Focused Ultrasound Liver Tumor Treatment Receives CMS Reimbursement


Key Points

  • The Centers for Medicare and Medicaid Services (CMS) has set a facility procedural payment level of $12,500.50, in addition to the costs associated with single-use devices, for histotripsy of liver tumors.
  • Histotripsy’s novel mechanism of action uses focused ultrasound to mechanically destroy and liquefy targeted liver tissue at sub-cellular levels.
  • HistoSonics is sponsoring ongoing clinical studies in the US and Europe, named #HOPE4LIVER, which are designed to evaluate the safety and technical efficacy of histotripsy in patients with primary and secondary liver tumors.

CMS logoThe Centers for Medicare and Medicaid Services (CMS) announced last week that as part of the calendar year 2022 Medicare hospital Outpatient Prospective Payment System (OPPS) final rule, they have set a facility procedural payment level of $12,500.50 for histotripsy (i.e., nonthermal ablation via acoustic energy delivery) of malignant hepatocellular tissue, including image guidance, assigned to CPT code 0686T. Additionally, and upon regulatory clearance in the US, the costs associated with the personalized, single-use devices utilized in the histotripsy procedure will be added to the procedural reimbursement recently assigned by CMS.

HistoSonics’ noninvasive platform – called EdisonTM – combines advanced imaging and proprietary software to deliver patient-specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues. The procedure is currently being investigated in patients with liver tumors in two similar clinical trials in Europe and the US – both called #HOPE4LIVER.

histosonics logo“This is a huge step forward for the field of focused ultrasound, and in particular for patients with primary and metastatic tumors in the liver,” explains Foundation Chairman Neal F. Kassell, MD. “Assuming the procedure receives FDA clearance and coverage is granted by CMS, patients with liver tumors will have greater access to the option of being treated with focused ultrasound.”

The CMS ruling is the latest positive news for HistoSonics. In July 2021, the American Medical Association issued a new Current Procedural Terminology (CPT®) procedure code for histotripsy of the liver. And just last month, the company announced their novel therapy platform was granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

It is important to note that focused ultrasound-based histotripsy of the liver is not yet approved by the FDA, and patients can only access the treatment now by participating in the #HOPE4LIVER studies. The Edison system by HistoSonics is under development and not currently approved in the US or Europe.