The Pharmacy Benefit Manger (PBM) industry, which is a critical player in transactions that facilitate the pricing and reimbursement of prescription drugs, has experienced a high level of vertical integration and aggregation of market power. Rujul Desai, Partner, Covington & Burling LLP, and Kendra Roberson, Partner, Faegre Drinker Biddle & Reath LLP, discuss the rise of PBMs and their role in drug pricing and the increasing scrutiny of the industry at the federal and state levels. Rujul and Kendra are co-authors of AHLA’s brand-new publication, Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
The Pharmacy Benefit Manger (PBM) industry, which is a critical player in transactions that facilitate the pricing and reimbursement of prescription drugs, has experienced a high level of vertical integration and aggregation of market power. Rujul Desai, Partner, Covington & Burling LLP, and Kendra Roberson, Partner, Faegre Drinker Biddle & Reath LLP, discuss the rise of PBMs and their role in drug pricing and the increasing scrutiny of the industry at the federal and state levels. Rujul and Kendra are co-authors of AHLA’s brand-new publication, Market Access, Pricing, and Reimbursement of Drugs and Devices: Legal Principles and Practice.
Watch the conversation here.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
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Speaker 2:This episode of A H L A speaking of health law is brought to you by A H L A members and donors like you. For more information, visit American health law.org.
Speaker 3:Welcome to today's podcast on the evolving landscape of the P B M industry. Uh, today's podcast will focus on the rise of PBMs and their role in drug pricing, as well as the increasing scrutiny of the industry at the, both the federal and state level. Uh, my name is Ru Desai . I'm a partner in the healthcare and life sciences practice at Covington and Burling based in Washington, DC where I lead a lot of the firm's work related to market access, drug pricing, reimbursement , um, contracting and work with payers , uh, as well as policy efforts in this area, and have been doing this type of work for the last 20 years. And I'm excited to be joined by my former colleague, Kendall Roberson, who will provide a brief introduction of herself.
Speaker 4:Sure. Um, thanks Rachel . I'm a partner , um, in the employee benefits group at Vaguery Drinker Biddle and wreath . And my practice focuses on representing large employers in the design and compliance of their employee benefit plans, including their health plans. And as you may know, large employers who sponsor health plans are some of the biggest customers of pharmacy benefit managers and employers rely on PBMs and their economies of scale to obtain access to prescription drug discounts and rebates and pharmacy networks for their employees. So , um, so I've been practicing in this area for 20 years and, and helping employers sort of navigate , um, sort of their service provider really relationships with, with PBMs.
Speaker 3:Great . Thanks, ginger . And I think in addition to the life science companies that I represent and then those, that employers that, that Kendra represents, we hope this conversation will be of interest to , to those in the P B M industry , um, you know, insurers , uh, those thinking about policy efforts in this area , uh, and, and just concerned about , um, the issues of, of drug pricing and the role of, of different supply chain entities. Uh, overall , uh, of course, the conversation today is, is , uh, those personal views of Kendra , uh, and I, not those of our respective firms or clients. And we're really excited , uh, to be partnering with , uh, H l A on this podcast, partly because Kendra and I also got to partner with H L A on a recently released legal treatise , uh, on market access, pricing, and reimbursement of drugs and devices. Uh, it's, it's something that we're, we're quite excited about. We think we thought that there was a , a gap in the legal literature on these issues and worked together with a number of other co-authors , uh, over the last couple of years to develop the treatise. And in particular, chapter five of the treatise focuses on the supply chain and the commercial channel in particular, there's a significant discussion of the P B M industry vertical integration of that industry, as well as , um, interesting diagrams and schematics of how , uh, different portions of drug pricing get spread out throughout , uh, the supply chain. And so we encourage you to , to think about , uh, the treatise and, and take a look at the chapter , uh, five in particular. And , uh, with that as a springboard. Uh , maybe I'll just start out by, for those that