News from AGA

AGA’s microbiome leaders recently met with representatives from FDA’s Center for Biologics Evaluation and Research (CBER) to share clinician and researcher perspectives on fecal microbiota transplantation (FMT) and understand CBER’s current thinking on the regulation of FMT for the treatment of Clostridioides difficile (C. difficile) infection. Here are the key takeaways from AGA’s discussion with CBER.

AGA made clear to FDA the needs and concerns of the clinical and research communities regarding FMT. AGA communicated clinician concerns about patient access to whole-stool FMT being restricted or perhaps eliminated once drugs containing live microbials are FDA approved. AGA’s representatives also shared concerns about the narrow inclusion criteria for current clinical trials and whether the new drugs will be as effective as whole-stool FMT for vulnerable populations such as the elderly or immunocompromised, who make up the majority of patients with C. difficile infection but are often excluded from current trials. Finally, AGA emphasized the need to encourage innovation in product development and the importance of performing controlled safety and efficacy studies on products that can be manufactured predictably and reproducibly.

All stakeholders agreed that the AGA FMT National Registry is an important effort to collect short- and long-term data on the safety and efficacy of FMT. AGA will maintain dialogue with CBER regarding data from the registry and lessons learned. Clinicians practicing FMT are strongly encouraged to participate in the FMT National Registry, which will follow short- and long-term outcomes of patients receiving FMT for up to 10 years. The registry is funded by a grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (award number R24 AI118629) and is a partnership of AGA, the Crohn’s &nd Colitis Foundation, the Infectious Diseases Society of America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

CBER is currently working on an update to the enforcement discretion policy on the use of FMT for C. difficile infection not responsive to standard therapies.Agency representatives noted that all comments will be considered as the agency finalizes the guidance. The current enforcement discretion policy has been in place since July 2013 and was most recently updated by CBER in a draft guidance in March 2016. The policy enables clinicians to use FMT for the treatment of C. difficile infection not responsive to standard therapies without having an investigational new drug (IND) application in place.

Human stool will continue to be regulated as a drug and biological product. The agency stated that human stool does not meet the definition of a tissue and FDA does not intend to change how it is currently classified.

CBER is interested in hearing ideas for novel trial designs that may help address the challenges of patient recruitment for clinical trials in C. difficile infection and other indications for FMT. AGA encourages members to share their thoughts on this topic through the AGA Community.

Following AGA’s meeting with CBER, FDA issued a safety alert because of the death of a patient who died from an FMT containing a multi-drug resistant organism. The agency has since issued additional requirements for IND holders on stool donor screening. AGA will continue to engage with FDA on this issue and share updates as they become available with all members.

Meeting participants from AGA membership included:

• Gail A. Hecht, MD, MS, AGAF, immediate past chair, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Colleen R. Kelly, MD, co-chair, AGA FMT National Registry Steering Committee

• Alexander Khoruts, MD, member, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Gary D. Wu, MD, AGAF, basic research councilor, AGA Institute Governing Board, and member, AGA FMT National Registry Steering Committee


Meeting participants from FDA/CBER included:

• Peter Marks, MD, PhD, Director, CBER

• Celia Witten, PhD, MD, Deputy Director, CBER

• Diane Maloney, JD, Associate Director for Policy, CBER

• Julie Tierney, JD, Senior Policy Advisor for Strategic Planning & Legislation, CBER

• Marion Gruber, PhD, Director, Office of Vaccines Research and Review (OVRR), CBER

• Theresa Finn, PhD, Associate Director for Policy, OVRR, CBER

• Doran Fink, MD, PhD, Deputy Director, Clinical, Division of Vaccines and Related Products Applications, OVRR, CBER

• Paul Carlson, PhD, Senior Staff Fellow, OVRR

• Lorrie McNeill, Director, Office of Communication, Outreach and Development, CBER


This meeting took place on May 6, 2019, at the FDA headquarters in Silver Spring, Md.
 

[email protected]

AGA’s microbiome leaders recently met with representatives from FDA’s Center for Biologics Evaluation and Research (CBER) to share clinician and researcher perspectives on fecal microbiota transplantation (FMT) and understand CBER’s current thinking on the regulation of FMT for the treatment of Clostridioides difficile (C. difficile) infection. Here are the key takeaways from AGA’s discussion with CBER.

AGA made clear to FDA the needs and concerns of the clinical and research communities regarding FMT. AGA communicated clinician concerns about patient access to whole-stool FMT being restricted or perhaps eliminated once drugs containing live microbials are FDA approved. AGA’s representatives also shared concerns about the narrow inclusion criteria for current clinical trials and whether the new drugs will be as effective as whole-stool FMT for vulnerable populations such as the elderly or immunocompromised, who make up the majority of patients with C. difficile infection but are often excluded from current trials. Finally, AGA emphasized the need to encourage innovation in product development and the importance of performing controlled safety and efficacy studies on products that can be manufactured predictably and reproducibly.

All stakeholders agreed that the AGA FMT National Registry is an important effort to collect short- and long-term data on the safety and efficacy of FMT. AGA will maintain dialogue with CBER regarding data from the registry and lessons learned. Clinicians practicing FMT are strongly encouraged to participate in the FMT National Registry, which will follow short- and long-term outcomes of patients receiving FMT for up to 10 years. The registry is funded by a grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (award number R24 AI118629) and is a partnership of AGA, the Crohn’s &nd Colitis Foundation, the Infectious Diseases Society of America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

CBER is currently working on an update to the enforcement discretion policy on the use of FMT for C. difficile infection not responsive to standard therapies.Agency representatives noted that all comments will be considered as the agency finalizes the guidance. The current enforcement discretion policy has been in place since July 2013 and was most recently updated by CBER in a draft guidance in March 2016. The policy enables clinicians to use FMT for the treatment of C. difficile infection not responsive to standard therapies without having an investigational new drug (IND) application in place.

Human stool will continue to be regulated as a drug and biological product. The agency stated that human stool does not meet the definition of a tissue and FDA does not intend to change how it is currently classified.

CBER is interested in hearing ideas for novel trial designs that may help address the challenges of patient recruitment for clinical trials in C. difficile infection and other indications for FMT. AGA encourages members to share their thoughts on this topic through the AGA Community.

Following AGA’s meeting with CBER, FDA issued a safety alert because of the death of a patient who died from an FMT containing a multi-drug resistant organism. The agency has since issued additional requirements for IND holders on stool donor screening. AGA will continue to engage with FDA on this issue and share updates as they become available with all members.

