This past weekend I was lucky enough to catch the performance of King Learwith 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 the opening scene where Lear bids his daughters express the breadth and scope of their love for him to introduce engaging your audience.
Lear has called a conference to divide his kingdom between his three daughters, Goneril, Regan and Cordelia, his youngest who is clearly is favorite. Goneril professes her love is more than words alone can convey, saying “A love that makes . . . speech unable / Beyond all manner of so much I love you”. Regan professes, “Myself an enemy to all other joys, Which the most precious square of sense possesses, And find I am alone felicitate in your dear Highness’ love.” However, Cordelia refuses to play the flattering fool. Her father twice gives her the opportunity to redress this decision but she holds firm saying “Nothing, my lord”. This leads to the break in the family, the deaths of the sisters and the fullest scope of tragedy.
Even after the intermission, where some of the most powerful scenes in all of Shakespeare playout; with 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.
This theme of engaging your audience ties into a part of the five-episode podcast series I am running this week on the use of independent monitoring in health care, with Jesse Caplan, Managing Director at Affiliated Monitors Inc. (AMI), the podcast series sponsor. Last week I discussed the use of an independent monitor as part of the solution to the combat the opioid crisis. Today, I want to consider how health regulatory agencies are engaging their audiences through independent monitoring, to serve important public policy goals – specifically to help ensure a ready supply of quality health care providers (HCPs), particularly for government programs like Medicaid and Medicare. 
Caplan explained, “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.” Unfortunately, there are times when HCPs cannot or will not meet these standards. When this occurs, regulators tend to come down hard, including taking action to exclude the business or the individual provider from delivering healthcare services. However, in many cases what the health care practitioner really need is remediation. Caplan explained, “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.”
Unfortunately, the government typically does not have the resources to closely monitor a healthcare 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, there are less resources available to investigate new complaints about other healthcare companies, or to take enforcement actions where necessary. From Caplan’s perspective, “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.”
The bottom line is that independent integrity monitoring can provide an alternative – it offers the ability to have an independent and credible firm closely monitor the healthcare company and their ongoing compliance thereby protecting the public without having to use government resources to do so.  
I asked Caplan what the value to the parties is in having an independent integrity monitor rather than a severe sanction such as putting a HCP out of business? He began with the benefits to the government agency or regulator. Here the value begins and ends with the monitor providing unfiltered reporting back to the regulator or agency. Caplan listed four additional key reasons: 

• The regulator gets to impose the conditions that the healthcare entity is required to meet;
• The regulator has the opportunity to choose or approve the independent agency or individual who will be monitoring the conditions;
• The regulator will receive back an independent confirmation that the healthcare organization is operating in a safe and effective manner;
• And, finally, the regulator is not required to expend scarce resources on a settled case but instead use those resources on other investigations or regulatory matters. 

We then turned to the benefits directed towards the healthcare organization which has an independent integrity monitor imposed. First and foremost, 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.  Yet, the monitoring engagement can be a real positive and benefit for the organization.
Caplan said that by “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.” Usually a monitor will communicate to the organization what they are doing well, and what they need to improve on before reporting to the regulating agency.
This feedback gives the organization the opportunity to remediate the required areas before these gaps are reported to the regulator. Moreover, if a HCP is not able to timely remediate the gap, it can be prepared to present a plan on how they intend to address an identified deficiency.  Caplan concluded the “independent monitor serves as a bridge between the organization and the regulator and can help the organization navigate its compliance with the required conditions.”
We concluded by looking at how independent monitoring in healthcare can be used in new and innovative ways. In Parts 1 and 2, I wrote about using an independent integrity monitor as part of the solution to the opioid crisis. Another innovative area is around patient safety. Caplan provided an example of  two hospital systems, which risked losing the accreditation status and their Medicare participation. They entered into consent agreements with the state Department of Health (DOH) and the decree “included a series of remedial measures, working with The Joint Commission, implementing 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.” By having an independent integrity monitor serve as a bridge in facilitating their compliance with all the conditions in the Consent Agreements saved the HCP and DOH a scarce resource in the community in which it operates.
I hope you will join me all week and, more importantly, enjoy 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 daily compliance topic this week. Tomorrow I will consider the focus on the family as the main storyline.
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 Report, iTunes, JDSupra, Panoply, YouTube, Spotifyand 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