Panel 2: Introduction to the Regulatory Process

Speaker 1 (00:00):

Great if everyone could start making their way back to their seats. We’re going to begin our second panel of the day. I’m pleased to welcome our second session, an introduction to the regulatory process. Our moderator is our wonderful board member and vice chair Mike Park. Mike is a partner at Alston and Birds Healthcare Legislative and public policy group. He has more than 25 years of health law and policy experience. Before joining Austin Byrd, Mike served as health policy counsel to Senator Charles Grassley during his tenure as chairman of the Senate Committee on Finance, where he developed legislation on issues including Medicare payment policy, health information technology and program integrity, and conducted congressional investigations on public and private healthcare stakeholders. Mike also served as a policy coordinator in the US Department of Health and Human Services Office of the Secretary, where he coordinated the regulations development process for agencies, including the Centers for Medicare and Medicaid Services as a project officer for Medicare payment demonstration programs at CMS and as a health research analyst at the Center for Studying Health System Change. We’re so thrilled to have you join us, Mike, and with that I will turn it over to you. 

Speaker 2 (01:10):

Thanks Allison, and thanks again for the opportunity to participate and I wanted to kick it off by first emphasizing or reinforcing what Rodney said to you all applauding you for being here. A big part of why I’m a board member is just how much I got out of the alliance starting out as a CMS staffer back in the late nineties. I mean back then it was called hifa or the Healthcare Financing Administration. So it shows how old I am, but it’s always been a resource for me working in the executive branch and then as a committee staffer and even this day on the other side as a healthcare lawyer. So again, thanks for being here and I’m sure you’re going to get a lot out of this. So we started this morning with a session on the congressional process and we’re going to switch from the legislative process to the regulatory process. 

Speaker 2 (02:06):

The goals of this panel are to provide you with a high level understanding of the different agencies of HHS and the regulatory process, as well as to detail when and how staffers can engage in this process and the implementation of laws. Just some housekeeping. We have a great panel here. They’re going to give introductory remarks and our goal is to have about 30 minutes for q and a. Like the last session, our remarks are going to be recorded, but the q and A will not so fire away with as many questions as you can. You’re going to hear from three excellent speakers. Folks I’ve looked up to over the years. As you notice in health policy, we’re all separated by one or two degrees of separation at most, so we’ve interacted over the years. First to my left we have John O’Brien. He is the president and chief executive officer of the National Pharmaceutical Council, which serves patients and society with policy relevant research on the value of patient access to innovative medicine medicines and the importance of scientific advancement. Before that, he was a senior advisor to the US Secretary of Health and Human Services and served as a deputy assistant secretary for planning and evaluation for health policy. During the first Trump administration, John earned his doctorate in pharmacy from Nova Southeastern University, his MPH from Johns Hopkins, and he studied pharmacy and public policy at the University of Florida. 

Speaker 2 (03:48):

I was visiting an Alabama congressional office and apparently the member lost of BET because there was a big University of Florida flag draped in the waiting room. So next we’ll hear from Jeremy Sharp who’s managing director at Waxman Strategies, a mission-driven consulting firm. He has more than two decades of health policy experience both in the executive and legislative branches of government. He served in senior positions at HHS and the Food and Drug Administration during the Obama administration where he helped advance policies and regulations on prescription drugs, food safety and nutrition, tobacco control, reproductive health, public health and preventative health care and pandemic and bioterrorism preparedness among other issues. He also spent an extensive period of time on Capitol Hill working for Senator Chris dod as his legislative director and on the staff of the Senate Health Education Labor and Pensions Committee where he worked on the enacting of laws including the Affordable Care Act and the Family Smoking Prevention and Tobacco Control Act. 

Speaker 2 (05:02):

He also worked on numerous reauthorizations including the Pandemic and All Hazards Preparedness Act, FDA, user fee bills, the Substance Abuse and Mental Health Services Administration authorization as well. He also worked for Congresswoman Lois Caps as well as a public health nonprofit trust for America’s Health. Last but not least, we’re going to hear from Christie Martin where she currently is a director at Canberra Collective and offers policy expertise and strategic counsel to advance impactful health policy with a focus on improving health and wellbeing through practical solutions. She has dedicated over 20 years to this work gaining valuable experience in the public sector, private sector and philanthropy. Most recently, Christie served as chief of staff and senior advisor to the deputy administrator in the Center for Medicare at CMS during the Biden administration. In this capacity, she was instrumental in advancing regulatory policy and Medicare and implementing the Inflation Reduction Act, including the Medicare drug price negotiation program. 