Meeting participants from AGA membership included:

• Gail A. Hecht, MD, MS, AGAF, immediate past chair, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Colleen R. Kelly, MD, co-chair, AGA FMT National Registry Steering Committee

• Alexander Khoruts, MD, member, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Gary D. Wu, MD, AGAF, basic research councilor, AGA Institute Governing Board, and member, AGA FMT National Registry Steering Committee


Meeting participants from FDA/CBER included:

• Peter Marks, MD, PhD, Director, CBER

• Celia Witten, PhD, MD, Deputy Director, CBER

• Diane Maloney, JD, Associate Director for Policy, CBER

• Julie Tierney, JD, Senior Policy Advisor for Strategic Planning & Legislation, CBER

• Marion Gruber, PhD, Director, Office of Vaccines Research and Review (OVRR), CBER

• Theresa Finn, PhD, Associate Director for Policy, OVRR, CBER

• Doran Fink, MD, PhD, Deputy Director, Clinical, Division of Vaccines and Related Products Applications, OVRR, CBER

• Paul Carlson, PhD, Senior Staff Fellow, OVRR

• Lorrie McNeill, Director, Office of Communication, Outreach and Development, CBER


This meeting took place on May 6, 2019, at the FDA headquarters in Silver Spring, Md.
 

[email protected]

AGA’s microbiome leaders recently met with representatives from FDA’s Center for Biologics Evaluation and Research (CBER) to share clinician and researcher perspectives on fecal microbiota transplantation (FMT) and understand CBER’s current thinking on the regulation of FMT for the treatment of Clostridioides difficile (C. difficile) infection. Here are the key takeaways from AGA’s discussion with CBER.

AGA made clear to FDA the needs and concerns of the clinical and research communities regarding FMT. AGA communicated clinician concerns about patient access to whole-stool FMT being restricted or perhaps eliminated once drugs containing live microbials are FDA approved. AGA’s representatives also shared concerns about the narrow inclusion criteria for current clinical trials and whether the new drugs will be as effective as whole-stool FMT for vulnerable populations such as the elderly or immunocompromised, who make up the majority of patients with C. difficile infection but are often excluded from current trials. Finally, AGA emphasized the need to encourage innovation in product development and the importance of performing controlled safety and efficacy studies on products that can be manufactured predictably and reproducibly.

All stakeholders agreed that the AGA FMT National Registry is an important effort to collect short- and long-term data on the safety and efficacy of FMT. AGA will maintain dialogue with CBER regarding data from the registry and lessons learned. Clinicians practicing FMT are strongly encouraged to participate in the FMT National Registry, which will follow short- and long-term outcomes of patients receiving FMT for up to 10 years. The registry is funded by a grant from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health (award number R24 AI118629) and is a partnership of AGA, the Crohn’s &nd Colitis Foundation, the Infectious Diseases Society of America and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition.

CBER is currently working on an update to the enforcement discretion policy on the use of FMT for C. difficile infection not responsive to standard therapies.Agency representatives noted that all comments will be considered as the agency finalizes the guidance. The current enforcement discretion policy has been in place since July 2013 and was most recently updated by CBER in a draft guidance in March 2016. The policy enables clinicians to use FMT for the treatment of C. difficile infection not responsive to standard therapies without having an investigational new drug (IND) application in place.

Human stool will continue to be regulated as a drug and biological product. The agency stated that human stool does not meet the definition of a tissue and FDA does not intend to change how it is currently classified.

CBER is interested in hearing ideas for novel trial designs that may help address the challenges of patient recruitment for clinical trials in C. difficile infection and other indications for FMT. AGA encourages members to share their thoughts on this topic through the AGA Community.

Following AGA’s meeting with CBER, FDA issued a safety alert because of the death of a patient who died from an FMT containing a multi-drug resistant organism. The agency has since issued additional requirements for IND holders on stool donor screening. AGA will continue to engage with FDA on this issue and share updates as they become available with all members.

Meeting participants from AGA membership included:

• Gail A. Hecht, MD, MS, AGAF, immediate past chair, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Colleen R. Kelly, MD, co-chair, AGA FMT National Registry Steering Committee

• Alexander Khoruts, MD, member, AGA Center for Gut Microbiome Research and Education Scientific Advisory Board

• Gary D. Wu, MD, AGAF, basic research councilor, AGA Institute Governing Board, and member, AGA FMT National Registry Steering Committee


Meeting participants from FDA/CBER included:

• Peter Marks, MD, PhD, Director, CBER

• Celia Witten, PhD, MD, Deputy Director, CBER

• Diane Maloney, JD, Associate Director for Policy, CBER

• Julie Tierney, JD, Senior Policy Advisor for Strategic Planning & Legislation, CBER

• Marion Gruber, PhD, Director, Office of Vaccines Research and Review (OVRR), CBER

• Theresa Finn, PhD, Associate Director for Policy, OVRR, CBER

• Doran Fink, MD, PhD, Deputy Director, Clinical, Division of Vaccines and Related Products Applications, OVRR, CBER

• Paul Carlson, PhD, Senior Staff Fellow, OVRR

• Lorrie McNeill, Director, Office of Communication, Outreach and Development, CBER


This meeting took place on May 6, 2019, at the FDA headquarters in Silver Spring, Md.
 

[email protected]

The AGA Research Foundation’s career development awards are invaluable tools for early career investigators to advance their careers in gastroenterology and hepatology research. When Ashish Nimgaonkar, MD, MTech, MS, received the AGA-Boston Scientific Career Development Technology and Innovation Award in 2014, he was able to step up his research and develop a new technological approach for managing patients with chronic liver disease-related complications. We are delighted to introduce you to the work of Dr. Nimgaonkar, medical director in the Johns Hopkins Center for Bioengineering Innovation and Design, department of biomedical engineering, and an assistant professor of medicine and business at Johns Hopkins University.

[email protected]

Help AGA build a community of investigators through the AGA Research Foundation.

Your donation to the AGA Research Foundation can fund future success stories by keeping young scientists working to advance our understanding of digestive diseases. Donate today at www.gastro.org/donateonline.

The AGA Research Foundation’s career development awards are invaluable tools for early career investigators to advance their careers in gastroenterology and hepatology research. When Ashish Nimgaonkar, MD, MTech, MS, received the AGA-Boston Scientific Career Development Technology and Innovation Award in 2014, he was able to step up his research and develop a new technological approach for managing patients with chronic liver disease-related complications. We are delighted to introduce you to the work of Dr. Nimgaonkar, medical director in the Johns Hopkins Center for Bioengineering Innovation and Design, department of biomedical engineering, and an assistant professor of medicine and business at Johns Hopkins University.

[email protected]

Help AGA build a community of investigators through the AGA Research Foundation.

