EPISODE 13: Policy and Power: Dismantling Middleman Dominance in Healthcare
- Whitney Vadeboncoeur
- Feb 27
- 15 min read
LISTEN BY CHOOSING YOUR PLATFORM
Join us on the Only Healthcare Podcast where hosts Michael Navin and Dr. Randy Vogenberg explore the pivotal healthcare policy changes under the Trump administration. This episode delves into the fresh legislative adjustments affecting PBMs, the impacts of new Medicare reports, and advancements in gene therapy and R&D. It also discusses the broader implications of these policies on healthcare costs, accessibility, and the expansion of IVF coverage. Tune in for a critical analysis of what these changes mean for public and industry stakeholders and how they align with the "Make America Healthy Again" agenda.
Episode Highlights:
Introduction to Current Healthcare Policies: Explore the critical changes brought about by the new administration, including a focused look at the fresh legislative and administrative shifts in healthcare policy.
Detailed Look at Commercial Insurance and Government Programs: Delve into the specifics of recent legislative efforts around Pharmacy Benefit Managers (PBMs) and the implications of the latest reports from CMS and OIG on Medicare and healthcare costs.
The Role of R&D and New Therapies: Discuss the ongoing advancements in gene therapy and other R&D improvements, examining how they are poised to transform healthcare delivery.
Impacts of Policy on Healthcare Costs and Accessibility: Analyze how these policies are intended to shift costs between government and private programs, emphasizing out-of-pocket patient expenses.
IVF Coverage Expansion Discussion: Highlight the recent policy developments related to In Vitro Fertilization (IVF), including expanding coverage and its potential implications on healthcare insurance and patient access.
Future Directions and Continued Debates: Consider the expected developments in healthcare policy, including the potential impacts of the Make America Healthy Again agenda and the expanded use of novel therapies under the new FDA leadership.
For feedback or to suggest topics for future episodes, reach out to us at onlyhealthcarepodcast@gmail.com.
About the Hosts:
Michael Navin brings 27+ years of experience in the pharmaceutical industry, specializing in commercialization. As the owner of a successful agency, he has launched numerous pharmaceutical products, making advanced treatments accessible to the public.
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Hosted by: Michael Navin & Randy Vogenberg, PhD
This Podcast is sponsored by:
Peek: Peek is reimagining access through innovation, technology, connectivity, and partnership. Peek offers a comprehensive and unique suite of solutions to help clients improve access and affordability for prescription drugs.
The Peek Meds Marketplace is one of Peek’s differentiated offerings that gives employers a revolutionary new approach to controlling runaway prescription costs for their employees by providing unprecedented transparency, simplicity - and cost savings. The Peek Meds Marketplace aggregates cash discount cards, manufacturer copay offset programs, and an employee’s insurance information to provide a holistic and personalized view of prescription price options. This easy-to-use platform offers a one-stop-shopping experience for prescription drugs.
Peek’s team has decades of experience in the pharmaceutical industry and offers various services to biopharma manufacturers, brokers, benefits consultants, third-party administrators and employers. Visit peekmeds.com to learn more.
Institute for Integrated Health (IIH): Health care benefits, insurance coverage regulations, and doing business in the healthcare industry can be complicated. At IIH, Dr. Randy Vogenberg and his team understand these unique challenges and provides strategic guidance customized to every client. To help overcome your unique challenges, IIH delivers education, planning and advisory on market trends, and U.S. health care market intelligence. The firm’s decades of proven success are due to strategic collaboration with associates from the business, clinical, and scientific communities. https://iih-online.com/.
Music by:Hanu Dixit, https://www.youtube.com/hanudixit
Episode 13 Transcript: (0:00) You are listening to the only healthcare podcast created to inform you on the why's, how's, (0:07) and what's of healthcare. Hosted by industry leaders Michael Maven and Dr. Randy Bogenberg, (0:13) discussing why costs and risks are so high and who should be held accountable. How will (0:18) technological advancements merge with the quality of care? And when does the public gain access to (0:25) advanced medical treatments? Listen in as Michael and Randy answer industry concerns for the public (0:32) and all stakeholders involved.
Welcome back to the only healthcare podcast. It's great to be back on (0:51) as we have been quite busy with the kickoff of so many new changes in healthcare policy in the U.S. (0:57) for 2025. Randy and I are also committed to increasing the quality of our audio and video (1:02) production for this year.
