ModifiedUnitedHealthcarePolicy CS060NM.C

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

This New Mexico–specific medical policy governs coverage and medical necessity criteria for Yttrium-90 TARE/SIRT for malignant liver tumors in individuals 19 years and older (with separate note for <19). It affects providers requesting coverage in New Mexico.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS060NM.C

Change TypeMaterial revision to covered indications and clarifying language (01/01/2026)

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of unresectable liver malignancy, performance status, mapping studies (MAA/angiography), and prior systemic therapy status.

SourceLink

POLICY UPDATE CHANGES

Policy applies to individuals 19 years of age and older; TARE/SIRT is covered without further review for individuals younger than 19 years of age.

Revised list of proven and medically necessary indications for TARE/SIRT, including addition of uveal/ocular melanoma confined to the liver and modification of language for HCC, neuroendocrine tumors, colorectal carcinoma, and intrahepatic cholangiocarcinoma to specify 'not surgical candidates' or 'chemotherapy-resistant/refractory' with predominant hepatic disease.

Medical records documentation requirements clarified, including that documentation may be required to assess clinical criteria and does not guarantee coverage.

Updated Clinical Evidence and References sections to reflect current information.

19+Applies to individuals age

ECOG 0-2

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Performance status eligible

NM onlyPolicy geographic application

Y-90Therapeutic isotope

S2095,37243,75894,79445Codes listed

Coverage Criteria for Y-90 TARE/SIRT

Medically Necessary Indications

Covered when ALL of the following are met for individuals aged 19 and older with ECOG 0–2:

Covered Indications: Indication is one of: (1) Liver-dominant primary hepatocellular carcinoma (HCC) in individuals who are not surgical candidates or as a bridge to liver transplantation; (2) Liver metastases from neuroendocrine tumors in individuals who are not surgical candidates when systemic therapy has failed to control symptoms; (3) Liver metastases from colorectal carcinoma in individuals with chemotherapy-resistant or refractory disease and with predominant hepatic metastases; (4) Liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates; (5) Metastasis from uveal/ocular melanoma when confined to the liver.ECOG Performance Status 0,1,or 2

Applies to individuals 19 years and older; policy states TARE/SIRT is covered without further review for individuals younger than 19 (per policy).

Not Medically Necessary / Unproven Indications

Not covered when:

Unproven Indications: Any indication not listed among the covered indications in this policy.

TARE/SIRT using yttrium-90 microspheres is unproven and not medically necessary for all other indications due to insufficient evidence.

Covered indications and preconditions

Covered when ALL of the following are met (as reflected in guideline consensus statements):

Patient selection: Predominantly hepatic disease that is refractory or intolerant to chemotherapy OR highly selected patients with chemotherapy-resistant/refractory disease and predominant hepatic metastases

Reflects ASCO and NCCN statements

Clinical evaluation: Pre-treatment evaluation includes laboratory exams (CBC, coagulation, liver and renal profile), prognostic markers (eg, CEA), and review of prior hepatic and systemic treatments

ASCO recommends these evaluations

Patient candidacy scenarios: May be considered for lobar/segmental (not diffuse) disease, for radiation lobectomy to induce hypertrophy when remnant liver volume is insufficient, or when prior biliary instrumentation increases infection risk with other embolotherapies

NCCN and ACR specify these scenarios

Evidence context

Comparative effectiveness considerations (context for coverage decisions):

HCC comparative outcomes: Evidence demonstrates mixed comparative effectiveness: some reviews and RCTs report no overall survival (OS) benefit of TARE versus standard care while showing improved time-to-progression or tumor control and fewer grade ≤3 adverse events in some studies; comparative results versus TACE, DEB-TACE, or systemic therapy vary by population and study design

Multiple systematic reviews, network meta-analyses, and RCTs cited

Coverage criteria — eligible indications and safety prerequisites

Covered when consistent with guideline-supported indications and patient selection

General eligibility: Patient has unresectable or inoperable primary HCC or intrahepatic malignancy with liver-dominant disease; performance status and life expectancy sufficient to benefit (guidance mentions life expectancy >= 3 months and preserved liver function)life expectancy >= 3 months

