ModifiedUnitedHealthcarePolicy CSNCT0445.03

Transarterial Radioembolization (TARE)/ Selective Internal Radiation Therapy (SIRT) for the Treatment of Malignant Cancers of the Liver (for North Carolina Only)

This UnitedHealthcare medical policy governs coverage and medical necessity criteria for Yttrium-90 TARE/SIRT for malignant liver tumors for members in North Carolina (individuals 19 years and older; special note for <19). It defines covered indications, limitations, and documentation expectations.

Policy Summary

PayerUnitedHealthcare

PolicyTransarterial Radioembolization (TARE)/ SIRT for Malignant Liver Cancers (NC)

Policy CodePolicy CSNCT0445.03

Change TypeRevised indications and documentation clarifications

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain and retain multidisciplinary evaluation documentation and supporting medical records demonstrating ECOG 0–2, liver-dominant disease, and prior therapy status for prior authorization.

SourceLink

POLICY UPDATE CHANGES

This policy applies to individuals 19 years of age and older; Transarterial Radioembolization/selective internal radiation therapy is covered without further review for individuals younger than 19 years of age.

Revised list of proven and medically necessary indications, including addition of metastasis from uveal/ocular melanoma confined to the liver and specification that several indications apply to individuals who are not surgical candidates or have chemotherapy-resistant/refractory disease.

Added language clarifying medical records documentation expectations and that coverage is determined by federal, state, or contractual requirements and applicable laws.

Updated Clinical Evidence and References sections to reflect the most current information and archived the previous policy version CSNCT0445.02.

NCApplicable state

≥19

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

inv-01: Covered Indications

Covered when ALL of the following are met:

Primary conditions: TARE/SIRT using yttrium-90 microspheres is covered for individuals with ECOG performance status 0, 1, or 2 for the following: liver-dominant primary hepatocellular carcinoma (HCC) in individuals who are not surgical candidates; primary hepatocellular carcinoma as a bridge to liver transplantation; liver metastases from neuroendocrine tumors in individuals who are not surgical candidates when systemic therapy has failed to control symptoms; liver metastases from colorectal carcinoma in individuals with chemotherapy-resistant or refractory disease and with predominant hepatic metastases; liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates; and metastasis from uveal/ocular melanoma when confined to the liver.ECOG 0-2

Applies to individuals 19 years and older; individuals younger than 19 are covered without further review (policy note).

inv-02: Clinical selection and sequencing considerations

Selection considerations aligned with society guidance:

Sequencing and selection: TARE is intended for predominantly hepatic disease that is refractory or intolerant to systemic chemotherapy (for example, chemotherapy-resistant/-refractory colorectal liver metastases); may be considered as second-line or later therapy, as a bridge to transplant, or to downsize disease to permit resection or increase future remnant liver (radiation lobectomy).

Clinical selection should include laboratory assessment (CBC, coagulation, liver and renal profile), prognostic markers (e.g., CEA), prior treatment history, and multidisciplinary evaluation per ASCO and NCCN guidance.

inv-03: General coverage criteria

Covered when ALL of the following are met (per guideline-supported contexts summarized in this section):

General eligibility: Patient has unresectable or inoperable primary or secondary liver malignancy with liver-dominant tumor burden; patient has adequate performance status allowing benefit (ECOG 0–2) and an anticipated life expectancy generally of at least 3 months; multidisciplinary team evaluation by clinicians experienced in SIRT/TARE documents suitability; required laboratory and imaging data indicate the procedure can be performed safely (including mapping angiography/MAA as appropriate).life expectancy ≥3 months; ECOG 0-2

Reflects joint society statements (AASLD, ACR/ASTRO/SIR/SNMMI joint parameters) and NCCN/ASCO selection principles.

inv-04: Colorectal liver metastases

Covered in select colorectal liver metastases when ALL are met:

Colorectal metastases (select): Disease is chemotherapy-resistant or -refractory with predominant hepatic metastases OR used as a radiation lobectomy to induce remnant hypertrophy/downsizing when resection is otherwise limited; selection is individualized and TARE is an option in highly selected patients per NCCN (category 2A).

