Placental and Umbilical Cord Blood as a Source of Stem Cells

POLICY NUMBER

L.7.01.442

DESCRIPTION

This policy addresses the collection, storage, and transplantation of placental and umbilical cord blood ("cord blood") as a source of stem cells for allogeneic and autologous stem cell transplantation.

Hematopoietic Cell Transplantation

HCT is a procedure in which hematopoietic stem cells are intravenously infused to restore bone marrow and immune function in cancer patients who receive bone marrow-toxic doses of cytotoxic drugs with or without whole-body radiotherapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT) or a donor (allogeneic HCT [allo-HCT]). These cells can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates.

Immunologic compatibility between infused hematopoietic stem cells and the recipient is not an issue in autologous HCT. In allogeneic stem cell transplantation, immunologic compatibility between donor and patient is a critical factor for achieving a successful outcome. Compatibility is established by typing of human leukocyte antigens (HLA) using cellular, serologic, or molecular techniques. HLA refers to the gene complex expressed at the HLA-A, -B, and -DR (antigen-D related) loci on each arm of chromosome six. An acceptable donor will match the patient at all or most of the HLA loci.

Conditioning for Hematopoietic Cell Transplantation

Conventional Conditioning

The conventional (“classical”) practice of allo-HCT involves administration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to cause bone marrow ablation in the recipient. The beneficial treatment effect of this procedure is due to a combination of the initial eradication of malignant cells and subsequent graft-versus-malignancy effect mediated by non-self-immunologic effector cells. While the slower graft-versus-malignancy effect is considered the potentially curative component, it may be overwhelmed by existing disease in the absence of pretransplant conditioning. Intense conditioning regimens are limited to patients who are sufficiently medically fit to tolerate substantial adverse effects. These include opportunistic infections secondary to loss of endogenous bone marrow function and organ damage or failure caused by cytotoxic drugs. Subsequent to graft infusion in allo-HCT, immunosuppressant drugs are required to minimize graft rejection and graft-versus-host disease, which increases susceptibility to opportunistic infections.

The success of autologous HCT is predicated on the potential of cytotoxic chemotherapy, with or without radiotherapy, to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of the bone marrow with presumably normal hematopoietic stem cells obtained from the patient before undergoing bone marrow ablation. Therefore, autologous HCT is typically performed as consolidation therapy when the patient’s disease is in complete remission. Patients who undergo autologous HCT are also susceptible to chemotherapy-related toxicities and opportunistic infections before engraftment, but not graft-versus-host disease.

Reduced-Intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

Reduced-intensity conditioning (RIC) refers to the pretransplant use of lower doses of cytotoxic drugs or less intense regimens of radiotherapy than are used in traditional full-dose myeloablative conditioning treatments. Although the definition of RIC is variable, with numerous versions employed, all regimens seek to balance the competing effects of relapse due to residual disease and non-relapse mortality. The goal of RIC is to reduce disease burden and to minimize associated treatment-related morbidity and non-relapse mortality in the period during which the beneficial graft-versus-malignancy effect of allogeneic transplantation develops. RIC regimens range from nearly total myeloablative to minimally myeloablative with lymphoablation, with intensity tailored to specific diseases and patient condition. Patients who undergo RIC with allo-HCT initially demonstrate donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to full-donor chimerism. In this review, the term reduced-intensity conditioning will refer to all conditioning regimens intended to be nonmyeloablative.

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 -

• Allogeneic Hematopoietic Cell Transplantation for Genetic Diseases and Acquired Anemias

• Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms

POLICY

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.

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 EXCEPTIONS

For Federal Employee Program (FEP) subscribers, the Service Benefit Plan includes specific conditions in which autologous or allogeneic blood or marrow stem cell transplants would be considered eligible for coverage.

For State and School Employee subscribers, all bone marrow/stem cell transplants must be certified as medically necessary by the Plan’s Utilization Review Vendor. No benefits will be provided for any transplant procedure unless prior approval for the transplant is obtained.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

8/1998: 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.

03/09/2016: Policy description updated. Policy statements unchanged.

05/31/2016: Policy number A.7.01.50 added.

09/30/2016: Code Reference section updated to add the following new ICD-10 procedure codes: 30230X2, 30233X2, 30240X2, 30243X2, 30230X3, 30233X3, 30240X3, 30243X3, 30230X4, 30233X4, 30240X4, and 30243X4.

01/30/2017: Policy description updated. Policy statements unchanged.

12/21/2017: Removed deleted ICD-10 procedure codes 30230X1, 30233X1, 30240X1, and 30243X1.

02/08/2018: Policy description updated. Policy statements unchanged.

03/01/2019: Policy reviewed. Policy statements unchanged. Code Reference section updated to remove deleted CPT code 86822.

09/30/2019: Code Reference section updated regarding deleted ICD-10 procedure codes.

02/19/2020: Policy description extensively revised. Policy statements unchanged. Code description for CPT code 38240 updated in Code Reference section.

03/31/2021: Policy reviewed. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted ICD-10 procedure codes 30250X0, 30250X1, 30253X0, 30253X1, 30260X0, 30260X1, 30263X0, and 30263X1.

12/30/2021: Code Reference section updated to make note of deleted ICD-10 procedure codes.

11/22/2022: Code Reference section updated to remove deleted ICD-10 procedure codes 30230X0, 30240X0, 30230X2, 30240X2, 30230X3, 30240X3, 30230X4, and 30240X4.

05/02/2023: Policy updated to change the medical policy number from "A.7.01.50" to "L.7.01.442." Policy reviewed. Policy statements unchanged.

04/29/2024: Policy Exceptions updated regarding Federal Employee Program and State and School Employee subscribers.

06/06/2024: Policy reviewed. Related medical policy links updated. Policy statements unchanged.

08/04/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.50

CODE REFERENCE

This 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.

Covered Codes

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