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FCPA Compliance Report

Emerging Issues in Healthcare Compliance and Monitoring-Episode 3-Expanded Use of Independent Monitoring by Health Regulators

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 this Episode 3, Jesse Caplan discusses how health regulatory agencies are using independent monitoring to serve important public policy goals – specifically to help ensure a ready supply of quality healthcare providers, particularly for government programs like Medicaid and Medicare.

Some of the issues we consider are:
How can independent monitoring can effectively and efficiently extend the ability of government regulators to oversee healthcare providers and organizations?

  1. As investigative, enforcement, and regulating agencies, the governments’ objectives are to ensure, above all, that patients and health care 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.In some cases, there are participants in the healthcare industry that simply cannot and will not meet these standards, and regulators will and should come down hard, including taking action to exclude the business or the individual provider from the industry. But in many cases what the health care company or practitioner really need is remediation.  If a healthcare company or practitioner can operate in the future in a manner that meets the government’s objectives – compliance, transparency and high-quality care – that is good for the industry and the patients and clients they serve. 
  1. But the challenge is that the government doesn’t typically have the resources to closely monitor a company or practitioner to ensure that they have satisfactorily remediated their problems, and are continuing to operate at the highest ethical and quality standards. When the government assigns resources to monitor ongoing activities of a company that has had significant compliance problems, that means there are less resources available to investigate new complaints about other healthcare companies, or to take enforcement actions where necessary.  Without independent integrity monitoring, the government may feel that the best way to protect the public and the government fisc is to take a very hardline enforcement approach that means exclusion from government healthcare programs, or revocation of an organization’s or practitioner’s healthcare license.  
  1. Independent integrity monitoring can provide an alternative – it offers the ability to have an independent and credible firm closely monitor the healthcare company future and ongoing compliance – thereby protecting the public and public fisc – without having to use government resources to do so. 

What is the value to the government of approving a monitoring relationship? 

  1. In all of these cases where monitoring is approved, the regulator, the regulator gets to impose the conditions that will be monitored. The regulator also gets to approve the firm or individual that will conduct the monitoring, and gets unfiltered reporting directly from the monitor.  And typically the monitoring is paid for by the healthcare company or practitioner that has had the compliance problems and that engages the monitor.  So the value to the regulating agency is pretty clear and significant:
  • They get to impose the conditions that the healthcare entity is required to meet;
  • They get to choose or approve the independent agency or individual who will be monitoring the conditions;
  • They get independent confirmation that the healthcare organization is operating in a safe and effective manner;
  • And the regulator doesn’t have to continue expending scarce resources on a settled case, and can instead use those resources on other investigatins or regulatory matters.

What are the benefits to a healthcare organization of an independent monitor?

  1. The organization may be in a position where agreeing to independent monitoring is their only alternative to having their licenses suspended or being excluded from government programs. So to some organizations they may see independent monitoring as a necessary evil.  But in our experience – and we’ve done well over 500 monitorships – the monitoring engagement can be a real positive and benefit for the organization. 
  1. For example, having an experienced third party assess your compliance with conditions – and in particular identify where the organization is meeting or exceeding its requirements as well as the areas where there are gaps in compliance – can be very valuable.Typically – at least in the matters where we serve as the independent monitor – we will communicate to the organization what they are doing well, and what they need to improve on, before reporting to the regulating agency.  This will give the organization the opportunity to remediate the areas that need remediation before these gaps are reported to the regulator; or, if they aren’t able to timely remediate the gap, to be prepared with a plan that they can communicate with the regulator on how they intend to address an identified deficiency.  
  1. We like to say that the independent monitor serves as a “Bridge” between the organization and the regulator, and frankly the independent monitor can help the organization navigate its compliance with the required conditions.

What are some recent examples of where healthcare regulators are using independent monitors in different contexts?

