CurrentBlue Cross Blue Shield - MassachusettsPolicy 191

Hematopoietic Cell Transplantation for Miscellaneous Solid Tumors in Adults

This policy governs coverage and prior authorization requirements for autologous and allogeneic hematopoietic cell transplantation (HCT) when used to treat various adult solid tumors, and applies to Commercial and Medicare products of Blue Cross Blue Shield Massachusetts.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyHematopoietic Cell Transplantation for Miscellaneous Solid Tumors in Adults

Policy CodePolicy 191

Change TypeClarification — coding and authorization

Effective Date

Next Review Date

Key ActionObtain precertification/prior authorization for HCT when performed inpatient; outpatient prior authorization is required for commercial products (including Medicare Advantage).

SourceLink

POLICY UPDATE CHANGES

Outpatient prior authorization is required for all commercial products including Medicare Advantage effective 1/1/2019.

Coding information clarified (annual policy review); policy statements unchanged.

Coding information clarified (6/1/2010 and 9/2010) with no changes to policy statements.

1BCBS Policy Number

MultipleInvestigational tumor types

RequiredInpatient prior authorization

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Coverage Criteria — Indications and Investigational Uses

Investigational Indications

Autologous or allogeneic cell transplant is investigational for the following adult malignancies:

Investigational indications list: Colon cancer; Lung cancer (any histology); Rectal cancer; Pancreas cancer; Stomach cancer; Esophageal cancer; Gall bladder cancer; Cancer of the bile duct; Renal cell cancer; Cervical cancer; Uterine cancer; Cancer of the fallopian tubes; Prostate cancer; Nasopharyngeal cancer; Paranasal sinus cancer; Neuroendocrine tumors; Soft tissue sarcomas; Thyroid tumors; Tumors of unknown primary origin; Tumors of the thymus; Malignant melanoma

Autologous or allogeneic HCT considered investigational for these listed solid tumor types in adults.

Outpatient hematopoietic cell transplantation (HCT) is specifically designated as not a covered service for multiple product types when performed in the outpatient setting. This includes Commercial Managed Care (HMO and POS) outpatient, Commercial PPO and Indemnity outpatient, Medicare HMO outpatient, and Medicare PPO outpatient members as stated in the policy.

The document references prior Medical Policy 191 (effective 6/1/2010) and notes that coding information was clarified at that time; the policy text indicates ongoing non-coverage described in that earlier policy but does not reproduce the full prior non-coverage conditions in this excerpt.

Autologous or allogeneic hematopoietic cell transplantation is listed as INVESTIGATIONAL (i.e., not medically necessary) for a set of adult solid tumors. The enumerated malignancies include but are not limited to colon cancer; lung cancer (any histology); rectal cancer; pancreas cancer; stomach cancer; esophageal cancer; gall bladder cancer; cancer of the bile duct; renal cell cancer; cervical cancer; uterine cancer; cancer of the fallopian tubes; prostate cancer; nasopharyngeal cancer; paranasal sinus cancer; neuroendocrine tumors; soft tissue sarcomas; thyroid tumors; tumors of unknown primary origin; tumors of the thymus; and malignant melanoma.

The excerpted policy text lists investigational indications and non-coverage references but does not contain separate, detailed medical necessity criteria for covered use versus noncovered use within this passage. Explicit medical necessity determinations and any specific medically necessary statements are addressed in the governing Medical Policy (Policy 191) and related sections not reproduced in this excerpt.

Evidence-based candidate notes

Evidence summaries for specific tumor types indicate insufficient evidence of benefit:

Autologous HCT evidence summary: For adult soft tissue sarcomas and small cell lung cancer, randomized trials and series have not demonstrated an overall survival benefit; the evidence is insufficient to determine improvement in net health outcome.

See policy evidence sections.

Allogeneic HCT evidence summary: For renal cell carcinoma, colorectal cancer, pancreatic cancer, and nasopharyngeal cancer, evidence is limited to single-arm series/case series and is insufficient to determine improvement in net health outcome.

See policy evidence sections.

Coding, CPT/HCPCS, and Related Notes

Investigational CPT CodesCPTNot Covered

38241

Hematopoietic progenitor cell (HPC), autologous transplantation

Investigational HCPCS CodesHCPCSNot Covered

S2142	Cord blood derived stem-cell transplantation, allogeneic
S2150	Bone marrow or blood-derived peripheral stem-cell harvesting and transplantation, allogeneic or autologous, including pheresis, high-dose chemotherapy, and the number of days of post-transplant care in the global definition (including drugs; hospitalization; medical surgical, diagnostic and emergency services)

Coding clarifications / prior policymixed

No codes listed

Conditioning intensity — myeloablative versus RIC

Full myeloablative (conventional) conditioningAdministration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total-body irradiation at doses sufficient to cause bone marrow ablation; intended to eradicate malignant cells prior to engraftment and associated with substantial toxicity

Reduced-intensity conditioning (RIC) distinctionRIC uses lower doses of cytotoxic drugs or less intense radiotherapy than full myeloablative regimens; intended to reduce treatment-related morbidity and non-relapse mortality while permitting graft-versus-malignancy effects

Patient selection implicationIntense myeloablative regimens are limited to patients medically fit to tolerate substantial adverse effects; RIC may be considered for less fit patients

Provider Actions — Authorization, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Precertification/prior authorization is required for inpatient services described in this policy. Outpatient prior authorization requirements depend on product and may result in denial when not obtained.

