CurrentPremera Blue Cross of WashingtonPolicy 8.01.521
Radioembolization for Liver Malignancies
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This policy governs when intra-arterial radioembolization may be considered medically necessary for primary and metastatic liver cancers. It applies to providers submitting requests for coverage and specifies documentation, coding, and investigational-use limitations.
Policy Summary
PayerPremera Blue Cross of Washington
PolicyRadioembolization for Liver Malignancies
Policy CodePolicy 8.01.521
Change TypeAnnual review — no material changes
Effective DateOctober 1, 2026
Next Review DateN/A
Key ActionSubmit medical records documenting that the radioembolization medical necessity criteria are met.
The 2026 annual review updated the literature review and references while leaving policy statements unchanged.
5Covered clinical indication groups
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8 cm
Maximum total tumor size for one HCC indication
ECOG 0–2Performance status referenced for candidates
Child-Pugh A or BLiver function referenced for candidates
InvestigationalOther hepatic metastases and indications
Medical Necessity and Coverage Criteria
Medical Necessity
Radioembolization may be considered medically necessary when at least ONE of the following indication groups is met:
ONE of the following
Treatment of primary hepatocellular carcinoma that is unresectable and has liver-dominant metastases; total tumor size does not exceed 8 cm, and the individual has good performance status.
Treatment of primary hepatocellular carcinoma as a bridge to liver transplantation.
Treatment of primary intrahepatic cholangiocarcinoma in an individual with unresectable tumors and liver-dominant metastases.
Treatment of hepatic metastases from neuroendocrine tumors, including carcinoid and noncarcinoid tumors, when disease is diffuse and symptomatic and systemic therapy has failed to control symptoms related to excess hormone production.
Treatment of unresectable hepatic metastases from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer when disease is progressive and diffuse in an individual with liver-dominant disease and is refractory to chemotherapy or the individual is not a candidate for chemotherapy or other systemic therapies.
General Eligibility and Selection
Radioembolization is generally appropriate only when ALL of the following eligibility considerations are met, with treatment selection based on disease distribution, prior therapy, hepatic function, and expected clinical benefit.
ALL of the following
The individual has unresectable or inoperable primary or secondary liver malignancy, particularly colorectal cancer or neuroendocrine tumor metastases. Tumor burden is generally liver dominant but need not be exclusively confined to the liver.
The individual has a performance status that allows them to benefit from radioembolization.
Life expectancy is at least 3 months.>= 3 months
Laboratory data indicate that the procedure can be performed safely.
Primary Hepatocellular Carcinoma
For primary hepatocellular carcinoma, radioembolization may be considered when ALL applicable treatment-selection requirements are met:
ALL of the following
The hepatocellular carcinoma is unresectable, or the individual is not a candidate for potential curative treatment such as resection, transplantation, or, for small lesions, ablative therapy.
The arterial blood supply can be isolated without excessive nontarget treatment.
ONE of the following disease settings
Unresectable disease with liver-dominant metastases, total tumor size not exceeding 8 cm, and good performance status.
Use as a bridge to liver transplantation.
Metastatic Neuroendocrine Tumors
For metastatic neuroendocrine tumors, radioembolization may be considered when ALL of the following are met:
ALL of the following
The hepatic neuroendocrine tumor metastases are diffuse and symptomatic, including symptoms related to excess hormone production, and systemic therapy has failed to control symptoms.
Disease distribution or treatment-planning setting supports TARE
Disease has a lobar distribution.
Disease has a segmental distribution.
The individual has undergone prior Whipple surgery.
The individual has prior biliary tract instrumentation.
Metastatic Colon Cancer
For metastatic colon cancer, radioembolization may be considered when ALL of the following are met:
ALL of the following
The disease is chemotherapy-resistant or refractory, or has progressed despite prior systemic therapy.
Metastatic disease is predominant in the liver.
The individual is selected for arterially directed catheter therapy based on clinical judgment and disease-specific factors.
Radioembolization may also be considered when hepatic metastatic disease is not optimally resectable because of insufficient future remnant liver volume.
Unresectable Colorectal Liver Metastases After Treatment Failure
Radioembolization may be considered medically necessary for unresectable intrahepatic colorectal metastases after treatment failure when ALL of the following are met:
ALL of the following
The intrahepatic colorectal metastases are unresectable.
Prior treatment, including chemotherapy, has failed or the disease has progressed despite treatment.
The disease is liver dominant and the individual is an appropriate candidate based on performance status, life expectancy, laboratory findings, hepatic reserve, and treatment-planning evaluation.
The expected benefits and risks of radioembolization have been evaluated, including treatment-related morbidity and the potential for improved tumor response or delayed hepatic disease progression.
