CurrentPremera Blue Cross of WashingtonPolicy 8.01.521

Radioembolization for Primary and Metastatic Liver Tumors

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This policy governs when hepatic radioembolization may be medically necessary for primary liver cancers and selected liver metastases, and identifies other indications as investigational. It also specifies supporting documentation and applicable procedure and supply codes for providers.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyRadioembolization for Primary and Metastatic Liver Tumors

Policy CodePolicy 8.01.521

Change TypeAnnual reviewno material change

Effective DateOctober 1, 2026

Last ReviewOct 1, 2026

Next Review DateNot specified

Key ActionSubmit medical records documenting that the applicable medical necessity criteria are met.

SourceLink

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CurrentPremera Blue Cross of WashingtonPolicy 8.01.521

Radioembolization for Primary and Metastatic Liver Tumors

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyRadioembolization for Primary and Metastatic Liver Tumors

Policy CodePolicy 8.01.521

Change TypeAnnual reviewno material change

Effective DateOctober 1, 2026

Last ReviewOct 1, 2026

Next Review DateNot specified

Key ActionSubmit medical records documenting that the applicable medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5Medical necessity pathways

8 cmMaximum tumor size

ECOG 0-2Candidate performance status

Child-Pugh A/BCandidate liver function

Y-90Treatment isotope

≥3 monthsMinimum life expectancy

Medical Necessity and Investigational Use

Medical Necessity — Radioembolization

Radioembolization may be considered medically necessary when ALL applicable requirements within at least ONE of the following pathways are met:

ONE of the following medical-necessity pathways

Primary hepatocellular carcinoma — unresectable, liver-dominant disease
- Primary hepatocellular carcinoma is unresectable and associated with liver-dominant metastases.
- The total tumor size does not exceed 8 cm.
- The individual has good performance status.
Primary hepatocellular carcinoma — bridge to transplantation
- Primary hepatocellular carcinoma is being treated as a bridge to liver transplantation.
Primary intrahepatic cholangiocarcinoma
- Primary intrahepatic cholangiocarcinoma is unresectable.
- Disease is liver dominant.
Neuroendocrine tumor hepatic metastases
- Hepatic metastases are from a neuroendocrine tumor, carcinoid or noncarcinoid.
- Disease is diffuse and symptomatic, with symptoms related to excess hormone production.
- Systemic therapy has failed to control the symptoms.
Colorectal carcinoma, melanoma, or breast cancer hepatic metastases
- Hepatic metastases are from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer.
- The metastases are unresectable.
- Disease is progressive and diffuse in an individual with liver-dominant disease.
- ONE of the following treatment-status requirements
  - Disease is refractory to chemotherapy.
  - The individual is not a candidate for chemotherapy or other systemic therapies.

Investigational Use

Radioembolization is considered investigational when the following applies:

ANY of the following

Hepatic metastases do not meet one of the medical-necessity pathways listed above.
The indication is not described in the Medical Necessity section.

General Guideline-Supported Indications

Consistent with the American College of Radiology multidisciplinary practice parameter, treatment should be considered only when ALL of the following clinical elements are present:

ALL required guideline-supported elements

There are unresectable or inoperable primary or secondary liver malignancies, particularly colorectal cancer or neuroendocrine tumor metastases. Tumor burden is generally liver dominant but is not required to be exclusively within the liver.
The individual has a performance status that will allow benefit from the therapy.
Life expectancy is at least 3 months.>= 3 months
Laboratory data indicate that the procedure can be performed safely.

Colorectal Cancer Evidence-Supported Use

For the evidence-supported colorectal cancer population, ALL of the following characterize the reviewed use:

Reviewed evidence population

The individual has unresectable intrahepatic metastases from colorectal carcinoma.
Prior treatment has failed, including progression after first-line chemotherapy.
Radioembolization is being used to address liver-dominant disease.
The treatment decision considers progression-free survival, hepatic progression-free survival, overall survival, functional outcomes, quality of life, and treatment-related morbidity.

Primary Hepatocellular Carcinoma — NCCN Context

NCCN describes yttrium-90 radioembolization as an arterially directed locoregional therapy that may be appropriate in the following primary hepatocellular carcinoma context:

NCCN-described treatment context

The individual is not a candidate for potentially curative treatment, including resection, transplantation, or ablation for small lesions.
The arterial blood supply can be isolated without excessive nontarget treatment.
Treatment context
- Disease is anatomically limited and radiation segmentectomy is being considered.
- The individual has advanced hepatocellular carcinoma with segmental or lobar portal-vein thrombosis rather than main portal-vein thrombosis.

