CurrentAlliance HealthPolicy Clinical Coverage Policy No: 11A-6

Hematopoietic Stem-Cell Transplantation in the Treatment of Germ Cell Tumors

NC Medicaid clinical coverage policy governing when hematopoietic stem-cell transplantation (HSCT) is covered or not covered for treatment of germ cell tumors, including autologous, tandem/sequential transplants, EPSDT exceptions, provider/billing requirements, and attachments for claims-related instructions.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem-Cell Transplantation in the Treatment of Germ Cell Tumors

Policy CodePolicy Clinical Coverage Policy No: 11A-6

Change TypePrior approval removed; template and attachment updates (see revision history)

Effective DateJan 1, 1994

Next Review DateN/A

Key ActionProvider must verify each beneficiary's Medicaid eligibility at each service and document how HSCT meets medical necessity and EPSDT criteria when applicable

POLICY UPDATE CHANGES

Prior approval requirement removed (effective 07/01/2021)

1Policy Number

3Covered scenarios

4Explicit exclusions

Coverage Summary

Scope: This NC Medicaid clinical coverage policy (Clinical Coverage Policy No: 11A-6) governs when hematopoietic stem-cell transplantation (HSCT) is covered or not covered for treatment of germ cell tumors. Medicaid covers autologous HSCT in specified salvage and platinum-refractory scenarios: single autologous HSCT as salvage therapy for beneficiaries with favorable prognostic factors after failure of conventional-dose salvage chemotherapy; single autologous HSCT for beneficiaries with unfavorable prognostic factors as initial treatment of first relapse and for beneficiaries with platinum-refractory disease; and tandem/sequential autologous HSCT for testicular tumors as salvage therapy or for platinum-refractory disease. The policy also notes EPSDT considerations for beneficiaries under 21 and general provider/billing requirements.

Medical Necessity Criteria

General Medical Necessity

Medicaid covers the procedure when medically necessary and all of the following are met:

ALL of the following

Procedure, product, or service is individualized, specific, and consistent with symptoms or confirmed diagnosis and not in excess of the beneficiary's needs
Procedure, product, or service can be safely furnished and no equally effective and more conservative or less costly treatment is available statewide
Procedure, product, or service is furnished in a manner not primarily intended

Specific Criteria Covered

Medicaid shall cover HSCT in treatment of germ cell tumors in the following situations:

ONE of

Single autologous hematopoietic stem-cell transplantation as salvage therapy for germ-cell tumors in beneficiaries with favorable prognostic factors who have failed a previous course of conventional-dose salvage chemotherapy
Single autologous hematopoietic stem-cell transplantation as salvage therapy for germ-cell tumors in beneficiaries with unfavorable prognostic factors as initial treatment of first relapse (without a course of conventional-dose salvage chemotherapy) and in beneficiaries with platinum-refractory disease
Tandem or sequential autologous hematopoietic stem-cell transplantation for the treatment of testicular tumors either as salvage therapy or with platinum-refractory disease

Policy Guidelines / Definitions impacting coverage

Definitions used to interpret specific criteria:

ALL of the following

Hematopoietic Stem Cell Transplantation (HSCT): refers to any source of stem cells, such as autologous, allogeneic, syngeneic, or umbilical cord blood
Salvage Therapy: treatment given after the cancer has not responded to other treatments
Tandem Transplants: a transplant technique where the preplanned intent involves sequential hematopoietic stem cell transplants
Refractory tumor response: Refractory defined as < 50% reduction in tumor burden measured by serial CT scans or levels of circulating tumor markers (e.g., AFP)< 50% reduction in tumor burden

Specific Exclusions (Not Covered)

Medicaid shall not cover HSCT for germ cell tumors in these situations:

ANY of the following

Autologous HSCT as a component of first-line treatment for germ-cell tumors
Allogeneic HSCT to treat germ-cell tumors, including use as therapy after a prior failed autologous HSCT
When the beneficiary's psychosocial history limits ability to comply with pre- and post-transplant medical care
When current beneficiary or caretaker non-compliance would make compliance with a disciplined medical regimen improbable

ALL of the following

Beneficiary does not meet eligibility requirements (Section 2.0) or does not meet criteria in Section 3.0
Procedure, product, or service duplicates another provider's procedure, product, or service
Procedure, product, or service is experimental, investigational, or part of a clinical trial

Coding and Claim Forms

ICD-10 / CPT / HCPCS / UB-04 guidancemixed

No codes listed

Claim Types Acceptedmixed

CMS-1500	Professional claim form / 837P transaction
UB-04	Institutional claim form / 837I transaction

Supplemental billing guidance: Attachment A accepts the UB-04 institutional claim form and professional claims (CMS-1500) per Attachment A; the policy removed published CPT/HCPCS/ICD-10 code lists from the policy. Providers must report the most specific CPT/HCPCS and ICD-10-CM/PCS codes to the highest level of specificity that supports medical necessity and follow National Coding and Uniform Billing guidelines. If no specific CPT/HCPCS code exists, report the appropriate unlisted procedure code with the required special report per the CPT/HCPCS instructions.

