BlueCross and BlueShield of Montana Medical Policy/Codes
Stem-Cell Transplant for Acquired Immunodeficiency Syndrome (AIDS)
Chapter: Surgery: Procedures
Current Effective Date: December 27, 2013
Original Effective Date: December 27, 2013
Publish Date: September 27, 2013
Description

Acquired immunodeficiency syndrome (AIDS) is a secondary immunodeficiency syndrome resulting from a human immunodeficiency virus (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.

Policy

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.

Investigational

Coverage of, evaluation for, and subsequent single treatment by stem-cell transplant (SCT) (using bone marrow, peripheral blood, or umbilical cord blood as a stem-cell source), derived from a specific donor category, and following a chemotherapy regimen for treatment of acquired immunodeficiency syndrome (AIDS) resulting from a human immunodeficiency virus (HIV) is identified in the grid below.

NOTE: SCT may be known by different terminology and used interchangeably. Hereinafter, SCT will be known as stem-cell support (SCS) throughout the balance of this medical policy.

Allogeneic

Is considered experimental, investigational and unproven for treatment of acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection. 

Autologous

 

Is considered experimental, investigational and unproven for treatment of AIDS and HIV infection.

Tandem or Triple Stem-Cell Support

Is considered experimental, investigational and unproven for treatment of AIDS or HIV infection. 

Donor Leukocyte Infusion

Is considered experimental, investigational and unproven for treatment of AIDS or HIV infection.

Hematopoietic Progenitor Cell Boost (Stem-Cell Boost)

Is considered experimental, investigational and unproven for treatment of AIDS or HIV infection.

Any use of short tandem repeat (STR) markers for the treatment of AIDS or HIV infection is considered experimental, investigational and unproven.

Rationale

High-dose chemotherapy (HDC) followed by hematopoietic stem-cell (HSC) transplant (HSCT) or stem-cell support (SCS) (i.e., blood or marrow) transplant 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 cells followed by rescue with peripheral blood, umbilical cord blood, or bone marrow stem-cells. 

This policy was based on MedLine literature search through September 2008. In 1990, Lenarsky and Parkman reported the initial attempts to treat patients with 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 reported the outcome of HSCT was strongly dependent on the patient’s age, clinical status at transplantation and the type of immunodeficiency. This review article generally described primary immunodeficiencies, not HIV or AIDS specifically. (2)

Allogeneic, autologous, tandem or triple stem-cell transplant and donor leukocyte infusion (DLI) for acquired immunodeficiency syndrome (AIDS) is a secondary immunodeficiency syndrome resulting from a human immunodeficiency virus (HIV) infection AIDS or HIV infection is considered experimental, investigational and unproven due to lack of adequate evidence of safety and effectiveness documented in published, peer-reviewed medical literature.

2013 Update

A search of peer reviewed literature through October 2012 was conducted. Few human clinical trials have been published. Studies with animal models of autoimmune diseases have provided the stimulus for further research in treating a variety of immune diseases, using autologous stem-cell support (AuSCS). (3)

Donor leukocyte infusion (DLI) to treat any stage of AIDS and HIV is considered experimental, investigational, and unproven due to lack of adequate evidence of safety and effectiveness documented in published, peer-reviewed medical literature. (4)

As with DLI, HPC Boost has a positive response rate for relapse following AlloSCS. (5) The boost of stem-cells, a second dose, may be helpful to reduce the graft failure process, avoiding the risk of serious bleeding and/or infection. However, the data is insufficient for the use of HPC Boost following AlloSCS for treatment of non-hematological malignancies to lessen post-transplant graft failures. (5, 6, 7, 8)

Short Tandem Repeat (STR) Markers

Following SCS therapy, it is important to determine whether the new blood forming system is of the donor or the recipient, based upon the proportion of donor and recipient cells. The characteristics of the engraftment are analyzed, which is called chimerism analysis. Using STR marker assay to characterize the hematological course and to evaluate the usefulness of the blood forming system (particularly for hematological malignancies, myelodysplastic/myeloproliferative processes, or certain genetic or metabolic disorders) has been tested initially after the SCS, when the patient is declared as disease-free, and at the point of the confirmed stable engraftment of only the donor pattern of the blood forming system. (9, 10) Without further randomized trials using STR markers prior to or post SCS therapy for treatment of AIDS and HIV, the data is insufficient to determine the outcome/effect of stem-cell engraftment. (9, 10, 11, 12, 13, 14)

Clinical Trials

A search in November 2012 found 24 studies. Of those only 11 studies are actively recruiting patients for the treatment research of bone marrow and stem-cell transplantation for AIDS or HIV infections, when the patient has another unrelated disease condition, such as cancer or liver disease. There were no active studies identified for the sole treatment of AIDS or HIV by HSCT.

