This is an unedited transcript.
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Hello, everyone. Thank you for joining today’s briefing: What’s Coming in 20 23: How Policy Priorities for the New Year.
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I am Katherine Martucci, Senior Director of Program Strategy and Management at The Alliance for Health Policy.
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For those of you who are not familiar with the Alliance, welcome. We are a non partisan resource for the policy community, dedicated to advancing knowledge and understanding of health policy issues.
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Today’s briefing is brought to you in partnership with the National Institute for Health Care Management Foundation, and we thank them for supporting this programming.
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You can join today’s conversation on Twitter, using the hashtag, all healthwise, and join our community at all health policy, as well as on Facebook and LinkedIn.
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And a recording of this webinar will be available on our website in the coming days.
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Today’s panel has a Q&A section at the end of the hour, and we want you all to be active participants. So, please get your questions ready.
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You should see a dashboard on the right side of your web browser that has a speech bubble icon with a question mark.
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You can use that speech bubble to submit questions you have for the panelists at anytime.
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We’ll be collecting these and addressing them throughout the broadcast.
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And throughout the webinar, you can also chat about any technical issues you may be experiencing, and someone will attempts to help.
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And now I’d like to introduce today’s moderator, Peter Sullivan.
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Peter covers healthcare for … hosts with a focus on Congressional policymaking.
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he previously covered health care for the ****.
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He’s a graduate of Grinnell College in Iowa.
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And Anita is Cambridge, Massachusetts.
1:47
Welcome, Peter, and I’m glad to be leading this conversation in your capable hands. Take it away.
1:53
Thanks, And thanks to everyone for joining us, and to our panelists, I’m going to do some quick introductions. Then I’ll ask them questions, you know, for the first portion of the panel. And then we’ll get into audience questions.
2:06
So, as you just heard, submit your questions if you have them.
2:12
So first off, Sarah Singleton is a principal with Levitt Partners, a health policy consulting firm based in DC. She advises clients throughout the healthcare sector on federal health care policy issues, including public health, social determinants of health, equity, research, and drug development, and the Affordable Care Act.
2:30
She served as deputy assistant secretary for legislation at HHS, and has significant experience on Capitol Hill in both committee and personal offices.
2:41
… joined Todd Strategy in the summer of 2018. He previously served as Chief Counsel for Health for the House Energy and Commerce Committee under Chairman Greg Walden.
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Leading the committee’s efforts on the broader array of health issues under its jurisdiction, including Medicare, Medicaid, Health Insurance, 340 B, FDA, pandemic response, and other public health policy.
3:04
Paul started with energy and commerce in 20 11 under the leadership of Chairman Fred Upton and was elevated to Chief Counsel for Health in 20 16.
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He also previously served speaker John Boehner us as Health Policy Advisor.
3:18
Hey, me too.
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Arson is the Executive Director of the National Academy of State Health Policy, a non partisan forum of policymakers throughout state governments, learning, leading, and implementing innovative solutions to health policy challenges.
3:32
She joined from the Duke Margolis Center for Health Policy, where she has been a leader of the Center’s Emerging State Policy portfolio, including covert …, testing and containment, vaccine distribution and education, coverage, and health system reform.
3:47
So let’s get into it. Paul, I guess I would start with you, given the, the House experience, that we have a new majority in the House. Unlike in the Senate, Republican majority, what do you kind of watching for, in terms of, of House Republicans, or just in general, and in health care policy making? This year, I’ll start with a broad question.
4:12
I think it’s, I think it’s fair to say it’s been an unusual January for, for, for the beginning of the Congress. A lot of this, just the normal organization work on committee work, and getting committees up and running has been delayed a little bit. Relative to primary, Congress says a lot of this stuff and new Chairman, new staff, a lot of that, usually what happened towards the end of the calendar year for the next Congress. But because of how the speaker’s race and build it and some of the concessions and sort of intra party debate amongst House Republicans, ended up doing things a little bit, but things are now up and running. You’re seeing new chairman, staff, staff being hired up, and I think it’s pretty apparent from the first couple of weeks in the week leading up and the week after the speaker’s race, on the floor. Budgetary issues are top of mind for, for House Republicans, and some Senate Republicans.
5:01
You know, I think from their perspective, after the emergency spending, in the last couple years, inflated levels of spending from their perspective. There’s interest from both House and Senate Republicans on how to best rein that in. I think the real question, I think it’s still an open question, is whether the focus from House Republicans ends up being mandatory spending programs like Medicaid, or does the focus today on the discretionary side of the ledger, So the normal routine, things that needed to be funded every year, by the Appropriations Committee, and the Congress’s. So, things like the operating budget for the Department of Health and Human Service. Human services, I think, will be under really heightened scrutiny relative to primer Congress’s. My gut at this point, And again, I think it’s still an open question. If you change that, much of the focus will end up staying on discretionary spending. I think there’s sort of differences of opinion among’s House Republicans on what the, what the focus should be.
5:54
But if you sort of look better and looked around the speaker’s raised and some of the comments room, some of the key members around that race, I think a lot of them were focused on the discretionary side of the ledger. So, I think that’s where the focus is probably gonna end up being on later this year. I think you’re gonna see a lot of interests and oversights, pretty natural for any incoming.
6:15
The Congress would, particularly, when there’s a change in, change in power, and the party in opposition, could control the White House. You usually see heightened oversight for the first several months of the Congress. So I think, in particular and healthcare, through the operations of CDC, FDA and NIH will be under really, really close scrutiny. That’s been telegraph by a lot of the chairman of the key committees. And the members of this committee is that there’s just a lot of questions about how it was handled operations of the departments and agencies moving forward, teleworking, civil servants. And how, how efficient or inefficient, so I’ve spent a lot of scrutiny and a lot of oversight letters. And a lot of hearings to be held. An authorizing committees for health care.
7:06
Yeah, Know, for sure, we’re gonna see a lot of a lot of letters, I think, Sarah, maybe let’s go shifting a little more to the Senate side. I guess, though, though, whatever you want to touch on, but, you know, we know the Senate and the House don’t always perfectly speak to each other. So, what do you kind of, watching for, I guess, with a focus on the Senate.
