Medical Alley Association startup member HistoSonics’ novel histotripsy procedure has been awarded procedural payment rate, taking effect on January 1st, 2022
Medical Alley, MN – The Centers for Medicare and Medicaid Services, as part of the 2022 Hospital Outpatient Prospective Payment System (OPPS) final rule, have set a facility procedure payment rate for histotripsy of the liver, the novel procedure pioneered by local Plymouth-based startup firm HistoSonics. The newly issued CMS facility procedural payment level for histotripsy of $12,500.50 set by CMS takes effect on January 1st, 2022. Upon FDA regulatory clearance in the United States the costs of the personalized, single use devices utilized to perform histotripsy will be added to the reimbursement recently assigned by CMS.
Earlier in 2021, HistoSonics was awarded the first Current Procedural Terminology (CPT) code for histotripsy of the liver, 0686T for histotripsy (i.e., nonthermal ablation via acoustic energy delivery) of malignant hepatocellular tissue, including image guidance.
HistoSonics Edison™ System utilizes proprietary non-invasive ultrasound technology and advanced on-board imaging to deliver personalized treatments and uses the science of histotripsy to mechanically destroy targeted liver tissue. HistoSonics completed their First-In-Man study in Barcelona, Spain in 2020 as part of their Theresa Study, and are currently actively enrolling patients in two similar clinical trials – in Europe and the US. The studies are called #HOPE4LIVER and #HOPE4LIVER US, and they are evaluating the safety and technical efficacy of histotripsy when destroying primary or metastatic liver tumors. One of the 8 US sites participating in the #HOPE4LIVER US Study is the University of Minnesota.
The CMS coding and payment rate awards capped a great year for HistoSonics as they were also recently granted “Breakthrough Device Designation” by the US Food and Drug Administration (FDA) for destruction of liver tissue using histotripsy.
It is important to note that 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.
HistoSonics is a venture-backed medical device startup company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy. Histotripsy utilizes the pressure created by focused sound energy to liquify and destroy targeted tissue, including diseased tissue and tumors, at sub-cellular levels. The company’s new platform deliverers personalized, tissue specific treatments with precision and control, and without the undesirable side effects of many of today’s interventional and surgical modalities. HistoSonics is led by a team of experienced domain experts and industry leaders with offices in Ann Arbor, Michigan and Minneapolis, MN.