ACG MAGAZINE | Vol. 5, No. 1 | Spring 2021

ACG MAGAZINE Spring 2021

MEMBERS. MEDICINE. MEANING.

Leading the Way in

Advancing Health Equity

ACG AWARD NOMINATIONS

Honor Your Colleague with an ACG Award Nomination

T ACG A C           ﹕ B/F C A A

D﹐ E  I A

This award recognizes an ACG Member who has provided distinguished contributions to clinical gastroenterology, including: (a) clinical medicine, (b) technology application, (c) health care delivery, (d) related factors such as humanism and ethical concern. It is not intended that this award be given in honor of one’s laboratory research accomplishments.

This award recognizes an ACG Member whose work in the areas of clinical practice, research, teaching and/or leadership has demonstrated an emerging or sustained commitment to the values of diversity, health equity and inclusion.

C S A This award is bestowed upon an ACG Member who has initiated or has been involved in numerous volunteer programs/activities, or has provided significant volunteer service post-training. The service must have been performed on a completely voluntary basis and not for the completion of training or position requirements.

D M  T A This award recognizes an ACG Member who has provided meaningful and sustained contributions to trainees/colleagues in gastroenterology. Such contributions could include mentorship or teaching to help develop the mentees’ career, clinical practice, research or academic practice.

I L A This award is given to an ACG Member in recognition of outstanding and substantial contributions to gastroenterology, to the College, and to the international gastroenterology community.

M   A C  G Masters of the College of Gastroenterology shall have been Fellows who, because of their recognized stature and achievement in clinical gastroenterology and because of their contribution to the College in service, leadership, and education, have been recommended for designation as Masters.

S S﹒ W A This award is given to an ACG Fellow or Master in recognition of outstanding service to the American College of Gastroenterology over the course of an individual’s career.

   ﹕ A ﹐

S  ﹕ ﹒/--- Nominations for all awards must: • • • •

Be accompanied by two le ers of recommendation Include the nominee’s CV Conform to the specific requirements listed Be unsolicited by the nominee

Nominations must be submi ed online: gi.org/acg-award-nomination-form Nomination requirements: gi.org/award-nomination-guidelines

SPRING 2021 // VOLUME 5, NUMBER 1

FEATURED CONTENTS COVER STORY

Leading the Way in Advancing Health Equity Highlighting important discussions from the ACG 2020 Health Equity Town Hall, Dr. Sophie Balzora, Dr. Darrell Gray, and Dr. Renee Williams share key insights on the role of ACG members in combatting health inequities and what we can do to continue progress

PAGE 22

Sage Advice Emeritus CTG Editor-in-Chief Dr. David Whitcomb reflects on his formative experiences and offers words of wisdom on embracing both your strengths and weaknesses PAGE 19

What Gastroenterology Clinicians Can Do to Help End the COVID-19 Pandemic Dr. Freddy Caldera & Dr. Francis Farraye discuss the critical role of GI physicians in getting vaccinated, advocating vaccine safety, and dispelling misinformation PAGE 39

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CALL for ABSTRACTS ACG 2021

SUBMIT your ABSTRACTS NOW for ACG 2021 in Las Vegas!

Don’t miss this opportunity to showcase your research alongside colleagues from the U.S. and abroad at the premier GI clinical event of the year.

OCTOBER 22–27, 2021 MANDALAY BAY • LAS VEGAS, NV

SUBMISSION DEADLINE MONDAY, JUNE 21, 2021 11:59 P.M., EASTERN TIME

The American College of Gastroenterology invites you to submit abstracts for presentation at the 2021 Annual Scientific Meeting and Postgraduate Course. Abstracts must be clinical or research-oriented, with a focus on gastroenterology or hepatology.

Visit acgmeetings.gi.org for complete rules and to submit your abstract online.

SPRING 2021 // VOLUME 5, NUMBER 1

CONTENTS

"As a GI hospitalist, it helps to be adaptable to the unpredictability of the day and to be capable of executing quick judgment with a calm temperament when life-threatening situations arise."

—Melissa Latorre, MD, MS, “In Retrospect: Perspectives from a GI Hospitalist,” PG 37

6 // MESSAGE FROM THE PRESIDENT

22 // COVER STORY

43 // INSIDE THE JOURNALS

Dr. David Greenwald on meeting fear with facts to address COVID-19 vaccine hesitancy

LEADING THE WAY IN ADVANCING HEALTH EQUITY Dr. Sophie Balzora, Dr. Darrell Gray, and Dr. Renee Williams share key insights on combatting health inequities head-on

44 AJG ACG releases its first Clinical Guideline on Irritable Bowel Syndrome by Lacy, et al., with an accompanying AJG podcast

7 // NOVEL & NOTEWORTHY Mourning the loss of Dr. Donald Castell; GIQuIC Board welcomes new leadership; ACG Women in GI Twitter chats launch & more

13 // PUBLIC POLICY WELCOMING NEW LEGISLATIVE & POLICY COUNCIL CHAIR DR. JAMES HOBLEY Dr. James Hobley shares his goals for the Council and approach to new opportunities and challenges

33 // ACG PERSPECTIVES 33 CONVERSATIONS WITH WOMEN IN GI Dr. Jill Gaidos talks with Dr. Jessica Allegretti on being your own best advocate 37 IN RETROSPECT: PERSPECTIVES FROM A GI HOSPITALIST Dr. Melissa Latorre discusses traits that contribute to success as a hospitalist

15 // GETTING IT RIGHT

39 // EDUCATION

15 BUILDING SUCCESS The nuts and bolts of negotiating an insurance contract

WHAT GI CLINICIANS CAN DO TO HELP END THE COVID-19 PANDEMIC Dr. Freddy Caldera & Dr. Francis Farraye emphasize the critical role of GI physicians in advocating vaccine safety and dispelling misinformation

19 SAGE ADVICE Emeritus CTG Editor-in-Chief Dr. David Whitcomb shares words of wisdom on embracing both your strengths and weaknesses

45 ACGCRJ Persistent Encephalopathy in a Noncirrhotic Patient: Do Not Shun This Shunt by Kassamali, et al.

45 CTG Community Health Behaviors and Geographic Variation in Early-Onset CRC Survival Among Women by Holowatyj, et al.

47 // A LOOK BACK 50 YEARS AGO IN AJG In a 1971 issue of The American Journal of Gastroenterology, Dr. Hans Popper published "The Problem of Hepatitis," introducing novel concepts to establish hepatitis as a diagnostic entity in which injury elicited an inflammatory reaction

Photo courtesy of Dr. Melissa Latorre

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ACG MAGAZINE MAGAZINE STAFF

CONNECT WITH ACG

Executive Director Bradley C. Stillman, JD

youtube.com/ACGastroenterology

Editor in Chief; Vice President, Communications Anne-Louise B. Oliphant Manager, Communications & Member Publications Becky Abel

facebook.com/AmCollegeGastro

twitter.com/amcollegegastro

instagram.com/amcollegegastro Copy Editors; Staff Writers Brad Conway, Esq.

bit.ly/ACG-Linked-In Art Director Emily Garel Graphic Designer Antonella Iseas

CONTACT

BOARD OF TRUSTEES

IDEAS & FEEDBACK We'd love to hear from you.

Send us your ideas, stories and comments.

President: David A. Greenwald, MD, FACG President-Elect: Samir A. Shah, MD, FACG Vice President: Daniel J. Pambianco, MD, FACG Secretary: Amy S. Oxentenko, MD, FACG Treasurer: Jonathan A. Leighton, MD, FACG Immediate Past President: Mark B. Pochapin, MD, FACG

ACGMag@ @gi.org

CONTACT ACG American College of Gastroenterology 6400 Goldsboro Rd., Suite 200 Bethesda, MD 20817 (301) 263-9000 | gi.org

Past President: Sunanda V. Kane, MD, MSPH, FACG Director, ACG Institute: Neena S. Abraham, MD, MSc, FACG Co-Editors, The American Journal of Gastroenterology: Brian E. Lacy, MD, PhD, FACG

DIGITAL EDITIONS

GI.ORG/ACGMAGAZINE

Brennan M. R. Spiegel, MD, MSHS, FACG Chair, Board of Governors: Patrick E. Young, MD, FACG

ACG MAGAZINE Summer 2020

MEMBERS. MEDICINE. MEANING.

Vice Chair, Board of Governors: Dayna S. Early, MD, FACG Trustee for Administrative Affairs: Irving M. Pike, MD, FACG ACG MAGAZINE Summer 2020

MEMBERS. MEDICINE. MEANING.

TRUSTEES

Feeling fine with fear:

Mastering Risk Perception and Decision Making in Medical Practice

Feeling fine with fear:

Mastering Risk Perception and Decision Making in Medical Practice

Jean-Paul Achkar, MD, FACG William D. Chey, MD, FACG Immanuel K. H. Ho, MD, FACG Costas H. Kefalas, MD, MMM, FACG Caroll D. Koscheski, MD, FACG Paul Y. Kwo, MD, FACG John R. Saltzman, MD, FACG Nicholas J. Shaheen, MD, MPH, MACG Neil H. Stollman, MD, FACG Renee L. Williams, MD, MHPE, FACG

4 | GI.ORG/ACGMAGAZINE

American College of Gastroenterology is an international organization with more than 16,000 clinician members representing some 86 countries. The College's vision is to be the pre-eminent professional organization that champions the evolving needs of clinicians in the delivery of high-quality, evidence-based and compassionate health care to gastroenterology patients. The mission of the College is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation and advocacy in the areas of scientific investigation, education, prevention and treatment.

CONTRIBUTING WRITERS

Jessica R. Allegretti, MD, MPH, FACG Dr. Allegretti is Associate Director of the Crohn's and Colitis Center and Director of the Fecal Transplant Program for Recurrent C. difficile at Brigham and Women’s Hospital.

Sophie M. Balzora, MD, FACG Dr. Balzora is vice chair of the ACG Committee on Diversity, Equity, and Inclusion, and Clinical Associate Professor, Department of Medicine at NYU Grossman School of Medicine.

Freddy Caldera, DO, MS Dr. Caldera is Associate Professor in the Division of Gastroenterology & Hepatology at the University of Wisconsin School of Medicine and Public Health.

Francis A. Farraye, MD, MSc, MACG Past Chair of the ACG Board of Governors, Dr. Farraye is Professor of Medicine at Mayo Clinic Jacksonville, where he directs the Inflammatory Bowel Disease Center.

Jill K.J. Gaidos, MD, FACG Dr. Gaidos is Associate Professor at Yale School of Medicine Section of Digestive Diseases and Director of Clinical Research for the Yale IBD Program.

Darrell M. Gray, II, MD, MPH, FACG Chair of ACG’s Committee on Diversity, Equity & Inclusion, Dr. Gray is Associate Professor of Medicine, Director of Community Engagement and Equity in Digestive Health, and Deputy Director at the Center for Cancer Health Equity at The Ohio State University Comprehensive Cancer Center, The James.

David A. Greenwald, MD, FACG Dr. Greenwald is the 2020-2021 ACG President and is Director of Clinical Gastroenterology and Endoscopy at Mount Sinai Hospital and Professor of Medicine at Icahn School of Medicine at Mount Sinai in New York City.

James C. Hobley, MD, MSc, FACG Dr. Hobley, ACG's new Public Policy & Legislative Council Chair, is in private practice in Shreveport, LA and holds an Adjunct Clinical Professorship at the LSU Health Science Center.

Melissa Latorre, MD, MS Dr. Latorre is Director of Inpatient Gastroenterology Services at NYU Langone Health Tisch Hospital and Kimmel Pavilion.

Ralph D. McKibbin, MD, FACG Dr. McKibbin is President and Director of Strategic Planning and Business Development at Blair Gastroenterology Associates in Duncansville, PA.

Shajan Peter, MD, FACG Dr. Peter is Clinical Assistant Professor at the University of Alabama at Birmingham.

Suriya V. Sastri, MD, FACG Dr. Sastri is Medical Director of Midwest Digestive Center in Willowbrook, IL.

Lawrence R. Schiller, MD, MACG ACG Past President Dr. Schiller is the Program Director of the Gastroenterology Fellowship at Baylor University Medical Center and chairs ACG’s Archives Committee.

Prof. David C. Whitcomb, MD, PhD, FACG Professor Whitcomb is Emeritus editor-in-chief of Clinical & Translational Gastroenterology and Professor of Medicine & Gastroenterology at the University of Pittsburgh.

Renee L. Williams, MD, MHPE, FACG ACG Trustee Dr. Williams is Associate Professor and Program Director of the Division of Gastroenterology at NYU Grossman School of Medicine.

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MESSAGE FROM THE PRESIDEN

FIGHTING FEAR WITH FACTS MEET FEAR WITH FACTS… Those words echo in my head frequently as we collectively consider the available COVID-19 vaccines and vaccine hesitancy.

I woke on December 21, 2020, to a world where two COVID-19 vaccines had been granted emergency use authorization in the United States. Health care workers, those who had been at the frontlines for what seemed like an endless series of excruciating months, were now being offered vaccinations. The start to a way out of the pandemic, I thought—the start to protecting those who had worked to so hard to heal everyone else. Within a few hours, I became aware that later that in day would come “my turn” and there was no question in my mind that I would take “my shot”—to paraphrase Hamilton in the most unlikely of ways. Science and scientists, our colleagues, had miraculously moved from discovery of a new vicious pathogen to vaccines that could prevent its disease in under a year. And so, I lined up for my turn and received my first dose (best sore arm ever!) I was struck by the emotion of the moment. We had all been through so much in 2020; I smiled as I received the shot but admit there were tears too as some of the anguish of the year gone-by flooded out.

But…the story of others with whom I work was very different. As I returned to the GI Endoscopy Suite later that day, to the GI practice offices later that week, and as I spoke to my colleagues and to my patients, many expressed concerns about vaccine safety, side effects and so many other issues.

Many said they would “wait and see” or “didn’t want to be first” or “had issues.” These concerns were important to hear, as in many cases they come from a deep-seated mistrust in medical trials and inequities in care that have been pervasive and longstanding. Really listening matters.

Recognizing the degree of vaccine hesitancy and its underpinnings are critical, but then what to do?

Meet Fear with Facts… So many myths to dispel.

The ACG has launched a campaign, “#1FACT1 MYTH”—what could be more timely? Look it over and share the information (bit.ly/ACGCOVIDVACCINE). Learn as much as possible about the vaccine trials; find ways to communicate those results in an easily understandable way.

6 | GI.ORG/ACGMAGAZINE

“The value of personal stories is paramount.

Sharing our individual stories and perhaps posting photos of our vaccination on social media of “how it went” is invaluable— people are watching...”

One step at a time, one person at a time.

Ask each person you see at the end of each encounter, “would you take a COVID-19 vaccine if it were offered to you?” I continue to do that each day­—and follow it up with facts if the answer is “no” or “I’m going to wait.” I urge each of you to do this at every contact you have with colleagues, staff, family, and patients. Indeed, the GI societies came together with a joint statement issued in late December 2020 recognizing that control of the pandemic would likely require at least 70 to 80% of the population to be immune, either through natural infection or vaccination, and implored each of our members to serve as a source of accurate information for our patients and our communities.

The value of personal stories is paramount. Sharing our individual stories and perhaps posting photos of our vaccination on social media of “how it went” is invaluable—people are watching—and then being armed with correct information so facts about expected side effects in the general population are explained accurately is equally invaluable. The process becomes demystified.

I work with a very courageous and brave environmental services worker who stepped forward to be a role model for others who were initially hesitant. She spoke in front of thousands of people to explain why she made her choice to get the vaccine. It was very impactful to those watching. Just the other day, one of our endoscopy technicians approached me after two months of hesitancy and quietly said, “I’m ready.” I walked her down to the vaccination pod immediately. She is now talking to others about her experience. We still have a long way to go. Vaccine hesitancy is real.

The available vaccines are over 94% effective and remarkably safe. As I write this, over 40 million people in the U.S. and over 105 million in the world have received at least one dose. One person at a time, one story at a time.

It is our collective responsibility to continue the remarkable progress of science and overcome the barriers to achieving mass vaccination throughout this country and throughout the world. Many challenges remain, but we can do it.

MEET FEAR WITH FACTS…

­­—David A. Greenwald, MD, FACG

Note hy wor t A NOTABLE LOSS FOR THE COLLEGE AND THE GI COMMUNITY is the death of Dr. Donald Castell from COVID-19 in January and we include a brief In Memoriam tribute in this issue.

Professional news of note includes a grateful farewell to Dr. Glenn Eisen from his leadership role for the GIQuIC registry. He was succeeded as President and Chair of the Board by Dr. Costas Kefalas in 2021. Dr. Jay Yepuri also joined the GIQuIC Board.

Learn more about this joint ACG and ASGE quality registry at giquic.org.

Career milestones and new roles are among the items included in ACG MAGAZINE Novel & Noteworthy. We welcome your professional news via email at ACGMag@gi.org

Novel & Noteworthy | 7

// N&N [IN MEMORIAM]

[TRUE BLUE]

DONALD O. CASTELL, MD, MACG 1935-2021

DR. MARIANNE RITCHIE'S BLUE LIGHTS

THE COLLEGE MOURNS THE LOSS OF DR. DONALD CASTELL TO COVID-19 IN JANUARY 2021. Dr. Castell’s long and distinguished career in gastroenterology included service as the founding Director of the ACG Institute for Clinical Research & Education from 1994 to 1995, and a member of its Board from 1995 to 1996. He became a Master of the College in 2001.

Dr. Castell’s career interests as an investigator included esophageal physiology and pathophysiology, as well as swallowing disorders. He authored or co-authored more than 500 publications on esophageal diseases and function and served as the editor and principal contributor of The Esophagus, a primary text on this subject.

Dr. Castell delivered the ACG Presidential Lecture in 1995, “Reflections of an Esophagologist,” at the invitation of Dr. Joel E. Richter, ACG President 1994-1995 and a trainee and colleague of Dr. Castell. In 2010, he was invited to present the J. Edward Berk Memorial Lecture, “Academic Mentoring,” during the ACG presidency of Dr. Philip O. Katz, another of Dr. Castell’s trainees.

Dr. Castell joined the U.S. Naval Reserves his freshman year of medical school, beginning a 20 year career in the Navy. Dr. Castell earned his medical degree from George Washington University in 1960.

After completing internship and residency at the National Naval

8 | GI.ORG/ACGMAGAZINE

Medical Center and fellowship at Tufts University, Dr. Castell moved to Jefferson Medical College in Philadelphia. In 1975, he returned to his alma mater George Washington University as Professor of Medicine and contributed to the creation of the Uniformed Services University of the Health Sciences. While Chairman of Medicine at the National Naval Medical Center (NNMC), he was Professor and Vice Chairman of Medicine at USU and Professor of Medicine at GW. He retired from the Navy in 1979 with the rank of captain.

