CurrentAlliance HealthPolicy 11A-7

Hematopoietic Stem-Cell Transplantation for Hodgkin Lymphoma

Coverage policy for hematopoietic stem-cell transplantation (HSCT) for beneficiaries with Hodgkin lymphoma under NC Medicaid; governs indications, eligibility, conditioning types, and procedural definitions relevant to transplant providers and payers.

Policy Summary

PayerAlliance Health (applies to NC Medicaid)

PolicyHematopoietic Stem-Cell Transplantation for Hodgkin Lymphoma

Policy CodePolicy 11A-7

Change TypeNo material change / routine review

Effective Date

Next Review Date

Key ActionVerify Medicaid eligibility and document medical necessity (use EPSDT documentation for beneficiaries under 21) before providing or billing for HSCT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NC MedicaidPayer and program

Autologous & AllogeneicTransplant types described

No prior approvalPrior authorization stance

2nd autologous HSCTNot covered

Aug 15, 2023Last amendment

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Coverage Criteria for HSCT in Hodgkin Lymphoma

Covered when clinical and procedural criteria are met

Policy addresses when HSCT is covered and not covered; includes general criteria and Hodgkin lymphoma–specific coverage considerations.

General HSCT Considerations: HSCT restores bone marrow function after marrow-ablative therapy; autologous HSCT is typically performed as consolidation when disease is in complete remission; allogeneic HSCT requires HLA compatibility and necessitates immunosuppressive therapy with attendant risks including graft-versus-host disease (GVHD) and increased infection risk.

See background on conditioning and donor selection.

Conditioning Intensity: Policy distinguishes conventional myeloablative versus reduced-intensity conditioning (RIC); RIC refers to regimens intended to be non-myeloablative and is selected to balance non-relapse mortality and relapse risk.

Use intensity tailored to disease and patient fitness.

Hodgkin Lymphoma Clinical Context: HL staging, bulky disease definitions, presence of B symptoms, and response to induction chemotherapy (including definitions of primary refractory disease and timing of relapse) are used to inform transplant candidacy and expected benefit from autologous versus allogeneic HSCT.

See Section 1.0 for definitions and prognostic details; autologous HSCT salvage rates vary by time to relapse.

Covered indications

Medicaid shall cover HSCT for Hodgkin Lymphoma in any of the following situations:

Covered HSCT indications: a) Single autologous HSCT for beneficiaries with primary refractory or relapsed Hodgkin lymphoma; b) Allogeneic HSCT (myeloablative or reduced-intensity conditioning) for beneficiaries with primary refractory or relapsed Hodgkin lymphoma; c) Tandem autologous HSCT for beneficiaries with primary refractory disease OR for beneficiaries with relapsed disease with poor‑risk features who do not attain a complete remission to cytoreductive chemotherapy prior to transplantation; d) Donor lymphocyte infusion (DLI) following allogeneic HSCT for relapse, for prevention in the setting of high relapse risk, or to convert mixed to full donor chimerism.

Refer to Section 1.0 for definitions of primary refractory disease, poor‑risk features, and timing of relapse.

The policy includes a section titled When the Procedure, Product, or Service Is Not Covered describing situations where HSCT is excluded. General exclusions state that Medicaid shall not cover HSCT when the beneficiary does not meet Section 2.0 eligibility requirements, does not meet the clinical criteria in Section 3.0, the procedure duplicates another provider's service, or the service is experimental, investigational, or part of a clinical trial. Specific exclusions for Hodgkin lymphoma are listed under the Specific Criteria Not Covered heading (see next block for the explicit examples).

Medicaid shall not cover a second autologous stem cell transplantation for relapsed lymphoma when the beneficiary has previously received an autologous HSCT. The policy also lists other specific non-covered uses in Hodgkin lymphoma, including HSCT used as initial therapy to consolidate a first complete remission, and excludes HSCT when the beneficiary's psychosocial history or current noncompliance would make adherence to required pre- or post-transplant care improbable.

