ACG MAGAZINE | Vol. 3, No. 3 | Fall 2019

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ACG MAGAZINE Fall 2019

MEMBERS. MEDICINE. MEANING.


A M E R I C A N

C O L L E G E

O F

G A S T R O E N T E R O L O G Y

Annual Scientific Meeting & Postgraduate Course Henry B. Gonzalez Convention Center, San Antonio, TX OCTOBER 25–30, 2019

REGISTER NOW! Learn the latest in clinical practice, exchange ideas with colleagues, and gain insight from the experts at the ACG 2019 Annual Scientific Meeting and Postgraduate Course.  Housing Deadline: Wednesday, October 2, 2019  Preregistration Deadline: Friday, October 18, 2019

 LEARN MORE: ACGMEETINGS.GI.ORG


FALL 2019 // VOLUME 3, NUMBER 3

FEATURED CONTENTS COVER STORY

CONQUERING THE PRIOR AUTHORIZATION MAZE

Submitting PAs can be tedious, time-consuming and anxietyprovoking. Experts offer tips on ways to conquer the process and advocate for reform. PAGE 26

PRACTICE-FRIENDLY PRIVATE EQUITY

Ann M. Bittinger, Esq. on what to look for when selling your practice PAGE 24

LEADERSHIP

Insights from a dialogue with ACG’s women Governors and ACG President Dr. Sunanda Kane PAGE 15

IN MEMORIAM

Celebrating the life of Arthur H. Aufses, Jr., MD, MACG, a remarkable leader and extraordinary educator PAGE 11

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Attend an upcoming

ACG POSTGRADUATE COURSE 2019 ACG 2019 Annual Scientific Meeting and Postgraduate Course  Henry B. Gonzalez Convention Center | San Antonio, TX  October 25–30, 2019 • GI Practice Course | October 25 • GI Pharmacology | October 25 • GI Pathophysiology | October 25 • Postgraduate Course | October 26–27 • Annual Scientific Meeting | October 28–30

ACG’s Hepatology School & Southern Regional Postgraduate Course  Omni Louisville | Louisville, KY  December 6–8, 2019

2020 ACG’s Functional GI Disorders School & Bridging the Leadership Gap in Gastroenterology Course

NEW!

Leadership Course

(A project of the Women in GI Committee)  Marriott Marquis Hotel | San Diego, CA  January 10–12, 2020

ACG’s IBD School & ACG Board of Governors / ASGE Best Practices Course  The Bellagio | Las Vegas, NV  January 24–26, 2020

ACG / LGS Regional Postgraduate Course  Hilton New Orleans Riverside | New Orleans, LA  March 6–8, 2020

ACG / FGS Annual Spring Symposium  Hyatt Regency Coconut Point | Bonita Springs, FL  March 13–15, 2020

FOR MORE INFO, VISIT: GI.ORG/ACG-COURSE-CALENDAR


FALL 2019 // VOLUME 3, NUMBER 3

CONTENTS

ACG President Dr. Sunanda Kane invited the College’s eight female Governors to share their experiences as women in GI and as ACG Governors. She asked them for tips and thoughts on ways female gastroenterologists can become more involved in ACG. —“Insights from a Dialogue with ACG's Women Governors,” Leadership PG 15

6 //MESSAGE FROM THE PRESIDENT

26 // COVER STORY

43 // INSIDE THE JOURNALS

Dr. Sunanda Kane shares her perspective on what patient safety looks like today and what it could look like in 2030

CONQUERING THE PRIOR AUTHORIZATION MAZE A collaboration between physicians and pharmacists offers strategies to successfully navigate the challenges of prior authorization

44 AJG Professor Paul Enck highlights his investigative research on probiotic strain, B. longum 1714TM, which suggests this strain may make it easier for healthy people to deal with stress

33 // ACG PERSPECTIVES

46 CTG Mucosa-associated microbiota of the pouch may contribute to clinical symptoms, particularly stool frequency, in IPAA

7 // NOVEL & NOTEWORTHY #DiversityinGI, College News, Gender Equity Resolution at the AMA, In Memoriam for Dr. Arthur Aufses, and more

15 // LEADERSHIP GOVERNORS’ VANTAGE POINT ACG's women Governors and Dr. Sunanda Kane highlight their experiences and offer some helpful tips

21 // GETTING IT RIGHT 21 BUILDING SUCCESS Dr. Stephen T. Amann and Dr. James C. DiLorenzo on Professional Service Agreements with a Hospital System 24 LAW MIND Strategies and legal considerations for selling a GI practice to a private equity firm

33 ACG'S YOUNG PHYSICIAN LEADERS Dr. Paine shares her account of ACG's Young Physician Leadership Scholars Program and their time on the Hill 35 FDA FELLOWSHIPS: INSIDE THE AGENCY Dr. Cartee and Dr. Hernandez-Barco reflect on their time as ACG FDA Fellows

37 // EDUCATION 37 EDGAR ACHKAR VISITING PROFESSORSHIPS Highlights from four EAVPs, including Dr. Rubin, Dr. Chey, Dr. Lacy, and Dr. Shaheen 40 ACG INTERNATIONAL TRAINING GRANT Dr. Cazacu of Romania describes her mentorship experience with Dr. Bhutani at MD Anderson Cancer Center

46 ACGCRJ Cocaine Gut

47 // A LOOK BACK 50 YEARS AGO IN AJG Observing the ileocecal junction in vivo from the November 1969 issue of The American Journal of Gastroenterology

48 // REACHING THE CECUM MEDITERRANEAN DIET FOR NAFLD A one-page reference to tear out for patient use by Michael Bass, MD of the ACG Patient Care Committee

Photo Caption: Women members of the ACG Board of Governors with President Sunanda V. Kane, MD, MSPH, FACG in Washington, DC, April 5, 2019. Photo by Ben Zweig.

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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 Sarah Richman Lindsey Topp

bit.ly/ACG-Linked-In

Art Director Emily Garel Graphic Designer Antonella Iseas

BOARD OF TRUSTEES President: Sunanda V. Kane, MD, MSPH, FACG President-Elect: Mark B. Pochapin, MD, FACG Vice President: David A. Greenwald, MD, FACG Secretary: Daniel J. Pambianco, MD, FACG Treasurer: Samir A. Shah, MD, FACG Immediate Past President: Irving M. Pike, MD, FACG

CONTACT IDEAS & FEEDBACK We'd love to hear from you. Send us your ideas, stories and comments.

ACGMag@gi.org

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

Past President: Carol A. Burke, MD, FACG Director, ACG Institute: Nicholas J. Shaheen, MD, MPH, 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: Neil H. Stollman, MD, FACG Vice Chair, Board of Governors: Patrick E. Young, MD, FACG Trustee for Administrative Affairs: Delbert L. Chumley, MD, FACG

ACG MAGAZINE Spring 2019

MEMBERS. MEDICINE. MEANING.

Profiles in Courage IN The Fight Against Colorectal Cancer

ACG MAGAZINE Spring 2019

MEMBERS. MEDICINE. MEANING.

TRUSTEES

Profiles in Courage IN The Fight Against Colorectal Cancer

Jean-Paul Achkar, MD, FACG William D. Chey, MD, FACG Immanuel K. H. Ho, MD, FACG Caroll D. Koscheski, MD, FACG Paul Y. Kwo, MD, FACG Jonathan A. Leighton, MD, FACG Amy S. Oxentenko, MD, FACG David T. Rubin, MD, FACG John R. Saltzman, MD, FACG Renee L. Williams, MD, MHPE, FACG

4 | GI.ORG/ACGMAGAZINE

American College of Gastroenterology is an international organization with more than 14,000 physician members representing some 85 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

Stephen T. Amann, MD, FACG

Paul Enck, PhD

Dr. Amann is a partner at Digestive Health Specialists, PA in Tupelo, MS and is a member of ACG's Practice Management Committee

Professor Paul Enck is Director of Research at the Dept. of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Germany

David E. Bernstein, MD, FACG Dr. Bernstein is Clinical Professor of Medicine at the Albert Einstein College of Medicine, Professor of Medicine at the Hofstra North Shore Long Island Jewish School of Medicine, and Chief of Hepatology at the North Shore-LIJ Health System

Francis A. Farraye, MD, MSc, FACG Dr. Farraye co-directs the Inflammatory Bowel Disease Center at the Mayo Clinic in Jacksonville, Florida. Prior to relocating in 2019, he was Clinical Director in the Section of Gastroenterology and the IBD Center at Boston Medical Center

Shubha Bhat, PharmD, BCACP Shubha Bhat is an Ambulatory Care Clinical Pharmacy Specialist in Gastroenterology at Boston Medical Center who trained at Northeastern University

Ann M. Bittinger, Esquire Ms. Bittinger is a health law expert at Bittinger Law Firm in Jacksonville, FL. She regularly contributes to ACG's publications on her areas of expertise, including legal relationships between hospital systems and physicians or physician groups (bittingerlaw.com)

Yasmin G. Hernandez-Barco, MD Dr. Yasmin Hernandez-Barco is a Gastroenterology and Hepatology Fellow in the Division of Gastroenterology at the Massachusetts General Hospital, and Research Fellow at the Harvard School of Medicine and Broad Institute of Massachusetts Institute of Technology and Harvard

Susan Lee, PharmD, BCPS, CDE Dr. Lee is a specialist pharmacist practicing in hepatology. She received her PharmD from St. John's University College of Pharmacy and Health Sciences

Amanda K. Cartee, MD Dr. Cartee finished her Gastroenterology fellowship at the Mayo Clinic, Rochester, MN in June 2019 and joined the University of Michigan GI faculty

Elizabeth R. Paine, MD Dr. Paine is Assistant Professor of Medicine at the University of Mississippi Medical Center where she directs the GI fellowship program

Irina M. Cazacu, MD Dr. Cazacu of the University of Medicine and Pharmacy in Craiova, Romania was ACG's International Training Grantee at MD Anderson Cancer Center

James C. DiLorenzo, MD

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

Dr. DiLorenzo is CEO of New York Associates in Gastroenterology, LLP, a 12-physician single specialty GI practice in Westchester, NY and the Bronx, and a member of ACG's Practice Management Committee

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THE BRITISH MEDICAL JOURNAL JUST PUBLISHED A META-ANALYSIS ON PREVENTABLE HARM and it got me thinking. Harm in medical care is inevitable, but it is the preventable harm by which a system is ultimately judged. Every system, whether it is a large practice or just five practitioners, has its gaps and weaknesses, and when those holes all line up during a patient journey something untoward occurs. Most of us are familiar with the “Swiss cheese” model of adverse events. The size of the system just drives how many slices of cheese there are. To prevent harm, we need to be reactive in the identification of how processes align to allow these to happen but then proactive in the elimination of the holes in each “slice” or step of the journey. What does safety look like today, and what will it look like in 2030? Today it means that safe care starts in a physical environment in which its citizens feel safe, a culture where an employee can speak up and feel comfortable doing so. As leaders in our practices, we need to set the example of what that looks like, allowing for open dialogue and engagement to identify problems before the holes in the Swiss cheese line up. Unfortunately, too many times folks are “siloed” in their work responsibilities and thus the holes of the Swiss cheese line up. One of the Top 10 safety issues in the U.S. today is falls with injury. This costs our health care system billions of dollars a year and is in most cases preventable. Most of us do not think about falls at all, why is that? I believe that it is because of this very silo effect. The issue of falls has been historically owned and championed by Nursing. However, patients in our care are sedated, frail, running to the washroom or encephalopathic. What does it take to remind a patient to ring the call light to get help to the toilet as they are in a vulnerable position to be harmed? Maybe about 20 seconds, and in those seconds a patient hears that their provider cares about them and is reiterating what they have heard from their nurse, thus resulting in the conclusion that everyone is really working as a team. Having been active on the Reduce Falls with Injury (REFINe) working group here at Mayo, I have come to appreciate how simple interventions from anyone working in roles ranging from

6 | GI.ORG/ACGMAGAZINE

“U.S. News and World Report evaluation has now replaced patient safety with patient satisfaction, at least for now. However, it is critical that we continue to provide safe care in the context of ensuring patient trust.”

­­—Sunanda V. Kane, MD, MSPH, FACG

Dr. Kane, Sen. Amy Klobuchar (D-MN), Dr. Prasad Iyer, Dr. Sahil Khanna

MESSAGE FROM THE PRESIDEN

LET'S TALK ABOUT SAFETY

food service to environmental service to gastroenterology consultation can impact a patient’s risk of falling. It was a deep dive into the problem that helped identify toileting as a major driver for patient fall risk; development of simple scripts one to two lines in length shared with all employees in the hospital to remind a patient not to go to the toilet unassisted is a way to get everyone on board and have them invested and own the problem as a unit. Use of consistent messaging in everything that we do is how culture is changed. Another area in which we all engage is the intended procedure with a procedural pause. Standardizing the process reduces the number of wrong procedures, incomplete procedures and wrong patients. It includes simplification so that no one has to guess as to: 1) where pertinent information is located, 2) who needs to be involved, and 3) what information is included. Hardwiring this process will take teamwork across surgical, procedural and nursing disciplines to work together, facilitated by a leader invested in change. U.S. News and World Report evaluation has now replaced patient safety with patient satisfaction, at least for now. However, it is critical that we continue to provide safe care in the context of ensuring patient trust. If safety in the future is tied to patient satisfaction, we need to be mindful that simple strategies like using layman’s terms to describe medical results and procedures, writing down names of medications, and setting expectations up front are some of the ways that patients are satisfied. So then what does safety look like in 2030? As we move towards construction of a virtual platform we will be able to harness the power of Artificial Intelligence to help us answer some key questions in regards to safety that are not obvious to us now. These for gastroenterology likely include predicting who needs urgent endoscopy, who needs continued surveillance of polyps, and timing of liver transplant. Change is hard for most people, and getting buy-in for new strategies, methodologies and protocols can be difficult. Balancing what has to happen with what should happen takes finesse, understanding and passion for the issue at hand, along with clear vision of a safe future for ourselves and our patients.


Note hy wor t ACG MAGAZINE showcases the accomplishments of ACG members and serves as forum to share developments in the GI profession as well as College news, including the #DiversityinGI social media campaign and a report on ACG’s role in sponsoring a resolution on gender equity in medicine adopted by the AMA House of Delegates. The College celebrates the life and illustrious career of Past President Dr. Arthur Aufses, who died in April. The ACG website, gi.org, is newly re-designed and completely re-envisioned. The Digital Communications & Publications Committee, under the leadership of Dr. Jordan J. Karlitz, provided thoughtful input and feedback to ensure the new site meets the needs of ACG’s diverse members and their patients.

Novel & Noteworthy | 7


// N&N [AWARDEES]

RESEARCH GRANTS

Dustin Carlson, MD, MSCI of Northwestern University received the 2019 ACG Junior Faculty Development Grant for his project, “Biomechanical Assessment of the Esophagogastric Junction and Application of Predictive Analytics to Enhance Evaluation of Functional Dysphagia.” This award of $100,000 per year for each of three years provides salary support for protected time to young investigators at critical points in their career development.

