Certificate of Medical Necessity Bone Marrow/Stem Cell Transplants Please forward the completed CMN forms and other required documentation (i.e., letter of medical necessity from physician, patient history of illness, all pertinent laboratory findings, diagnostic testing including radiology reports, and other pertinent documentation) to: Fax: 904-357-6331 Email: CentralizedTransplantUnit@bcbsfl.com Phone: 1-800-955-5692 x84157 SECTION A Patient Name: Patient Address: City: State: Zip Code: Patient Fl DOB: Gender: Patient BCBSF ID # Physician’s Name Physician’s NPI No. Physician’s Address: City: State: Zip Code: Physician Phone: Transplant Facility Name: Provider Number: Phone: Fax: NPI No. Transplant Coordinator Name: Phone: Other: Fax: Financial Coordinator Name: Phone: Fax: Referring Physician Name ICD-9 Codes Diagnosis Codes Description (include co morbidity): Caregiver/Support Person Contact: Phone: Relationship: Urgent Request: Currently Inpatient: Fl (###) ###-#### (###) ###-#### (###) ###-#### (###) ###-#### (###) ###-#### (###) ###-#### (###) ###-#### (###) ###-#### Yes Yes No No SECTION B – MUST BE COMPLETED Please answer ALL of the following questions: Check Response 1. General Information: A. Type of Stem Cell Transplant? B. Specify: Autologous C. Is this a tandem request? Allogeneic Yes No If yes what #: D. Stem Cell Source: Bone Marrow Peripheral Blood Umbilical Cord Blood 2. Current Medical Information: Were there any previous stem cell transplants? If yes, please indicate type: Autologous Did any previous stem cell transplant fail? If yes, please indicate type: Autologous Revised 09/15/13 Yes No Yes No Allogeneic Allogeneic Date: Page 1 of 4 Created: 08/31/10 Is the diagnosis in accordance with Chapter 59-B of the Florida Administrative Code, allogeneic hematopoietic bone marrow transplantation for one of the following (excluding Florida Blue Federal Employee Plan members)? Chronic myelogenous leukemia Acute myelogenous leukemia Acute lymphoblastic leukemia Chronic lymphocytic leukemia Non-Hodgkin’s lymphoma Myelodysplastic syndrome Myeloid sarcoma Hodgkin’s disease relapsed after autologous transplant, but not progressing on salvage therapy Severe or very severe aplastic anemia, from HLA-compatible siblings for individuals below 40 years of age Severe aplastic anemia unresponsive to immunosuppression Hodgkin’s disease to treat primary refractory or relapsed disease Multiple myeloma for: Yes No Yes No Yes No o Newly diagnosed disease Treatment following initial round of autologous hematopoietic stem-cell transplantation Treatment following primary graft failure or failure to engraft o Is the allogeneic hematopoietic , bone marrow transplantation for one of the following indications, to be performed in the context of a well designed and conducted Phase II or Phase III clinical treatment trial? Multiple myeloma and other plasma cell dyscrasias (e.g., Waldenstrom’s, amyloidosis) Renal cell carcinoma Hodgkin’s disease Sickle cell anemia, thalassemia and other severe red cell disorders Is allogeneic bone marrow transplantation being requested for one of the following indications? Absent or defective natural killer function (eg, Chediak-Higashi syndrome) Absent or defective neutrophil function (eg, Kostmann syndrome, chronic granulomatous disease, leukocyte adhesion defect) Aplastic anemia (including hereditary forms, such as Fanconi anemia, dyskeratosis congenital, ShwachmanDiamond, Diamond Blackfan, and acquired anemia (eg, secondary to drug or toxin exposure) Wiskott-Aldrich syndrome Severe combined immunodeficiency (SCID) Sickle cell with either a history of prior stroke or at increased risk of stroke or end-organ damage Homozygous beta-thalassemia (eg, thalassemia major) Infantile malignant osteopetrosis (Albers-Schonberg disease or marble bone disease) Inherited metabolic disease (eg, lysosomal and peroxisomal storage disorders) Mucoplysaccharidoses in patients who are neurologically intact Mucolipidoses for patients who have failed conventional therapy and are neurologically intact Kostmann’s syndrome Leukocyte adhesion deficiencies X-linked lymphoproliferative syndrome Recurrent or refractory medulloblastoma and other primitive neuroectodermal tumors (PNETS) Recurrent or refractory Ewing’s sarcoma Revised 12/15/14 Page 2 of 4 Created: 08/31/10 Is the diagnosis in accordance with Chapter 59-B of the Florida Administrative Code, autologous bone marrow transplantation for one of the following (excluding Florida Blue Federal Employee Plan members)? Acute myelogenous leukemia Hodgkin’s disease Non-Hodgkin’s lymphoma Ewing’s sarcoma, chemotherapy sensitive after first relapse Neuroblastoma Germ cell tumor, after failure of first therapy but not progressing on salvage therapy Multiple myeloma (including double bone marrow transplant) Primary amyloidosis PNET (including medulloblastoma and pinealoblastoma) chemotherapy sensitive after first relapse Medulloblastoma and other PNET