Your donation to the AGA Research Foundation can fund future success stories by keeping young scientists working to advance our understanding of digestive diseases. Donate today at www.gastro.org/donateonline.

The AGA Research Foundation’s career development awards are invaluable tools for early career investigators to advance their careers in gastroenterology and hepatology research. When Ashish Nimgaonkar, MD, MTech, MS, received the AGA-Boston Scientific Career Development Technology and Innovation Award in 2014, he was able to step up his research and develop a new technological approach for managing patients with chronic liver disease-related complications. We are delighted to introduce you to the work of Dr. Nimgaonkar, medical director in the Johns Hopkins Center for Bioengineering Innovation and Design, department of biomedical engineering, and an assistant professor of medicine and business at Johns Hopkins University.

[email protected]

Help AGA build a community of investigators through the AGA Research Foundation.

Your donation to the AGA Research Foundation can fund future success stories by keeping young scientists working to advance our understanding of digestive diseases. Donate today at www.gastro.org/donateonline.

The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.

The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.

The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.

House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.

Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.
 

[email protected]

The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.

The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.

The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.

House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.

Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.
 

[email protected]

The House of Representatives passed two bills aimed at speeding up the development of generics and biosimilars while the Trump administration finalized a rule to require drug companies to list the price of their products in their television ads.

The House passed two bills to address drug pricing. The House passed H.R. 1503, the Orange Book Transparency Act of 2019, legislation that would make changes to the FDA’s “orange” book to provide better information on brand drug and patent exclusivity. The orange book is used by doctors and pharmacists for information on generic drug approvals and availability. It is also used by generic drug manufacturers to make decisions on where to invest in research and development as it provides information on the exclusivity period for brand name drugs. Similarly, the House passed H.R. 1520, the Purple Book Continuity Act, legislation that would update FDA’s “purple” book on patents and exclusivity for biologics. These are the first bills of the 116th Congress to pass that address the costs of drugs.

The Administration finalizes rule on drug costs in advertising. The Trump administration finalized a rule that would require drug manufacturers to disclose prices on their products in television advertisements. Manufacturers must list a product’s monthly wholesale price or the cost of a typical treatment if it is greater than $35 for 30 days. The information must appear in text large enough for people to read it and should also include a statement that people with insurance may pay a different amount for the product. The rule takes effect in 60 days and the drug industry opposes the rule, which they say could sway patients away from certain medications and lead to more misinformation on the actual costs.

House Appropriations Committee approves $2 billion NIH increase. The House Appropriations Committee approved their fiscal year 2020 Labor, HHS, and Education Appropriations bill that includes a $2 billion increase in NIH funding. The Committee also includes critical report language on several GI research areas including inflammatory bowel disease, colorectal cancer screenings, early onset colorectal cancer, and the role of food as medicine in treating diseases. The bill also includes important language directing CMS to require Medicare Advantage plans to exclude from prior authorization requirements those services that align with evidence-based guidelines and have a high prior authorization approval rate. The language also calls for more transparency for MA plans with prior authorization so physicians are aware of what services require it.

Medical Nutrition Equity Act introduced in House. Rep. Jim McGovern, D-Mass., introduced H.R. 2501, the Medical Nutrition Equity Act, legislation that would mandate coverage of medically necessary foods for individuals with digestive and inherited metabolic disorders. AGA is supportive of this legislation that is critical for patients with digestive diseases and ensures their access to these lifesaving products.
 

[email protected]

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ)

A 22-year-old Crohn’s patient presented to the hospital in septic shock with acute renal failure due to pyogenic liver abscess, which had ruptured into the peritoneal cavity. Member seeks consult from the AGA Community on treatment options given this serious infection.

2. EUS-guided cholecystoenterostomy with LAMS (http://ow.ly/IqLP50uyXLg)

A member poses the question: how long should the stent stay in?

3. Colorectal cancer surveillance in Crohn’s colitis and small duct PSC (http://ow.ly/tbe650uyXQh)

A member asks if you would continue yearly CRC surveillance on a patient with Crohn’s colitis with very limited colonic involvement in the ascending colon, who is currently in clinical remission. The patient also has small duct PSC with early cirrhosis.

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ)

A 22-year-old Crohn’s patient presented to the hospital in septic shock with acute renal failure due to pyogenic liver abscess, which had ruptured into the peritoneal cavity. Member seeks consult from the AGA Community on treatment options given this serious infection.

2. EUS-guided cholecystoenterostomy with LAMS (http://ow.ly/IqLP50uyXLg)

A member poses the question: how long should the stent stay in?

3. Colorectal cancer surveillance in Crohn’s colitis and small duct PSC (http://ow.ly/tbe650uyXQh)

A member asks if you would continue yearly CRC surveillance on a patient with Crohn’s colitis with very limited colonic involvement in the ascending colon, who is currently in clinical remission. The patient also has small duct PSC with early cirrhosis.

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. In case you missed it, here are the most popular clinical discussions shared in the forum recently:

1. Crohn’s disease, infliximab and liver abscess (http://ow.ly/mTod50uyXCQ)

A 22-year-old Crohn’s patient presented to the hospital in septic shock with acute renal failure due to pyogenic liver abscess, which had ruptured into the peritoneal cavity. Member seeks consult from the AGA Community on treatment options given this serious infection.

2. EUS-guided cholecystoenterostomy with LAMS (http://ow.ly/IqLP50uyXLg)

A member poses the question: how long should the stent stay in?

3. Colorectal cancer surveillance in Crohn’s colitis and small duct PSC (http://ow.ly/tbe650uyXQh)

A member asks if you would continue yearly CRC surveillance on a patient with Crohn’s colitis with very limited colonic involvement in the ascending colon, who is currently in clinical remission. The patient also has small duct PSC with early cirrhosis.

Access these clinical cases and more discussions at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Perianal fistula found in UC patient (http://ow.ly/S8bJ30okWuO)

A 20-year-old male patient with no previous medical history was seen and treated last year for pancolitis. His physician solicits drug therapy preferences from the GI community, given the age of the patient and a newly discovered perianal fistula.

2. IBD patient with risk of cancer (http://ow.ly/KoGz30oHdjG)

A 62-year-old female patient with a long history of Crohn’s disease developed acute hepatitis. She had a colectomy in 2011 where a one-stage ileo rectal anastomosis was performed instead of a J-pouch. She was in remission under surveillance and mesalamine, until recently. She also has primary sclerosing cholangitis (PSC) and multifocal dysplasia, a combination that raised concern among the GI community about the patient’s risk of cancer.