2019 Clinical Research Awardees

Each year, the ACG Institute offers Clinical Research Awards, in the amount of $50,000 for original clinical research. The Institute also considers proposals within the Clinical Research Award category for pilot awards of up to $15,000. For 2019, Clinical Research Awards will go to twelve investigators, including one for a Smaller Programs Clinical Research Award, for a total of $407,420. The ACG Institute is very proud of all the 2019 awardees and their commitment to advancing clinical research in gastroenterology and hepatology. Their names and photos can be viewed via the ACG website.  VIEW THE AWARDEES:

[RESOLUTION]

ACG At AMA: Gender Equity in Medicine On June 11th, the AMA House of Delegates adopted a comprehensive set of principles on gender equity in medicine based on a resolution introduced back in 2018. With the assistance of ACG member Suriya Sastri, MD, FACG the resolution was this year introduced by ACG’s two physician representatives to the AMA House of Delegates, R. Bruce Cameron, MD, FACG and March E. Seabrook, MD, FACG. The ACG resolution was combined by the AMA with a resolution introduced simultaneously last year by the American College of Cardiology. Dr. Sastri commented, “Our draft resolution squarely dealt with the day-to-day issues that greatly impact gender equity in medicine, such as transparency

in pay scale and periodic review to remedy any such disparity.” The “Principles for Advancing Gender Equity in Medicine” adopted by the AMA include opposition to any exploitation or discrimination in the workplace based on personal characteristics (i.e., gender). Further, the principles affirm the concept of equal rights for all physicians as well as the concept that equality of rights under the law shall not be denied or abridged by the U.S. Government or by any state on account of gender. Among other important provisions, the principles endorse equal opportunity of employment and practice in the medical field.  READ MORE: bit.ly/AMAGenderEquity

bit.ly/ACG2019Grants

[EDUCATION]

GROW YOUR LEADERSHIP SKILLS IN GI

Have you ever wondered what is holding you back as a leader? Some individuals appear to rise seamlessly into leadership roles, while others may feel that they reach a ceiling and wonder what they can do to break through it. “Bridging the Leadership Gap in Gastroenterology,” a project of the Women in Gastroenterology Committee, was designed to provide

8 | GI.ORG/ACGMAGAZINE

insight and strategy to those who want to maximize their leadership potential and trajectory. This unique program highlights GI practice challenges and ways to build resilience, professional success, and career satisfaction in a changing healthcare environment. The course faculty are established GI leaders and are excited to share their tips and tricks for you to be the most successful in your current or future roles. Join us January 10 to 12, 2020 in San Diego, CA and kick off the weekend with ACG’s new Friday course, Functional GI School.

“We know there are leadership gaps in gastroenterology, particularly for women and those underrepresented in medicine. We also know that while some leadership skills may be innate, others can be learned.” —Amy S. Oxentenko, MD, FACG and Jill K. J. Gaidos, MD, FACG, Course Co-Directors

 LEARN MORE: bit.ly/ACGBridgingtheGap

Top Right: Dr. Suriya Sastri, author of ACG resolution on gender equity in medicine adopted by the AMA House of Delegates. ACG’s Representatives to the AMA House of Delegates, Dr. R. Bruce Cameron and Dr. March E. Seabrook.

2019 ACG Junior Faculty Development Grant Awardee


[ACG INSTITUTE]

NEW RESEARCH FUNDS FOR MEDICAL STUDENTS & RESIDENTS

The ACG Institute for Clinical Research and Education announces two new clinical research awards targeted to residents and medical students. The purpose of these grants is to recognize and support trainees as they develop a career in clinical research in gastroenterology and hepatology and help cultivate an interest in a career in GI or hepatology among medical students. ACG Medical Student Research Awards will fund a mentored research experience in patient-

[MILESTONES]

Civilian Job for Dr. Mark Riddle Mark S. Riddle, MD, DrPH, has been appointed by the University of Nevada, Reno School of Medicine and the VA Sierra Nevada Health Care System to dual clinical research appointments. After a long career as a U.S. Navy physician, Dr. Riddle will be a professor of internal medicine and associate dean for clinical research. The VA Sierra Nevada Health Care System has also named Dr. Riddle Associate Chief of Staff for Research.

oriented research. Funding of up to $5,000 will cover summer projects of 6 to 10 weeks related to clinical gastroenterology under the mentorship of an ACG member. In addition, the award covers registration and up to $1,500 of travel costs to attend the ACG Annual Scientific Meeting. ACG Resident Research Awards will fund up to $10,000 for original research in clinical gastroenterology for physicians-in-training (residents) under the mentorship of an ACG member. Additionally, the award covers registration and travel costs of up to $1,500 attend the ACG Annual Scientific Meeting. The deadline for both awards is Friday, December 6, 2019.  LEARN MORE Residents: bit.ly/ResidentGrantsACG Medical Students: bit.ly/MedStudentGrantsACG

Dr. Riddle brings more than two decades of combined research and development, public health, academic and clinical medicine expertise to his new role. His specific areas of expertise include the global impact of infectious and gastrointestinal disease, population-based epidemiological study design and execution, population health, health economics and analysis, biomarker discovery and translational research, among other key areas.

Most recently, Dr. Riddle served as professor and chair of the Department of Preventive Medicine and Biostatistics at the F. Edward Hébert School of Medicine, Uniformed Services University in Bethesda, Maryland, where he oversaw more than 60 full-time faculty members supporting ten programs and divisions responsible for enhancing health through medical education, research and service. He also served the U.S. Army and Navy in various director roles including leading the U.S. Military Diarrheal Diseases Vaccine Research Program and the Enteric Diseases Department at the Naval Medical Research Center.

[ACG NEWS]

A New L ook, A New Exper ience:

GI.ORG The College has re-envisioned and re-built its gi.org website to be a more useful resource. ACG’s goal was to make it easier and faster to find tools and resources that matter most to our members, GI health care teams, their patients, and the public. The site is optimized for mobile use and features an intuitive search function and new site architecture to provide the best possible user experience.  Explore GI.ORG

Novel & Noteworthy | 9


MAXIMIZE your LEADERSHIP POTENTIAL!

Attend the ACG

Bridging the Leadership Gap in Gastroenterology Course “Bridging the Leadership Gap in Gastroenterology” was designed to provide insight and strategy to those who want to maximize their leadership potential and trajectory. Learn from a faculty of established leaders, that are excited to share their tips and

ACG’s Functional GI Disorders School & Bridging the Leadership Gap in Gastroenterology course JANUARY 10-12, 2020 Marriott Marquis Hotel | San Diego, CA

tricks for you to be most successful in your current and future roles.

A project of the Women in GI Committee 10 | GI.ORG/ACGMAGAZINE


His Mt. Sinai colleague Dr. Michael Marin commented on Dr. Aufses’ 90th birthday that, “Dr. Aufses has touched many lives. He helped break down barriers for women and ethnic-minority surgeons, and his support has helped many residents and fellows become better physicians than they ever thought possible.”

[TRENDING]

#DIVERSITYINGI SOCIAL MEDIA CAMPAIGN Diversity and inclusion in gastroenterology and in medicine are the focus of a new social media campaign launched in April by the ACG Public Relations Committee, in collaboration with the Minority Affairs & Cultural Diversity Committee, under the leadership of Sophie M. Balzora, MD, FACG (pictured right below), and Darrell M. Gray, II, MD, MPH, FACG (pictured left below), the respective committee chairs.

The campaign aims to increase visibility of and promote diversity and inclusion within gastroenterology through the #DiversityInGI hashtag. The primary goals of the campaign are to motivate students and postgraduate trainees who aspire to a career in the GI field and enrich the pipeline of trainees and providers from underrepresented populations.

Upon launch, the campaign generated an immediate wave photos and personal reflections by U.S. gastroenterologists and colleagues around the world, as well as coverage by Healio Gastroenterology on April 30, 2019. At the start of the academic year on July 1st, ACG partnered with pediatric colleagues from NASPGHAN to engage new fellows and celebrate the diversity of incoming trainees in gastroenterology by reaching out to GI program directors and engaging via social media. Dr. Balzora and Dr. Gray published an op-ed which articulates the campaign’s rationale in which they write, “diversity of people and thought is pivotal to the health of our patients and innovation in the field.” The op-ed appeared in the July issue of Gastroenterology & Endoscopy News.

 LEARN MORE: bit.ly/DiversityCampaign READ: Healio Gastroenterology, “It matters for everyone: ACG’s social media push promotes diversity, inclusion” bit.ly/HealioDiversityinGI READ: Op-Ed, Gastroenterology & Endoscopy News, “#DiversityInGI: A Movement Beyond Hashtags, Tweets and Posts to More Inclusivity” bit.ly/GandENewsDiversity

[IN MEMORIAM]

A REMARKABLE LEADER AND EXTRAORDINARY EDUCATOR With the death of Arthur H. Aufses, Jr., MD, MACG, the College has lost a great friend, and medicine has lost a remarkable leader and extraordinary educator. During his long and illustrious career, Dr. Aufses was Chair of the Department of Surgery at the Icahn School of Medicine at Mt. Sinai in New York City. He practiced general surgery for more than four decades before he retired in 1996 and represented the highest standards as a surgeon, an educator, a leader, and role model. A Master of the College, Dr. Aufses served with distinction as ACG President from 1986 to 1987 and as a committee chair through the 1990’s and 2000’s. Dr. Aufses joined the College in 1975 and was the first male member of the Women in Gastroenterology Committee. Dr. Aufses’ many awards include the Jacobi Medallion— named for Dr. Abraham Jacobi, an early Mount Sinai Medical Board President—the highest award for distinguished achievement in medicine or extraordinary clinical and educational services within Mount Sinai Hospital. In 2003, Dr. Aufses delivered the commencement address at the graduation exercises of the Mount Sinai School of Medicine, where he was awarded an honorary Doctor of Humane Letters degree.

In His Own Words His own words from his ACG Presidential Address speak more eloquently about Dr. Aufses' character and values than any tribute the College might pay:

“We are the ones who must be the role models for college students, our medical students, and our residents. To again quote Dr. Eisenberg, ‘as physicians, we have a moral imperative to sustain the highest aspirations of the students we teach.’ (Eisenberg C. It is Still a Privilege to be a Doctor. N Engl J Med 1986:314:1134) We also have the obligation to practice our science and our art to the best of our ability… We must be our patients' advocates. We are here to serve them, and must always do right by them regardless of outside forces. It is our obligation to preserve excellence in medicine.” From “The Preservation of Excellence in a Hostile Health Care Environment,” ACG Presidential Address by Dr. Arthur H. Aufses, Jr., Am J Gastroenterol 1988:83:351-354.

Novel & Noteworthy | 11

ACG CALENDAR

// N&N


DECEMBER 6 ACG RESEARCH GRANTS DEADLINE Learn More: gi.org/na-intl-training-grant

DECEMBER Register Now: acgmeetings.gi.org

6

HEPATOLOGY SCHOOL AT SOUTHERN REGIONAL

DECEMBER 6

 Louisville, KY

ACG MEDICAL STUDENTS & RESIDENTS GRANTS DEADLINE

Register: meetings.gi.org

Medical Students Info: gi.org/medical-student-research-award-details Residents Info: gi.org/resident-clinical-research-award-details

DECEMBER

7–8

FUNCTIONAL GI DISORDERS SCHOOL

JANUARY

10

JANUARY

11-12

JANUARY

 San Diego, CA

 Louisville, KY Register: meetings.gi.org

BRIDGING THE LEADERSHIP GAP IN GI (A project of the Women in GI Committee)

Register: meetings.gi.org

MARCH 30 2020 GI TRAINING GRANTS DEADLINE

 San Diego, CA

Learn More: gi.org/gi-training-grants Register: meetings.gi.org

MARCH

JANUARY

24

25–26

IBD SCHOOL AT BEST PRACTICES

ACG BOG/ASGE BEST PRACTICES COURSE

 Las Vegas, NV

 Las Vegas, NV

Register: meetings.gi.org

Register: meetings.gi.org

12 | GI.ORG/ACGMAGAZINE

SOUTHERN REGIONAL POSTGRADUATE COURSE

20–22 NORTH AMERICAN CONFERENCE OF GI FELLOWS (NACGF)

 Orlando, FL Learn More: www.abstractscorecard.com/ cfp/submit/login.asp?EventKey=YCFOFAJN


IMPORTANT SAFETY INFORMATION SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. WARNINGS AND PRECAUTIONS: SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether this product can cause fetal harm or can affect reproductive capacity. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 375 patients who took SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, while 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. DRUG INTERACTIONS: Oral medication administered within one hour of the start of administration of SUPREP may not be absorbed completely. ADVERSE REACTIONS: Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Oral Administration: Split-Dose (Two-Day) Regimen: Early in the evening prior to the colonoscopy: Pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Consume only a light breakfast or have only clear liquids on the day before colonoscopy. Day of Colonoscopy (10 to 12 hours after the evening dose): Pour the contents of the second SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy. Consume only clear liquids until after the colonoscopy. STORAGE: Store at 20°-25°C (68°-77°F). Excursions permitted between 15°-30°C (59°-86°F). Rx only. Distributed by Braintree Laboratories, Inc. Braintree, MA 02185

For additional information, please call 1-800-874-6756 or visit www.suprepkit.com

©2018 Braintree Laboratories, Inc. All rights reserved.

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THE ORIGINAL 1 LITER PRESCRIPTION BOWEL PREP SOLUTION

1 MOST PRESCRIBED,

#

BRANDED BOWEL PREP KIT1 WITH MORE THAN 15 MILLION KITS DISPENSED SINCE 20101

A CLEAN SWEEP

EFFECTIVE RESULTS IN ALL COLON SEGMENTS2 · SUPREP® Bowel Prep Kit has been FDA-approved as a split-dose oral regimen3 · >90% of patients had no residual stool in all colon segments2* †

These cleansing results for the cecum included 91% of patients2*

SUPREP Bowel Prep Kit also achieved ≥64% no residual fluid in 4 out of 5 colon segments (ascending, transverse, descending, and sigmoid/rectum)2* †

Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies.4

*This clinical trial was not included in the product labeling. †Based on investigator grading. References: 1. IQVIA. National Prescription Audit Report. September 2018. 2. Rex DK, DiPalma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 3. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2017. 4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

©2018 Braintree Laboratories, Inc. All rights reserved.

