FDA: Fecal Microbiota for Transplantation and Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms
Last week, the U.S. Food and Drug Administration (FDA) raised concerns of bacterial infections caused by multi-drug resistant organisms (MDROs) transmission during fecal microbiota for transplantations (FMT).
Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli). One of the individuals died. Of note:
- FMT used in these two individuals were prepared from stool obtained from the same donor.
- The donor stool and resulting FMT used in these two individuals were not tested for ESBL-producing gram-negative organisms prior to use. After these adverse events occurred, stored preparations of FMT from this stool donor were tested and found to be positive for ESBL-producing E.coli identical to the organisms isolated from the two patients.
Healthcare providers must obtain adequate consent for the use of FMT from the patient or his or her legally authorized representative. The consent should include, at a minimum, a statement that the use of FMT to treat C. difficile is investigational and a discussion of its potential risks. FDA is informing members of the medical and scientific communities and other interested persons of the potential risk of transmission of MDROs by FMT and the resultant serious adverse reactions that may occur.
- Donor screening with questions that specifically address risk factors for colonization with MDROs, and exclusion of individuals at higher risk of colonization with MDROs.
- MDRO testing of donor stool and exclusion of stool that tests positive for MDRO. FDA scientists have determined the specific MDRO testing and frequency that should be implemented.
Read the FDA statement here.
ACG will continue to educate membership on important FDA news impacting clinical GI.
Urge Your Representative to Support H.R. 1570
From ACG Legislative and Public Policy Council Chair, Whitfield L. Knapple, MD, FACG
Take Action: The ACG Board of Governors urges you to contact your members of Congress and request that they cosponsor the Removing Barriers to Colorectal Screening Act of 2019, (H.R. 1570 and S. 668).
Legislative Status: Over 260 House members support H.R. 1570, and roughly 50 Senators have cosponsored S. 668 as well! ACG, national and state GI societies, as well as patient advocacy groups have all been advocating for this important bill that will protect Medicare beneficiaries from surprise medical bills, help to increase CRC screening rates, and reduce Medicare costs due to lower CRC incidence.
Why Your Help Matters Now:
An important threshold in the House of Representatives is 290 cosponsors. H.R. 1570 currently has 266 cosponsors at the time of this writing. According to the U.S. House of Representatives Rules Committee, Speaker Pelosi and the U.S. House must consider one bill (at a minimum) from the “Consensus Calendar” each session week. For a bill to be eligible for the Consensus Calendar, a measure must accumulate 290 cosponsors for at least 25 legislative days. While a vote is not guaranteed just for meeting the criteria, not many bills will meet this threshold, thus improving the likelihood of consideration.
A Recent Review of Medicare Fee-for-Service Claims Emphasizes the Need for Congress to Pass H.R. 1570 and S. 668.
ACG and the Moran Company recently reviewed Medicare claims data from 2011 to 2017 and found that the incidence of polypectomy during screening colonoscopy is increasing dramatically. This is good news. For each percent increase in pre-cancerous polyp detection, there is a 3 percent reduction in CRC incidence and a 4 percent reduction in CRC death.[i]
Thanks to the improved quality of CRC screening procedures, gastroenterologists have improved adenoma detection rates. At the same time, CRC incidence rates in the Medicare-age population have been declining as well.
Quality is Improving!
... But Medicare Beneficiary Liability is Increasing with the “Post-Polypectomy Surprise”
Due to a quirk in federal law, Medicare will cover the full cost of a "screening" colonoscopy. However, when a polyp is detected and removed, this "therapeutic" procedure is no longer considered a "screening" for coding and reimbursement purposes. Thus:
- Medicare beneficiaries incur surprise out-of-pocket medical costs.
- This is counter to the U.S. public healthcare goal of removing barriers to increasing CRC screening rates.
[i] N Engl J Med 2014; 370:1298-1306. DOI: 10.1056/NEJMoa1309086. Available here: https://www.nejm.org/doi/full/10.1056/NEJMoa1309086
At The State Level: ACG Advocating for Various Colorectal Cancer Screening Legislation
From Neil Stollman, MD, FACG and Patrick Young, MD, FACG, Chair and Vice Chair of the ACG Board of Governors:
ACG Board of Governors Chair Neil Stollman, MD, FACG
ACG Board of Governors Vice Chair Patrick Young, MD, FACG
- In Arkansas: Rep. Fred Allen introduced a bill introduced a bill to create the Arkansas Colorectal Cancer Screening Initiative, designed to help certain residents to access to screening and creates a public awareness program.
- In Maine: Important news in Maine. Recently, Gov. Janet Mills signed into law a bill that removes references to a patient's age for purposes of colorectal cancer screening coverage for average-risk individuals and instead requires coverage in accordance with the most recently published guidelines of a "national cancer society," like the American Cancer Society. In addition, the law requires coverage of all screening and laboratory tests in accordance with these published guidelines. The requirements related to colorectal cancer screening apply to health insurance plans issued or renewed on or after January 1, 2020.
- In Massachusetts: ACG is working with Rep. Louis Kafka on a bill that removes certain patient cost-sharing for a screening colonoscopy or a screening sigmoidoscopy, or any out-of-pocket expenses for an additional colonoscopy or sigmoidoscopy ordered in the same policy year.
- In New York: Reps. Jeffrey Dinowitz, Sandy Galef, Michael Cusick, Steven Cymbrowitz, and Kenneth Zebrowski introduced a bill that provides coverage for colorectal cancer screening as well as physician consultations for examination prior to these screenings, in accordance with ACG guidelines, among others.
- In Rhode Island: RI State Senator Maryellen Goodwin (D-RI-1) has introduced Senate Bill 679, "An Act Relating to Insurance--Accident and Sickness Insurance Policies," (S.679). This bill prohibits insurers from requiring patient cost-sharing for screening colonoscopy, when a screening colonoscopy turns therapeutic, or when a patient is referred for a diagnostic colonoscopy subsequent to another colorectal cancer screening test. We need Rhode Island ACG members to contact the House Speaker Nicholas A. Mattiello and urge him to support this important bill. Use the ACG Legislative Action Center to contact Speaker Mattiello!
Remember to contact your ACG Governor on important state and local issues impacting you and your practice.
The ACG Board of Governors is one of the most unique aspects of the American College of Gastroenterology. Governors are ACG Fellows that are elected from the membership of a particular state or region. There are currently 77 Governors across seven different regions in the U.S. and abroad. The Board of Governors acts as a two-way conduit between College leadership and the membership at-large. This helps the College make certain it is meeting the evolving needs of the membership.
How Can YOU Get Involved?
What are some important bills impacting GI in Congress? In your state? How can you easily voice your support?
ACG's Legislative Action Center is your one-stop resource to review and advocate for various federal and state bills impacting your profession, practice, and patients.