June 7, 2022

Changes to CMS and Joint Commission Standards in the Wake of the Pandemic

Point by Point

On today's episode, Morgan interviews Vice President of Compliance and High Reliability at Greeley, Lisa Eddy, Vice President of Bylaws and Governance at Greely, Dr. Mary Hoppa, and healthcare compliance partner at Waller, Jesse Neil. They will discuss the changes made to CMS and Joint Commission regulations in light of the COVID-19 pandemic and give practical advice for hospitals and hospital systems to ensure they are complying with new regulations. 

This episode of Point By Point was produced prior to the combination of Waller and Holland & Knight.



Morgan: Welcome to PointByPoint. This is Waller's Chief Business Development Officer and the host of the podcast, Morgan Ribeiro on today's episode, Jesse Neil, Lisa Eddy, and Dr. Mary Hoppa are joining me for discussion on compliance challenges facing hospitals and other healthcare providers. As we surpass year two and the COVID pandemic, Jesse, as a partner in Waller, healthcare compliance and operations group.

Lisa is vice-president of clinical compliance and high reliability at Greeley. And Dr. Hoppa is vice-president of bylaws and governance at Greeley. Jesse, Lisa and Dr. Hoppa. Welcome to the show,

Lisa: Morgan.

Mary: Thank you.

Jesse: Great to be here. Thank you.

Morgan: So, I am looking forward to this conversation. I think we've covered a lot on the podcast over the last couple of years, just on of course how the pandemic is impacting providers, but now.

Sort of luck to the future and what we all may have missed over the last couple of years, having been really consumed with just the urgent priorities of the pandemic. Lisa and Dr. Hoppa. Of course you're from you, [00:01:00] have, you are in the trenches when it comes to compliance. Greeley is a leader in healthcare consulting, education, interim staffing solutions with great experience in the areas of regulatory compliance, accreditation quality, patient safety bylaws, peer review, as well as credentialing and privileging.

And really your mission is to help healthcare organizations, improve efficiency, comply with regulations and standards and achieve practitioner engagement and alignment. And so I think, this is so relevant to what we're talking about today and you all really bring that expertise. Before we really launch into the specifics of our conversation, we'd love to just hear from each of you your individual areas of responsibility and an expertise.

So Lisa, I'll start with you.

Lisa: Okay, thanks, Morgan. As you mentioned, I'm the vice president of clinical quality and high reliability. And that brings to the healthcare arena my experience over 25 years. I'm a registered nurse by background ICU trained and went over to nursing leadership CNO, and then COO hospital operations, and then migrated over to quality regulatory compliance, and have been with the company for over 16 years.

But we really focus in the clinical compliance and high reliability area on getting hospitals to a better level of compliance with the regulations as well as patient care and safety. And so we generally go into a hospital and work with them to bring up their level of compliance, to help meet the regulations. And as I said, improve patient safety.

Morgan: Great. And Dr. Hopper, anything you wanna highlight about your background?

Mary: Thank you, Morgan. I'm Mary Hoppa. . I've been with Greeley not quite as long, but for almost 16 years. I am the vice-president of bylaws and governance, but I also oversee the peer review practice. And you can see the intersection of Lisa in an overarching hospital quality with myself as doing peer review in looking at the competence of individual practitioners [00:03:00] at the same point.

I also am the vice president of bylaws and governance and work with the medical staff at creating a more effective and a more efficient medical staff decreasing their administrative burden. So it allows them more time to take care of patients and to be compliant while doing so

Morgan: great. And then of course, Jesse, I've asked you to join us for today's conversation.

You have been in house with a health system in the past for many years, and want to provide any more background on your expertise for our listeners.

Jesse: Sure. Thanks Morgan. I started my career in healthcare on the government enforcement side as assistant attorney general in Tennessee, focusing on hospital systems, providers and pharmaceutical companies. And that was when I was first exposed to how the compliance and the quality and the regulatory items are really intertwined. You can't really tease one out from the other. From there, I worked almost 10 years in-house at a large investor owned hospital company based in Tennessee and my main responsibilities there were day to day operations for a group of hospitals, 10, 12, 15 hospitals, that I was responsible for everything from medical staff bylaws, medical staff matters fraud, abuse, regulatory compliance, operations contracting.

