Dive Brief:

• Boston Scientific on Monday said CMS approved its application for a transitional pass-through payment category for single-use endoscopes, including its Exalt Model D duodenoscope, under the Medicare hospital outpatient prospective payment system.
• The payment status gives Medicare beneficiaries access to new devices sooner by providing reimbursement while cost data is still being collected by CMS for incorporation into the procedure's Ambulatory Payment Classifications (APC) rate.
• The new code C1748 may be used to bill for EXALT Model D beginning July 1, when the device is used to treat Medicare beneficiaries in the hospital outpatient setting. CMS instituted the alternative reimbursement pathway in January 2020 for innovative technologies that have received FDA marketing authorization and breakthrough device designation.

Dive Insight:

FDA as recently as April updated a safety communication recommending hospitals transition to duodenoscope designs that have disposable components, such as caps or distal ends, to help reduce risk of infection from contamination between patients. The devices are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures in the U.S. annually to diagnose and treat pancreatic and bile duct conditions, according to the agency.

FDA's recommendation arose from concern about contamination rates associated with traditional fixed end cap duodenoscopes, which can be hard to clean. Postmarket studies showed higher than expected levels of contamination, and newer studies by manufacturers Fujifilm, Olympus Medical Systems and Pentax Medical continued to show elevated rates, including the presence of organisms such as E. coli and Pseudomonas aeruginosa that are associated with disease transmission, FDA said.

Results from Fujifilm and Olympus also suggested that users of the devices frequently had trouble understanding and following manufacturers' instructions for reprocessing the duodenoscopes.

Newer duodenoscope designs, including those with disposable components such as end caps can eliminate the need for reprocessing. FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing: Boston Scientific's EXALT Model D fully disposable duodenoscope, Fujifilm's model ED-580XT, Olympus Medical Systems' Evis Exera III Duodenovideoscope, and Pentax Medical's model ED34-i10T and model ED34-i10T2.

Boston Scientific's Exalt D, which was designated by FDA as a breakthrough device prior to gaining marketing clearance in December 2019, is the first single-use, flexible duodenoscope to be cleared by the agency. The company has valued its single-use endoscope product line, of which Exalt D is a part, as a $2 billion-plus market opportunity. However, Boston Scientific said sales slowed as sales reps' access to hospitals was curbed during the COVID-19 pandemic.