Limiting Adverse Consequences

Many compliance practitioners in the health care space (and those in commercial space) often ask if an independent integrity review and monitoring would 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 health care space. Government expects – in fact, demands – that health care organizations self-report certain types of compliance violations. Some examples include over-payments providers may have received from the government, false or fraudulent claims they have billed the government and certain types of privacy breaches.

Using an independent compliance expert can be useful in dealing with a 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 health care organization where they may have compliance violations. It can even be true with current health care issues, such as the opioid crisis and excessive opioid prescribing.

This is where an independent integrity monitor can be useful when a 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 engaged 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 isolated.

This can help to provide both confidence to the public that the entity can continue to operate safely in compliance and 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 impact what types of action the government or regulator will take.

The bottom line in health care regulation is that government regulatory and enforcement agencies would prefer not to exclude important health care providers who have compliance issues.

Their goal to ensure access to enough quality providers is a constant challenge for health care 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. Engaging an independent compliance expert and monitor can provide the government with confidence that organization has remediated and will be an effective, compliant participant.

To use a couple of live examples, let’s look at how an independent integrity monitor could have intervened in the fraud at Theranos, Inc. and the opioid crisis. With regard to Theranos, a wide variety of stakeholders could have requested a truly independent monitor 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 health care 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 their 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 health care space can be used in a variety of ways and through a variety of mechanisms.

Please join me next week when I begin a new five-part series on what ethical culture is and why it matters.

In case you missed the earlier installments of this ongoing series, please see the links below.

Everything You Always Wanted to Know About Monitors But Were Afraid to Ask

Part 1, Part 2, Part 3, Part 4 and Part 5

Potential Issues in Corporate Monitorships

Part 1, Part 2, Part 3, Part 4 and Part 5

Suspension and Debarment in Monitoring

Part 1, Part 2, Part 3, Part 4 and Part 5

Monitoring in the Health Care Sector

Part 1, Part 2, Part 3, Part 4