While the healthcare industry has always been highly regulated, recent developments mandate that transparency and compliance monitoring are not afterthoughts for manufacturers, health care organizations and health care professionals.
The number of regulations continues to grow, and the penalties for violations become significantly larger given the availability of large volumes of spend and prescription data in public domain. Already strapped for time, compliance teams simply cannot afford to devote the hours required for all that tracking, analysis, and reporting manually or through spreadsheets — and even if they could, the risk of human error is simply too high.
If manufacturers are to take a proactive stance in complying with today’s massive (and growing) web of regulations, new solutions are needed. Fortunately, today’s advanced analytics platforms give organizations the actionable insights that they need within their day-to-day working environment, not only to stay compliant, but also to become aware of and address potential violations before they cause expensive problems.
The Sunshine Act: A New Level of Expense Reporting
To cite just one example of recent regulatory burdens, the Sunshine Act of 2013 requires all pharmaceutical, medical device, and biotechnology companies to collect, track, and report all payments made to healthcare professionals. The Act defines a “payment” as any transfer of value, monetary or nonmonetary, which means it covers everything from speaker fees to research funds to the cost of lunch a sales rep might bring in for a meeting.
The Sunshine Act requires companies to record all transfers of value, analyze these expenditures against pre-established company thresholds, and report them to the federal government as well as to designated state agencies. Failure to comply and follow an established process for engaging with healthcare professionals can result in significant fines — as well as multi-year audits of the company’s processes and procedures.
As you might imagine, tracking these expenditures manually can involve sifting through hundreds of Excel spreadsheets. Not only do administrative staffs not have the time that would be required, but the company can ill afford the high risk of human error involved.
Keep in mind that all that is needed to comply with just one set of regulations. Multiply it by ten or more and you’ll have an idea of what companies are up against when it comes to meeting their regulatory obligations.
The Analytics Solution
For organizations looking to maintain a stance of proactive compliance in today’s regulatory environment, a manual approach simply isn’t viable. Forward-thinking companies are already making the leap into intelligent technologies that can simplify, streamline, and ensure the accuracy of their compliance processes.
Today’s advanced analytics platforms can automatically monitor business rules and codes of conduct to ensure that the organization is always compliant and is able to address exceptions quickly and in a timely manner. Compliance teams can create filters, drill down into their data and flag outliers that could indicate compliance risks.
When our customers began asking for a more robust analytics solution, we knew that a basic dashboard wouldn’t suffice. So we partnered with GoodData to build configurable dashboards that took into account specific compliance policies for a customer to highlight exceptions without needing to build customized dashboards for each customer. We needed a solution that would allow us to rapidly deploy those dashboards to all of the different users throughout our customer’s organization. The result, MediSpend Insight, not only removes much of the administrative burden from our clients’ already-packed to-do lists, but also helps them sleep better at night knowing that their compliance process is as solid as it can be.
Returning to the Sunshine Act example, MediSpend Insight enables customers to benchmark their spend against the competition, determine which Key Opinion Leaders are being sought after by companies, for what purpose and how much they are being paid. MediSpend Insight also enables customers to monitor field force activities in real time, identify and manage off-label use of products or devices and identify outliers and correct non-compliant behaviors.
Solutions for the Regulatory Minefield
For healthcare organizations looking to stay on the right side of compliance, we have bad news and good news. The bad news is that current regulatory requirements probably won’t be going away anytime soon — in fact, we can probably expect more (think General Data Protection Regulation (GDPR) that take effect on May 25, 2018). The good news is that advanced analytics offers the solutions needed to stay on top of the rules, to be proactive in addressing problems as they arise, and to fulfill obligations, all without placing undue burdens on staff. Now that’s a healthy solution we can all live with.