Radioembolization is considered investigational for hepatic metastases other than the specified covered indications in the Medical Necessity section.
Radioembolization is considered investigational for all indications not described in the Medical Necessity section.
Absolute contraindications and exclusion considerations include: inability to catheterize the hepatic artery; fulminant liver failure; clinically unacceptable nontarget deposition on mapping angiography, contrast-enhanced cone-beam CT, or technetium-99m macroaggregated albumin hepatic arterial perfusion scintigraphy that cannot be corrected by embolization or delivery adjustment; unacceptable hepatopulmonary shunt fraction for the specific yttrium-90 product; active hepatic infection; and uncorrectable coagulopathy. Relative contraindications include excessive hepatic tumor burden with more than 50% to 70% of the parenchyma replaced by tumor, although treatment may be considered when synthetic hepatic function is preserved; total bilirubin greater than 2 mg/dL in the absence of biliary obstruction or Gilbert disease; and prior radiation therapy to the liver or upper abdomen involving a significant liver volume. In hepatocellular carcinoma, elevated bilirubin may be acceptable when segmental or subsegmental infusion can be performed.
For metastatic uveal melanoma, the NCCN guidelines state that further study is required to determine the appropriate patients for radioembolization and the risks and benefits of this approach.
This medical policy does not apply to Medicare Advantage.
Radioembolization is considered investigational for unresectable intrahepatic metastases from non-colorectal cancers, including examples such as breast, melanoma, and pancreatic cancers, because available evidence is insufficient to establish an improvement in net health outcome.
The 2023 ASCO guideline for metastatic colorectal cancer states that selective internal radiation therapy (SIRT), including yttrium-90 microsphere radioembolization, is not routinely recommended for patients with unilobar or bilobar liver metastases because harms outweigh benefits; the evidence quality is low and the recommendation is weak.
Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.
ApplicabilityPrimary hepatocellular carcinoma with unresectable, liver-dominant disease
Maximum total tumor sizeDoes not exceed 8 cm
Performance statusGood performance status is required
ECOG performance status
SystemEastern Cooperative Oncology Group performance status
Acceptable range0-2
Documentation, Eligibility, and Risk Checks
Documentation Required
Submit Records Supporting Coverage Criteria
Submit medical records demonstrating that the applicable medical-necessity criteria are met for radioembolization. The submission should support the diagnosis, disease distribution and progression, resectability, prior or alternative systemic therapy, and treatment candidacy.
Include relevant office visit notes, history and physical examination findings, imaging, pathology, laboratory results, treatment history, and specialist assessments.
Document the applicable covered indication and all required disease-specific characteristics.
Documentation Required
Confirm Pre-Treatment Eligibility and Mapping
Before treatment, document the malignancy and confirm that the individual meets the applicable eligibility requirements for radioembolization. The record should establish an unresectable or inoperable primary or secondary liver malignancy, a performance status likely to permit benefit, life expectancy of at least 3 months, and laboratory evidence that treatment can be performed safely.
For primary hepatocellular carcinoma, document unresectability and liver-dominant disease; tumor size must not exceed a total of 8 cm and the individual must have good performance status when required by the coverage criteria.
Clinical Background
Radioembolization, also called selective internal radiotherapy, delivers microspheres impregnated with yttrium-90 through the hepatic artery. The microspheres preferentially reach liver tumors, become permanently embedded, and emit localized beta radiation. Candidates are evaluated with hepatic angiography and technetium-99-labeled albumin simulation to assess arterial anatomy and possible gastrointestinal or pulmonary shunting.
Definitions
Child-Pugh Score
名称Child-Pugh Score
PurposeUsed to assess the prognosis of chronic liver disease
Typical conditionUsually cirrhosis
Eastern Cooperative Oncology Group (ECOG)
名称Eastern Cooperative Oncology Group (ECOG)
PurposePerformance-status system used to assess disease progression
Functional impactAssesses how disease affects activities of daily living
Policy Summary
PayerPremera Blue Cross of Washington
PolicyRadioembolization for Liver Malignancies
Policy CodePolicy 8.01.521
Change TypeAnnual review — no material changes
Effective DateOctober 1, 2026
Next Review DateN/A
Key ActionSubmit medical records documenting that the radioembolization medical necessity criteria are met.
Disease-specific selection criteria and treatment planning support radioembolization, including assessment of hepatic arterial anatomy, tumor distribution, prior treatment, hepatic reserve, and anticipated benefit.
Advanced disease in which radioembolization is clinically appropriate, including selected individuals with segmental or lobar portal-vein thrombosis rather than main portal-vein thrombosis.
For anatomically limited disease, radiation segmentectomy with yttrium-90 or ablative-dose stereotactic body radiation therapy has been considered as an alternative or preferred locoregional approach when appropriate.
