Libby Park: Hello, everyone and welcome to the Healthcare Real Estate Advisor podcast. I’m Libby Park, an attorney with Hall Render, the largest healthcare focused law firm in the country. Today we will be speaking with John Williams. John is an attorney with Hall Render and based out of our Washington, D.C. office. I consider John a resource on all things healthcare related at the federal level.

Libby Park: Today we’ll talk with John about the post-election outlook for healthcare in the United States. John is a seasoned veteran in the healthcare industry and he has a great story to tell us today about his career and also what’s happening in D.C.

Libby Park: John, thanks for joining me today.

John Williams: Great to be with you, Libby.

Libby Park: John, before we talk about the post-election outlook, let’s talk about your background. Tell us where you’re from, where you went to school and what you aspired to be.

John Williams: Well, born in Indianapolis, Indiana, raised in Galveston, Texas until I was 16, back to Indianapolis where I finished high school and then went to Embry-Riddle University in Daytona Beach, Florida where I intended to be a commercial airline pilot.

John Williams: When I got out of college in 1992 the airline industry had suffered a number of bankruptcies. Pan Am, Eastern, Midway had all gone out of business and you couldn’t find a flying job and so I ended up looking elsewhere and meandered my way into politics, like so many young people before me and after me.

John Williams: Somebody said to me, “You need to go to work on a political campaign.” And so I ended going to work for the mayor of Indianapolis, who at the time was Steve Goldsmith and my job was to drive Steve around and be what they refer to as his body guy. So I did that, bounced around with some other campaigns, did some work at the Indiana State House and then eventually when Republicans took over the House of Representatives in 1994, subsequent to that I went to Washington.

John Williams: Again, like many before and after me who had done campaign work and then ended up making their way to D.C. So I worked on Capitol Hill as a Congressional staffer, mostly at the House Committee on Government Reform and Oversight, where I served as the press secretary, but I also served a policy role for the chairman of the committee. So in that role I covered issues like Social Security, Medicare, Medicaid and that was my first real, real taste of healthcare policy.

Libby Park: So then how did you transition into more fully focused healthcare work.

John Williams: I went to law school in Washington at night while I lobbied during the day for the Aircraft Owners and Pilots Association. So my parents were thrilled that I was actually using my undergraduate degree for something. It came to the point, as for many lawyers, where you have to decide where you’re going to take the bar exam and I realized that if I took the bar exam in Virginia where I was living that I was going to stay in D.C. probably for the rest of my life.

John Williams: And so I was engaged at the time and really in transition and used that as the opportunity to come back to Indiana. And my initial course in Washington at that point had run and I was ready to go and I was done with politics at that point. And so I moved back to Indianapolis, got married and started at Hall Render and that would have been in 2003. I started at Hall Render as a litigator doing medical malpractice and other healthcare defense work, largely because that was as far away from politics that I could humanly get myself, which was my desire at that point.

John Williams: But politics is like the Mafia, in that you never really get out and so along the way I did some things like when Mitch Daniels was elected governor of Indiana I ran the transition for the Indiana State Department of Health for Mitch. We had a Republican mayor in Indianapolis get elected at one point, Greg Ballard, and I helped to the transition of the mayor’s office for him. So I stayed active here and there.

John Williams: And then it just so happened that about eight and a half years into it I had actually made shareholder and it interestingly coincided with the time that Mitch Daniels was deciding not to run for President of the United States, which a lot of us had expected him to do, and had become somewhat invested in that idea. That coincided with the leadership change at Hall Render where John Render retired and Bill Thompson became the chairman, John Ryan became the president and we instituted a growth strategy that happened to include opening an office in Washington.

John Williams: So I decided to take on the task of opening a Washington, D.C. office and dived back into healthcare policy and that’s where I’ve been ever since.

Libby Park: I am learning a lot about you today as well, John, because you have a very interesting background. Before we jump into our specific healthcare topics I have a very important question, do you still fly planes?