Thereafter, he served as Chief of Gastroenterology at Bowman Gray. Then, in 1989, Dr. Castell returned to Philadelphia as Professor of Medicine and Director of the GI Division at Jefferson. In 1992, he became Kimbel Professor and Chair of Medicine at Graduate Hospital. In 2001, he moved to the Medical University of South Carolina as Professor of Medicine and Director of the Esophageal Disorders Program.

He was President of the American Gastroenterological Association from 1998 to 1999 and was a member of the American Motility Society.

For the past eight years, the Blue Lights CampaignTM has led the crusade in Philadelphia and beyond during March for Colorectal Cancer Awareness. Over 30 landmark buildings shine in blue, including skyscrapers, arenas, iconic Boat House Row, the Ben Franklin Bridge and even the Pennsylvania State Capitol. In 2017,

the initiative won an ACG SCOPY Award for spreading this lifesaving message.

Dr. Marianne Ritchie, Associate Professor and gastroenterologist at Thomas Jefferson University is the Campaign Director. She is partnering with the ACG to grow the effort.

[MILESTONE]

DR. DANIEL DEMARCO APPOINTED The AMA RUC (RVS Update Committee) approved long time ACG member and past Governor for North Texas Daniel C. DeMarco, MD, FACG to fill one of the rotating internal medicine seats representing gastroenterology and

internal medicine.

ASGE spearheaded his application to the RUC, with endorsement from ACG and AGA. The RUC is a volunteer group of 31 physicians who advise Medicare on how to value a physician's work.

[RETIREMENT]

MICHAEL E. COX, MD, FACG After 39 years of service to the Mercy Medical Center in Baltimore, Maryland, Dr. Michael Cox is retiring. He served as ACG Governor for Maryland from 2002 to 2006 and was a member of the ACG Public Relations Committee from 2006 to 2014, serving with enthusiasm and commitment as Chair from 2012 to 2014. As

advocate at the state level in 2001, he fought for passage of Maryland legislation to ensure access to screening colonoscopy.

Dr. Cox helped establish what is now the Melissa L. Posner Institute for Digestive Health and Liver Disease at Mercy.

[GIQUIC]

RECOGNIZING DR. EISEN & WELCOMING DR. KEFALAS

[WOMEN IN GI]

NEW ACG WOMEN IN GI TWITTER CHAT SERIES In January 2021, the ACG Women in GI Committee held the first ACG Women in GI Twitter Chat focused on The Job Search. The chat was the first in a monthly series in which the Committee invites Twitter users to participate in a moderated discussion on key issues of relevance to women in GI. To participate in the monthly chats, follow ACG on Twitter (@AmCollegeGastro) and tune in during the first Wednesday of

each month at 8 pm Eastern to follow the discussion questions with moderators and guest experts. Join the conversation and be sure to use the hashtag #ACGwomen to follow along for #WednesdayNiteACG. If you don't currently have a Twitter account but would like to create one, the College has a helpful guide to Getting Started on Twitter from ACG 2020, which you can view at bit.ly/ACG2020-SM101.

After 11 years of service, Glenn M. Eisen, MD, MPH, will step down from his leadership role for the GI Quality Improvement Consortium (GIQuIC) Board of Directors.

He has served as President and Chair for the past four years. Dr. Eisen made countless contributions to the GIQuIC registry from his integral role in the initial development of the registry concept and design to his part in developing a research arm of the registry resulting in multiple gastrointestinal endoscopy publications.

GIQuIC, ACG and ASGE welcome Costas H. Kefalas, MD, MMM, FACG, of Akron Digestive Disease Consultants, as the next President and Chair of the Board of Directors. Dr. Kefalas most recently served as Vice-President of the GIQuIC Board.

In 2021, Jay Yepuri, MD, MS, FACG, becomes the newest member of the GIQuIC. Dr. Yepuri is a partner with Digestive Health Associates of Texas (DHAT) and practices general gastroenterology and advanced therapeutic endoscopy in Dallas, Texas. The other members of the GIQuIC Board of Directors are: Colleen M. Schmitt, MD, MHS, FACG, FASGE, Director and Vice President; Brett Bernstein, MD, MHS, FASGE, Director and Secretary; and Michael S. Morelli, MD, CPE, FACG, Director and Treasurer.

GIQuIC photos (L to R) Dr. Eisen and Dr. Kefalas

Novel & Noteworthy | 9

MARCH

MARCH 2021

NORTH AMERICAN INTERNATIONAL GI TRAINING GRANTS

COLORECTAL CANCER AWARENESS MONTH

31

More Info: gi.org/gi-training-grants

APRIL

9–10

APRIL 2021 ACG AWARD NOMINATIONS Nominate Your Colleague

FUNCTIONAL GI DISORDERS SCHOOL & EASTERN REGIONAL  VIRTUAL Register: meetings.gi.org

AUGUST

13–15

Learn More: gi.org/award-nominations

MAY

28 ENTER TO WIN A SCOPY Submit your Entry: gi.org/scopy

FUNCTIONAL GI DISORDERS SCHOOL & MIDWEST REGIONAL Register: meetings.gi.org

SEPTEMBER

10–12

HEPATOLOGY SCHOOL & ACG / VGS / ODSGNA REGIONAL Register: meetings.gi.org

10 | GI.ORG/ACGMAGAZINE

SAVE THE DATE FOR ACG 2021

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use.

INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINSTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be Packaging and consumed. After breakfast, only clear liquids may be consumed until after the tablets not shown colonoscopy. Early in the evening prior to colonoscopy, open one bottle of actual size.

12 tablets. Fill the provided container with 16 ounces of water (up to the fill line).

Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Dose 2 - Day of colonoscopy: Continue to consume only clear liquids until after the colonoscopy. The morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1), open the second bottle of 12 tablets. Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias; Seizures: Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia; Use in Patients with Risk of Renal Injury: Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at risk for renal injury.

Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients; Colonic Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD); Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of SUTAB. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities. STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Rx only. Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com.

References: 1. SUTAB® [package insert]. Braintree, MA; 2020. 2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. Published online November 6, 2020. doi: 10.14309/ajg.0000000000001020 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 4. IQVIA. National Prescription Audit Report. November 2020.

For additional information, please call 1-800-874-6756 ©2021 Braintree Laboratories, Inc.

All rights reserved.

201-133-v1-A January 2021

!

W! E NEW N

A NEW TABLET CHOICE A BOWEL NEW TABLET CHOICE IN PREPARATION IN BOWEL PREPARATION

• NO SODIUM PHOSPHATE1

• SAFE AND EFFECTIVE1,2 1 • NO SODIUM PHOSPHATE • ACG-RECOMMENDED1,2 SPLIT-DOSE REGIMEN3 • SAFE AND EFFECTIVE 1 – Two SUTAB doses are required for a complete preparation

Dose 1 consists of 12 tablets and 16 oz of water REGIMEN3 • ACG-RECOMMENDED SPLIT-DOSE Dose 2 consists of 12 tablets and 16 oz of water 1 – Two are required for a complete preparation EachSUTAB dose isdoses followed by two additional 16 oz of water Dose 1 consists of 12 tablets and 16 oz of water Dose 2 consists of 12 tablets and 16 oz of water Packaging and tablets not shown size.

Each dose is followed by actual two additional 16 oz of water

92% OF PATIENTS IN TWO PIVOTAL TRIALS ACHIEVED SUCCESSFUL BOWEL CLEANSING WITH SUTAB1,2* 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY TO CONSUME2† 1,2 ® 1,2‡ 92% OF PATIENTS IN TWO PIVOTAL TRIALSreported ACHIEVED SUCCESSFUL CLEANSING SUTAB * • 52% of all SUTAB and MoviPrep patients at least one selectedBOWEL gastrointestinal adverseWITH reaction • More SUTAB patients reported experiencing nausea and vomiting than competitor, with ≤1%TO of these reports2† 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY CONSUME 2‡ Packaging and tablets not shown actual size.

considered severeand MoviPrep® patients reported at least one selected gastrointestinal adverse reaction1,2‡ • 52% of all SUTAB

2† 78% OF PATIENTS ONE reported PIVOTALexperiencing TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE • More SUTAB IN patients nausea and vomiting than competitor, with ≤1% ofCOLONOSCOPY these reports

considered severe * Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned on withdrawal of colonoscope.

OF PATIENTS IN ONE PIVOTAL TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE COLONOSCOPY2† † Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This * questionnaire has not undergone formal validation.

Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; ‡ scores were assigned on withdrawal of colonoscope.

Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion †of study drug, rating the intensity as mild, moderate, or severe.

Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This questionnaire has not undergone formal validation.

ACG=American College of Gastroenterology ‡ ® Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion is a registered trademark of Velinor AG. MoviPrep of study drug, rating the intensity as mild, moderate, or severe.

ACG=American College of Gastroenterology MoviPrep® is a registered trademark of Velinor AG. IMPORTANT SAFETY INFORMATION 2‡

78%

SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After IMPORTANT SAFETY INFORMATION breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required ® SUTAB (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG SUTAB.com.

INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUTAB.com.

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

PUBLIC POLICY

ACG Welcomes B:11.25"B:11.25"

S:9.75" S:9.75"

T:10.75"T:10.75"

James C. Hobley, MD, FACG New ACG Legislative and

Public Policy Council Chair

By Brad Conway, Esq., Vice President Public Policy, Coverage & Reimbursement

ABOUT DR. HOBLEY Dr. Hobley is a native of California. He received his undergraduate degree from Tulane University and his medical degree and training at The Pennsylvania State University. He is currently in private practice in Shreveport, LA. He also holds an Adjunct Clinical Professorship at the LSU Health Science Center in Shreveport.

While Dr. Hobley is the new Chair of the Council, he is no stranger to ACG and ACG’s public policy initiatives. Dr. Hobley recently served two terms as ACG’s Governor for Louisiana and ACG Regional Councilor. He remains very active in advocacy efforts at the state and local levels. Dr. Hobley was a recipient of an ACG Board of Governors’ Service Award in 2020. 

Public Policy | 13

// PUBLIC POLICY

“The same challenges that COVID-19 has brought to our practices also exist in advocacy efforts—specifically, the lack of in-person meetings and face-to-face time.”

ABOUT THE ACG LEGISLATIVE AND PUBLIC POLICY COUNCIL The ACG Legislative and Public Policy Council is tasked with engaging in policy development and helping to tie policy changes to everyday practice management and patient care. The Council does this by working closely with the ACG Board of Governors, chairs of the Practice Management and FDA-Related Matters Committees, as well as other ACG leaders.

A CONVERSATION WITH DR. JAMES HOBLEY What are some of your goals as chair of the Council?

My first goal is to fulfill the mission and role of the Council, which is to help align the various policy objectives and goals among the College’s leadership and volunteers. We do this by listening to the ACG Board of Governors and reviewing the ACG Governor Regional Councilor reports (which are a collection of insights and feedback from ACG members in that state or area).

The Council also receives feedback from the various ACG physician advisors and ACG representatives to various medical associations and patient advocacy groups. It is a consistent loop of soliciting feedback from ACG members and committees, setting the agenda, developing guidance on implementing policy changes into practice, communicating this guidance

to ACG members, and then soliciting more feedback from ACG members.

For example, the Council helps set the agenda for annual legislative advocacy by the Board of Governors, typically during a fly-in to Washington, DC. This agenda is essentially the byproduct of feedback from various ACG leaders and volunteers. The LPPC wants to ensure ACG is meeting the needs of its membership and advocating for our patients.

My personal goal as the new chair of the Council is to advocate for reducing the disparity of care in GI, especially for colorectal cancer screening. I hope to engage and join forces with high-profile advocates on these issues, who share ACG’s passion for patient advocacy. The Council can also help promote and educate policymakers on the initiatives of the ACG Committee on Diversity, Equity, and Inclusion, for example.

Together we can bring this collective passion (and science) to leaders in Washington, DC, and to state houses across the country. The College provides a unique perspective to these discussions.

I hope to highlight the work of other ACG initiatives and committees.

We are not an ACG committee in the traditional sense, but deliberately designed to help advise ACG committees and the ACG Board of Governors. I welcome the opportunity to work with the various ACG committee chairs.

What opportunities and challenges does a new administration and new Congress offer to ignite our agenda?

Like any new administration and Congress, policymakers start with a fresh agenda of important goals and a lot of passion. Thus, it is important for ACG to get involved early, outline our public policy objectives, and help tie our objectives into their plans and goals. This involves communication and education. Highlighting the work of ACG committees and volunteers can be a really effective way to educate the new policymakers. While there is a new administration and a new Congress, many policymakers and staff are not “new” to ACG. The transition affords ACG a wonderful opportunity to educate new policymakers, but also to foster established relationships with others.

Like many of my ACG colleagues, the same challenges that COVID-19 has to brought to our practices also exist in advocacy efforts—specifically, the lack of in-person meetings and face-to-face time.

We now treat more patients via telehealth visits. Likewise, ACG currently relies more on virtual and online advocacy. This is still effective, but does provide a challenge when meeting policymakers and staff for the first time. Personal connection is very important. I look forward to walking down the halls of the Capitol and meeting with policymakers in the near future.

Another challenge is maintaining our enthusiasm for policy efforts. As we recently experienced with the passage of the Removing Barriers to Colorectal Cancer Screening Act, advocacy requires a lot of coordinated effort, time, patience, and persistence. This can sometimes be frustrating to ACG members and patient advocates. But this is all part of the legislative and policymaking process.

Ongoing advocacy and cultivating relationships with legislators and their staff creates more opportunities to work together and forge like-minded coalitions on many other ACG priorities. I enjoy the process. I enjoy representing my ACG colleagues before Congress and at the state and local level. I enjoy meeting fellow ACG members during this process and appreciate the College’s trust in me to lead the ACG Legislative and Public Policy Council in 2021.

Photo this page (L to R): James C. Hobley, MD, FACG, with Senator Bill Cassidy (R-LA). Page 13 photo (L to R): James C. Hobley, MD, FACG; Joseph G. Cheatham, MD, FACG; and Patrick E. Young, MD, FACG, in Washington, DC, at the ACG Governors' Fly-in, April 2019.

14 | GI.ORG/ACGMAGAZINE

GETTING IT

GETTING it Right

PAYER CONTRACTS ARE AN IMPORTANT SOURCE OF PRACTICE REVENUE AND SHOULD BE PERIODICALLY EVALUATED. Changes in

The Nuts & Bolts of negotiating an

insurance contract

By Ralph D. McKibbin, MD, FACG, Suriya Sastri, MD, FACG, and Shajan Peter, MD, FACG

the cost of living, state or federal statutes, and government regulations can render our contracts outdated. Contracts with automatic renewals can leave us unaware that our reimbursement rates are not keeping up with the market. Whatever the size of your practice, this summary should come in handy for solo, small, and large GI practices. The goal is to help prepare you for the annual review of your contracts, in order to maximize and maintain correct and timely payments.

While large health plans have the built-in advantage of legal, financial, and analytic resources, many smaller, solo, and even larger physician groups may find themselves disadvantaged in their ability to accurately portray their volume of care, quality markers, resource utilization, and patient satisfaction scores. Sound knowledge about contract provisions covering claims, payment terms, medical necessity, appeal processes, notification for policy changes, credentialing requirements, termination, etc., are essential to influence your negotiation with the health plans. Familiarity with contract terms and structure can enable physicians to negotiate from a position of strength in order to achieve higher reimbursements and better payment terms.

Getting it Right | 15

// GETTING IT RIGHT: BUILDING SUCCESS

Suggested steps for negotiating an insurance contract: 1. Review existing data 2. Analyze to determine goals and leverage 3. Negotiation with the health plan/ insurance carrier

REVIEW EXISTING DATA Preparation for the negotiation is key. It is critical to be well-informed about members served, quality measure performance of your practice, the negotiation process, definitions and requirements for contracts in your state and locality, and the status of the health plan itself. It is a good idea to have your attorney review contracts and provide an update on state, federal, and other regulations’ impacts on your practice. Each team member should be educated on the status of their service area, which will improve accuracy of their review. Outlining the process and using checklists to mark progress will streamline your efforts and boost success. Information gathering in core areas is the first step. These lists define this core information. Additional information may be needed depending on your reimbursement methods, terms, and other contractual arrangements.

Practice service and quality data: • CMS episode of care data with comparison2 (Figures 1 & 2) • Payer episode of care data (needs to be requested) with regional averages • GIQuIC or other quality data (ADR, cecal intubation rate, MIPS, patient satisfaction, QRUR, etc.)

Contract basics: • The current contract should be reviewed well in advance of the termination date.

• Review key terms and definitions for healthcare contracts.

• Identify state, local, and federal regulatory changes for health insurance contracts.

• Locate any state medical society updates on carriers in your region.

• Review your current policy and procedure manual to ensure compliance with contracts.

Carrier data: • Fee schedules for all carriers • The National Committee for Quality Assurance (NCQA) financial performance & health plan report card (ncqa.org/report-cards/health-plans) • Market percentage by population/age/ employer/hospitals • Sample key employers • The Healthcare Effectiveness Data and Information Set (HEDIS) data (www.ncqa.org/programs/hedis) • The Centers for Medicare and Medicaid Services (CMS)/Medicare fee schedule • Medical necessity definitions and procedures • Ask colleagues for their experiences on your carriers. Identify issues.

• Ask your staff to evaluate each carrier (use a rating form) on key areas.

Financial data (a continuous review process is recommended): • Current charge master • Complete current fee schedule for all carriers • Accounts receivable by carrier and product

• Patient severity of illness data

• Denial percentages

• NPI value data (www.qpp.cms.gov) for your practice and competitors

• Billing audit results

• Hospital length of stay for key diagnoses with comparison

• Cost of living allowances, national /community/healthcare/CMS/ carrier employees

• Medicare spending per beneficiary (MSPB)

• Complete list of CPT codes (ACG/CMS) to determine intensive services

• Market percentage by population/ age/employer/hospitals

• Regional cost information (e.g. www.fairhealthconsumer.org)

16 | GI.ORG/ACGMAGAZINE

ANALYZE TO DETERMINE GOALS AND LEVERAGES A focused review of data and discussion should be done with the intent of answering two key questions: A) What do we want to negotiate? B) What is our leverage? It is important to clearly define and prioritize your goals, but you will also need to assess the interests of the carrier and your place in the community. Choose several concrete goals and decide which is most important.

What are my goals?