7:29
Great to be here today with all of you. I think I agree with a lot of what Paul said, in terms of the priorities, those, those line up with what I’m thinking. From the Senate side. Obviously, the Senate Democrats have retained their majority, and, you know, made a tiny bit of ground. But we saw last Congress, you know, the Senate, it is razor thin margins are hard to work with, particularly with so many things.
7:52
Requiring a 60 vote majority, even when you have a bigger majority, it can be difficult to work with.
7:57
You know, I think we’ll probably get into what happened, last Congress and what it means for this, Congress.
8:03
You know, we have a lot of the same chairman and some of the major health committees that we do have some changes. And in the situation that we’re in, where it’s the President’s party, there’s probably different oversight priorities, very different oversight priorities between the House and the Senate. But the oversight ability of Congress is an important thing that many Chairman look towards. And Senator Sanders has now taken over the help committee. And I think we’ll use that to do a lot of work. So in any Congress, there is sort of that question of how much do we want to talk about things? And where do we wanna get to action and find bipartisanship and legislating? So we can probably get into that more. As the discussion goes on, I think we’ll see elements of both of that, this Congress with some of the carryover priorities. You know, descending and working with the Administration on some of their major priorities, like equity. Like Australia, the Affordable Care Act, like working on Medicaid.
9:00
And continuing to make sure that as many people who are enrolled as possible, stay on, as we move towards the end of the public health emergency.
9:08
So there is a lot on the plate of Congress, a lot of interests, and obviously a little bit tricky of an environment to figure out how to get something done, but that doesn’t mean that nothing is going to get done. I think, actually, there’s room for lots of things to happen.
9:23
It makes sense, and, Amy, let’s go to you. for the more from the state perspective, what are you watching for in the states. Obviously, a broad question, but maybe top of mind, in healthcare this year, and also, you know, bringing it back to DC, are there things that states want from Congress, or are watching from Congress, more GC policymakers of this year?
9:44
Yeah, no, thanks for the question, It’s great to be here. So, in our work at NIOSH Be, you know, are working across all different types of state leaders, state legislators, governors’ offices, Medicaid directors, public health officials, insurance commissioners. And so it’s really been interesting to kind of watch and see what is on unrolling in the States. And so, you know, there were 36 gubernatorial elections on this fall. We have nine new governor, or so we have another 27 incumbents that have been elected for another four years and now you’re seeing the state of the state speeches roll out And it really is, I think, a time of like, let’s redefining priorities. And you know, my previous time was at the National Governors Association, where I led the health division. And so it’s really interesting to watch sort of the emergence. I’ll use that term from the pandemic of really now states wanting to focus on some of these issues and challenges really that have been exacerbated by the pandemic.
10:36
You’re really seeing that across the board, and sort of a push of, like, you know, what legislation, What, you know, what executive actions can we be taking to address this? And just, sort of top of mind continues to be healthcare workforce.
10:48
So, um, you know, back when I was at NJ, that was, like, It was important, but it was a lower tier, But, you know, what the pandemic with, you know, serve the challenges that hospitals nurses, and, you know, behavioral health, long-term care.
10:59
Really, I think we’ll see lots of different ideas, both at the legislative side, in the Executive branch side, of how to bring instead of a broader workforce. And really think about how to address some of the needs that have really been, I think, escalating, frankly, since this, during, and since this sort of where we were in the pandemic, the unwinding of the public health emergency and the, the end of the Medicaid continuous enrollment requirements. April, first, huge, focus for states, right. There’s estimates that there might be up to 50 million people that lose coverage.
11:30
And so just, states have been planning and they had them preparing, but the sheer volume and number is going to be challenging for them to navigate. So I think that will really require a lot of focus. and look, it’s a time where we’re all seeing vacancies across different jobs that include State agencies. So, really understanding, You know, do we have the workforce, and how are we really going to be prepared for that, along with the training of had to go through all of these processes, Is going to be something to watch. I think, in other areas, behavioral health, there have been a couple of areas, You know, there was the rollout of the 9, 8 8 line, earlier last summer, and and states have really been thinking about, how do we bolster our crisis systems? Because of the demands, and also because of the different pieces, both coming from the Federal government, as well as, from sort of state need, and Rachel need. So, I think there’ll be renewed. Focus on that.
12:21
I also think children’s mental health, we are seeing children really being, you know, not seen, you know? Spent a lot of time in the ED. You know, there’s litigation that’s arising across the states, because of the circumstances of the inability to serve children. I think, states would be very interested in getting some federal support. And thinking about, how do we really double down and really think about how we’re really bolstering our mental health capabilities across the country, especially for children, but also for others.
12:51
one thing we’re watching is the $50 billion that’s rolling out an opioid settlement funds. There are a number of states, are figuring out how to spend that money. It’s over 18 years. But it is, it is a timely. I think, opportunity because of the overdose rates, and the continued challenges with really helping people who are in crisis, with opioid use disorder and substance use disorder more generally. So we’re watching that very carefully, and really trying to help States. think about, kind of what comes next. And then just two more things than we can sort of get into more discussion. And affordability. That continues to come back to the top of the list.
13:29
I think the Inflation Reduction Act, states are like, is that going to happen? It happens. Drug pricing continues to behind. The list for consumer asks for both legislators and executive branch officials to try to address kind of, what are you doing at the State level? We aren’t. We track all of that here at Nash B and really work closely with states on all of those pieces. Prescription PBMs continues to be sort of the predominant and highest category of bills that are being introduced to date now, legislation just get started. So there’s, there’s going to be more that comes after that, But there’s also an interest in how do we think about if Medicare isn’t going to negotiate drugs? How can states benefit from that?
