VOL. 12 NO. 1 JANUARY 2018

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Hispanic patients INSIDE NEWS trail blacks, whites HHS nominee questioned on drug prices in Azar responds to Senate HELP committee. • 13 BY RANDY DOTINGA reasons for this gap in the Frontline Medical News delivery of care. Further DISEASE research will need to be

, MD Live liver transplants ao SAN DIEGO – A study of done to understand the safe procedures at academic reasons and the ways to ina K Single-center analysis centers provides evidence close this gap.” of donation found that obese Hispanics in the Dr. Nguyen presented low rate of severe D ourtesy

C United States undergo bar- the findings at the annual complications. • 14 Dr. Dina Kao and associates found that capsules were preferred by iatric surgery at a much clinical congress of the patients and less expensive to administer. lower rate than whites American College of Sur- GI ONCOLOGY and blacks. It also reveals geons. marked regional varia- According to Dr. Nguyen, Hemostat powder FMT by oral capsule tions in overall weight-loss the researchers under- effective for GI tumor surgery. took the study to better bleeding “Our findings do suggest understand how bariatric Tc-325 more reliably found noninferior to that severely obese His- surgery is delivered across stopped bleeds than panics are utilizing bar- ethnicities and geograph- standard treatments. • 17 iatric surgery much lower ic regions in the United than other ethnic groups,” States. said study coauthor Ninh The researchers ana- Analysis suggests BY BIANCA NOGRADY noscopy or to 40 capsules T. Nguyen, MD, FACS, chair lyzed statistics from the bariatric surgery safe Frontline Medical News of processed fecal microbi- of the department of sur- Vizient health care per- for seniors ota swallowed under direct gery at the University of formance database for the Surgery can improve ecal microbiota trans- observation. California Irvine Medical years 2013-2015. They fo- quality of life. • 20 plantation (FMT) using At 12 weeks after the Center, in an interview. cused on patients at about Foral capsules as the treatment, 96.2% of pa- “Our research does not 120 academic centers who delivery method has been tients in both groups specifically address the See Bariatric · page 20 shown to be noninferior to reported the absence of delivery using colonoscopy recurrent C. difficile in- for the treatment of Clos- fection. Two patients in MMR deficiency testing remains low tridium difficile infection, each group had a recur- but with a significantly low- rence of infection, and BY SHARON WORCESTER despite national guide- Shaikh, MD, and colleagues er price tag. were successfully treated Frontline Medical News lines calling for universal at Fox Chase Cancer Center, In an unblended nonin- again with FMTs using testing, according to an Philadelphia. The report feriority trial, published in the same modality (JAMA. verall utilization of analysis of cases from the was published in JAMA JAMA, 116 adults with at 2017 Nov 28;318:1985- Omismatch repair National Cancer Database. Oncology (2017 Nov 9. least three documented epi- 93. doi: 10.1001/ (MMR) deficiency testing The findings suggest that doi: 10.1001/jamaon- sodes of C. difficile infection jama.2017.17077). is poor among patients interventions that target col.2017.3580). were randomized to either Dina Kao, MD, of the de- with colorectal cancer, and groups at risk for nonad- Of 152,993 adults with 360 mL of fecal slurry deliv- partment of medicine at the utilization also remains herence to guidelines may colorectal cancer (CRC) who ered to the cecum via colo- See Capsule · page 19 low among young adults be warranted, wrote Talha See Testing · page 17

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LETTER FROM THE EDITOR: Fiscal focus and health equity s the Editor in Chief of the AGA’s official revenues and add substantially to our national of DaVita’s primary care consortium will have publication, I try, in this column, to keep debt. Is our general commitment to the Triple implications for physicians and health systems Amy personal opinions to a minimum and Aim and health equity just empty rhetoric? that will rival anything happening at the federal project a balanced political view of current level. We are in for mas- health care events. This is becoming increas- sive disruption spurred ingly difficult. This fiscal focus comes as Congress is by current high prices and I understand competing federal agendas and I easy access to high-cost am a student of American history who is inter- about to pass ... a comprehensive tax specialty medicine. ested in themes of federalism (Hamilton) versus reform that will reduce federal revenues Next month, The New states’ rights (Jefferson), limited government Gastroenterologist will versus Washington overreach, and how Article 1 and add substantially to our national debt. convert to an all-digital Section 8 of the U.S. Constitution led eventually Is our general commitment to the Triple format with a key article to massive federal expansions under FDR, LBJ, to be published in GI & and Barack Obama (facilitated by several key Aim and health equity just empty rhetoric? Hepatology News. This Supreme Court decisions dating back over 75 month, we have interest- years). DR. ALLEN ing articles on fecal mi- But now we are witnessing the loss of federal crobiome transplant (via support for 9 million children who depend on Politics aside, there are enormous shifts in capsule), biosimilars, AASLD highlights, and the Children’s Health Insurance Program (CHIP), the landscape with regard to health care de- new approaches to GI cancer bleeding, among because we “don’t have the money” (Sen. Or- livery – changes that will affect your practices. others. rin Hatch, R-Utah). This fiscal focus comes as Mergers between payers and frontline delivery Congress is about to pass, at press time, a com- companies (Aetna and CVS), Amazon‘s 1492 John I. Allen, MD, MBA, AGAF prehensive tax reform that will reduce federal stealth lab, and United Health Group’s purchase Editor in Chief

Quick quiz Which of the following is the most associated with the highest risk of ever, over the past 3 months, she appropriate next step? cirrhosis and hepatocellular Q1. A 45-year-old woman under- has developed new dysphagia carcinoma? went anti-reflux surgery 5 years following solid meals, sometimes A. Upper ago for well-characterized reflux associated with epigastric pain. B. Omeprazole once a day A. 1 disease and a 5-cm hiatal . She localizes the dysphagia to C. pH study off PPI B. 2 After brief initial postoperative the retrosternal region, with D. Esophageal manometry C. 3 dysphagia treated conservatively infrequent regurgitation but no E. Barium swallow D. 4 with dietary adjustment, symp- heartburn. toms completely resolved. How- Q2. Which HCV genotype is The answers are on page 13.

Editor in ChiEf Gi & hEpAtoloGy nEws is the official newspaper of the American frontlinE mEdiCAl CommuniCAtions soCiEty pArtnErs John I. Allen, MD, MBA, AGAF Gastroenterological Association (AGA) Institute and provides the VP/Group Publisher; Director, FMC Society Partners Mark Branca AssoCiAtE Editors gastroenterologist with timely and relevant news and commentary about Editor in Chief Mary Jo M. Dales clinical developments and about the impact of health care policy. Content for Megan A. Adams, MD, JD, MSc Executive Editors Denise Fulton, Kathy Scarbeck Gi & hEpAtoloGy nEws is developed through a partnership of the newspaper’s Editor Lora T. McGlade Ziad Gellad, MD, MPH, AGAF medical board of editors (Editor in Chief and Associate Editors), Frontline Kim L. Isaacs, MD, PhD, AGAF Creative Director Louise A. Koenig Medical Communications Inc. and the AGA Institute Staff. “News from the Bryson Katona, MD, PhD AGA” is provided exclusively by the AGA, AGA Institute, and AGA Research Director, Production/Manufacturing Rebecca Slebodnik Gyanprakash A. Ketwaroo, MD, MSc Foundation. All content is reviewed by the medical board of editors for National Account Manager Artie Krivopal, 973-206-2326, Larry R. Kosinski, MD, MBA, AGAF accuracy, timeliness, and pertinence. To add clarity and context to important cell 973-202-5402, [email protected] Sonia S. Kupfer, MD developments in the field, select content is reviewed by and commented on by Digital Account Manager Rey Valdivia, 973-206-8094, Wajahat Mehal, MD, PhD external experts selected by the board of editors. [email protected] Senior Director of Classified Sales Tim LaPella, 484-921-5001, [email protected] Editors EmEritus The ideas and opinions expressed in Gi & hEpAtoloGy nEws do not Colin W. Howden, MD, AGAF necessarily reflect those of the AGA Institute or the Publisher. The AGA Advertising Offices 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609 973-206-3434, fax 973-206-9378 Charles J. Lightdale, MD, AGAF Institute and Frontline Medical Communications Inc. will not assume MEDICAL COMMUNICATIONS AGA institutE stAff responsibility for damages, loss, or claims of any kind arising from or related FRONTLINE to the information contained in this publication, including any claims related Vice President, Marketing & Customer Managing Editor Brook A. Simpson to the products, drugs, or services mentioned herein. Advertisements do Chairman Stephen Stoneburn President/CEO Alan J. Imhoff Advocacy Jim McDonough Special Content Editor Lindsey M. Brounstein not constitute endorsement of products on the part of the AGA Institute or CFO Douglas E. Grose Vice President, Operations Jim Chicca Senior Publications Coordinator Jillian L. Schweitzer Frontline Medical Communications Inc. Vice President, Sales Mike Guire Vice President of Publications Erin C. Landis President, Digital Douglas E. Grose Vice President, Society Partners Chief Digital Officer Lee Schweizer offiCErs of thE AGA institutE POSTMASTER Send changes of address (with old mailing Mark Branca Vice President, Digital Publishing Circulation Director Jared Sonners President Sheila E. Crowe, MD, AGAF label) to GI & Hepatology News, Subscription Service, 151 Amy Pfeiffer Corporate Director, Research & Fairchild Ave., Suite 2, Plainview, NY 11803-1709. President-Elect David A. Lieberman, MD, AGAF President, Custom Solutions JoAnn Wahl Communications Lori Raskin Editor in Chief Mary Jo M. Dales Vice President Hashem B. El-Serag, MD, MPH, AGAF The AGA Institute headquarters is located at 4930 Del Ray Vice President, Custom Programs Secretary/Treasurer Francis M. Giardiello, MD, AGAF Avenue, Bethesda, MD 20814, [email protected]. Carol Nathan Editorial Offices 2275 Research Blvd, Suite 400, Rockville, MD Vice President, Custom Solutions Wendy In affiliation with Global Academy for Raupers Medical Education, LLC ©2018 by the AGA Institute. All rights reserved. No part of this publication 20850, 240-221-2400, fax 240-221-2548 Scan this QR Code to visit may be reproduced or transmitted in any form or by any means, electronic or Gi & hEpAtoloGy nEws Senior Vice President, Finance Vice President, Medical Education & (ISSN 1934-3450) is published monthly for gihepnews.com mechanical, including photocopy, recording, or any information storage and Steven J. Resnick Conferences Sylvia H. Reitman, MBA $230.00 per year by Frontline Medical Communications Inc., Vice President, Human Resources & retrieval system, without permission in writing from the publisher. 7 Century Drive, Suite 302, Parsippany, NJ 07054-4609. Vice President, Events David J. Small, Facility Operations Carolyn Caccavelli MBA Phone 973-206-3434, fax 973-206-9378 GIHEPNEWS.COM • JANUARY 2018 NEWS 7 FROM THE AGA JOURNALS Eradicating HCV significantly improved liver stiffness

