Decision Memo for Stem Cell Transplantation (Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease) (CAG-00444R)

(Source – CMS.gov)

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:

• Multiple Myeloma
• Myelofibrosis, and
• Sickle Cell Disease.

MULTIPLE MYELOMA

CMS 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. We are finalizing the following decision:

Allogeneic 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. 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. host disease (GVHD) prophylaxis, donor type and cell source. Read more…

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