Key Health Law Developments in 2020 and What to Expect in 2021

William Horton, Jones Walker; Judith Waltz, Foley & Lardner; Daniel Murphy, Bradley Arant Boult Cummings; and Serra Schlanger, Hyman Phelps & McNamara, editors of AHLA Federal Health Care Laws and Regulations, speak about key health care happenings in 2020 and what to look forward to in 2021. Topics discussed include emergency use authorizations, Stark and AKS reforms, telehealth, issues surrounding lab developed tests, drug pricing, workforce issues in light of the COVID-19 pandemic, and more. 

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Transcript

Speaker 1: 0:14

Welcome to this latest edition of H l a, speaking of Health Law podcast. I'm Bill Horton. I'm in the Birmingham Alabama office of the Jones Walker Law Firm, and have the pleasure of having three great friends with us today to talk about what's happened in health law in the last year, and what we think is gonna happen in the coming year. It's sort of the genesis of this, uh, I hope most people listening to this are familiar, but for, gosh, something like 20 years now, a H L A has published, uh, I think what is the most comprehensive collection of federal healthcare laws and regulations, uh, outside the US Government Printing Office, uh, which is our now, I guess, four volume, ALA's Federal Healthcare Laws and Regulations book, and which I've had the privilege of, of being the, uh, general editor of for about 11 years now, I guess. And we have subject matter editors who are responsible for the different components of that. And we thought it would be kind of cool to get some of our subject matter editors here to talk about sort of what they've seen this year, what they think they will see next year. And we literally have our, our panel today, uh, spanning from coast to coast. We have Judy Waltz, uh, with Foley and Laer San Francisco office. Uh, we have Dan Murphy with Bradley Aran about a block from my office in Birmingham. And then from Washington DC we have Sarah Sch Langer from Hyman Phelps and McNamara. And with that perspective and that many time zones involved, we should hopefully have some interesting perspectives to offer. And, uh, you know, it's not like this is a year where lots of things have happened in the healthcare universe, I know, but we'll try to, uh, we'll try to find some things to talk about in, in this very strange year. And, and I guess I wanted to throw it out, and I'm gonna pick on Sarah first because Sarah and her firm, uh, do a tremendous amount of work in, uh, in FDA regulation, which is something that I know that I'm not terribly familiar with. I suspect a number of people who may listen to this podcast aren't terribly familiar with it. And all of a sudden, all of my Facebook friends are experts on EUAs. So I've thought it might be interesting to hear a little bit about kind of how the F D A has, uh, handled this unprecedented challenge and this frankly unprecedented public spotlight. And, you know, sort of what, what you've seen there, Sarah, and how, how that has played out in your universe. Universe.

Speaker 2: 3:00

Sure. So thanks for that introduction. And it is, uh, certainly a year for f d A to be, um, all over<laugh> the news and, and, and really at the forefront. Uh, you know, I, I think everybody throws around the term e uua, which, you know, for listeners who haven't read the newspaper today, it's emergency use authorization. And, uh, they, they've certainly been in the, the, the forefront of everyone's minds. But EUAs have actually been around for a little bit. They've been around since, uh, 2000 fours National Defense Authorization Act. Uh, but certainly taken on a greater importance this year. And I, I think one of the things that, that we've seen is just the, the unprecedented number of e u a inquiries and, and communications and things. Um, you know, when there've been previous public health emergencies, think back to Ebola or Zika, um, EUAs were issued in those instances, but where we're talking, you know, maybe a handful, you know, of EUAs here, covid has resulted in something like, you know, 300,000, uh, e u a communications, uh, to f D A in, in, in a, you know, while Covid seems like it's been going on forever, certainly<laugh>, it's a fairly short timeframe from a, from the in, in the greater scheme of things. So, uh, yeah, certainly the, the Covid 19 emergency declaration that allowed, uh, FDA to start issuing EUAs and guidance documents and, and things to allow for products to, to reach the market, it, um, much faster has been a tremendous area of focus this year. Um, I think related to that, that the Prep Act and the Prep Act declarations, which provide protection for, um, providers and, and companies who are offering and using these products have, have really been, um, two key areas that we've been working in.