Speaker 2 (06:08):

Prior to her role at CMS, Christy served as vice president for healthcare at Arnold Ventures where she led the philanthropies prescription drug pricing portfolio. She also held the position of managing director of Waxman Strategies health practice and served as a senior advisor in the Obama Administration’s Office of Health Reform where she oversaw the implementation of crosscutting departmental public health and prevention initiatives under the Affordable Care Act. Christie’s a proud wildcat from the University of Kentucky with both a bachelor’s and master’s degree in health communication and also has a Master’s of Public Administration from George Washington. So just listening to their credentials, you have an incredible panel, not knee deep, but neck deep in regulatory experience. So why don’t we get started? I will turn it over to John to kick it off. 

Speaker 3 (07:08):

Awesome, thanks Mike. I am new to QR codes. They’re not for my generation, but the young people I work with tell me that you should show ’em at the beginning of your presentation, not at the end of the presentation so that people actually have time to take a picture of them. I’m delighted to be with you. I love this meeting. I love the alliance. I too cut my teeth in health policy, not just on their content but on the boxed lunches that they’ve been passing out for decades now I’m a pharmacist by training. Mike shared a bit of my bio, but I’ve also been lucky enough to work at a health plan and for a pharmaceutical company. But more important than that, I’m a caregiver myself. I had the opportunity to help my dad with his cancer journey before he passed in June, and I’m still helping mom with that. 

Speaker 3 (08:02):

So the people that you help as a result of your work up here is incredibly important and something that I never forget. While Christie was making policy in the Obama administration, I had the coolest job that you’ve never heard of, and I believe that the reason I ultimately had a chance to shape policy in the Trump administration is by making copies and getting signatures in the first Obama administration. And that’s why it’s so cool for me to talk about the road to the Federal Register. I feel like the first panel did a great job. They even teed up schoolhouse rock. I feel like that’s the easy part. Nobody ever talks about what happens to Bill after he becomes a law and all of the people who are waiting for the policy that was promised to them during the debate or during the campaign on the new law actually happens. 

Speaker 3 (09:06):

So the road to the Federal Register is not as famous, but it is still very important because the quiet process behind the scenes that ultimately results in a law being implemented with the backing of statutory authority is really what matters most to people who benefit from health programs. I’m old enough to remember the paper version of the Federal Register. There actually is a public inspection desk. It is not just a website, but most people are aware of the Federal Register website, the public inspection desk website that you can go see the unofficial versions before things are actually printed in PDF as register copies. I swear the register font is getting smaller and it has nothing to do with me getting older. But why agencies use the Federal Register is an important conversation and all of the cool kids know that if you’re waiting to see when something is actually going to show up in the register, you can follow the reg info.gov website. 

Speaker 3 (10:18):

I’ve learned there’s an app now and the app will actually notify you and policy that you’re watching has a new date or is moving, but the Office of Information and Regulatory Affairs are what the cool kids call O IRA is an office within the Office of Management and Budget. And it is an incredibly influential part of the policy process when a law is passed that statutory authority is implemented or can be implemented in a number of different ways. Most of us are familiar with regulations. They’re published in the Code of Federal Regulations. They are more granular than the statute, and oftentimes the length of time between the passage of a law and the implementation of that law, the reason that takes time is because there’s so much discussion not just within the agencies, but as we heard in the last panel with the Hill on what exactly should go into the regulations to inform how this policy or program is actually going to happen. 

Speaker 3 (11:29):

Except in Christie’s case, they did it rather quickly with the Inflation Reduction Act. And that process of getting a loss stood up is something that if you’ve ever had a part, if you’ve ever had an opportunity to be a part of how important it’s, but aside from regulations which carry the force of law and you can be sued for not following, the agency oftentimes will implement policy via guidance. These guidance documents are published by the agency. They’re typically found on the agency website. They don’t have the force of law in the fact that they’re subregulatory, but they do describe important agency thinking about regulations. And you can sometimes run afoul of a regulation if you don’t pay attention to the guidance. And I think one of the more interesting questions in Washington right now is with the Inflation reduction Act being implemented via guidance, but it was guidance that the statute said you can do by implementing this law in the first couple three years via program instruction. 

