ModifiedUnitedHealthcarePolicy CS060OH.D

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

Ohio-only UnitedHealthcare medical policy governing coverage and medical necessity evaluation for TARE/SIRT (Y-90 microspheres) for malignant liver cancers; applies to individuals 19 years and older (policy notes coverage without further review for <19). Refers to InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver for clinical criteria.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS060OH.D

Change TypeModified (age applicability, InterQual reference, removed prior enumerated indications, added documentation requirements)

Effective DateJan 1, 2026

Next Review Date

Key ActionMaintain complete, legible medical records and obtain prior authorization when required using InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver for adults (≥19).

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.

Replaced instruction to 'refer to the InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver for age ≥ 18' with 'refer to the InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver' for medical necessity clinical coverage criteria.

Removed prior enumerated proven/medically necessary indications (HCC, bridge to transplant, NET mets, CRC mets, intrahepatic cholangiocarcinoma) and the prior blanket 'unproven/not medically necessary for all other indications' statement.

Added documentation requirements language emphasizing benefit coverage determined by federal/state/contractual requirements and that records must fully support medical necessity.

Removed definitions including ECOG Performance Status, Limited Extra-Hepatic Disease, and Refractory.

Removed 'Description of Services' and 'Clinical Evidence' sections and related content.

Description of Services and Clinical Evidence sections were removed from the policy and archived previous policy version CS060OH.C.

Multiple archived previous policy version CS060OH.C entries indicate 'Removed Description of Services' and removal of 'Clinical Evidence' in prior revisions.

1State-specific policy (Ohio)

19+Adult age threshold for standard review

PreapprovedCoverage for <19 years

CS060OH.CArchived previous version referenced

InterQualExternal criteria source referenced

Coverage Summary & Scope

This is an Ohio-only UnitedHealthcare medical policy (CS060OH.D) governing Transarterial Radioembolization (TARE)/Selective Internal Radiation Therapy (SIRT) using yttrium-90 microspheres. The policy applies to individuals 19 years of age and older. For individuals younger than 19 years of age, TARE/SIRT is covered without further review. For adults (≥19), medical necessity and coverage determinations follow the InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver. FDA approvals for the commercial Y-90 products (TheraSphere and SIR-Spheres) are noted in the policy for informational context.

Policy attributes

StateOhio

Adult age threshold19+

Pediatric coveragePreapproved for individuals younger than 19 (covered without further review)

Coverage stanceMixed (proven/medically necessary in certain circumstances; overall coverage stance: mixed)

Referenced external criteriaInterQual CP: Procedures, Ablative or Transarterial Therapy, Liver

Policy numberCS060OH.D

Effective dateJanuary 1, 2026

Medical-Necessity Criteria (by criteria group)

Age applicability

Policy application by age:

ALL of the following

Geographic scope: This medical policy only applies to the state of Ohio
Geographic scope
Applies to individuals 19 years of age and older
Clinical criteria for medical necessity use InterQual for adults
Pediatric coverage preapproved: Transarterial radioembolization/selective internal radiation therapy is covered without further review for individuals younger than 19 years of age
Pediatric (<19) coverage is preapproved

Applicable Procedure Codes (reference)

Applicable procedure codes (reference only)CPT|HCPCS

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

Provider Actions & Operational Requirements

Documentation Required

Support medical necessity with complete records

Ensure the patient's medical record fully supports the medical necessity for the requested service. Include the items below and make documentation available upon request.

Relevant medical history (oncologic history, prior therapies, performance status)
Physical examination findings
Pertinent diagnostic tests and procedures (imaging, labs, pathology reports, tumor staging)
InterQual criteria results or decision support documentation when used
Prior authorization correspondence and treatment plan, if applicable

Prior Authorization

Adult prior authorization / medical necessity review

Background & Regulatory Context

TARE/SIRT uses yttrium-90 (90Y) microspheres delivered via the hepatic arterial circulation to provide targeted internal radiation to malignant liver tumors. The policy identifies the two commercial 90Y products: SIR-Spheres (resin microspheres) and TheraSphere (glass microspheres). SIR-Spheres are indicated in the FDA PMA for treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of floxuridine (FUDR). TheraSphere has been regulated historically under an HDE and, in March 2021, received PMA approval for use as SIRT for local tumor control of solitary unresectable hepatocellular carcinoma tumors 1–8 cm in diameter in selected patients meeting specified liver function and clinical criteria.

Definitions

InterQual definitionInterQual CP: Procedures, Ablative or Transarterial Therapy, Liver — external clinical criteria referenced for medical necessity determinations

InterQual® noteInterQual is used by UnitedHealthcare for primary medical/surgical decision support; refer to the InterQual CP for medical necessity clinical coverage criteria

OAC (Ohio Administrative Code)Ohio Administrative Code (OAC) rules (e.g., OAC 5160-1-01) may govern coverage and medical necessity evaluations for Ohio plans

Regulatory Approvals

The policy references the following FDA regulatory actions for 90Y microspheres: SIR-Spheres PMA P990065 (premarket approval March 5, 2002) for resin 90Y microspheres for unresectable metastatic colorectal liver tumors with IHAC of floxuridine, and TheraSphere PMA P200029 (approved March 17, 2021) for glass 90Y microspheres as SIRT for local tumor control of solitary unresectable hepatocellular carcinoma (1–8 cm) in selected patients meeting Child‑Pugh A and other clinical criteria.

