Top Ten 2026: Redefining Public Health Policy

Based on AHLA's annual Health Law Connections article, this special ten-part series brings together thought leaders from across the health law field to discuss the top ten issues of 2026. In the third episode, Anna M. Lozoya, General Counsel, Physician Alliance Group PC, speaks with Miranda Franco, Senior Policy Advisor, Holland & Knight LLP, about the forces currently shaping public health policy and why 2026 marks a turning point. They discuss the advancement of the administration’s “Make America Healthy Again” agenda through the Center for Medicare and Medicaid Innovation, drug pricing, vaccine policy, and where health systems can devote resources based on current public health trends. From AHLA’s In-House Counsel Practice Group.

Watch this episode: https://www.youtube.com/watch?v=_aCBcqNZRJg

Read AHLA's Top Ten 2026 article: https://www.americanhealthlaw.org/content-library/connections-magazine/article/a879dda5-35f9-46fb-ad45-1b0799343d74/Health-Law-Forecast-2026

Access all episodes in AHLA's Top Ten 2026 podcast series: https://www.americanhealthlaw.org/education-events/speaking-of-health-law-podcasts/top-ten-issues-in-health-law-podcast-series

Learn more about AHLA’s In-House Counsel Practice Group: https://www.americanhealthlaw.org/practice-groups/practice-groups/in-house-counsel 

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Transcript

SPEAKER_00 0:02

Welcome to AHLA's annual Top 10 Series, where we discuss the major health law trends and developments of 2026. Learn more about AHLA at americanhealthlaw.org.

SPEAKER_02 0:16

Thank you for joining our podcast today. I'm Anna Luzoya, a vice chair with the In-house Council Practice Group. And joining me today is Miranda Frankel, a senior policy advisor with Holland and Knight, based out of DC. And today's podcast is based on her Health Law Connections article entitled Refining Public Health Policy. Miranda, so based on your article, you've written that the 2026 represents a turning point for the US public health policy. Stepping back, what makes this moment different from prior reform cycles? And what do you see as the defining forces reshaping public health right now?

SPEAKER_01 0:56

Thanks, Anna, and a pleasure to be with you this morning. So it's a it's a pretty big question, right? So, first, uh federal public health institutions have undergone an unusually deep and rapid transformation in the last year. So we've seen changes to agency staffing, organization, and funding that have really altered some of the core functions from disease surveillance to research oversight and just how all of these things are carried out. So I think on like past reform efforts that focused on expanding or refining programs this past year really reflected a rethinking of the federal government's role in public health capacity itself, and certainly with some long-term implications. The other thing I would underscore is that health policy, I think we're seeing increasingly shaped by the courts, if not more, than by Congress. And so last year we saw some major Supreme Court decisions that clarified some issues, such as preventive services coverage, while opening new avenues for some state-level divergence in areas, particularly in the Medicaid arena, for example. And then there's ongoing litigation over federal authority and funding decisions and agency actions that has made health policy a bit more fragmented and certainly less predictable than in prior reform eras. And then lastly, and I touched briefly about this in the article that I crafted, but as we all know, Congress passed HR one, which has significant implications for coverage and access and state budgets. And then at the same time, Congress has not yet or will not extend the enhanced premium tax credits for ACA coverage. So those are pretty significant elements that are certainly have impacted the last year, but will have these ripple implications moving forward. So for 2026, all this is unfolding in terms of implementation in the shadow of the 2026 midterm elections. So there's some heightened political sensitivity around healthcare affordability, Medicaid, and public health spending. So I think we're in for another um spin-heading, uh head spinning year, certainly.

SPEAKER_02 3:01

I definitely agree. It's been head spinning, um, I think for everyone in healthcare, like you said, very fragmented, very unpredictable. Um the administration has kept all of us on our tolls. Along those lines, uh, the administration's Make America Healthy Again agenda places a strong emphasis on chronic disease prevention and long-term management. How is the CMS Innovation Center being used as a vehicle to advance that agenda?

SPEAKER_01 3:28

Sure, it's a great question. So the current administration, I think, is really repositioning the innovation center. We've seen several models be removed, we've seen several models be revamped, and a litany of new models introduced. So I think this CMI is really focused on balancing sort of low-risk models that deliver predictable near-term savings with longer horizon initiatives. Many of those sort of follow the Maha agenda, so focused on chronic care prevention and management that require uh incubation but have potential to drive system level change. So last year, as I was noting, we saw a sharp acceleration in CNI's launch of new value-based care models. And I think that'll be pivotal as stakeholders decide this year which models to pursue, assess their impacts, and then identify some key markets and partners.