Reviewing your existing contracts will identify those contracts/provisions you deem unacceptable. This will define the contract provisions and clauses that need to be negotiated. They can usually be divided into financial terms or legal terms and form the basis for your principled negotiation goals. External legal assistance is often needed if there is any confusion over legal terms. This review can also provide a model for new carrier contracts. Table 1 gives some key areas for contract review.

TABLE 1 Number of days a provider has to submit a claim Number of days the payer has to pay the claim for services Claim denial dispute procedures List and scope of services covered by the payer Fee schedule for all covered services Notice periods for renegotiation and termination Term of the contract and renewal options

What is my leverage/value?

Leverage is used to induce the payer to agree to your objectives. Areas of value can be used as leverage. To determine leverage, it is vital that a medical practice or group understand their strengths, weaknesses, and place in the community, as well as the interests and goals of the payer.

A SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis

is often done to organize thinking around these key issues. High quality, recognized brand, large market share, and high satisfaction are practice strengths, but the ability to be creative and participate in shared savings plans are also things of value that can constitute leverage with the payer.

Leverage is critical to the success of your negotiation. A shared view and agreement on a negotiation’s goal and priorities is critical to plan a leverage strategy. Practices can grow leverage and value by taking advantage of opportunities. These can be classified as: 1. Leverage in Numbers: A significant amount of a plan’s provider panel constitutes a desirable goal and a plan will try to preserve this.

2. Geographic Advantage: Geographic holes are undesirable and make enrolling covered lives difficult for health plans.

3. No competition: This is a leverage against managed care and reduced payments.

4. Quality: Utilization and outcomes data define this. Savings could be shared but must be asked for.

5. Patient Volume: This is similar to Leverage in Numbers but can also be tied to the popularity of your practice.

6. Termination: Forcing a plan to reengage after terminating a contract. This can be effective but can be damaging to trust and relationship building.

NEGOTIATION WITH THE HEALTH PLAN/INSURANCE CARRIER After gathering and analyzing the information and setting goals, the negotiation can begin. A written plan is important so that you can remain focused on your goals. It is recommended to review negotiation tactics as a team, so that those negotiating understand their individual roles. Typical smaller office team members would be the office manager, medical director, and the executive officer, but larger organizations should communicate with stakeholders in the organization, such as financial

leaders, patient accounting experts, and other physicians. A contract attorney or negotiation consultant can be helpful.

The payer will need to be contacted. Your carrier likely has a liaison that can facilitate setting up a meeting. A payer relations specialist or contract specialist will be part of their team. A face-to-face meeting is typical and likely several meetings may be needed. Many guides to negotiations are available but most contain similar core principles. The ACG Practice Management Toolbox, Negotiation 101: How to Get What You Want in A Negotiation10, summarizes the negotiation process and provides worksheets to guide you.

Basic negotiation principles include: 1. Listen to the other party: Get as much information as possible about their issues.

2. Monitor your emotions: Validate the other party’s emotions and avoid negative emotions.

3. Build trust: This may be difficult.

Use reflective interview techniques.

4. Understand the other party: Identify their tradeoffs.

5. Be a problem solver and look for new solutions.

6. Give and take: Anchor the negotiation with an offer but remember your priorities.

7. Allow the other party to save face: You may have to say “no.”

8. Look at creative ways to present an offer: Two small losses may be better than one large loss.

Here are lists of recognized desirable outcomes and things to avoid.

Top 10 Plums to go after4 1. Access to complete fee schedule information at all times.

2. Interest payments for clean claims not paid within 30 days.

3. Multiyear contracts with predefined fee schedule escalators.

4. Ability to opt out of specific benefit plans.

5. Ability to negotiate individual fee schedules that apply only to your practice.

6. Financial incentive programs that reward sound medical management.

7. Reduced or minimized referral and prior authorization requirements.

8. Advance written notification of changes to policies and procedures.

9. Online access to eligibility, benefit, and claim information.

10. Utilization of standardized credentialing/recredentialling applications.

Top 10 Deal Breakers4 1. The health plan’s ability to amend the contract without your signature.

2. Restricted access to all applicable fee schedule information.

3. Ambiguous definition of the entities that can access the contract and discounts.

4. Inability to independently establish panel limits and practice parameters.

5. Any reference to a “most favorednation” clause.

6. Unacceptable risk levels or risk for services you cannot manage.

7. Cumbersome or nonstandard coding/billing requirements.

8. Application of the fee schedule for noncovered services.

9. Labor intensive referral or prior authorization requirements.

10. Timely filing requirements shorter than 90 days.

FINAL EXECUTION When coming to an agreement on contract terms, the contract will need to be carefully reviewed for accuracy.

All terms should be defined and may be cataloged in an appendix. Further, members of the team should review for items important to their job functions.

After each successful negotiation of a payer contract, the practice can benefit from a “debriefing session” reviewing the process to define improvements for future contract negotiations. Once both parties execute the contract, the practice organization should designate responsible personnel or departments to be familiar with the terms of the contract. The practice should monitor performance and compliance of the terms, and work on deadlines

Getting it Right | 17

// GETTING IT RIGHT: BUILDING SUCCESS

for internal review and reporting to management. It may be prudent to initiate the next cycle of review well before the current contract expires.

It is important to build a long-term relationship with the insurance carriers.

You can expect to repeat this process with them through ongoing cycles of negotiation. This will help to build confidence and ultimately achieve long-term success for your practice.

RESOURCES

6. https://gi.org/2017/03/15/law-mind-its-not-all-about-thatrate-how-to-approachnegotiations-with-payers

1. https://www.ama-assn.org/system/files/2019-05/2019-

ACG blog article by Ann M. Bittinger, JD, defining the

cost-faqs.pdf. Medicare MIPS cost category FAQ including

negotiation process.

MSPB 2. https://data.medicare.gov/data/physician-compare

7. https://www.ama-assn.org/practice-management/ payment-delivery-models/bargaining-table-success-

Physician Compare datasets. The Centers for Medicare

starts-these-common-elements. Andis Robeznieks’

& Medicaid Services (CMS) provides official datasets for

synopsis on bargaining success.

the Medicare.gov Physician Compare website to give you useful information about groups and clinicians listed on

8. Fisher, Roger, Bruce Patton, and William Ury. Getting to

Physician Compare.

Yes: Negotiating Agreement Without Giving in. Rev. ed.

3. Kefalas C. “Negotiating Payer Contracts in the Age of

New York: Penguin Books, 2011. A classic on coming on

Cost and Quality.” Presented at: American College of Gastroenterology Annual Scientific Meeting; Oct. 5-10, 2018; Philadelphia.

compromised settlements.

9. Voss, Chris., and Tahl Raz. Never Split the Difference: Negotiating As If Your Life Depended On It. First

4. Negotiating a Contract with a Health Plan. Christine Jones, BS and Terry Mills, Jr. MD, FAAP. Family Practice

edition. New York, NY: Harper Business, an imprint

Management. November-December 2006, pg. 49-55.

of HarperCollins Publishers, 2016. The FBI hostage negotiator approach. Empowering to physicians using

5. https://www.ama-assn.org/sites/ama-assn.org/files/corp/

It is important to build a long-term relationship with the insurance carriers. You can expect to It is important to build a long-term relationship with the insurance carriers. You can expect to repeat this process with them through ongoing cycles of negotiation. This will help to build repeat this process with them through ongoing cycles of negotiation. This will help to build confidence and ultimately achieve long-term success for your practice. confidence and ultimately achieve long-term success for your practice. mediabrowser/member/about-ama/pay-performancecontracts.pdf. This guide contains an appendix with a

many of the techniques commonly used in interviews.

10. https://gi.org/practice-management/toolbox. Sameer

checklist of contract provisions to help you understand

Islam, MD, MBA, FACG and Vonda Reeves, MD, MBA,

key contractual terms and conditions commonly used

FACG, Negotiation 101: How to Get What You Want In A

in pay-for-performance agreements and increase your

Negotiation

ability to strategically negotiate with commercial payers.

Figure 1 Example of CMS episode care cost data.

FIGURE 1: of EXAMPLE OF CMS EPISODE OF CARE COST DATA. Figure 1 Example of CMS episode of care cost data.

FIGURE 2: EXAMPLE PROVIDER DATA WITH Figure 2: Example CMS provider dataCMS with comparison toCOMPARISON others. TO OTHERS. Figure 2: Example CMS provider data with comparison to others.

Ralph D. McKibbin, MD, FACG, Blair Gastroenterology Associates, Altoona, PA

18 | GI.ORG/ACGMAGAZINE

Suriya Sastri, MD, FACG, Midwest Digestive Center, Willowbrook, IL

Shajan Peter, MD, FACG, University of Alabama, Birmingham, AL

// GETTING IT RIGHT: SAGE ADVICE

of caffeine I could understand and retain written material, my grades went from C- to A+, and the rest is history. Through this I learned that everybody has strengths and weaknesses, and we are not all from the same cookie cutter. Embrace your strengths and work with others who are strong in the areas where you are weak so that together the whole is greater than the sum of the parts. Finally, I learned compassion for those who struggle. I determined to be like the few teachers who believed in me and gave me the encouragement that I needed when it appeared that all the cards were stacked against me.

2 Perspectives and Advice

to Trainees and the Next Generation

of Physicians and Scientists

By Prof. David C. Whitcomb, MD, PhD, FACG

I WAS SHOCKED BY A REQUEST TO PROVIDE “SAGE ADVICE” BY THE LEADERSHIP OF THE AMERICAN COLLEGE OF GASTROENTEROLOGY. I see myself as one of many peers, trying to do my job to the best of my abilities.

But, in retrospect, I have enjoyed a wonderful career (so far) and am honored to provide some perspectives and advice to trainees and the next generation of physicians and scientists.

Several years ago, I was honored to receive the “Palade Medal” from the International Association of Pancreatology (IAP) at their annual meeting in Shanghai, China. This is the highest honor of the IAP, awarded to one physician or scientist, conferred once every other year. I realized that, for my acceptance speech, nobody wanted to hear a rehash of my research papers! Instead, many members of the association wanted guidance and encouragement. So, I told five short stories about my struggles and successes.

Afterwards, dozens of attendees

approached me, many with tears running down their face, thanking me for these words. The talk has now been published.

(1) Here, I want to summarize three of the short stories that make important points about life, and then 10 personal attributes that my colleagues believe contributed to our successes.

1

MY LIFE IN A NUTSHELL. First, I suffer from dyslexia, a language processing disorder that affects reading, spelling and listening to boring lectures. I struggled in elementary and high school with my junior high school guidance counselor determining that I was “not college material” and that I should seek a manual labor job in landscaping. Thankfully, there were a few teachers that pulled me aside, told me that I was actually very talented, and helped me navigate my way to college. I worked so hard to get my education, but things didn’t click. Then, near the end of my sophomore year I discovered coffee. With adequate doses

TWO OLD LADIES. During my GI fellowship at Duke University, I met two old ladies in the outpatient clinic with painful calcific chronic pancreatitis.

There was no explanation. My attending physician insisted that they were alcoholics, a hypothesis that I rejected since they were conservative Baptist who don’t drink and don’t lie. I can still see their faces when I told them that I had no explanation—but I knew that it was not alcohol! Then, to my surprise, I told them that research into pancreatitis was considered a “hopeless cause.” But every hopeless cause needs a champion, and at that moment, I determined to study pancreatitis for my career. I determined to be that champion.(1) This was among the best decisions that I ever made. The lesson is that dedication to a noble cause is an important thing. Physicians and scientists are uniquely positioned to champion noble causes, but it takes life-long dedication, innovation, and hard work. The benefits of your efforts go to others—but there is that personal satisfaction that your efforts made the difference.

3

I PUT A MAN ON THE MOON! As a child, I remember traveling with my father to various small Bible churches in rural Indiana. He was a brilliant and internationally acclaimed theologian, but a humble man who was always happy to support regional ministries (I wrote his biography, now in press(2)). One Sunday, after church, I found myself in a small home where my dad was invited for lunch.

I was sitting across from an older man in the living room while everyone else was in the kitchen. I tried to strike up a conversation by asking what he did for a living. He told me, “I put a man on the moon!” He explained that he grew up in the Great Depression, and although his

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// GETTING IT RIGHT: SAGE ADVICE

“Embrace your strengths and work with others who are strong in the areas where you are weak so that together the whole is greater than the sum of the parts.” ambition was to be a doctor or a lawyer, his family needed him to earn some money, and he got a job as a welder, joining pieces of metal together. He decided to be the best welder he could be, and it became his career. “But,” he explained, “when the U.S. government was building the Saturn V rockets to take a man to the moon, some key parts were made by our company and they asked ME to do the welding.” Then, as he gazed upward and pointed to the sky, he said emphatically, “When that rocket was speeding to the moon with our astronauts on board, and those parts were called upon to do their function, my welding did not fail! And because of me, a man walked on the moon.”(1) I realized that he was right! Although few people knew his name, he knew that he had done his job well, that his small contribution was important. He contributed to one of the greatest achievements in recorded history.

The same is true for most of us, who work hard but go unrecognized. Our work is important, and if we work hard and do our jobs well, we can say that because of our efforts, many lives have been impacted for good—and this is more important than the fact that a flag sits on the moon.

Attributes for Success. I have been told that I have accomplished an amazing number of things in my career. Perhaps one of the keys is being dyslexic, where people “think differently.” While we typically are terrible at reading, spelling and languages, we are great at understanding how complex systems work.

Prof. Adam Slivka, MD, PhD, Associate Chief of the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh described my ability to think differently by saying, “It is amazing to watch you solve unsolvable problems: sideways.” But it has been through teamwork with other talented people that revolutionary insights into pancreatic diseases have been achieved, such as the >100 people who worked with me within the North American Pancreatitis Study group (NAPS2).(3-5) Teamwork. As Chief of the Division of Gastroenterology, Hepatology and Nutrition at the University of Pittsburgh for 17 20 | GI.ORG/ACGMAGAZINE

years, I tried to create an environment that allowed each faculty to be a “world expert” in a specific area, being part of a disease-specific clinic on the one hand, and representing the group from a unique scientific discipline on the other.(6) This gave me the chance to work with talented pancreatologists with different scientific and investigational skill sets, while being united in finding solutions to pancreatic diseases. The team began with Dr. Slivka and me working on understanding and classifying his patients through my translational studies. We then recruited and helped develop the careers of Randall Brand, MD, FACG (biomarkers, familial GI cancers), Dhiraj Yadav, MD, MPH (pancreatic epidemiology), Georgios Papachristou, MD, PhD, FACG (clinical acute pancreatitis) and others by intentionally working together.

We have published hundreds of papers together, with each faculty recognized for their translational focus—in contrast to me insisting on being senior author on “everything.” Thus, we are all colleagues with enormous respect for each other and the talent that each brings to the team.

For this “Sage Advice” column, I asked three of my colleagues, Professors Brand, Papachristou and Yadav, what they learned from my example that may have contributed to our successes. Besides noting the power of collaborations, they each listed six attributes that they believed to be important.

I integrated these into 10 principles:

7. Celebrate all faculty, clinicians and staff, as important team members—not everyone has the same intelligence, accomplishment, and skills as the leaders, but this is their career (see, “I put a man on the moon.”)

8. Love learning—show that you love to learn from your colleagues and trainees as well as from experts in your own field and in other fields.

9. Stamina and dedication—lead by example. Young people need to see the hard work and persistence of successful leaders.

10. Never give up—regardless of difficulties, keep moving forward and success will follow.

In conclusion, I believe that God put us on the earth for a purpose. In retrospect, my odd combination of strengths and weaknesses were of little value without the complementary contributions and efforts of some great friends and colleagues. More importantly, the future is now very much in the hands of the next generation of physicians and scientists that I helped mentor. And for a field of medicine that was once considered “hopeless,” the future is now bright.

REFERENCES: 1. Whitcomb DC. Innovation and hard work: The 2015 George E. Palade Medal Award Lecture. Pancreatology. 2015;15(6):611-5.

PMID:26481054 2. Whitcomb DC. John C Whitcomb: A Good and Faithful Servant.

Green Forest, AR New Leaf Publishing Group; 2021. (in press).

3. Whitcomb DC, Yadav D, Adam S, Hawes RH, Brand RE, Anderson MA, et al. Multicenter approach to recurrent acute and chronic pancreatitis in the United States: the North American Pancreatitis Study 2 (NAPS2). Pancreatology. 2008;8(4-5):520-31.

PMID:18765957 4. Conwell DL, Banks PA, Sandhu BS, Sherman S, Al-Kaade S, Gardner TB, et al. Validation of Demographics, Etiology, and Risk Factors for Chronic Pancreatitis in the USA: A Report of

TEN ATTRIBUTES MODELED BY PROFESSOR WHITCOMB 1. Don’t believe dogma—approach diseases scientifically from scratch.

2. Push the envelope—advances require new knowledge, new approaches and rejection of failed concepts.

3. Show your enthusiasm for your research—it is contagious.

4. Make long-range plans to accomplish important goals­—this provides a vision for the future.

5. Promote and showcase your trainees’ work—this helps young investigators to be successful. (Trainees need to find a good mentor!)

6. Be generous with opportunities—this expands capabilities and benefits everyone.

the North American Pancreas Study (NAPS) Group. Dig Dis Sci. 2017;62(8):2133-40. PMID:28600657 5. Whitcomb DC, Larusch J, Krasinskas AM, Klei L, Smith JP, Brand RE, et al. Common genetic variants in the CLDN2 and PRSS1PRSS2 loci alter risk for alcohol-related and sporadic pancreatitis.

Nature genetics. 2012;44(12):1349-54. PMID:23143602 6. Whitcomb DC. Going MAD: Development of a "Matrix Academic Division" to Facilitate Translating Research to Personalized Medicine. Academic medicine : journal of the Association of American Medical Colleges. 2011;86.(11):1353-9. PMID:21952059

Prof. David C. Whitcomb, MD, PhD, FACG Giant Eagle Foundation Professor of Cancer Genetics, Professor of Medicine, Cell Biology & Molecular Physiology, and Human Genetics, Division of Gastroenterology, Hepatology and Nutrition; Director, UPMC Precision Medicine Service, University of Pittsburgh and UPMC; Editor-in-Chief Emeritus, Clinical and Translational Gastroenterology

SUBMIT YOUR APPLICATION for the ACG

2021 International GI Training Grant Awards

The International Relations Commi ee of the American College of Gastroenterology is now accepting applications for the 2021 International GI Training Grants. Each training grant will award one fellowship, with a maximum of $10,000, during 2021. Grants are to be used for travel to and from the training center and to the ACG Annual Meeting, as well as for incidental expenses related to the training. The training must take place between July 1, 2021, and June 30, 2022.