14 | GI.ORG/ACGMAGAZINE

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(1) Dr. Pais, (2) Dr. Kroser, (3) Dr. Schneider, (4) Dr. Kane, (5) Dr. Chokhavatia, (6) Dr. Tuskey, (7) Dr. Adrain, (8) Dr. Early, (9) ACG’s women Governors, (10) Dr. Aytaman. Photos 1 to 10: Ben Zweig. Photos 11-14 ACG Governors Fly-In, April 2019

LEADERSHIP

// GOVERNORS' VANTAGE POINT

INSIGHTS from a DIALOGUE with ACG’s WOMEN GOVERNORS  ACG PRESIDENT DR. SUNANDA KANE

invited the College’s eight female Governors to join her for a conversation in April in Washington, DC, during the ACG Board of Governors Fly-in visits to Capitol Hill. The College celebrates the leadership and contributions of all the Governors and particularly seeks to increase the visibility of ACG’s women Governors among the membership. The genesis for this session grew from the strong, clear sense expressed by Dr. Kane and Past President Dr. Carol Burke—and echoed by Chair of the Board of Governors Dr. Neil Stollman and Vice Chair Dr. Patrick Young—that the College should aim to increase participation by women in the Board of Governors.

“The College celebrates the leadership and contributions of all the Governors and particularly seeks to increase the visibility of ACG’s women Governors among the membership.”

Dr. Kane invited the group to share their experiences as women in GI and as ACG Governors. She asked them for tips and thoughts on ways female gastroenterologists can become more involved in ACG and see the Board of Governors as a path to participation and leadership within the College. The wideranging conversation covered some of the critical challenges facing those who want to get more involved in ACG and other professional organizations, generating some actionable insights from the group.

THE IMPORTANCE OF NETWORKING & MENTORSHIP Key themes of the discussion included the importance of networking and the impact of mentoring on careers in medicine and Leadership | 15


// LEADERSHIP: GOVERNORS' VANTAGE POINT

GI. According to Dr. Dayna Early: “Mentoring is a really big issue. If you see a woman who has balanced her life successfully then you feel like you can do it too. That was a big issue for me and that is a big issue for a lot of us. Having role models and seeing other women succeed in doing what you want to do helps you believe you can do that as well.” The group agreed that having role models for involvement in ACG is so important. Dr. Alison Schneider observed that, “For young women coming into GI who may not have the time or who have really young families, even if they are not that involved [in ACG] now, it’s important for women gastroenterologists to be there for them. The time will come when they will have more time. They see you as a role model. Be there. Talk to them. Even if they are not going to the Annual Meeting now, they will know that they will be welcomed when the time comes.”

TIPS FOR NEGOTIATING TIME AWAY FOR PROFESSIONAL ACTIVITIES In discussing how women can become more engaged in ACG, the group identified securing time away for professional activities as a major barrier. There was a consensus that as more and more physicians are becoming salaried, time away is a challenge. For Dr. Alyn Adrain, who has been active as ACG Governor at the same time she held state level leadership roles, to fulfill her numerous commitments she joked, “There goes my vacation!” Dr. Joyann Kroser shared, “I’m finding now what’s problematic—and I’ve been in private practice and academics—is getting co-workers and supervisors to value the time away [for involvement in professional organizations]. I resent that this time away has to be counted as PTO; there should be a separate category. It’s not CME, it’s not PTO, it’s not community service. As I am beginning to negotiate my next contract, I’m thinking of this.” Dr. Kroser continued, “For the first time, I finally got a lawyer that’s a health lawyer. Her job is negotiating

16 | GI.ORG/ACGMAGAZINE

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contracts for physicians. It’s her job to know the MGMA data. Now, [lawyers] don’t come cheap, but if I had known before, I feel that it’s money worth spending. If I had any advice to an early career physician, I would say, ‘get a good health employment lawyer.’” Dr. Shireen Pais agreed and shared that, in her experience, having a lawyer review her employment contract was, “Worth every penny. It was expensive, but I got extra weeks of time off, additional CME funding, and dropped a restrictive covenant. Extremely, extremely valuable.” Dr. Pais now refers friends and former fellows to this lawyer.

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“YOU HAVE TO KNOW TO ASK.” Even as the discussion covered ways to negotiate for days off for involvement with professional societies, several Governors made the point that young physicians need to know to ask, and this relates to salary negotiations as well. Dr. Early noted, “Your boss is not going to give you a higher salary or more days off; you have to ask. That’s what a lot of women don’t know they can do, and a lot of men just do it.”

WITH ACG’S FEMALE GOVERNORS Who are your role models? My role models have been the women who blazed the path ahead of me: Grace Elta, Juanita Merchant, Chris Surawicz, Carol Burke, as well as my male mentor, Steve Hanauer. —Dr. Kane

I want to give a shout out to my mentors Chris Surawicz and David Sachar, amongst so many along the way. We learn from our mentors and our mentees, our patients and staff. —Dr. Sita Chokhavatia I was first inspired to consider a career in GI during my medical school training, rounding on medical wards with Arvey Rogers. Some of my most important mentors are from my fellowship years (Asyia Ahmad, James Reynolds, Scott Myers). Another very important role model and inspiration has been my parents. My father has been a practicing general dentist for the past 45 years (solo practice and still practicing!) with my mother working the front office. Even though this is not exactly gastroenterology, I have learned important values, attitudes, behavior, and ethics that apply to medicine and patient care. —Dr. Schneider


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My dad is definitely a role model for me. He has MS and has been wheelchair bound for the last 5 years and yet he is the most optimistic person I know—and he manages to work out at the Y more often than I do. Both he and my mother instilled in me an attitude of gratitude and perseverance. —Dr. Anne Tuskey

Who encourages or inspires you? My parents, and my husband and family, have always given me guidance, encouragement, and overall support to be where I am today. —Dr. Schneider

“Mentoring is a really big issue. If you see a woman who has balanced her life successfully then you feel like you can do it too. That was a big issue for me and that is a big issue for a lot of us. Having role models and seeing other women succeed in doing what you want to do helps you believe you can do that as well.” ­—Dr. Early

ACG’S MENTORING PROGRAM

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I find that it is my patients that inspire me. They have a terrible condition which can severely affect even the simplest of pleasures the rest of us take for granted. Trying to help them and understand their condition is what drives me. —Dr. Kane ACG inspires me to aim high and facilitates reaching these goals! —Dr. Chokhavatia

During the discussion with the women Governors, Dr. Kane mentioned that ACG sponsors a Mentoring Program to provide residents, fellows-intraining, and junior faculty access to faculty from diverse practice models, academic departments, and geographic regions. The College hopes to foster informal dialogue between mentors and mentees, while affording mentees the opportunity to gain valuable guidance and career advice from faculty not accessible to them at their institutions.  Learn more: gi.org/mentoring-program

My family is my biggest support and my biggest cheerleaders. I also draw inspiration from my patients, my students (I teach the GI course for the first-year medical students), and strong women in our field. —Dr. Tuskey

Leadership | 17


I came to the US carrying the genes and morals of my parents, and the culture and customs of my home country, Turkey. I studied in Austria (medical school), again being influenced by Europe, and ended up in Brooklyn, the true melting pot of the world. My mom and dad were the true inspirations for me. —Dr. Aytaman

What are you most proud of personally and/or professionally? When a colleague asks me to care for them or their family, I am incredibly honored and proud. —Dr. Early I am most proud of the opportunity to care for my patients and develop long-lasting relationships with them. —Dr. Schneider I am most proud of my family. As a child, I dreamed about being a doctor; I never focused on marriage or children. I was fortunate to meet a very supportive soulmate and have a lovely family so when I have an exhausting day at work, coming home to them is my haven. Professionally, I am most proud of my achievements. While I may not be a Grace Elta (a true trailblazer!), I influence many in my practice, as well as younger physicians in training and early in their careers. —Dr. Pais When I chose medicine, I had decided not to get married, as I thought I would never have time for [family]. I was so wrong. I am so proud of my two daughters and am thankful to my husband for always supporting me. Professionally, I think my biggest achievement has been to bring the national liver cancer providers together and initiate a very impactful system re-design all across the nation to improve the care, access to expertise, and management of all veterans with liver cancer. —Dr. Aytaman

9

Ask or reach out to get involved. No one necessarily knows you are interested unless you tell someone. The staff and officers of the ACG are all eager to hear from you and are easily accessible. Heck, pick up the phone and call the headquarters and tell them you want to get involved, and you will be connected to a live person who can help (unless it is the Annual Meeting and then all the staff are busy on-site running the best GI meeting of the year)! —Dr. Kane Being involved in ACG is a great way to network for your personal and professional growth. We can all learn and grow from each other. —Dr. Schneider Get involved; it helps make a difference. You develop a great network of people with similar interests and goals. —Dr. Pais

What advice would you give to your “younger self” about your career and your life today? It’s okay to allow yourself a nap and/or a trip to the gym instead of answering emails. If you really don’t want to do something, or your gut is telling you it’s a bad idea, speak up. —Dr. Kane Pace yourself. —Dr. Early Enjoy the journey, keep reading, spend more time with your family; it all works out. —Dr. Pais

11

Stop stressing about the plan. I spent so much time worrying over the details on how to get from A to B (when to get married, when to have the baby, where to do fellowship, and on, and on, and on) that I missed out on parts of the journey itself. —Dr. Tuskey Appreciate your own value rather than going with the flow. Create a better work/ family balance. Know when to say no. Define your path better. Get involved with our professional organizations earlier. Find mentors early on and hang on to them, rather than waiting for opportunities to come to you. —Dr. Aytaman

What specific advice would you give to other women in GI about getting involved in ACG? Join. Take part in the [GI] Circles. Send an email to see if you can participate on a committee. Apply for Fellowship (FACG), if eligible. There are so many ways to get more involved and you have nothing to lose, but a lot to gain. —Dr. Tuskey

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(1) Dr. Pais, (2) Dr. Kroser, (3) Dr. Schneider, (4) Dr. Kane, (5) Dr. Chokhavatia, (6) Dr. Tuskey, (7) Dr. Adrain, (8) Dr. Early, (9) ACG’s women Governors, (10) Dr. Aytaman Photo Credits: Photos 1 to 10 Ben Zweig. Photos 11-14 ACG Governors’ Fly-In, April 2019


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ABOUT THE CONTRIBUTORS Sunanda V. Kane, MD, MSPH, FACG, ACG President 2018-2019, Mayo Clinic, Rochester, MN Dr. Kane’s leadership trajectory in ACG did not involve service as a Governor. She recalls that she lost a two-person race for ACG Governor for Illinois, but moved up in ACG leadership through the long pathway of committee work and serving as a committee chair. She also was course codirector for the ACG Postgraduate Course in 2007, the same year she was appointed to the ACG Board of Trustees.

Alyn L. Adrain, MD, FACG, ACG Governor for Rhode Island, Gastroenterology Associates, Providence, RI Dr. Adrain characterizes her current term as “ACG Governor 2.0” since she ran and served 12 years ago when her Rhode Island colleague Samir Shah, MD, FACG was tapped to serve as Vice Chair of the Board of Governors. At that same time, she was serving as president of the RI Medical Society. She is active in organized medicine and represents Rhode Island at the AMA.

Alison Schneider, MD, FACG, ACG Governor for Southern Florida, Cleveland Clinic Florida, Weston, FL After a long tenure on the Women in GI Committee, Dr. Schneider was encouraged to run for Governor by former ACG Governor for Southern Florida Gerardo S. Lanes, MD, FACG. In addition to her involvement in ACG, Dr. Schneider is also active in the Florida Gastroenterologic Society and appreciates the benefit of both the state and national perspectives.

Ayse Aytaman, MD, FACG, ACG Governor for Brooklyn, NY, Brooklyn VA NY Harbor Healthcare System A member of ACG since her fellowship training, Dr. Aytaman was nominated for ACG Governor by her mentees and was strongly encouraged to run by her colleague Frank G. Gress, MD, FACG, who preceded her as ACG Governor for Brooklyn.

Dayna S. Early, MD, FACG, ACG Governor for Missouri, Washington University in St. Louis, St. Louis, MO Dr. Early got involved with the College because she likes ACG’s Annual Scientific Meeting and could relate to what was presented as a clinician. One of her colleagues suggested, “why don’t you run for ACG Governor?” and she was inspired to jump right in and run.

Shireen A. Pais, MD, FACG , ACG Governor for Southern New York, New York Presbyterian Medical Group, Yorktown Heights, NY Dr. Pais has been Governor for Southern New York since 2016 and sees mentorship as playing an invaluable role in her career. As role models, she recognizes Julia Le Blanc, Laurie Deleve, Shelly Lu, Loren Laine, Russel Yang, and John Dewitt as “just some of the few who have been part of my life tapestry.”

Sita S. Chokhavatia, MD, FACG, ACG Governor for Northern New Jersey, Valley Medical Group, Ridgewood, NJ Dr. Chokhavatia found ACG the most welcoming of the GI societies and got involved with the College during the time she was junior faculty. She was encouraged by one of her mentors, ACG Past President Christina M. Surawicz, MD, MACG, to serve on ACG committees. Anne G. Tuskey, MD, FACG, ACG Governor for Virginia, University of Virginia, Charlottesville, VA Dr. Tuskey started her participation in ACG as a resident when she attended the 2011 ACG Annual Scientific Meeting in Washington, DC. She was inspired and felt empowered by attending a Women in GI Committee luncheon and served on that committee for six years. She credits ACG President Sunanda V. Kane, MD, MSPH, FACG for urging members of the Women in GI Committee to stand for election as an ACG Governor. Joyann A. Kroser, MD, FACG, ACG Governor for Eastern Pennsylvania, Crozer Gastroenterology Associates, Glen Mills, PA Dr. Kroser has been active in ACG and values the many opportunities to network. She chaired the ACG Patient Care Committee from 2015 to 2016. She has also been active in her county medical society and state GI society.

Leadership | 19


Accessible. Relevant. Practical.

The information you need to improve your practice. The ACG Practice Management Committee’s mission is to equip College members with accessible tools to overcome management challenges, improve operations, enhance productivity, and support physician leadership in their private and physician-lead clinical practices. Learn from practicing colleagues, through articles and podcasts on topics important to you. Articles include a topic overview, suggestions, examples, and a list of resources or references.

Explore the Podcast

Alignment but NOT Employment: Professional Service Agreements with a Hospital System Listen as Dr. Louis J. Wilson, Chair of ACG’s Practice Management Committee, goes deeper into the topic with authors Stephen T. Amann, MD, FACG, and James C. DiLorenzo, MD.

