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Department of Origin: Integrated Healthcare Services Approved by: Integrated Health Quality Management Subcommittee Date approved: 12/12/17 Department(s) Effected: Integrated Healthcare Services Effective Date: 12/12/17 Medical Criteria Document: Bone Marrow/Stem Cell Transplantation Replaces Effective Policy Dated: 12/13/16 Reference #: MC/T001 Page: 1 of 9 PRODUCT APPLICATION: PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group Please refer to the member’s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member’s benefit plan or certificate of coverage, the terms of the member’s benefit plan document will govern. Benefits must be available for health care services. Health care services must be ordered by a physician, physician assistant, or nurse practitioner. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration. PURPOSE: The intent of this criteria document is to ensure services are medically necessary. GUIDELINES: Medical Necessity Criteria - must satisfy: I and none of II I. Bone marrow/stem cell transplantation (initial or retransplantation)–must satisfy both of the following: A and B A. Request is for one of the following indications: 1 - 3 1. Allogeneic Bone Marrow/Stem Cell Transplantation – any of the following: a-g a. Leukemias b. Lymphomas i. Adult T cell lymphoma/leukemia (ATLL) - HTLV-1 virus positive ii. Burkitt lymphoma/Burkitt cell leukemia iii. Diffuse large B cell lymphoma iv. Extranodal natural killer (NK)/T cell lymphoma, nasal type v. Follicular lymphoma vi. Hodgkin lymphoma vii. Mantle cell lymphoma viii. Peripheral T cell lymphoma c. Myelodysplastic Syndrome (MDS) and Pre-Leukemic Syndrome i. Myelodysplastic syndrome (MDS) ii. Myelofibrosis and related conditions iii. Chronic Myelomonocytic Leukemia (CMML), including Juvenile Myelomonocytic Leukemia (JMML) d. Multiple Myeloma/Plasma Cell Disorders i. Multiple Myeloma ii. Waldenstrom’s Macroglobulinemia

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Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 1 of 9

PRODUCT APPLICATION:

PreferredOne Administrative Services, Inc. (PAS) ERISA PreferredOne Administrative Services, Inc. (PAS) Non-ERISA PreferredOne Community Health Plan (PCHP) PreferredOne Insurance Company (PIC) Individual PreferredOne Insurance Company (PIC) Large Group PreferredOne Insurance Company (PIC) Small Group

Please refer to the member’s benefit document for specific information. To the extent there is any inconsistency between this policy and the terms of the member’s benefit plan or certificate of coverage, the terms of the member’s benefit plan document will govern. Benefits must be available for health care services. Health care services must be ordered by a physician, physician assistant, or nurse practitioner. Health care services must be medically necessary, applicable conservative treatments must have been tried, and the most cost-effective alternative must be requested for coverage consideration. PURPOSE: The intent of this criteria document is to ensure services are medically necessary. GUIDELINES: Medical Necessity Criteria - must satisfy: I and none of II

I. Bone marrow/stem cell transplantation (initial or retransplantation)–must satisfy both of the following: A and B A. Request is for one of the following indications: 1 - 3

1. Allogeneic Bone Marrow/Stem Cell Transplantation – any of the following: a-g a. Leukemias

b. Lymphomas

i. Adult T cell lymphoma/leukemia (ATLL) - HTLV-1 virus positive ii. Burkitt lymphoma/Burkitt cell leukemia iii. Diffuse large B cell lymphoma iv. Extranodal natural killer (NK)/T cell lymphoma, nasal type v. Follicular lymphoma vi. Hodgkin lymphoma vii. Mantle cell lymphoma viii. Peripheral T cell lymphoma

c. Myelodysplastic Syndrome (MDS) and Pre-Leukemic Syndrome

i. Myelodysplastic syndrome (MDS) ii. Myelofibrosis and related conditions iii. Chronic Myelomonocytic Leukemia (CMML), including Juvenile Myelomonocytic Leukemia

(JMML)

d. Multiple Myeloma/Plasma Cell Disorders i. Multiple Myeloma ii. Waldenstrom’s Macroglobulinemia

