FDA Recommends Transition to Duodenoscopes with Innovative Designs

From ACG FDA Related Matters Committee Chair, Stephen B. Hanauer, MD, FACG

On Thursday, the U.S. Food and Drug Administration (FDA) issued a Safety Communication titled "The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety." The FDA has provided an update on the mandated post-market surveillance study results for duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) since issuing the April 2019 Safety Communication.

This Communication also provides additional recommendations and updates including the FDA:

  • Recommending that hospitals and endoscopy facilities begin transitioning to duodenoscopes with innovative designs that facilitate or eliminate the need for reprocessing.
  • Issuing new mandated post-market surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that the new designs reduce the contamination rate. Upon completion of the post-market surveillance studies, the FDA expects the labeling on duodenoscopes with disposable endcaps to be updated with contamination rate data.
  • Warning health care facilities that adenosine triphosphate (ATP) test strips should not be used to assess duodenoscope cleaning. To date, the FDA has not evaluated them for effectiveness for assessing duodenoscope reprocessing. Manufacturers of ATP test strips are advised to submit data to support the legal marketing of these strips for this use.
  • Planning to convene the General Hospital and Personal Use Device Panel of the Medical Device Advisory Committee in late 2019 to further discuss duodenoscope reprocessing.

The FDA is also reminding patients that the risk of infection from inadequate reprocessing is relatively low and patients should not cancel or delay any planned procedure without first discussing with their health care provider.

Read the full safety alert here. ACG will continue to update members on important FDA alerts impacting clinical GI and our patients.

Will ACG Members Subject to Additional Documentation Requirements? CMS and Congress Can Easily Fix This

From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG

Background: CMS recently released the CY 2020 proposed regulation on the Medicare physician fee schedule payment changes. In this rule, CMS seeks comment on whether ACG members should be required to notify patients of the cost-sharing implications prior to performing a screening colonoscopy, and then document these notifications in the medical record. CMS also seeks comment on how to monitor and audit compliance. ACG and the GI societies oppose this proposal. ACG members would be subject to additional audit and compliance requirements due to a problem that CMS and Congress can easily resolve.

ACG, AGA, and ASGE recently met with CMS officials to discuss CMS’ recent proposal on whether gastroenterologists should be required to educate patients on the Medicare cost-sharing quirk with patients prior to performing a screening colonoscopy.

This is a policy solution that should not be borne by ACG members: Urge U.S. House Leadership to Take Up H.R. 1570 Now!

The Removing Barriers to Colorectal Screening Act of 2019, (H.R. 1570 and S. 668) achieved an important milestone of securing over 290 supporters in the U.S. House of Representatives (currently, H.R. 1570 has 294 cosponsors). Thank you for lending your voice to support this bill!

Why Your Help Matters Now: According to the U.S. House of Representatives Rules Committee, Speaker Pelosi and the U.S. House must consider one bill (at a minimum) from the “Consensus Calendar” each session week. For a bill to be eligible for the Consensus Calendar, a measure must accumulate 290 cosponsors for at least 25 legislative days. While a vote is not guaranteed just for meeting the criteria, not many bills will meet this threshold, thus improving the likelihood of consideration.

A Recent Review of Medicare Fee-for-Service Claims Emphasizes the Need for Congress to Pass H.R. 1570 and S. 668

ACG and the Moran Company recently reviewed Medicare claims data from 2011 to 2017 and found that the incidence of polypectomy during screening colonoscopy is increasing dramatically. This is good news. For each percent increase in pre-cancerous polyp detection, there is a 3 percent reduction in CRC incidence and a 4 percent reduction in CRC death.

Thanks to the improved quality of CRC screening procedures, gastroenterologists have improved adenoma detection rates. At the same time, CRC incidence rates in the Medicare-age population have been declining as well.

Quality is Improving!

... But Medicare Beneficiary Liability is Increasing with the “Post-Polypectomy Surprise”
Due to a quirk in federal law, Medicare will cover the full cost of a "screening" colonoscopy. However, when a polyp is detected and removed, this "therapeutic" procedure is no longer considered a "screening" for coding and reimbursement purposes. Thus:

  • Medicare beneficiaries incur surprise out-of-pocket medical costs.
  • This is counter to the U.S. public healthcare goal of removing barriers to increasing CRC screening rates.

In April 2019, 100 ACG Governors and member of the ACG Leadership advocated for the Removing Barriers bill and other important issues impacting your GI practice and patients.

Interested in learning more about how to incorporate clinical research? Attend the ACG Annual Meeting and the "Roadmap for a Successful Community or Academic GI Practice Course: Ramp-Up Your Practice, Super-Charge Your Staff."

Back By Popular Demand: Joint ACG-FDA Fellowship Program!

Current first and second-year fellows are invited to submit their application for a one-month rotation at the U.S. Food and Drug Administration (FDA), sponsored by ACG. Third-year fellows who are taking a 4th year of advanced fellowship may apply as well.

Awardees will have the opportunity to participate in daily FDA activities and will gain firsthand knowledge of the drug and device approval process. The College will provide a stipend for travel and daily living expenses.

Eligible applicants must complete an online application which must include two recommendations: one from the fellow's current Program Director and one from a Fellow of the American College of Gastroenterology (FACG).

All applications must be submitted to ACG and will be reviewed by the ACG FDA Related Matters Committee along with staff at the FDA. The candidate will be chosen and notified of acceptance by November 2019.

The application deadline is Friday, September 27, 2019.

For complete details regarding the FDA-ACG Fellowship Program, click HERE.