ModifiedCentenePolicy CP.MP.162

Tandem Transplant

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Medical necessity criteria for planned tandem (sequential/double) high-dose therapy with hematopoietic cell transplant (HCT) within six months of the first course, for members/enrollees of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyTandem Transplant

Policy CodePolicy CP.MP.162

Change TypeContraindications revisedHIV criteria added

Effective Date

Next Review Date

Key ActionObtain prior authorization for tandem autologous transplant and document diagnosis, planned second transplant within six months, stem cell collection details, and organ function assessments showing absence of listed contraindications.

SourceLink

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ModifiedCentenePolicy CP.MP.162

Tandem Transplant

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Policy Summary

PayerCentene

PolicyTandem Transplant

Policy CodePolicy CP.MP.162

Change TypeContraindications revisedHIV criteria added

Effective Date

Next Review Date

SourceLink

POLICY UPDATE CHANGES

Replaced all previous contraindications (I.B.1 through 15) with a new contraindication list I.B.1 through 6.

Added CD4 and HIV-related conditions to contraindications (CD4 > 200 cells/mm3; absence of active AIDS-defining opportunistic infection; on effective ART).

Replaced prior broad contraindications list with a new, narrower list addressing specific conditions such as GFR thresholds, acute liver failure, acute renal failure, septic shock, disseminated infection, active TB, HIV with detectable viral load, progressive cognitive impairment, and other severe uncontrolled medical conditions.

Added substance use as a contraindication.

Updated HIV-related candidate criteria to require CD4 > 200 cells/mm3, absence of active AIDS-defining opportunistic infection, and current effective antiretroviral therapy.

6 monthsmaximum planned interval between transplants for a tandem transplant

3 disease indicationsprimary diagnoses listed as covered for tandem autologous transplant (MM, testicular GCT, high-risk neuroblastoma)

EF < 45%cardiac ejection fraction contraindication threshold

FEV1 ≤50% / DLCO ≤60%pulmonary function contraindication thresholds

CD4 >200HIV candidate requirements

15 → 6contraindication list reduced

Coverage Criteria for Tandem Autologous Hematopoietic Cell Transplant

Initial (medically necessary) indications and contraindications

Covered when ALL of the following are met for tandem autologous transplant:

Overall coverage rule: Member/enrollee has one of the listed diagnoses AND does not have specified contraindications

Acceptable diagnoses (I.A): 1. Newly diagnosed or responsive multiple myeloma (MM); 2. Testicular germ cell tumors: a) relapsed testicular cancer, or b) tumors refractory to a cisplatin-based chemotherapeutic regimen; 3. High-risk neuroblastoma defined by stage, age, and MYCN amplification criteria (see policy for I.A.3.a-d).

Supported by policy section I.A (chunk 2)

Contraindications/Exclusions (I.B): No significant dysfunction of a major organ system or severe comorbidities, including but not limited to: bilirubin > 2 mg/dL; INR > 1.6 (unless on oral anticoagulants); cardiac EF (MUGA/echo) < 45%; pulmonary: FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted; performance status: Karnofsky/Lansky < 70% or ECOG > 2; uncontrolled or disseminated infection.see numeric thresholds in policy (chunk 2)

Specific numeric thresholds provided in I.B (chunk 2)

Autologous followed by allogeneic transplant rules

Covered with additional stipulations:

Tandem autologous → allogeneic (HLA-identical sibling): Tandem autologous transplant followed by an allogeneic transplant from an HLA-identical sibling donor with reduced-intensity conditioning is medically necessary for untreated, newly diagnosed multiple myeloma when none of the contraindications in section I.B. are present.

chunk 4

Tandem autologous → allogeneic (HLA-compatible unrelated): Tandem autologous followed by an allogeneic transplant from an HLA-compatible unrelated donor for untreated, newly diagnosed multiple myeloma will be considered on a case-by-case basis when none of the contraindications in section I.B. are present.

chunk 4

Contraindications / Candidate exclusion criteria

Policy includes updated contraindications and candidate requirements; applies when documented criteria and the indicated diagnosis are met per referenced guidelines.

Contraindications (revised list): Member must NOT have any of the following specific contraindications: concerning GFR (numeric thresholds referenced in full policy), acute liver failure, acute renal failure, septic shock, active extrapulmonary or disseminated infection, active tuberculosis infection, HIV with detectable viral load, progressive cognitive impairment, other severe uncontrolled medical condition, or active substance use. This revised list replaced the prior broader contraindication list (I.B.1–15).see full policy for numeric thresholds

Replaced prior I.B.1-15 with I.B.1-6 (chunks 18,19,20)

HIV candidate criteria

When considering candidates with HIV infection, the following ALL must be met:

HIV-specific criteria: a) CD4 cell count > 200 cells/mm3; b) absence of active AIDS-defining opportunistic infection; c) member/enrollee is currently on effective antiretroviral therapy (ART).CD4 > 200 cells/mm3

Added to I.B.10 (chunk 19)

Policy language was updated to remove a prior blanket statement that “current evidence does not support tandem transplants for any other indication than what is listed above.” The removal clarifies that the policy now focuses on specific, enumerated indications and that previous broad exclusionary language has been deleted from the criteria set. Refer to the revisions recorded in the policy history for details of the change.