And then in addition to that, I developed a niche at the company that focused on EMTALA prevention and compliance. And with that role, I was really the hub of the policy development, the training, the oversight, and the response effort when we got a survey deficiency or any kind of regulatory kind of response required.

And I've learned a good bit about how CMS and ultimately the OIG interact with the hospitals on that compliance front on the intolerant particular.

Morgan: Great. Thank you all for that. I think that's really helpful and you all bring a lot of insight to this conversation today, which is to provide our listeners, primarily the hospitals and health systems. But I would say a lot of this also applies to just healthcare providers in general. And this is an update on what they might have missed or possibly overlooked while everyone's had their heads down and dealing with the coronavirus.

 Over the last two years, I think hospitals have faced considerable challenges, keeping up with regulatory changes outside of those immediate priorities posed by COVID-19. And yet as organizations move past year two of the pandemic, it's really critical at this moment to pause and understand the regulatory changes that will undoubtedly impact compliance requirements.

So with that introduction I would love to hear first from Lisa on, providing our listeners with an overview of those changes that we've seen over the last 24 months or so that hospitals may have possibly overlooked.

Lisa: Greeley as a company goes into hospitals and help them with some of their problematic challenges, right? Infection prevention, not uncommon to be a problematic challenge, but we're seeing central sterile processing, which is for those of you unfamiliar with that, the surgical instrumentation, the sterilization of that, how those instruments move through a facility, how they're managed. Infection control practices in that area, just due to staffing have decreased to some component and then other infection control practices, the use of personal protective equipment, isolation, just general infection control practices overall have been problematic for hospitals.

And those things are now really highlighted because of the pandemic.

Then we want to talk a little bit more about what emergency department patient population management brings to the healthcare setting.

but one of the things that's very important for hospitals to realize is that hospitals that have the things I talked about as threats, if you will: infection prevention, central sterile processing, high-level disinfection, infection control practices, safe management of the patient population, management of the patient population in the ED. These are all weaknesses in hospitals surfacing to the highest level of attention. The hospitals that've been cited for these kinds of things before, either by CMS or the joint commission, if CMS or the joint commission comes back for a resurvey, it would be a validation complaint, and they find the same things wrong there's a threat to the hospital's ongoing certification.

 The joint commission has a policy where if you're cited for a condition level finding and they come back on resurvey in the next triennial survey process, they have the ability to put you into what's called preliminary denial of accreditation because you haven't fixed the underlying problem.

You said you were going to fix it. They accepted your plan of correction in your evidence of standards. Compliance is what that's called for joint commission, but they came back and it's not fixed fairly. They can say, we don't think you're safe. If you've had a statement of deficiencies and you send in your corrective action plan and CMS comes back to resurvey you and you pass no problem. They come back on another validation complaint. Meaning patient has complained to the state agency. CMS comes in state agency surveys for CMS and finds the same or very similar thing wrong. They're not going to take that lightly because they feel that you're not keeping the patient population safe. So those things that we know are problematic in the industry, that the pandemic has now highlighted, we really encourage hospitals to take a good strong look at remediating those things because they can really provide a big problems for hospitals, challenges that the hospitals right now just don't need.

I do want to point out that CMS issued a memorandum in February of this year, I believe, pretty much telling the state agencies to get back into the field and survey for validation complaints. And if they did not do it, CMS would then take the funding that they normally give the state agencies to do that validation complaint for CMS.

They would take that funding for the state agencies and use that themselves as CMS proper and conduct a survey. So that's a big fire under the state agencies to get back into the hospitals and survey. Even though we're at the tail end of this pandemic, they see some of the state agencies weren't getting out as frequently as CMS felt they should be.

And then we have the joint commission that's added, over the past 18 months, about 180 new surveyors to their team, which means they're really wanting to get out in force, get their backlog completed and get hospitals back on track.

So you've got that pressure mounting from CMS, getting back in the field. And when I say CMS state agencies, again, they survey per CMS. When CMS gets a complaint, the state agency gets it and goes and surveys for CMS in most states and most instances. So you've got that double-edged sword of joint commission and CMS coming into your organization to survey.

