News from AGA

We’re celebrating diversity in our field with a new series spotlighting members of the AGA Diversity Committee and AGA FORWARD Program.

Born and raised in Cuba, Mayra Sanchez, MD, came to this country as an adult, with little money in her pocket and no recognition of her previous medical training. Unfortunately, she explains, her story is not uncommon.

“I first got involved with the AGA Diversity Committee to ensure there is recognition of those who come to our field from nontraditional paths such as this.”

Her professional hero is Dr. Guadalupe Garcia-Tsao, a senior hepatologist at Yale.

“She is inspiring as an engaging teacher and as a role model for practicing cutting-edge medicine, but she also is my hero because she was able to rise to a leadership position despite the challenges of being a minority.”

An issue affecting underrepresented minorities at the top of her radar is the need for more mentorship.

While serving on the committee, she also wants to stimulate a deeper understanding among colleagues of the value people bring by virtue of their different backgrounds, both in the gastroenterology and hepatology fields, and in GI patients.

“The practice of gastroenterology allows me to understand mind-body interactions and to appreciate how each person’s life experiences and emotional well-being contributes to her or his digestive health.”
 

Let’s get personal

What are you most proud of in your career? “I am proud that I built a very large, very busy, state-of-the-art motility practice at Yale University. Despite the fact that we have one of the biggest motility practices on the East Coast, we also pride ourselves on our dedication to patient care and patient satisfaction.”

... In your personal life? “In my personal life, I am proud to have two beautiful children and a wonderful husband who serve as constant reminders of the importance of life outside of the workplace.”

What’s your favorite part of your job? “Making a difference in people’s lives, especially when others have not been able to.”

What do you know now that you wish someone told you when you started your career? “The importance of persistence cannot be overstated.”

If I weren’t in gastroenterology, I would be ... “a writer.”

In my free time I like to ... “travel with my family to experience new cultures.”

We’re celebrating diversity in our field with a new series spotlighting members of the AGA Diversity Committee and AGA FORWARD Program.

Born and raised in Cuba, Mayra Sanchez, MD, came to this country as an adult, with little money in her pocket and no recognition of her previous medical training. Unfortunately, she explains, her story is not uncommon.

“I first got involved with the AGA Diversity Committee to ensure there is recognition of those who come to our field from nontraditional paths such as this.”

Her professional hero is Dr. Guadalupe Garcia-Tsao, a senior hepatologist at Yale.

“She is inspiring as an engaging teacher and as a role model for practicing cutting-edge medicine, but she also is my hero because she was able to rise to a leadership position despite the challenges of being a minority.”

An issue affecting underrepresented minorities at the top of her radar is the need for more mentorship.

While serving on the committee, she also wants to stimulate a deeper understanding among colleagues of the value people bring by virtue of their different backgrounds, both in the gastroenterology and hepatology fields, and in GI patients.

“The practice of gastroenterology allows me to understand mind-body interactions and to appreciate how each person’s life experiences and emotional well-being contributes to her or his digestive health.”
 

Let’s get personal

What are you most proud of in your career? “I am proud that I built a very large, very busy, state-of-the-art motility practice at Yale University. Despite the fact that we have one of the biggest motility practices on the East Coast, we also pride ourselves on our dedication to patient care and patient satisfaction.”

... In your personal life? “In my personal life, I am proud to have two beautiful children and a wonderful husband who serve as constant reminders of the importance of life outside of the workplace.”

What’s your favorite part of your job? “Making a difference in people’s lives, especially when others have not been able to.”

What do you know now that you wish someone told you when you started your career? “The importance of persistence cannot be overstated.”

If I weren’t in gastroenterology, I would be ... “a writer.”

In my free time I like to ... “travel with my family to experience new cultures.”

We’re celebrating diversity in our field with a new series spotlighting members of the AGA Diversity Committee and AGA FORWARD Program.

Born and raised in Cuba, Mayra Sanchez, MD, came to this country as an adult, with little money in her pocket and no recognition of her previous medical training. Unfortunately, she explains, her story is not uncommon.

“I first got involved with the AGA Diversity Committee to ensure there is recognition of those who come to our field from nontraditional paths such as this.”

Her professional hero is Dr. Guadalupe Garcia-Tsao, a senior hepatologist at Yale.

“She is inspiring as an engaging teacher and as a role model for practicing cutting-edge medicine, but she also is my hero because she was able to rise to a leadership position despite the challenges of being a minority.”

An issue affecting underrepresented minorities at the top of her radar is the need for more mentorship.

While serving on the committee, she also wants to stimulate a deeper understanding among colleagues of the value people bring by virtue of their different backgrounds, both in the gastroenterology and hepatology fields, and in GI patients.

“The practice of gastroenterology allows me to understand mind-body interactions and to appreciate how each person’s life experiences and emotional well-being contributes to her or his digestive health.”
 

Let’s get personal

What are you most proud of in your career? “I am proud that I built a very large, very busy, state-of-the-art motility practice at Yale University. Despite the fact that we have one of the biggest motility practices on the East Coast, we also pride ourselves on our dedication to patient care and patient satisfaction.”

... In your personal life? “In my personal life, I am proud to have two beautiful children and a wonderful husband who serve as constant reminders of the importance of life outside of the workplace.”

What’s your favorite part of your job? “Making a difference in people’s lives, especially when others have not been able to.”

What do you know now that you wish someone told you when you started your career? “The importance of persistence cannot be overstated.”

If I weren’t in gastroenterology, I would be ... “a writer.”

In my free time I like to ... “travel with my family to experience new cultures.”

Long-term AGA congressional champion and fierce physician-community advocate Congressman Phil Roe (R, Tenn), announced that he will not seek reelection in the upcoming 2020 election. Following his retirement announcement, Congressman Roe communicated to AGA and fellow health care organizations that he is still committed to ensuring the success of the prior authorization bill, H.R. 3107, before leaving Congress.

