Healthcare Entrepreneurship Must-Have: Putting Compliance Front & Center
Troutman Pepper’s Miranda Hooker joins the Integrity Through Compliance podcast to discuss her 20 years of experience as a white-collar attorney in the healthcare space, both as corporate defense attorney and as a federal healthcare fraud prosecutor. Together with AMI’s Jim Anliot and Jesse Caplan, she discusses the the growing opportunities, the significant compliance risks, the available compliance guidance (and the limits to that guidance), and how to mitigate the potential for government investigations and enforcement actions. There are huge potential opportunities for healthcare entrepreneurs in 2021, in addition to potential landmines that business leaders trip upon when they aren’t properly prepared.
Keep reading for some of Miranda Hooker’s highlights and main takeaways:
COVID-19 triggered some major changes to the healthcare industry, and many of those changes are here to stay:
” . . . with the widespread adoption of telehealth services come additional opportunities to improve upon those services. And I think we’ll also create a lot of opportunity for those in the healthcare industry to think about how to better operationalize the way in which healthcare is delivered to patients . . . how to view healthcare from a more holistic perspective than simply treating one specific condition . . . and it’s encouraging what I think will be a slow shift — but nonetheless a shift — away from the typical fee-for-service payment models that we’ve always operated under, in favor of alternative payment models that include value-based care, or models that allow for incentive payments based on patient outcomes.
All of this comes down to the point that the government is sort of catching up to the innovation that’s already existed in the industry, and it’s creating a lot of opportunities for venture capitalists, private equity, and others to enter the healthcare market.”
Healthcare entrepreneurship is rife with regulatory landmines if compliance takes a back seat to other business considerations:
“And to the extent there is an emphasis on compliance, it’s really around regulatory compliance relating to product safety . . . and it’s less about fraud and abuse issues. So that’s the sticky area for those who are entering this marketplace, because you’re thinking about how to grow your business, how to educate users and customers . . . you can come into the industry with common sense, and your common sense of what you can usually do is not necessarily going to translate. And that’s a hard lesson for very smart, ambitious, driven entrepreneurs and companies, who have really fantastic and great products to offer.
So that’s all to say, I have clients who are entering this space who just don’t necessarily fully appreciate that there are these landmines that you can trip upon.”
Updated federal guidance is helping to educate entrepreneurs without having to rely on the hard lessons learned by others who run afoul of regulations:
“. . . for many, many years, I would say manufacturers and providers were educating themselves on the rules of the road through settlement agreements, or enforcement actions . . . That’s a very hard way to learn lessons, because what it means is that some company has to find itself in a position it never wants to be in, in order for others to glean any learnings.
But beginning in 2017, the Department of Justice started issuing pretty substantive guidance to prosecutors on how to evaluate corporate compliance programs, and this is guidance that the industry can use to shape their programs . . . there’s a lot to unpack in the guidance, but I think it really does provide a substantive roadmap for companies who are looking to ensure that they have a compliance program that keeps them on the straight and narrow.”
In the event of a compliance problem, companies can potentially avoid enforcement action if they demonstrate a high-quality compliance program:
“. . . if you’ve discovered the problem, that’s evidence that your compliance program works, so I think you can view that as a positive . . . I think DOJ is recognizing that there can be a compliance program that’s effective, and yet there can be misconduct in the organization. Misconduct can occur. And I think it’s in these instances that DOJ is putting out there into the industry that it wants to incentivize compliance.
[if] there’s still no corporate intent for any type of misconduct, and that should be something that DOJ is evaluating very carefully in the context of its investigations.”
On the importance of the Chief Compliance Officer, and communicating the importance of compliance to the entire organization:
“. . . when you have an experienced compliance officer, I think they bring to bear the notion that their role is not to be the police, but rather to be a resource . . . that is actually really the right tone you want to strike. And that’s what creates an environment whereby people come to trust compliance, and recognize that it’s not there to stop you from doing your job, it’s actually there to help you do your job.
I think of various companies that I investigated as a prosecutor whereby the compliance officer would be outwardly mocked by the head of the organization in front of the entire sales force. And so, what’s the message you’re sending there about compliance? Sure, you have a manual. You have some auditing, you have some monitoring. But . . . that’s not really creating a tone that’s going to bring about an effective compliance program.”