 Then when you couple that sort of double-edged sword with what we just learned from a recent article in the New England Journal of Medicine, talking about the increase in preventable harm, we've got just this perfect storm of negative challenges facing a hospital system, a hospital, a critical access hospital, ambulance, or whatever it happens to be, that's already crunched under the pandemic with these new stressors.

Mary: I just want to reiterate, these agencies are being asked to go out into the field and survey. They know where the low-hanging fruit is. They know where to survey and potentially find things. And one of the ways that they know where to look is it was just highlighted in that article that you had mentioned. It was an article by a doctor by the name of Lee Fleisher, who also works for CMS. And it's really interesting.

What we've also found is that staffing and nursing homes is also a problem. And this article highlighted that there was a 17.4% in increase in falls, not just routine falls, but false, that caused significant harm to the patient. They also noted a 41.8% increase in pressure ulcers because we're not giving the patients in those environments.

The more frequent turning, the more frequent attention that they need to prevent these conditions. We're short on staff. Hospitals and nursing homes, we're short on supplies. We're stretched things that if we have certain nursing ratios that Lisa has said, and we're stretching our staff, what are they, those people going to concentrate on?

They're going to concentrate on direct patient care, what they can so that they can take care of patients. So that the time we had potentially for safety rounds or the time to do safety audits and other measuring may have decreased. And we've noticed a decrease in error reporting. And unless we find this stuff, we can't correct this stuff.

What we found, what Lisa said is that the pandemic exposed areas. It just blew off some of the light cover up and exposed things. And one of the things that it really exposed to us is that a lot of our safety issues and all the checklists and the protocols and everything we put in place, they weren't hard wired. They went away when we were stressed in the system. So my question is we've seen this with infection. What other types of regulatory issues have you been seeing Lisa besides the ones that I've iterated, basically from that New England journal article.

Lisa: Thanks Mary. But yes, when you made the comment, the processes we thought were hardwired weren't that is very true. We're seeing that across the country at hospitals, leadership are surprised. They're just absolutely taken aback by the fact that we'll go in and we'll do a regulatory readiness rehearsal. If you will agree, the company does that kind of work and find a number of significant findings, observations of non-compliance, and hospital leadership's completely surprised because they thought that they had that quote unquote hardwired when in fact the processes that are the routine [00:13:00] monitoring activities that we usually conduct in hospitals totally fell away during the pandemic.

And we have to make a collective decision as leadership oversight. Do we want to put those back into place? Do we want to revise those? So those are the things we want to keep on the forefront for ourselves. I want to bring up the fact that there have been some minor changes in the joint commission’s performance improvement chapter. The hospital has always been required to have a strong quality program. CMS requires a quality assessment and performance improvement, QA PI chapter a condition with a number of sort of regulatory components related to that joint commission follows suit with the PI chapter performance improvement chapter and issues related to quality and safety in the leadership chapter.

But they've added some changes to the joint commissions PI chapter that require the hospital to identify processes in need of improvement and update progress made with respect to improvement. So what's happening is joint commission is saying, "Hey guys, You have to fix problems and you have to keep leadership apprised of what you're doing to fix it. And we want to know not just what the quality aspect is, but what the performance improvement aspect is. And we want you to evaluate that and make sure leadership is kept abreast of that." So, that's an important issue.

And then that joint commission also further identified Sentinel events in terms of harm, to the extent of What isn't a Sentinel event. If a fall should be reviewed as a Sentinel event or not, if there was a fall with injury, that kind of thing, they clarified that a bit.

And then there are the workplace violence standards that came into effect. And that means now that organizations need to have a workplace violence prevention program that you have to now do a workplace violence assessment analysis of where these things are occurring.

And hospitals have always had to record events that related to patient safety, but most hospitals would record if there was an event related to staff safety, but not necessarily did they record when a staff member was accosted by a patient or a visitor. Now those things are required to be recorded in your event reporting system. And joint commission goes on to describe workplace violence as a pretty much bullying, harsh language, there's a lot of various descriptive language in what represents workplace violence.

I'm a nurse I'd consider if a patient is rude to me or if a family member yells at me, or if a behavioral health patient spits at me, or a patient strikes you when you're trying to move them or whatever that happens. Those kinds of things can be, if you look at the literal definition by the joint commission, considered workplace violence to some degree.

