This Week – May 11, 2013

This Week in Washington DC:

  1. FDA Releases Guidance on Fecal Microbiota Transplantation (FMT)
  2. Medicare Reimbursement Reform Gaining Momentum on Capitol Hill

FDA Requires an IND for All FMT Procedures
In responding to a letter ACG and other societies sent to the Food and Drug Administration (FDA) seeking clarification on the requirements when using FMT, the Agency stipulated that because FMT is not approved for any therapeutic purpose, an investigational new drug (IND) application is required for all uses of FMT.

The FDA believes that FMT falls within the definition of a “biologic product” as well as a “drug,” thus requiring an IND prior to any treatment or clinical investigation. 

Please click here to read the multi-society letter to the FDA.

Please click here to read the FDA letter to the societies.

Please click here to learn more about the IND process.

ACG will continue to work with the FDA on this issue and other important issues impacting clinical gastroenterology, together with our sister societies as well as through the ACG-FDA Liaison Council, a group of ACG members and FDA leaders who routinely discuss important issues affecting the GI clinician.

Medicare Reimbursement Reform Taking Shape in Congress
On Tuesday, May 7th, the House Ways & Means Committee held a hearing to discuss recent proposals to repeal the sustainable growth rate (SGR) formula and reform the Medicare reimbursement system. House leaders on both sides of the political-aisle continue to be encouraged on the possibility of passing meaningful SGR reform this year. Congress usually holds hearings to gather facts and opinion in order to draft and finalize legislation. The Senate Finance Committee is scheduled to hold a hearing on Medicare reimbursement reform next week. On May 10th, the Senate Finance Committee also solicited ACG’s opinion on Medicare reimbursement reform.    

The impetus for this interest in reimbursement reform was a recent Congressional Budget Office (CBO) analysis on the 10-year cost to replace the SGR formula. The CBO now estimates this cost to be $138 billion. In late 2012, the CBO estimated the price tag to repeal SGR and freeze physician payments was $244 billion over the same period. That is real money even in Washington D.C.! This differential is due to lower projected growth of physician services. The CBO is expected to release an updated cost-estimate in the upcoming weeks. These new calculations could be the catalyst for reform or derail the process altogether, depending on how much money Congress must find – and more importantly – where the offsetting savings will come from in the federal budget. Although there appears to be broad agreement on a blueprint for reform, it is unclear whether there has been an agreement on the offsets.

In February and April of this year, the House Ways & Means and House Energy & Commerce Committees released joint-committee proposals on SGR reform and also solicited ACG’s opinion on each proposal.

"This Week" – February 23, 2013
"This Week" – April 20, 2013

ACG continues to meet with congressional leaders during this process and represent the voice of clinical gastroenterology.

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 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

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

Brad Conway