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Chelation Therapy

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This policy describes Select Health coverage determinations for chelation therapy (intravenous or oral chelating agents) for treatment of metal toxicity and specified indicated conditions across Commercial, Medicare, and Medicaid lines of business.

Policy Summary

PayerSelectHealth

PolicyChelation Therapy

Policy CodePolicy N/A

Change TypeCoverage criteria modified / additions

Effective Date

Last ReviewMar 30, 2025

Next Review Date

Key ActionVerify member benefits and obtain prior authorization when required before providing chelation therapy or related infusion services.

SourceLink

POLICY UPDATE CHANGES

Modified requirements in criterion #3 for Commercial Plan Policy to reference patients who have an increased risk of complications associated with other therapies or who have other medical comorbidities.

For Commercial Plan Policy, added criterion #2: 'For patients with stage III ovarian cancer' as a qualifying factor for coverage of this procedure.

For Commercial Plan Policy, added criterion #3: 'For patients diagnosed with metastatic colon cancer to the peritoneum, if the following are not present: biliary obstruction, extensive disease at the gastrohepatic ligament/porta hepatis, extensive retroperitoneal disease, intraparenchymal liver lesions (requiring major resection), diffuse small bowel serosa/mesenteric involvement, and/or multiple sites of small bowel obstruction' as a qualifying factor for coverage.

For Commercial Plan Policy, added new coverage criterion #4: 'For patients diagnosed with gastric cancer, only with peritoneal carcinoma with a low ... and who are candidates to undergo complete cytoreduction; and who have completed at least 3 months of chemotherapy.'

11+listed indications covered

96365-96367Listed CPT infusion codes

96547,96548HIPEC CPT codes listed

Commercial/Medicare/MedicaidPlan applicability

3new coverage items (Revision History)

Coverage Criteria and Indications

Literature citations and context

Literature citations and context — Select Health references and supporting literature cited in this section (representative list from policy source).

36. 1996 TEC Assessment; Tab 3.

37. 1998 TEC Assessment; Tab 24.

38. Stadtmauer EA, O'Neill LJ, Goldstein P et al. Phase III randomized trial of high-dose chemotherapy and stem cell support shows no difference in overall survival or severe toxicity compared to maintenance chemotherapy with cyclophosphamide, methotrexate, and 5-fluorouracil for women with metastatic breast cancer who are not responding to conventional induction chemotherapy: The Philadelphia Intergroup Study (PBT-1) Proc ASCO 1999; 18:1a (abstract no 1).

39. Lotz JP, Cure H, Janvier F et al. High dose chemotherapy with hematopoietic stem cells transplantation for metastatic breast cancer. Results of the French protocol PEGASE-04. Proc ASCO 1999; 18:42a (abstract no. 161).

Policy Summary

PayerSelectHealth

PolicyChelation Therapy

Policy CodePolicy N/A

Change TypeCoverage criteria modified / additions

Effective Date

Last ReviewMar 30, 2025

Next Review Date

Key ActionVerify member benefits and obtain prior authorization when required before providing chelation therapy or related infusion services.

SourceLink

On This Page

Billing Codes and Key Coding Parameters

Covered CPT CodesCPTCovered

96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
96366	Each additional hour
96367	Additional sequential infusion of a new drug/substance, up to 1 hour

HCPCS / J-codesHCPCSCovered

G0068	Professional services for the administration of anti-infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biological) for each infusion drug administration calendar day in the individual's home, each 15 min
G0088	Professional services, initial visit, for the administration of anti-infective, pain management, chelation, pulmonary hypertension, inotropic, or other intravenous infusion drug or biological (excluding chemotherapy or other highly complex drug or biological) for each infusion drug administration calendar day in the individual's home, each 15 min
J0470	Injection, dimercaprol, per 100 mg
J0600	Injection, edetate calcium disodium up to 1,000 mg
J0895	Injection, deferoxamine mesylate, 500 mg
J3520	Edetate disodium, per 150 mg
S9355	Home infusion therapy, chelation therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

Not covered / MiscellaneousmixedNot Covered

M0300

IV chelation therapy (chemical endarterectomy)

