Tag Archives: waiver

FDA Amends Regulations for Acceptance of Data from Foreign and Domestic Investigation for Medical Devices

On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as well as modifying certain regulations applicable to data from US-sited investigations. The Final Rule does not go into effect until February 21, 2019 – a full year after promulgation.  The FDA also issued guidance in the form of Frequently Asked Questions (FAQ) addressing the new regulations.  In the FAQ document, the FDA explained its …

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical research studies conducted at a non-profit medical center.  In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS).  The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework …

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