Speaker 1: 4:58

And I, and I think, uh, um, you know, Judy, another area that, uh, the National Public Health emergency and the Covid Crisis have brought into focus is the also somewhat arcane world of clea regulation. And we've, as, as everyone has tried to get into the COVID testing business, I know there has been a lot of activity there. And a lot of people will try to get their arms around what clea permits and what kind of registrations and certifications you have to have. And tell us a little bit about what you, uh, um, have seen there, if you would.

Speaker 3: 5:40

So, so lab work, as Bill said, has become a big opportunity for a lot of people who've never been doing lab work,<laugh>. And so a lot of questions have come up. The, the CLEA program, CLEA stands for Clinical Laboratory Improvement, um, amendments. And, and it also incorporates the act, and it's basically a partnership between three components of H H s. So, um, F D A, which approves the tests and, and, and in, in, in a world outside of E U a categorizes them, um, C M s, which issues clea certificates at various levels that determine what types of tests you can perform and the C D C, which provides a lot of process and, and, um, other types of contextual, um, advice. So it's been a big question about who can test a lot of confusion, um, at least in the early months about what it meant to be a waived test. There were,<laugh> were a number of, of entities that interpreted that as meaning that you didn't need to have a CLEA certificate, that it was waived. That is not, in fact, what it means. Um, it means that you need to get a certificate of waiver, which is a, a low level, um, lab certificate CMS has, has announced, as of a couple months ago, they've already done about a 170 some odd cease and desist orders for, um, labs or so-called labs that were doing testing without clea certificates or that did not have the appropriate clea. So the first question has been whether what you're doing is, is a test<laugh> or not, and then whether you're doing a test that's been approved, we've also seen some off-label uses of tests, or at least proposals to do so. Um, a lot of very creative proposals have come up over the past few months. We had one entity that had a vet lab that wanted to see if they could do human testing out of, out of that. Um, um, and the answer of course is get a clea certificate<laugh>, and you may be able to do it, but you can't just do it under your vet lab. Um, approvals. So there are other questions that have come up with respect to Clea is, um, um, or our, um, scope of practice. So I know here in California, there was for a while on the, on, on our Department of Public Health website, a specific statement that Phlebotomists did not have the scope of practice to do nasal swabs. And I've always figured there was a story there,<laugh>, but I never heard it. And that, that statement is since, um, been taken down or at least, uh, phrased a bit more euphemistically. So trying to figure out who can do what, um, uh, with respect to this, another question that's come up a lot has to do with what's called pool testing, which is a way of, of, um, doing fewer tests. You don't get an accurate result, you get a, a test for a pool of people. But, um, for example, we had one question about a, a county that was processing, um, jail inmates.<laugh> needed to get them out of the holding area, and with the delays in testing, um, they were really backing up in terms of moving people from, from one place, um, to another. So a pooled testing where you can at least take a small group and say, this five is good, chip them off. Um, it can be appropriate, but that needs to be approved by the, um, by an e uua, as Sarah was just talking about. So a lot of different issues. Now we're starting to see the evolution. Um, uh, I'm working on one issue now involving somebody who didn't do the reporting totally, um, totally accurately. So it, you know, this is gonna evolve as we go on, but it has been a very big business for, for a lot of our clients,

Speaker 1: 9:45

You know, and the other thing not to, not to get, uh, hung up on this topic forever, but I know the other thing that I've seen, uh, is sort of a, a raft of contracts and proposals from various people, essentially about connecting, uh, labs with people who need testing. And I've just seen a fair number of what I would consider to be rather questionable proposed arrangements, particularly in light of Ecra, you know, which still has an over broad reach as far as as marketing for clinical labs. And I think they're, you know, every crisis brings about its entrepreneurs. And, um, um, every crisis also brings out its entrepreneurs who are not necessarily interested in asking for permission, but would prefer to ask for forgiveness. And I think we've certainly seen that. Um, and of course we've had a, um, you know, just in the past several days, a, a huge development in the more general category of, of fraud and abuse regulation. And, and overall, I think, a rather more cheerful one than we sometimes see. And you know, Dan, I'm sure you've had a chance to look over the new Stark and, and any kickback final rules and be very interested in your take on those.

