Aetna considers compatibility testing of prospective donors who are members of the immediate family (first-degree relatives, i.e., parents, siblings and children) and harvesting and short-term storage of peripheral stem cells or bone marrow from the identified donor medically necessary when an allogeneic bone marrow or peripheral stem cell transplant is authorized by Aetna.  

Aetna considers umbilical cord blood stem cells an acceptable alternative to conventional bone marrow or peripheral stem cells for allogeneic transplant.  

Aetna considers medically necessary the short-term storage of umbilical cord blood for a member with a malignancy undergoing treatment when there is a match.  Note: The harvesting, freezing and/or storing umbilical cord blood of non-diseased persons for possible future use is not considered treatment of disease or injury.  Such use is not related to the person’s current medical care.

Notes:

• When a covered family member of a newborn infant has a medically necessary indication for an allogeneic bone marrow transplant and wishes to use umbilical cord blood stem cells as an alternative, Aetna covers the testing of umbilical cord blood for compatibility for transplant under the potential recipient’s plan.
• Performance of HLA typing and identification of a suitable donor does not, in and of itself, guarantee coverage of allogeneic bone marrow or peripheral stem cell transplantation.  Medical necessity criteria and plan limitations and exclusions may apply.

See also the following CPBs related to bone marrow and peripheral stem cell transplantation:

• CPB 0494 - Hematopoietic Cell Transplantation for Non-Hodgkin's Lymphoma
• CPB 0495 - Hematopoietic Cell Transplantation for Hodgkin's Disease
• CPB 0496 - Hematopoietic Cell Transplantation for Selected Childhood Solid Tumors 
• CPB 0497 - Hematopoietic Cell Transplantation for Multiple Myeloma
• CPB 0606 - Hematopoietic Cell Transplantation for Autoimmune Diseases and Miscellaneous Indications 
• CPB 0617 - Hematopoietic Cell Transplantation for Testicular Cancer 
• CPB 0626 - Allogeneic Bone Marrow or Peripheral Stem Cell Transplant for Thalassemia Major and Sickle Cell Anemia
• CPB 0627 - Hematopietic Cell transplantation for Aplastic Anemia and other Bone Marrow Failure Syndromes  
• CPB 0634 - Non-myeloablative Bone Marrow/Peripheral Stem Cell Transplantation (Mini-Allograft / Reduced Intensity Conditioning Transplant)
• CPB 0635 - Hematopoietic Cell Transplantation for Ovarian Cancer
• CPB 0638 - Donor Lymphocyte Infusion
• CPB 0640 - Bone Marrow or Peripheral Stem Cell Transplant for Selected Leukemias 
• CPB 0674 - Hematopoietic Cell Transplantation for Chronic Myelogenous Leukemia
• CPB 0830 - Hematopoietic Cell Transplantation for Primary Immunodeficiency Disorders
• CPB 0833 - Hematopoietic Cell Transplantation for Waldenstrom Macroglobulinemia
• CPB 0836 - Hematopoietic Cell Transplantation for Myelodysplastic Syndrome

According to the American Academy of Pediatrics (2007), cord blood transplantation has been shown to be curative in patients with a variety of serious diseases.  Physicians should be familiar with the rationale for cord blood banking and with the types of cord blood banking programs available.  Physicians consulted by prospective parents about cord blood banking can provide the following information:

• Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use, because most conditions that might be helped by cord blood stem cells already exist in the infant's cord blood (i.e., pre-malignant changes in stem cells).  Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood.  Although not standard of care, directed cord blood banking should be encouraged when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) that could potentially benefit from cord blood transplantation.

• Cord blood donation should be encouraged when the cord blood is stored in a bank for public use.  Parents should recognize that genetic (e.g., chromosomal abnormalities) and infectious disease testing is performed on the cord blood and that if abnormalities are identified, they will be notified.  Parents should also be informed that the cord blood banked in a public program may not be accessible for future private use.

• Because there are no scientific data at the present time to support autologous cord blood banking and given the difficulty of making an accurate estimate of the need for autologous transplantation and the ready availability of allogeneic transplantation, private storage of cord blood as "biological insurance" should be discouraged.  Cord blood banks should comply with national accreditation standards developed by the Foundation for the Accreditation of Cellular Therapy (FACT), the U.S. Food and Drug Administration (FDA), the Federal Trade Commission, and similar state agencies.  At a minimum, physicians involved in procurement of cord blood should be aware of cord blood collection, processing, and storage procedures.

Eapen and colleagues (2010) stated that umbilical-cord blood (UCB) is increasingly considered as an alternative to peripheral blood progenitor cells (PBPCs) or bone marrow, especially when an human leukocyte antigen (HLA)-matched adult unrelated donor is not available.  These investigators aimed to determine the optimal role of UCB grafts in transplantation for adults with acute leukemia, and to establish whether current graft-selection practices are appropriate.  They used Cox regression to retrospectively compare leukemia-free survival and other outcomes for UCB, PBPC, and bone marrow transplantation in patients aged 16 years or over who underwent a transplant for acute leukemia.  Data were available on 1,525 patients transplanted between 2002 and 2006.  A total of 165 received UCB, 888 received PBPCs, and 472 received bone marrow.  Umbilical-cord blood units were matched at HLA-A and HLA-B at antigen level, and HLA-DRB1 at allele level (n = 10), or mis-matched at 1 antigen (n = 40) or 2 antigens (n = 115).  Peripheral blood progenitor cells and bone-marrow grafts from unrelated adult donors were matched for allele-level HLA-A, HLA-B, HLA-C, and HLA-DRB1 (n = 632 and n = 332, respectively), or mis-matched at 1 locus (n = 256 and n = 140, respectively).  Leukemia-free survival in patients after UCB transplantation was comparable with that after 8/8 and 7/8 allele-matched PBPC or bone-marrow transplantation.  However, transplant-related mortality was higher after UCB transplantation than after 8/8 allele-matched PBPC recipients (hazard ratio [HR] 1.62, 95 % confidence interval [CI]: 1.18 to 2.23; p = 0.003) or bone-marrow transplantation (HR 1.69, 95 % CI: 1.19 to 2.39; p = 0.003).  Grades 2 to 4 acute and chronic graft-versus-host disease (GVHD) were lower in UCB recipients compared with allele-matched PBPC (HR 0.57, 95 % CI: 0.42 to 0.77; p = 0.002 and HR 0.38, 95 % CI: 0.27 to 0.53; p = 0.003, respectively), while the incidence of chronic, but not acute GVHD, was lower after UCB than after 8/8 allele-matched bone-marrow transplantation (HR 0.63, 95 % CI: 0.44 to 0.90; p = 0.01).  These data support the use of UCB for adults with acute leukemia when there is no HLA-matched unrelated adult donor available, and when a transplant is needed urgently.