Selection should follow ASCO and NCCN guidance including prior systemic therapy assessment and multidisciplinary review.

inv-05: Neuroendocrine tumor liver metastases

Covered in neuroendocrine tumor liver metastases when ALL are met:

Neuroendocrine liver metastases: Liver-dominant, unresectable neuroendocrine tumor metastases in individuals who are not surgical candidates and for whom systemic therapy has failed to control symptoms; selection by a multidisciplinary team at experienced centers is required. TARE may be preferred for lobar/segmental disease and in patients with prior biliary instrumentation due to lower hepatobiliary infection risk compared with TACE/TAE.

Evidence from multiple retrospective and prospective series demonstrates objective response, high disease control rates, and preserved HRQOL in many series; specialized center experience required.

inv-06: Primary hepatocellular carcinoma (HCC)

Covered for primary hepatocellular carcinoma in certain contexts when ALL are met:

Primary HCC contexts supported: TARE is an acceptable option for solitary unresectable HCC, may be used as an alternative intra-arterial therapy for intermediate-stage HCC, can serve as neoadjuvant therapy or a bridge to liver transplantation, and radiation segmentectomy may be performed for focal control; TARE may also be used as radiation lobectomy to induce hypertrophy. Evidence shows improvements in time to progression and in select trials improved OS vs DEB-TACE, though overall OS benefit across trials is inconsistent.

Supported by AASLD 2023, TRACE RCT, systematic reviews and comparative evidence; center and patient selection critical.

inv-07: General coverage criteria

Covered when ALL of the following are met (per professional society guidance)

General eligibility: Patient has unresectable or inoperable primary or secondary liver malignancy with liver-dominant tumor burden; performance status allows benefit (ECOG 0–2) and life expectancy generally at least 3 months; multidisciplinary team evaluation has determined TARE/SIRT is appropriate and laboratory data indicate safe performance of the procedure.life expectancy ≥3 months; ECOG 0-2

Consensus from AASLD and joint professional society practice parameters; laboratory and mapping angiography data should be documented.

inv-08: Absolute contraindications

Contraindications that preclude coverage

Absolute contraindications: Any of the following: inability to catheterize the hepatic artery; fulminant liver failure; mapping angiography/contrast-enhanced cone-beam CT and/or technetium-99m MAA perfusion demonstrating clinically unacceptable non-target deposition that cannot be corrected; pretreatment MAA demonstrating lung shunt fraction exceeding product-specific acceptable limits; acute hepatic infection; uncorrectable coagulopathy.product-specific lung shunt limits

Presence of any absolute contraindication precludes the procedure per guidance.

inv-09: Relative contraindications and cautions

Relative factors requiring individualized assessment

Relative contraindications/considerations: Any of the following require individualized assessment and multidisciplinary judgment: excessive hepatic tumor burden (generally >50–70% parenchymal replacement) unless synthetic function preserved; elevated total bilirubin (NCCN notes relative contraindication if >3 mg/dL unless segmental treatment feasible; other guidance suggests caution at >2 mg/dL); prior significant liver or upper-abdominal radiation; concurrent systemic therapies that may increase radioembolization toxicity; pregnancy (requires multidisciplinary review).bilirubin thresholds vary by guideline; tumor burden >50-70%

Decisions should be individualized and documented per society recommendations.

inv-10: Coverage considerations by tumor type

Contextual coverage considerations based on evidence and guideline statements in this excerpt

HCC - bridge to transplant/downstaging: SIRT/TARE may be considered as a bridge to transplant or for downstaging in individuals with HCC when intent is to slow progression and reduce transplant waitlist dropout; available evidence is limited but suggests comparable or better outcomes versus other LRTs in some series with low-quality evidence.

Hayes and NCCN note SIRT as a locoregional therapy option for bridging/downstaging.

Uveal melanoma hepatic metastases: SIRT/RE has phase II and observational evidence demonstrating disease control and median overall survival in the range reported in series for liver-dominant uveal melanoma metastases; consider for disease confined to or predominantly involving the liver though prospective validation is limited.disease confined or liver-dominant metastases

NCCN includes regional therapies for liver-confined disease and policy revisions added uveal/ocular melanoma as a covered indication.