Speaker 4: 11:17

Yeah. And when you haven't been reading about emergency youth authorizations, um, you might have gotten a few hundred emails and summaries about this, um, the regulatory sprint to coordinated care. Um, and if you spent any time looking at those summaries or rules, you'll, you'll know that that's a pretty significant, um, reform of the Stark and Kickback regulations. Also some for the, um, CMP law, beneficiary, anti inducement, um, provisions. But, um, it's really, the, the rules are really the culmination of about a two year process that h h s started in 2018. Um, they kicked it off with a request for information where they gathered comments from the public, um, that they used to create a proposed rule back in 2019, um, in October. And then just before Thanksgiving this year, they published the Final Rule. Um, and the, the goal, the, the goal really, and just pulling from something they said in their final rule, it, it's, it's to transition the healthcare delivery and payment system from fee for service to value-based care. And, um, specifically they said the purpose of the rule making is to remove potential barriers to more effective care coordination and management of patient care and delivery. Um, so, um, at a high level, I, I would say there's a few, there's a few categories of changes in the couple hundred, few hundred pages of rules. Um, the, the first and foremost is a new set of safe harbors and exceptions for value-based arrangements. Um, and I'll, I'll get a little more into that real briefly. Um, second category is stark regulatory reforms to some key definitions and exception. Uh, and, and concepts like fair market value, commercial reasonableness, um, what it means to take into account the volume or value of referrals, things that have really been, you know, kind of a thorn in the side of both CMS as they've been fielding self disclosures and the healthcare bar as we've tried to interpret those things. So some really welcome, uh, clarifications and definitions there. And then, um, another category I would just categorize as a variety of other stark changes that generally make it easier for, uh, for providers to comply with some of the more technical cms, um, stark requirements. So if you, if you ever have a chance to read through that, the Stark rule, you'll see that CMS really gained a lot of experience in, you know, the self-disclosure process over the last several years. And, um, what they found is they were getting a lot of violations and disclosures for things that they thought really didn't, uh, cause a lot of harm to, um, the Medicare program or beneficiaries. So a lot of helpful stuff in the rule to help, um, ease back on and help help providers, you know, find ways to avoid what would otherwise be technical violations. And then there's some, um, there's some miscellaneous other changes that sort of fit in the value-based idea. Um, there's a new, a, a new outcomes-based payment, safe harbor in the kickback statute regulations, um, and some other things. So, um, you know, just a, a last thing on the, um, the value-based safe harbors, it's a pretty, uh, it's a fairly elaborate new idea or construct for, at least for purposes of the safe harbors and the exceptions and, um, will require providers and others to do some kind of building of infrastructure, for lack of a, a better term, um, the creation of a value-based enterprise, for example. But, um, the really interesting thing to me is that when you look at, um, you know, kickback, safe harbors stark exceptions over time, most of the time, uh, not all the time, but most of the time, I would say what the agency's trying to do is protect the arrangements that are commonplace in the industry that already exist. And they realize, you know, we've gotta allow this cuz they're not harmful and it's what their people are doing anyway, um, on, on these value-based safe harbors and exceptions. There, there are precedents for it. There are things like ACOs, clinically integrated networks, but because you really, they've really created a new type of entity out of, uh, uh, regulation. It's a creature of regulation, the value-based enterprise. I think what what HHS has done here is positioned itself to, to be the catalyst for some changes in healthcare delivery and, um, payment. And I think in, you know, 2021 and beyond, we're gonna see a lot of, uh, providers restructuring some legal arrangements, some payer arrangements to, you know, take advantage of these new, um, regulations.

