Donn Herring (dherring@spencerfane.com) is a Partner in the St. Louis office of Spencer Fane LLP.
The core message of compliance is fairly simple: Follow the rules.
That is not to say that the work of a compliance officer is simple. In order to ensure that people follow the rules, a compliance officer must (1) know the rules, (2) communicate the rules, (3) monitor compliance with the rules, (4) impose discipline for violating the rules, and (5) rinse and repeat. Although these steps seem simple enough, a compliance officer spends a lifetime acquiring the education, training, and experience necessary to perform them effectively. Even then, all of this education, training, and experience presupposes that the underlying circumstances to which it is applied are at least somewhat consistent with the norm.
But what happens when something occurs that literally shatters the norm? What happens when the scope of that occurrence is global in scale? What happens when the powers that be struggle to grasp and accept the significance and impact of that occurrence? What happens when, as a result, those in charge are slow to respond? What happens when the rules they create are poorly constructed, disjointed, and infected by political agenda? What happens when the very people making those rules refuse to follow them and encourage others to do the same? What happens when the people who have been negatively affected by this occurrence (or the government acting on their behalf) are looking for someone to blame for the manner in which the healthcare industry responded to this occurrence?
Unfortunately, no one knows the answers to any of these questions yet. Welcome to the world of compliance in the age of COVID-19.
So, what is a compliance officer to do when faced with this reality? The good news is that all the education, training, and experience you have accumulated at this point in your career provide you with all the tools necessary to address this situation.
Throughout your career, you have honed your skills in learning the rules so you could communicate them to others.
Let’s be honest; it is not like the world of healthcare was stagnant before COVID-19. Quite honestly, I cannot imagine a field that sees more changes in its underlying rules on a daily basis than healthcare. Given this fact, you have been forced to become adept at tracking the underlying rules as they change so you could communicate the changes to others. COVID-19 will just force you to take this ability to a new level.
What’s next in COVID-19 compliance?
Because of the constant changes in the rules of healthcare, you have also become skilled in developing ways to communicate these changes to the members of your organization. You have also learned to deal with the natural tendency of people to resist change. As a result, to combat this tendency, you have created strategies to help people become more comfortable with the need for change.
Most importantly, you have learned to help the leaders of your organization embrace both the need for and the benefit of change in the face of new circumstances.
This skill set will be particularly important in the current situation. Given the inconsistencies in the government’s response to the COVID-19 outbreak, its tendency to undermine the views of the very experts upon which it relies for guidance, its tendency to ignore that guidance, and its rhetoric about those who comply with that guidance, you will be faced with a number of constituents who believe the new rules are merely an orchestrated attack on their civil liberties, not an effort to protect the health and safety of themselves and others.
You have also created systems to monitor compliance with a variety of rules (both technical and behavioral) and have worked with your organization’s human resources team to develop scaled and appropriate discipline for those who do not comply. Quite honestly, your ability to be effective at each of these tasks in the current situation (especially discipline) will be directly affected by your success at communicating the extent and need for the changes in the rules. The greater your success in communicating these messages, the easier it will be to monitor and enforce compliance with the new rules.
Gating criteria tops healthcare-specific concerns
With all this as background, let’s take a closer look at one of the most significant decisions your healthcare facility/clinic/practice (collectively, healthcare organization) has been required to make since the beginning of the COVID-19 outbreak—namely, the decision to reopen for normal operations. More significantly, let’s focus on your role as the compliance officer in helping your healthcare organization plan for this event.
As a starting point, it is important to understand the rules that govern (or governed) the decision by your healthcare organization to reopen for normal operations. While the actual decision as to whether the conditions for reopening set forth in these rules have been met will likely be made by senior leadership, it is still important that you understand these rules and their conditions to assist your healthcare organization as it plans to reopen and returns to normal operations.
In fact, both the federal and some state governments have provided guidance to assist healthcare organizations as they consider reopening. Some of this guidance is healthcare specific,[1] and some comes from the government’s guidance for other businesses.[2]
From a healthcare standpoint, the baseline guidance to be used in making this decision is the “Opening up America Again: Centers for Medicare & Medicaid Services (CMS) Recommendations: Re-opening Facilities to Provide Non-emergent Non-COVID-19 Healthcare: Phase I” (the reopening guidelines).[3] Under the reopening guidelines, CMS lays out eight measures a healthcare organization should consider implementing as it begins the process of returning to normal operations.