3. Significant daily pain in Crohn’s patient (http://ow.ly/FHUI30oHdI8)

A recent colonoscopy for a 39-year-old man with Crohn’s disease revealed active disease in the ileum and sigmoid colon with narrowing at the recto-sigmoid colon. The MRE revealed active inflammation at the ileo-colonic anastomosis and of the sigmoid and descending colon, with no noted fistulas. His physician solicits advice in the forum on next steps for the patient, who was experiencing significant pain daily, despite being on a low residue diet and consistent drug therapy.

Other popular clinical discussions:

• WATS imaging in Barrett’s esophagus (http://ow.ly/PrJ330oHdCN)

Members share their opinions and experiences with Wide-Area Transepithelial Sampling (WATS) in Barrett’s esophagus (BE) after mention of recent data demonstrating its promising potential for surveillance in BE patients, despite not yet being approved by the FDA.



• Positive FIT with negative colonoscopy (http://ow.ly/zSxC30oHcZM)

A physician solicits advice on next steps in managing average-risk patients with a positive FIT and negative colonoscopy screening, and asks colleagues if their actions would change after discovering a patient also had non-bleeding hemorrhoids on exam.

More clinical cases and discussions are at https://community.gastro.org/discussions.


 

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Perianal fistula found in UC patient (http://ow.ly/S8bJ30okWuO)

A 20-year-old male patient with no previous medical history was seen and treated last year for pancolitis. His physician solicits drug therapy preferences from the GI community, given the age of the patient and a newly discovered perianal fistula.

2. IBD patient with risk of cancer (http://ow.ly/KoGz30oHdjG)

A 62-year-old female patient with a long history of Crohn’s disease developed acute hepatitis. She had a colectomy in 2011 where a one-stage ileo rectal anastomosis was performed instead of a J-pouch. She was in remission under surveillance and mesalamine, until recently. She also has primary sclerosing cholangitis (PSC) and multifocal dysplasia, a combination that raised concern among the GI community about the patient’s risk of cancer.

3. Significant daily pain in Crohn’s patient (http://ow.ly/FHUI30oHdI8)

A recent colonoscopy for a 39-year-old man with Crohn’s disease revealed active disease in the ileum and sigmoid colon with narrowing at the recto-sigmoid colon. The MRE revealed active inflammation at the ileo-colonic anastomosis and of the sigmoid and descending colon, with no noted fistulas. His physician solicits advice in the forum on next steps for the patient, who was experiencing significant pain daily, despite being on a low residue diet and consistent drug therapy.

Other popular clinical discussions:

• WATS imaging in Barrett’s esophagus (http://ow.ly/PrJ330oHdCN)

Members share their opinions and experiences with Wide-Area Transepithelial Sampling (WATS) in Barrett’s esophagus (BE) after mention of recent data demonstrating its promising potential for surveillance in BE patients, despite not yet being approved by the FDA.



• Positive FIT with negative colonoscopy (http://ow.ly/zSxC30oHcZM)

A physician solicits advice on next steps in managing average-risk patients with a positive FIT and negative colonoscopy screening, and asks colleagues if their actions would change after discovering a patient also had non-bleeding hemorrhoids on exam.

More clinical cases and discussions are at https://community.gastro.org/discussions.


 

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org/discussions) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Perianal fistula found in UC patient (http://ow.ly/S8bJ30okWuO)

A 20-year-old male patient with no previous medical history was seen and treated last year for pancolitis. His physician solicits drug therapy preferences from the GI community, given the age of the patient and a newly discovered perianal fistula.

2. IBD patient with risk of cancer (http://ow.ly/KoGz30oHdjG)

A 62-year-old female patient with a long history of Crohn’s disease developed acute hepatitis. She had a colectomy in 2011 where a one-stage ileo rectal anastomosis was performed instead of a J-pouch. She was in remission under surveillance and mesalamine, until recently. She also has primary sclerosing cholangitis (PSC) and multifocal dysplasia, a combination that raised concern among the GI community about the patient’s risk of cancer.

3. Significant daily pain in Crohn’s patient (http://ow.ly/FHUI30oHdI8)

A recent colonoscopy for a 39-year-old man with Crohn’s disease revealed active disease in the ileum and sigmoid colon with narrowing at the recto-sigmoid colon. The MRE revealed active inflammation at the ileo-colonic anastomosis and of the sigmoid and descending colon, with no noted fistulas. His physician solicits advice in the forum on next steps for the patient, who was experiencing significant pain daily, despite being on a low residue diet and consistent drug therapy.

Other popular clinical discussions:

• WATS imaging in Barrett’s esophagus (http://ow.ly/PrJ330oHdCN)

Members share their opinions and experiences with Wide-Area Transepithelial Sampling (WATS) in Barrett’s esophagus (BE) after mention of recent data demonstrating its promising potential for surveillance in BE patients, despite not yet being approved by the FDA.



• Positive FIT with negative colonoscopy (http://ow.ly/zSxC30oHcZM)

A physician solicits advice on next steps in managing average-risk patients with a positive FIT and negative colonoscopy screening, and asks colleagues if their actions would change after discovering a patient also had non-bleeding hemorrhoids on exam.

More clinical cases and discussions are at https://community.gastro.org/discussions.


 

Recognition is increasing among GI practitioners about the influence of nutrition and diet on patient outcomes. From irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), celiac, mast cell activation syndrome, and other maladies, what patients consume plays a role in how well they combat these diseases. Increasingly, clinicians are working with allied health professionals including allergists, nutritionists, and dietitians to forge partnerships to promote sound gut health. In response to this growing trend, the 2019 James W. Freston Conference – Food at the Intersection of Gut Health and Disease, Aug. 9-10, 2019, in Chicago, will examine how nutrition management therapies can combat GI disorders and how diet supports improvement across the care continuum.

Since 2008, Freston has focused on single-issue topics where experts gather to address practitioner challenges and solutions as well as gastroenterological science. Following this year’s Freston, attendees will leave with a deep understanding about:

• How to recognize and differentiate food-induced GI disorders.

• Diets that promote sound gut health care.

• How nutrient-gene interactions may alter gastrointestinal conditions.

• How nutrition can help patients with gastroesophageal reflux disease (GERD), IBS, IBD, FGIDs and mast cell activation syndrome.

• Implementing nutrition management therapies.

Join like-minded practitioners and industry counterparts in Freston’s intimate environment designed to foster learning, networking, and engagement. Registration is open and early bird rates are in effect through June 5. Learn more by visiting freston.gastro.org

[email protected]

Recognition is increasing among GI practitioners about the influence of nutrition and diet on patient outcomes. From irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), celiac, mast cell activation syndrome, and other maladies, what patients consume plays a role in how well they combat these diseases. Increasingly, clinicians are working with allied health professionals including allergists, nutritionists, and dietitians to forge partnerships to promote sound gut health. In response to this growing trend, the 2019 James W. Freston Conference – Food at the Intersection of Gut Health and Disease, Aug. 9-10, 2019, in Chicago, will examine how nutrition management therapies can combat GI disorders and how diet supports improvement across the care continuum.