John Williams: I do. As a matter of fact. I belong to a flying club in Indianapolis and still fly somewhere between 30 and 50 hours a year. So that’s one thing that I have not given up on.

Libby Park: Great. Well, thanks, John, for sharing about your background. Let’s jump into some topics that we would like to cover today. So as of the recording of this podcast Joe Biden has been declared the winner of the election and is poised to become the 46th President of the U.S. Can you tell us what the atmosphere is like in D.C. with this recent news?

John Williams: I keep telling myself that I’m not going to use the word unprecedented any more but it’s 2020 and all that so it’s hard not to. The atmosphere in D.C. today is really unlike any other in history because of the pandemic.

John Williams: For people who do what I do, being on Capitol Hill, meeting with members and staff, being in Congressional offices and hearing rooms is vital but Capitol Hill’s been closed to the public for months, I think since March, and D.C. as a whole has almost become a ghost town, almost like New York. So D.C. is unlike any other time that anyone can really remember.

John Williams: As far as the transition goes, on the one hand you’ve got an incoming administration that’s doing all the typical things that an incoming administration does, making Cabinet appointments, making White House staff appointments, putting things in place to take office in January.

John Williams: And then on the other hand, you’ve got an outgoing administration that’s refusing, to a large extent, to accept the results of the election, which again is unprecedented. So you’ve got that playing out on one side and then on the other side you’ve got President-elect Biden who’s doing all the things that you traditionally do to put a new administration into place.

Libby Park: Let’s jump to another topic. On November 20th, the Centers for Medicare and Medicaid, CMS and the Office of Inspector General released long awaited Final Rules under the Federal Stark Anti-Kickback and Civil Monetary Penalties Laws. What’s been the response in Washington to the release of these Final Rules?

John Williams: The response has been great and we’re thrilled as a law firm for that. One of the first things that we did when we opened our office in Washington, D.C. was undertake an effort to reform Stark and eight years ago we would travel to Capitol Hill to have meetings with congressional staff and say, “Hi, we’re here to talk about the Stark Law.” We would get this deer-in-headlights look because Stark, as everyone who’s probably listening to this knows, is so convoluted and it’s so confusing.

John Williams: In the time since then we’ve had some success in terms of getting some changes to Stark made. From a regulatory perspective in the 2016 physician fee schedule we were successful in getting some changes there as far as the writing requirements are concerned and some other technical issues. And then we were able to get those changes codified into the statute, subsequently to that in 2018.

John Williams: So Stark is something that we’ve been working on for a long time and when this administration came in and Seema Verma became administrator of CMS, because she’s from Indiana and so many of us have known her for so long, we jumped at the opportunity to encourage her to take on Stark reform and so she in fact asked us to prepare recommendations for her on what they should consider pursuing and so we did.

John Williams: And those things included things like defining commercial reasonableness or what it means to take into account and creating a rebuttable presumption for fair market value. So we were thrilled to see CMS take a lot of this stuff into consideration. Rebuttable presumption, they obviously did not but the reception so far to what’s been produced has been great. We’re thrilled that they’re able to get it out the door before this administration ends and the response, I think from the industry has been favorable and the response on Capitol Hill’s been favorable.

John Williams: We’ve had members of Congress from both parties praise the administration’s work on Stark and anti-kickbacks. So it’s been great. It’s been great. Now as you well know they’re both long and very convoluted and confusing so we’re still working through it and we may not be as thrilled once we are able to analyze the details of it. But, no, to this point we’re really pleased.

Libby Park: Okay, great. Well thank you for that update. I know that Hall Render has been digesting and processing those rules since they came out and hosted a webinar yesterday in a round table format that discussed these Final Rules and if any listeners of the podcast are interested in that webinar it is available on our website at hallrender.com. So take a look at that.

Libby Park: And, John, can you tell us about the COVID special package? What is this and what should we expect from this?