Revision History

01/01/2026material_changeLatest

Material change (added): Policy now states age applicability — applies to individuals 19 years of age and older; TARE/SIRT covered without further review for individuals younger than 19 years of age. (Material)

01/01/2026material_changeLatest

Material change (revised): Clarified InterQual reference — replaced instruction referencing InterQual CP for age ≥18 with a general reference to 'InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver' for medical necessity clinical coverage criteria. (Material)

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS060OH.D

Change TypeModified (age applicability, InterQual reference, removed prior enumerated indications, added documentation requirements)

Effective DateJan 1, 2026

Next Review Date

Key ActionMaintain complete, legible medical records and obtain prior authorization when required using InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver for adults (≥19).

SourceLink

On This Page

Adult medical necessity

For individuals ≥19 years...

ALL of the following

InterQual reference: Refer to the InterQual CP: Procedures, Ablative or Transarterial Therapy, Liver for medical necessity clinical coverage criteria
InterQual criteria govern specific indications and eligibility

Removed prior specific indications

Policy history shows removal of prior enumerated covered indications; they are no longer stated here:

ANY of the following

Previously-removed: Primary HCC unresectable limited to liver: Previously-removed: Primary hepatocellular carcinoma (HCC) unresectable and limited to the liver
Previously-removed: Primary HCC bridge to transplant: Previously-removed: Primary HCC as a bridge to liver transplantation
Previously-removed: NET mets after systemic therapy failed: Previously-removed: Unresectable liver metastases from neuroendocrine tumors when systemic therapy has failed to control symptoms
Previously-removed: CRC mets limited extra-hepatic refractory: Previously-removed: Unresectable liver metastases from colorectal carcinoma with limited extra-hepatic disease refractory/relapsed after systemic chemotherapy
Previously-removed: Intrahepatic cholangiocarcinoma: Previously-removed: Unresectable intrahepatic cholangiocarcinoma
Previously-removed: Unproven for all other indications statement: Previously-removed: Statement that TARE/SIRT is unproven and not medically necessary for all other indications

Medical records/documentation requirements

Coverage determination requires documentation; medical records must fully support medical necessity:

ALL of the following

May require documentation to assess clinical criteria: Medical records documentation may be required to assess whether the member meets clinical criteria for coverage
Records must fully support medical necessity: The patient's medical record must contain documentation that fully supports the medical necessity for the requested services
Include relevant history, exam, diagnostic results: Documentation includes relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures
Legible, maintained, available on request: Documentation supporting the medical necessity should be legible, maintained in the patient's medical record, and must be made available upon request
Benefit coverage determined by federal/state/contractual requirements: Benefit coverage is determined by federal, state, contractual requirements and applicable laws

For individuals age 19 years and older, coverage is assessed using the InterQual® CP: Procedures, Ablative or Transarterial Therapy, Liver clinical criteria. Providers should obtain prior authorization per the member's plan requirements before scheduling services.

Prior Authorization

Potential prior authorization requirement based on plan

UnitedHealthcare may require prior authorization for TARE/SIRT depending on the member's specific plan. Prior authorization processes and any utilization management criteria (including use of InterQual) are determined by plan-level rules.

Plan-specific prior authorization requirements apply — check member eligibility and benefits
InterQual criteria may be used to determine medical necessity during review

Documentation Required

Follow federal/state/contractual requirements and InterQual criteria

Benefit coverage is determined by federal, state, or contractual requirements and applicable laws. Follow any applicable Ohio Administrative Code provisions and the InterQual clinical criteria when documenting and requesting coverage.

Adhere to federal/state/contractual mandates that may supersede policy language
Use InterQual criteria for medical necessity determinations for individuals ≥19

Documentation Required

Archived version reference

Reference the current version of this policy and any archived versions when determining applicable rules or reviewing prior decisions.

Effective date: 2026-01-01 (Policy Number: CS060OH.D)
Maintain copies of prior authorization determinations and policy versions in the medical record

Material change (removed): Prior enumerated proven/medically necessary indications and the prior blanket 'unproven/not medically necessary for all other indications' language were removed from the policy (lists including HCC, bridge to transplant, NET mets, CRC mets, intrahepatic cholangiocarcinoma). (Material)

01/01/2026material_changeLatest

Material change (added): Operational documentation expectations added — benefit coverage determined by federal/state/contractual requirements and medical records must fully support medical necessity; documentation may be required and must be made available upon request. (Material)

non_material_changeLatest

Removed non-essential content: Definitions (ECOG Performance Status, Limited Extra‑Hepatic Disease, Refractory) and content sections 'Description of Services' and 'Clinical Evidence' were removed/archived from the policy (non‑material).