CurrentPremera BluecrossPolicy 8.01.21

Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms

Defines when allogeneic hematopoietic cell transplantation (myeloablative or reduced-intensity conditioning) may be considered medically necessary for individuals with myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN). Affects providers requesting transplant authorization for eligible patients.

Policy Summary

PayerPremera Bluecross

PolicyAllogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms

Policy CodePolicy 8.01.21

Change TypeNo material changes

Effective Date

Next Review DateApr 1, 2025

Key ActionObtain prior authorization with documentation showing medical necessity criteria are met and planned conditioning intensity (myeloablative vs reduced-intensity).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

IPSSMDS risk stratification

>2HCT-CI threshold

>5Blast % consideration

04/01/2025Most recent review

MultipleRelated policies

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Coverage Criteria for Allogeneic Hematopoietic Cell Transplantation

inv-01: Medical necessity for allo-HCT

Covered when ALL of the following are met

Myeloablative allo-HCT: Myeloablative allogeneic hematopoietic cell transplantation may be considered medically necessary as a treatment of myelodysplastic syndromes (MDS) OR myeloproliferative neoplasms (MPN)

Reduced-intensity conditioning (RIC) allo-HCT: Reduced-intensity conditioning allo-HCT may be considered medically necessary as a risk-adapted treatment of MDS OR MPN in individuals who are at high-risk of intolerance of a myeloablative conditioning regimenhigh-risk of intolerance

inv-02: Indications for Allogeneic HCT (general)

Covered when ALLO-HCT (myeloablative or RIC) is clinically indicated based on disease risk, patient age, and comorbidities

Indication core criteria

MDS high-risk features: IPSS intermediate-2 or high risk; increasing blast percentage; refractory anemia with excess blasts or refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia (CMML); high-risk cytogenetics or significant cytopeniasIPSS categories per Tables
References IPSS and 5-category IPSS
MPN features: Progression to myelofibrosis or toward acute leukemia; essential thrombocythemia with thrombotic or hemorrhagic complications; cytopenias or transfusion dependence; increasing blast percentage over 5%blast % > 5%
Patient selection for RIC: Older age (typically >60), HCT-CI > 2, comorbidities (eg, liver or kidney dysfunction), prior intensive chemotherapy, low Karnofsky performance status may lead to consideration of reduced-intensity conditioningAge >60 or HCT-CI >2
RIC intended for those who cannot tolerate myeloablative conditioning

inv-03: General coverage stance

Covered when supported by evidence and guideline-based indications:

Overall: Allo-HCT (MAC or RIC) is considered an effective, potentially curative treatment for MDS and MPN when patients are transplant candidates and disease characteristics align with guideline recommendations; RIC may be preferred in older or comorbid patients because it lowers nonrelapse mortality but is associated with higher relapse risk compared with MAC.

Based on systematic reviews, RCTs, observational data, and guideline endorsements (NCCN, ASTCT) showing typical 3–5 year OS around 40–50% for MDS and supporting risk-adapted use of RIC.

inv-04: Covered with criteria — RIC allo-HCT (risk-adapted statements and updates)

Policy statements have been updated over time to align with literature and guideline evidence; RIC allo-HCT is considered a risk-adapted strategy for patients at high risk of intolerance to myeloablative conditioning.

RIC as medically necessary in select patients: Reduced-intensity conditioning allogeneic HCT may be considered medically necessary as a risk-adapted strategy for patients who for medical reasons would be unable to tolerate a myeloablative conditioning regimen (older age or co-occurring medical conditions).risk of MAC intolerance

Based on literature review and policy updates noted in history.

The Introduction section is informational and intended to orient clinical reviewers and providers; it is not itself a list of coverage criteria. It summarizes that myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN) are bone marrow disorders that can progress to acute myelocytic leukemia and that allogeneic hematopoietic stem cell transplantation (allo‑HCT)—transplantation of donor-derived hematopoietic stem cells—is a treatment sometimes used for these conditions. Readers should use the specific medical necessity criteria elsewhere in the policy to determine coverage decisions rather than the introductory text.

This space is reserved for additional explanatory or transitional language related to the coverage criteria. Use this area to clarify process points, cross-reference related transplant policies, or add operational notes for reviewers as needed; do not restate the policy criteria themselves.

Medicare limits payment for allogeneic HSCT in certain situations. Specifically, coverage for allogeneic HSCT for MDS (and for myelofibrosis in defined DIPSSplus categories) is restricted by Medicare to beneficiaries who are participating in an approved prospective clinical study under a Coverage with Evidence Development (CED) arrangement; when the CED conditions apply, Medicare payment is limited to enrolled patients.

