Capitol Gains: Navigating the Hill's Health Hurdles

Host: Rick Gannotta
Producer: Joe Woolworth
Guest: Andrew Barnhill, Director for Federal Policy at BioDelivery Sciences

Show Notes:

Introduction:

• Welcome to the Healthcare Nation Podcast, hosted by Rick Gannotta, produced by Joe Woolworth.
• Introduction to the guest, Andrew Barnhill, a returning policy expert.
• Andrew's background: Director for Federal Policy at BioDelivery Sciences, advocate for value-based healthcare and patient reform, and instructor at NYU.

Episode Highlights:

Federal Health Policy Overview:

• Current focus on PBM (Pharmacy Benefit Manager) reform and transparency in Congress.
• Data privacy discussions and their implications for healthcare.
• Rollout of the Inflation Reduction Act (IRA) and its impact on drug pricing.
• Concerns about clinical trials and healthcare data involving China.

State-Level Health Policy Updates:

• Maryland: Value-based purchasing pilot program for behavioral healthcare.
• Oklahoma: Optional value-based arrangements for Medicaid providers.
• Pennsylvania: Reauthorization of Rural Health Redesign Center Authority.
• Minnesota: Analysis of total public healthcare spending for better financing.

Medicaid Developments:

• Increased private sector interest in Medicaid solutions.
• States experimenting with new ways to optimize care delivery.

Medicare Advantage Oversight:

• Office of Inspector General (OIG) report on Medicare Advantage plans.
• Focus on equitable access, financial oversight, fraud prevention, and data accuracy.

Impact of Upcoming Elections:

• Potential shift in Senate control to Republicans and its implications for NIH and CDC.
• Differences between a second Biden term and a potential Trump administration return.
• Focus on public health agencies and drug pricing continuity under different administrations.

GLP-1 Drugs and Reimbursement:

• Growing interest and debate over GLP-1 drugs for weight loss and diabetes.
• State health plans making tough decisions about coverage.

AI in Healthcare:

• Federal discussions on AI regulation, focusing initially on tech companies.
• Healthcare sector developing policy principles for AI use.
• Importance of high-quality data, patient-centered frameworks, and global alignment.

Data Privacy Legislation:

• Progress on federal data privacy bill (APRA) gaining traction.
• Importance of aligning privacy standards with healthcare data needs.

Healthcare Economics and Insurance:

• Challenges in the insurance market, including cost pressures from innovative therapies.
• Impact of the IRA on premiums and plan availability.

Venture Capital and Private Equity:

• VC interest in gene therapy and innovative therapies despite IRA concerns.
• Impact of policy on startup investments, particularly in med tech.

Key Takeaways:

1. Pricing: Focus on drug pricing reforms and premium impacts.
2. Privacy: Importance of passing federal privacy legislation with healthcare components.
3. Public Health Programs: Continued support and potential changes in funding and leadership for public health agencies.

Conclusion:

• Thank you to Andrew Barnhill for sharing his insights on health policy.
• Encouragement to listeners to stay updated on healthcare policy developments.

Call to Action:

• Subscribe to the Healthcare Nation Podcast for more expert discussions.
• Follow us on social media and visit our website for the latest updates.

Creators & Guests

Host

Rick Gannotta

Health sector executive clinician educator & researcher, RTs/links 🚫 not endorsements, TEDX; https://t.co/51mnBxpPqv @NYUWagner

What is Healthcare Nation?

Welcome to Healthcare Nation, the podcast for enthusiasts passionate about the healthcare sector and eager to explore its current state and future trajectory. Join us as we delve into the heart of the healthcare, biotech, and MedTech industries with the help of top thought leaders.

I'm your host, Rick Gannotta, with over four decades of experience in healthcare, spanning from the hospital bedside to the boardroom, C-Suite roles in renowned health systems, advising game-changing startups and established companies, and educating the next generation of healthcare leaders.

In each episode, we'll bring you conversations with distinguished guests, including innovators, scholars, practitioners, and influencers shaping the healthcare landscape. Gain valuable insights from their perspectives and stay updated on the latest developments, trends, and noteworthy news.

Join us on this exciting journey and become a part of the Healthcare Nation community. Subscribe now on Apple Podcasts, Spotify, or your favorite podcast platform to stay in the loop.

joe-woolworth--he-him-_1_05-09-2024_135355: [00:00:00] Welcome to the Healthcare Nation Podcast, your host Rick Genta here, along with our great producer, Joe Woolworth in the studio. Joe, how are you my friend? I'm doing good. How are you? Good. Good to see you. As I've said before, I love being in the studio. It's good to have a little bantering with you and I'm looking forward, you and I gonna do a little segment go over what's new and noteworthy in the health sector in a couple weeks.