The policy references subsections 5.2.1 (General) and 5.2.2 (Specific) under Prior Approval Requirements and explicitly states None Apply for both, indicating there are no additional specified prior-approval requirement exceptions in those subsections.

Medicaid requires that donor transplant-related medical expenses be billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number. Only actual donor transplant-related medical expenses are reimbursable, and Medicaid does not reimburse for unsuccessful donor searches.

For autologous HSCT in poor-risk or primary progressive Hodgkin lymphoma, the policy notes that only approximately 25%–35% of patients achieve a durable remission. The document indicates that most treatment failures after autologous transplant are due to disease progression, with most relapses occurring within 1–2 years and median survival after relapse being less than 12 months.

Claims or services may be denied when the beneficiary fails to meet policy requirements: if the beneficiary does not meet Section 2.0 eligibility, does not meet Section 3.0 clinical criteria, or the requested procedure duplicates another provider's service. Additional denial triggers include services that are experimental/investigational or part of a clinical trial, and situations where psychosocial history or current noncompliance make HSCT inappropriate.

Candidate and Indication Criteria

HL-specific candidate considerations — stage, bulky disease, B symptoms, response to induction, timing

Clinical factors described to guide candidacy for HSCT in Hodgkin lymphoma include stage, bulky disease, B symptoms, response to induction, and timing of relapse.

Relapse timing and salvage: Late first relapse (>12 months from remission) has higher likelihood of salvage with autologous HSCT (≈70%); early first relapse (≤12 months) has lower salvage rates (≤40%).

Used to assess likely benefit from autologous HSCT.

Primary refractory disease: Primary refractory HL is defined as <50% regression after 4–6 cycles of anthracycline-containing chemotherapy, progression during induction, or progression within 90 days after completion of first-line treatment; these patients have worse prognosis and are considered candidates for HSCT.

Influences candidacy and choice between autologous and allogeneic HSCT.

Bulky disease and B symptoms: Presence of bulky disease (10‑cm mass or mediastinal disease with transverse diameter >33% of transthoracic diameter) or B symptoms, and advanced stage (III–IV) are clinical factors that typically prompt combination chemotherapy and are important in assessing transplant candidacy.

Provider Requirements, Prior Authorization, and Billing Actions

Prior Authorization

Prior Authorization Status

Prior approval is not required for Hematopoietic Stem Cell Transplantation (HSCT) for Hodgkin Lymphoma under this Medicaid policy. Providers should note that failure to follow any other applicable requirements in this policy (e.g., documentation, coding, provider eligibility) may still affect claim adjudication.

Prior approval NOT required for HSCT for Hodgkin Lymphoma (see 5.1).

Prior Authorization

Prior Approval Required

While prior approval is not required for HSCT for Hodgkin Lymphoma, providers must still adhere to all policy requirements and submission instructions. When prior authorization references appear elsewhere in practice settings or payer communications, verify current payer guidance.

Do not submit PA for HSCT for Hodgkin Lymphoma to obtain coverage; follow standard claim submission processes.
If a separate procedure (e.g., donor lymphocyte infusion) is later indicated, follow any applicable guidance in payer updates.

Coding, Claims and Attachment Guidance

Attachment A (ICD-10-CM / PCS / CPT / Modifiers guidance)mixed

No codes listed

Accepted claim typesmixedCovered

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

Unlisted procedure guidanceCPT

Unlisted CPT/HCPCS

Report unlisted procedures per CPT/HCPCS instructions with special report when no specific code exists

Bulky disease (definition)

Bulky disease definition10-cm mass or mediastinal disease with transverse diameter >33% of transthoracic diameter

Context — stagingAppears in description of stage grouping where bulky disease influences need for combination chemotherapy ± radiation

Clinical implicationPresence of bulky disease classifies patients into early-stage unfavorable or advanced-stage groups impacting therapy selection

Coding specificity

Coding specificity requirementReport ICD-10-CM/PCS and CPT/HCPCS/UB-04 codes to the highest level of specificity that supports medical necessity

