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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 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

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FCPA Compliance Report

Emerging Issues in Healthcare Compliance and Monitoring-Episode 2- Focus on Opioid Prescribing – Identifying and Mitigating the Risks

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 Episode 1, Jesse Caplan discussed the many different types of potential regulatory and liability risks healthcare provider organizations and practices face in connection with the prescribing of opioids.  In this Episode 2, we discuss how healthcare organizations can identify and mitigate the risks from opioid prescribing by their practitioners.

Some of the issues considered are:
What can healthcare organizations and their compliance departments do to identify and mitigate the risks from opioid prescribing?

  1. Healthcare organizations and medical practices can be proactive in making sure they have an opioid compliance program or plan, that the program incorporates all relevant federal and state laws and regulations, CDC prescribing guidelines and relevant standards of practice, that prescribers have been educated on the opioid prescribing program, and that the organization is assessing actual prescribing in order to flag potentially risky practices.
  2. An effective opioid prescribing program will incorporate policies and procedures that inform prescribers what they need to do before they prescribe opioids, and what needs to be documented. For example, what needs to be asked as part of the medical history of the patient?  Has the physician checked the state’s Prescription Drug Monitoring Program database (or PDMP) for that patient’s prescribing history?  Has the physician counseled the patient on alternatives as well as the  risks of using opioids?  Does the patient have a “pain contract”? And is all of this documented in the medical record?
  3. The program should also inform on the limitations on prescribing – quantity and dosages, and what combinations of drugs are counter-indicated.
  4. And the program should address what follow-up the physician should engage in with the patient after prescribing opioids – like what needs to be done before renewing a prescription – for example should blood or urine screening be required?
  5. The organization should also make sure that prescribers are being adequately educated on all appropriate prescribing policies, procedures, laws and regulations – both by the organization and whether the physician is taking MCLEs that are relevant to their practice.
  6. And finally, is physician prescribing being audited or monitored to identify potentially risky practices.

What are some examples of deficient opioid prescribing practices by, otherwise, experienced and caring physicians?

  1. Affiliated Monitors, working with physicians with expertise in opioid prescribing and pain management, have assessed the prescribing practices of many physicians who are legitimately trying to address the needs of their patients. In many cases, these physicians are not following evolving best practices, state and federal regulations, or CDC guidelines.  And as a result, they are putting not just their patients at risk of harm, but they are also putting themselves and their organizations at risk of legal jeopardy.
  1. Some of the most common deficiencies we see in opioid prescribing include:
  2. Physicians not conducting sufficient examinations to truly determine the cause of the patient’s pain that would warrant treatment with opioids, as opposed to other medications or non-medication treatments, like physical therapy. We see physicians prescribing opioids for conditions where opioid treatment is not the appropriate first line treatment, or not indicated as a treatment at all.
  3. Physicians not documenting sufficient medical, social or family histories, or considering those factors that could raise red flags for potential addiction or substance misuse.
  4. Not checking the state’s PDMP to see whether the patient is being prescribed controlled substances by other physicians.This is very important to see whether the patient may be doctor shopping, abusing medications, or taking combinations of medications that may be very dangerous.  
  5. Prescribing opioids in dosages, or numbers of pills, or in combinations with other drugs, that are inconsistent with guidelines or state laws and regulations.
  6. Not closely following patients on chronic opioid treatment programs and re-evaluating their pain diagnosis, and the efficacy of the opioid treatment, on a regular basis. Many patients on chronic opioid treatment programs should be subject to toxicology screens to help inform the physician whether the patient is taking the prescribed medications, and whether they are taking controlled substances that they have not been prescribed.  If a tox screen is negative for the medications prescribed, that could be a sign that the patient is diverting those medications.  If the tox screen is positive for controlled substance that have not been prescribed, that could be a sign that the patient has an addiction and is abusing medications. 
  7. Patients on chronic opioid treatment often should be followed with a “Pain Contract” – an agreement that the patient signs with the physician that explains the risks of opioid treatment, and that sets out the ground rules for what the patient is and is not permitted to do with the medications being prescribed. This Agreement will not only provide valuable information for the patients, but it also gives the physician a basis for discontinuing opioid treatment if the patient violates the Agreement.   
  8. Finally, the CDC recommends that naloxone be considered for many at-risk patients receiving 50 or greater Medical Morphine Equivalents of opioid medication.

What help is available to healthcare organizations to address these risks?

  1. Healthcare organizations can take a proactive approach by having experienced and expert clinicians in pain management and opioid prescribing assess the organization’s opioid program and policies, and review samplings of patient charts where patients have been prescribed opioids.Such an assessment can help identify gaps in the program, flag physicians who may be engaging in risky prescribing practices, and most important, offer recommendations for improving the program and physician prescribing practices.  This information can be used to mitigate risk to the organization, physicians and patients. 