Looking forward to that. Yeah, so along those lines, please send in your questions to healthcare nation podcast.com. We love to hear from you. And don't forget on our YouTube channel, like and subscribe all of this brought to you by Washington Square Advisors. So really pleased with that. So we got a great.

Show, I think planned here. Joe, what do you think? Who's our guest? We've got Andrew Barnhill back on, and as I've often said, said, listen, third time's still a charm. And Andrew's been on the show a couple times before. I consider him our resident policy expert. Currently he's the director for federal policy at Bio [00:01:00] BioDelivery Sciences.

It actually, it. Public policy across the board. He's an advocate for value-based healthcare, patient reform and expert in there teaches alongside yours truly at NYU in the healthcare administration program there, degree in law from Duke. Great background also in politics where he ran for state senate here.

So really looking forward to, once again, having Andrew on the show. So with that, let's welcome Andrew Barnhill.

Welcome to the Healthcare Nation Podcast. We're committed to bringing you thought leaders in the field to discuss what's new and noteworthy in the healthcare sector. Now, your host, Rick Gen.

joe-woolworth--he-him-_2_05-09-2024_140320: Welcome Andrew. So glad to have you back on the show. How are you Doing my friend?

squadcaster-13ca_1_05-09-2024_140321: Doing great. You know, it's an exciting end of the spring and start to summer around here in Washington. But always good to see you. A lot going on federally and in the states.

joe-woolworth--he-him-_2_05-09-2024_140320: I cannot [00:02:00] wait to talk about that. I would tell you, and for our audience, you know, I, I consider Andrew our in-house health policy expert. Andrew. This is the third time, and, and, and you're still a charm along those lines, my friend. I.

just said that, so I.

squadcaster-13ca_1_05-09-2024_140321: Try to be

joe-woolworth--he-him-_2_05-09-2024_140320: We are so happy to have you. Let's just jump right in.

Listen, I'm gonna go over federal state. Let's, let's, let's kick it up to the, to the federal piece. What's happening in general terms on the federal side with respect to health policy? I know there's a lot going on in Medicare Advantage, obviously I won't talk about the elections as well, but gimme a quick kind of summary from your perspective.

What's, what's the chatter on the hill?

squadcaster-13ca_1_05-09-2024_140321: So by way of overview, we have seen continued discussions surrounding PBMs and PBM reform. There have been a number of stops and starts to those discussions over the past year in this Congress. I think we're still where we were several months ago now. Viewers and listeners may have heard some recent news where [00:03:00] House Ways and means has moved a bill forward towards some comprehensive PBM reform that focuses on transparency, but I think we are still at a negotiating point in the Senate.

So the likelihood of seeing significant PBM changes surrounding. Transparency, the issues that we're talking about a lot. This Congress, meaning before the end of 2024, is still probably on the less than 50%. Side of things. In addition to that those conversations that are happening, there's a lot which we can get into later about data privacy as it relates to the healthcare sector.

So there's a data privacy bill that is making its way through the House Energy and Commerce Committee that's making it further than the previous ones have. And one of the big debates is about components surrounding healthcare. In it. There's also the continued rollout of the Inflation Reduction Act, known as the IRA [00:04:00] and the drug pricing provisions.

We are in that early stage of what CMS is calling price negotiation, what the industry is calling price controls surrounding 10 drugs. And we're in that, see how this works stage with the IRA right now? There are also some discussions, particularly as the Biden administration begins to have some concerns about US business relationships with China, about clinical trials taking place in China, healthcare data as it is moving between China and the us.

Those are other discussions that are taking place on the hill right now. Many more things, but if you were to ask what's top of mind before the August recess? I would say the PBM reforms and the rollout of the IRA.

joe-woolworth--he-him-_2_05-09-2024_140320: And I'm gonna come back to that because I think there's so much happening just in the drug pricing side, the market dynamics [00:05:00] part, you know, BD and how that's all impacted, particularly on the, on the PBM side. So thank you for that, that quick overview. How about what's, what's, what's happening at the state level?

Anything that pops up in any particular area. And I'm sure Medicaid is, is gonna be a big one. That's, that's at least in the top three.

squadcaster-13ca_1_05-09-2024_140321: Certainly me, Medicaid's there. We saw a number of states in late 2023, and then those who have sessions in 2024 that are focusing on some financing and payment reforms at the states. So three that I will mention, Maryland, Oklahoma, and Pennsylvania. So Maryland established a value based. Purchasing pilot program that's gonna be run by the State Department of Health focused on behavioral healthcare.