SPEAKER_02 4:31

What in your opinion is fundamentally different how CMMI is approaching chronic conditions in this new generation of models?

SPEAKER_01 4:39

Sure. So I think we're still learning a lot about those models in real time and still awaiting some details. But Access, for example, is a 10-year voluntary model structured around outcome-aligned payments for technology supported care options that prevent and manage chronic disease in conditions that represent a pretty large share of the Medicare population. And then Elevate, also voluntary, is a$100 million initiative that funds up to 30 pilot projects focusing on lifestyle, behavioral, and nutritional interventions to prevent chronic diseases. I think the Elevate's charge is even more explicit in that it aims to address lifestyle choices and behaviors to chronic disease prevention and long-term cost. So I think what we're seeing with some of these models is instead of what we've historically done under the Nation Center, which is paying mainly for episodic treatment after deterioration, these models are designed to pay for sustained engagement, function, and prevention, especially when digital tools or team-based supports can help keep people stable.

SPEAKER_02 5:49

They fall outside of traditional Medicare benefit categories. How is CMMI using its model authority to test these approaches without prematurely locking in permanent decision coverage decisions?

SPEAKER_01 6:02

Yeah, no, great question. I think CMI is essentially creating a controlled testing line, right? That that is the whole purpose of the Innovation Center. And so in this instance, instead of declaring a new nationwide benefit, uh, we can look at access again. So access is a good example of that approach. It's designed to expand access to technology-supported care options through model payment structures while still operating as a demonstration with evaluation criteria. So, for example, there are no CPT codes to determine payment under this model. Payments are on a per patient revenue line as long as a provider meets outcome targets at the population level. So, in other words, CMMI can ask does this improve outcomes and lower total cost in the real world before anything becomes a permanent benefit?

SPEAKER_02 6:53

Also touched upon drug pricing. Um renewed attention to drug pricing, right? Um, includes a new wave of most favored uh nation proposals and the next phase of IRA negotiations, many of which affect drugs used to manage chronic disease. How do these uh pricing reforms impact patients?

SPEAKER_01 7:17

Yeah, it's I think there's a lot of talk about how to diminish list prices and not a lot of discussion around the patient piece and how this impacts patients. So just to back up for a second, on MFN style approaches, which pegs US prices to the lowest level paid by comparable countries, I would say this has really to date sort of function like retail deal making rather than durable wholesale policy. So it's been very narrow, it's been manufacturer by manufacturer, and it creates leverage for negotiated arrangements that can get manufacturers through the next few years. But it doesn't necessarily sort of rewrite the underlying incentives, um, the way that broad rulemaking or legislation would, or the way that IRA Medicare price drug negotiation has. I think for patients, specifically on the impact for um, if you look at the Medicare Part B drugs out-of-pocket exposure, it's often buffered by supplementary coverage, right? So it's not about the list price, it's about what is the patient actually paying. And so if you look at Avalier, for example, they did an analysis on the proposed GLOBE methodology. And so the GLOBE models is again focused on Part B, found that only about 0.3% of sampled fee for service beneficiaries would be directly affected by changes in out-of-pocket liability. And that's largely because most users of eligible drugs have some form of supplemental coverage that offsets the 20% coinsurance. So even when a policy reduces program spending, it may produce limited direct out-of-pocket savings for most beneficiaries under the model as designed. Um, that's not to say the model is irrelevant, though it can't undo the basic economics of the global drug marketplace. And I think, in my humble opinion, it's easily gamed. But if you're if your main goal is lowering what patients pay at the pharmacy counter, then I don't think these MFN style models by themselves may move the ball as much as people assume.

SPEAKER_02 9:16

You're Andre, I think those are those are valid points. They're uh two different uh agendas and goals in terms of negotiating uh the pricing there. Since the article was written, vaccine policy has continued to evolve. The Trump administration unilaterally reduced the number of recommended uh pediatric vaccines. How should policymakers, providers, and payers interpret this shift? And what are the potential downstream implications for coverage, reimbursement, and public health infrastructure?