Since 2008, Freston has focused on single-issue topics where experts gather to address practitioner challenges and solutions as well as gastroenterological science. Following this year’s Freston, attendees will leave with a deep understanding about:

• How to recognize and differentiate food-induced GI disorders.

• Diets that promote sound gut health care.

• How nutrient-gene interactions may alter gastrointestinal conditions.

• How nutrition can help patients with gastroesophageal reflux disease (GERD), IBS, IBD, FGIDs and mast cell activation syndrome.

• Implementing nutrition management therapies.

Join like-minded practitioners and industry counterparts in Freston’s intimate environment designed to foster learning, networking, and engagement. Registration is open and early bird rates are in effect through June 5. Learn more by visiting freston.gastro.org

[email protected]

Recognition is increasing among GI practitioners about the influence of nutrition and diet on patient outcomes. From irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), celiac, mast cell activation syndrome, and other maladies, what patients consume plays a role in how well they combat these diseases. Increasingly, clinicians are working with allied health professionals including allergists, nutritionists, and dietitians to forge partnerships to promote sound gut health. In response to this growing trend, the 2019 James W. Freston Conference – Food at the Intersection of Gut Health and Disease, Aug. 9-10, 2019, in Chicago, will examine how nutrition management therapies can combat GI disorders and how diet supports improvement across the care continuum.

Since 2008, Freston has focused on single-issue topics where experts gather to address practitioner challenges and solutions as well as gastroenterological science. Following this year’s Freston, attendees will leave with a deep understanding about:

• How to recognize and differentiate food-induced GI disorders.

• Diets that promote sound gut health care.

• How nutrient-gene interactions may alter gastrointestinal conditions.

• How nutrition can help patients with gastroesophageal reflux disease (GERD), IBS, IBD, FGIDs and mast cell activation syndrome.

• Implementing nutrition management therapies.

Join like-minded practitioners and industry counterparts in Freston’s intimate environment designed to foster learning, networking, and engagement. Registration is open and early bird rates are in effect through June 5. Learn more by visiting freston.gastro.org

[email protected]

On April 12, FDA issued a safety communication releasing new information on the duodenoscope contamination rate from postmarket surveillance studies and medical device reports. While the outlook has improved significantly since this issue first arose in 2015, we are not yet at our goal of zero device-associated infections.

AGA encourages all members to stay vigilant when it comes to duodenoscope reprocessing and strictly adhere to the manufacturer’s reprocessing and maintenance instructions.

In the safety communication, FDA reports:

• In the past 6 months, three people died and 45 people developed infections from contaminated endoscopes.

• Results from sampling studies show up to 5.4% of all properly collected samples tested positive for “high concern” organisms. “High concern” bacteria are more often associated with disease, such as E. coli or Staphylococcus aureus.

• Additionally, up to 3.6% of properly collected samples tested positive for low to moderate concern organisms; while these organisms don’t usually lead to dangerous infections, they are indicative of a reprocessing failure.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, also issued a communication on continued efforts to assess duodenoscope contamination risk. Dr. Shuren puts this new data into perspective:

“While the current contamination rates we’re seeing in the postmarket studies show the need for improvement, I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use.”

The AGA Center for GI Innovation and Technology (CGIT) continuously monitors this issue and engages with industry and FDA on efforts that will help us reach our goal of zero device-transmitted infections to our patients.

“We continually meet with industry partners, just as recently as last week at the AGA Tech Summit, to understand how they are innovating to reduce the risk of potential infection. We are also in close communication with FDA and other key stakeholders. We all have a role in preventing device-transmitted infections, and we don’t take our role lightly,” added V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair of the AGA CGIT.
 

[email protected]

On April 12, FDA issued a safety communication releasing new information on the duodenoscope contamination rate from postmarket surveillance studies and medical device reports. While the outlook has improved significantly since this issue first arose in 2015, we are not yet at our goal of zero device-associated infections.

AGA encourages all members to stay vigilant when it comes to duodenoscope reprocessing and strictly adhere to the manufacturer’s reprocessing and maintenance instructions.

In the safety communication, FDA reports:

• In the past 6 months, three people died and 45 people developed infections from contaminated endoscopes.

• Results from sampling studies show up to 5.4% of all properly collected samples tested positive for “high concern” organisms. “High concern” bacteria are more often associated with disease, such as E. coli or Staphylococcus aureus.

• Additionally, up to 3.6% of properly collected samples tested positive for low to moderate concern organisms; while these organisms don’t usually lead to dangerous infections, they are indicative of a reprocessing failure.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, also issued a communication on continued efforts to assess duodenoscope contamination risk. Dr. Shuren puts this new data into perspective:

“While the current contamination rates we’re seeing in the postmarket studies show the need for improvement, I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use.”

The AGA Center for GI Innovation and Technology (CGIT) continuously monitors this issue and engages with industry and FDA on efforts that will help us reach our goal of zero device-transmitted infections to our patients.

“We continually meet with industry partners, just as recently as last week at the AGA Tech Summit, to understand how they are innovating to reduce the risk of potential infection. We are also in close communication with FDA and other key stakeholders. We all have a role in preventing device-transmitted infections, and we don’t take our role lightly,” added V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair of the AGA CGIT.
 

[email protected]

On April 12, FDA issued a safety communication releasing new information on the duodenoscope contamination rate from postmarket surveillance studies and medical device reports. While the outlook has improved significantly since this issue first arose in 2015, we are not yet at our goal of zero device-associated infections.

AGA encourages all members to stay vigilant when it comes to duodenoscope reprocessing and strictly adhere to the manufacturer’s reprocessing and maintenance instructions.

In the safety communication, FDA reports:

• In the past 6 months, three people died and 45 people developed infections from contaminated endoscopes.

• Results from sampling studies show up to 5.4% of all properly collected samples tested positive for “high concern” organisms. “High concern” bacteria are more often associated with disease, such as E. coli or Staphylococcus aureus.

• Additionally, up to 3.6% of properly collected samples tested positive for low to moderate concern organisms; while these organisms don’t usually lead to dangerous infections, they are indicative of a reprocessing failure.

Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, also issued a communication on continued efforts to assess duodenoscope contamination risk. Dr. Shuren puts this new data into perspective:

“While the current contamination rates we’re seeing in the postmarket studies show the need for improvement, I want to emphasize that an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use.”

