- The American Medical Association has issued a new Current Procedural Terminology (CPT®) procedure code for histotripsy of the liver.
- The code is the first for a histotripsy-based focused ultrasound therapy.
- HistoSonics is conducting clinical trials in the US and Europe to investigate its propriety platform’s ability to destroy liver tumors.
HistoSonics has announced that the American Medical Association has issued a new Current Procedural Terminology (CPT®) procedure code for histotripsy of the liver. The code – 0686T Histotripsy – will become effective on January 1, 2022.
CPT® codes are used by insurance companies to document and reimburse properly for any procedure. Category III CPT® codes – like that obtained by HistoSonics – are temporary codes used to track utilization of new or emerging medical technologies. The aim is to acquire enough data and users to apply for a Category I code, which is a permanent code that designates the procedure has full FDA clearance and has demonstrated clinical efficacy which will support broad adoption and coverage.
“This is an important reimbursement milestone for providers who will utilize this new therapy option for their patients,” commented Mike Blue, President and CEO of HistoSonics. “This specific CPT® code will enable data collection of the use of histotripsy procedures and facilitate reimbursement with payers to enable broad access for the many patients who could potentially benefit from histotripsy’s unique capabilities.”
HistoSonics’ noninvasive platform combines advanced imaging and proprietary software to deliver patient-specific treatments and uses the science of histotripsy to mechanically destroy targeted tissues at sub-cellular levels. The procedure is currently being investigated in patients with liver tumors in two similar clinical trials in Europe and the US – both called #HOPE4LIVER.
“The intention in the next year or so is to use the data from these clinical trials to seek US Food and Drug Administration (FDA) approval for histotripsy of liver tumors,” said Josh King, the company’s VP of Marketing. “But considering near term objectives, it was clear that establishing a precedent for the tracking and reimbursement of a histotripsy-based treatment was an important milestone.”
Histotripsy differs from the more established focused ultrasound therapies in that it employs a different mechanism of action and mechanically destroys tissue without heat. The focused ultrasound procedures that are currently available commercially in the US use ablative therapy that kills tissue by heating it.
“HistoSonics has prioritized building an experienced team dedicated to coding, coverage, and payment,” added King. “We have earned the support of a multidisciplinary team of physicians and experts, and we strive to take a holistic approach to put this therapy in the best position as we move towards commercialization.”