aren't as familiar with the P B M industry, making a , a , a brief statement about the fact that they're a critical player , uh, in this supply chain , uh, in terms of transactions , uh, that facilitate pricing and reimbursement of innovative therapies. Uh , so, you know, they've had a history of being processor of claims. So with the pharmacy counter helping pharmacies determine , uh, beneficiaries , uh, coverage for a particular drug, what their cost sharing will be helping to adjudicate that claim to make sure the right parties receive their respective level , uh, of payment , um, as well as adding additional value in terms of, of drug to drug inter interaction alerts. And then over time, helping employers and insurers develop formularies , uh, to cover certain drugs in a preferred or exclusive status over the years. Also in , in increase that role to negotiate rebates , uh, on behalf of, of their clients with pharmaceutical manufacturers and process dose payments , uh, as well. And then over the years have also grown to in include some PBMs, large retail or specialty pharmacy operations to actually dispense drugs , uh, to patients as well. And more recently have added G P O , uh, affiliates to their , um, to their vertical chain. Uh, as well as, you know, moving into a host of different areas. And in particular, there are are three PBMs that have, have aggregated , um, to, to really have a significant market share , uh, and create that vertical integration. And it's partly because of that vertical integration and aggregation of market power that there's been , uh, particularly recent scrutiny , um, on the industry. And so with that scrutiny is where I'll ask maybe Kendra to weigh in first to talk about , uh, the F T C in particular , uh, that currently has an open investigation. Uh, Kendra, if you could share with the audience kind of an overview of what's going on. Why is the F T C interested? What areas are they looking at and what should we expect?
Speaker 4:Sure. So in June of last year, the F T C voted to conduct a market market inquiry of the P B M industry and required, you know, six largest PBMs to provide information and records regarding their business practices. And fast forward to this June, June of this year, the F T C A expanded the investigation and issued compulsory orders to three group purchasing organizations or GPOs, which I know you mentioned Ruel , but just to level set , um, these are sometimes called rebate aggregators. And these are the entities that negotiate rebates with drug manufacturers on behalf of PBMs and hold the contracts that govern those rebates. And so the F T C is now looking at GPOs as well as the initial , um, six PBMs. And the F T C has stated that its in inquiry is aimed at shedding light on several P B M practices , um, including charging fees and clawback to unaffiliated pharmacies, methods to steer patients to P B M owned pharmacies, potentially unfair auditing of unaffiliated pharmacies. Um, the use of complicated pharmacy reimbursement methods and how negotiated rebates and fees with drug manufacturers impact the cost of prescription drugs. So they're sort of looking at all, all of these aspects , um, of the drug chain drug supply chain. Um, and I think most recently, and one of the most interesting developments out of the investigation is that in July, the F T C , at least so far , um, is that in July, the F T C issued a statement warning the public not to rely on prior F T C advocacy statements and studies opposing mandatory P B M transparency and disclosure requirements. And one of the more interesting points in the statement was a note that in the past the F T C was concerned that mandated disclosure requirements between PBMs and their customers, which are namely large employers and health plans , um, would encourage , um, price coordination and inclusion . Um, however, the E T F F T C is now of the view that that , that the trends towards extensive consolidation by PBMs and extensive vertical integration by PBMs into the entire , um, into the entire drug supply and payment chain, has put employers and other payers at a disadvantage , um, and in both the marketplace, you know, and just in terms of the information that they have to make purchasing decisions. And so it's interesting 'cause now that FT C in that statement has suggested that it's appropriate for policy makers to require PBMs to provide accurate and timely information for buyers. So I feel like now Congress and, you know, of course, state legislatures as we're gonna talk about, have sort of now, you know, picked up that , um, picked up that mantle, you know, and they're now sort of , um, you know, pursuing those , um, those , um, initiatives.