John Williams: Yeah, there’s two things that are happening right now as far as legislation on Capitol Hill is concerned. One, funding for the federal government expires on December 11th. Congress funds the federal government on an annual basis and the last funding legislation expires on December 11th. So Congress must renew that or else we begin to default on our loans and a whole lot of other nasty things happen. So they’ve got to deal with that on the one hand.

John Williams: The other thing is obviously COVID relief and what are they going to do and that has been in a real big stalemate for weeks, even since the election there hasn’t been a lot of action on COVID. That’s changed significantly in just the last 48 hours. And so in the last 48 hours obviously we know that government funding has got to get done and appropriators on the Capitol Hill are working through that right now.

John Williams: We don’t know what the funding levels for each federal agency are going to be. We know that some things might get added to that, non-COVID related. For example, there’s talk about trying to put surprise medical billing legislation into the year end package. I know people are lobbying for that. I don’t think they’re going to be successful because there still isn’t consensus in the House of Representatives on what that should be but I just want to let everybody know that it is out there.

John Williams: But what we’re now hearing in the last 48 hours is that the leadership on Capitol Hill wants to use the government funding bill as a vehicle, what we call a vehicle, to put all the COVID relief language into. And so what you’ve seen this week is you’ve seen different pockets come out with their own COVID proposals. So for example, on the one hand, Senate majority leader, Mitch McConnell has rereleased really what the Senate passed back in September with some adjustments to funding levels for things like unemployment insurance and PPP. He’s tweaked those a little bit but otherwise it essentially remains the same.

John Williams: What everybody is really talking about in the last 24 hours is this bipartisan group of senators and also members of what’s called the House Problem Solvers Caucus, which is 50 members from both parties in the House. They have come together and reached the framework of a deal that would provide $980 billion in COVID relief and that would be spread out in a lot of different areas. Again, it’s the framework right now. So Washington is very much a the devil is in the details type of place so we’re really not going to know where they are until they reduce it to what we call legislative language. They put it in bill form.

John Williams: But right now they’re talking about an extra $300 a week add-on for unemployment insurance, which is lower than the $600 that’s been in existence for quite some time. More money for PPP, a temporary liability shield, which I know a lot of hospitals and other providers are interested in as well as a whole bunch of different industries. $50 billion for vaccine distribution. We’re also hearing that there’s $35 billion in there that would go into the CARES Act provider relief fund.

John Williams: So in other words, more money for hospitals. Now, that’s in the Problem Solvers Caucus bill, this bipartisan proposal. I can’t even call it a bill because it’s not a bill yet. That’s in there. That’s not in McConnell’s proposal. And then on the other hand, we’ve got Speaker Pelosi talking to Treasury Secretary Mnuchin about a deal between them and the White House. So there’s a lot of moving parts to all of this but I think what I can say is we’re seeing more action on COVID relief in the last 48 hours than we’ve seen in the last month.

John Williams: And there’s a recognition in Washington that they’ve got to get something done and no group of people play chicken more than the members of Congress. That’s why everything gets done at the last second. So as I sit right now I think there is a good chance that you’re going to see targeted COVID relief be part of the year-end spending bill that gets passed on December 11th.

John Williams: But I could be wrong. God knows I have been before so…

Libby Park: Well we never know until we know, right?

John Williams: Right. Exactly. Exactly.

Libby Park: Interesting. Well, let’s shift then to a hospital focus. You said potentially this Problem Solvers bill could have earmarked $35 billion towards hospitals, maybe something like the CARES Act type funding that we’ve seen but what should hospitals expect even up … not necessarily through December 11th or in the coming weeks but in the next few years as the administration changes and a second question on that, what is the future of the 340B drug pricing program?

John Williams: So in terms of the Biden administration’s healthcare priorities and Capitol Hill are concerned it’s going to come down to what happens in the Georgia run-offs in January. There are two seats that need to be filled out from there. If Republicans hold at least one of those two seats, which I expect that they will at least one, perhaps two, they’ll keep control of the Senate. Republican control of the Senate means things like Medicare for All, adding a public option to the ACA, the Green New Deal, things that President-elect Biden talked about a lot on the campaign trail are complete non-starters. They’re not going to happen.

