Hot Topics in CV Nursing Advocacy: Inflation Reduction Act

Geralyn Warfield (00:20) 

Welcome to today's episode, the third of four on advocacy in nursing and current policies that can affect your cardiovascular patients. Our previous episode looked at the Treat and Reduce Obesity Act, also known as TROA, and its implications for those patients. Today we're going to explore another hot-button topic, the Inflation Reduction Act. 

And if you're a frequent listener to the Heart to Heart Nurses podcast, you'll likely recognize today's guest, Ryan Gough. But for those people that don't know you, could you please introduce yourself to us? 

Ryan (00:49) 

Hey, Geralyn, great to be here. Thank you so much for having me on the podcast. Yes, my name's Ryan Gough, I’m the Executive Director of the Partnership to Advance Cardiovascular Health, or PACH for short. We are a non-profit coalition of about 20 different heart advocacy groups, so either patient groups or medical societies like PCNA. PCNA has been a member of PACH pretty much since its beginning in 2016. 

And our goal and mission is to advocate for patients. We look to lift patient and healthcare provider voices into policy discussions that are happening in Washington, DC, but also in all 50 states where we can. So again, thank you for having me and happy to be here. 

Geralyn Warfield (01:38) 

Well, we're so grateful to you for spending time with us today and we're going to dive right into our topic. And I suspect that most of our audience members are familiar with at least the title of the bill that we're focusing on today, and that is the Inflation Reduction Act or IRA. But for those who maybe aren't quite as familiar, could you provide an overview for us? 

Ryan (01:56) 

Sure, yeah, happy to. So, I think it's important to realize or recognize that the Inflation Reduction Act, as people are probably familiar with it, kind of like broad strokes, did a lot of different things. There were some climate and kind green energy applications to the bill. There were a lot of infrastructure pieces to the bill. But then there was also a major healthcare function to the bill as well.  

And honestly, from an impact standpoint, if you were to just break out the healthcare piece of the Inflation Reduction Act alone, it would be one of the most significant pieces of healthcare legislation, you know, passed in the last two or three decades. So, you think about some of the major things that are major pieces of legislation that have moved that impact healthcare, you know, in the last two to three decades, you think about the creation of Medicare Part D, for instance, and you think about the Affordable Care Act. The Inflation Reduction Act is on the level of those pieces of legislation.  

So, from a healthcare perspective there were a couple of major things that that occurred. One is that the IRA the Inflation Reduction Act gave Medicare for the first time the ability or opportunity to negotiate or set the price of drugs that the government would pay based upon the amount of money that they're spending on specific medications. In this case, Medicare took 10 medications that were big kind of budget items for the federal government, and they put them through for the first time a negotiation or drug setting, price setting process. And those prices were recently released just in the last couple months or so. 

There are two functions or two things that change with the Inflation Reduction Act that are positive for patients in our mind. One is that there was an out-of-pocket cap created of $2,000 for patients. So, patients for their Part D medications will not pay more than $2,000 a year now. That's number one.  

The second thing that the Inflation Reduction Act did was create something that they're calling the Medicare Prescription Payment Plan or MP3. Also in Washington, this has been called the smoothing mechanism. And so, what that does is it essentially makes it so that patients can pay down that $2,000 out of pocket cap over the course of 12 months. So, patients used to, if they had many medications or one expensive medication, they'd have to pay that bill upfront in January. And so, you could get hit with a pretty sizable medication or a prescription bill. But now if you opt into the program, you can pay that down over the course of 12 months. 

And there's some stipulations to that, but that's also a really positive development for patients without question. 

Geralyn Warfield (05:00) 

So, you've talked about two really positive things for patients thus far. And I suspect, though, that this is not all rosy glasses that we're looking through, that there might be some other unintended consequences, I should say, to this particular act. And I'm hoping you could address those as well. 

Ryan (05:19) 

Sure, so, Geralyn, I think when we talk about some of the challenging aspects of the Inflation Reduction Act or IRA, I really kind of put it into two different buckets. So, one bucket is kind of the out-of-pocket cost and the utilization management bucket. And so, what are the challenges that nurses are going to see, that patients are going to see at the pharmacy counter essentially. So that's number one. 

