Stem Cell Transplant/Bone Marrow Transplant

Coverage Summary & Scope

Scope: Clinical review criteria governing medical necessity, indications, contraindications, documentation, and coding for stem cell (blood and marrow) transplantation including autologous, allogeneic, cord blood, haploidentical, myeloablative and non-myeloablative (mini) transplants; includes MTAC technology assessment summaries and procedure code guidance (CPT/HCPCS set).

Coverage stance: Mixed — many hematologic and selected non-malignant indications are covered when the policy criteria are met, while multiple specific indications and non-myeloablative approaches are not supported by MTAC; stem cell storage (long-term) is not medically necessary unless the patient is scheduled for transplant and requires case-by-case clinical review.

Subject: Stem Cell Transplant / Bone Marrow Transplant — criteria address eligibility, general principles, disease-specific indications, contraindications, required documentation, and applicable procedure codes.

High-level policy position: Transplantation is considered medically necessary for listed indications when all applicable criteria are met and documentation submitted; conversely, several indications and non-myeloablative uses do not meet Kaiser Permanente MTAC and are not recommended. Stem cell storage is explicitly limited to patients scheduled to receive a transplant and may be denied if not meeting that condition.

Key thresholds & quick eligibility

Heart EFLeft ventricular ejection fraction (EF) <45% is a contraindication for myeloablative regimens

Lung functionFEV1 <50% predicted or DLCO <50% predicted is a contraindication for myeloablative regimens

Kidney functionCreatinine clearance <60 ml/min is a contraindication for myeloablative regimens (exception: MM and primary systemic amyloidosis may have autologous transplants if <60 ml/min)

Liver functionBilirubin >3.0 mg/dL or transaminases >3x ULN is a contraindication for myeloablative regimens

Substance abstinenceCandidates with history of substance abuse must be free from alcohol and other substance abuse for six (6) months and evaluated by a substance abuse program (exceptions case-by-case)

Stem Cell Storage Policy PartStem cell storage covered only when member is scheduled to receive a stem cell transplant; reviewed case-by-case by Clinical Review

Medical-Necessity Criteria

Stem Cell Storage (long-term)

Policy position:

Stem cell storage (long-term) is considered not medically necessary unless patient is scheduled for transplant

Coding

No explicit codes listed in Part 1mixed

No codes listed

Considered Medically Necessary when applicable policy criteria met (Non-Medicare)CPTCovered

38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous
38207	Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage
38208	Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor
38209	Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing, per donor
38210	Transplant preparation of hematopoietic progenitor cells; specific cell depletion within harvest, T-cell depletion
38211	Transplant preparation of hematopoietic progenitor cells; tumor cell depletion
38212	Transplant preparation of hematopoietic progenitor cells; red blood cell removal
38213	Transplant preparation of hematopoietic progenitor cells; platelet depletion

1–10 of 19

1/2

Stem Cell Storage (long-term)mixedNot Covered

86999

No specific code for storage - often submitted as 86999 Unlisted transfusion medicine procedure (storage considered not medically necessary unless scheduled for transplant)

Provider Actions & Billing Impact

Documentation Required

Submit clinical notes

Provide the last 6 months of clinical notes from the requesting provider and/or specialist to support medical necessity when requesting transplant services.

Prior Authorization

Clinical Review for stem cell storage

Stem cell storage is covered only when the member is scheduled to receive a stem cell transplant; medically indicated storage is reviewed by Clinical Review on a case-by-case basis.

Background & Evidence Summary

Background: Stem cell transplantation (also called bone marrow transplant or cord blood transplant) involves collection of hematopoietic stem cells from the patient (autologous) or a donor (allogeneic), possible cryopreservation, administration of high-dose chemotherapy ± radiation (conditioning), then reinfusion of stem cells to reconstitute hematopoiesis; peripheral blood, bone marrow, or cord blood are common sources.

Transplant types and process: Autologous transplants use the patient’s own cells (harvested, frozen, and reinfused after high-dose therapy); allogeneic transplants use donor cells and can provide graft-versus-tumor effects but carry risks such as graft-versus-host disease. Non-myeloablative (reduced-intensity or “mini”) regimens use lower intensity conditioning to allow donor engraftment with less toxicity and are intended for older or less fit patients.

Rationale: Myeloablative allogeneic HSCT aims to eradicate disease and rescue marrow, and is an effective curative approach for many hematologic malignancies in appropriately selected patients. Non-myeloablative approaches seek to exploit graft-versus-tumor effects while reducing regimen-related mortality for patients ineligible for full myeloablation.

MTAC evidence assessments: Historical MTAC reviews summarized condition-specific evidence — examples include CML (autologous SCT did not meet MTAC based on limited evidence), multiple sclerosis and breast cancer (HDC with SCT did not meet MTAC), mixed conclusions for multiple myeloma over time, and generally insufficient evidence to support non-myeloablative transplants for several solid tumor and hematologic indications. MTAC determinations and literature reviews (case series, registries, some nonrandomized trials) form the evidence base summarized in the background.

Administrative notes: Applicable CPT/HCPCS codes for harvesting, preparation, transplantation, and storage are listed and claims for long-term storage often face denial unless the member is scheduled for transplant; documentation requirements include last 6 months of clinical notes and other prior-authorizations as required by plan.

Medicare Determinations

name	number	type	effective
Stem Cell Transplantation Formerly 110.8.1 (110.23)	110.8.1 (110.23)	NCD

Revision History

06/18/2020code_update

Administrative code update: Removed CPT 30206/30207 and added CPT 38206/38207 (code set for harvesting and cryopreservation updated).

12/16/2021policy_addition

Material change: Added stem cell storage policy language — stem cell storage considered only when member is scheduled to receive a stem cell transplant and medically indicated storage is reviewed case-by-case (storage otherwise not medically necessary).

10/17/2022code_update

Administrative code update: Applicable codes list updated per record (general code maintenance and verification of CPT/HCPCS listings).

Definitions

Myeloablative conditioning: High-dose chemo/radiotherapy regimen intended to eradicate bone marrow prior to transplant; requires stringent organ function thresholds (contraindications include EF <45%, FEV1 <50% or DLCO <50% predicted, creatinine clearance <60 ml/min with limited exceptions, and bilirubin >3.0 mg/dL or transaminases >3x ULN).

Non-myeloablative (mini) transplant: Reduced-intensity conditioning regimen intended to allow donor engraftment with less toxicity; may have less stringent organ function requirements and was reviewed as investigational for many indications per MTAC (insufficient high-quality evidence for most hematologic and solid tumor uses).

NST definition (Non-myeloablative / mini transplant): Conditioning regimens not resulting in permanent marrow aplasia, causing only mild myelodepression but potent immunosuppression and often inducing mixed chimerism; designed to allow relatively prompt hematopoietic recovery without full ablation.

MTAC: Kaiser Permanente Medical Technology Assessment Criteria (MTAC) is the assessment framework used to evaluate evidence and determine whether specific transplant indications or approaches meet criteria for coverage.