Listen Now: bit.ly/PMToolboxPodcastPSAs

"Pressures are high as gastroenterologists make important management decisions that profoundly affect their business future, their private lives, and their ability to provide care to patients." —Louis J. Wilson, MD, FACG

Start Building Success Today. GI.ORG/TOOLBOX 20 | GI.ORG/ACGMAGAZINE


GETTING IT

GETTING it Right

// BUILDING SUCCESS

PROFESSIONAL SERVICE AGREEMENTS HOSPITAL SYSTEM Alignment but NOT Employment: with a

This article is part of a series sponsored by the ACG Practice Management Committee. See more: gi.org/toolbox

Stephen T. Amann, MD, FACG, Partner, Digestive Health Specialists, PA, Tupelo, MS; James C. DiLorenzo, MD, New York Associates at Montefiore and New York GI Center, LLC, Bronx, NY

 AN EVOLUTION OF THE PHYSICIAN TO HOSPITAL RELATIONSHIP IS ONGOING. Changes are being driven by the need to provide value and quality, the economic pressures on private practices, and the need for physicians to protect the valuable resource of time. Hospital employment is not the preferred option for many due to a desire for autonomy and personal stewardship. An alternative contractual vehicle, the professional services agreement (PSA), offers an avenue to advance alignment with your hospital system and remain independent while acquiring financial support for direct services provided. PSAs provide an option open to practices of any size.  Getting it Right | 21


// GETTING IT RIGHT: BUILDING SUCCESS

BACKGROUND Radically different reimbursement paradigms, rising expenses, and uncertainty of future revenue have pushed private practice physicians to consider new ways to economically relate to hospital systems. Full hospital employment can provide security and frees the physician of many of the burdens of private practice. However, the loss of autonomy experienced when moving from a private practice to a larger facility is significant. A PSA may be a more attractive option to foster alignment without employment. These agreements are typically fostered through an Internal Revenue Service (IRS) 1099 payment structure (rather than a W-2). Through a PSA, the physician is still employed at their practice corporation, but agrees to provide services at the hospital as an independent contractor. PSAs are fundamentally flexible and customizable. While there are a variety of different types of PSAs, the most common types are discussed below. Entering into a PSA can confer several advantages—enhanced compensation, strategic planning, including joint development of clinical programs, installation of the electronic health record systems, data sharing, joint recruiting of new physicians, and bridging participation in clinically integrated networks (CINs) or accountable care organizations (ACOs). Through PSAs, physicians receive fair market value (FMV) compensation for any clinical or administrative services provided.

GENERAL RISKS OF A PSA VS. AN EMPLOYMENT AGREEMENT:  Pressure from hospital to expand services provided  Easier for hospital to terminate  Easier for hospital to non-renew

 Physician independence from hospital  Greater flexibility  Physicians can keep their existing benefits structures  Stability for the physician-hospital relationship  Easing implementation into a hospital CIN or ACO  Easier to terminate  Increased leverage to re-negotiate

22 | GI.ORG/ACGMAGAZINE

 Hospital contracts with the physicians through the existing practice entity.  Physician compensation is based on a work RVU formula.  Physicians remain employees of the practice entity.  Hospital owns accounts receivable, establishes fee structures and contracts with payors as well as billing and collections.  Ownership of ancillary revenue and real-estate are negotiable.

WHAT ARE THE MOST COMMON PSA TYPES? WHAT ARE THE KEY COMPONENTS? 1. Global PSA  Hospital pays all practice overhead, along with work relative value unit (RVU)-based compensation for the physicians. Support staff remain employees of the practice.  A joint-management committee with hospital and physician representation manages the practice.  Physicians remain directly involved in running their practice (practices must be capable of management and reporting to the hospital’s professional services and finance department).  Hospital owns accounts receivable, establishes fee structures and contracts with payors.

KEY BENEFITS OF A PSA VS. AN EMPLOYMENT AGREEMENT:

2. Traditional PSA  Hospital employs all support staff, assumes and manages the practice through their practice entity. This frees the physicians from the responsibility for the typical day-today practice management.

 Ownership of ancillary revenue, real-estate, billing and collections are negotiable.  As the practice infrastructure remains intact, at dissolution, physicians can return to their original practice format with minimal disruption.  The duration of this type of agreement is typically short (1–2 years) and will likely need to be renegotiated based on the outcome of the contract term.

 Significant changes may be developed at your practice, depending on the nature of the work culture that the hospital establishes for its employees. Once the contract expires, re-entering private practice typically requires hiring an entirely new office staff.  Hospital employment may prove advantageous to support staff.  The productivity and financial data acquired during the PSA contract term can provide transparency to the process of negotiating to fulltime employment at the end of the contract term. 3. Practice Management Arrangement (PMA)  Hospital employs the physicians directly (W-2 type payment).  Physician group-practice management and administrative structure is independently preserved, but contract with the hospital for these services. • Hospital pays fair market value (FMV) for management services.  Lacks flexibility of a typical PSA, but eases transition to employment and can simplify dissolution or transfer completely to hospital.


4. Carve-Out PSA  Physician groups can agree to provide specific services or needs, such as call coverage, endoscopy services or various combinations of services.  This is a limited provision for specific services provided, that is tailored to the needs of the hospital and the practice.  Physician services are paid based on FMV and are typically work RVU-based.  Related administrative costs would be carved out and reimbursed by the hospital separately.  This is limited in scope and does little to advance strategic initiatives for either the hospital or the practice but can provide specific services in need without higher levels of integration by the practice to the hospital. 5. “Wrap–arounds” to PSAs  Can be a part of some aspects of PSAs to add focus on quality and value. This includes: cost saving initiatives, administrative duties, teaching functions, or medical directorships.  Can be simple incentive payments, or up to and including, “at-risk” compensation for demonstrating quality of care and cost-efficiencies.  Becoming more common, as the focus on quality and value for services increases.

KEY CONCERNS FOR THE PRACTICE WHEN CONSIDERING A PSA:  Does the agreement fit into applicable Stark Law and anti-kickback statutes?  Does the proposed agreement provide a fair compensation package based on FMV?

 Will the new management structure allow a sufficient degree of shared decision-making?  Is the contract long enough to make it worthwhile? Ability to renegotiate over time?  Will the hospital seek to push you to full employment?  What happens to your practice with non-renewal?  Are there hidden costs in the overhead which do not exist in your current practice?  How does your practice value moving forward with reimbursement changes?  How are physician extenders factored into the FMV calculation?

1. Evaluate your practice's current status and review all available options. While the focus of this article is practice alignment and retaining independence through PSA arrangements with hospital partners, other options to consider include full independence, full employment by a hospital/system, or employment within a large group corporate model.

1. PSAs as an alternative to employment: White Paper: A contemporary option for alignment and integration. The Coker Group; Reiboldt M, Greeter A, Khan M, Harrison T. March 2016; 3-31. 2. Safreit SM, Hutzler AC. HealthCare Apprasers, Inc. The ABA Health Law Section. The Health Lawyer. Feb 2012; 24(3):1-33. 3. Allen JI, Kaushal N. New Models of Gastroenterology Practice. Clin Gastroenterol Hepatol 2018; 16:3-6. 4. www.healthcareappraisers. com/insights/valuationof-professional-servicesarrangements

Depending on how you answer these questions, one type of PSA may be a better fit for your practice’s specific needs.

2. Evaluate the PSA models and choose which best suits your goals. Work with the proposed hospital partner to provide raw data that can be used to devise a compensation plan, and address operational issues and human resources concerns.

SUGGESTIONS AND COMMENTS:

RESOURCES:

 Is the intended hospital partner or MSO capable of running your practice as efficiently as you or your current staff?

3. Expert legal guidance is recommended to ensure any agreement meets requirements for FMV, Stark, anti-kickback statutes, and state-specific laws. 4. Work together as a group to choose and devise the best longterm arrangement. Do not be afraid to get creative! Find ways to help your group and make it attractive to your partners, such as a cohesive approach to GI care and other possible value-added services.

5. Many of these structures are relatively new and have not yet been tested legally to the fullest degree. Thus, consult with an experienced healthcare attorney before entering into any arrangement. 6. Ensure that the appraisal and valuation approaches are done by an experienced third-party valuation company. The hospital system internal valuation will not be adequate or impartial. a. See The Valuation Process and Fair Market Value: bit.ly/toolbox-1 7. Use the Employment Checklist from the “White Paper: A contemporary option for alignment and integration” from The Coker Group1 to review key discussion topics as you explore your options. b. See the Employment Checklist from the White Paper: “A contemporary option for alignment and integration:” bit.ly/toolbox-2 Getting it Right | 23


// GETTING IT RIGHT: LAW MIND

// LAW MIND

PRACTICE-FRIENDLY

PRIVATE EQUITY What to Look for When Selling Your Practice

By Ann M. Bittinger, Esq., a health care attorney with physician group clients across the country. Questions? Email ann@bittingerlaw.com

PRIVATE EQUITY BASICS

 APPROACHING A PRIVATE EQUITY SALE without a clear understanding of your legal rights and liabilities postsale is like Sandra Bullock’s character in the movie Bird Box trying to survive, blindfolded to avoid deadly eye contact with ambivalent forces: you might survive in the short term, but in the end it’s best to find a safe place where you can see. It’s important to consider any sale—particularly with a private equity firm—with eyes wide open. Make sure that you are in a good place with proper financial, legal, and operational advisors who help you see through the private equity mystique.

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Private equity investments are purchases by firms, owned by individuals or other companies, that provide funding to companies in exchange for equity. Equity means ownership. Put simply, private equity firms provide physician organizations or surgical center companies funding in exchange for ownership in the company.

WHAT YOU GIVE UP BY SELLING TO PRIVATE EQUITY Many physicians fail to appreciate the importance of giving another company ownership of the physician practice until it is too late. When a private equity firm takes over the majority of shares in your physician practice, it gains the controlling interest in the practice. The majority owner usually calls the shots in an organization. If that owner is not a physician or lacks healthcare experience, the physicians sometimes find themselves in opposition with the new owners.

Legally speaking, the opposite of a funding by ownership is funding by loan. Loans are paid back with interest. With ownership, you sell shares in your company and get funding in exchange. You don’t pay anything back, and there’s no interest, but you give up certain rights in your company. Private equity does not provide physician groups with funds without wanting something in return. What they usually want is the right to make financial and operational decisions about the company so that the private equity firm can make more money and, accordingly, get a return on their investment. Private equity firms don’t invest in GI groups because they are interested in the developing science of gastroenterology. They invest in GI groups for the same reason they invest in any other company—to get a return on their investment.

PRIVATE EQUITY PRACTICE PRICE I am often asked, “What’s the difference between selling to a private equity group versus selling to a hospital?” The differences are many. First and foremost in importance to the seller is the selling price. Hospital systems are bound by the federal Anti-Kickback Statute and the Stark Law and perhaps similar state laws. The amount that hospitals pay physician groups for their practices generally must be at fair market value. There is an exception for one-time sales of practices, but, generally, counsel for hospitals advise against paying more than the value of the physician group’s assets when buying groups consisting of physicians who refer to the hospital. Any amount over fair market value (usually low-balled at the value of the hard assets of the company— not good-will or going-concern value) can be construed as a one-time mega-kickback for past or future referrals from the selling physician to the buying hospital. Private equity firms don’t have to worry that their purchase prices will be construed as kickbacks because they don’t have hospitals to which the sellers will refer. The kickback and self-referral laws don’t usually apply to them. As such, private equity firms can often pay much more for ownership in a physician group than hospitals can or will.

THE CATCH So, what’s the catch? If you are hesitant to sell to a hospital system because hospital administrators generally don’t know how to run physician groups (much less, endoscopy centers and GI groups specifically), how do you think a firm that doesn’t deal day-in and day-out in healthcare will operate your practice after you sell? To be fair, a


number of private equity firms are dedicating a lot of time and money to retention of advisors and managers who are experienced in healthcare. If the representative from the private equity firm does not know what a wRVU is, that might be a good sign that the firm is not completely dedicated to understanding how your practice operates. Another con about private equity I hear from clients and others is that the new owners treat physicians like they are the furniture in the room­—an asset to be moved and replaced on a whim. Perspective is important. Culture change is important. If your GI group was founded as a mom-and-pop shop, totally physicianowned, with board meetings attended by all shareholders who all get an opportunity to provide input on the management and direction of the practice, you should probably brace yourself for a bumpy culture change ride if you decide to sell to a private equity firm. Although “being treated like furniture” may be a bit exaggerated and dramatic, the fact is that you will likely no longer be an owner of the company at which you work. You’ll just be an employee. Employees generally have no say over the direction of their employer company. That being said, physicians may retain some ownership rights post-sale. Read the fine print about what rights are attached to that stock. Are you in a new, separate class of stock from the private equity firm, and your class has no say on any decisions? Read the fine print of the proposed sale and ownership documents to understand your rights, if any.

NOT OFF THE HOOK And read the fine print as to ongoing liabilities. Many practices find themselves considering private equity like a football offensive coordinator would consider calling for a Hail Mary pass—they are down on their luck and hope that this move will save them. Just how down on your luck are you? Chances are that the private equity company will know and will not take responsibility for any liabilities that may be actual or lurking at the time of sale. Private equity firms often make you integrate into their existing corporate structure. That means that your practice corporation or limited liability company will remain in existence after the sale, and the private equity buyer will have absolutely no responsibility. Even if they do take over your company and your corporation or LLC continues under their control, there will be language in the purchase documents that say that the buyer has absolutely no liability for anything that occurred prior to the purchase. What that means is that if a letter arrives from Medicare asking for a refund of overpayment due to prior billing and coding improprieties, or a letter arrives from the state saying your medical assistants filed a wage-and-hour claim for unpaid overtime, liability rests on the seller. That may mean that the former practice corporation or LLC will have to pay the money. Worse, it could mean that the individual physicians might have to pay out-of-pocket. Sometimes, the private equity seller puts a somewhat large amount of its purchase price on

“Private equity firms don’t invest in GI groups because they are interested in the developing science of gastroenterology. They invest in GI groups for the same reason they invest in any other company —to get a return on their investment.”

reserve to cover liabilities like that. For example, if they would buy a practice for $10 million, they may require that $3 million of that be held in reserve for three years to cover exposure like this. Imagine the price dropping by 33% with the receipt of just one letter. Who pays the lawyers in these situations? Often the private equity firm will have its own lawyers, the selling physician group will have theirs, and then individual physicians will seek their own counsel. I strongly encourage individual physicians to hire their own counsel and not rely on group counsel. Although the continuing liabilities situation could arise when selling to any buyer (including a hospital), it can be particularly dicey in private equity because they usually have well-heeled counsel whose interest is to protect the private entity firm, not to protect the physicians or seller group.