Hepatic metastases from conditions other than the specifically listed medical-necessity pathways are excluded from medical necessity and are considered investigational.

Radioembolization is considered investigational for all indications not described in the Medical Necessity section.

Coverage requires evaluation of procedure-related contraindication and risk conditions. Radioembolization should not be performed when any absolute contraindication is present, including inability to catheterize the hepatic artery; fulminant liver failure; clinically unacceptable nontarget deposition on mapping angiography, contrast-enhanced cone-beam CT, or technetium-99m MAA hepatic arterial perfusion scintigraphy that cannot be corrected by embolization or delivery adjustment; unacceptable hepatopulmonary shunt function or shunt fraction above product-specific limits; active hepatic infection; or uncorrectable coagulopathy. Relative contraindications requiring clinical judgment include excessive hepatic tumor burden with more than 50%–70% of the parenchyma replaced by tumor, total bilirubin greater than 2 mg/dL absent biliary obstruction or Gilbert disease, and prior radiation to the liver or upper abdomen involving a significant liver volume. Treatment may be considered with extensive tumor burden when synthetic hepatic function is preserved, and elevated bilirubin in hepatocellular carcinoma may be acceptable when segmental or subsegmental infusion can be performed.

Radioembolization for metastatic uveal melanoma requires further study to determine the appropriate patients and the risks and benefits of this approach; therefore, it is considered investigational.

This medical policy does not apply to Medicare Advantage.

Procedure, Supply, and Clinical Coding

CPTCPT

37243	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.
75894	Transcatheter therapy, embolization, any method, radiological supervision and interpretation

CPTCPT

79445

Radiopharmaceutical therapy, by intra-arterial particulate administration.

HCPCSHCPCS

C2616	Brachytherapy source, nonstranded, yttrium-90, per source.
S2095	Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrrium-90 microspheres

FDA Product Codemixed

NAW	FDA product code for Y-90 microspheres

Historical CPT coding updateCPT

37204

CPT code 37204 discontinued effective 12/31/13.

Historical CPT coding updateCPT

37243

CPT code 37243, effective 1/1/14, added to the policy; later removed because it does not apply to this policy.

Historical CPT coding updateCPT

77776	CPT code 77776 added to the policy; later removed as a deleted code effective 1/1/16.
77778	CPT code 77778 removed; deleted code as of 1/1/16.
77399	CPT code 77399 removed in the 2017 coding update.

Historical ICD-9 coding updateICD-10

197.7

ICD-9 diagnosis code 197.7 added.

Historical HCPCS coding updateHCPCS

C2616

HCPCS code C2616 added to the policy.

Total Tumor Size

Maximum total tumor sizeDoes not exceed 8 cm

Applies toUnresectable primary hepatocellular carcinoma with liver-dominant metastases

Additional clinical factorGood performance status is required

ECOG Performance Status

Eligible ECOG range0-2

Documentation, Planning, and Contraindications

Documentation Required

Medical Records Supporting Medical Necessity

Submit medical records demonstrating that the radioembolization medical-necessity criteria are met. Include office visit notes with the relevant history and physical, disease status, treatment history, and supporting clinical documentation.

Document unresectable or inoperable primary liver cancer limited to or dominant in the liver, including tumor size not exceeding 8 cm in total and good performance status when applicable.
Document hepatocellular carcinoma treatment as a bridge to liver transplantation, or unresectable primary intrahepatic cholangiocarcinoma with liver-dominant metastases.
For neuroendocrine metastases, document diffuse, symptomatic hepatic disease and failure of systemic therapy to control symptoms related to excess hormone production.
For breast, colorectal, or ocular/cutaneous melanoma metastases, document progressive, diffuse, unresectable liver-dominant disease and failed chemotherapy or ineligibility for chemotherapy or other systemic therapy.

Documentation Required

Clinical Eligibility and Safety Documentation

Therapy Overview

Radioembolization, also called selective internal radiotherapy, delivers yttrium-90 (Y-90) microspheres through the hepatic artery. The microspheres preferentially reach liver tumors, become permanently embedded, and deliver localized beta radiation while also embolizing the tumor’s blood supply. Evaluation includes hepatic angiography and technetium-99-labeled albumin simulation to assess arterial anatomy and potential gastrointestinal or pulmonary shunting. Treatment is generally reserved for individuals with adequate functional status, liver function and reserve, and liver-dominant metastases.