Speaker 3 (12:38):

It begs the question, is the IRA drug price negotiation program super guidance? And if so, do we need to update the slides for the next year? Excuse me. But in addition to regulations and guidance, there are often waivers and demonstration programs and Congress provides the administrations the authority to do waivers and guidance with statutory authority, but they don’t necessarily specify the actual ways that waiver or demonstration authority can be exercised. So this is typically temporary flexibility to test new approaches that may or may not become permanent. So regulations, guidance, waivers and demos are the things that I’m typically watching to see how statutory authority is going to be implemented by an agency. And this overly simplified eye chart describes the agency clearance process At a very high level, the agency drafts a rule either in response to a new statute or in response to leadership priorities, and then before the agency ultimately approves that rule, they consult within and outside the agency. 

Speaker 3 (14:01):

They ask, for example, a new Medicare regulation. They would ask the Medicare program staff, Hey, can we do this? Do we actually have the systems in place? Is this consistent with the way that we operate? They’ll go to the budget shop or the office of the actuary and ask, is the way that we are doing this consistent with the way that we want to spend money and are we going to achieve a return on investment? They ask their press and their office of legislation shops, is there going to be Hill Impact? What’s the media going to say? How are stakeholders going to feel? And when they get all of that input and everybody within the agency has signed off, it’s only then that it goes to the head of the agency or in this instance the CMS administrator to get the administrator’s signature, at which point the process starts all over again. 

Speaker 3 (14:53):

Because once the agency has approved a policy, it then goes up to the department level. The department follows a similar process with all of its operating divisions and staff divisions, and then it also goes through interagency appearance. The White House also gets involved in a number of ways. We talked about OMB, the office management budget and the role of O ira, but there are also other places within the executive office of the president that are very important to that clearance process, including the Domestic Policy Council, the NEC and the Office of White House Council. That is a very high level discussion of a process that can take years sometimes. But what impressed me the most about being a part of that process was the depth of the conversations that you hear when an agency is implementing a law and the tough questions that is asked. So look forward to your questions, look forward to staying in touch, and I’m now going to turn it over to Jeremy. 

Speaker 4 (16:00):

Thanks, John. So thanks for having me today. Like Mike and John, I just want to associate myself with appreciation for the Alliance. When I was a young health LA who really didn’t even know what Medicare or Medicaid was, I came to one of these kinds of things to learn a lot and it was really valuable to me. And so it’s actually exciting to be able to be up here. I will also say I am not a lawyer, a doctor, a scientist, an economist. I have no qualifications whatsoever for the jobs that I’ve had over the years, and that’s not terribly surprising, but I just say that to all of you who are probably far more qualified than I ever was. There’s lots of stuff ahead of you in your careers that could be really fun and interesting, but today I’m talking about the regulatory process at HHS and particularly the subagencies. 

Speaker 4 (16:49):

When we planned out this panel and when actually, I wrote these slides a year ago for a similar panel, but when we were planning out this slides, we were looking at this slide, these slides, we were like, okay, these still work, right? This is, well, last couple of weeks, this slide quickly became moot. Some of these agencies don’t exist anymore. Some of ’em won’t exist soon. They’ll be in a larger agency. Others of the agencies are much smaller versions of what they are now, but I don’t know how to teach to that. So I’m just going to talk about the way the system was and where it may head again after the dust settles from what’s going on right now at HHS, John alluded to this, most of the action in the regulatory process is at the agency level, if you’re paying attention to Medicare or Medicaid, you are looking primarily at CMS and even within CMS to the offices that run Medicaid and Medicare, each of those agencies has had own personality, right? 

Speaker 4 (17:50):

So CMS is largely an insurance bill payer system, and they do all the things that does. That means a lot of what they’re doing is watching the budget, making sure spending is controlled, but they’re also thinking about how can we use the budget and the spending to improve quality or to reduce fraud or whatever else is in their priority mix. FDA is a public health agency that primarily thinks in terms of managing the drug and device supply in this country, tobacco products as well, and they operate from a standpoint of being very protective and frankly a little suspicious of the consumer in terms of the consumer’s ability to manage their own healthcare. So it’s a different kind of mentality that happens there. And so that drives the way each of these agencies do. And so if you’re going to work on an issue, as the panel before said, go talk to the agencies that are involved in the work you’re doing, you also need to understand where they’re coming from, what their attitudes are, so you can assess whether you agree or disagree with what they’re trying to do. 

