Assuring Quality for Non-Hospital Based Biologic Infusions in Pediatric Inflammatory Bowel Disease: A Clinical Report from the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition

The primary aim of this Clinical Report by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition is to provide formal guidance to pediatric gastroenterologists and clinicians, health systems, and insurance payers regarding home- and office-based infusions for biologic therapies in pediatric inflammatory bowel disease (IBD). Patients in North America are increasingly denied coverage by payers based on "place of service" codes at hospital-based infusion units where the treating clinicians primarily provide care. A task force with topic expertise generated 8 best practice recommendations to ensure quality of care for pediatric patients with IBD receiving non-hospital based biologic infusions. Pragmatic considerations discussed in this report include patient safety, pediatric-trained nurse availability, care coordination, patient-centeredness, shared liability, administrative support, clinical governance, and costs of care. Address correspondence and reprint requests to K.T. Park, MD, MS, 750 Welch Road, Suite 116, Palo Alto, CA 94304 (e-mail: ktpark@stanford.edu). Received 15 May, 2017 Accepted 22 December, 2017 Potential Conflicts of Interest: RS has received research support from Janssen and AbbVie Inc., and is a consultant for Protagonist. EH received research support from Janssen. SS is on the Speaker's Bureau for AbbVie, Inc. SK was a consultant with Abbott (education programs and speaker) until 10/31/16. JM is on the Speaker's bureau for AbbVie Inc. GW receives research support from AbbVie Inc and Janssen, is on the advisory board for Janssen, and is a consultant/DMC for AbbVie Inc. KTP has received research support from Janssen, Takeda, AbbVie Inc., and is supported by NIDDK094868. Disclaimer: The NASPGHAN practice guidelines are evidence-based decision-making tools for managing health conditions. Practice Guidelines include Clinical Practice Guidelines (CPGs), clinical reports, technical reports, and position statements. They are authorized by the NASPGHAN Executive Council, peer reviewed, and periodically updated. They are not to be construed as standards of care and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. All decisions regarding the care of a patient should be made by the health care team, patient, and family in consideration of all aspects of the individual patient's specific medical circumstances. While NASPGHAN makes every effort to present accurate and reliable information, these guidelines are provided "as is" without any warranty of accuracy, reliability, or otherwise, either express or implied. NASPGHAN does not guarantee, warrant, or endorse the products or services of any firm, organization, or person. Neither NASPGHAN nor its officers, directors, members, employees, or agents will be liable for any loss, damage, or claim with respect to any liabilities, including direct, special, indirect, nor consequential damages, incurred in connection with the guidelines or reliance on the information presented. This article has been developed as a Journal CME Activity by NASPGHAN. Visit http://ift.tt/2ioSD8w to view instructions, documentation, and the complete necessary steps to receive CME credit for reading this article. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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