Clinical Terms

Child-Pugh Score

DefinitionA score used to assess the prognosis of chronic liver disease, usually cirrhosis

Clinical useAssesses liver disease severity and prognosis

Policy applicationChild-Pugh class A or B identifies generally suitable liver function for radioembolization candidates

Eastern Cooperative Oncology Group (ECOG)

DefinitionA performance status used to assess disease progression and how disease affects activities of daily living

Eligible rangeECOG performance status 0-2

Policy application

Policy Summary

PayerPremera Blue Cross of Washington

PolicyRadioembolization for Primary and Metastatic Liver Tumors

Policy CodePolicy 8.01.521

Change TypeAnnual reviewno material change

Effective DateOctober 1, 2026

Last ReviewOct 1, 2026

Next Review DateNot specified

Key ActionSubmit medical records documenting that the applicable medical necessity criteria are met.

SourceLink

On This Page

Locoregional arterially directed therapy is otherwise appropriate based on clinical judgment.

Assesses disease progression and the impact of disease on activities of daily living

Candidate suitabilityRadioembolization should be reserved for individuals with adequate functional status

Child-Pugh Classification

Eligible Child-Pugh classesA or B

Clinical requirementAdequate liver function and reserve

Use in selectionIdentifies liver function suitability for radioembolization candidates

Minimum Life Expectancy

Minimum life expectancyAt least 3 months

Patient populationUnresectable or inoperable primary or secondary liver malignancy

Additional requirementLaboratory data must suggest that the procedure can be performed safely

Excessive Hepatic Tumor Burden

Relative contraindicationGreater than 50%-70% of the liver parenchyma replaced by tumor

Clinical concernExcessive hepatic tumor burden

Possible considerationTreatment may be considered with more extensive tumor burden if synthetic hepatic function is preserved

Relative Bilirubin Threshold

Increased-risk thresholdTotal bilirubin greater than 2 mg/dL

Exceptions to interpretationThreshold applies in the absence of biliary obstruction or Gilbert disease

HCC considerationIndividuals with HCC and elevated bilirubin may be treated if segmental or subsegmental infusion can be performed

HCC Arterially Directed Therapy

Relative contraindicationBilirubin greater than 3 mg/dL

ExceptionArterially directed therapy may be considered when segmental treatment can be performed

Therapy contextApplies to arterially directed therapies for primary hepatocellular carcinoma

HCC Tumor Dose

Tumor dose205 Gy or more

Clinical associationMay be associated with increased overall survival

Treatment contextYttrium-90 microsphere radioembolization for hepatocellular carcinoma

HCC Normal-Liver Dose

Recommended doseGreater than 400 Gy

Liver volumeTo 25% or less of the liver

Applicable liver functionChild-Pugh A

Document that the individual is an appropriate candidate for radioembolization and that the procedure can be performed safely. The record should establish disease distribution, functional status, expected benefit, life expectancy, and relevant laboratory results.

Document unresectable or inoperable primary or secondary liver malignancy; disease is generally liver dominant but need not be exclusively confined to the liver.
Document performance status sufficient for the individual to benefit from treatment and life expectancy of at least 3 months.
Include laboratory data indicating that radioembolization can be performed safely.
Confirm the applicable covered disease pathway and document treatment candidacy, including prior systemic therapy or lack of candidacy when required.

Documentation Required

Pre-treatment Vascular Mapping

Complete pretreatment vascular mapping before treatment and submit the results. Mapping must assess arterial anatomy, identify potential nontarget perfusion, and evaluate hepatopulmonary shunt function.

Include initial mapping angiography results.
Include contrast-enhanced cone-beam CT results when performed.
Include technetium-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy results.
Document any embolization or delivery adjustment used to ameliorate potentially nontarget deposition and the resulting assessment.

Documentation Required

Liver Function and Treatment-Planning Details

Provide liver-function and treatment-planning data sufficient to evaluate procedural risk and the planned radiation delivery. Address tumor burden, hepatic reserve, prior radiation, arterial isolation, and portal-vein anatomy.

