CMS grants additional reimbursement for EXALT Model D Single-Use Duodenoscope

The US Centers for Medicare & Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for single-use duodenoscopes, applicable to Boston Scientific’s EXALT Model D Single-Use Duodenoscope, as part of its Fiscal Year 2022 Hospital Inpatient Prospective Payment System. NTAP was created to facilitate patient access for qualifying new medical technologies that substantially improve the diagnosis or treatment of Medicare beneficiaries. Beginning October 2021, CMS will provide hospitals with additional device reimbursement when the EXALT Model D Single-Use Duodenoscope is used for eligible cases in the hospital inpatient setting.

The EXALT Model D Single-Use Duodenoscope is designed to eliminate the risk of infection due to ineffective reprocessing of traditional reusable duodenoscopes. Duodenoscopes are used to diagnose and treat various pancreatic and biliary conditions during endoscopic retrograde cholangiopancreatography (ERCP) procedures. Every year, more than 700,000 ERCP procedures are performed in the US and approximately 1.5 million are completed worldwide. In 2019 the FDA recommended that providers utilise duodenoscopes with disposable components or fully disposable devices, when available.

The EXALT Model D Single-Use Duodenoscope previously received Breakthrough Device Designation from the FDA as well as transitional pass-through (TPT) payment by CMS, the latter of which allows for incremental device reimbursement for Medicare cases performed in the hospital outpatient setting. Further, in response to a Boston Scientific request, CMS created two unique ICD-10 procedure codes for hospitals to facilitate reporting the use of single-use duodenoscopes when used in the hospital inpatient setting beginning October 2021.

"Securing NTAP, in addition to TPT, for the EXALT Model D Duodenoscope will support health care providers in accessing this device for Medicare patients – a group that represents over 40% of all ERCPs performed in the US each year," said Dave Pierce, executive vice president and president, MedSurg and president, Endoscopy, Boston Scientific. "Adequate reimbursement is key for the adoption of any new technology, and this decision from CMS will help provide hospitals with the means to treat Medicare patients with this device."