Provider Actions & Billing Rules

Documentation Required

Verify Medicaid eligibility and document medical necessity

Provider must verify each beneficiary's Medicaid eligibility at each service and document how HSCT meets medical necessity and EPSDT criteria when applicable.

Billing Rule

Claim forms and coding specificity

Report most specific CPT/HCPCS and ICD-10-CM/PCS codes to the highest level of specificity that supports medical necessity; use UB-04 for institutional claims and CMS-1500 for professional claims; if no specific code exists report the appropriate unlisted procedure or service code and submit the required special report per CPT/HCPCS instructions.

Billing Rule

Follow national billing guidelines

Institutional claims must be billed according to the National Uniform Billing Guidelines. All claims must comply with National Coding Guidelines and NCTracks guidance as specified in Attachment A and the NCTracks Provider Claims and Billing Assistance Guide.

Prior Authorization

Prior approval not required

Prior approval is not required for Hematopoietic Stem Cell Transplantation in the treatment of germ cell tumors.

Documentation Required

Provider qualifications to bill

Providers must meet Medicaid qualifications for participation, have a current and signed Department of Health and Human Services (DHHS) Provider Administrative Participation Agreement, and bill only for procedures, products, and services that are within the scope of their clinical practice.

Background

Background: HSCT encompasses autologous, allogeneic (including donor sources) and umbilical cord blood transplants; autologous transplants use the patient's own stem cells while allogeneic transplants require immunologic HLA compatibility and carry risks such as graft-versus-host disease. Preparative conditioning approaches include conventional myeloablative regimens (high-dose cytotoxic drugs with or without total body irradiation) intended to eradicate malignant cells and allow engraftment, and reduced-intensity conditioning (RIC), which uses lower-intensity regimens to balance reduced treatment-related morbidity with graft-versus-malignancy effects. Germ-cell tumors include seminomatous and nonseminomatous histologies (e.g., embryonal carcinoma, teratoma, choriocarcinoma, yolk sac tumor, mixed tumors) and are staged by TNM and serum tumor markers (hCG, LDH, AFP); risk groups (good/intermediate/poor) and histology guide treatment. First-line systemic therapy for higher-stage disease typically uses cisplatin-based multiagent regimens (3–4 cycles), often followed by surgery for residual masses; second-line salvage regimens (e.g., ifosfamide-containing combinations) are used for relapsed or cisplatin-resistant disease and timing of high-dose chemotherapy with HSCT is determined by response, prognostic factors, and prior salvage therapy.

Key definitions

Hematopoietic Stem Cell Transplantation (HSCT)Refers to any source of stem cells, such as autologous, allogeneic, syngeneic, or umbilical cord blood.

Salvage TherapyTreatment that is given after the cancer has not responded to other treatments.

Tandem TransplantsA transplant technique where the preplanned intent for therapy involves sequential hematopoietic stem cell transplants.

Revision History

1994-01-01policy_effective

Original effective date of the policy.

10/01/2019revision

Definitions for Hematopoietic Stem Cell Transplantation, Salvage Therapy, and Tandem Transplants were added; Attachment A updated to accept UB-04 and removed published code lists; template language and other clarifications updated throughout the policy.

07/01/2021material_change

Prior approval requirement removed (Section 5.0) — Medicaid shall not require prior approval for HSCT in the treatment of germ cell tumors.

04/01/2023revision_effective_dateLatest

Policy posted 08/15/2023 with effective date 04/01/2023 due to NC Health Choice move to Medicaid; template language updated across all sections and attachments.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem-Cell Transplantation in the Treatment of Germ Cell Tumors

Policy CodePolicy Clinical Coverage Policy No: 11A-6

Change TypePrior approval removed; template and attachment updates (see revision history)

Effective DateJan 1, 1994

Next Review DateN/A

Key ActionProvider must verify each beneficiary's Medicaid eligibility at each service and document how HSCT meets medical necessity and EPSDT criteria when applicable

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