ModifiedUnitedHealthcarePolicy CS060NM.C

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

Policy governing coverage of Yttrium-90 TARE/SIRT for malignant liver tumors for New Mexico members aged 19 and older; specifies covered indications, limitations, and documentation expectations.

Policy Summary

PayerUnitedHealthcare

PolicyTransarterial Radioembolization (TARE)/ Selective Internal Radiation Therapy (SIRT) for the Treatment of Malignant Cancers of the Liver (for New Mexico Only)

Policy CodePolicy CS060NM.C

Change TypeRevised indicationsage applicability addeddocumentation clarified

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain and submit multidisciplinary evaluation, mapping angiography/MAA results, performance status, laboratory data, and prior treatment documentation to support prior authorization and medical necessity.

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 proven and medically necessary indications for TARE/SIRT using Y-90 microspheres, including adding uveal/ocular melanoma metastasis confined to the liver and updating language to specify 'not surgical candidates' and 'chemotherapy‑resistant or refractory disease with predominant hepatic metastases.'

Medical records documentation requirements were expanded to state that records must fully support medical necessity and may be requested.

Supporting Information: Clinical Evidence and References sections were updated to reflect current information.

≥19 yrsApplies to individuals age

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Coverage Criteria for Y-90 TARE/SIRT

Covered indications

Transarterial Radioembolization/SIRT using Y-90 microspheres is covered when ALL of the following apply for individuals aged 19 and older with ECOG 0–2:

General eligibility

Covered clinical indications: One of: liver-dominant primary hepatocellular carcinoma (HCC) in individuals who are not surgical candidates (including as 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 with predominant hepatic metastases; liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates; metastasis from uveal/ocular melanoma when confined to the liver
Each indication requires ECOG 0-2

Unproven / Not medically necessary

Not covered when NOT meeting the above indications:

Not medically necessary: Use of TARE/SIRT with Y-90 microspheres for all indications not listed as covered (see Covered indications).

Determined unproven/not medically necessary due to insufficient evidence

Coverage criteria for SIRT/TARE

Covered when ALL of the following are met (per summarized guideline recommendations):

Patient selection: Predominantly hepatic (liver-dominant) disease and either chemotherapy-refractory/intolerant or highly selected per NCCN guidance (eg, to downsize disease or for radiation lobectomy).

ASCO and NCCN recommend selection for liver-dominant, chemotherapy-refractory or highly selected cases

Multidisciplinary evaluation: Case reviewed and selection documented by a multidisciplinary team experienced in SIRT/TARE; treatment to be performed by clinicians trained in SIRT, at specialized centers when indicated.

NCCN and NICE emphasize MDT selection and specialist centers

Pre-treatment assessment: Documented laboratory evaluation including CBC, coagulation, liver and renal profile, and relevant prognostic markers (e.g., CEA) and review of prior local and systemic treatments (surgery, TACE, ablation).

ASCO guideline-recommended assessments for candidate selection

Primary HCC — when TARE is an option

Covered when clinical and anatomic criteria consistent with guideline recommendations are met

Primary HCC candidate criteria: Unresectable or liver-dominant primary HCC in individuals who are not surgical candidates or as bridge to transplant; preserved/acceptable liver function and performance status documented; tumor arterial supply targetable without excessive nontarget treatment; estimated life expectancy >= 3 months.see guideline references

AASLD, ACR, and Hayes summaries support TARE as an option for solitary unresectable HCC, for bridging/downstaging, and for anatomically challenging tumors

Intrahepatic cholangiocarcinoma (iCCA) — when TARE may be considered

Covered when criteria for patient selection used in reported series and guidelines are met

iCCA candidate criteria: Adults with unresectable, locally advanced, or liver-dominant intrahepatic cholangiocarcinoma evaluated by a multidisciplinary team; preserved synthetic liver function (examples used in studies: total bilirubin < 2.0 mg/dL and albumin > 3 g/dL) or ability to perform segmental/lobar treatment; intent and expected benefit documented (palliation, downstaging, or bridging to resection/transplant).examples: bilirubin <2.0 mg/dL; albumin >3 g/dL