This medical policy does not apply to Medicare Advantage plans. For members with Medicare Advantage coverage, plan-specific benefit rules and prior authorization requirements should be confirmed with the member’s plan or customer service representative.

Absence of an explicit “not medically necessary” statement in a given section does not imply coverage. Procedures or services that do not meet the specific medical necessity criteria for myeloablative or reduced‑intensity conditioning (RIC) allogeneic HCT as set forth in this policy may be considered noncovered and are subject to denial unless otherwise supported by documented clinical justification.

This space is available for any remaining, non‑criteria explanatory notes or operational reminders that may assist reviewers or providers when preparing documentation for transplant authorization requests; do not add or change policy criteria here.

The American Society for Transplantation and Cellular Therapy (ASTCT) practice recommendations advise against routinely offering early allo‑HCT for patients with lower‑risk (low/int‑1) de novo MDS. ASTCT’s guidance specifically recommends not offering routine early transplantation in this lower‑risk group while supporting consideration of allo‑HCT for higher‑risk MDS consistent with the disease‑specific recommendations.

Coding and Prognostic Thresholds

Transplant CPT/HCPCS codes listedmixed

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

Clinical trial identifiersmixed

NCT05367583	COMYRE trial identifier listed in document
NCT02757989	Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Myelodysplastic Syndrome Low Risk trial identifier

Historical coding changes referencedCPT

38232	Code added to policy historically (listed in history)
38204	Code removed from policy historically
86817	CPT code referenced as removed and re-added historically

IPSS category thresholds — prognostic groups and drivers

IPSS risk groupsLow (includes Low and Int-1), Intermediate-2, High — grouped by marrow blasts, cytopenias, and karyotype per IPSS Tables

Key driversMarrow blast percentage, number/severity of cytopenias, and cytogenetic risk (karyotype)

Clinical implicationsLow/Int-1: focus on quality of life; Int-2/High: treatment aimed to slow progression to AML and improve survival (consider allo-HCT)

Blast percentage

Threshold> 5% marrow blasts cited as an increasing blast percentage that supports consideration of allo-HCT

Context

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior authorization required — prior auth implied for allo-HCT and must demonstrate medical necessity

Prior authorization is required for allogeneic hematopoietic cell transplantation (allo-HCT). Requests must demonstrate medical necessity and specify whether a myeloablative or reduced-intensity conditioning regimen is planned. Services that do not meet medical necessity criteria may be denied.

Prior authorization required for allo-HCT (myeloablative or RIC)
Document planned conditioning intensity on prior auth request

Prior Authorization

Prior authorization and coding — requires clinical documentation including planned conditioning intensity

Submit clinical documentation with the prior authorization request that supports the transplant plan and coding. Include the planned conditioning intensity (myeloablative vs reduced-intensity) and relevant procedural/coding details to aid accurate processing.

Include planned conditioning intensity (myeloablative or RIC)
Provide any relevant procedure codes and expected services for coding review

Background and Evidence Summary

Myelodysplastic syndromes (MDS) and myeloproliferative neoplasms (MPN) are clonal bone marrow disorders that impair blood cell production and may progress to acute myelocytic leukemia. Allo‑HCT is the only potentially curative therapy for many patients with MPN and is an established curative option for selected patients with MDS. Decisionmaking for transplant depends on disease prognostic category (for MDS commonly using IPSS/IPSS‑R), marrow blast percentage, cytopenias, cytogenetic risk, patient age and functional status, and comorbidity burden. The policy distinguishes myeloablative conditioning (MAC) and reduced‑intensity conditioning (RIC), and recommends RIC as a risk‑adapted strategy for patients judged unlikely to tolerate MAC (for example older age or elevated HCT‑CI), noting that RIC lowers nonrelapse mortality but may increase relapse risk compared with MAC.

Definitions and Terminology

Allogeneic hematopoietic stem cell transplant (summary)

DefinitionTransplantation in which hematopoietic stem cells are obtained from a donor and infused into a recipient to restore bone marrow and immune function

Donor sourcesDonor stem cells may be harvested from bone marrow, peripheral blood, or umbilical cord blood

Compatibility requirementDonor–recipient HLA compatibility is a critical factor for successful allo‑HCT

IPSS (International Prognostic Scoring System)

DefinitionInternational Prognostic Scoring System (IPSS): a scoring system for MDS risk stratification based on marrow blasts, degree of cytopenias, and cytogenetics (karyotype)

Risk categoriesGroups include Low, Intermediate‑1, Intermediate‑2, and High (and an updated 5‑category proposal for more granular stratification)

Policy Revision History

2020-06-10Interim review / reinstatement

Interim review approved June 9, 2020 and effective June 10, 2020; policy was reinstated and will no longer be deleted as previously planned.

