In this episode of the NASP Podcast, Sheila Arquette, President & CEO of NASP, speaks with Jeffrey S. Baird, Esq., Chairman of the Health Care Group at Brown & Fortunato, P.C. and Bradley W. Howard, shareholder and director at Brown & Fortunato, P.C. In today’s environment, it is challenging enough to profitably run a specialty pharmacy. The pharmacy needs to avoid the additional challenge of inquiries, audits and investigations by governmental agencies and PBMs. This podcast will discuss the proactive steps the specialty pharmacy can take to lower the risk of inquiries, audits and investigations. This podcast will also set out steps the pharmacy can take to resolve inquiries, audits and investigations before they spin out of control. The podcast will focus on the following: • Corporate Compliance Program – The specialty pharmacy needs to implement a robust compliance program that is specific to the pharmacy’s business model. Such a program will head off many problems before they arise…and a compliance program will resolve problems, once arisen, before they spin out of control. • PBMs – A PBM is in a stronger negotiating position than that of the specialty pharmacy. At the end of the day, the PBM “possesses the pharmacy’s money.” This podcast will discuss the steps the pharmacy should take to establish a “win-win” relationship with a PBM. Doing so will eliminate uncertainty and prevent many problems from arising. However, if the PBM ends up bringing an inquiry, audit or investigation against the pharmacy, the podcast will set out the steps the pharmacy should take to resolve the inquiry, audit or investigation without it devolving into an adversarial action. • Governmental Agencies – There are a number of federal and state governmental agencies that a specialty pharmacy may have to deal with. These include (i) the Department of Justice, (ii) the Office of Inspector General, (iii) the DEA, (iv) the FDA, (v) state Attorneys General, and (vi) State Boards of Pharmacy. This podcast will discuss the steps the pharmacy should take when it is investigated by a governmental agency. As with working with PBMs, the pharmacy should strive to resolve a government investigation before it spins out of control.