CurrentPremera Blue Cross of WashingtonPolicy 8.01.521

Radioembolization for Primary and Metastatic Liver Tumors

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This policy governs when intra-arterial radioembolization may be considered medically necessary for primary liver cancers and selected hepatic metastases. It applies to providers submitting coverage requests and defines documentation and coding requirements.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyRadioembolization for Primary and Metastatic Liver Tumors

Policy CodePolicy 8.01.521

Change TypeAnnual reviewno material clinical or coverage changes

Effective DateOctober 1, 2026

Next Review DateNot specified

Key ActionSubmit medical records documenting that medical necessity criteria are met, including office visit notes supporting the applicable covered clinical situation.

SourceLink

POLICY UPDATE CHANGES

The October 1, 2026 annual review updated the policy literature through June 2, 2026, while leaving policy statements unchanged.

5Potentially medically necessary tumor settings

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CurrentPremera Blue Cross of WashingtonPolicy 8.01.521

Radioembolization for Primary and Metastatic Liver Tumors

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Sign up for premerabluecrossofwashington Policy 8.01.521 alerts

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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 clinical or coverage changes

Effective DateOctober 1, 2026

Next Review DateNot specified

Key ActionSubmit medical records documenting that medical necessity criteria are met, including office visit notes supporting the applicable covered clinical situation.

SourceLink

POLICY UPDATE CHANGES

The October 1, 2026 annual review updated the policy literature through June 2, 2026, while leaving policy statements unchanged.

5Potentially medically necessary tumor settings

Adequate candidate performance status

A or BAcceptable liver function classification

8 cmMaximum total tumor size for qualifying HCC

≥3 monthsMinimum expected survival for candidacy

Medical Necessity and Clinical Criteria

Medical Necessity Indications

Radioembolization may be considered medically necessary when ANY of the following situations applies:

ONE of the following

Primary hepatocellular carcinoma
- Primary hepatocellular carcinoma is unresectable and associated with liver-dominant metastases.
- The total size of the tumor or tumors does not exceed 8 cm.<= 8 cm
- The individual has good performance status.
Treatment of primary hepatocellular carcinoma as a bridge to liver transplantation.
Primary intrahepatic cholangiocarcinoma
- The tumor is unresectable.
- The disease is associated with liver-dominant metastases.
Hepatic metastases from neuroendocrine tumors
- The disease is diffuse and symptomatic.
- Systemic therapy has failed to control symptoms related to excess hormone production.
Unresectable hepatic metastases from colorectal carcinoma, melanoma, or breast cancer
- The metastases are from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer.
- The metastases are both progressive and diffuse in an individual with liver-dominant disease.
- The disease is refractory to chemotherapy, or the individual is not a candidate for chemotherapy or other systemic therapies.

General Candidate Considerations

Radioembolization should generally be reserved for individuals who meet ALL of the following candidate considerations:

ALL of the following

Adequate functional status, defined as Eastern Cooperative Oncology Group Performance Status 0-2.
Adequate liver function and hepatic reserve, generally Child-Pugh class A or B.
Liver-dominant metastases.
When considering repeated radioembolization treatments, recognize that there is little information on the safety or efficacy of repeated treatments or on the number of treatments that should be administered.
For metastatic neuroendocrine tumors, symptomatic disease refers to symptoms related to excess hormone production.

Other Hepatic Metastases

Radioembolization is considered investigational for hepatic metastases other than the tumor types and clinical situations specifically described in the Medical Necessity section.

Hepatic metastases from tumor types or in clinical situations not specifically described in the Medical Necessity section are investigational.

Indications Not Otherwise Described

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

All other indications not described in the Medical Necessity section are investigational.

General Radioembolization Candidacy

ACR multidisciplinary guidance identifies the following general indications and assessment elements for radioembolization with glass- or resin-based yttrium-90 microspheres:

ALL of the following

Unresectable or inoperable primary or secondary liver malignancy, particularly colorectal cancer or neuroendocrine tumor metastases. Tumor burden is generally liver dominant but is not required to be exclusively within the liver.
Performance status that will allow the individual to benefit from radioembolization.
Life expectancy of at least 3 months.>= 3 months
Laboratory data suggest that the procedure can be performed safely.