14:08
And so there’s been some ideas around, do we introduce bills where there’s going to be the ability negotiate and and rely on those negotiate rates that Medicare does at the state level across a broader population? So main is the first day to introduce that type of bill. But there’s, there’s more just, I think to come. And I’ll just say on the health system side, a lot of interest in understanding how do we get our arms around health system costs. It’s a tough time because hospitals are also say now they’re struggling coming out of the pandemic. And they don’t have as much reserves as they did before. But consolidation is sort of, on the minds of many legislators about how to address it, and also thinking about what comes next, in terms of transparency, and understanding what’s going on. And then I’ll just list of topics, and we can assess, if we want to delve into it, public health, what’s happening with public health money, continues to flow. But what’s next? There’s a lot of legislation uploading that we saw during the pandemic about, you know, more limitations on requirements for vaccines and thinking about, and whether that it’s, it’s just kilobyte, or is it beyond coven.
15:06
I think there’s also some thinking about, how do we re-organized public health not just at the Federal level, but also at the State level, So I think we’ll see some movement on that.
15:15
And last but not least, there’s maternal health.
15:18
Lots of interest in post-partum coverage. You know there was 27 states that that actually expanded post-partum coverage. I think there’ll be a number of states that that will follow this legislative session to do the same thing. So, there’s more tax topics we could talk about, but maybe I’ll turn it back to you for now. Keep right, Yeah, that’s given that’s given us a lot of good things to talk about, so maybe I’ll zoom in on one thing you mentioned, which is drug pricing.
15:42
That’s obviously, I mean, obviously, was a big topic in the IRA. We got some form of Medicare Negotiation, Paul or Sarah. What’s, what do you kind of view next on drug pricing? There’s been some interest among House Republicans and some Democrats, for instance, on PBMs, Pharmacy benefit managers, do you think that’s kinda where the drug pricing discussion is going, now?
16:05
You see the chance of anything more passing, you know, especially on that front.
16:14
I’m happy to start, Sarah. On the on the direct pricing for my gut is, you know, given the major impact of IRA and the fact that CMS has a really big program to start implementing my thought it’s released the beam in the Congress. I think it’s probably going to be pretty slow on the issue. Legislatively. I do think there’s gonna be a lot of questions. And they’ve started to come from the lead Republican finance ways and means, and energy and commerce about how CMS is going to get this program up and running. If you talk to our friends in, in, in in Baltimore, they are through heavily recruiting new staff to help implement the program. It’s a new thing for CMS, just logistically. So regardless of whether you agree with the underlying merits of the law or not, it’s just it is a logistical challenge where CMS they were given a fair bit of money.
17:07
I’m usually large amount of money from my perspective and some of the perspectives of my conversations with House and Senate Republicans, almost $3 billion to implement the program. So they posted a lot of job openings and are trying to recruit staff from the drug industry from a value assessors from the plan and PBM industry so they can bring industry expertise in house and CMS. It’s my understanding that a lot of the agency staff at CMS has been detailed to help roll out this program staff is being pulled by the administrator. From other parts of CMS to try to implement this program. Because, you know, again, they were at CMS was asked to do a lot. In a short period of time. They have a lot of guidance to rollout.
17:55
A lot of decision to make about which drugs will be selected for negotiation. So, they’ve got a lot of agency activity, a lot of scrutiny for capital. How about how Spencer be or how funds are being used? How CMS is making its first decisions on a program that, you know, passed on partisan basis, and in the Congress, and signed into law. So I think that’s really going to be the focus on drug pricing. You have heard some interest from some key republicans, particularly in a house on the PBM issue. Genes Kumar, who is the incoming Member of the House Oversight and Government Reform Committee, has raised a lot of scrutiny about the margins. Pharmacy benefit managers are getting in the Part D benefit in in some state Medicaid programs Where state MCOs operate the program and sort of the general value proposition or PBMs in the supply chain. So I do expect a lot of hearings on that issue.
18:49
There’s been some previous legislation that’s been bipartisan. The one thing, in particular, I would point out is the Help Co-pays Act, which was introduced by two members, are no longer with the Congress, but co-sponsored by several members who are still there.
19:05
That would address some of the Some of the issues patients and manufacturers have raised related to PBMs, on plan management. So, issues related to accumulator programs and the fact that discounts and coupons that are used in those programs don’t count towards patients out of pocket. So patients are sorta, forever in a in a cost sharing leap as it relates to their drug benefit. So things like that, I think, could get a lot of scrutiny. But I think overall, legislators will be pretty slow out of the gate.
19:38
Yeah, Sarah, anything to add on that front?
19:41
I agree with your bottom line there, Paul, that legislating is not likely to happen this Congress. I’ve worked on both the hillside and the administration side. And then the hillside you always want sort of to pass the law and have it shouldn’t happen now. And there’s so much more that goes into it in setting up a big program.
19:59
And there’s lessons learned from setting up Medicare Part D from setting up the Affordable Care Act exchanges, so that, that big amount of money that Paul is talking about, that’s sort of front loaded.
20:10
Upfront NFL, I think, is sort of agency experience from years past that you don’t have any time to lose and setting things up, particularly if there was some no controversy And passing it. There will be attempts to slow it down, to ask questions, to challenges to the process, so the administration really doesn’t have any time to spare in doing this.
20:30
You know, there’s some provisions of at the ticket that even this year in terms of rebates if drug prices rise faster than inflation. And, you know, some of the benefit design changes that take place over the next couple of years in terms of the cap on coverage and the elimination of the co-insurance that were part of the original Part D design. But to get to direct negotiation by 2026, a lot of work has to happen. So, I think, you know, Congress still has an appetite for this issue, as Paul was saying. But, it’s not just not realistic that there’s anything that can happen faster than what’s already been put into place. So, as he was saying, I think this is a, this is sort of continuing to make the case, Congress on the issue of drug pricing.
21:12
As I was mentioning, there’s new, There’s new leadership in some places, and there has been a lot of work on committees and there’s some of it on a very bipartisan basis. So I think there’s a lot that Congress can do in terms of bringing to light the issues and trying to understand it’s incredibly complex about how the money flows in drug pricing and there’s a lot of actors in the system and of course there’s lots of finger pointing out which actor is the one that should be looked at for the prices you know. As manufacturers as the PBMs is at the pharmacies as the insurance plans of the program, so I think Congress has a lot to do in talking about and investigating the issue that probably not as Congress.
