Based on AHLA’s annual Health Law Connections article, this special series brings together thought leaders from across the health law field to discuss the top ten issues of 2022. In the seventh episode, Michael Ramey, Principal, PYA, speaks with Sarah Swank, Counsel, Nixon Peabody LLP, and Michael Herald, General Counsel and Chief Administrative Officer, Guardian Healthcare, about the supply chain distribution challenges that providers have faced during the pandemic. They discuss tips for providers navigating agency regulations, how providers are shifting their approaches to supply chain issues, and changes and opportunities that providers should prepare for. Sponsored by PYA.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
A H L a is pleased to present the special series, highlighting the top 10 health law issues of 2022, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year support for a H a . And this series is provided by PPY , which helps clients find value in the complex challenges related to mergers and acquisitions, clinical integrations, regulatory compliance, business value, fair market value assessments, and tax and assurance for more information, visit pya pc.com .Speaker 2:
Hello, I'm Michael Ramey , a principal and leader in transaction advisory services for the , uh , accounting and consulting firm. PPY I'm joined today by Sarah Swank and Michael her , he recently contributed to the a H L a top 10 issues in healthcare articles, specifically focusing on securing the supply chain for healthcare providers , uh , by way of introduction. Sarah Swank is with the law firm, Nixon Peabody . She is a former senior in-house council for two national healthcare systems and provide strategic regulatory and operational advice to healthcare systems, hospitals, and academic medical centers, as well as large national and regional physician organizations, telehealth companies, and other startup ventures. Uh, she also holds leadership physicians , uh, for publications and education in both the a H L a and , and ABA. Michael Harold is chief administrative officer and general counsel for guardian healthcare . He's responsible for legal affairs and leading the human resources. It shared services and loss prevention teams for the post-acute care enterprise. Um, he also serves as an adjunct professor and on various boards, Sarah and Michael . Welcome, and thank you for participating in today's podcast.Speaker 3:
Thank you for having us.Speaker 4:
Thanks, Michael. Thank you for having us.Speaker 2:
Yeah, well, I know we have several stories to share. Um, so we'll dive right in. Um , I'll start with Sarah , uh , Sarah providers and regulators. We're having to react to the changing dynamics come by , or cause at the pandemic's outset , uh , from your a vantage point counseling healthcare providers, can you share what you witnessed as providers were dealing with these interesting challenges?Speaker 3:
Yeah, I can see in the beginning of the pandemic in 2020, it was a bit wild. Um, we had , um, shut downs of offices. We had , uh , cancellation of electric elective surgeries, all, you know, started because of supply chain issues , uh , because of , uh , PPE. Uh, and I have to tell you as a healthcare lawyer, what was particularly interesting was I had to pivot myself. Um , for example, we, we had clients that were , um , fashion manufacturers that were wanted to contribute to the cause and trying to figure out, okay, how do they produce cloth masks or do they produce shields, face shields to support healthcare and healthcare workers and , uh , emergency responders and doing that without guidance yet from the FDA. And then I know that moment as lawyers have where you , a lot of us probably had where we look back at our work and see whether now that we have the guidance or were we , were we close? Were we, did we advised correctly? And I , I think that happened a lot of times in , in real time . Um, and I think we're still, we're still working on those issues around prioritization , uh , telehealth and, and other supply chain distribution issues.Speaker 2:
That's great. Sarah , thank you. Uh , Michael, wanna give you the opportunity to weigh in here as well. Um, reflecting on your experience at the outset of the pandemic and the skilled nursing industry, what were some of those firsthand challenges you encountered? Uh, and how did you overcome them ?Speaker 4:
Sort of seems like a lifetime ago at this point. Um , and thinking about Sarah's comment on , um, quickly pivoting from what we were so used to in our day to day , uh , in 2020 , uh , from really February to March. Um , it's , it's surprising to think about now and , and just reflect on , um , some of what happened during that period we experienced as an organization. I think a lot of , um , the same in types of things that Sarah mentioned in terms of encountering , um, you know, difficulty acquiring and obtaining PPE and , um, you know, I think what was most , um, impressive to me and to, you know, other leaders within our organization. And , um, certainly I think just generally our , our , all of our employees is really how we were , um , able to step up and find other sources work with other partners in some cases, community members, or , um, you know, other community businesses to meet some of those PPE needs . Um , we had employees in the guardian organization who were, you know, making cloth masks at home. Um, it became a fun activity and project