CurrentPremera BluecrossPolicy N/A

8.01.542 Hematopoietic Cell Transplantation for Acute Myeloid Leukemia

Defines medical necessity criteria for allogeneic and autologous hematopoietic cell transplantation (HCT) — including myeloablative and reduced-intensity conditioning — for treatment of acute myeloid leukemia (AML), documentation requirements, coding, evidence, guidelines, and related policy history. This is Part 1 of 2; captures criteria, background, evidence, guidelines, and coding listed in this part.

Policy Summary

PayerPremera Bluecross

Policy8.01.542 Hematopoietic Cell Transplantation for Acute Myeloid Leukemia

Policy CodePolicy N/A

Change TypeMaterial addition (second HCT considered medically necessary when criteria met)

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, history and physical, prior treatments, poor-risk features, and remission/relapse history to demonstrate the policy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Policy statement that second HCT for relapsed AML after initial HCT may be considered medically necessary when criteria are met.

Policy updated with Effective Date May 1, 2026 and Last Revised Apr. 14, 2026; related policies listed.

Annual review updated literature through December 2, 2025; policy statements unchanged in 04/01/26 review except addition above.

Policy language standardized from 'patient' to 'individual' in 04/01/23 review.

4Covered Indications (main categories: MAC allogeneic, RIC allogeneic, second allo-HCT, autologous HCT)

1Investigational category (not meeting criteria)

Key CPT/HCPCS codes listed

1Material coverage addition in 2026

multipleHistorical CPT/HCPCS code updates noted

Coverage Summary

This policy (Part 1 of 2) defines medical necessity criteria for allogeneic and autologous hematopoietic cell transplantation (HCT) — including myeloablative conditioning (MAC) and reduced-intensity conditioning (RIC) — for treatment of acute myeloid leukemia (AML). It summarizes covered indications (MAC allo-HCT, RIC allo-HCT, second allo-HCT, and autologous HCT) and investigational determinations when criteria are not met, and it became effective May 1, 2026 with last review on Apr. 14, 2026.

High-level policy metadata

Policy titleHematopoietic Cell Transplantation for Acute Myeloid Leukemia

PayerPremera (company medical policy)

Policy numberN/A

Effective dateMay 1, 2026

Last review dateApr. 14, 2026

Material changeYes — added statement that second HCT for relapsed AML after initial HCT may be considered medically necessary when criteria are met (05/01/26).

Medical-Necessity Criteria

Allogeneic HCT with Myeloablative Conditioning (MAC) — Medical Necessity

Covered when ANY of the following are met:

ANY of the following

Poor to intermediate risk acute myeloid leukemia (AML) in first complete remission (CR1) (see Table 1 for risk definitions)
AML that is refractory to standard induction chemotherapy but can be brought into complete remission (CR) with intensified induction chemotherapy
AML that relapses following chemotherapy-induced CR1 but can be brought into CR2 or beyond with intensified induction chemotherapy
AML in individuals who have relapsed following a prior autologous HCT, but can be brought into CR with intensified induction chemotherapy and are medically able to tolerate the procedure

Coding

Relevant CPT codes listedCPT

38230	Bone marrow harvesting for transplantation; allogeneic
38232	Bone marrow harvesting for transplantation; autologous
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
38241	Hematopoietic progenitor cell (HPC); autologous transplantation

Relevant HCPCS codes listedHCPCS

S2142	Cord blood derived stem cell transplantation, allogeneic
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; global definition

Removed / historical CPT/HCPCS references (document notes many code updates over time)mixed

38220	Removed from policy (historical note)
38221	Removed from policy (historical note)
38232	Added 01/24/12 (historical)
38204	Removed from policy (historical note) (not specific to transplant)
38242	Removed 04/01/20, does not match criteria
38240	Description updated 06/09/17 (historical)
38241	Description updated 06/09/17 (historical)
S2140	HCPC code removed 10/01/22

Provider Actions

Prior Authorization

Prior authorization required per plan

Prior authorization is required per member plan benefits. Contact the member's plan to verify coverage and obtain any required preapproval prior to scheduling hematopoietic cell transplantation (HCT). Visit the member’s benefits portal or call the preauthorization phone number on the member ID card for specific submission instructions and required forms.

Check member benefits for prior authorization and medical necessity requirements
Submit preauthorization requests with supporting clinical documentation as outlined below

Documentation Required

Documentation required for medical necessity review

The individual's medical record must clearly document clinical information to support medical necessity for HCT. Provide concise, contemporaneous documentation in the chart to facilitate review.

Background & Evidence

Background: AML is a marrow-based myeloid malignancy with a high incidence of relapse; postremission strategies include autologous and allogeneic hematopoietic cell transplantation (HCT). Allogeneic HCT uses donor hematopoietic stem cells (related HLA-identical sibling preferred, matched unrelated donors commonly used, and haploidentical donors an option with higher GVHD/morbidity risk) while autologous HCT uses the individual’s own collected stem cells. Conditioning regimens include myeloablative conditioning (high-dose cytotoxic agents with or without total body irradiation to ablate marrow) and reduced-intensity conditioning (RIC: lower-dose or less intense regimens intended to be nonmyeloablative). Relapse after transplant is common; second allogeneic HCT can be considered in select individuals who can be brought into remission. Genetic risk categories (Table 1: favorable, intermediate, poor/adverse) are used to stratify recommendations for CR1 management.

Evidence summaries

Evidence — MAC (intermediate/poor-risk CR1)Systematic reviews, RCTs, and matched cohort studies show improved overall and disease-specific survival versus chemotherapy.

Evidence — RICRCTs, meta-analyses, and comparative studies report similar outcomes to MAC for selected unfit patients (OS, nonrelapse mortality, relapse rates).

