This Week – June 22, 2013
This Week in Washington DC:
- FDA Revises FMT Policy: Will not require an IND for certain FMT procedures
- ACG Refutes Certain Claims Made to HHS OIG: Defends Clinical Gastroenterology
FDA Will Not Enforce IND Requirements for Refractory CDI
On Monday, June 17, 2013 the U.S. Food and Drug Administration (FDA) released a statement on IND requirements for fecal microbiota for transplantation (FMT). Specifically, the FDA announced that it would use discretion in enforcing investigational new drug (IND) requirements for indications of refractory Clostridium difficile infection (CDI) by FMT. Please click here to read the statement.
What does this FDA announcement mean?
This is a change from the FDA’s guidance earlier this year requiring providers/facilities to obtain an IND for all FMT procedures and research.
- ACG members may interpret this announcement as the FDA allowing the use of FMT for refractory CDI without having to go through the administrative hurdles of obtaining an IND (or even an emergency IND).
- However, physicians/facilities must be able to demonstrate ‘informed consent’ on all FMT procedures where an IND was not obtained: this includes at minimum a discussion regarding the risks of the procedure and full disclosure that the procedure is still considered ‘investigational.’
- While this announcement eases administrative burdens for both research and treatment of refractory CDI, the FDA announcement applies to refractory CDI only. FMT for other research or treatment still requires an IND.
- The FDA will make a public announcement prior to any decision to re-enforce IND requirements for FMT or other policy changes.
- The FDA is also expected to release more formal guidance on FMT in the upcoming weeks.
Please visit ACG’s “FDA News and Recent Committee Actions” website to learn more about this policy change, find suggestions on what to include in FMT patient consent forms, as well as instructions on how to complete an IND application form.
The College continues to work with the FDA to help streamline these guidelines as well as the approval process for FMT. This includes drafting recommendations to the FDA regarding FMT screening and testing, working through the ACG FDA Related Matters Committee as well as the College’s unique “ACG-FDA Liaison Council,” a group that meets with the FDA regularly to discuss issues important to the GI clinician.
ACG Compelled to Comment on “Company Model” Debate and Defend Gastroenterology
In response to recent comments made to the Department of Health and Human Services (HHS) Office of Inspector General (OIG), ACG President Ron Vender on Friday, June 21, 2013 refuted unfounded allegations of overutilization and unnecessary GI procedures in ambulatory surgical centers (ASCs) and offered certain rationale for structuring “company model” arrangements. As background, the HHS OIG in June 2012 released an advisory opinion on one iteration of the “company model” while noting that there may be bona fide reasons for structuring such arrangements in the ASC setting. As ACG noted in previous alerts (June 15, 2012 “This Week”), this advisory opinion is only applicable to a certain fact-pattern and those parties involved in the review. However, it should also be used as guidance for any ACG member in any “company model” arrangement or contemplating a change in your practice structure.
In response to the June 2012 advisory opinion, and as part of comments in opposition to all “company model” arrangements in general, allegations of fraud and overutilization of unnecessary services were made about gastroenterology in particular. For these reasons, ACG believed a response to the OIG was warranted.
Please click here to read ACG’s letter to the HHS OIG.
Please click here to read the comments made about the practice of gastroenterology in the ASC setting by the American Society of Anesthesiologists, leading to the ACG response.
In an effort to educate ACG members on issues such as the “company model” and other practice management related topics, please visit ACG’s newly unveiled “Health Reform and Practice Management Center” website. This new website will host short and concise discussions on specific topics related to your practice and 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 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 firstname.lastname@example.org.
Contact Brad Conway, VP Public Policy, with any questions or for more information.