Legal and compliance insights from a PAP perspective

Doreen Rice, director of patient assistance programs at AstraZeneca, shared her experience working strategically with legal and compliance teams at the recent Access USA conference.

With more than 15 years of working in patient assistance programs (PAPs), Rice explained how her experience has given her an understanding of diverse viewpoints when tackling legal and compliance considerations inherent in PAPs.

Doreen Rice, director of patient assistance programs, AstraZenecaWhether the PAPs program is a manufacturer program, non-profit charitable organization, or a foundation that assists in copay, Rice said “those are all things that will drive how you think about your program and the legal and compliance considerations associated with it.”

In addition to the type of programs, the organizational structure is important, she added. Some PAPs operate under separate foundations, while others are integrated within corporate affairs or market access departments.

“The way that structure is set up is really important and will drive some of the conversations, how you have those conversations, and who you have those conversations with. And then we know that there are various regulations, statutes, and guidance that we all have to be very mindful of when we’re having conversations,” she said.

Rice recounted an experience earlier in her career where a routine patient call unexpectedly triggered a federal investigation. “When I talk about legal and compliance considerations … I saw and lived what it meant to make sure that your compliance guardrails are intact, that you’re living and breathing the policies of your organization, and the importance of collaboration with your legal and compliance partners,” she said. While she was found not to be involved in the case, Rice said she had to testify in court as a witness, and an individual was prosecuted for pharmaceutical diversion.

“Having all of our documents as part of evidence, having our training question, having our compliance guardrails question, are things that have really shaped the manner in which I approach leading the programs that I oversee,” she said.

Rice then asked delegates who are leading PAPs programs if they meet regularly with their legal and compliance partners. Their responses were positive.

“It is important. I think that we all recognize that the more they know, the more we are able to design our programs [and] respond to situations as they come up.”

Bridging global understanding

Rice gave another example in how she partnered with legal and compliance to navigate a request from a global clinical team that was unfamiliar with the intricacies of the US healthcare system.

The global clinical trial team requested free drug access for about 30 US patients nearing the trial’s end.

While Rice supports minimizing out-of-pocket costs, she considered this request in light of the existing free drug program’s eligibility requirements.

“But as we started to have more conversations, and I’m thinking about it in the context of our existing free drug program, and as we all know, our free drug program has eligibility guidelines,” she said. “And those eligibility guidelines ultimately mean that if someone doesn’t meet those guidelines, they may not be accepted into the program.”

Since no-cost drug access is not a standard in the US, the process would normally involve a reimbursement hub, coverage assistant, and referral to a PAP, she said.

“We have very specific policies and laws in the US, and we have to make sure that we protect the integrity of our programs,” Rice said.

“It was through the collaboration and discussions with my compliance and legal partners, first and foremost, to help educate our global colleagues on the US laws and policies that we have to adhere to. Those conversations are still ongoing, but ultimately, what was probably about a six-to-nine-month journey of conversations where we landed currently, is to follow our existing practices,” Rice further explained

“Had I not had my legal and compliance partners as part of the initial conversation, it would have been a challenge to help my global colleagues understand the difference in the US market.”

DepositPhotos/3dconceptsman