for , um, some of the, their children, employees, children , um, to help support our sites. But I think, you know, we found opportunities to partner with other local businesses , um, to help meet some of those needs as well. And there was certainly just a real sense and feeling of comradery to help out and try to find ways to meet the needs that the organization and really , um, that the residents had the employees and residents that, that we were working to protect, you know, Sarah's example of , um, working with a , a client in fashion , um, is , is a great one. And, and I think I had shared with her at some point along the way that, you know, we had a similar situation at guardian too , where , um, outside counsel was helping to connect , um, us to , um, various other that they had , who , who had access to PPE or were , um , developing or manufacturing their own PPE . Um , you know, we, we had a similar experiences and examples of that within our organization. So , um, it really was just a, you know, I think a time when people tried their best to figure out ways that they could pick to help meet the needs that, that really employees and , um , residents or patients have.Speaker 2:
Great. Thanks, Michael. Um, going back to Sarah from a , a legal perspective and , and actually the article mentions this , uh, there were, there were various regulations that were put forth from agencies, curious, were there any notable enforcement actions or challenges you witnessed , uh, which you'd like to share or for that matter? Do you have any words of wisdom for providers who were having to navigate or who are navigating , uh , those , those regulations and policies?Speaker 3:
Yeah, I think there's, there's a couple , um , one is OSHA. And as a in-house attorney, I was aware of OSHA. I worked a lot with our employee health around OSHA , um , issues, but I had never spent so much time thinking about OSHA or spending it with OSHA attorneys. Um, so I'd do a shout out to , uh , Rachel and Ben who are with me at really bizarre hours trying to inform clients. Um, a lot of times with news, it didn't always make sense to the clients like these obligations are gonna be there, but the PPEs not , um , and, and watching how OSHA has changed over time. And I think that's something, you know, we all had to do, which was to keep track of the changes they were fast and furious in the beginning. Uh , but they are , are still happening and they , and I would expect to see those enforcement actions still be in place. And also, you know, look at state level like Cal OSHA , other , um, other agencies. So, and a good example, Cal OSHA was, you know, as those a wildfires were happening in California, there was a need for PPE there. Um , at the same time is you had a competing need at , at hospitals and, and health providers. So E even then , um, you know, keeping an eye out for what was happening was really important. I think the other thing besides , uh , OSHA that I , I , we saw and, and to keep an eye out on was , was around fraud. Um, we saw , um , um , you know, during, especially the beginning of the pandemic, some big enforcement actions, some alerts coming from the department of justice and the FBI , uh , where people were ordering PPE and they were sending money and the , they just didn't show up, you know, they , the supplies just did not show up. And so I guess one thing to keep on everyone's radar is in chaos, we're gonna see more potential fraud. Now we have vaccine card fraud and other types of fraud to add to those , um, as well as cyber security issues. So, you know, types of issues keep an eye out for it. You know, the FBI alert talked about like changing payment terms, you know, things supplies coming in saying they're gonna be in a certain time, but then that changes. So, you know, if it looks suspicious, you know, take a look at it. And I think that's something attorneys can do , um , in reviewing contracts, but also in supporting , uh , reports of fraud.Speaker 2:
Very interesting. Thank you, Sarah . Um, so we've been talking about kind of what was shifting gears just a little bit to what is, and what , what may be become , uh, so Sarah , as you're working with clients and also , uh, garnering your , or thinking back on your experience in house council for large health systems, what do you feel may be changing and how providers are approaching supply chain given lessons learned from, from the pandemic?Speaker 3:
Yeah, I , I remember being in house and this idea of trying to consolidate supply chain and be efficient cost efficient, and making sure I , that you had the supplies on hand and there was like a science to it, like what would expire, what it wouldn't expire and would you have just what you needed, right . What you needed it, but not extra. Right. And , um, we even saw with the, the government's stockpile that some of the masks, for example, and the stockpile had expired, the elastics were gonna break. I mean, even something as , as masks, I have expiration dates on them. And so as you saw that, move away from like having a big repository of supplies that actually hurt healthcare providers when they didn't have those supplies on hand. And so it will be interesting to see what happens in the future around supply chain, because I know a lot of healthcare organizations are reconsidering the , or supply chain , um, process. And I think the other thing I think I've learned as outside council , but just also