Multidisciplinary evaluation required per professional society guidance

Guideline-supported HCC indications: TARE may be used for solitary unresectable HCC (including subcapsular/anatomic locations challenging for ablation), as an alternative to TACE for intermediate-stage (BCLC B), for radiation segmentectomy to provide durable local control, and as bridge to liver transplantation

AASLD, ACR and NCCN support these uses

Guideline-supported ICC indications: TARE/SIRT may be considered for peripheral intrahepatic cholangiocarcinoma (peripheral lobar lesions <3 cm without biliary ductal dilatation, macroscopic vascular invasion, regional lymphadenopathy, or distant metastases) and as a locoregional option for unresectable ICC in selected patients

Indication-specific evidence summaries and guideline positions

Coverage/clinical stance varies by indication and guideline recommendations

Cholangiocarcinoma (intrahepatic): Some guidelines (ACR) consider radioembolization appropriate for select peripheral hepatic lobar cholangiocarcinoma <3 cm without biliary ductal dilatation, macroscopic vascular invasion, regional lymphadenopathy, or distant metastases; NICE recommends use only in the context of research due to inadequate efficacy evidence.

ACR and NICE positions cited

Uveal (ocular) melanoma liver metastases: Guidelines (NCCN) recommend considering regional therapies when disease is confined to the liver; prospective and retrospective studies report median OS in the range of approximately 8–19 months, but evidence is limited and largely nonrandomized.

NCCN and phase II/series evidence referenced

Hepatocellular carcinoma — bridge to transplant/downstaging: Evidence and assessments report TARE may be comparable or advantageous for bridging/downstaging to transplant with favorable safety and long-term post-transplant outcomes; NCCN lists SIRT/TARE as a locoregional therapy option to slow progression and reduce waitlist dropout.

COVERAGE CRITERIA

Covered when ALL of the following are met (summary of revised indications):

Indications

Included tumor types: liver-dominant primary HCC in non-surgical candidates; liver metastases from neuroendocrine tumors when systemic therapy failed to control symptoms and patient is not a surgical candidate; liver metastases from colorectal carcinoma with chemotherapy-resistant or refractory disease and predominant hepatic metastases; liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates; metastasis from uveal/ocular melanoma confined to the liver.
Specific phrasing updated in 01/01/2026 revision.

Absolute contraindications summarized in guidance from ASCO and AAPM identify conditions that should preclude Y-90 TARE/SIRT because of unacceptable patient risk or futility. These include pregnancy or lactation, life expectancy less than 3 months, clinical hepatic impairment, and disseminated extrahepatic disease. The AAPM guidance further highlights high tumor burden and severe liver dysfunction as important contraindicating or relative risk factors that affect candidacy and outcomes.

Guideline-based absolute contraindications that must be documented prior to authorization include pregnancy or lactation, life expectancy < 3 months, clinical hepatic impairment, and disseminated extrahepatic disease. These criteria are listed explicitly by ASCO and are echoed in AAPM selection recommendations.

Additional absolute contraindications comprise procedural or mapping findings that prevent safe delivery of Y-90 microspheres: inability to catheterize the hepatic artery, presence of fulminant liver failure, and pre-procedure mapping (angiography/contrast cone-beam CT and/or Tc‑99m MAA perfusion scintigraphy) that demonstrates clinically unacceptable non‑target deposition or an unacceptable lung shunt fraction per product limits. Acute hepatic infection and uncorrectable coagulopathy are also listed as absolute exclusions.

NICE concludes that evidence on the efficacy of SIRT for unresectable primary intrahepatic cholangiocarcinoma is inadequate in quantity and quality and explicitly recommends that SIRT for this indication be used only in the context of research. NICE advises multidisciplinary patient selection and performance in specialist centers while prospective studies addressing survival and quality‑of‑life outcomes are undertaken.

For breast cancer liver metastases, ESO‑ESMO guidance cautions that there are no randomized data demonstrating a survival benefit for local liver-directed therapies and that these approaches should be reserved for very selected patients with good performance status, limited liver involvement, no extrahepatic disease, and after systemic therapy has demonstrated disease control.

Use of TARE/SIRT for indications not listed among the policy's covered indications is considered unproven and not medically necessary due to insufficient evidence of efficacy. Coverage is limited to the specified liver‑dominant and unresectable indications described in the policy.

