News

U.S. Centers for Medicare and Medicaid Services (CMS) has issued its final rules establishing, for the first time, a Category 1 CPT code which facilitates reimbursement for the ablation of malignant prostate tissue with HIFU technology, effective January 1, 2021. LYON, France, December 9, 2020 -- EDAP TMS SA (Nasdaq: EDAP) (“the Company”), the global leader in robotic energy based therapies, announced today that the U.S. Centers for Medicare and Medicaid Services (CMS) has issued its final rules establishing, for the first time, a Category 1 CPT code which facilitates reimbursement for the ablation of malignant prostate tissue with HIFU technology, effective January 1, 2021. On the Hospital Payment side, the final rule maintains the HIFU procedure in the Level 5 Urology Ambulatory Payment Classification (APC) in 2021. This translates into a payment for a hospital performing a HIFU procedure on a Medicare patient of around $4,500 as a national average, adjusted locally based on the wage index. This represents an increase of $256, or 6%, from the payment hospitals receive from Medicare for a HIFU procedure in 2020. In the Physician Fee Schedule final rule, CMS has established for the first time a payment to physicians performing a HIFU procedure in the US. In the final rule, CMS has set a total Relative Value Units (RVUs) for a physician performing a HIFU procedure at 29.09. This translates to an average payment of $943 for a urologist performing a HIFU procedure on a Medicare patient in a facility setting. As a reference, a comparable established minimally invasive therapy for prostate cancer, cryotherapy, yields 22.72 RVUs, which translates to $736 for the urologist under the same setting and patient conditions. A radical prostatectomy would grant the urologist 34.73 RVUs, which translates to a Medicare payment of $1,125, or 42.74 RVUs and $1,385 if performed laparoscopically. Marc Oczachowski, Chairman and Chief Executive Officer of EDAP, commented: “We are very pleased that CMS, through the establishment of physician reimbursement, further validates the value of HIFU in treating prostate diseases. The process was finalized in a timely manner and has positioned the therapy very well among the existing treatment options such as cryosurgery, brachytherapy and surgery. We anticipate that this incremental revenue stream will also be a significant driver to further adoption of Focal One as physicians and hospitals seek to differentiate themselves by offering this cutting edge, non-invasive treatment option.”