Cord blood banking is a process of salvaging the cord and placental blood and cryogenically freezing it immediately after the birthing process.  Currently, most cord blood is salvaged from a sibling or close family member for a patient who requires allogeneic bone marrow transplantation, and is unable to find a match in the National Bone Marrow Bank.  Both malignant and non-malignant, including genetic diseases, can be treated with cord blood.

Note:  For additional stem cell transplant information and criteria, see the applicable document:

• TRANS.00023 High-Dose Chemotherapy with Hematopoietic Stem Cell Transplantation for Multiple Myeloma and Amyloidosis;
• TRANS.00024 High-Dose Chemotherapy with Hematopoietic Stem Cell Transplantation for the Leukemias and Myelodysplastic Syndrome;
• TRANS.00027 High-Dose Chemotherapy with Hematopoietic Stem Cell Transplantation for Pediatric Solid Tumors;
• TRANS.00028 High-Dose Chemotherapy with Hematopoietic Stem Cell Transplantation for Hodgkin's Disease and non-Hodgkin's Lymphoma;
• TRANS.00029 High-Dose Chemotherapy with Hematopoietic Stem Cell Transplantation for Genetic Diseases and Acquired Anemias

Medically Necessary:

1. The use of umbilical cord blood progenitor cell transplantation is considered medically necessary for selected patients when when all of the following criteria are met:
   • A single donor is used for a single recipient
   • The cord blood cell count is > 0.23 x 10⁸ per kg
   • The umbilical cord blood stem cell unit is used for an allogeneic stem cell transplant for an approved indication and the appropriate stem cell transplant policy criteria are met.
2. Collection and storage of cord blood is considered medically necessary only when an allogeneic transplant is imminent for an identified recipient and the above criteria are met.  Storage will only be authorized at centers approved by one of the following accreditation bodies:
   • Foundation for Accreditation for Cell Therapy (FACT)
   • National Cancer Institute (NCI)
   • American Association of Blood Banks (AABB)
   • California Biologic Bank

Investigational/Not Medically Necessary:

Prophylactic collection and storage of umbilical cord blood is considered investigational/not medically necessary when proposed for an unspecified future use for an autologous stem cell transplant in the original donor or for an unspecified future use as an allogeneic stem cell transplant in a related or unrelated donor.
 

The evidence from multiple case series studies indicates that the pattern of immune reconstitution with umbilical cord blood is similar to that reported for other stem cell sources and that it is also an effective means for increasing survival rates. The one-year survival rate may be as high as 73% when HLA-matched siblings are the donor but only 29% for unrelated donors.
 
The indications for autologous transplantation are limited, and the potential for future expansion is unlikely. This position is supported by multiple case series.

Given the difficulty in estimating the need for using one’s own cord blood cells for transplantation, there is a paucity of evidence to support the private storage of cord blood for “biological insurance.” The best available evidence investigating cord blood as a source of stem cells has been that of well designed controlled trials without randomization.

In recent years, umbilical cord blood has been used successfully to treat a variety of genetic, hematologic and oncologic disorders. It has been shown that umbilical cord blood contains a large number of hematopoietic stem cells.

Blood harvested from the umbilical cord and placenta shortly after delivery of a neonate contains stem and progenitor cells capable of restoring hematopoietic function after myeloablative therapy. Cord blood is being used as an alternative source of allogeneic stem cells when a suitable donor is unavailable. Cord blood is readily available and is thought to be antigenically "naïve," hopefully minimizing the incidence of graft-versus-host disease (GVHD) and permitting the broader use of unrelated cord blood transplants.

Two characteristics that can influence the outcome of a cord blood transplantation are the dose of cells infused and the recipient's weight. It is widely accepted that the dose of cells infused is a major factor contributing to durable long-term engraftment of bone marrow or peripheral blood stem cells. The minimal cell dose needed is variable, depending on parameters that include the preparative regimen used for marrow ablation, the nature of the underlying disease, the degree of immunologic mismatch between donor and recipient, and the source of stem cells to be used. Smaller volumes of cord blood and, thus, fewer nucleated cells can be harvested from the umbilical cord and placenta of a single neonate than is possible when bone marrow or peripheral blood stem cells are obtained from adults.

Based on the limited volumes that can be collected, studies of cord blood transplants have focused on children and adolescents. Although the majority of patients transplanted with cord blood stem cells have weighed 50 kg or less, successful engraftment and hematopoietic recovery has been observed in some patients up to 82 kg. No upper limit for patient weight has been established. A recommendation has been adopted to avoid the use of a cord blood transplant that contains a cell dose of less than 1x107/kg of recipient's weight, a dose associated with a 100% mortality rate.

Several private, for-profit companies have begun offering a fee-based service to harvest, process, and store cord blood stem cells for possible autologous use. Empirical evidence that children will need their own cord blood for future use is lacking.