Evidence from retrospective series, single-arm trials, and systematic reviews supports use in selected unresectable ICC cases; NICE recommends research-only use in some settings

Comparative effectiveness and device choice considerations

Coverage decisions may incorporate comparative effectiveness and safety evidence

Comparative evidence summary: Systematic reviews and network meta-analyses suggest TARE has comparable survival to TACE and potential advantages in tumor response and tolerability in some studies; evidence is insufficient to conclude superiority versus DEB-TACE or to definitively favor resin versus glass for efficacy; observational data indicate differing safety profiles with glass microspheres showing fewer GI and pulmonary adverse events in some reviews.evidence quality mostly low to moderate

Hayes and systematic reviews report limited and heterogeneous comparative evidence

Evidence-based indication summaries

Evidence and guideline summaries relevant to clinical use and selection:

Primary HCC - Bridge/Downstage: SIRT/TARE with Y-90 may be used to bridge or downstage HCC for liver transplant; systematic reviews and cohort studies suggest similar or better efficacy and safety compared with other locoregional therapies and may reduce waitlist dropout, particularly where wait times are long.

Hayes HTA and cohort studies report comparable outcomes for bridging/downstaging

Intrahepatic Cholangiocarcinoma (ICC): Guideline and review positions vary: ACR and NCCN describe locoregional therapy as an option in selected cases; NICE recommends SIRT for unresectable primary ICC only in research settings due to inadequate efficacy evidence and safety concerns.

See ACR, NCCN, and NICE guidance summaries

Uveal (Ocular) Melanoma liver metastases: Prospective phase II and retrospective series report disease control and median OS in the range of approximately 8–19 months with acceptable toxicity; evidence is limited and mostly small studies.

Gonsalves et al. phase II trial and systematic reviews provide supporting data

Proven and Medically Necessary Indications (revised)

Covered when the patient meets the revised proven/medically necessary indications as specified in the policy (high-level summary from this section):

Proven/Medically Necessary Indications (summary): Includes: liver-dominant primary hepatocellular carcinoma (HCC) in individuals who are not surgical candidates; liver metastases from uveal/ocular melanoma confined to the liver; 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 with predominant hepatic metastases; liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates.

Policy revisions (effective 01/01/2026) updated wording to emphasize 'not surgical candidates' and chemotherapy-resistant/refractory disease

Per the 2024 ASCO guidance, absolute contraindications to Y-90 TARE/SIRT include pregnancy and lactation, life expectancy less than 3 months, clinical hepatic impairment, and disseminated extrahepatic disease. These conditions should be absent and documented as part of the pre-treatment assessment before approving TARE/SIRT.

The policy follows guideline thresholds regarding prognosis and liver function: candidates should have an estimated life expectancy of at least 3 months and no clinical hepatic impairment. Laboratory evaluation (including bilirubin and other liver function tests) and clinical judgment about hepatic synthetic function are required to confirm that hepatic impairment does not represent an absolute contraindication to treatment.

Patients meeting absolute technical or safety contraindications are excluded from coverage. Examples include inability to catheterize the hepatic artery, fulminant liver failure, and pretreatment mapping studies showing unacceptable nontarget deposition or lung shunt fraction that cannot be corrected. Acute hepatic infection and uncorrectable coagulopathy are also absolute exclusions.

The National Institute for Health and Care Excellence (NICE) advises that SIRT for unresectable primary intrahepatic cholangiocarcinoma (iCCA) should only be used in the context of research. NICE cites inadequate evidence on efficacy and recognized, serious but rare safety concerns and therefore recommends use within prospective studies at specialist centers with multidisciplinary selection.

For breast cancer liver metastases, European guidance emphasizes that local therapy should not be broadly applied. There are no randomized data demonstrating a survival benefit for local hepatic therapies in this population, and locoregional treatment should be reserved for very selected patients after adequate systemic therapy and with good performance status and limited liver involvement.

Outside the specifically listed, evidence-supported liver‑dominant indications, TARE/SIRT using Y-90 microspheres is considered unproven and not medically necessary. The policy therefore does not cover TARE/SIRT for indications other than the enumerated primary HCC, selected metastatic liver disease types, and other specified liver-dominant scenarios.