ALWAYS BE PREPARED It is imperative that your group get its house in order, so to speak, before approaching a private equity investor. Not only does it minimize future liabilities, it makes you a more attractive target. Private equity investors usually begin their target assessment with a due diligence process, where an executive asks to review your financials, your compliance plans, etc. While this is normal in any acquisition in any industry, it’s particularly interesting in healthcare private equity because the executive asking the questions may not be experienced in healthcare, your specialty, or your market. The seller physician group might have to work a little harder in explaining nuances to the potential buyer. This is less-so the case in medical specialties that have frequented the private equity arena in the last decade, such as dermatology, emergency, and radiology. Gastroenterology is just now getting looks from private equity. In closing, let’s return to the reason a private equity group would buy a GI practice in the first place—to get a return on its investment. I tell clients to expect a simple fact; some things (perhaps a lot of things) are going to have to change post-sale if the firm is going to get a return on its investment. Your addition to their portfolio is going to have to produce some sort of synergy or result that benefits the firm financially. To do that, things will change. For example, you might have to start doing endoscopies only at surgery centers that are in their portfolio. You might have to purchase supplies only from a supplier that is in its portfolio. This might have an indirect but important impact on how you practice medicine. Face this fact with eyes wide open. Getting it Right | 25


// COVER STORY

By Shubha Bhat, PharmD, BCACP; Susan Lee, PharmD, BCPS, CDE; David E. Bernstein, MD, FACG; Francis A. Farraye, MD, MSc, FACG


Cover Story | 27


// COVER STORY

PRIOR AUTHORIZATION: TEDIOUS, TIME-CONSUMING, AND ANXIETY-PROVOKING

THE PATIENT EXPERIENCE Anthony, Retiree, Long Island, NY

Zachary, Student, Age 18, Florida

“You really shouldn’t have to go through an unwieldy process for something that saves a life,” said Anthony, who learned of his Hepatitis C diagnosis upon his retirement. To secure coverage for treatment, Anthony needed an “ombudsman” to work on his behalf and to navigate his insurance plans. He found just the right person to help him in Susan Lee, PharmD, a pharmacist who works with Dr. David Bernstein and Dr. Henry Bodenheimer. In an interview with ACG MAGAZINE, Anthony recalled that Susan was a “catalyst to make things happen” when it came to dealing with Medicare and the union health plan he has in retirement. The cost of treatment was a big issue for Anthony. “All kudos to Susan for finding ways to find a medication that was right for me and that was affordable,” he added. “Without Susan, forget it!” Susan not only navigated successfully with Anthony’s health plans, she also followed up with him by phone and checked in frequently. Anthony credits her with helping to make sure he completed the full course of treatment for HCV so he can be there for his children and grandchildren.

Newly diagnosed with severe ulcerative colitis this spring, Zachary was admitted to the hospital and started on steroids. Zachary's insurance declined vedolizumab. He was subsequently re-admitted to the hospital for a 14-day stay and received his first dose of infliximab. The insurance company declined an outpatient course of 10 milligrams/kilogram of infliximab. His gastroenterologist at the Mayo Clinic in Jacksonville, Florida, Dr. Francis Farraye, submitted a peer-to-peer request which took so much time that Zachary's condition worsened, requiring a third hospital admission where he again received infliximab. Zachary described this experience as “terrible, scary, not fun” in an interview with ACG MAGAZINE. For this high school junior, his diagnosis changed everything, “in a bad way.” Zachary's mother, Rhonda, is a nurse who was a health care finance major in college. She shared that she is, “still perplexed how insurance companies can sit on the phone and dictate to you patient care, I never agreed about it, never understood it.” For her, the hardest part was seeing the mental toll that the fight to get medication coverage took on Zachary, but she found working with Dr. Farraye and his team one of the things that was a “ray of sunshine” for their family. Coverage was ultimately obtained and Zachary is doing much better.

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*To honor patient anonymity, only first names are used.

Stories, such as the ones outlined above, are unfortunately a common occurrence in gastroenterology practices. Prior authorization (PA), which is a cost containment and quality control process mandated by many health insurance plans, requires providers to submit documentation for review by the insurer to determine if a mutually agreed upon treatment plan by the patient and the medical provider is medically necessary for the patient and warrants coverage. The process of submitting PAs and awaiting determination is often tedious, time-consuming, and anxiety-provoking. It has also been linked to negative outcomes, including delays in initiating treatment, worsening clinical outcomes, patient dissatisfaction, and even abandonment of optimal treatment plans.1 Gastroenterologists are constantly dealing with the PA process due to the increased frequency of prescribing high-cost medications such as biologics and direct-acting antivirals, and insurers failing to recognize updated treatment pathways. Per a survey of 156 gastroenterologists, approximately 63% of gastroenterology practices spend more than 25% of their time communicating with payers.2 Additionally, one-third of providers endorse switching from their preferred treatment plan once a week or more due to the arduous PA process.3 Given the time spent and the profound impact of the PA process on patient care, it is critical for gastroenterologists to know how to successfully conquer the PA process and advocate for reform.


AN OVERVIEW OF THE PA PROCESS Gastroenterologists typically collaborate with their patients when designing optimal and patient-centered treatment plans. Depending on the medical condition being treated and the gastroenterologist’s experiences with medication acquisition, the gastroenterologist should inform patients of a potential alternative treatment plan in case payers deny coverage of the preferred treatment. This may alleviate any unforeseen stress when the patient is informed a PA is required or the medication is not covered. Regardless, this scenario is not ideal as it can generate patient confusion and/or dissatisfaction with the treating gastroenterologist, given that most patients lack awareness and understanding of medication coverage and the acquisition process within the U.S. healthcare system. Once it is determined that a PA is required for the treatment, the gastroenterologist or staff may complete an electronic or paper version of the PA form to submit to the payer with the necessary accompanying documents such as progress notes, lab results, and imaging. The payer then reviews the materials and may request additional information prior to deciding coverage outcomes. If the PA is approved, the requested medication can be dispensed or provided to the patient. It is in the best interest of the patient and the office staff for the gastroenterologist to set a realistic expectation of the approval timeline. The time frame of approval is highly variable and can range from a few hours to several weeks. Explaining this process to the patient at the time of prescribing the medication will help set realistic expectations for the patient and foster a good relationship with the provider’s office.

COMMON CHALLENGES IN ACCESSING DISEASE-SPECIFIC TREATMENTS Inflammatory Bowel Disease

Commonly, PAs for inflammatory bowel disease (IBD) are initially denied because payers enforce step therapy, in which patients must try and fail more than one lower-cost medication before payers are willing to cover the requested medication.4 While step therapy used to be the standard of care, it is no longer acceptable based on

disease severity and the supporting data for early use of high-cost medications in subsets of patients with IBD to effectively induce and maintain remission.5,6

Hepatitis C

156 SURVEY OF

GASTROENTEROLOGISTS

63% SHOWED APPROXIMATELY

OF GASTROENTEROLOGY PRACTICES

25% SPEND MORE THAN

OF THEIR TIME COMMUNICATING WITH PAYERS

Medication access for hepatitis C treatment is highly dependent on the type of insurance plan and the state in which the prescriber or patient resides. For the purpose of this article, insurance types will be generalized to federal insurance programs (Medicaid and Medicare) and private commercial insurance.7 Medicaid, which is stateand federally-funded, has significant variation in approval criteria for hepatitis C medication across the country. When approved by Medicaid, copayment costs tend to be low.8 Federally-funded Medicare plans are more or less uniform in their approval criteria, but the copayment costs vary significantly across the country and may be too costly for most.9 Therefore, Medicare approval does not always guarantee patient access to the prescribed medication. Adding to the challenge of access, each private commercial insurance plan has its own criteria for medication approval. Copay costs may be high, but patients with these plans can use manufacturer-sponsored coupons which can substantially decrease copay costs. Rarely, commercial plans may be self-funded or self-insured, which may require the patient to reach out to the employer’s human resource or benefits manager instead of the insurance company to determine coverage. The documentation necessary for PA submission may include office notes, lab results, and degree of liver fibrosis. Insurance payers may request additional information such as drug testing, HIV testing, a written patient attestation letter, and/or an alcohol and illicit drug use questionnaire.10 The top three reasons for denial of hepatitis C therapy are a lack of advanced hepatic fibrosis, failure to document abstinence from alcohol or recreational drugs, and the prescriber lacking experience with hepatitis C treatment. Cover Story | 29


// COVER STORY

For denied PA requests, the gastroenterologist or their staff may submit an appeal with a letter of medical necessity. If the payer is Medicare and the appeal is denied, the gastroenterologist or their staff may submit an appeal for internal review and then a contracted external company for review, who then makes the final decision. If the external company denies the appeal, the gastroenterologist will need to use an alternative medication. If the payer is not Medicare and the appeal is denied, the gastroenterologist can request a peer-to-peer to provide a verbal appeal as to why the requested medication is necessary for the patient. The payer then makes a decision, and, if denied, the gastroenterologist will have to use an alternative medication, but may resubmit a PA for the original requested treatment in six months. The appeal process may differ slightly depending on the state and plan type. Approved PAs are often valid for a certain amount of time and once expired, a new PA will need to be submitted. Additionally, if patients change insurance plans, a new PA may be required by the new insurer.

CONQUERING THE PA PROCESS While the PA process can be tedious and dealing with denials can lead to frustration and delays in patient care, there are certain approaches that can be used to successfully obtain PA approvals.11

Identify one individual or a team to oversee and own the PA process from beginning to end.

One of the most essential steps is to designate an individual or team of individuals to own the process. Depending on the resources available in the gastroenterology practice, the PA process may be allocated to a pharmacy team (pharmacists and pharmacy technicians) located in the practice or in an on-site or outside specialty pharmacy. In this model, the pharmacy technicians can oversee all gastroenterology PAs and employ pharmacists’ assistance as needed to provide further rationale as to why the selected treatment is medically necessary.

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Having an on-site specialty pharmacy permits for easier direct communication about PA approvals and faster processing of medications to further minimize delays in treating patients. If pharmacy support is not available in the gastroenterology practice, the PA process may be delegated to medical assistants, registered nurses, or an external specialty pharmacy or manufacturer hub. When outsourcing the PA process, the gastroenterology office and its staff remain responsible for providing the external pharmacy or manufacturer hub with patient-specific information, given that these entities do not have direct access to patients’ medical charts.

“While the PA process can be tedious and dealing with denials can lead to frustration and delays in patient care, there are certain approaches that can be used to successfully obtain PA approvals.”

Know the top payers in the practice, obtain their formularies and PA forms, and establish a point-of-contact.

Once an individual or team is identified to own the PA process from beginning to end, it is important for that individual or team to identify the most common payers in the practice and become familiar with those payers’ formularies and PA processes. Formularies and PA forms can often be obtained online and kept on file for organizational and time-saving purposes. Additionally, when possible, the person or team responsible for the PA process should identify a contact person within each insurance company and obtain his or her contact information. If a PA follow-up is required, the office can reach out directly to the contact person so time is not wasted on automated phone prompts. Having a point of contact with each payer also permits for escalation of grievances to appropriate individuals if the PA process becomes difficult to navigate.

Verify benefits and identify if the requested treatment will be covered by medical or pharmacy.

Prior to starting the PA process, the individual or team responsible for the PA process should be comfortable with performing benefit verification to determine which plan a patient has, so that the correct PA form and information can be submitted without causing further delays in the patient’s treatment. Benefit verification can be performed via telephone or the specific insurer’s website. It is also important to verify if the requested


medication should be billed through medical or pharmacy benefits to identify the correct PA form to use. If patients are planning to acquire their medications through pharmacy benefits, insurance eligibility may also be confirmed by contacting the patient’s preferred pharmacy to verify the prescription coverage they have on file.

If the PA is rejected, submit an appeal.

Spend time completing the initial PA request and include all pertinent information justifying why the requested treatment is medically necessary.

Once the correct PA form has been acquired for the patient’s insurer, ensure that all necessary fields are completed and pertinent information justifying why the requested treatment is medically necessary has been included with the PA form. Consider including progress notes, pertinent laboratory results, reports of imaging studies, procedure findings, and a list of previous treatments. Providing comprehensive information will allow the insurer to make a more informed decision and may prevent unnecessary denials. Attaching a letter of medical necessity may escalate the PA to a clinical pharmacist or nurse for direct review and expedite the process by bypassing the algorithm that most insurers use to make an initial determination for PA request. If electronic PA (ePA) is used, this still requires paper documents to be printed and converted into PDF format to be uploaded to a specific insurance plan or general electronic PA platform.12,13 The ePA process may save time in obtaining medication approval.

Track when the PA was submitted and follow-up as needed to ensure appropriate outcomes.

Upon submitting a completed PA request, the individual or team responsible for the PA process should document the submission in an Excel spreadsheet (Figure 1) or similar digital document to allow the office staff to record whether a decision from the insurance company is received in a timely manner. This should serve as the reference tool for the individual or team members responsible for the PA process. It should record the submission of each patient’s PA and the current status. Maintenance of the “Date to follow up” column will assist in the efficiency of the process. If a decision is not received within 3 business days, the individual or team should follow up with the insurer. A database should also be maintained for all approved PAs, so that a new PA can be submitted in a timely manner when the original PA expires.

“The prescribing gastroenterologist should request to speak with a gastroenterologist representing the insurance company and emphasize the consequences of treating the patient with other treatment options or letting the disease worsen or progress.”

If the PA is denied, an appeal should be submitted. This may require submitting the original PA form with more information or requesting a peer-to-peer review, in which the gastroenterologist speaks with a representative of the insurance company to provide a verbal or written appeal as to why the requested medication is medically necessary. The written appeal should be concise and to the point, addressing each insufficient reason for denial. The prescribing gastroenterologist should request to speak with a gastroenterologist representing the insurance company and emphasize the consequences of treating the patient with other treatment options or

Figure 1. Fields to Track PA Submissions  Date to Follow-up  Patient Name  Date of Birth  Medication  Date PA Sent  Comments

letting the disease worsen or progress. Additionally, information about why other medication alternatives covered by the insurer are not appropriate for the patient should be provided. Lastly, clinical information should be included again, with supporting references of practice guidelines or clinical studies justifying why the requested treatment option is preferred.14 Once the appeal is approved, the story is not over. The out-ofpocket costs may be too high for the patient and deter them from starting treatment. Financial assistance counseling may not be in the list of services provided by the prescriber’s office, but for such situations an informational tool should be prepared to be given to patients as a financial resource guide.15,16

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// COVER STORY

While the PA process may be arduous for the provider and their office staff, it can also be traumatizing for patients. For example, patients who failed previous HCV treatments may have experienced difficulties with older interferon-based treatment regimens and anxiously await initiating the newer HCV therapies, which have higher cure rates and fewer side effects. Patients starting IBD treatment may be apprehensive about possible adverse effects and needle injections. Unfortunately, the insurance plan-mandated PA process can prolong patients’ wait time for these medications and increase their anxiety, also delaying medically-necessary therapies.