INTERNATIONAL

GI TRAINING GRANT

This grant provides partial financial support to physicians outside the United States and Canada to receive clinical or clinical research training or education in Gastroenterology and Hepatology in selected medical training centers in North America.

WHO IS ELIGIBLE? Physicians who are not citizens or residents of the United States or Canada, and who are working in gastroenterology or related areas, are eligible to apply together with their training institution.

SUBMISSION DEADLINE March 31, 2021 APPLY HERE gi.org/gi-training-grants

NORTH AMERICAN INTERNATIONAL

GI TRAINING GRANT

This grant provides partial financial support to United States and Canadian GI Fellows in training, or GI Physicians who have completed their training within the last five years, to receive clinical or clinical research training or education in Gastroenterology and Hepatology outside of North America.

WHO IS ELIGIBLE? GI Fellows in training who are enrolled in an accredited gastroenterology fellowship program, or GI Physicians who completed their training within the last five years, and are citizens of the United States or Canada, are eligible to apply together with their training institution.

SUBMISSION DEADLINE March 31, 2021 APPLY HERE gi.org/gi-training-grants

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// COVER STORY

Leading the Way in Advancing Health Equity

By Sophie M. Balzora, MD, FACG, Darrell M. Gray, II, MD, MPH, FACG, and Renee L. Williams, MD, MHPE, FACG

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Health equity is when everyone has a fair and just opportunity to attain their highest level of health possible. The term speaks to a process and an outcome. In contrast to equality, which refers to allocation of the same resources across populations, equity necessitates that some populations be given more resources to achieve an equal outcome.

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A

As we reflect on 2020, specifically the COVID-19 pandemic and global outcry to end racism, the inequities that plague our nation were and remain undeniable.

The health disparities experienced by some of our patients and peers, from the disproportionate burden of COVID-19 cases and deaths within to the high prevalence of chronic diseases, are symptoms of underlying systemic and structural forces such as racism and discrimination that have disadvantaged communities of color. Health disparities are not unique to racial and ethnic minorities, however. We observe them among other minority groups including but not limited to those living with a disability and LGBTQ+ populations.

The American College of Gastroenterology is well-positioned to significantly reduce disparities in GI and liver diseases and mitigate the upstream determinants that lead to them. Our membership, over 16,000 strong, is diverse in practice setting, specialty, level of training, years of practice, populations served, race, ethnicity, and gender. We have committees including, but not limited to, the Committee on Diversity, Equity and Inclusion that are dedicated to identifying and leveraging opportunities to address inequities in health and health care and that partner with other committees and stakeholders to engage, educate, and empower health care providers and patients to do so as well.

We have been leading the way. Under the leadership of Dr. Mark Pochapin and Dr. David Greenwald, we’ve worked towards plugging the leaky pipeline to health careers through our “Prescriptions for Success” Program, invested in research opportunities for underrepresented minorities in medicine through our Summer Scholars Program, enriched accessible educational programming for patients and health care providers, led an international, multi-society #DiversityInGI campaign, and hosted a Racism in Medicine series that catalyzed positive changes in practice and academic GI practices and training programming across the country.

Yet, there’s more we can and need to do in the journey to health equity. Recently, an Equity Think Tank was formed as a small group of thought leaders to compliment and work synergistically with the Committee on Diversity, Equity, and Inclusion. As a result, new programming and resources are

being developed that are aligned with the ACG pillars of patient care, education, scientific investigation, advocacy and practice management. For our efforts to be successful, however, it will take the engagement of all of us.

We hosted a town hall during the ACG 2020 Annual Scientific Meeting to heighten awareness and engagement. Physicians and physician scientists from across the nation shared their perspectives and expertise on opportunities to advance diversity, equity and inclusion within and outside of the clinic, hospital and research lab walls.

Herein, we revisit highlights from the program.

—Darrell M. Gray II, MD, MPH, FACG

TRANSCRIPT ACG TOWN HALL, “LEADING THE WAY ON ADVANCING HEALTHY EQUITY” OCTOBER 27, 2020, ACG VIRTUAL ANNUAL SCIENTIFIC MEETING Dr. Darrell Gray: Welcome Good evening, everyone. Welcome to this special ACG Town Hall. I'm Darrell Gray, an Associate Professor at The Ohio State University Wexner Medical Center, and Chair of the Committee on Diversity, Equity, and Inclusion. I'm joined by Dr. Sophie Balzora, Associate Professor of Medicine at NYU Langone Health. We will be answering questions live, so please engage with us, interact with us, and ask questions.

I'd like to for us to open with a moment of silence. 2020 has been a heavy year.

We've lost colleagues, friends, family, patients, community members, and neighbors to COVID-19, chronic medical conditions, violence, and police brutality.

And for that, let's take a moment of silence.

Thank you.

Dr. Darrell Gray: Introduction The American College of Gastroenterology has really been invested in advancing health equity. And we have to challenge our notion of equality, and focus on equity. We've recognized, whether you are in the clinic, research lab, or through your community engagement activities, we see that there are diseases that some

people experience disproportionately compared to others. And so, as we think about our work, as we develop programs that impact people in our communities, nationally and internationally. It is so important that we keep that in mind and we recognize that not everyone needs the same resources that other people do. As we chart this course towards health equity, recognize that there are some populations that require different tactics that other populations may not require to achieve an equitable outcome. When we talk about health equity, we're talking about ensuring that everyone has an equal and fair opportunity to be as healthy as possible. And as the Chair of the Committee on Diversity, Equity, and Inclusion, I am excited about the work that the ACG is doing to meet this challenge.

Dr. Darrell Gray: “Diversity of Ideas” and a Health Equity Lens Certainly, one of the things that we're doing as an organization is leveraging our diversity. Diversity is intertwined into the fabric of what makes our organization great, but also makes us, as a community of gastroenterologists, hepatologists, nurse practitioners, and patient advocates, even stronger.

It's not only our diversity in terms of race and ethnicity; it's also a diversity of ideas. The diversity of ACG allows us to challenge the status quo, as we have been doing and will continue to do. We've even partnered with other organizations such as NASPGHAN to get the message out. Transitioning from Dr. Mark Pochapin’s leadership as ACG President to Dr. Dave Greenwald's leadership, we've been raising our voices. Yes. Many of you have been raising your voices about injustice. We're not just called to be physicians but we are called to also be advocates. And part of being an advocate, yes, can be outside of that white coat, outside of the hospital walls. Even if you are writing your



“ “Make sure that

there's diversity at every level of your organizational structure, and make sure that we're looking at these things through the lens of race and ethnicity.”

WATCH “Leading the Way on Advancing Healthy Equity,” from the ACG 2020 Virtual Annual Scientific Meeting: bit.ly/ACG-Health-Equity-Town-Hall

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“ “When we think

about education,

having our members understand more

about the health disparities and think about how we can get to health equity in very systematic ways is crucial.

The more diverse our leadership, the better we can treat our patients.”

—Dr. Sophie Balzora

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grant, and you are not in the clinic, it's so important to think of it through a health equity lens. How does my work translate to the person in the urban community, or in the rural community who may have challenges accessing physicians, WiFi for telehealth? Maybe it's thinking about insurance or how they can access a provider who can understand them, not just with language, but culturally.

Our patients need to feel comfortable making themselves vulnerable. And that's what being an advocate is. And, so, part of what we've been doing in this journey with ACG is we've been raising our voices. Most recently, this has manifested in our webinar series, “Racism in Medicine.” We started out with one seminar in which we talked about shifting the culture in practice, extended that to talk about the journey to health equity in particular, talking with trainees and faculty. Our series not only featured the providers, but also we had a patient in that series.

This is going to be a critical part of how we advance—continuing the dialogue. Sophie?

Dr. Sophie Balzora: Equity Think Tank and ACG’s Ongoing Commitment to Addressing Diversity, Equity & Inclusion Thank you, Darrell. As Darrell has mentioned, this really is a journey. And so through the vision and leadership of Dr. Renee Williams, who is an ACG Board of Trustees member, and with the support of ACG leadership of now past president, Dr. Pochapin, and our current president, Dr. Greenwald, the Equity Think Tank was born.

The Equity Think Tank is currently comprised of Dr. Renee Williams, Darrell, myself, and Dr. Fola May, and will work alongside the ACG Committee on Diversity, Equity, and Inclusion to accomplish these goals.

Our four pillars align with the ACG Strategic Plan, and its key priorities for the College. I want to emphasize that some of these things that are listed here are things that we've been doing successfully for years. Other plans are more innovative approaches that the College is excited to bring to its

members and community-at-large.

When we think about education, having our members understand more about the health disparities and think about how we can get to health equity in very systematic ways is crucial. The more diverse our leadership, the better we can treat our patients. So that's what we see in the journey.

We are enriching the pipeline very early on. An example is the Prescriptions for Success Program through the DEI Committee. Each ACG Annual Scientific Meeting, we visit a local high school, and do a hands-on workshop—students understand what we do, our journeys and, hopefully, see themselves in us. This is so important. And seeing that they can achieve their goals of entering science fields and medicine, and ultimately making our field more diverse, inclusive, and excellent.

We also have the Summer Scholars Program where medical students are paired with mentor, encouraging scholarship. These are some of the initiatives that we plan to achieve through this Equity Think Tank.

Dr. Sophie Balzora: #DiversityinGI Virtual 5K & Diversity in ACG Happy Hour It’s important to have the passion. It's important to have the fun and joy of things. And there's no better time

than this year to inject some joy into an otherwise very bleak, disheartening and gut-wrenching year. With ACG’s #DiversityinGI virtual 5K, Darrell and I have been thrilled with its success.

We saw over 500 registrants, which far surpassed what we had imagined.

Recall that the proceeds are going towards the Summer Scholars Program.

Again, we're supporting that pipeline.

With our virtual Diversity in ACG Happy Hour at ACG 2020, we had almost 100 people participate. This was co-sponsored with the Women in GI Committee. Again, another successful event that really shows what the College is about and what we prioritize, which is collegiality, inclusiveness, and that journey to having our patients achieve the best health that they possibly can.

Dr. Sophie Balzora: Introducing the Panel And so, with that, Darrell and I would like to introduce this stellar panel of experts. We have Dr. Valerie AntoineGustave, Dr. Adjoa Anyane-Yeboa, Dr. Rotonya Carr, Dr. Sandy Guillaume, Dr. Ugo Iroku, Dr. Rachel Issaka, Dr. Fola May, Dr. Pascale White and Dr. Renee Williams. Thank you all for participating today and joining in the conversation. We hope for an informative evening.

Dr. Gray: Kicking Off with a Question About the Equity Think Tank I am so excited to welcome all of these esteemed guests, leaders in the field of health equity in their respective subspecialties within gastroenterology. Renee, I want to start with you: Particularly given your engagement on the Board of Trustees, can you speak to some of the specific initiatives of the Equity Think Tank and particularly those that you think are novel and how that aligned with the strategic plan of the College?

had one first author publication from that mentorship relationship and just submitted her second paper off that project she worked on through the Summer Scholars Program with her mentor Dr. Marla Dubinsky. I'm also very excited to say is that this weekend the Board of Trustees approved the concept of a health equity research award for faculty; this will live within the ACG Institute and details are forthcoming. The College already has leadership and mentorship programs in place. And we’re looking now also into policies and practices. Sophie alluded to the diversity scorecard. I think it's important to note why we put that in place this year. The reason why that card exists is specifically for quality improvement. Can we look at ourselves? Can we do better? Do we have race/ethnicity/gender equity?

How are we doing with the Board of Governors and Committee Chairs?

That's where the diversity scorecard comes from. We are going to expand the ACG Education Universe to now include a health equity section.

When these ideas were presented to the Board of Trustees, they were 110% supportive. It’s important that our membership realize how much the College is committed to diversity, equity and inclusion.

Dr. Renee Williams: ACG’s Commitment to New and Existing DEI Initiatives Thank you, Darrell. One of the key College priorities is working with a diverse membership. It's important to stress that the College feels that inclusivity is very important. Something Sophie mentioned that I want to highlight is now there's a lot of attention around health equity and anti-racism. I think we need to realize that ACG has been doing this work—the Prescriptions for Success Program has been around since 1999. Additionally, we're going to award $1,000 to a high school student to help them in their educational journey.

Another initiative in research and funding is the ACG Summer Scholars Program. We met, in one of our prior Racism in Medicine webinar series, Dr. Aiya Aboubakr, who was one of our first recipients, and she'll be applying to GI fellowship next year. She's

Dr. Gray Thank you, Renee, for that. This is just the beginning, which is fantastic to hear. I am looking at the Q&A, and I see a question that we wanted to ask Dr. Rachel Issaka. We’re jumping into health disparities with very big news about the draft of guidelines that will lower the screening age [for colorectal cancer] to 45 for average risk individuals. Rachel, if you can comment on how you think this could impact health disparities in medically underserved groups who have lower screening rates, particularly in Hispanics, higher incidence rates with Native Americans and Black patients, and of course, highest mortality rates among Black patients. Where do you think that this new guideline will fit into that?

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"Be an ally and a voice. If you are not a person of color, if you see something happening, speak up, and support your colleagues.”

Dr. Rachel Issaka: Colorectal Cancer Screening Age Thank you so much, Sophie and Darrell, for the invitation. I'm thrilled to be here with my colleagues. There are potentially some good intended outcomes that could arise from decreasing the screening age.

African Americans, Hispanics, Native Americans have some of the highest incidence of colon cancer. We know Black people are more likely to die from colon cancer and we also know that screening for African Americans is lower, specifically, for those between the ages of 50 and 55. So, by reducing the screening age to 45, one potentially good outcome of this is that we are able to capture more Black people starting at age 45, screening them earlier and also then catching cancer earlier, potentially leading to better outcomes.

We also have to keep in mind potentially unintended consequences of lowering the screening age—when we increase screening for people who are 45 to 50, it is very possible that those who come are not going to be underserved. Colonoscopy, if relied upon as the only screening tool, is of limited availability, that then decreases the ability for Blacks, Hispanic and Native Americans to get it. The other issue is that with this decline in screening age, there could also be a selection for those who have better insurance plans. When there's such a demand for colonoscopy or for other screening services, Black, Hispanic and Native American groups may get excluded.

And so I think as we move forward, we need to be thoughtful about how we ensure that with this drop in screening age, access is not limited, and not just consider colonoscopy as the only screening tool available for this really high risk population.

Dr. Gray And I want to I want to dig into that just a little bit more because this is hot off the press. I want to open it up. Adjoa, I want to bring you into this, particularly as we think about some campaigns that have really

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targeted colonoscopy as the only test. I want to hear your thoughts about what we should be doing. When we're going out into the communities educating about colorectal cancer screening, what we should be doing at the bedside, in the clinic, or when we're talking to our colleagues in primary care, about screening tests, and how we should be educating folks.

Dr. Adjoa Anyane-Yeboa: CRC Screening Options I want to echo what Rachel said: “the best test is the test that gets done.” So if you have a patient in front of you who doesn't want to have a colonoscopy, who doesn't have a ride home, offering stool-based testing is a really big opportunity to get somebody screened.

I think it's really important to have open discussions with patients about different screening options.

Dr. Gray And Fola, can you piggyback on that, because you've also published this work with your experience at UCLA? Can you talk about the impact of having some FIT outreach and differences that can happen when we start ensuring that we're offering choice to patients?

Dr. Fola May Absolutely. And first, I want to thank the ACG and Darrell and Sophie for having us and for doing this Town Hall today. This is phenomenal for us to all to come together and talk about these issues. We all have been waiting with bated breath to see what USPSTF was going to say. American Cancer Society came out, we waited two years. Now, finally, it's here. We're not surprised by their statement.

But I think, as Rachel has said, it's important that we think about all of the consequences of this draft recommendation. And we encourage

everyone to make comments in the next four weeks before it's finalized. I agree that we are going to save lives of people who are aged 45 and 49. But I also am concerned about the 50 to 75 year olds, who are low income, poor access, ethnic and racial minorities. As you've alluded to, Darrell, we have a lot of data that demonstrates that this group needs targeted, focused, and tailored efforts for them to participate in screening. And we know that that is multifactorial, with patient factors, provider factors, system, and also policy. So, given we have policies in place to protect access to preventive services like colorectal cancer screening, we need to use our full armamentarium, we need to make sure that patients who aren't interested in colonoscopy, who are in settings that they can have access to colonoscopy, have access to non-invasive screening tests. There are many studies out there that show that FIT kits can be mailed to patients, handed out in clinic with decent uptake, especially in Federally Qualified Health Centers. I think that needs to be emphasized in this conversation as we continue to talk about decreasing the age for screening.

Dr. Balzora I think there's been some really excellent points made, especially thinking about other ways we can screen our patients who are average risk.

Pascale and Sandy, thinking about your leadership roles in academia, how do you each leverage your position in the journey to health equity and advancing it, with the people that you're mentoring or sponsoring, or, folks that you're training and working with on a daily basis?

Dr. Sandy Guillaume: Advancing Healthy Equity in Academia Thank you, Sophie. Thank you, Darrell, ACG, for having me. The first thing that I think about is that I make myself present in certain key committees or events in my institution. I'm the Director of Motility at Stony Brook and I utilize my knowledge and my voice as often as I can, and make sure that

I can help to foster change and make myself known as the Black physician.

I also chose to be an advisor for the PACE program, which is the premedical access to clinical experience for underrepresented minorities in college so they can have a role model.

So those are some things I try to do to really make my voice heard—by placing myself in positions where there aren't many people that look like me to normalize my presence in these in these key areas.

Dr. Pascale White: Advancing Healthy Equity in Academia Thank you, Darrell and ACG, for having me and all of us here on this panel. For me, as the director of the gastroenterology clinic, I'm in a unique position to identify the gaps in health equity within the clinic and address them. And, so, addressing issues such as access to the clinic, or triage in urgent cases or creating teams that address more efficient scheduling, especially now with COVID and telehealth access disparities, while also tackling the disparities in screening by not only educating this predominantly Hispanic and African American population that we have in the clinic, but as well as educating the fellows right, educating them on the barriers that our population faces to obtaining screening. It's been a multi-pronged approach to how I use my leadership platform to advance health equity.

Dr. Gray Thank you for that. Rotonya, Ugo, Valerie: I want to bring you in. I'm also going to bring in a question from the Q&A. They wanted someone to comment on disparities outside of colorectal cancer. Rotonya, I'll start with you because of your work in liver disease. And then I'm going to ask Ugo, and Valerie if you can comment on either inflammatory bowel disease, any other GI diseases?

Dr. Rotonya Carr: Health Disparities in Liver Diseases Great. Thanks, Darrell. And thank you to the organizers for inviting me

to participate in this panel tonight, thank you to the ACG for really being visionary for laying out this platform to discuss these important issues.

