FDA Safety Communication: FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings

From ACG FDA Related Matters Chair, Stephen Hanauer, MD, FACG

On December 10, the U.S. Food & Drug Administration (FDA) released interim results from post-market surveillance studies on contamination rates with duodenoscopes after reprocessing.

In 2015, the FDA ordered all three manufacturers of duodenoscopes sold in the U.S.(Fujifilm Medical Systems USA, Inc, Olympus Medical Systems Corporation, Pentax of America), to conduct post-market surveillance studies, so the FDA can better understand how duodenoscopes are reprocessed in real-world settings. Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure, and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as “organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa.”

The FDA recommends facilities and staff strictly adhere to the manufacturer’s reprocessing and maintenance instructions, and follow these best practices:

Read the full blog here to review the recommended best practices.

Tri-Society Alert: CY 2019 Medicare PFS Final Rule: A Comprehensive Review from ACG, AGA and ASGE

On November 1, 2018, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2019 Medicare Physician Fee Schedule (PFS) final rule, which includes several significant policy and payment changes that are expected to impact practitioners beginning in CY 2021.

  • Conversion Factor
  • Misvalued Code Initiative
  • Evaluation and Management (E/M) Payment
  • Market-Based Supply and Equipment Pricing Update
  • Virtual Check-in
  • Remote Evaluation of Pre-Recorded Patient Information
  • Off-campus Provider-Based Hospital Departments Paid Under the PFS
  • Wholesale Acquisition Cost-Based Payment for Part B Drugs
  • Summary of MIPS Performance Categories
  • Performance Threshold
  • Gastroenterology Specialty Measure Set
  • Cost Category
  • Improvement Activities Category
  • Promoting Interoperability Category
  • Low-Volume Threshold and MIPS Opt-in Policy
  • Small Practice Bonus
  • Facility-Based Measurement

At the State and Local Level: Step Therapy Bill Passes Senate in Ohio

On Wednesday, December 5th, the Ohio Senate Committee of Health, Human Services and Medicaid unanimously voted to pass legislation that aims to limit insurer Step Therapy requirements. Introduced by State Senators Peggy Lehner and Charleta B. Tavares, Senate Bill 56, or the “Adopt requirements for step therapy protocols” Act, would allow for specific exemptions to be made for the current requirements. It now awaits passage in the Ohio House of Representatives. Senator Lehner stated, “Balancing cost containment for insurers with the ability of physicians to make decisions is in the best interest of Ohioans, and it is my hope that the House of Representatives will act before the end of the year.”

Step Therapy entails the “fail first” drug therapy requirements, in which patients are forced by insurers to try and fail with one or more medications before the insurer approves the cost of the medication which ACG members originally prescribed. ACG has been active on both the federal and state levels in order to ease this arduous and time-consuming process for patients and patients. The College also supports the federal “Restoring the Patient’s Voice Act of 2017 (HR. 2077),” introduced by Representative Brad Wenstrup. As outlined by ACG Governor for Southern Ohio, Christopher South, MD, FACG, in the latest issue of ACG Magazine, this victory in Ohio and other states can help build the momentum needed to garner more support on the federal level.

Remember to contact your ACG Governor on important state and local issues impacting you and your practice.

The ACG Board of Governors is one of the most unique aspects of the American College of Gastroenterology. Governors are ACG Fellows that are elected from the membership of a particular state or region. There are currently 77 Governors across seven different regions in the U.S. and abroad. The Board of Governors acts as a two-way conduit between College leadership and the membership at-large. This helps the College make certain it is meeting the evolving needs of the membership.

ACG Members: Don’t forgot about your 2018 MIPS Reporting Requirements!

December 31st is right around the corner, and ACG is here to help. If you have to participate in MIPS, please ensure that you are meeting MIPS reporting requirements as you prepare to submit your MIPS performance data to CMS early next year.

How do you know if you need to participate in MIPS? Please click here.

Guide for Obtaining an EIDM Account and ‘Physician Quality and Value Programs’ Role for the Quality Payment Program (QPP)

CMS….SGR… MACRA… MIPS… APMs… QCDRs… ACOs… Why does Washington D.C. love acronyms and complicated payment systems? ACG Hopes to Keep This Simple. We compiled a detailed overview for you that seeks to make some sense out of this alphabet soup – but hopefully in a simplified fashion and in plain English. Read the summary and potential impact to GI.

Dissecting MACRA: Year 2

Impact on Smaller and Rural GI Practices: 15 or fewer eligible clinicians in your practice

ACG continues to look out for the small and independent GI practices. Do you need to report measures? Read ACG’s summary to learn more on whether you have to participate in the Merit-Based Incentive Payment System (MIPS), and if so, what scoring bonuses are available to your practice.

CMS has recently released guidance for the CY 2018 reporting year, as well as for each MIPS performance category. Check them out here:

MIPS Scoring 101 Guide for Year 2 (2018)

MIPS Participating in the Promoting Interoperability Performance Category in 2018 (Year 2)

MIPS Participating in the Quality Performance Category in 2018 (Year 2)

MIPS Participating in the Cost Performance Category in 2018 (Year 2)