So there's going to have to be some very careful analysis by hospitals and definition of what they consider workplace violence. And then there's education that has to be given to all of the hospital staff, and, to some degree, you're going to want to be able to make sure that your staff is competent in terms of reporting workplace violence.

And then you have to track that and look at your trends over time and report that on up through your QA PI system. So that's a new endeavor. Some hospitals already have this sort of thing in place, but typically not to the depth now that's required by the current commissioner. So that's something a little bit new.

And then we want to make sure that we talk about the vulnerabilities in the emergency department that are really facing the nation because not only do they lead to what we consider condition level findings, but they can lead to EMTALA, the emergency medical treatment and labor act, EMTALA vulnerabilities, which can lead to fines and so forth.

So I'm actually going to ask Jesse and Mary to weigh in on that, but I will tell you, that's where a lot of businesses being driven right now, about vulnerabilities in their emergency department because of EMTALA findings.

Jesse: Sure. Now this has been extremely helpful. I've got so many clients who are hospital systems who, in part because quality and compliance, are now integrated in the reimbursement and the rise and consumerism. A lot of these outcomes and data points are available to community members and they're turning their eyes towards this as a priority.

They're looking for a playbook on how to accomplish these compliance and quality outcomes. They're realizing it's incredibly resource intensive to have what the OIG expects with regard to quality and compliance oversight. You have to have personnel who are knowledgeable. There has to be oversight. And there has to be reporting. There has to be monitoring. There has to be remediation for us to be data tracking and reporting internally and externally. It is an extremely intensive, not just monetarily, but just human capital to get in place.

 If there's one component of the compliance function that the government harps on is that it cannot be the same next quarter as it is this quarter. And that kind of challenge in the middle of a global pandemic, you sound like a broken record when you say that the staffing problems are really causing issues. It's incredibly difficult to meet the challenge of proper compliance and quality function, when you have difficulty getting people there to fill those spots. And the demand for the services is going up, particularly in behavioral health. It's a perfect storm in my experience.

I spend a lot of my time on working with hospitals and working through an enforcement action. A few years ago, I gave a presentation with the federal government Chief EMTALA enforcement officer at the Office of Inspector General. And she actually let me call this presentation Great Expectations because so much of what it takes to meet the expectations of enforcement officials and to properly mitigate the risk are things that aren't in the black letter law. They're not even in the statement. Things like we don't believe that there's any motor transportation that is appropriate for a transfer except an ambulance.

They look at the care that was provided and they look at the outcome. And if the outcome is not what they think should be happening in today's environment from their perch in DC or wherever then they go back through the chain of events and there's real material risk for a deficiency. And you can lose your license to operate in as short as 23 days.

It is draconian and in a lot of ways and their expectations are not, I'll say, always crystal clear. So on the telephone, I worked with hospitals a lot where between the policies and procedures what do you do to mitigate the risk around, for example, behavioral health, it drives a lot of it.

What do you have to do to keep them in the ED? When they try to leave, do you have to forcefully keeps them there? Do you have to have a policy and procedure that you trained on and had to protocol on periodically? I think that's probably a bare minimum.

And some locations, depending on the state, allow you to get a call and an order from a court to restrain the individual, which has its own issues and risks and costs.

And at the end, you don't want your employees to be in danger. It's one of those things where you look to the rags and you look at the policies and procedures, but you just can't let your employees be in danger when they're interacting with these patients. So it really is a big challenge. And I'll say that, the resources that this group brings to bear incredibly valuable to hospitals, hospital systems.

It's no longer enough to have one or two staffers who deal with surveys. Those days have come and they have gone. And I think they're exactly right that COVID brought that into stark relief because of the demand for the services and the difficulty of bringing them to bear when you've got a pandemic, but the bottom, those are the same issues that are trying to manage for some time.

Morgan: Great. That's helpful. Doctor Hoppa, did you have some additional thoughts on that front?

 I think a lot of this conversation can feel pretty overwhelming to say, okay, now I have all this information what do I do with this? And what does this mean from a practical standpoint? And again, you layer that, like you still have these staffing issues. So how do we actually get the work done and prioritize like the low hanging fruit or the things that are going to be most impactful?

Lisa, maybe you can start with some practical tips.