Speaker 1: 16:38

Thanks, Dan. Yeah, and I'd be interested in other people's reactions. I guess one of the things that impressed me in looking at the final rules and, and obviously they're with the preambles, they're long and it's gonna take a while to study, but, uh, there did seem to be a real effort by both C M s and the OIG to recognize that perhaps they had in the past gone a bit overboard on sort of hyper-technical regulation and that, uh, they needed to stop worrying so much about some of the minutiae and, and, you know, conform somewhat more to the realities of healthcare delivery and reimbursement today. And I, I would argue that the Stark rules didn't conform to the reality of, of delivery and reimbursement when they were adopted in 25 years ago. And, you know, certainly have not since then, but I, I really felt like this was a great effort and I've spent more time with the, the stark, uh, rules than with the anti kickback say far, so far. But it was a great effort by C M S and I think also by the OIG to actually be responsive to some of the concerns that had been raised and focus on, you know, an appropriate balance between enforcement priorities and not stifling innovation and cooperation that are, uh, necessary, particularly with this shift of value-based care. So I really may have thought, you know, we can all find things to criticize or complain about and, and certainly this is no exception, but I think overall it was a really positive effort, uh, to be helpful and not simply intimidating, which has sometimes been, I think, the tenor in the past. So I was, I was pleased. What about, I guess one other thing that, uh, um, has had a lot of prominence in the last year, uh, since the pandemic arose is the, the evolution of telehealth regulation. And, and I think one of it's hard to say, well, there was something positive about a pandemic, but to the extent there was one, is it really, uh, in my view has become a, uh, almost a clinical lab test of things that can be done with telehealth, uh, that from a regulatory standpoint had not been permitted before the waivers went into effect. What have, what have y'all seen about that? What do you think, what do you think we're seeing going forward in the, in the, the telehealth area?

Speaker 3: 19:20

So this, this is Judy and I just have to comment and I have a little bit of bias because I, I was with the office of the Regional Council for h h s for, for 17 years, um, or at least with h h s 12 years in, in O G C, I really think that c m s needs to be commended for all its efforts under the pandemic, uh, not just on telehealth, but they have made an incredible number of accommodations for, um, that help get care provided, um, and have given up on some of the things that were more technicalities. I think it's been most prevalent in the telehealth space. And, and I think with the recent, um, physician fee schedule, we see that a lot of those changes are going to stick. Um, although CMS has said, um, someplace that, that they think they've gone as far as they can go now without, um, more help from Congress in terms of some statutory changes, but it's, it's not just in telehealth. You know, if you look at the hospital at home issues, some of the, um, some of the provisions that, you know, required some paperwork or face-to-face visits that are now allowed by telehealth, um, to me, this, and I say this, you know, coming from a background at, at H H S change is generally not easy<laugh> for the agency. And, and the pandemic has really, um, encouraged and allowed C M S to, um, to make some changes that probably would've taken years otherwise to come about, if ever, um, and they've come about in a very short period of time. So I, I think that part has been both exciting for us as health lawyers and, and, um, you know, just, it is just been really good for healthcare delivery overall.

Speaker 4: 21:24

Yeah. Um, and I agree with Judy. And one, one other interesting thing is the, to, to me, the convergence of all this value-based care, um, movement and telehealth during the pandemic. I mean, a lot of, um, a lot of what we see in the value-based care, regulatory changes, even, you know, reimbursement changes in the last two years have been, um, have involved telehealth, um, have involved telehealth, uh, access to care for patients, um, lowering costs, things like that. And so when we were all forced into, when our clients were all forced into this mass experiment on telehealth, I think it sort of was one in one way accelerated, um, this value-based care push. And, you know, it'll be interesting to see how much of the telehealth, um, waivers and other accommodations stick. I think a ju as Judy pointed out, you know, some good signs from the, uh, fee schedule rule for 2021, but, um, you know, now that providers see they can do it, uh, a lot of patients see they like it. It'll be interesting to see, um, hopefully a lot of it sticks.

