![]() ![]() host disease (GVHD) prophylaxis, donor type and cell source.Ī prospective clinical study seeking Medicare coverage of allogeneic HSCT for sickle cell disease pursuant to Coverage with Evidence Development (CED) must address the following question: There must be appropriate statistical techniques in the analysis to control for selection bias and potential confounding by age, duration of diagnosis, comorbid conditions, type of preparative/conditioning regimen, graft vs. We are finalizing the following decision:Īllogeneic HSCT for sickle cell disease (SCD) will be covered by Medicare only for beneficiaries with severe, symptomatic sickle cell disease who participate in an approved prospective clinical study. Prospectively, compared to patients who do not receive allogeneic HSCT, do Medicare beneficiaries with MF who receive allogeneic HSCT have improved outcomes as indicated by:ĬMS will cover items and services necessary for research under §1862(a)(1)(E) for allogeneic HSCT for certain Medicare beneficiaries with Sickle Cell Disease using the Coverage with Evidence Development (CED) paradigm. host disease (GVHD) prophylaxis, donor type and cell source.Ī prospective clinical study seeking Medicare coverage of allogeneic HSCT for myelofibrosis pursuant to Coverage with Evidence Development (CED) must address the following question: There must be appropriate statistical techniques in the analysis to control for selection bias and potential confounding by age, duration of diagnosis, disease classification, DIPSSplus score, comorbid conditions, type of preparative/conditioning regimen, graft vs. We are finalizing the following decision:Īllogeneic HSCT for myelofibrosis will be covered by Medicare only for beneficiaries with Dynamic International Prognostic Scoring System (DIPSSplus) intermediate-2 or High primary or secondary MF and participating in an approved prospective clinical study. Other transplant-related adverse events ĬMS will cover items and services necessary for research under §1862(a)(1)(E) for allogeneic HSCT for certain Medicare beneficiaries with myelofibrosis (MF) using the Coverage with Evidence Development (CED) paradigm. ![]() Prospectively, compared to patients who do not receive allogeneic HSCT, do Medicare beneficiaries with multiple myeloma who receive allogeneic HSCT have improved outcomes as indicated by: host disease (GVHD) prophylaxis, donor type and cell source.Ī prospective clinical study seeking Medicare coverage of allogeneic HSCT for multiple myeloma pursuant to CED must address the following question: There must be appropriate statistical techniques in the analysis to control for selection bias and potential confounding by age, duration of diagnosis, disease classification, International Myeloma Working Group (IMWG) classification, ISS staging, Durie-Salmon staging, comorbid conditions, type of preparative/conditioning regimen, graft vs. We are finalizing the following decision:Īllogeneic HSCT for multiple myeloma will be covered by Medicare only for beneficiaries with Durie-Salmon Stage II or III multiple myeloma, or International Staging System (ISS) Stage II or Stage III multiple myeloma who are participating in an approved prospective clinical study that meets the criteria below. The Centers for Medicare & Medicaid Services (CMS) will modify our existing National Coverage Determinations Manual to expand national coverage for allogeneic hematopoietic stem cell transplantation (HSCT) for three separate medical conditions:ĬMS will cover items and services necessary for research under §1862(a)(1)(E) for allogeneic HSCT for certain Medicare beneficiaries with multiple myeloma (MM) using the Coverage with Evidence Development (CED) paradigm. ![]()
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