This Week – April 10, 2015

This Week in Washington DC:

  1. Senate Expected to Take Up SGR Reform Next Week
  2. CMS Releases Guidelines for Surveyors on Cleaning and Reprocessing Duodenscopes
  3. ACG and FDA Hold 2 Day Public Workshop on IBD and Celiac Disease

SGR Reform Update: CMS Holding Medicare Claims until Senate Action Next Week

As ACG members know, the temporary sustainable growth rate (SGR) formula patch averting Medicare reimbursement cuts formally expired March 31st. However, CMS is holding paying claims until April 15th and awaiting Senate action. The U.S. Senate returns on the afternoon of April 13th, leaving the Senate with only a couple of days to get this important bill done.

The House passed the SGR reform bill on March 26th by an overwhelming 392-37 vote. The Senate is expected to address the measure quickly next week, having punted on SGR after a marathon series of votes on the chamber’s fiscal 2016 budget resolution on March 26th and 27th.

This week, momentum was building to scrap an offsets exemption in the House-passed deal, a move that would pressure Congress to offset $141 billion of the package’s cost not currently paid for in the House bill. ACG is closely monitoring these issues in the Senate, where a group is considering offering an amendment to require the bill to be fully offset. This group reportedly includes Sen. Ben Sasse (R-NE), Jeff Sessions (R-AL), Mike Lee (R-UT), Ted Cruz (R-TX), and David Vitter (R-LA).

Please note that this amendment would not necessarily torpedo the bill. Stripping out the “pay-as-you-go” exemption in the House bill would result in “sequestration” cuts next year unless the additional savings are found later this year. By eliminating the “pay-as-you-go” provision, senators allow the bill to proceed next week with the understanding that Congress will work until the end of the year to come up with more offsets. ACG has cautioned members throughout this process regarding the issue of offsets and its impact on passing this legislation. ACG appreciates the hundreds of members reaching out to their congressional leaders urging them to address SGR reform.

ACG supports the House-passed bill. This legislation is a positive step for the House of Medicine. What’s more, the bill provides pathways for specialty societies to work directly with CMS as opposed to through the various accreditation or consensus-based organizations under current law. To be clear, there is also nothing in the bill that mandates maintenance of certification (MOC), nor does the bill implement any penalties for not participating in MOC. With that said, however, there is much more work to do for improving access to GI patient care, adequately reimbursing ACG members, and easing administrative burdens for GI practices. ACG will be very busy this spring and summer on Capitol Hill dealing with these issues.

Please click here to read ACG’s alert from March 27th to learn more about why ACG supports the House-passed bill and how this bill impacts ACG members vs. current law.

ACG is actively working with Congress during this SGR debate and will continue to update membership.

CMS Conditions of Coverage Guidelines Effective Immediately

On April 3rd, CMS released a condition of coverage memorandum to the state surveyors stating that all hospitals and ASCs are expected to strictly follow the manufacturers’ instructions for cleaning and reprocessing duodenoscopes, and to adhere to current nationally recognized practice guidelines as reflected in a 2011 Multi-Society Guidance document (ACG endorses these guidelines).

Of note to ACG members, while the FDA states that using brushes and cleaning accessories not specified in manufacturer’s instructions is of unknown benefit, CMS expects surveyors to assess facilities’ compliance with the manufacturer’s instructions for use.

“Surveyors, when surveying hospitals, CAHs or ASCs, must ask during the entrance conference whether duodenoscopes are used. If the answer is yes, then surveyors must request a copy of the manufacturer’s instructions for use (IFU) for the duodenoscope(s) as well as any automated endoscope reprocessors (AERs) the facility uses in reprocessing duodenoscopes. Further, surveyors must observe endoscopes being reprocessed and should ask the responsible staff to demonstrate and explain how they are adhering to manufacturers’ instructions and the Multisociety Guidance recommendations. Any identified noncompliance must be cited accordingly, and the increased risk to patient safety resulting from improper reprocessing should be taken into consideration when determining the appropriate level of citation.”

The full CMS memo to state surveyors can be found here:
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-32.pdf

The FDA’s instructions on cleaning and reprocessing duedonscopes:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm

ACG’s official statement on the recent infections from duodenoscopes, as well as the Multi-Society Guidelines, may be found here:
http://gi.org/wp-content/uploads/2015/02/022015_ACG_Member_Email-Infection_Risk_from_Duodenoscopes_Used_in_ERCP.pdf

ACG will continue to update membership on this evolving issue.

ACG Co-sponsors FDA GREAT 3 Conference

On March 30th and 31st, the ACG and the FDA, in partnership with other stakeholders, held a 2-day public workshop entitled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).” The purpose of this workshop was to provide a forum to review endpoints and clinical outcomes appropriate for drug development in inflammatory bowel (IBD) disease and celiac disease. The first day of the workshop discussed the assessment of efficacy in Crohn’s disease trials and patient participation in IBD drug development programs. The second day of the workshop reviewed the appropriate target population for pharmacological therapy in celiac disease, including the role and timing of assessment of histological and serological endpoints.

This the third time the ACG has partnered with the FDA and other stakeholders to host this GREAT conference. To access the transcripts and presentations for each day, please visit the GREAT 3 website.

http://www.great3.org/about/

ACG continues to have a close and unique relationship with the FDA, working collaboratively to improve quality of care and treatment options for our patients.

Please stay tuned for further updates. Please also share and discuss your thoughts with fellow ACG members on the ACG GI Circle. To login and share your comments, go to gi.org and sign in as a member. Once you have done so, click the orange “Visit ACG GI Circle” button to be taken to the GI Circle site. If you have not yet activated your ACG GI Circle account, please email us at acgcirclefeedback@within3.com.

Contact Brad Conway, VP Public Policy, with any questions or for more information.

Brad Conway
bconway@gi.org
301-263-9000