Earlier this month, the U.S. Attorney’s Office for the District of Massachusetts announced a $100,000 FCA settlement.
This settlement resolved allegations of a Pharmaceutical company violating the Anti-Kickback Statute (AKS). In addition, this also caused the submission of false claims through incentive compensation payments to the company’s employees for conduct outside the scope of an employee relationship.
The role of a whistleblower was integral to the launch of a complaint alleging that the company “OraPharma” violated the FCA (False Claim Act). This led to an investigation to uncover the truth behind the allegation.
The findings were that OraPharma wrongly instructed dental providers to bill Medicare Part D & erroneously double-bill dental insurance for OraPharma’s drug, Arestin.
Furthermore, the complaint launched also highlighted that OraPharma employed Registered Dental Hygienists as Sales Reps (Representatives). Some practiced actively in their territories, encouraging dentists to prescribe the company’s products.
The qui tam complaint doesn’t consider this a violation of the Anti-Kickback statute but rather a tactic to steer the prescribing decision in the company’s favor.
Moreover, the qui tam complaint doesn’t address billing allegations as an integral part but solely resolves claims based on allegations that the Registered Dental Hygienists or sales representatives, in this case, were given incentives or monetary compensations for prescribing, promoting, and encouraging the use of the drug “Arestin” to Medical beneficiaries while they were in their dental offices performing dental hygienist duties.
It was also considered that the Dental Hygienists operated outside their scope with OraPharma. What’s even more interesting is the fact that the company “OraPharma” may not have been fully aware of this act because although some of the dental hygienists were occasionally working in dental offices or in their assigned sales territories, they were not disclosing certain instances in this occasional hygiene practice to OraPharma which was required by the company’s “Conflict-of-Interest” policy.
Although it seems unlikely that the Department of Justice (DOJ) could’ve established a willful violation of the Anti-Kickback Statute and knowingly submission of false claims if put to the task. To read the full copy of the settlement agreement, click here.
Staying Compliant by Leveraging qordata’s Data-Driven Compliance Platform
The OraPharma situation might have been mitigated if the company was leveraging a data-driven compliance platform to monitor and detect inappropriate activities, Identify sales representatives violating company policies, and then implementing corrective/preventive actions immediately to mitigate risks at all levels.
Utilizing traditional methods to identify potential policy breaches that may lead to potential investigations is challenging. However, identifying the problem is only one part of the solution.
Compliance professionals must utilize comprehensive risk-assessment tracking, enhance monitoring programs that tie to identified risks, ensure remediation of breaches, and establish mechanisms for effective risk mitigation.
Therefore, the potential of data-driven compliance cannot be overlooked, given that the Life sciences industry is highly scrutinized.
The challenges and issues that need to be addressed keep evolving and changing. The best way to manage these changes is by adapting to a data-driven and automated compliance platform that helps compliance teams stay ahead by identifying compliance risks before the government does.
To learn how qordata’s data-driven compliance platform can help Life Sciences and compliance leaders resolve entrenched compliance risks and assure compliance business growth, schedule a meeting today.
