In this five-part podcast series, I am taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of healthcare services, the public. I am joined in this exploration with two individuals at Affiliated Monitors, Inc. (AMI), the sponsor of this series, Catherine A. Keyes, Vice President of Operations, and Jesse Caplan, Managing Director of Corporate Oversight. In this third episode, I visit with Keyes to discuss how an independent integrity monitor can be used in healthcare licensing and disciplinary proceedings.

I started off by asking Keyes about the situation where a state Medicaid Fraud Control Unit finds a provider billing for an unusually high number of patients or procedures per day. Through an investigation, the state unit finds poor documentation that looks like fraud. How can an independent integrity monitor serve as an overall part of a resolution? Keyes noted that initially such a settlement will allow the provider or clinic to continue to practice, which is important for Medicaid providers. Keeping a Medicaid practice open is often very important in some areas, where there are very few Medicaid providers, so having a Medicaid provider remain open is important, not just for the person whose business it is, but also in the community. Keeping or bringing up such a healthcare provider to professional standards is also important. Finally, it is critical all the way around to keeping pressure on the provider to make the promised changes to fix the system and it protects the public by bringing the provider in line with professional standards.

We next discussed the scenario where someone makes a complaint to a licensing board, the complaint is investigated, and the licensing board finds, among other things, that the practitioner’s patient records lack basic elements: for example, adequate notes about treatments. Keyes noted that oftentimes a complaint is made to a state regulatory agency, a licensing board, for example. It might be a dental board, it might be a medical board, it might be a chiropractic board. Most of these licensing boards have regulations that say what minimally should be included in patient records. And this is the standard you would hope that any kind of a medical provider is recording in writing. This is critical  for a patient’s medical care going forward.

Here Keyes believes that an independent integrity monitor can be an excellent option as it allows the healthcare provider to continue to practice while providing prompt feedback to the agency about whether the healthcare provider is making promised changes. This is because a straight suspension may hit the pocketbook without helping the provider make meaningful change.

Yet there is an equal if not greater benefit to the healthcare provider as the independent integrity monitor can provide tailored advice about how to bring the practice up to professional standards. Keyes provided a simple yet straight-forward example, “I once saw the difference between having a chiropractor’s friend act as a monitor and write an overly simplistic report – “the charts look fine” – and the in-depth feedback given by professional monitors: “the history of present illness needs to be more complete, including info about the effectiveness of other treatments received”.”

I asked Keyes about using an approach of an independent integrity monitor in a current situation such as the opioid crisis. She said that such use could allow an independent integrity monitor to track prescriptions and prescribers of opioids and other drugs. She said that as part of a multi-pronged approach to the opioid abuse issue, many states are looking to see who their high prescribers are and whether these are legitimate practices or just pill mills. A monitor can help a provider to put policies and procedures in place to (a) assess the underlying need for pain medication; (b) determine whether someone is actually taking the medications; (c) refer to other specialists for supplemental care: physical therapy, acupuncture, pain clinics; and (d) appropriately terminate care of patients who appear to be getting prescriptions primarily to re-sell the pills.

Yet the benefits do not end there as monitoring, as part of settlement agreement, could require the provider to reduce the number of pain patients and the quantity of pills prescribed over a certain period. An independent integrity monitor can keep the regulators informed as most state agencies do not have the staff available to track compliance with the details of such an agreement. Independent monitoring is paid for by the licensee. Such use of a monitor also works to protect the public by bringing the professional in line with national standards for assessment, treatment and follow-up of pain patients. Finally, using a monitor can allow the provider to remain open and demonstrate their commitment to improved practice. Healthcare providers are quick learners and, in some cases, putting a structured program in place is a relief.

Next up, using monitors in administrative proceedings not related to discipline and licensing issues.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

In this five-part podcast series, I am taking a deep dive into healthcare monitoring and how the pro-active use of a healthcare monitor can positively impact all stakeholders in the healthcare industry: the regulators, the healthcare industry and the consumers of health care services, the public. I am joined in this exploration with two individuals at Affiliated Monitors, Inc. (AMI), the series sponsor, Catherine A. Keyes, Vice President of Operations, and Jesse Caplan, Managing Director of Corporate Oversight. In this Episode 2, I visit with Jesse Caplan on the significance of proactive assessment in healthcare ethics and compliance program in determining culture.

Caplan noted that not every healthcare participant has a good handle on how effective their compliance program is and whether the culture of the organization is such that compliance risks are likely to be timely identified, mitigated and remediated.  However an independent integrity monitor can help healthcare participants to do a thorough pro-active assessment of a healthcare organization’s ethics and compliance program and culture.

