Life science companies know they have to reduce risk by implementing a process to manage HCP engagements. But when compliance experts start asking them about specifics, such as compliance controls and documentation, they get tripped up. Many simply do not have a scalable, flexible system, using the latest in technology, to enforce compliance with healthcare laws.
If they are trying to comply, they are doing it by cobbling together multiple systems or gathering information on Excel spreadsheets with no controls. Internal IT departments are constantly trying to play catch up by customizing in-house systems.
How Life Science Companies Render Themselves Vulnerable
Even though their intentions are good, they are at a loss when the U.S. Department of Justice (DOJ), for instance, asks for proof of compliance. Recently, the authorities alleged that Novartis was using sham speaker events to pay kickbacks to doctors for prescribing its drugs. The government asked for evidence to the contrary for back-up documentation on 79,236 events.
Novartis went to court and argued that it was physically impossible and burdensome to produce back-up documentation on so many activities. However, the judge ruled in favor of the Department of Justice and said it was a valid request (https://blog.medispend.com/hubfs/FederalBilottaVsNovartis.pdf). The case is ongoing. Novartis failed to reduce risk.
Finding a Compliance System of Record
Companies like Novartis need a single, closed-loop system of record. Engagement Manager is a cloud-first, SaaS solution, which automates workflows to manage compliance surrounding interactions with healthcare providers (HCP). Engagement Manager was designed to enable companies to follow best-practices as outlined by the DOJ in numerous Corporate Integrity Agreements.
Life science companies are moving to cloud-first, open-source technologies that can be customized and easily modified. They find it more economical and efficient to outsource to a cloud provider as opposed to building and continuing to maintain homegrown applications.
Simply by implementing such compliance technology, companies are committing to a compliance process with controls, which reduces risk of a violation. This demonstrates to DOJ and other authorities that compliance is part of the corporate culture and not just a policy. As a result, the government might be more lenient if it finds errors on the part of the company.
What to Expect Next from DOJ
This is particularly important when you read the tea leaves of the DOJ. From 2012 to 2017, DOJ scrutinized speaker programs as a mode of doling out kickbacks to doctors to get them to prescribe their drugs more often.
Now, the big push is to look at patient-assistance programs, where companies funnel money to nonprofits to pay for things, such as copays for people who can’t afford a medication. The DOJ is seeking to discover who is abusing the patient-assistance programs to inappropriately influence prescriptions.
How to Reduce Risk With Compliance Technology
DOJ and other authorities are not out to get businesses or squeeze them for money. They are seeking compliance. And they recognize that sometimes bad actors present themselves at good companies.
Sometimes, people make mistakes, and information slips through the cracks. But if you’re showing genuine effort at compliance, they might give you the benefit of the doubt. It is when you have an outdated compliance program with manual processes that you expose yourself to the most risk.
When used as part of the MediSpend Compliance Cloud, Engagement Manager provides companies with end-to-end business process workflows across the whole enterprise. As a result, they can remain compliant with local and global laws. By using such systems to reduce risk, they create value and build trust within the organization and the public at large.
Why Engagement Manager is the Right Solution
Most importantly, life science companies can document and track all aspects related to HCP engagements, weed out bad actors, and follow best practices. And when the government calls on them to produce proof of compliance, all documentation and approvals will be at their fingertips.
Engagement Manager facilitates compliance with DOJ best practices. life science companies go from manual processes, managed through disparate systems, to utilizing a closed loop, purpose-built cloud-based solution to manage the end-to-end HCP engagement process and demonstrate compliance if DOJ comes knocking.
This is the second in a five-part series. We’ll be unpacking more details about Engagement Manager in forthcoming blogs. Up next, a closer look at compliance records and streamlining business processes. For more information, or to request a demo, visit https://info.medispend.com/request-a-demo.