BY AMY KARON ber 2016 for studies of HCV-infected Frontline Medical News adults who underwent liver stiffness he current era of new-genera- Although it has been debated measurement by vibration-controlled Ttion DAAs have revolutionized that some of the initial improve- radicating chronic hepatitis C vi- transient elastography before and at the treatment of chronic HCV infec- ments in liver stiffness measure- rus (HCV) infection led to signif- least once after completing HCV treat- tion, providing short-duration, safe, ments may be more reflective of Eicant decreases in liver stiffness ment. All studies also included data and consistently effective improvements in liver in a systematic review and me- on median liver stiffness in patients regimens that achieve SVR inflammation that may ta-analysis of nearly 3,000 patients. who did and did not achieve SVR. The or cure in nearly 100% of confound fibrosis as- Mean liver stiffness fell by 4.1 kPa search identified 23 observational patients. While achieving sessment, what is most (95% confidence interval, 3.3-4.9 studies and one post hoc analysis of SVR is important, even striking about this study kPa) 12 or more months after pa- a randomized controlled trial, for a more important is the is the durability of fibro- tients achieved sustained virologic total of 2,934 patients, of whom 2,214 long-term impact of SVR sis improvement beyond achieved SVR. and whether cure trans- the first year after treat- In patients who lates into outcomes such ment. Even beyond 1 year achieved SVR, mean liv- as improved mortality or after completing HCV er stiffness decreased a reduced risk of disease DR. WONG treatment, patients who by 2.4 kPa at the end of progression. Although achieved SVR had a 28% treatment (95% CI, 1.7- improved mortality after SVR has median reduction in liver stiff- response (SVR) following HCV treat- 3.0 kPa), by 3.1 kPa 1-6 months later been demonstrated, one of the ness. Although the findings of this ment, but did not significantly change (95% CI, 1.6-4.7 kPa), and by 3.2 kPa main drivers of risk of disease pro- study are expected, the rigorous in patients who did not achieve SVR, 6-12 months after completing treat- gression is the severity of hepatic and systematic method by which reported Siddharth Singh, MD, of the ment (90% CI, 2.6-3.9 kPa). A year or fibrosis. the authors conducted their work University of San Diego, La Jolla, Ca- more after finishing treatment, pa- In the current meta-analysis, further adds to the indisputable lif., and his associates in the January tients who achieved SVR had a 28% Singh et al. elegantly addressed a evidence supporting the benefit of issue of Clinical Gastroenterology median decrease in liver stiffness (in- recurring question regarding the HCV treatment. and Hepatology (doi: 10.1016/j. terquartile range, 22%-35%). Liver effectiveness of DAAs: Does achiev- cgh.2017.04.038). The results were stiffness did not significantly change ing SVR actually lead to durable Robert J. Wong, MD, MS, is in the de- especially striking in patients who in patients who did not achieve SVR, improvements in hepatic fibrosis? partment of medicine and is director received direct-acting antiviral agents the reviewers reported. This is an especially critical ques- of research and education, division (DAAs) or who had high baseline lev- Mean liver stiffness declined sig- tion as sustained improvements in of gastroenterology and hepatology, els of inflammation, the investigators nificantly more in patients who re- fibrosis would translate into a long- Alameda Health System – Highland added. ceived DAAs (4.5 kPa) than in those term reduction in disease progres- Hospital, Oakland, Calif. He has re- Based on these findings, about receiving interferon-based regimens sion. Among a total of 24 studies ceived a 2017-2019 Clinical Transla- 47% of patients with advanced fibro- (2.6 kPa; P = .03). However, stud- that included 2,934 chronic HCV tional Research Award from AASLD, sis or cirrhosis at baseline will drop ies of DAAs included patients with patients, the authors observed sig- has received research funding from below 9.5 kPa after achieving SVR, greater liver stiffness at baseline, nificant improvements in hepatic Gilead and AbbVie, and is on the they reported. “Future research is which could partly explain this dis- fibrosis, as measured by transient speakers bureau of Gilead, Salix, and warranted on the impact of magni- crepancy. Baseline cirrhosis also was elastography, with the greatest im- Bayer. He has also done consulting tude and kinetics of decline in liver associated with a greater decline in provements seen among patients for and been an advisory board stiffness on improvement in liver-re- liver stiffness (mean, 5.1 kPa, vs. 2.8 with baseline cirrhosis. member for Gilead. lated outcomes.” kPa in patients without cirrhosis; P Eradicating HCV infection was = .02), as was high baseline alanine known to decrease liver stiffness, but aminotransferase levels (P less than stiffness decrease to less than 9.5 kPa Health/National Library of Medicine. the magnitude of decline was not well or equal to .01). In patients whose after SVR. None had conflicts of interest. understood. Therefore, the reviewers baseline liver stiffness measurement One reviewer disclosed fund- searched the literature through Octo- exceeded 9.5 kPa, 47% had their liver ing from the National Institutes of [email protected] Adjusting FIT thresholds improved their performance

BY AMY KARON National Center for Tumor Diseases in Heidel- 18%, 21%-24%, and 30%-35%, respectively) Frontline Medical News berg, Germany, with his associates. and rates of positivity (2.8%-3.4%, 5.8%-6.1%, The investigators directly compared nine dif- and 10%-11%, respectively), the researchers hysicians can minimize the heterogeneity ferent fecal immunochemical assays using stool reported. Pof fecal immunochemical colorectal cancer samples from 516 individuals, of whom 216 had Increasingly, physicians are using FIT to screen screening tests (FIT) by adjusting thresholds for advanced adenoma or colorectal cancer (CRC). for colorectal neoplasia. In a prior study (Ann positivity, according to researchers. The report Using thresholds recommended by manufac- Intern Med. 2009 Feb 3;150[3]:162-90) investi- is in the January issue of Gastroenterology (doi: turers (2-17 mcg Hb/g feces) produced widely gators evaluated the diagnostic performance of 10.1053/j.gastro.2017.09.018). ranging sensitivities (22%-46%) and specifici- six qualitative point-of-care FITs among screening “Rather than simply using thresholds rec- ties (86%-98%). Using a uniform threshold of 15 colonoscopy patients in Germany, and found that ommended by the manufacturer, screening mcg Hb/g feces narrowed the range of specific- the tests had highly variable sensitivities and programs should choose thresholds based on ity (94%-98%), but sensitivities remained quite specificities for the detection of colorectal neo- intended levels of specificity and manageable variable (16%-34%). Adjusting detection thresh- plasia. Not surprisingly, the most sensitive tests positivity rates,” wrote PhD student Anton Gies olds to obtain preset specificities (99%, 97%, or were the least specific, and vice versa, which is of the German Cancer Research Center and the 93%) greatly narrowed both sensitivity (14%- Continued on following page 8 NEWS JANUARY 2018 • GI & HEPATOLOGY NEWS FROM THE AGA JOURNALS Continued from previous page he FIT is an important option for CRC It is appealing for program administra- the problem with using fixed thresholds in qualitative FITs, the T screening, endorsed by guidelines and tors to adjust hemoglobin cutoffs, manag- researchers asserted. effective for mass screening using mailed ing positivity, specificity, and sensitivity Quantitative FITs are more flexible than qualitative assays outreach. Patients offered FIT or of FIT. Colonoscopy resources because users can adjust thresholds based on fecal hemoglo- a choice between FIT and colo- are difficult to expand, and a bin concentrations. However, very few studies had directly noscopy are more likely to be high positivity rate can lead to compared sensitivities and specificities among quantitative screened. excess patient and physician FITs, and “it is unclear to what extent differences ... reflect true In the United States, FIT is anxiety. In the Dutch national heterogeneity in test performance or differences in study pop- a qualitative test (reported as CRC screening program, chang- ulations or varying pre-analytical conditions,” the investigators positive or negative), based ing brands between the pilot wrote. Patients in their study underwent in Ger- on Food and Drug Administra- phase and implementation led many between 2005 and 2010, and fecal samples were stored tion regulations, in an attempt to a disruptive increase in test at –80 °C until analysis. The researchers calculated test sen- to simplify clinical decision positivity. This strained avail- sitivities and specificities by using colonoscopy and histology making. In Europe, FIT has DR. LEVIN able colonoscopy resources reports evaluated by blinded, trained research assistants. been used quantitatively, with and led to long backlogs for fol- “Apparent heterogeneity in diagnostic performance of adjustable positivity rate and sensi- low-up colonoscopy. Program stakehold- quantitative fecal immunochemical tests can be overcome to tivity pegged to available colonoscopy ers responded by raising the positivity a large extent by adjusting thresholds to yield defined levels resources. Adding complexity, there are threshold. In the United States, however, of specificity or positivity rates,” the investigators concluded. multiple FIT brands, each with varying adjustable FIT thresholds are not cur- Only 16 patients in this study had CRC, which made it difficult performance, even at similar hemo- rently an option for clinical practice. Re- to pinpoint test sensitivity for this finding, they noted. How- globin concentrations. Each brand has search such as this will help inform the ever, they found similar sensitivity estimates for CRC in an a different sensitivity, specificity, and need for flexible hemoglobin cutoffs. ancillary clinical study. positivity rate, because reagents, buffers, Manufacturers provided test kits free of charge. There were and collection devices vary. Ambient Theodore R. Levin, MD, is chief of gastroen- no external funding sources, and the researchers reported temperature during mailing and trans- terology, Kaiser Permanente Medical Cen- having no conflicts of interest. port time to processing labs also can ter, Walnut Creek, Calif. He has no conflicts affect test performance. of interest. [email protected] Biologics in pregnancy did not affect infant vaccine response

