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FCPA Compliance Report

Emerging Issues in Healthcare Compliance and Monitoring-Episode 4 – Independent Integrity Monitoring of Healthcare Organizations

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 Episode 3, we discussed how independent monitoring can serve important public policy goals in the healthcare industry.  In this Episode 4, we consider examples of independent monitoring involving healthcare organizations or systems.

We consider some of the following issues:
How do healthcare organizations or the agencies that regulate them may use monitoring in connection with significant business transactions – as opposed to law enforcement or disciplinary proceedings. 

  1. Healthcare transactions – like acquisitions, mergers, non-profit conversions, and even capital improvements – are subject to regulatory oversight and scrutiny that may be more intense than in other industries.For example, major capital improvements to hospitals are often subject to a state’s Certificate of Need – CON — or Determination of Need – DON –approval.  Not-for-profit hospitals that seek to convert to for-profit – often as part of a merger or acquisition transaction – are likely to face scrutiny and require approval by those agencies that regulate and oversee both their licensing and their charities functions – typically the state department of health and state Attorney General’s Office.  A merger or acquisition of a hospital, health insurance company, or even a physician practice can be subject to antitrust scrutiny –by state authorities like the Attorney General’s Offices, and possibly federal review by the Department of Justice or the Federal Trade Commission.   
  1. In each of these healthcare transactions, the government agencies involved are not seeking to address compliance violations or to take disciplinary action. In most of these matters the healthcare organization is not doing anything wrong. But these transactions are likely to impact the structure and dynamics of the local healthcare market, and the regulators – typically state regulators – have both the authority and the objective of ensuring those impacts are a net positive for the local healthcare marketplace. The government’s healthcare regulators and policymakers will want to ensure that the transaction improves the quality of healthcare, increases access to healthcare – particularly for vulnerable and under-served communities, and does so more efficiently. In order to withstand government review, and to get the approvals required, the healthcare organizations entering into the transaction often offer up representations and concessions about actions, investments and improvements they will agree to take and engage in going forward – actions designed to address the state’s concerns and objectives.  And the state regulators themselves will often seek to impose additional conditions or requirements on the transacting healthcare organizations to address the state’s public policy objectives. 
  1. Whenever you have conditions being imposed or being offered as a prerequisite of approval of a healthcare transaction, there is a need to have someone monitoring whether those conditions are being effectively implemented and sustained. The government agencies can do the monitoring themselves, but as we previously discussed, that may require resources that are not readily available. We find that a better alternative will often be that the regulators and the healthcare organizations agree to an independent monitoring firm to oversee that the conditions, investments and improvements are being timely and effectively implemented.  In these matters, the independent monitor is paid for by the healthcare organization but reports to the government agencies.

What are some examples of where organizations and government regulators have jointly agreed to use an independent firm to monitor implementation and compliance with conditions of a healthcare transactions?

  1. AMI is currently engaged in monitoring conditions imposed by a state Attorney General’s Office on two separate hospital systems, both of which converted not-for-profit hospitals in the state to for-profit companies as part of major acquisitions. In this state the Attorney General’s Office is charged with regulating public charities registered with the state.  When the not-for-profit healthcare organizations sought to convert to for-profit, the Attorney General’s Office imposed conditions to ensure the charitable assets of the original entities were appropriately used for charitable purposes, that there were no impermissible conflicts of interest, that the entities maintained sufficient local representation and control, and that the new entity followed through on capital investments.  The state attorney general’s office, the healthcare organizations, and our firm entered into a three-way agreement where our firm provided the monitoring of these conditions, where we reported the status and progress of implementation of those conditions to the attorney general’s office, but where we were paid by the healthcare organization.  
  1. Other areas where regulatory agencies are using independent monitors with healthcare organizations include the US Department of Justice and Federal Trade Commission in their review and approval of mergers requiring divestitures of certain assets. These two agencies are relying on independent monitors to make sure that the divestitures are accomplished consistent with the agreements approving the mergers, and in ways that don’t otherwise compromise competition. 
  1. Related to those examples, we are currently engaged in monitoring a very large multinational corporation in connection with the company’s acquisition of another large company. That acquisition was approved by federal regulators only after the parties agreed to specific conditions meant to ensure continued competition in the industry and enhanced consumer welfare.  While this engagement is not in the healthcare field, the value proposition in using an independent monitor to oversee implementation of these conditions in a merger or acquisition transaction would apply in the healthcare context.  In this engagement, we hired certain subject matter experts – for example, engineers – to address those conditions that required specialized training and experience. 

Join us for our final installment, Episode 5, where we tie it all together by discussing how to use an independent integrity monitor in a proactive approach that can lead to greater business efficiency and profitability.
For more information on Affiliated Monitors, check out their website here.

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Life with GDPR

Life With GDPR: Episode 24- Phishing

In this episode, I visit with Jonathan Armstrong consider the increasing business risk around phishing. There have recently been some multi-million-dollar losses around phishing so you need to be prepared. Some of the issues and highlights are:

  1. What is phishing?
  2. The largest number of data breach have come through phishing. Why has it become such a business risk?
  3. What are the requirements a company take against phishing under GDPR?
  4. What are the three key concepts in data protection?
  5. Modern phishing attacks are very sophisticated.
  6. What are some of the most intricate frauds seen in this area?

For more information on Cordery Compliance, go their website here. Also check out the GDPR Navigator, one of the top resources for GDPR Compliance by clicking here.