The AGA Center for GI Innovation and Technology (CGIT) continuously monitors this issue and engages with industry and FDA on efforts that will help us reach our goal of zero device-transmitted infections to our patients.

“We continually meet with industry partners, just as recently as last week at the AGA Tech Summit, to understand how they are innovating to reduce the risk of potential infection. We are also in close communication with FDA and other key stakeholders. We all have a role in preventing device-transmitted infections, and we don’t take our role lightly,” added V. Raman Muthusamy, MD, AGAF, FACG, FASGE, chair of the AGA CGIT.
 

[email protected]

Rep. Ruiz was a virtually unknown candidate and defeated then incumbent Mary Bono, R-CA, for the seat that represents Coachella Valley and Palm Springs. Rep. Ruiz is the son of migrant farmers from Mexico who went on to medical school and became the first Latino to receive three graduate degrees from Harvard — a medical degree, a masters of public policy, and a masters of public health. Rep. Ruiz is an emergency physician by training and AGA got to know him early in his congressional career and provided support for his initiatives that aligned with our policy priorities and support through AGA PAC.

When Rep. Ruiz was elected to Congress, the Democrats were in the minority in the House and as a freshman member in the minority, did not yield a lot of power and influence. However, AGA continued to work with Rep. Ruiz in garnering his support for repealing the Independent Payment Advisory Board (IPAB) that was created under the Affordable Care Act (ACA) — it was charged with making budgetary decisions for the Medicare program that would have disproportionately impacted physicians. Rep. Ruiz was willing to work with Republicans to support legislation to repeal IPAB; Congress eventually repealed it in the last Congress.

AGA also worked with Rep. Ruiz in support of increasing access to colorectal cancer screening especially for underrepresented minorities and he has been a strong supporter of the Removing Barriers to Colorectal Cancer Screening Act that would fix the current Medicare screening colonoscopy coinsurance problem that disproportionately impacts poorer Medicare beneficiaries who lack supplemental coverage.

Recently, AGA has been working closely with Rep. Ruiz as he champions an issue that impacts GI patients with inflammatory bowel disease and their ability to access the treatment that their doctor recommends. Rep. Ruiz has introduced H.R. 2279, the Safe Step Act, legislation that would provide a clear, transparent, and easily accessible appeals process for physicians and their patients when subject to step therapy protocols. Step therapy, also known as “fail first,” requires patients to try and fail one or more medications before the insurer will provide coverage for the therapy that their doctor thinks is the best to manage their condition. The Safe Step Act would not eliminate step therapy but would provide some common sense guardrails for patients and reasonable exceptions for patients who would be harmed if subjected to such a policy.

Because of AGA PAC’s and other physician organizations’ PAC support for Rep. Ruiz, he was able to secure a seat on the highly coveted Energy and Commerce Committee and its Health Subcommittee. The Committee has jurisdiction over all public health programs such as NIH, CDC, FDA, and Medicare Part B which is all physician services. Given Rep. Ruiz’s background and the committee position he holds, he is well-suited to continue to help champion AGA’s policy priorities and those of all organized medicine.

Over the years, Rep. Ruiz has spoken to AGA members at our annual Advocacy Day on the importance of physicians being involved politically and also in advocacy. He has also met with AGA Government Affairs Committee member Gaurav Singhvi, MD, in the district on issues important to the gastroenterology community and our patients.

AGA looks forward to working with Rep. Ruiz to continue to ensure that patients have access to specialty care, that the administrative burdens that physicians face like prior authorization are reduced, we continue to invest in research, and that we continue to train the next generation of GIs.

[email protected]

Rep. Ruiz was a virtually unknown candidate and defeated then incumbent Mary Bono, R-CA, for the seat that represents Coachella Valley and Palm Springs. Rep. Ruiz is the son of migrant farmers from Mexico who went on to medical school and became the first Latino to receive three graduate degrees from Harvard — a medical degree, a masters of public policy, and a masters of public health. Rep. Ruiz is an emergency physician by training and AGA got to know him early in his congressional career and provided support for his initiatives that aligned with our policy priorities and support through AGA PAC.

When Rep. Ruiz was elected to Congress, the Democrats were in the minority in the House and as a freshman member in the minority, did not yield a lot of power and influence. However, AGA continued to work with Rep. Ruiz in garnering his support for repealing the Independent Payment Advisory Board (IPAB) that was created under the Affordable Care Act (ACA) — it was charged with making budgetary decisions for the Medicare program that would have disproportionately impacted physicians. Rep. Ruiz was willing to work with Republicans to support legislation to repeal IPAB; Congress eventually repealed it in the last Congress.

AGA also worked with Rep. Ruiz in support of increasing access to colorectal cancer screening especially for underrepresented minorities and he has been a strong supporter of the Removing Barriers to Colorectal Cancer Screening Act that would fix the current Medicare screening colonoscopy coinsurance problem that disproportionately impacts poorer Medicare beneficiaries who lack supplemental coverage.

Recently, AGA has been working closely with Rep. Ruiz as he champions an issue that impacts GI patients with inflammatory bowel disease and their ability to access the treatment that their doctor recommends. Rep. Ruiz has introduced H.R. 2279, the Safe Step Act, legislation that would provide a clear, transparent, and easily accessible appeals process for physicians and their patients when subject to step therapy protocols. Step therapy, also known as “fail first,” requires patients to try and fail one or more medications before the insurer will provide coverage for the therapy that their doctor thinks is the best to manage their condition. The Safe Step Act would not eliminate step therapy but would provide some common sense guardrails for patients and reasonable exceptions for patients who would be harmed if subjected to such a policy.

Because of AGA PAC’s and other physician organizations’ PAC support for Rep. Ruiz, he was able to secure a seat on the highly coveted Energy and Commerce Committee and its Health Subcommittee. The Committee has jurisdiction over all public health programs such as NIH, CDC, FDA, and Medicare Part B which is all physician services. Given Rep. Ruiz’s background and the committee position he holds, he is well-suited to continue to help champion AGA’s policy priorities and those of all organized medicine.

Over the years, Rep. Ruiz has spoken to AGA members at our annual Advocacy Day on the importance of physicians being involved politically and also in advocacy. He has also met with AGA Government Affairs Committee member Gaurav Singhvi, MD, in the district on issues important to the gastroenterology community and our patients.

AGA looks forward to working with Rep. Ruiz to continue to ensure that patients have access to specialty care, that the administrative burdens that physicians face like prior authorization are reduced, we continue to invest in research, and that we continue to train the next generation of GIs.