Do monitoring firms like AMI provide these types of proactive assessments of opioid prescribing programs and practices?

  1. We have been engaged by hospital systems and physician practices to assess opioid prescribing programs and practices. We have relationships with experienced physicians who are experts in pain management and opioid prescribing who work with us to assess the programs, review patient charts, and make recommendations for improvement. 
  1. The bottom-line is that the goal of these proactive assessments is to identify areas for improved practices, provide clear guidance, and recommend relevant medical education to help physicians provide better and safer treatments for their patients, while also protecting them and their organizations from legal risks.

Join us for Episode 3, where we discuss the expanding use of independent monitors by health regulators.
For more information on Affiliated Monitors, check out their website here.

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Innovation in Compliance

Marketing through Podcasting with Gordon Firemark


What do you get when you mix podcasting with the law? Joining us on this episode is Gordon Firemark, an attorney in Los Angeles with a background in entertainment and podcasting law, and a podcaster himself. Find out how you can use podcasting to ethically market your firm, and how to protect yourself legally in this space.

The growth of podcasting
It’s developed as a really remarkable communications tool, but is still underutilized in many ways. It’s very exciting and a great opportunity for lawyers and businesses that are looking to reach their audiences in a different yet very powerful and effective way.
Legally, the issues are similar to the media law area: intellectual property, ownership, business entities, partnerships that happened by accident. There was once a major case where somebody filed a patent on podcasting technology, but now it’s been resolved. Hopefully that opens things up for people to start using it as a medium.
A marketing tool
Because Gordon does the show every month, that means SEO is fantastic and their website is easily discoverable. Audiences also get to hear your voice, get a sense of who you are, and can hear that you are knowledgeable and an expert in your field. This leads to a lot of international referrals — and not to mention, it’s a lot of fun and a great way to get the word out.
Objections and answers
Gordon takes on a few common questions would-be podcasters have:
“When does podcasting become attorney advertising that’s subject to regulation in my state?”
“It takes too much time.”
“What if I make a mistake on air?”
“I’m nervous about being on the microphone.”
Short form podcasts
People love short form content. It’s great customer outreach, and it’s a great opportunity for companies to reach their employees with updates, as well. People can listen at their desk, or, since it’s mobile, they can listen on their phone from wherever they are. For example, a CEO could become an even bigger celebrity in his company by doing a five-minute morning podcast!
The future of podcasting
Gordon sees more disputes on the horizon, especially as it concerns the use of third party content. Unlicensed music has become a big issue. Many podcasters don’t understand the legalities of using music for digital streaming, and Gordon is hoping to develop a streamlined approach to licensing music for podcasters to use in their shows.
Another thing coming up is ownership disputes. Podcasting is maturing to the point where people are breaking up fighting over the podcasts they started together. We’re going to start seeing cases involving the right of a person to control the use of their name, likeness, and persona.
Podfest teaser
Gordon is speaking at Podfest on a panel with two other lawyers. They’ve broken up the subject matter into different legal issues (e.g. intellectual property, copyright, trademarks and patents, ownership), with a lot of time for Q&A. They’ll also be talking about branding — with a lot of podcasts about things like TV shows and movies, it’s potentially a lot of hot water to fall into.
Resources
Gordon Firemark (Website)
Entertainment Law Update (Podcast)
Law Offices of Gordon P. Firemark (Website)
The Podcast, Blog & New Media Producer’s Legal Survival Guide: An essential resource for content creators (Amazon)

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Daily Compliance News

Daily Compliance News: March 26, 2019-the UK AG edition

MARCH 26, 2019 BY TOM FOX


In today’s edition of Daily Compliance News:

  • Why is UK Attorney General sitting on Airbus corruption case? (The Guardian)
  • Ex-HK official sentenced to jail for FCPA, AML violations. (FCPA Blog)
  • Duke pays over $110MM for filing false research grant applications? (New York Times)
  • Charitable institutions to Sacklers: We don’t want your money. (New York Times)
Categories
Blog

King Lear Week: Part II – Engaging Your Audience

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

Categories
FCPA Compliance Report

Emerging Issues in Healthcare Compliance and Monitoring-Episode 1–Focus on Opioid Prescribing – Regulatory and Liability Risks

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. Healthcare provider organizations and practices face many different types of potential regulatory and liability risks – in this first episode we focus on the risks posed by opioid prescribing. We consider the some of the following issues: 

What are the risks to providers and health care organizations from opioid prescribing? 

