Medicare Proposes New Coverage Policy for Stem Cell Transplant for Sickle Cell, Myelofibrosis, and Myeloma

On October 29, 2015, the Centers for Medicare and Medicaid Services (CMS) released a new proposed coverage policy for hematopoietic stem cell transplant for Medicare patients. In May, ASH supported a request made by the National Marrow Donor Program (NMDP) and American Society for Blood and Marrow Transplantation (ASBMT) to change the national coverage determination to explicitly include sickle cell disease and myelofibrosis as well as eliminate the prohibition of coverage for multiple myeloma. CMS has proposed to include coverage for all three of those conditions (for certain indicated patients) under a process called coverage with evidence development.

Most services provided under Medicare do not have a National Coverage Determination – coverage is instead determined by local contractors known as Medicare Administrative Contractors (MACs). At one time, there were different contractors for each state but the contracts have consolidated so that there are only twelve regions. These MACs are given the opportunity to develop their own local coverage determinations but many procedures and services do not have stated coverage determinations even at the local level. Medicare patients with sickle cell disease or myelofibrosis who received a hematopoietic stem cell transplant could theoretically be financially liable for the cost of the entire procedure and follow-up if a local medical director found it to be not medically necessary. In the case of multiple myeloma, Medicare would not pay for a stem cell transplant, regardless of the local region.

This proposed change would add those three conditions to covered status under the process known as coverage with evidence development. Coverage with evidence development is used by Medicare when the agency finds that the scientific evidence of a procedure’s efficacy is lacking in a particular population. Medicare agrees to pay for the service in exchange for those providing it gathering data, often using a registry. Coverage with evidence development is intended to be a temporary evidence-gathering step but some coverage with evidence development policies have been in place for many years.

As a supporter of the original request for coverage, ASH is pleased to see the positive reaction and proposed expansion of the national coverage indications. ASH leaders will be reviewing the proposed coverage in more detail and will send comments by the deadline at the end of the month. Members are also encouraged to review the coverage determination and offer their own comments. If you have questions and/or would like to share any additional comments to ASH, please contact Brian Whitman, ASH Senior Manager of Policy and Practice.