CoveredneutralCovered

No codes listed

Covered CPT Codes (cryoablation)CPTCovered

50250	Ablation, open, one or more renal mass lesion(s), cryosurgical, including intraoperative ultrasound, if performed
50542	Laparoscopy, surgical; ablation of renal mass lesion(s), including intraoperative ultrasound guidance and monitoring, when performed
50593	Ablation, renal tumor(s), unilateral, percutaneous, cryotherapy

HCPCS CodesHCPCS

No codes listed

Covered CPT Codes / Not coveredCPT

96547	Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) procedure, including separate incision(s) and closure, when performed; first 60 minutes
96548	Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) procedure, including separate incision(s) and closure, when performed; each additional 30 minutes
96549	Unlisted chemotherapy procedure

HCPCS CodesHCPCS

No codes listed

Commercial CPT Codes (GammaTile)CPTCovered

77799

Unlisted procedure, clinical brachytherapy

Covered CPT CodesCPTCovered

38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition
38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogenic
38206	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous
38207-38215	Code range for transplant preparation of hematopoietic progenitor cells
38230	Bone marrow harvesting for transplantation; allogeneic
38232	Bone marrow harvesting for transplantation; autologous
38240	Bone marrow or blood-derived peripheral stem cell transplantation, allogenic
38241	Bone marrow or blood-derived peripheral stem cell transplantation, autologous
38242	Allogenic donor lymphocyte infusion
86812	HLA typing; A, B, or C (eg, A10, B7, B27), single antigen

1–10 of 14

1/2

Additional CPT CodesCPTCovered

86825	HLA crossmatch, non-cytotoxic; first serum sample
86826	HLA crossmatch, non-cytotoxic; additional serum sample
96401-96450	Chemotherapy administration code range

HCPCS CodesHCPCSCovered

J9000-J9999

Chemotherapy drugs code range

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

Informational coding statementmixed

No codes listed

Tumor size — ≤ 3 cm

Tumor size≤ 3 cm

ContextApplies to cryoablation coverage for renal cell carcinoma when other criteria are met

Source policyPolicy #337 - CRYOABLATION FOR RENAL CELL CARCINOMA (RCC)

GFR — ≤ 60 ml/min

Glomerular filtration rate (GFR)≤ 60 ml/min

ContextPart of renal function criteria for cryoablation eligibility

Associated thresholdsUsed with serum creatinine ≥ 2.0 and BUN/Cr <20/1

Serum creatinine — ≥ 2.0

Serum creatinine≥ 2.0 mg/dL

ContextUsed as a criterion for reduced renal function in cryoablation candidacy (Commercial/CHIP)

Related prognostic noteIn amyloidosis selection, serum creatinine <1.5 mg/dL associated with better outcomes (refer to transplant candidacy guidance)

BUN-to-creatinine ratio — < 20/1

BUN-to-creatinine ratio< 20/1

ContextRequired alongside GFR ≤60 ml/min and creatinine ≥2.0 to define reduced renal function for cryoablation eligibility

ApplicationUsed by Select Health Commercial/CHIP policy to determine cryoablation candidacy

HIPEC perfusion duration and core temperature monitoring — Perfusion up to 90 minutes; core temperature maintained approximately 97°-102°F

Perfusion durationUp to 90 minutes

Core temperature monitoringCore temperature maintained approximately 97°-102°F (esophageal and bladder probes) during perfusion

Perioperative measuresPatient cooled preoperatively (cooling blanket); ambient OR temperature reduced to ~60°F during perfusion

Not applicable — Not applicable

Not applicableNot applicable

ContextNo threshold or numeric requirement specified

Usage noteDisplayed where a threshold does not apply

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior authorization and benefits verification

Select Health requires providers to verify member benefits and obtain prior authorization when required by the member's contract. Application of coverage criteria depends on the individual's benefit coverage at the time of request; inclusion or exclusion of codes in this policy does not itself guarantee coverage or reimbursement. Providers should contact Customer Service or Provider Relations for benefit-specific questions.

