CurrentUniversity Health Alliance (HSA)Policy MPP-0016-120117
Treatment of hepatic neoplasms (non-systemic chemotherapy)
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Defines medical necessity, prior authorization, covered and experimental treatments, and coding guidance for procedures treating primary or metastatic liver tumors outside of systemic chemotherapy for University Health Alliance members.
Policy Summary
PayerUniversity Health Alliance (HSA)
PolicyTreatment of hepatic neoplasms (non-systemic chemotherapy)
Policy CodePolicy MPP-0016-120117
Change TypeNo material changes
Effective DateAug 1, 2022
Last ReviewAug 1, 2022
Next Review DateN/A
Key ActionObtain prior authorization via UHA's online portal whenever liver tumors are considered for treatment outside of systemic chemotherapy.
SourceLink
POLICY UPDATE CHANGES
No material clinical or coverage changes in this revision.
1Prior auth required
<=4 cmLesion size limit
<50%Liver involvement
multipleCovered modalities
2Primary HCPCS listed
2022-08-01Effective date
Coverage and Medical Necessity Criteria
Hepatic neoplasm coverage criteria
Covered when the following general administrative requirements and modality-specific selection criteria are met:
ALL of the following
- Prior authorization is required whenever liver tumors are considered for treatment outside of systemic chemotherapy alone.
See administrative submission and documentation requirements.
- Documented evaluation by a surgeon with formal training in hepatic surgery (e.g., hepatobiliary fellowship or hepatic transplantation training) is required; this may be a second-opinion consultation or formal tumor board review.
Patient must be informed of opinions and offered a second opinion when evaluation occurs in tumor board.
- Clinical notes and documentation of the surgical evaluation must be submitted with authorization requests (including symptoms, physical findings, and preoperative imaging).
ALL of the following
- PEI is medically necessary for hepatocellular carcinoma (HCC) without extra-hepatic spread.
- PEI is not supported as an alternative to surgical resection for hepatic metastases due to inadequate evidence.
- Combined radiofrequency ablation (RFA) and PEI is considered experimental/investigational for HCC.
ALL of the following
- CE is medically necessary for neuroendocrine liver metastases (carcinoid or pancreatic endocrine tumors) only after failure of systemic therapy with octreotide to control carcinoid syndrome.
- CE is medically necessary for unresectable primary hepatocellular carcinoma (HCC).
- CE is medically necessary for liver-only metastasis from uveal (ocular) melanoma.
- Preoperative hepatic artery CE followed by orthotopic liver transplantation for HCC is medically necessary (bridge to transplant).
- CE is experimental/investigational for other indications (including palliative treatment of non-neuroendocrine liver metastases) because of inadequate evidence.
ALL of the following
- Intra-hepatic chemotherapy infusion is medically necessary for liver metastases from colorectal cancer.
- Intra-hepatic chemotherapy is experimental/investigational for other indications (including one-shot arterial chemotherapy and transarterial gene therapy).
- Intra-hepatic microspheres (e.g., TheraSphere, SIR-Spheres) are medically necessary for symptomatic neuroendocrine liver metastases after failure of octreotide to control carcinoid syndrome, for unresectable primary HCC, for unresectable colorectal liver metastases, and as preoperative bridge to transplant for HCC.
ALL of the following
- Ablation is medically necessary for isolated colorectal cancer liver metastases or isolated HCC when the patient is not a candidate for surgical resection and ALL selection criteria are met.
- Selection criteria: lesion(s) must be from colorectal primary or HCC; disease must be isolated to the liver (no nodal or extra-hepatic metastases); pre-operative imaging must indicate all tumors could potentially be destroyed by ablation; the member must be an unacceptable surgical candidate due to tumor location/extent or comorbidities; and lesions must be ≤ 4 cm in diameter and occupy < 50% of liver parenchyma.
- Ablation is considered experimental/investigational when these criteria are not met or when used palliatively for colorectal or hepatocellular metastases.
ALL of the following
- Surgical excision (anatomic or nonanatomic resection) is covered when all hepatic tumor (primary or secondary) can be extirpated with clear margins in one or two stages.
- Isolated and resectable pulmonary metastases or the need for neoadjuvant chemotherapy are not strict contraindications to resectional therapy.
ALL of the following
- Indications not listed in this policy and not supported by the medical literature as medically necessary are not covered.
ALL of the following
- All tumors in the liver, as determined by pre-operative imaging, must be potentially destroyable by the chosen ablative modality (cryotherapy, microwave, or RFA).
