Thomson Reuters Westlaw Publishes Akin Gump Preview of FCA MedTech Trends to Watch
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Thomson Reuters Westlaw has published the article “MedTech update 2020 — Legal and regulatory issues to watch for in the medical technology industry in the new year: False Claims Act enforcement,” written by Akin Gump health care and life sciences partner Robert Salcido. The article looks at some of the significant changes—legal, regulatory and market—that could have “a lasting impact” on medical device and diagnostics companies and laboratories this year with regard to False Claims Act (FCA) enforcement.
Originally included as part of a lengthier Akin Gump client alert, this article outlines several trends to look for in 2020. They include:
- Continued application of Anti-Kickback Statute to MedTech consulting arrangements.
- FCA materiality defenses will continue to be tested.
- Continued challenges to the use of subregulatory guidance as the foundation for an FCA action.
To read the article in its entirety, please click here.