Inpatient: Precertification/prior authorization IS REQUIRED for all products when the procedure is performed inpatient.
Outpatient: Authorization requirements vary by product; for many commercial and Medicare products outpatient services are listed as not covered — confirm member contract and obtain prior authorization when required.

Denial Risk

Investigational Indications — Denial Risk

Autologous or allogeneic cell transplant is considered investigational for multiple adult solid tumor malignancies and may be denied when submitted for these indications.

Listed investigational adult solid tumor indications include (not limited to): colon, rectal, lung (any histology), pancreas, stomach, esophagus, gall bladder, bile duct, renal cell, cervical, uterine, fallopian tube, prostate, nasopharyngeal, paranasal sinus, neuroendocrine tumors, soft tissue sarcomas, thyroid tumors, tumors of unknown primary, thymus, and malignant melanoma.

Pretransplant Evaluation and Testing Requirements

Documentation Required

Evaluation requirements: HLA typing and donor compatibility testing required for allogeneic HCT

HLA typing and donor compatibility testing are required for allogeneic HCT, and appropriate pretransplant workup and documentation of conditioning regimen selection must be completed and available.

Compatibility is established by HLA typing (cellular, serologic, or molecular techniques) and an acceptable donor will match the patient at all or most HLA loci.
Document the pretransplant evaluation and chosen conditioning regimen in the medical record.

Contraindications and Patient Fitness

Patients who are medically unfit to tolerate myeloablative (conventional/intense) conditioning regimens are limited from receiving those intense conditioning approaches because of the substantial risk of opportunistic infections and organ damage or failure associated with marrow-ablative cytotoxic therapy. The policy notes that intense conditioning regimens are reserved for patients judged sufficiently medically fit, and that reduced-intensity conditioning (RIC) may be considered for less-fit patients to reduce treatment-related morbidity.

Transplant Center Requirements and Accreditation

Note

Center requirements: meet standard transplant center and accreditation expectations

Transplant centers must meet standard transplant center requirements and accreditation expectations as referenced by the policy when providing HCT services.

Follow applicable accreditation and center-specific standards for hematopoietic cell transplantation.
Maintain documentation of center qualifications and accreditation in case of review.

Post-Transplant Global Care and Billing

Post-transplant global care (HCPCS S2150)

HCPCS code S2150 global definitionBone marrow or blood-derived peripheral stem-cell harvesting and transplantation, allogeneic or autologous, including pheresis, high-dose chemotherapy, and the number of days of post-transplant care in the global definition (including drugs; hospitalization; medical/surgical/diagnostic and emergency services)

Components included in global periodDrugs, hospitalization, medical and surgical services, diagnostic and emergency services are included in the S2150 global definition

ScopeApplies to bone marrow or peripheral blood–derived stem-cell harvesting and transplantation for allogeneic or autologous procedures

Background — Hematopoietic Cell Transplantation Overview

Hematopoietic cell transplantation (HCT) involves intravenous infusion of hematopoietic stem cells to restore bone marrow and immune function after marrow-ablative therapy. Autologous HCT uses the patient’s own stem cells and is typically performed as consolidation when disease is in remission; allogeneic HCT uses donor-derived stem cells and requires HLA compatibility plus post-transplant immunosuppression to manage graft rejection and graft-versus-host disease. The therapeutic effect of conventional allogeneic HCT combines pretransplant eradication of malignant cells with a subsequent graft-versus-malignancy effect.

Definitions — Key Terms

Autologous hematopoietic cell transplantation — definition

Immunologic compatibilityImmunologic compatibility between infused cells and the recipient is not an issue in autologous HCT

Allogeneic hematopoietic cell transplantation — definition

DefinitionTransplant using donor-derived hematopoietic stem cells that requires HLA compatibility testing between donor and recipient

Source of cellsDonor cells may be harvested from bone marrow, peripheral blood, or umbilical cord blood

Post-transplant considerationsAllogeneic HCT requires immunosuppressant drugs after graft infusion to minimize graft rejection and graft-versus-host disease

Reduced-intensity conditioning (RIC) — definition

Revision History and Policy Changes

2025-03coding clarificationLatest

Annual policy review clarified coding information; policy statements unchanged.

2024-03coding clarification

Annual policy review updated description, summary, and references; policy statements unchanged.

2023-03coding clarification