Ablation of Hepatic Lesions

Coverage Summary

Overview: This policy addresses ablation therapies for hepatic lesions with a mixed coverage stance. Primary indications covered when selection criteria are met include isolated colorectal liver metastases, hepatocellular carcinoma, and unresectable neuroendocrine liver metastases. Open surgical resection remains the preferred treatment; cryoablation, microwave ablation (MWA) and radiofrequency ablation (RFA) are options for carefully selected patients who are not candidates for resection. Key policy dates: effective 1998-08-28, last review 2023-11-09, next review 2024-03-14.

Medical-Necessity Criteria

Medically Necessary - Cryosurgery, Microwave, or Radiofrequency Ablation

Aetna considers cryosurgery, microwave, or radiofrequency ablation medically necessary when ALL of the following criteria are met:

ALL of the following

Member has hepatic metastases from a colorectal primary cancer or has a hepatocellular cancer.
Member has isolated liver disease; members with nodal or extra-hepatic systemic metastases are not candidates for these procedures.
All tumors in the liver, as determined by pre-operative imaging, would be potentially destroyed by cryotherapy, microwave, or radiofrequency ablation.
Member is an unacceptable open surgical candidate due to the location or extent of the liver disease or due to co-morbid conditions such that the member is unable to tolerate an open surgical resection.
Open surgical resection is the preferred treatment; these procedures are for those who are not candidates for resection.
Liver lesions must be 4 cm or less in diameter and occupy less than 50% of the liver parenchyma.<= 4 cm; < 50%
Lesions larger than this may not be adequately treated by these procedures.

Medically Necessary - Unresectable Neuroendocrine Tumor Liver Metastases

Aetna considers cryosurgery, microwave, or radiofrequency ablation medically necessary when ALL of the following are met:

ALL of the following

Unresectable neuroendocrine tumors metastatic to the liver.

Medically Necessary - Combination RFA and TACE for Unresectable HCC

Aetna considers combination treatment of radiofrequency ablation and transcatheter arterial chemoembolization medically necessary when ALL of the following are met:

ALL of the following

Treatment is for unresectable hepatocellular carcinoma.
Criteria for radiofrequency ablation for hepatocellular carcinomas (as above) are met.

Experimental and Investigational (Not Medically Necessary)

The following procedures are considered experimental and investigational because effectiveness has not been established:

ANY of the following

Combinational treatment of high-intensity focused ultrasound (HIFU) and transcatheter arterial chemo-embolization (TACE) for hepatoblastoma.
Cryosurgery, microwave, or radiofrequency ablation as a treatment of hepatic metastases from non-colonic primary cancers.
Cryosurgical, microwave or radiofrequency ablation as a palliative treatment of either hepatic metastases from colorectal cancer or hepatocellular cancer.
Electro-chemotherapy for hepatocellular carcinoma and colorectal liver metastases.

Coding

CPT codes covered if selection criteria are metCPTCovered

37243	Vascular embolization or occlusion ... for tumors, organ ischemia, or infarction [covered for treatment of hepatocellular carcinomas]
47380	Ablation, open, of one or more liver tumor(s); radiofrequency
47381	Ablation, open, of one or more liver tumor(s); cryosurgical
47382	Ablation, one or more liver tumor(s), percutaneous, radiofrequency
47383	Ablation, 1 or more liver tumor(s), percutaneous, cryoablation
75894	Transcatheter therapy, embolization, any method, radiological supervision and interpretation [covered for treatment of hepatocellular carcinomas]

CPT codes not covered for indications listed in the CPBCPTNot Covered

0600T	Ablation, irreversible electroporation; 1 or more tumors per organ, including imaging guidance, when performed, percutaneous
0601T	Ablation, irreversible electroporation; 1 or more tumors, including fluoroscopic and ultrasound guidance, when performed, open
0686T	Histotripsy (ie, non-thermal ablation via acoustic energy delivery) of malignant hepatocellular tissue, including image guidance
37242	Vascular embolization or occlusion, arterial, other than hemorrhage or tumor

Other CPT/Imaging codes related to the CPBCPTCovered

76940	Ultrasound guidance for, and monitoring of, parenchymal tissue ablation
77013	Computerized tomography guidance for, and monitoring of, parenchymal tissue ablation
77022	Magnetic resonance guidance for, and monitoring of, parenchymal tissue ablation

HCPCS codes not covered for indications listed in the CPBHCPCSNot Covered

C9734	Focused ultrasound ablation/therapeutic intervention, other than uterine leiomyomata, with MR guidance [not covered for combinational HIFU + TACE for hepatoblastoma]
C9790	Histotripsy of malignant renal tissue, including image guidance

Other HCPCS related to the CPBHCPCS

C1886

Catheter, extravascular tissue ablation, any modality (insertable)

ICD-10 codes covered if selection criteria are metICD-10Covered

C18.0-C20	Malignant neoplasm of colon, rectosigmoid junction and rectum [isolated with liver metastases]
C78.7	Secondary malignant neoplasm of liver and intrahepatic bile duct [also required]
C22.0	Malignant neoplasm of liver [hepatoblastoma]
C22.2-C22.8	Other malignant neoplasms of liver
C7B.02	Secondary carcinoid tumors of liver [unresectable with liver metastases]
D01.5	Carcinoma in situ of liver, gallbladder and bile ducts [hepatocellular cancer]

