What are the biggest pain points that GP Professionals in pharma are dealing with?

Q&A with Chris Cobourn, Vice President of Regulatory Compliance, Compliance Implementation Services
 
Beyond waiting for AMP, what do you think are the biggest pain points that GP professionals in pharma are dealing with right now?

Chris: That’s a good question. I’ll hone in on that word choice – “pain point”. I think pharma compliance in general and GP specifically, we think of that term a lot. When I think “pain point” I think of what keeps CEOs or CFOs up at night. Or what keeps a GP professional up at night. So, let’s remember the intense level of compliance and accountabilities and risk – the expectation that manufacturers get this right and the risk if they don’t. The level of scrutiny out there by the Office of Inspector Generals and the Department of Justice will continue to grow and become intense. There is a huge focus on program integrity. So, the expectation is clear. Manufacturers have to get it right. The visibility across the organization increases. CEOs and CFOs understand the risk. They are certifying these calculations. That’s what we’ve seen really dramatically increase over the years.
 
The level of visibility in the organization and the understanding of the need to get this right. So, now you start introducing uncertainty and change into that, especially the C-chains that can come with AMP final rule, 340B Program integrity initiatives, constant complicated things that are hitting us – like the recent Texas reporting requirement. So, you’ve got organizations struggling with how to implement it all, understand it all, yet very high-level visibility. So, you’ve got CEOs and CFOs looking at a GP professional and saying: “You’ve got to protect the organization here. You’ve got to make sure we’re compliant. What does all this mean? How are we doing it? Tell me what to anticipate. Tell me the financial impact.” That’s, I think, the pain point at the C-level. And I think worry about some big pieces of it, especially such as will the final rule have the build-up methodology or not? We certainly hope not. But, there are a lot of changes that are going to ripple through the industry and it’s all going to start with a GP professional needing to educate their organization with what it means.
 
So, what are the biggest pain points? I think that’s what really drives people to attend conferences like this and the importance of GP professionals as a community having that dare-to-open dialogue.



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