Medical Policies - Surgery


Hematopoietic Stem-Cell Transplantation for Acquired Immunodeficiency Syndrome (AIDS)

Number:SUR703.047

Effective Date:06-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Hematopoietic stem-cell transplantation is considered experimental, investigational and/or unproven as a treatment of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection.

NOTE: See Medical Policy SUR703.002 Hematopoietic Stem-Cell Transplantation (HSCT) or Additional Infusion Following Preparative Regimens (General Donor and Recipient Information) for detailed, descriptive information on HSCT related services.

Description:

Hematopoietic Stem-Cell Transplantation

Hematopoietic stem-cell transplantation (HSCT) refers to a procedure in which hematopoietic stem-cells are infused to restore bone marrow function in cancer patients who receive bone-marrow-toxic doses of cytotoxic drugs with or without whole-body radiation therapy. Hematopoietic stem-cells may be obtained from the transplant recipient (autologous HSCT) or from a donor (allogeneic HSCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates. Although cord blood is an allogeneic source, the stem-cells in it are antigenically “naïve” and thus are associated with a lower incidence of rejection or graft-versus-host disease (GVHD).

Immunologic compatibility between infused hematopoietic stem-cells and the recipient is not an issue in autologous HSCT. However, immunologic compatibility between donor and patient is a critical factor for achieving a good outcome of allogeneic HSCT. Compatibility is established by typing of HLA using cellular, serologic, or molecular techniques. HLA refers to the tissue type expressed at the Class I and Class II loci on chromosome 6. Depending on the disease being treated, an acceptable donor will match the patient at all or most of the HLA loci (with the exception of umbilical cord blood).

Background

Acquired immunodeficiency syndrome (AIDS)/Human immunodeficiency virus (HIV)

AIDS is a secondary immunodeficiency syndrome resulting from a HIV infection, characterized by opportunistic infections, malignancies, neurologic dysfunction, and a variety of other conditions.

HIV is an infection caused by several retroviruses that become incorporated into a host cell and result in a wide range of conditions varying from asymptomatic carrier-states to severe debilitating and fatal disorders.

Regulatory Status

The U.S. Food and Drug Administration (FDA) regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research (CBER), under the Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. (6) Hematopoietic stem-cells are included in these regulations.

Rationale:

High-dose chemotherapy (HDC) followed by hematopoietic stem-cell transplant (HSCT) (i.e., blood or marrow) is an effective treatment modality for many patients with certain malignancies and non-malignancies. The rationale of this treatment approach is to provide a very dose-intensive treatment in order to eradicate malignant/non-malignant cells followed by rescue with peripheral blood, bone marrow, or umbilical cord blood stem-cells.

The literature search of the MedLine database for this medical policy was updated through May 2017. The following is a summary of the key literature to date.

In 1990, Lenarsky and Parkman reported the initial attempts to treat patients with acquired immunodeficiency syndrome (AIDS) due to the lack of effective concomitant anti-viral therapy. They concluded that HSCT would continue to be in the forefront of human bone marrow transplantation. (1) Fasth et al. reported the outcome of HSCT was strongly dependent on the patient’s age, clinical status at transplantation and the type of immune-deficiency. This review article generally described primary immunodeficiencies, not human immunodeficiency virus (HIV) or AIDS specifically. (2)

Recently, published anecdotally-reported literature has been centering around treatment using HSCT for HIV-related diseases, not actively treating AIDS/HIV directly with HSCT. These related diseases include lymphoma and adaptive responses to rebound simian-HIV (SHIV) viremia, primate studies when viruses enter the bloodstream. (3, 4) Few human clinical trials have been published to treat AIDS/HIV using HSCT. Therefore, studies continue with animal models of autoimmune diseases to provide the stimulus for further research in treating a variety of immune diseases, using autologous HSCT for humans. (5)

Ongoing and Unpublished Clinical Trials

A current ongoing trial that might influence this review is listed in Table 1.

Table 1. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion Date

Ongoing

NCT02732457

Allogeneic Hematopoietic Stem-Cell Transplantation in HIV-Infected Patients

10

Sep 2019

Table Key:

NCT: National Clinical Trial.

