CurrentAlliance HealthPolicy Clinical Coverage Policy No.: 11A-15

Hematopoietic Stem-Cell Transplantation for Solid Tumors of Childhood

NC Medicaid clinical coverage policy defining medical necessity, covered and non-covered indications, prior approval and billing requirements for HSCT (autologous and allogeneic) in pediatric solid tumors.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem-Cell Transplantation for Solid Tumors of Childhood

Policy CodePolicy Clinical Coverage Policy No.: 11A-15

Change TypeTemplate updates; coverage expansions and prior approval removal

Effective DateJan 1, 1994

Next Review Date

Key ActionProvider shall verify each Medicaid beneficiary's eligibility each time a service is rendered.

POLICY UPDATE CHANGES

08/15/2023: Updated policy template language due to North Carolina Health Choice Program's move to Medicaid; policy posted 08/15/2023 with an effective date of 04/01/2023.

07/01/2018: Added coverage for planned tandem autologous SCT for neuroblastoma and single autologous SCT for metastatic retinoblastoma; added allogeneic stem cell transplantation to non-coverage.

07/01/2021: Prior approval requirement removed.

5Covered Indications (single autologous HSCT)

1Covered Indications (planned tandem autologous HSCT)

4Explicitly Not Covered Tumor Types

Original Effective Year

Coverage Summary

NC Medicaid Clinical Coverage Policy No.: 11A-15 (status: CURRENT, original effective year: 1994) defines medical necessity, covered and non-covered indications, prior approval, and billing requirements for Hematopoietic Stem-Cell Transplantation (HSCT) for pediatric solid tumors. The policy expressly covers single autologous HSCT when medically necessary for specified indications: initial treatment of high-risk neuroblastoma; recurrent or refractory neuroblastoma; initial treatment of high-risk Ewing's sarcoma; recurrent or refractory Ewing's sarcoma; and metastatic retinoblastoma. The policy also covers planned tandem autologous HSCT when medically necessary for high-risk, refractory, or relapsed neuroblastoma. Conversely, the policy states that allogeneic HSCT is not covered for treatment of pediatric solid tumors (including both myeloablative and nonmyeloablative allogeneic transplants), and further restricts salvage allogeneic HSCT and most autologous uses for low- or intermediate-risk disease and several tumor types.

Policy Metadata

Policy NumberClinical Coverage Policy No.: 11A-15

Subject/TitleHematopoietic Stem-Cell Transplantation (HSCT) for Solid Tumors of Childhood

StatusCURRENT

Original Effective Year1994

Last Review Date2023-08-15

Coverage StanceMixed (policy includes both covered indications for autologous HSCT and explicit non-coverage for allogeneic HSCT and other situations)

General Medical Necessity Criteria

Specific Covered Indications — Single Autologous HSCT

Specific Covered Indications — Planned Tandem Autologous HSCT

Not Covered / Exclusion Criteria

Coding Guidance

Coding guidancemixed

No codes listed

Place of Servicemixed

Inpatient hospital	Place of service allowed
Outpatient hospital	Place of service allowed

Claim Type acceptedmixed

CMS-1500/837P	Professional claim type
UB-04/83711	Institutional claim type

Provider Actions & Billing Requirements

Prior Authorization

Prior approval not required

Medicaid shall not require prior approval for HSCT for Solid Tumors of Childhood. Policy records show the prior approval requirement was removed effective 07/01/2021.

Documentation Required

Verify Medicaid eligibility

Provider shall verify each Medicaid beneficiary's eligibility each time a service is rendered.

Definitions & Background

Hematopoietic stem-cell transplantation (HSCT) is used to restore bone marrow function after marrow-toxic chemotherapy and/or whole-body radiation. Autologous HSCT uses the patient’s own harvested stem cells to permit escalation of chemotherapy doses (rescue transplant), while allogeneic HSCT uses donor stem cells and may provide a graft-versus-tumor effect. The policy notes that allogeneic HSCT is uncommonly used for pediatric solid tumors and may be considered only in limited situations (for example, when autologous stem cells cannot be harvested or cleared of tumor), but is otherwise not covered for these indications.

Term	Definition
HSCT	Refers to any source of stem cells, i.e., autologous, allogeneic, syngeneic, or umbilical cord blood.
Relapse	Tumor recurrence after a prior complete response.
Primary Refractory Disease	A tumor that does not achieve a complete remission after initial standard-dose chemotherapy.
Salvage Therapy	Treatment that is given after the cancer has not responded to other treatments.
Rescue Transplant	A method of replacing blood-forming stem cells that were destroyed by treatment with high doses of anticancer drugs or radiation therapy; usually done using the patient's own previously saved stem cells to help the bone marrow recover and allow more chemotherapy or radiation to be given.
Tandem Transplants	A transplant technique where the preplanned intent for therapy involves sequential hematopoietic stem cell transplants.

Revision History

07/01/2018revised

Added coverage for planned tandem autologous SCT for neuroblastoma and single autologous SCT for metastatic retinoblastoma; added allogeneic stem cell transplantation to non-coverage.

07/01/2021revised

Prior approval requirement removed.

08/15/2023revisedLatest

Updated policy template language due to North Carolina Health Choice Program's move to Medicaid; policy posted 08/15/2023 with an effective date of 04/01/2023.

Policy Summary

PayerAlliance Health

PolicyHematopoietic Stem-Cell Transplantation for Solid Tumors of Childhood

Policy CodePolicy Clinical Coverage Policy No.: 11A-15

Change TypeTemplate updates; coverage expansions and prior approval removal

Effective DateJan 1, 1994

Next Review Date

Key ActionProvider shall verify each Medicaid beneficiary's eligibility each time a service is rendered.

On This Page

Documentation Required

EPSDT considerations for beneficiaries under 21

For beneficiaries under 21, EPSDT may override policy limitations if provider documentation demonstrates the service is medically necessary to correct or ameliorate a condition. Note: EPSDT does not eliminate a prior approval requirement if one applies (this policy currently specifies that no prior approval is required).

Billing Rule

Use most specific codes and national billing guidelines

Report the most specific CPT, HCPCS, ICD-10-CM, and PCS codes that accurately describe the service and follow National Uniform Billing Guidelines. If no specific CPT or HCPCS code exists, report the appropriate unlisted procedure or service code and include the required special report per CPT/HCPCS instructions.

Billing Rule

Billing claim types and place of service

Accepted claim types and allowed places of service for billing HSCT:

Accepted claim types: Professional (CMS-1500/837P) and Institutional (UB-04/83711).
Place of service allowed: Inpatient hospital and Outpatient hospital.

Documentation Required

Provider qualifications to bill

To bill for HSCT, providers must meet Medicaid participation qualifications, have a current, signed DHHS Provider Administrative Participation Agreement, and bill only for procedures within their licensed scope of clinical practice.

Billing Rule

Reimbursement and rates

Providers shall bill their usual and customary charges. For specific rates and fee schedules, refer to the NC Medicaid website and published fee schedules.