You're absolutely right, disparities are not unique to colorectal cancer, not unique to COVID. They've existed long before the pandemic. But in terms of liver disease, we've been talking about this issue for a long time, from the time at which Black patients especially are referred for management of their chronic liver disease to whether they have adequate access to liver transplantation should that be a need.

These disparities and the prevalence of them are literally determining whether someone lives or dies in liver disease.

Some examples: we know that Blacks in particular are less likely to even have their cirrhosis complications managed appropriately, and not as likely to be listed for transplantation when compared with white patients. And one interesting statistic that a lot of people don't know is in liver transplantation that the older people do worse, that we tend not to want to transplant

“Everybody has a role when it comes to ending structural racism and improving health equity.” older individuals because their risk of death is so high even with transplant.

The disparity in African Americans actually matches that, like we refer African Americans about as commonly as we do older individuals. I mean, this is really, very concerning. And it's not because of what people think: maybe Blacks have higher MELDs, and they're not really qualified. In fact, it's quite the opposite. When we look at younger African Americans, they tend to have the lowest MELD scores. But even with being not too sick to transplant yet, they're just not being managed the same way. When we talk about liver cancer, it's the same

story. Black patients are half as likely to undergo liver transplant for hepatocellular carcinoma, even when adjusting for tumor stage. And we can't even get to referring all the patients at an early enough stage; 15% of Black patients are not even referred for evaluation compared to white patients.

That's very important to me. I use my own platform in hepatology to try to shed light on these issues and ask questions at conferences where people aren't necessarily thinking about the impact on minorities.

Dr. Gray Rotonya, thank you for that. I want to piggyback on something you said. You said, "I asked questions." And I think that's so important to just have that curiosity to ask the questions. I'll take a moment to give a shout out to the fellows at Mayo Clinic, Arizona. I had the pleasure of talking with them. And they had a case of HCC in a Native American patient. And it turned out by asking questions, they got a better understanding of why that person wasn't showing up for their transplant evaluation. Well, it turns out, one of the visits was virtual, and the person lived three hours from WiFi. It turns out there were some language barriers and other— what we call social determinants of health —that impacted this person's care. And so, certainly, when we as providers and advocates are thinking about what barriers people experience, we have to think about the social determinants of health that are impacting the care and the access as well.

And with that, Valerie, I want to bring you in. And then Ugo. Dr. Valerie Antoine-Gustave: Social Determinants of Health & Health Literacy That's a perfect piggyback for how I see patients. First, you have to be intentional.

With my public health background, when we thought about Healthy People 2020, it was the social determinants of health and really evaluating each patient with that framework in mind. So, it's not just their healthcare, or their health literacy, you also have to also think of their economic situation, the community. And,, so with each question, it has to be intentional.

What resources can you provide to all levels of economics, especially in this pandemic?

So, again, the social determinants are the

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"Advocacy efforts, starting early with the pipeline, and having people see what we can do and can achieve is really how we’ll advance and succeed.” economic stability, the education, the social and community context—all those pieces need to come into one discussion with the patient, so that you can tailor the care to that person so that they can come back. We really struggle with health literacy. And we don't take enough time to talk to patients and really understand where their understanding is, and always checking in with the patient and say, is that clear? That's one of the struggles: a lot of my patients come to me and say, I don't feel like I've been heard. And we have to hear them in the different context of the social determinants of health in order to establish better equity.

Dr. Gray And Ugo, tell us about your practice, what kind of disparities you're seeing in your practice, but not only that; how are you leveraging your position to help people overcome some of the things that you're seeing as far as disparities in your clinic?

Dr. Ugo Iruko: Barriers to Care So, again, I'd like to thank the ACG and Darrell and Sophie for this wonderful panel. I'm very honored to be speaking with you all. When I think about the barriers that exist against underrepresented minorities in general, I think of a couple of things. I recently moved back to the city From Greenville, North Carolina. It’s very different. The first one is that people do not have access to healthcare, because of the costs—as hard as it is for white American families to access health care, it's even harder for Black families.

We know that there is a silent Black tax that essentially is levied against Black families. For every dollar that the white family makes, African American families make 59 cents. So that's a 41% tax on the basis of demographics, that

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has to be adjusted for. If you're seeing a patient population that's fairly broad, for a white American, one in 14 will be coming from a position of being below the poverty line. It's much more frequent with Black families — one in six. And so it's hard for a patient to say, “Hey, Doc, I can't afford the laxative prep just prescribed.” And along with that is an issue of underinsurance. We know that too many Americans live without insurance. It's high in white populations, about 8-9%.

It's even higher in Black populations, about 14%. And so clearly, we have a situation a lot of us have been in where the patient finally is able to get to your office and you're hearing them out and you detail your diagnostic plan.

And they say “Doc, I can't afford to get a colonoscopy, I can't afford to go for a CAT scan.” And so we have to figure out ways to address this as well.

And I think the third barrier I see is just the access to diversity amongst physicians. We know for a fact that underrepresented minority physicians take care of underrepresented minority patients, and tend to serve in underserved areas. We talked about COVID, we talked about colorectal cancer, there are many other diseases, hepatitis B­—we have a lot of African immigrants who have a higher risk of having viral hepatitis and who may not be able to access care, because they're just not able to connect with a physician. We know that it's not just a matter of speaking in Creole or Spanish, from a patient standpoint.

Just because you're speaking to me in English doesn't mean you're speaking my language. There are studies that show that Black men in particular are willing to do more tests, even invasive tests, if they're asked to do it by a diverse population of physicians. And so what are the potential solutions? In terms of costs, we need to think about

non-invasive colorectal cancer screening amongst many options that to cater to patients who do not have the money.

When it comes to under-insured or people without insurance, we have to participate in programs that exist, like New York City Community Cares, here in the city, or we provide colonoscopies for people who do not have insurance. And then when it comes to diversity, I think we need to decide, does diversity matter or not? And if we decide that it does, then we have to develop a pipeline to make sure that our African American, Hispanic, Native American, etc., physicians are there and ready, or women are there and ready to meet the needs of our diverse population.

Dr. Renee Williams: Implicit Bias I'm going to mention something to attach to what Ugo said. We all have implicit bias.

And I would challenge everyone to take the Implicit Association Test. And we know that those biases affect our decisions when it comes to patients and patient care. We should all recognize those biases, own up to them, and actually try to change the ones that are negatively affecting our patients.

Dr. Balzora: Barriers to Advancing Equity Goals Absolutely. I think that's an important point. And just thinking about and calling on some of the questions that are coming in are very insightful. I'll say this to Renee and Fola, as members of the Equity Think Tank—when we think more globally about the ACG, what kind of barriers may we encounter in achieving the goals the Equity Think Tank has proposed? What do you see as some of those key barriers that we need to overcome that will trickle down to some of those individualized barriers that Ugo and Valerie have mentioned?

Dr. Renee Williams: Challenges to Advancing Equity Goals Earlier, I didn't mention the pillars for the ACG Strategic Plan are Patient Care, Education, Scientific Investigation, Advocacy and Practice Management. One question that came up when we spoke about our Health Equity Research Award is: do we have enough people doing this research? Are we going to get applicants for this research award when it does become available? How many people

within our field are actually looking at health equity, looking at antiracism, looking at racism as a social determinant of health? I think that's one challenge. I think a big challenge that you have in any situation is buyin from your leadership. If you want change management, you have to have leadership involved, and they have to be committed. Luckily, As I mentioned, the ACG board is absolutely committed to our ideas and initiatives. So that's not a challenge. However, if we propose certain things, are people going to do it?

I think Fola had mentioned specifically having speakers incorporate a slide on equity. We can say do this for us, but are the speakers going to do it? I'll turn it over to Fola.

Dr. Fola May: Resources to Advance Equity: Time, People & Platform I agree completely with Renee. I believe that our biggest limitation and challenge is resources, and resources in the sense of time, people, and platform.

So ACG has given us the platform and hopefully we have the personnel to commit to these issues. We as Black physicians are a 4%. That is stretched very thin. So for us to tackle these problems of equity and disparities, we need non-Blacks to be part of the conversation and action. Our biggest call-to-action as the task force is to use this platform and to be convincing to everyone that these are problems worthy of everyone's attention. And I think that if we keep that in mind, doing things like sprinkling in these topics, over the course of a meeting, everyone has exposure to these topics and we get more allies on board with our mission.

Dr. Gray: Closing Remarks There are so many more questions left in the Q&A and chat. We could literally spend another hour going through this and I love doing it with such awesome friends, too. Renee and Fola, you just gave some comments, I want to go kind of round robin and have folks give closing comments. And then Sophie and I will wrap it up.

Dr. Rachel Issaka: “Everybody has a role when it comes to ending structural racism and improving health equity.”

I think I've been trying to preach this message and evangelize this message from earlier this summer. Everybody has a role when it comes to ending structural racism and improving health equity. And the example that I really like to give is when we think about curb cuts: they were created for people who have disabilities. But ultimately people who use strollers, people who have luggage, or folks who just need an extra lift all benefit from those curb cuts. So if we can think about the focus on health equity with racial/ethnic minority populations as a curb cut, even though it may immediately benefit those populations, ultimately, it will benefit us all. And, therefore, it behooves us all to work towards those goals.

Dr. Rotonya Carr: “…[M]ake sure that there's diversity at every level of your organizational structure, and make sure that we're looking at these things through the lens of race and ethnicity.”

I would say a little more simply and if everyone can just accept the facts, that would be a great start? We have so much evidence. It all says the same thing. These disparities are real. And because they're painful to acknowledge, that we in the medical community have allowed this to happen. And then I think once people get to the acceptance phase, and then the next step is really starting with oneself and not with the institutions sharing your new knowledge, just as we would share the new guidelines or the guideline proposals that came out today. Broadly, we should be sharing what we've learned about healthcare disparities, and ideas about solutions. Finally, make sure that there's diversity at every level of your organizational structure, and make sure that we're looking at these things through the lens of race and ethnicity.

Dr. Pascale White: “I would say: see one, do one, teach one, right?”

I would say: see one, do one, teach one, right? We have trainees watching us have these panels. So they need to see us discussing this and taking action. And then we need to teach them how to look at their patients with the lens that racism exists. Once we acknowledge it, try to incorporate that within our practice to do better.

Dr. Adjoa Anyane-Yeboa: “…[B]e an ally and a voice. If you are not a person of color, if you see something happening, speak up, and support your colleagues.”

Mine will be quick. So in terms of antiracism work, and diversity and equity, I would say be an ally and a voice. If you are not a person of color, if you see something happening, speak up, and support your colleagues. If you come across trainees from underrepresented backgrounds, offer them a research project to work on with you, put their name out for other opportunities, and also support equity work, and really understand that it's racism and not race that leads to many disparities.

Dr. Valerie Antoine-Gustave: “… [T]oday, each patient that you see, you are going to fully assess them in the guise of the determinants of health. Because otherwise, there won’t be change.”

So I would say, mine is very simple: every day just remind yourself to be intentional about these changes that you want to see happen. And there has to be a daily reminder: today, each patient that you see, you are going to fully assess them in the guise of the determinants of health. Because otherwise, there won’t be change.

Dr. Ugo Iruko: “…[T]here's a lot to be gained in celebrating racial diversity…

We will do better if we embrace it.”

It's a thrill getting to see this amazing collection of Black female

"Today, each patient that you see, you are going to fully assess them in the guise of the determinants of health. Because otherwise, there won’t be change.”

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gastroenterologists. I’ll celebrate the gender diversity in that regard. And I think there's a lot to be gained in celebrating racial diversity as well. We will do better if we embrace it.

Dr. Sandy Guillaume: “The more we can pull in individuals like ourselves, health inequity becomes commonplace.”

I would say to get involved at all levels so that your presence is normalized.

And when your presence is normal, you open the door for others. The more we can pull in individuals like ourselves, health inequity becomes commonplace.

So definitely get involved.

Dr. Darrell Gray: “Start with yourself and think about ways in which you can contribute to the change.”

Sophie, you get the last word, but I just wanted to thank all of you for joining us. We look forward to the next time we can get together and certainly I encourage our attendees to stay tuned for our ACG Racism in Medicine webinar series. We'll have another one coming soon. But I'll say this: start with yourself and think about ways in which you can contribute to the change. If you're at the bench, how can you make sure that your research is relevant to health equity? How is it relevant to the patient who lives in a rural or urban community? How can you explain what you do? That's one start. The other piece is, if you're at the bedside, think about ways that you can offer screening, or offer testing, whether it's screening for HCC or colorectal cancer, how can you make that more accessible? It starts with you thinking about ideas of how you can leverage your talent to address these health disparities. Sophie?

Dr. Sophie Balzora: “…[A]dvocacy efforts, starting early with the pipeline, and having people see what we can do and can achieve is really how we’ll advance and succeed.”

So, the final word. Thank you to all the panelists tonight. We value your expertise and your insight and being so candid. And this is just the beginning, as has been mentioned many times, there are going to be more series on this. We can't do this without

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leadership behind us. And it truly is everybody's business. It's not just ours.

Everyone will benefit from the things that we're hearing today. But it does take a village. Now is the time and we have to take advantage of that time. So, advocacy efforts, starting early with the pipeline, and having people see what we can do and can achieve is really how we’ll advance and succeed. So thank you, everybody.

RESOURCE LIST ANTI-RACISM READING LIST

1. Me and White Supremacy by Layla F. Saad 2. Medical Aparthied by Harriet Washington 3. The Color of Law by Richard Rothstein 4. The Fire Next Time by James Baldwin 5. Bad Feminist by Roxane Gay 6. The Bluest Eye by Toni Morrison 7. How to be Antiracist by Ibram X. Kendi 8. White Rage by Carol Anderson, PhD 9. White Fragility by Robin DiAngelo 10. Why Are All the Black Kids Sitting Together in the Cafeteria by Beverly Daniel Tatum 11. So You Want Talk About Race

by Iseoma Oluo 12. Fearing the Black Body by Sabrina Strings HEALTH EQUITY MULTIMEDIA VIDEOS  CME Special Program: “Achieving

Health Equity, Becoming Actively Antiracist” bit.ly/Actively-Antiracist-CME

 Camara P. Jones, MD, MPH, PhD:

TEDxEmory, “Allegories of Race and Racism” bit.ly/Jones-Allegories-Racism

 Camara P. Jones, MD, MPH, PhD:

“Why is Racism Causing More COVID-19 Deaths for Black People?” bit.ly/COVID19-Death-Disparities

 Camara P. Jones, MD, MPH, PhD:

“Social Determinants of Equity” bit.ly/Jones-SDOEquity

EXPERT PANEL: ACG ADVANCING HEALTH EQUITY TOWN HALL MODERATORS Sophie M. Balzora, MD, FACG NYU Grossman School of Medicine

Darrell M. Gray, II, MD, MPH, FACG The Ohio State University Wexner Medical Center

PANELISTS Valerie Antoine-Gustave, MD NYU Grossman School of Medicine

Adjoa N. Anyane-Yeboa, MD, MPH Massachusetts General Hospital

Rotonya M. Carr, MD Hospital of the University of Pennsylvania

Alexandra Guillaume, MD Stony Brook University Hospital

Ugo Iroku, MD NY Gastroenterology Associates

Rachel Issaka, MD Fred Hutchison Cancer Research Center

Folasade P. May, MD, PhD, MPhil UCLA Health Center for Health Science

Pascale M. White, MD Icahn School of Medicine at Mount Sinai

Renee L. Williams, MD, MHPE, FACG NYU Grossman School of Medicine

Conversations with Women in GI Dr. Jill Gaidos talks to

Dr. Jessica Allegretti on “Being Your Own Best Advocate”

I HAD THE OPPORTUNITY TO MEET DR. JESSICA ALLEGRETTI at the ACG IBD School in Williamsburg, VA in 2018. I had contacted her several months ago about being interviewed for this series, however, due to COVID, the interview was postponed. We were finally able catch up this summer to complete the interview over the phone.

For those who don’t know you and aren’t familiar with your work, you are the Associate Director of the Brigham and Women’s Hospital Crohn’s and Colitis Center, the Center’s Director of Clinical Trials and the Director of the Fecal Transplant Program for recurrent Clostridioides difficile at Brigham and Women’s Hospital. What got you interested in fecal microbiota transplantation (FMT) as an area of research?

It’s interesting, as with most things, it started with a patient.

I was actually in residency. I was already interested in inflammatory bowel disease and was GI fellowship bound and was rotating at the IBD center during an elective. We had a patient who had refractory ulcerative colitis and we were recommending colectomy. And the patient said, “I won’t even meet with the surgeon until you consider this treatment that I’ve been reading about called fecal transplantation.” At the time, I had never heard of it and knew nothing about it. And so, I went on a journey investigating what had been done in the space. And really, at the time, there was almost nothing in IBD, really only small case series in C. difficile. This was before any randomized controlled trials. So unfortunately, we couldn’t offer the patient this therapy at that time. But it really started me thinking about this therapy and the potentials of it.  ACG Perspectives | 33

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So, when I transitioned to my fellowship at the Brigham, I really had this still in my mind and I wanted to work with whoever was doing work in this area. So, I asked, “Who is doing FMT? I would love to get involved.” The answer was nobody. So, I asked my program leadership and the endoscopy leadership if they would be ok if I started a program at Brigham during my 1st year of fellowship. And they said, “Go for it. Whatever you need support with, we are happy to help.” And so, at the time, C. diff wasn’t a big clinical interest of mine. It really evolved out of my interest in FMT as a potential therapy for IBD and C. diff was the obvious place to start. So, I built it from there, I met with infection control, infectious disease, and the billing department to figure out how to put together this program. We did the first fecal transplant at Brigham the spring of my 1st year of fellowship and it really just sort of took off from there. Naturally, C. diff became a really big focus of my clinical practice and really became this other passion of mine. There was a nice link between my interest in C. diff and IBD and the emergence of microbial therapeutics.

So, that’s really where it all started.

You also have a Master’s in Public Health (MPH).

Did you do that during fellowship or after you completed fellowship training?

I did that during fellowship. I was really lucky because the Brigham has a big focus on clinical research. As part of my fellowship I was able to do a program called the Program for Clinical Effectiveness at the Harvard School of Public Health which is a summer program that serves as a primer for an MPH with an introduction to statistics and methodology. For those interested, we were able to apply for an MPH through the fellowship program and they select up to 2 people every year to pursue an MPH. I was selected so I was able to build the remaining MPH requirements into my 3 years of fellowship. So, I was very lucky because I really did learn to become self-sufficient from a research standpoint through that experience.

