This week, I am running a special five-part podcast series, Monitoring in Healthcare. In it, I take 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 series is sponsored by Affiliated Monitors, Inc. One of the lessons that I learned in researching and producing the series is that while healthcare monitoring has its own unique challenges, there are many techniques, strategies and tools which have wider application to commercial and financial entities. Even if you are not in healthcare, checking out the series could provide you with some new innovative approaches for the enhancement of your compliance program.

Healthcare occupies a unique space in the American business world. First of all is the size of the healthcare industry as it accounts for almost 20% of our economy. Moreover a very large portion and an ever-growing portion of that money comes from the taxpayers, federal programs like Medicare, Medicaid, the VA and state funded programs. When you have lots of money being spent in a particular industry, there is always the potential for fraud, waste and abuse. Now overlay this with the public money involved, there is the potential for a False Claims Act or government action, civility or criminally. Finally, the healthcare industry is highly regulated, with most, if not, all healthcare providers, whether individuals or organizations, licensed by the state, either by a Board or state agency and some might even be licensed or certified by federal authorities.

Not every healthcare organization has a good handle on either the effectiveness of their compliance program or the compliance culture of their organization. Independent integrity monitoring can proactively assess compliance programs and culture, identify potential areas of compliance risk.  By using an independent compliance expert to do a proactive assessment of a compliance and ethics program and culture, a healthcare organization can get a lot of value by assessing not just whether the organization has a compliance program that appears to meet all the elements of an effective compliance program but the monitor can come in and actually assess whether that program truly is effective. The assessment can identify the ethical culture of the organization, detect gaps, make recommendations to remediate those gaps and provide the organization with a particular level of comfort that the structure of the program is truly effective and that the culture of the organization is such that compliance has been embraced by the workforce throughout the organization from the top to the bottom.

An independent compliance expert can bring a fresh set of eyes to any organization or entity. Such an expert can provide several valuable inputs to any organization including: demonstrating to the Board organization’s ethical culture and effective compliance program; identify gaps or weaknesses in the compliance program when a healthcare organization has a problem, for instance, a compliance problem where the government gets involved; provide recommendations for remediations demonstrate to government regulators the seriousness and effectiveness of the organizations compliance program; educating an organization’s workforce; and, finally, sending a strong positive message throughout the entire organization that they take compliance very seriously and expects the workforce to take it seriously as well.

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.

In healthcare, when the government or the regulators come knocking, bringing in a compliance monitor can help demonstrate to the government that any compliance violations are not indicative of a systematic problem with the compliance program or the ethical culture of the company. It can show the problems have been remediated. Through monitoring, the government can feel comfortable that the organization is going to be a compliant organization going forward. Using an independent integrity monitor can help an organization avoid more severe sanctions, such as license suspension or even exclusion from a government healthcare program.

There is also value to the government of approving a monitoring relationship in a matter they are involved in. Governments and healthcare regulators want to ensure, above all, that patients and healthcare consumers receive high quality and safe care, that taxpayer money is efficiently and well spent, and that there is a healthcare industry environment and culture of compliance, transparency, and quality. An independent monitor can help the company meet these objectives and provide assurance to the government that the compliance risks have been addressed.

An independent integrity monitor can work with the government to ensure compliance with an oversight requirement, such as a Corporate Integrity Agreement (CIA) or other resolution agreement. Yet an independent compliance monitor typically is going to be an expert in compliance and ethics. The healthcare industry is incredibly complex. Hospitals have many different regulations with which they must comply, which are different from regulators under which a health insurance company must comply, which, again, are different from a medical device company. These are but some of the challenges that an independent compliance monitor needs to have expertise on. The independent monitor can come in and do a proactive assessment, identify gaps in particular areas, such as HIPPA (Health Insurance Portability and Accountability Act of 1996) privacy, data security, compliance program and internal controls.

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.

All of this has significance for commercial and financial institutions. By using an independent compliance monitor in a pro-active approach, your organization can both assess and nip in the bud any matters before they become matters, issues or problems.

This publication contains general information only and is based on the experiences and research of the author. The author is not, by means of this publication, rendering business, legal advice, or other professional advice or services. This publication is not a substitute for such legal advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified legal advisor. The author, his affiliates, and related entities shall not be responsible for any loss sustained by any person or entity that relies on this publication. The Author gives his permission to link, post, distribute, or reference this article for any lawful purpose, provided attribution is made to the author. The author can be reached at tfox@tfoxlaw.com.

© Thomas R. Fox, 2018

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