That being said, we hope to give you better content with more (1:07) applicable insights. And we want to thank everyone that shares this content. And for those that (1:12) haven't, please share this with a colleague or a friend that you think can benefit from these (1:17) episodes.
The more you share, the more the algorithm share and the more people can have access to this (1:22) pertinent information. As we all know, it affects all Americans in our country. So Randy, great to (1:28) see you again.
Great to be back. And let's dive in. (1:32) Well, thanks, Michael.
It's certainly been a busy time in the first weeks of the new administration (1:39) at the White House. And we had done a previous episode where we talked about where we ended in (1:46) 24, what we thought was going to be happening in 2025 with Jason Slotnick. So I wanted to (1:53) just touch on some of those continuing issues that were identified while we also talk about (1:59) what's actually happened and what we're currently dealing with in the landscape of healthcare policy.
(2:06) A variety of different government programs, but we also have been focusing in on the commercial (2:11) insurance in particular. So topics such as the legislation around PBMs, which were not enacted (2:18) last year, continue into this new congressional year as well as new administration in the White (2:26) House. OIG released some reports on PBMs.
CMS released its annual report on Medicare as well. (2:35) The Congressional Budget Office, CBO, put out a report on sickle cell disease. And we have, (2:41) as many of you are aware, a new gene therapy and other improvements that are beginning to hit the (2:46) marketplace from the R&D side.
There was another OMB report that came out, Office of Management (2:54) and Budget, on Medicare and healthcare costs. And then finally, commercial trends have continued to (3:00) be impacted by a lot of the regulatory efforts that were underway in Washington, as well as (3:06) legislation both in Washington and in all the 50 states. And this has led into a whole variety of (3:14) cost shifts between government programs and private sector programs.
After the last episode, (3:22) a report that came out from Acuvia about what would be important to look at in 2025 (3:28) related to what changes we would expect to see with healthcare policy and what kind of progress (3:33) could be made. So a way to kind of benchmark as a way to think about it. So some of the items (3:39) that were identified in that report, were we able to create greater trust in Life Sciences Company? (3:48) That's going to be a continuing discussion both in Congress and through the White House.
(3:55) What can be done to improve what we've seen happening in the R&D areas? Where does it (4:02) intersect with what's good for the patients and so forth? What kinds of new products can we expect (4:08) to see because of all the prior legislation that was enacted over the last decade? Secondly is, (4:15) speaking about patients, how can we reduce our out-of-pocket costs? And we'll be talking more (4:19) about that in some other episodes as well. So that continues to be a big issue, not only in government (4:24) programs, but also in commercial programs. That's part of the platform that President Trump ran on (4:31) and something that he's committed to doing something about.
Next in that report as a progress (4:38) marker was inclusive progress on the Make America Healthy Again agenda. As we are aware now, (4:46) Robert F. Kennedy Jr. was confirmed to be the Secretary of Health and Human Services. (4:51) So that certainly is going to be a major area that we all need to be following closely.
(4:57) Included in that is expanded patient access to healthcare services, as well as more of a focus (5:03) on disease prevention and early intervention, particularly around chronic diseases. Next was (5:09) improvements in clinical decision-making processes and technology deployment. So kind of building on (5:16) some of the lessons learned out of the pandemic, but how can we incorporate them more (5:20) efficiently into the healthcare delivery system as well as in the administrative areas of how we (5:26) manage healthcare benefits? Another area that we'll be touching on in some of the other episodes.
(5:32) And then finally was looking at the expanded use of novel advanced therapies. So this kind of (5:38) ties back into that life science issue in the pipeline and what may happen at the Food and (5:43) Drug Administration under the new Secretary. But looking for not only what would be developed here (5:49) in the U.S., what would be marketed in the U.S., but what we might see from markets outside of the (5:54) U.S. So the kind of global view and the global sales impact that life sciences companies may have (6:02) on what is happening within the U.S. as part of the Make America Great Again agenda.
(6:08) So there was quite a bit that's kind of thrown on the table and different metrics that could be (6:13) looked at to follow as to what and where we'll be making a real difference as this thing begins to (6:21) play out. So we know a few policy changes and Michael, do you want to touch on a couple to get (6:27) us started? Yeah. Recently, as of yesterday, we heard about the new expansion of coverage in (6:33) the IVF space.
And while I think your top level talking points are critically important, there's (6:41) the devil's in the details, right? And the devil's in the details on all of these changes. You know, (6:45) we have such a complex ecosystem between the health insurer, the providers, the manufacturers, (6:53) the employers who are behind the effort to provide quality health care for their employees. (7:00) All of these have implications when there's an expansion of coverage, right? Because that means (7:04) somebody is either going to pay more or there's going to be more services available that may have (7:11) a lot more controls in the system today that might have less controls tomorrow.
