of outcomes.

Chronic Pancreatitis

Chronic pancreatitis is a progressive inflammatory disease of the pancreas that results in irreversible deterioration of pancreatic structure and function. Pathological features include atrophy and fibrosis. Individuals with chronic pancreatitis may experience intractable pain that can require a total or near-total pancreatectomy. Pain relief must be balanced against the outcome of insulin-dependent diabetes. Autologous islet cell transplantation has been investigated as a technique to prevent this morbidity. During the removal of the pancreas, a suspension of isolated islet cells is created from the pancreas specimen and then injected into the portal vein of the liver, where the cells function as a free graft.

Type 1 Diabetes

Type 1 diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin to properly control blood glucose levels. Transplantation of pancreatic islet cells has been investigated as an alternative to insulin injections or pancreas transplantation. Islet cell transplantation is proposed as a treatment for type I diabetes, whether due to unknown causes or to partial or total pancreatectomy.  

Definitions

Acinar: Any secreting cell lining a gland, especially as applied to the cells of the pancreas that furnish pancreatic juice and enzymes to distinguish them from the islets of Langerhans, which secrete hormones.

Allogeneic: Derived from individual(s) other than the recipient.

Autologous: Derived from the individual's own body.

Islet of Langerhans: Groups of cells found within the pancreas; A-cells and B-cells which secrete insulin and glucagon.

Pancreas: A glandular organ lying below and behind the stomach that secretes insulin and glucagon (both regulate blood sugar), as well as digestive enzymes.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

CPT  
48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells
   
ICD-10 Procedure  
3E030U0-3E033U0 Introduction of autologous pancreatic islet cells into peripheral vein [by approach; includes codes 3E030U0, 3E033U0]
3E0J3U0-3E0J8U0 Introduction of autologous pancreatic islet cells into biliary and pancreatic tract [by approach; includes codes 3E0J3U0, 3E0J7U0, 3E0J8U0]
   
ICD-10 Diagnosis  
K86.0-K86.1 Chronic pancreatitis

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary for allogeneic transplantation:

CPT  
48999 Unlisted procedure, pancreas [when specified as pancreatic islet cell transplantation ]
   
HCPCS  
G0341 Percutaneous islet cell transplant, includes portal vein catheterization and infusion
G0342 Laparoscopy for islet cell transplant, includes portal vein catheterization and infusion
G0343 Laparotomy for islet cell transplant, includes portal vein catheterization and infusion
S2102 Islet cell tissue transplant from pancreas, allogeneic
   
ICD-10 Procedure  
3E030U1-3E033U1 Introduction of nonautologous pancreatic islet cells into peripheral vein [by approach; includes codes 3E030U1, 3E033U1]
3E0J3U1-3E0J8U1 Introduction of nonautologous pancreatic islet cells into biliary and pancreatic tract [by approach; includes codes 3E0J3U1, 3E0J7U1, 3E0J8U1]
   
ICD-10 Diagnosis  
  All diagnoses
   
References

Peer Reviewed Publications:

