Transplants These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

HealthPartners Centers of Excellence Many plans require that transplant procedures be performed at HealthPartners Transplant Centers of Excellence (COE). Some plans allow for use of non-Center of Excellence transplant facilities. Check your plan documents or contact Member Services to determine what facilities are available to you and how your choice will affect your coverage.

Please note: Cornea transplants are outside the scope of this policy. They are covered without prior notification or authorization. Cornea transplants may be received from providers outside the HealthPartners Transplant COEs.

Prior Notification/Authorization Process 1. Prior to selecting a transplant provider submission of a transplant pre-consultation prior authorization form from the referring physician is required. This prior authorization will support the initiation of care and benefit coordination. 2. Prior notification or prior authorization is required before the actual visit date for pre-transplant evaluation as outlined below. 3. Prior notification or prior authorization is required at the time of pre-transplant listing or start of treatment for deemed transplant candidate as outlined below.

For more information, please see the related content at right for the HealthPartners Transplant Resources and COE Networks and for the transplant prior notification and authorization process and form.

Prior notification is required for the following situations Prior notification is required at the time of pre-transplant evaluation and at the time of pre-transplant listing when performed at a HealthPartners Transplant Center of Excellence (COE) for the following transplants: 1. Kidney 2. Heart 3. Liver 4. Lung 5. Simultaneous pancreas kidney (SPK) and pancreas after kidney (PAK) 6. Stem cell, blood and bone marrow transplants for diagnoses listed below under Indications that are Covered, #8 and #9.

Prior authorization is required for the following situations Prior authorization is required at the time of pre-transplant evaluation and at the time of pre-transplant listing for all of the following transplants: 1. New techniques for transplants listed above as only requiring prior notification. 2. Any transplant at non-designated COEs (Out of Network, need for transfer, etc.) 3. Any transplant for a diagnosis that is not listed below under Indications that are Covered section, #1 through #9. 4. Pancreas transplant alone (PTA) 5. Small bowel transplant 6. Multiple organ transplants

Does Not Require Prior Authorization or Prior Notification for consultation, evaluation or listing 1. Donor Lymphocyte Infusion

Coverage Transplants are generally covered per the indications listed below and per your plan documents. The list of covered transplants is subject to periodic review and modification by the HealthPartners medical director or his or her designee.

Page 1 of 6 Indications that are eligible for coverage The following transplants are eligible for coverage: 1. Kidney transplants for end stage disease. 2. Heart transplants for end stage disease. 3. Lung transplants or heart/lung transplants for: A. Primary pulmonary hypertension; B. Eisenmenger's syndrome; C. End stage pulmonary fibrosis; D. Alpha 1 antitrypsin disease; E. Cystic fibrosis; F. Emphysema. 4. Liver transplants for: A. Biliary atresia in children; B. Primary biliary cirrhosis; C. Chronic hepatitis A, B, or C resulting in acute liver failure, cirrhosis or post necrotic cirrhosis; D. Primary sclerosing cholangitis; E. Alcoholic cirrhosis, F. Hepatocellular carcinoma. 5. Simultaneous pancreas-kidney transplant (SPK), pancreas after kidney transplant (PAK), and living related segmental simultaneous pancreas , as treatment for diabetic patients with renal disease. 6. Pancreas transplant alone (PTA) for treatment of diabetes when the following indications are met: A. A history of frequent, acute and severe metabolic complications, such as hypoglycemia, hyperglycemia, or ketoacidosis requiring medical attention. B. Clinical and emotional problems with exogenous insulin therapy that are severe enough to be incapacitating, such as hypoglycemic unawareness. C. Consistent failure of insulin-based management to prevent acute complications. 7. Small bowel transplantation on a case by case basis. 8. Allogeneic bone marrow transplants or blood stem cell support (myeloablative or non- myeloablative) associated with high dose chemotherapy for: A. Acute lymphocytic leukemia; B. Chronic myelogenous leukemia; C. Severe combined immunodeficiency disease; D. Wiskott-Aldrich syndrome; E. Aplastic anemia; F. Acute myelogenous leukemia. G. Sickle Cell Anemia; H. Non-relapsed or relapsed non-Hodgkin's Lymphoma; I. Multiple Myeloma; J. Myelodysplastic syndromes associated with intermediate, high or very high revised international prognostic scoring system (IPSS-R) scores 9. Autologous bone marrow transplants or blood stem cell support associated with high dose chemotherapy for the following: A. Acute leukemias; B. Non-Hodgkin's Lymphoma; C. Hodgkin's Disease; D. Burkitt's Lymphoma; E. Neuroblastoma. F. Multiple myeloma; G. Chronic myelogenous leukemia; H. Nonrelapsed non-Hodgkin's lymphoma. I. Immunoglobulin light chain (AL) amyloidosis J. Testicular cancer 10. Donor Lymphocyte Infusion following a relapsed allogeneic bone marrow or blood stem cell transplantation.