Evidence — Autologous HCTProspective cohorts and RCTs show reduced relapse and improved disease-free survival versus chemotherapy but no difference in overall survival.

Medicare Determinations

Determination	Effective Year/Number/Type
Stem Cell Transplantation (autologous/allogeneic)
2024 / 110.23 (formerly 110.8.1) / NCD

Revision History

04/01/23editorial

Policy language standardized from 'patient' to 'individual' (minor editorial refinements; intent unchanged).

04/01/26annual_review

Annual review updated literature through December 2, 2025; policy statements unchanged in 04/01/26 review except later addition of a new statement.

05/01/26administrative

Policy updated with Effective Date May 1, 2026 and noted Last Revised Apr. 14, 2026; related policies listed and replacement of prior policy number noted.

Policy Summary

PayerPremera Bluecross

Policy8.01.542 Hematopoietic Cell Transplantation for Acute Myeloid Leukemia

Policy CodePolicy N/A

Change TypeMaterial addition (second HCT considered medically necessary when criteria met)

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, history and physical, prior treatments, poor-risk features, and remission/relapse history to demonstrate the policy criteria are met.

SourceLink

On This Page

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Allogeneic HCT with Reduced-Intensity Conditioning (RIC) — Medical Necessity

Covered when ALL of the following are met:

ALL of the following

Individual is in complete marrow and extramedullary remission (CR1 or beyond)
Individual has medical reasons precluding tolerance of a myeloablative conditioning regimen

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Second Allogeneic HCT — Medical Necessity

Covered when ALL of the following are met:

ALL of the following

Relapsed AML after an initial allogeneic HCT
Individual can be brought into complete remission (CR)
Individual is medically able to tolerate the procedure

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Autologous HCT — Medical Necessity

Covered when ALL of the following are met:

ALL of the following

AML in CR1 or beyond, or relapsed AML, that is responsive to intensified induction chemotherapy
Individual is not a candidate for allogeneic HCT

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Not Medically Necessary / Investigational

Not covered when NONE of the above criteria are met:

Allogeneic and autologous HCT are investigational in individuals not meeting any of the above criteria

Medically Necessary Indications (high-level summary from history statements present in this part)

Policy statements (as amended in 2026) include criteria for second HCT and use of RIC allo-HCT in select patients; exact detailed criteria were in Part 1 and are not repeated here. The following logical structure reflects changes noted in history:

ANY of the following

Second HCT for relapsed AML after initial HCT may be considered medically necessary when criteria are met
Specific eligibility criteria referenced as 'when criteria are met' are in the policy body (Part 1).
Use of RIC allo-HCT in patients who are in complete marrow and extramedullary first or second remission and who for medical reasons would be unable to tolerate a myeloablative conditioning (MAC) regimen is considered medically necessary
This statement reflects acceptance of RIC allo-HCT for select patients per 04/01/21 update; detailed criteria in Part 1.

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Investigational/Not Medically Necessary (historic policy statements referenced)

Historic investigational determinations noted in policy history and prior iterations:

Allogeneic HCT after a prior failed autotransplant was previously considered investigational (history 2000); policy statements have evolved since then

Current policy updated in 2026 added second HCT may be medically necessary when criteria met, superseding older investigational stance for some scenarios.

Diagnosis and relevant diagnostic test results
History and physical examination documenting current severity
Prior treatments and responses (induction, consolidation, salvage regimens)
Any poor-risk features (cytogenetic/molecular abnormalities, antecedent hematologic disorders, treatment-related AML)
History of remissions and relapses, including dates and durations

Documentation Required

Document clinical criteria for second HCT and RIC candidacy

For requests involving a second allogeneic HCT or consideration of reduced-intensity conditioning (RIC), explicitly document the clinical criteria that justify the second transplant and RIC candidacy.

Evidence the individual was brought into an appropriate complete remission (e.g., CR2) prior to repeat HCT
Medical assessment of transplant fitness and organ function supporting ability to tolerate second HCT or RIC
Rationale for selecting reduced-intensity conditioning versus myeloablative regimen (comorbidities, age, prior regimen toxicity, performance status)
Prior transplant details: date, donor type, conditioning regimen, graft-versus-host disease history, and cause of prior transplant failure/relapse

Billing Rule

Billing: use current CPT/HCPCS transplant codes

Ensure CPT and HCPCS coding for transplantation services align with current AMA and CMS code sets. Use the current-year CPT/HCPCS codes when submitting claims and prior authorization requests; do not rely on historical or retired codes.

Historical/commonly referenced codes in this policy: CPT 38230, 38232, 38240, 38241; HCPCS S2142, S2150
Verify and use up-to-date CPT/HCPCS codes and descriptions from the AMA and CMS prior to claim submission
Include appropriate diagnosis codes and modifiers as applicable and attach operative/transplant notes and facility billing details to support coding

Evidence — Second HCTClinical trials and registry studies report high early mortality (25–50%) but select patients achieve long-term leukemia-free survival (11–42% at 3–5 years).

Literature reviewPolicy updated with literature review through December 2, 2025 (04/01/26 review); references added.

Definitions: Primary refractory AML: leukemia that does not achieve a complete remission after conventionally dosed (non-marrow ablative) chemotherapy; Myeloablative conditioning (MAC): high-dose cytotoxic agents with or without total body irradiation at doses sufficient to cause bone marrow ablation; Reduced-intensity conditioning (RIC): lower doses or less intense regimens of cytotoxic drugs/radiotherapy intended to be nonmyeloablative; CR: complete remission (complete marrow and extramedullary remission); HCT: hematopoietic cell transplantation (term used in policy).

05/01/26addedLatest

Added material policy statement: second allogeneic HCT for relapsed AML after initial HCT may be considered medically necessary when criteria are met (approved April 14, 2026; effective May 1, 2026).