Use current code editions

Definitions

Hematopoietic Stem Cell Transplantation (HSCT)

Definition of HSCTHematopoietic stem-cell transplantation (HSCT) — infusion of hematopoietic stem cells to restore bone marrow function

Sources of stem cellsAutologous (patient), allogeneic (donor), syngeneic, and umbilical cord blood

Harvest sitesStem cells may be harvested from bone marrow, peripheral blood, or umbilical cord blood

Induction Therapy

Induction Therapy — basic definitionThe first treatment given for a disease; often part of a standard set of treatments and also called first-line or primary therapy

Role in treatment sequenceMay be followed by additional therapies if induction does not cure or causes severe side effects

Post-Transplant Coverage and Donor-Related Billing

Post-transplant supportive care and potential DLI

Post-transplant risksPatients are susceptible to pre-engraftment opportunistic infections and chemotherapy-related toxicities prior to engraftment

Reduced-intensity conditioning considerationReduced-intensity regimens may produce initial mixed chimerism and can require subsequent interventions such as DLI to eradicate residual malignant cells

Supportive care needsPost‑transplant supportive care includes infection monitoring and management of immunosuppression-related complications

Donor Lymphocyte Infusion (DLI) coverage

DLI coverage indicationsDLI is considered medically necessary and covered following allogeneic HSCT for relapse, to prevent relapse in high‑risk settings, or to convert mixed to full donor chimerism

Relation to allogeneic HSCT

Evaluation and Workup Requirements

Documentation Required

Evaluation requirements — eligibility verification and referenced prior‑approval/evaluation steps

The policy references evaluation and prior approval requirements for transplant workup and reiterates that providers must verify Medicaid eligibility at each service.

Verify beneficiary eligibility at the time of each service (chunk 21).

Center and Provider Qualifications

Documentation Required

Center and provider requirements to be eligible to bill

Provider qualifications and prior approval sections establish requirements for eligible billing providers: meet Medicaid participation rules, have a current signed DHHS Provider Administrative Participation Agreement, and bill within licensed scope.

Comply with applicable laws, agreements, and NC Medicaid policies in effect at time of service (chunk 42).

Revision History and Document Metadata

2019-10-01content_update

Multiple content changes across sections including additions to Section 3.2.4, edits to Section 5.1 clarifying that separate prior authorization is not required for DLI when PA was given for allogeneic HSCT, updates to Section 5.3 and Section 7.0, and Attachment A changes such as adding UB-04 and removing code lists.

2020-01-15template_update

Updated policy template language to advise Prepaid Health Plan (PHP) beneficiaries to contact their PHP about benefits and services; added Institutional Claims billing guidance per National Uniform Billing Guidelines in Attachment A.

2021-07-01

Policy Summary

PayerAlliance Health (applies to NC Medicaid)

PolicyHematopoietic Stem-Cell Transplantation for Hodgkin Lymphoma

Policy CodePolicy 11A-7

Change TypeNo material change / routine review

Effective Date

Next Review Date

Key ActionVerify Medicaid eligibility and document medical necessity (use EPSDT documentation for beneficiaries under 21) before providing or billing for HSCT.

SourceLink

On This Page

10-cm mass or mediastinal transverse diameter >33% of transthoracic diameter

Consider in overall risk assessment prior to HSCT.

Response to induction: Achievement of complete remission to cytoreductive chemotherapy prior to autologous HSCT is an important prognostic factor; failure to attain complete remission in relapsed disease may prompt consideration of tandem autologous HSCT or allogeneic HSCT depending on risk features.

Document response to induction when considering transplant.

Candidate indications — covered candidate groups for HSCT in Hodgkin lymphoma

Candidate groups for HSCT in Hodgkin lymphoma covered by Medicaid:

Candidate indications: Primary refractory Hodgkin lymphoma; relapsed Hodgkin lymphoma; relapsed disease with poor‑risk features who do not attain a complete remission to cytoreductive chemotherapy prior to transplantation; candidates for donor lymphocyte infusion (DLI) after an allogeneic HSCT for relapse, prevention in high‑risk settings, or conversion from mixed to full donor chimerism.