21:53
Well, let’s shift to another thing. Hey, mentioned with mental health, that has gotten a lot of discussion, obviously, coming out of … effect in schools among young people, and, just in general. So, maybe hear me if you want to expand a little on on the mental health work that’s going on in the states, and is there anything there they’re looking for from DC or watching from federal policymakers?
22:19
Yeah, so, I, can, I just add one thing on the drug pricing? During this education period for this, Congress, really would encourage looking to the States, some of whom have really done a lot of work on transparency and soundtracked price negotiation and have some success and had some challenges. And I think there’s just a lot to learn from, from what the states have been trying. As you think about, you know, how implementation control at the Federal level. I just wanted to say that so. On behavioral health.
22:46
So, I, there’s a lot of really interesting pieces that states are working on, and none of it is easy. And it’s these strategies that have been around for a long time. And it’s, like, how do we really, sort of get momentum? I will say a couple of things where I think it can really help at the federal level to to then also support what’s happening at the state level, there’s a real interest in integration.
23:06
Thinking about integrated behavioral health, and that’s been a buzz term for for a long time now if this is not new, but renewed interest in, like, place based. So, what can we do in the schools? What can we do in the primary care offices? And I think, you know, from from a state perspective, you really have to think about cross sector work. It’s not just about the Medicaid agency or Behavioral Health Agency. It’s really working across folks. And so, how, at the federal level can that, can that support that cross agency thinking? How can federal agencies work together, And they are, and they’re collaborating or really having server renewed commitment to really think about across funding streams, across sort of different programs? How do we think holistically on workforce? I really think there’s an interest in thinking about, OK, if we don’t have enough psychologists and psychiatrists, where do we go for, for some of the workforce challenges? And really, peer support specialists and the community based workforce, I think is really, really need some support. And so it’s not just funding. It’s also thinking about the contours of the program and how to have more flexibility. And in allowing people to do more than they, they can.
24:08
And then I would just say on the public health emergency is going to end at some point at the federal level, some of the flexibilities with respect to licensure and telehealth, and all of that will will end with the end of that public health emergency. And so some states are being proactive and saying, where are legislating to permanently extend some of these pieces. Telehealth, I think has been really important to some pockets of sort of mental health providers, and people receiving those services. And, so, are there things that we can think about at the federal level, as states try to sort of manage their own populations, and kind of navigate whether they’ll permanently extend or not, is their federal work.
24:43
that can be done to really help, sort of, quite a path forward? And where we go next on that?
24:50
Yeah, So, so, Sarah and Paul, on the same topic, things that come to my mind in terms of Congress is the Support Act, which was passed in 20 18 around opioids, mental Health. It needs to be re-authorized. And also, there has been some discussion the Senate Finance Committee had had bipartisan working groups on mental health last year.
25:11
So to either, Sarah, Paul, do you see any kind of Congressional action, or at least continued discussion in the, in the mental health slash substance abuse area?
25:22
Yeah, I think that’s one of the areas for bipartisanship that Congress has show no for the past several years, that they can work together on mental health and Behavioral Health and opioids. In the end of the year, on the best package, some mental health and substance abuse programs re-authorized not a lot of big changes though. So there’s still room. And as I was talking with folks, even though, you know, it’s not easy to get those things done. I think there’s appetite for more. So I do think that this is a ripe area. And as you said, the Finance Committee started work on this last year through a structure that really involves a lot of its members through creating some different subgroups to create white papers. But the process happened late enough in the Congress that there wasn’t time to get all that done. So I think that this is one of the biggest areas and it’s it’s a cute.
26:11
It resonates with people, we all know that mental health and substance abuse got worse during the pandemic, really at all ages from kids all the way up to adults.
26:21
So I think there’s ample room for Congress to work there, and then that, that is one of the things we’ll see.
26:28
I agree with Sarah. You know, if you take a look at last Congress, there was that there was a really big mental health package that passed the House with broad bipartisan support that can’t be Rogers and then Chairman on. So it was one of the few things that I’ve got a big, sort of around 400. To look at the exact count. Don’t have it off the top of my head, but I got a lot of support, and I’m sure, And Sarah, reference, some of it was packed with the year as part of the Omnibus package, somebody who sort of left on the table. So I expect Congress to pick up a lot of that work. Chairman Widens spend a lot of bandwidth and time working on this issue. There were several white paper’s release of the Finance committee on that issue, so I know you’ve expressed a lot of interest.
27:08
But there’s also been a lot of interest from from House Republicans as well. So particular areas of workforce. I think that it’s an area of interest on the Republican side. The other area. I would point out, I don’t know what is going to be more legislative. Or, there’ll be more regulatory from the CMS run, but the role of digital technology and digital apps.
27:30
That technology has a short, an uncertain reimbursement trajectory under the Medicare Program. There’s questions about whether CMS has authority to provide benefit to existing benefit categories. There’s also legislation on Capitol Hill. From Capital Center Shaheen and the Senate side, that would create a new Medicare benefit category, for that, for that group of technology. So, it’s an area of interest on Capitol Hill, FDA spent a fair bit of time talking about how to streamline the regulation of it, and bring it to market, as well. So, you see, both regulators and lawmakers talk about it a lot, so it’s an area that, that I’m watching. It’s not exactly easy to create a new benefit category of Medicare, particularly when in time to the budget constraint. But there might be sort of flexible way of CMS can take part of that legislation, introduced it, and move it through the regulatory apparatus to see if they can provide a more meaningful benefit to patients on the Medicare side.
28:27
Um, yeah, I guess, you know, coming off of that topic, you know, the Senate Help Committee is going to be very involved in mental health. Maybe I’d go to you, Sarah, on this one, given your background there. You know, obviously, Bernie Sanders is the chairman. Now we have Bill Cassidy, also a new ranking member there.
28:46
It’s going to be an interesting dynamic, I mean, what do you, What do you make of that dynamic? Do you feel like they there will be a chance for some bipartisan work, obviously, there might also be some sort of more progressive fireworks going on and some big hearings maybe. What do you kind of expecting from, from that committee?