Professional society guidance does not support routine use of SIRT for metastatic colorectal cancer in patients who can receive systemic therapy. ASCO and NICE note low‑quality evidence and limited benefit, and ASCO specifically states that SIRT is not routinely recommended for mCRC with unilobar or bilobar liver metastases.

Relative contraindications and safety cautions include excessive tumor burden—generally when tumor replaces more than 50%–70% of hepatic parenchyma—and impaired liver function reflected by elevated bilirubin. Guidance references total bilirubin thresholds (commonly 2 mg/dL for suitability, with some organizations allowing up to 3 mg/dL if segmental treatment is feasible) and emphasizes preserved synthetic function when larger tumor burdens are present.

For many other primary tumor types that metastasize to the liver, current evidence is limited to small cohorts and retrospective series. Randomized controlled trials are needed to define benefit and appropriate selection; therefore routine use of TARE/SIRT for these indications is not supported outside of research settings or highly selected specialist cases.

Device regulatory status is informational only: FDA approval or clearance of Y‑90 devices (for example, TheraSphere or SIR‑Spheres) does not by itself establish coverage. Product labeling and approvals are provided for reference; coverage decisions are governed by applicable federal, state, and contractual requirements.

Applicable Codes and Coding Notes

Applicable procedure and HCPCS/CPT codesmixed

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 listed in policy (Description not provided in document)

FDA approved devicesmixed

No codes listed

Bilirubin thresholds referenced

Study inclusion thresholdSerum total bilirubin <= 2.0 mg/dL used as an inclusion criterion in some intrahepatic cholangiocarcinoma studies

Relative contraindicationTotal bilirubin >2 mg/dL is cited as a relative contraindication in guidance

Alternative threshold notedSome guidance (NCCN) allows consideration up to >3 mg/dL if segmental/subsegmental treatment is possible

Solitary tumor size for TheraSphere PMA

TheraSphere PMA solitary tumor sizeSolitary tumor size indication: 1–8 cm in diameter (PMA approval)

Device-specific context

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization: Eligibility and Mapping Requirements

Prior authorization is required for Y-90 transarterial radioembolization/selective internal radiation therapy (TARE/SIRT) and documentation must demonstrate eligibility, mapping results, and multidisciplinary evaluation. Medical records must fully document history, exam, and diagnostic results to support medical necessity; lack of required documentation may result in denial.

Prior authorization must document unresectable liver malignancy or indication consistent with policy-covered diagnoses (e.g., HCC as bridge to transplant, CRC liver metastases refractory to chemotherapy, neuroendocrine liver metastases after systemic therapy failure, intrahepatic cholangiocarcinoma when not surgical candidate, uveal/ocular melanoma confined to liver).
Document performance status (ECOG 0–2) and estimated life expectancy (generally ≥3 months).
Provide prior treatment history including systemic therapy, surgeries, prior locoregional therapies (TACE, ablation), and reason for TARE (e.g., chemotherapy-refractory/intolerant or bridge-to-transplant).
Include baseline laboratory data: CBC, coagulation profile, liver function tests (including total bilirubin), renal function, and tumor markers (eg, CEA for colorectal cancer; AFP for HCC) as applicable.
Provide imaging reports demonstrating liver‑dominant disease and tumor burden (estimate percent liver replacement).
Submit multidisciplinary evaluation documentation listing participating specialties (eg, interventional radiology, radiation oncology, nuclear medicine, medical physics, hepatology, surgical oncology) and consensus that TARE is appropriate.

Background and Rationale

Transarterial radioembolization (TARE), also called selective internal radiation therapy (SIRT), delivers yttrium‑90 impregnated microspheres via the hepatic arterial circulation directly to liver tumors. This approach permits delivery of a high, localized internal radiation dose to tumors while largely sparing surrounding normal liver tissue, and is used for unresectable disease or as a bridge to transplant when patient selection—based on liver function, tumor burden, and performance status—is appropriate.