ASCO guidance specifically states that SIRT is not routinely recommended for metastatic colorectal cancer (mCRC) with unilobar or bilobar liver metastases (evidence quality low; harms may outweigh benefits). Similarly, comparative reviews in non-surgical HCC do not consistently show an overall survival benefit versus standard treatments, supporting a restricted, guideline‑based approach rather than routine use.

TARE is considered not medically necessary for patients with excessive hepatic tumor burden when tumor replaces a majority of the liver parenchyma. Specifically, treatment is generally avoided when tumor burden replaces more than 50–70% of the liver, unless preserved synthetic hepatic function clearly supports a localized (segmental) approach; bilirubin and other function tests must be assessed to determine candidacy.

Information about FDA regulatory status is provided for context only. The policy states that FDA approval alone is not a basis for coverage. Device labeling and approvals (for example, TheraSphere and SIR‑Spheres) are informational; medical necessity and policy criteria must be met for coverage decisions.

Procedure, Device, and Clinical Criteria Codes

Procedure codes listed for referencemixed

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	HCPCS code S2095

Device regulatory identifiers and approvalsmixed

P990065	PMA identifier for SIR-Spheres
H980006	Humanitarian Device Exemption identifier for TheraSphere
P200029	PMA identifier for TheraSphere SIRT approval (March 17, 2021)

inv-20: Bilirubin — clinical threshold reference

Bilirubin thresholdTotal bilirubin < 2 mg/dL is preferred; ideally < 1.3 mg/dL for planned lobar or bi‑lobar treatment (selective/segmental treatment may allow higher levels)

Context/SourceAAPM 2023 practice guideline considerations for patient selection to minimize severe/fatal toxicity

Implication for authorizationDocument preprocedural bilirubin result; note if segmental/ selective infusion planned to justify higher bilirubin values

inv-21: Albumin — clinical threshold reference

Albumin thresholdSerum albumin > 3 g/dL associated with improved survival after Y‑90 TARE

Clinical relevance

Prior Authorization, Documentation, and Clinical Steps

Prior Authorization

Prior Authorization Required

Prior authorization is required for yttrium-90 transarterial radioembolization (TARE)/selective internal radiation therapy (SIRT). Requests should reference the applicable procedure codes and be submitted prior to scheduling the procedure.

Prior authorization required for Y-90 TARE/SIRT (see codes above).
Coverage decisions will be made using the policy's clinical criteria and required documentation; federal, state, or contractual requirements govern final determinations.

Documentation Required

Prior Authorization and Governing Requirements

Benefit coverage for services is determined by federal, state, or contractual requirements and applicable laws; inclusion of a code in this policy does not guarantee coverage or payment. Medical records documentation may be requested and must fully support medical necessity.

Documentation must include relevant history, physical exam, diagnostic test results, prior therapies, and rationale for SIRT.

Definitions and Key Terms

inv-47: ECOG Performance Status — standard criteria (0-5)

ECOG scale overviewECOG Performance Status scale 0–5: 0 = fully active; 1 = restricted in strenuous activity but ambulatory; 2 = ambulatory and capable of self‑care but unable to work; 3 = limited self‑care; 4 = completely disabled; 5 = dead

Use in policyECOG 0–2 is the performance status range referenced for covered indications

Authorization requirementRecord ECOG performance status in preprocedural documentation for prior authorization

inv-48: Limited Extra-Hepatic Disease — definition thresholds for limited pulmonary or nodal metastases

Definition — Limited extra‑hepatic diseaseMetastases limited to lung with < 5 nodules ≤ 1 cm or a single nodule ≤ 1.7 cm and/or a single lymph node area < 2 cm

Clinical implication

Background and Evidence Summary

Transarterial radioembolization (TARE), also known as selective internal radiation therapy (SIRT), delivers yttrium‑90 microspheres via the hepatic arterial system to concentrate high focal radiation in liver tumors while relatively sparing normal liver parenchyma. The preferred treatment for liver tumors remains surgical resection when feasible; TARE/SIRT is used for unresectable or liver‑dominant disease for palliation, as a bridge to transplantation or downstaging, or when systemic therapies have failed to control disease or symptoms.