[email protected]

Rep. Ruiz was a virtually unknown candidate and defeated then incumbent Mary Bono, R-CA, for the seat that represents Coachella Valley and Palm Springs. Rep. Ruiz is the son of migrant farmers from Mexico who went on to medical school and became the first Latino to receive three graduate degrees from Harvard — a medical degree, a masters of public policy, and a masters of public health. Rep. Ruiz is an emergency physician by training and AGA got to know him early in his congressional career and provided support for his initiatives that aligned with our policy priorities and support through AGA PAC.

When Rep. Ruiz was elected to Congress, the Democrats were in the minority in the House and as a freshman member in the minority, did not yield a lot of power and influence. However, AGA continued to work with Rep. Ruiz in garnering his support for repealing the Independent Payment Advisory Board (IPAB) that was created under the Affordable Care Act (ACA) — it was charged with making budgetary decisions for the Medicare program that would have disproportionately impacted physicians. Rep. Ruiz was willing to work with Republicans to support legislation to repeal IPAB; Congress eventually repealed it in the last Congress.

AGA also worked with Rep. Ruiz in support of increasing access to colorectal cancer screening especially for underrepresented minorities and he has been a strong supporter of the Removing Barriers to Colorectal Cancer Screening Act that would fix the current Medicare screening colonoscopy coinsurance problem that disproportionately impacts poorer Medicare beneficiaries who lack supplemental coverage.

Recently, AGA has been working closely with Rep. Ruiz as he champions an issue that impacts GI patients with inflammatory bowel disease and their ability to access the treatment that their doctor recommends. Rep. Ruiz has introduced H.R. 2279, the Safe Step Act, legislation that would provide a clear, transparent, and easily accessible appeals process for physicians and their patients when subject to step therapy protocols. Step therapy, also known as “fail first,” requires patients to try and fail one or more medications before the insurer will provide coverage for the therapy that their doctor thinks is the best to manage their condition. The Safe Step Act would not eliminate step therapy but would provide some common sense guardrails for patients and reasonable exceptions for patients who would be harmed if subjected to such a policy.

Because of AGA PAC’s and other physician organizations’ PAC support for Rep. Ruiz, he was able to secure a seat on the highly coveted Energy and Commerce Committee and its Health Subcommittee. The Committee has jurisdiction over all public health programs such as NIH, CDC, FDA, and Medicare Part B which is all physician services. Given Rep. Ruiz’s background and the committee position he holds, he is well-suited to continue to help champion AGA’s policy priorities and those of all organized medicine.

Over the years, Rep. Ruiz has spoken to AGA members at our annual Advocacy Day on the importance of physicians being involved politically and also in advocacy. He has also met with AGA Government Affairs Committee member Gaurav Singhvi, MD, in the district on issues important to the gastroenterology community and our patients.

AGA looks forward to working with Rep. Ruiz to continue to ensure that patients have access to specialty care, that the administrative burdens that physicians face like prior authorization are reduced, we continue to invest in research, and that we continue to train the next generation of GIs.

[email protected]

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Biologic blood levels for pediatric IBD patient

An 11-year-old was experiencing right lower quadrant pain, a low-grade fever, painful red nodules in his legs, joint pain, moderate anemia, a peri-anal abscess and high fecal calprotectin. An MRI revealed signs of lower small bowel disease and moderate narrowing of the ileum. He was treated and showing no symptoms at about 20 weeks. The community discussed if the patient would benefit from adding adalimumab blood levels to his maintenance.
 

2. False positives in new DNA-based colon cancer tests

A discussion around some noninvasive colon cancer tests, such as Cologuard and liquid biopsy tests like Epi proColon, revealed community frustrations with false positives and dealing with an increased number of anxious patients awaiting colonoscopies.
 

3. Olmesartan-induced enteropathy

A female patient switched blood pressure medications and developed diarrhea, abdominal discomfort, and weight loss. She tested positive for celiac-type enteropathy and was placed on a gluten-free diet, with symptoms resolving a couple weeks later. She switched back to her original medication, and her GI had questions for the community regarding potential for a long-term condition, as well as celiac serology follow-up.
 

4. Inactive UC

A 49-year-old woman with a history of pancolitis hasn’t required therapy for over 10 years. Recent biopsies showed architectural distortion and atrophy consistent with inactive colitis, without any active colitis in the rectum, but the descending colon presented a polyp mucosa with chronic colitis, erosion, and regenerative hyperplasia. Given her history, the physician solicited advice on therapy and rescoping consistency going forward.



More clinical cases and discussions are at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Biologic blood levels for pediatric IBD patient

An 11-year-old was experiencing right lower quadrant pain, a low-grade fever, painful red nodules in his legs, joint pain, moderate anemia, a peri-anal abscess and high fecal calprotectin. An MRI revealed signs of lower small bowel disease and moderate narrowing of the ileum. He was treated and showing no symptoms at about 20 weeks. The community discussed if the patient would benefit from adding adalimumab blood levels to his maintenance.
 

2. False positives in new DNA-based colon cancer tests

A discussion around some noninvasive colon cancer tests, such as Cologuard and liquid biopsy tests like Epi proColon, revealed community frustrations with false positives and dealing with an increased number of anxious patients awaiting colonoscopies.
 

3. Olmesartan-induced enteropathy

A female patient switched blood pressure medications and developed diarrhea, abdominal discomfort, and weight loss. She tested positive for celiac-type enteropathy and was placed on a gluten-free diet, with symptoms resolving a couple weeks later. She switched back to her original medication, and her GI had questions for the community regarding potential for a long-term condition, as well as celiac serology follow-up.
 

4. Inactive UC

A 49-year-old woman with a history of pancolitis hasn’t required therapy for over 10 years. Recent biopsies showed architectural distortion and atrophy consistent with inactive colitis, without any active colitis in the rectum, but the descending colon presented a polyp mucosa with chronic colitis, erosion, and regenerative hyperplasia. Given her history, the physician solicited advice on therapy and rescoping consistency going forward.



More clinical cases and discussions are at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses.

In case you missed it, here are the most popular clinical discussions shared in the forum recently:
 

1. Biologic blood levels for pediatric IBD patient

An 11-year-old was experiencing right lower quadrant pain, a low-grade fever, painful red nodules in his legs, joint pain, moderate anemia, a peri-anal abscess and high fecal calprotectin. An MRI revealed signs of lower small bowel disease and moderate narrowing of the ileum. He was treated and showing no symptoms at about 20 weeks. The community discussed if the patient would benefit from adding adalimumab blood levels to his maintenance.
 

2. False positives in new DNA-based colon cancer tests

A discussion around some noninvasive colon cancer tests, such as Cologuard and liquid biopsy tests like Epi proColon, revealed community frustrations with false positives and dealing with an increased number of anxious patients awaiting colonoscopies.
 

