The Centers for Medicare and Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for Terumo Aortic’s Thoraflex Hybrid device—used to treat aortic arch disease—under the inpatient prospective payment system (IPPS).
The add-on payment is effective in CMS’ FY23 fiscal year, starting on Oct. 1, has been assigned the maximum new technology add-on payment—65% of the average cost of the technology, for a case involving the use of the Thoraflex Hybrid device. The Thoraflex Hybrid received CE mark approval in 2012, with more than 13,000 devices sold commercially around the world over the past 10 years.
Thoraflex Hybrid is the first of its kind device used in frozen elephant trunk (FET) repair in the U.S., according to Terumo Aortic. It was granted Breakthrough Device designation by the Food and Drug Administration (FDA) in 2020 followed by FDA approval for commercial sale in the USA earlier this year. This hybrid device allows patients with suitably limited disease to be treated in a single stage procedure rather than two procedures which has previously been the conventional pathway in the U.S. for this group of patients.
The add-on payment will allow hospitals to be reimbursed for the incremental costs relating to the implantation of the Thoraflex Hybrid FET device to support the treatment of patients with complex aortic arch disease—this is in addition to the diagnosis related group (DRG) reimbursement.