So it essentially requires some type of value-based purchasing model that would incentivize providers to meet certain outcome measures. So that's in state of Maryland. Oklahoma authorized contracted entities to offer [00:06:00] optional value-based arrangements for providers in the Medicaid program that require some provider incentives and reimbursements aligned with the Oklahoma.

Healthcare department, they call the HE healthcare authority and their quality measures. So we're seeing some changes there in Oklahoma to support alternative payment arrangements. Pennsylvania has focused on rural health and reauthorized. Its rural health redesign center authority, and that's the pot of money that manages the budget for rural hospitals in the state.

So those are some significant things. Minnesota. Has enacted some legislation. This was late 2023, beginning of 2024. That requires their State Department of Health to analyze total public healthcare spending and look for alternatives to better financing in the state. So it's essentially setting up a analysis or a task [00:07:00] force that's targeted for implementation by 2027.

So we saw some of those things taking place. There's also been a little bit of a focus on primary care. Colorado has enacted some legislation that would really cement a program they developed called the Regional Health Connectors Program that brings together primary care practices and providers to you know, sort of directly address social needs in local communities.

So we saw that coming out of Colorado. You know, a number of other things related to payment reform surrounding Medicaid, but those are, those are some of the highlights that I would mention.

joe-woolworth--he-him-_2_05-09-2024_140320: You know, I wanna just kind of go down the Medicaid channel for a second. It seems to me there's so much activity, obviously at the state level, but I'm talking about more from the private sector in terms of, hey, this population, the solutions that need to be applied to optimize care [00:08:00] delivery, that it's really got more than just, you know, a, a.

A, a passing or fleeting idea like, Hey, is there solutions we can apply that it's really got legs from an investment perspective. Do you agree with that?

squadcaster-13ca_1_05-09-2024_140321: I would agree with that. And I think the challenge you have with Medicaid is, you know, obviously most, most of our listeners know it's state run, and so you have these individual state Medicaid directors with their own policies, but they're layered by. You know, types of, you know, federal rule making that will influence what can actually move in the states.

And so you've, you've always got this tension between state and federal with Medicaid. But as there's been more flexibility sort of post the last big round of Medicaid expansion, some of the later states later expansion states are starting to experiment a little bit. And so you're seeing, you know, new, new ways of working, if you will.

But yeah, that, that, that's certainly a big 2024 issue.

joe-woolworth--he-him-_2_05-09-2024_140320: Let me go back to the fed side of things by just, [00:09:00] I just weigh in on what's happening in MA Medicare advantage. Know, legislative regulatory measures really to, to get the oversight, I think, tightened up based on some, let's just, let's just say initial less than optimal quality reports.

squadcaster-13ca_1_05-09-2024_140321: Yeah. Yeah. So the OIGs office, inspector General, within HHS put out a report at the beginning of the year, their strategic plan for oversight for MA plans to sort of, sort of crack down a little bit. There, there were several categories or goals on that. One was really. Sort of promoting access and ensuring that there is effective and equitable access within MA plans.

Another, and the big one I think is providing some comprehensive financial oversight by HHS to Medicare, paid Medicare Advantage plans sort of making sure that the incentives are aligned. Well [00:10:00] with good financial oversight also identifying and preventing fraud in some of the plans. It's been something that OIG has focused on.

Sort of they put together a new office within HHS that is specifically focused on identifying. Fraudulent practices within those plans. That's new in 2024. But also ensuring data accuracy within the plans is something that they've devoted some, some efforts to. They're doing more audits from the OIGs office into the MA plans starting in 2024.

Those are, so those are all things that are taking place that are new, maybe over the past five to six months.

joe-woolworth--he-him-_2_05-09-2024_140320: .

Let me stay on the hill and get maybe a little bit more political. There was word that came out. Senator Bill ca Cassidy, Republican, Louisiana. The republican line, the lead, the Senate committee that oversees the NIH if the GOP wins senate control.

That could be a lot of [00:11:00] scrutiny and perhaps some overhaul of the NIH. What are your thoughts on that? And let me, let

squadcaster-13ca_1_05-09-2024_140321: Okay.

joe-woolworth--he-him-_2_05-09-2024_140320: start with NIH, but not necessarily stop there.

squadcaster-13ca_1_05-09-2024_140321: Yeah, because I also wanna take on CDC. We'll talk about that as well. So let, let me give a little bit of background for the listeners here about why one particular Senator, Senator Bill Cassy matters in this particular case. And you may have seen the news come out through Politico about this. So, Senate help committee is currently led by Senator Sanders.