Indications not covered The following are not covered because they are considered experimental/investigational. 1. Hand transplants 2. Face transplants 3. Uterine transplants

Page 2 of 6 Definitions

Autologous bone marrow or stem cell transplant refers to harvesting the bone marrow or stem cells from the patient and storing it for future use. The patient undergoes treatment including tumor ablation with high-dose chemotherapy and/or radiation. After the treatment, the bone marrow or stem cells are reinfused (transplanted) into the patient.

Allogeneic bone marrow or stem cell transplant refers to harvesting the bone marrow or stem cells from a related or unrelated donor and storing it for future use. The patient undergoes treatment including tumor ablation with high- dose chemotherapy and/or radiation. After the treatment, the bone marrow or stem cells are reinfused (transplanted) into the patient.

Transplant Center of Excellence is any health care provider, group or association of health care providers designated by HealthPartners to provide services, supplies or drugs for the specified transplant performed on a covered person. For more information, please select the link under Transplants, Related Policies titled, “Transplant Resources and COE Networks”.

Donor lymphocyte infusion (DLI) therapy is usually done after an allogeneic bone marrow transplant (BMT) has failed. The DLI procedure involves taking a blood donation from the original bone marrow or peripheral blood stem cell donor. This blood is separated and certain white cells (lymphocytes) are selected to give to the patient. The goal of the therapy is to assist in remission or recovery of the patient's bone marrow.

Revised international prognostic scoring system (IPSS-R) The International Prognostic Scoring System (IPSS-R) is the most widely used system for classifying the severity of myelodysplastic syndrome (MDS).The IPSS-R considers the percentage of blasts in the bone marrow, the types of blood abnormalities, and a panel of chromosome abnormalities. Based on these criteria, the IPSS-R score defines five risk groups. The score helps determine treatment recommendations for the patient.

Revised international prognostic scoring system (IPSS-R) in myelodysplastic syndrome Risk group IPSS-R score Very low ≤1.5 Low >1.5 to 3 Intermediate >3 to 4.5 High >4.5 to 6 Very high >6

Evaluation period is the first step in the process for the patient transplant candidate. The transplant program will schedule visits for biopsychosocial assessments based on protocols.

Listing or treatment period occurs when the evaluation is complete and the patient is deemed a transplant candidate. The program places the patient on a national waiting list or will initiate the blood and marrow treatment protocol.

Transplant services include the transplant (or re-transplant) of the human organs or tissues listed below, including all related post-surgical treatment and drugs and multiple transplants for a related cause. Transplant services do not include other organ or tissue transplants or surgical implantation of mechanical devices functioning as human organs, except surgical implantation of FDA approved ventricular assist devices (VAD), functioning as a temporary bridge to or as destination therapy for members end stage heart failure meeting the criteria specified in the VAD coverage policy. (See the VAD policy by selecting the link under Transplants, Related Policies titled “Ventricular Assist Device- VAD”.)

Codes If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive. Codes Description 32851 Lung transplant, single; without cardiopulmonary bypass 32852 Lung transplant, single; with cardiopulmonary bypass 32853 Lung transplant, double (bilateral sequential or en bloc); without cardiopulmonary bypass 32854 Lung transplant, double (bilateral sequential or en bloc); with cardiopulmonary bypass 33935 Heart- lung transplant with recipient cardiectomy- pneumonectomy 33945 Heart transplant, with or without recipient cardiectomy

Page 3 of 6 38240 Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor 38241 Hematopoietic progenitor cell (HPC); autologous transplantation 38242 Allogeneic lymphocyte infusions 38243 Hematopoietic progenitor cell (HPC); HPC boost 44135 Intestinal ; from cadaver donor 47135 Liver allotransplantation; orthotopic, partial or whole, from cadaver or living donor, any age 47399 Unlisted procedure, liver 48160 Pancreatectomy, total or subtotal, with autologous transplantation of pancreas or pancreatic islet cells 48554 Transplantation of pancreatic allograft 50360 Renal allotransplantation, implantation of ; without recipient nephrectomy 50365 Renal allotransplantation, implantation of graft; with recipient nephrectomy S2053 Transplantation of small intestine and liver allografts S2065 Simultaneous pancreas kidney transplantation CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Products

This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.

