Minneapolis — HistoSonics announced a major reimbursement milestone this week, as Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network have become the first insurers to provide coverage for the company’s non-invasive histotripsy treatment for liver tumors. The policy, effective February 1, 2025, will allow 4.5 million Michigan residents access to histotripsy using the Edison® Histotripsy System.
Histotripsy is a novel, incisionless procedure that uses focused ultrasound to mechanically destroy liver tumors through acoustic cavitation, avoiding the need for heat, radiation, or surgery. The Edison System, which received De Novo FDA authorization in 2023 and two 510(k) clearances in 2024, is now reimbursable under CPT code 0686T for the treatment of both primary and metastatic liver tumors.
“This milestone marks an important precedent,” said Mike Blue, President and CEO of HistoSonics. “We applaud BCBSM for being the first to recognize the clinical value of histotripsy and for leading the way in providing insurance coverage for this transformative therapy. We expect other insurers across the country to follow suit.”
BCBSM’s decision was based on clinical data showing histotripsy’s effectiveness and safety in patients who have not responded to or are intolerant of standard-of-care therapies. The procedure has demonstrated precision in targeting and destroying tumors while sparing vital surrounding structures such as blood vessels and bile ducts. Recent results from a 12-month follow-up of the HOPE4LIVER trial reported a 90% local tumor control rate, comparing favorably with traditional locoregional therapies.
HistoSonics’ Edison System is currently in use at over 50 leading medical centers across the U.S. and has been used to treat more than 1,500 patients. In addition to this commercial insurance recognition, the United Network for Organ Sharing (UNOS) now includes histotripsy as a recognized bridging therapy for liver transplant candidates, with that guideline taking effect in July 2024.
While the FDA has authorized the Edison System for mechanical destruction of liver tumors, it has not yet evaluated the device for cancer-specific treatment outcomes, including long-term survival. Use of the system is limited to physicians trained by HistoSonics and guided by clinical judgment.
The BCBSM policy’s broader effective date begins July 1, 2025, making Michigan the first state where patients can routinely access this non-invasive option as part of standard liver cancer care.