Verify member benefits and eligibility prior to service; benefits determine coverage and applicability of policy criteria.
Obtain prior authorization when required by the member's contract or plan rules.
Member/customer service and provider relations contact: phone on member ID card; Select Health Provider Relations 801-442-3692.

Prior Authorization

Preauthorization for transplant indications

For transplant-related indications (HSCT/BMT, autologous or allogeneic), preauthorization is generally required. Prior authorization requests should document transplant indication, prior lines of therapy, risk stratification (for example high- or high-intermediate IPI for NHL consolidation), evidence of refractory disease when applicable, and other selection criteria used to justify transplant candidacy.

Document indication for transplant and rationale (e.g., consolidation of first CR for high/high-intermediate IPI, relapsed Hodgkin's disease after salvage therapy).
Include prior therapies and response, duration of remission, and lines of therapy.
Provide candidacy parameters: age, organ function measures (e.g., serum creatinine, cardiac ejection fraction, interventricular septal thickness), performance status, number of organs involved (for amyloidosis), and other transplant-specific thresholds.
Attach supporting literature/guideline citations when available (NCCN, PDQ, InterQual references applicable).

Note

Payer alignment and applicable authorization pathway

Select Health Community Care (Medicaid) typically aligns with State of Utah Medicaid policy and may use InterQual. Medicare coverage is determined by CMS and may supersede Select Health Commercial criteria when a CMS determination exists. Providers must follow the appropriate payer-specific pathway (Commercial, Medicare/CMS, or Medicaid/Select Health Community Care) when requesting authorization.

Check whether a CMS NCD/LCD applies for Medicare members; if present, CMS rules govern coverage.
For Community Care/Medicaid members, reference Utah Medicaid manuals and InterQual criteria as applicable.
When no payer-specific guidance exists, Select Health Commercial policy may apply.

Documentation Required

Clinical and procedural documentation required

Clinical and procedural documentation must be submitted to support medical necessity for procedural therapies (e.g., cryoablation, HIPEC, GammaTile) and transplant requests. Lack of sufficient clinical evidence or inadequate documentation can lead to denial.

Include operative reports, imaging guidance (ultrasound/MRI), tumor size/location, and approach (open, laparoscopic, percutaneous) for ablative procedures.
For HIPEC, document disease extent, PCI where applicable, prior chemotherapy (e.g., at least 3 months for gastric cancer), and absence of exclusionary anatomic findings.
For GammaTile, document prior maximal resection and standard-of-care adjuvant therapy, and recurrence within the high-dose radiotherapy volume.
For transplants, provide detailed prior therapy history, disease stage, laboratory and organ function data, and performance status.

Denial Risk

HIPEC coverage limitations and coding

HIPEC is covered only for specified indications; requests for HIPEC outside listed indications are considered investigational/experimental and will generally be denied. Providers must document that the patient meets all listed clinical criteria for coverage.

Covered indications include mucinous appendiceal carcinoma with pseudomyxoma peritonei, diffuse malignant peritoneal mesothelioma, stage III ovarian cancer, select metastatic colon cancer to the peritoneum (with specified anatomic exclusions), and gastric cancer with low PCI ≤ 10 after ≥3 months chemotherapy when candidate for complete cytoreduction.
CPT codes 96547 and 96548 apply when HIPEC criteria are met; CPT 96549 (unlisted) is not covered for investigational/unproven indications.
Requests for other indications should be expected to be denied as investigational/experimental.

Denial Risk

Denial risk: evidence insufficiency and high-risk indications

Evidence insufficiency or high treatment-related mortality for certain indications (for example many autoimmune diseases, ependymoma, select solid tumors) increases the risk of denial. When evidence is limited or outcomes are heterogeneous, documentation must clearly justify the clinical rationale and patient selection.

High transplant-related mortality or insufficient peer-reviewed data for some indications may lead to denial.
For autoimmune indications and certain solid tumors, randomized trials are lacking; provide strong rationale and selection criteria if requesting coverage.
Clinical trial enrollment is encouraged where conventional therapy uncertainty exists.

Billing Rule

Coding and billing documentation required

Required coding and billing documentation must be supplied on claims for transplantation and associated services. Inclusion or exclusion of codes in this policy is informational and does not guarantee coverage; verify benefit-specific code coverage prior to claim submission.