Speaker 3:Right ? I can say that, you know, that that recent statement really kind of points out the FTC is saying, you know, historically, you know, perhaps they've been less active in pushing back on the vertical consolidation, that that basically took over 40 different companies and consolidated them into three , uh, that, that, you know, have by some measures, 70, 80, 90% , uh, of the market. And I think there's been an interest in, in , at the Senate, a number of, of , of senators on a bipartisan basis have have said to FTC publicly, you need to hurry up and finish your inquiry, right? Um, you know, because we wanna see the findings, and if you, you know, don't move fast enough, we're gonna step in front of you and, and continue our own efforts because these issues are so , um, so paramount , uh, uh, in the, in the on drug pricing and costs , uh, overall. And I think it's interesting that the FTCs also been looking at that these same , same vertical vertically integrated entities more as platform companies in similar ways. They look at the technology industry as having platform companies, and are there platform company type abuses , uh, that are going on, on in the supply chain due to this vertical integration , uh, whether that's, you know , um, uh, predatory pricing or, or, you know , self-dealing or steering , um, using certain information that the platform has because it's, it's facilitating all these transactions across the industry. And so I think everybody's eagerly anticipating the close of the inquiry, the report to be issued , uh, likely, you know, by the spring , um, if not sooner. Uh, and then, you know, it has often happened, happened in past F T C inquiries of this type . Uh, there may be new investigations launched into one or more other vertically integrated PBMs or public exposure that there's already an ongoing investigation. And, and here's where , uh, it currently sits. Uh , but as I , uh, Kendra mentioned , uh, the , uh, the Hill in particular has been active on this front. I think we've seen, you know, this past year , um, you know, close to to 30 different bills introduced in the house and, and senate , uh, taking on different aspects of, of P B M reform. And while, you know, in this podcast, we don't wanna walk through every single one of those bills. I think this tender drive has , and I have discussed, there are certain themes that come out of, of these bills. And, and there's about half a dozen , um, that maybe I'll highlight and then Kendra , and I'll walk through , uh, what , what the policy goals are , uh, with, with each of those, those types of themes. And so the half dozen or so are, are transparency reporting requirements, prohibitions on spread pricing, rebate pass through requirements , uh, restrictions on patient steering , uh, de-linking of P B M fees to rebate amounts , uh, and then additional government investigation and oversight authority over the P B M industry. So, Kendra, maybe you wanna take the, the first handful of those first and, and give a lens on, on what it is that policymakers at the federal level , uh, are trying to achieve with, with, with some of these bills that, that mention those themes.
Speaker 4:Sure. Well, measures to increase P B M transparency are a common provision , um, across the multiple bills aimed at PBMs. And I think this is one of the , um, measures that has the most bipartisan support, and we're likely to, if, if anything passes this fall, I think it definitely will get something on transparency. Um, the Senate Health Committee in may pass the Pharmacy Benefit Manager Reform Act, which would require disclosure of certain information and prohibit employers and health insurers from doing business with A P B M that fails to make those disclosures. And that seems to be sort of a common theme theme among many of the, of , of the bills. Um, the Senate Commerce Committee bill, the P B M Transparency Act , um, would require PBMs to disclose complete ag , the complete aggregate amount of compensation received from prescription drug manufacturers and other payments or credits res retained by the P B M. And the House has similarly passed bills requiring PBMs to provide employers and health plans with information on prescription drug spending. So I, I think generally large employers support strong transparency. I I think one of , um, when their concerns is that they just think , um, PBM reform needs to go further mm-hmm . <affirmative> . So while they're supportive of transparency, I think they're looking for additional measures , um, to be included to address the rise of prescription drug costs , um, including policies that address consolidation and, and bundled services that , um, can drive patients to, you know, the more high profit pharmacies. So , um, so I think , um, you know, there is support for transparency, and we're probably likely to see , to see something on that included in one of the bills. Um, the prohibition on spread pricing. So spread pricing is where , um, PBMs charge the plan more , um, more than what the P B M pays the pharmacy for a prescription drug. Um, and then the P B M is able to sort of keep the difference right between what the plan pays the PB m and what the pb m paid the pharmacy. And so , um, so , so there are at least some bills , um, particularly one of the, the Senate bills, the Senate P B M Reform Act that would propose , um, prohibiting spread pricing , um, and then rebate passthrough. Um, so rebate passthrough is the concept there is that, you know, prescription drug manufacturers will pay rebate on prescription drugs that are purchased by plan participants, right? And so the idea is, you know, how much of that rebate gets retained by the P B M and how much of it gets passed through to the plan? And ultimately, MA makes its way, you know, back to , um, potentially back to the, the drug consumer, right? And so the idea is in these provisions is to sort of require PBMs to pass through a hundred percent of the rebates and fees and other discounts that they receive from drug manufacturers back to the health plans.