  1. AMI is currently engaged in monitoring conditions imposed by a state Department of Health on two hospital systems. Both these hospital systems encountered significant patient safety issues and risked losing the accreditation status and their Medicare participation.  They entered into consent agreements with the state DOH that included a series of remedial measures, working with The Joint Commission, implementing what are called Targeted Solution Tools, reporting to the Boards of Trustees and Quality Oversight Committees of the two systems, and reporting progress to the DOH.  In both cases the DOH required the hospital systems to engage an independent monitor to observe, validate, and report on their compliance with all of these conditions.  I believe in these instances both the regulatory agency and the healthcare organizations would attest to the benefits of having the independent firm serve as a bridge between them in facilitating their compliance with all the conditions in the Consent Agreements, and in maintaining productive communications.

Join us for Episode 4, where we discuss independent integrity monitoring of healthcare organizations or systems.
For more information on Affiliated Monitors, check out their website here.

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Compliance Into the Weeds

Compliance into the Weeds: Episode 116-Brexit Risks

Compliance into the Weeds is the only weekly podcast which takes a deep dive into a compliance related topic, literally going into the weeds to more fully explore a subject. In this episode, Matt Kelly (the coolest guy in compliance) and I take a deep dive into Brexit and what it might mean from an operational, regulatory and compliance perspective for a US company.

Some of the highlights include:

  • What are the operational risks around Brexit?
  • What are the regulatory risks for US companies?
  • Why is the SEC so concerned by US companies disclosing Brexit risks?
  • What are the disclosure requirements?
  • What is key supplier risk?
  • What is key customer concentration risks inherent in Brexit?
  • What is the role of internal audit in preparing a US company for Brexit?
  • What are the lessons for the compliance practitioner?
  • What are some examples of adequate and inadequate Brexit disclosure risks?
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Great Women in Compliance

Great Women in Compliance-Radiate Confidence and Gravitas with Marianne Ibrahim

How can you assert yourself and rise to the top? Marianne Ibrahim is the Director of Global Compliance for Baker Hughes, a GE company, and on this episode, she talks about building your executive presence, traveling internationally as a woman, and her advice for the next generation of female compliance professionals.
Why compliance
For Marianne, building a career where one can drive a culture of ethics and integrity is a dream. Compliance has an impact on human rights, and when senior leaders of major corporations truly believe in it, it affects the communities we operate in.
A strong executive presence
To improve your executive presence and command the room with gravitas, communicate with purpose. Believe in what you do and what you’re saying, look your senior management in the eye, and project your voice. Mind your body language, and don’t be hesitant. A lot of it has to do with how you come across in meetings or day-to-day conversations.
Tips for traveling
When traveling to a country for the first time, read about the culture. Learn not just the business etiquette, but the etiquette and expectations of different genders. Then when you show up, mean business. Own your space, know your subject matter, and be confident so that you’re taken seriously regardless of your gender.
If you’re going to the Middle East, don’t pack a button-down shirt! Be true to your own personal style, but be conservative.
Inspiring the next generation of female compliance officers
Invest in your younger talent. Reach out to them because they’re not going to automatically come to you for advice.  Take them out to lunch, ask them how they’re doing, and talk about where they want to go. Many times, they’ll need your advice or direction. Take that initiative, and then constantly check in so it’s not a one-time thing. Not only is it rewarding, but you’re also investing in the future.
Combat the stereotype
Are you assertive… or do they call you bossy instead? To combat this stereotype, Marianne makes sure she’s approachable in everything that she does, and lets her team know she has an open door. They’re all in this together, and improving their culture and their compliance environment is a collectivegoal. The team spirit really counts.
What she wishes she’d known earlier as an investigator
Be yourself. When she was younger, she thought she had to be aggressive and assertive. But it works out much better for her to operate her own way: taking her time to get to know the individual, ask how they’re doing, and witness how they truly open up.
Resources
Marianne Ibrahim
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Daily Compliance News

Daily Compliance News: March 27, 2019-the Autonomy trial begins edition

MARCH 27, 2019 BY TOM FOX


In today’s edition of Daily Compliance News:

  • Former Autonomy CEO goes to trial in UK. (The Register)
  • Want credit in FCPA sentencing? Engage in random acts of kindness while in jail. (New York Times)
  • SEC pays whistleblowers $50MM. (FCPA Blog)
  • Stormy Daniels lawyer charged with attempted extortion. (Wall Street Journal)
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Blog

