Settlement is first involving a copay assistance program operated through Caring Voice Coalition since the HHS Office of Inspector General rescinded a safe harbor for the charity's activities in late November. Is it the first of a wave?

US OIG's first-ever rescission means the advisory is revoked retroactively to its date of issue, which could lead to anti-kickback enforcement actions against behavior by the charity and manufacturer donors since then. 

Stakeholders differ on whether the rapid growth in spending is to be expected, given the realities in health care and specialty drug costs, or that the data underscores the need for oversight and reform of the 340B program.