Speaker 3:And I think, Ken , the key statement you made was not just rebates, but other discounts and, and amounts that are based on a percentage of the drug cost . Because as we've seen over the years, there's been a , a narrowing and narrowing of the definition of rebate , uh, in order to create other pockets of, of potential revenue and profitability , uh, that even if there is a requirement for pass through , so it's all in, you know, what , how rebate gets defined if there's a pass through requirement. But to your earlier point, I think, you know, if, I think a lot of people, while getting transparency will be seen as a, a , a initial win from a policy reform perspective , uh, around the P B M industry, many will do that as a very skinny win . Uh , you know, they want , uh, some of these other a aspects that you've talked about as well as things like , uh, prohibitions on patient steering, delinking, and additional government investigation. So , um, you know, patient steering, there's concern around the fact that , uh, all the large PBMs, you know, have significant specialty pharmacy operations. Some have retail pharmacy as well, but in particular, you know, moving patients , uh, sometimes are oftentimes on an exclusive basis mandating use of the PBMs own specialty pharmacy, you know, creates , uh, perhaps antitrust concerns around the way in which market power and platform use is happening , uh, but also perhaps creates self-dealing concerns. So if, if the P B M through its own specialty pharmacy is saying to manufacturers, give us larger discounts at the pharmacy and lower rebates, you know, because I have to pass the rebates along, but I get to keep all the discounts myself because I'm saying those are discounts to me as a pharmacy owner, you see how that patient steering and, and consolidation of that , um, of that activity into your own owned assets or affiliated assets can be problematic. Uh, that would certainly mean a much broader reform that would be more problematic , uh, for the profitability of the P B M industry going forward , uh, as , uh, potentially delinking, which is , uh, uh, uh, the notion that , uh, P B M payments should not be tied , uh, in any way to a percentage of a drug price. Whether that's, you know, a percentage of rebate retention, whether that's administrative fees or other service fees or other activity or spread pricing. You know, there shouldn't be any, any ability for A P B M , uh, to, to link their financial , uh, rewards to a percentage or based on a percentage of a drug price or a margin that instead there should just be a, a flat fee or a, a non percentage based fee for the activity that they're doing in terms of processing a claim or negotiating a contract , uh, or the like. And, and so that would be certainly a much more transformative reform that I'm sure , uh, you know, PBMs are , are advocating strongly on the hill against, and I think is probably , uh, uh, a higher reach in terms of actually getting that type of reform into , uh, bill at the end of this year. But I know particular Senator Sch Schumer and others are, are strongly advocating for that as is a life science industry , uh, because of, of the amount, significant amount of profitability that's captured in the middle , uh, if you allow linking to, to occur. Um , and also just from a overall investigation and oversight perspective, you know, if you think about the size of this industry and, and perhaps not having the same type of regulator that other industries of similar size and scale have at a federal level to oversee , uh, you know , their activity, conduct audits, you know, provide regular guidance, there's maybe a call for that activity that may be this fractured approach across F T C or D O J or others just leaves too many gaps , um, in the system. And there needs to be strengthened oversight of those entities as well as potential , uh, new entities or regulators that would oversee the vast amount of financial transactions that are going through the P B M industry. And so, with that, I know one thing that, you know, mayor may not make it is, is this notion of some form of fiduciary obligation. Kendra , I , I know, you know, employers in particular , uh, have been voicing the need for some form of fiduciary standard. Um, do you wanna talk about that a little bit and why that's so important?