Congressman Roe, who was first elected to Congress in 2008 and is currently serving his sixth term, is an ob.gyn. by trade who practiced for 30 years before running for office. He originally ran for Congress on a platform touting his experience as a practicing physician to drive and positively impact health care policy. Upon entering Congress, he did just that – focusing his legislative attention and efforts on policies that protect patients, ease administrative burdens, and protect fair reimbursements for specialty physicians. Throughout his tenure, Congressman Roe served both his constituents and his colleagues in the House of Representatives as a valued and respected leader on health care issues. He currently serves as the top-ranking Republican on the Veteran’s Affairs Committee and as co-chair of both the House Doctor’s Caucus and the Congressional Academic Medicine Caucus. His primary focus as a member of Congress has always been on health care issues – many of which include AGA’s top policy priorities.
 

GI wins with Roe

Sustainable Growth Rate (SGR). Congressman Roe was an instrumental figure in the bipartisan victory to repeal the flawed Medicare physician payment formula, known as SGR, in 2015. Throughout the deliberation of SGR repeal legislation, he stayed in close contact with physician groups and actively whipped House members for support.

Independent Payment Advisory Board (IPAB). Congressman Roe was a key ally in the fight to repeal the IPAB, which was created under the Affordable Care Act and which AGA and all of organized medicine long opposed since its sole purpose was to make budgetary cuts to Medicare if it reached a certain threshold of spending. Largely because of Congressman Roe’s leadership on this issue, the IPAB was successfully repealed after years of advocacy on the issue.

Through AGA PAC, AGA staff was afforded the opportunity to cultivate a strong working relationship over the years with Congressman Roe and his staff. While his leadership and commitment to pro-patient, pro-physician policies will be missed following his retirement from Congress, AGA staff looks forward to working with Congressman Roe through the remainder of his term on issues that impact our patients and our practice.

Long-term AGA congressional champion and fierce physician-community advocate Congressman Phil Roe (R, Tenn), announced that he will not seek reelection in the upcoming 2020 election. Following his retirement announcement, Congressman Roe communicated to AGA and fellow health care organizations that he is still committed to ensuring the success of the prior authorization bill, H.R. 3107, before leaving Congress.

Congressman Roe, who was first elected to Congress in 2008 and is currently serving his sixth term, is an ob.gyn. by trade who practiced for 30 years before running for office. He originally ran for Congress on a platform touting his experience as a practicing physician to drive and positively impact health care policy. Upon entering Congress, he did just that – focusing his legislative attention and efforts on policies that protect patients, ease administrative burdens, and protect fair reimbursements for specialty physicians. Throughout his tenure, Congressman Roe served both his constituents and his colleagues in the House of Representatives as a valued and respected leader on health care issues. He currently serves as the top-ranking Republican on the Veteran’s Affairs Committee and as co-chair of both the House Doctor’s Caucus and the Congressional Academic Medicine Caucus. His primary focus as a member of Congress has always been on health care issues – many of which include AGA’s top policy priorities.
 

GI wins with Roe

Sustainable Growth Rate (SGR). Congressman Roe was an instrumental figure in the bipartisan victory to repeal the flawed Medicare physician payment formula, known as SGR, in 2015. Throughout the deliberation of SGR repeal legislation, he stayed in close contact with physician groups and actively whipped House members for support.

Independent Payment Advisory Board (IPAB). Congressman Roe was a key ally in the fight to repeal the IPAB, which was created under the Affordable Care Act and which AGA and all of organized medicine long opposed since its sole purpose was to make budgetary cuts to Medicare if it reached a certain threshold of spending. Largely because of Congressman Roe’s leadership on this issue, the IPAB was successfully repealed after years of advocacy on the issue.

Through AGA PAC, AGA staff was afforded the opportunity to cultivate a strong working relationship over the years with Congressman Roe and his staff. While his leadership and commitment to pro-patient, pro-physician policies will be missed following his retirement from Congress, AGA staff looks forward to working with Congressman Roe through the remainder of his term on issues that impact our patients and our practice.

Long-term AGA congressional champion and fierce physician-community advocate Congressman Phil Roe (R, Tenn), announced that he will not seek reelection in the upcoming 2020 election. Following his retirement announcement, Congressman Roe communicated to AGA and fellow health care organizations that he is still committed to ensuring the success of the prior authorization bill, H.R. 3107, before leaving Congress.

Congressman Roe, who was first elected to Congress in 2008 and is currently serving his sixth term, is an ob.gyn. by trade who practiced for 30 years before running for office. He originally ran for Congress on a platform touting his experience as a practicing physician to drive and positively impact health care policy. Upon entering Congress, he did just that – focusing his legislative attention and efforts on policies that protect patients, ease administrative burdens, and protect fair reimbursements for specialty physicians. Throughout his tenure, Congressman Roe served both his constituents and his colleagues in the House of Representatives as a valued and respected leader on health care issues. He currently serves as the top-ranking Republican on the Veteran’s Affairs Committee and as co-chair of both the House Doctor’s Caucus and the Congressional Academic Medicine Caucus. His primary focus as a member of Congress has always been on health care issues – many of which include AGA’s top policy priorities.
 

GI wins with Roe

Sustainable Growth Rate (SGR). Congressman Roe was an instrumental figure in the bipartisan victory to repeal the flawed Medicare physician payment formula, known as SGR, in 2015. Throughout the deliberation of SGR repeal legislation, he stayed in close contact with physician groups and actively whipped House members for support.

Independent Payment Advisory Board (IPAB). Congressman Roe was a key ally in the fight to repeal the IPAB, which was created under the Affordable Care Act and which AGA and all of organized medicine long opposed since its sole purpose was to make budgetary cuts to Medicare if it reached a certain threshold of spending. Largely because of Congressman Roe’s leadership on this issue, the IPAB was successfully repealed after years of advocacy on the issue.