If and as we likely expect the Senate is going to be controlled by Republicans after the November election, and we, we say we expect that because you look, look at the seats that are in play, that is much more likely than not that Republicans will have the majority post-November. So starting in January of 2025, if that is in fact the case, bill Cassidy of Louisiana.

Would almost certainly [00:12:00] become the chair of the Senate Health Committee, the health education and Labor and Pension Committee that has jurisdiction over organizations such as the NIH. So that's why Cassidy matters in this case. So what, what has he been saying? He has been focusing over the past few weeks, probably in the press, but really months internally with his staff on funding sources within NIH, what NIH is doing with the federal dollars they're receiving for clinical research.

What is the ROI for the public? That's been a big question. I think there is a. There is a sentiment by Cassidy, and maybe you could extrapolate into Republican circles on the Hill more broadly that. There's, there's not a lot of communication with how specifically the NIH is partnering with the private sector.

One, two, the turnaround time on the investment that the [00:13:00] federal appropriations process puts in to add additional dollars to the NIH. And there's another complicating factor of this. There's recently a launch of a new federal program called ARPA H, which was a Biden initiative that started now two years ago.

Which is to run alongside NIH and provide sort of a, a moonshot effort. So it was modeled after the Biden Cancer Moonshot. But to expand into other the therapeutic categories, and the idea is that you give people from the private sector along with the public sector, this sort of open. Slate to pursue the most aggressive and difficult challenges in the healthcare space and broadly life sciences and see what, what types of new innovations they can come up with.

Well, there were, there were a significant chunk of federal dollars put towards this and. Folks like Senator Cassidy want to know, okay, what's happening so far? How are those dollars being used? What's the ROI? And [00:14:00] so I think we're likely post-November going to reach this point of, okay, significant investment to NIH, significant investment to RFAH.

If we are going to continue those in the next appropriations process, we wanna see some results. That's what, that's what a Republican would, would say in, in that particular case.

joe-woolworth--he-him-_2_05-09-2024_140320: So, let me sting on that thought, but, but being a little bit more broad on it, the impact of healthcare policy, let's just start with with the agencies based on the election outcomes. So how, how might, you know, policy change, how might. Voter behavior change with when, with respect to healthcare issues and how might these agencies actually be impacted, under both a Biden reelection or a, a Trump coming back in.

squadcaster-13ca_1_05-09-2024_140321: Okay, so, so let's, let's play out both scenarios here. I think if you see a Biden [00:15:00] reelection, you're likely most likely gonna see a. Status quo with the federal agencies. There will probably be some changes in personnel. I think Secretary Becerra at HHS has indicated he's interested in going back home to California to pursue other things.

So there will likely be a little bit of a shakeup there. I think Mandy Cohen at CDC has the confidence of the president, so most likely she would either stick around or go to maybe something else. But, but I think there would be a sort of stay the course. There, I think there would be a real push to expand his signature ARPA H program as well as Cancer Moonshot.

I think you would see an expansion of the IRA's efforts because, because it's really a tiered process. What we're in right now with the drug pricing piece is step one of what was included in that, that statute. So I think status quo plus expansion of the signature programs. IRA and RPH, so that will be a Biden.

Term two. I think [00:16:00] a Trump return or Trump term two would look different in some ways, but as we've referenced maybe on a previous podcast, more similar than the public might. I. Recognize in healthcare. So the differences are there is certainly a lack of trust in the CDCs capabilities and deliveries by Republicans and of course by extension Trump.

And so I think you would see. More of a focus of taking some of the CDCs work products and sort of transferring those duties to private sector contractors, I think you would likely see a, a change up of sort of the entire leadership at, at CDC with the Trump administration. I think it's to be determined.

Who would come in at, at HHS? I don't think Alex Azar would be back. I, I think it would be someone who's more closely aligned with Trump personally [00:17:00] in a Trump term two. But on the drug pricing piece, which is a, you know, a major question right now, I think there's a lot of consistency between Donald Trump and Joe Biden.

You know,

joe-woolworth--he-him-_2_05-09-2024_140320: Yeah, we, I,

squadcaster-13ca_1_05-09-2024_140321: Yeah, go ahead.

joe-woolworth--he-him-_2_05-09-2024_140320: I think we could arguably say that it started with Trump, right? During his, his term.

squadcaster-13ca_1_05-09-2024_140321: It did. And I, and I think, you know, true to Trump's style, he'll probably take credit for it and say it's something that he started and, you know, Biden couldn't carry it out, so he's gonna carry it out. So, so I don't think you're going to see this complete turnaround. You know, I, I have some colleagues in the sort of broader healthcare world that say, oh, well, you know.