The second piece or challenge that we anticipate and are seeing a little bit now has to do with research and development and investment in new cardiovascular medications. And I think that the law will definitely have some impact on that. And we can talk a little bit about that as well. 

So, with any big piece of legislation like this, whenever you are kind of capping the prices of medications, you are changing how things are being paid for, you're changing the timelines in which they're being paid for, you're going to see the market shift in order to kind of absorb those costs and change those costs.  

In particular, the pharmacy benefit managers who are kind of managing these prescription drugs for the Medicare plans will likely have to make some changes in order to absorb these extra costs that are being passed on to them.  

So used to, frankly, the government and some of the pharmaceutical companies were taking on some of these extra costs, but now that's really been pushed to the pharmacy benefit managers as a part of this legislation. So, one thing that we are looking out for, for patients that are on these cardiovascular medications, and I should really make a point here, Geralyn, that I mentioned at the top that there were 10 medications that were initially, went through this kind of drug price negotiation or price setting process. It's important to realize that five of those 10 were cardiovascular medications. A couple others were diabetes medications that a lot of your nurses probably prescribe and work with. So, technically, you could almost say seven of the 10. A lot of the patients that listen to, that work with your nurses are on.  

So, I would say that any impacts that we have from this law, we're going to feel them in cardiovascular. Things that we are concerned about as a result of this price setting and capping is how the pharmacy benefit managers are going to kind of manage these increased costs that they're going to take on. 

And, in particular, you know, there was a study that we looked at, that Dr. Robert Popovian put forward. We did a podcast on this or a webinar on this recently. And his thesis is that essentially the pharmacy benefit managers in order to kind of, blunt the impact, the financial impact from the changes in the law are going to inch up costs on patients for these, these drugs. 

So even though there's a $2,000 out of pocket cap, it is possible that people at the pharmacy counter would be paying more for these medications that are on this kind of list of 10 than they have in the past. What Dr. Popovian did to kind of test what would happen here, as he looked at, there are generally six tiers on a formulary. And as you go up in tier, you’re getting more to that specialty kind of tier, whether you have more, you're more expensive medications. And so, we just, he just took kind of a, he assumed that most of these medications are kind of on a tier three and he moved them all to a tier six. And what that was supposed to do is kind of increase the out-of-pocket costs for the patient, just in theory. And then looking at some other data that's been published on this, if you look at the blood thinner class, for instance, as a patient's out of pocket costs go up predictably, adherence goes down. And as people stop taking their blood thinners, for instance, everyone that listens to this podcast knows what the consequences of that are.  

And so, one thing that a lot of advocates, including PACH and others have said to the Centers for Medicare and Medicaid Services is as this law is implemented, we hope that CMS will watch what the kind of formulary makers, the pharmacy benefit managers are doing to ensure that these drugs are not being switched on the tiers. And I think that that won't happen. I actually think that they will keep these drugs on the same tier because it's kind of an obvious change if they were to do that and CMS could call them out on that.  

But what may happen and what Dr. Popovian said was really the surprising thing that he learned from looking at a lot of claims data that was actually provided by the PBMs is that the copay or the co-insurance that a patient pays on any tier. So, on a tier three, for instance, so if you're just existing in that same tier three, their copay could be $5, it could be $105. It just kind of depends on the plan that you have. And so, the fear is that over time, patients’ out of pocket costs will actually be inched up. Now, it'll be capped at that $2,000, but the reality is, is that at the pharmacy counter, you could have a situation where patients are actually paying more than they were before this law was implemented.  

Now that is surprising because if you look at the rhetoric you're hearing on the campaign trail and with folks that tried to really champion this law, the idea is that costs would come down for patients. That's yet to be seen. I mean, hopefully that's the case, but I think it's important for any prescriber or anyone that's working with a patient to really pay attention to these five medications or, in particular, to make sure that patient out-of-pocket costs are not going up. So that's one aspect, Geralyn.  

The second thing that that could happen as a result of this is that access could get a little more difficult for patients. With this price cap we could see that prior authorizations get a little bit more challenging. We could see step therapies or fail first protocols becoming a little more prevalent and hopefully not, but we could see some non-medical switching that happens. You know, it's something that we are paying very close attention to.  

We will rely frankly on PCNA and your members to kind of flag this for us if you're seeing it with your patients on specific medications. But it's just some things that we want to keep in mind as this law is implemented. 