Through AGA PAC, AGA staff was afforded the opportunity to cultivate a strong working relationship over the years with Congressman Roe and his staff. While his leadership and commitment to pro-patient, pro-physician policies will be missed following his retirement from Congress, AGA staff looks forward to working with Congressman Roe through the remainder of his term on issues that impact our patients and our practice.

Recently, the leadership of AGA, AASLD, ACG, and ASGE met with Richard Battaglia, MD, the chief medical officer of ABIM, about the status of ABIM’s efforts to move toward a longitudinal testing model, which ABIM describes as “a self-paced pathway for physicians to acquire and demonstrate ongoing knowledge.”

ABIM anticipates that the new option will be available beginning in 2022, in as many specialties as possible. In the meantime, all current MOC program policies remain in effect and ABIM directs diplomates to use the current options to maintain certification.   

While we would like to see ABIM waive testing requirements while it works with GI to create a new longitudinal model, ABIM has declined to do so. Notwithstanding this fact, the GI societies are committed to advocating for the needs of gastroenterology while working with ABIM to ensure the new model is relevant to gastroenterology and hepatology.
 

ginews@gastro.org 

Recently, the leadership of AGA, AASLD, ACG, and ASGE met with Richard Battaglia, MD, the chief medical officer of ABIM, about the status of ABIM’s efforts to move toward a longitudinal testing model, which ABIM describes as “a self-paced pathway for physicians to acquire and demonstrate ongoing knowledge.”

ABIM anticipates that the new option will be available beginning in 2022, in as many specialties as possible. In the meantime, all current MOC program policies remain in effect and ABIM directs diplomates to use the current options to maintain certification.   

While we would like to see ABIM waive testing requirements while it works with GI to create a new longitudinal model, ABIM has declined to do so. Notwithstanding this fact, the GI societies are committed to advocating for the needs of gastroenterology while working with ABIM to ensure the new model is relevant to gastroenterology and hepatology.
 

ginews@gastro.org 

Recently, the leadership of AGA, AASLD, ACG, and ASGE met with Richard Battaglia, MD, the chief medical officer of ABIM, about the status of ABIM’s efforts to move toward a longitudinal testing model, which ABIM describes as “a self-paced pathway for physicians to acquire and demonstrate ongoing knowledge.”

ABIM anticipates that the new option will be available beginning in 2022, in as many specialties as possible. In the meantime, all current MOC program policies remain in effect and ABIM directs diplomates to use the current options to maintain certification.   

While we would like to see ABIM waive testing requirements while it works with GI to create a new longitudinal model, ABIM has declined to do so. Notwithstanding this fact, the GI societies are committed to advocating for the needs of gastroenterology while working with ABIM to ensure the new model is relevant to gastroenterology and hepatology.
 

ginews@gastro.org 

Sometimes known as “fail first,” step therapy is a tool used by insurance companies that requires patients to fail medications before agreeing to cover a health care provider’s initial treatment recommendation.

Largely affecting patients with inflammatory bowel disease (IBD), step therapy focuses on the use of insurer-preferred treatments rather than effective, patient-centric therapies. In addition to causing many patient hardships and health problems, this protocol allows insurance companies to come between the provider-patient relationship and dictate a patient’s course of treatment.

To help clinicians navigate this challenging landscape, AGA is pleased to offer a new step therapy webpage, gastro.org/step-therapy, that details the step therapy protocol and opportunities to advocate for patient protections.

Additional education modules — including videos, podcasts and other resources — are also available for several states that have implemented safe step therapy laws, including Illinois, New York, and Texas.

Visit the Navigating State Step Therapy Laws program page to learn more:

• What is the step therapy protocol?
• How does step therapy impact a health care provider’s ability to provide patient care?
• Which states have implemented step therapy laws?
• How do state step therapy laws provide physician rights and patient protection?
• Tips to share with your patients.
• What are AGA’s advocacy efforts — and how can I help?

Education modules for additional states will be available in early 2020.

AGA’s Navigating State Step Therapy Laws program is funded by an unrestricted educational grant from Takeda and Pfizer.

ginews@gastro.org

Sometimes known as “fail first,” step therapy is a tool used by insurance companies that requires patients to fail medications before agreeing to cover a health care provider’s initial treatment recommendation.

Largely affecting patients with inflammatory bowel disease (IBD), step therapy focuses on the use of insurer-preferred treatments rather than effective, patient-centric therapies. In addition to causing many patient hardships and health problems, this protocol allows insurance companies to come between the provider-patient relationship and dictate a patient’s course of treatment.

To help clinicians navigate this challenging landscape, AGA is pleased to offer a new step therapy webpage, gastro.org/step-therapy, that details the step therapy protocol and opportunities to advocate for patient protections.

Additional education modules — including videos, podcasts and other resources — are also available for several states that have implemented safe step therapy laws, including Illinois, New York, and Texas.

Visit the Navigating State Step Therapy Laws program page to learn more:

• What is the step therapy protocol?
• How does step therapy impact a health care provider’s ability to provide patient care?
• Which states have implemented step therapy laws?
• How do state step therapy laws provide physician rights and patient protection?
• Tips to share with your patients.
• What are AGA’s advocacy efforts — and how can I help?

Education modules for additional states will be available in early 2020.

AGA’s Navigating State Step Therapy Laws program is funded by an unrestricted educational grant from Takeda and Pfizer.

ginews@gastro.org

Sometimes known as “fail first,” step therapy is a tool used by insurance companies that requires patients to fail medications before agreeing to cover a health care provider’s initial treatment recommendation.

Largely affecting patients with inflammatory bowel disease (IBD), step therapy focuses on the use of insurer-preferred treatments rather than effective, patient-centric therapies. In addition to causing many patient hardships and health problems, this protocol allows insurance companies to come between the provider-patient relationship and dictate a patient’s course of treatment.

To help clinicians navigate this challenging landscape, AGA is pleased to offer a new step therapy webpage, gastro.org/step-therapy, that details the step therapy protocol and opportunities to advocate for patient protections.

Additional education modules — including videos, podcasts and other resources — are also available for several states that have implemented safe step therapy laws, including Illinois, New York, and Texas.