Use appropriate CPT/HCPCS codes for harvesting, transplantation, HLA testing, chemotherapy administration, HIPEC (96547/96548), and other related services as listed in the policy.
Document procedure duration and additional units when billing time-based HIPEC codes (first 60 minutes and each additional 30 minutes).
Claims lacking required supporting documentation or with codes billed for investigational indications may be denied.

Note

References and guideline resources

Operational notes and references: this section provides literature citations and references to guidance (e.g., NCCN, UpToDate, InterQual, CMS/Medicare manuals, Utah Medicaid manuals) that support policy rationale. Providers may cite these resources in prior authorization requests when relevant.

Policy cites peer-reviewed literature, consensus guidelines, and public payer manuals to justify coverage positions.
Providers may reference NCCN, PDQ, InterQual, CMS, and State Medicaid guidance when submitting documentation.

Note

When prior authorization is not specified

Prior authorization requirements are not always specified explicitly for every procedure or indication in this section. Where no explicit prior authorization rule is provided, providers must still verify benefits and follow the member's contract and payer pathway to determine if preauthorization is required.

Some chunks contain clinical evidence or coding tables but do not state an explicit prior authorization procedure.
When authorization is not specified, default to verifying member benefits and follow payer-specific rules (Commercial, Medicare/CMS, Medicaid/Community Care).

Step Therapy

Step therapy and sequencing expectations

Step therapy: no step-therapy rules are provided in this section for the listed surgical, transplant, or procedure-based therapies. Where step-up from conventional salvage therapy is clinically expected (for example relapsed Hodgkin's disease prior to HDC/AuSCS), document prior conventional therapies and rationale for escalation.

No formal step-therapy requirements described here; however, several indications expect that conventional therapies or enrollment in clinical trials be considered before high-dose or transplant approaches.
Document prior salvage chemotherapy and outcomes when requesting transplant for relapsed disease.

Background and Rationale

Background: GammaTile intracavitary brachytherapy involves placement of bioresorbable tiles with cesium‑131 seeds into the surgical resection cavity. Select Health limits its coverage to the specific recurrent Grade IV astrocytoma scenario described in policy and requires documentation of prior maximal resection and standard adjuvant therapy prior to use.

Chelating agents — definition and examples

DefinitionChelating agents are drugs that form complexes with toxic heavy metals to render them inactive and facilitate urinary excretion

ExamplesDeferoxamine mesylate, dimercaprol (BAL), edetate (EDTA), succimer (DMSA), penicillamine

Clinical useUsed to treat symptomatic metal toxicity (eg, iron, lead, arsenic, mercury, copper)

cryoablation — definition

DefinitionCryoablation is an ablation technique using cryoprobes cooled by liquid nitrogen or argon to produce subfreezing temperatures causing tumor cell destruction and thromboembolic ischemia

ApproachesCan be performed open, laparoscopic, or percutaneous with imaging guidance (ultrasound or MRI)

Clinical intentUsed to provide oncologic control for small renal masses while preserving renal function

Hyperthermic Intraperitoneal Chemotherapy (HIPEC) — definition and description

DefinitionHyperthermic Intraperitoneal Chemotherapy (HIPEC) is a technique where, after cytoreductive surgery, a heated chemotherapy solution is continuously circulated in the peritoneal cavity to target residual tumor cells

Technical featuresPerfusion is performed intraoperatively immediately after cytoreduction, typically up to 90 minutes, using heat-synergistic agents and specialized perioperative measures

Clinical intentUsed as an adjunct to cytoreductive surgery for select peritoneal surface malignancies (eg, pseudomyxoma peritonei, DMPM, selected colorectal/ovarian/gastric cases)

Cryoablation for renal tumors — definition and context

DefinitionCryoablation for renal tumors is ablation of renal mass lesions using cryosurgical techniques performed open, laparoscopically, or percutaneously to achieve tumor destruction while preserving renal function

IndicationsConsidered for small (T1) renal cell carcinomas when patients cannot tolerate nephrectomy or to preserve renal function