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 2 of 9

e. Hematological Disorders

i. Aplastic Anemia ii. Congenital Amegakaryocytic Thrombocytopenia iii. Congenital Agranulocytosis, aka Kostmann Syndrome, or severe congenital neutropenia,

autosomal recessive type 3 iv. Chronic Granulomatous Disease v. Diamond-Blackfan Anemia/Blackfan-Diamond Syndrome (pure red cell aplasia) vi. Dyskeratosis Congenita vii. Fanconi Anemia viii. Paroxysmal Nocturnal Hemoglobinuria (PNH) ix. Schwachman-Diamond Syndrome (SDS) x. Sickle Cell Disease xi. Beta Thalassemia major

f. Immunodeficiency Syndromes

i. CD40 Ligand Deficiency ii. Chediak-Higashi Syndrome iii. Hemophagocytic Lymphohistiocytosis (HLH) (aka familial erythrophagocytic

lymphohistiocytosis) iv. Leukocyte Adhesion Deficiency v. Omenn Syndrome vi. Severe combined immunodeficiency disease (SCID) vii. Wiskott-Aldrich Syndrome viii. X-linked Lymphoproliferative Syndrome ix. Gaucher disease type I x. Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome

g. Inherited Metabolic Disorders

i. Adrenoleukodystrophy ii. Globoid Cell Leukodystrophy (Krabbe Disease) iii. Hurler Syndrome (MPS-1H) iv. Osteopetrosis v. Metachromatic Leukodystrophy

2. Autologous Bone Marrow/Stem Cell Transplantation – any of the following: a-c

a. Leukemias i. Acute myelogenous leukemia (AML) ii. Prolymphocytic leukemia

b. Lymphomas

c. Multiple Myeloma/Plasma Cell Disorders

i. Multiple Myeloma ii. AL Amyloidosis (primary) in members with amyloid deposition in less than or equal to 2

organs and a cardiac left ejection fraction greater than 45% iii. Waldenstrom’s Macroglobulinemia iv. Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Gammopathy Skin defects

Syndrome (POEMS)

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 3 of 9

3. Retransplantation indications – any of the following: a-c

a. Relapse of original disease b. Failure to engraft or poor graft function c. Graft rejection

B. Selection criteria - presence of relapsed or refractory disease and both of the following: 1 and 2

1. Life expectancy limited by disease; and 2. Other medical or surgical therapy is ineffective or unavailable for cure.

[Note: Other indications will be reviewed on a case-by-case basis.]

II. Contraindications - none of the following: A or B

A. Absolute contraindications

1. A pattern of demonstrated patient noncompliance which would place a transplanted organ at serious risk of failure.

2. Active alcohol or substance abuse 3. Smoking when the transplant center determines that the member’s smoking status will compromise the

transplant outcome. 4. Uncontrolled psychiatric disorder that impairs the member’s ability to give informed consent and/or be

compliant with treatment regimen. 5. Presence of local or systemic disease, such as, but not limited to, systemic infection and co-existing

medical conditions such as advanced heart or lung disease) likely to limit survival. 6. Inadequately treated malignancy with substantial likelihood of recurrence.

[Note: For Bone Marrow/Stem Cell Transplant, non-Hodgkin lymphoma (neoplasm) is not a contraindication.]

7. Inadequately controlled HIV/AIDS infection, defined as all of the following: a - d a. CD4 count less than 200 cells/mm3 for more than 6 months b. HIV-1 RNA (viral load) detectable c. Not on stable antiviral therapy for more than 3 months d. Other complications from AIDS, such as opportunistic infection, eg, aspergillus, tuberculosis,

coccidioidomycosis, resistant fungal infections or neoplasms, eg, Kaposi's sarcoma. 8. Presence of any factors likely to limit/hinder one of the following: a or b

a. Rehabilitation potential b. Ability to comply with pre- and post-transplant protocols