Visit the Navigating State Step Therapy Laws program page to learn more:

• What is the step therapy protocol?
• How does step therapy impact a health care provider’s ability to provide patient care?
• Which states have implemented step therapy laws?
• How do state step therapy laws provide physician rights and patient protection?
• Tips to share with your patients.
• What are AGA’s advocacy efforts — and how can I help?

Education modules for additional states will be available in early 2020.

AGA’s Navigating State Step Therapy Laws program is funded by an unrestricted educational grant from Takeda and Pfizer.

ginews@gastro.org

AGA members and staff worked closely with representatives across the FDA on a number of key issues impacting gastroenterologists including duodenoscope reprocessing, fecal microbiota transplantation and new drug approvals for GI indications.

Center for Devices and Radiological Health (CDRH). The issue of duodenoscope reprocessing regained national attention when a safety communication issued by CDRH was covered by the New York Times.

The safety communication had noted that about one in 20 samples collected from reprocessed duodenoscopes tested positive for high-concern organisms such as E. coli and Pseudomonas aeruginosa.

AGA partnered with ACG, ASGE and SGNA to develop a letter to the editor and provided insights to AGA members in subsequent communications. CDRH issued another safety communication in August recommending a transition to disposable-component duodenoscopes and convened a public advisory committee meeting in November where AGA gave public testimony including several overarching principles for the evolution of clinical practice focusing on patient safety and outcomes. AGA has been at the forefront of this issue since risk of infection transmission during ERCP first came to light in 2015, and we will continue to work closely with FDA and industry to ensure solutions, like the recently approved disposable scopes and parts, meet the needs of our members.

Center for Biologics Evaluation and Research (CBER). Though it is not an approved therapy for Clostridioides difficile infection (CDI), FDA permits the use of fecal microbiota transplantation (FMT) for CDI unresponsive to standard antibiotic therapies under a temporary “enforcement policy” that has been in place since 2013. In response to concerns from the physician community that patient access to FMT may be discontinued once manufactured microbiota-based products come to market, AGA reengaged CBER in dialogue about the future of FMT through a meeting with CBER Director Peter Marks and eight senior CBER officials. In response to a June safety alert reporting a patient death from FMT using donor stool that was not screened for extended-spectrum beta-lactamase (ESBL)-producing E. coli, AGA requested clarification from CBER on new donor screening requirements announced for those who hold investigational new drug permits for FMT. Most recently, AGA was the only professional society to give public testimony at a November public hearing on the use of FMT to treat CDI. AGA will continue to engage CBER as the agency works to finalize its policy on FMT.

Center for Drug Evaluation and Research (CDER). AGA organized two joint scientific sessions at Digestive Disease Week® 2019 with representatives from CDER’s Division of Gastrointestinal and Inborn Errors Products: the inaugural FDA Town Hall and a session on controversies around measuring drug toxicity. The FDA Town Hall, which will continue at DDW 2020, featured four FDA speakers providing the data and rationale behind recent GI drug approvals. The session titled, “Controversies Around Measuring Drug Toxicity” gave FDA and gastroenterologists’ perspectives on 5-HT3 antagonists (e.g., alosetron) and 5-HT4 agonists (e.g., prucalopride), as well as proton pump inhibitors. These sessions aimed to promote an interchange of ideas among regulators, clinicians and pharmaceutical manufacturers to advance the development and use of new therapies for GI disorders.

ginews@gastro.org

AGA members and staff worked closely with representatives across the FDA on a number of key issues impacting gastroenterologists including duodenoscope reprocessing, fecal microbiota transplantation and new drug approvals for GI indications.

Center for Devices and Radiological Health (CDRH). The issue of duodenoscope reprocessing regained national attention when a safety communication issued by CDRH was covered by the New York Times.

The safety communication had noted that about one in 20 samples collected from reprocessed duodenoscopes tested positive for high-concern organisms such as E. coli and Pseudomonas aeruginosa.

AGA partnered with ACG, ASGE and SGNA to develop a letter to the editor and provided insights to AGA members in subsequent communications. CDRH issued another safety communication in August recommending a transition to disposable-component duodenoscopes and convened a public advisory committee meeting in November where AGA gave public testimony including several overarching principles for the evolution of clinical practice focusing on patient safety and outcomes. AGA has been at the forefront of this issue since risk of infection transmission during ERCP first came to light in 2015, and we will continue to work closely with FDA and industry to ensure solutions, like the recently approved disposable scopes and parts, meet the needs of our members.

Center for Biologics Evaluation and Research (CBER). Though it is not an approved therapy for Clostridioides difficile infection (CDI), FDA permits the use of fecal microbiota transplantation (FMT) for CDI unresponsive to standard antibiotic therapies under a temporary “enforcement policy” that has been in place since 2013. In response to concerns from the physician community that patient access to FMT may be discontinued once manufactured microbiota-based products come to market, AGA reengaged CBER in dialogue about the future of FMT through a meeting with CBER Director Peter Marks and eight senior CBER officials. In response to a June safety alert reporting a patient death from FMT using donor stool that was not screened for extended-spectrum beta-lactamase (ESBL)-producing E. coli, AGA requested clarification from CBER on new donor screening requirements announced for those who hold investigational new drug permits for FMT. Most recently, AGA was the only professional society to give public testimony at a November public hearing on the use of FMT to treat CDI. AGA will continue to engage CBER as the agency works to finalize its policy on FMT.