For people who are interested in research and are unable to get a Master’s degree during fellowship, do you think getting a Master’s in Public Health is something they should ask for early in their academic career? Do you think it’s really a game changer having that educational background?

That’s a really good question. I would say, ultimately, no. When you think of everything that an MPH encompasses, there’s a lot of aspects to it. Unless you are really interested in a career in public health, I don’t think that it’s absolutely necessary. I think if you have a focus in clinical research, I do think asking for classes in statistics

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and being able to understand how to perform your own statistics and to have the vocabulary to be able to communicate effectively with statisticians is important. I remember in residency trying to design studies and not understanding how the analyses are actually performed. It makes it very difficult to design an effective study without having that background and you need to be able to ask the statistician the appropriate questions. Now, I’m lucky that I’m at a point where I don’t have to do all my own statistics anymore, but I can have informed conversations with statisticians about design. So, I do think that is what I would ask for above all else.

“[At the beginning of my career]...I really felt like I had to advocate for myself and I had to put myself out there in many regards. I had to network as much as I could at meetings to let people know about the work I was doing…”

Too, understanding the statistical analysis is important for designing the data collection. If you have a spreadsheet with a bunch of words on it and send that to the statistician, they are going to look at you like you're crazy.

Absolutely. Understanding how the statistics are done, how to clean the data, how to code the data even so that, again, you are all speaking the same language. I do think that is incredibly helpful. Let’s say you are designing something as simple as a survey study, you need to know how to design the questions in a way so that the output makes sense to a statistician and actually answers the questions you set out to study. I do think those are some of the most important lessons that I took away from the MPH and that is the critical aspect of it.

We were talking, I think it was at the last ACG Annual Meeting, and you made a comment about how you are now finally being taking seriously for your research. What was it that made you feel you weren’t being taken seriously?

And what changed that made you feel you are now finally being taken seriously as a scientist and researcher?

For me, I struggled a bit in the beginning as I was getting started. I started a program when I was a fellow. So, I really felt like from the get-go that I had expertise in an area that no one else in my division, even my hospital, had. But because of my age and because of my junior status, it felt very much like I still I had to “pay my dues” in order to be taken seriously. In training, it’s always assumed you are working underneath someone else.

So, I did experience a lot of frustrations in the beginning of my career when I transitioned to an attending as I already truly felt like I was an expert in this space, but because of my age and, in some ways my gender, I really wasn’t being taken seriously or considered a leader. I really felt like I had to advocate for myself and I had to put myself out there in many regards. I had to network as much as I could at meetings to let people know about the work I was doing and what I had done

at the Brigham, that I would be happy to give talks, happy to come help set up FMT programs, and share what I knew. I also focused on doing really good work and publishing as much as I could. Really, it was just a lot of hustle. I wanted to be taken seriously and I wanted a seat at the grown-ups' table and I really felt like it took a while. My husband even laughs at me when I say this now. He says, “It took a while, Jessica? You’ve only been an attending for six years” (laughs).

So ultimately, I do think I was able to lift myself up quickly, but I was quite frustrated when I was getting started.

Now I have a seat at the table and people consider me a leader in this space. I’m grateful for that because that is where I always wanted to be.

I really felt like I had to advocate for myself and put my work out there and really network and meet people like you and many others to explain what I was doing and get my name out there. So, my advice to people when they ask me “How do you get to that place?” A lot of it is not expecting other people to lift you up. Some people have great people in their corner who do that for them, but in some ways, you still have to be your own best advocate. I found, often, more senior people don’t want to give talks. I was like, “I’ll fly anywhere, I’ll do anything. If you want me to give a talk, I will be there.” I never said no to those opportunities so I could get my work out there. I think that is really what helped.

Do you feel like you had to do more to advocate for yourself to become recognized as a thought leader in this area than a man six years out of fellowship would have had to do?

My answer is always yes. I do think that, even though I work with many amazing women, even my division is equal parts women and men now, I do think that it’s still a maledominated profession and I am at a disadvantage in that I look like a very young woman. Even still to this day, I still often get the “you’re the doctor?” comments.

Exactly!

I don’t feel like I should have to alter my appearance or try to look older to try to be taken seriously. I feel that the science and the work should speak for itself. I did feel that in the beginning people were kind of eying me up and down, going “You? This is you?” (laughing). I wish that the answer was no, but I do think that the answer is yes.

Also, at the last ACG annual meeting, you had co-chaired the Women in GI Luncheon.

Yes, I’m doing it again this year.

You were really excited about the experience you had co-chairing that session. There’s an impression that after training, you don’t need to that type of networking and social connection anymore, but really we need that throughout our careers. What did you get out of that experience as the co-chair organizing and moderating that session?

It’s such a fabulous session and I’m very excited that I’m co-chairing it again this year with Dr. Jami Kinnucan.

I think one of the biggest take-aways is it wasn’t just fellows or women who are about to graduate who attended, it was anyone who was interested in either a career change or looking for that type of networking. And this year, because it’s virtual, it’s open to all woman. For me, the biggest takeaway is that we all have a lot of the same concerns. For women in GI, there’s a lot of fear and uncertainty with regards to navigating careers.

How do you balance wanting to have a family and a career and still be taken seriously by your male colleagues?

That was a big theme that a lot of women expressed concerns about.

How do you choose which path you are going into? Is there a path that will be easier with all of the other aspects that we have to take into consideration? One of the pieces of advice I was trying to share with attendees and also one of the things that I have learned along the way is that some of the best networking I have done was well after fellowship. A lot of the important female colleagues that I have met along the way was

while traveling and speaking at meetings like you and Aline (Dr. Aline Charabaty).

Really just this huge network of women in IBD, specifically, that I would have never known otherwise. I think, as attendings and academics, we have been able to really support each other in ways that I didn’t really know was possible even as a fellow. I think a lot of the more important and supportive relationships were created once I became an attending. I think we as women like to think that other women, especially where you work, will be our best allies but that’s not always the case.

That’s true.

There is sometimes a feeling of competition among other women specifically in your division or in your space that can be unfortunate. So, having allies and advocates at other institutions, for me, has been career-making. In the very beginning, when I was trying to get the FMT program going, one of the best things that happened to me was I met a bunch of other women who were doing FMT around the country and they became my network. If I hadn’t met Dr. Colleen Kelly and Dr. Monika Fischer early in my career, I don’t know where I would be right now. And, I didn’t have anyone to turn to within my local space, so that was one of the big talking points that came out of that lunch.

Exactly. Another issue that women face is feeling less respected by the clinic and endoscopy staff as an attending when they stay at the institution where they trained for fellowship. Did you experience that? And, if so, how did you handle that?

It is really interesting. When you are transitioning to attending from a fellow, the staff knows you as a fellow, and sometime garnering respect as the attending can be challenging. I do think that, as women, this is something that we particularly face. For me, I would say that I have been fortunate. Because I was running my own program, even as a fellow, I had sort of earned some of that clout, if you will, as I transitioned, because there was no one else to go to if you wanted an FMT, you had to come to me. I felt like I had a bit of an advantage and why I was quite happy to stay at the Brigham and didn’t have a lot of the

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same concerns that I know some of my female colleagues have had. For me, the thing that benefited me and the advice I give is, if you treat the endoscopy staff and clinic staff with respect, they will return that respect. I have befriended a lot of the clinic and endoscopy staff and have tried to create a collegial environment. They would never disrespect me because I wouldn’t disrespect them. That has really been helpful.

Out of the gate, I always introduce myself if there is someone I don’t know on the endoscopy floor.

I say, “Hi, I’m Jessica. I’m the attending today.”

It’s easy to get defensive and say, “Well, I’m the attending.” If that is your attitude, people are going to mirror that back to you. So, I think that has helped me along the way. Being on time, showing up, and being responsible, I haven’t had a lot of those issues.

One of the things that you do really well is that you are a physician, a researcher, a scientist, but you are also not afraid to be a woman. You and I have talked about your love of make-up and spending time at Sephora and you have shared a picture of your shoe room on Twitter (available at bit.ly/2Zoh2gh).

(Laughs) I’m very proud of it!

In this field and in other male-dominated fields, women sometimes feel that they need to be more "manly" to be taken seriously or respected. Do you ever get push back from that?

It sort of goes back to the fact that I look like a young woman and I’m also 4’ 10." I have very blond hair and I wear hot pink lipstick most days. It’s a balance between wanting to be taken seriously but also wanting to be myself. I actually started really dressing up towards the end of fellowship as I felt that that type of appearance allowed patients to take me more seriously. It really worked and it sort of blossomed from there. I got very into the artistry of make-up which is how I de-stress. That is my creative outlet. Some people paint or write music. My husband is a saxophone player and that is what he does to unwind. For me, doing make-up is how I unwind and how I clear my head. I do think that it is an interesting balance in that I do get a lot of comments whether it’s from colleagues or from patients about my appearance. I don’t ever want it to be about my appearance but you have to learn this balance between wanting to be yourself and dressing how you can be comfortable—but also shielding yourself from some of the sexist and, quite frankly, offensive comments that you get day in and day out. I do think it is a balance. I think if I didn’t do that, if I didn’t put myself together in a way that I’m

36 | GI.ORG/ACGMAGAZINE

“I don’t ever want it to be about my appearance but you have to learn this balance between wanting to be yourself and dressing how you can be comfortable—but also shielding yourself from some of the sexist and quite frankly offensive comments that you get day in and day out.”

comfortable with, I don’t think I would perform in the way that I want to perform because I just wouldn’t feel like myself. We all have the right to dress how we want, to wear as much make-up and to be as feminine or as non-feminine as you want to be. The fact that colleagues feel they can freely comment on your appearance is something I’ve never quite gotten used to though. This never happens to men. One example, I was on service in the hospital about two weeks ago and my fellow, another female, and I and we were about to go see a patient when a female nurse on the floor walked up to us and said, “What are you two children doctors doing here? You are too pretty, you’re too this, you're too that” and I was literally like, “What is going on right now?”

(Laughs) That is crazy!

I’m an attending gastroenterologist and this is my fellow and we are about to go see a patient and we are being riddled with critiques about our appearance. It was so off-putting. Even though I do think that sometimes people think they are being complimentary. I don’t put on make-up or dress a certain way because I want people’s comments on it. I do it because that is how I feel my best. It is a bit of a balance. This is something we talked about at the luncheon because you kind of have to have a set series of retorts on how you respond to microaggressions when people say X, Y or Z. I don’t tolerate it.

In that scenario, it’s really important for that fellow to hear how you respond to that and, really, you are supporting her by sticking up for both of you.

Absolutely. This was a senior female nurse and before we walked into the patient’s room, I said to her, “What you just said was extremely offensive and incredibly inappropriate and negates our years and years of combined training.” It was so off-putting. She apologized, but we shouldn’t have to deal with that not only from men but from other women.

You are so right!

Jill J.K. Gaidos, MD, FACG Yale School of Medicine New Haven, CT

Jessica R. Allegretti, MD, MPH, FACG Brigham & Women’s Hospital Crohn’s & Colitis Center Chestnut Hill, MA

with gastrointestinal diseases.

Beyond this simple definition, the role of a GIH can look very different from place-to-place.

Most often, the GIH role includes some combination of providing consultative services, performing endoscopic procedures, and supervising GI trainees and physician extenders. For this reason, the position often appeals to those with a strong interest in clinical education.

Some GIHs may additionally choose to have an outpatient practice in a reduced capacity. Being centrally located at the hospital also positions the GIH for additional leadership roles in hospital administration, quality improvement, education and research.

Overall, the experience can be tailored to the GIH’s individual interests, thus making flexibility one of the more appealing aspects of the job.

I was fortunate that the opportunity at NYU found its way to me but the path to becoming a GIH is not always clear.

In Retrospect: Perspectives from a GI Hospitalist

By Melissa Latorre, MD, MS

IN 2016, WHILE LOOKING FOR MY FIRST JOB OUT OF FELLOWSHIP, I received an email that NYU was looking for a GI Hospitalist (GIH). Having worked previously as a medicine hospitalist, this email immediately piqued my interest. Until then, it had not occurred to me that this could be a career path within GI but, given my prior experiences, I saw the potential to improve upon inpatient GI care.

I accepted the position, which generated a few perplexed looks from my colleagues, and without much precedent, I set forth to carve my own path as a GIH.

A DEFINITION OF THE GI HOSPITALIST EXPERIENCE If we extrapolate from the definition of a medicine hospitalist, a GIH is someone who predominantly cares for hospitalized patients

“The GIH model increases inpatient and outpatient endoscopic procedural volume, reduces unnecessary costs, shortens time-to-endoscopy, and decreases complications.”

A MINDSET FOR SUCCESS AS A GI HOSPITALIST Certain personality traits, preferences and skills lend themselves well to a hospitalist role. Looking back, the first sign that I would evolve into a GIH was that I always had a inclination for the quick pace of the inpatient world.

As a GIH, it helps to be adaptable to the unpredictability of the day and to be capable of executing quick judgement with a calm temperament when life-threatening situations arise. The hospitalist role demands mental agility to be able to multitask, prioritize, forethink and prognosticate for multiple patients at the same time.

Additionally, hospitalists need to be able to simplify complex procedures into manageable steps and remain sensitive to the individual needs of each learner and team member.

Patience is also important when working as a clinical educator and leader. In taking care of inherently sicker patients there will be complications and losses, but also lifesaving successes. It is important for

ACG Perspectives | 37

// PERSPECTIVES

“It is important for the GIH to remember that the goal is always to keep patients with chronic diseases out of the hospital and to work closely with their outpatient gastroenterologist to implement preventative strategies.” a GIH to be tolerant of the emotional waves associated with the role. The hospital environment generates an incredible spirit of teamwork and comradery which is often appreciated by those who enjoy multidisciplinary engagement. Finally, a GIH position caters well to those whose image of work-life balance is to leave their clinical responsibilities within the walls of the hospital.

“GI HOSPITALIST HANGOUT”— CREATING A VIRTUAL NETWORK Since becoming a GIH, I have been fortunate to meet a few other physicians in this role and to help others start their careers.

I had long been searching for the right opportunity to introduce everyone and this new era of video conferencing lent itself well for the occasion. In January 2021, I hosted the first ever “GI Hospitalist Hangout” which virtually connected twelve GIHs from across the country. When the meeting began, we were all amazed to see so many faces on the screen, especially since many of us had perceived ourselves to be a rare breed of gastroenterologist. The enthusiasm was palpable, and we were all excited to have finally found like-minded individuals who shared a similar passion for inpatient GI care.

We reflected upon our common experiences as GIHs and share a few of our insights below: 1. Sometimes the simplest GI problems (e.g., hemorrhoids, chronic anemia), the ones deemed acceptable for outpatient follow-up in lieu of inpatient evaluation, can contribute to frequent readmissions. For certain patients, such as those with

38 | GI.ORG/ACGMAGAZINE

chronic illnesses or complex medical issues, GI issues are best managed proactively.

2. Delays in care have profound effects on hospital operations and throughput. A GIH understands the value in timely endoscopic evaluation and care. In the recent pandemic with hospitals operating in states of overflow, delays in discharge have profound impacts on resources. For the GIH, this means helping to ensure timely endoscopic procedures, such as percutaneous gastrostomy tube placement for patients with SARSCoV-2.

3. Some patients with chronic GI conditions may see the GIH more regularly than their outpatient gastroenterologist. There is the potential for paradoxical continuity of care on the inpatient side. It is important for the GIH to remember that the goal is always to keep patients with chronic diseases out of the hospital and to work closely with their outpatient gastroenterologist to implement preventative strategies.

model for inpatient GI care as it has for general medicine. So far studies have shown that the GIH model increases inpatient and outpatient endoscopic procedural volume, reduces unnecessary costs, shortens time-to-endoscopy, and decreases complications.1-6 Following our initial “GI Hospitalist Hangout,” the idea for a Society of GI Hospitalists came to life. Alongside my fellow GIHs we vowed to raise awareness of the GIH model, to demonstrate its value through research and to provide support for anyone considering a career as a GIH. By sharing our insights and experiences, we hope to inspire the next generation of GIHs.

REFERENCES 4. Schoeppner HL, Miller SL. Developing a gastroenterology hospitalist service. Gastrointest Endosc Clin N Am 2006;16:743-50.

5. Overholt BF, Wagonfeld JB, Miller SL, Oblinger M. Revenue enhancement for the practice and the endoscopic ambulatory surgery center. Gastrointest Endosc Clin N Am 2002;12:385-93.

6. Shung D, Hung H, Laine L, Hughes M. Adopting a GI Hospitalist Model: A New Method for Increasing Procedural Volume. Session: Oral Paper Presentations - General Endoscopy presented at the American College of Gastroenterology Annual Scientific Meeting 2020.

7. Hughes M, Sun E, Enslin S, Kaul V. The Role of the Gastroenterology Hospitalist in Modern Practice.

Gastroenterology & Hepatology 2020;16.

8. Latorre M, Meneses M, Arbuah N, Adenikinju A, Wasterlain A, Swensen S. Multidisciplinary Quality Improvement Initiative to Reduce Bowel Complications in Post-Operative Orthopedic Patients. Am J Gastroenterol. 2019;114:S73-S74.

9. Levine I, Hong S, Bhakta D, McNeill MB, Gross S, Latorre M. Predictors of Hospital Readmission Among Patients With Obscure Gastrointestinal Bleeding Following Inpatient Capsule Endoscopy. Am J Gastroenterol. 2019;114:S665.

10. Tran J, Kimmel J, Betesh A, et al. Effect of a Team-Based Approach to Improve Enteral Access Decision-Making. Am J Gastroenterol. 2018;113:S607.

11. Mahadev S. LB, Ramirez I., Garcia-Carrasquillo R.J., Freedberg, D.E. . Transition to a GI Hospitalist System

A MODEL FOR INPATIENT GI CARE Since receiving that first email there has been a growing demand for GIHs and it is likely that will become the preferred

is Associated with Expedited Upper Endoscopy.

Gastroenterology. 2016;150[4]:S639-40.

“As a GIH, it helps to be adaptable to the unpredictability of the day and to be capable of executing quick judgement with a calm temperament when life-threatening situations arise.”

Melissa Latorre, MD, MS Director, Inpatient GI Services at Tisch Hospital & Kimmel Pavilion; Director, Enteral Access Team, NYU Langone Health; Assistant Professor of Medicine, NYU School of Medicine

EDUCATION

What Gastroenterology Clinicians Can Do to Help End the COVID-19 Pandemic

By Freddy Caldera, DO, MS and Francis A. Farraye, MD, MSc, MACG

THE COVID-19 PANDEMIC HAS TRANSFORMED HEALTHCARE in many ways, including the incorporation of telemedicine into clinical practice.

