In this special five-part podcast series, sponsored by Affiliated Monitors, Inc., I visit with AMI Managing Director Jesse Caplan on emerging issues in healthcare compliance and monitoring. In the previous episodes, we considered how healthcare organizations can benefit by having an independent compliance expert – a fresh set of eyes, so to speak – evaluate the organization’s compliance program.  We explored the emerging risks involved in opioid prescribing and how organizations can mitigate that risk by pro-actively assessing the prescribing practices of their physicians and physician extenders.  In this final episode we discuss how an independent integrity review can be helpful for organizations that may be facing actual or potential compliance issues.

Some of the issues we consider are:

Can independent integrity review and monitoring be helpful where a healthcare 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 imposed by the government?

  1. The use of an independent compliance expert to assess a healthcare organization’s ethics and compliance program at a point in time where the organization has reason to believe it has a compliance problem and is likely to face an enforcement action can have tremendous value to the organization. Where a healthcare organization has reason to believe it has a compliance issue, that organization will be faced with a range of obligations and potential consequences, and the organization and their counsel will likely seek to mitigate those potential consequences to the extent possible.  Using an independent compliance expert to review and assess the organization’s ethics and compliance program, make recommendations for remediation and improvement, and then offering to have that independent expert monitor the organization’s implementation of those remedial measures and improvements can be a useful tool in dealing with the government enforcement agency and convincing that agency to grant the organization some leniency in the sanctions that might otherwise be imposed. 

How engaging an independent integrity monitor in these circumstances can help an organization in dealing with an enforcement agency?

  1. Coming from my enforcement background, and consistent with guidance from the Justice Department and the CMS Inspector General, we know that the government expects – in fact demands – that healthcare organizations self-report certain types of compliance violations – like overpayments they’ve received, or false or fraudulent claims that they’ve billed the government, to certain types of privacy breaches. The government also wants to see that the violation has been investigated and remediated, and just as importantly, that the violation is not indicative of a systematic failure of the organization’s ethics and compliance program.  While the organization can and should investigate compliance violations using internal resources or outside counsel, using an independent compliance expert to assess the ethics and compliance program and culture, make recommendations, and then monitor implementation of those recommendations, provides a level of objectivity and credibility that is more likely to resonate with the government enforcers. 
  1. We have had many engagements where the healthcare organization either directly, or through their legal counsel, engaged our firm to conduct an assessment of the ethics and compliance program and culture, where we made recommendations for improvement and remediation, and where we monitored the organization’s implementation of those recommendations and remedial measures. In many of those cases the organization and their counsel were able to convince the government enforcement agency that the company’s actions in addressing its deficiencies justified leniency – in effect, the organization and its lawyers were able to say to the government: “you don’t have to take our word for it; you can rely on the assessment and monitoring of this independent, objective and credible monitoring firm.”  In some of these cases, using the independent monitor likely meant the difference between the healthcare organization being permitted to continue to participate in government healthcare programs, as opposed to being excluded or having a license revoked. 

Why is it government enforcement and regulatory agencies would prefer not to exclude important health care providers who have compliance issues?  

  1. Ensuring access to sufficient quality health care providers – whether they be behavioral health providers, or providers serving other vulnerable and under-served populations – is a constant challenge for healthcare policymakers. Excluding an important provider with significant compliance issues may address those compliance concerns, but it may raise a different problem and challenge when it means there are not sufficient accessible healthcare resources.  The better solution, of course, is to have providers with compliance issues remediate their problems and implement a sustainable and effective ethical and compliance program so that the healthcare market has the benefit of high-quality, efficient, and transparent providers.  While the government is suspicious of healthcare participants who run afoul of their regulatory and compliance obligations, engaging an independent compliance expert and monitor can provide the government with the tools to temper, if not overcome, those suspicions. 

For more information on Affiliated Monitors, check out their website here.