BY AMY KARON fants given the rotavirus vaccine, bodies in serum samples from in- blood at birth. Seven developed Frontline Medical News there was no association with sig- fants aged 7 months and older and mild vaccine reactions consisting nificant adverse reactions,” they analyzed measured concentrations of fever (six infants) or diarrhea he use of biologic therapy also reported. of biologics in cord blood. (one infant). This proportion (18%) Tduring pregnancy did not low- Active inflammatory bowel dis- Among 179 mothers with IBD, resembles that from a large study er antibody titers among infants ease (IBD) increases the risk of most had inactive (77%) or mild (N Engl J Med. 2006;354:23-33) vaccinated against Haemophilus adverse pregnancy outcomes. Ret- disease activity (18%) during preg- of healthy infants who were vac- influenzae B (HiB) or tetanus toxin, rospective studies have found no nancy, the researchers said. Eleven cinated against rotavirus, the re- according to the results of a study link between anti–tumor necrosis (6%) mothers were not on immu- searchers noted. “Despite our data of 179 mothers reported in the factor therapy and adverse birth nosuppressives while pregnant, 15 suggesting a lack of severe side January issue of Clinical Gastroen- outcomes or congenital malforma- (8%) were on an immunomodulator, effects with the rotavirus vaccine terology and Hepatology (2017. doi: tions, but some biologics can cross and the rest were on biologic mono- in these infants, in the absence 10.1016/j.cgh.2017.08.041). the placenta and remain in infants therapy (65%) or a biologic plus an of robust evidence, one should Additionally, there was no link for up to a year after birth, the re- immunomodulator (21%). A total continue to avoid live vaccines in between median infliximab concen- searchers noted. In 2010, an infant of 46 infants had available HiB titer infants born to mothers on biologic tration in uterine cord blood and whose mother was on infliximab data, of whom 38 were potentially therapy (excluding certolizumab) antibody titers among infants aged for Crohn’s disease died (J Crohns exposed to biologics; among 49 in- during the first year of life or un- 7 months and older, wrote Dawn B. Colitis. 2010 Nov;4[5]:603-5) after fants with available tetanus titers, til drug clearance is confirmed,” Beaulieu, MD, with her associates. receiving the BCG vaccine, which is 41 were potentially exposed. In all, they suggested. “With the growing “In a limited cohort of exposed in- contraindicated in individuals on 71% of exposed infants had protec- availability of tests, one conceivably immunosuppressives. tive levels of antibodies against HiB, could test serum drug concentra- Experts now recommend against and 80% had protective titers to tion in infants, and, if undetectable, live vaccinations for infants who tetanus toxoid. Proportions among consider live vaccination at that may have detectable concentrations unexposed infants were 50% and time, if appropriate for the vaccine, of biologics, but it remained unclear 75%, respectively. Proportions of particularly in infants most likely to whether these infants can mount protective antibody titers did not benefit from such vaccines.” adequate responses to inactive vac- significantly differ between groups The Crohn’s and Colitis Founda- cines. Therefore, the researchers even after excluding infants whose tion provided funding. Dr. Beaulieu analyzed data from the Pregnancy mothers received certolizumab disclosed a consulting relationship in IBD and Neonatal Outcomes (PI- pegol, which has negligible rates of with AbbVie, and four coinvestiga- ANO) registry collected between placental transfer. tors also reported ties to pharma-

stock 2007 and 2016 and surveyed wom- A total of 39 infants received live ceutical companies. en about their infants’ vaccination rotavirus vaccine despite having de- arinca / i

Y history. They also quantified anti- tectable levels of biologics in cord [email protected] GIHEPNEWS.COM • JANUARY 2018 NEWS 9 FROM THE AGA JOURNALS Follow up patients with risky adenomas, serrated polyps

BY AMY KARON who underwent index morphology (flat versus polypoid), Frontline Medical News and follow-up colo- but the association might be re- noscopies a median lated to right-sided or flat lesions, he simultaneous colonoscopic of 4.9 years apart and which colonoscopists are more presence of serrated polyps and were tracked in the increased the likelihood of finding likely to miss or to incompletely Thigh-risk adenomas led to a population-based New Hampshire large metachronous serrated polyps excise than more defined polypoid fivefold increase in the odds of meta- Colonoscopy Registry. The cohort had on subsequent colonoscopy (OR, lesions, the researchers comment- chronous high-risk adenomas in a a median age of 61 years and half of 14.0; 95% CI, 5.0-40.9). “This has ed. “Additional research is needed large population-based registry study individuals were male. clinical relevance, since previous to further clarify the associations reported in Gastroenterology (2017. After adjusting for age, sex, smok- studies have demonstrated an in- between index patient characteris- doi: 10.1053/j.gastro.2017.09.011). ing status, body mass index, and creased risk for colorectal cancer in tics, polyp location, size, endoscopic The data “support the recommen- median interval between colonosco- individuals with large serrated pol- appearance and histology, and the dation that individuals with large and pies, individuals were at significantly yps,” the researchers wrote. “How- metachronous risk of advanced high-risk serrated lesions require increased risk of metachronous high- ever, this increased risk may occur lesions and colorectal cancer in closer surveillance,” said Joseph C. risk adenoma if their baseline colo- over a protracted time period of 10 order to refine current surveillance Anderson, MD, of White River Junc- noscopy showed high-risk adenoma years or more, and addressing vari- recommendations for individuals tion Department of Veterans Affairs and synchronous serrated polyps ation in serrated polyp detection undergoing colonoscopy,” they com- Medical Center, Vt., with his asso- (odds ratio, 5.6; 95% confidence in- rates and completeness of resection mented. ciates. When discounting size and terval, 1.7-18.3), high-risk adenoma may be more effective than a short- The study spanned January 2004 to histology, the presence of serrated with synchronous sessile serrated er surveillance interval at reducing June 2015, and awareness about the polyps alone was not associated with adenomas (or polyps) or traditional risk in these individuals.” importance of serrated polyps rose an increased risk for metachronous serrated adenomas (OR, 16.0; 95% The index presence of sessile during this period, they also noted. high-risk adenoma, they also report- CI, 7.0-37.0), or high-risk adenoma serrated adenomas or polyps, or The National Cancer Institute and ed. Although serrated polyps are alone (OR, 3.9; 95% CI, 2.8-5.4), vs. traditional serrated adenomas, also the Norris Cotton Cancer Center pro- important precursors of colorectal participants with no findings. predicted the subsequent develop- vided funding. The researchers re- cancer, relevant longitudinal surveil- The researchers also found that ment of large serrated polyps (OR, ported having no conflicts of interest. lance data are sparse. Therefore, the the index presence of large (at 9.7; 95% CI, 3.6-25.9). The study investigators studied 5,433 adults least 1 cm) serrated polyps greatly did not examine polyp location or [email protected] CLINICAL CHALLENGES AND IMAGES What is your diagnosis?

By Mareike Röther, MD, Jean-Francois Dufour, during the venous phase the lesion’s density neal surface including the left-sided diaphragm MD, and Beat Schnüriger, MD. Published pre- was similar to the surrounding liver parenchy- (Figure D). Laparoscopic viously in Gastroenterology (2013;144[3]:510, ma (Figure B). To rule out a small hepatocel- and resection of the suspicious nodule at the 659). lular carcinoma, diagnostic was Calot’s triangle was performed. The specimen performed. The nodule could be visualized at was sent for histology (Figure E). The postop- 62-year-old man with chronic hepatitis C the Calot’s triangle of the (Figure erative course was uneventful. A and Child A liver cirrhosis was referred for C). We found unexpected, multiple nodules of abdominal computed tomography (CT) after a different sizes throughout the entire left upper The diagnosis is on page 18. nodular liver lesion in segment V was found on abdominal ultrasonography. His medical history included quadrant. esophageal varices grade I, reflux esophagitis These nod- grade III, and a posttraumatic splenectomy ules were 50 years ago. The physical examination was located unremarkable and the laboratory values were within the normal (alpha-fetoprotein, 1.9 mcg/L). Abdom- greater inal CT scan revealed a homogenous, smoothly omentum outlined, round lesion measuring 15 × 18 mm and the located between the gallbladder and the liver mesentery (segment V). During the arterial phase the as well as at lesion seemed to be enhanced (Figure A) and the perito- nstitute i

a G a 12 NEWS FROM THE AGA JANUARY 2018 • GI & HEPATOLOGY NEWS The New Gastroenterologist goes digital eginning in February 2018, News website (http://www.md- Nitin K. Ahuja, MD, MS, and James The New Gastroenterologist edge.com/gihepnews). Moreover, C. Reynolds, MD, AGAF (University The NEW GASTROENTEROLOGIST B(TNG) – a supplement to GI we are excited to debut “In Focus: of Pennsylvania). And be sure to A Quarterly Supplement to GI & Hepatology News | Fall 2017 & Hepatology News that addresses Brought to You by The New Gastro- watch out for subsequent In Focus issues pertinent to trainees and features in the May, August, and 17 Social Media Understanding Social early-career GIs – will switch to a November issues of GI & Hepatolo- Media in GI Practice primarily digital format. We are gy News. excited about this change and con- If you have any questions about fident that it will allow for a more these changes, or if there are any effective and widespread dissemi- topics you’d be interested in writ- nation of content that is valuable to ing or reading about in TNG, please both AGA members and our reader- enterologist” in the February print contact Editor in Chief Bryson ship more broadly. issue of GI & Hepatology News. Katona, MD, PhD (bryson.katona@ In TNG’s new format, current This section will feature expert-au- uphs.upenn.edu) or Managing Ed- Cholangio- and future readers will receive thored updates on pertinent top- itor Ryan Farrell (rfarrell@gastro. pancreatoscopy each issue via a quarterly e-news- ics in the field. The first of these org). 13 Legal Issues Recent Advances 8 Legal Issues for the Gastroenterologist: Part II letter and all full articles will be will be a practical overview of the available on the GI & Hepatology management of constipation by [email protected] Memorial and honorary 4 Tips to help you talk to gifts: a special tribute your patients about PPIs

ake a tribute gift to honor one. A memorial gift is a mean- ecent studies have linked the use ids, especially in conjunction with Msomeone whose life has been ingful way to celebrate the legacy Rof proton pump inhibitors (PPIs) lifestyle changes. AGA offers patient touched by GI research or cele- of a family member, friend, or to gastric cancer and chronic kidney education materials on GERD, www. brate a special occasion such as a colleague. disease. It is important that gastroen- gastro.org/GERD, including lifestyle birthday while supporting the AGA • Tell your friends and family mem- terologists understand these studies management, that you can share with Research Awards Program through bers to donate to the AGA Re- and address any patient concerns your patients. the AGA Research Foundation. A search Foundation in YOUR honor. appropriately. 2. Be honest. Having open commu- tribute gift will make your loved When discussing studies like these nication with your patients is im- one feel special because it honors To learn more, visit our website at with your patients, try the following portant, so they can feel confident in their passion, and also provides us www.gastro.org/contribute or con- strategies to help alleviate their con- informing you if symptoms are still with needed support in furthering tact Harmony Excellent at 301-272- cerns. happening, what side effects they are basic digestive disease research. 1602 or [email protected]. 1. Start simple. For mild reflux symp- experiencing, or if they are thinking • Give a gift to the AGA Research toms, patients can first try histamine of stopping the medication. Help

Foundation in memory of a loved [email protected] H2-receptor antagonists and antac- contextualize their concerns and pro- vide your opinion. AGA offers talking points on several recent PPI studies, www.gastro.org/GERD. 3. Reassure patients that PPIs, like all drugs, have side effects. GIs should be 2018 AGA cautious when prescribing long-term PPIs for acid reflux. Patients shouldn’t TECH SUMMIT stop medication without first talking with you about the risks and benefits. Connecting Stakeholders The benefits of using PPIs often out- in GI Innovation weigh the possible risks. In patients who remain on long-term PPIs, it is MARCH 21-23, 2018 | BOSTON, MA good practice to try to reduce the Explore critical elements impacting the adoption, dose to maintain patients on the coverage and reimbursement for new GI lowest dose possible to control their technologies in today’s health care environment. symptoms, since, in general, PPI side You’ll be able to network and engage with leaders effects are related to the total dose. from the physician innovator, medtech, investor 4. Recommend and reassess. Patients should consider lifestyle modifica- and regulatory communities to help shape tions that may reduce or eliminate future directions and decisions. the need for PPIs for long-term use. REGISTER TODAY AT AGA has recommendations from the Choosing Wisely campaign, GIs techsummit.gastro.org should sustain follow-up appoint- ments with patients on PPIs to see if Developed in collaboration with SAGES. dosages should be lowered. 2691-014MIT_17-6 [email protected] GIHEPNEWS.COM • JANUARY 2018 NEWS 13 Drug prices a focus of Senate examination of Azar