Breast cancer liver metastases:

inv-11: Proven and medically necessary indications (summary)

Policy revised proven and medically necessary indications (summary):

Covered Indications (summary): Includes liver-dominant primary hepatocellular carcinoma in individuals who are not surgical candidates; primary HCC as a bridge to transplant; liver metastases from colorectal carcinoma with chemotherapy-resistant or refractory disease and predominant hepatic metastases; liver metastases from neuroendocrine tumors in individuals who are not surgical candidates when systemic therapy has failed to control symptoms; liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates; and metastasis from uveal/ocular melanoma when confined to the liver.

Detailed per‑indication clinical criteria (imaging, performance status, liver function, prior therapies) are referenced in the full policy.

Use of Transarterial Radioembolization (TARE)/Selective Internal Radiation Therapy (SIRT) with yttrium-90 microspheres for indications other than those explicitly listed as covered in this policy is considered unproven and not medically necessary due to insufficient evidence of efficacy. The policy’s proven and medically necessary indications are limited to the specific liver-dominant primary and metastatic scenarios described in the Coverage Rationale and require that individuals meet performance status and other clinical criteria before coverage is approved.

Routine use of TARE/SIRT in certain non-surgical hepatocellular carcinoma (HCC) populations is limited by randomized and comparative evidence demonstrating no consistent improvement in overall survival. Meta-analyses and systematic reviews of randomized trials comparing Y-90 TARE with standard care in non-surgical HCC have not shown an OS benefit (e.g., HR 0.99, 95% CI 0.81–1.21), although TARE may reduce some adverse event rates and increase time to progression in select studies. Therefore, selection for routine use should be individualized and aligned with guideline recommendations rather than applied broadly.

The National Institute for Health and Care Excellence (NICE) (2018) concluded that evidence on the efficacy of SIRT for unresectable primary intrahepatic cholangiocarcinoma (ICC) is inadequate in quantity and quality and that SIRT should be used for this indication only in the context of research. NICE recommends that such uses be performed in specialist centers by clinicians experienced in cholangiocarcinoma and that further prospective studies, including randomized controlled trials, address patient selection and outcomes such as survival and quality of life.

European professional guidance (ESO/ESMO) emphasizes that local therapies should be proposed only in very selected cases — patients with good performance status, limited liver involvement, no extrahepatic disease, and after systemic therapy has demonstrated disease control. Patients must be informed that randomized data showing a survival benefit are lacking and that no single local therapy technique is established as superior; careful multidisciplinary selection is therefore required.

The U.S. Food and Drug Administration has approved two commercial yttrium-90 microsphere products: SIR-Spheres® (resin Y-90 microspheres; PMA P990065) with an FDA-labeled indication for unresectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy (floxuridine), and TheraSphere® (glass Y-90 microspheres) which has regulatory approvals (Humanitarian Device Exemption and subsequent PMA expansion) for specific HCC indications including solitary tumors 1–8 cm in appropriately selected patients.

TARE/SIRT using yttrium-90 microspheres is considered unproven and not medically necessary for all indications that are not explicitly listed as covered in this policy. Coverage is limited to the proven indications outlined in the Coverage Rationale and requires that patients meet the specified clinical criteria (e.g., ECOG 0–2 and other per-indication requirements).

Procedures performed without evidence of multidisciplinary selection, at centers or by clinicians lacking specific training/experience in SIRT, or in patients who do not meet clinical suitability thresholds (for example, inadequate performance status or anticipated life expectancy insufficient to benefit) are considered inappropriate and do not meet medical necessity criteria. Documentation of multidisciplinary evaluation and center/clinician experience is required to support coverage.

NICE’s interventional procedures guidance for unresectable primary intrahepatic cholangiocarcinoma states that the evidence is inadequate to support routine use of SIRT outside research settings. NICE recommends that such procedures be restricted to research protocols conducted in specialist centers with multidisciplinary selection and appropriately trained clinicians.