ADVOCATING FOR PA REFORM The PA process is intended to minimize use of excessive drug spending and encourage appropriate prescribing practices. However, when not executed properly by insurers, this process can end up causing harm to patients. Given that healthcare reform begins with legislation, it is crucial that gastroenterologists participate in advocacy efforts. The American College of Gastroenterology (ACG), as well as various other organizations in GI and hepatology are committed to helping gastroenterologists and their patients with advocacy and policy.17,18 ACG and others are currently advocating for payers to standardize the PA requirements and criteria, improve transparency and accessibility of the PA process, and reduce PA requirements and physician administrative burden. Furthermore, there is a push for payers to approve PAs for a minimum of one year and to develop true “peer-to-peer” interactions in which gastroenterologists can speak with a representative who practices in a similar location and manages similar conditions. Given the numerous barriers surrounding hepatitis C treatment as discussed previously, the AASLD has focused more on improving access to hepatitis C medications, and still meet with patient advocates to determine where to focus future advocacy efforts.19,20

HOW YOU CAN PARTICIPATE Gastroenterology practices should promote advocacy efforts to encourage reform with the PA process: 1. Contact your local legislator or government regulators via telephone or email to voice the impact of the PA process on your practice and patient care. 2. Become active in various medical organizations and get involved in their public policy activities. 3. Educate your patients on the PA process and equip them with resources to engage in advocacy efforts at the patient level.

“The process of submitting PAs and awaiting determination is often tedious, timeconsuming, and anxietyprovoking. It has also been linked to negative outcomes.”

4. Social media is a very powerful and effective platform for informing and mobilizing communities to participate in advocacy.21 Social media platforms like Twitter, Instagram, and Facebook permit gastroenterologists to comment in real time and tag appropriate individuals to foster awareness and conversation.

RESOURCES 1. American Medical Association (AMA). 2018 AMA prior authorization (PA) physician survey. https://www.ama-assn.org/system/files/2019-02/priorauth-2018.pdf. Accessed February 25, 2019. 2. Rubin D, Patel S. Integrated specialty pharmacy improves access to IBD drugs. https://www.healio.com. Accessed November 15, 2018. 3. RN Sights. Prior authorization headaches for pharma brand managers. www. rnsights.com. Accessed November 15, 2018. 4. Crohn’s and Colitis Foundation. Step Therapy. http://www. crohnscolitisfoundation.org/. Accessed February 25, 2019. 5. American Gastroenterological Association. Ulcerative colitis clinical care pathway. https://www.gastro.org/guidelines/ibd-and-bowel-disorders. Accessed February 25, 2019. 6. American Gastroenterological Association. Crohn’s disease clinical care pathway. https://www.gastro.org/guidelines/ibd-and-bowel-disorders. Accessed February 25, 2019. 7. United States Census Bureau. Health insurance coverage in the United States: 2017. https://www.census.gov/content/dam/Census/library/publications/2018/ demo/p60-264.pdf Accessed February 25, 2019. 8. Hepatitis C: The state of Medicaid Access. The National Summary Report. https://stateofhepc.org/report/. Accessed February 25, 2019. 9. Medpagetoday. Huge spread in patient copays for HCV drugs. https://www. medpagetoday.com/MeetingCoverage/ACG/60839?xid=nl_mpt_DHE_2016-1018&eun=g605133d0r&pos=1 Accessed February 25, 2019. 10. SAMHSA. CAGE-AID Questionnaire. https://www.integration.samhsa.gov/ images/res/CAGEAID.pdf February 25, 2019. 11. Bhat S, Zahorian T, Robert R, Farraye FA. Advocating for Patients With Inflammatory Bowel Disease: How to Navigate the Prior Authorization Process. Inflamm Bowel Dis. 2019 Feb 8. doi: 10.1093/ibd/izz013 12. Expressscript. Electronic Prior Authorization. https://www.express-path.com/ login.aspx February 25, 2019. 13. Covermymeds. Electronic Prior Authorization. https://www.covermymeds. com/main/ February 25, 2019. 14. Empire Liver Foundation. Fighting for your patients: Successful prior authorization tips from the pros. https://hepfree.nyc/wp-content/ uploads/2017/11/ELF-Fighting-for-your-Patients-Successful-PriorAuthorization-Tips-from-the-Pros-6-7-16-2.pdf Accessed February 25, 2019. 15. American Liver Foundation. Financial Assistance Resources. https:// liverfoundation.org/wp-content/uploads/2017/07/ALF-Financial-ResourcesGuide.pdf February 25, 2019 16. Crohn’s & Colitis Foundation. Financial Help. https://www. crohnscolitisfoundation.org/living-with-crohns-colitis/financial-resources.html February 25, 2019. 17. American Gastroenterological Association. Advocacy & Policy. https://www. gastro.org/advocacy-and-policy Accessed February 25, 2019. 18. American College of Gastroenterology. Public Policy. https://gi.org/publicpolicy Accessed February 25, 2019. 19. American Association of the Study of Liver Diseases. AASLD deepens its relationship with patient group. https://www.aasldnews.org/aasld-deepens-itsrelationship-with-patient-groups/ Accessed February 25, 2019. 20. American Association of the Study of Liver Diseases. Hepatitis C guideline. https://www.hcvguidelines.org/ Accessed February 25, 2019. 21. Scott JT, Maryman J. Using social media as a tool to complement advocacy efforts. Global Journal of Community Psychology Practice. 2016;7:1-22.

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AS THE PLANE BEGAN ITS SLOW, TILTING DESCENT into

An Eye-Opening and Edifying Experience: ACG’s Young Physician Leadership Scholars Program “Leadership is a way of thinking, a way of acting, and, most importantly, a way of communicating” – Simon Sinek By Elizabeth R. Paine, MD, Madison, MS

lighted bundles of buildings and streets, I found a familiar old fluttering stirring in my gut. After years of comprehensive, intensive training in medical management, endoscopic practice, and diagnostic evaluation, I was very ready for just about any clinical conundrum that I might face. Yet some of the knowledge now most necessary to my professional practice had been, up to now, learned through trial and error and without formal instruction. The jerk of tires on pavement pulled me forward out of my seat and hit me with a sudden realization: I am now an intern in the fellowship of leaders. In 2018, I was honored to be chosen as part of the inaugural class of the American College of Gastroenterology’s new Young Physician Leadership Scholars Program (YPLSP). This program provides a vital resource for early-career gastroenterologists to learn and practice leadership strategies, complex communication, and professional advocacy. Having been in practice for close to five years, I can emphatically and unequivocally say that this program fills a huge gap in typical medical training.  ACG Perspectives | 33


// ACG PERSPECTIVES

As physicians, we are asked to lead medical teams, services, programs, divisions, and sometimes even departments with little to no formal training or practical tools. Much like being a third year medical student again, we are forced to figure it out as we go. Thankfully, the YPLSP is changing all of that.

CHALLENGING PRECONCEPTIONS ABOUT THE ROLE OF PHYSICIANS AS ADVOCATES The program began in the fall of 2018 with stimulating online modules and readings that guided us through various facets of modern leadership, advocacy preparation, financial wellness, and emotional intelligence. Each module expanded my understanding of the complexity of our changing healthcare system and challenged my preconceptions about the role that physicians can play in advocating for impactful and important transformation of our healthcare landscape. It was October 2018, and the plane was landing in Philadelphia – the site of the first in-person training component of the program at the ACG Annual Scientific Meeting. It was here that the rubber really met the road for me—figuratively speaking this time. I met my fellow participants—sisters and brothers in the trenches of early career and trial-and-error leadership learning. Soon we would meet Dr. Mark Pochapin and Dr. David Hass as they led us through an informative and open discussion of state-of-the-science leadership, networking, organizational development, and models of individual influence. Particularly poignant was when I stood in front of a large blank paper with instructions to start creating my own leadership model. As I grouped valued characteristics into categories, my model began to take shape as a kite. As I looked around the room at each of the scholars’ models, I paused as I recognized what an amazing experience this was—to be in a group of leaders just starting their careers with so many gifts and so much promise.

ADVOCACY TRAINING AND EXPERIENCE IN WASHINGTON, DC When the plane landed again it was April 2019 and I was in Washington, DC. What was a VA gastroenterologist from Mississippi doing in the national power-seat—what could I do? That question was soon to be answered, and, in the answering, this program and this experience fundamentally changed how I see my role as an ACG diplomat. I walked through buildings named for luminaries of our national discourse and met with fascinating and passionate Representatives and Senators from my state. I found, more surprisingly, that the YPLSP had given me an awareness of my own passion for my profession and the patients for whom we provide care. More importantly, the training of the program had given me the language, the understanding, and the voice for the role I was about to play. Specifically, when I met with Senator Cindy Hyde-Smith with my ACG Governor

34 | GI.ORG/ACGMAGAZINE

“As I looked around the room at each of the scholars’ models, I paused as I recognized what an amazing experience this was—to be in a group of leaders just starting their careers with so many gifts and so much promise.” —Dr. Paine

for Mississippi, Dr. Stephen Amann, I remember sharing about the importance of eliminating barriers to colon cancer screening among residents of our home state. I had become an advocate, and in so doing, a leader. In closing, this experience has been one of the most eye opening and edifying of my entire journey in medicine. The founders of the YPLSP have much of which to be proud. They have provided critical and timely training for physicians looking to be leaders and advocates for the field of gastroenterology specifically and the ACG and the practice of medicine more broadly. The skills I have learned and tools I have been given will serve me life-long, and I have been inspired to be a change agent in the rapidly evolving state of national healthcare. Thank you for affording us such an amazing opportunity to grow! (Page 35) Dr. Paine at the United States Capitol, April 4, 2019. This page (Photo top) YPLSP attendees at a Congressional Briefing with ACG President Dr. Sunanda V. Kane and Rep. Kim Schrier (D-WA) (center front). (Photo bottom) L to R: Dr. Pooja Singhal, Dr. Sunanda Kane, Dr. Sadeea Abbasi, and Dr. Elizabeth Paine.


What was your specific project/assignment?

REFLECTING on MY EXPERIENCE as an ACG Fellow at the FDA ACG’s FDA Visiting Fellowship Program gives current first- or second-year GI fellows the opportunity to apply for a one-month rotation at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, Division of GI and Inborn Error Products. Fellows gain valuable experience in the drug/ medical device registration and approval process and observe the interaction between FDA, academia, and industry. Recently, ACG MAGAZINE invited Dr. Amanda Cartee and Dr. Yasmin Hernandez-Barco to offer reflections on their experiences as ACG-FDA fellows and the insights they gained.

“I also learned about the emphasis the FDA places on patients and their role in drug approval.” —Dr. Cartee 

Amanda K. Cartee, MD, GI Fellow, University of Michigan Dr. Cartee was an ACG FDA Fellow during her training at Mayo Clinic Rochester.

What motivated you to apply to serve as an ACG fellow at the U. S. Food & Drug Administration? My main clinical interest is in celiac disease and gluten-related disorders. One of the emerging areas in celiac disease is non-dietary therapeutics in addition to or in place of a gluten-free diet. There are several agents in the early phases of drug development. I thought that visiting the FDA would give me greater insight in to the process of drug development from non-clinical to approval, post marketing surveillance, and the interaction between the agency and industry. The fellowship exceeded my expectations. From the moment that I arrived, all of the staff were welcoming and eager to teach me. I could not have imagined a better, more fulfilling experience.

Throughout the five-week fellowship, I attended meetings (internal and with industry), courses, and a public workshop on pediatric drug development for Inflammatory Bowel Disease. During the public workshop, the FDA, investigators, and industry came together for a full day of discussion about barriers to drug approval for pediatric IBD patients, emerging topics (i.e., therapeutic drug monitoring), and solutions to difficulties in pediatric drug approval. The division also arranged for me to meet one-on-one with people from different groups within and that work with the division: toxicology, chemistry, statistics, labeling, epidemiology, devices, and over-the-counter (OTC). This gave me an opportunity to see the depth and breadth of the FDA’s role in drug approval and drug regulation. In addition, I completed a literature review project on histologic small bowel assessment for celiac disease to review the role of biopsy in diagnosis and monitoring response to treatment, proper biopsy technique, and pros and cons to various histologic scoring systems for celiac disease.

What new understanding or appreciation for the role of the FDA did you develop? I have a new appreciation of the FDA’s role in regulation post-drug approval. I learned that drugs and industry are regularly monitored after approved in several ways. First, drugs manufactured are audited and tested to ensure that the chemical composition and active metabolites are the same as when the drug was going through the approval process, ensuring safety and efficacy of the product itself. There is also an epidemiology group who monitors for side effects reported by patients, providers, and industry as part of post-marketing surveillance. I learned about how this can be more difficult for the FDA than other regulatory bodies in countries with a unified health system. Lastly, I learned how important clinical trial design is to drug labeling and the FDA’s role to ensure that claims remain true to study findings.

What surprised you most about FDA’s role in the federal health landscape? One of my first activities was learning about the history of the FDA and its interaction between Congress. The main tenets of the FDA are to ensure that drugs are both safe and effective. Previously, I had not known ACG Perspectives | 35


how the FDA is entrusted to protect vulnerable populations, including healthy volunteers and children. Until my rotation at the FDA, I was not familiar with the laws requiring industry to perform studies in children after adult approval to again ensure safety and efficacy for this group. I also learned about the emphasis the FDA places on patients and their role in drug approval. This was evident in the requirement for patient reported outcome measures in clinical studies. In addition, listening sessions were held between patient advocacy groups and the agency to help increase communication of the important aspects that new treatments can improve quality of life and effects to measure.

What take-aways will you bring into your clinical career as a result of this experience? After this experience, I have a greater appreciation for the thoughtfulness and effort that goes in to ensuring the drugs we prescribe are safe and effective for our patients.

Would you recommend this program to others—why or why not? I would absolutely encourage other GI fellows to apply to this program. Whether interested in clinical medicine, research, and/or regulatory medicine, this program has something to offer everyone. The program allows you to get a glimpse of the nuances of drug labels, clinical trial design, and the various components of drug approval.

and the factors which matter to this important body. I gained so much more from this fellowship than I ever imagined and can definitely say I left a better physician and researcher.

What was your specific project/ assignment?

“The FDA represents the doctors and safety gatekeepers for the country. The most surprising thing about the FDA is the organizational structure leveraged for the drug development process.” —Dr. Hernandez-Barco

Yasmin G. Hernandez-Barco, MD, GI Fellow, Massachusetts General Hospital, Research Fellow, Harvard School of Medicine

What motivated you to apply to serve as an ACG FDA fellow? As a physician-scientist, my research focuses on making a significant impact on the lives of patients through medical advances. The FDA shares my goal and plays a critical role in the approval of ground-breaking treatments found through major laboratory and clinical discoveries. I applied for this fellowship to gain insight into the way the FDA works, 36 | GI.ORG/ACGMAGAZINE

My project involved describing the natural history of pancreatic diseases and the unique challenges in pancreatic disease drug development. Currently, no guidance exists for pancreatic disease drug development, and it is my hope that my work at the FDA will help to inform the evaluation and development of potential treatments for patients with these diseases. As part of my project, I had the opportunity to work closely with the entire team at the Division of Gastroenterology and Inborn Errors Products (DGEIP) in the Center for Drug Evaluation and Research (CDER). I was immediately welcomed by my mentor, associate director, and extended team. From the beginning of my time there, I was fully immersed as a team member and had the opportunity to attend meetings with research and industry sponsors. I also met with experts from each of the labeling subdivisions and had the opportunity to work in the Center for Devices and Radiological Health (CDRH), where I was able to learn about the latest devices and radiographic developments for the treatment and diagnosis of GI diseases.

