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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 some cases, 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 allogeneic 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. Unrelated donors are typically typed at low resolution for HLA -A and -B and at high resolution only for HLA-DR; HLA matching at 4 of 6 loci is considered acceptable. Under this matching protocol, an acceptable donor can be identified for almost any patient.
Several cord blood banks have now been developed in Europe and in the United States. In addition to obtaining cord blood for specific related or unrelated patients, some 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 autologous transplantation. In addition, some cord blood is collected and stored 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.
Standards and accreditation for cord blood banks are important for assisting transplant programs in knowing whether individual banks have quality control measures in place to address such issues as monitoring cell loss, change in potency, and prevention of product mix-up. Two major organizations are working toward these accreditation standards; NetCord/FACT and the American Association of Blood Banks (AABB). NetCord, Foundation for the Accreditation of Cellular Therapy (FACT) has developed and implemented a program of voluntary inspection and accreditation for cord blood banking. In September 2012, NetCord and FACT released the fifth edition of their international standards for cord blood banks. The voluntary program includes standards for collection, testing, processing, storage, and release of cord blood products.
According to the U.S. Food and Drug Administration (FDA), cord blood stored for potential use by a patient unrelated to the donor meets the definitions of “drug” and “biological products.” As such, products must be licensed under a biologics license application or an investigational new drug application before use. Facilities that prepare cord blood units only for autologous and/or first- or second-degree relatives are required to register and list their products, adhere to Good Tissue Practices issued by the FDA, and use applicable processes for donor suitability determination.
Related policies -
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.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The 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.
11/12/2014: Policy reviewed; description updated regarding standards and accreditation for cord blood banks. Policy statements unchanged.
08/21/2015: Code Reference section updated for ICD-10.
11/09/2015: Policy reviewed. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.
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.