Republican in the White House, doesn't that mean the IRA is repealed and I give an emphatic no, I one. You know, one thing that we know of those of us who've worked in politics and in legislation is that once you pass a piece of legislation with a significant government program, it's very difficult to take that away.

So [00:18:00] rolling it back is, is more difficult than just one regulation that you're gonna, you know, ignore. Right? This is a significant program that has developed a new. Function within CMS. So that would just be very difficult to change. In addition to that, you have you know, another president, Donald Trump, who has said that he wants to, you know, quote, hit big pharma, and this would be a way of, you know, carrying out what he articulated in the first term.

So, continuity in drug pricing. Difference in the relationship between the White House and the federal health and public health agencies. The other things like PBM reform, I think that depends on what happens with Congress. I think there is some general interest across party lines of pursuing some sort of PDM legislation, so I could see us continuing that debate even if the chambers flip.

[00:19:00] I think the, maybe the heightened scrutiny on ma plans coming from HS no i's office might slow down a little bit, just given that there would be new leadership at HHS and you'd have somebody new in charge of the OIG, so that, that might shift a bit. But those are some of the initial things that I would say are, are likely to take place.

And then of, then of course, you have to question, you know, there are elections up and down the ballot. So there are changes in the state level too. There are some high profile governors races. There are some states where, you know, depending on who the governor is, will determine who is head of the state health department, which could determine how Medicaid is implemented and run in those respective states.

Those are key questions for us to think about heading towards November, 2024, in addition to whether Biden gets another term or Trump comes back.

joe-woolworth--he-him-_2_05-09-2024_140320: Let me use stay on, on the, the drug issue or maybe one drug and use that as [00:20:00] a, as a bridge to, to some other questions. But let, let me ask you really quick the role of GLP ones. What do you think about that? It's, it's so, it, it's just so a top of mind, you know. Part of everyone's conversation now, whether it's at the policy side, treatments, does it work, does it. but who's gonna pay for It, is a big part of this.

Are you are you seeing a lot of chatter along the lines of GLP ones where it's at reimbursement? Oh, it. Andrew?

squadcaster-13ca_1_05-09-2024_140321: It, it's constant chatter. And I was just at a conference two weeks ago talking about innovation and the price of innovation and GLP ones was about a third of the entire agenda in conversation. So it definitely is, and, and we're seeing, you know, state health plans making difficult decisions about whether or not they're, they're going to provide coverage to GLP ones for, for weight loss or not.

You know, there's been a lot of news in North Carolina, for instance, about it, state health plan and decision there. I, I think it's a tough [00:21:00] call for particularly public programs when they see the, the cost. But I, I think we're seeing enough new literature coming out about sort of the wide scope of, of benefits to GLP ones beyond weight loss.

Beyond you know, diabetes looking in broader cardiovascular space. There are a number of other areas where, where we've seen some phase three trials with some interesting data as well. I, I think we're still early, right? I think we need to give it, you know, a year or two of more data to come out to see whether or not the public programs are willing to take a gamble and say, you know, the, the long-term benefits of patients having.

More easy access to GLP ones will save us money in the long run on other things, but I don't think, you know, you're likely gonna ha need a first mover. But, you know, a large state that's going to [00:22:00] say, we stand behind coverage of this and seeing other state health plans follow or, you know, a, a more definitive.

Statement from CMS and I don't think anybody wants to be that first mover right now. I think, you know, they've been relying on the, the private plans that have been sort of more receptive here, but, but not across the board. So let's see. I think this is something we can come back to maybe, you know, mid next year to see sort of where does the data meet the willingness from the, the state health plans and CMS

joe-woolworth--he-him-_2_05-09-2024_140320: Yeah, I think the, the care coordination component of it, you, you'd have to have a substantial plan with, with enough, you know, line of sight clinically Right. the efficacy on, the backend for the,

squadcaster-13ca_1_05-09-2024_140321: Yeah, there are a lot of, there are a lot of adherence issues in particular with GLP one injection injections. So I think, you know, a lot of [00:23:00] questions there. You know, to be determined still working out the supply issues as well in some parts of the country more than others, but very promising exciting example of innovation in the life sciences.

joe-woolworth--he-him-_2_05-09-2024_140320: Let's, let's stay on that innovation, kind of technological, point and talk about ai. Obviously, besides GLP one's, probably the other top of mind, you know, issue that's out there, particularly in healthcare, where I think there's, there's not, there's certainly a lack of, of a clear path forward when it comes to regulatory frameworks, ethical, effective use, monopolies, just in general, those, those legal and regulatory oversight components that go Yeah. What's the Yeah. the hill with, with ai, particularly as it relates to the health sector and delivery?

squadcaster-13ca_1_05-09-2024_140321: So this is a great question that most of us who are, you know, lobbyists in health space have been dealing with over the past month or two because the [00:24:00] AI discussions, you know, about. Legislation and regulation of AI at the federal level have largely until very recently focused on your pure tech companies.