SPEAKER_01 9:47

Yeah, and just to sort of recap, because I, as we were saying in the beginning, there has been such uh as I was preparing for this, I forgot about so many of the things that have transpired in the last 12 months because there's just been such a deluge. So, just to recap, in 2025, HHS made some pretty significant changes to federal vaccine policy and governance. So the secretary is, as I'm sure everyone recalls, replaced the full membership of CDC's advisory uh committee on immunization practices. And so they update on national vaccine schedule, and the reconstituted committee proposed revisions to several vaccine use recommendations, and some of those are currently being challenged in court. And then separately, HHS removed certain immunization measures from the Medicaid state reporting requirements and began winding down many uh MRA research projects. And so that's just touching on a few of the changes. But I think what I wrote about and what's transpired and sort of been updated since I wrote my article is regarding some of the most recent action on CDC changes to pediatric vaccines. So children under CDC recommendations would be routinely vaccinated for about 11 diseases rather than the prior 17. And so we've already seen just in the last few weeks, major medical organizations respond by maintaining their own broader schedules. So the American Academy of Pediatrics, for example, published a 2026 schedule continuing to recommend routine immunization against diseases that the CDC updated, um, moving away from again what they recommended universally. So, and it's interesting, just as someone with a small child, I think we've seen, I've seen my pediatrician in email come out and sort of emphasize that they're not changing their vaccine schedules. So the messaging of this is something that we're seeing really ramp up. But I would say with all of that in mind, downstream there are three, um, and I'm sure there are many more, but just to narrow it for the purposes of this podcast, things to watch. So I think the coverage variability could be impacted by this. So if payers anchor their coverage to federal schedules, you could see more prior authorization, more medical necessity disputes, or more differences across plans and less states. And this was sort of touched on my article, sort of the variation between state approach and federal approach, or purchasers hold a line with their own requirements. The second piece here is around sort of the provider workflow. I think more shared uh decision-making documentation is going to have to transpire, more time counseling, and potentially more friction for physicians to get reimbursed cleanly. And then just public health capacity. You know, when guidance diverges, confidence and uptake can drop. And then you're relying more on sort of outbreak response and catch-up campaigns and then having to create a safety net infrastructure. So those are the things I think uh in the public health community, we're all be we will all be watching for.

SPEAKER_02 12:41

Yeah, and recently we've seen you know outbreaks of uh childhood diseases that we thought were eradicated um at least when I was growing up as um recently throughout uh the country. So in closing, if you were advising a health system or organization deciding where to invest time and resources right now, what is the one strategic bet you would make based on where the innovation center and public health policy are headed in 2026?

SPEAKER_01 13:14

Yeah, I think for CMMI, they're they you know unveiled a new strategic direction. And I think it makes it pretty clear that engagement and data and fiscal accountability is sort of the new center of gravity. And so I think health systems and invest now in scalable patient engagement infrastructure, not just tools, but workflows that use behavioral science, um, you know, sort of defaults and and feedback loops, will be positioned for some of the models that come next. And I think concretely that means embedding behavioral design into care pathways, um, not treating sort of engagement as a patient afterthought. So I think there's a lot of focus on patient adherence, certainly. And then pairing that, there's, you know, as we were talking about earlier, just pairing that with deployable digital tools. I think there's a huge desire by this administration to look at remote monitoring, AI-enabled clinical decision sport, um, you know, asynchronous care that's done through digital tech that can sort of flex across the fee schedule or ACOs and future CMMI models. And then, you know, this CMMI is moving, as I was mentioning, sort of at a like a DARPA-like pace. They're going to move much quicker than I think we've historically seen, but obviously lowering cost is always top of mind. And so designing everything with sort of an actuarial or taxpayer scrutiny in mind. So showing real utilization shifts, not just um some of those other elements I was I was mentioning earlier. So, in other words, sort of build engagement that changes behavior, supported by tech that can be reimbursed or absorbed into value-based models is some of the things I'd be looking at from a from a regulatory perspective.

SPEAKER_02 14:53

Well, thank you, uh, Miranda, uh, for joining us with the podcast. Thank you so much.

SPEAKER_00 15:03

If you enjoyed this episode, be sure to subscribe to AHLA Speaking of Health Law wherever you get your podcasts. For more information about AHLA and the educational resources available to the health law community, visit AmericanHealth Law.org and stay updated on breaking healthcare industry news from the major media outlets with AHLA's Health Law Daily Podcast, exclusively for AHLA comprehensive members. To subscribe and add this private podcast feed to your podcast at go to americanhealthlog.org slash daily podcast.