Clifford Chance

HHS-OIG Rescinds Advisory Opinion on Pharma Funding of Patient Charities

4 December 2017

On November 28, 2017, the Office of Inspector General of the US Department of Health and Human Services rescinded an earlier advisory opinion that permitted a pharmaceutical manufacturer to fund patient charities that defrayed the costs of certain patient co-payments in connection with drugs paid by the Medicare program. This decision could have significant implications going forward for pharmaceutical companies that contribute to such patient assistance programs. As DOJ and state governments continue to investigate the funding arrangements between pharmaceutical manufacturers and patient assistance foundations, it is more important than ever for pharmaceutical companies that donate to such foundations to examine closely their funding arrangements to ensure compliance with federal health care laws and regulations.

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