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 4 of 9

B. Relative contraindications - retransplantation when first transplant rejected due to noncompliance issues

EXCLUSIONS: The following is considered investigative (see Investigative List): Xenotransplantation DEFINITIONS: Abuse: A maladaptive pattern of use leading to clinically significant impairment or distress Active alcohol or substance abuse: Absence of formal behavioral/psychological treatment (for abuse) and has not been abstinent from alcohol or other substance/s for at least 3 (three) months prior to transplant. Allogeneic Bone Marrow Transplant Donor and recipient are not of the same genetic origins Autologous Bone Marrow Transplant The patient’s own stem cells are removed and stored for future use in restoration of bone marrow function after high dose chemotherapy or radiotherapy Chemosensitive disease Malignant disease that responds, at least partially, to a course of chemotherapy Mini-transplant (non-myeloablative): A type of allogeneic transplant that uses lower, less toxic doses of chemotherapy and/or total body irradiation to prepare the patient for the transplant. The use of low doses of anticancer drugs and total body irradiation eliminates some, but not all, of the patient’s bone marrow. It also reduces the number of cancer cells and suppresses the patient’s immune system to prevent rejection of the transplant. Once the bone marrow cells from the donor begin to engraft, they often cause what is called a “graft versus tumor effect” and may work to destroy the cancer cells that were not eliminated by the anticancer drugs or irradiation. Reliable evidence: Consensus opinions and recommendations reported in the relevant medical and scientific literature, peer-reviewed journals, reports of clinical trial committees, or technology assessment bodies, and professional consensus opinions of local and national health care providers. Stem Cells Blood cells found in the bone marrow at its earliest stage of development; may be taken from the bone marrow, peripheral bloodstream, or from umbilical cord blood. Syngeneic graft Donor and recipient are genetically identical, i.e. have the same genotype, as in identical twins. Tandem transplant: Two planned courses of high dose chemotherapy and stem cell transplant at intervals of two to six months depending on recovery from prior toxicity.

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 5 of 9

Transplant/Graft Portion of the body or complete organ removed from its natural site and transferred to a separate site in the same or different individual. Treatment Response Improvement related to treatment • Complete response/remission – disappearance of all signs of disease in response to treatment • Partial response/remission – decrease in tumor size, or in the extent of cancer/disease in the body in response to

treatment Umbilical Cord Blood: Blood harvested from the umbilical cord and placenta of a newborn that contains high concentrations of stem cells. These stem cells are associated with a lower incidence of rejection or graft vs. host disease. Cord blood transplants are usually used for children since the number of stem cells obtained in the collection is usually insufficient for the levels needed for an adult transplant. BACKGROUND: A designated transplant center/center of excellence may be required by the terms of the member’s benefit plan for maximum benefit coverage. There are often many clinical trials and studies associated with transplants (where transplant is considered standard of care). Any component of the transplant that is part of a clinical trial or a study is not eligible for coverage. Refer to benefit plan and medical policy for transplant and re-transplantation benefits, limitations and exclusions, non-coverage explanation of investigative and study generated protocol services, and eligible/non-eligible benefits for the donor. When an absolute contraindication is present, the transplant will not be approved. The decision regarding the appropriateness of transplantation in the presence of one or more relative contraindications will be left up to transplanting facility. All approved transplants will be reviewed annually for medical necessity and to assess new medical/scientific evidence addressing the therapeutic benefit and safety of the transplant procedure or new contraindications to performing the transplant. All transplant requests require physician review. See Attachment A for documentation required before sending request to physician review. See Attachment B for standard physician review questions.