Refer to Section 1.0 for definitions of primary refractory disease and poor‑risk features.

The policy references contraindications indirectly under the General and Specific non-coverage criteria: absolute or relative contraindications are addressed by the statements that HSCT is not covered when a beneficiary does not meet eligibility or clinical criteria or when psychosocial factors or noncompliance would make adherence to required care improbable. Specific named contraindications are not listed in this excerpt.

Billing Rule

Place of Service — Claim Reporting

Place of service for HSCT claims should be reported as Inpatient Hospital or Outpatient Hospital as appropriate for the service rendered.

Report place of service as Inpatient Hospital or Outpatient Hospital per Attachment A guidance.

Documentation Required

Provider Eligibility and Billing Authorization

To bill for HSCT-related services, providers must meet Medicaid participation requirements and have a current, signed DHHS Provider Administrative Participation Agreement. Providers must bill only for services within their licensed scope of practice.

Participating Medicaid provider in good standing.
Current signed DHHS Provider Administrative Participation Agreement on file.
Services billed within the provider's licensed scope of practice.

Billing Rule

Attachment A: Claims Guidance (ICD-10, CPT/HCPCS, Place of Service, Donor Billing)

See Attachment A for claims guidance: claim type, ICD-10-CM/PCS reporting, CPT/HCPCS coding, modifiers, billing units, place of service, co-payments, reimbursement, and billing for donor expenses.

Report ICD-10-CM and PCS to the highest level of specificity supporting medical necessity.
Use the most specific CPT/HCPCS or appropriate unlisted code when no specific code exists.
Follow Attachment A sections for modifiers, billing units, place of service, co-payments, and reimbursement instructions.
Donor transplant-related medical expenses must be billed on the beneficiary's transplant claim using the beneficiary's Medicaid ID; only actual donor transplant-related medical expenses are reimbursed; unsuccessful donor searches are not reimbursable.

Documentation Required

Eligibility Verification and EPSDT Documentation

Verify Medicaid eligibility for each beneficiary at the time of each service. For beneficiaries under 21, consider EPSDT provisions: document medical necessity and how the requested HSCT corrects, ameliorates, or prevents worsening of a health problem; EPSDT may allow exceptions to policy limitations when criteria are met.

Verify Medicaid eligibility at every encounter.
For beneficiaries under 21, include EPSDT-specific documentation showing medical necessity to correct or ameliorate health problems and why less-restrictive alternatives are not effective.

Documentation Required

Required Documentation and Coding Specificity

Providers must retain complete medical records and comply with applicable laws. Report ICD-10-CM/PCS and CPT/HCPCS codes to the highest level of specificity that supports medical necessity. Use current code editions in effect at the time of service. Documentation must demonstrate that services are individualized, necessary, safe, and that no equally effective, more conservative, or less costly treatment is available statewide.

Retain full medical records per HIPAA and state record-retention requirements.
Code to highest specificity for ICD-10-CM/PCS and CPT/HCPCS.
Documentation must support medical necessity and why HSCT is indicated vs conservative alternatives.

Billing Rule

Billing and Documentation Requirements

Bill usual and customary charges and follow the Medicaid reimbursement schedule. Donor transplant-related medical expenses are billed on the beneficiary's transplant claim using the beneficiary's Medicaid ID. Medicaid reimburses only actual donor transplant-related medical expenses and does not reimburse for unsuccessful donor searches.

Bill usual and customary charges; consult Medicaid fee schedule at https://medicaid.ncdhhs.gov/ for rates.
Use the beneficiary's Medicaid identification number when billing donor transplant-related medical expenses.
Do not bill or expect reimbursement for unsuccessful donor searches.