BY GREGORY TWACHTMAN gested that although Hatch-Waxman ket by the Affordable Care Act.” treatment for those suffering from Frontline Medical News rules give innovators a time frame to Mr. Azar signaled that he will con- dependence and addiction.” exclusively sell products “there should tinue the push toward value-based Mr. Azar also was challenged on WASHINGTON – Escalating drug be a certain moment” when full ge- women’s health issues, particularly prices topped the agenda as mem- neric competition should begin. the ability of employers to exclude bers of the Senate Health, Educa- Sen. Paul also challenged Mr. Azar health insurance coverage of contra- tion, Labor & Pensions Committee on the notion of drug importation. ception because of religious objec- interviewed Alex Azar regarding There has not been a successful tions. He noted that there needs to be his nomination as secretary of the path to certify that drugs being im- a balance between the medical needs Department of Health & Human ported are “safe and reliable,” Mr. of the patient and the rights of an or- Services. Azar noted. ganization to follow its conscience. Mr. Azar, a former HHS depu- Sen. Paul countered that “you When queried about making con- ty secretary and general counsel would have to sit there and say that traception available over the counter, during the Bush Administration the European Union has unsafe he noted that the regulations regard- and a former president of Eli Lilly’s drugs. ... It’s just frankly not true.” ing OTC conversion are outdated, U.S. operations, outlined his priori- Sen. Paul told Mr. Azar that if he and he was encouraged that FDA ties to the Senate HELP committee cannot come up with a way to reim- Commissioner Scott Gottlieb, MD, is during the Nov. 29 hearing. port drugs as a means of addressing looking into that. “With a department the size of the high cost of pharmaceuticals in Mr. Azar also committed to working HHS, it is often difficult to prioritize. the United States, “I can’t support Mr. Alex Azar with improving interoperability of Nonetheless, should I be confirmed, you.” electronic health records as well as I do envision focusing my personal Regarding his other priorities, care and will use the power of Medi- working with physicians to reduce the efforts in four critical areas,” includ- Mr. Azar noted that, through his care to lead the rest of the health care associated documentation burden. ing lowering drug prices, improving “experience helping to implement delivery system to follow suit. He voiced his support of reform- health care access and affordabilty, [Medicare] Part D and with my ex- “We can better channel the power ing the Affordable Care Act, adding paying for outcomes, and tackling tensive knowledge of how insurance, of health information technology that, “if it remains the law, my goal the opioid crisis. manufacturers, pharmacy, and gov- and leverage what is best in our pro- is to implement a way that leads Drug prices were the focus of ernment programs work together, I grams and in the private competitive to affordable insurance, leads to many senators’ questions, and believe I can bring the skills and ex- marketplace to ensure the individual choice of insurance that leads to while many contentious questions periences to the table that can help patient is the center of decision mak- real access and not a meaningless came from panel Democrats, Sen. us address these issues, while still ing and his or her needs are being insurance care, and insurance that Rand Paul (R-Ky.) signaled he was encouraging discovery so Americans met with greater transparency and has the benefits that people want, not yet on board with his approval have access to high-quality care.” accountability.” not what we say in D.C. for them.” for Mr. Azar’s nomination. He called for making health care Regarding the opioid crisis, Mr. He also expressed support for “I think many [Americans] per- “more affordable, more available, Azar said that “we must heed Presi- the use of block grants to help fund ceive [that drug companies use] their and more tailored to what individ- dent Trump’s call to action and tackle Medicaid. economic might to manipulate the uals want and need. … Under the the scourge of the opioid epidemic Mr. Azar’s appearance before the system to maximize profits,” Sen. Paul status quo, premiums have been that is destroying so many individ- HELP committee was a courtesy said. skyrocketing year after year, and uals, families, and communities. We as the Senate Finance Committee “There are clearly abuses, Senator, choices have been dwindling. We need aggressive prevention, educa- holds jurisdiction over his nomina- in the system, and that is why one of must address these challenges for tion, regulatory, and enforcement tion. No confirmation hearing had the steps that I mentioned ... that I be- those who have insurance coverage efforts to stop overprescribing and been scheduled at press time. lieve we have to go after, is the gaming and for those who have been pushed overuse of these legal and illegal of that,” Mr. Azar responded. He sug- out or left out of the insurance mar- drugs. And we need compassionate [email protected]

Quick quiz answers ards model was used to determine 0.55; 0.47, 0.63), and genotype 4 negative, esophageal manometry risk of developing cirrhosis and (0.99; 0.68, 1.45). Q1. Correct answer: A and barium swallow are the next hepatocellular carcinoma for gen- It is speculated that the hepatic studies of value. A pH study off PPI otypes 1-4, after adjusting for age, steatosis that is a direct result of Rationale therapy is performed if recurrent period of service, race, sex, human genotype 3 HCV may contribute In patients with a good response reflux is suspected that does not immunodeficiency virus (HIV) in- to the accelerated progression to to anti-reflux surgery who develop respond to anti-reflux medications. fection, alcohol use, diabetes, body cirrhosis and HCC, but this has not new dysphagia, an upper endos- mass index, and antiviral treat- been proven and was not evaluat- copy is the test of choice. This will Reference ment. Despite genotype 3 patients ed in this Veteran Affairs study. evaluate the structural integrity of 1. Johnson D.A., Younes Z., Hogan being younger, their risk of devel- the fundoplication, and evaluate W.J. Endoscopic assessment of oping cirrhosis was highest with Reference for disruption and paraesophageal hiatal . Gastrointest hazard ratio = 1.30 (1.22, 1.39), 1. Kanwal F., Kramer J.R., Ilyas J., herniation. The can Endosc. 2000;52(5):650-9. compared to genotype 1 (refer- et al. HCV genotype 3 is associated be inspected for esophagitis, and ence, HR 1.0), genotype 2 with HR with an increased risk of cirrhosis dilation of the fundoplication site Q2. Correct answer: C = 0.68 (0.64, 0.73), and genotype 4 and hepatocellular cancer in a na- can be performed. In the absence with HR = 0.94 (0.78, 1.14). Like- tional sample of U.S. Veterans with of heartburn or the original reflux Rationale wise, the risk of development of HCV. Hepatology. 2014;60(1):98- symptoms, empiric acid suppres- In a population study of U.S. veter- HCC was highest for genotype 3 105. sion is not expected to improve ans infected with hepatitis C (n = HCV with HR = 1.80 (1.60, 2.03), the dysphagia. If the endoscopy is 110,484), a Cox proportional haz- compared to a genotype 2 (HR = [email protected] 14 LIVER DISEASE JANUARY 2018 • GI & HEPATOLOGY NEWS Small study supports safety of living liver donation

BY JIM KLING University of Minnesota, Minneapolis. Overall, the incidence of Clavien grade 3 or Frontline Medical News The researchers examined long-term com- higher complications was 7%, there were no plications and quality of life among 176 liver complications involving organ failure, and there SCOTTSDALE, ARIZ. – A single-center analysis donors who underwent surgery between 1997 were no deaths. of complications following living liver donation and 2016 at the University of Minnesota. At to- Quality of life, as measured by the 36-item found a low rate of severe complications and a tal of 140 donors un- Short Form Health Survey and an high quality of life among donors. The results derwent a right-lobe internally designed donor-spe- are similar to what has been seen in a previous without cific survey, was higher among multicenter study in the United States, and the middle hepatic vein, recipients than in the general authors hope that the results can help inform 14 underwent right population at all time points. The potential donors and their physicians. lobe with middle primary long-term complaints There is a significant shortage of deceased hepatic vein, 4 under- were incisional discomfort, which liver donors, leading to the death of about 3,500 went left lobe, and 18 ranged from about 23% to 38% in liver transplant hopefuls in 2016, compared underwent left lateral frequency, and intolerance to fatty with about 2,900 who received a transplant. segmentectomy. meals, which had a frequency of Living donor transplant was developed and first The researchers 20%-30%, and is likely attributable attempted in 1996 as an attempt to counter this then analyzed com- to accompanying cholecystectomy, shortage, and for a brief period it was popular, plications graded by according to Dr. Chinnakotla. peaking at 500 donor surgeries in 2001. But that the Clavien scale. They “The overall results appear to year the death of a donor occurred in New York found that 59.1% of Dr. Srinath Chinnakotla have been excellent,” said William C. and received widespread publicity. right-lobe donors Chapman, MD, who was invited by “That started a debate about the risks of do- experienced no complications at all; 5.8% the meeting organizers to review and comment ing liver donation, which resulted in a decrease had Clavien scale 1 complications, meaning on the study. Dr. Chapman is surgical director of in numbers, and at the moment we are doing something abnormal occurred but required no transplant surgery at Washington University in about 250-350 living liver donations (per year) intervention; and 27.3% had a Clavien 2 com- St. Louis. in the United States,” Srinath Chinnakotla, MD, plication, requiring pharmaceutical treatment, Dr. Chapman also noted that some studies in said during a presentation of the research at the a blood transfusion, or parenteral nutrition. Asia have looked at reducing complications in annual meeting of the Western Surgical Associ- Clavien 3a complications, which required an donors, while avoiding a small-for-size graft, by ation. intervention without general anesthesia, oc- using two left-lobe grafts from separate living Overall, though, the study showed relatively curred in 1.9% of cases, and Clavien 3b compli- donors (Liver Transpl 2015;21[11]1438-48). few complications and that donors reported cations, which required anesthesia, occurred in “We haven’t been brave enough to do that in the good quality of life. “There was a slight dip in 5.8%. United States, but I think that is a strategy we health-related quality of life at 5 years and 10 A total of 81.8% of left-lobe donors experi- can look forward to in the future,” said Dr. Chin- years, but at all times the donors had signifi- enced no complications, 4.5% had a Clavien 1 nakotla. cantly better quality of life compared to the complication, and 13.6% a Clavien 2. There were No funding source was disclosed. standard population,” said Dr. Chinnakotla, clin- no Clavien 3 or 4 complications in left-lobe do- ical director of pediatric transplantation at the nors. [email protected] The Liver Meeting 2017 NAFLD debrief – key abstracts