Center for Drug Evaluation and Research (CDER). AGA organized two joint scientific sessions at Digestive Disease Week® 2019 with representatives from CDER’s Division of Gastrointestinal and Inborn Errors Products: the inaugural FDA Town Hall and a session on controversies around measuring drug toxicity. The FDA Town Hall, which will continue at DDW 2020, featured four FDA speakers providing the data and rationale behind recent GI drug approvals. The session titled, “Controversies Around Measuring Drug Toxicity” gave FDA and gastroenterologists’ perspectives on 5-HT3 antagonists (e.g., alosetron) and 5-HT4 agonists (e.g., prucalopride), as well as proton pump inhibitors. These sessions aimed to promote an interchange of ideas among regulators, clinicians and pharmaceutical manufacturers to advance the development and use of new therapies for GI disorders.

ginews@gastro.org

AGA members and staff worked closely with representatives across the FDA on a number of key issues impacting gastroenterologists including duodenoscope reprocessing, fecal microbiota transplantation and new drug approvals for GI indications.

Center for Devices and Radiological Health (CDRH). The issue of duodenoscope reprocessing regained national attention when a safety communication issued by CDRH was covered by the New York Times.

The safety communication had noted that about one in 20 samples collected from reprocessed duodenoscopes tested positive for high-concern organisms such as E. coli and Pseudomonas aeruginosa.

AGA partnered with ACG, ASGE and SGNA to develop a letter to the editor and provided insights to AGA members in subsequent communications. CDRH issued another safety communication in August recommending a transition to disposable-component duodenoscopes and convened a public advisory committee meeting in November where AGA gave public testimony including several overarching principles for the evolution of clinical practice focusing on patient safety and outcomes. AGA has been at the forefront of this issue since risk of infection transmission during ERCP first came to light in 2015, and we will continue to work closely with FDA and industry to ensure solutions, like the recently approved disposable scopes and parts, meet the needs of our members.

Center for Biologics Evaluation and Research (CBER). Though it is not an approved therapy for Clostridioides difficile infection (CDI), FDA permits the use of fecal microbiota transplantation (FMT) for CDI unresponsive to standard antibiotic therapies under a temporary “enforcement policy” that has been in place since 2013. In response to concerns from the physician community that patient access to FMT may be discontinued once manufactured microbiota-based products come to market, AGA reengaged CBER in dialogue about the future of FMT through a meeting with CBER Director Peter Marks and eight senior CBER officials. In response to a June safety alert reporting a patient death from FMT using donor stool that was not screened for extended-spectrum beta-lactamase (ESBL)-producing E. coli, AGA requested clarification from CBER on new donor screening requirements announced for those who hold investigational new drug permits for FMT. Most recently, AGA was the only professional society to give public testimony at a November public hearing on the use of FMT to treat CDI. AGA will continue to engage CBER as the agency works to finalize its policy on FMT.

Center for Drug Evaluation and Research (CDER). AGA organized two joint scientific sessions at Digestive Disease Week® 2019 with representatives from CDER’s Division of Gastrointestinal and Inborn Errors Products: the inaugural FDA Town Hall and a session on controversies around measuring drug toxicity. The FDA Town Hall, which will continue at DDW 2020, featured four FDA speakers providing the data and rationale behind recent GI drug approvals. The session titled, “Controversies Around Measuring Drug Toxicity” gave FDA and gastroenterologists’ perspectives on 5-HT3 antagonists (e.g., alosetron) and 5-HT4 agonists (e.g., prucalopride), as well as proton pump inhibitors. These sessions aimed to promote an interchange of ideas among regulators, clinicians and pharmaceutical manufacturers to advance the development and use of new therapies for GI disorders.

ginews@gastro.org

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) 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. Possible congestive heart failure, tuberculosis (http://ow.ly/QdmG30pZqqo) – Join the GI community in discussing the echocardiogram results of a Holocaust survivor with a history of diabetes, hypothyroidism, benign prostate hyperplasia and hypercholesterolemia, and whose daughter was recently found to be QuantiFERON Gold positive.

2. Recurrent diarrhea in Behcet’s disease patient (http://ow.ly/YX6L30pZqws) – A 42-year-old patient diagnosed with Behcet’s disease at age 13 presented with recurrent diarrhea; a colonoscopy revealed terminal ileal and cecal ulcerations.

3. Gastroparesis patient unable to take anti-emetics (http://ow.ly/E5jD30pZqw4) – Help your colleague address a tricky patient with prolonged QT and gastroparesis.

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) 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. Possible congestive heart failure, tuberculosis (http://ow.ly/QdmG30pZqqo) – Join the GI community in discussing the echocardiogram results of a Holocaust survivor with a history of diabetes, hypothyroidism, benign prostate hyperplasia and hypercholesterolemia, and whose daughter was recently found to be QuantiFERON Gold positive.

2. Recurrent diarrhea in Behcet’s disease patient (http://ow.ly/YX6L30pZqws) – A 42-year-old patient diagnosed with Behcet’s disease at age 13 presented with recurrent diarrhea; a colonoscopy revealed terminal ileal and cecal ulcerations.

3. Gastroparesis patient unable to take anti-emetics (http://ow.ly/E5jD30pZqw4) – Help your colleague address a tricky patient with prolonged QT and gastroparesis.

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) 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. Possible congestive heart failure, tuberculosis (http://ow.ly/QdmG30pZqqo) – Join the GI community in discussing the echocardiogram results of a Holocaust survivor with a history of diabetes, hypothyroidism, benign prostate hyperplasia and hypercholesterolemia, and whose daughter was recently found to be QuantiFERON Gold positive.

2. Recurrent diarrhea in Behcet’s disease patient (http://ow.ly/YX6L30pZqws) – A 42-year-old patient diagnosed with Behcet’s disease at age 13 presented with recurrent diarrhea; a colonoscopy revealed terminal ileal and cecal ulcerations.

3. Gastroparesis patient unable to take anti-emetics (http://ow.ly/E5jD30pZqw4) – Help your colleague address a tricky patient with prolonged QT and gastroparesis.

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

Creating a legacy of giving is easier than you think. As the new year begins, take some time to start creating your legacy while supporting the AGA Research Foundation. Gifts to charitable organizations, such as the AGA Research Foundation, in your future plans ensure your support for our mission continues even after your lifetime.

Here are two ideas to help you get started.