Absolute Contraindications

Treatment is contraindicated when ANY of the following absolute contraindications is present:

ONE of the following

Inability to catheterize the hepatic artery.
Fulminant liver failure.
Initial mapping angiography, contrast-enhanced cone-beam CT, and/or technetium-99m macroaggregated albumin hepatic arterial perfusion scintigraphy demonstrates clinically unacceptable nontarget deposition that cannot be ameliorated with embolization or delivery adjustment.
Pretreatment hepatic arterial administration of technetium-99m MAA demonstrates unfavorable or unacceptable shunt function between the liver and pulmonary parenchyma. The shunt fraction must not exceed acceptable limits specific to the yttrium-90 product.
Active hepatic infection.

Relative Contraindications and Cautions

The following are relative contraindications or circumstances requiring individualized clinical judgment and caution:

Relative contraindication or caution

Excessive hepatic tumor burden, with greater than 50%-70% of the hepatic parenchyma replaced by tumor. Treatment may be considered with more extensive tumor burden if synthetic hepatic function is preserved.
Total bilirubin greater than 2 mg/dL in the absence of biliary obstruction or Gilbert disease, indicating severe liver function impairment. Nonobstructive bilirubin elevation may indicate that liver metastases have impaired hepatic function to the degree that risks outweigh benefits.
Hepatocellular carcinoma with elevated bilirubin may still be treated if a segmental or subsegmental infusion can be performed.
Prior radiation therapy to the liver or upper abdomen that included a significant volume of the liver; clinical judgment by the authorized user is required.

Primary Hepatocellular Carcinoma

NCCN guidance (v.1.2026) indicates that arterially directed therapies, including yttrium-90 radioembolization, may be appropriate in selected individuals with primary hepatocellular carcinoma.

ALL of the following

The arterial blood supply can be isolated without excessive nontarget treatment.
Locoregional therapy is being considered because the individual is not a candidate for potentially curative treatment, including resection, transplantation, or ablative strategies for small lesions.
Arterially directed therapies are 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.
Delivery of 205 Gy or more to the tumor may be associated with increased overall survival.

Metastatic Neuroendocrine Tumors

NCCN guidance (v.1.2026) recommends consideration of transarterial radioembolization for metastatic neuroendocrine tumors in the following settings:

ONE of the following disease distributions or treatment contexts

Lobar disease distribution.
Segmental disease distribution.
Prior Whipple surgery.
Biliary tract instrumentation.
TARE may be better tolerated than transarterial embolization or transarterial chemoembolization, but late radioembolization-induced chronic hepatotoxicity may occur in long-term survivors, particularly with bilobar radioembolization.

Metastatic Colon Cancer

NCCN guidance (v.2.2026) describes yttrium-90 radioembolization as an option in selected individuals with metastatic colon cancer:

NCCN-described circumstances

Chemotherapy-resistant or chemotherapy-refractory disease with predominant hepatic metastases.
Hepatic metastatic disease that is not optimally resectable because of insufficient remnant liver volume.
The role of radioembolization at earlier stages of disease, particularly in patients with a right-sided primary tumor, remains under investigation.

Metastatic Uveal Melanoma

NCCN guidance (v.2.2026) states that further study is required to determine the appropriate patients for radioembolization and to define its risks and benefits in metastatic uveal melanoma.

The appropriate patients for radioembolization and the risks and benefits of this approach remain to be determined; further study is required.

COVERAGE CRITERIA: Hepatic metastases other than those specifically described in the Medical Necessity section are considered investigational.

COVERAGE CRITERIA: Indications not described in the Medical Necessity section are considered investigational.

COVERAGE CRITERIA: Radioembolization must not be performed when an absolute contraindication is present, including inability to catheterize the hepatic artery, fulminant liver failure, uncorrectable nontarget deposition or pulmonary shunt, active hepatic infection, or uncorrectable coagulopathy. Relative contraindications and cautions require individualized clinical judgment as described above.

COVERAGE CRITERIA: This medical policy does not apply to Medicare Advantage. Coverage remains subject to the limits and conditions of the applicable member benefit plan.

Coding and Clinical Thresholds

CPT CodesCPT

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

CPT Radiopharmaceutical CodeCPT

79445

Radiopharmaceutical therapy, by intra-arterial particulate administration.