BY RICHARD MARK KIRKNER inflammation, immune modulation, almost twice the incidence of hepa- patients with NASH,” Dr. Watt said. Frontline Medical News cell death, etc.” tocellular carcinoma (HCC) as wom- “In addition, we need to be more She noted several studies that en – 0.43%-0.5% vs. 0.22%-0.28%, aware of the elevated risk in these WASHINGTON – Nonalcoholic fatty evaluated the prevalence of NAFLD, with both groups significantly patients and not just approach liver disease (NAFLD) is a com- including a study that found that higher than the general population them in the same way as the gener- plex disease that involves multiple “about one-third of patients walk- (abstract 2116). “And looking fur- al population.” systems, and several standout ing through the door of the clinic ther, we can actually quote an HCC Physicians may be tempted to dis- abstracts at the annual meeting of had nonalcoholic steatohepatitis incidence in NASH of 0.009%,” she continue statin therapy in patients the American Association for the [NASH],” suggesting physicians added. with chronic liver disease, but Dr. Study of Liver Diseases empha- should consider screening at-risk Again emphasizing the multisys- Watt cited a poster that showed sized the importance of multisys- patients (abstract 58). A Korean tem impact of NAFLD, Dr. Watt cited that this results in worse outcomes tem management and the potential study found about 18% of asymp- a study that calculated the cardio- (abstract 2106). The researchers of combination therapies, Kym- tomatic lean individuals (body mass vascular risks incumbent with liver found that continued statin use berly D. Watt, MD, said during the index less than 23 kg/m2) had NA- disease. Researchers reported that was associated with a lower risk of final debrief. FLD and identified sarcopenia as a men and women at the time of death with compensated and de- “The actual underlying mecha- significant risk factor for NAFLD in NAFLD diagnosis had significantly compensated liver function. “These nisms and the underlying processes these lean patients (abstract 59). higher rates of either angina/isch- data help to educate certain pa- that are going on are way more “Sarcopenia is something that we emic heart disease or heart failure tients of their risk of decompensa- complicated than just inflamma- really need to pay a lot more atten- (abstract 55). Women, specifically, tion over time,” Dr. Watt said. tion and scarring,” said Dr. Watt, tion to,” Dr. Watt said. had a higher risk for cardiovascular An international study determined associate professor of medicine and Other studies better outlined the events earlier than men and over- that the severity of advanced com- medical director of liver transplan- increasing association between NA- all are at equal risk to men, unlike pensated liver disease is a key de- tation at the Mayo Clinic, Rochester, FLD and hepatocellular carcinoma, in the general population where terminant in outcomes, finding that Minn. “We have numerous areas to Dr. Watt noted (abstracts 2119 and women are at lower risk. “We need those with bridging fibrosis are at target, including insulin resistance, 2102). Another study confirmed to start looking at screening and greater risk of vascular events, but lipid metabolism, oxidative stress, that men with NAFLD/NASH have prevention of other diseases in our Continued on page 16 SEE BEFORE YOU SAMPLE High-Definition Narrow Band Imaging® targets suspicious areas to biopsy for Barrett’s esophagus.

White Light NBI White Light NBI Fewer Biopsies Less Time Better Interpretation Tool Improved View Using HD NBI to target HD NBI facilitates targeted HD NBI provides contrast, which HD NBI in EVIS EXERA III suspicious areas in Barrett’s biopsies in patients with may aid in the interpretation of is significantly brighter esophagus patients can result Barrett’s esophagus, which mucosal morphology, vascular and provides up to twice in significantly fewer biopsies can save valuable procedure patterns, and blood vessel the viewable distance in than white light examination time. appearance in patients with the lumen. with the Seattle protocol. Barrett’s esophagus.

Clinical images courtesy of Horst Neuhaus, MD, Roy Soetikno, MD and Tonya Kaltenbach, MD Contact a sales representative at 800-848-9024 ©2016 Olympus America Inc. Registered Trademark of Olympus or its affiliates. I www.medical.olympusamerica.com I OAIGI0813AD11668

GIHEP_15.indd 1 12/15/2017 9:21:36 AM 16 LIVER DISEASE JANUARY 2018 • GI & HEPATOLOGY NEWS

Continued from page 14 One study reported that three bio- deuterated cholic acid (d4-CA) liver enzymes on treatment (ab- markers – alpha-2-macroglobulin, solution may be a minimally inva- stract 182). “So I think we need to those with cirrhosis and Child-Tur- hyaluronic acid, and tissue inhibi- sive alternative to biopsy for diag- remain cautious and watch these cotte-Pugh A5 and A6 disease have tor of metalloproteinase-1 – have a nosing NASH (abstract 96). patients closely, but overall it much higher risks of hepatic decom- high sensitivity for differentiating Management studies focusing seems to be reasonably safe data,” pensation and HCC out to 14 years low-stage and stage F3-F4 dis- on varying targets were also pre- she said. Another drug trial of the (abstract 60). “The reason to look ease (abstract 95). Another study sented. A trial of fibroblast growth acetyl-CoA carboxylase inhibitor at these is to be able to tell your pa- found that a measure using Pro-C3 factor–21 for treatment of NAFLD GS-0976 also showed promise for tients that they probably have a 30% and other clinical markers were found that patients in the 10- and overall improvement in MRI ste- increased risk of decompensation by predictive of F3 or F4 fibrosis in 20-mg dose arms showed improve- atosis measures (abstract LB-9). 4 years,” Dr. Watt said. NAFLD (abstract 93). And other re- ment in MRI hepatic fat fraction, Three preclinical studies of dual- Dr. Watt pointed out three searchers found that a HepQuant- ALT, AST, and liver stiffness at 16 agent therapies in animals have studies that shed more light on STAT measure of greater than 0.50 weeks vs. placebo. A few patients demonstrated improvement in in- important biomarkers of NAFLD. microM in patients who ingested had some mild elevation to their flammatory and fibrosis scores, Dr. Watt noted (abstracts 2000, 2002 and 2052). “There’s no one drug that’s going to be likely the magic cure,” Dr. Watt said. “There will likely be a lot more focus and data coming out on dual-action agents.” Another animal study addressed the burning question of whether decaffeinated coffee has the same protective effect against NASH as caffeinated coffee (abstract 2093). Said Dr. Watt: “If 2018 you are interested in the potential benefits of coffee but really can’t AGA handle the caffeine, this study sug- gests you may still be OK.” Finally, Dr. Watt noted an early study of three-dimensional printing has shown potential for replicat- Saturday, June 2, 2018 ing NASH tissue for bench studies 8:15 a.m.–5:30 p.m. (abstract 1963). “3-D printing is certainly a wave of the future,” she FROM ABSTRACT TOSunday, REALITY June 3, 2018 said, pointing out that researchers 8:30 a.m.–12:35 p.m. have created a 3-D model that has some metabolic equivalency to Learn more at pgcourse.gastro.org. NASH, with the inflammatory cy- POSTGRADUATE RegisterCOURSE by April 18, 2018, and save $75. tokine release, hepatic stellate cell 2200-080EDU_17-16 activation, “and all of the features that we see in NASH. This may be of potential use down the road to avoid relying on animal models in preclinical studies.” The Liver Meeting next convenes Nov. 9-13, 2018, in San Francisco. Dr. Watt disclosed ties to Bris- APPLY TO BE THE NEXT tol-Myers Squibb, Exelixis, and Se- attle Genetics.

EDITOR-IN-CHIEF [email protected]

Apply and make a lasting contribution to the success of AGA’s highly regarded basic and translational science journal, Cellular and Molecular Gastroenterology and Hepatology (CMGH ).

Deadline for applications is March 1, 2018

Learn more at cmgh.gastro.org.

2150-320PUB_17-9 GIHEPNEWS.COM • JANUARY 2018 GI ONCOLOGY 17 Insurance status plays a role PERSPECTIVE Testing from page 1 Study highlights ‘sobering’ lack of testing were included in the study, only 28% testing were older age (OR, 0.31), he findings by Shaikh et al. are of testing among certain demo- underwent MMR deficiency testing, insurance status (Medicare, Medic- Tsobering, given the overwhelm- graphic groups suggests a need to and of 17,218 aged 30-49 years, only aid, uninsured; ORs, 0.89, 0.83, and ing published evidence regarding address underserved and under- 43% were tested. The proportion 0.78, respectively), research facility the importance of MMR deficiency resourced patient populations, of patients tested in both groups type (nonacademic vs. academic; testing, and they underscore a he said, concluding that efforts OR, 0.44), rectosigmoid or rectal tu- need to determine the causes of must continue to meet the goal of ‘Although the proportions of mor location (OR, 0.76), unknown the low testing rates, according to universal testing and that those grade (OR, 0.61), and nonreceipt of Stanley R. Hamilton, MD, AGAF. efforts must be accompanied by patients tested increased during definitive surgery (OR, 0.33). Importantly, they also highlight studies to evaluate the clinical the study period, our results MMR deficiency occurs in up to areas that are “potentially action- utility of testing in reducing CRC suggest that underutilization of 15% of sporadic CRC and is a feature able.” For example, the higher mortality. of Lynch syndrome, which occurs frequency of testing among those MMR deficiency testing was most often in patients under age with higher educational levels, Dr. Hamilton is with the Uni- significant and pervasive, even 50 years. National guidelines have and underuse of testing in older versity of Texas MD Anderson long recommended routine MMR patients and those from non- Cancer Center, Houston. He is a among young patients with deficiency testing for CRC patients in academic facilities suggest that member of the Fred Hutchinson CRC with a well-established that age group, and universal testing better education of physicians Cancer Research Scientific Advi- risk of Lynch syndrome.’ has been recommended since 2014. and patients about the value of sory Committee, a consultant for “Although the proportions of pa- testing could improve adherence LOXO Oncology, and a member of tients tested increased during the to guidelines, Dr. Hamilton wrote the HalioDx Scientific Advisory increased between 2010 and 2012 study period, our results suggest in an editorial (JAMA Oncol. 2017 Committee. He has a financial re- (from about 22% to 33%, and from that underutilization of MMR defi- Nov 9. doi: 10.1001/jamaon- lationship with The Johns Hopkins about 36% to 48%, respectively). ciency testing was significant and col.2017.3574). University School of Medicine and After the researchers controlled pervasive, even among young pa- Further, the lower frequency with Merck. for all other covariates, factors tients with CRC with a well-estab- significantly associated with being lished risk of Lynch syndrome. Our tested were higher educational lev- study ... identifies significant groups socioeconomic status, insurance This study was funded by a grant el (odds ratio, 1.38), later diagnosis at risk for potential nonadherence status, and cancer program location from the National Institutes of year (OR, 1.81), early-stage disease to newly implemented universal are of particular concern. Health, National Cancer Institute. (OR, 1.24), and number of regional testing guidelines moving forward,” Ongoing analyses to track prog- The authors reported having no lymph nodes examined (OR, 1.44 the investigators said, noting that ress toward “closing this important conflicts of interest. for 12 or more lymph nodes). Fac- the associations between type and clinical service gap,” will be needed, tors associated with underuse of utilization of patient testing and they concluded. [email protected] Tc-325 effective for immediate GI tumor bleeding