29:05
OK, so I totally have a bias, having been a health committee staffer, but even putting that aside committee to me is one of the most exciting ones to watch this Congress, mostly because we have new leadership on the Democratic and Republican side. So, I really don’t know how it’s going to play out both Sanders and Cassidy Love hearing.
29:24
I mean, they both really enjoy the ability to sort of share their platform and also ask a lot of questions.
29:32
Senator Cassidy is very curious, kind of, senator, that needs a time limit, otherwise, he would be there for a long, long time.
29:39
So, it’s, you know, it’s a very interesting role because Sanders obviously has a national profile now, you know, instead of presidential candidate.
29:47
So and he has made his name as sort of that outsider or the person that would be the one senator to vote against the FDA user.
29:56
The reauthorization, yeah, He’s not been a senator that will usually stop something from happening, even though he’s so progressive. usually. It will sort of take the position that is, step four is a step forward and not get in the way. But he’s not usually been in the position of being the dealmaker himself. So it’s quite a different dynamic to be the one that has to find the consensus to move forward. And the Help Committee has a lot of history of working on a bipartisan basis on the Public Health Rios conversations in particular, usually on the nominations, and then also sometimes when it hasn’t been vary by person. You know, during the Affordable Care Act. And during elements of other bills have been passed and reconciliation.
30:36
So there’s sort of room for both here of, I imagine the hearings, there will be some that are bipartisan, and there will be some where there’s some pretty different views that will be put forward when it comes to legislating. There’s not a lot of things that have to happen, there’s a few sort of important bills that the Committee could work on. So I think it’ll be a question of, you know, if the help committee wants to work, hard to find that consensus. And they think that it can get through the house. Or if they made the call that, even if they come to agreement in the Senate, that you know things like a tangled up in the house because of other issues that might get attached to it.
31:12
So it’s really early to make a prediction on that. But, to me, it’s the most interesting one to watch for this Congress.
31:19
Yeah. I guess you mentioned. I mean, there’s not a ton on this front but are there any sort of must pass bills this year in health care I know there’s the pandemic bill, the pop up.
31:30
Maybe a few others.
31:32
I mean, do you think there’s any chance for attaching little health care priorities to those kinds of things, going forward this year?
31:40
Yeah, I mean, there’s always, there’s members with an array of interests across public health. And in lots of divided Congress is, there has been a way to find the ability to agree on either reauthorizing or creating programs in the public health space across SAMHSA, HRSA, CDC, et cetera.
31:59
I think it is a tough environment with this sort of oversight and scrutiny on the agencies that Paul was talking about from the house that’s anticipated.
32:08
There’ll be hard to say, we want to give you new programs when the overall sort of, um, authority and actions of the agencies are being question. But I do think you mentioned Peter the Pandemic, an All Hazards Preparedness Act that sort of sets up a lot of our structures for emergency preparedness and response that needs to be re-authorized. Congress has a history of doing it. So I think that that’s the most right vehicle. And there will be interest certainly on the Democratic side, on expanding that concept into things like how do we address equity and social determinants of health and look at the other factors besides just the research infrastructure to respond. I think that that will be hard to get through, and I imagine similarly, on the Republican side, there’ll be some interest and attaching things to that. So, it’s not going to be an easy one to get done. But I do think that that’s one of the most likely vehicles or action out of the committee, this Congress.
33:04
Well, staying on the sort of public health pandemic area. I know, Amy, you mentioned that as something, obviously states are working on, we’re, I mean, we’ve gotten given this, the somewhat better state of covert, at least these days.
33:17
We’re out of the sort of peak crisis of states having to do masking order, mandatory masking orders and so forth. But, so, where did states kinda stand on the public health front.
33:30
These days are where are they kind of, looking for, from DC also.
33:35
Yeah. So, we’re definitely in a different time in this pandemic. And I think we’re all glad that we’re at a different time, but we’re not, you know, they’re still, cover one thousand cases and whatnot and as I mentioned, it’s interesting. There’s eight states is still have their own public health emergency orders in place for different reasons, supply chain and making sure there’s reciprocity for physicians and nurses, overstate lines, those sorts of things. But, you know, last legislative session we saw a lot on, you know, implementing bans on Coburn 19 vaccine mandates and exemptions to mandates. There’ll be more legislation at the state level along those lines, are seeing bills already that are addressing that. I think there’s a couple of states where it’s being debated about whether there should be some restrictions vermeer’s, so routine vax immunizations, like HPV. So that has definitely sort of come into the conversation.
34:28
There’s conversation around establishing parental rights to consent to immunizations for kids, and then there’s also, on the flip side side, establishing rights to be vaccinated, and, and using personal protective equipment without discrimination.
34:40
So, I think the debate continues, frankly, on, you know, vaccines and masks, and, and that’s, I think, a tough conversation. I think that the bigger question for first aid agencies is, there is some money flowing now, for public health workforce. Every state is organized differently with respect to public health, and I don’t think everybody always realize, is that, you know, some have lots of local public health capacity. Some states have less. It depends how they’re organized, And where the, where the authority lies within the state. Some states have moved that authority to start to let the legislature, in some cases, for making certain decisions. So, there’s a lot going on in that space.
35:18
And, I think, um, questions around sort of the future CDC, CDC, historically has been a very strong partner for states in thinking Besser public Health initiatives. There hasn’t been a lot of guidance coming from CDC in terms of, you know, here’s how you should spend your money, in terms of, you know, updating your data. We know data needs to be upgraded, and, you know, now there’s some money to do that, that states are having to navigate that themselves. So you know from my perspective really having, some, say, best practices kind of where do we want to go in terms of thinking about how we’re going to be ready if there’s another pandemic or if there’s other sort of emergency how to really merge emergency response. And so traditional public health, which comes together when there is disasters. But thinking about that and sort of a more comprehensive way in. And helping identify, you know, where we should move as a country. That would be sort of my ideal of kind of where we could go on. But right now, there’s a lot of different conversations going on. What’s next for public health?
36:16
Well, we’re getting close to an audience question times. We’ve got a lot coming in, which is good. But before we get there, let me just open it up to all of you.
36:25
What’s let’s maybe something I haven’t mentioned that you think is a there’s an undercover or sleeper issue in health care coming up this year, or, or, even if it has gotten some attention, just something you think people should be sure to watch this year.
