Minneapolis-based HistoSonics develops a histotripsy treatment for liver tumor procedures. Last month, the FDA granted de novo authorization for its Edison system and novel histotripsy therapy platforms.
Edison, an image-guided sonic beam therapy system uses advanced imaging and proprietary sensing technology. It delivers non-invasive, personalized treatments with precision and control. The system received FDA investigational device exemption in February. In March, HistoSonics announced the first kidney tumor treatment with its novel therapy system.
CMS set a new payment rate for this therapy, increasing the payment to $17,500. In its rule-making process, CMS utilized claims data from the HistoSonics #HOPE4LIVER trial in the U.S. to increase the outpatient payment rate. Non-thermal ablation via acoustic energy delivery of malignant hepatocellular tissue, including image guidance, was previously priced at $12,500.
According to a news release, the new payment rate supports hospitals and physicians using the non-invasive procedure in an outpatient setting. Diagnosis-related group payment rates remain applicable for those who require hospital admission.
“CMS’s reassignment of the histotripsy liver procedure payment rate enables Medicare patients much-needed access to histotripsy and its potential benefits. We commend CMS on facilitating access to breakthrough devices like ours for Medicare patients, many of whom historically have had delayed access to innovative technology,” said HistoSonics President and CEO Mike Blue.
HistoSonics reports new American Medical Association code, too
The American Medical Association (AMA) also issued a new Category III CPT code for histotripsy of kidney tissue. This provides patients and clinicians with the first automated external beam therapy using acoustic energy to mechanically destroy diseased kidney tissue without using incisions, ionizing radiation, or heat.
HistoSonics said the new CPT code goes into effect on July 1, 2024, in the U.S. At that time, providers can utilize the code when performing histotripsy procedures as part of the #HOPE4KIDNEY IDE trial.
Medicare, Medicaid and other government payors widely use the CPT codes granted and regulated by the AMA. HistoSonics called the new code “a major reimbursement milestone.” Upon FDA marketing authorization, the code can allow for histotripsy to become an option to treat kidney tissue non-invasively. It could also eliminate potential complications seen with conventional therapies like bleeding, infection or pain from surgery.
“Obtaining this kidney CPT code is another significant milestone in our progress to bring histotripsy to the clinic, enabling providers with a mechanism to capture data on the use of histotripsy for destroying targeted kidney tissue and will facilitate reimbursement with payers to enable broad access for the many patients who could potentially benefit from histotripsy’s unique capabilities,” Blue said.
