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DESCRIPTIONA variety of malignant diseases and non-malignant bone marrow disorders are treated with myeloablative therapy followed by infusion of allogeneic stem and progenitor cells collected from immunologically compatible donors, either from family members or an unrelated donor identified through a bone marrow donor bank. In many patients a suitable donor is not found.
Blood harvested from the umbilical cord and placenta shortly after delivery of neonates contains stem and progenitor cells capable of restoring hematopoietic function after myeloablation. This "cord" blood has been used as an alternative source of allogenic stem cells. Cord blood is readily available and is thought to be antigenically "naive" thus, hopefully minimizing the incidence of graft-versus-host disease GVHD) and permitting the broader use of unrelated cord blood transplants. Several cord blood banks have now been developed in Europe and in the United States.
The U. S. Food and Drug Administration (FDA) is collecting data in an effort to eventually developing product standards and criteria for a biologics license for cord blood banks. Therefore at the present time, cord blood banks are not rigorously regulated. Facilities with cord blood banks, such as the New York Blood Center or the American Red Cross, are currently offering cord blood as part of an open Phase I/Phase II trial. In its early stage of development, the collection, storage, and distribution of cord blood was funded by a National Institutes of Health (NIH) study and was offered at no charge to transplant centers. Now, however, the FDA has given cord blood banks the right to charge for the cord blood based on cost recovery.
Other cord blood banks are offering the opportunity of collecting and storing a neonate's cord blood for some unspecified future use in the unlikely event that the child develops a condition that would require allogeneic transplantation. In addition, some cord blood is collected and sorted from a neonate for use by a sibling in whom an allogeneic transplant is anticipated due to a history of leukemia or other condition requiring allogeneic transplant.
POLICYNo benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.
Transplantation of cord blood stem cells from related or unrelated donors may be considered medically necessary in patients with an appropriate indication for allogeneic stem-cell transplant.
Transplantation of cord blood stem cells from related or unrelated donors is considered investigational in all other situations.
Collection and storage of cord blood from a neonate may be considered medically necessary when an allogeneic transplant is imminent in an identified recipient with a diagnosis that is consistent with the possible need for allogeneic transplant.
Prophylactic collection and storage of cord blood from a neonate is considered not medically necessary when proposed for some unspecified future use as an autologous stem-cell transplant in the original donor, or for some unspecified future use as an allogeneic stem-cell transplant in a related or unrelated donor.
POLICY GUIDELINESThe coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY8/1998: Approved by Medical Policy Advisory Committee (MPAC), CPT 86812, 86813, 86816, 86817, 86821, 86822 added, ICD-9 diagnosis 205.10-205.11, 238.7, 272.7, 277.5, 279.12, 279.2, 281.3, 282.4, 282.6-282.69, 284.0-284.9, 285.00, 287.3-287.5, 288.0, 330.0, 756.52, 758.9 added
7/13/2001: Code Reference section updated, CPT code 38999 added, ICD-9 procedure code 41.06 added, HCPCS S2140, S2142 added
2/7/2002: "Transplantation of cord blood stem cells from related or unrelated donors is considered investigational and not eligible for coverage." and "Collection and storage of cord blood from a neonate is considered not medically necessary." has been deleted. Code Reference section changed from non-covered to covered. Hyperlinks added
4/18/2002: Type of Service and Place of Service deleted
5/29/2002: Code Reference section updated, ICD-9 diagnosis 200.00-200.88, 201.00-201.98, 202.00-202.98, 204.00, 204.01, 208.00, 208.01, 786.52, V12.59, V17.1 added
3/18/2003: Code Reference section updated, code range 86812-86822 listed separately, ICD-9 diagnosis added to "Code Reference" section from "Allogeneic Stem Cell Transplant" medical policy for clarity with "Note" for coverage criteria, CPT code 38204, 38205, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38242 added
3/25/2004: Policy aligned with BCBSA policy # 7.01.50, Policy title “Cord Blood as a Source of Stem Cells” renamed “Placental and Umbilical Cord Blood as a Source of Stem Cells”, “Cord Blood as a Source of Stem Cells is appropriate in adult patients with an appropriate indication for Allogeneic Stem Cell Transplant when other sources are not available (added 2-7-2002).” deleted, “No benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorization through case management from Blue Cross & Blue Shield of Mississippi.” added, Sources updated
9/2/2004: Code Reference section updated, CPT code 38204, 38205, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38242, 38999 deleted, ICD-9 procedure code 99.79 added, ICD-9 diagnosis codes 200.00-200.88, 201.00-201.98, 202.00-202.98, 204.00, 204.01, 205.10-205.11, 208.00, 208.01, 238.7, 272.7, 277.5, 279.12, 279.2, 281.3, 282.4, 282.6-282.69, 284.0-284.9, 285.00, 287.3-287.5, 288.0, 330.0, 756.52, 758.9, 786.52, V12.59, V17.1 deleted
11/18/2004: Reviewed by MPAC, no changes
10/26/2005: Code Reference section updated: CPT-4 code 38240 added, HCPCS S2150 added
12/31/2008: Policy reviewed, no changes
3/30/2010: Code reference section updated. CPT code 86825 and 86826 added to covered table.
07/08/2010: Policy description unchanged. Policy statement revised to remove the verbiage "but without a hematopoietic stem-cell donor" from the first policy statement. For clarification purposes, policy statement added to indicate that transplantation of cord blood stem cells from related or unrelated donors is considered investigational in all other situations.
11/10/2011: Policy reviewed; no changes.
12/13/2012: Policy reviewed; no changes.
11/15/2013: Policy reviewed; no changes to policy statement. Deleted outdated reference from Sources section.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.50
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.