Practice Guidelines and Position Statements

There are no professional guidelines and position statements that would likely influence this review.

Summary of Evidence

The evidence is insufficient to support the use of hematopoietic stem-cell transplantation (HSCT) for the treatment acquired immunodeficiency syndrome (AIDS)/human immunodeficiency virus (HIV). This is based on the lack of published clinical trials in humans. Therefore, the use of HSCT to treat AIDS/HIV is considered experimental, investigational and/or unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

36511, 38204, 38205, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38220, 38221, 38222, 38230, 38232, 38240, 38241, 38242, 38243, 81265, 81266, 81267, 81268, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, 81383, 86805, 86806, 86807, 86808, 86812, 86813, 86816, 86817, 86821, 86822, 86825, 86826, 86828, 86829, 86830, 86831, 86832, 86833, 86834, 86835, 86849, 86950, 86985, 88240, 88241

HCPCS Codes

S2140, S2142, S2150

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Lenarsky C, Parkman R. Bone marrow transplantation for the treatment of immune deficiency states. Bone Marrow Transplant. Dec 1990; 6(6):361-9.

2. Fasth A. Bone marrow transplantation in primary immunodeficiency syndrome and in osteoporosis. Nord Med. 1995; 110(12):316-7. PMID 8524633

3. Alvarnas JC, Le Rademacher J, Wang Y, et al. Autologous hematopoietic cell transplantation for HIV-related lymphoma: results of the BMT CTN 0803/AMC 071 trial. Blood. Aug 25, 2016; 128(8):1050-8. PMID 27297790

4. Reeves DB, Peterson CW, Kiem HP, et al. Autologous stem-cell transplantation disrupts adaptive immune responses during rebound SHIV viremia. J Virol, Jun 9, 2017; 91(13). PMID 28404854

5. van Bekkum DW. Experimental basis of hematopoietic stem-cell transplantation for treatment of autoimmune diseases. J Leukocyte Biol. Oct 2002; 72(4):609-20. PMID 12377928

6. Food and Drug Administration (FDA). Tissue and Tissue Products. Available at //www.fda.gov> (accessed September 22, 2015).

Policy History:

Date Reason
6/15/2018 Reviewed. No changes.
7/15/2017 Document updated with literature review. Coverage unchanged.
7/15/2016 Reviewed. No changes.
2/15/2015 Document updated with literature review. Coverage language modified, without change to coverage position. CPT/HCPCS code(s) updated. Title changed from: Stem-Cell Transplant for Acquired Immunodeficiency Syndrome (AIDS).
10/15/2013 Document updated with literature review. The following was added: 1) Donor leukocyte infusion and hematopoietic progenitor cell boost are considered experimental, investigational and unproven; and 2) Any related services for the treatment of AIDS or HIV infection, such as short tandem repeat (STR) markers, are considered experimental, investigational and unproven. Otherwise, coverage unchanged. Rationale significantly revised.
4/1/2010 New medical document originating from: SUR703.017, Peripheral/Bone Marrow Stem-cell Transplantation (PSCT/BMT) for Non-Malignancies; SUR703.018, Peripheral/Bone Marrow Stem-cell Transplantation (PSCT/BMT) for Malignancies; SUR703.022, Cord Blood as a Source of Stem-cells (CBSC); SUR703.023, Donor Leukocyte Infusion (DLI); and SUR703.024, Tandem/Triple High-Dose Chemoradiotherapy with Stem-cell Support for Malignancies. Stem-cell transplant remains experimental, investigational and unproved when used to treat AIDS. NOTE: A link to the medical policies with the following titles can be found at the end of the medical policy SUR703.002, Stem-Cell Reinfusion or Transplantation Following Chemotherapy (General Donor and Recipient Information): Peripheral/Bone Marrow Stem-cell Transplantation (PSCT/BMT) for Non-Malignancies; Peripheral/Bone Marrow Stem-cell Transplantation (PSCT/BMT) for Malignancies; Cord Blood as a Source of Stem-cells; Donor Leukocyte Infusion (DLI); and Tandem/Triple High-Dose Chemoradiotherapy with Stem-cell Support for Malignancies.

Archived Document(s):

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