like observing and talking to my ELA and other, you know, colleagues, which is the role of like healthcare systems speaking to the state and how those allocation, the resources were happening at the government level, but also like that, that, that discussion and advocacy at the state level for your organization, but actually for the state itself and what , what supplies were needed for that state and how powerful that was. So that's definitely a lesson I think, learned outta this pandemic. And I think the last one I , I would say is just how collegial people were and how collaborative. And I just keep hearing that theme over and over again . And I, I felt it , um, but I , but seeing that , um, at a , at a new level, like we were in crisis and people were sharing information, trying to share supplies and resources, and this wasn't like a nine 11 or , um, or a , a , you know, a anthrax attack where you would have like an incident and you would get over it and you'd have to use the resources. I mean, this is ongoing. And so I think that collaboration, I hope continues as well. And is a lesson learned out of this,Speaker 2:
Michael, any, any response there , uh, given your firsthand experience as well to what, what Sarah observed that you were also , uh , observing those kind of specific operational changes that, that , that had to be implemented in the , uh, the support of other healthcare providers?Speaker 4:
Yes, absolutely. And I think , um, you know, Sarah hit on a great point in , and one of the things that I've noticed within our org organization and that I've heard from some of our colleagues in other organizations, is this experience. And particularly at the start of the pandemic, there really was this opportunity to have more communication, direct dialogue with state agencies or, or the public health authorities to be able make sure that really we were sharing information between provider slash, you know, state slash regulator , um , and really drawing upon the resources of both parties to meet the needs of , um, of people. And so I think we, as an organization have certainly tried to continue to maintain those open, you know, the openness of that dialogue. And , um, you know, we now know there are just various reporting requirements that help us document that. But , um , in addition, I think the, the relationships that were fostered during that period with more frequent communication and or something that we now look to as ways to make sure that , um, going forward, there is just a better exchange of information and helping both sides to see where there's access to new supplies or ways to create efficiencies within , um, how we go about planning and preparing for what could be another concern in addition, our organization. And, and I'm sure many others , um, are focused on, you know, making sure that we have a better understanding sort of in real time of what those supply needs are. And , you know , Sarah sort of touched on that as well , um, with some of her comments and that's certainly something that our organization has really focused on prioritizing over the last couple of years. And I personally have witnessed just from my place in the organization. Um, I've seen our team make improvements there and using technology to help our organization and really all the sites that we serve better monitor to , and, and adjust to the needs of employees and residents , um , with respect to VP . So looking at the flow and usage and predicting now based upon outbreaks with insights , um, what some ne needs might be. So , um , we've really, I think made a lot of progress as realization , um , to try and get a better sense in real time of what that looks like. And I think a lot of that was, you know, directly attributable to the pandemic because in the past there really wasn't that sense of urge. You could wait an extra day or two for a delivery of masks because you probably had a couple boxes on site , but , um, you know, it's, it's a different, different world now.Speaker 2:
Absolutely. And you, you emphasize the word now because , uh, we , we don't speak of the pandemic in the past tense. Uh , it is still very, it's evolving , uh , new challenges every day . So this is where I ask you all to look into your crystal balls and , uh , provide any thoughts that you have in terms of 2022 , uh , for , for the rest of 2022 , what are those additional things that appear to be on the horizon , uh , changes , um, that providers need to be ready for, or, or prepared for that we haven't talked about yet?Speaker 3:
Yeah , I'll start with there . I can go . Yeah , I can go first. I think the biggest one that I keep hearing and the one I've been thinking a lot about is this idea of burnout and compassion, fatigue. Um, the idea that our supply chain distribution issues and concerns disruptions are impacting our clinicians, our frontline workers and other workers, and that that's gonna have a ripple effect after the pandemic, if the , whenever after is or D or 2022, if we're still considered in the pandemic, because we are seeing people retire, we're seeing the great resign we're seeing. Um , we're seeing people change their jobs because they don't necessarily wanna protect , be in a care setting. And then I also wonder how will this will impact people that are considering going into that profession? Um , maybe it will be like a card call to , to action for some people, but it may also be a , maybe I don't wanna quite