HCPCS CodesHCPCS

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

FDA regulatory and product identifiersmixed

H980006	FDA humanitarian drug exemption identifier for TheraSphere
P200029	FDA premarket approval identifier for TheraSphere
P990065	FDA premarket approval identifier for SIR-Spheres
NAW	FDA product code

Qualifying HCC Tumor Size

Maximum total tumor sizeDoes not exceed 8 cm

Applicable conditionUnresectable primary hepatocellular carcinoma with liver-dominant metastases

Performance statusGood performance status is also required

ECOG Performance Status

Acceptable ECOG range0-2

Functional statusAdequate functional status is required

Documentation and Coverage Risk

Documentation Required

Medical Records and Office Visit Notes

Submit medical records and office visit notes documenting that medical necessity criteria are met. Notes should include the relevant history and physical findings supporting the applicable diagnosis, disease status, prior treatment, and proposed radioembolization.

Include: relevant history and physical examination findings.
Document the disease-specific criteria supporting the request, including unresectability, liver-dominant disease, progression, tumor burden, and prior or unsuitable systemic therapy when applicable.

Documentation Required

Clinical Eligibility Evidence

Provide clinical evidence establishing that the requested radioembolization indication meets the coverage criteria. Documentation must identify the primary or metastatic disease, its distribution and treatment status, and the characteristics relevant to eligibility.

For primary hepatocellular carcinoma (HCC), document that the tumor is unresectable, liver-dominant or limited to the liver as applicable, total tumor size does not exceed 8 cm, and the individual has good performance status; document bridge-to-transplant status when applicable.

Therapy Background

Radioembolization, also called selective internal radiotherapy, delivers yttrium-90 microspheres through the hepatic artery. The microspheres preferentially reach liver tumors, become permanently embedded, and provide localized beta radiation while also producing embolization. Pretreatment evaluation includes hepatic angiography and technetium-99-labeled albumin simulation to assess arterial anatomy and possible gastrointestinal or pulmonary shunting.

Key Terms

Child-Pugh Score

DefinitionA score used to assess the prognosis of chronic liver disease

Typical disease contextUsually used in cirrhosis

Clinical roleProvides a prognostic assessment of chronic liver disease

Eastern Cooperative Oncology Group (ECOG)

SystemEastern Cooperative Oncology Group performance status

PurposeAssesses an individual's disease progression

Functional impactAssesses how disease affects activities of daily living

Policy Summary

PayerPremera Blue Cross of Washington

PolicyRadioembolization for Primary and Metastatic Liver Tumors

Policy CodePolicy 8.01.521

Change TypeAnnual reviewno material clinical or coverage changes

Effective DateOctober 1, 2026

Next Review DateNot specified

Key ActionSubmit medical records documenting that medical necessity criteria are met, including office visit notes supporting the applicable covered clinical situation.

SourceLink

On This Page

Uncorrectable coagulopathy.

Systemic therapies that may potentiate or alter the impact of radioembolization; use caution when combining therapies such as capecitabine.

Pregnancy. Treatment during pregnancy may be considered only in extraordinary circumstances with multidisciplinary consultation and ethical consideration.

For individuals with Child-Pugh class A liver function, delivery of greater than 400 Gy to 25% or less of the liver is recommended.

For anatomically limited disease, radiation segmentectomy with yttrium-90 or ablative-dose stereotactic body radiation therapy should be considered.

Radioembolization may be more appropriate in some individuals with advanced hepatocellular carcinoma, specifically those with segmental or lobar portal vein thrombosis rather than main portal vein thrombosis.