Bilirubin and hepatic function are acceptable for treatment. Arterially directed therapy is relatively contraindicated when bilirubin is greater than 3 mg/dL unless segmental treatment can be performed; yttrium-90 radioembolization has increased risk of radiation-induced liver disease when bilirubin is greater than 2 mg/dL.
Treatment planning accounts for dose and liver reserve; delivery of at least 205 Gy to the tumor may be associated with increased overall survival, and a dose greater than 400 Gy to 25% or less of the liver is recommended in individuals with Child-Pugh A liver function.
Clinical considerationRadioembolization should be reserved for individuals with adequate functional status
Child-Pugh class
Liver-function measureChild-Pugh class
Acceptable classesA or B
Clinical considerationAdequate liver function and reserve are required
Minimum life expectancy
Minimum life expectancyAt least 3 months
Applies toCandidates with unresectable or inoperable primary or secondary liver malignancies
Additional considerationLaboratory data must indicate that treatment can be performed safely
Liver tumor burden
ThresholdMore than 50%-70% of hepatic parenchyma replaced by tumor
Clinical significanceRelative contraindication
Possible exceptionTreatment may be considered with more extensive tumor burden if synthetic hepatic function is preserved
Total bilirubin
Greater than 2 mg/dLIndicates severe liver-function impairment and increased risk of radiation-induced liver disease
Greater than 3 mg/dLRelative contraindication for arterially directed therapy
Segmental treatment exceptionTreatment may be performed when segmental or subsegmental infusion is feasible
Hepatocellular carcinoma tumor dose
Tumor dose threshold205 Gy or more
Clinical associationMay be associated with increased overall survival
Treatment contextRadioembolization with yttrium-90 microspheres for hepatocellular carcinoma
Normal liver dose in Child-Pugh A HCC
Patient populationPatients with Child-Pugh A liver function
Dose constraintGreater than 400 Gy to 25% of the liver or less is recommended
Treatment contextNormal-liver dose constraint for hepatocellular carcinoma radioembolization
For intrahepatic cholangiocarcinoma, document an unresectable primary tumor with liver-dominant metastases.
For covered metastases, document the qualifying tumor type, diffuse or progressive disease, liver-dominant involvement, symptoms and failed systemic therapy when applicable, or lack of candidacy for chemotherapy or other systemic therapy.
Complete initial mapping angiography, contrast-enhanced cone-beam CT when used, and technetium-99m MAA hepatic arterial perfusion scintigraphy before delivery; assess arterial anatomy, nontarget deposition, and pulmonary shunt fraction.
Documentation Required
Document Medical Necessity
Provide office visit notes containing the relevant history and physical examination findings needed to establish medical necessity for the requested treatment. Documentation must connect the clinical findings to the specific covered indication rather than merely listing a diagnosis.
Primary liver cancer: document that the tumor cannot be removed surgically, is limited or dominant in the liver, and meets the applicable size and performance-status requirements.
Hepatocellular carcinoma: document whether treatment is being used before liver transplantation and the individual’s suitability for locoregional treatment.
Neuroendocrine metastases: document diffuse, symptomatic hepatic disease, including symptoms related to excess hormone production, and failure of systemic therapy to control symptoms.
Breast, colorectal, or ocular or cutaneous melanoma metastases: document unresectable, progressive disease that is liver dominant and refractory to chemotherapy or for which chemotherapy or other systemic therapy is not suitable.
Documentation Required
Evaluate Patient Selection and Safety
Perform and document a clinical assessment confirming that the individual is an appropriate candidate and that the expected benefit outweighs treatment risks. The assessment should address performance status, life expectancy, hepatic reserve, tumor burden, bilirubin, prior radiation, coagulopathy, infection, arterial access, and treatment-planning results.
Confirm a performance status that allows the individual to benefit and a life expectancy of at least 3 months.
Review laboratory data and hepatic synthetic function to determine whether the procedure can be performed safely.
Evaluate whether excessive tumor burden, elevated bilirubin, prior radiation to a significant liver volume, or other high-risk features require individualized authorized-user judgment.
Do not proceed when an absolute contraindication is present, including inability to catheterize the hepatic artery, fulminant liver failure, active hepatic infection, or uncorrectable coagulopathy.
Documentation Required
Document Hepatocellular Carcinoma Suitability
For hepatocellular carcinoma, document why potentially curative options are not appropriate and why radioembolization is suitable. The record should address resection, liver transplantation, and ablation for small lesions, as well as arterial isolation and treatment planning.
Document that the tumor is not suitable for resection, transplantation, or, when applicable, ablative treatment; if radioembolization is being used as a bridge to transplantation, document transplant intent and eligibility.