Right. And it, and it's focused a lot on, you know, kind of. Aligning with, with Google and Microsoft, et cetera, and the healthcare companies have really been late to those conversations. Recently, the senate leadership in a bipartisan way, I might add convened a group of sort of a working group on the healthcare components of ai.

And this is you know, people like Senator Heinrich Senator Rounds. Schumer is also of course, taking a lead. And, and it's, and it's actually been a, a fairly thoughtful process. Senator Cassidy's involved in it as well. I. And this effort has sort of led to more questions than answers, but I think a number of stakeholder groups, so trade associations in healthcare, have started [00:25:00] trying to align on policy principles that we all can get behind.

So I've been working on the, the real world evidence side with developing some of those. We, we did the same for my own company. Some of the principles that I think are being. Pushed in the healthcare side are okay. We need high quality and reliable data. So healthcare AI needs to be developed and deployed using high quality data.

It needs to be, you know, healthcare, AI should be trained using representative data, for instance including from real world sources. Policy frameworks need to be developed with patients at the forefront, and there needs to be some level of explainability. I. To the patients themselves in the development and deployment of ai.

That, that the policy framework should identify processes to expedite the review of AI tools using some level of predictability, and that there should [00:26:00] be alignment between the US and other markets that are making use of healthcare AI tools. So those are all things, there are a number of others, but those are some of the key principles that I think there's sort of cross healthcare ecosystem agreement on.

Right now, the US is behind. I mean, I, I will say the EU was first developing some AI frameworks. Of course, they were in the data space as well. So in some ways we are playing catch up, but I think I. Since most of us operate in organizations that are global, we are trying to take cues for what worked with eMASS efforts and EU broadly and try to align those with what we're recommending in the us.

But this is early stages. I mean, I don't think, I don't think we're gonna have an AI bill gain significant traction. This Congress. We're still sort of debating data privacy and then we'll get to ai.

joe-woolworth--he-him-_2_05-09-2024_140320: Yeah.

I, and my thought is, you know, I think particularly when you look at [00:27:00] Europe, I don't know how much innovation has been, I. Blunted with some of the regulation there versus the us. But I think that's that's just something that at least I've heard when I've been out talking to some folks in the tech area that are

squadcaster-13ca_1_05-09-2024_140321: Yeah.

joe-woolworth--he-him-_2_05-09-2024_140320: ion in healthcare.

In some ways the, the, I don't wanna say the lack of regulation, but the looser,

squadcaster-13ca_1_05-09-2024_140321: Oh, it's helped. I mean, yeah, I mean, it, it's helped new healthcare, AI companies to really grow and, and blossom and I'm, I mean, I think that's. Sort of part and parcel our, our US sort of innovative mindset. That that stands a bit apart from Europe's approach. So certainly benefits to our environment, but, but I think we have to take cues from Europe's regulatory efforts so that, you know, a, a US based company that's operating in Europe doesn't have the challenge of being faced with, you know, AI requirements that are difficult in Europe and having to figure out how to operate differently [00:28:00] between.

Between the two places which can be a particular challenge.

joe-woolworth--he-him-_2_05-09-2024_140320: You know, earlier you, you, you mentioned the the data privacy piece and that, you know, this month for the first time really making more progress

squadcaster-13ca_1_05-09-2024_140321: Yeah.

joe-woolworth--he-him-_2_05-09-2024_140320: cycles. Any comments on that, Andrew? I.

squadcaster-13ca_1_05-09-2024_140321: Yeah, that's taking up a significant portion of my time right now. So a little bit of background. Your listeners might be aware that back in 2022 we saw a federal data privacy bill. Gained some traction that was known as A-D-P-P-A. They, they always have long names to these that are abbreviated.

And the rationale for that at the time was that in the US there are so many states with data bills that were starting to pass and different data privacy standards. And, and this matters significantly to healthcare and the, the sharing and the selling of [00:29:00] healthcare data in particular. But there was not a consensus in 2022, and so it sort of.

Stalled this Congress a, a bill that was very similar, but not entirely to that one, has been introduced, and that's a PR or a PRA and it's gained more traction than we've ever seen in the past for a couple of reasons. One, the, the chairwoman of the House Energy and Commerce Committee, Kathy McMorris Rogers, is really making this a signature effort of hers.

