C9790, Histotripsy (i.e., non-thermal ablation via acoustic energy delivery) of
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Technical success / early post-procedure imaging for investigational device: HistoSonics trial: "Following histotripsy treatment of liver tumor(s), subjects will undergo imaging less than or equal to 36 hours post-index procedure to determine technical success. Subjects will then be followed for 30 days."
- Assessment of necrosis / efficacy timing in clinical reports: e.g., EUS-RFA authors compared CH-EUS (contrast harmonic EUS) performed >24 hours post-treatment vs CT at 30 days and recommended CT scan at 30 days for more accurate assessment of necrosis (de Nucci et al 2020).
- Outcome measurement in clinical studies: many trials used CT or MRI and defined endpoints such as complete ablation on imaging at 1 month, recurrence-free survival, overall survival; e.g., Peng et al (2013): primary end point was OS, secondary was recurrence-free survival, tertiary was adverse effects; imaging follow-up 7–62 months.
Key Coverage Criteria
- Cryoablation / cryosurgery for liver tumors and colorectal liver metastases
- Percutaneous MR-guided ablation of small (≤ 12 mm) hepatic malignancies
- Cryosurgery, microwave, or radiofrequency ablation for members with isolated colorectal cancer liver metastases or isolated hepatocellular cancer who are not candidates for open surgical resection when the selection criteria specified below are met.
- Members must either have hepatic metastases from a colorectal primary cancer or have a hepatocellular cancer.
- Members must have isolated liver disease. Members with nodal or extra-hepatic systemic metastases are not considered 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.
2 Active Policies
ANTHEM-CG-SURG-78, CG-SURG-78 Cryosurgical, Radiofrequency, Microwave, or Percutaneous Ethanol Ablation to Treat Solid Tumors in the Liver
AETNA-CPB-0274, Ablation of Hepatic Lesions
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