ACG is extremely disappointed that Congress and CMS chose to finalize the 2016 Medicare reimbursement rates without alleviating significant cuts to life-saving colonoscopy codes. ACG remains committed to showing CMS and Congress that this mistake may impede all of the positive momentum and strides the U.S. has made over the past decade in lowering colorectal cancer incidence and death rates.
ACG is also committed to helping members and GI practices plan for 2016. To that end, ACG has compiled a summary of the 2016 Medicare reimbursement rates and RVUs for common GI procedures and services, with a comparison to the 2015 data. Please note that these are the estimated national averages based on CMS-released data.
FDA clears the TJF-Q180V duodenoscope 510(k) with design modifications
On January 15, 2016, the FDA cleared the TJF-Q180V duodenoscope 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
In March 2015, the FDA provided Updated Information for Health care Providers Regarding Duodenoscopes. At that time, Olympus had a pending 510(k) application for its TJF-Q180V duodenoscope. The company continued to market this device while its application was under review.
Also on January 15, 2016, Olympus alerted its customers by issuing a Customer Notification Letter that:
- Includes information about the TJF-Q180V duodenoscope’s design and labeling changes per the cleared 510(k);
- Outlines Olympus’ strategy to repair all customers’ TJF-Q180V elevator mechanism in accordance with the new design; and
- Informs customers that Olympus will set up a return schedule with them for duodenoscope repair.