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 6 of 9

FOR INTERNAL USE ONLY COVERAGE: Prior Authorization: Yes Coverage is subject to the member’s contract benefits. CODING: CPT® 38240 Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor 38241 Hematopoietic progenitor cell (HPC); autologous transplantation 38243 Hematopoietic progenitor cell (HPC); HPC boost 38242 Allogeneic lymphocyte infusions (donor lymphocyte infusion [DLI]) CPT codes copyright 2017 American Medical Association. All Rights Reserved. CPT is a trademark of the AMA. The AMA assumes no liability for the data contained herein. RELATED CRITERIA/POLICIES: Integrated Healthcare Services Process Manual: UR015 Use of Medical Policy and Criteria Medical Policy: MP/C009 Coverage Determination Guidelines Medical Policy: MP/I001 Investigative Services Medical Policy: MP/T006 PreferredOne Designated Transplant Network Provider REFERENCES: 1. American Society for Blood and Marrow Transplantation. ASBMT Position Statement: The Role of Cytotoxic

Therapy with Hematopoietic Stem Cell Transplantation in the Treatment of Adult Acute Lymphoblastic Leukemia: Update of the 2006 Evidence-Based Review. Biol Blood Marrow Transplant 18:16-17, 2012.

2. American Society for Blood and Marrow Transplantation. ASBMT Position Statement: The Role of Cytotoxic Therapy with Hematopoietic Stem Cell Transplantation in the Therapy of Myelodysplastic Syndromes. Biol Blood Marrow Transplant 15:135-136, 2008.

3. American Society for Blood and Marrow Transplantation. ASBMT Position Statement: The Role of Cytotoxic Therapy with Hematopoietic Stem Cell Transplantation in the Treatment of Follicular Lymphoma. Biol Blood Marrow Transplant 17:190-191, 2011.

4. Angelucci E. efficacy of hematopoietic cell transplantation in beta thalassemia major. In: UpToDate, Landaw SA (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

5. Bertuch AA. Inherited aplastic anemia in children and adolescents. In: UpToDate, Tirnauer JS (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

6. Bleesing JJH. X-linked lymphoproliferative disease. In: UpToDate, TePas E (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

7. Bonilla FA. Hematopoietic cell transplantation for primary immunodeficiency. In: UpToDate, TePas E (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

8. Braskett M, Chatila T. IPEX: Immune dysregulation, polyendocrinopathy, enteropathy, X-linked. In: UpToDate, Feldweg AM (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

9. Chintagumpala M, Muscal JA. Treatment and prognosis of Wilms tumor. In: UpToDate, Kim MS (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

10. Coates TD. Congenital neutropenia. In: UpToDate, Tirnauer JS (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

11. Cowan MJ. T-B-NK+SCID: Clinical manifestations, diagnosis, and treatment. In: UpToDate, TePas E (Ed), UpToDate, Waltham, MA. (Accessed on July 22, 2014.)

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 7 of 9

12. Cruse RP. Metachromatic leukodystrophy. In: UpToDate, Dashe JF (Ed), UpToDate, Waltham, MA. (Accessed

on July 15, 2014.) 13. Cruse RP. Overview of Niemann-Pick disease. In: UpToDate, Dashe JF (Ed), UpToDate, Waltham, MA.

(Accessed on July 15, 2014.) 14. Deeg HJ, Sandmaier BM. Determining eligibility for allogeneic hematopoietic cell transplantation. In:

UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.) 15. Deegan P. Gaucher disease: Treatment. In: UpToDate, TePas E (Ed), UpToDate, Waltham, MA. (Accessed on

July 15, 2014.) 16. Etzioni A. Leukocyte adhesion deficiency. In: UpToDate, Feldweg AM (Ed), UpToDate, Waltham, MA.

(Accessed on July 15, 2014.) 17. Freedman AS, Aster JC, Dearden C. B cell prolymphocytic leukemia. In: UpToDate, Connor RF (Ed),

UpToDate, Waltham, MA. (Accessed on July 22, 2014.) 18. Genge A, Massie R. Mitochondrial myopathies: Treatment. In: UpToDate, Dashe JF (Ed), UpToDate, Waltham,

MA. (Accessed on July 15, 2014.) 19. Harmon DC, Gebhardt MC. Treatment of the Ewing sarcoma family of tumors. In: UpToDate, Savarese DMF

(Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.) 20. Holmberg LA, Deeg HJ, Sandmaier BM. Determining eligibility for autologous hematopoietic cell

transplantation. In: UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.) 21. Kakkis E, Wynn R. Mucopolysaccharidoses: Complications and management. In: UpToDate, TePas E (Ed),