She's retiring at the end of the year and she wants to see this happen. So that's one reason She also worked hard to get bipartisan and bi al. So both House and Senate support for this, the chair of the Senate Commerce Committee, Maria Cantwell is a Democrat. She is signed on to this bill. So that's a significant thing 'cause those are the two of the key committees on this issue.

Now, the healthcare community has been, and I, and when I say that sort of [00:30:00] broadly, you know, hospitals, payers, providers. Pharma have come together to try to make sense of you know, what, what sort of language is workable for our respective sectors. That a lot of the, the provider community was okay because there were some clear HIPAA protections and carve outs within the initial bill.

Those of us on the clinical research side were more concerned because there wasn't special attention. Played to the safety and protection of clinical trial data. And so we've been working collaboratively. In fact, I had a meeting just a couple of days ago with various stakeholders to, to align on recommendations to help the committee with that, because, you know, the, the committee may be thinking about privacy broadly, but they don't.

They don't necessarily know how it's going to impact different parts of healthcare. And so that's, you know, the job of, you know, those of us in the industry to come in and say, okay, here's something you might not have thought about. [00:31:00] And so it's gaining a lot of traction. I, I can't say for sure that it's actually going to, I.

Passed this year because there, there's just, you know, it's just tough to get things crossed the finish line in Congress and there are must pass bills like the, you know, appropriations, you know, you gotta fund the government first. And that's been a challenge this year, this congress, but I think the odds are much higher than they ever have been.

And so I, I would not be shocked if we, you know, come back in our next podcast next year and say that we've passed federal privacy legislation for the first time. So.

joe-woolworth--he-him-_2_05-09-2024_140320: I know it's taking up a lot of your time and with everything else that's happening right now. In Yeah. election cycle, obviously Yeah, and federal. It's it, it shows the importance of this topic, though.

squadcaster-13ca_1_05-09-2024_140321: yeah, yeah. And, and of course it's become even more important as there have been certain things happen, like the, you know, the change healthcare situation with Mm-Hmm. has certainly become top of mind. So I think you know, I think people are paying attention to data and privacy. [00:32:00] Yeah.

joe-woolworth--he-him-_2_05-09-2024_140320: Yeah.

so important and I think another breach in fact today as well as we, as we speak here, may, May 9th, so it's, it's endless. Let me switch gears over to economics and look at it through the lens of healthcare insurance. What should policy makers be focused on when they think about. Stability, affordability in the broader insurance markets out there.

There's a lot happening. I think Mar, in the commercial space, I think margins are kind of getting squeezed a bit this post covid world, I think. I hope that's the last time I ever say post covid world, but what are your thoughts on that and what's what's the word out there?

squadcaster-13ca_1_05-09-2024_140321: They are. And, and one of the things that I'm hearing a lot when I, I talk to folks in the payer community and then of course, you know, inevitably they ask me questions about innovation. 'cause they're interested from the, the pharma and clinical side of what, what's happening. They, they indicate to me that, you know, the high cost per patient [00:33:00] for cell and gene therapies is really, you know, driving up.

Cost concerns and just pricing pressures So. I, I, I, I think there's gotta be some sort of broader conversation about spending surrounding some of those in particular high cost therapies and the impact that that's having on the payers themselves. So, so that's a, that's a big thing that I hear.

The IRA also has posed some challenges to the payer side. It's leading to some premium increases. We're only seeing the first round of those right now. I'm really curious to see, you know. Next, next year, I guess in the next January. How, what premiums look like overall, you know, a declining number of, of plans.

Also perhaps the result of some unintended consequences of the IRA. So I, I think those are all things that payers are concerned about right now. So.

joe-woolworth--he-him-_2_05-09-2024_140320: [00:34:00] You know, it's interesting how much of it you circle back to drug pricing in this and, and obviously in rare diseases or very expensive drugs, oncology space along those lines. You agree with that, Andrew? I.

squadcaster-13ca_1_05-09-2024_140321: I, you know, I, I think we, I think there's a tendency to say that drug pricing is maybe a larger problem than, than it actually is. But it does impact a lot, a lot of different things, and particularly, these, these most innovative new therapies, which are truly exciting. Cell and gene therapies, you know, things like the GLP ones, right?

I, I think we, and, and I shared this at a conference that I was speaking on a couple weeks ago, is that we've never really, the public in the United States has never really had a conversation a genuine one about the trade-offs that we're willing to make for lower cost. If we, we really want access to.

You know, the sort of maintenance drugs and in things that [00:35:00] we can get more cheaply and focus on lowering cost across the board for prescription drugs and then keeping with that lower cost premiums. Then I think I. We're gonna have a little bit of a different innovation ecosystem. But one of the things that we've always, I, I think prized in the United States is that, yeah, we spend a lot of money on r and d.