Speaker 4 (18:47):

Sometimes what Congress is trying to do is change the way an agency thinks or operates, and that appears to be at least part of the stated reason for some of the reorganization that Secretary Kennedy is endeavoring in. They also have very different ways of implementing policy. CMS does a series of annual payment rules, which is their primary space for making changes in Medicare and Medicaid. They do a variety of other things as well. And John talked about guidance, and Christie could teach the whole book on how CMS operates. So I feel a little like an imposter even try to explain it FDA, but I should say, so CM S’S process is annualized often, and it’s a very structured, they know how to do it, they know how to process it. All the review parts of the system respond to it on that timeline. They know it’s all designed to hit a certain date on the calendar. 

Speaker 4 (19:35):

FDA completely different. It takes, as John said, years for some regulations to get finalized. It can go as quick as two years if you’re on an accelerated timeline at FDA, but it really is a sitting there and trying to figure out what’s the right thing to do and how should we do this and when do we have sufficient evidence to support whatever standard we’re setting forth in array? Because FDA is challenged all the time on that. And that gets to the third way to think about these different agencies is they each have very different legal authorities tied to this, and I’m talking about FDA lot because that’s where I worked. But a lot of people say, oh, we want FDA to care about this or that, or Why don’t they demand more of this? And the answer is because their statutory authority for carrying out the regulatory process is tied back to ensuring safety and efficacy. 

Speaker 4 (20:26):

And there’s even a statutory definition of what they need to be thinking about when they are doing that. And if they don’t get the right to just say, we think that the right level of arsenic is X in rice, they have to go and build an evidentiary standard for Y that is, or they will be challenged and beaten in court for setting that standard. And that is very frustrating to many people who want the FDA to do more and create more. CMS has its own legal restrictions. The last thing I should say about this slide, which really goes back into the personality, is some of these agencies have a lot of experience doing regulatory process CMS and the FDA in particular. Some of them only have a handful of regs. NIH has maybe double digit number of regs that they manage at any time. So they are not constantly doing this. And as with anybody with their jobs, the agencies that do a lot of it, really have it down well, they know how to do it. The agencies that don’t do it frequently, they tend to take longer to work through the processes. And that can be a good thing or a bad thing depending on what your perspective is. 

Speaker 4 (21:28):

How do these agencies work with the rest of HHS? And this allude to some of what John had in his clearance slide. Sometimes what you have are priorities of the agency leadership that drive things. Sometimes you have priorities coming from the Secretary of HHS or other senior officials at HHS who have come in for a two or three year period of time in order to drive one particular kind of change. And sometimes these things come from the White House from a presidential campaign commitment or something the president has said in his State of the Union. And so HHS can often initiate these policies. It oversees the agency implementation, it engages White House and OMB. There’s a lot of turf fighting between senior officials at HHS and senior officials at the agencies about who gets to talk to OMB, who gets to talk to DPC, what’s the right chain of command? And by the way, there are agencies that have a lot of clout that can decide they just want to talk to the White House. CMS is one of those. FDA was always pretty happy not to be directly talking to the White House because that usually got us into trouble. 

Speaker 4 (22:33):

And so there’s a very elaborate official process that John laid out. But there’s an unofficial process that happens ahead of all that. A lot of conversations are happening between HHS and the White House. The White House will sometimes convene agency officials and department officials to talk about an issue and try to think through solutions. They’ll try to drive change. Usually the agencies are trying to explain them why the idea that that White House person has isn’t workable. But sometimes if we’re lucky, the agency people will be creative about saying, okay, well let’s try it a different way or about this. And so that unofficial process usually proceeds, but is also parallel to the regular process. 

