Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) Device Coverage & Billing: Compliance Insights

John Dortero, Compliance Specialist, UW Medicine Compliance.

April 9, 2019

  • The key FDA and CMS regulations affecting IDE and HDE device use and coverage, and the corresponding roles and the responsibilities across a health system - including Compliance, Providers, IRB, Clinical Trials Office, Supply Chain, and Billing

  • Tips for how Compliance departments can promote collaboration and successful partnerships across a health system (such as education and outreach, task forces, and policy review) to reduce regulatory risk and promote system-wide compliance

  • Sample process for analyzing IDE and HDE devices as they enter a health system to help ensure compliant device usage and billing

This document is only available to subscribers
Purchase

About SCCE

The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

952.933.4977

About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

952.988.0141

Facebook Twitter LinkedIn
Copyright © 2024 by Society of Corporate Compliance and Ethics (SCCE) & Health Care Compliance Association (HCCA). No claim to original US Government works. All rights reserved. All information provided through this site, including without limitation all information such as the “look and feel” of the site, data files, graphics, text, photographs, drawings, logos, images, sounds, music, video or audio files on this site, is owned and/or licensed by SCCE & HCCA or its suppliers and is subject to United States and international copyright, trademark and other intellectual property laws. Any third party logos and/or content provided herein is owned by such third parties and is used by permission herein. Your use of this site to is subject to our Terms Of Use and Privacy Statement.
Cookie settings