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

There are multiple ways to conduct a pro-active assessment of an organization’s ethics and compliance program and AMI selects the style and techniques which best fit the situation. Caplan noted some of these techniques can include areview of applicable policies and procedures, whether the organization has a hotline which is use and compliance training.However, Caplan emphasized such techniques can only get you so far.

This means you need to also perform an assessment of compliance program effectiveness by a variety of mechanisms such as determining if the compliance policies and procedures are effectively implemented, whether staff are familiar with and truly understand their compliance obligations and even whether they feel they can communicate compliance and ethical concerns or questions without fear of adverse consequences.   

We next turned to how to make such an assessment. Here Caplan noted there are several ways to do so. It can include interviews with individual employees, focus groups with larger numbers of employees, visits to not only the corporate headquarters but also remote company locations and, of course, the analysis of all relevant data. He provided an example where AMI would test a hotline and how, when complaints come in, they are actually handled. Such testing would use all these techniques including employee interviews, focus groups meetings and review of data on hotline complaints and case closure rates and data.

A proactive assessment can be used in times simply beyond when an organization may have a reason to believe that it has an ethics or compliance problem. It can be used when there is a change in leadership and the new leadership team wants to see more precisely where they may be on the ethics and compliance scale. It can also be used when there is a major acquisition or a healthcare provider establishes new business units or even goes into new markets.

In some situations an independent evaluation team may be called to work collaboratively with others such as outside counsel. It all starts with the value of the pro-active assessment that they are independent and unbiased which gives them  greater credibility with stakeholders.  However, the organization and evaluation team can and should work collaboratively to develop the work plan and target potential risk areas. There should also be collaboration in deciding findings and recommendations of the assessment to be communicated. All of this helps to provide an independent, unbiased proactive assessment of a compliance and ethics programs and can make the organization stronger and the workforce more engaged in compliance.

One of the key differences in healthcare as opposed to perhaps the energy or tech sector or another commercial enterprise, is that the government and the regulators would prefer not to exclude healthcare providers from the healthcare industry. This means even if a healthcare provider has a compliance issue, the government and regulators may be loathed to deliver an ultimate sanction and put a healthcare provider out of business. Access to quality healthcare providers is a continuing issue within the industry and particularly for government programs like Medicaid. One of the reasons is that not every healthcare provider is willing to participate in Medicaid programs and’ particularly for vulnerable populations, there can be an inadequate number of healthcare providers available to treat those populations. This means from a public policy perspective, whether it is the federal government or state government departments of public health, they all want to have as many quality providers as possible so people and the patients have adequate access to those services.

This can sometimes run up against the tension of healthcare providers in those areas of medical services who have run into difficulties that could pose a threat to patients and the public or could pose a threat to the public financing by misusing or abusing the funds that are being paid. This means that the government or regulators must be comfortable that the problems an organization has have been remediated and will be addressed so that those issues will not arise going forward. If using an independent integrity monitor can help the government by meeting these two objectives of both quality providers and providing sufficient access for its citizens, it is a win for all involved.

Next up, using independent integrity monitoring in licensing and disciplinary proceeding.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

 

 

Everyone should see a doctor for a check-up, even the largest and most far-reaching companies. Today, Tom talks with Brian Alster, the Global Head of Compliance & Supply Products at Dun & Bradstreet, about their new, innovative technique called the supply chain health check.