Before considering the implementation of these measures, however, a healthcare organization must determine whether the White House’s gating criteria for reopening have been met in the community in which the organization is located.[4] The gating criteria focus on three sets of factors to determine whether a community has passed the peak of the COVID-19 infection and is ready to safely return to normal activities. These factors include (1) a downward trajectory of influenza and COVID-19-like symptoms within a 14-day period, (2) a downward trajectory of documented COVID-19 cases and positive test results within a 14-day period, and (3) the ability of hospitals in the community to treat all patients within the normal standard of care and to provide COVID-19 testing for at-risk healthcare workers.
How to determine your gating criteria
Unfortunately, in many communities it has been difficult—if not impossible—to find information as to whether the community meets the gating criteria.
Given this fact, many healthcare organizations have been forced to rely on public directives from the governor, county executive, or mayor of their community regarding whether the community has met the gating criteria. In some cases, governors, county executives, and mayors have decided to reopen their community and authorize healthcare organizations to reopen for normal operations while ignoring the fact that their community has not yet met the gating criteria.[5]
Unfortunately, in those situations, healthcare organizations have been left with the difficult choice of following the directive of local leaders or independently determining whether the gating criteria have been met.
Once the decision has been made that the time is right to reopen (regardless of whether that decision is based on a directive from local leaders or a determination that the gating criteria have been met), the healthcare organization must consider whether and how it plans to implement the eight measures identified in the reopening guidelines. These measures are:[6]
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Establishing a methodology for determining which patients need to receive in-person care and which patients can continue to receive remote care (e.g., telephonic consultation, telehealth);
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Establishing a process for screening patients for potential COVID-19 symptoms before they are permitted to enter the office of the healthcare organization to receive in-person care;
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Prohibiting patients receiving in-person care from bringing a guest, unless the guest is actively involved in the patient’s care and is screened for potential COVID-19 symptoms in the same manner as the patient;
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Implementing a policy requiring all healthcare providers and staff to wear appropriate face masks at all times and requiring patients to wear face masks;
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Implementing a process for requiring all staff to be regularly screened for COVID-19 and requiring staff who test positive to quarantine;
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If you anticipate regularly treating patients with COVID-19, segregating patients with COVID-19 to a separate part of the facility (including a separate waiting area, recovery area, and treatment rooms) and segregating staff treating patients with COVID-19 from treating other patients;
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Establishing a process for thoroughly cleaning and disinfecting patient treatment areas following the use of such areas by a patient; and
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Confirming the availability of an adequate supply of masks, other personal protective equipment, cleaning supplies, and other supplies necessary to implement the policies and procedures adopted by the healthcare organization to prevent the spread of COVID-19.
Please note, a healthcare organization is not required to implement any of the measures identified in the reopening guidelines, which are merely guidelines, not mandates or requirements.
As a result, a healthcare organization is free to implement, alter, or ignore each of the measures identified in the reopening guidelines. Further, the failure of a healthcare organization to implement any of these issues is not a violation of federal law, although it may form the basis of a claim by a patient or staff member that the actions/inactions of the healthcare organization caused or contributed to injuries suffered by the patient or staff member as a result of COVID-19.
Some state or local governments (e.g., Oklahoma[7] ) have offered their own healthcare-specific guidance for healthcare organizations considering returning to normal operations. To the extent that this guidance is mandatory, healthcare organizations in those states or jurisdictions are required to comply with such guidance. To the extent the guidance is merely recommendations, healthcare organizations are free to use, alter, or ignore such guidance as they see fit.
In addition, some private organizations have offered their own healthcare-specific recommendations for healthcare organizations considering returning to normal operations.[8] Obviously, healthcare organizations are free to consider implementing, altering, or ignore these recommendations as they see fit.
What to consider on business-specific guidance
Separate from the healthcare-specific guidance, healthcare organizations should also consider federal and state guidance to businesses considering reopening.
Although there is federal guidance on the reopening of businesses, the state and local guidance on this topic tends to be more specific. As a result, healthcare organizations should be familiar with the general business reopening guidance in their state, county, and city.
