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

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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.

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