Treatment contextRadioembolization should be reserved for individuals with adequate functional status

Child-Pugh Classification

Acceptable classificationChild-Pugh class A or B

Clinical meaningIndicates adequate liver function and reserve for candidate selection

Treatment contextRadioembolization should be reserved for individuals with adequate liver function and reserve

Excessive Hepatic Tumor Burden

Relative contraindication thresholdMore than 50%-70% of the hepatic parenchyma replaced by tumor

Clinical concernExcessive tumor burden in the liver

Possible exceptionTreatment may be considered when extensive tumor burden is present if synthetic hepatic function is preserved

Total Bilirubin

Bilirubin thresholdGreater than 2 mg/dL

Relative contraindication applies whenThe elevation occurs in the absence of biliary obstruction or Gilbert disease

Clinical significanceThe level indicates severe liver function impairment

HCC Bilirubin

HCC bilirubin thresholdGreater than 3 mg/dL

Treatment exceptionRadioembolization may be performed if segmental treatment can be performed

Additional risk thresholdBilirubin levels greater than 2 mg/dL are associated with increased risk of radiation-induced liver disease

HCC Tumor Dose

Tumor dose205 Gy or more

Reported associationMay be associated with increased overall survival

Clinical settingPrimary hepatocellular carcinoma treated with yttrium-90 radioembolization

Child-Pugh A HCC Liver Dose

Recommended doseGreater than 400 Gy

Maximum treated liver volume25% of the liver or less

Applicable liver functionChild-Pugh A

For intrahepatic cholangiocarcinoma, document an unresectable primary tumor with liver-dominant metastases.

For neuroendocrine tumor metastases, document diffuse, symptomatic hepatic disease, symptoms related to excess hormone production, and failure of systemic therapy to control symptoms.

For colorectal, melanoma (ocular or cutaneous), or breast cancer metastases, document that disease is hepatic, progressive, diffuse, and unresectable, and that chemotherapy failed or the individual is not a candidate for chemotherapy or other systemic therapy.

Prior Authorization

Eligibility and Safety Assessment

Before requesting or performing treatment, assess and document whether the individual is an appropriate candidate for radioembolization. Coverage and treatment suitability depend on unresectable or inoperable primary or secondary liver malignancy, a performance status allowing benefit, expected survival, and laboratory evidence that the procedure can be performed safely.

Document unresectable or inoperable disease and that tumor burden is generally liver-dominant, although it need not be exclusively within the liver under the cited clinical guidance.
Document performance status sufficient to benefit from treatment.
Document life expectancy of at least 3 months.
Provide laboratory data supporting safe performance of the procedure.

Documentation Required

Pretreatment Vascular and Shunt Evaluation

Complete and submit the pretreatment vascular and shunt evaluation. The record should include mapping angiography, contrast-enhanced cone-beam CT, and technetium-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy, with the findings and any corrective embolization or delivery adjustments documented.

Document whether hepatic arterial catheterization is technically feasible.
Identify any nontarget deposition and whether it is clinically acceptable or was ameliorated with embolization or delivery adjustment.
Document the MAA pulmonary shunt fraction and confirm that it is within the acceptable limit for the specific yttrium-90 product.

Denial Risk

Risk-Factor Documentation

Document clinical factors that may increase treatment risk or require individualized judgment before radioembolization. The request should address tumor burden, hepatic function, prior radiation, interacting systemic therapies, and pregnancy status.

Address tumor replacement of more than 50%-70% of the liver parenchyma; treatment with more extensive burden requires preserved synthetic hepatic function.
Address total bilirubin greater than 2 mg/dL, excluding biliary obstruction or Gilbert disease; segmental or subsegmental infusion may permit treatment of some individuals with HCC and elevated bilirubin.
Document prior radiation to the liver or upper abdomen involving a significant liver volume and the authorized user's clinical judgment.
Use caution with systemic therapies that may potentiate or alter radioembolization, including capecitabine.
Address pregnancy; treatment generally requires extraordinary circumstances, multidisciplinary consultation, and ethical consideration.

Denial Risk

Unlisted Hepatic Metastases

Radioembolization is considered investigational for hepatic metastases other than the specifically listed covered settings. Do not assume coverage for an unlisted metastatic primary or disease presentation.

Covered metastatic settings specifically include neuroendocrine tumors and unresectable, progressive, diffuse, liver-dominant metastases from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer when the stated systemic-therapy criteria are met.

Denial Risk

Indication Not Described

Radioembolization is considered investigational for indications not described in the Medical Necessity section. Confirm that the requested indication matches a listed covered setting before submitting the request.

Indications outside the defined primary HCC, intrahepatic cholangiocarcinoma, neuroendocrine tumor, colorectal cancer, melanoma, or breast cancer settings may be considered investigational.