Speaker 4:Sure. Some employers would like to see P B M S be subject to a fiduciary standard that will require PBMs to conduct their business in a manner that puts the best interests of plans in their enrollees first, right? And the goal is to impose a standard of conduct on PBMs to discourage practices that are perceived as increasing drug costs and spending, I mean, I feel like we're sort of at right now in a little bit of a whack-a-mole situation, right? Where, you know, every time some bad behavior pops up or behavior that people think is bad, you know, they feel like they have to go run to the legislature to get a law passed to prohibit it, right? And so I think the theory here is, well, if they're subject to the same standard of conduct, you know , um, as employers are when their plan fiduciaries to their prime participants , um, then for then, you know, then there'd be more alignment in the interests and maybe, you know, it would prevent like some behaviors from arising that would later have to be addressed, you know, and some sort of statutory initiative. Um, so I do think that, you know, employers had hoped that the proposed P B M legislation that's, you know , um, circulating on the hill right now would include fiduciary requirements for PBMs. So far, the only provision touching on this , um, is in the Senate Health Committee's PBM Reform Act, which merely instructs the DE Department of Labor to study PBMs fiduciary responsibilities. And I think one of the possible reasons that we haven't yet seen a fiduciary provision included in legislation , uh, that is that it's potentially difficult to reach consensus on some aspects of it. You know, for example, if A P B M has an exclusive obligation to act in the best interests of participants and beneficiaries, which is, you know, the ERISA fiduciary standard , um, then presumably the legislation has to include a carve out , right? That would allow PBMs to still receive reasonable compensation for their services. I mean, I don't think, you know, I think people want PBMs to be in business, they provide useful services, right? So we need to find a way, but then it's, well, how would reasonable compensation be defined and does Congress wanna be in the business of defining it? Right? So , um, so I think it's just gonna become a question of, you know, what, what, you know, how do we come up with a standard that, you know, can be measured and is enforceable? Um, and that, you know, sort of achieves the goal of maybe, you know, just kind of , um, you know, sort of creating a more alignment of, of the interests of some of the, the consumers of the prescription drugs with PDMs. Right ?
Speaker 3:I've long thought , I think the , the , you know, the notion of creating a risk or fiduciary standard may be a bridge too far, <laugh> , especially long term , uh, just to get consensus if they're trying to get something passed. But it doesn't mean there can't be prohibition, basic prohibitions on things like self-dealing, right ? You know, that wouldn't require , uh, necessarily, you know, reaching into ERISA and the complexity of, of, of working through there. So I'm still hopeful that we'll see some form of maybe like fiduciary standard , uh, at least, you know, on, on self-dealing in particular as a platform company , uh, could be really beneficial , uh, to patients and, and many other stakeholders , uh, in the system. Um, you know, I think it's important for us to, to to, to turn and, and kind of close on this notion of, of state activity in this area. And I know you mentioned this notion of, of of kind of play whack-a-mole on all these different areas that, that the PBMs are involved in because of their vertical integration. I'll mention , uh, the chapter five of, of the treatise that we talked about earlier has a really helpful chart on all the different profit levers that PBMs have across the different stakeholders , uh, that they deal with. And so that can be a really helpful level setting for those that aren't as familiar with, with each aspect , uh, of the, of the profit stream, as well as some examples of how a drug moves through the system and, and who keeps what percentage of it. Um, and it could be really enlightening, but I know on the state level, there's one, you know, clearly, you know, PBMs have been, have been fighting back on whether it's the, the state ag efforts , uh, and investigations, but also some of these statutes that they feel have gone too far , uh, and and violate existing law. And I think in particular 10th circuit's decision , um, about the Oklahoma law could be really helpful. And so why don't we close on you, you talking about , um, about that decision and how that kind of pull back the ability to do P B M reform in certain areas.