Speaker 1: 22:37

You know, I do have to recount, I have, uh, represented a number of physicians, and I was talking with one of my physician clients a couple of months ago, and he, he was recounting this experience where the telehealth appointment set with one of his patients. He called the patient and the patient said, well, do you want me to come on back now? And the doctor said, what? And she said, well, I'm sitting here in your lobby. And apparently he didn't entirely understand the full scope of telehealth. So it's a learning curve, but it certainly, I think has changed, uh, sort of the patient expectations in some way and, and, and, uh, concepts of how we can perhaps make care more timely and convenient. Um, Sarah, what are you, what are you seeing in terms of trends that you think have some staying power?

Speaker 2: 23:32

Well, I think, you know, related to the idea of, um, you know, telehealth, we're also seeing on the F d A side, and, and this has been started a few years ago, but certainly picked up steam this year. Um, F d A has a new center of excellence for digital health. And so the agency now has made sort of a, an explicit, um, commitment and a center that's going to focus on digital health issues. So, uh, certainly it seems as a, I mean, we're all doing this, uh, podcast recording through Zoom. Everybody's life is digital at this point. And, and now the agency has sent, um, set up a center that's going to, to really streamline or, or attempt to streamline the issues that face, uh, manufacturers and, and, and companies that are working in the digital health space. Um, and I think we'll continue to see that growing. Um, I don't think apps are going anywhere<laugh> or, or, uh, or are gonna slow down. And now that folks are, um, really exploring how we can use digital health technologies, that's going to continue. Um, I think, uh, and I'd be curious what Judy's thoughts are on this. Um, there's a, a little bit of a controversy that's bubbled up. You know, lab testing, as Judy mentioned, has been certainly at the front of, uh, the covid issues. Uh, and, and there's a, a I'll, I'll call it a controversy maybe about how laboratory developed tests are going to be handled in the future. Um, you know, f d A for, oh gosh, 20 plus years now, has said they have authority over LDTs as they're called. And, uh, they, you know, then h h s in in August came out and said, F D A doesn't have the, that authority really, uh,<laugh>. They, they, they need to do some notice and comment rulemaking in that regard. So, um, how lab tests are going to be regulated in the future, I think is another, uh, area that I'm certainly watching. And then, um, you know, I think the third thing I'm watching is, you know, various efforts on drug pricing. Um, you know, how, how the new administration is going to handle some of the changes that have been started. Uh, this year there were, um, rules passed for importation of drugs from Canada or other countries. Uh, there was the recent most favored nation model proposed. Um, uh, both, both of those are now being challenged, but, um, with lawsuits. But, uh, I think drug pricing is another area that I'm certainly keeping my eye on.

Speaker 1: 26:11

Let me, let me throw out, uh, also just a couple of things that I think are gonna be interesting to watch for the future that have, uh, I think perhaps not gotten the same level of focus, because they frankly don't have the same urgency as some of what we talked about. But, you know, I've still gotta dig into this, but, but last week, while everyone was talking about Stark and, and Annie Kickback rule making, h h s also finalized, its so-called good guidance practices, final Rule, dealing with H H S's ability to rely on subregulatory guidance. And, you know, one of the things that has, uh, always been kind of fascinating about the area in which we work is the, the very, and I shouldn't say this in, in when we were talking about the laws in reg's book, but the, the very limited utility of actually pulling down the US code or the CFRs and trying to figure out how healthcare is actually regulated. Because in practice we have to know so much from preambles, not just preambles to final rules, but the proposed rules, and from advisory opinions and from speeches made at conferences and on webinars, um, and it, you know, this, this rule would, in response to, uh, the Azar against a line of health services Supreme Court case, you know, it's gonna be interesting to see how that plays out. Um, and the degree to which, uh, some of the things that have been passed, uh, have in the past been, you know, effectively added to laws and regs via preamble comments, uh, end up go now having to go through notice and comment making. And sort of the other side of that coin is, is the proposed rule, um, that came out this fall, uh, in the, you know, in the never ending quest to give things weird names that will make acronyms. This is the securing updated and necessary statutory evaluations timely, uh, rule the Sunset rule, uh, which is, you know, part of, you know, uh, the Trump administration's desire to say, we're cutting back on regulatory burdens that essentially says that h h s if the rules adopted, h h s would've to periodically assess all of its regulations to determine if they were subject to the regulatory flexibility Act. Uh, if they are perform a review that satisfies the criteria act. Uh, and if that review is not performed, then after a varying period of time, depending on, uh, several factors, the rules would automatically sunset. Um, and I know I was involved in, in the submission of some comments on that, and, you know, the, the consensus of the, our group was that, gee, this could be a nightmare because we have so many interlocking regulations, and if, if something were to inadvertently, uh, sunset because the review didn't get conducted in a timely fashion, that could really be, uh, something that had a real domino effect in, in healthcare regulation<affirmative>. And so there's been, uh, I, I think it is fair to say there have been a lot of ideas, some of them pandemic driven, and some of'em just political philosophy driven coming out of this administration about the nature of regulation and healthcare and sort of seeing how those play out over the next year and after can be pretty exciting. And I would, I would qualify that by saying, exciting is not always the same as fun or good, but we'll see. Any, any other big picture trends? Uh, we're getting near the end of our time here, but anything, anything else you particularly see coming down the horizon that people ought to be watching out for?