Lisa: Sure. The very first thing I would say. When facing the many challenges that we are as a healthcare system across the country facing the worst thing that you can do is to try to fix everything. Your things would be coming at you fast and furious. You cannot boil the ocean.

We tell our clients to really focus on the 25% of findings, most significant findings over their last two year period. If there are two survey cycles, if they're a joint commission or depending on whatever accrediting agency. We'll use joint commission as a watermark, their findings from any requirements for improvement, that's initialed as an RFI requirement for improvement, they're scored as a pattern of issues with a moderate likelihood of harm or above on that joint commissions quote, unquote, safer matrix. Those are things that are scored as a moderate pattern, moderate, widespread high likelihood of harm, regardless of the frequency. Those are the findings that you want to focus on because those are the things that bubble up to the top in terms of severity of harm to patients.

We have hospitals that have 50, 60, sometimes, unfortunately, that come to us. We always wish they'd come to us first, but they come to us after a survey and they have all these findings and it's not unusual. Now I think the joint commission's average number of findings is somewhere around the fifties. So it's not uncommon, but we say don't pay attention to all the little white noise things. Those are things that are not really pressing into patient harm, but the significant findings look at the 25% of those most significant findings and try and fix those.

And then when we're talking about CMS, it's very important, any corrective actions that you've undertaken to address cited deficient practice. Make sure the deficient practice is actually corrected. So we've, as a company, really been introduced to multiple clients when they're unable to really sustain improvements. And CMS comes back for either a resurvey or they've had a resurvey they've done fine. Then they come back on this validation complaint and they find that the same or very similar issues exists.

 I deal with a lot of CMS regional office directors and so forth. They're not the boogeyman. They simply know, as does joint commission, that they are responsible for patient safety in the healthcare environment. The beneficiaries of Medicare and Medicaid, CMS is responsible for that safety of the patient population.

And so they have a lack of tolerance for repeated poor performance that impacts the patient. So you want to make sure that if you've said you're going to fix a problem, that you actually make sure that it's fixed. And then we encourage our clients to take the long view of compliance.

Although specific observations related to significant issues can be addressed with joint commission, you've got 60 days generally to address them. With CMS, if you have conditionable plannings, you really have 45 days to get those things, quote, unquote fixed, but we would encourage you to take the long view of what is sustainable over time.

Don't commit to a corrective action that doesn't align with solid operational practice. If you think you're going to fix something by changing an educational program, without really looking at the root cause of what's causing non-compliance, it's not going to stay fixed. So think of this in terms I do as a medical professional. I think in terms of gee, the patient's bleeding what's causing the bleeding? What's the root cause so that they can actually get that root cause fixed.

Mary: Absolutely, Lisa. One of the things I like to catchphrase is simplify and comply. Just don't keep putting band-aids over the same wound. Sometimes you just got to rip all the band-aids off and say, " what's the right way to handle this. How can we simplify it?" Cause the more complex we make things, the harder it is going to be to comply with that.

 A lot of it is not only do we have to comply with again, CMS and joint commission regulations, but the medical staffs have these documents called bylaws and rules and regulations, and sometimes they've put so much additional burden on themselves that they may be compliant with CMS and joint commission, but they're not compliant with their own documents. So what we say is don't shoot yourself in the foot. How much effort is it going to take to have this extra compliance? And how is it a benefit to patients or to the medical staff? Do the benefits of having these higher standards for us ourselves? Does that outweigh any other regulatory burden? It actually puts on us to comply with it all the time. So what we try to say is follow your practice. Make your documents follow your practice. As long as that practice is compliant.

A lot of times we get into the Bailey wick of, "oh, we're just going to change the policy and then magically, everybody's going to follow that policy." That's not how it works. Putting a black type face on a white piece of paper doesn't mean that people are suddenly just going to magically follow that and we've just flipped the light switch and they're going to be compliant with it. Let your practice drive a lot of your documents, if that practice itself is compliant.

Lisa: I completely agree, Mary.

 Greeley as company tells clients, look, don't over require something in a policy. Look at your operational practice, including now in the pandemic. Is that operational practice compliant with the regulations? Is it efficient? Is it effective? Are we actually providing the care we intend to provide? And then align that operational practice with the regulation in a way that's executable for the nurse at the point of care at the bedside or for the physician. So we do focus on that, which we found to be quite helpful for hospitals in terms of simplification and streamlining, but in the face of what we're left with in this healthcare environment, the pandemic really has sheared away layers of hospital bureaucracy.