I think a lot (7:17) of our audience is going to be thinking about when they listen to this is, what can I do about (7:22) these things? How do I stay ahead of it? And what resources can be at my fingertip to make sure that (7:28) I'm either up to date with what's happening and I can react to it or I know that, you know, what's (7:34) going to be the mechanism in which I'm able to effectuate any change that the government's (7:39) putting down on this or whether it's not just the government, but maybe it's coming from the (7:43) private sector as well. I think from our perspective, how do we create solutions and (7:49) solutions to a challenge that hasn't really been specified, right? We kind of know it from our end (7:55) because we deal with manufacturers, we deal with employers who have their individual issues, (8:03) but what's going to happen in terms of the capability of what needs to take place (8:08) in order to make sure you're ahead of the change and that you're implementing strategies to affect (8:15) that change. And going back, I think what you and I have talked about before is it seems like (8:21) people are almost paralyzed because they don't know if they do something aggressive and they (8:27) go against traditional wisdom, that could backfire on them, right? But at the end of the day, (8:33) everybody owns their own space, right? The manufacturer owns the product that they make.
(8:38) The employer, you know, whatever their business is, owns the employee-employer relationship and (8:44) the healthcare that they're providing to those employees. But what happens, right? Who's going (8:49) to pull the trigger in all of this? And I guess that would be a question for you. (8:53) Yeah, and IVF is a good starting point to kind of segue back to the employer and (8:59) clearly manufacturers have to find ways to collaborate more effectively with employers (9:04) who are the largest funder of healthcare insurance in this country.
The IVF effort is going to take (9:13) at least 90 days going through its process and trying to figure out what it's going to look like (9:19) in terms of a potential law that would be signed into effect by the president. (9:25) So, like anything else with healthcare policy, you got to be there at the beginning, as you (9:31) pointed out, you got to be engaged. I just pulled something up before our conversation and I'm going (9:35) to read it.
And this is a snippet of a contract that is put in place by PBMs to prevent any (9:46) relationship with an employer and a manufacturer. It's called a solicitation of participants and (9:53) clients. Non-solicitation in a term of this agreement, company will not X company's prior (10:00) consent, knowingly enter into an arrangement with any participant or client pursuant to which (10:05) company would pay rebates or similar discounts on products.
Utilization of the participant or client (10:12) where rebates or similar discounts would be payable with respect to the same product. (10:16) So what that's saying is, you're not allowed to sell your product to somebody unless it's (10:21) our ecosystem. You've got a middleman entity preventing a manufacturer who makes a product (10:29) from going to someone who's paying for that said product directly and not being able to get it, (10:36) right? Unless you go through that middleman entity.
So are these the types of language changes, (10:43) Randy, you think the administration or any of the coalition groups could make and say, (10:50) you got to create free, fair, and open market, right? Free, fair, and open market is what drives (10:55) competition, what creates innovation. This type of language does not feel like you're creating a (11:02) fair and open market. (11:10) But briefly, changes in drug pricing, as well as potential changes in employer-sponsored (11:15) health insurance are both on the table, as well as this issue of PBMs and what you point out with (11:21) the contract language is a good one. So absolutely, there has to be more engagement by all these (11:28) key parties to really make a change happen and make sure it's sustainable. So we don't revert (11:36) back to the problem that we've been living under for the last several decades.
The other thing I (11:41) wanted to bring up, which I think cuts across a lot of this that we've both brought up already, (11:48) there's enhanced subsidies expiration coming up for health insurance exchange plans under the (11:54) Affordable Care Act that will expire at the end of 2025. Whether you like it or not, that expiration (12:00) right now is on the table. And it can have some other far-reaching effects because we have other (12:08) expirations that have occurred from the pandemic funding.
So specific to the ACA plans, as they're (12:16) known, it could lead to higher premiums and a reduction in coverage. We've already seen higher (12:21) premiums happen. We've already seen reductions in coverage happen in ACA plans, ACA plans not (12:28) increasing in population.
So there's a lot of questions that are surrounding that for that group (12:35) within the United States population that is covered right now under an ACA plan. (12:42) A lot of them could be employees of employers who have decided not to offer a health plan (12:48) and put them into an ACA plan. So there's an employer relationship there.
