CurrentAetnaPolicy 0617

Hematopoietic Cell Transplantation for Testicular Cancer

Aetna's clinical policy bulletin defining medical necessity criteria for hematopoietic cell transplantation (primarily autologous) in persons with testicular cancer, and listing procedures considered experimental/investigational (including allogeneic transplants and autologous as initial therapy).

Policy Summary

PayerAetna

PolicyHematopoietic Cell Transplantation for Testicular Cancer

Policy CodePolicy 0617

Change TypeNo material change

Effective DateMay 14, 2002

Next Review DateJul 11, 2024

Key ActionProviders must ensure that autologous (including tandem) transplantation meets the specified medical necessity criteria (refractory disease defined as <50% tumor reduction; partial response defined as >=50% reduction; relapse after standard-dose chemotherapy) to qualify for coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3Covered indications

2Uncovered/experimental

3Covered code groups

Coverage Summary

Scope: Aetna's Clinical Policy Bulletin (Number 0617) defines medical necessity criteria for hematopoietic cell transplantation in persons with testicular cancer, focusing primarily on autologous approaches (including tandem/autologous consolidation) and specifying procedures considered experimental/investigational. Coverage stance: mixed (some autologous transplants covered when criteria met; other approaches not covered). Status/current: CURRENT.

Thresholds and Quick Facts

Threshold (tumor burden) - refractory< 50% reduction

Threshold (tumor burden) - partial response>= 50% reduction

Effective date2002-05-14

Last review2023-09-11

Next review2024-07-11

Evidence highlight - durable remissions (range)10-25% in refractory disease (some series report 20-50% CR/PR post-ASCT)

Evidence highlight - systematic review recommendationMinimum of 2 HDCT cycles with ASCT suggested as standard for relapsed/refractory germ cell cancer

Medical-Necessity Criteria

Medically Necessary

Aetna considers the following types of hematopoietic cell transplantations medically necessary for testicular cancer when criteria are met:

Medically Necessary criteria

Autologous HCT for refractory or partial responders: Autologous hematopoietic cell transplantation for the treatment of persons with testicular cancer who do not attain a complete remission after an initial course of standard-dose chemotherapy, i.e., those with refractory (less than 50% reduction in tumor burden) testicular cancer or those exhibiting a partial response (at least a 50% reduction in tumor burden).refractory: <50% reduction; partial response: >=50% reduction
Autologous HCT as consolidation for relapse: Autologous hematopoietic cell transplantation as consolidation therapy for persons with testicular cancer who relapse after an initial course of standard-dose chemotherapy.
Tandem autologous HCT for relapsed disease: Tandem autologous hematopoietic cell transplantation for persons with testicular cancer who have relapsed.

Experimental and Investigational (Not Covered)

The following are considered experimental and investigational because effectiveness has not been established:

Experimental and Investigational exclusions

Autologous HCT as initial therapy (Not Covered): Autologous hematopoietic cell transplantation as initial treatment (i.e., instead of an initial course of standard-dose chemotherapy with Food and Drug Administration-approved drugs) of persons with testicular cancer.
Not covered - effectiveness not established.
Allogeneic HCT (Not Covered): Allogeneic hematopoietic cell transplantation for the treatment of persons with testicular cancer.
Not covered - effectiveness not established.

Not Covered / Experimental Approaches

Non-coverage callout: Autologous hematopoietic cell transplantation used as initial treatment instead of standard‑dose chemotherapy is considered experimental/investigational and is not covered. Similarly, allogeneic hematopoietic cell transplantation for testicular cancer is considered experimental/investigational and is not covered because effectiveness has not been established.

Coding

CPT codes covered if selection criteria are metCPTCovered

38206-38230	Bone marrow or stem cell services/procedures (except allogenic).
38241	Hematopoietic progenitor cell (HPC); autologous transplantation.
96401-96549	Chemotherapy administration.

CPT codes NOT covered for indications listed in the CPBCPTNot Covered

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, allogenic.
38230	Bone marrow harvesting for transplantation; allogenic.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.

HCPCS codes covered if selection criteria are metHCPCSCovered

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 codes covered if selection criteria are metICD-10Covered

C62.00-C62.92	Malignant neoplasm of testis.
D07.69	Carcinoma in situ of other male genital organs [testis].

Provider Actions

Prior Authorization

Selection criteria required for coverage

Providers must ensure that autologous (including tandem) transplantation meets the specified medical necessity criteria to qualify for coverage: refractory disease defined as <50% tumor reduction; partial response defined as ≥50% reduction; or relapse after an initial course of standard-dose chemotherapy.

Affected codes: 38206-38230, 38241, S2150
Selection criteria summary: refractory (less than 50% reduction in tumor burden); partial response (at least 50% reduction in tumor burden); relapse after standard‑dose chemotherapy

Denial Risk

Requests for excluded procedures will be denied

Requests for the following procedures will be denied as experimental/investigational or not covered for the indications in this policy: autologous transplantation as initial therapy instead of standard‑dose chemotherapy, and allogeneic hematopoietic cell transplantation for testicular cancer.

Excluded procedure codes: 38205, 38230, 38240
Note: Autologous transplantation as initial therapy and allogeneic hematopoietic cell transplantation are considered experimental/investigational and are not covered.

Background & Evidence

Background: Testicular germ cell tumors (seminomas and non-seminomas) typically affect men aged ~20–40 and are staged I–III based on local and metastatic spread. First-line treatment for advanced disease is cisplatin‑based combination chemotherapy (commonly cisplatin, bleomycin, etoposide for 3–4 cycles), often followed by surgery for residual masses. Salvage regimens for relapsed disease include cisplatin plus ifosfamide with etoposide or vinblastine. For relapsed or refractory disease, high‑dose chemotherapy with autologous stem cell transplantation (ASCT/ABMT), including tandem ASCT approaches, has been used and multiple series and reviews report durable remissions (reported CR rates and durable remissions in select refractory patients and pooled data supporting use of ≥2 HDCT cycles with ASCT in relapsed/refractory germ cell cancer).

Evidence Highlights

Reported durable complete remissions with high-dose chemo + ABMT10-25% in refractory disease; some studies report 20-50% CR/PR post-ASCT in select series

Systematic review conclusion (Bin Riaz 2018)Pooled data suggest a minimum of 2 HDCT cycles with ASCT should be standard for relapsed/refractory germ cell cancer; failure of HDCT leads to poor prognosis with ~10% lasting remission with salvage therapy