36:44
I’ll give a few thoughts on that. one that doesn’t get a lot of attention, but it’s just important to sort of running a government is nominations Senate confirmed nominations, and we’re halfway through the Biden administration. And they can be really exciting and grueling jobs which means people will leave. And you need to have leadership in place to run your programs effectively. And, you know, it goes all the way up to Cabinet Secretary level. But there’s a lot of lower level assistant secretaries and such under secretaries that have to be confirmed, and that can become a vehicle for questioning policy. Particulary, particularly if you are not in the presence our party, but also sometimes if you are sometimes on the issue that’s relevant to that person’s position, and sometimes not.
37:28
So I’d say that’s one to watch, because that becomes a place where things can get done because you know the administration wants a nominee put into place or it can really cause things to grind up. So that’s one that people often think about, but actually is sort of a vehicle for action.
37:45
The second is that, you know, in a Congress that might be tough.
37:48
There are other things that are sort of must do’s or really want to do in other areas that can become the place where health policy gets done.
37:56
So I’d be looking at things like the Farm Bill and the National Defense Authorization Act, and ones that generally get done you know, we’ve seen them sort of pick up more and more in the health space. So those are you might not traditionally be thinking about your health legislating opportunities, but they can become. And then the third thing is just, you know, that the X factor, the unpredictable twist that comes up, not every Congress has one. But a lot of them do.
38:20
And Health Care is often the precipitating issue. You know, if it’s obviously the Corona virus, or Ebola, or Zika when I was at HHS, or it’s sort of health related, you know, a terrible mass shooting that causes conversations about mental health in a new way. Or, you know, something like, when the people were second in 20 12, because of a compounding pharmacy issue. And it was sort of an off year. There wasn’t supposed to be an FDA user fee reauthorization. But something so big happen, and it really couldn’t be fixed without Congress intervening. And so created the space to have this big FDA policy debate when nobody expected that. So, you know, right now, the Congress is pretty recently done a user fee bill, so you wouldn’t expect it to be a big, heavy time at FDA. But who knows what might happen, So it’s hard to prepare for that one. But, it is, I would say almost more, common than not. That’s something comes up in the health space that creates this opportunity space or need for action that you haven’t expected.
39:20
So those are the places that I look beyond what you can exactly predict right now.
39:26
I want to leave time for audience questions. But any any quickfire thoughts up Paul or Amy on that one?
39:33
These are just a couple, and I totally agree with Sarah, few other areas of interest that I think could pop up. You know, the Trump Administration did a fair bit of work on coverage of medical devices, They had a breakthrough designation. It was called the … rule, it was it was it was pulled back by the administration, but they have continued to work stream. And it’s been rebranded t-shirt. So, I expect a fair bit of interest from members on both sides of the aisle. About is there a way to potentially codify that? are sort of move that to a legislative process and some give and take between the administration and particularly, particularly the house on that. There was some pushback from House Democrats when the Byte Administration Center roll back that rule, beginning at the beginning of the administration, so that’s one area on keeping an eye on.
40:20
Think, the other area of interest, there’s a lot of general interest amongst members on AI, and how, how to pay for it in the context of services and software in the Medicare program. I don’t think members have really good answers on how to do that. But there’s been a lot of CMS’s raised this question, a lot of its rulemaking over the past few years, and they’re trying to develop its thinking further and further, and how to actually incentivize the use of AI, how to properly reimbursement in the normal programs. And Medicare is paying for pays for the fee schedule inpatients. And it’s something that, I think lawmakers are thinking about a topic. I’m watching, and then I know the IRA has gotten a lot of tension, but so two areas of interest that I’ve heard initially.
41:06
That, I think, didn’t get a lot of tension around passage, but could get more scrutiny over the next couple of years. The impact of the IRA on the orphan drug market.
41:14
There is an exemption in the IRA for, for Orphan Drug, it’s only drugs related to that one designation, So to think about sort of programs that are a drug that can have multiple orphan drug indications of The Irish and have sort of severe impact, I think. You’re starting to see this and earning statements from, from quarterly calls, from pharmacy and sort of smaller. Biotech, About, you know, whether that could be an issue. Moving forward, I think the other issue that get a little more attention around the time that I think we’ll get more over the course of this Congress and in coming years as relates to IRA is the disparity between small molecule and biologic drugs.
41:55
You know, under the under the IRA, biologics have a longer runway before they have to deal with Medicare price negotiations or traditional pill per day drugs have a shorter runway. So, some folks on the street, and some CEOs have pointed out it’s creating screening disparity in terms of venture capital and capital flow into the drug as opposed to biologic. So how Congress rectifies that, don’t do they rectified, I don’t know, but I think there’ll be more scrutiny on both of those issues.
42:26
Amy, 1 or 2 sleeper issue is before we go to audience questions and get to the question. So, one thing we didn’t talk about is Social Drivers of health, or health related social needs. And there has been definitely a, sort of, an encouragement guidance, approval of recent waivers from CMS of really allowing states to expand what they’re doing, with, with the Medicaid program, and paying for things like supportive employment, nutrition, housing. So, I think there are some real interest, and we’re seeing it with the states we’re working with. What more can we do on housing? How can really think about this? And so, I hope, Congress has an interest in looking at that issue. Another topic, where it’s, like, I think it’s 14 states now, are banding together. They really would like to get some coverage of Medicaid while people are incarcerated to really help with their transition out of correction correctional facilities.
43:14
CMS has an approved any of their requests yet, but it’s something that it, if we peaked at it a little bit with the juvenile population where they’re going to be allowed to cover them 30 days before their release. And I think there’s a real interested in expanding on that. So we can really get to, sort of, transitional services and get people out of the recidivism cycle. And then, one thing I’ll just say, is accelerated approval of drugs.
43:37
Lots of concern of blockbuster drugs that are in the pipeline. And sort of states being able to, from a state perspective, being able to sort of afford that with the budgets that they have, and so how do we address that? Collectively, as, you know, we know they’re in the pipeline. We know some of them are going to be coming. And states, you know, under the Medicaid drug rebate rule, have to cover them. They don’t have an option, like commercial plans, do so. So where do we go next on that?
