CurrentAetnaPolicy 0634

Non-myeloablative Hematopoietic Cell Transplantation (Mini-Allograft / Reduced Intensity Conditioning Transplant)

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Defines Aetna's medical necessity and experimental/investigational determinations for non-myeloablative (reduced intensity) allogeneic hematopoietic cell transplantation, lists covered and not-covered ICD-10/CPT/HCPCS/J-codes when selection criteria are met, and provides clinical background and evidence references. This is Part 1 of 2; criteria are those present in this part only.

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CurrentAetnaPolicy 0634

Non-myeloablative Hematopoietic Cell Transplantation (Mini-Allograft / Reduced Intensity Conditioning Transplant)

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Coverage Summary

This policy (Policy Number 0634) defines Aetna's determinations for non-myeloablative hematopoietic cell transplantation (mini-allograft / reduced intensity conditioning transplant), specifying conditions under which the procedure is considered medically necessary versus experimental/investigational, and listing covered CPT/HCPCS/ICD-10/J-codes when selection criteria are met. This document is Part 1 of 2 and is current with an effective date 08/02/2002 and last review 02/20/2024.

Policy Metadata

Policy Number0634

Effective Since08/02/2002

Last Review02/20/2024

Next Review07/11/2024

Coverage Stancemixed

StatusCURRENT

Policy Stats

Covered Indications Listed15

Not-covered/Investigational Indications Listed12

ICD-10 codes referenced (ranges)~40

Cited ReferencesReferences: 1-81

Policy IdentifierPolicy Number 0634

Effective SinceEffective 2002-08-02

Last Review DateLast Review 2024-02-20

Medical-Necessity Criteria

Medically Necessary

Aetna considers non-myeloablative hematopoietic cell transplantation (mini-allograft) medically necessary for members with any of the following diseases for which conventional allogeneic hematopoietic cell transplantation is considered an established alternative:

Medically Necessary indications

Acute lymphoblastic leukemia (ALL)
see CPB 0640 - Hematopoietic Cell Transplantation for Selected Leukemias
Acute myelogenous leukemia (AML)
see CPB 0640 - Hematopoietic Cell Transplantation for Selected Leukemias
Aplastic anemia (AA), including paroxysmal nocturnal hemoglobinuria (PNH)
see CPB 0627 - Hematopoietic Cell Transplantation for Aplastic Anemia and other Bone Marrow Failure Syndromes

Coding

Covered CPT codes (if selection criteria are met)CPTCovered

38204
38205
38207
38208
38209
38210
38211
38212
38213
38214

1–10 of 23

1/3

Covered HCPCS codes (if selection criteria are met)HCPCSCovered

S2150

Bone marrow or blood-derived stem cells (peripheral or umbilical), allogenic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and post-transplant care in the global definition.

Other HCPCS / J-codes referencedHCPCS|NDC

J7502	Cyclosporine, oral, 100 mg
J7515	Cyclosporine, oral 25 mg
J7516	Cyclosporine, parenteral 250 mg
J7517	Mycophenolate mofetil, oral, 250 mg
J8610	Methotrexate, oral, 2.5 mg
J9185	Fludarabine phosphate, 50 mg
J9250	Methotrexate sodium, 5 mg
J9255	Injection, methotrexate (accord) not therapeutically equivalent to j9250 or j9260, 50 mg
J9260	Methotrexate sodium, 50 mg

ICD-10 codes covered (if selection criteria are met)ICD-10Covered

C74.00 - C74.92	Malignant neoplasm of adrenal gland
C81.00 - C81.99	Hodgkin's lymphoma
C82.50 - C82.59
C83.10 - C83.19	Mantle cell lymphoma
C83.30 - C83.39	Diffuse large B-cell lymphoma
C83.80 - C83.89
C84.a0 - C84.z9
C84.90 - C84.99
C85.10 - C85.99	Other lymphoma
C88.4	Other non-follicular lymphoma

1–10 of 23

1/3

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive)ICD-10Not Covered

C43.0 - C43.9	Malignant melanoma of skin
C50.011 - M50.929	Malignant neoplasm of breast
C62.00 - C62.92	Malignant neoplasm of testis
C64.1 - C65.9	Malignant neoplasm of kidney and renal pelvis
D03.0 - D03.9	Melanoma in situ [skin]
D45	Polycythemia vera
D47.3	Essential (hemorrhagic) thrombocythemia
D51.0	Vitamin B12 deficiency anemia due to intrinsic factor deficiency
D76.1	Hemophagocytic lymphohistiocytosis
D80.0 - D89.9	Disorders involving the immune mechanism

1–10 of 27

1/3

Provider Actions

Prior Authorization

Selection criteria required for coverage

Transplant-related CPT/HCPCS/ICD-10 codes (listed in policy) are covered only if the member meets the policy selection criteria. Obtain prior authorization that documents eligibility per the policy before billing these codes.