UpToDate, Waltham, MA. (Accessed on July 15, 2014.) 22. Kaufman PL, Paysse EA. Overview of retinoblastoma. In: UpToDate, Torchia MM (Ed), UpToDate, Waltham,

MA. (Accessed on July 15, 2014.) 23. Khan S. Hematopoietic cell transplantation for Diamond-Blackfan anemia and the myelodysplastic syndromes

in children and adolescents. In: UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

24. Khan S, Rodgers GP. Hematopoietic cell transplantation in sickle cell disease. In: UpToDate, Tirnauer JS (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

25. McClain KL. Treatment and prognosis of hemophagocytic lymphohistiocytosis. In: UpToDate, Tirnauer JS (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

26. Murrell DF, INtong L. Overview of the management of epidermolysis bullosa. In: UpToDate, Corona R (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

27. National Cancer Institute at the National Institutes of Health. Myelodysplastic/Myeloproliferative Neoplasms Treatment (PDQ). Chronic Myelomonocytic Leukemia. Updated: March 31, 2017. Retrieved from http://www.cancer.gov/cancertopics/pdq/treatment/mds-mpd/HealthProfessional/page2. Accessed October 25, 2017.

28. National Cancer Institute at the National Institutes of Health. Myelodysplastic/Myeloproliferative Neoplasms Treatment (PDQ). Juvenile Myelomonocytic Leukemia. Updated: March 31, 2017. Retrieved from http://www.cancer.gov/cancertopics/pdq/treatment/mds-mpd/HealthProfessional/page3. Accessed October 25, 2017.

29. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Acute Lymphoblastic Leukemia. Version 4.2017, 09/27/17.

30. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Acute Myeloid Leukemia. Version 3.2017, 06/06/17.

31. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Chronic Myeloid Leukemia. Version 2.2018, 10/19/17.

32. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Hodgkin Lymphoma. Version 1.2017, 03/01/17.

33. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Multiple Myeloma. Version 2.2018, 10/02/17.

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 8 of 9

34. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN

Guidelines) Myelodysplastic Syndromes. Version 1.2018, 08/29/17. 35. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN

Guidelines) Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lymphoma. Version 1.2017, 01-31-17. 36. Negrin RS. Hematopoietic cell transplantation in aplastic anemia. In: UpToDate, Tirnauer JS (Ed), UpToDate,

Waltham, MA. (Accessed on July 15, 2014.) 37. Negrin RS. Hematopoietic cell transplantation in myelodysplastic syndromes. In: UpToDate, Connor RF (Ed),

UpToDate, Waltham, MA. (Accessed on July 15, 2014.) 38. Okcu MF, Hicks J, Horowitz M. Rhabdomyosarcoma and undifferentiated sarcoma in childhood and

adolescence: Treatment. In: UpToDate, Savarese DMF, Kim MS (Eds), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

39. Pomeroy SL. Treatment and prognosis of medulloblastoma. In: UpToDate, Eichler AF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

40. Rajkumar SV. Allogeneic hematopoietic cell transplantation in multiple myeloma. In: UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

41. Rajkumar SV. POEMS syndrome. In: UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

42. Rajkumar SV. Treatment and prognosis of Waldenstrom macroglobulinemia. In: UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

43. Roberts RL, Wang KYS. Chediak-Higashi syndrome. In: UpToDate, TePas E (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

44. Shimamura A. Shwachman- Diamond syndrome. In: UpToDate, Tirnauer JS (Ed), UpToDate, Waltham, MA. (Accessed on July 15, 2014.)

45. Shohet JM, Nuchtern JG. Treatment and prognosis of neuroblastoma. In: UpToDate, Savarese DMF (Ed), UpToDate, Waltham, MA. (Accessed July 24, 2015.)

46. Tefferi A. Prognosis and treatment of primary myelofibrosis. In: UpToDate, Connor RF (Ed), UpToDate, Waltham, MA. (Accessed on July 22, 2014.)