The policy text that previously limited tandem transplants only to the listed indications (see former section IV) was removed. This operational edit is documented in the revision history and reflects deletion of the prior restrictive clause rather than expansion of covered diagnoses.

Although prior policy language asserting lack of evidence for indications beyond those listed was removed, the policy context and criteria continue to emphasize that the principal supported indications remain multiple myeloma, testicular germ cell tumors, and high-risk neuroblastoma. Other indications are not detailed in this excerpt and should be considered unsupported by the specific evidence summaries referenced in the policy unless addressed elsewhere.

The restriction that had limited tandem transplants to the listed indications was deleted (see revision notes). This change is an operational removal of the prior clause rather than an affirmative statement expanding covered indications; exclusions and final coverage determinations remain governed by the enumerated criteria and the member’s benefit contract.

Candidate Selection and Indications

Candidate selection

Candidates must meet diagnosis-specific criteria and must not have any contraindications listed in the policy.

Multiple myeloma: Newly diagnosed or responsive multiple myeloma (MM). Consider tandem autologous transplant for patients who do not achieve at least a very good partial response (VGPR) after the first autologous HCT and for those with high-risk features; collect enough hematopoietic stem cells for two transplants when possible (NCCN guidance).

chunks 2,8

Testicular germ cell tumors: Relapsed or cisplatin-refractory testicular germ cell tumors (GCTs); high-dose chemotherapy with autologous SCT (single or tandem) is an accepted option for these patients.

chunks 2,14

High-risk neuroblastoma as defined by INSS/INRG criteria and MYCN amplification/age/stage thresholds in the policy; tandem ASCT has been shown to improve event-free survival in high-risk patients.

chunks 2,13

Coding and Clinical Thresholds

Referenced transplant and harvesting codesCPT | HCPCS

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous.
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.
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic 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

ICD-10 codesICD-10

No codes listed

Ejection fraction — EF contraindication threshold

Ejection fraction (EF)Multigated acquisition (MUGA) scan or echocardiogram EF < 45% is a contraindication

Source guidanceCardiac function threshold specified in pre-transplant contraindications

Actionable noteDocument EF by MUGA or echocardiogram in pre-transplant evaluation to confirm EF ≥ 45%

Bilirubin — lab threshold

Total bilirubinBilirubin > 2 mg/dL is a contraindication

ContextListed among major organ dysfunction criteria that exclude transplant candidacy

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior authorization required for tandem HCT and related procedures

Prior authorization is required for tandem autologous hematopoietic cell transplant and related hematopoietic progenitor cell (HPC) procedures; referenced procedure codes include CPT 38206, 38241 and HCPCS S2150 for harvesting and transplantation services.

CPT 38206 (autologous blood-derived HPC harvesting) and CPT 38241 (autologous HPC transplantation) are listed in the policy coding group.
HCPCS S2150 is referenced for comprehensive transplant/harvesting services and related complications.

Prior Authorization

Prior authorization implied by policy (no code-level PA detail here)

This clinical policy implies that prior authorization applies to the services described, but the document does not specify additional code-level prior authorization rules or procedural exceptions within this section.

Pre-Transplant Evaluation Requirements

Documentation Required

Evaluation requirements: document liver, coagulation, cardiac EF, and pulmonary function

Pre-transplant evaluation documentation should include liver function tests and bilirubin, coagulation/INR, cardiac ejection fraction by MUGA scan or echocardiogram, and pulmonary function tests (FEV1 and DLCO) to demonstrate absence of the policy’s contraindications.

Liver tests including bilirubin (policy threshold: bilirubin > 2 mg/dL is a contraindication).
Coagulation/INR (policy threshold: INR > 1.6 unless on oral anticoagulants).
Cardiac EF by MUGA or echocardiogram (policy threshold: EF < 45% is a contraindication).
Pulmonary function testing: FEV1 and DLCO (policy thresholds: FEV1 ≤ 50% predicted; DLCO ≤ 60% predicted).