Definitions and Key Terms

ECOG Performance Status

Scale rangeECOG Performance Status scale ranges from 0 to 5 (0 = fully active; 5 = dead)

ECOG 0 descriptionFully active, able to carry on all pre-disease performance without restriction

ECOG 2 descriptionAmbulatory and capable of all self-care but unable to carry out work activities; up and about >50% of waking hours

Limited Extra-Hepatic Disease

DefinitionLimited extra-hepatic disease = metastases limited to lung with <5 nodules ≤1.0 cm or a single nodule ≤1.7 cm and/or a single lymph node <2.0 cm

Anatomic examplesAllows small pulmonary nodules or a single small nodal site while maintaining liver-directed therapy candidacy

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS060NM.C

Change TypeMaterial revision to covered indications and clarifying language (01/01/2026)

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of unresectable liver malignancy, performance status, mapping studies (MAA/angiography), and prior systemic therapy status.

SourceLink

On This Page

Provider and setting: Procedure should be performed by clinicians with specific training/experience in SIRT in specialized centers

NICE and professional society guidance require trained clinicians and specialist centers

lesion < 3 cm for peripheral lobar ICC

ACR and NCCN statements referenced

Pre-procedure safety criteria: Mapping angiography/contrast cone-beam CT and Tc-99m MAA perfusion scintigraphy demonstrating acceptable lung shunt fraction and no clinically unacceptable non-target deposition; laboratory data consistent with safe procedure (bilirubin considerations) and ability to catheterize hepatic arteryacceptable lung shunt fraction per product

Absolute contraindications include inability to catheterize hepatic artery, fulminant liver failure, acute hepatic infection, uncorrectable coagulopathy

Bilirubin / tumor burden considerations: Relative contraindications include total bilirubin >2 mg/dL (or >3 mg/dL per some guidance unless segmental treatment is possible) and excessive tumor burden (>50–70% liver replacement) unless synthetic hepatic function is preserved and a segmental approach is feasiblebilirubin >2-3 mg/dL; tumor burden >50-70%

AAPM, ASCO, and NCCN referenced for thresholds and segmental exceptions

Hayes assessment and NCCN guidance cited

Breast cancer liver metastases: Systematic reviews and cohort studies report median survival post-SIRT of approximately 9–11 months with heterogenous evidence and no randomized data demonstrating survival benefit; local therapy should be reserved for highly selected patients after systemic control.

ESO/ESMO and systematic review data referenced

Other nonconventional liver metastases (pancreas, renal cell, lung, etc.): Limited small-cohort evidence suggests SIRT may provide palliative disease control and modest survival benefits in select cases, but randomized trials are needed to define utility and selection criteria.

Evidence limited; RCTs recommended

Approval applies to unresectable hepatocellular carcinoma with Child-Pugh A and well-compensated liver function

Source actionPMA language is informational for coverage decisions; FDA approval alone does not guarantee coverage

Include life‑threatening contraindications assessment (pregnancy/lactation, fulminant liver failure, disseminated extrahepatic disease, uncorrectable coagulopathy).

Prior Authorization

Prior Authorization: Bridge‑to‑Transplant Use

For individuals considered for TARE as bridge-to-transplant, prior authorization must include documentation that the planned treatment intent is bridging or downstaging for liver transplantation and provide evidence supporting that intent.

Document transplant candidacy evaluation and listing status (eg, within or outside Milan criteria) and transplant center plan for bridging/downstaging.
Provide evidence from imaging and tumor markers showing treatment targets and response goals (eg, downstaging to meet transplant criteria).
Include prior studies or literature rationale when applicable (Hayes assessments and cohort data supporting TARE use as bridge/downstaging).
Report expected timeline to transplant and monitoring plan to assess dropout risk and treatment response.

Documentation Required

Suggested Monitoring and Documentation (prospective trial schedules as guidance)

Prospective-trial informed monitoring and documentation expectations are recommended to support clinical decision-making and post-procedure assessment.