tumors, metastatic, at diagnosis Severe aplastic anemia unresponsive to immunosuppression Is the autologous bone marrow transplantation for one of the following indications, to be performed in the context of a well designed and conducted Phase II or Phase III clinical treatment trial? Chronic lymphocytic leukemia Plasma cell dyscrasias other than multiple myeloma (e.g., Waldenstrom’s) Breast cancer Ewing’s sarcoma, localized, greater than 8 cm or metastatic at presentation Soft tissue sarcoma, pediatric, after failure of first therapy Wilm’s tumor, at relapse Germ cell tumor, high risk, at diagnosis Multiple autologous bone marrow transplants for pediatric solid tumors Metastatic malignant melanoma Embryonic tumors of the central nervous system to treat recurrence or as consolidation therapy for previously Yes No Yes No Yes No Yes No untreated tumors that show partial or complete response to induction chemotherapy, or stable disease Testicular tumors as salvage therapy or platinum refractory disease Ewings sarcoma as initial treatment of high-risk Ewings sarcoma or recurrent or refractory disease Germ cell tumor with favorable prognostic factors that failed a previous course of conventional-dose salvage therapy Germ cell tumor as initial treatment of first relapse in member with unfavorable prognostic factors or for platinum- refractory disease Is the bone marrow transplantation for one of the following rare diseases, in accordance with Chapter 59-B of the Florida Administrative Code, to be performed at a Blood and Marrow Transplant Clinical Trials Network (BMT CNT) core or non-core facility? Myelofibrosis Chronic myelomonocytic leukemia (CMML) Paroxysmal nocturnal hemoglobinuria (PNH) POEMS syndrome For a bone marrow transplant outside of a clinical trial are the following criteria met? The plan of care follows a clinical trial protocol that meets the requirements the note section below Member cannot be enrolled in the proposed clinical trial Bone marrow transplant treatment is medically necessary Treatment Center is part of the Blood and Marrow Transplant Clinical Trials Network Member is appropriate candidate for bone marrow transplant Note: A well-designed and conducted clinical treatment trial is one which includes an IRB-approved written protocol. At a minimum, such protocol shall have specific criteria for evaluating the effect of treatment with defined endpoints that are precise, meaningful, and reliable and which allow valid conclusions to be drawn about therapeutic efficacy and safety. Protocols should include an adequate statistical section describing the method of randomization and stratification, if any, expected outcome parameters relating to response rates, time to progression, survival times and other relevant information. Such clinical treatment trials shall be consistent with protocols reviewed and approved by the National Cancer Institute for scientific merit. Revised 09/15/13 Page 3 of 4 Created: 08/31/10 Is a reduced-intensity allogeneic hematopoietic stem cell transplantation for a member who would otherwise meet Yes No Is reduced-intensity allogeneic hematopoietic stem cell transplantation for the following indications when the bone marrow transplantation procedure is performed in the context of a well-designed and conducted Phase II or Phase III clinical treatment trial? Multiple myeloma and other plasma cell dyscrasias (e.g., Waldenstrom’s, amyloidosis) Renal cell carcinoma Hodgkin’s disease Sickle cell anemia, thalassemia and other severe red cell disorders Yes No Is reduced-intensity allogeneic hematopoietic stem cell transplantation for the following indications? Yes No selection criteria for high-dose chemotherapy and allogeneic stem cell transplantation for the following indications? Acute myelogenous leukemia Chronic myelogenous leukemia Acute lymphoblastic leukemia Chronic lymphoblastic leukemia Non-Hodgkin’s lymphoma Myelodysplastic syndrome Myeloproliferative neoplasms Hodgkin’s disease To treat primary refractory or relapsed disease To treat member who has failed a prior autologous HSCT used to treat primary refractory or relapsed disease To treat member who would otherwise qualify for a myeloablative allogeneic transplant, but would be unable to tolerate a standard myeloablative conditioning regimen When insufficient stem cells are collected for an autologous HSCT. Multiple myeloma To treat newly diagnosed multiple myeloma following an initial round of autologous hematopoietic stem-cell transplantation To treat multiple myeloma with primary graft failure or failure to engraft Form completed by: Name/Title (Printed): Signature: ______________________________________________________ Date: Please complete all parts as clearly and as specifically as possible. Omissions, generalities and illegibility will result in the form being returned for completion or clarification. All supporting documentation should be sent with this form. Revised 12/15/14 Page 4 of 4 Created: 08/31/10