Post-Transplant Coverage and Follow-up Services

Transplant harvesting, transplantation, and related complications and follow-up services — references comprehensive services and global definitions

Comprehensive services reference (S2150)HCPCS S2150 describes harvesting, transplantation, related complications, supplies, hospitalization, and outpatient follow-up included in global definition

Procedure codes for harvesting and transplantCPT codes referenced include 38205, 38206, 38230, 38232, 38240, 38241 for harvesting and transplantation

Actionable noteUse professional coding guidance and reference listed CPT/HCPCS when submitting claims for transplant services

Post-transplant follow-up and related services — coverage subject to member benefits and regulatory requirements

Coverage subject to member benefitsPost-transplant follow-up and related services are governed by the member's contract, state Medicaid provisions, and applicable Medicare NCDs/LCDs

Coding and References (Supplemental)

Referenced transplant and harvesting codesCPT | HCPCS

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous.
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.
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic 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

Background on Tandem Transplant

A tandem transplant is defined operationally as a planned second course of high-dose chemotherapy with hematopoietic cell transplant performed within six months of the first transplant, undertaken prospectively (not performed in response to relapse) to improve the depth and durability of response. Peripheral blood hematopoietic stem cells are typically collected during induction recovery or after mobilization to support the second preparative regimen.

Definitions

Definition — Tandem transplant: planned second course within six months, performed prospectively rather than for relapse

Definition (timing)A tandem transplant is a planned second course of high-dose therapy and HCT within six months of the first, performed prospectively rather than for relapse

SynonymsAlso called sequential or double transplant

Actionable notePlanned intent and ≤6-month interval distinguish tandem transplant from repeat HCT for relapse

Definition — Two planned sequential high-dose chemotherapy with stem cell rescue procedures (autologous/autologous or autologous/reduced-intensity allogeneic)

Definition (procedure types)Two planned sequential high-dose chemotherapy courses with stem cell rescue procedures, often autologous followed by autologous or reduced-intensity allogeneic

Intended use

Center and Operational Requirements

Billing Rule

Center requirements: coding referenced; accreditation/volume requirements not specified here

The policy references standard transplant procedure and coding guidance (including CPT and HCPCS codes) but does not specify center accreditation, minimum volume, or FACT-specific requirements in this section.

Use professional coding guidance prior to claim submission; referenced codes include 38205–38241 and S2150.
Accreditation and center-volume expectations are referenced elsewhere and are not specified in this policy excerpt.

Revision History and Policy Updates

02/24annual_review

Annual review: added HIV-specific candidate criteria requiring CD4 > 200 cells/mm3, absence of active AIDS-defining opportunistic infection, and current effective ART; background on testicular cancer updated; references reviewed and updated.

02/23annual_review

Annual review: updated verbiage for pediatric age criteria and multiple IA sections; added substance use as a contraindication; removed prior criterion stating evidence does not support tandem transplants for indications beyond those listed.

01/23annual_review

Policy Summary

PayerCentene

PolicyTandem Transplant

Policy CodePolicy CP.MP.162

Change TypeContraindications revisedHIV criteria added

Effective Date

Next Review Date

SourceLink

On This Page

Indications

Indications referenced include the following tumor types; see the full policy for detailed, indication-specific eligibility criteria.

Referenced indications: Multiple myeloma; high-risk neuroblastoma (stage/age/MYCN-defined high risk); testicular/germ cell tumors (relapsed or cisplatin-refractory). Additional indication-specific criteria and supportive evidence are detailed in the main policy and cited literature (NCCN, ASBMT, COG, J Clin Oncol, JAMA Oncol).

Supported by chunks 2,8,13,14

Candidates with significant organ dysfunction or severe comorbidities are excluded per the updated contraindications. Specific numeric thresholds cited in the policy include bilirubin > 2 mg/dL, INR > 1.6 (unless on oral anticoagulants), and left ventricular ejection fraction < 45%. Pulmonary function thresholds include FEV1 ≤ 50% predicted and DLCO ≤ 60% predicted. Poor performance status is listed as a contraindication—Karnofsky/Lansky < 70% or ECOG > 2. These measurements should be documented in the pre-transplant evaluation to support absence of exclusion criteria.

Actionable noteObtain and document serum bilirubin prior to transplant; values ≤ 2 mg/dL preferred

INR — coagulation threshold (unless on oral anticoagulants)

INR thresholdINR > 1.6 is a contraindication unless the member is on oral anticoagulants

ContextListed under hemostasis criteria for major organ dysfunction/severe comorbidity

Actionable noteDocument coagulation testing and anticoagulant use in the pre-transplant workup

FEV1 — pulmonary function threshold

FEV1Forced expiratory volume in 1 second (FEV1) ≤ 50% of predicted value is a contraindication

ContextPulmonary function thresholds are required components of pre-transplant evaluation

Actionable noteObtain and document pre-transplant spirometry to confirm FEV1 > 50% predicted when possible