2020-03-10Approval / update

Policy approved March 10, 2020 (note: earlier plan indicated deletion effective July 2, 2020 and replacement with InterQual criteria for later dates of service).

2000-02-01New policy / add to therapy sectionLatest

Policy Summary

PayerPremera Bluecross

PolicyAllogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes and Myeloproliferative Neoplasms

Policy CodePolicy 8.01.21

Change TypeNo material changes

Effective Date

Next Review DateApr 1, 2025

Key ActionObtain prior authorization with documentation showing medical necessity criteria are met and planned conditioning intensity (myeloablative vs reduced-intensity).

SourceLink

On This Page

Rising blast percentage signals possible transformation toward AML (includes refractory anemia with excess blasts and CMML)

DocumentationMarrow blast percentage should be recorded in the transplant evaluation to support medical necessity

HCT‑CI threshold for conditioning selection

HCT‑CI threshold> 2 on the hematopoietic cell transplantation–comorbidity index (HCT‑CI) is referenced as a level prompting consideration of reduced‑intensity conditioning (RIC)

Associated factorsHigher HCT‑CI reflects multiple comorbidities that increase intolerance risk to myeloablative conditioning

Use in planningHCT‑CI should be included in documentation to justify selection of RIC versus myeloablative conditioning

Prior Authorization

Prior authorization: transplant indication and conditioning — confirm indication, donor availability, prognostic scoring, prior treatments, and conditioning plan

Confirm transplant indication and donor availability when requesting prior authorization. The request should document prognostic scoring (IPSS, DIPSS/MIPSS/MIPSS-70 as applicable), prior treatments and responses, and the planned conditioning regimen.

Document transplant indication and donor type/availability
Provide prognostic scores (IPSS, IPSS-R, DIPSS/MIPSS etc.)
Include prior therapies, responses, and contraindications to myeloablative conditioning if applicable

Prior Authorization

Prior authorization guidance — follow member benefit limits and contact member services for plan-specific prior auth rules

Verify member-specific prior authorization rules and benefit limits before submission. Contact Member Services or consult the member benefit booklet to confirm plan-specific prior authorization pathways, coverage limitations, and any pre-service requirements.

Check member benefit booklet for transplant benefit limits
Contact Member Services for plan-specific prior auth rules

Denial Risk

Denial triggers — services not meeting medical necessity criteria may be denied

Services that do not meet the policy's medical necessity criteria or that lack required documentation are subject to denial. Typical denial triggers include: absence of documented transplant indication, lack of documented prognostic risk supporting transplant, missing donor availability information, or no evidence that contraindications to myeloablative conditioning were considered when RIC is proposed.

Absence of documented diagnosis/indication
No documented prognostic scoring supporting transplant candidacy
Missing donor availability or suitability documentation
Lack of documentation of contraindications to myeloablative conditioning when RIC is used

Documentation Required

Documentation-based denial risk — lack of medical record documentation that criteria are met increases denial risk

Denials are more likely when the medical record does not substantiate that the policy criteria are met. Ensure submitted records explicitly show the clinical rationale for transplant, prognostic scores, prior therapies and responses, donor identification status, and planned conditioning intensity.

Provide operative notes, consultation notes, and pathology reports as needed
Include transplant candidacy evaluation and donor search documentation

Prior Authorization

Medicare CED participation requirement — Medicare restricts payment to beneficiaries in approved prospective clinical studies for MDS/myelofibrosis

Medicare coverage may be limited by Coverage with Evidence Development (CED) requirements for certain MDS and myelofibrosis indications. Medicare payment for allogeneic HSCT in these contexts is restricted to beneficiaries enrolled in approved prospective clinical studies that meet CMS requirements.

Medicare CED applies for some MDS and myelofibrosis HSCT indications
Ensure Medicare beneficiaries are enrolled in an approved prospective clinical study when required

Note

Benefit limitations and member contract mismatch — coverage subject to member benefit plan limits

Coverage is subject to the member's contract. Member benefit plan limits, exclusions, or different eligibility rules may apply and can affect coverage. Always verify benefits and any plan-specific exclusions before scheduling services.

Coverage subject to member benefit plan limits and exclusions
Consult member booklet or Member Services for benefit confirmation

Documentation Required

Required clinical documentation — IPSS and diagnostics (blast %, cytopenias, karyotype) should be documented

Required clinical documentation for prior authorization and medical necessity review includes: the documented diagnosis, prognostic scoring (IPSS or disease-specific scores), marrow blast percentage, degree of cytopenias, cytogenetics/karyotype, and history of prior therapies and responses.