38204-38205
38207-38215
38230-38240
38242
S2150

Documentation Required

Confirm conventional allogeneic HCT is established alternative

Document that the member has one of the diseases listed for which conventional allogeneic hematopoietic cell transplantation is an established alternative, or that the member cannot tolerate conventional allogeneic transplant which justifies a non‑myeloablative approach. This documentation should be included in the medical record and submitted with any coverage requests.

Background & Evidence

Non-myeloablative or reduced-intensity conditioning (RIC) regimens are designed to permit donor engraftment while reducing regimen-related organ toxicity and mortality, thereby extending allogeneic transplantation to older patients or those with pre-existing organ dysfunction. Typical approaches include low-dose total body irradiation (TBI) or fludarabine-based regimens, often combined with short-course post-graft immunosuppression (e.g., cyclosporine, methotrexate, or mycophenolate mofetil).

Risks of RIC/min i-allograft include increased susceptibility to infections, acute and chronic graft-versus-host disease (GVHD), relapse due to lower upfront anti-malignancy cytotoxicity, and uncertain long-term outcomes. The evidence base is evolving and heterogeneous—mostly uncontrolled or early phase studies—with some promising results in selected indications but a need for larger, controlled trials to define long-term effectiveness and optimal indications.

Non-myeloablative / Reduced intensity conditioning (RIC): Less intensive preparative regimens (e.g., low-dose TBI or fludarabine-based) intended to facilitate donor engraftment with lower immediate toxicity than conventional myeloablative regimens.

Citation	Key finding
Nagler et al (2000)
Fludarabine-based low-intensity conditioning showed engraftment with moderate organ toxicity; survival and DFS at 37 months 40% in n=23 high-risk lymphoma patients.
Martino et al (2001)
Prospective multicenter (n=71): low early toxicity and stable engraftment; chronic GVHD significant; infections remain a threat.
Burt et al (2009)
Autologous non-myeloablative HSCT in relapsing-remitting MS (n=21) showed clinical improvements and progression-free outcomes at ~3 years; requires randomized confirmation.
Literature citations
Numerous peer-reviewed studies, systematic reviews, and meta-analyses (references 1-81) supporting reduced-intensity conditioning transplantation in various indications.

Revision History

2002-08-02effective

Policy became effective 08/02/2002.

2024-02-20last_reviewLatest

Last review recorded 02/20/2024; Last review recorded with no clinical policy statement changes indicated in this part of the document (no material clinical changes present).

Experimental and Investigational (Not Covered)

Aetna considers non-myeloablative hematopoietic cell transplantation (mini-allograft) experimental and investigational for diseases for which conventional allogeneic hematopoietic cell transplant has not been established as effective:

Experimental / Not Covered indications

Acquired angioedema
Autoimmune diseases (see CPB 0606 - Hematopoietic Cell Transplantation for Autoimmune Diseases and Miscellaneous Indications)
Breast cancer
see CPB 0507 - Hematopoietic Cell Transplantation for Breast Cancer
Essential thrombocythemia and polycythemia vera
see CPB 0606 - Hematopoietic Cell Transplantation for Autoimmune Diseases and Miscellaneous Indications
Inherited hemophagocytic lymphohistiocytosis
Melanoma
see CPB 0811 - Hematopoietic Cell Transplantation for Solid Tumors in Adults
Ovarian cancer
see CPB 0635 - Hematopoietic Cell Transplantation for Ovarian Cancer
Renal cancer
see CPB 0811 - Hematopoietic Cell Transplantation for Solid Tumors in Adults
Testicular cancer
see CPB 0617 - Hematopoietic Cell Transplantation for Testicular Cancer