Nationally Covered Indications

I. Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) 

a. General 

Allogeneic stem cell transplantation (ICD-9-CM Procedure Codes 41.02, 41.03, 41.05, and 41.08,; ICD-10-PCS codes 30230G1, 30230Y1, 30233G1, 30233Y1, 30240G1, 30240Y1, 30243G1, 30243Y1, 30250G1, 30250Y1, 30253G1, 30253Y1, 30260G1, 30260Y1, 30263G1, and 30263Y1) is a procedure in which a portion of a healthy donor's stem cells are obtained and prepared for intravenous infusion to restore normal hematopoietic function in recipients having an inherited or acquired hematopoietic deficiency or defect.

Expenses incurred by a donor are a covered benefit to the recipient/beneficiary but, except for physician services, are not paid separately. Services to the donor include physician services, hospital care in connection with screening the stem cell, and ordinary follow-up care.

b. Covered Conditions

i. Effective for services performed on or after August 1, 1978: 

For the treatment of leukemia, leukemia in remission, or aplastic anemia when it is reasonable and necessary; 

ii. Effective for services performed on or after June 3, 1985: 

For the treatment of severe combined immunodeficiency disease (SCID), and for the treatment of Wiskott-Aldrich syndrome; 

iii. Effective for services performed on or after August 4, 2010: 

For the treatment of Myelodysplastic Syndromes (MDS) pursuant to Coverage with Evidence Development (CED) in the context of a Medicareapproved, prospective clinical study.

iv. Effective for claims with dates of service on or after January 27, 2016: 

1. Allogeneic HSCT for multiple myeloma is 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, and participating in an approved prospective clinical study. 

2. Allogeneic HSCT for myelofibrosis (MF) is 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. 

3. Allogeneic HSCT for sickle cell disease (SCD) is covered by Medicare only for beneficiaries with severe, symptomatic SCD who participate in an approved prospective clinical study.