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. 

3. 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.  

4. 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. 

2. 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.  

3. 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.