
A charity that has received hundreds of millions of dollars from drug makers lost an important designation from federal authorities for allowing donors to influence how patient data was used.
Caring Voice Coalition, which takes industry donations to help patients pay for their medicines, allowed drug makers access to information that could be used in deciding whether to raise prices. By doing so, authorities said, the companies could shield patients from the immediate effect of increased out-of-pocket costs, because federal health care programs, such as Medicare, would pick up the tab. Charities are prohibited by government regulations from disclosing detailed information about their operations.
Technically, the Office of Inspector General at the U.S. Department of Health and Human Services revoked an advisory opinion, which was first issued in 2006, that shielded the charity from kickback liability, according to this letter posted on the OIG site on Tuesday. This was the first time the OIG has ever taken such a step, an agency spokeswoman explained. As a practical matter, the revocation means that Caring Voice will find it more difficult to solicit donations from drug makers.