The pandemic has also forced gastroenterology clinicians to be adaptable in the way they provide care to patients due to stay-at-home orders or COVID-19 surges. Additionally, many gastroenterologists have needed to take on new professional or personal roles by working as hospitalists due to COVID-19 surges, or playing the role of a teacher to assist their children with homeschooling. We have demonstrated that gastroenterology clinicians can successfully adapt to an ever-changing health care environment. 

Education | 39

// EDUCATION

“GI clinicians should become COVID-19 vaccine advocates by personally receiving a COVID-19 vaccine and sharing their experience with their staff, patients, and family members.”

Gastroenterology clinicians should strongly consider accepting one final role to help end the COVID-19 pandemic. GI clinicians should become COVID-19 vaccine advocates by personally receiving a COVID-19 vaccine and sharing their experience with their staff, patients, and family members. They should also consider learning about general vaccine safety, COVID-19 vaccine development, and clinical trials. Our recent article published in Clinical Gastroenterology & Hepatology summarized everything a gastroenterology clinician needs to know about COVID-19 vaccines.

By acquiring this knowledge, we will be able to make a strong recommendation for our patients, friends, family, and co-workers to accept a COVID-19 vaccine when a vaccine is offered. All health care workers and providers need to help dispel myths and misconceptions about the COVID-19 vaccines perpetrated on social media.

The overabundance of information online and offline has resulted in an “infodemic.” Even before the COVID-19 pandemic, there was a vast amount of misinformation about vaccines on social media resulting in vaccine hesitancy among patients with inflammatory bowel disease and other conditions seen in our gastroenterology practices.

Vaccine hesitancy has not improved during the pandemic but only worsened because political polarization has resulted in general mistrust of public health and governmental agencies. This has resulted in widespread public unease of a COVID-19 vaccine once they become available to the general public. Over the past several months, we have spoken with many patients and health care workers about COVID-19 vaccines. They have

40 | GI.ORG/ACGMAGAZINE

expressed concern about the speed of vaccine development and whether steps were skipped in assessing the safety and efficacy of these vaccines before being released for use.

It is not widely known that coronavirus vaccine development has been ongoing since the initial severe acute respiratory syndrome (SARS) epidemic in China in the early 2000s continuing with Middle Eastern respiratory syndrome (MERS) outbreak in 2012. Thus, vaccine discovery has been going on for over 15 years, which is typically the longest period in vaccine development.

The goal of Operation Warp Speed (OWS) was to produce a safe and effective COVID-19 vaccine. OWS did not skip any steps but only truncated the downtime between trial phases that usually occurs during typical vaccine development because industry partners need to assure that a vaccine is not only effective but also marketable. Furthermore, OWS took away all the financial risk from pharmaceutical partners and assisted them to harmonize protocols and use existing clinical trial networks.

To further assure patients, providers should consider sharing that Moderna in collaboration with the NIH had designed their COVID-19 vaccine on January 13, 2020. This was before

COVID-19 became a household term and still, the vaccine did not receive emergency use authorization until December 2020 after it was found to be safe and effective in a large phase III clinical trial of over 30,000 individuals.

To end the pandemic, experts such as Dr. Fauci and others have stated that 70 to 80% of the general population will need to be vaccinated to achieve herd immunity. If we hope to end this pandemic soon, educating patients about COVID-19 vaccines and dispelling myths and misconceptions cannot fall solely on primary care providers. This is a task for all health care providers including specialists such as gastroenterologists, nurse practitioners, and physician assistants in our practices.

We take care of many patients with chronic medical conditions, such as inflammatory bowel disease, who value the opinion of their specialty clinicians.

Thus, we need to start making a strong recommendation for a COVID-19 vaccine to our patients now and educating them to overcome vaccine hesitancy.

This will assure that our patients will accept a COVID-19 vaccine once it's available to them.

 LEARN MORE: ACG #1Fact1Myth Patient and Physician Education Resources on COVID-19 Vaccinations and Overcoming Vaccine Hesitancy bit.ly/ACG-COVIDVACCINE

“If we hope to end this pandemic soon, educating patients about COVID-19 vaccines and dispelling myths and misconceptions cannot fall solely on primary care providers.”

Freddy Caldera, DO, MS, University of Wisconsin School of Medicine and Public Health

Francis A. Farraye, MD, MSc, MACG, Mayo Clinic, Jacksonville, FL

Inside the

JOURNALS

G

AC RTS EPO CASE RO J URN L G OM I.OR TS.C TS.G POR POR ERE ERE CAS CAS ACG ACG

VOLUME 6

ed by orts edit e Rep ed by nal of CasRep orts edit ne Jour ows An Onli nal of Case atology Fell ne Jour ows An Onli ology & Hep atology Fell Gastroenter ology & Hep Gastroenter

THE FIRST EVER ACG CLINICAL GUIDELINE ON THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME WAS PUBLISHED in The American Journal of Gastroenterology in January 2021. Lead author Dr. Brian E. Lacy noted that he and his co-authors identified 25 clinically important questions clinicians frequently ask and then used GRADE methodology to develop new guidelines that can be effectively used in daily practice to help expedite care and to improve symptoms in patients with IBS. In Clinical and Translational Gastroenterology, Holowatyj, et al., using SEER data, published the first study to define areas of high earlyonset CRC mortality (hot spots) in the contiguous United States among women.

The breadth of interesting cases published

by ACG Case Reports Journal continues to expand under the leadership of Co-Editorsin-Chief, Dr. Ahmad Bazarbashi and Dr. Isabel Hujoel. We share highlights of a case

by Kassamali, et al. on Encephalopathy in a Noncirrhotic Patient. Read more at ACGCaseReports.com

Inside the Journals | 41

// INSIDE THE JOURNALS

INSIDE THE JOURNALS [THE AMERICAN JOURNAL OF GASTROENTEROLOGY]

ACG’s First Clinical Guideline on Management of Irritable Bowel Syndrome Roadmap for Clinicians to Provide a More Holistic Approach to Treating IBS Patients  ACG’S FIRST-EVER CLINICAL GUIDELINE ON THE MANAGEMENT OF IRRITABLE BOWEL SYNDROME was published in the January 2021 issue of The American Journal of Gastroenterology. The guideline provides clinical recommendations for both diagnostic testing and therapeutic treatments for IBS. The authors identified 25 clinically important questions that clinicians frequently ask and then used GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) methodology to carefully and critically evaluate the data.

The guideline, jointly authored by Brian E. Lacy, PhD, MD, FACG; Mark Pimentel, MD, FRCPC; Darren M. Brenner, MD, FACG; William D. Chey, MD, FACG; Laurie Keefer, PhD; Millie D. Long, MD, MPH, FACG; and Baha Moshiree, MD, FACG, provides clinical recommendations, including:

• Diagnostic testing to rule out celiac disease and inflammatory bowel disease (IBD) in patients with suspected IBS and diarrhea, which is not routinely performed by many health care providers • Recommending against routine colonoscopy in patients with IBS symptoms under age 45 who do not exhibit warning signs such as unintentional weight loss, older age of onset of symptoms, or family history of IBD, colon cancer, or other significant gastrointestinal disease • Treatment of IBS with constipation (IBS-C) symptoms with guanylate cyclase activators and treatment of IBS with diarrhea (IBS-D) symptoms with a gut-selective antibiotic • The use of tricyclic antidepressants to treat global symptoms of IBS, including its key symptom, abdominal pain • Gut-directed psychotherapies to treat overall IBS symptoms as part of a comprehensive management strategy, rather than as a last resort, that can be used in conjunction with dietary therapies and medications

A key approach that the guideline recommends is a positive diagnostic strategy involving a careful history, physical examination, and limited diagnostic testing, which can substantially shorten time to appropriate therapy and be more cost-effective for patients. The guideline also recommends against some therapies that do not improve global symptoms of IBS, aiming to help providers determine the most effective and efficient treatment modalities for their patients.

In addition to a comprehensive analysis of the efficacy of prescription medications for IBS, the guideline also provides detailed discussions and recommendations on diet, over-thecounter, and behavioral treatments such as the low FODMAP diet, fiber supplements, probiotics, as well as cognitive behavioral therapy and gut directed hypnosis.

 READ bit.ly/ACG-Guideline-IBS  LISTEN TO THE PODCAST:

bit.ly/IBS-Podcast-Pimentel Dr. Mark Pimentel in conversation with AJG Co-Editor-in-Chief Dr. Brennan Spiegel

Management of Irritabl

42 | GI.ORG/ACGMAGAZINE r anatomy.

Adapted with permission from Advances in diagnostic assessment of fecal incontinence and dyssyn

Community Health and Early-Onset CRC Survival

7

Community Health Behaviors and Geographic Variation in Early-Onset CRC Survival Among Women

Figure 2. Early-Onset Colorectal Cancer Hot Spots Among Women. Years 1980-2018

Holowatyj, et al. December 2020

COLON

[CLINICAL & TRANSLATIONAL GASTROENTEROLOGY]

Andreana N. Holowatyj, PhD, MS; Marvin E. Langston, PhD, MPH; Yunan Han, MD; Richard Viskochil, MS, PhD; Jose Perea, MD, PhD; Yin Cao, MPH, ScD; Charles R. Rogers, PhD, MPH, MS; Christopher H. Lieu, MD; Justin X. Moore, PhD, MPH

spot counties). In addition, physical inactivity and fertility were community health behaviors that moderately correlated with hot spot residence among women diagnosed with early-onset CRC. Our study is the first to define areas of high early-onset CRC mortality (hot spots) in the contiguous United States among women, an analysis undertaken to minimize sex differences in early-onset CRC-specific outcomes, and to assess factors associated with geographic variation in early-onset CRC survival among women in the United States.

 READ: bit.ly/CTG-CRCHotspots

Kassamali et al

[ACG CASE REPORTS JOURNAL]

Persistent Encephalopathy in a Noncirrhotic Patient: Do Not Shun This Shunt Farah Kassamali, MD; Steve Hu, MD; Marina Roytman, MD

This is a unique case of a large spontaneous portosystemic shunt without underlying cirrhosis contributing to persistent portal-systemic encephalopathy. Hepatic encephalopathy associated with portosystemic shunting is known as type B encephalopathy, and occlusion of the shunt by

8

Holowatyj et al.

Figure 2. Early-onset colorectal cancer survival hot spot regions: Centers for Disease Control and Prevention (CDC), 1980–2017. Pop, population.

COLON

 DESPITE OVERALL REDUCTIONS IN COLORECTAL CANCER (CRC) MORBIDITY AND MORTALITY, survival disparities by sex persist among young patients (age <50 years). Our study sought to quantify variance in earlyonset CRC survival accounted for by individual/communitylevel characteristics among a population-based cohort of U.S. women.

Our analysis of the variation in CRC survival, accounted for by individuallevel and community-level characteristics among 28,790 women diagnosed with a first primary invasive cancer before age 50 years, revealed distinct variance patterns in early-onset CRC survival by geographic region (hot spot vs. non–hot

Figure 3. and areas of the South (32). Our findings among young women are consistent with these geographic disparities in CRC mortality among individuals of all ages. By contrast, our results differ from breast cancer mortality hot spots among women—because 53% of female early-onset CRC hot spot counties vs 72.5% of female breast cancer hot spot counties were in the South (16). Strikingly, a recent study of hot spots in early-onset CRC mortality aggregated for both men and women between 1999 and 2017 revealed that 92% of hot spot counties were in the Southern United States.

(33). Yet from 1980 to 2018, we report a marked shift in female early-onset CRC hot spots because nearly half of all female hot spot counties were in the Midwest and Northeast regions of the United States, including northern Appalachia. Furthermore, there persists a strong differential impact of socioeconomic status on overall well-being, quality of life, income, and psychological and physical health, by sex. Poverty rates for all groups of adult women are higher than for their male counterparts (34), women with low income are more likely to develop alcohol and drug additions influenced by the social stressors linked to poverty (35), and the effects of pregnancy on work/educational opportunities and costs associated for pregnancy are higher for women than men (36). Together, these factors may uniquely contribute to sexspecific disparities in early-onset cancer etiology and outcomes (3), including differences in community-level features by sex, and

are critical to unravel the underpinnings of the early-onset CRC epidemic.

The use of data from the population-based SEER registry program is a strength of this study because it allowed for a large number of pathologically verified cases to be identified among women across the United States with standardized 5-year followup. However, we acknowledge the inherent limitations in cancer registry data. One weakness of this study is that state-level colonoscopy data for this population could not be assessed. Although CRC screening among individuals younger than 49 years was not considered routine during our study period, differences in colonoscopy screening could partly contribute to variations in earlyonset CRC survival among women. However, recent reports— which indicate that trends in colonoscopy screening do not fully align with early-onset CRC incidence patterns—further suggest the rising early-onset CRC burden is not fully explained by screening practices (37). We also acknowledge the inability to assess changes in female early-onset CRC mortality hot spots over time due to CDC data limitations at the county level (CDC data are suppressed at the county level when there are fewer than 10 deaths). SEER also lacks data on patient-level characteristics that can impact young patient outcomes, such as comorbid conditions (e.g., diabetes and insulin use) (38), comprehensive tumor histopathology and molecular phenotypes (e.g., microsatellite

American College of Gastroenterology

Clinical and Translational Gastroenterology

Figure 3. Generalized R2 values for independently fit models among women with early-onset CRC by hot spot classification using the Cox proportional hazards regression: SEER 18 linked with American Community Survey and County Health Rankings county-level data. R2 values represent the variance explained by each independent factor. ACS, American Community Survey; AJCC, American Joint Committee on Cancer; CRC, colorectal cancer; SEER, Surveillance, Epidemiology, and End Results.

Figure 2. Early-onset colorectal cancer survival hot spot regions: Centers for Disease Control

and (CDC),body 1980–2017.

3. Generalized values for independently fit models elucidate the R2 unexplained variance in early-onset CRC survival instability andPrevention somatic mutations), mass index,Figure history of amongpolyps, women with early-onset CRC by hot spot classification Cox proportional hazards among women in theusing Unitedthe States—particularly in counties gastrointestinal family history of cancer, and individualwith high rates of early-onset CRC mortality—to reduce dislevel socioeconomic regressionfactors. However, use of county-level proparities in the early-onset CRC burden and improve young portions of the population with an annual household income Kassamali et al Persistent Encephalopathy in a Noncirrhotic Patient patient outcomes. ,$20,000 as a proxy for socioeconomic status allowed us to explore potential differences in healthcare access that may contribute to geographic disparities in CRC outcomes. Although our CONFLICTS OF INTEREST findings raise the possibility that these individual/communityGuarantor of the article: Andreana N. Holowatyj, PhD, MS. level features uniquely contribute to variation in early-onset CRC Specific author contributions: A.N.H. and J.X.M.: had full access to survival by geographic region, we are unable to provide evidence all of the data in the study and take responsibility for the integrity of for causation between these features and early-onset CRC outthe data and the accuracy of the data analysis. A.N.H., M.L., Y.H., comes among women given the ecologic design of the study.

R.V., and J.X.M.: contributed to the planning and conducting the Persistent in aand Noncirrhotic Patient revision In summary, our findings emphasize the importance of study, collecting andEncephalopathy interpreting data, drafting/critical defining patterns of variance in early-onset CRC survival to of the manuscript. All authors participated in the interpretation of data and drafting and critical revision of the manuscript for imporunderstand the impact of community health behaviors on early-onset CRC outcomes. We observed that physical intant intellectual content. A.N.H. and J.X.M.: obtained funding and activity and fertility were community health behaviors that provided support and supervision for this study.

Financial support: A. N. Holowatyj was supported by the modestly correlated with regions of high early-onset CRC mortality among women. We also observed that individualDepartment of Medicine at the Vanderbilt University Medical Center Figure 1. under (A) Axial and the National Institutes of Health (NIH) Ruth L.contrastand community-level factors accounted for approximately Kirschstein National Service Award T32 HG008962 from one-third of the variation in tomography early-onset CRC survival among Figure 1. (A) Axial contrast-enhanced computed demonstrating segment 7 large intrahepatic portovenous shuntResearch and (B) coronal enhanced computed contrast-enhanced tomography demonstrating segment 5 large intrahepatic portovenous theshunt.

National Human Genome Research Institute. M. E. Langston was womencomputed and yielded distinct patterns by hot spot residence. tomography demonstrating supported by the National Institutes of Health K12 DK111028 from Further study of community health behaviors and healthcare 2,3 Similar technique used to on the second classified into extrahepatic (48.9%) orInstitute intrahepatic (36.2%). segment 7 and large intrahepatic the National of Diabetes and Digestive Kidney Diseases. access, was as well asintervene modifiable CRC risklarge factors, is critical to

Portosystemic shunts are usually believed to be due to portal portovenous shunt and (B) hypertension in the setting of underlying hepatic disease. Along VOLUME 11 coronal | DECEMBER 2020 www.clintranslgastro.com with a comprehensive biochemical workup, various imaging contrast-enhanced modalities can assist in the detection and characterization of the computed tomography anatomical anomaly, including ultrasound and cross-sectional imaging such computed tomography. Doppler ultrasonogrademonstrating segment phy allows visualization of abnormal blood flow and estimation 5 large intrahepatic of the shunt. Unmetabolized ammonia, a known culprit of Kassamali et al Persistent Encephalopathy in a Noncirrhotic Patient DISCUSSION portovenous shunt.

Figure hepatic encephalopathy, is highly dependent on portal flow and is elevated in the setting of a shunt.4 An abnormal connection between the portal and systemic cir-

intrahepatic portovenous shunt in segment 5 and resulted in stagnant flow postembolization. A final main portal venogram Clinical and Translational Gastroenterology demonstrated enhanced visualization of the hepatic parenchyma and no hepatofugal flow (Figure 3). On follow-up, the patient had no further episodes of hepatic encephalopathy and ammonia levels were normalized to 32 mmol/L.

endovascular management 2. Transhepatic venogram is the preferred treatment culation is known as a portosystemic shunt. These can be with selective injection of the The prevalence of spontaneous portal shunts in cirrhotic patients Figure 1A. Figure 1B. is 38%–40% and is seen in 46%–70% of those with refractory provided the images. S. Hu and vein M. Roytman edited the manof choice. Providers right posterior portal encephalopathy. In a retrospective study with 2,000 patients, uscript and made critical comments and revised the manuscript Figure 1. (A) Axial contrast-enhanced computed tomography demonstrating segment60% 7 large intrahepatic shunt and (B) coronal demonstrates portovenous approximately of cirrhotic patients hadportovenous a spontaneous porfor intellectual content.