Name the AGA Research Foundation as a beneficiary. This arrangement is one of the most tax-smart ways to support the AGA Research Foundation after your lifetime. When you leave retirement plan assets to us, we bypass any taxes and receive the full amount.

Include the AGA Research Foundation in your will or living trust. This gift can be made by including as little as one sentence in your will or living trust. Plus, your gift can be modified throughout your lifetime as circumstances change.

Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website at https://gastro.planmylegacy.org or contact Harmony Excellent at 301-272-1602 or hexcellent@gastro.org.
 

ginews@gastro.org

Creating a legacy of giving is easier than you think. As the new year begins, take some time to start creating your legacy while supporting the AGA Research Foundation. Gifts to charitable organizations, such as the AGA Research Foundation, in your future plans ensure your support for our mission continues even after your lifetime.

Here are two ideas to help you get started.

Name the AGA Research Foundation as a beneficiary. This arrangement is one of the most tax-smart ways to support the AGA Research Foundation after your lifetime. When you leave retirement plan assets to us, we bypass any taxes and receive the full amount.

Include the AGA Research Foundation in your will or living trust. This gift can be made by including as little as one sentence in your will or living trust. Plus, your gift can be modified throughout your lifetime as circumstances change.

Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website at https://gastro.planmylegacy.org or contact Harmony Excellent at 301-272-1602 or hexcellent@gastro.org.
 

ginews@gastro.org

Creating a legacy of giving is easier than you think. As the new year begins, take some time to start creating your legacy while supporting the AGA Research Foundation. Gifts to charitable organizations, such as the AGA Research Foundation, in your future plans ensure your support for our mission continues even after your lifetime.

Here are two ideas to help you get started.

Name the AGA Research Foundation as a beneficiary. This arrangement is one of the most tax-smart ways to support the AGA Research Foundation after your lifetime. When you leave retirement plan assets to us, we bypass any taxes and receive the full amount.

Include the AGA Research Foundation in your will or living trust. This gift can be made by including as little as one sentence in your will or living trust. Plus, your gift can be modified throughout your lifetime as circumstances change.

Want to learn more about including a gift to the AGA Research Foundation in your future plans? Visit our website at https://gastro.planmylegacy.org or contact Harmony Excellent at 301-272-1602 or hexcellent@gastro.org.
 

ginews@gastro.org

Bridgette Wilson, PhD, RD, postdoctoral research associate in nutritional sciences, and Kevin Whelan, PhD, RD, professor of dietetics, King’s College London, England, share talking points to help your patients understand what is currently known about the use of prebiotics for GI disorders.

Explaining prebiotics for GI disorders

Different prebiotic supplements have different effects on gut symptoms. For example, lower doses of noninulin type fructans (e.g., beta-galacto-oligosaccharides [GOS], pectin, partially hydrolyzed guar gum) are likely to be better tolerated in patients with functional gut symptoms, including irritable bowel syndrome (IBS).

Though prebiotic-containing foods are thought to benefit gut health in general, some prebiotics are FODMAPs that have been associated with symptoms in IBS patients. Individual patients on restrictive diets should systematically introduce prebiotic foods to identify the type and quantity they can tolerate.

ginews@gastro.org

Bridgette Wilson, PhD, RD, postdoctoral research associate in nutritional sciences, and Kevin Whelan, PhD, RD, professor of dietetics, King’s College London, England, share talking points to help your patients understand what is currently known about the use of prebiotics for GI disorders.

Explaining prebiotics for GI disorders

Different prebiotic supplements have different effects on gut symptoms. For example, lower doses of noninulin type fructans (e.g., beta-galacto-oligosaccharides [GOS], pectin, partially hydrolyzed guar gum) are likely to be better tolerated in patients with functional gut symptoms, including irritable bowel syndrome (IBS).

Though prebiotic-containing foods are thought to benefit gut health in general, some prebiotics are FODMAPs that have been associated with symptoms in IBS patients. Individual patients on restrictive diets should systematically introduce prebiotic foods to identify the type and quantity they can tolerate.

ginews@gastro.org

Bridgette Wilson, PhD, RD, postdoctoral research associate in nutritional sciences, and Kevin Whelan, PhD, RD, professor of dietetics, King’s College London, England, share talking points to help your patients understand what is currently known about the use of prebiotics for GI disorders.

Explaining prebiotics for GI disorders

Different prebiotic supplements have different effects on gut symptoms. For example, lower doses of noninulin type fructans (e.g., beta-galacto-oligosaccharides [GOS], pectin, partially hydrolyzed guar gum) are likely to be better tolerated in patients with functional gut symptoms, including irritable bowel syndrome (IBS).

Though prebiotic-containing foods are thought to benefit gut health in general, some prebiotics are FODMAPs that have been associated with symptoms in IBS patients. Individual patients on restrictive diets should systematically introduce prebiotic foods to identify the type and quantity they can tolerate.

ginews@gastro.org

AGA and 17 other specialty physician and patient advocacy organizations partnered with the Digestive Disease National Coalition (DDNC) on an advocacy day focused on the need for step therapy reform.

We met with congressional offices to seek support for patient protection guardrails in step therapy and to encourage co-sponsorship of the Safe Step Act. This bipartisan legislation would create a clear process for a patient or physician to request an exception to a step therapy protocol. It also would require insurers to grant exemptions to step therapy in the following situations:

• Patient already tried and failed on a required treatment
• Delayed treatment will cause irreversible damage
• Required treatment will cause harm to the patient
• Required treatment will prevent a patient from working or fulling daily activities
• Patient is stable on their current treatment

AGA representatives and patient advocates met with the congressional offices of these legislators who serve on key committees that have jurisdiction over this issue.

Sen. Chris Van Hollen, D-Md

Sen. Tim Scott, R-S.C.

Sen. Thom Tillis, R-N.C.

Sen. Lamar Alexander, R-N.C.

Rep. Alma Adams, D-N.C.

Rep. Mark Walker, R-N.C.