Use of TARE/SIRT for indications beyond those supported by current evidence (other metastatic primaries or nonstandard clinical scenarios) is considered investigational. The policy indicates that randomized controlled trials are needed to establish clinical utility before such uses can be considered proven and medically necessary.

Meeting the policy’s documentation requirements and the specific clinical criteria is necessary for coverage. Medical records must fully support the medical necessity of the service and include multidisciplinary review notes, ECOG performance status, life expectancy estimation, relevant laboratory values (e.g., bilirubin), and mapping angiography/MAA results. Absence of adequate documentation or failure to meet clinical criteria may result in denial of coverage.

Procedure Codes, Key Clinical Thresholds, and Device Approvals

Applicable procedure codes (reference)mixed

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.
79445	Radiopharmaceutical therapy, by intra-arterial particulate administration.
S2095	Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres.

Referenced FDA approvals / PMA codesmixed

P990065

FDA premarket approval identifier for SIR-Spheres

Referenced FDA approvals / PMA codesmixed

P200029

FDA PMA identifier for TheraSphere expanded SIRT indication

inv-26: Bilirubin — < 2 mg/dL (ideally < 1.3 mg/dL if lobar or bilobar treatment planned)

Bilirubin thresholdTotal bilirubin < 2 mg/dL (ideally < 1.3 mg/dL if lobar or bilobar treatment is planned)

Selective exceptionsHigher bilirubin levels may be acceptable when selective radiation segmentectomy is performed

Clinical rationaleThresholds recommended to minimize risk of severe or fatal hepatic toxicity after Y-90 radioembolization

inv-27: Albumin — > 3 g/dL associated with improved survival

Albumin threshold> 3 g/dL associated with improved survival after TARE

Clinical implication

Prior Authorization, Documentation, and Operational Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is implied for transarterial radioembolization/selective internal radiation therapy (TARE/SIRT); medical record documentation is required to assess clinical criteria and to support medical necessity. Device-specific indications (e.g., FDA-labeled uses for TheraSphere® and SIR-Spheres®) and regulatory status may affect authorization decisions and should be noted in the prior authorization submission.

Document FDA-approved device when applicable (TheraSphere, SIR-Spheres) and note any device-specific labeled indications or Humanitarian Device Exemption status.
Include documentation of licensure or institutional NRC compliance if applicable.

Prior Authorization

Multidisciplinary Selection and Experienced Centers/Clinicians

Selection of candidates for TARE/SIRT must occur via multidisciplinary evaluation and be performed by clinicians and centers with appropriate training and experience. The record should demonstrate multidisciplinary input (for example, interventional radiology, nuclear medicine, medical oncology, hepatology, surgical oncology, radiation oncology, medical physics, and radiation safety) supporting the chosen approach.

Background and Evidence Context

TARE/SIRT using yttrium-90 microspheres delivers high-dose radiation to liver tumors by administering microspheres into the hepatic arterial circulation, allowing targeted tumor irradiation while relatively sparing non-tumorous liver parenchyma. Surgical resection remains the preferred curative approach when feasible; TARE is used for unresectable or liver-dominant disease and may serve as a bridge to transplant, a downsizing strategy, or palliation depending on tumor type and patient factors.

Key Definitions and Clinical Terms

inv-53: ECOG Performance Status — Standard scale; policy requires ECOG 0-2 for covered indications

ECOG scale overviewStandard performance-status scale ranging 0 (fully active) to 5 (dead)

Policy requirementPolicy requires ECOG performance status 0–2 for covered indications

Clinical implicationECOG >2 is an indicator of poor outcome and may preclude benefit from TARE

inv-54: Limited Extra-Hepatic Disease — Definition from Wasan et al., 2017

DefinitionLimited extra-hepatic disease: metastases limited to lung with <5 nodules ≤1 cm or a single nodule ≤1.7 cm and/or single lymph node <2 cm (Wasan et al., 2017)

Use in selectionDefines acceptable limited extrahepatic spread for considering locoregional liver therapies

Policy Changes and Version History

2026-01-01policy_revisionLatest

Policy applies to individuals 19 years and older and clarifies that TARE/SIRT is covered without further review for individuals younger than 19; medical records documentation requirements clarified regarding content and availability upon request.

