Boston Scientific Single-Use Duodenoscope Approved For Transitional Pass-Through Payment

The Centers for Medicare and Medicaid Services (CMS) have approved Boston Scientific’s single-use endoscope, the EXALT Model D Single-Use Duodenoscope, for transitional pass-through payment. Under the outpatient prospective payment system (OPPS), patients will have greater access to the device while experiencing less of an impact on their wallets.

The EXALT Model D’s new billing code, C1748, will be active and ready to use beginning July 1st of this year. This is the first and only single-use duodenoscope available, and has been approved by the Food and Drug Administration (FDA) to diagnose and treat biliary and pancreatic conditions. More than 700,000 endoscopic retrograde cholangiopancreatographies are (ERCPs) are performed each year in the U.S., and more than 1.5 million are performed worldwide.

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The FDA expedited the EXALT Model D development, prioritizing it in hopes of obtaining a more effective diagnosis and treatment for chronic and life-threatening diseases and conditions. Since January, CMS has paved the route for novel healthcare technologies to qualify for pass-through payment. The EXALT Model D is one of the first devices to receive CMS approval in this way.

"The approval of this new payment category in the outpatient setting will help ensure healthcare providers have access to EXALT Model D at a time when there is heightened awareness of the need to eliminate infection risk for patients, physicians, and hospital staff. With EXALT Model D, physicians can use a new, sterile duodenoscope for every procedure," says Boston Scientific chief medical officer Brian Dunkin, M.D. "Boston Scientific has been dedicated to advancing the care of pancreaticobiliary diseases for over 30 years, and we are proud that the Centers for Medicare & Medicaid Services, the country's largest payer for health care, recognizes the importance of our technology to its beneficiaries."

The endoscope market was valued at $10.4 billion globally at the end of 2019, and is projected to continue expanding. An increasing elderly population and a growing awareness of the benefits of preventive medicine are fueling the steady market drive. The approval of the EXALT Model D should provide even more of a bump in Boston Scientific’s business.