- Members must be unacceptable candidates for open surgical resection for reasons of location, extent of disease, or co-morbid conditions to qualify for ablation.
ALL of the following
- Maximum lesion diameter for ablation: 4 cm or less.
- Maximum hepatic involvement for ablation: lesions must occupy less than 50% of liver parenchyma.
Coverage for brachytherapy radioelements
HCPCS codes are covered when the policy's selection criteria for the associated procedure are met.
Q3001 (Radioelements for brachytherapy, any type, each) is covered if the selection criteria for brachytherapy are met.
Coverage for Y‑90 microsphere embolization
Yttrium-90 microsphere embolization is covered when the policy's clinical selection criteria for intra-hepatic microsphere therapy are met.
S2095 (Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres) is covered if the selection criteria for intra-hepatic microsphere therapy are met (e.g., symptomatic neuroendocrine liver metastases after octreotide failure, unresectable HCC, unresectable colorectal liver metastases, or as bridge to transplant).
Related octreotide J‑codes
The following octreotide J‑codes are listed in the policy as related to the clinical practice bundle (coverage status not specified in this section):
Billing and Code Reference
Related CPT codes for hepatic proceduresCPTCovered
| 76940 | Ultrasound guidance for, and monitoring of, parenchymal tissue ablation |
| 77013 | Computed tomography guidance for, and monitoring of, parenchymal tissue ablation |
| 77022 | Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation |
| 36245 | Selective catheter placement, arterial system; each first order abdominal, pelvic, or lower |
| 37241 | Vascular embolization or occlusion, inclusive of radiological supervision and interpretation |
| 47120 | Hepatectomy, resection of liver; partial lobectomy |
| 96446 | Chemotherapy administration into the peritoneal cavity via indwelling port or catheter |
HCPCS / J-codes related to hepatic treatmentsHCPCSCovered
| C1886 | Catheter, extravascular tissue ablation, any modality (insertable) |
| Q3001 | Radioelements for brachytherapy, any type, each |
| S2095 | Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres |
| J2353 | Injection, octreotide, depot form for intramuscular injection, 1 mg |
| J2354 | Injection, octreotide, nondepot form for subcutaneous or intravenous injection, 25 mg |
inv-10: Maximum lesion size for ablation
Maximum lesion diameter for ablation4 cm
Measurement requirementDiameter measured by pre-operative imaging
ApplicabilityApplies to cryosurgery, microwave, or radiofrequency ablation selection criteria
inv-11: Maximum liver involvement for ablation
Maximum liver involvement for ablationLess than 50% of liver parenchyma
Assessment methodDetermined by pre-operative imaging documenting extent of hepatic disease
ApplicabilityRequirement for cryosurgery, microwave, or radiofrequency ablation eligibility
Provider Requirements and Billing Notices
Prior Authorization
Prior authorization and submission
Prior authorization is required whenever liver tumors are considered for treatment outside of systemic chemotherapy alone. Requests should be submitted via UHA's online portal or by contacting UHA to establish access. Providers must include clinical notes describing symptoms/physical findings and documentation that the member was evaluated by a surgeon with formal training in hepatic surgery (this evaluation may be a second opinion or tumor board presentation).
- Submit clinical notes describing symptoms and physical findings.
- Provide documentation of evaluation by a surgeon with formal training in hepatic surgery (hepatobiliary fellowship or hepatic transplantation training).
- If evaluation occurred in a tumor board, document that the patient was informed of opinions rendered and offered a second opinion.
Billing Rule
Covered HCPCS when criteria met
Bill HCPCS Q3001 (radioelements for brachytherapy, any type, each) and S2095 (transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres) only when the policy's selection criteria for those procedures are met.
Terms and Code Definitions
inv-15: Prior authorization
DefinitionPrior authorization is the requirement that UHA approve treatments for liver tumors when treatment is outside of systemic chemotherapy alone.
When requiredWhenever liver tumors are considered for operative, radiologic, chemical, thermal, and all ablative therapies excluding systemic chemotherapy.
SubmissionRequests should be submitted via UHA's online portal or by contacting UHA to establish access (administrative guidance).
inv-16: Chemoembolization (CE)
DefinitionIntra-arterial procedure delivering chemotherapy and embolic material to liver tumors.
Medically necessary indicationsNeuroendocrine liver metastases after failure of octreotide to control carcinoid syndrome; unresectable primary HCC; liver-only metastasis from uveal (ocular) melanoma; preoperative hepatic artery CE followed by orthotopic liver transplantation for HCC.
