Allogeneic Hematopoietic Stem Cell Transplant for Multiple Myeloma
The NCD for Stem Cell Transplantation Multiple Myeloma (MM), Myelofibrosis (MF) and Sickle Cell Disease (SCD), released by CMS on January 27, 2016, concluded that, CMS will cover items and services necessary for research under §1862(a)(1)(E) for a allogeneic hematopoietic stem cell transplant (HSCT) for certain Medicare beneficiaries with multiple myeloma (MM) using the Coverage with Evidence Development (CED) paradigm.
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.
A prospective clinical study seeking Medicare coverage of allogeneic HSCT for multiple myeloma pursuant to CED must address the following question:
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:
- Graft vs. host disease (acute and chronic);
- Other transplant-related adverse events;
- Overall survival; and
- Quality of life (optional).
Instructions on how to submit an application for CMS approval of study protocols can be found on Appendix C of the Final Decision Memo.
Below is a list of Medicare-approved clinical studies we have reviewed and determined meet the requirements for coverage under CED.
Study Title: Assessment of Allogeneic Hematopoietic Cell Transplantation in Medicare Beneficiaries With Multiple Myeloma: A Study to Develop Evidence of Effectiveness for the Centers for Medicare and Medicaid Services (CMS)
Sponsor: Center for International Blood and Marrow Transplant Research
Clinicaltrials.gov number: NCT03127761
CMS Approval Date: 06/05/2017