  1. Alejandro R, Barton FB, Hering BJ, Wease S; Collaborative Islet Transplant Registry Investigators. 2008 Update from the Collaborative Islet Transplant Registry. Transplantation. 2008; 86(12):1783-1788.
  2. Balamurugan AN, Naziruddin B, Lockridge A, et al. Islet product characteristics and factors related to successful human islet transplantation from the Collaborative Islet Transplant Registry (CITR) 1999-2010. Am J Transplant. 2014; 14(11):2595-2606.
  3. Barton FB, Rickels MR, Alejandro R, et al. Improvement in outcomes of clinical islet transplantation: 1999-2010. Diabetes Care. 2012; 35(7):1436-1445.
  4. Bellin MD, Balamurugan AN, Pruett TL, Sutherland DE. No islets left behind: islet autotransplantation for surgery-induced diabetes. Curr Diab Rep. 2012; 12(5):580-586.
  5. Bellin MD, Beilman GJ, Dunn TB, et al. Islet autotransplantation to preserve beta cell mass in selected patients with chronic pancreatitis and diabetes mellitus undergoing total pancreatectomy. Pancreas. 2013; 42(2):317-321.
  6. Bramis K, Gordon-Weeks AN, Friend PJ, et al. Systematic review of total pancreatectomy and islet autotransplantation for chronic pancreatitis. Br J Surg. 2012; 99(6):761-766.
  7. Chinnakotla S, Bellin MD, Schwarzenberg SJ, et al. Total pancreatectomy and islet autotransplantation in children for chronic pancreatitis: indication, surgical techniques, postoperative management, and long-term outcomes. Ann Surg. 2014; 260(1):56-64.
  8. Close N, Alejandro R, Hering B, Appel M.; CITR Investigators. Second annual analysis of the collaborative islet transplant registry. Transplant Proc. 2007; 39(1):179-182.
  9. Close NC, Hering BJ, Eggerman TL. Results from the inaugural year of the Collaborative Islet Transplant Registry. Transplant Proc. 2005; 37(2):1305-1308.
  10. Dong M, Parsaik AK, Erwin PJ, et al. Systematic review and meta-analysis: islet autotransplantation after pancreatectomy for minimizing diabetes. Clin Endocrinol (Oxf). 2011; 75(6):771-779.
  11. Garcea G, Weaver J, Phillips J, et al. Total pancreatectomy with and without islet cell transplantation for chronic pancreatitis: a series of 85 consecutive patients. Pancreas. 2009; 38(1):1-7.
  12. Gruessner RW, Sutherland DE, Dunn DL, et al. Transplant options for patients undergoing total pancreatectomy for chronic pancreatitis. J Am Coll Surg. 2004; 198(4):559-567.
  13. Halban PA, German MS, Kahn SE, Weir GC. Current status of islet cell replacement and regeneration therapy. J Clin Endocrinol Metab. 2010; 95(3):1034-1043.
  14. Lablanche S, Borot S, Wojtusciszyn A, et al; GRAGIL Network. Five-year metabolic, functional, and safety results of patients with type 1 diabetes transplanted with allogenic islets within the Swiss-French GRAGIL Network. Diabetes Care. 2015; 38(9):1714-1722.
  15. Markmann JF, Deng S, Huang X, et al. Insulin independence following isolated islet transplantation and single islet infusions. Ann Surg. 2003: 237(6):741-750.
  16. Merani S, Shapiro AM, Current status of pancreatic islet transplantation. Clin Sci (Lond). 2006; 110(6):611-625.
  17. Pileggi A, Alejandro R, Ricordi C. Clinical islet transplantation.Minerva Endocrinol. 2006 Sep; 31(3):219-232.
  18. Qi M, Kinzer K, Danielson KK, Martellotto J, et al. Five-year follow-up of patients with type 1 diabetes transplanted with allogeneic islets: the UIC experience. Acta Diabetol. 2014; 51(5):833-843.
  19. Rickels MR, Bellin M, Toledo F, et al.; PancreasFest Recommendation Conference Participants. Detection, evaluation and treatment of diabetes mellitus in chronic pancreatitis: recommendations from PancreasFest 2012. Pancreatology. 2013; 13(4): 336-342.
  20. Robertson RP. Islet transplantation as a treatment for diabetes – a work in progress. N Engl J Med. 2004; 350(7):694-705.
  21. Rodriguez Rilo HL, Ahmad SA, D'Alessio D, et al. Total pancreatectomy and autologous islet cell transplantation as a means to treat severe chronic pancreatitis. J Gastrointest Surg. 2003; 7(8):978-989.
  22. Speight J, Reaney M, Woodcock A, et al. Patient-reported outcomes following islet cell or pancreas transplantation (alone or after kidney) in Type 1 diabetes: a systematic review. Diabet Med. 2010; 27(7):812-822.
  23. Sutherland DE, Gruessner AC, Carlson AM, et al. Islet autotransplant outcomes after total pancreatectomy: a contrast to islet allograft outcomes. Transplantation 2008; 86(12):1799-1802.
  24. Sutherland DE, Radosevich DM, Bellin MD, et al. Total pancreatectomy and islet autotransplantation for chronic pancreatitis. J Am Coll Surg. 2012; 214(4):409-424.
  25. Sutherland DE, Radosevich D, Gruessner R, et al. Pushing the envelope: living donor pancreas transplantation. Curr Opin Organ Transplant. 2012; 17(1):106-115.
  26. Wu Q, Zhang M, Qin Y, et al. Systematic review and meta-analysis of islet autotransplantation after total pancreatectomy in chronic pancreatitis patients. Endocr J. 2015; 62(3):227-234.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food & Drug Administration.  Guidance for Industry: considerations for allogeneic pancreatic islet cell products. September 2009. Available at: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/
    UCM182441.pdf. Accessed on November 30, 2016.
Websites for Additional Information
  1. Collaborative Islet Transplant Registry (CITR). Available at: http://citregistry.org/. Accessed on December 8, 2016.
  2. National Diabetes Information Clearinghouse (NDIC) – Pancreatic Islet Transplantation. September 2013. Available at: http://diabetes.niddk.nih.gov/dm/pubs/pancreaticislet/index.aspx. Accessed on November 30, 2016.
Index

Allogeneic Islet Cell Transplant
Autologous Islet Cell Transplant
Islet Cell Transplant
Pancreatectomy, Partial or Complete
Pancreatic Islet Cell Transplant
Pancreatitis

Document History
Status Date Action
Reviewed 02/02/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Rationale , References and Websites sections updated.
Reviewed 02/04/2016 MPTAC review. Rationale, Background and Reference sections updated. Removed ICD-9 codes from Coding section.
Reviewed 02/05/2015 MPTAC review. Updated Rationale, References and Websites sections.
Reviewed 02/13/2014 MPTAC review. Updated Rationale, References and Web Sites sections.
Reviewed 02/14/2013 MPTAC review. Updated Rationale, References and Web Sites sections.
Revised 02/16/2012 MPTAC review. Clarified investigational and not medically necessary Position Statements. Updated Rationale, and References sections. Added Web Sites section.
  01/01/2012 Updated Coding section with 01/01/2012 CPT changes; removed codes 0141T, 0142T, 0143T deleted 12/31/2011.
Reviewed 02/17/2011 MPTAC review. Title, Rationale, Background, Definitions, and References updated.
Reviewed 02/25/2010 MPTAC review. Rationale and references updated.
Reviewed 02/26/2009 MPTAC review. Rationale, background and references updated.
Reviewed 02/21/2008 MPTAC review. Rationale, background and references updated. Clarified note for multi-organ requests. The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Reviewed 03/08/2007 MPTAC review. References and coding updated.
Reviewed 03/23/2006 MPTAC review. References and codes updated.
  01/01/2006 Updated Coding section with 01/01/2006 CPT/HCPCS changes
  11/18/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) National Coverage Determination (NCD).
Revised 04/28/2005 MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.
Pre-Merger Organizations Last Review Date Document Number Title
Anthem, Inc. 04/27/2004 TRANS.00010 Autologous and Allogeneic Islet Cell Transplant
WellPoint Health Networks, Inc. 12/02/2004 7.06.05 Transplantation-Autologous and Allogeneic Islet Cell