References 1. Alhamad, T., Stratta, R. Pancreas-kidney transplantation in diabetes mellitus: Benefits and complications In:UpToDate , Brennan, D., Nathan, D., UpToDate, Waltham, MA. (Accessed on November 29, 2018.) 2. Alhamad, T, Stratta, R. . Pancreas-kidney transplantation in diabetes mellitus: Patient selection andpretransplant evaluation . In: UpToDate, Brenna, D. (Ed), UpToDate, Waltham, MA. (Accessed on December 4, 2020.) 3. Brännström M,, Johannesson, L., Bokstrom, H., Kvarnstrom, N., Molne, J., Dahm-Kahler, P.,…Nilsson, L. (2014). Livebirth after transplantation. Lancet, Volume 385(607-16 4. Breidenbach, W., Meister, E., Becker, G., Turker, T., Gorantla, V., Hassan,K,, Kaplan, B.2016, A Statistical Comparative Assessment of Face and Outcomes to Determine Whether Either Meets the Standard of Care Threshold Plastic and Reconstructive Surgery Journal, Volume 137, Number 1 5. Chung, K., Yoneda, H. Upper extremity amputation. In: UpToDate, Berman, R.(Ed), Butler, C. (Ed) UpToDate, Waltham, MA. (Accessed on December4, 2020). 6. Ciberia, M., Sanchorawala, V., Seldin, D., Quillen, K., Berk, J.,Dember, L….Skinner, M, 2011. Outcome of AL amyloidosis after high-dose melphalan and autologous stem cell transplantation: long-term results in a series of 421 patients,Blood , October 2011, Volume 118, Number 16. 7. Deeg, H., Sandmaier B., Determining eligibility for allogeneic hematopoietic cell transplantation. In:UpToDate , Chao, N. (Ed), UpToDate, Waltham, MA. (Accessed on December 12, 2018.) 8. Diaz-Siso JR,, Parker, M., Bueno, E., Sisk, G., Pribaz, J, Eriksson, E., ….Pomahac, B. (2013). Facial allotransplantation: a 3-year follow-up report. Journal of Plastic, Reconstructive & Aesthetic Surgery: Volume 66(11):1458-63 9. Diaz-Siso, Rodriguez, E. ,( 2016) Facial transplantation: knowledge arrives, questions remain, The Lancet Volume 388, Issue 10052, pages 1355-1356 10. Dove, L., Brown, R., in adults: Patient selection and pretransplantation evaluation In: UpToDate, Lindo, K. (Ed), UpToDate, Waltham, MA. (Accessed on December 11, 2019.) 11. ECRI Institute. (2017). Criteria for Kidney Transplantation Patients, Plymouth Meeting, PA: ECRI Institute. 12. Elliot, R., Tintle, S., Levin, L. (2013) Upper extremity transplantation: current concepts and challenges in an emerging field, Current Reviews in Musculoskeletal Medicine Volume 7 (1): 83-88 13. Erlichman, J., Loomes K., Biliary atresia In: UpToDate, Rand, E. (Ed), UpToDate, Waltham, MA. (Accessed onDecember 4, 2020.) 14. Estey, E. Prognosis of the myleoplastic syndromes in adults In: UpToDate, Last Name Larson, R. (Ed), UpToDate, Waltham, MA. (Accessed on December 11, 2019.) 15. Estey, E., Schrier, S. Treatment of high or very high risk myelodysplastic syndrome In: UpToDate, Larson, R., (ed) UpToDate, Waltham, MA. (Accessed on November 29, 2018.) 16. Farrell R, , Falcome, T. (2015)Uterine transplant: new medical and ethical considerations. Lancet, 385 (pp581-82) 17. Fischer S, , Kueckelhaus, M., Pauzenberger, R., Bueno, E. M, Pomahac, B. (2014)Functional outcomes of face transplantation. American Journal of Transplantation, 15 (1) (pp 220-233) 18. Gilligan, T., Kantoff, P.. Diagnosis and treatment of relapsed and refractory testicular germ cell tumors. In:UpToDate , Oh, W. (Ed), UpToDate, Waltham, MA. (Accessed on December 4, 2020 19. Gruessner R., Gruessner A., 2013 Pancreas Transplant Alone, A procedure coming of age Diabetes Care, Volume 36 pp 2440-2447 20. Hachem, R., : Disease-based choice of procedure In: UpToDate, Trulock, E. (Ed), UpToDate, Waltham, MA. (Accessed on December4, 2020.)