Denial Risk

Failure to Meet Disease or Treatment Criteria

Coverage may be denied when the disease or treatment criteria are not documented or are not met. Ensure the record supports the applicable disease-specific requirements before requesting authorization.

Primary HCC must be unresectable and meet the stated tumor-size, liver-dominance, and performance-status criteria, unless requested as a bridge to liver transplantation.
Intrahepatic cholangiocarcinoma must be unresectable with liver-dominant metastases.
Neuroendocrine tumor metastases must be diffuse and symptomatic, with hormone-related symptoms not controlled by systemic therapy.
Colorectal, melanoma, or breast cancer metastases must be progressive, diffuse, liver-dominant, and unresectable, with chemotherapy failure or lack of candidacy for chemotherapy or other systemic therapy.

Denial Risk

Absolute Clinical Contraindications

Do not proceed when an absolute clinical contraindication is present. Resolve correctable issues when possible and document the clinical decision for any treatment consideration.

Inability to catheterize the hepatic artery.
Fulminant liver failure.
Clinically unacceptable nontarget deposition on mapping angiography, contrast-enhanced cone-beam CT, or MAA scintigraphy that cannot be corrected with embolization or delivery adjustment.
Unfavorable or unacceptable liver-to-lung shunt function, with the shunt fraction exceeding the acceptable limit for the specific yttrium-90 product.
Active hepatic infection.
Uncorrectable coagulopathy.

Denial Risk

Unacceptable Mapping or Lung Shunt

Treatment should not proceed when pretreatment mapping demonstrates unacceptable nontarget deposition that cannot be corrected, or when the MAA pulmonary shunt fraction exceeds the product-specific acceptable limit. Document the evaluation, findings, and any attempted corrective intervention.

Review mapping angiography, contrast-enhanced cone-beam CT, and MAA hepatic arterial perfusion scintigraphy for nontarget deposition.
Document embolization or delivery adjustment when used to ameliorate nontarget deposition and the resulting findings.
Document the product-specific pulmonary shunt limit and the measured MAA shunt fraction.

Denial Risk

Relative Contraindications and Treatment Cautions

Treat relative contraindications as factors requiring individualized risk-benefit assessment rather than automatic exclusion. Document the findings, mitigation plan, and authorized user's clinical judgment before treatment.

Tumor burden replacing more than 50%-70% of the liver parenchyma; extensive burden may be considered only when synthetic hepatic function is preserved.
Total bilirubin greater than 2 mg/dL, absent biliary obstruction or Gilbert disease; elevated bilirubin may indicate risks outweigh benefits, although segmental or subsegmental infusion may be considered for HCC.
Prior radiation to the liver or upper abdomen involving a significant liver volume.
Systemic therapies that may potentiate or alter radioembolization; use caution with combinations such as capecitabine.
Pregnancy, except potentially in extraordinary circumstances with multidisciplinary consultation and ethical consideration.

Note

Benefit Plan Limitations

Coverage for radioembolization is subject to the member's benefit plan limits and conditions. Providers and members should consult the member benefit booklet or contact customer service to determine whether applicable benefit limitations affect coverage.

This medical policy does not apply to Medicare Advantage.
Medical necessity under this policy does not override member-specific benefit limitations or exclusions.

Symptomatic Disease from Metastatic Neuroendocrine Tumors

DefinitionSymptoms related to excess hormone production

Applicable diseaseMetastatic neuroendocrine tumors

Treatment contextThe disease is diffuse and systemic therapy has failed to control symptoms

Radioembolization (RE)

Treatment typeRadioembolization using yttrium-90 microspheres

Microsphere materialsGlass- or resin-based

Delivery routeThrough the hepatic arterial circulation

TARE

AbbreviationTARE

Full termTransarterial radioembolization

Clinical useConsidered for lobar or segmental neuroendocrine tumor liver metastases

SIRT

AbbreviationSIRT

Full termSelective internal radiation therapy

Treatment modalityA form of intra-arterial yttrium-90 radioembolization

Technetium-99m MAA

Full nameTechnetium-99m macroaggregated albumin

Pretreatment useUsed for hepatic arterial perfusion scintigraphy

Assessment purposeEvaluates hepatopulmonary shunting and helps identify unacceptable shunt function