And that's kind of like part one of the unintended consequence. And I'll pause there, Geralyn, if you have any follow-ups on that one. 

Geralyn Warfield (12:12) 

I'll tell you what, Ryan, why don't we take a quick break for our listeners and then we will be right back with more information. 

We're back with Ryan Gough talking about the nuances of the Inflation Reduction Act, or IRA, and how it affects our patients in cardiovascular disease management and prevention even. And Ryan, before the break, we were talking a little bit about out-of-pocket items. We talked a little bit about PBMs. But I know that PACH has been quite involved in terms of the second bucket that you had described right at the top of our discussion. It has to do with research and development, and then also has to do with the pipeline for cardiovascular medications. I'm hoping you could address that a little bit further for our audience. 

Ryan (12:54) 

Yeah, happy to, Geralyn Thank you.  

You know, I'll start with the story. So, I was at the American College of Cardiology meeting a couple of years ago, right after the Inflation Reduction Act had passed. And I had a number of cardiologists who I was meeting with and, they are clinical trialists and they work and kind of research and development. And they asked me, they said, Ryan, are you looking at the IRA and its impact on R and D? And I thought, you know, not really, cause it's not something that we really focus on is, you know, R and D and kind of investment in cardiovascular therapy. 

But because these specific cardiologists had kind of a window into clinical trials and they had managed clinical trials and they understood the cardiovascular pipeline, they said, I think that you should look at the impact to CV research and development. And so, in order to do that, I contracted a firm out of Washington DC called Avalere, which is kind of a, it's kind of like a health policy think tank is what I would describe them as. And I asked them to look at the impact of the Inflation Reduction Act on cardiovascular research and development versus other chronic diseases.  

And what they looked at were respiratory and diabetes in particular. And I think that the concern or the hypothesis was that because of the negotiating timeline from the IRA. So, in the IRA, they essentially give Medicare the opportunity to cap drug costs at seven years for small molecules and 11 years for biologic medicines. I mean, your listeners will know this, 90% plus of cardiovascular medications are small molecule.  

And so, essentially what that means is that a company would have only seven years to recoup its costs for a medication they brought to market if it was small molecule. Secondly, as many of your listeners will know as well, a lot of R &D goes into these medications after they're approved. So, if you have this really small timeline, there's not a lot of incentive for a company to do that. And that matters because as some of your listeners will know, in particular with the diabetes medications where we've seen cardiovascular benefit, after they'd been approved for diabetes purposes, there's massive cardiovascular benefit. Under this current structure, there's some concern that those studies would have never been done. So, we looked at, I asked Avalere to look into this and they said, actually, frankly, Geralyn the results were more confirmatory than I had suspected.  

And what they said to me was, look, cardiovascular trials are some of the largest in the world, if not the biggest in the world. The number of sites, vastly outpace those for diabetes and respiratory, for instance. The number of patients that we have to enroll and the length of time it takes to get these things done, which means the expense of them is very high. And yet, you have the smallest window to recoup those costs. And so, there's kind of a disparate incentives going on here. 

And so, there's a lot of concern, I think among, the cardiovascular community that some of these novel agents that could potentially come to market and some of the incredible innovation that we've seen really in the last 10 years, we won't be able to add onto that. And so we think about, hypertension medications that are kind of RNA based you can get like a hypertension shot once a year, things like that, that are coming down the pipeline.  

The LP(a) medications, same idea. Are we going to be able to get those things to market? There's, some concern about it. And frankly, we've seen the reverberations of this now. In oncology, one manufacturer, they said publicly, we're not going to do small molecule development anymore. And that was in oncology, but the principles apply in CV as well. So, there is some concern that, you know, there's a disincentive in CV R and D and we'll see how that plays out. 

But we're also looking at some small technical fixes that could encourage continued investment in cardiovascular R and D as well. And we can talk about that later, Geralyn. 

Geralyn Warfield (17:30) 

So, I'm thinking particularly about our listeners who have patients with hypertrophic cardiomyopathy or HCM and a novel treatment that's come on the market recently that's really making a difference for some of our patients. Are you thinking, are you indicating that patients gaining access to these kinds of medications is going to be more difficult now or in the future? 