To date, there are no new clinical trial publications or any additional information that would change the coverage position of this medical policy. Thus the use of SCS, as a single treatment or infusion, tandem or triple stem-cell transplant and DLI in AIDS or HIV remains experimental, investigational and unproven.

Based on a search of scientific literature in the MedLine database through March 2013, HPC boost to reduce the graft failure process and STR markers to monitor engraftment chimerism for the treatment of AIDS and HIV are considered experimental, investigational, and unproven due to the lack of adequate evidence of safety and effectiveness documented in published, peer-reviewed medical literature.

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. 

ICD-9 Codes

Experimental, Investigational and Unproven for all codes.  41.00, 41.01, 41.02, 41.03, 41.04, 41.05, 41.06, 41.07, 41.08, 41.09, 41.91, 99.25, 99.74, 99.79

ICD-10 Codes

Experimental, Investigational and Unproven for all codes.  30230G0, 30230G1, 30233G0, 30233G1, 30240G0, 30240G1, 30243G0, 30243G1, 30250G0, 30250G0, 30250G1, 30253G0, 30253G1, 30260G0, 30260G1, 30263G0, 30263G1, 3E03005, 3E03305, 3E04005, 3E04305, 3E05005, 3E05305, 3E06005, 3E06305, 6A550Z2, 6A551Z2, 6A550ZT, 6A550ZV, 6A551ZT, 6A551ZV

Procedural Codes: 36511, 38204, 38205, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38220, 38221, 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, S2140, S2142, S2150
References
  1. Lenarsky, C., and R. Parkman. Bone marrow transplantation for the treatment of immune deficiency states. Bone Marrow Transplantation (1990 December) 6(6):361-9.      
  2. Fasth, A., et al. Bone marrow transplantation in primary immunodeficiency syndrome and in osteoporosis. Nordisk Medicine (1995) 110(12):316-7 (Review).
  3. van Bekkum, D.W. Experimental basis of hematopoietic stem cell transplantation for treatment of autoimmune diseases. Journal of Leukocyte Biology (2002 October) 72(4):609-20.
  4. Donor Leukocyte Infusion for Hematologic Malignancies Treated with an Allogeneic Stem Cell Transplant. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2012 May) Medicine: 2.03.03.
  5. ACS – Stem Cell Transplant (Peripheral Blood, Bone Marrow, and Cord Blood Transplants) (2013). American Cancer Society. Available at http://www.cancer.org (accessed – 2013 April 15).
  6. Slatter, M.A., Bhattacharya, A., et al. Outcome of boost hematopoietic stem cell transplant for decreased donor chimerism or graft dysfunction in primary immunodeficiency. Bone Marrow Transplantation (2005) 35:683-9.
  7. Larocca, A., Piaggio, G., et al. A boost of CD35+-selected peripheral blood cells without further conditioning in patients with poor graft function following allogeneic stem cell transplantation. The Hematology Journal (2006) 91(7):935-40.
  8. NIH – Marrsson, J., Ringden, O., et al. Graft failure after allogeneic hematopoietic cell transplantation. Biology and Blood Marrow Transplant (2008 January) 14(Supplement 1):165-70. National Institutes of Health Public Access. Available at http://www.nih.gov (accessed – 2013 April 15).
  9. Borrill, V., Schlaphoff, T., et al. The use of short tandem repeat polymorphisms for monitoring chimerism follow bone marrow transplantation: a short report. Hematology (2008 August) 13(4):210-4.
  10. Crow, J., Youens, K., et al. Donor cell leukemia in umbilical cord blood transplant patients: a case study and literature review highlighting the importance of molecular engraftment analysis. Journal of Molecular Diagnostics (2010 July) 12(4):530-7.
  11. Park, M., Koh, K.N., et al. Clinical implications of chimerism after allogeneic hematopoietic stem-cell transplantation in children with non-malignant diseases. Korean Journal of Hematology (2011 December) 46(4):258-64.
  12. Odriozola, A., Riancho, J.A., et al. Evaluation of the sensitivity of two recently developed STR multiplexes for the analysis of chimerism after hematopoietic stem-cell transplantation. International Journal of Immunogenetics (2013 April) 40(2):88-92.
  13. Lawler, M., Crampe, M., et al. The EuroChimerism concept for standardized approach to chimerism analysis after allogeneic stem-cell transplantation. Leukemia (2012 August) 26(8):1821-8.
  14. Tilanus, M.G. Short tandem repeat markers in diagnostics: what’s in a repeat? Leukemia (2006 August) 20(8):1353-55. Available at http://www.nature.com (accessed – 2013 April 22).
History
September 2013  New 2013 BCBSMT medical policy.
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Stem-Cell Transplant for Acquired Immunodeficiency Syndrome (AIDS)