BY MADHU RAJARAMAN Overall, 27.3% of patients experienced repeat 0.59), Dr. Barkun and his colleagues reported. Frontline Medical News bleeding within 30 days of Tc-325 treatment, all Although the results show promise for Tc-325 from upper GI sites. No recurrent bleeding oc- as an immediate treatment in the case of failed he powder Tc-325 is effective for immediate curred from lower GI lesions. Recurrent bleeding standard endoscopic hemostatic techniques or Themostasis in patients with malignant gas- occurred in 38% patients who did not receive when definite hemostasis via radiation, surgery, trointestinal bleeding, according to results pub- definite hemostasis within 30 days. and chemotherapy are unavailable, the long- lished in Gastrointestinal Endoscopy. An international normalized ratio value greater term effects are comparable with conventional The compound achieved immediate hemosta- than 1.3 was significantly associated with early methods, at least in the upper GI tract, the au- sis in 97.7% of patients with GI tumor bleed- thors said. Better results in the lower GI tract ing, reported Alan Barkun, MD, AGAF, of the ‘Tc-325 seems to be more predictably may be attributed to the presence of gastric division of gastroenterology at McGill Universi- juice in the upper GI tract, the investigators ty Health Centre, Montreal, and his coauthors. effective in providing initial hemostasis noted. Conventional endoscopic hemostatic methods, in upper GI tumor bleeding compared Limitations of the study include “its retrospec- by contrast, have shown highly variable hemo- with conventional methods.’ tive design with the possibility of missing infor- stasis rates in prior studies, ranging from 31% mation and selective data collection,” as well as to 93%, the authors said. the possibility of decreased generalizability of “Tc-325 seems to be more predictably effec- recurrent bleeding in univariable analysis (P = results, Dr. Barkun and coauthors wrote. Never- tive in providing initial hemostasis in upper GI .02; odds ratio, 5.08; 95% confidence interval, theless, its immediate effectiveness at achieving tumor bleeding compared with conventional 1.33-19.33), as was an Eastern Cooperative On- hemostasis and prevention of early bleeding methods,” they added. cology Group (ECOG) score of at least 3 (P = .049; indicate that the results may still be “used with The study included 88 eligible patients who OR, 3.94; 95% CI, 1.01-15.38). Definite hemostat- confidence as guidance for any physician man- initially presented with bleeding either as a ic treatment was associated with less recurrent aging such patients,” the authors said. result of a primary GI tumor, or metastases to bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62). The investigators did not disclose any con- the upper or lower GI tract. Almost 60% had an Factors significantly associated with 6-month flicts of interest. The study was funded by the upper GI cancer site. Twenty-five patients died survival in multivariable analysis were an ECOG Grant for International Research Integration: before the end of the 30-day observation period. score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, Chula Research Scholar, Ratchadaphiseksom- The recurrent bleeding rate at 72 hours was 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; phot Endowment Fund. 15%. Bleeding rates at 7, 14, and 30 days’ fol- 95% CI, 0.10-0.96), and receiving definite hemo- low-up were 7%, 7.8%, and 1.9%, respectively. stastic treatment (P = .002; HR, 0.24; 95% CI, 0.09- [email protected] 18 GI ONCOLOGY JANUARY 2018 • GI & HEPATOLOGY NEWS CLINICAL CHALLENGES AND IMAGES The diagnosis history of splenic trauma or splenic surgery.1 workup to exclude hepatocellular carcinoma Nevertheless, hepatic splenosis is rare.2 The is indicated. Hepatocellular carcinoma usually Answer to “What’s your diagnosis?” literature documents only 16 case reports of presents as solitary or multifocal nodules lo- on page 9: Posttraumatic splenosis hepatic splenosis, although the difficulty of cated within the liver parenchyma. Neverthe- diagnosis could have contributed to underre- less, several cases of superficial hepatocellular athologic examination of the specimen porting. Although usually harmless, splenosis carcinoma on the surface of the liver have been revealed a splenosis showing regular red is a rare cause of bowel obstruction or abdom- reported.3 Splenosis may mimic abdominal Pand white pulp (Figure E). Splenosis is inal pain.2 Moreover, splenic implants mimick- neoplasia in patients with a history of severe the heterotopic autotransplantation of splenic ing renal, intestinal, and hepatic masses have splenic trauma or splenectomy and should be tissue within the abdominal or pelvic cavity been described.2 Usually, splenosis appears on considered during oncologic workup. and occurs in 16%–67% of patients with a CT as numerous round to oval structures with absent hilum, and with the same density as References the spleen proper. Because CT’s differentiation 1. Fleming, C.R., Dickson, E.R., Harrison, E.G. between tissues can be unreliable,2 selective Splenosis: autotransplantation of splenic tis- Tc-99m–labeled heat-denatured autologous sue. Am J Med. 1976;61:414-9. red blood cell scintigraphy has been suggest- 2. D’Angelica, M., Fong, Y., Blumgart, L.H. Isolat- ed.2 However, the lack of data on the accuracy ed hepatic splenosis: first reported case. HPB of Tc-99m-scintigraphy renders its diagnostic Surg. 1998;11:39-42. efficacy questionable. In our patient with hep- 3. Ohmoto, K., Mimura, N., Iguchi, Y. et al. Per- atitis C, a diagnostic laparoscopy was indicated cutaneous microwave coagulation therapy for to diagnose the posttraumatic splenosis at the superficial hepatocellular carcinoma on the infundibulum of the gallbladder. In high-risk surface of the liver. Hepatogastroenterology. patients, detection of a new liver lesion with 2003;50:1547-51. nstitute i radiologically uncertain contrast behavior, a G

a diagnostic laparoscopy including histologic [email protected]

FDA approves first trastuzumab biosimilar

BY LAURA NIKOLAIDES This is the first biosimilar ap- The approval of trastuzumab-dkst headache, di- Frontline Medical News proved in the United States for the is based on structural and function- arrhea, nausea, treatment of breast cancer or gas- al characterization, animal study chills, fever, infec- he Food and Drug Administration tric cancer and the second biosim- data, human pharmacokinetic and tion, congestive Thas approved trastuzumab-dkst ilar approved for the treatment of pharmacodynamic data, clinical im- heart failure, (Ogivri) as a biosimilar to trastu- cancer, the FDA said in a statement. munogenicity data, and other clini- insomnia, cough, and rash. Common zumab (Herceptin) for the treatment The FDA approved a biosimilar to cal safety and effectiveness data. expected side effects for the treat- of patients with metastatic gastric or bevacizumab in September for the Common expected side effects of ment of HER2+ metastatic gastric gastroesophageal junction adenocar- treatment of certain colorectal, lung, trastuzumab-dkst for the treatment cancer include neutropenia, diar- cinoma or HER2+ breast cancer. brain, kidney, and cervical cancers. of HER2+ breast cancer include rhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia,

Research Funding Opportunity AGA Resource To prepare for the entry of bi- The AGA Research Foundation will award over $2 million in research osimilars to the market, AGA funding to support researchers in gastroenterology and hepatology. is taking the lead in educating • AGA-Allergan Foundation Pilot JAN. 12, 2018 health care professionals and Research Award in Irritable patients about biosimilars. Visit • AGA-Pfizer Young Investigator • AGA-Elsevier Pilot Research ($30,000) www.gastro.org/biosimilars to Pilot Research Award in Award ($25,000) • AGA-Allergan Foundation Pilot Inflammatory Bowel Disease learn more. • AGA-Elsevier Gut Microbiome Research Award in ($30,000) Pilot Research Award ($25,000) ($30,000) • AGA-Rome Foundation Functional • AGA-Caroline Craig Augustyn • AGA-Boston Scientific Technology mucosal inflammation, nasopharyn- GI and Motility Disorders Pilot & Damian Augustyn Award in and Innovation Pilot Award Research Award ($30,000) gitis, and dysgeusia. Digestive Cancer ($40,000) ($30,000) The biosimilar label contains a Boxed Warning – as trastuzumab does – about increased risks of car- diomyopathy, infusion reactions, pulmonary toxicity, and fetal toxicity. Apply at www.gastro.org/research-funding. The FDA’s Oncologic Drugs Advi- sory Committee voted unanimously in July to recommend approval of the biosimilar, made by Mylan and Biocon. 2750-050RSH_17-3

[email protected] GIHEPNEWS.COM • JANUARY 2018 IBD AND INTESTINAL DISORDERS 19 Dose-dependent response tifying alternative diagnoses,” the authors wrote. “Conversely, when AGA Resource Capsule from page 1 FMT is given by oral capsules, it can be administered in an office setting, The AGA Center for Gut Micro- University of Alberta, Edmonton, Both treatment modalities which could substantially reduce biome Research and Education and coauthors commented that the achieved similar quality of life im- cost and wait time.” serves as a virtual “home” for response rate with the capsules provements. Both groups reported Both groups also showed signifi- AGA activities related to the gut was higher than that seen in other major improvements in domains cantly improved gut microbiota microbiome, including the AGA studies of fecal microbiota capsules, including physical and emotional diversity, which approached that of FMT National Registry, which which they suggested may partly be health, physical and social func- the donor just 1 week after admin- will assess short- and long-term due to the larger amount of donor tioning, and general health, with no istration of the treatment. patient outcomes associated stool used in the study: 80-100 g, significant differences between the While 30% of patients character- with FMT. Learn more at http:// compared with 17 g and 25 g used two arms of the study. ized FMTs as “unpleasant, gross, www.gastro.org/about/initia- in other studies. The cost per treatment in the or disgusting,” 79% of participants tives/aga-center-for-gut-micro- “The higher efficacy observed in colonoscopy group was $874 per said the unpleasantness was the biome-research-education. this study suggests a dose-depen- patient, compared with $308 per same or less than anticipated, and dent response to FMT, and a ben- patient in the capsule group. 97% said they would undergo the efit of bowel lavage prior to FMT, “Although colonoscopy delivery is same treatment by the same deliv- colonoscopy group. because residual vancomycin was more invasive, resource intensive, ery method again if needed. The authors acknowledged that detected up to 8 days despite its costly, and inconvenient for pa- However, significantly more the lack of a placebo group in the discontinuation,” they wrote. tients, it has the advantage of iden- patients in the capsule group de- study meant they were not able to scribed their experience as “not at measure the size of the effect of all unpleasant,” compared with the fecal microbiota transplantation by colonoscopy group (66% vs. 44%; either route. One earlier trial had 95% CI, 3%-40%; P = .01). also shown a placebo response rate There were no colonic perfo- of 45%. rations seen in the colonoscopy The study was funded by Alberta group, and no infectious complica- Health Services and the University tions relating to the treatment in of Alberta Hospital Foundation. either group. One patient in each Four authors declared grants group died of underlying cardiopul- and other funding from the study monary illness that was unrelated funder and the pharmaceutical in-