do this either, or I don't wanna necessarily be in that care setting and, and just the , the burnout and , and a lot of that really had to do with when I , when I talked to physicians that are my clients or friends, what I hear over and over again is we didn't have what we needed, whether that was a nurse, a mask , um, a particular, you know, supply for a , a pediatric surgery , um, whatever it was, they didn't have what they needed. And I think healthcare workers are, you know, they , they they're drawn to, to doing the right thing and, and working. And they're fine. A lot of 'em are fine in being these in these bad situations, but they're not okay. Not , not having , it's hard to not have the resources. And, and so we've seen standard crisis standard of care being implemented. We've seen this because of the supply chain distribution. So, you know, it's, it's one thing like if you think about like , how did get here, it's like one little thing in the supply chain can get to the point where there's a , a , a child that needs surgery and they can't get it. Or there's a resident at Michael's facility that doesn't have what they need. And it could just be something as simple as the one little thing didn't get produced that has to go into the thing. Like if we think about like a washing machine, there was a disruption on washing machines and they were missing a chip. And so the whole washing machine didn't go out. We also saw like, people, just, people are getting sick. The people that are driving the trucks, the, you know, the supplies are made overseas and maybe not here, and we're relying on them to get into port. And so, you know , as we see the other variants go through, it's impacting workers outside of healthcare that ultimately help or hurt supply chain in healthcare . So , um, I think, you know, compassion, fatigue, and what will happen with these variants and, and our response to public health, even after in 2020 or after the pandemic, we'll , we'll have a big impact on supply chain in healthcare .Speaker 2:
That's a great point , Sarah , because I'm definitely hearing that the impacts of one issue supply chain is, are from providers, are impacting , uh, the satisfaction, especially on the clinical staff and the challenges that are already present from a labor market perspective. We have , that's a phenomenal point. You make Michael, I'll give you the opportunity as well.Speaker 4:
One of the things that I'm hopeful for is that this is an opportunity for , um, organizations, people to innovate and create new ways to protect , um, our employees and our residents. And it concerns me , um, that disruptions and supply chain might impact that. Uh , because I know that that's one of the things that's important to helping to make sure that we have the caregivers available to provide the care. And , um, you know, really going back to what Sarah said, that the staffing challenges that all organizations face right now in healthcare really are, are I think unprecedented. And they always have been challenging and now more than ever. And so finding ways to make life easier for people and particularly the people who provide care is really what , um , is the focus for us as an organization and where I hope that there are some opportunities for innovation , um, and where we might see , um, you know, suppliers of PPE , finding ways to innovate, be more efficient with , um, the resources that they have and still, you know, creating equipment that can protect an individual, but at the same time, provide some level of comfort or, or a bit more comfort to them . So , um, that's my hope. And , uh, we'll , we'll see if that, if any of that comes fruition in 22 ,Speaker 3:
Uh , I'd like to add to that since I , we can end on a more opt , you know , an optimistic note, you know, we did see supply chain dis like disruptions actually impact like, and push for digital health and some other . So I think there are some positives that came out of it. Um, I don't, I hope that those get pushed forward, not because we still are having supply chain , um , issues, but because we saw the value of it. And so I, I like to piggyback off of what Michael said about innovation , um , you know, pandemic really highlighted issues that we already had in healthcare and really like shined a light on them. A lot of us already knew like health equity and getting the right places , get the person to the right care, set, all those things. We already knew if you're in healthcare . Um, but I hope that we can use the lessons learned to innovate and , and to , uh , and to make healthcare better if we can. And it doesn't look like this is going away. I mean, we're not the health, we're not the public health physicians out there, but it , it , it's looking like we're gonna , it's gonna be around in some form in some way impacting our lives. And so I hope it , I hope we can find some way to take the , the good out of it and, and innovate and, and move healthcare forward.Speaker 2:
Great point , Sarah . Well, I wanna thank Sarah Michael for joining us today . Thank you for your insights. Very valuable. Thank you again.Speaker 3:
Thank you for having us.Speaker 4:
Thanks for having us.Speaker 1:
Thank you for listening. If you enjoy this episode, be sure to subscribe to a H L a speaking of health law, wherever you get your podcasts to learn more about ALA and the educational resources available to the health law community, visit American health law.org.