Proposed LCD - Allogeneic Hematopoietic Cell Transplantation for Primary Refractory or Relapsed Hodgkin's and Non-Hodgkin's Lymphoma with B-cell or T-cell Origin (DL39513)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member.CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 2,110.23 Stem Cell TransplantationCMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, 310.1 Routine Costs in Clinical TrialsCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing Manual, Chapter 3, 90.3 Stem Cell TransplantationCMS Internet-Only Manual, Pub. 100-04, Medicare Claims Processing, Chapter 32, 90 Stem Cell Transplantation and 90.1 GeneralCoverage Indications, Limitations, and/or Medical NecessityStem celltransplantation is a process in which stem cellsare harvested from either a patients (autologous) or donors (allogeneic) bone marrow or peripheral blood for intravenous infusion. Autologousstem celltransplantation (AuSCT) is a technique for restoring stemcells using the patient's own previously stored cells. AuSCT must be used to effect hematopoietic reconstitution following severely myelotoxic doses of chemotherapy (HDCT) and/or radiotherapy used to treat various malignancies.Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a procedure in which a portion of a healthy donor's stem cells or bone marrow is obtained and prepared for intravenous infusion. Hematopoietic stem cells are multi-potent cells that give rise to all the blood cell types; these stem cells form blood and immune cells. A hematopoietic stem cell is a cell isolated from blood or bone marrow that can renew itself, differentiate to a variety of specialized cells, can mobilize out of the bone marrow into circulating blood, and can undergo programmed cell death, called apoptosis - a process by which cells that are unneeded or detrimental will self-destruct.The Centers for Medicare & Medicaid Services (CMS) has clarified that bone marrow and peripheral blood stem cell transplantation is a process which includes mobilization, harvesting, and transplant of bone marrow or peripheral blood stem cells and the administration of high dose chemotherapy or radiotherapy prior to the actual transplant. When bone marrow or peripheral blood stem cell transplantation is covered, all necessary steps are included in coverage.NCD 110.23 Stem Cell Transplantation covers allo-HSCT for the following conditions, when reasonable and necessary:LeukemiaAplastic AnemiaSevere Combined Immunodeficiency disease (SCID)Wiskott-Aldrich SyndromeAllo-HSCTis covered for Medicare beneficiaries with the following indications only when participating in approved prospective clinical studies meeting specific criteria under the Coverage with Evidence Development (CED) paradigm:Myelodysplastic SyndromesMultiple myeloma with Durie-Salmon Stage II or III disease, or International Staging System (ISS) Stage II or Stage III diseaseMyelofibrosis (MF) with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary disease; orSickle cell disease (SCD) that is severe and symptomatic(Please refer to CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual,Chapter 1, Part 2, 110.23 Stem Cell Transplantation)Per the NCD,all other indications forstemcelltransplantation not otherwise noted as covered or non-covered remain at local Medicare Administrative Contractor (MAC) discretion.This policy describes additional locally covered indications for allo-HSCT for primary refractory or relapsed Hodgkin's and non-Hodgkin's lymphomas with B-cell or T-cell origin that are medically necessary in patients for whom there are no other curative intent options.Documentation to support the reasonable and necessary nature of allo-HSCTs must speak to the serious illness of the patient, the reasons why the patient is considered to have relapsed or refractory disease, relevant clinical contextual information such as age, frailty, performance status, cardiopulmonary function, any associated organ dysfunction that could impact complications or recovery, screening for infectious diseases that could impact transplant care, nutritional status and patient specific psychosocial and financial support structures. Risk assessment scoring, such as the European Society for Blood and Bone Marrow Transplantation (EBMT) or the HCT Comorbidity Index (HCT-CI), should be strongly considered and in the case of any nationally covered indications per NCD 110.23 would of course be required.General InformationAssociated InformationN/ASources of InformationAmerican Society of HematologyAmerican Society for Transplantation and Cellular TherapyBibliographyShah NN, Ahn KW, Litovich C, et al. Outcomes for Medicare-age eligible NHL patients receiving RIC allogeneic transplantation: A CIBMTR analysis.Blood Advances.2018;2(8):933-940.Muffly L, Pasquini MC, Martens M, et al. Increasing use of allogeneic hematopoietic cell transplantation in patients aged 70 years and older in the United States.Blood. 2017;130(9):1156-1164.Majhail NS, Farnia SH, Carpenter PA, et al. Indications for autologous and allogeneic hematopoietic cell transplantation: Guidelines from the American society for blood and marrow transplantation.Biol Blood Marrow Transplant. 2015:21(11):1863-1869.Kharfan-Dabaja MA, Kumar A, Ayala E, et al. Clinical practice recommendations on indication and timing of hematopoietic cell transplantation in mature t cell and nk/t cell lymphomas: An international collaborative effort on behalf of the guidelines committee of the American society for blood and marrow transplantation.Biol Blood Marrow Transplant. 2017;23(11):1826-1838.DSouza A, Lee S, Zhu X, Pasquini M. Current use and trends in hematopoietic cell transplantation in the United States.Biol Blood Marrow Transplant. 2017;23(9):1417-1421.Kanate AS, Majhail NS, Savani BN, et al. Indications for Hematopoietic cell transplantation and immune effector cell therapy: Guidelines from the American society for transplantation and cellular therapy.Biol Blood Marrow Transplant.2020;26:1247-1256.Deeg HJ, Sandmaier BM. Determining eligibility for allogeneic hematopoietic transplantation. In: Rosmarin AG, ed.UpToDate.2022.Khouri IF, Champlin RE. Nonmyeloablative allogeneic stem cell transplantation for non-hodgkin lymphoma.Cancer J.2012;18(5):457-462.Bellei M, Foss FM, Shustov AR, et al. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: A report from the prospective, international t-Cell project.Haematologica. 2018;103(7):1191-1197.