Procedural detailsMultiple cryoprobes placed under imaging guidance with intraoperative ultrasound monitoring of the ice ball; FDA-approved systems available

Pseudomyxoma peritonei — definition and clinical context

DefinitionPseudomyxoma peritonei is a peritoneal surface malignancy frequently originating from the appendix characterized by disseminated mucinous tumor deposits

Clinical contextCRS with HIPEC has produced prolonged survival in cohorts of patients with pseudomyxoma peritonei (eg, Elias series reporting 5-year OS ~80%)

Operative outcomesIn reported series, a high proportion achieved no visible residual disease after CRS but operative morbidity and mortality can be substantial

Diffuse malignant peritoneal mesothelioma (DMPM) — definition and outcomes summary

DefinitionDiffuse malignant peritoneal mesothelioma (DMPM) is a primary peritoneal malignancy for which CRS and HIPEC have been used

Outcomes summaryReported median overall survival varies widely across series; operative mortality and morbidity are significant with median OS reported from ~29.5 to >100 months in different studies

Evidence baseEvidence consists primarily of prospective uncontrolled case series and systematic reviews summarizing heterogeneous protocols and outcomes

GammaTile intracavitary brachytherapy — definition

DefinitionGammaTile intracavitary brachytherapy consists of bioresorbable collagen tiles containing four cesium-131 seeds placed into the surgical resection cavity after debulking

Intended useLocalized intracavitary radiation delivered at time of resection to the tumor cavity to treat recurrent brain tumors (eg, recurrent Grade IV astrocytoma)

Coverage contextSelect Health covers GammaTile only for recurrent Grade IV astrocytoma when all listed clinical criteria are met

Ideal allogeneic donor — definition

DefinitionIdeal allogeneic donor: HLA-identical sibling matched at HLA-A, B, and DR loci

AlternativesRelated donors mismatched at one locus, matched unrelated donors (via registry), and haploidentical donors may be considered when identical sibling donors are unavailable

Clinical implicationDonor selection impacts graft-versus-host risk and transplant-related morbidity

Severe and very severe aplastic anemia — definition

DefinitionSevere aplastic anemia: platelets <20 x10^9/L, granulocytes <0.5 x10^9/L, and reticulocytes <1% after correction for hematocrit; very severe when granulocytes <0.2 x10^9/L

Clinical relevanceSevere/very severe AA are indications considered for allogeneic HSCT or ATG depending on donor availability and patient factors

Treatment alternativesAllogeneic HSCT and anti-thymocyte globulin (ATG) have comparable outcomes in selected patients

AuSCS — Autologous stem cell support definition

DefinitionAuSCS (Autologous stem cell support) — reinfusion of a patient's own hematopoietic stem cells following marrow-ablative high-dose chemotherapy

Clinical useUsed to rescue marrow function after high-dose chemotherapy in consolidation or salvage settings for various malignancies

RisksReinfusion may carry risk of tumor cell contamination; selection criteria impact outcomes

Myelodysplastic syndrome (MDS) — definition

DefinitionMyelodysplastic syndrome (MDS) is a heterogeneous group of clonal hematopoietic disorders with impaired maturation and risk of transformation to AML

ClassificationTypically categorized by FAB subtypes (RA, RARS, RAEB, RAEBT, CMML) reflecting increasing blast counts

Clinical implicationHigh-dose chemotherapy or HSCT considered for patients with rising blasts, high-risk cytogenetics, or progressive disease

Myeloproliferative disorders — definition

DefinitionMyeloproliferative disorders are clonal disorders with expansion of hematopoietic cells (eg, PV, ET, primary myelofibrosis, CML) that may evolve to blast crisis

Clinical implicationHigh-dose chemotherapy or HSCT may be considered with progression to myelofibrosis or evolution toward acute leukemia

ExamplesPolycythemia vera (PV), Essential thrombocythemia (ET), primary myelofibrosis, chronic myeloid leukemia (CML)

Responsive multiple myeloma — definition

DefinitionResponsive multiple myeloma: tumors achieving a complete or partial (≥50% tumor reduction) response to chemotherapy

Clinical implicationAutologous HSCT is supported for newly diagnosed or responsive multiple myeloma in appropriate patients