Page 4 of 6 21. Hachem, R., Lung Transplantation: General guidelines for recipient selection In: UpToDate, Trulock, E. (Ed), UpToDate, Waltham, MA. (Accessed on December 20, 2018.) 22. Hayes, Inc. Hayes Medical Technology Directory Report. Allogeneic Hematopoietic Stem Cell Transplantation for Sickle Cell Disease in Children and Young Adults. Lansdale, PA: Hayes, Inc.; February, 2016 Reviewed May 2020 23. Hayes, Inc. Hayes Medical Technology Directory Report. Comparative Effectiveness of Allogeneic Hematopoietic Stem Cell Transplant Versus Drug-Based Strategies for Treatment of Chronic Myelogenous Leukemia Lansdale, PA: Hayes, Inc.; April 2016 Reviewed June 2020 24. Hayes, Inc. Hayes Medical Technology Directory Report. High-Dose Chemotherapy with Autologous Stem Cell Transplantation, Treatment for Germ Cell Testicular Transplantation Lansdale, PA: Hayes, Inc.; October 1998. Reviewed October 2005/Archived January 2006. 25. Hayes, Inc. Hayes Medical Technology Directory Report. High-Dose Chemotherapy with Autologous Stem Cell Support, Treatment for Neuroblastoma Lansdale, PA: Hayes, Inc.; May, 2000. Reviewed October 2006/Archived January 2007. 26. Hayes, Inc. Hayes Medical Technology Directory Report. Pancreas-After-Kidney (PAK) Transplantation in Diabetic Patients. Lansdale, PA: Hayes, Inc.; June, 2006 Reviewed June 2010/Archived July 2011. 27. Holmberg, L., Deeg, H., Sandmaier, B. Determining eligibility for autologous hematopoietic cell transplantation In: UpToDate, Chao, N.(Ed) UpToDate, Waltham, MA. (Accessed on December 4, 2020) 28. Infante-Cossio P, , Barrera,-Pulido, F., Gomez-Cia, T., Sicilia-Castro, D., Garcia-Perla-Garcia, A.,Gacto -Sanchez, P., …Gonzalez-Padilla, J. (2013)Facial transplantation: A concise update. Medicina Oral, Patologia Oral y Cirugia Bucal, 18(2) (263-271) 29. Järvholm s, ,Johannesson, L., Clarke, A., Brannstrom, M. (2015) trial: Psychological evaluation of recipients and partners during the post-transplantation Fertility and Sterility. 104(4):1010-5 30. Johannesson L, , Kvarnstrom, N., Molne, J., Dahm-Kahler, P., Enskog, A., Diaz-Garcia, C., ….Brannstrom, M. (2015) Uterus transplantation trial: 1-year outcome. Fertility and Sterility, 103(1):199-204 31. Kesseli, S., Sudan, D. (2018) Small Bowel Transplantation, Surgical Clinics of North America, 99 103-116 32. Khalifian, S, Brazio, P, Mohan, R., Shaffer, C, Brandacher, G, Rodriguez, E. (2014)Facial transplantation: the first 9 years. Lancet, Volume 384 33. Khan, F., Selveggi, G., Overview of intestinal and multivisceral transplantation In: UpToDate, Brown, R. (Ed), UpToDate, Waltham, MA. (Accessed onDecember 4, 2020). 34. Lantieri L, Grimbert,, P Ortonne, N Suberbielle, C, Bories, D,Gil-Vernet, S., Lemogne, C….Hivelin, M., . (2016) : long-term follow-up and results of a prospective open study.The Lancet Volume 388, Issue 10052 1398-1407 35. MacKay, B., Nacke E., Posner, M. (2014 Hand Transplantation: A review, Bulletin of the Hospital for Joint Diseases , 72 (1): 76-88 36. Majhail N., Farnia, S., Carpenter, P., Champlin, R.,Crawford, S., Marks, D….LeMaistre, C. 2015 Indications for Autologous and Allogeneic Hematopoietic Cell Transplantation: Guidelines from the American Society for Blood and Marrow Transplantation, Biology of Blood and Marrow Transplantation, 21 1863-1869 