ICD-10 codes not covered for indications listed in the CPBICD-10Not Covered

D13.4	Benign neoplasm of liver
D18.03	Hemangioma of intra-abdominal structures [giant hepatic hemangioma]

Procedure codes lacking a specific code but referenced (e.g., microwave ablation for hepatic hemangioma)mixedNot Covered

Microwave ablation for hepatic hemangioma - no specific code

Category III CPT code mentioned for histotripsyCPT

Category III CPT (unique code for histotripsy of liver effective 2022-01-01)

AMA issued a new Category III CPT code for histotripsy of the liver effective January 1, 2022 (exact numeric code not listed in this excerpt).

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Selection criteria must be documented

Providers must document that all medical necessity selection criteria are met before authorization: the primary tumor type (colorectal primary or hepatocellular cancer), that disease is isolated to the liver (no nodal or extra‑hepatic systemic metastases), pre-operative imaging showing all liver tumors would be potentially destroyable by the chosen ablation, that the member is unsuitable for open surgical resection (location/extent or co-morbidities), and that lesions meet size and liver‑involvement limits (≤ 4 cm and < 50% of liver parenchyma).

Primary tumor type: colorectal liver metastases or hepatocellular cancer
Isolated liver disease (no nodal or extra‑hepatic metastases)
Pre-operative imaging demonstrating tumors potentially destroyable by ablation
Documented unsuitability for open resection (location, extent, or co-morbidities)
Lesion size ≤ 4 cm and occupying < 50% of liver parenchyma

Background & Evidence Summary

Background summary: The liver is a common site of colorectal metastases; surgical resection offers the only potential for cure in selected patients and remains the preferred approach. Many patients are not resection candidates because of tumor size, location, multifocality, or inadequate hepatic reserve. Ablative therapies (RFA, MWA, cryotherapy and combinations with arterially directed therapies such as TACE) have been developed as minimally invasive regional options for unresectable or non-surgical candidates. National guidance (NICE, NCCN) and systematic reviews/ASCO evidence reviews are cited regarding safety, comparative effectiveness and limits of evidence; combination RFA+TACE has randomized and meta-analytic data showing benefit for selected HCC sizes.

Evidence	Key finding
Randomized controlled trial (Peng et al 2013)
TACE + RFA superior to RFA alone for HCC < 7 cm — improved overall survival and recurrence‑free survival
Large multi‑institutional MWA series (Groeschl et al 2014)
Complete ablation confirmed in 97% of tumors; overall local recurrence 6%; tumor size >=3 cm predicted poorer recurrence‑free survival
Large registry complete ablation rate
839 of 865 tumors (97.0%) confirmed complete ablation on follow‑up imaging
MR‑guided MWA series (Hoffmann et al 2017; Weiss et al 2019)
Technical success and technique effectiveness achieved in all 18 lesions (15 patients) and high technical success in small (<=12 mm) lesions with no major complications reported
IRE bi‑institutional series (Mafeld et al 2019 / Schicho 2018)
Complete ablation achieved in 75% of cases; complication rate 17%; median survival 38 months — IRE induces local control but less consistently curative
Histotripsy regulatory status (HistoSonics)
FDA Breakthrough Device designation (Oct 2021); Category III CPT code effective 2022‑01‑01; device investigational and limited to IDE use
Meta‑analyses of RFA + TACE vs RFA alone
Multiple meta‑analyses show improved overall survival and recurrence‑free survival with combination therapy, especially for intermediate/large HCC
MWA for hepatic hemangioma pooled results (Li & Xing 2023)
Pooled mean diameter decrease 3.009 cm and pooled volume reduction 53.17%; pooled major complication incidence 0.017; no MWA‑related mortality reported
MWA synchronized multi‑antenna benefit (Han 2022)
Synchronized multi‑antenna MWA associated with ~22% better local tumor progression‑free (LTPF) for larger tumors (>=2 cm) compared with single‑antenna approaches

Definitions

Definitions (glossary):

Isolated liver disease: Disease confined to the liver without nodal or extra‑hepatic systemic metastases.

RFA: Radiofrequency ablation — a thermal ablation technique.

MWA: Microwave ablation — a thermal ablation technique using microwave energy to induce tumor necrosis.

IRE: Irreversible electroporation — a non-thermal ablative technique that can preserve collagenous structures (vessels and ducts).

TACE: Transcatheter arterial chemoembolization — an arterially directed therapy often combined with ablation.

Electrochemotherapy: Combination of chemotherapeutic drugs (e.g., bleomycin) with reversible electroporation to enhance drug uptake.

Histotripsy: Image-guided, non-invasive focused high-amplitude ultrasound that mechanically fractionates tissue (non-thermal); currently investigational and limited to IDE/clinical trials.

EUS-RFA: Endoscopic ultrasound-guided radiofrequency ablation — RFA delivered via an endoscopic ultrasound approach for lesions not amenable to percutaneous access.

Revision History

1998-08-28Effective Date

Policy effective date

2023-11-09Last ReviewLatest

Policy last reviewed

2024-03-14Next Review

Scheduled next policy review