Speaker 3: 30:23

Well, I agree with Sarah that that drug pricing is gonna be a huge deal. I personally, and this is just my personal view, I don't think the existing proposals are going to do exactly what they're intended to do.<laugh>. And, and, you know, with, with respect to the importation, for example, you know, Canada's not all that keen<laugh> us taking their drugs, um, and using them here. So, so long term, I don't know that these are going to be solutions, but a and, and you can sort of see the dichotomy here, how anxious we've been for vaccine and we've thrown a lot of money at vaccine development and it's worked and, you know, thank God it's worked and now we're all excited to have it. But if we start imposing price, um, price restrictions and, uh, I mean, somehow we have to reach a balance between what we want in terms of, of new drug development and, and a control over, um, the cost to the people who need these drugs. And that, unfortunately, I don't have an easy solution for that, um, myself. Um, but I do think that that's just gonna be a real, a, a real debate in the years, um, going forward.

Speaker 4: 31:48

I had 1, 1, 1 hopefully optimistic trend I'd like to see, and we hope, hope is coming up soon, is that the public health emergency will end one day, hopefully not too far off in the future. And, um, I think a lot of us, um, have, have, and our clients have structured some operations and business arrangements that rely on waivers, uh, issued, um, for the public health emergency. And so one thing I think, um, hopefully we'll soon have to start thinking about do we have to unwind those arrangements? Do we have to restructure preparing for that? Um, you know, some things that won't, will be physically and operationally difficult, like if you've converted an ASC for hospital space or, um, you know, uh, for stark purposes using the in-office ancillary exception to provide services some places you might not be able to when the waivers end. So, um, I'm, that's, that's an unwinding process I'm greatly looking forward to.

Speaker 2: 32:53

I think, you know, related to that, um, all of these products that have now received EUAs, those are tied to that public health emergency. And so once, you know, again, fingers crossed it is over, um, how those products and, and the, the companies that have those products on the market are going to handle, um, you know, are are we going to see companies going through the more formal approval or clearance process with F FDA to get to keep those products on the market, or, um, you know, how those products are gonna be handled once the emergency ends is, is something that, uh, you know, will, will also be tracking.

