The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition

In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition recently announced it would not provide financial assistance for any diseases in 2018. As a result of this announcement, HHS OIG is turning to PhRMA for help.

We have been covering for some time now the apparent war on patient assistance programs (“PAPs”) being waged by the Department of Health and Human Services Office of Inspector General (“OIG”). It seems that at the core its OIG is inherently suspicious of any PAPs that cover a patient’s insurance co-payment especially if the patient is covered by a government health care program (e.g., Medicare) and the PAP receives support from the pharmaceutical industry.

This innate suspicion was at the heart of the recent case against United Therapeutics, Inc. and its relationship with the Caring Voice Coalition (“CVC”). The government contended that United Therapeutics made donations to the fund and “used it as a conduit to pay the copay obligations of thousands of Medicare patients” taking the United Therapeutics PAH drugs “to eliminate price sensitivity of patients purchasing or physicians prescribing” the drugs and “to induce those patients’ purchases” of the drugs. In other words, that United Therapeutics used the charity to circumvent the Anti-Kickback Statute (“AKS”) restrictions.