After more than a year of waiting with baited breath, on February 1, 2013 CMS announced the Final Rule implementing the Physician Payments Sunshine Act. The industry finally had the specific requirements outlined so that they could put the last touches on their aggregate spend processes and solutions. The timeline was laid out; that August 1 collection date seems to be right around the corner.
This year is going to be a lot about Sunshine, don’t get us wrong. And we have plenty to say about Sunshine –– but we’ll cover that in another blog post.
Yet, we all know that companies aren’t able to just drop everything else and focus on Sunshine. The demands on legal and compliance executives come from many other entities – both externally and internally. The first CIA of 2013 was inked in March. A week later, chilling allegations were unsealed in Boston related to another company’s whistleblower case – did you gasp when you saw the “soccer ball” analogy, too?
So, (albeit rightfully so), while Sunshine is grabbing all of the headlines right now given the massive undertaking to finalize HCP spend capture readiness before the temperatures start to rise this summer, what else are we seeing compliance professionals focus on?
In the first three months of 2013, more than 500 individuals have discussed these points at two meetings in CBI’s Compliance Series. The insights shared at these meetings shed light on a number of other compliance initiatives that are top of mind.
Here's what we gleaned during PCC 2013 - CBI's 10th Annual Pharmaceutical Compliance Congress in January and the inaugural meeting on Compliance Monitoring Programs in March.
1) The 2013 Focus of the DOJ.
We heard it from the top. And when it comes from the top, we know we need to listen.
"When CBI asked me to address our top areas of focus for the Department this year, drug safety immediately came to mind, and within drug safety, the illegal conduct that came to mind was misbranding and adulteration of drugs," said Maame Ewusi-Mensah Frimpong, Deputy Assistant Attorney General of the DOJ during PCC in January.
Drug safety, particularly in relation to GMP compliance hasn’t traditionally been an area where corporate compliance departments have focused. When Ms. Frimong spoke of the Department’s focus on misbranding and ensuring promotional claims are truthful and balanced, we all nodded our heads. She called out the particulars of some recent cases. We know. The government has collected billions through settlements for off-label promotion, particularly as it relates to violations of the FCA.
However, I found the GMP Compliance discussion very interesting and I know the CCOs in the audience took it to heart as well. It begs the question we’ve been asking for more than a year now – how is the role of the Compliance Officer evolving? We’re now seeing enterprise risk responsibilities fall into the responsibilities of the CCO. If a company is not structured in such a way to have ERM or Risk Officer responsibilities rest squarely on the shoulders of the Chief Compliance Officer, how can companies at least make sure that one arm of the company is ‘talking to’ the other so that there is clear communication and awareness? CIAs require Compliance Officers to self-disclose interactions with other agencies. That includes FDA Audits at manufacturing plants. This is undoubtedly an area that needs further exploration as compliance departments figure out how to incorporate risk mitigation related to the drug safety issues the DOJ so specifically points out within their work plans for 2013.
To download the full text of Ms. Frimong’s speech at the 10th Annual Pharmaceutical Compliance Congress, click here.
2) It’s all about effective monitoring.
Sure, it was in response to the monitoring requirements laid out within its CIA, but we still found it interesting that one company upped its monitoring team from 6 to 45. Typically, monitoring teams double when the company enters a CIA, the audience at the Compliance Monitoring Programs conference learned. Not every company can dedicate that many personnel against the effort, but it’s clear that with a CIA or without, increased resources are being put towards monitoring across the industry.
The enormous bandwidth required for records review proved to be a common challenge amongst monitoring professionals. What varied however were the stances companies took on different records – namely, whether companies would even monitoring emails (let alone text messages or social media) and the best way to capture and monitor sales call notes. Does allowing free text call notes open the door to potential liability? Or, if you only allow drop-down menus for reps to use, do the same potential liabilities exist but they’re just written in a notebook instead of logged in a system?
Another common discussion point was finding ways to really get the business engaged in the monitoring efforts. Particularly on the commercial side, compliance departments want to lean on midlevel and senior leaders to be a partner in these efforts. One company shared how they have a requirement that two field ride-alongs to be completed by the DMs (and we all got a chuckle when she shared that they had to update the policy when they saw these occurring on March 31 and April 1 … but you said one per quarter….). GSK has put into practice a model for working with “individuals within the business” - both manager-level employees (Level 1 controls) and independent control and monitoring functions (Level 2 monitoring).
We also heard how some companies are moving from transactional monitoring to interactional monitoring – how they are looking at data to get a more complete picture of activities and relationships with HCPs. As more data becomes available with Sunshine reporting, monitoring teams will provide even greater value to their organizations.
3) How much does the Caronia case really matter?
When Tim Grimes of Johnson & Johnson and Erik Eglite of Lundbeck asked the PCC audience whether the Second Circuit Court of Appeals decision caused any re-evaluation of their company's policies regarding the dissemination of information during the interactive session, a whopping 65% said "No" that they "maintain and enforce current policies." I saw one person take a photo of the results slide on his phone so that he could pass those results along in real-time to some (commercial) peers in his company who had been pushing for more lax policies as a result of the case.
Sure, the Caronia case was big news. But, these benchmarking results were very telling. You could feel a collective sigh of relief, ‘comfort in numbers’ if you will, when we all saw that it wasn’t causing an upheaval of reactionary change. Coupled with earlier comments from the DOJ and Tom Abrams, Director of FDA's OPDP, who said the outcome doesn't change the way that the government looks at cases either, until we see off-label enforcement change because of it, we’ll just mark Caronia down as another piece of interesting case law.
Curious to learn, from an anti-bribery perspective, how many companies require 3rd party vendors to fill out due diligence questionnaires? Or the percent of companies that felt they were fully operational in capturing Agg Spend info? (We had to talk about Sunshine some, didn’t we?)
By downloading the below report, you will receive a great sampling of the industry's stance on these and other compliance topics.