Some of it, as we said, is a very bad thing and some of it can be a very good thing. So we just really leave you with that thought in terms of how to simplify and comply. So I thank you for that, Mary.

Jesse: And this is Jesse. I just want to reiterate that my experience is exactly the same with regard to policies, procedures, implementations. When you submit a plan of correction, they don't want to see the form or the new policy. They want to know when the training was complete and a checklist of the names who got the training. You cannot manage this process via a memo or an email or even a policy.

And there are different schools of thought about, do your policies and procedures, particularly on the clinical side, do you shoot for the stars are they aspirational? I'll be honest, in my experience it's much better to have policies and procedures that track, what is then the standard practice. That meets the standards. Because I have seen violations enforcement actions based on violations of their own policies. Not even the underlying regulation, but their own policies. And the way they bootstrap that is to say, for example, know each patient that comes to the ED with a similar presentation needs to get a similar screening exam and a screening and make sure that they track each other. Otherwise there's going to be a potential for discrimination and they'll look at a policy, and if there's any kind of deviation from a policy that's above and beyond, what's otherwise required it often ends up as a deficiency in a notice. So I couldn't agree more with very sound wise counsel across the board here.

Morgan: Thanks everyone. And I have just a question. I don't know if this is applicable in this situation, but I saw that the AHA, the AMA, and several other organizations on modern healthcare, were asking HHS to extend the COVID-19 emergency status. If we're still in this sort of emergency mode, how does that impact some of these compliance initiatives or does it at all?

Lisa: I'll go ahead and answer that to a certain degree, and Mary and Jesse can weigh in. If they extend the public health emergency, those blanket waivers that have been allowed would be extended.

 So, for example, we are under the burden of producing a nursing care plan for every patient. That's been alleviated during that the blanket waiver. So she don't have to do that. So my question would be, for food for thought, if I can go for two years without having to do patient care plans, what value are they really ?

But that's up to CMS and, state agencies. I'm from California, and so the California CDPH, California Department of Public Health, requires a nursing care plan. But for those state agencies that don't, other things like the utilization management condition, you don't have to comply with that during the public health emergency.

So the extension of that will keep those blanket waivers in place. Jesse and Mary, how you feel about that?

Jesse: My hope would be is that there is a rigorous assessment cost benefit analysis based on data during the COVID with regard to regulatory requirements, oversight reporting.

Some of the stuff should go away. Some of the stuff should stay. And I don't know that at the federal or state level that there's going to be the will to do that. Some states are more proactive than not, but there is a lot of data and there has been a lot that has been learned. If it could be, properly organized and assessed and distributed, I think there is a lot that the whole healthcare ecosystem could gain from it.

I'd love to see it. I'll put it that.

Mary: And I'll just chime in at the very end. It's saying, the COVID pandemic has challenged healthcare and healthcare systems, as Lisa said, if we were able to blanket waiver some of this stuff away, and we've done very well regarding that in that stressed situation.

Raise the question of whether administration and the bureaucrats want to say, what is the worth of some of these regulations. As Jesse has said, whether they'll do that introspection on themselves or not, that remains to be seen. But at the same point, we've had to streamline and simplify things within the healthcare environment.

Cause we've had to deal with more patients with less staff and less resources can, again, we streamline some of the regulations and make them and retain the ones that are truly pertinent and are advantageous for patient care, but stripped down some of the extraneous things that we have found we've done well with without with those blanket waivers, without doing certain parts within the past two years.

Morgan: Some of the things that have happened over the last two years are sort of no going back as well.

 I just think, plowing forward things are just going to look different and maybe it is that we operate in a world where there is less staff and things like telemedicine and other technologies that are coming online, maybe at some point we'll catch up to that and be able to operate with reduced staffing.

But this has been really valuable and really great practical information for those that are hospital and administrators of other healthcare facilities. So thank you all for your time today. Really appreciate and value your insight and look forward to connecting again soon.

Mary: Great. Thank you.

Jesse: Thanks guys.

Lisa: Thanks.

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