ThresholdsOften recommended for stage II/III disease and patients with good performance status

Resistant or refractory multiple myeloma — definition

DefinitionResistant or refractory multiple myeloma: tumors achieving <50% reduction in tumor burden after therapy

Clinical implicationEvidence is insufficient to support routine HDC/AuSCS or allogeneic transplant for resistant/refractory disease in unselected patients

OutcomesNonrandomized reports show median survival ~31 months and 5-year OS ~27% in some series

Tandem (serial) transplant — definition

DefinitionTandem (serial) transplant: two planned hematopoietic stem cell transplants regardless of the outcome of the initial transplant

Evidence summaryRandomized trials show improved response rates but inconsistent survival benefit and higher treatment-related mortality

Use contextStudied both as first-line consolidation and in salvage settings with heterogeneous outcomes

HDC AuSCS — definition

Clinical applicationUsed as consolidation or salvage in various malignancies; candidate selection affects outcomes and transplant-related mortality can be substantial

ExamplesRegimens include busulfan + melphalan, high-dose melphalan, BCNU-based regimens among others described in the literature

Allogeneic HSCT — definition

DefinitionAllogeneic HSCT — transplantation using donor (usually HLA-matched related) hematopoietic stem cells

Clinical effectCan establish normal erythropoiesis and be potentially curative for certain hematologic and genetic disorders (eg, severe aplastic anemia, sickle cell anemia) but carries graft-versus-host disease risk

Donor hierarchyIdeal donor is HLA-identical sibling; matched unrelated donors and haploidentical donors are alternatives

Autologous stem cell transplantation (ASCT) — definition

Clinical roleUsed in various malignancies as consolidation or salvage to allow marrow recovery after myeloablative regimens

Coding noteAssociated CPT codes include 38206, 38232, 38241 among others for harvesting and transplant procedures

High-dose chemotherapy with autologous stem cell support — definition

Clinical considerationsCandidate selection, prior therapies, organ function, and disease sensitivity influence outcomes and transplant-related mortality

Evidence baseSupported in selected indications (eg, relapsed Hodgkin’s, germ cell tumors, some pediatric solid tumors) with variable evidence across tumor types

Autologous HSCT — definition (additional)

Practical noteUsed as consolidation or salvage; timing of collection and avoidance of extensive alkylator exposure are important considerations

EvidenceRandomized and registry data inform use in multiple myeloma, Hodgkin’s, and certain pediatric tumors; evidence is heterogeneous for many adult solid tumors

High-Dose Chemotherapy Regimens and Examples

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
Thiotepa ± etoposide ± temozolomide / carmustine	High‑grade gliomas / CNS tumors (consolidation or salvage)	Phase I/II series report occasional long‑term survivors but substantial treatment‑related morbidity and mortality; authors note results are disappointing and emphasize selection bias; no phase III trials identified through 1999 searches.	Experimental
High‑dose thiotepa with autologous stem cell rescue	Oligodendroglioma / recurrent aggressive oligodendroglioma	Small series (e.g., Cairncross) reported some complete and partial responses but notable treatment‑related deaths; Phase II data only; need for randomized trials noted.	Experimental

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
Thiotepa + etoposide (high‑dose) regimens	Recurrent ependymoma (salvage therapy)	Small case series (Mason et al.; Grill et al.) reported poor outcomes with multiple treatment‑related deaths; authors concluded thiotepa‑based HDC was not effective for ependymoma.	Not medically necessary / Experimental

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
Melphalan‑based high‑dose regimens ± radiotherapy	Recurrent or refractory Ewing's sarcoma; salvage and consolidation settings	Registry and phase II reports (EBMT registry: 210 patients; complete response ~27%, 5‑year OS ~19%). Melphalan regimens commonly used; some long‑term survivors but overall outcomes modest and subject to selection bias.	Experimental

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
High‑dose melphalan + etoposide + total‑body irradiation (Meyers et al. regimen)	Consolidation for newly diagnosed metastatic Ewing's sarcoma	Meyers et al. treated 23 patients with this intensive consolidation; two‑year event‑free survival 24%; authors concluded this high‑dose approach did not improve prognosis in that cohort.	Experimental