Documentation Required

Conservative Treatment and Necessity

HSCT services must be individualized and medically necessary. Providers must document that HSCT is appropriate because no equally effective, more conservative, or less costly treatment is available statewide and that the service can be safely furnished for the beneficiary.

Document prior conservative treatments and rationale for why HSCT is required.
Demonstrate that HSCT can be safely furnished for the beneficiary given medical status and psychosocial considerations.

Use the current ICD-10 edition and any subsequent editions in effect at time of service

Refer to codebook descriptionsProviders shall refer to the applicable code edition for code descriptions (not listed in the policy)

SynonymsAlso called first-line therapy, primary therapy, or primary treatment

Tandem Transplants

Tandem transplants — definitionA transplant technique where the preplanned intent for therapy involves sequential hematopoietic stem cell transplants

Planned strategyBoth transplants are preplanned as part of the therapeutic intent rather than repeated salvage transplants

Use in policyTandem autologous HSCT is an acknowledged covered option for specified poor‑risk or primary refractory cases

Induction Therapy (duplicate)

Induction Therapy — repeated entryThe first treatment given for a disease; often part of a standard set of treatments and also called first-line or primary therapy

Clinical noteIf induction fails or causes severe toxicity, additional or alternative therapies may be used

Terminology consistencySame definition appears elsewhere in the policy to ensure consistent use

Tandem Transplants (duplicate)

Tandem transplants — repeated entryA transplant technique where the preplanned intent for therapy involves sequential hematopoietic stem cell transplants

Policy contextListed among covered transplant approaches for Hodgkin lymphoma in specified circumstances

DistinctionPreplanned sequential transplants differ from repeat autologous transplants after prior autologous HSCT (which is not covered)

Donor Lymphocyte Infusion (DLI)

DLI — definitionDonor lymphocyte infusion (DLI) is therapy in which lymphocytes from the original donor are given to a patient post-transplant

Therapeutic intentDLI may kill remaining cancer cells or help convert mixed chimerism to full donor chimerism

AssociationDLI is used after an allogeneic HSCT from the same donor

DLI is provided after a medically necessary allogeneic HSCT from the same donor

Referential noteSee Section 1.1 for the DLI definition and further context

DLI prior authorization note

Prior authorization for DLI when allogeneic HSCT had PAIf an allogeneic HSCT previously received prior authorization and DLI is later indicated, a separate prior authorization is not required

Policy revision basisThis change was added in revision notes dated 10/01/2019 and reflected in Section 5.1/5.3 revisions

Operational implicationProviders should document the previous authorized allogeneic HSCT when requesting reimbursement for later DLI

Donor transplant-related medical expenses

Billing method for donor expensesDonor transplant-related medical expenses are billed on the Medicaid beneficiary's transplant claim using the beneficiary's Medicaid identification number

Reimbursable amountsMedicaid reimburses only for the actual donor's transplant-related medical expenses

Non-reimbursable itemsMedicaid does not reimburse for unsuccessful donor searches

prior_authorization_change

Prior approval requirement for Hematopoietic Stem-Cell Transplantation was removed (Section 5.0).

2023-08-15policy_posting_and_template_updateLatest

Policy posted with an effective date of 2023-04-01 and template language updated for North Carolina Health Choice Program's move to Medicaid; comprehensive updates to all sections and attachments were applied.

Background: Hematopoietic stem-cell transplantation (HSCT) is a therapeutic procedure that restores bone marrow function after marrow‑toxic cytotoxic therapy. Stem cells may be autologous or allogeneic and can be sourced from bone marrow, peripheral blood, or umbilical cord blood. Autologous HSCT is typically performed as consolidation when disease is in remission and avoids graft‑versus‑host disease risk, whereas allogeneic HSCT requires HLA compatibility, necessitates immunosuppression, and carries risks such as graft‑versus‑host disease and infection. The policy also describes conditioning approaches, distinguishing conventional myeloablative regimens from reduced‑intensity conditioning (RIC) aimed at balancing nonrelapse mortality and relapse risk.