Ryan (17:52) 

Well, first of all, let me just say that we've had some of these patients that are on these novel hypertrophic cardiomyopathy medications to the Hill, in Washington, DC, to meet with their representatives. And to hear their stories about the impact is just unbelievable. Like they can just live their lives again and it's just incredible. And they’ll tell you stories about how difficult it was for them to even go get the mail at the mailbox. And now they can do anything. It’s just wonderful to hear, and this is what it's all about.  

But to your question specifically, Geralyn, I think that actually for Medicare patients specifically, that this law would actually make access a little bit easier for those people, that are on, these novel hypertrophic cardiomyopathy medications. And the reason for that is because of that out-of-pocket max that we talked about that out-of-pocket cap and that Medicare prescription payment program the MP3 or the smoothing mechanism. 

These medications are not inexpensive, and with that out-of-pocket cap, and with the smoothing mechanisms that are in place, it will make it a little bit more affordable if folks are having are meeting that cap or if they have extra other medications they're also on, so, they're prescription drug bills, high as it is. So, I think that you know in this instance for Medicare patients specifically that they will that the access will be a little bit easier.  

Now that being said I think that you know as I mentioned a little bit earlier, there could be prior auth hurdles, there could be you know step therapy protocols, and that kind of thing and we need to be diligent about that. But from an out-of-pocket cost perspective, I think that the law could actually be in a lot of ways great for patients. 

Geralyn Warfield (19:42) 

We have covered a lot of ground today when it comes to legislative issues that affect our patients and our ability to get them the medicines that they need. And I’m hoping, this might be a tough question, but is there one key takeaway that you would leave our audience with about our conversation? 

Ryan (19:59) 

Yeah, there is. I think, you know, I think that it's really important to remember with big pieces of legislation like this, there's good and there's bad. They’re not, it's not all, all always good and it's not all always bad. And as a result of that, it's important to be diligent about the potential challenges in laws. And it's also really important to get out the good news about these pieces of legislation. 

And so, for instance, on the positive side, what I would say takeaway for your listeners is with this out-of-pocket cap max, you know, we should be talking about that as much as possible to patients where they were maybe nervous about filling certain prescriptions or trying to gain access to some of these medications. They should know that that out-of-pocket cap is in place now. 

The second thing is that, and this is really, really important, Geralyn, is that that Medicare prescription payment plan, the MP3 or the smoothing mechanism, is an opt-in program. So, in other words, you're not automatically just going to be able to pay that in monthly installments. You have to opt into it. And so, for your listeners, as you're working with your patients, make sure that when they're signing up for their Medicare plan that you're talking to them about that payment program so that they can opt into it. And so that's the good stuff that we should talk about.  

You know, on the other hand, there are some challenges. We talked a little bit about that today, the utilization management issues, the potential R and D issues. And on that side, what's important here is, is to make sure that we're being diligent about it and ensuring that the law is working the way that legislators intended.  

And I will say that, you know, PCNA just recently had a number of your members up to the Hill and I joined them, and we were talking about the IRA and its implementation. And honestly, the feedback that we were getting from legislators was overwhelmingly, “This is great.”, “Please keep coming back and talking to us about these issues.”, “We want this law to work for patients and we're willing to tweak things where we need to.”.  

But we can only do that if number one, we're identifying these issues in the clinic and number two, you're bringing them either to PACH or you guys are coming yourselves up to the hill and communicating that to legislators.  

And so first, I just want to say thanks so much for PCNA for coming. We love seeing you guys in DC and let's do it again! 

Geralyn Warfield (22:34) 

Sounds perfect. So you audience members have been left with several calls to action, and not the least of which is if you need more information, you can certainly find that in our show notes. We'll put in some links there so you can continue to be educated about these topics. Also, as we said at the top of our show, this is one of a four-part mini-series about advocacy in nursing, and we hope that you will listen to those other episodes as well.  

We want to make sure to thank our just amazing guest, Ryan Gough for being with us today from PACH and talking us through all the complexities of this legislation on the Inflation Reduction Act. We're so grateful to you for your time and for your expertise. And we'd also like to thank Amgen, Bristol-Meyers Squibb, Novartis, and Novo Nordisk for their unrestricted grant funding for PCNA's advocacy efforts. This is your host, Geralyn Warfield, and we will see you next time.