Speaker 4 (23:14):

And then finally, when it gets out of HHS, as John said, it goes into interagency clearance. The most important there are the White House equities and then the Department of Justice, because the Department of Justice often has to be involved when there’s going to be litigation. I talked a little bit about the informal and formal agency driven process versus White House versus HHS. The biggest thing for you all to be thinking about, and I think Christie will probably talk about, is you want to have relationships with as many staff as you can. They can sometimes talk to you off the record and give you useful things, your stakeholders, the outside groups, talk to the agencies, use them, be in touch with them. Hopefully the good ones are actually engaging with the professional staff. I don’t know if the staff will be left anymore at the agencies to talk to them or how open they will be right now, but eventually we’ll get back to that. But then also understand that they may not be able to talk to you or the stakeholders because they’re in the middle of a rulemaking and they really can’t talk about that, and there are legal consequences if they don’t. So I think I got through it now. It’s Christie. 

Speaker 5 (24:07):

Well done. So two things before I get started. One, like everybody else on this panel, the alliance fed me throughout my twenties and I really appreciate that. But more importantly, the alliance also offered me, I moved to DC not knowing a single person. I moved because I took a job and going to the Alliance. If you go to these every week, you’ll meet people and those people will be in your circle forever. The former CEO of the Alliance, Sarah Dash is one of my oldest friends in dc. So not only do you build your knowledge here and you get fed lunch, but also you can network. And in DC that’s the most important thing you can do. Secondly, I think this applies to everything that’s probably going to be said today when it comes to health policy, everything’s complicated and there’s always caveats. So when we’re talking generally this is how things work, but there’s always nuances. 

Speaker 5 (24:58):

And so we probably won’t get into those nuances today. And Jeremy kind of pointed out some of these early on, the agencies within the Department of Health and Human Services, even differences between how culturally they engage with stakeholders is very different. So when you start to build relationships with the agencies, one thing to think about is you might have to go through a different process if you’re building those relationships with one agency versus another. So as we go through this, like Jeremy, I did these slides before certain Thursday, so we’ll see what happens. So HHS, I’m going to talk a little bit about how HHS interacts with the Hill officially through the office of the Assistant Secretary for legislation, which is at the department level and really is the legislative affairs for the department and the staff divisions within the department. And then the agencies, the operating divisions have their own offices of legislation. 

Speaker 5 (26:04):

Some of them are unstaffed right now, but we’re just going to pretend they are how it normally works. These offices are really important. So they do a number of things. One, they’re the main conduit. So if you’re talking to the agency or the department officially, they’re the main conduit. If you’re thinking about your bosses getting ready for a hearing or they’re planning a hearing, that’s who you go through. If you are thinking about ta, that’s who you go through. The budget process happens, that’s who you go through. So they’re your main go-to for official business. So just know, and like Jeremy said, the people who are typically in this career, staff in particular that are in these offices, they’ve been in these jobs forever and they’ve seen everything. And so they know you’re not the first person probably to ask. So ask your questions, get to know them. 

Speaker 5 (26:53):

Make sure that you’re using all your ability to build that relationship and that relationship can look like different things, right? Emailing them when you see them out and talk to them, they sometimes come up onto the hill, make sure and say hello to them. You can also ask for staff briefings when they have rollout calls and they do the hill briefings, show up, ask questions, they’ll be really appreciative. I think it’s really a two-way street for them. So a couple of differences between a SL and the offices of legislation. So one is where they sit. And so one of ’em is really focused on the agency and one’s focused more on the department with that. The one at the department level is a little bit more political by nature, right? Because they are in the secretary’s office. And so there’s a little bit of a different, you’ll feel the difference when you talk to them whenever you go to the Office of Legislation. It’s not unusual for the politicals never to be involved. 

Speaker 5 (28:00):

Politicals typically don’t get involved in ta. They might not be on briefing calls. So you’ll see and feel more of the career staff presence there. And so that’s really important. It also dictates how they interact with you and what you can ask from them and what you’re getting from them. So one thing that I think is really important is that A SL supports the legislative agenda and also the president’s budget. That’s kind of really their bread and butter. And so you will see them working all year long toward those two goals. They also coordinate travel for the secretary’s office if there’s any travel that needs to be coordinated with a congressional schedule and coordinate audits with GAO. So they really serve as that conduit for the department. The office of Legislation, this is where you get into technical assistance. They evaluate proposals that are coming from the Hill and they assess those and then they’ll provide that analysis to the staff within the agency. 