DLCO — pulmonary diffusion threshold

DLCODiffusing capacity of the lung for carbon monoxide (DLCO) ≤ 60% of predicted value is a contraindication

ContextDLCO is listed with FEV1 under pulmonary function contraindications

Actionable noteDocument DLCO during pulmonary evaluation; aim for DLCO > 60% predicted for transplant candidacy

Performance status — Karnofsky/Lansky and ECOG thresholds

Performance status (Karnofsky/Lansky)Karnofsky or Lansky score < 70% is a contraindication

Performance status (ECOG)Eastern Cooperative Oncology Group (ECOG) performance score > 2 is a contraindication

Actionable noteAssess and document performance status (Karnofsky/Lansky or ECOG) in the pre-transplant evaluation

CD4 count — HIV-related threshold (> 200 cells/mm3)

CD4 cell count requirementCD4 cell count > 200 cells/mm3 is required for consideration of transplant in persons with HIV

Additional HIV criteriaAbsence of active AIDS-defining opportunistic infection and current effective antiretroviral therapy are required

Actionable noteDocument recent CD4 count, absence of active OI, and ART status in candidate evaluation

Note

Collect stem cells for two transplants when eligible (NCCN recommendation)

NCCN guidance recommends collecting enough hematopoietic stem cells for two transplants in all eligible patients; collect peripheral blood HSCs during induction recovery or after mobilization to permit a planned second transplant when indicated.

Collect sufficient stem cells for two transplants when patient is eligible and collection strategy allows.

Step Therapy

Step therapy: none specified

No step therapy requirements are specified in this portion of the clinical policy.

Documentation Required

Documentation required to support tandem transplant requests

Documentation submitted for authorization/medical necessity should include the member’s diagnosis, evidence that the second transplant is planned within six months of the first, details of stem cell collection (timing and intended number of transplants), and peri-transplant evaluation supporting absence of listed contraindications.

Diagnosis and indication (e.g., MM, testicular GCT, high-risk neuroblastoma).
Plan showing second transplant within 6 months of the first (tandem transplant definition).
Stem cell collection details (peripheral blood HSC collection/mobilization and intended number of transplants).
Pre-transplant organ function and infection assessments documenting absence of contraindications.

Note

Policy governance: annual reviews and specialist review documented

Policy governance is documented via annual reviews and external specialist review; updates to criteria and contraindications are recorded in the policy revision history.

Annual review and reference updates are noted in the policy history.
External specialist review and recorded revisions (e.g., contraindication list changes) are part of governance.

Documentation Required

Document significant organ dysfunction or severe comorbidities

Document any significant organ dysfunction or severe comorbidities (examples listed in policy) in the medical record, as these conditions may affect eligibility for tandem transplant.

Bilirubin > 2 mg/dL
INR > 1.6 (unless on oral anticoagulants)
Ejection fraction (MUGA/echo) < 45%
Pulmonary function: FEV1 ≤ 50% predicted or DLCO ≤ 60% predicted
Poor performance status: Karnofsky/Lansky < 70% or ECOG > 2

Denial Risk

Denial triggers: contraindications that may lead to claim denial

Claims and authorization requests may be denied if the member has contraindications listed in the policy, including inadequate organ function, acute organ failure, uncontrolled or disseminated infection, active tuberculosis, HIV with detectable viral load, progressive cognitive impairment, or active substance use.

Concerning GFR or acute renal failure
Acute liver failure or bilirubin > 2 mg/dL
Septic shock or active extrapulmonary/disseminated infection
Active tuberculosis infection
HIV infection with detectable viral load
Progressive cognitive impairment or other severe uncontrolled medical conditions
Active substance use

Policy roleThis clinical policy provides a guide to medical necessity but does not guarantee payment or replace coverage documents

Actionable noteVerify member benefits and applicable regulatory/NCD/LCD requirements prior to authorizing post-transplant services

Used as consolidation for high-risk malignancies to improve depth and durability of response

Actionable notePlan and document stem cell collection for intended second rescue when tandem approach is considered

Annual review: references reviewed and updated; ICD-10 codes removed; external specialist review and minor background edits with no change to coverage criteria.

01/25annual_reviewLatest

Annual review: updated I.A.3.b., c., and d. to reflect months of age instead of days and replaced the prior comprehensive contraindication list (I.B.1–15) with a new condensed list (I.B.1–6); background updated and references reviewed.

This document is a clinical medical necessity guide for planned tandem high-dose therapy with hematopoietic cell transplant and is not a guarantee of coverage. Final coverage determinations are subject to the member’s contract, applicable state regulations, and any Medicare National Coverage Determinations or Local Coverage Determinations. The policy history documents material revisions; reviewers should consult the member’s plan benefits and regulatory requirements when applying these criteria.