3. Olmesartan-induced enteropathy

A female patient switched blood pressure medications and developed diarrhea, abdominal discomfort, and weight loss. She tested positive for celiac-type enteropathy and was placed on a gluten-free diet, with symptoms resolving a couple weeks later. She switched back to her original medication, and her GI had questions for the community regarding potential for a long-term condition, as well as celiac serology follow-up.
 

4. Inactive UC

A 49-year-old woman with a history of pancolitis hasn’t required therapy for over 10 years. Recent biopsies showed architectural distortion and atrophy consistent with inactive colitis, without any active colitis in the rectum, but the descending colon presented a polyp mucosa with chronic colitis, erosion, and regenerative hyperplasia. Given her history, the physician solicited advice on therapy and rescoping consistency going forward.



More clinical cases and discussions are at https://community.gastro.org/discussions.

Medicare beneficiaries who have a screening colonoscopy and have polyps found and removed, find themselves on the hook for the coinsurance since the screening is now classified as a therapeutic procedure. AGA has been working for years with Congress to change this since removal of polyps is integral to the screening. Screenings save lives and Congress must enact legislation to fix this “surprise bill” that beneficiaries face.

Sens. Sherrod Brown, D-OH, Roger Wicker, R-MS, Ben Cardin, D-MD, and Susan Collins, R-ME, and Reps. Donald Payne Jr., D-NJ, Rodney Davis, R-IL, Donald McEachin, D-VA, and David McKinley, R-WV, have introduced the Removing Barriers to Colorectal Cancer Screening Act. This bipartisan, bicameral legislation would waive the Medicare coinsurance for a screening colonoscopy that becomes therapeutic. Fixing this barrier will ensure that seniors will have access to lifesaving screenings and we will continue to make progress in fighting colorectal cancer.

AGA continues to advocate that Congress support and pass the Removing Barriers to Colorectal Cancer Screening Act and we need your help. Please take a moment to ask your legislator to support this important legislation by going to www.gastro.org/take-action.

Colorectal cancer remains the second leading cancer killer in the U.S. despite the evidence that screening can save lives. The Affordable Care Act made great strides in ensuring that all Americans have access and coverage of lifesaving colorectal cancer screenings without cost sharing and clarified that private insurers could not impose cost sharing on screening colonoscopies that become therapeutic since “removal of polyps is integral” to the screening. We believe that same policy should be applied to our nation’s seniors and the Centers for Medicare and Medicaid should use their authority to make this change.

AGA is committed to ensuring that patients have access to quality lifesaving screenings. Unfortunately, this current Medicare policy has caused enormous confusion among patients and providers and we continue to provide information and education to practices on how this policy impacts their patients. Fixing this problem will alleviate this confusion and ensure that Medicare patients are incentivized to have preventive screenings.
 

[email protected]

Medicare beneficiaries who have a screening colonoscopy and have polyps found and removed, find themselves on the hook for the coinsurance since the screening is now classified as a therapeutic procedure. AGA has been working for years with Congress to change this since removal of polyps is integral to the screening. Screenings save lives and Congress must enact legislation to fix this “surprise bill” that beneficiaries face.

Sens. Sherrod Brown, D-OH, Roger Wicker, R-MS, Ben Cardin, D-MD, and Susan Collins, R-ME, and Reps. Donald Payne Jr., D-NJ, Rodney Davis, R-IL, Donald McEachin, D-VA, and David McKinley, R-WV, have introduced the Removing Barriers to Colorectal Cancer Screening Act. This bipartisan, bicameral legislation would waive the Medicare coinsurance for a screening colonoscopy that becomes therapeutic. Fixing this barrier will ensure that seniors will have access to lifesaving screenings and we will continue to make progress in fighting colorectal cancer.

AGA continues to advocate that Congress support and pass the Removing Barriers to Colorectal Cancer Screening Act and we need your help. Please take a moment to ask your legislator to support this important legislation by going to www.gastro.org/take-action.

Colorectal cancer remains the second leading cancer killer in the U.S. despite the evidence that screening can save lives. The Affordable Care Act made great strides in ensuring that all Americans have access and coverage of lifesaving colorectal cancer screenings without cost sharing and clarified that private insurers could not impose cost sharing on screening colonoscopies that become therapeutic since “removal of polyps is integral” to the screening. We believe that same policy should be applied to our nation’s seniors and the Centers for Medicare and Medicaid should use their authority to make this change.

AGA is committed to ensuring that patients have access to quality lifesaving screenings. Unfortunately, this current Medicare policy has caused enormous confusion among patients and providers and we continue to provide information and education to practices on how this policy impacts their patients. Fixing this problem will alleviate this confusion and ensure that Medicare patients are incentivized to have preventive screenings.
 

[email protected]

Medicare beneficiaries who have a screening colonoscopy and have polyps found and removed, find themselves on the hook for the coinsurance since the screening is now classified as a therapeutic procedure. AGA has been working for years with Congress to change this since removal of polyps is integral to the screening. Screenings save lives and Congress must enact legislation to fix this “surprise bill” that beneficiaries face.

Sens. Sherrod Brown, D-OH, Roger Wicker, R-MS, Ben Cardin, D-MD, and Susan Collins, R-ME, and Reps. Donald Payne Jr., D-NJ, Rodney Davis, R-IL, Donald McEachin, D-VA, and David McKinley, R-WV, have introduced the Removing Barriers to Colorectal Cancer Screening Act. This bipartisan, bicameral legislation would waive the Medicare coinsurance for a screening colonoscopy that becomes therapeutic. Fixing this barrier will ensure that seniors will have access to lifesaving screenings and we will continue to make progress in fighting colorectal cancer.

AGA continues to advocate that Congress support and pass the Removing Barriers to Colorectal Cancer Screening Act and we need your help. Please take a moment to ask your legislator to support this important legislation by going to www.gastro.org/take-action.

Colorectal cancer remains the second leading cancer killer in the U.S. despite the evidence that screening can save lives. The Affordable Care Act made great strides in ensuring that all Americans have access and coverage of lifesaving colorectal cancer screenings without cost sharing and clarified that private insurers could not impose cost sharing on screening colonoscopies that become therapeutic since “removal of polyps is integral” to the screening. We believe that same policy should be applied to our nation’s seniors and the Centers for Medicare and Medicaid should use their authority to make this change.

AGA is committed to ensuring that patients have access to quality lifesaving screenings. Unfortunately, this current Medicare policy has caused enormous confusion among patients and providers and we continue to provide information and education to practices on how this policy impacts their patients. Fixing this problem will alleviate this confusion and ensure that Medicare patients are incentivized to have preventive screenings.
 

[email protected]