44:00
Yeah, that’s definitely, definitely Wunder Watch. Well, let’s, let’s shift to some of our good audience questions here.
44:09
First one, the last several years have seen strong increases for NIH and research funding, and the ARPA H.
44:16
It sounds like discussions are centered on rolling back discretionary spending. How will this impact NIH and research funding?
44:23
So whoever wants to jump in on.
44:29
Peter, I’m happy to start. You know, I do think NIH will be the face to face a fair bit of scrutiny. Is interesting because some of the key champions were increased NIH funding have have left the Congress or in different approaches to do that. I would flag Fred Upton from for Michigan, my former boss, the House Energy and Commerce.
44:51
You for help provide cash infusion to the NIH, is part of the 21st Century Cures Act. I think the Republican caucus as a whole was probably in a different place right now than it was several years ago on an issue. You know, you know, given all that’s given all we know that have happened in the past few years. The other, the other member that I would flag Senator Roy Blunt again through a very big champion for increased NIH’s spending. He had a very powerful person be the Ranking Member of the Labor, Each Subcommittee, in the Senate, for Senate Appropriations Committee. He’s no longer bears, and he just retired to the flag of Tom Cole. Obviously still a member of Congress are very active member of the Appropriations Committee, and very senior member of the House Republican Conference, but he’s no longer the chairman of the subcommittee that deals with NIH funding. So, you, obviously, have a very big role, and any package at rules, committee, but he’s in a different part to this Congress, relative to others.
45:48
So, I think that the mixed employers means, I think, NIH will, for, most certainly, faced by more budget scrutiny. This go around, the House Republican process in the appropriations process this year.
46:03
We haven’t talked too much about the debt limit but, obviously, that’s the issue that overhangs a lot of the work, probably at least in the first half of the year. So, no agnostic to the issues of NIH. Specifically, the question of how much discretionary spending we have, and what kind of deals are cut, will impact. You know, NIH’s budget has grown over, you know, it had a period where the budget doubled, and then, it was sort of relatively flat. For a long time. And it has increased a lot. So, even getting to a small increase, It’s not, it’s not nothing in federal dollars, and we’re talking such big numbers, but the NIH budget is substantial these days, so getting keeping the kind of increases that we’ve seen requires a lot in a very tight discretionary environment.
46:50
Next question at, at the state level.
46:53
We saw South Dakota finally expand Medicaid, leaving only 11 states who have not expanded any expectations for Holdouts states to expand North Carolina or other states using ballot initiatives to expand Medicaid.
47:07
Yeah. So, I think this legislative session, so Wyoming and Florida, are the only two states remaining. That can even expand using Ballot Initiative. I don’t think we’ll see Bell Initiatives in those states this year, but Wyoming is the legislature that meets every two years.
47:22
They are in session this year, and we do expect a bill to be introduced to expand Medicaid, last time it wasn’t voted on. So we’ll see what happens this time around. I also think, in North Carolina, we will see that issue emerge. Again, Senate Leadership in North Carolina is working on introducing an expansion bill, and we’ll see how they perceive their. I’ll also mention the Governor of Kansas, who was very interested in expanding Medicaid in that state in 20 18, 20 19. And then kill that happened. Has a renewed interest in, in thinking about how to tattoo moves that forward. Whether that’s going to happen less this legislative session, I don’t know. But there’s continued conversations in Kansas as well.
48:03
Well, this is a, this is a broad one, but let’s, let’s see how we could have our own panel about this, but is Congress likely to encourage or discourage possible changes to Medicare, towards evidence based payments, to replace a fee for service? I know there’s been a lot of discussion around MACRA and change that is needed to be revisited. Any thoughts on that?
48:29
Peter, I’m happy to start. You know, I’ve heard some interests in from Congressional Republicans about potentially hearings to sort of review review MACRA, whether it needs to be updated. There’ve also been through a number over the past couple of years, provisions in the end of year bill that addressed payment for physicians. Because the adjustments in the fee schedule Congress, he provided a short-term cash infusion into the fee schedule for positions across the board. So, I do think there is general interests and sort of revisiting, or at least reviewing sort of how how macros work. I also think there’s a lot of interest from.
49:07
From, from, from Republicans in both chambers about kogod flexibilities at the end of last year. There was a, there was a runaway given to provide an extension, at least a temporary extension for, for telehealth and face-to-face services. So I think there’ll be a lot of, sort of behind the work review, sort of, sort of, meetings, and thinking about once that period and what’s worth extending, and what’s worth not. So, that’s how, I think about it, and that’s what I think that’s what I’ve been hearing.
49:43
On it, perhaps somewhat related, or at least in the Medicare Medicaid space.
49:51
Hospital Medicaid dish payment cuts are coming up. Do you see, how do you see these being addressed?
50:01
Do you see Congress finding a way to deal with the has given pressure on entitlement spending?
50:10
Peter, you know that that usually gets coupled with some other public health extend or programs that expires. So, last go around there was an extension of Medicaid dish with a with a with a, with a confusion of billions of dollars for community health centers because they get their funding funding through two basic funding streams. The regular appropriations process and then a mandatory part of funding that was first created in the Affordable Care Act and has been extended on a bipartisan basis over the past. So, I’m expecting those issues to get coupled towards the end of year. There’ll be questions about how it’s paid for?
50:45
I think Congress and the committee’s probably have some ideas on papers in their, in their jurors about that. They’re thinking about sort of flushing out, but I think it will get done. It’s gotten gotten done. In the past, and into Medicaid Dish thing has often been dealt with in a budget gimmick way. Sometimes, Congress will adjust, adjust payments at the beginning of the budget window, and then tack on cut at the end of the budget window then end up getting revisit it later. In your 10 by staffers, tenure, Young, 10 years younger than me.
51:16
So, that’s not how it usually works. But I do expect both of those programs to get it get bipartisan support for extension towards toward the end of the year.
51:30
Can we talk more about what will occur when the …
51:33
public health emergency ends, who will lose coverage, et cetera?