ulsey to the treatment, and the rate of dustry. minor adverse events was 5.4% in the capsule group and 12.5% in the [email protected] CDC/J ennifer H This illustration depicts the ultrastructural morphology exhibited by a single Gram- positive Clostridium difficile bacillus. June 2–5, 2018 Exhibit Dates: June 3–5 PERSPECTIVE Walter E. Washington Convention Center Washington, DC Uncertainties remain on fecal www.ddw.org microbiota transplants lostridium difficile infection infection, including the use of Monumental Developments C costs the U.S. health care sys- vancomycin tapers with and in Science & Medicine tem an estimated $1.5 billion each without “chasers” of fidaxomicin/ Washington, DC year, with 450,000 cases reported rifaximin, the use of defined mi- annually, 20% of which involve crobial communities, and the use a recurrence of the infection. Fe- of sterile, fecal-derived products, cal microbiota transplantation which may even supplant stan- Register online at is increasingly being used as a dard fecal microbial transplants www.ddw.org/registration treatment, but more widespread in the future. adoption is limited partly by the logistical difficulties of delivery. Krishna Rao, MD, Vincent B. Young, This study offers encouraging MD, PhD, and Preeti N. Malani, MD, Discover monumental developments in science and data on delivery of fecal microbi- are with the division of infectious medicine at Digestive Disease ota transplants via capsule, which diseases in the department of in- Week® (DDW) 2018. DDW may reduce barriers to adoption ternal medicine at the University generates and shares capital of this treatment; however, there of Michigan, Ann Arbor. These ideas for global impact are still some questions to be comments are taken from an ac- in the fi elds of gastroenterology, REGISTER BY APRIL 18 AND SAVE AT LEAST $80. answered about the treatment’s companying editorial (JAMA. 2017 hepatology, GI Jan. 17, 2018 AASLD, AGA, ASGE and SSAT efficacy, such as the timing of de- Nov 28;381:1979-80. doi: 10.1001/ endoscopy members-only registration opens. livery and the relative importance jama.2017.17969). Dr. Young re- and GI surgery. Jan. 24, 2018 General registration opens. of stool components. ported consulting fees from Vedan- Attend DDW 2018 in Washington, DC. DDW On Demand is Included There are also other approach- ta, Merck, and Finch Therapeutics with Registration! Get access to the online digital es that should be considered and grants from MedImmune. No presentations from DDW 2018 so in future research on C. difficile other disclosures were reported. you don’t miss a single session.. 20 OBESITY JANUARY 2018 • GI & HEPATOLOGY NEWS

understanding of the benefits of features], it’s certainly there for Insurance status may be an issue bariatric surgery and its low risk; Hispanics,” said Dr. Morton. “[His- Bariatric from page 1 lack of understanding of the urgen- panic patients] have high rates of cy for treatment by the patient and obesity and diabetes, both of which underwent 73,119 laparoscopic in the Midwest, with whites at 1.07 provider; and hurdles in obtaining are helped by bariatric surgery.” sleeve , laparoscopic and blacks at 0.69. coverage for the operation by in- He said about 40% of patients in Roux-en-Y gastric bypass, and lapa- Across the country, however, surers.” his Palo Alto, Calif., practice are His- roscopic adjustable gastric banding obese Hispanics were less likely John Magaña Morton, MD, chief panic, reflecting the high number in procedures. The than persons of the other two of bariatric and minimally invasive the local population. patients were races to undergo weight-loss sur- surgery at Stanford (Calif.) Univer- It helps that Dr. Morton and sever- stratified by gery. The gap was fairly small in sity School of Medicine and past al of his partners speak Spanish. “If race and region. the Northeast, where 1.74 per president of the American Society you have a welcoming environment,” Research- 1,000 obese Hispanics underwent for Metabolic and Bariatric Sur- he said, “that can make a difference.” ers found that weight-loss surgery, compared gery, doesn’t think discrimination The study authors and Dr. Morton bariatric pro- with rates of 2.02 and 2.35 among is causing the disparity. report no relevant disclosures. No cedures were whites and blacks, respectively. But “It’s probably a reflection of in- specific study funding is reported. performed at the disparity was much larger in surance status – Hispanics tend a much high- the other parts of the country, with to be less insured than Caucasian [email protected] er rate in the DR. NGUYEN rates at 0.14 in the West, 0.11 in or African American patients – as Northeast ac- the South, and 0.33 in the Midwest, well as preference for patients to ademic centers (2.21 per 1,000 compared with rates from 0.43 to go to nonacademic centers,” he AGA Resource obese persons), compared with the 1.07 among blacks and whites. said. Midwest (0.73), South (0.50), and The reasons for the surgery gap Indeed, a Kaiser Family Founda- The AGA Obesity Practice Guide West (0.33). are unknown. Dr. Nguyen pointed tion analysis found that 21% of the provides a comprehensive, mul- In regard to race, the rates for to several possible explanations: 52 million Hispanics younger than tidisciplinary process to per- blacks and whites were fairly simi- “lack of education of obesity as a 65 years in the United States were sonalize innovative obesity care lar in the Northeast (2.02 and 2.35 disease by the primary care pro- uninsured in 2015, compared with for safe and effective weight bariatric procedures per 1,000 viders and the need for referral 9% of whites and 13% of blacks. management, including the obese persons, respectively), the to a bariatric surgeon for patients Only Native Americans/Alaska Na- use of bariatric endoscopy and South (0.59 and 0.63, respectively) with body mass index greater than tives had an uninsured rate as high surgery. Learn more at www. and the West (0.45 and 0.43, re- 40 kg/m2 or 35 kg/m2 with obe- as Hispanics. gastro.org/obesity. spectively). There was a wider gap sity-related comorbidities; poor “In terms of need [for weight-loss Database analysis suggests bariatric surgery safe for seniors

BY TED BOSWORTH Both rates reached significance by the conven- However, some of that difference may be Frontline Medical News tional definition (P < .05), but he suggested that explained by baseline disparities between the they are lower in this study than those in prior two groups. In the gastric bypass group, there NATIONAL HARBOR, MD. – Gastric bypass and studies of MBSAQIP datasets and that they are were higher rates of preoperative diabetes sleeve gastrectomy procedures for weight loss acceptable relative to the anticipated health ben- (54% vs. 40%; P < .001), sleep apnea (57% vs. should not be denied to patients older than 60 efits. 50%; P < .001), and hyperlipidemia (59% vs. years, despite a slight increase in unadjusted Above the age of 60 years, no correlation 54%; P < .001). Also, gastric bypass patients mortality rates, according to an analysis of data could be made between increasing age and in- were more likely to have a history of a previ- from the Metabolic and Bariatric Surgery Ac- creasing risk of morbidity, mortality, or rate of ous bariatric procedure (11% vs. 8.5%; P < creditation and Quality Improvement Program reoperations, according to Dr. Zeni. .001) and to be in the American Society of An- (MBSAQIP). Why should bariatric surgery be considered esthesiologists Physical Status score of 3 (84% Based on data that was collected in 2015 and in older patients? He cited data from a study vs. 80%; P < .001), according to Dr. Zeni. submitted to MBSAQIP, “bariatric surgery is safe that showed the life expectancy in a 70-year-old The specific complications more common in in the elderly, even in those 70 years old and without functional limitations is 13 years. As a the gastric bypass group than the sleeve gastrec- older,” reported Tallal Zeni, MD, director of the result, he added, “it behooves us to provide them tomy group included anastomotic leak (0.56% Michigan Bariatric Institute in Livonia. with the best quality of life we can.” vs. 0.3%; P = .017), surgical site infection (1.74% Although the analysis was drawn from one Relative to prior MBSAQIP evaluations of vs. 0.61%; P < .001), pneumonia (0.87% vs. of the largest datasets to evaluate the safety bariatric surgery in the elderly, the proportion 0.32%; P < .001), and bleeding (1.14% vs. 0.5%; of bariatric surgery in the elderly, it is not the of patients undergoing sleeve gastrectomy rel- P = .024). Although the average operating time first to conclude that morbidity and mortality ative to gastric bypass has been increasing, Dr. was 40 minutes longer in the bypass group, rates are acceptably low, according to Dr. Zeni. Zeni reported. In the analysis, approximately there were no significant differences in throm- This may explain why the proportion of bariat- two-thirds of the bariatric procedures were per- boembolic complications. ric procedures performed in patients 60 years formed with sleeve gastrectomy, which is higher Overall, despite a modest increase in the risk of age or older has been increasing. In figures relative to what previous MBSAQIP analyses of complications for bariatric surgery in elderly provided by Dr. Zeni, that proportion rose from have shown. patients, that risk can be considered acceptable 2.7% during 1999-2005 to 10.1% during 2009- Based on rates of morbidity for those two in relation to the potential health benefits, ac- 2013. surgical approaches in the analysis, that trend cording to Dr. Zeni. He suggested that the data There were 16,568 patients older than age makes sense. While the higher 30-day mortality might encourage further growth in the rates of 60 years entered into the MBSAQIP database for gastric bypass, compared with sleeve gastrec- bariatric procedures among patients older than in 2015. When those were compared with the tomy, was not significant (0.38% vs. 0.26%; P = 60 years. 117,443 younger patients, the unadjusted rates .221), all-cause morbidity was almost two times Dr. Zeni reports no relevant financial relation- of morbidity (6.5% vs. 6.0%) and mortality greater for those undergoing gastric bypass than ships. (0.3% vs. 0.1%) were higher for the older pa- it was for those undergoing sleeve gastrectomy tients, but “they are close,” according to Dr. Zeni. (10.61% vs. 5.81%; P < .001), Dr. Zeni reported. [email protected] GIHEPNEWS.COM • JANUARY 2018 PRACTICE MANAGEMENT 21 PRACTICE MANAGEMENT TOOLBOX: How to be an advocate for your profession and your practice

BY WALTER G. PARK, MD, MS cians currently serving in Congress screening. Because of an oversight partments: ASCs are reimbursed (including a gastroenterologist, in the legislation, when a polyp is an average of 49% of the hospital ur profession continues to Sen. Bill Cassidy, a Republican from found and removed, the procedure outpatient department rate (com- be in the midst of significant Louisiana), seeking political office becomes a diagnostic colonosco- pared with 86% in 2003).4 This has Otransformation, which began is not the py and beneficiaries are liable for occurred because ASC reimburse- with the passage of the Affordable only way to coinsurance, which can amount to ment updates are tied to the All Care Act (ACA) in 2010, and the actively par- $100-$300, disproportionately af- Urban Consumer Price Index rather Medicare Access and Children’s ticipate.2 This fecting lower-income beneficiaries than the hospital market basket up- Health Insurance Program Reau- article briefly because they often lack supple- date. The All Urban Consumer Price thorization Act (MACRA) in 2015, summarizes mental insurance coverage.3 This Index measures inflation for goods and continues with the current some of the legislation (H.R. 1017) will correct and services that poorly correlate attempts to repeal and replace the ongoing feder- this mistake by waiving the coin- with typical ASC purchases. This ACA. Passed with strong bipartisan al legislation surance for Medicare beneficiaries piece of legislation (H.R. 1838, S. support, MACRA introduced a new and issues in who undergo a screening colonos- 1001) would change the ASC reim- system of rules and regulations for the current DR. PARK copy regardless of the outcome and bursement update to the hospital the Centers for Medicare & Medic- session of hopefully will remove one barrier market update, which would im- aid Services (CMS) reimbursement, Congress pertaining to gastroenter- to getting patients screened for co- prove ASC payment predictability. and with it an expanding lexicon of ology, and how one can participate lon cancer. In addition, it also would require acronyms (i.e., MACRA, electronic in advocating for these issues. publication of ASC quality data, im- health records [EHR], value-based Ambulatory Surgical Center proving transparency in delivered modifier [VBP], meaningful use Removing Barriers to Colorectal Quality and Access Act of 2017 endoscopic quality of care. [MU], Quality Payment Program Cancer Screening Act of 2017 Many gastroenterologists perform [QPP], Advancing Care Information In the Affordable Care Act of 2010, endoscopy in ambulatory surgery Independent Payment [ACI], and certified EHR technology Medicare beneficiaries were in- centers (ASCs), which are safe, Advisory Board [CEHRT]).1 One way to adapt (and tended to have free access to any cost effective, and convenient sites Under the Affordable Care Act, evolve) is to become more informed preventive health service designat- for providing patient care. There the Independent Payment Advi- of health policy and learn how to ed Grade A by the U.S. Preventive has been a growing disparity in sory Board (IPAB) was created to advocate on behalf of the profes- Services Task Force, which includes payment rates by CMS between control excess Medicare spend- sion. Although there are 15 physi- colonoscopy for colon cancer ASCs and hospital outpatient de- Continued on following page Patient INFO FIND YOUR NEEDLE

Trying to find that perfect job or candidate can be a daunting task. ENGAGE YOUR PATIENTS Use the search tools within GICareerSearch.com to brush aside the in Their Health Care fray and quickly find your needle in the haystack. GICareerSearch com Use AGA PatientINFO Center Materials to Get the Conversation Started Enhance and improve patient conversations and outcomes with visually appealing and easy-to-read patient education materials written in English and Spanish. AGA members have free, quick and easy access.

