This Week – October 26, 2013

This Week in Washington DC:

  1. CMS Provides Timing on Final Medicare Payment Regulations: Delay in release will still be effective
    January 1, 2014
  2. ACG Co-Hosts FDA GREAT 2 Workshop on IBD

Medicare payment regulations delayed until late November
On Wednesday, October 23rd, the Centers for Medicare and Medicaid Services (CMS) announced that, due to the Federal Government shutdown, the final 2014 Medicare payment regulations will not be released until circa November 27th. CMS usually releases the payment regulations during the first week in November so that the agency complies with federal law and rules. 

As background, a number of laws and executive orders govern the timing for a payment rule release and effective date. The effective dates of all “major” federal rules are delayed for 60 calendar days after they are submitted to Congress or after they are published in the Federal Register – whichever date is later. However, there are statutory exceptions for “good cause.” If CMS finds “good cause” to waive the 60 day requirement because the delay is considered “unnecessary, impractical, or contrary to the public’s interest,” the final rule may become effective upon the agency’s determination (including the date of publication). That appears to be the case here as CMS announced this week that while these payment regulations will be released around November 27th, the policy changes will still be effective beginning January 1, 2014. 

ACG will update members as soon as these final Medicare payment regulations are released in late November. It is important to note that practices will have a shorter preparation and transition period compared to years past, as there will be less than 60 days to prepare for reimbursement and other related policy changes effective January 2014.

ACG and the FDA hold successful public workshop on IBD
ACG, the Food and Drug Administration (FDA), and other stakeholder groups such as the AGA, CCFA, NASPGHAN, and the Pediatric IBD Foundation hosted the second Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT 2) conference on Monday and Tuesday. This public workshop discussed issues important to structuring IBD adult and pediatric clinical trials. Stephen Hanauer, MD, FACG and Marla Dubinsky, MD represented ACG and were also involved in the planning and selection of topics and speakers. ACG thanks Drs. Hanauer and Dubinsky for their work and time away from their practices and families to participate in this important workshop. The audience feedback was overwhelmingly positive. The FDA thanked ACG and the other societies for providing the necessary resources to hold the workshop.

Of note, the panel discussed the importance in selecting the proper endpoints in structuring clinical trials, including: treating patient symptoms vs. treating the disease, other endpoints to consider when structuring a trial, the proper scales and measurement systems to determine efficacy, the role of endoscopy, and problems associated with structuring and populating pediatric IBD clinical trials.     

You can access the agenda and presentations here:
http://great2.org/

ACG will continue to partner with the FDA on these workshops as well as at the ACG Annual Meeting. The College will also continue to collaborate with the FDA via the unique ACG-FDA Liaison Council and as a member of the FDA’s “network of experts” panel.

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 here and then 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