Speaker 5 (28:58):

They’ll coordinate with a SL on the budget process. And so a lot of times, like in the CMS Office of Legislation, that office of Legislation actually runs the budget process for CMS. So they collect all the A nineteens, they go through them, they figure out which ones to send up. They do all that coordination for the agency. And I’m assuming it’s the same for the others office of Legislation too, is that they kind of help to facilitate some of that work, which makes it a lot easier for the career staff because a set process. And then they also coordinate any participation in congressional hearings, scheduling, prepping, getting witnesses, things like that. And typically when you start, if you’re working on a hearing with an office of legislation, that’s a pretty close relationship because you’ll have a lot of back and forth before you actually get to the hearing date. 

Speaker 5 (29:48):

And then they’ll also coordinate if there’s any questions for the record afterwards. So that’s a really important way to build a relationship with them. And then they are also part of the audit process as well. Theirs is a little bit different because the H-H-S-O-I-G also coordinates with them, and at least for C-M-S-O-L, they have a regularly scheduled meeting. And there’s one person whose job is just to coordinate audits. And she was amazing. And that’s what she did. And she made sure that the career staff within the centers had what they needed as they went to entrance meetings, exit meetings as they were responding and giving comment on audits that were coming through. If OIG was thinking about an audit, kind of coordinating those conversations. And then at least with the H-H-S-O-O-I-G, they have rulemaking authority, which is interesting. So like Stark Amendment, PBM rebates sit under there a number of things. 

Speaker 5 (30:48):

And so they also help to facilitate if something’s going on in that process as well. And so thinking about how to really engage with the Office of Legislation or OSL, there’s different ways to do it. You can do it through correspondence, official letters, they can be public letters to HHS or N or agency. They can be letters that aren’t made public. They will coordinate the written response back to, they respond to every correspondence that they get. And I think there’s always a question of is the response made public or not made public? And that’s something you would work with the Office of Legislation staff on how to handle that. Correspondence always goes through clearance process. So for example, my boss was in charge of the Center for Medicare. She signed every letter about Medicare that came from the Hill and every response. So it does go up through that process. 

Speaker 5 (31:44):

And then they coordinate if there’s any coordination that needs to happen with a SL on who delivers the letter or who’s the signature on the letter, they’ll coordinate that. Technical assistance is confidential. I cannot stress that enough. Technical assistance is confidential. So whenever we would get technical assistance requests, if somebody asked us about it, we didn’t talk about it. Very, very important when you think about they can provide feedback on operations. They can also give subject matter expertise. One thing I want to talk a little bit about with the technical assistance, I think this is kind of a misnomer, and I think Sarah and Ryan mentioned this earlier, you need to come to technical assistance with an agency with a clear idea of what your policy goal is. A clear idea in being able to explain what your you’re trying to do. And most importantly, nail down definitions cannot stress that enough. 

Speaker 5 (32:46):

If you nail down definitions, that means you’re speaking the same language and you will get better ta. You get faster ta. So make sure it kind of have your thoughts formed. Technical assistance is not for policy. Muddling agency technical assistance is to give you, will this policy work? What operational changes need to happen? Is their operational admin budget that needs to be provided for that. Would the agency need more people? What would the rulemaking look like? If we had to do this, what would the timing need to be to execute it? Right? So think about they’re going to come to it very operationally. They’re not here to help you figure out your policy. That’s your job. And then the last is staff briefings. Also, these can be confidential. So there’s the briefings that happen every time. There’s a rollout where they’ll get on, you’ll get the email 15 minutes, 30 minutes before or whatever, and you jump on the call. That is your time to ask questions. I don’t know how many times I’ve sit on those calls and they’re audio only and it’s like crickets. 

Speaker 5 (33:54):

I always appreciated Connor Shehe because that man always asked a question. And one, it makes the career staff who are taking their time to brief, you feel like you care about their stuff and you’re interested in it. Two, it gives you an opportunity to learn more. One, you can ask about what they’re briefing you on. You can also ask about stuff adjacent to it, right? It’s an opportunity for you to interact and you should think through that. And the end, the last thing I’ll just say about the staff briefings, if you want to know a status update, you can also ask for a staff briefing on a status update. And they also coordinate if any leadership needs to have meetings with your bosses. So time’s up. So I think we’re going to do turn it back over to Mike. 

Speaker 3 (34:34):

I 

Speaker 2 (34:34):

Love those colors. Well, thanks so much for your remarks.