What new understanding or appreciation for the role of the FDA did you develop? I learned that the FDA operates through an incredible network of individuals, comprised of physicians, scientists, statisticians, pharmacologists, epidemiologists, and more. These individuals form teams, which work together to ensure that industry and researchers can effectively and safely develop new drugs and treatments for patients across the country. These teams work within the parameters of outlined regulations and guidance

to ensure that safe and efficacious treatments reach patients.

What surprised you most about FDA’s role in the federal health landscape? The FDA represents the doctors and safety gatekeepers for the country. The most surprising thing about the FDA is the organizational structure leveraged for the drug development process. These robust teams of incredibly intelligent individuals work tirelessly with researchers and industry to ensure that clinical trials are well-designed and that the indications, ultimately printed on drug labels, are informative and useful for payers, physicians, and patients.

What take-aways will you bring into your clinical career as a result of this experience? I developed a greater understanding of the labeling process and the indications printed on drug labels (both over-the-counter and prescribed). There is a wealth of information included on each label, which is carefully included by FDA experts after their careful review of available clinical trial data. I will certainly be able to better counsel patients as a result of understanding the incredible amount of information included on each label.

Would you recommend this program to others—why or why not? Absolutely. Moreover, I specifically recommend this program to individuals interested in regulatory science, population health, or clinical trial research. This experience came at a pivotal moment in my career. I am very grateful for this tremendous opportunity and wish to thank all of the incredible individuals who I met during my time at the FDA. I hope to have the opportunity to continue to be a part of the development of FDA guidances, specifically those for pancreatic diseases.  LEARN MORE:

gi.org/acg-fda-visiting-fellowship-program


EDUCATION THE ACG EDGAR ACHKAR VISITING PROFESSORSHIP Providing Noteworthy Speakers for Training in Your Communities

Photo Top: Dr. David Rubin visits with GI fellows at Brown University.

THROUGH THE EDGAR ACHKAR VISITING PROFESSORSHIP PROGRAM

(EAVP), the ACG Institute is committed to creating opportunities for speakers to serve as faculty for medical grand rounds presentations and to enhance the educational experience of GI fellows-intraining while providing clinically relevant presentations that also include ACG member physicians in the community. EAVP visits continue to reach diverse GI programs across the country and to spark excellent discussions while inspiring and

educating fellows. Here ACG MAGAZINE highlights visits by David T. Rubin, MD, FACG, to Brown University; Brian E. Lacy, MD, PhD, FACG, to New York Presbyterian/Weill Cornell; William D. Chey, MD, FACG, to the University of Colorado; and ACG Institute Director Nicholas J. Shaheen, MD, FACG, to Wayne State University/Detroit Medical Center.

“This was an incredible opportunity to learn from a world-renowned expert on IBD in an intimate and friendly setting in our own backyard... the ACG Edgar Achkar Visiting Professorship is an innovative and effective way to foster the exchange of knowledge at the forefront of GI and furthers the education of gastroenterology trainees directly from highly regarded subspecialty experts. ” —Chung Sang Tse, MD, Gastroenterology Fellow

Education | 37


// EDUCATION

“Dr. Lacy's talk on functional bowel disorders (i.e., in particular, irritable bowel syndrome) was incredibly thought-provoking and insightful. Perhaps, what was most impressive and distinct from any prior functional bowel talk, is the way he presented a cogent argument for better understanding the underlying pathobiology of irritable bowel syndrome in helping guide treatment options. It was a transformative talk in making a condition, that is often a great source of frustration for both patients and providers alike, into a disease process akin to inflammatory bowel disease or gastroesophageal reflux disease.” —Shawn L. Shah, MD, Gastroenterology Fellow

“The most interesting and engaging lecture was on Thursday evening when multiple metro Detroit GI fellowship programs came together for this lecture. There were engaging discussions on screening, surveillance, and endoscopic management of Barrett’s as well as on some of the newer diagnostic modalities.” —Stephanie L. Judd, MD

38 | GI.ORG/ACGMAGAZINE


2019

ACG EDGAR ACHKAR VISITING PROFESSORSHIPS EAMONN M. M. QUIGLEY, MD, MACG Mount Sinai Beth Israel, St. Luke and West FEBRUARY 26–27 AMY S. OXENTENKO, MD, FACG NYU School of Medicine APRIL 2 STEPHEN B. HANAUER, MD, FACG Lehigh Valley Health Network APRIL 3–4 DAVID T. RUBIN, MD, FACG Brown University MAY 8–9 BRIAN E. LACY, MD, PHD, FACG New York Presbyterian/Weill Cornell MAY 9 NICHOLAS J. SHAHEEN, MD, MPH, FACG Wayne State University/ Detroit Medical Center MAY 9–10

“I gave grand rounds to a packed house and then spent more than an hour with the fellows. I found this particularly gratifying and I think they did as well. It was a great opportunity for the fellows to get a fresh take on career and personal development as a gastroenterologist.”­­

WILLIAM D. CHEY, MD, FACG University of Colorado JUNE 6–7 DAVID J. HASS, MD, FACG Cooper University Hospital JUNE 13 DOUGLAS K. REX, MD, MACG Texas Tech University Health Sciences Center El Paso JUNE 14 ASHWANI K. SINGAL, MD, MS, FACG University of Iowa Hospitals & Clinics JULY 25 EDWARD V. LOFTUS JR., MD, FACG University of California, Davis SEPTEMBER 19 MARIA T. ABREU, MD Mountain Vista Medical Center/ Midwestern University NOVEMBER 12-13

—William D. Chey, MD, FACG

Education | 39


TRAINING IN ONCOLOGIC ASPECTS

of Gastroenterology and Endoscopy at MD Anderson Cancer Center, Houston, Texas Irina M. Cazacu, MD, ACG International Training Grant Recipient

RECEIVING THE ACG GRANT AND TRAINING AT MD ANDERSON CANCER CENTER was, for me, a dream come true. I was honored to have the opportunity to train and perform research under the mentorship of the renowned gastroenterology expert, Dr. Manoop S. Bhutani, who has offered incredible support throughout the process of my application and during my fellowship. I received my medical degree from the University of Medicine and Pharmacy in Craiova, Romania four years ago. There is a significant cancer burden in Romania and an acute need for oncologists, so I decided to begin

40 | GI.ORG/ACGMAGAZINE

abroad and acquire clinical and research experience from a leading cancer center in the United States.

FINDING A ”SECOND HOME” AT MD ANDERSON

my training in medical oncology to fight against one of the world’s most dreaded diseases. My plan is to develop a clinical and research career with a focus on oncologic aspects of gastroenterology. With this goal in mind, I started my PhD studies with an emphasis on molecular profile and early detection of pancreatic cancer. I am fortunate to have an outstanding mentor, Dr. Adrian Saftoiu, who shared with me his continuous excitement of practicing in the field and all the challenges faced during attempts to improve the diagnosis of gastrointestinal cancers. He encouraged me to apply for the ACG International Travel Grant that would offer me the chance to train

Houston and MD Anderson became my second home very quickly. I was pleasantly surprised with the philosophy of this prestigious institution, with its focus on excellence, respect, and value of diversity. I came to understand the pure dedication this institution has toward patients with cancer, and it really dawned on me that the simplest things can make a huge difference in the lives of our patients. During my training at MD Anderson, I was exposed to a wide variety of complex oncological cases and gained experience from the highvolume of patients I saw. I shadowed and observed various complex endoscopic procedures performed by Dr. Bhutani in cancer patients, enriching my medical knowledge by understanding the indications, findings and clinical implications for each case.


Dr. Bhutani is part of the multidisciplinary expert panel who developed the pancreatic cancer screening algorithm. As part of his team, I was involved in research projects regarding pancreatic cancer screening and this experience offered me a better understanding of this concept, from clinical benefits to psychological impact.

LEARNING FROM MULTIDISCIPLINARY TUMOR BOARDS I attended various multidisciplinary tumor boards related to gastrointestinal cancers, where I gained first-hand knowledge from experts in the field. At the moment in Romania, there are only vague recommendations for the use of multidisciplinary teams. At MD Anderson, I became familiar with the principles and practice of multidisciplinary teams and my plan is to promote interdisciplinary interactions that will facilitate effective teamwork at my home institution. I had also the chance to attend various educational sessions, teaching rounds, journal clubs, and lectures from world-class faculty. I grew so much as a doctor in this past year due to the sheer number of opportunities afforded to me.

A TURNING POINT IN MY RESEARCH CAREER My training at MD Anderson under the mentorship of Dr. Bhutani was a turning point in my research career. I was placed in a stimulating environment with an outstanding team who facilitated my scientific training and productivity. I was able to extend the output of my research papers by a considerable amount, both in qualitative and in quantitative terms. I participated in several research projects, from study design, Institutional Review Board submission, data collection, data analysis, to drafting of the manuscripts. My work resulted in six manuscripts accepted for publication and two presentations at international meetings, DDW 2018 and ACG’s Annual Scientific Meeting in 2018. EUS-guided fiducial markers placement for image-guided radiotherapy in gastrointestinal malignancies was another area of research during my training at MD Anderson. We have conducted a meta-analysis showing that EUS-guided placement of fiducial markers is safe and has a high rate of technical success. Furthermore, I was part of the ongoing research projects looking at the clinical and survival benefits of fiducial markers in patients with pancreatic cancer. I had also the

“At MD Anderson, I became familiar with the principles and practice of multidisciplinary teams and my plan is to promote interdisciplinary interactions that will facilitate effective teamwork at my home institution.” —Irina M. Cazacu, MD 

incredible opportunity to observe new treatment modalities for pancreatic cancer that are under research at MD Anderson and are likely to change the clinical practice in the future.

PLANS FOR THE FUTURE My dream and future career plan is to be actively involved not only in the treatment of gastrointestinal cancers but also in the diagnosis of these devastating diseases by training in interventional gastroenterology. I plan to become a pioneer of the pancreatic cancer screening program in Romania upon my return. Being part of Dr. Bhutani’s team was a tremendous experience which will inspire and encourage me as a person and as an oncologist/ interventional gastroenterologist for the rest of my professional career to achieve and to provide the best possible care for my patients. Dr. Bhutani was not only my mentor but also my biggest career advocate. I am very grateful to the ACG for providing me with an awesome learning experience that is invaluable to me and the patients I will care for. Without question, training at MD Anderson Cancer Center under the mentorship of Dr. Manoop Bhutani was a wonderful, lifechanging experience that I will carry with pride and honor for the rest of my medical career.

Education | 41


APPLY

for an ACG Clinical

Research Award

Deadline: Friday, December 6, 2019 ACG Junior Faculty Development Award $100,000 a year for three years Clinical Research Awards up to $50,000 for clinical research; up to $15,000 for pilot projects “Smaller Programs” Clinical Research Awards up to $35,000 for programs with 15 or fewer full-time faculty NEW!

NEW!

Resident Clinical Research Award up to $10,000 Medical Student Research Award up to $5,000 for 6–10 week summer project

Learn more about ACG 2020 Clinical Research Opportunities and Submit Your Application:

GI.ORG/GRANT-ANNOUNCEMENTS 42 | GI.ORG/ACGMAGAZINE


Inside the

JOURNALS

G

AC RTS EPO CASE RO J URN L

an of the Americ Official Journal enterology College of Gastro

Volume 114

| Number 7

G OM I.OR TS.C TS.G POR POR ERE ERE CAS CAS ACG ACG

| July 2019

The GUT E MICROBIOuM Iss e EDITORS: Brian

E. Lacy, MD, PhD,

VOLUME 6

n Spiegel, MD,

FACG and Brenna

MSHS, FACG

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

A SPECIAL ISSUE of The American Journal of Gastroenterology in July 2019 was dedicated to the Gut Microbiome. The issue "adds important new information to the evolving and dynamic field of microbiome science in gastroenterology and beyond" according to AJG Co-Editors-in-Chief Brian E. Lacy, MD, PhD, FACG, and Brennan M. R. Spiegel, MD, MSHS, FACG. Read featured articles and explore the Red Journal Table of Contents at amjgastro.com ACG MAGAZINE invited Dr. Paul Enck to provide an Author Insight on his research from the Microbiome issue, “Bifidobacterium longum 1714™ Strain Modulates Brain Activity of Healthy Volunteers During Social Stress” which found that B. longum 1714™ modulated resting neural activity that correlated with enhanced vitality and reduced mental fatigue. Furthermore, B. longum 1714™ modulated neural responses during social stress, which may be involved in the activation of brain coping centers to counterregulate negative emotions. Finally, for the Microbiome issue AJG Podcast, Dr. Lacy recorded a conversation with Jessica R. Allegretti, MD, MPH, on her article, “Fecal Microbiota Transplantation in Patients with Primary Sclerosing Cholangitis: A Pilot Clinical Trial.”