Rep. Tim Walberg, R-Mich


A special thanks to AGA members who contacted your legislators online. A combination of 344 tweets and emails were sent urging federal legislators to support the Safe Step Act.
 

Sharing is caring

Legislators and their staff are always asking us for real-life examples from constituents about step therapy burdens to humanize the issue. Contact AGA staff at agaadvocacy@gastro.org to share your story.

AGA and 17 other specialty physician and patient advocacy organizations partnered with the Digestive Disease National Coalition (DDNC) on an advocacy day focused on the need for step therapy reform.

We met with congressional offices to seek support for patient protection guardrails in step therapy and to encourage co-sponsorship of the Safe Step Act. This bipartisan legislation would create a clear process for a patient or physician to request an exception to a step therapy protocol. It also would require insurers to grant exemptions to step therapy in the following situations:

• Patient already tried and failed on a required treatment
• Delayed treatment will cause irreversible damage
• Required treatment will cause harm to the patient
• Required treatment will prevent a patient from working or fulling daily activities
• Patient is stable on their current treatment

AGA representatives and patient advocates met with the congressional offices of these legislators who serve on key committees that have jurisdiction over this issue.

Sen. Chris Van Hollen, D-Md

Sen. Tim Scott, R-S.C.

Sen. Thom Tillis, R-N.C.

Sen. Lamar Alexander, R-N.C.

Rep. Alma Adams, D-N.C.

Rep. Mark Walker, R-N.C.

Rep. Tim Walberg, R-Mich


A special thanks to AGA members who contacted your legislators online. A combination of 344 tweets and emails were sent urging federal legislators to support the Safe Step Act.
 

Sharing is caring

Legislators and their staff are always asking us for real-life examples from constituents about step therapy burdens to humanize the issue. Contact AGA staff at agaadvocacy@gastro.org to share your story.

AGA and 17 other specialty physician and patient advocacy organizations partnered with the Digestive Disease National Coalition (DDNC) on an advocacy day focused on the need for step therapy reform.

We met with congressional offices to seek support for patient protection guardrails in step therapy and to encourage co-sponsorship of the Safe Step Act. This bipartisan legislation would create a clear process for a patient or physician to request an exception to a step therapy protocol. It also would require insurers to grant exemptions to step therapy in the following situations:

• Patient already tried and failed on a required treatment
• Delayed treatment will cause irreversible damage
• Required treatment will cause harm to the patient
• Required treatment will prevent a patient from working or fulling daily activities
• Patient is stable on their current treatment

AGA representatives and patient advocates met with the congressional offices of these legislators who serve on key committees that have jurisdiction over this issue.

Sen. Chris Van Hollen, D-Md

Sen. Tim Scott, R-S.C.

Sen. Thom Tillis, R-N.C.

Sen. Lamar Alexander, R-N.C.

Rep. Alma Adams, D-N.C.

Rep. Mark Walker, R-N.C.

Rep. Tim Walberg, R-Mich


A special thanks to AGA members who contacted your legislators online. A combination of 344 tweets and emails were sent urging federal legislators to support the Safe Step Act.
 

Sharing is caring

Legislators and their staff are always asking us for real-life examples from constituents about step therapy burdens to humanize the issue. Contact AGA staff at agaadvocacy@gastro.org to share your story.

AGA, ACG, ASGE and SAGES were represented by three physicians who made oral remarks to the panel: Michael Kochman, MD, AGAF, Wilmott Professor of Medicine and Surgery at the University of Pennsylvania; Bret Petersen, MD, FASGE, professor of medicine and advanced endoscopist at the Mayo Clinic in Rochester, Minn. and Danielle Walsh, MD, associate professor of surgery at East Carolina University.

The GI societies over-arching goal is to ensure patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.

The panel discussed the adequacy/margin of safety for high-level disinfection, as well as the challenges and benefits of sterilization for routine for duodenoscope reprocessing. The panel’s consensus was that cleaning is the most important step in duodenoscope reprocessing. The panel noted that in properly cleaned duodenoscopes, high-level disinfection is appropriate; however, panel members acknowledged that reports indicate that duodenoscopes are not properly cleaned. The panel also discussed the challenges of implementing sterilization of duodenoscopes, such as potential decreased patient access to endoscopic retrograde cholangiopancreatography (ERCP) and increased costs.

On behalf of the GI societies, Dr. Kochman and Dr. Petersen proposed several overarching principles for the future evolution of our clinical practices focusing on patient safety and outcomes:

We encourage embracing multiple solutions, using a measured step-wise approach to the transition with both iterative and novel devices and processes.

We encourage data-based solutions addressing real-world efficacy while incorporating ongoing surveillance of processes and performance to ensure that early trouble signals are detected.

We believe that device or reprocessing transitions can be incorporated over the lifecycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology.

We accept minimizing extensive premarket studies, while expecting vigilant post-market surveillance, for technologies or device changes made exclusively with intent to convert to conceptually more safe designs without significant changes in mechanism or function.

We support the addition of durability testing for devices undergoing both standard reprocessing and, in particular, those undergoing sterilization.

Our societies are prepared to support and participate in continued discussion regarding:

Mandatory servicing and inspections.

Mandatory device retirement for reusable devices.

Assessment of the role and standards for third-party inspection and repair.

Our societies strongly support the importance and oversight of succinct, practical, reproducible, user-friendly guidance in manufacturers’ instructions for use (IFUs), which should incorporate post-market validation studies and updates.

We recommend that devices that incorporate programmable features (AERs, washers, sterilizers) should have lock-down mechanisms in place to prevent both user and manufacturer from deviating from the FDA-cleared IFU parameters for the device.

Our societies, as well as numerous guidelines, include high-level disinfection as a currently acceptable option for endoscope reprocessing, assuming use of enhanced washing and drying standards of practice.

Finally, we support the FDA in its efforts to convey to companies the necessary endpoints and goals for performance and expectations relative to post-market review and development of new data to ensure efficacy in the community.

