This Week – January 16, 2016

This Week in Washington, DC

  • 2016 Medicare Reimbursement Rates: Updated GI Codes and RVUs for ACG Members
  • FDA clears Olympus 510(k) application for duodenoscope (TJF-Q180V) with design modifications to the elevator channel sealing mechanism: Updated Guidance for ACG members
  • Senate Committee Weighs-in on FDA Review of Duodendscopes: Check out the related AJG article and podcast

National Affairs.jpg 2016 Medicare Reimbursement Rates: Popular GI Codes

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.

Read the full post here.

National Affairs - Koscheski .jpg From National Affairs Committee Chair, Whitfield L. Knapple, MD, FACG

Senate Committee Weighs-in on FDA Review of Duodendscopes

On Wednesday, Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member, Sen. Patty Murray (D-WA) released a new report: “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.”  According to the press release, the report is the result of a yearlong investigation by Sen. Murray’s staff into the cause of and response to outbreaks of antibiotic resistant infections linked to medical devices called duodenoscopes at hospitals nationwide.  The report concludes that manufacturers were aware of design defects and problems without notifying the FDA, and hospitals were delinquent in notifying the FDA of subsequent patient adverse events.  Further, the FDA then failed to both properly review these issues and notify the public in an effective and efficient manner.

Read my full post here.