  1. Policymakers and the healthcare industry are trying to address the opioid crisis in a number of different ways. One of those ways is to focus on the prescribing of opioids, with the goal of significantly reducing the number of people who are prescribed opioids and become addicted or who divert legally prescribed drugs. 
  2. Health care providers who engage in inappropriate opioid prescribing are increasingly subject to discipline by professional medical boards. They face restrictions on their licenses to practice, and in certain cases, have had their licenses suspended or revoked. 
  3. Where patients are harmed, providers face civil medical malpractice liability.
  4. And in the most egregious cases, providers have been prosecuted criminally, either under the federal Controlled Substances Act or state criminal laws. 

What has been the response of the Department of Justice? 

  1. The Department of Justice (DOJ), both in Washington and in individual United States Attorney’s Offices, have become more aggressive at identifying providers with problematic or suspicious opioid prescribing records.
  2. For example, in 2017, then Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit.In his announcement the Attorney General stated DOJ would use data analytics to identify physicians who are writing opioid prescriptions at a rate that exceeds other physicians, and how many of a doctor’s patients died within 60-days of an opioid prescription.
  3. In 2018, US Attorneys in Massachusetts and Georgia sent warning letters to physicians who had relatively high opioid prescribing histories, or physicians who may have had a patient die from an overdose, or who died for any reason within two-months of being prescribed opioids.
  4. In the letters in Massachusetts, the US Attorney reminded the physicians that prescribing opioids without a legitimate medical purpose or in excessive amounts is illegal. Of course, this begs the question:  for physicians who genuinely care about their patients and are trying to treat real chronic pain, how do they ensure they are prescribing for a legitimate medical purpose or diagnosis where opioid treatment is both indicated and appropriate?  What dosages or number of pills is “an excessive amount” that could put the physician at legal jeopardy?  

What are legislators and regulators doing to address the opioid crisis? 

  1. The crisis has resulted in new laws and regulations addressing hospital staffing, their discharge and treatment processes, limits on the quantity and dosages of opioids that can be prescribed, and mandated use of state Prescription Drug Monitoring Program databases (PDMPs).   
  2. Just this February, CMS issued a letter to all Medicare providers with what they call their “roadmap”, focusing on “preventing new cases of opioid-ise disorder,” “treating patients with opioid use disorders,” and “using data to target prevention and treatment activities.” 
  3. As a result of this evolving legal environment, individual physicians and physician extenders, group practices, hospitals, and even insurance companies who are increasingly employing physicians, face significant regulatory and liability risks if they are engaging in inappropriate and dangerous opioid prescribing practices, or not complying with the increasingly complex prescribing laws and regulations. 

What is the legal and regulatory framework impacting opioid prescribing?

  1. There are a number of federal and state laws impacting opioid prescribing practices. Some of the more recent and significant developments include state laws limiting the quantity and dosage of opioids that can be prescribed and requiring providers to use and check PDMP databases before prescribing certain drugs to a patient.  There are also more sophisticated guidelines for practitioners, including CDC Guidelines, for prescribing opioids, which are becoming the standard of care for prescribers. 
  2. For example, just about every state has a PDMP, which is a database that tracks a patient’s history of opioid prescriptions.Increasingly, states require providers to check the PDMP before prescribing opioids.  By checking the PDMP the physician can be informed whether the patient appears to have an addiction problem, may be doctor-shopping for opioid prescriptions, may be diverting drugs, or might be at risk for dangerous drug interactions. 
  3. More and more states are passing laws limiting the quantity or dosage of opioids prescribed. For example, Massachusetts, the first state to pass such a law in 2016, set a seven-day limit on initial opioid prescriptions. 
  4. The CDC’s Guidelines are targeted to primary care physicians treating adult patients for chronic pain and are designed to improve communications between providers and patients about the benefits and risks of using opioids, and ultimately to reduce opioid addiction and overdoses.  According to the CDC, the three main principles behind the Guidelines are:
  5. Non-opioid therapy is preferred for chronic pain in most circumstances;
  6. The lowest possible effective dosage should be prescribed; and
  7. Clinicians should always exercise caution when prescribing opioids and should closely monitor their patients who have been prescribed opioids.
  8. The CDC then offers 12 separate recommendations addressing each of these principles.

What should be the primary compliance concerns for healthcare organizations in connection with the opioid crisis?

  1. The big questions for healthcare organizations are:
  2. Do you have policies and procedures in place to ensure that your staff, and particularly your physicians, are aware of all the new requirements for opioid prescribing?
  3. Have your providers and staff been educated in those policies and procedures?
  4. And are they actually following appropriate opioid prescribing practices, and all relevant laws and regulations, including the organization’s own prescribing polices? 

Join us for Episode 2, where we discuss how healthcare organizations can identify and mitigate the risks from opioid prescribing.
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