For more information, visit patientinfo.gastro.org.

2525-688COM_16-3 2525-500COM_15-2 22 PRACTICE MANAGEMENT JANUARY 2018 • GI & HEPATOLOGY NEWS

Continued from previous page Medical research funding Trump administration recently complexities of our health system. Every year, Congress appropriates released its budget request for FY Most importantly, this helps devel- ing. This would occur when the funds for the National Institutes 2018, calling for a decrease in NIH op a relationship with the legislator CMS actuary finds that per-capita of Health (NIH). In fiscal year (FY) funding to $26.9 billion (22% cut).8 and/or their staff. If you are inter- Medicare spending is projected to 2016, NIH invested nearly $32.3 ested in learning more about how grow more quickly than the target billion dollars annually in medical These selected brief summaries to schedule such an appointment growth rate; the IPAB then will of federal legislation currently or need resources and tips for your be tasked with finding savings. being considered show the reach, visit, you can contact the AGA (ad- The IPAB includes 15 members Another way to get more relevance, and potential impact of [email protected]) or one of the nominated by the president and involved is to volunteer Congress on the daily practice of Gastrointestinal (GI) societies for confirmed by the Senate, of which gastroenterology. In response, there assistance. fewer than half can be health your time within the various are many opportunities to advocate In addition, many medical soci- care providers and none may be GI societies on respective for your practice and your patients. eties and coalition groups sponsor practicing medicine. Although committees that focus on GI Perhaps the easiest way is to voice advocacy events where you can the Board has not been formed, your concerns by emailing or call- travel to Washington, D.C., to meet it is predicted that the IPAB will and health-related policies. ing your members (both House with your representatives and their be triggered this year. Regardless members and Senators) of Con- legislative staff. Another way to get of whether there is a board in gress. Representatives in Congress more involved is to volunteer your place, the statute would require research. For FY 2017, NIH was al- routinely track and count these time within the various GI societies the secretary of Health and Hu- located $33.1 billion, an increase of calls and emails to define their on respective committees that focus man Services to implement cuts. $825 million.6 Despite this increase, constituents’ concerns. You can call on GI and health-related policies. Furthermore, most of the cuts NIH had previously lost 22% of its the Capitol Switchboard at (202) Volunteering for one of these com- would impact physicians dispro- capacity to fund research because 224-3121. Ask the operator to con- mittees is an excellent way to quick- portionately because hospitals of previous budget cuts, sequestra- nect you with the senators and rep- ly become informed and advocate are exempt from IPAB proposed tion, and inflationary losses from resentative from your state. When for your profession. Finally, some cuts until 2020.5 Legislation has FY 2003 to FY 2015.7 Most advo- you reach your congressperson’s medical organizations have their been introduced and passed in the cates of research argue for higher office, let them know the following: own political action committees. House (H.R. 849) and is now being levels of funding to restore a path of • Your name and where you are Learn more about AGA political considered in the Senate (S. 260, S. sustained and predictable growth calling from in the state. action committees at http://www. 251) to repeal the IPAB. for U.S. biomedical research. The • What you are opposing or sup- gastro.org/agapac. porting in pending legislation. Recently, I received a note from Many medical societies have my representative thanking me for available online tool kits on their CLASSIFIEDS webpage to easily identify a mem- ber’s appropriate representatives Also available at MedJobNetwork.com Take-away points: in Congress and also provide pre- PROFESSIONAL OPPORTUNITIES populated templated letters (that 1. Health care reform is not you also can personalize) to email. going away – get informed and This takes approximately 5 minutes get active as there are many op- of your time and is effective. You portunities to advocate for the WHERE A LANDSCAPE OF can find these on the AGA’s website value of your practice and the (https://www.gastroadvocacy.org/ care of your patients. OPPORTUNITIES AWAITS A actionalerts.aspx). Similar resourc- 2. The AGA, ASGE, and ACG es are available on the American have wonderful resources on GASTROENTEROLOGIST Society for Gastrointestinal Endos- their websites to get educated copy and American College of Gas- and opportunities to get in- Gundersen Health System in La Crosse, Wisconsin troenterology websites. volved in advocacy. is seeking a BC/BE Gastroenterologist to join its For those who would like to do 3. Start by making a call to the established medical team. more, you can visit in person to ad- office of your House member Practice in our state-of-the-art Endoscopy Center vocate for your concerns. Members or senator, or visit their local and modern outpatient clinic. Outreach services are of Congress have offices both locally office. provided at our satellite clinics located within an and in Washington, D.C. Members easy drive from La Crosse. In addition, you will have of Congress often have office hours opportunities for clinical research and will be while they are home in their dis- visiting her office and for advo- actively involved in teaching our Surgical, Transitional, and Internal Medicine residents. tricts and often do not have the cating for the “Removing Barriers You’ll join a physician-led, not-for-profit health distractions of votes or committee to Colorectal Cancer Screening system with a top-ranked teaching hospital and hearings so they are able to take Act.” Consequently, she decided one of the largest multi-specialty group practices more time to meet. When visiting, to cosponsor the legislation. I am with about 700 physicians and associate medical highlight your background and try not sure how much of an impact staff. Visit gundersenhealth.org/MedCareers to keep your concerns focused, I had and I can understand the Send CV to Kalah Haug sharing how a piece of legislation skepticism about one’s individual Medical Staff Recruitment or regulation impacts you person- contribution to this process. In Gundersen Health System ally. Another great way to get to response, I submit that the act of [email protected] know your legislators – both rep- participating in advocacy affirms a or call (608)775-1005. resentatives, senators, and local sense of agency – that there is al- officials – is to invite them to visit ways a choice and that voicing your your practice, your ASC, or your endorsements and concerns is an hospital. Members of Congress extension of one’s right to vote and EEO/AA/Veterans/Disabilities usually welcome such opportu- responsibility as a citizen. If this nities to learn more about health appeal to ideals is not persuasive, care delivery and see firsthand the Continued on following page GIHEPNEWS.COM • JANUARY 2018 PRACTICE MANAGEMENT 23

Continued from previous page pendent payment advisory board. Avail- nih/index.html. Accessed July 10, 2017. ernment. Available from https://www. able from https://www.ama-assn.org/ 7. Federation of American Societies for govinfo.gov/app/collection/budget/2018. then I would remind you of the practice-management/independent-pay- Experimental Biology. Research funding Accessed July 10, 2017. well-known political adage, “If you ment-advisory-board. Accessed July 10, trends. Available from http://faseb.org/ are not at the table, you are on the 2017. Science-Policy-and-Advocacy/Feder- Dr. Park is in the department of medi- menu.” Not participating by putting 6. US Department of Health and Human al-Funding-Data/NIH-Research-Funding- cine, division of gastroenterology and one’s head in the sand also has con- Services. HHS FY 2017 budget in brief - Trends.aspx. Accessed July 10, 2017. hepatology, Stanford University School sequences. Although most members NIH. Available from https://www.hhs.gov/ 8. United States Government Publishing of Medicine, Stanford, Calif. He disclos- of Congress appreciate how import- about/budget/fy2017/budget-in-brief/ Office. Budget of the United States Gov- es no conflicts of interest. ant health care is for their constit- uents, legislation often advances slowly and requires persistent,

Content from this column was originally published in the “Practice Management: The Road Ahead” section of Clinical Gastroenterology and Hepatolo- gy (2017;15:1489-91). iterative acts of advocacy. For ex- ample, in the previous session of IMPORTANT SAFETY INFORMATION Congress, 289 House members co- 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 sponsored the Removing Barriers common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache. to Colorectal Cancer Screening Act, 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 yet it was not introduced for a vote. 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 Driven by persistent excess costs 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 that threaten the sustainability of 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 Medicare and Medicaid, health care and ingestion of additional water as recommended is important to patient tolerance. will remain a priority legislative topic for the next decade. To thrive, the GI community needs to provide 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. leadership through education and 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 engagement. 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, References 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 1. Centers for Medicare & Medicaid Ser- 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. vices. Quality Payment Program. Available 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 from qpp.cms.gov. Accessed July 10, 2017. 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 2. Becker’s Hospital Review. Meet the 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 15 physician members of the 115th US 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 Congress. Available from http://www. 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 beckershospitalreview.com/hospital-man- 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, agement-administration/meet-the-15-phy- 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 sician-members-of-the-115th-us-congress. 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 html. Accessed July 10, 2017. 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 3. Fight Colorectal Cancer Coalition. Leg- 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 islative goals. Available from https:// (68°-77°F). Excursions permitted between 15°-30°C (59°-86°F). Rx only. Distributed by Braintree Laboratories, Inc. Braintree, MA 02185. fightcolorectalcancer.org/advocacy/hill/ legislative-goals/. Accessed July 10, 2017. 4. Ambulatory Surgery Center Association. ASC Quality and Access Act of 2017. Avail- able from http://www.ascassociation.org/ govtadvocacy/legislativepriorities/asc- qaa-2017. Accessed July 10, 2017. 5. American Medical Association. Inde-

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

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Braintree Laboratories, Inc. SUPREP 23-24 Olympus America Inc. EVIS EXERA III 15 Pfizer Inc. Corporate 10-11 Takeda Pharmaceuticals U.S.A., Inc. Entyvio 2-5 # 1 MOST PRESCRIBED, BRANDED BOWEL PREP KIT1

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. IMS Health, NPA Weekly, May 2017. 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; 2012. 4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.

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