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# FDA Approval Not Needed for Medicare Coverage: Court
- URL: https://www.fdaweb.com/fda-approval-not-needed-for-medicare-coverage-court/
- Published: 2016-01-13T12:00:00.000Z
- Updated: 2026-09-15T02:27:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5134417

> Attorney **Michelle Yeary** (Dechert) says a Texas federal court recently rejected a whistleblower’s argument that because FDA has not determined the safety and effectiveness of off-label use of biliary stents used in a vascular stenting procedure, Medicare payment claims for the stents were false. Essentially, she writes in an online blog [post](http://www.lexology.com/library/detail.aspx?g=d5406ad2-7619-4133-aa0c-32332af6b315&ref=fdaweb.com), “plaintiffs’ theory is a ban on off-label use where government health insurance is involved. Plaintiffs want the court to say that off-label use is across the board ‘not reasonable,’ ‘unnecessary,’ and/or ‘experimental.’”  
>  
> Yeary says that FDA review of a medical device is not a substitute for an insurance eligibility determination. And of more significance in the decision, she says, lack of FDA approval or clearance for a specific use does not categorically disqualify a device from Medicare coverage. “As we’ve seen time and time again, however, off-label use is often the standard of care,” she writes. “Medicine leads, regulations follow.”