This Week – August 12, 2017

This Week in Washington, D.C.

  • August Recess: Great time to advocate for your patients and GI practices
  • FDA Safety Alert: Liquid-filled Intragastric Balloon Systems – Potential Risks
  • Back by Popular Demand: Joint ACG-FDA Fellowship Program
  • MACRA Tidbit for the Week: How long does CMS think it takes for you to report Advancing Care Information (Meaningful Use) Measures?

From ACG National Affairs Committee Chair, Whitfield L. Knapple, MD, FACG

August Recess: Great time to advocate for your patients and GI practices

While Congress is on recess, August is a great time to advocate on behalf of your patients and ACG colleagues.  Whether it is improving access to colorectal cancer screening, access to drugs, or enhancing funding for GI research, ACG’s website makes this very easy to do.  Reach out to your elected officials while they are at home—health care reform is stalled in Congress but far from over.  Now is the perfect time to remind Congress of the important health policy issues impacting ACG members and your patients.

ACG is also busy in August on the regulatory front, as we aim to improve policies impacting your practice, and to reduce the number of administrative and regulatory burdens associated with practicing medicine.

You can view the available action alerts for any current key legislation on the home page of the linked site below. Also, by clicking on the “Bills” section, you can view information about any relevant bills that ACG is tracking at both the federal and state level. See one missing? Let us know!

Click here to take action now!


From ACG FDA Related Matters Committee Chair, Tedd Cain, MD FACG

FDA Safety Alert: Liquid-filled Intragastric Balloon Systems – Potential Risks

The FDA this week issued an update to alert health care providers of 5 reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc.  All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as 1 to 3 days after balloon placement.

The Agency has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the Orbera Intragastric Balloon System, and one esophageal perforation with the ReShape Integrated Dual Balloon System).

The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications and that you report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Read the full FDA safety alert here.


Back by Popular Demand: Joint ACG-FDA Fellowship Program

Current fellows are invited to submit their application for a one-month rotation at the FDA, sponsored by ACG. The candidate chosen will have the opportunity to participate in daily FDA activities, and will gain first-hand knowledge of the drug and device approval process. The College will provide a stipend for travel and daily living expenses. All applications must be submitted directly to ACG, and will be reviewed by the ACG FDA Related Matters Committee along with staff at the FDA.

Upon completion of the rotation (while you are a fellow), the candidate will be invited by ACG to present his or her experiences at the following ACG Annual Scientific Meeting. The application process is now open. All applications must be submitted by September 22, 2017. The candidate will be chosen and notified of acceptance by November 2017.

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

How long does CMS think it takes for you to report Advancing Care Information (Meaningful Use) Measures?

When the MACRA rules are published, ACG reviews CMS’ time and burden estimates for participating in MIPS and APMs.  It provides some insight into the policy decision-making, and whether or not CMS’ estimates are accurate or completely off-base (garbage in-garbage out theory).

For example, CMS burden estimates for CY 2017 assume that for the Advancing Care Information performance category, 3 hours of a clinician’s time would be required to collect and submit Advancing Care Information (Meaningful Use) data.  ACG and ACG Governors continue to educate policymakers on the accuracy of these estimates.  For CY 2018, CMS anticipates that “the year-over-year consistency of data submission processes, measures, and activities and the further alignment of the advancing care information performance category with other performance categories will reduce the clinician time needed under this performance category in the 2018 MIPS performance period.”  In 2018, CMS estimates 3 additional hours of a computer analyst’s time above and beyond the clinician, practice manager, and computer system’s analyst time required to submit quality data.

Do these figures sound about right?  How about the estimate of 3 hours time to collect and submit Advancing Care Information data? ACG wants to hear from you.

CMS assumes that the employee hourly rate of a practice’s analyst is $88.10 (or $264.30 in total).  CMS also assumes that less than 5% of providers will receive a cut in reimbursement in CYs 2019 and 2020 due to gradually implementing MIPS requirements.  The downside to this is that there is less money available in the bonus pool if there are few providers getting cut.  So if you factor in the hourly rate of other employees needed to report Advancing Care Information data —as well as your time— does it actually cost you more to meet the Advancing Care Information requirements than you would receive bonuses in CYs 2019 and 2020?  It is important to have this discussion with your colleagues at your practice.  ACG is here to help!