Speaker 4:Right. So the, the case is P C M A versus Mul Mulready . Um, and in that case, what happened is the Oklahoma pasta statute , um, that would've required PBMs to be subject to retail pharmacy network access standards and would've prohibited PBMs, you know, from promoting in-network pharmacies by offering cost sharing discounts and also using their mail , mail order pharmacies to satisfy some of the retail network standards. Um, it also included , a provi included a provision that said that PBMs cannot deny a provider the opportunity to participate in a pharmacy network , um, at preferred status if they're willing to accept the terms and conditions of participating in that. And it also included a provision that said that PBMs can't deny limit or terminate a provider's contract based on the employment status of an employee who has an active license to dispense , um, despite pro , despite probation status. So in other words, you know, if the pharmacy has someone's on who's on probation status, then you know, it would've prevented , um, the P B M from excluding that pharmacy from the network. Um, so P C M A sued to enjoin the law from taking effect on grounds, that's preempted by ERISA and Medicare Part D. And the parties then filed dueling motions of summary judgment in the wake of the Supreme Court's decision in Rutledge , um, and Rutledge, the Supreme Court held , um, an Arkansas P B M regulation that governed P B M pharmacy reimbursements rate was not preempted by erisa. And by way of background, you know, ERISA preempts state laws that relate to, you know, employee benefit plans , um, and a state law relates to an, an ERISA plan if it has a connection with, with or reference to an ERISA plan. So in Rutledge , the court stated that this boils down to asking whether the state law governs a central matter of plan administration or interferes with National Uniform Plan Administration. Um, and in ish the Supreme Court upheld the Arkansas P B M regulation , um, because it determined that the Arkansas statute, although it might increase cost to plans by requiring PBMs to pay pharmacies, at least the acquisition cost of a drug , um, it didn't affect the ability of employers to structure their employee benefit plans in a certain manner, right? So in re the court said, look, this is not preempted by erisa. So in the wake of that, the district court, you know, held that ERISA did not preempt the Oklahoma statute. Um, it did held that that Medicare Part D preempted some of the challenge provisions, but it largely held that ERISA did not. Um, and the district court reason that the law was not preempted 'cause it merely alters the incentives, but doesn't force ERISA plans to make specific choices, right? And so, for example, for the network access provisions, they said, well, that doesn't prohibit using mail order pharmacies, it just says that you can't, they don't count towards meeting the access standards. So that's not, you know, they're saying that doesn't really affect it , you know, administration. Um, and they said the , any willing provider statute, it doesn't require the plan to accept any pharmacy into the network. It just relates to whether the pharmacy has preferred status or not. Um, and then on the prohibition standard , um, or the probation standard, they say , well, that only relates to contracts between providers and PBMs. And that has a di minimis effect on pharmacy benefit design. So, so then of course, the case gets appealed right to the 10th circuit, and the 10th circuit says, well, wait a minute here, we do think that these laws are preempted and here's why. First of all, you know, for the, any willing provider standard, you know, we've, by increasing the poten potential providers and directly, we, we are directly affecting the administration of the plans because we're essentially forcing them to go to a single tier network. Um, because if you can't preclude a plan from, you know , you know, if , if you're, if you're , if the plan is precluded from excluding providers from a network, then you're essentially, you know, no longer allowing it to have a preferred pharmacy network and you're sort of eventually collapsing it into a single tier . Um, and on the network adequacy, again, it said, you know, this does affect, you know, planned administration because you know, you are dictating, which pharmacies must, must be included in the network, you're requiring cost sharing to be the same for all of the in-network pharmacies, which is key and fundamental to benefit designs , um, and pharmacy networks. The , the sense circuit was the , you know, reasoned are a cornerstone of the benefit design and, you know, and the network restrictions don't say anything about P B M costs, right? So they just felt like these clearly are a target to network design. Um, and on the probation prohibition, again, you know , the argument is , um, you know, the 10th circuit sort of disagreed with the district court's reasoning that the state laws have only a di minimis effect plan on plan design are not preempted. 