51:42
I’m happy to start that. So, you know, so it ends officially, April wine. But most states are taking up to 14 months to actually process all of the different redetermination, and they’re categorizing different populations Who to start with. And and all of that so that it’s not all going to happen in April. Thank, goodness. States are really going to take their time because they need to just from a logistical perspective.
52:05
So, but they’re going to be a number of people who are who are no longer going to be eligible for Medicaid. I mean, SB estimated around 15 million whether that number turns out to be true. We’ll see, but that’s that, that’s their estimate, and they said of that 50 million, there could be eight million that would technically be eligible to continue continue eligibility for Medicaid. But they won’t fill out the paperwork, so they won’t, they won’t retain their coverage. So, I think states are preparing and trying to do their best to estimate that. The other thing, just to think about is of that 15 million, there was an estimate that, like, four million could qualify for subsidies on the marketplace.
52:41
So there’s also, I think, the ability to really communicate it about different coverage options, to give people choices, to kind of merge to other coverage. But, I mean, we’re talking, we’re talking massive redetermination. So you’re gonna have to happen at that kind of scale.
52:58
Amy, I feel like you’ve pointed out.
53:00
You know, if people are just no longer eligible because of their income, they’re certainly not much that can be done about that. But it’s a, it’s not insubstantial, that group who will will not retain their coverage even though they’re eligible because of the difficulty in reaching them in having them understand what’s to be done. So, I think, you know, there is, there is a population there really worth focusing on its big numbers, and it’s people who may not have the resources or knowledge, or ability to understand that they can get coverage continuously through Medicaid or other sources. So, we saw a little bit of good news yesterday about a technical thing, about the Telephone Consumer Protection Act about how you can outreach to people to let them know.
53:43
This is conversations I’ve had with a lot of Managed care plans and providers they’re very interested in trying to help consumers stay in their coverage. But want to make sure that they’re doing in a compliant way. So, I think, you know, there’s definitely things that can be done.
53:58
You know, there are certain parts of this that can’t be flexed but there’s a lot of room to help people who could stay enrolled reach them and help them do that.
54:11
We’re getting near the end here, but we haven’t talked a lot about the FDA. So, maybe this is an audience question about the FDA.
54:19
In light of the report on inappropriate behavior around the helm approval and other difficulties the agency has encountered recently, for example, the Baby formula shortage. Is there any traction to try to re-organize the agency to make it more effective?
54:40
Peter, I haven’t seen too many concrete proposals on how to do, you think, again, from an oversight perspective, there’s a lot of interest on their person hearings, on the baby formula issue. Last Congress. There’s a lot of questions about how FDA is going to process some of the EU ways, from Kuwait and how those are transition in a new World order as we as the pandemics wind it down. So, I think those are those are areas of interest. I think the tobacco Center will be an area of interest. It has been I think it’s fair to liberation and flown announcements often. And I think to the chagrin and concern of a lot of members of Congress on the Republican side. So I think lots of parts of FDA will be under scrutiny.
55:27
The incoming help Ranking member, Senator Cassidy, is also expressed a lot of concerns about telework at the agency and that’s a lot of agency review staff are not at White Oak. Quoting some of the GAO and OIG work on it and sort of and telework during the pandemic. So I think there’ll be a lot of work for scrutiny. At the same time, agency leadership is facing a hard time recruiting new people in the agency to so, you know, did their challenges and Bhutan?
56:00
Here you’re talking about you know if Congress would get involved, in re-organizations. It’s a hard thing to do to you know Congress doesn’t have an interest in how an agency is organized and you can say you can say certain things even in statute, but you know whether that translates to the kind of culture that you want to see. It’s hard to know. And, you know, sort of on the opposite side of that we just saw yesterday, CDC announcing the re-organization of offices. And, you know, historically over time there were a lot of people that reported to the CDC director, and then 100, Julie Gerberding. She’s streamline that. And how you are reporting to her: this is sort of a move towards more officers appointed according to the director. So, you know, that’s an example of that was hanging out with agency action, being the prompt for it.
56:44
And I, we’ve seen that there will probably be a lot of oversight of the agency. And I don’t know that Congress will necessarily be satisfied with it if they don’t do it themselves. So it’s a tricky one that that interplay between Congress and the administration, about how agencies are organized.
57:01
Peter, one thing I failed to forget it, groups here on that. And the other thing is typically re-organization, or major policy related to FBA usually rides on the FDA a user fee process, which was re-authorized in the last year. You know, there’s there’s a smaller animal generic drug and animal drug user fee that needs to be re-authorized in the year, but it isn’t typically carry a lot of major policy related to human drugs. The other thing on that list them as your home front. There were some minor reforms to the Accelerated reformed Accelerated Approval Program at the end of the year. Included in the Omnibus related to sponsor an agency engagement, public meetings, the ability to the FDA to more expeditiously rescinded accelerated approval, giving the feasibility sort of more authority and tools to demand posts, confirmatory studies after accelerated approval.
57:54
So, know, I don’t, I tend to think that there won’t be a lot. It’s going to be hard to do from the Republican perspective. I think their concern on the home front has been related to more less FDA and more how CMS handle coverage of as your home. But it’s sort of the broad class of amyloid impacting drugs through a national coverage determination. There was a lot of scrutiny out of House energy and Commerce, A lot of scrutiny house, ways and means. Some democratic members of the aisle joined Republicans in expressing pushback to have CMS handled it.
58:29
CMS essentially told Congress to pound sand on that politely, did not really adjust in CD, based on the comments and ladders for Members of Congress. So I expect that to be sort of another area of interest for, particularly House Republicans over the course of this year.
58:49
Got it?
58:50
Well, we are, we are out of time, unfortunately, so we got to most of the good audience questions, Sorry if we didn’t get to you. But thanks, Thanks to our panelists, and thanks to everyone in the audience for coming to those in the audience.
59:05
You will be getting a brief evaluation survey.
59:08
So, if you don’t mind taking a moment to fill that out, and a recording of this webinar will be on the Alliance website, along with other materials, so you can find that there. And thanks again, and have a good rest of your day.