47. Majhail NS, Farnia SH, Carpenter PA, et al. Indications for Autologous and allogeneic hemtopoietic cell transplantation: Guidelines from the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2015;1-7. Retrieved from http://asbmt.org/sites/default/files/asbmt_admin/Indications_for_Auto_and_All.pdf. Accessed October 25, 2017.

48. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) B-cell Lymphomas. Version 5.2017, 09/26/17.

49. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. Version 2.2018, 10/23/17.

50. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Hairy Cell Leukemia. Version 2.2018, 09/26/17.

51. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Primary Cutaneous B-cell Lymphomas. Version 2.2017, 04/27/17.

52. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) T-cell Lymphomas. Version 2.2017, 02/21/17.

DOCUMENT HISTORY:

Created Date: 02/94 Reviewed Date: re-adopted 07/12/12, 07/09/13, 06/10/14, 06/10/15, 06/10/16, 11/15/16, 10/04/17 Revised Date: 11/16/04, 11/15/05, 11/28/06, 05/22/07, 07/12/12, 08/06/13, 07/21/14, 09/28/15, 08/19/16, 11/15/16, 10/04/17 Retired Date: 06/24/04

Department of Origin: Integrated Healthcare Services

Approved by: Integrated Health Quality Management Subcommittee

Date approved: 12/12/17

Department(s) Effected: Integrated Healthcare Services

Effective Date: 12/12/17

Medical Criteria Document: Bone Marrow/Stem Cell Transplantation

Replaces Effective Policy Dated: 12/13/16

Reference #: MC/T001 Page: 9 of 9

Attachment A Required documentation – must have all of the following before sending to physician review: A - E

A. Letter of medical necessity outlining the member’s medical and treatment history and rationale for the proposed transplant.

B. Formal transplant evaluation including, but not limited to, cardiac, pulmonary, and renal function. C. Recent relevant imaging reports. D. Recent relevant laboratory studies. E. Current psychosocial studies documented by a formal psychological or psychosocial evaluation.

Attachment B Standard questions for physician review: A-G A. Is this procedure for this indication the subject of an ongoing Phase I, II, or III clinical trial?

B. Do consensus opinions or recommendations in relevant scientific and medical literature, peer-reviewed journals,

or reports of clinical trial committees and other technology assessment bodies (reliable evidence) support conclusively that this procedure is proven effective for this indication?

C. Does reliable evidence suggest a high probability of improved outcomes compared to standard treatment (eg, significantly increased life expectancy or significantly improved function)?

D. Does reliable evidence suggest conclusively that beneficial effects outweigh any harmful effects?

E. Does the applicable NCCN (National Comprehensive Cancer Network) guideline support this procedure for this

indication? [Include if this for an oncology diagnosis]

F. Does reliable evidence suggest that this treatment is medically appropriate for this member?

G. Are there any contraindications to this procedure for this member?

PreferredOne Community Health Plan (“PCHP”) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PCHP does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.

PCHP:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PCHP has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Community Health PlanPO Box 59052Minneapolis, MN 55459-0052Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

PreferredOne Community Health Plan Nondiscrimination Notice

Language Assistance Services

NDR PCHP LV (10/16)

PreferredOne Insurance Company (“PIC”) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. PIC does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex.

PIC:Provides free aids and services to people with disabilities to communicate effectively with us, such as:

• Qualified sign language interpreters• Written information in other formats (large print, audio, accessible electronic formats, other formats)

Provides free language services to people whose primary language is not English, such as:• Qualified interpreters• Information written in other languages

If you need these services, contact a Grievance Specialist.

If you believe that PIC has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with:

Grievance SpecialistPreferredOne Insurance CompanyPO Box 59212Minneapolis, MN 55459-0212Phone: 1.800.940.5049 (TTY: 763.847.4013)Fax: [email protected]

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, a Grievance Specialist is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services200 Independence Avenue, SWRoom 509F, HHH BuildingWashington, D.C. 202011-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

PreferredOne Insurance Company Nondiscrimination Notice

Language Assistance Services

NDR PIC LV (10/16)