'cause they're like, that's never been a standard <laugh> . They're like, you know, di minimis effect on plan design is not the Supreme Court's test for determining whether something is preemptive by erisa . Um, and so there they're just saying, look, you know, the, the probation prohibition forces PBMs to capitulate to all, you know, including all pharmacies in their network. Um, even those employing pharmacists on probations. And they're like, look, we can't, you know, we, again, that goes to sort of dictating the design of someone's network. And that is not something that, you know, and that goes to the heart of administration and therefore is preempted by erisa. I mean , I think one of the other really interesting points in the case is that one of the arguments that Oklahoma have tried to make is that, well, no, the state laws are regulating PBMs. They're not reg , they're not reg regulating plans, and therefore this doesn't relate to employee benefit plans. And so the 10th Circuit did spend some time discussing how, because of, you know, it is almost virtually or very difficult for a plan to self administer the functions that A P B M provides. The P B M is almost synonymous to the plan, and it has to be analyzed <laugh> , you know, as essentially the plan in the context of an ERISA preemption analysis. So I thought that was just a really interesting, you know, point that they focused on, in the case about how, and they cited some other case law and precedent for that, you know, where HMOs are often synonymous to plans. Um, and there have been other cases, so there was case precedent for it, but I think this is the first time that a court has actually talked about how PBMs are, you know, synonymous to plans in many ways. And so I thought that that was just, you know, very interesting. Um, and then, you know, not really my area focus, but the 10th circuit also ruled that the any willing provider provision is preempted by Medicare Part D as well. So , um, that was just another aspect to
Speaker 3:That . I mean , this case is a great reminder that while there's a , a strong appetite for P B M reform across a lot of different levers, you're often gonna run into sometimes a brick wall over risk of preemption. And having PBMs rely on that, have they had , as they have for decades to win a number of cases. And certainly Supreme Court , uh, opened up some aperture , uh, in Rutledge for, for further reform. But things need to happen in line with that decision and maybe we'll see further cases that hold a little differently, and then it gets back to the Supreme Court. Um, so it is certainly gonna be an area of contentious debate in terms of what the, what the , um, how far you could go on P B M reform and not run into ERISA preemption issues. Uh, that, that, that , um, that, that pull it back. Um, I also think you're gonna see , uh, more activity at the state ag level. Um, you know, where the insurance commissioners haven't perhaps been as active. The state AGS will say, you know, we, we think , uh, we've got authority to look here and do more, such as Ohio in particular has led the way. Uh, and in some ways the platform PBMs is , uh, particular ones that are vertically integrated. One can make the argument that the PBM is really engaged in the practice of insurance. And the state insurance commissioners should be more , uh, active 'cause they've got state authority to, to regulate them as an insurer , uh, and, and part of a consolidated P B M insurer enterprise. And I think if the state commissioners , uh, insurance commissioners don't do that, I think the state ags will do more of that. And so, you know, it's gonna play out across all these different landscapes of the states, the federal level , uh, agencies such as F T C and D O J . And it is just an area that, that, that , uh, folks would need to , to pay careful attention to and really see and predict what's coming around the corner to advise clients appropriately as to what's in the near term, what are the implications of that, what's more medium term , long term , uh, and, and when do we think that'll happen and what's the likelihood of that? And then how are different PBMs coming up to solve for some of these issues and creating more innovative models, maybe ones where they don't take a percentage, they don't keep the rebate or, or don't , uh, tie their compensation as a percentage of drug pricing. So that's another area to advise and be mindful of. But this has been a fantastic discussion. I think it's been a great , uh, um, springboard off of that, the chapter five that you and I worked on closely , uh, in the H l A treatise on market access and drug pricing. And I think we're just thankful for you and I to be able to connect again , uh, in a different venue and , uh, you know, appreciate the partnership and look forward to future events like this with you. Great.
Speaker 2:Thanks so much Rouel . Likewise, and
Speaker 3:Thanks everyone for joining us.
Speaker 2:Thank you for listening. If you enjoyed this episode, be sure to subscribe to a H L A speaking of health law wherever you get your podcasts. To learn more about a H L A and the educational resources available to the health law community, visit American health law.org.