King Lear Week: Part III – Changing Your Focus

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 am using King Lear as a deep dive into several compliance topics this week. Today, I want to discuss how this production changed the focus of the play, away from the madness of the king to the actions of the three daughters.
Perhaps it was my perception of the play or perhaps it was the director’s intention but the focus in the first half of the play was clearly on the daughters and their families. Both Goneril and Regan played much more prominent roles throughout the first scene and their joint liaisons with Edmund, later the Earl of Gloucester, were key components of this production. Moreover, their husbands, the Duke of Cornwall and the Duke of Albany, also played prominent roles. The Duke of Cornwall, for instance his role in this production was more than the traditional highlight for him, which is the blinding of the original Earl of Gloucester. (Even in this production it still elicited gasps from the audience.)
Even after the intermission, where some of the most powerful scenes in all of Shakespeare playout, including the blinded Earl of Gloucester and the mad Lear wandering the moor, this production held a distinct focus on Lear’s daughters and their families, adding in the complexity of Edmund, the new Earl of Gloucester, having an affair with Goneril while secretly pledged to wed Regan.
This change in the focus of the play informs today’s review of the use of an independent integrity monitor not for a regulatory or enforcement purpose, but in connection with significant business transactions. This 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 the podcast series.
We began by consider a plethora of business activities; acquisitions, mergers, non-profit conversions, and even capital improvements which 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 a Determination of Need (DON) approval. Additionally, not-for-profit hospitals which seek to convert to for-profit status, often as part of a merger or acquisition (M&A) transaction, are likely to face scrutiny and require approval by those agencies that regulate and oversee both their licensing and charities functions. This oversight is often by two distinct state agencies, most usually a state department of health for healthcare oversight and a state Attorney General’s Office for charitable concerns. M&A of a hospital, health insurance company, or even a physician practice can also be subject to antitrust scrutiny, by state authorities like the Attorney General’s Offices and possibly federal review by the Department of Justice (DOJ) or the Federal Trade Commission (FTC).
Caplan emphasized that in each of these healthcare transactions, the government agencies involved are not seeking to address compliance violations or to take disciplinary action. However, these transactions are likely to impact the structure and dynamics of the local healthcare market, and the state regulators have both the authority and the objective of ensuring those impacts are a net positive for the local healthcare marketplace by ensuring that the transaction improves the quality of and increases access to healthcare, most particularly for vulnerable and under-served communities, and does so more efficiently.
To meet this burden 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. Moreover, 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.
Whenever you have conditions being imposed or being offered as a prerequisite of approval of a healthcare transaction, there is a need to have independent monitoring of whether those conditions are being effectively implemented and sustained. It is always possible that the government agencies can do the monitoring themselves, but may require resources that are not readily available.  This has led regulators and healthcare organizations to agree to an independent integrity monitoring firm to oversee that the conditions, investments and improvements are being timely and effectively implemented.
We next turned to some examples where organizations and government regulators have jointly agreed to use an independent firm to monitor implementation and compliance with conditions of a healthcare transactions. Caplan provided two examples, both of which converted not-for-profit hospitals to for-profit companies as part of major acquisitions. The state Attorney General’s Office was 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 the independent integrity monitor entered into a three-way agreement that provided ongoing monitoring of these conditions. The monitor reported the status and progress of implementation of those conditions to the Attorney General’s Office, but the costs were borne by the healthcare organization.
Caplan also related other areas where regulatory agencies, including the DOJ and FTC, are using independent integrity monitors with healthcare organizations 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 which do not otherwise compromise competition.
I hope you will continue to join me this week during my exploration of this most innovate and unique production of King Learas well as the story of one of Shakespeare’s greatest tragedies to introduce a compliance topic each day this week. Join me tomorrow where I consider how Jackson as King Lear added a new level of complexity and nuance to my interpretation of the play.
Join Jesse Caplan and myself for our 5-part exploration of emerging issues in healthcare compliance and monitoring. The podcast will be 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