New CPT Code Established for EDAP’s Focal One Prostate Cancer Treatment


In a June 10 announcement, EDAP-TMS shared positive news with regard to the billing and reimbursement of their Focal One high-intensity focused ultrasound (HIFU) treatment for prostate cancer. After submitting an application to the American Medical Association (AMA) CPT® Editorial Panel and gaining the support of both the American Urological Association and the American Association of Clinical Urologists, the company has been notified that the AMA established a new Category 1 CPT code* for HIFU ablation of malignant prostate tissue with their Focal One device. The code, which will be described as “ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance,” goes into effect on January 1, 2021.

EDAP TMS RGB 300dpi 20160111Marc Oczachowski, EDAP’s Chief Executive Officer, said, “The AMA’s acceptance of our request for a Category 1 CPT code is a significant milestone for EDAP in the reimbursement process of HIFU in the US and a major step forward in the recognition of Focal One, which combines HIFU with proprietary ultrasound guidance technology, as a highly differentiated tool for the targeted ablation of prostate tissue. Additionally, we believe the specific reference to malignant tissue, transrectal approach, and ultrasound guidance in the code description is clearly favorable to EDAP and its unique and latest HIFU device generation, the Focal One.”

Although a temporary (HCPCS C-) code went into effect on July 1, 2017, for ablation of prostate tissue, the new CPT code is specific for ablation of malignant prostate tissue. This assignment of the more permanent CPT code demonstrates that the use of focused ultrasound for the treatment of malignant prostate diseases reflects the latest medical care provided to patients.

Read EDAP’s Press Release >

*Current Procedural Terminology (CPT®) is a medical code set that is used to report medical, surgical, and diagnostic procedures and services to entities such as physicians, health insurance companies, and accreditation organizations.