2026-01-01indication_update

Revised proven and medically necessary indications: added metastasis from uveal/ocular melanoma confined to the liver; rephrased multiple indications to specify applicability to individuals who are not surgical candidates or have chemotherapy-resistant/refractory disease.

Policy Summary

PayerUnitedHealthcare

PolicyTransarterial Radioembolization (TARE)/ SIRT for Malignant Liver Cancers (NC)

Policy CodePolicy CSNCT0445.03

Change TypeRevised indications and documentation clarifications

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Documentation Required

Clinical Suitability and Multidisciplinary Evaluation

Clinical suitability must be clearly documented. Procedures should be avoided in patients with insufficient performance status or limited life expectancy. The multidisciplinary review should address performance status, life expectancy, liver-dominant burden, laboratory evaluations, and mapping angiography findings prior to treatment.

Document ECOG performance status (generally 0–2 recommended) and estimated life expectancy (joint society guidance generally ≥3 months).
Provide recent laboratory results (CBC, coagulation, liver and renal profile) and tumor markers (e.g., CEA when relevant).
Include imaging and mapping angiography/MAA results demonstrating treatable arterial anatomy and acceptable lung shunt fraction.

Documentation Required

Medical Record Documentation Used for Reviews

The patient's medical record must contain documentation that fully supports medical necessity. This includes relevant medical history, physical examination, prior treatment history (systemic and locoregional), diagnostic imaging, laboratory data, tumor burden description (including predominance of hepatic disease), and the multidisciplinary rationale for TARE/SIRT.

Include prior systemic therapy details and response (e.g., chemotherapy-refractory/resistant status when applicable).
Include documentation of contraindications or rationale if relative contraindications are present and why benefits outweigh risks.
Maintain legible, readily available records; lack of adequate documentation may result in denial.

Note

Regulatory Context May Affect Coverage

Regulatory approvals and device labeling are informational but may influence coverage decisions. Identify the specific yttrium-90 product to be used and its regulatory status in the member’s record and prior authorization materials.

Note FDA-approved indications for SIR-Spheres and TheraSphere and any PMA or HDE status.
Document any additional regulatory or licensing considerations (e.g., U.S. NRC licensing) relevant to facility use.

Documentation Required

Suggested Follow-up and Monitoring Documentation from Trials

Trial and guideline–based follow-up schedules and monitoring may inform expected post-procedure surveillance and should be included in the care plan submitted for review. Provide planned monitoring and follow-up imaging/testing to detect treatment response and toxicity.

Describe planned laboratory monitoring frequency (examples from trials: weekly for 1 month, then every 2 weeks for 2 months, then monthly thereafter) and specific tests to be followed.
Specify planned imaging schedule (examples from trials: CT chest/abdomen/pelvis at 1 month; CT/PET/MRI every 3 months with MRI at 3 months if concerns about response).
Document the plan for acute and delayed toxicity assessment (e.g., evaluations at 1 month and every 3 months).

Note

Unspecified Provider Action Note

Provider action not otherwise specified in this document: when a required item or action is not specified here, include a statement in the prior authorization or medical record noting that the multidisciplinary team reviewed the case and identifying any additional institutional or device-specific requirements that were addressed.

If an institutional protocol or device manufacturer requirement influenced care (e.g., fractionation schedule, dosimetry method), document that the requirement was considered and satisfied.
If an unusual clinical circumstance applies (e.g., pregnancy considered as exceptional), document multidisciplinary consultation and rationale.

inv-59: Mapping angiography / MAA — Pre-treatment diagnostic procedures including cone-beam CT and Tc-99m MAA perfusion scintigraphy

DefinitionMapping angiography / MAA: pre-treatment diagnostic procedures (including contrast-enhanced cone-beam CT and technetium-99m MAA hepatic arterial perfusion scintigraphy) to evaluate arterial anatomy, non-target deposition risk, and lung shunt fraction

PurposeDetermines suitability for Y-90 delivery and identifies corrective measures (embolization, delivery adjustment)

DocumentationResults must be available to demonstrate acceptable targeting and shunt fraction for prior authorization and safety