From the AGA Journals

Single-use duodenoscope is cost effective in ERCP

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SUD subsidies may make the difference

Consider for a moment: The single-use duodenoscope (SUD) represents a revolutionary approach to duodenoscope infection control. Who, even 10 years ago, would have imagined that a disposable duodenoscope would even be technically achievable, much less economically feasible? Notwithstanding, determining how to incorporate such a revolutionary new technology and its associated capital and recurring costs can be every bit as complex and challenging as conceiving and developing the SUD. The authors provide insights into answering these questions through Markov modeling, comparing cost-effectiveness of SUDs to traditional duodenoscopes (TD) using available data on TD and SUD performance, and extrapolating from nonendoscopic infection management data.

This analysis is helpful because it demonstrates that, despite SUD cost approaching $3,000, Centers for Medicare & Medicaid Services inpatient and outpatient cost-defrayment payments may result in SUDs being cost-effective within limits and assumptions the study incorporates. This information is also timely, because these CMS subsidies are guaranteed only through mid-2022 for Medicare inpatients and 2023 for Medicare outpatients.

Though useful and timely, this study does make assumptions that narrow its applicability to real-world endoscopic retrograde cholangiopancreatography (ERCP). Clinically, it considers only patients with uncomplicated common bile duct stones. While choledocholithiasis is the indication for ERCP in the majority of patients, over 40% of ERCPs in the United States are performed for other, often more complex applications. While most procedures in the referenced studies were performed by high-volume ERCP experts, a substantial proportion of ERCPs are performed by lower-volume ERCP proceduralists, who actually perform a substantial proportion of straight-forward ERCPs addressing uncomplicated choledocholithiasis.

This study focuses on cost implications on CMS Transitional Pass-through (TPT) and New Technology Add-On Payment (NTAP) subsidies available only for Medicare inpatients and outpatients, respectively. These reimbursements are set to expire in 2022 (inpatients) and 2023 (outpatients). What will happen after that? Also, the amount of TPT and NTAP cost defrayments are institution-dependent, because cost-to-charge ratio (CCR), an important factor in calculating these subsidies, varies substantially between institutions and regions. Looking to the future, how will the cost of SUDs be incorporated into the hospital business model when TPT and NTAP are over?

SUDs are a technological marvel and a remarkable advance in endoscopic infection control. But innovations in medical technology are expectedly accompanied by new operational challenges: How to incorporate them into day-to-day practice and develop a business model that avails valuable new resources to patients. Such operational challenges require as much heavy lifting as the technological innovation needed to produce innovative devices like SUDs. The authors’ vision and effort in ideating and executing this study give us a head-start on this path by helping us to imagine what is possible.

John A. Martin, MD, is associate professor and consultant at the Mayo Clinic, Rochester, Minn. He is a former member of the editorial board for GI & Hepatology News, but has no relevant conflicts to disclose.



The EXALT Model-D single-use duodenoscope may be a cost-effective alternative to high-level disinfection (HLD) of reusable duodenoscopes, according to a new analysis.

The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.

Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.

“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.

Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.

In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.

The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.

The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.

A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).

In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.

The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.

“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.

The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.

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