Insurance Coverage Granted for Non-Invasive Histotripsy Liver Tumor Treatment

Blue Cross Blue Shield of Michigan (BCBSM) and Blue Care Network have created a new medical policy for liver histotripsy.

The policy covers non-thermal histotripsy using HistoSonics’ technology for treating primary and metastatic liver tumors. As of Feb. 1, histotripsy is a reimbursable procedure for the non-invasive mechanical destruction of liver tumors under CPT code 0686T, giving eligible Michigan patients early access to the, non-invasive, incisionless treatment ahead of the broader policy effective date (July 1).

“Liver tumors are often a leading cause of death for patients with serious cancers, and it’s critical that they have access to safe, effective and non-invasive treatment options,” HistoSonics President/CEO Mike Blue said. “We applaud BCBSM for being the first to recognize the clinical value of histotripsy and for leading the way in ensuring their members have insurance coverage for this novel therapy. This milestone marks an important precedent, and we expect additional states and payers to follow in expanding access to histotripsy for patients with liver tumors across the U.S.”

The Edison Histotripsy System received U.S. Food and Drug Administration (FDA) De Novo authorization in 2023 and subsequently received two 510(k) clearances in 2024. The system uniquely employs high amplitude focused ultrasound to mechanically destroy targeted tumor tissue through acoustic cavitation, eliminating the need for heat, radiation, or incisions. The platform enables real-time image guidance, allowing the treating physician to continuously monitor treatment progress.

To date, the Edison Histotripsy System has been adopted at more 50 U.S. medical centers and has been used by surgeons, radiologists, and oncologists to treat over 1,500 patients.

BCBSM’s coverage decision was based on clinical evidence demonstrating that histotripsy is a safe, effective, and non-invasive treatment option for patients with primary or metastatic liver tumors who have not responded to, or are intolerant of, standard-of-care therapies. Histotripsy has shown to precisely target and destroy tumors while tending to spare critical structures such as blood vessels and bile ducts within and adjacent to the treated area. A key finding from the recently released 12-month #HOPE4LIVER trials follow-up analysis is a 90% local tumor control rate observed across all treated tumors regardless of tumor type or origin, which compares favorably to current standard of care local regional therapies at one year. The performance of these outcomes provides sufficient evidence to determine the technology’s impact on health outcomes.

In addition to commercial insurance recognition, the United Network for Organ Sharing (UNOS) recognizes histotripsy as an accepted loco-regional treatment option for patients needing bridging therapy for liver transplant. Histotripsy’s addition to UNOS guidelines became active last summer.

The Edison System is intended to non-invasively destroy liver tumors, including partially or completely ablating unresectable liver tumors using histotripsy. The FDA has not evaluated the Edison System for the treatment of any specific disease, including cancer, nor has it assessed outcomes such as local tumor control, five-year survival, or overall survival.

HistoSonics is a privately held medical device company developing a non-invasive platform and proprietary sonic beam therapy utilizing histotripsy, a novel mechanism of action that uses focused ultrasound to mechanically destroy and liquify unwanted tissue and tumors. The company is currently focused on commercializing the Edison System in the United States and select global markets for liver treatment while expanding histotripsy applications into other organs like kidney, pancreas, prostate, and others. HistoSonics has offices in Ann Arbor, Mich., and Minneapolis.