CurrentIndependent HealthPolicy M20180212005

Radioembolization for Hepatic Tumors

Defines Independent Health's medical necessity coverage for radioembolization (Selective Internal Radiation Therapy) using TheraSphere or SIR-Spheres for primary and metastatic liver tumors and identifies contraindications and applicable lines of business.

Policy Summary

PayerIndependent Health

PolicyRadioembolization for Hepatic Tumors

Policy CodePolicy M20180212005

Change TypeNo material change

Effective Date4/1/2018

Next Review Date

Key ActionPre-authorization is not required; clinical criteria will be applied during retro-review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ECOG 0-2required performance status for coverage

>=3 monthsminimum life expectancy required

Child-Pugh A/Brequired liver function for colorectal metastases

Not requiredpre-authorization

TheraSphere, SIR-Spheresdevices specified

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 Criteria for Yttrium-90 Radioembolization

Medical necessity criteria

Covered when ALL of the following are met:

Primary and metastatic liver disease criteria: Indication is one of: (1) unresectable, pathology-proven primary hepatocellular carcinoma (HCC) limited to the liver; OR (2) unresectable, pathology-proven liver tumors from primary colorectal cancer with Child-Pugh A or B; OR (3) as a bridge to transplant for HCC patients who meet transplant criteria and are awaiting liver transplantation; OR (4) treatment of unresectable, pathology-proven, liver-only or liver-dominant metastases from neuroendocrine cancers when other systemic therapies have failed to control symptoms.

Logical OR within this node for acceptable indications

Functional and survival requirements: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 AND life expectancy of at least 3 months.ECOG 0-2; life expectancy >= 3 months

Both required

All indications for radioembolization not explicitly listed as medically necessary in this policy are non-covered. Specific contraindications that exclude coverage include: inability to catheterize the hepatic artery; exaggerated hepatopulmonary shunting; fulminant liver failure, severe liver dysfunction, or pulmonary insufficiency; technetium-99m macroaggregated albumin (99Tc MAA) perfusion scintigraphy showing significant reflux or nontarget deposition to gastrointestinal organs that cannot be corrected by angiographic techniques; portal vein occlusion; any other contraindication to hepatic artery catheterization; and pregnancy.

Use of radioembolization for indications other than those specified in the medical necessity criteria is considered non-covered. The policy limits coverage to: unresectable, pathology-proven primary hepatocellular carcinoma (HCC) limited to the liver; unresectable, pathology-proven colorectal liver metastases with Child-Pugh A or B liver function; use as a bridge to transplant for HCC patients meeting transplant criteria and awaiting liver transplantation; and treatment of unresectable, pathology-proven, liver-only or liver-dominant neuroendocrine metastases when other systemic therapies have failed to control symptoms. In addition, eligible patients must have ECOG performance status 0-2 and a life expectancy of at least 3 months.

Provider Actions, Documentation, and Denial Risk

Note

Pre-authorization / Retro-review

Pre-authorization is not required for radioembolization at this time. Criteria listed in the medical necessity section will be applied on retroactive review to determine coverage.

Pre-authorization: No
Retro-review: Criteria in policy will be used to adjudicate claims

Prior Authorization

Prior systemic therapy for neuroendocrine metastases

Treatment of unresectable, pathology-proven, liver-only or liver-dominant metastases from neuroendocrine tumors is considered medically necessary only when other systemic therapies have failed to control symptoms.

Applicable to liver-only or liver-dominant neuroendocrine metastases
Must have prior systemic therapy with inadequate symptom control

Background on Selective Internal Radiation Therapy (SIRT)

Selective internal radiation therapy (radioembolization) delivers microspheres labeled with Yttrium-90 (commercially TheraSphere or SIR-Spheres) via catheterization of the hepatic arterial circulation to exploit tumor hypervascularity and treat unresectable primary or liver-dominant metastatic tumors. Candidate selection relies on documented pathology, cross-sectional imaging, assessment of liver function and performance status, and expected survival to ensure appropriate benefit from the procedure.

Definitions and Scoring Systems

Child-Pugh (Childs-Pugh) score

PurposeScoring system for severity of liver disease and likelihood of survival based on encephalopathy, ascites, albumin, INR (prothrombin time) and bilirubin.

Scoring categoriesChilds A: 5-6 points; Childs B: 7-9 points; Childs C: 10-15 points (higher score indicates worse liver function).

Category survival examplesChilds A (5-6): 10-year survival ~80-90%; Childs B (7-9): 5-year survival ~60-80%; Childs C (10-15): 2-year survival <50%.

Component parametersEncephalopathy (1=none, 2=moderate, 3=severe); Ascites (1=none, 2=mild, 3=moderate); Albumin (1=>3.5, 2=2.8–3.5, 3=<2.8 mg/dL); Prothrombin time INR prolongation (1=<4, 2=4–6, 3=>6); Bilirubin (1=1–4 mg/dL, 2=4–10 mg/dL, 3=>10 mg/dL).

Use in policyChild-Pugh classification is used to determine eligibility for radioembolization (e.g., colorectal liver metastases require Child-Pugh A or B).

Denial Risk

Non-covered indications and contraindications

Procedures and indications not listed as medically necessary in this policy are non-covered and will be denied on retro-review. Contraindications to radioembolization include inability to catheterize the hepatic artery, exaggerated hepatopulmonary shunting, fulminant liver failure or severe liver dysfunction, pulmonary insufficiency, 99mTc MAA demonstrating significant reflux or nontarget gastrointestinal deposition that cannot be corrected angiographically, portal vein occlusion, any contraindication to hepatic artery catheterization, and pregnancy.

Non-covered: any indication not meeting the policy's medical necessity criteria
Contraindications: inability to catheterize hepatic artery; significant hepatopulmonary shunt; fulminant liver failure/severe liver dysfunction; pulmonary insufficiency; uncorrectable nontarget GI deposition on 99mTc MAA; portal vein occlusion; pregnancy