Report total bilirubin and relevant hepatic reserve; bilirubin greater than 2 mg/dL generally indicates increased risk, and nonobstructive elevation may indicate severe impairment. Bilirubin greater than 3 mg/dL is relatively contraindicated unless segmental treatment can be performed.
Document whether more than 50%-70% of the hepatic parenchyma is replaced by tumor and whether synthetic hepatic function is preserved when tumor burden is extensive.
Document prior radiation therapy to the liver or upper abdomen that included a significant liver volume and the authorized user's clinical assessment.
Confirm that arterial blood supply can be isolated without excessive nontarget treatment and document portal-vein thrombosis distribution; segmental or lobar, rather than main portal-vein, thrombosis may be a setting in which treatment is considered for advanced HCC.
Include the planned radiation approach and dose considerations when relevant, including segmental or subsegmental treatment, radiation segmentectomy, and dose-related risk of radiation-induced liver disease.

Denial Risk

Other Hepatic Metastases

Radioembolization is considered investigational for hepatic metastases other than the specified neuroendocrine, colorectal, melanoma, and breast cancer pathways and the covered primary liver malignancy indications.

Exceptions are limited to the medical-necessity pathways described for neuroendocrine tumors and unresectable, progressive, diffuse, liver-dominant metastases from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer meeting the stated treatment-resistance or treatment-ineligibility criteria.

Denial Risk

Unlisted Indications

Radioembolization is considered investigational for indications not described in the policy's medical-necessity criteria.

Do not represent an unlisted indication as medically necessary without documentation that it falls within an expressly covered pathway.

Denial Risk

Absolute Clinical Contraindications

Do not proceed when an absolute clinical contraindication is present. These conditions indicate that radioembolization cannot be safely performed or is not appropriate.

Inability to catheterize the hepatic artery.
Fulminant liver failure.
Active hepatic infection.
Uncorrectable coagulopathy.

Denial Risk

Uncorrectable Nontarget Deposition

Do not treat when mapping demonstrates clinically unacceptable nontarget deposition that cannot be corrected. The finding must be assessed using pretreatment vascular mapping and documented in the treatment record.

Unacceptable nontarget deposition on initial mapping angiography, contrast-enhanced cone-beam CT, and/or technetium-99m MAA hepatic arterial perfusion scintigraphy is a contraindication when it cannot be ameliorated with embolization or delivery adjustment.
Document the corrective measure and repeat assessment when embolization or delivery adjustment is attempted.

Denial Risk

Unacceptable Hepatopulmonary Shunt

Do not proceed when pretreatment technetium-99m MAA testing demonstrates an unfavorable or unacceptable shunt between the liver and pulmonary parenchyma. The shunt fraction must remain within the acceptable limit for the specific yttrium-90 product.

Include the pretreatment hepatic arterial MAA shunt assessment.
Apply the product-specific acceptable shunt-fraction threshold; a shunt fraction above that limit is a contraindication.

Denial Risk

Relative Contraindications and Treatment Cautions

Evaluate relative contraindications and document the authorized user's clinical judgment before treatment. These factors may increase toxicity or reduce expected benefit, particularly when combined with other hepatic or treatment-related risks.

Excessive tumor burden replacing more than 50%-70% of the liver is a relative contraindication; treatment may be considered only when synthetic hepatic function is preserved.
Total bilirubin greater than 2 mg/dL, absent biliary obstruction or Gilbert disease, indicates severe liver impairment and increased risk. In HCC, elevated bilirubin may still permit treatment when segmental or subsegmental infusion is feasible; bilirubin greater than 3 mg/dL is generally relatively contraindicated unless segmental treatment can be performed.
Prior radiation to a significant liver volume requires individualized clinical judgment because of increased risk of liver injury.
For HCC, consider the increased risk of radiation-induced liver disease with bilirubin greater than 2 mg/dL, planned dose and treated liver volume, and whether segmental treatment or radiation segmentectomy is appropriate.
Assess portal-vein thrombosis and overall hepatic reserve; segmental or lobar portal-vein thrombosis may be more compatible with treatment than main portal-vein thrombosis.

Indicates adequate functional status for radioembolization candidates

Symptomatic Disease From Metastatic Neuroendocrine Tumors

DefinitionSymptoms related to excess hormone production

Disease contextDiffuse, symptomatic hepatic metastases from neuroendocrine tumors

Treatment contextSystemic therapy has failed to control the symptoms

SIRT

AbbreviationSIRT

MeaningSelective internal radiation therapy

Guideline contextNot routinely recommended for metastatic colorectal cancer with unilobar or bilobar liver metastases

TARE

AbbreviationTARE

MeaningTransarterial radioembolization

Neuroendocrine tumor contextMay be considered for lobar or segmental disease distribution, including in patients with prior Whipple surgery or biliary tract instrumentation