Fact Sheets

MEDICARE PROPOSES TO COVER STEM CELL TRANSPLANTATION FOR PRIMARY AMYLOID LIGHT CHAIN (AL) AMYLOIDOSIS

Overview:    Autologous stem cell transplantation (AuSCT) can treat AL Amyloidosis, a rare blood disorder which affects the heart, kidneys, nervous system and gastrointestinal system and results in extensive organ system impairment. In this transplantation, stem cells are retrieved from a patient’s bone marrow or blood, stored, and then transplanted back into the patient following high dose chemotherapy used to treat various cancers. For patients younger than 63 years old, this procedure is currently covered at the local contractor’s discretion. Since October 1, 2000, primary AL amyloidosis has had a national non-coverage determination for Medicare beneficiaries 64 years of age or older.    

Affected Group:  Two thirds of people with AL Amyloidosis are male. 

Proposed Coverage: Previously, stem cell transplants were not covered for beneficiaries age 64 or older.  After analyzing the medical and scientific evidence for AuSCT for AL Amyloidosis and considering the recommendations of professional societies and other experts in the field, CMS determined that AuSCT will improve the care of Medicare beneficiaries with primary AL Amyloidosis. AuSCT can provide a health benefit for Medicare beneficiaries of any age with primary AL Amyloidosis and recommends coverage for beneficiaries who meet three specific criteria regarding extent of disease, particularly involvement of the kidneys or heart.  CMS encourages providers to submit data regarding this procedure to existing registries. CMS will accept public comments on the draft decision memorandum for 30 days, and will make the decision final within 90 days. The proposed decision memorandum appears on the CMS on its web site at http://www.cms.hhs.gov/coverage.