Our societies appreciated this opportunity to comment on the complex and critical topic at hand. Our over-arching goal as physicians remains that of ensuring patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.
 

ginews@gastro.org

AGA, ACG, ASGE and SAGES were represented by three physicians who made oral remarks to the panel: Michael Kochman, MD, AGAF, Wilmott Professor of Medicine and Surgery at the University of Pennsylvania; Bret Petersen, MD, FASGE, professor of medicine and advanced endoscopist at the Mayo Clinic in Rochester, Minn. and Danielle Walsh, MD, associate professor of surgery at East Carolina University.

The GI societies over-arching goal is to ensure patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.

The panel discussed the adequacy/margin of safety for high-level disinfection, as well as the challenges and benefits of sterilization for routine for duodenoscope reprocessing. The panel’s consensus was that cleaning is the most important step in duodenoscope reprocessing. The panel noted that in properly cleaned duodenoscopes, high-level disinfection is appropriate; however, panel members acknowledged that reports indicate that duodenoscopes are not properly cleaned. The panel also discussed the challenges of implementing sterilization of duodenoscopes, such as potential decreased patient access to endoscopic retrograde cholangiopancreatography (ERCP) and increased costs.

On behalf of the GI societies, Dr. Kochman and Dr. Petersen proposed several overarching principles for the future evolution of our clinical practices focusing on patient safety and outcomes:

We encourage embracing multiple solutions, using a measured step-wise approach to the transition with both iterative and novel devices and processes.

We encourage data-based solutions addressing real-world efficacy while incorporating ongoing surveillance of processes and performance to ensure that early trouble signals are detected.

We believe that device or reprocessing transitions can be incorporated over the lifecycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology.

We accept minimizing extensive premarket studies, while expecting vigilant post-market surveillance, for technologies or device changes made exclusively with intent to convert to conceptually more safe designs without significant changes in mechanism or function.

We support the addition of durability testing for devices undergoing both standard reprocessing and, in particular, those undergoing sterilization.

Our societies are prepared to support and participate in continued discussion regarding:

Mandatory servicing and inspections.

Mandatory device retirement for reusable devices.

Assessment of the role and standards for third-party inspection and repair.

Our societies strongly support the importance and oversight of succinct, practical, reproducible, user-friendly guidance in manufacturers’ instructions for use (IFUs), which should incorporate post-market validation studies and updates.

We recommend that devices that incorporate programmable features (AERs, washers, sterilizers) should have lock-down mechanisms in place to prevent both user and manufacturer from deviating from the FDA-cleared IFU parameters for the device.

Our societies, as well as numerous guidelines, include high-level disinfection as a currently acceptable option for endoscope reprocessing, assuming use of enhanced washing and drying standards of practice.

Finally, we support the FDA in its efforts to convey to companies the necessary endpoints and goals for performance and expectations relative to post-market review and development of new data to ensure efficacy in the community.

Our societies appreciated this opportunity to comment on the complex and critical topic at hand. Our over-arching goal as physicians remains that of ensuring patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.
 

ginews@gastro.org

AGA, ACG, ASGE and SAGES were represented by three physicians who made oral remarks to the panel: Michael Kochman, MD, AGAF, Wilmott Professor of Medicine and Surgery at the University of Pennsylvania; Bret Petersen, MD, FASGE, professor of medicine and advanced endoscopist at the Mayo Clinic in Rochester, Minn. and Danielle Walsh, MD, associate professor of surgery at East Carolina University.

The GI societies over-arching goal is to ensure patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.

The panel discussed the adequacy/margin of safety for high-level disinfection, as well as the challenges and benefits of sterilization for routine for duodenoscope reprocessing. The panel’s consensus was that cleaning is the most important step in duodenoscope reprocessing. The panel noted that in properly cleaned duodenoscopes, high-level disinfection is appropriate; however, panel members acknowledged that reports indicate that duodenoscopes are not properly cleaned. The panel also discussed the challenges of implementing sterilization of duodenoscopes, such as potential decreased patient access to endoscopic retrograde cholangiopancreatography (ERCP) and increased costs.

On behalf of the GI societies, Dr. Kochman and Dr. Petersen proposed several overarching principles for the future evolution of our clinical practices focusing on patient safety and outcomes:

We encourage embracing multiple solutions, using a measured step-wise approach to the transition with both iterative and novel devices and processes.

We encourage data-based solutions addressing real-world efficacy while incorporating ongoing surveillance of processes and performance to ensure that early trouble signals are detected.

We believe that device or reprocessing transitions can be incorporated over the lifecycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology.

We accept minimizing extensive premarket studies, while expecting vigilant post-market surveillance, for technologies or device changes made exclusively with intent to convert to conceptually more safe designs without significant changes in mechanism or function.

We support the addition of durability testing for devices undergoing both standard reprocessing and, in particular, those undergoing sterilization.

Our societies are prepared to support and participate in continued discussion regarding:

Mandatory servicing and inspections.

Mandatory device retirement for reusable devices.

Assessment of the role and standards for third-party inspection and repair.

Our societies strongly support the importance and oversight of succinct, practical, reproducible, user-friendly guidance in manufacturers’ instructions for use (IFUs), which should incorporate post-market validation studies and updates.

We recommend that devices that incorporate programmable features (AERs, washers, sterilizers) should have lock-down mechanisms in place to prevent both user and manufacturer from deviating from the FDA-cleared IFU parameters for the device.

Our societies, as well as numerous guidelines, include high-level disinfection as a currently acceptable option for endoscope reprocessing, assuming use of enhanced washing and drying standards of practice.

Finally, we support the FDA in its efforts to convey to companies the necessary endpoints and goals for performance and expectations relative to post-market review and development of new data to ensure efficacy in the community.

Our societies appreciated this opportunity to comment on the complex and critical topic at hand. Our over-arching goal as physicians remains that of ensuring patient safety and ready access to clinically indicated procedures employing duodenoscopes and other elevator-channel endoscopes.
 

ginews@gastro.org