John Williams: Republicans in the Senate will never go for that. So the focus then shifts to what a Biden administration can do from a regulatory perspective and that is going to focus a lot right out of the gate on undoing a lot of what the Trump administration has done from a regulatory perspective. I think one of the first things … well, the first thing that you’re going to see happen because it happens in every administration is the incoming Chief of Staff, who in this case is Ron Klein, is going to issue a memorandum to all federal agencies instructing them to freeze work on any unfinished rule.

John Williams: So that’s going to take place first. So if something isn’t done by that point then it’s going to get frozen. And when I say done, it means that there’s got to be a certain amount of time too for implementation that has to pass. So if that clock hasn’t run then that’s going to be a problem for a lot of unfinished rules. And again, every administration does that.

John Williams: The second thing I think you’re going to see happen is that Biden is going to do what Trump did in terms of going to the Oval Office on the day that he’s sworn in and start issuing some executive orders and I think that one of the first executive orders you’re going to see is going to be directed at what’s going to be his biggest priority and that’s shoring up the ACA. So I think you’re going to see Biden issue an executive order that reopens enrollment for the Affordable Care Act.

John Williams: My understanding is that closes on December 15th but Biden can use the public health emergency as an excuse, a reason, justification for issuing an executive order to immediately reopen enrollment for the Affordable Care Act. So there’s one thing that he could do. He could also start using the public health emergency to direct monies to things like increased marketing for enrollment, funding navigators to help with enrollment. These are things that the Trump administration drained money from. They didn’t market enrollment. It was their way of trying to starve the ACA to death.

John Williams: So you’re going to see Biden reverse those. One of the interesting things that people are talking about is whether or not he can actually move money around from different federal agencies to do things like increase subsidies for the ACA without having to go to Congress in order to do that or even to go through the rule making process to do that and I think you’re going to see the Biden administration look to some of the Trump administration moves for around things like the border wall where the Trump administration moved money around internally from agency to agency in order to fund construction of the border wall because Congress wouldn’t fund it.

John Williams: So I think you’re going to see the Biden administration use that precedent to try to do things like increase subsidies. Beyond that, actions to reverse other Trump administration regulations are going to have to go through the traditional rule making process. So that means notice and comment, that means it takes time, right? That could take up to a year in some cases.

John Williams: So if you want to talk about things like reversing the funding cuts for Planned Parenthood or other abortion providers, rolling back the contraception mandate coverage stuff from the ACA, the anti-discrimination rules for transgender patients, even eliminating the Medicaid work requirements in some states, which were done under waiver, that’s going to take time if they want to try to reverse those things.

John Williams: So the Biden administration is going to have their hands full from an administrative standpoint undoing what they want to undo from the Trump administration. So that’s where the focus is going to be and it could be for the first couple of years. Beyond that, what they want to do from a regulatory perspective is a guessing game right now because nobody really knows because there’s just so much to do in terms of rolling back the Trump administration’s regulations.

Libby Park: Okay. Well, thanks for your thoughts on that and definitely sounds like there is a lot to do. I know that some of our listeners are likely pretty interested in the future of the 340B Drug Pricing Program.

John Williams: Right.

Libby Park: Do you have any intel on what may be happening with that in the short term and the long term?

John Williams: Well, I think as a general rule the Biden administration is going to be much more favorable to 340B than the Trump administration has been. It’s no secret in Washington that pharma hates 340B and they took advantage of the, I guess, if you will, pro business position of the Trump administration to try to really do damage to the 340B Program and you saw that with significant cuts to 340B and in other regulatory actions.

John Williams: So I think that 340B entities can feel more comfortable that they’re not going to get additional cuts from a Biden administration. They could see a rollback of some of the cuts that were made by the Trump administration and just a general overall positive attitude or more positive attitude towards 340B. It’s a controversial issue on Capitol Hill too. The overall growth of the program in the last 10 years has gotten an awful lot of attention.

