With 7 days until the federal Sunshine rules kick in, companies are hammering out the final details of their physician payment reporting strategies, but they’d do well to look beyond the August 1 deadline.
Beyond mere compliance with regulation, companies need to consider how they’ll handle public scrutiny over the financial relationships that are about to come to light, according to compliance attorney Jennifer Geetter, a partner with McDermott Will & Emery and a Chambers USA-ranked leader in her field.
She is coaching her clients to use the new rules as a "springboard" to develop an even more flexible program that tracks not only physician relationships but also responds to conflicts of interest and other financial tracking issues. In a phone interview with MassDevice.com, Geetter talked about reporting strategies and future challenges for life science companies bound by Sunshine rules.
MassDevice: First off, can you tell us a little bit about your consulting work? How do you approach the Sunshine regulations with your clients?
Jennifer Geetter: For a number of years now there’s been a lot more scrutiny on financial relationship between the companies that make and sell products and the providers who prescribe them. There are a lot of questions on how to manage those relationships.
From what I’ve seen, there’s no perfect answer. You don’t want to wall off the provider community from industry because you want providers in the mix, telling companies what their patients need. On the other hand you don’t want something resembling “open season” where there is no scrutiny of those relationships because, unfortunately, sometimes folks have compromised judgment.
The debate is around where you draw that line in the middle. The way I think of it is as a gravitational pull. My son is very into space so I think a lot about the universe, but it’s not a bad metaphor. You’ve got to keep all the planets in the biomedical universe working together and avoid galactic collision. We want relationships and connections between these groups, but we also want a nice healthy distance. Federal Sunshine is the latest star in this universe. It’s not the first, it’s probably not the last.
“You’ve got to keep all the planets in the biomedical universe working together and avoid galactic collision.” -Jennifer Geetter
MD: How often do larger companies with an in-house legal team outsource these Sunshine questions to your firm?
JG: Even institutional providers who have robust internal legal compliance teams work with outside council on specific compliance topics, especially when they’re ramping up in a new area or when there’s a change in the law. The other reason outside council plays an important role is because these are brand new areas, and to a certain extent it’s about finding the middle of the pack. There are always questions and gray zones, and sometimes it’s helpful for companies to ask us, “What have you seen other companies do?”
MD: How does compliance differ for smaller companies without a current reporting infrastructure?
JG: I think it’s really important to understand that smaller and mid-sized companies are not going to have the same head start with financial relationship compliance generally.
All companies can comply with Sunshine law. The more difficult question is asking how to build a financial reporting program more generally that can include fraud and abuse, aggregate spend issues or the emerging area of best practices and conflict of interest. Smaller and mid-sized companies might see Sunshine as the final push they needed to develop a comprehensive program.
Complying with Sunshine in a vacuum is not the task at hand. The task at hand is how find a balance. Sunshine might be front and center, but it doesn’t eclipse the entire field. There were rules that existed before Sunshine and there are rules that will come after, and it won’t necessarily be enough to just comply with Sunshine.
MD: You say companies need to use this as a “springboard” not only for Sunshine, but for conflict of interest and other spending practices. Can you expand on this a bit?
JG: Applicable manufacturers are the life science entities that apply for this rule – that’s a very broad constituency. It could be a multi-conglomerate pharmaceutical or a life science startup that just got its 1st product approved.
“There were rules that existed before Sunshine and there are rules that will come after, and it won’t necessarily be enough to just comply with Sunshine.”
Larger companies are likely to have a pre-existing compliance structure for fraud and abuse that isn’t a perfect structure for Sunshine, but they can build out from there. Companies that are smaller are less likely to have that scalable infrastructure. So Sunshine can be a springboard to ramp up.
Maybe it’s time that we should be building a financial relationship compliance programs more broadly. Compliance with Sunshine law alone is not compliance. You might be completely compliant with Sunshine but might have gaps in fraud and abuse; these are overlapping circles. Regardless of where you are on the food chain, you’re going to have some work to do. It’s an opportunity to re-evaluate how all the integrated pieces fit together.
MD: What has manufacturers wringing their hands?
JG: It depends a little bit on size, because the smaller the company, potentially the more headaches they might have. There are some common challenges. They need to get ready to track and the tracking rules are very specific. Another challenge is with the physician community, which is calling industry asking “What does this mean?” Physicians are concerned that there will be information in error and there will be no chance to vet it. There are a lot of relationship problems.
Another example is: how prepared are companies for public scrutiny? Are companies prepared for the public records? There are concerns about people taking a close look at these records – individuals, special interest groups, opposing council for opposing industry, the media. Companies are starting to think about the post-tracking phase. We are at the starting gate in every way in terms of the scope of this law.
MD: In April the FDA issued draft guidance with suggestions for reporting physician/company interactions. Will the government agencies continue to provide compliance suggestions?
JG: We can expect guidance can continue to be forthcoming for a while. Often these guidance documents are propelled by questions, so as the program ramps up, more guidance will come out. A regulation of this complexity is bound to have some hiccups along the way. Round peg/square hole questions will be sorted out over time. We are at the beginning of a long runway. This is true for the agency, all affected parties and the public.
“A regulation of this complexity is bound to have some hiccups along the way.”
MD: Which agency will be auditing the systems? Who in CMS will be auditing?
JG: That’s a good question and we don’t know the answer yet. The mere existence of public information is a safeguard for lapses in judgment. CMS has enforcement authority over the data collection process. Yes, everyone is focused on tracking, but there’s a whole 2nd wave of what happens with this data. Who in the public will be looking at the data, peeking behind it? I don’t think we know that yet, but we can assume that auditing will happen. Folks need to be ready.