The article below, How Specialty Pharmacies Can Safeguard Against Fraud When Using Patient Assistance Programs, details yet another case including a specialty pharmacy. In this instance the SP was pinched by the feds for participating in a scheme to mickey with patient co-pay programs for Copaxone. Advanced Care Scripts, an Orlando based specialty pharmacy, was recently fined $3.5 million!
The details of the case are summarized in the article (link below)… but here’s the bottom line. If you want to avoid a big financial penalty, don’t step over well-defined lines of business behavior to collude with a manufacturer to violate laws.
Here are some best practices from the article that can keep specialty pharmacies (you) out of hot water related to patient assistance programs:
Carefully review data elements provided to drug manufacturers in data reports to ensure information about charitable support or status of a charitable support request is not provided.
Do not enter into contractual arrangements with drug manufacturers to coordinate charitable foundation support. Assisting patients in identifying such funding should be conducted as part of the pharmacy’s core services and not as directed by a drug manufacturer.
Train staff to avoid any coordination with pharmaceutical manufacturers on the provision of charitable funding to patients. This includes not only through contractual agreements but also by avoiding such discussions informally or in scheduled business reviews.
Ensure robust contractual language is in place clearly prohibiting pharmaceutical manufacturers from utilizing data provided by the specialty pharmacy to make charitable funding decisions.
One need not have been a lawyer to know when lines had been crossed in the ACS/TEVA case. Since $3.5 million is a whole lot bigger number than, say, $5000-$10,000 in legal fees, having your SP’s lawyer on speed dial might be the very next thing you do today.
Click here to read the complete article from Bass, Berry & Sims PLC
Anton RX Reports are copyrighted by Anton Health, LLC.