Policy Revision History

2026-01-01Material policy revisionLatest

Policy updated to apply to individuals 19 years and older; clarified coverage for those younger than 19; revised and clarified the list of proven/medically necessary indications (added uveal/ocular melanoma metastasis confined to liver and revised wording to emphasize 'not surgical candidates' and 'chemotherapy‑resistant or refractory' colorectal metastases).

Administrative update

Medical records documentation language expanded to state coverage is determined by federal, state, or contractual requirements and that documentation may be requested to assess clinical criteria; supporting information and references were updated and prior policy CS060NM.B archived.

Policy Summary

PayerUnitedHealthcare

PolicyTransarterial Radioembolization (TARE)/ Selective Internal Radiation Therapy (SIRT) for the Treatment of Malignant Cancers of the Liver (for New Mexico Only)

Policy CodePolicy CS060NM.C

Change TypeRevised indicationsage applicability addeddocumentation clarified

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

inv-23: Total bilirubin level — relative contraindication thresholds referenced

Relative bilirubin contraindicationTotal bilirubin > 2 mg/dL is a relative contraindication to Y‑90 TARE in non‑obstructive cases; NCCN notes bilirubin > 3 mg/dL is generally relative contraindication unless segmental treatment feasible

InterpretationNonobstructive bilirubin elevation suggests impaired liver function where risks may outweigh benefits; segmental infusion may permit treatment in select HCC cases

Prior auth noteDocument bilirubin value and whether segmental/ subsegmental infusion is planned to justify proceeding when bilirubin above standard thresholds

Note

ASCO: Not Routinely Recommended for mCRC

ASCO guidance advises that SIRT (Y-90 TARE) is not routinely recommended for metastatic colorectal cancer (mCRC); use is intended for patients with predominantly hepatic disease who are refractory or intolerant to chemotherapy.

In routine practice, reserve Y-90 TARE for patients with liver-dominant, chemotherapy-refractory or -intolerant disease.
Pre-treatment laboratory evaluation and assessment of prognostic markers (e.g., CEA) should be documented.

Note

NICE: Research-Only / Specialist-Center Preference

NICE recommendations limit SIRT use for certain indications to research settings or specialist centers where evidence is inadequate; for unresectable intrahepatic cholangiocarcinoma (iCCA) use should be in the context of research.

SIRT for unresectable iCCA: recommend use only in research settings and specialist centers.
SIRT for neuroendocrine liver metastases: recommend multidisciplinary selection and performance in specialized centers.

Documentation Required

Medical Records to Support Necessity

The patient's medical record must contain documentation that fully supports medical necessity for SIRT/TARE. This documentation should be legible, maintained in the medical record, and available upon request.

Required elements: relevant medical history, physical examination, prior systemic and local therapies, imaging reports, laboratory results, and performance status (e.g., ECOG).
Include documentation of prior systemic therapy and response (or intolerance) when applicable.

Documentation Required

Pre-treatment Evaluation and MDT Documentation

Prior to authorization and treatment, multidisciplinary team (MDT) evaluation and specific pre-treatment assessments are expected and should be documented in the record.

Document MDT review including interventional radiology, medical oncology, radiation oncology, hepatology, nuclear medicine, and surgical oncology as applicable.
Document baseline labs (CBC, coagulation, liver and renal profile) and prognostic markers (e.g., CEA).
Document treatment history (previous surgeries, TACE, ablation, systemic therapies) and rationale for selecting SIRT.

Documentation Required

Required Preprocedural Evaluation and Documentation

Required preprocedural evaluation and mapping data must be available for review as part of the authorization and must demonstrate safe candidacy for Y-90 delivery.

Initial mapping angiography, contrast cone-beam CT, and/or technetium-99m MAA perfusion scintigraphy results must be documented.
Document acceptable lung shunt fraction per product-specific limits and absence of clinically unacceptable nontarget deposition, or steps taken to mitigate it.
Document coagulation status and absence of uncorrectable coagulopathy, absence of acute hepatic infection, and ability to catheterize the hepatic artery.

Documentation Required