US federal government withdraws approval of major patient charity over donor misconduct

The Department of Health and Human Services’ Office of Inspector General (OIG) has rescinded authorisation for one of the US’ biggest patient assistance charities, Caring Voice Coalition (CVC), following its discovery that the organisation could have been allowing its donors to influence prescriptions and raise prices on their drugs.

The Virginia charity, which was originally awarded authorisation from the federal government in 2006, focuses its work on improving the lives of patients with chronic conditions, supporting their access to expensive treatments by covering co-payments that can exceed $10,000 a year.

Companies including Pfizer and Johnson & Johnson recently revealed they had been investigated relating to their support of charities with similar remits to CVC. Drug makers in the US are forbidden from subsidising co-payments for patients enrolled in government such as Medicare as it would be considered a kickback, but they are able to donate to non-profit organisations that act in the same way, so long as they are independent.

Unsurprisingly, big pharma companies are accused of exploiting this loophole, and their increased donations to such organisations in recent years has been in step with large increases to the price of their drugs.

While not required, OIG approval is a big boon to charities such as CVC, and drug manufacturers are unlikely to donate to one that doesn’t have the stamp of approval. This latest decision by the OIG could even lead to the charity to close its doors.

"Our board of directors is evaluating this very serious matter and will determine the most appropriate path forward," Gregory Smiley, chief executive officer of Caring Voice, said in an email. "We are very disappointed to receive this news, particularly given the work we have undertaken over the past six months, including dramatic leadership and comprehensive policy overhauls."