We spend a lot of money on commercialization of these sort of new first in class therapies, but we're willing to accept that because we're, you know, this is the one place in the world where we can pay for it and make it happen. And we think those therapies should be available, but I don't know if we've ever.

Actually reach that consensus because there's always gonna be pricing pressures and those as we have more and more innovative therapies, those are going to raise cost across. The, the healthcare sector. Now, let me also say this, the prescription drugs are still under 20% of total cost of healthcare in this country.

I [00:36:00] think no matter who is looking at the data, depending on what perspective you come from, you know, some on the low end would say, you know, 10 to 12%, some on the, the upper end, 18 to 20%. But that, that percentage still matters to of the, the shape of healthcare spending.

joe-woolworth--he-him-_2_05-09-2024_140320: It's interesting how much of that will trickle over into influencing. You know, your preferences and, and whether it's a state or presidential election, how much of it is a pain point for me? When you think about the trade off of access, cost, innovation, let me switch over to the, to the private markets or the capital markets and think about the VC and private equity space through a policy lens.

I really, and I, I, I always go down this road with our guests. When you think about that space. Is there an impact on venture capital and private equity right now that is influenced by policy that's out there? [00:37:00] And we talked a little bit about some of it, but I'm just interesting. If I was a, if I was in a startup Yeah. I'm out in the valley, I'm thinking it's a med tech.

What do I need to be looking out for on either existing policies evolving policies or new administration policies that might impact the trajectory of what I'm doing?

squadcaster-13ca_1_05-09-2024_140321: So, you know, everybody in the VC world is interested in the implications of the IRA. And I think. That and, and not just the, the direct pricing piece, but there are multiple pieces of the, of that. So I, I think that has generated a lot of. A lot of questions as to whether it's worth investing in the sort of, you know, one product sort of, you know, your, your gene therapy companies with, with one candidate one immunotherapy, for instance, that might be very expensive.

Some of those at the very earliest stages are having a little bit of difficulty. But [00:38:00] I, I don't think we've seen, you know, there was, there was a little bit of fear mongering that all the. VC funding for you know, early stage, you know, preclinical and clinical stage therapies in the gene therapy space.

Immunotherapy space was going to dry up as soon as the IRA passed. I don't think we've seen that, but I do think there is a lot of fear out there still. And, you know, time will tell. We haven't seen it as much in the device space. I still think there's an appetite there, but we're not seeing as much.

Regulation on the pricing side in the, in the device and tech space yet so.

joe-woolworth--he-him-_2_05-09-2024_140320: All right. Well, Andrew, as we wrap things up, why don't you sum up for our audience, for our listeners, you know, what's the, what's the big three things that you think about in the health policy world that. We should have our eyes fixed on as things evolve, not only through the election coming up, but [00:39:00] also beyond that, that these are going to be the big issues.

We talked about a few of them, and I'm hate to put you on the spot to, to rank order them, but what's, what's on your mind? What do you see the Hill focused on? How is it going to impact, you know, the general public as well as folks who have a vested interest in the sector?

squadcaster-13ca_1_05-09-2024_140321: Good question. I'll give you three, but I'm sure I could pick others. And there, they're always trade offs. So I would say it's, you know, I'll, I'll name them and then I'll go through them. I would say it's pricing privacy. And support of the public health programs. So by pricing all the questions surrounding the IRA drug pricing side as well as premiums.

So all things pricing. Second privacy, as we've discussed, passing federal privacy legislation with a significant healthcare component is top of mind by legislators. Little bit less with agencies, but, but particularly Capitol Hill. And then third, support of the public health programs, the [00:40:00] C-D-C-H-H-S with, you know, depending on what happens with the elections, who's going to be in charge?

Will those programs see significant shifts in funding changes? I. No matter what happens in November, there will be conversations about our public programs related to healthcare and particularly those that demand significant amounts of federal dollars. So those are the three that I would name. Of course, there are many more that others could choose, but if you're asking what's top of mind from my perspective, those definitely make the list.

joe-woolworth--he-him-_2_05-09-2024_140320: Okay. Well, Andrew, it's been a great show. Obviously look forward to having you back before the end of the year because I think we'll have a lot to talk about after November and obviously leading up to and immediately after. So thank you my friend. Always incredibly. I think spot on summary and insights to what's happening on the hill and, and, and in fact at the state level in health policy.

So thank [00:41:00] you Andrew for being here on the Healthcare Nation Podcast.

squadcaster-13ca_1_05-09-2024_140321: Thanks, Rick. Always a pleasure to be here. We'll talk soon.

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