  • Daily, large-scale, geopolitical change has become the new normal and all kinds of organizations need to become more agile to keep up. Tom asks Brian about how the supply chain health check can and should be used in the context of an ever-changing landscape.
  • Due to intensifying globalization, today’s supply chains are criss-crossing borders daily. Layered with political instability, this brings on new risks for these supply chains.
  • Process, process, process! One of the best ways to mitigate risk proactively is to perform continual health checks on the supply chain process.
  • There are two key elements to implementing these health checks:
    1. Your company needs the culture to execute consistently.
    2. You’ll also need established policies to dictate the check-up process.
  • From the corporate compliance perspective, what might a compliance professional, supply chain expert, or lawyer do to execute a supply chain health check? Brian takes Tom through the four main steps of performing a health check:
    1. Diversity: If you’re working with a diverse range of suppliers from various geographies, you’ll be prepared to pivot quickly in times of disruption. You’ll be able to efficiently weather events like natural disasters, regional sanctions, or political insecurity. How quickly you can pivot your supply chain will dictate how quickly you can get back up and running – and how effectively you can minimize losses.
    2. Visibility: Using the right tools that employ data and analytics will help you understand and vet who you’re doing business with. From parent companies and subsidiaries down to the smaller organizations they are tied to, having a broad and deep visibility into the supply base can help you stay proactive instead of reactive when assessing potential risks across multiple dimensions of the chain.
    3. Onboarding: Building out an efficient onboarding process that validates vendors early in the process can save you time, money and resources. Brian gives us an example: to smooth out the process, create a simple, online portal for third-party suppliers that hosts a dynamic and multilingual online questionnaire. Using this data, you can beef up the vetting process of your suppliers, enrich your records of the organization, and create a preliminary risk assessment.
    4. Monitoring: Continual monitoring of your supplier will enable you to reassess your relationship with them at any time. This proactive approach will help your organization ensure business continuity, stay on top of compliance, prevent financial waste, and avoid production shortfalls. Setting up an alert system – as opposed to a timed report – will help keep you in the know if something has changed in the risk profile. This approach enables you to re-certify, continue business as usual, or offboard a supplier, all within a shorter window of time.
  • While this health check is centered on the supply chain, can these steps be used by compliance professionals and lawyers or in other corporate contexts, such as internal audit? Brian talks about the effectiveness of the health check in a variety of situations.
  • As the worlds of compliance and third-party procurement begin to merge, innovation and automation can no longer afford to be used as stop-gaps. In response, the health check isn’t just an innovative technique but a high-level approach to maximizing efficiency across various departments, especially within the broad context of rolling global disruptions.

If you’re a compliance professional looking for a convenient and effective way to fulfill your continuing education requirements, go to FCPAComplianceReport.com/Courses and choose from 4, hour-long training packages that will keep you up-to-date with the latest developments in the compliance field.

In this five part podcast series, I will be taking a deep dive into healthcare monitoring and how the pro-active use of a health care monitor can positively impact all stakeholders in the healthcare industry: the regulators, the health care industry and the consumers of health care services, the public. I am joined in this exploration with two individuals from Affiliated Monitors, Inc. (AMI), the sponsor of this series. The first is Catherine A. Keyes, Vice President of Operations and the second is Jesse Caplan is Managing Director of Corporate Oversight. In this first episode, I visit with Jesse Caplan to introduce the use of an independent integrity monitor in the healthcare sector and explain how such a monitor can increase value.

Independent integrity monitoring can be particularly valuable and important in the healthcare sector because in many way healthcare is the perfect storm for significant compliance risks, but also has a greater opportunity to mitigate those risks. Using an independent third-party compliance expert or monitor can be one strategy to help mitigate risks.

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

Not every healthcare organization has a good handle on either the effectiveness of their compliance program or the compliance culture of their organization. Independent integrity monitoring can proactively assess compliance programs and culture, identify potential areas of compliance risk. Furthermore they can help mitigate or limit the adverse consequences of violations and help persuade regulators to look more favorably on an organization.

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

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

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

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

Next up, how proactive assessments can enhance healthcare ethics and compliance programs and culture.

For more information on how an independent monitor can help improve your healthcare entity’s ethics and compliance program, visit our sponsor Affiliated Monitors at www.affiliatedmonitors.com.

In this episode I podcast favorite James Koukios returns to discuss some of the highlights from the Morrison and Foerster newsletter on Top Ten International Anti-Corruption Developments for April 2018. Some of the highlights include:

  • D&B Declination for FCPA violations-how did the company get such a great result?
  • IMF “Steps Up” Engagement on Governance and Corruption. On April 22, 2018, the IMF announced that its Executive Board had endorsed a new framework for “stepping up” engagement on governance and corruption in its member countries. What does this mean for companies?
  • Individual prosecutions continue related to PDVSA. What does this mean, together with the tightening sanctions against Venezuela for US companies still trying to do business in that country or stuck it out hoping for regime change.
  • Aruban Official and Florida-based Telecom Executive Plead Guilty in Connection with Bribery Scheme. Use these guilty pleas to discuss the bookends of corruption; bribe payor and bribe receiver. How does the DOJ look at this problem and what tools are available to prosecutors?
  • Areas of the globe in which companies currently doing business need to take a close look at their operations. I have suggested South African and Malaysia. Are there others the DOJ might be looking at?.
  • As an added feature we move to a current event, the news of a Subpoena issued to Glencore by the Justice Department, in part related to a FCPA investigation. We consider what delivery of a Subpoena means from the DOJ and company perspective.

For the full Morriston and Foerster April Top Ten International Anti-Corruption Developments for April 2018, click here.