Baseline and early post-procedure laboratory monitoring: weekly labs for 1 month, then every 2 weeks for 2 months, then monthly as clinically indicated (including CBC, liver panel, coagulation, renal function).
Imaging schedule: cross-sectional imaging (CT/MRI) and/or PET at ~1 month post-treatment to assess for extrahepatic disease, and surveillance imaging every ~3 months to evaluate tumor response; MRI at 3 months may be used to confirm response when indicated.
Adverse event and toxicity monitoring using standard classification (eg, Society of Interventional Radiology complications grading).
Document mapping procedure results: angiography, cone-beam CT, and Tc-99m MAA hepatic arterial perfusion scintigraphy reports including calculated lung shunt fraction and any embolization performed to mitigate nontarget flow.
Record delivered activity/dose, treated territories (segmental/lobar/whole-liver), and any deviations from planned delivery.
Provide follow-up notes documenting clinical status, treatment response, development of extrahepatic disease, and any complications or hospitalizations.

Source studyDefinition cited from Wasan et al., 2017 in policy definitions

Refractory

DefinitionRefractory = cancer that does not respond to treatment; may be resistant at the start or become resistant during treatment

SynonymAlso described as resistant cancer (NCI, 2021)

Clinical implicationUsed in policy to qualify patients (eg, chemotherapy-resistant/refractory disease) for TARE/SIRT consideration

Transarterial Radioembolization (TARE)

DefinitionTransarterial radioembolization (TARE) is an intra-arterial therapy that delivers radioactive microspheres impregnated with yttrium-90 to liver tumors

SynonymsAlso called radioembolization or selective internal radiation therapy (SIRT)

Delivery routeMicrospheres are delivered via the hepatic arterial circulation to target tumors while sparing normal liver parenchyma

SIRT / TARE

TerminologySIRT and TARE are used interchangeably to describe yttrium-90 microsphere selective internal radiation delivered via the hepatic artery

Clinical framingGuidelines refer to SIRT/TARE for lobar/segmental approaches, radiation lobectomy, and locoregional control depending on indication

Usage notePolicy uses both terms (SIRT/TARE) to reflect guideline and device literature

Absolute contraindications (examples)

Examples of absolute contraindicationsPregnancy and lactation; life expectancy < 3 months; clinical hepatic impairment; disseminated extrahepatic disease

Additional absolute examplesInability to catheterize the hepatic artery; fulminant liver failure; acute hepatic infection; uncorrectable coagulopathy

Mapping-based contraindicationMapping demonstrating clinically unacceptable non-target deposition that cannot be corrected

Unacceptable lung shunt fraction

DefinitionUnacceptable lung shunt fraction = a lung shunt fraction measured on Tc-99m MAA mapping that exceeds product-specific acceptable limits and contraindicates Y-90 administration

Measurement methodAssessed during pretreatment mapping with technetium-99m macroaggregated albumin (Tc-99m MAA) hepatic arterial perfusion scintigraphy

Product-specific limitsAcceptable shunt fraction thresholds vary by yttrium-90 product and must not be exceeded

Non-target deposition

DefinitionNon-target deposition = delivery of radiotracer or microspheres to nonhepatic tissues identified on mapping angiography or MAA study that is clinically unacceptable and cannot be corrected

Clinical significanceUnacceptable non-target deposition that cannot be ameliorated by embolization or delivery adjustment is an absolute contraindication

DetectionIdentified during initial mapping angiography, contrast cone-beam CT, or Tc-99m MAA perfusion scintigraphy

SIRT/TARE summary definition and guidance linkage

Summary definitionSIRT/TARE is a locoregional therapy delivering yttrium-90 microspheres via the hepatic arterial circulation to irradiate liver tumors

Guidance linkageGuideline statements (ACR, NCCN, ASCO, NICE) define appropriate indications, patient selection, and emphasize specialist centers and multidisciplinary evaluation

Policy stancePolicy covers SIRT/TARE for specified unresectable or liver-dominant malignancies when selection and safety prerequisites are met

Y-90 microsphere products

Commercial productsTwo commercial Y-90 microsphere products: TheraSphere (glass) and SIR-Spheres (resin)

Regulatory status — SIR-SpheresSIR-Spheres received FDA premarket approval (P990065) for unresectable metastatic colorectal liver tumors with adjuvant IHAC of floxuridine (FUDR)

Regulatory status — TheraSphereTheraSphere has FDA Humanitarian Device Exemption status historically and received a PMA (P200029) approval for solitary tumors 1–8 cm in 2021; both products are subject to U.S. NRC licensing for use