John Williams: So I think you’re still going to see folks in Washington looking at issues like transparency within 340B Program. “Where does your money go?” I know that we’ve gotten that question a lot from members of Congress when we would go to the Hill to represent our 340B clients. Simply, “Tell me where your money goes? Where does the money go? What do you spend the money on?” I don’t think that’s going to go away necessarily but I think that the Biden administration is going to be much, much less likely to propose additional cuts to 340B.

Libby Park: Okay. Thanks for your thoughts on that, John. And do you foresee any additional challenges or restrictions in regard to physician owned hospitals?

John Williams: This is another controversial issue in Washington. I know that we saw some relaxing of the rules, right, in … during COVID, during the pandemic. Let me put it to you this way, when Republicans controlled the White house, the House and the Senate, if they were not able to roll back the moratorium on physician owned hospitals I don’t know how it’s going to happen otherwise.

John Williams: American Hospital Association and a whole host of others are adamantly opposed to that. It is a huge issue for them and they will lobby hard against any rollback of that moratorium. And that moratorium you’ve got to remember, right, it was part of the ACA. So Democrats are not in favor of rolling back physician owned hospital moratoriums. So unfortunately for folks in that sector I really don’t see any changes coming. That train left the station when Republicans were in control and they didn’t get it even done.

Libby Park: Okay. I’ve got a couple more topics here, two more questions I’d like to ask you, John.

John Williams: Sure.

Libby Park: So have you heard anything on the life sciences front and do you anticipate there will be more or less funding from the National Institutes of Health?

John Williams: Everything is going to focus around the pandemic, right, and so NIH is one of those entities in Washington that’s as much as anything can be noncontroversial because lawmakers can make anything controversial these days, it’s NIH and NIH has really had fairly broad support amongst both parties for quite a long time.

John Williams: When we’ve seen healthcare funding bills come out of Capitol Hill you see cuts to site neutral payments and these other things but for some reason, not for some reason, for the reason that people like the NIH on Capitol Hill, it gets more money.

John Williams: So I do think that you’re going to see more money go into NIH during a Biden administration. I think there’s a lot of support for that and so you’re going to see much more of the life sciences get support as well.

Libby Park: Will there be ACA challenges under a conservative majority court?

John Williams: Well, I think one of the things that you’re going to see and this happens with the change of any administration, right, is that you’re going to have new folks at the Department of Justice and how DOJ goes about participating in ACA related lawsuits is going to change. When the Trump administration came in and it was a Republican Department of Justice they took a different position. There were lawsuits they were pursuing that they just dropped because it didn’t serve their political purposes any more.

John Williams: So you’re going to see a Democratic, democratically run DOJ do the same thing as far as the ACA is concerned. They’re not going to take any litigation position that’s going to undermine the ACA. Now, what Republican Attorneys Generals across the country are going to do could be a different story. We all know that there was oral argument before the court last month, no one really believes that the ACA is going to be taken down in its entirety. It’s much more of a political issue that was both put out during the campaign. We should get that opinion next year.

John Williams: So it’s really going to be up to Republicans at the state level to decide what lawsuits go forward against the ACA and that might reach the Supreme Court because the Democrats are not going to do it. It’s long been a political issue and I don’t see Democrats doing anything that is going to undermine that in the future. So I would be surprised if we get much more ACA related legislation, or excuse me litigation before the Supreme Court in the next four years.

Libby Park: Okay. Well thanks for your thoughts on that as well, John. I feel like we’ve covered a lot of ground today and I’ve learned a lot and I know you have a wealth of knowledge so thanks so much for sharing it with me and with our listeners today.

Libby Park: For folks that tuned in if you would like to pick John’s brain or my brain please feel free to reach out to us. John’s email is jwilliams@hallrender.com and mine is lpark@hallfrender.com. And as always, if you have any topics you’d like to hear covered on the podcast please feel free to email me directly.

Libby Park: Thanks for your time today, John, and thanks to our listeners for tuning in.