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
BEAM (BCNU/carmustine, etoposide, cytarabine, melphalan) with autologous stem‑cell support	Relapsed Hodgkin's lymphoma (salvage)	Randomized trial comparing BEAM‑AuSCS to conventional Dexa‑BEAM in relapsed patients (n=166 randomized): freedom‑from‑treatment‑failure was significantly better after HDC/AuSCS; no OS difference reported at median 39‑month follow‑up but subgroup benefits noted.	Covered (when criteria and prior therapy sequencing met)

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
Carboplatin/thiotepa/etoposide; cyclophosphamide/cisplatin/vincristine; thiotepa/carboplatin; cisplatin/vincristine/cyclophosphamide/etoposide	Recurrent or high‑risk medulloblastoma/PNET and selected pediatric solid tumors	Largest series and phase II reports describe event‑free survivors in selected patients (e.g., recurrent medulloblastoma: 7 event‑free survivors at median 54 months in a 23‑patient series); no phase III trials; results influenced by patient selection and minimal residual disease at HDC.	Experimental / investigational

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
High‑dose BCNU (carmustine) ± radiotherapy with ASCT	Supratentorial glioblastoma / high‑grade gliomas	Pilot and prospective reports described use of high‑dose BCNU with ASCT and subsequent radiation; small series show benefit in selected patients but overall evidence limited and lacking randomized confirmation.	Informational / Experimental
Thiotepa + etoposide with autologous rescue	Recurrent CNS tumors (children and young adults)	Phase II pilot studies report responses but with treatment‑related toxicity; authors call for randomized trials to control for selection bias.	Experimental
Busulfan + melphalan combinations	High‑grade gliomas and other solid tumors in selected protocols	Reported across series and reviews as one of multiple conditioning/regimen approaches; evidence consists of case series and institutional reports.	Informational / Experimental

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
Busulfan + melphalan (high‑dose)	Various malignancies as conditioning or consolidation (e.g., Ewing's, pediatric solid tumors)	Cited across registry reports and clinical series (e.g., Oberlin et al. on busulfan+melphalan in metastatic Ewing tumors); data derive from nonrandomized studies and phase II series.	Informational / Experimental
High‑dose melphalan + etoposide + total‑body irradiation	Consolidation in high‑risk settings (e.g., Ewing's sarcoma studied by Meyers et al.)	Used in phase II protocols; Meyers reported lack of improved event‑free survival in one cohort; evidence insufficient for routine adoption.	Experimental
Ifosfamide/carboplatin/etoposide (ICE‑type) and fludarabine‑based reduced intensity conditioning	Used across conditioning strategies for hematologic malignancies and reduced‑intensity allogeneic approaches	Described in reviews and policy citations as examples of regimens employed; outcomes vary by disease and transplant type; evidence base heterogeneous.	Informational / regimen examples

Regimen / Drugs	Indication / Setting	Evidence summary	Coverage stance
Carboplatin ± paclitaxel; melphalan‑based regimens; topotecan/carboplatin/paclitaxel; TMC (topotecan, melphalan, cyclophosphamide)	Advanced ovarian epithelial carcinoma and other solid tumors in phase I/II trials	Multiple phase I/II studies and institutional series evaluated these combinations with autologous stem‑cell support; outcomes variable and nonrandomized; randomized evidence lacking to demonstrate consistent survival benefit.	Experimental / investigational
Busulfan + thiotepa; carboplatin‑thiotepa‑etoposide; other multi‑agent high‑dose combinations	PNET/medulloblastoma, pediatric solid tumors, and other trial contexts	Cited in phase II trials and collaborative studies (e.g., Dunkel, Strother); phase III data not identified for most regimens; evidence limited to uncontrolled series.	Experimental

Chelation Therapy

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Coverage Criteria and Indications

Billing Codes and Key Coding Parameters

Prior Authorization, Documentation, and Operational Requirements

Background and Rationale

Line of Therapy Context

Biomarker and Diagnostic Requirements

High-Dose Chemotherapy Regimens and Examples

Policy Revisions and Material Changes