LimitationsConsidered experimental/investigational for other indications (including palliative treatment of non-neuroendocrine metastases) due to inadequate evidence.
inv-17: Intra-hepatic microspheres
DefinitionYttrium-90 or similar intra-hepatic microsphere therapy (e.g., TheraSphere, SIR-Spheres).
Medically necessary indicationsSymptomatic neuroendocrine liver metastases after octreotide failure; unresectable primary HCC; unresectable colorectal liver metastases; pre-operative bridge to orthotopic liver transplantation for HCC.
ExamplesTheraSphere (MDS Nordion) and SIR-Spheres (Sirtex) referenced as intra-hepatic microsphere products.
inv-18: Q3001
HCPCS CodeQ3001: Radioelements for brachytherapy, any type, each
Coverage noteCovered when selection criteria in the policy are met.
Use caseBrachytherapy requiring radioelements for treatment of hepatic neoplasms as applicable per criteria.
inv-19: S2095
HCPCS CodeS2095: Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres
Coverage noteCovered if policy selection criteria are met for intra-hepatic microsphere therapy.
Procedure contextUsed for yttrium-90 microsphere embolization of liver tumors.
inv-20: J2353
J-codeJ2353: Octreotide, depot form for intramuscular injection, 1 mg
Relation to policyListed as an HCPCS code related to the clinical procedure bundle (CPB); document does not state separate coverage determination in this section.
Typical useSystemic octreotide therapy referenced in criteria for CE and microsphere indications (failure of octreotide may trigger CE/microsphere eligibility).
inv-21: J2354
J-codeJ2354: Octreotide, nondepot form for subcutaneous or intravenous injection, 25 mg
Relation to policyListed as an HCPCS code related to the clinical procedure bundle (CPB); document does not state separate coverage determination in this section.
Typical useReferenced in relation to systemic octreotide therapy for neuroendocrine tumors; failure of such therapy is part of selection criteria for regional procedures.
Therapy Line Designation
Second-line
Covered as second-line when the single condition below is met:
Chemoembolization is considered only after failure of systemic therapy with octreotide to control carcinoid syndrome for neuroendocrine tumors.
Covered Procedures and Regimens
| Regimen | Coverage status | Indication / Notes |
|---|---|---|
| Intra-hepatic chemotherapy (infusion) | Covered | Medically necessary for members with liver metastases from colorectal cancer; experimental/investigational for other indications including treatment of liver primaries, 'one-shot' arterial chemotherapy for colorectal metastases, and transarterial gene therapy |
| Example approaches | Policy notes that single‑shot arterial chemotherapy and transarterial gene therapy are considered experimental due to insufficient evidence |
| Regimen | Coverage status | Indications / Notes |
|---|---|---|
| Yttrium‑90 microsphere therapy (TheraSphere, SIR‑Spheres) | Covered | Medically necessary for: symptomatic neuroendocrine liver metastases after failure of octreotide to control carcinoid syndrome; unresectable primary HCC; unresectable colorectal liver metastases; and pre‑operative bridge to orthotopic liver transplantation for HCC |
| HCPCS coding | HCPCS code S2095 is listed as covered if selection criteria are met; Q3001 (radioelements for brachytherapy) is listed elsewhere in the policy as covered when criteria apply |
| Procedure / Approach | Coverage status | Rationale / Policy detail |
|---|---|---|
| Combined radiofrequency ablation (RFA) and percutaneous ethanol injection (PEI) | Experimental | UHA considers combined RFA and PEI experimental and investigational for treatment of HCC because of insufficient evidence in the peer‑reviewed literature |
| Transarterial gene therapy | Experimental | Listed as experimental/investigational due to insufficient evidence |
| 'One‑shot' arterial chemotherapy for colorectal metastases | Experimental | Specifically noted as experimental for intra‑hepatic chemotherapy outside the established colorectal metastases indication |
| Chemoembolization (CE) for palliative treatment of non‑neuroendocrine metastases | Experimental | CE is considered experimental/investigational for indications other than neuroendocrine tumors, unresectable HCC, uveal melanoma liver‑only metastasis, or preoperative bridge to transplant because of inadequate evidence |
Policy Summary
PayerUniversity Health Alliance (HSA)
PolicyTreatment of hepatic neoplasms (non-systemic chemotherapy)
Policy CodePolicy MPP-0016-120117
Change TypeNo material changes
Effective DateAug 1, 2022
Last ReviewAug 1, 2022
Next Review DateN/A
Key ActionObtain prior authorization via UHA's online portal whenever liver tumors are considered for treatment outside of systemic chemotherapy.
SourceLink
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