The state and local reopening guidance tends to focus on the possibility that direct human interaction or contact in a retail, business, or social setting will hasten the spread of COVID-19. As a result, this general reopening guidance usually focuses on the use of masks, the implementation of social distancing, and the constraint of large gatherings.
In the healthcare context, this reopening guidance would require healthcare organizations to consider the implementation of social distancing between members of the staff and each other, between members of the staff and patients (except as needed for patient treatment), and between patients and each other. Further, some state and local reopening guidance focuses on the use of waiting rooms, suggesting that patients wait in their cars until they are called into the office by staff, as opposed to waiting in the waiting room.
In any event, healthcare organizations should be familiar with and consider the implications of the state and local general reopening guidance as they consider returning to normal operations.
Putting the pieces together
As the compliance officer, you will be responsible for (1) coordinating with clinical/operational staff to understand how your healthcare organization will address each of the measures identified in the reopening guidelines and other state or local guidance, (2) documenting through policies or otherwise the steps being taken by your healthcare organization to address these measures, (3) educating relevant staff as to the steps being taken by your healthcare organization and to be taken by such staff members to address the measures applicable to them, (4) establishing a process to monitor your healthcare organization’s compliance with these measures, including compliance by individual staff members, and (5) working with your healthcare organization’s human resources team to establish appropriate discipline for staff members who do not comply with these measures.
One of the most difficult issues you will face in connection with your responsibility as compliance officer is how to respond to your healthcare organization’s unwillingness to meaningfully address one or more of the measures outlined in the reopening guidelines or applicable state or local guidelines. For example, how do you respond if your healthcare organization elects not to implement or enforce a policy requiring staff members or patients to wear surgical masks, or a policy to screen patients for COVID-19 symptoms before entering the facility, or a policy requiring social distancing within the facility?
When confronted with this situation, it is important to remember that most, if not all, of the federal, state, and local reopening guidance consists of recommendations, not mandates or requirements. As a result, your healthcare organization is free to implement, alter, or ignore such guidance as it sees fit. That is not to say that altering or ignoring the guidance might not have consequences from a claims standpoint, but that is primarily an issue for your healthcare organization’s risk manager.
Obviously, if a particular measure is mandated, it is important that your healthcare organization is aware of this fact and meaningfully addresses this measure. If not, your healthcare organization is free to act—or not—as it chooses.
Further, regardless of whether your healthcare organization implements, alters, or ignores any recommended measures, you should document the steps taken by your healthcare organization in reaching this decision, the rationale for doing so, and the actual measure implemented. Your healthcare organization should also be prepared to consistently enforce each of the measures it has adopted against its staff, patients, and visitors.
Finally, your healthcare organization should not adopt any measure that it is unprepared or unwilling to fully implement and enforce.
Please recall, most (if not all) of the measures recommended by the reopening guidelines and other applicable guidelines are voluntary in nature. As a result, a healthcare organization is not required to implement such measures. That said, if a healthcare organization formally adopts an otherwise voluntary measure and then fails to implement or enforce it, the healthcare organization leaves itself wide open to a claim that a COVID-19-related injury or illness resulted from the healthcare organization’s knowing refusal to comply with its own rules.
In effect, by adopting the measure, the healthcare organization validates its significance beyond the significance it might have as a mere recommendation.
In closing, as the compliance officer, you have a significant and meaningful role to play in helping your healthcare organization address the myriad new issues that have arisen and will continue to arise as a result of the COVID-19 outbreak. Your education, training, and experience give you all the skills you need to help your healthcare organization address these issues with confidence. While the rules applicable to these new and emerging issues are often being made at the same time the issues are identified, your skills give you the ability to play a meaningful role in helping your healthcare organization navigate this ever-changing playing field.
Takeaways
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COVID-19 has changed the landscape in which compliance work is performed at hospitals and other medical facilities.
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Compliance professionals will need to build on existing skills to deal with what promises to be consistent change related to COVID-19 guidance.
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Federal and state guidance on reopening facilities includes both healthcare-specific and business-specific directives.
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Healthcare organizations have been forced into difficult decisions related to reopening given discrepancies between the policies adopted by the government and the actions of its leaders, increasing the importance of documentation.
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The key to operations will be in combining guidance, implementing best practices and policies, and assessing and understanding potential risk.