37. Malcovati, L., Hellstron-Lindberg E., Bowen D., Ades L., Cermak, J., Del Canizo, C…..Cazzola, M. 2013 Diagnosis and Treatment of primary myelodysplastic syndromes in adults: recommendations for the EuropeanLeukemiaNet , Blood, Volume 122, Number 17 38. Martin, P., DiMartini A., Feng, S., Brown, R., Fallon , M. 2014 Evaluation for Liver Transplantation in Adults: 2013 Practice Guideline by the American Association for the Study of Liver Diseases and the American Society of Transplantation Hepatology, Volume 59, No. 3 39. Negrin, R., Hematopoietic cell transplantation in myelodysplastic syndromes In: UpToDate, Chao, N. (Ed), UpToDate, Waltham, MA. (Accessed on December 11, 2017.) 40. National Institute for Health and Care Excellence (2011) Hand allotransplantation Retrieved from nice.org.uk/guidance/ipg383, 41. Ochs, H. Wiskott-Aldrich syndrome In: UpToDate, Puck, J. (Ed), UpToDate, Waltham, MA. (Accessed on December 11, 2019.) 42. Rajukumar, S., Dispenzieri, A. Treatment and prognosis of immunoglobulin light chain (AL) amyloidosis and light and heavy chain deposition diease In: UpToDate, Glassoic, R., Kyle, R., Schwab, S. (Ed), UpToDate, Waltham, MA. (Accessed on November 29, 2018). 43. Rajkumar, S., Allogeneic hematopoietic cell transplantation in multiple myeloma, In:UptoDate , Kyle, R. (Ed) Waltham, MA (AccessedDecember 4, 2020) 44. Rajkumar, S.. Mulitple myeloma: Use of autologous hematopoietic cell transplant. In: UpToDate, Negrin, R. Kyle, R. (Ed), UpToDate, Waltham, MA. (Accessed onDecember 4, 2020) 45. Robertson, R., Davis, C., Larsen, J., Stratta, R. Sutherland, S., 2006, Position statement: Pancreas and Islet Transplantation in Type 1 Diabetes, American Diabetes Association, Diabetes Care, volume 29, Number 4 46. Robertson, R., Pancreas and islet transplantation in diabetes mellitus, In:UpToDate , Hirsch, I. (Ed), UpToDate, Waltham, MA. (Accessed onDecember 4, 2020) 47. Salminger, S., Roche, A.D., Struma, A., Aszmann, O., 2016, Hand Transplantation Versus Hand Prosthetics: Pros and Cons, Current Surgery Reports, 4: 8 48. Sanchorawala, V. 2014, High Dose Melaphan and Autologous Peripheral Blood Stem Cell Transplantation in AL Amyloidosis, Hematology/Oncology Clinics of North America, Volume 28, Issue 6, pages 1131-1144. 49. Shah, N., Callander, N., Ganguly, S., Gul, Z., Hamadani, M., Costa, L…..Savani, B. (2015) Hematopoietic Stem Cell Transplantation for Multiple Myeloma: Guidelines from the American Society for Blood andMarros Transplantation, Biology of Blood and Marrow Transplantation, 21, 1155-116., 50. Shanmugarajah, K, , Hettiaratchy, S., Clarke, A., Butler, P. 2011, Clinical outcomes of facial transplantation: A review. International Journal of Surgery, 9 600-607. 51. Shores, J., Malek, V., Andrew Lee, W.P., Brandacher, G. Tissue regeneration or regeneration of engineered tissue? Outcomes after hand and upper extremity transplantation, 2017 Journal of Materials Science,28:72

Page 5 of 6 Approved: Medical Director & Benefits Committees 07/01/95, 3/21/18; Revised 7/9/04, 1/24/11, 1/25/13, 1/1/16, 3/8/16, 1/19/2017, 3/12/18, 8/29/18, 10/15/18; Annual Review 7/9/04, 6/1/05, 7/1/06, 8/1/07, 6/25/08, 9/9/09, 7/6/10, 7/2011, 7/2012, 1/25/13, 1/1/2014, 1/2015, 1/2016, 1/2017, 1/2018, 11/2018, 11/2019, 11/2020

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