Secondly, (12:55) this expiration issue because of the post-pandemic will also affect commercial insurance lines of (13:02) business as well. And so we can see the same thing happening going into 26 where higher premiums (13:09) would be a starting point along with the reduction in coverage that would be offered to plan (13:14) participants, which would be the patients. Can we take a step back on that though? Sure.
(13:21) What is the subsidy and who does it affect? Okay, good question. So the subsidies are for (13:28) the health insurance plans themselves. So if it was an ACA plan in South Carolina or Florida or (13:38) California, New York, wherever, those plans were eligible to get an enhanced subsidy from the (13:45) federal government.
And that's what we're talking about. The pandemic funding, the additional (13:51) funding similarly also went to any health plan that was offering services during the pandemic (13:58) as a way to offset the losses where you had such a catastrophic increase in care costs because (14:06) so many more people were sick, they were hospitalized, et cetera. It was an unforeseen (14:11) scenario.
But those began to expire in 24 and the remaining subsidies expired in early 25. (14:20) Those are not anticipated to be extended any further or renewed. So that means that as we (14:28) go forward, health plans could be going into not only 2025 but 2026 plan years where they're (14:37) suffering losses and they're not going to be able to recoup anything for that.
So they're going to (14:41) look to make it up in premium increases going forward or reductions in care that's available. (14:47) There's an overflow effect on that in Medicare. (14:51) Are these health plans that are making hundreds of billions of dollars a year that are getting (14:56) the subsidies? Or is it sort of a smaller health plan like a local plan that is driven by a group (15:03) of employers? (15:04) All of the above.
So it's any health plan that was operational during those time periods that (15:12) the law covers. (15:12) So you're anticipating that to make up for that specifically, it's just going to be an (15:18) increase in premiums, limited innovation, right? No creative thinking, just, (15:25) hey, we need to charge you more. (15:27) That is the basic way it tends to operate.
For the last two years, we've had double digit (15:33) increases on premiums that employers paid. And Medicare costs also went up marginally, (15:40) but the difference was made up by the treasury. So we've already seen some of that happening, (15:46) even without the subsidies going away entirely.
So it's only going to increase as we look (15:51) towards 2026. So yeah, it's going to have a dampening effect and it could reduce what (15:56) will be covered in a lot of plans. (15:59) Now, is this an HHS issue or is it a DOJ issue or is it both? (16:03) Nothing to do with DOJ.
This was all before DOJ. So this is all about Congress and health (16:10) and human services implementing the wishes of Congress. (16:14) So in terms of what else is anticipated, there are so many areas that are on the table (16:21) right now.
And I kind of encapsulate that in my earlier comments. So there's going to (16:28) be more coming for sure. We have to be engaged in not only following what's being talked (16:35) about, but really look at what's the reality.
Will some of these things happen? Probably (16:39) not. Will we see them in 2025? Most likely not. But 2026, we're going to see a lot of (16:46) change because it takes time for all these changes to work through not only the federal (16:51) system, but also the state system.
And with the new administration's policy of pushing (16:59) more things down to states, states are going to be more important as we look at, well, (17:04) how are you going to implement this change and who will be the key players? So if you're (17:10) an employer who has a plan, you're a manufacturer that's trying to get coverage for products, (17:15) whoever you are as a stakeholder in the ecosystem, you have to stay on top of all these different (17:20) things that are happening and really look at it realistically as to, so what will really (17:27) happen and when would it happen? If it requires a change in law, is it some kind of a regulatory (17:32) change? How would it be changed and who's going to implement it? So there's more questions still (17:39) as we go forward than answers right now. (17:44) With that, let's say thank you for tuning in today and our short follow-up on healthcare (17:51) policy and anticipated changes. As we continue to navigate what has been really turbulent (17:58) waters of healthcare policy changes just in the first few weeks, it will continue to be (18:04) more crucial than ever that we stay informed and proactive.
We encourage each of you to (18:09) delve deeper into these issues, engage with your peers and policymakers and help shape (18:15) a healthcare system that is equitable and effective for all. Remember that change begins (18:21) with awareness and action, and hopefully we're playing a small part in that. We look forward (18:27) to continuing this conversation and others and exploring the new solutions together with (18:32) our audience.
Until next time, keep pushing the boundaries and making a difference in (18:37) what you do. Thank you for joining us on The Only Healthcare Podcast, and feel free to (18:43) share with your friends and colleagues. (18:54) Thank you for tuning in to The Only Healthcare Podcast.
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