Allogeneic: the bone marrow donor and recipient are two different people

Autologous: the same patient is both the donor and the recipient

Hematologic: relating to hematology, that is that branch of medical science that studies blood and blood forming tissues

Hematopoietic stem cells: cells that give rise to distinct daughter cells, one cell that replicates the stem cell and one cell that will further proliferate and differentiate into a mature blood cell

HLA: human leukocyte antigens

Oncologic: pertaining to cancer

Umbilical or placental cord blood: blood taken post partum from the umbilical cord or placenta

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.   Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

CPT

HCPCS

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure codes listed above, when criteria are not met; or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary.

Peer Reviewed Publications:

1. Annas GJ. Waste and longing – the legal status of placental-blood banking. N Engl J Med. 1999; 340(19): 1521-1524.
2. Barker, JN, Weisdorf DJ, DeFor TE, et al. Rapid and complete donor chimerism in adult recipients of unrelated donor umbilical cord blood transplantation after reduced-intensity conditioning. Blood. 2003; 102(5):1915-1919.
3. Barker, JN, Weisdorf DJ, DeFor TE, et al. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005; 105(3):1343-1347. Available at: http://www.bloodjournal.org/cgi/content/full/105/3/1343. Accessed on October 10, 2006.
4. Cairo MS, Wagner JE. Placental and/or umbilical cord blood: an alternative source of hematopoietic stem cells for transplantation. Blood. 1997; 90(12): 4665-4678.
5. Ebrahim GJ. Umbilical cord blood – a rich source of hematopoietic stem cells. Journal of Tropical Pediatrics. 2002; 48: 64-65.
6. Gluckman E, Rocha V, Boyer-Chammard A, et al. Outcome of cord blood transplantation from related and unrelated donors. N Engl J Med. 1997; 337(6): 373-381.
7. Gluckman E. Hematopoietic stem-cell transplants using umbilical cord blood. N Engl J Med. 2001; 344(24):1860-1861.
8. Kurtzberg J, Laughlin M, Graham ML, et al. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated donors. N Engl J Med. 1996; 335(3): 157-166.
9. Kurtzberg J, Martin P, Chao N, et al. Unrelated placental blood in marrow transplantation. Stem Cells. 2000; 18(2): 153-154.
10. Laughlin, Mary J, Eapen M, Rubinstein P, et al. Outcomes after transplantation of cord blood or bone marrow from unrelated donors in adults with leukemia. N Engl J Med. 2004; 351(22):2265-2275.
11. Mao, P, Wang S, Wang S, et al. Umbilical cord blood transplant for adult patients with severe aplastic anemia using anti-lymphocyte globulin and cyclophosphamide as conditioning therapy. Bone Marrow Transplant. 2004; 33(1):33-38.
12. Nishihira H, Kato K, Isoyama K, et al. The Japanese cord blood bank network experience with cord blood transplantation from unrelated donors for haematological malignancies: an evaluation of graft-versus-host disease prophylaxis. Br J Haematol. 2003; 120(3):516-522.
13. Work group on cord blood banking. American Academy of Pediatrics: Cord blood banking for potential future transplantation: subject review. Pediatrics. 1999; 104: 116-118.
14. Silberstein LE, Jefferies LC. Placental-blood banking-a new frontier in transfusion medicine. N Engl J Med. 1996; 335(3); 2-4.
15. Thomson BG, Robertson KA, Gowan D, et al. Analysis of engraftment, graft versus host diseases, and immune recovery following unrelated donor cord blood transplantation. Blood. 2000; 96(8): 2703-2711.
16. Vanderson Rocha, Labopin M, Sanz G, et al. Transplants of umbilical-cord blood or bone marrow from unrelated donors in adults with acute leukemia. N Engl J Med. 2004; 351(22):2276-2285.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Hayes Inc. Alert-Clinical Studies. Cord-blood transplant acceptable alternative for selected adults without matched marrow donor. Lansdale, PA: Hayes, Inc.; December 2004. 
2. Hayes Inc. Medical Technology Directory. Umbilical Cord Blood Stem Cell Transplantation. Lansdale, PA: Hayes, Inc.; May 6, 2005. Search updated May 16, 2006.
3. Work group on cord blood banking. American Academy of Pediatrics: Cord blood banking for potential future transplantation: subject review. Pediatrics. 1999; 104: 116-118.

1. The National Marrow Donor Program. Available at:  http://www.marrow.org/PATIENT/Undrstnd_Disease_Treat/ Undrstnd_Treat_Opt/Lrn_BMT_Cord/Cord_Blood_Tx/index.html. Accessed on October 9, 2006.

Allogeneic Stem Cell Transplant
Autologous Stem Cell Transplant
Cord Blood
Cord Blood as a Source of Stem Cells
Cord Blood Banking
Stem Cell Transplant
Umbilical and Placental Cord Blood for Stem Cell Transplant

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

©CPT Only - American Medical Association