Over this five-part podcast series, I have been taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of healthcare services, the public. I have been joined in this exploration by two individuals at Affiliated Monitors, Inc. (AMI), the sponsor of this series. They were Jesse Caplan, Managing Director of Corporate Oversight, and Catherine Keyes, Vice President of Operations. Today, I conclude the series with Caplan on using independent integrity assessment and monitoring to limit adverse consequences.

Many compliance practitioners in the healthcare space (and those in commercial space) often ask if an independent integrity review and monitoring be helpful where an organization may have reason to believe it has an actual or potential compliance problem but has not yet been subject to an enforcement action or a Corporate Integrity Agreement (CIA)  imposed by the government. There are several reasons this is particularly true in the healthcare space. He noted that the government expects, in fact demands, that healthcare organizations self-report certain types of compliance violations. He provided some examples such as overpayments healthcare providers may have received from the government, or false or fraudulent claims that they have billed the government and certain types of privacy breaches.

Caplan believes that using an independent compliance expert can be useful in dealing with the government enforcement agency and convincing that agency to look more favorably where severe sanctions might otherwise be imposed. An independent integrity monitor can be helpful to a healthcare organization where they may have compliance violations. It can even be true with current healthcare issues such as the opioid crisis and excessive opioid prescribing.

Moreover, this is where an independent integrity monitor can be very useful when the organization thinks they have a problem. A monitor can be brought in to assess the compliance program, make recommendations for improvements and then be available to monitor the remedial recommendations as they are implemented. If an organization makes a self-disclosure or if the government comes and investigates the company, they can use the fact that they have used an independent integrity monitor to assess the compliance program and, equally importantly, themselves and they will continue to use the monitor to ensure continued compliance.

By using an independent integrity assessment, an organization can demonstrate to the government entity that the problems with the company’s compliance regime are not endemic or structural but more of an isolated incident. This can help to provide confidence to the public that they can continue to operate safely and in compliance and provide assurance to the government and regulators that it can continue to participate in the government programs with little fear of having those violations reoccur. This can have a very large impact on what types of action the government or regulator will take.

The bottom line in healthcare regulation is that government enforcement and regulatory agencies would prefer not to exclude important healthcare providers who have compliance issues. Their goal to ensure access to sufficient quality providers is a constant challenge for healthcare policymakers. Regulators generally agree that the best solution is to have providers with compliance issues remediate their problems and implement a sustainable and effective ethical compliance program. By engaging an independent compliance expert and monitor can provide the government with confidence that organization has remediated and will be an effective, compliant participant.

We conclude this episode with a few of Caplan’s thoughts on how an independent integrity monitor could have impacted two matters widely in the public eye. They are the matter of Theranos, Inc. and the opioid crisis. With regards to Theranos, a wide variety of stakeholders could have requested a truly independent come in and assess compliance at the company. It could have been the Board of Directors, the Securities and Exchange Commission (SEC), state or federal healthcare regulators or even third parties who were looking to do joint ventures with the company. Such an assessment might have saved many jobs, investments, careers and reputations.

In the opioid crisis, an independent monitor could have done the assessment around large numbers of drugs being prescribed by one doctor or prescribed to be delivered through one pharmacy. But the analysis could have gone much deeper by focusing on the corporate compliance programs, their implementation and training. It could have also looked at those who spoke up by using the hotline or other internal reporting mechanisms.

All of this means that an independent integrity monitor in the healthcare space can be used in a variety of ways and through a variety of mechanisms.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

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