 Listen: bit.ly/AJG-Podcast-Allegretti

Inside the Journals | 43


INSIDE THE JOURNALS [THE AMERICAN JOURNAL OF GASTROENTEROLOGY]

Author Insight: Why Probiotics May be Helpful for Mood, Stress, and Sleep Disturbances Paul Enck, PhD, Director of Research, Dept. of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Germany; Bifidobacterium longum 1714™ Strain Modulates Brain Activity of Healthy Volunteers During Social Stress, Huiying Wang, PhD; Christoph Braun, PhD; Eileen F. Murphy, PhD; and Paul Enck, PhD, Am J Gastroenterol 2019;00:1–11

 THERE ARE MANY DIFFERENT PROBIOTICS IN YOGURTS, OTHER FERMENTED FOODS, DIETARY SUPPLEMENTS, AS WELL AS SOME DRUGS. By WHO definition, probiotics are living bacteria that, when consumed in adequate amounts, provide health benefits to their host. Probiotic products have been on the market for more than 100 years, and their predominant claim is improvement of intestinal function. That makes them potentially valuable in intestinal dysfunction, such as in patients with irritable bowel syndrome, constipation, diarrhea, bloating and similar conditions; following intestinal infections or antibiotic-associated diarrhea; and food sensitivities such as lactose intolerance. But as with their opponents, antibiotics, not all probiotics are alike. To regard them as equal under all circumstances would be like claiming Wang etone al. antibiotic is as good as that

another, or one pain killer is as effective as the next. It is also a misunderstanding to mix many different probiotics into a new product to gain higher efficacy, when the efficacy of the single strains has not been proven, and as long as synergy between them has not been demonstrated. Traditionally, the purpose of mixing them is to allow for patenting, which cannot be done with single strains unless they have 6 Wang et al. been developed and characterized for a specific purpose. Traditional probiotics (either single or multi-strains) have no pronounced effects on central nervous system (CNS) functions; it would have been noted by consumers if they were at all effective in brain function. This view changed substantially with animal research focusing on manipulation of the gut microbiota, and especially with observation in gnotobiotic (sterile) mice deprived of all intestinal bacteria. Their neurodevelopmental abnormalities normalized when commensal bacteria were added to the intestines, giving rise to the idea that a

FUNCTIONAL GI DISORDERS

6

// INSIDE THE JOURNALS normal gut microbiota maybe needed for normal development of CNS functions such as memory, fight-flight reactions and stress response, mood, sleep, and social behavior. When this became evident, the search for novel probiotics specifically aiming towards CNS functions began, first in animals and then in humans. The probiotic that we used in our study (Bifidobacterium longum 1714TM) (1714TM) has this background: it was selected following animal studies and was successful in translational studies in healthy humans. When I first became aware of this new line of research—microbiota affecting the CNS—I was highly skeptical, but willing to test this in an experimental approach during a 4-year project, Training Network NeuroGUT, funded by the European community. The company producing 1714TM, University of Cork, Ireland start-up Alimentary Health/ PrecisionBiotics Ltd., provided the probiotic, but had no further influence on the study design and course. My student Huiying Wang from China, who had done her MSci in the United Kingdom, completed her PhD through the project. My colleague Christoph Braun suggested using the less common imaging technique magnetoencephalography (MEG), rather than the more common functional magnetic resonance imaging (fMRI). We selected a human stress model that specifically mimics a social stress instance, social exclusion (ostracism) using the Cyber Ball Game

M ha co N sc 2 pa w je tw

B. by

Af pl th in as (A be fu su lef

MEG power in each frequency band showed brain regions that had significantly different activities during the exclusion compared with the inclusion condition (Figure 3). The global NTS (t37 5 13.39, P , 001) and SEP (t38 5 9.99, P , 001) scores were significantly higher, and the MQ scores (t39 5 29.42, P , 001) were lower in the exclusion condition compared with inclusion condition (Table 1). At baseline, there were no significant differences in SF36 scores or CBG subjective scores (NTS, MQ, and SEP) after the social stress between groups (Table 1). B.

wi B. longum 1714™ altered resting-state brain activity measured N by MEG af

Difference of neural activity change during resting state comparing B. longum 1714™ vs placebo.

44 | GI.ORG/ACGMAGAZINE

After a 4-week intervention, comparison between probiotic and placebo group showed that B. longum 1714™ feeding increased theta band (6 Hz) power (P , 0.05; Figure 4a) in the bilateral Figure 4. Difference of neural activity change resting state comparing inferior, middle, and superior frontalduring cortex (IFC, MFC, and SFC) B. longum placebo. (a) After the intervention, an increased as well1714™ as in vs the bilateral anterior and middle cingulatetheta cortex band (6 Hz)and power was obtained in a cluster including regions1714™ of bilateral (ACC MCC). Furthermore, feeding B. longum reduced inferior frontal cortex, middle frontal cortex, and the bilateral anterior cingubeta-2 band (26 Hz) power (P , 0.05; Figure 4b) in the bilateral

la st 2 bo be ch G


(CBG), that can be easily applied to a brain scanning situation. In short, the scanned volunteer, together with two virtual players (said to be real persons in another room), is engaged in computerbased ball tossing game. After some time, the two virtual players start neglecting the volunteer and play amongst themselves; this leaves the volunteer isolated and induces mood changes. We decided to run the experiment on healthy male and female volunteers, selected for their stress susceptibility or acute stress level. A total of 40 volunteers were selected who for four weeks received either a daily dose of 1x109 cfu (colony-forming units) of 1714TM or a similarlooking placebo in a double-blind and randomized fashion. MEG recordings were done prior to and at the end of the 4 weeks, and at each occasion during resting as well as during the CBG, with phases of inclusion and exclusion evaluated separately. In addition, health-related quality of life was assessed in both groups before and after the study, and subjective mood ratings were taken prior to and after the CBG. MEG is somewhat different from fMRI by allowing higher resolution of brain responses in terms of time (in msec), while providing lower resolution with respect to location—which has to do with its being based on electro-magnetic activity, similar to EEG. As with EEG, the brain activity is separated into different frequency bands (alpha, beta, and theta waves here), that represent predominant activities during relaxation, mental concentration, and deep relaxation/sleep, respectively. Based on prior anatomical MRI scans, brain activity and its changes were projected onto individual brain scans for visualization of the results. Because of the complex design (three-factor interacting: pre-post, 1714TM-placebo, inclusion-exclusion), data for a resting state and CBG activity

were analyzed separately, and they were also correlated with subjective measures. Results can be summarized as follows: 1. 1714TM altered resting state neural oscillations, with an increase in theta band power in the frontal and cingulate cortex, and a decrease in beta band power in the hippocampus, fusiform, and temporal cortex; this was associated with subjective increase in vitality and reduced mental fatigue. 2. Both groups showed similar social stress with CBG after four weeks of intervention. However, only the 1714TM group showed changed neural oscillation following CBG stress, with increased theta and alpha band power in the frontal and cingulate cortex and supramarginal gyrus, which may be involved in counter-regulation of negative emotions. This study confirms what animal experiments suggested for a long time—specific probiotic strains such as the 1714TM strain can improve stress processing and make it easier for healthy people to deal with stress. Does that make the 1714TM strain a drug that can be used for posttraumatic stress disorder or other clinical conditions associated with high stress susceptibility, mood disorders, or anxiety and depression? Presumably not. The effects seen are mild, and certainly well below the level of clinical relevance for major psychiatric disorders. What it does show is that even in healthy adults, certain probiotics may affect CNS functions at levels not subjectively perceived by the volunteers. Hence, they may at least serve as a natural and safe alternative in cases of sub-clinical mental states, such as sleep disturbances and daily life hassles.  READ the article: bit.ly/AJGBLongum1714

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DOWNLOAD THE ACG MOBILE APP Download the app via the Apple or Android Store. Inside the Journals | 45


[ACG CASE REPORTS JOURNAL]

Cocaine Gut Raghav Bansal, MD; Malay Sharma, MD; Joshua Aron, MD

Cocaine causes bowel ischemia by blocking norepinephrine reuptake in presynaptic nerve endings leading to arterial vasospasm or vasoconstriction. Other potential mechanisms include direct vasoconstriction and platelet aggregation. Cocaine has been associated with an array of complications involving the upper and lower gastrointestinal tracts with significant morbidity and mortality. Prepyloric and duodenal perforations are the most common gastrointestinal complications produced by cocaine consumption

 READ the full case: bit.ly/ACGCRJ-Cocaine-Gut

[CLINICAL & TRANSLATIONAL GASTROENTEROLOGY]

Mucosa-Associated Microbiota in Ileoanal Pouches May Contribute to Clinical Symptoms, Particularly Stool Frequency, Independent of Endoscopic Disease Activity Williams Turpin, PhD; Orlaith Kelly, MD; Krzysztof Borowski, MSc; Karen Boland, MD; Andrea Tyler, PhD; Zane Cohen, MD; Kenneth Croitoru, MD and Mark S. Silverberg, MD, PhD

 RESEARCHERS AT THE UNIVERSITY OF TORONTO examined whether the individual clinical components of the pouch activity scoring systems are associated with specific microbiota. In the absence of inflammation, an increase in stool frequency reported over 24 hours was associated with a decrease in Bacteroidetes relative abundance, and this was the strongest association found. Phylogenetic Investigation of Communities by Reconstruction of Unobserved States (PICRUSt) analysis in inflamed groups showed that an increase in 24hour stool frequency

46 | GI.ORG/ACGMAGAZINE

WHAT IS KNOWN  Pouchitis can occur in 30%–50% of individuals after IPAA.  Microbiome composition is associated with health and disease. WHAT IS NEW HERE  Clinical components of the pouch activity scoring systems are associated with microbiota.  Stool frequency is associated with mucosal microbiome composition and function. TRANSLATIONAL IMPACT  Future therapies directed at modulation of the microbiome may be a particularly important approach in the management of pouchitis, especially for treatment of clinical symptoms.

was associated with an increase in biofilm formation. These findings indicate that in patients with IPAA, the composition of mucosa-associated microbiota of the pouch may contribute to clinical symptoms, particularly stool frequency, independent of endoscopic disease activity.

 READ the full article: bit.ly/CTG-Turpin


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

50 YEARS AGO...

A A LO LOOK OK BA BACK CK

from the pages of The American Journal of Gastroenterology By Lawrence R. Schiller, MD, MACG for the ACG Archives Committee

W

ith colonoscopy now a routine procedure, we forget that observing the ileocecal junction in living human beings was an unusual event not that long ago. This report highlights the appearance and function of the ileocecal junction as viewed through a cecostomy. “This report summarizes the observations made by one of the authors (DiDio) on the termination of the ileum in the large intestine in nine living subjects and describes the tenth patient whose ileal opening and surrounding area were exteriorized and examined in detail. When the termination of the ileum is viewed through a cecostomy or through a cecocolostomy, it is found to protrude into the lumen of the large intestine for a distance of 2–3 cm and is ensheathed by the surrounding colon and cecum. The anatomic configuration is that of a “papilla” with a star-shaped orifice. There is no evidence for the concept of a “valvular” mechanism at the junction between the small and large intestines. Functionally, the musculature of the ileal papilla acts as a pylorus, similar to the gastroduodenal and biliopancreatic pylori. We agree that this structure should be renamed the ileal “papilla”, as has been proposed by others.”

Figure 1

—J. C. Rosenberg & L. J. A. DiDio. In vivo appearance and function of the termination of the ileum as observed directly through a cecostomy. Am J Gastroenterol 1969;52(5):411–9. Figure 1: Exteriorized and incised cecocolic junction of a patient (J.S., 71-year old African American male, North American). Through the incision the mucosal surface of the large intestine is seen. The termination of the ileum is conic with truncated apex, justifying the name of “ileal papilla” (2 cm high, 2.5 cm in diameter at the base and 2 cm in diameter at the apex). A semilunar orifice, concave dorsally, is observed at the apex of the papilla. Figure 2: Open orifice of the terminal ileum discharging semisolid ileal contents (same case as Fig. 1). The size of the ileal papilla increased during emptying of the terminal ileum and decreased afterwards.

Figure 2

Inside the Journals | 47


NON-ALCOHOLIC FATTY LIVER DISEASE t ie D an e an r r e it d e M & THE What is Non-Alcoholic Fatty Liver Disease (NAFLD)? A condition in which fatty deposits develop on your liver, found by an imaging study (e.g., ultrasound or CT scan) or a liver biopsy.

To be classified as NAFLD, you must drink less than 21 drinks of alcohol per week if you’re a man, and less than 14 if you’re a woman. This is to confirm that alcohol consumption is not likely the cause of the fatty deposits.

NAFLD is an increasingly common problem, estimated to affect 20% of people worldwide.

The most common risk factors are  obesity  type 2 diabetes  high blood lipids. Making the right dietary choices in combination with weight loss can help reverse NAFLD.

What is the best diet for NAFLD?  Many diets have been studied, but the Mediterranean diet, which consists of the foods and cooking styles commonly eaten in the countries that surround the Mediterranean Sea, has the most evidence of working.

 If you have NAFLD, losing 10% of your total body weight has been shown to drastically decrease the amount of fat on your liver.

This diet mainly consists of: Monounsaturated fats (good fats) like olive or canola oil instead of saturated fats (bad fats) found in butter and lard; Fish and poultry, limiting processed meat and red meat consumption; Plant-based foods including fresh fruits and vegetables, whole grains, legumes (beans, peas, lentils and peanuts), and nuts;

 Finding the right dietary plan can be tricky and needs to be individualized for each person. That’s why we recommend contacting a dietitian or nutritionist to help you and your doctor determine your personalized plan.

Red wine in moderation (one glass per day.) Dietary guidelines caution against beginning to drink or drinking more often on the basis of potential health benefits. Courtesy of Dr. Michael Bass, ACG Patient Care Committee | More Info: patients.gi.org

48 | GI.ORG/ACGMAGAZINE


IMPORTANT SAFETY INFORMATION SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

BRIEF SUMMARY: Before prescribing, please see Full Prescribing Information and Medication Guide for SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution. INDICATIONS AND USAGE: An osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. CONTRAINDICATIONS: Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. WARNINGS AND PRECAUTIONS: SUPREP Bowel Prep Kit is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Pre-dose and post-colonoscopy ECGs should be considered in patients at increased risk of serious cardiac arrhythmias. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted. It is not known whether this product can cause fetal harm or can affect reproductive capacity. Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Geriatric Use: Of the 375 patients who took SUPREP Bowel Prep Kit in clinical trials, 94 (25%) were 65 years of age or older, while 25 (7%) were 75 years of age or older. No overall differences in safety or effectiveness of SUPREP Bowel Prep Kit administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. DRUG INTERACTIONS: Oral medication administered within one hour of the start of administration of SUPREP may not be absorbed completely. ADVERSE REACTIONS: Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. Oral Administration: Split-Dose (Two-Day) Regimen: Early in the evening prior to the colonoscopy: Pour the contents of one bottle of SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Consume only a light breakfast or have only clear liquids on the day before colonoscopy. Day of Colonoscopy (10 to 12 hours after the evening dose): Pour the contents of the second SUPREP Bowel Prep Kit into the mixing container provided. Fill the container with water to the 16 ounce fill line, and drink the entire amount. Drink two additional containers filled to the 16 ounce line with water over the next hour. Complete all SUPREP Bowel Prep Kit and required water at least two hours prior to colonoscopy. Consume only clear liquids until after the colonoscopy. STORAGE: Store at 20°-25°C (68°-77°F). Excursions permitted between 15°-30°C (59°-86°F). Rx only. Distributed by Braintree Laboratories, Inc. Braintree, MA 02185.

For additional information, please call 1-800-874-6756 or visit www.suprepkit.com

©2018 Braintree Laboratories, Inc. All rights reserved.

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THE ORIGINAL 1 LITER PRESCRIPTION BOWEL PREP SOLUTION

1 MOST PRESCRIBED,

#

BRANDED BOWEL PREP KIT1 WITH MORE THAN 15 MILLION KITS DISPENSED SINCE 20101 2

FIVE-STAR EFF1CACY WITH SUPREP ® Distinctive results in all colon segments • SUPREP Bowel Prep Kit has been FDA-approved as a split-dose oral regimen3 • 98% of patients receiving SUPREP Bowel Prep Kit had “good” or “excellent” bowel cleansing2* †

• >90% of patients had no residual stool in all colon segments2*

These cleansing results for the cecum included 91% of patients2*

Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies.4 *This clinical trial was not included in the product labeling. †Based on investigator grading. References: 1. IQVIA. National Prescription Audit Report. September 2018. 2. Rex DK, DiPalma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72(2):328-336. 3. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2017. 4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

©2018 Braintree Laboratories, Inc. All rights reserved.

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