Confirm that arterial blood supply can be isolated without excessive nontarget treatment.
Assess portal-vein thrombosis, including whether disease is segmental or lobar rather than main portal-vein thrombosis, when relevant to treatment selection.
Address bilirubin and liver function: arterially directed therapy is relatively contraindicated when bilirubin is greater than 3 mg/dL unless segmental treatment can be performed; radioembolization has increased risk of radiation-induced liver disease when bilirubin exceeds 2 mg/dL.
Denial Risk
Unlisted Hepatic Metastases
Radioembolization is investigational for hepatic metastases other than the covered metastatic indications identified in the medical-necessity criteria. Do not represent treatment of an unlisted hepatic metastasis as covered without documentation showing that it falls within a specified indication.
Covered metastatic settings are limited to qualifying neuroendocrine tumors and unresectable, progressive, liver-dominant metastases from colorectal carcinoma, melanoma, or breast cancer meeting the systemic-therapy requirements.
Denial Risk
Unlisted Indications
Radioembolization is investigational for indications not described in the policy’s medical-necessity criteria. Verify the diagnosis and intended treatment indication before requesting or performing the procedure.
Do not assume coverage based solely on the presence of liver disease or a primary or metastatic cancer not expressly identified in the policy.
Denial Risk
Prevent Denial for Unestablished Criteria
Coverage may be denied when the submitted record does not establish the applicable tumor type and all required clinical criteria. Ensure the record clearly supports unresectability, liver-dominant disease, progression or symptoms when required, and the relevant treatment-history requirements.
Document the qualifying primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, neuroendocrine tumor, colorectal carcinoma, melanoma, or breast cancer diagnosis.
For HCC, establish unresectability, liver-dominant or liver-limited disease, the applicable tumor-size limit, and good performance status.
For metastatic disease, establish unresectability, liver-dominant involvement, and progression or diffuse symptomatic disease as applicable.
For neuroendocrine tumors, establish hormone-related symptoms and failure of systemic therapy to control symptoms.
For colorectal, melanoma, or breast metastases, establish progression and failure of chemotherapy or that the individual is not a candidate for chemotherapy or other systemic therapy.
Denial Risk
Screen for Absolute Contraindications
Do not treat when an absolute contraindication to radioembolization is present. Resolve or exclude these conditions before treatment and retain the supporting assessment in the medical record.
Inability to catheterize the hepatic artery.
Fulminant liver failure.
Clinically unacceptable nontarget deposition on mapping angiography, contrast-enhanced cone-beam CT, or MAA perfusion imaging that cannot be corrected with embolization or delivery adjustment.
Unfavorable hepatic-artery-to-pulmonary shunt function exceeding the acceptable limit for the specific yttrium-90 product.
Active hepatic infection.
Uncorrectable coagulopathy.
Denial Risk
Address Relative Contraindications and High-Risk Features
Assess relative contraindications and document the authorized user’s individualized judgment when treatment is considered despite elevated risk. The expected benefit must outweigh the risk of hepatic injury or other complications.
Tumor replacing more than 50%-70% of the liver parenchyma; treatment may be considered with more extensive burden when synthetic hepatic function is preserved.
Total bilirubin greater than 2 mg/dL, absent biliary obstruction or Gilbert disease, indicating severe liver impairment and potentially unfavorable risk-benefit balance.
Prior radiation therapy to the liver or upper abdomen involving a significant liver volume.
Explain the rationale for proceeding or deferring treatment and document the relevant hepatic reserve and treatment plan.
Denial Risk
Evaluate Hepatic Dysfunction in HCC
For HCC, elevated bilirubin requires particular caution because radioembolization increases the risk of radiation-induced liver disease. Arterially directed therapy is relatively contraindicated when bilirubin exceeds 3 mg/dL unless a segmental treatment can be performed; document the exception and treatment plan when applicable.
Assess bilirubin, Child-Pugh class or other measures of hepatic reserve, and the extent of liver involvement.
A segmental or subsegmental infusion may permit treatment of selected individuals with HCC and elevated bilirubin when disease is anatomically limited and adequate uninvolved liver can be preserved.
Document why the planned infusion is sufficiently limited and why the anticipated benefit outweighs the risk.
Symptomatic disease from metastatic neuroendocrine tumors
ConditionMetastatic neuroendocrine tumor disease
DefinitionSymptoms related to excess hormone production
Coverage contextRelevant when disease is diffuse and symptomatic and systemic therapy has failed to control symptoms
Radioembolization (RE)
TreatmentYttrium-90 microspheres delivered through the hepatic arterial circulation
Alternative termSelective internal radiation therapy (SIRT)
Another alternative termTransarterial radioembolization (TARE)