Diagnosis and date of diagnosis
IPSS/IPSS‑R or other disease‑specific prognostic score
Marrow blast % and peripheral blood counts
Cytogenetics/karyotype and molecular markers
Prior therapies, responses, and contraindications

Documentation Required

Required clinical documentation for transplant evaluation — document transplant candidacy and donor availability

For transplant evaluation and prior authorization, document transplant candidacy assessment and donor availability. Include performance status, comorbidities, psychosocial evaluation, HLA testing results, donor type (matched sibling, matched unrelated, haploidentical, cord blood), and any planned bridging therapy.

Performance status and comorbidity assessment
HLA testing and donor identification status
Psychosocial and caregiver availability documentation
Planned bridging therapy if applicable

Documentation Required

Conditioning selection — risk-adapted selection of RIC vs myeloablative based on intolerance risk and IPSS

Conditioning regimen selection should be risk‑adapted. Choose myeloablative conditioning for appropriate younger/fit candidates and reduced‑intensity conditioning (RIC) for individuals at high risk of intolerance to myeloablative regimens (advanced age, comorbidities, poor performance status). Document rationale for the selected conditioning intensity.

Document reasons for selecting RIC vs myeloablative (age, comorbidities, prior therapies, Karnofsky score)
Specify planned conditioning agents and intensity on the prior authorization request

Note

Bridging therapy before transplant — consider hypomethylating agents, JAK inhibitors, venetoclax, or intensive induction as appropriate

Bridging therapy may be appropriate to reduce marrow blasts or control disease prior to transplant. Common bridging options include hypomethylating agents, JAK inhibitors, venetoclax-based regimens, or intensive induction chemotherapy as clinically indicated; document the intent and timing relative to planned transplant.

Document type of bridging therapy and treatment dates
Provide response assessments to bridging therapy prior to transplant authorization

Clinical useIPSS is typically calculated at diagnosis and guides treatment goals and transplant consideration

Reduced‑intensity conditioning (RIC) — summary

DefinitionReduced‑intensity conditioning (RIC): pre‑transplant regimens using lower doses of cytotoxic drugs or less intense radiotherapy than myeloablative conditioning to reduce early treatment‑related morbidity and nonrelapse mortality while enabling graft‑versus‑malignancy effects

Regimen intensityRIC regimens vary from nearly myeloablative to minimally myeloablative with lymphoablation; intensity is tailored to disease and patient condition

Clinical goalBalance reduced early toxicity against increased relapse risk compared with myeloablative conditioning

Allogeneic hematopoietic cell transplantation (alternate summary)

Definition (alternate)Allogeneic hematopoietic cell transplantation: infusion of donor hematopoietic stem cells to reconstitute recipient marrow and immunity; donor cells require HLA matching for success

PurposeUsed as a potentially curative therapy for MDS and MPN when disease features and patient candidacy align with guideline recommendations

Post‑transplant careImmunosuppression is required to reduce graft‑versus‑host disease risk, with attendant infection susceptibility

Myeloablative conditioning (MAC)

DefinitionMyeloablative conditioning (MAC): high‑dose cytotoxic agents, with or without total body irradiation, intended to ablate recipient bone marrow and eradicate malignancy prior to allo‑HCT

Patient selectionReserved for individuals sufficiently fit to tolerate substantial adverse effects including organ toxicity and infection risk

Therapeutic intentCombines tumor eradication with subsequent graft‑versus‑malignancy effect to achieve curative outcomes

Reduced‑intensity conditioning (RIC) — additional entry

Definition (additional)Reduced‑intensity conditioning (RIC) refers to lower‑dose cytotoxic or less intense radiotherapy regimens intended to reduce early treatment‑related morbidity and nonrelapse mortality while relying on graft‑versus‑malignancy effects for disease control

IntentEnables allo‑HCT in patients who may not tolerate full myeloablative regimens (e.g., older age, comorbidities)

ChimerismInitial mixed donor chimerism is common with subsequent conversion to full donor chimerism in many patients

Reduced‑intensity conditioning (RIC) — supporting references

Supporting evidenceMultiple peer‑reviewed studies and reviews report that RIC can produce durable remissions and enable allo‑HCT in higher‑risk or older patients (e.g., Tauro et al. J Clin Oncol 2005; Valcarcel & Martino reviews)

Systematic reviewsMeta‑analyses and multicenter studies compare RIC and MAC outcomes, documenting lower nonrelapse mortality but higher relapse risk with RIC

Guideline citationsNCCN and ASTCT guidance are cited supporting risk‑adapted use of RIC in selected patients

New policy added February 1, 2000 representing a revision to prior policy 7.03.10 to focus on myelodysplasia and myeloproliferative disorders.