All the authors approved the final should consider type contrast-enhanced computed tomography demonstrating segment 5 large intrahepatic shunt. intrahepatic rare instances, spontaneous tosystemic shunt. Inportovenous version of manuscript. 7 with shunt inthe segment portosystemic shunts can be found in the absence of congenital hepatic vein B encephalopathy in abnormalities, trauma, or chronic liver disease. Although the massive etiFinancial disclosure: None to report.

2,3 ology of shunt formation may not be clear, such venous Similar technique was used to intervene on the second large classified into extrahepatic (48.9%) or malforintrahepatic (36.2%). dilation and lack of portal mations bypass the liver, causing unmetabolized portal blood Previous to presentation: This case was presented at the NCSCG patients with intractable Portosystemic shunts are usually believed to be due to portal intrahepatic portovenous shunt in segment 5 and resulted in perfusion of liver.

Figure flow directly into the systemic circulation and subsequently cause Liver Symposium; December 7, 2019; San Francisco, California. hypertension in the Our setting underlying hepatic disease. Along stagnant flow postembolization. A final main portal venogram persistent encephalopathy. patientof presented with a porto3. Transhepatic venogram presentations of hepatic systemic shunt within the right lobe of the liver. Previous cases Informed consentimaging was obtained for this case report. with a comprehensive biochemical workup, various demonstrated enhanced visualization of the hepatic parenpostintervention with hypothesize an embryonic explanation of shunts in the right lobe encephalopathy. chyma and no hepatofugal flow (Figure 3). On follow-up, the modalities assist inbetween the detection and characterization of the Received March 20, 2020; Accepted July 17, 2020 because of the can communication the omphalomesenteric Amplatzer II 16 mm vascular 5

6

patient had no further episodes of hepatic encephalopathy and ammonia levels were normalized to 32 mmol/L.

 Read the Case: DISCUSSION bit.ly/ Figure 2.

ACGCRJ-Kassamali-etal An abnormal connection between the portal and systemic cir-

7,8

venous system that empties intoincluding the sinus venosus. anatomical anomaly, ultrasoundplugs and cross-sectional and adjacent Azur and REFERENCES imaging computed tomography.

Doppler ultrasonogra1. Riggio O, Efrati C, Catalano C, et al. coils High prevalence On the basissuch of having high ammonia levels, lack of advanced Nester embolization of of spontaneous portalsystemic shunts in persistent hepatic encephalopathy: A case-control study. liver allows fibrosis, and the presence of of a large intrahepaticblood shunt on phy visualization abnormal flow and estimationshunts, Hepatology 2005;42:1158–65. portovenous imaging, the case is formally classified as portal-systemic both en2. Qi X, Ye C, Hou Y, Guo X. A large spontaneous intrahepatic portosystemic ofcephalopathy the shunt. ammonia, a known culprit of shunt in a cirrhotic patient.

Intractable Rare Dis (also Unmetabolized known as type B encephalopathy) rather now demonstrating restoredRes 2016;5(1):58–60.

3. Watanabe A. Portal-systemic encephalopathy in non-cirrhotic patients: 3,7,9 In cases where than traditional hepatic encephalopathy. hepatic encephalopathy, is highly dependent on portal anddiagnosis and treatment. J Gastroenterol Classification of flow clinical types, portal vasculature. recurrent portal-systemic encephalopathy to be Hepatol 2000;15:969–79.

Figureis3.unable 4 ismanaged elevated the setting of aappropriate shunt. shunt clo4. Córdoba J. New assessment of hepatic encephalopathy. J Hepatol 2011; within conservative treatment, 54(5):1030–40.

3. Transhepatic II sure using coils venogram or surgicalpostintervention intervention with mustAmplatzer be considered.

5. Wu W, Han G. Diagnosis and treatment of patients with cirrhotic portal 2. Transhepatic venogram with selective injection culation is known asFigure a portosystemic shunt.

These canof the berightFigure 16 mmMost vascular plugs and adjacent Azurare andin Nester embolization coilsand of asso- hypertension and spontaneous portal shunt. J Clin Hepatol 2015;31(9): studied interventions cirrhotic patients posterior portal vein demonstrates portovenous shunt in segment both 7 portovenous shunts, now demonstrating restored portal vasculature.

The prevalence of spontaneous portal shunts in cirrhotic patients with massive hepatic vein dilation and lack of portal perfusion of liver. ciated with improved survival, liver function, and prevention of 1528–31.

6. Simón-Talero M, Roccarina D, Martínez J, et al. Association between is 38%–40% and is seen in 46%–70% of those with shunts refractory portosystemic and increased complications and mortality in patients hepatic encephalopathy.10,11 This case demonstrates successful 5 with cirrhosis. Gastroenterology 2018;154(6):1694–705.e4. a retrospective study with 2,000 patients, encephalopathy. angiographic embolization of aIn spontaneous intrahepatic porACG Case Reports Journal / Volume 7 acgcasereports.com7.2 Raskin NH, Price JB, Fishman AA. Portal-systemic encephalopathy due to tosystemic shunt, with confirmatory reduction in serum amcongenital intrahepatic shunts. N Engl J Med 1964;270:225–9. approximately 60% of cirrhotic patients had a spontaneous 8. Park JH, Cha SH, Han JK.porIntrahepatic portosystemic venous shunt. Am J monia and restoration of normal hepatic portal circulation.

Roentgenol 1990;155:527–8. the Journals | endovascular 43 management of spontaneous intrahepatic tosystemic shunt.6 In rare instances,Inside 9. Saad WE. Portosystemic shunt syndrome and This portosystemic is a unique case of a large spontaneous portosystemic shunt hepatic encephalopathy. Semin Intervent Radiol 2014;31(3):262–5. shunts can be found in the absence of congenital 10. An J, Kim K, Han S, Lee J, Lim Y. Improvement in survival associated with 3,9

AJG Special Issue!

CHANGING LANDSCAPE in GI PRACTICE 2020 WAS A LANDMARK YEAR for practice changes in medicine. These changes involved all aspects of gastroenterology and hepatology.

Many of these changes are a continuation of the transformation in GI practice clinicians have encountered over the past decade. With this in mind, it’s time to update the map of GI practice.

In 2021, the Red Journal will publish a special issue dedicated to the changing landscape in GI practice. The editors request your highquality, clinically relevant on topics affecting current practices including technology, payment models, government regulations, environmental

Submit Your Manuscript!

Submit manuscripts to:

www.editorialmanager.com/ajg

DEADLINE: MAY 1, 2021

sustainability, educations, and treatment options.

We will collect the very best articles into a special issue mapping how our field has rerouted, and how we can best adapt to future trends affecting GI practice and policy.

Please address questions to Claire Neumann, Managing Editor: cneumann@gi.org www.amjgastro.com

Please clearly state in your cover letter that your manuscript is intended for the special issue on the Changing Landscape in GI Practice. Depending on the responses to this request, some accepted manuscripts may be published in other upcoming issues of AJG.

44 | GI.ORG/ACGMAGAZINE

50 YEARS AGO... from the pages

of The American Journal of Gastroenterology

By Lawrence R. Schiller, MD, MACG for the ACG Archives Committee

Hans Popper and “The Problem of Hepatitis”

F

ifty years ago, The American Journal of Gastroenterology published the Distinguished Lecture delivered at the 35th Annual Meeting of the ACG by Hans Popper, MD, PhD, FACG, the father of modern hepatology.1 The talk was entitled, “The Problem of Hepatitis,” and was an attempt to establish ‘hepatitis’ as a diagnostic entity in which injury elicited an inflammatory reaction, and disfunction of organelles in the hepatocytes produced functional disturbances. He advanced the concepts that the different etiologies of acute hepatitis had similar functional disturbances and that differential diagnosis depended on epidemiology, demonstration of “hepatitis-associated antigen” (what we now know as hepatitis B surface antigen), and liver biopsy. He also proposed that periportal inflammation was a key component of chronic hepatitis and could serve as a prognostic finding.

Although we take these concepts as gospel now, these conclusions were novel 50 years ago. They resulted from Dr. Popper’s adoption of new technologies and keen histological observations, honed by investigations in renal pathology and biochemistry dating back to his postdoctoral studies in Vienna in the early 1930s.2 After the takeover of Austria by Nazi Germany in 1938, he was dismissed from the University of Vienna because of his Jewish ancestry and fled to the United States. He became a researcher at Cook County Hospital in Chicago.

There he turned his attention to liver diseases and published many papers highlighting mechanisms of liver injury and their effects on liver morphology. He identified intrahepatic cholestasis and delineated the development of hepatic fibrosis with liver diseases.3 Dr. Popper was instrumental in founding the American Association for the Study of Liver Diseases (AASLD) in 1948, and the International Association for the Study of the Liver (IASL) in 1958.

He moved from Chicago to Mount Sinai Hospital in New York in 1957 as Chief of Pathology and sparked the formation of a new medical school there. Following his retirement from administration of the medical school at age 70, he was back in the laboratory exploring the liver and its disorders.

During this phase of his career, he developed the idea that hepatitis B could be a precursor of hepatocellular carcinoma.

Those who knew him best always commented on his brilliant intellect, curiosity, tirelessness, precision, gentleness, and humility.2 He was deeply invested in sharing his knowledge and inspiring young investigators to advance the field. Perhaps the most telling characterization was revealed in the dedication of the 1974 yearbook to Hans Popper by the students at Mount Sinai School of Medicine: Few times in life is one fortunate enough to come to know a man as rare as Dr. Popper. He is a kind and gentle individual, a scholar and teacher who loves learning and who delights in sharing his knowledge with others. He loves life with an exuberance which he joyously imparts to those around him.

References: 1. Popper H. The problem of hepatitis. Am J Gastroenterol 1971;55(4):335-346.

2. Schmid R, Schenker S. Hans Popper in memoriam, 19031988. Hepatology 1989;9(5):669-674.

3. Schmid R. Hans Popper. Chapter 15, in National Academy of Sciences. Biographical Memoirs: Volume 65. Washington, DC: The National Academies Press, 1994, pages 291-309. https://doi.org/10.17226/4548.

Inside the Journals | 45

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Eastern Time

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use.

INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

DOSAGE AND ADMINSTRATION: Split Dose (2-Day) Regimen: Dose 1 – On the day prior to colonoscopy: A low residue breakfast may be Packaging and consumed. After breakfast, only clear liquids may be consumed until after the tablets not shown colonoscopy. Early in the evening prior to colonoscopy, open one bottle of actual size.

12 tablets. Fill the provided container with 16 ounces of water (up to the fill line).

Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Dose 2 - Day of colonoscopy: Continue to consume only clear liquids until after the colonoscopy. The morning of colonoscopy (5 to 8 hours prior to the colonoscopy and no sooner than 4 hours from starting Dose 1), open the second bottle of 12 tablets. Fill the provided container with 16 ounces of water (up to the fill line). Swallow each tablet with a sip of water and drink the entire amount over 15 to 20 minutes. Approximately one hour after the last tablet is ingested, fill the provided container a second time with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes.

Approximately 30 minutes after finishing the second container of water, fill the provided container with 16 ounces of water (up to the fill line) and drink the entire amount over 30 minutes. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.

CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Serious Fluid and Electrolyte Abnormalities: Advise all patients to hydrate adequately before, during, and after the use of SUTAB. If a patient develops significant vomiting or signs of dehydration after taking SUTAB, consider performing post-colonoscopy lab tests (electrolytes, creatinine, and BUN). Fluid and electrolyte disturbances can lead to serious adverse events including cardiac arrhythmias, seizures and renal impairment. Correct fluid and electrolyte abnormalities before treatment with SUTAB. Use SUTAB with caution in patients with conditions, or who are using medications, that increase the risk for fluid and electrolyte disturbances or may increase the risk of adverse events of seizure, arrhythmias, and renal impairment; Cardiac arrhythmias: Use caution when prescribing SUTAB for patients at increased risk of arrhythmias (e.g., patients with a history of prolonged QT, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, or cardiomyopathy). Consider pre-dose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias; Seizures: Use caution when prescribing SUTAB for patients with a history of seizures and in patients at increased risk of seizure, such as patients taking medications that lower the seizure threshold (e.g., tricyclic antidepressants), patients withdrawing from alcohol or benzodiazepines, or patients with known or suspected hyponatremia; Use in Patients with Risk of Renal Injury: Use SUTAB with caution in patients with impaired renal function or patients taking concomitant medications that may affect renal function (such as diuretics, angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or non-steroidal anti-inflammatory drugs). These patients may be at risk for renal injury.

Advise these patients of the importance of adequate hydration with SUTAB and consider performing baseline and post-colonoscopy laboratory tests (electrolytes, creatinine, and BUN) in these patients; Colonic Mucosal Ulcerations and Ischemic Colitis: Osmotic laxative products may produce colonic mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Concurrent use of stimulant laxatives and SUTAB may increase these risks. Consider the potential for mucosal ulcerations resulting from the bowel preparation when interpreting colonoscopy findings in patients with known or suspect inflammatory bowel disease (IBD); Use in Patients with Significant Gastrointestinal Disease: If gastrointestinal obstruction or perforation is suspected, perform appropriate diagnostic studies to rule out these conditions before administering SUTAB. Use with caution in patients with severe active ulcerative colitis. ADVERSE REACTIONS: Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. POTENTIAL FOR DRUG ABSORPTION: SUTAB can reduce the absorption of other co-administered drugs. Administer oral medications at least one hour before starting each dose of SUTAB. Administer tetracycline and fluoroquinolone antibiotics, iron, digoxin, chlorpromazine, and penicillamine at least 2 hours before and not less than 6 hours after administration of each dose of SUTAB to avoid chelation with magnesium. Pregnancy: There are no available data on SUTAB use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No reproduction or developmental studies in animals have been conducted with sodium sulfate, magnesium sulfate, and potassium chloride (SUTAB). Lactation: There are no available data on the presence of SUTAB in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 471 patients who received SUTAB in pivotal clinical trials, 150 (32%) were 65 years of age or older, and 25 (5%) were 75 years of age or older. No differences in safety or effectiveness of SUTAB were observed between geriatric patients and younger patients. Elderly patients are more likely to have decreased hepatic, renal or cardiac function and may be more susceptible to adverse reactions resulting from fluid and electrolyte abnormalities. STORAGE: Store at 20º to 25°C (68º to 77°F). Excursions permitted between 15º to 30°C (59º to 86°F). See USP controlled room temperature. Rx only. Manufactured by Braintree Laboratories, Inc. Braintree, MA 02185 See Full Prescribing Information and Medication Guide at SUTAB.com.

References: 1. SUTAB® [package insert]. Braintree, MA; 2020. 2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. Published online November 6, 2020. doi: 10.14309/ajg.0000000000001020 3. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; ACG. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 4. IQVIA. National Prescription Audit Report. November 2020.

For additional information, please call 1-800-874-6756 ©2021 Braintree Laboratories, Inc.

All rights reserved.

201-133-v1-A January 2021

!

W! E NEW N

A NEW TABLET CHOICE A BOWEL NEW TABLET CHOICE IN PREPARATION IN BOWEL PREPARATION

• NO SODIUM PHOSPHATE1

• SAFE AND EFFECTIVE1,2 1 • NO SODIUM PHOSPHATE • ACG-RECOMMENDED1,2 SPLIT-DOSE REGIMEN3 • SAFE AND EFFECTIVE 1 – Two SUTAB doses are required for a complete preparation

Dose 1 consists of 12 tablets and 16 oz of water REGIMEN3 • ACG-RECOMMENDED SPLIT-DOSE Dose 2 consists of 12 tablets and 16 oz of water 1 – Two are required for a complete preparation EachSUTAB dose isdoses followed by two additional 16 oz of water Dose 1 consists of 12 tablets and 16 oz of water Dose 2 consists of 12 tablets and 16 oz of water Packaging and tablets not shown size.

Each dose is followed by actual two additional 16 oz of water

92% OF PATIENTS IN TWO PIVOTAL TRIALS ACHIEVED SUCCESSFUL BOWEL CLEANSING WITH SUTAB1,2* 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY TO CONSUME2† 1,2 ® 1,2‡ 92% OF PATIENTS IN TWO PIVOTAL TRIALSreported ACHIEVED SUCCESSFUL CLEANSING SUTAB * • 52% of all SUTAB and MoviPrep patients at least one selectedBOWEL gastrointestinal adverseWITH reaction • More SUTAB patients reported experiencing nausea and vomiting than competitor, with ≤1%TO of these reports2† 91% OF PATIENTS IN ONE PIVOTAL TRIAL RATED SUTAB AS TOLERABLE TO VERY EASY CONSUME 2‡ Packaging and tablets not shown actual size.

considered severeand MoviPrep® patients reported at least one selected gastrointestinal adverse reaction1,2‡ • 52% of all SUTAB

2† 78% OF PATIENTS ONE reported PIVOTALexperiencing TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE • More SUTAB IN patients nausea and vomiting than competitor, with ≤1% ofCOLONOSCOPY these reports

considered severe * Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned on withdrawal of colonoscope.

OF PATIENTS IN ONE PIVOTAL TRIAL WOULD REQUEST SUTAB AGAIN FOR A FUTURE COLONOSCOPY2† † Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This * questionnaire has not undergone formal validation.

Success was primary endpoint and was defined in noninferiority trials as an overall cleaning assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; ‡ scores were assigned on withdrawal of colonoscope.

Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion †of study drug, rating the intensity as mild, moderate, or severe.

Patients completed preference questionnaire following completion of study drug to capture the subject’s perceptions of the preparation experience. This questionnaire has not undergone formal validation.

ACG=American College of Gastroenterology ‡ ® Patients were queried for selected gastrointestinal adverse reactions of upper abdominal pain, abdominal distension, nausea, and vomiting following completion is a registered trademark of Velinor AG. MoviPrep of study drug, rating the intensity as mild, moderate, or severe.

ACG=American College of Gastroenterology MoviPrep® is a registered trademark of Velinor AG. IMPORTANT SAFETY INFORMATION 2‡

78%

SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After IMPORTANT SAFETY INFORMATION breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required ® SUTAB (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose colon in preparation for colonoscopy in adults. DOSAGE AND ADMINSTRATION: A low residue breakfast may be consumed. After of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each before colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients bowel perforation, toxic colitis or toxic megacolon, gastric retention. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration. ADVERSE REACTIONS: Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting and upper abdominal pain. DRUG SUTAB.com.

INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance.

Please see Brief Summary of Prescribing Information on reverse side. See Full Prescribing Information and Medication Guide at SUTAB.com.

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

From the makers of SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution for adults—

THE #1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT4

ACG MAGAZINE ARCHIVE 2020 ACG MAGAZINE Spring 2020

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