Speaker 1: 33:32

And I, and I guess one other thing related to what you all have said that I think will be interesting to watch, uh, the, the public health emergency I think has really, uh, uh, raised the, the, the visibility of, of the multi-layered nature of healthcare regulation, and in particular the, the sort of separate but overlapping universes of federal reimbursement regulation and state licensure and scope of practice regulation. And, and, you know, when, uh, uh, h h s acted very promptly, uh, when the public health emergency, uh, was declared to, you know, introduce all kinds of flexibility from a standpoint of what they would permit and reimburse for, uh, and I know a lot of clients were a little disconcerted to be told that, well, you still have to figure out if your state will let you actually do this, even though you know, it can be paid for by Medicare, that doesn't mean that you actually are legally permitted to do it under your state laws. And, and I would love to, I mean, our, our, I'm of the view that our scope of practice laws, you know, need a good revamping because they are, you know, they're frankly creatures of a long time ago that haven't changed very much. And I'm hoping that this will give us a chance to focus a little bit more on balancing state protection interests and advances in how healthcare is delivered. Real, real quickly, just before we close here, uh, I wanna get back to you all, um, as, as I think Sarah mentioned, we're all kind of living on Zoom these days, and I, I look at our panel and I see people who are in their offices and people who are in their home offices, and we've all, I think probably zoomed with various cats and dogs and small children, uh, this has not been the easiest time, time in the world to work. And, you know, how have you all, how are you all doing? How have you been coping with all the changes that we've gone through? Are you ever gonna go back to the office again if you're not in the office now?

Speaker 3: 35:50

So this is Judy and I'm in California where, um, at the moment we have a pretty strict, um, shutdown. And in fact, my office has been closed since March, completely closed. So if anyone, um, has to go in, we have to get a special approval to do so. We ha we do have somebody that goes in and checks for mail and, you know, can send us, like, for me, the books that I've decided that I can't live without, um, but it actually has not been that bad. You know, it's been, I mean, I, I did invest in some new technology. I got an additional screen for, uh,<laugh> for my computer and things of that sort. But, um, I doubt that we are going to go and I, I'm not sure this is my firm's, um,<laugh>, my firm's official view, but I, I doubt that we are going to go back at least here in California in large, um, numbers to the office, even when we can

Speaker 4: 36:53

Bill in, I'm, I'm a block away from you in Birmingham, Alabama. So we're in a little different situation, um, probably than some parts of the country. Um, our, our kids, I have kids who are nine years old and they went back to school in person in August and have thankfully been able to stay there. Um, and so, um, but I will say that the, the biggest, the hardest part for us has been my wife's also a lawyer. And, um, practicing law with, with, um, young children in the same place as you're working was really hard. So, um, I'm hoping not to go back to that situation again.

Speaker 2: 37:35

Yeah, I think our office has taken an approach where we, uh, you know, if folks need to go in, we have a, a method for them to do that. Um, and so I think we'll, we'll continue to see that flexibility. Um, but, you know, I think one of the things Zoom is, is certainly great. Um, and it's nice to see folks who you wouldn't normally see because they're, you know, in California or across the country. So, um, having that opportunity is great. But you, you, you know, I think, uh, especially in in health law where things are changing and, and as you mentioned, there are so many interlock, locking and overlapping, um, things, one of the things I'm missing about not being in the office is that, you know, option of popping my head into my colleagues, uh, office and saying, you know, I heard this, do, have you heard the same thing? Um, which is a little hard to, to mimic on Zoom, uh, just cuz you can't talk over each other quite as easily and, uh, you can't really pop your head into somebody else's zoom box.

Speaker 1: 38:32

Yeah. And I, and I will say from my own standpoint, one of the things that has really, uh, I think been the hardest for me to deal with is I have thankfully a tremendous number of friends in the health law community that I am typically going to see at least once and in some cases several times a year at conferences, at seminars. And I've got, you know, really good friends that I, you know, will now not have seen in more than a year and may not see until maybe next summer if things are lucky. And that's just hard because I, this is a great community and it's really hard not to, not to see the people that you enjoy exchanging ideas with and, and having a, a sandwich or a drink with. But it's great that h l a gives us these opportunities to at least share virtually. And, and with that, I want to thank all of you, Judy, Walt, Stan Murphy, Sarah Slinger for, uh, spending some time today to talk about what we've seen, what we think is to come. And one thing that I think we can say for sure is, um, well, I hope, I hope we can say two things for sure. One is I hope we can say that next year will be better all around than this year. But two, I think we can definitely say that in the healthcare world next year is going to continue to be interesting and continue to provide, uh, new challenges and thankfully new opportunities for healthcare lawyers. So thank y'all for being with us today, and I hope we get to see each other in person sooner rather than later.