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Daily Compliance News

Daily Compliance News: March 28, 2019-the SFO sued edition

MARCH 28, 2019 BY TOM FOX


In today’s edition of Daily Compliance News:

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Blog

King Lear Week: Part IV – Jackson Provides a Different Interpretation

This past weekend I was lucky enough to catch the performance of King Lear with Glenda Jackson as the mad king. It was a magnificent production and if you have the chance to see, I would certainly urge you to do so. The production had many interesting features and interpretations which seemed to be great entrees into several compliance topics. Therefore, inspired by octogenarian Jackson and her performance, I have used King Lear as a deep dive into several compliance topics this week. Today, I want to discuss how Jackson, starring in the role of King Lear, added a new level of complexity, nuance and interpretation to the entire play.
Jackson is an octogenarian, the oldest person I have ever seen play Lear. Having seen my two parents age, I have some understanding that a person does not gain in stature, power or strength after they cross the 80-birthday mark. In other productions I have seen Lear roared and railed at Cordelia however, Jackson played it understated with nary a raised voice.
Even after the intermission, one of the most powerful scenes is when Lear carries of the lifeless body of Cordelia. Lear is in shock, bereaving and clearly quite mad. Yet to pull this off this scene requires an actress playing Cordelia to be of a size that the actor playing Lear can physically carry. Jackson is far too frail to do so. In this penultimate scene she sat on the stage with Cordelia’s head cradled in her lap, gently stroking her dead daughter’s hair. It was one of the most tender, loving and affectionate presentations I have ever seen in Lear.
Jackson’s performance as Lear added a shading of interpretation that certainly works. It also informs today’s review of the use of an independent integrity monitor not for a regulatory or enforcement purpose, not in connection with significant business transactions but in a proactive manner. This blog post is based upon a five-part podcast series I am presenting this week, with Jesse Caplan, Managing Director at Affiliated Monitors, Inc. (AMI); the sponsor of this week’s podcast series.
In the previous episodes, Caplan explained how healthcare organizations can benefit by having an independent compliance expert, a fresh set of eyes, to evaluate the organization’s compliance program. He has spoken at length about the emerging risks involved in opioid prescribing and how organizations can mitigate that risk by proactively assessing the prescribing practices of their physicians and physician extenders. He further explains how an independent integrity review can be helpful for organizations that may be facing actual or potential compliance issues.
The proactive use of an independent integrity monitor is becoming more pronounced. Caplanexplained that to do so can bring tremendous value to the organization. This is particularly true when a healthcare organization has reason to believe it has a compliance issue, and may be faced with a range of obligations and potential consequences that the organization and their counsel will likely seek to mitigate to the fullest extent possible. Caplan believes that by “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.”
Moreover,using an independent integrity monitor can help a healthcare organization in dealing with regulators and enforcement agencies. Based upon his professional enforcement background, consistent with guidance from the Department of Justice (DOJ) and Centers for Medicare and Medicaid Services (CMS) Inspector General, he said, “the government expects and even demands, that healthcare organizations self-report certain types of compliance violations.” These include overpayments they may have received and false or fraudulent claims a healthcare organization may have billed to the government and certain types of privacy breaches.
Caplan noted,“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.”
Caplan provided a couple of examples where he made recommendations for improvement and remediation and monitored an organization’s implementation of those recommendations and remedial measures. By doing so, those healthcare providers (HCPs) and their counsel were able to convince the government enforcement agency that the company’s actions in addressing its deficiencies justified leniency. He stated, “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.”
One of the key differences between healthcare regulators and others, such as anti-trust regulators, is that ensuring access to sufficient quality HCPs, whether they be behavioral HCPs or providers serving other vulnerable and under-served populations, is a constant challenge for healthcare policymakers. The bottom line is that excluding an important provider with significant compliance issues may address those compliance concerns, but it may raise a different problem and challenges when it means there are not sufficient accessible healthcare resources. Caplan believes “the better solution is to have healthcare providers with compliance issues remediate their problems and implement a sustainable and effective ethical compliance program so that the healthcare market has the benefit of high-quality, efficient, and transparent providers.” While the government may well be 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.”
I hope you have enjoyed my exploration of this most innovate and unique production of King Lear as well as the story of one of Shakespeare’s greatest tragedies to introduce a daily compliance topic this week. Join me tomorrow where conclude the series and consider the portrayal of my favorite character in all of Shakespeare—The Fool.
Join Jesse Caplan and myself for our 5-part exploration of emerging issues in healthcare compliance and monitoring this week.  The podcast is available on the FCPA Compliance ReportiTunesJDSupraPanoplyYouTubeSpotifyand Corporate Compliance Insights.
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, 2019

Categories
Jamming with Jason

Creating a Support Network and Some Werewolves in London

When we try to go through this thing called life and our career alone, the road is hard and usually full of landmines. It’s better to admit we need help and create or join a group that can be a support network and group of advisors before the stress and pressures from work spill over into our personal life and send us spiraling downward.
There is magic in groups. When the right people get together, develop real connections, and provide support and encouragement for each others, some really amazing things happen. Learn how magic happened during the writing of “Werewolves of London,” hear a story of what happens when you try to do it alone, and how you can create your own support network, or join a group like the new CAE Roundtable.

Jason Mefford is a Rock Star – Internal Audit, Risk Management and Compliance. He helps Chief Audit Executives (CAE) and professionals with technical & soft-skills training and coaching to navigate the mine fields of audit, risk and compliance in organizations. http://www.jasonmefford.com/  and http://www.meffordassociates.com
Apple Podcast: https://itunes.apple.com/us/podcast/jamming-with-jason-mefford/id1456660699
PodBean: https://jammingwithjason.podbean.com/
#internalaudit #chiefauditexecutive #cae