Subscribe
Share
Share
Embed
Health Affairs This Week places listeners at the center of health policy’s proverbial water cooler. Join editors from Health Affairs, the leading journal of health policy research, and special guests as they discuss this week’s most pressing health policy news. All in 15 minutes or less.
Hello, and welcome to Health Affairs This Week. I'm your host, Jeff Beyers. We are recording on 04/28/2026. Today on the pod, we are talking about how changing screening guidelines affects health care use and costs. And as a reminder, we have a Health Affairs Insider event on ICRA with Urban Institute's Jason Lovitis on May 13.
Jeff Byers:Please join us. And here to talk about changing guidelines, specifically in cholesterol and others, and how they affect healthcare use and costs, we have Duke University School of Medicine's Mike Pignone. Michael, welcome to the program.
Mike Pignone:Thanks, Jeff. Great to be here.
Jeff Byers:So to start us off, the ACC and updated guidelines for for managing lipids or cholesterol. So really quick, can you give us some of the overview of these changes?
Mike Pignone:Yeah. I think the recent new guidelines really help cement some developments that have really been going on over the last ten years where we have, you know, increasingly strong evidence that more aggressive treatment of elevated cholesterol, particularly LDL cholesterol, seems to be beneficial across a range of risk levels in a way that reduces the number of heart attacks and strokes that people in our community is suffering. So the recent guidelines, I think, help codify a little bit better how to approach that kind of decision making and probably will result in more people being treated for their cardiovascular risk and hopefully preventing heart attacks and strokes.
Jeff Byers:Yeah, so real quick, what are the actual numbers to these changes? So we kind of alluded to it, but for anyone that like, if I have LDL over a 200 marker, or something along those lines.
Mike Pignone:I will say just to start with, there's nothing fundamentally different about our approach to primary prevention of cardiovascular events through treating abnormal blood lipids. And I think probably everybody in the pod is familiar, but just to kind of go over a couple things, you know, we've known for many decades now that LDL cholesterol is associated with cardiovascular events, particularly heart attacks and strokes. And at least for the duration of my career, about thirty years, we've had good trial evidence in both secondary prevention, people who've already had events, and primary prevention, people who've not had events, that reducing lipid levels, particularly with statin medications, can effectively reduce cardiovascular events in the future. Now, you know, the challenge gets in exactly what populations and exactly how much lipid lowering. And the new guidelines do help us sort out that approach a little bit better.
Mike Pignone:I think here are a couple of key features. First key feature of the new guidelines is that they recommend using a more recent risk calculator called the prevent risk equations in order to guide treatment decision making. So in the past, we had used a set of risk equations called the pooled cohort equations. They tended to overestimate risk at the low end somewhat, and the prevent equations do a little bit better job. They're better calibrated in estimating risk, okay?
Mike Pignone:So that's, you know, a moderate change. I'll just say for our own healthcare system, my EHR currently gives me the pooled cohort equation based risk, and we're in the active process of switching over to the prevent equations. Prevent brings in a few more other risk factors that help you just better assess, what you or my tenure cardiovascular risk would be. So that's probably important point number one. Related to that, once you have a risk level, you need to decide the right thresholds for treatment.
Mike Pignone:And I just say in general, the new guidelines tend to appropriately encourage decision making about lipid lowering in people that are what I would call low intermediate risk. So risk from five percent to ten percent over ten years. That's where there's a little bit more equipoise. It's not absolutely clear decision that everybody should be treated, but these guidelines tend to encourage that decision making and treatment at that levels. And I'll say, you know, just again, for your PODS listeners, that treating people in that risk range, there's a lot of people in that risk range, first of all, but treating people in that risk range is very cost effective.
Mike Pignone:So even though it's kind of pushing down on the risk spectrum from where prior guidelines had, tended to recommend treatment, that still is in a range that from our best cost effectiveness analyses, treatment is a very good value, better value than many of the cancer screening tests, for example, that we already recommend. When you get down below five percent ten year risk, there's not a lot of evidence, A, for clear benefits of treatment. And the net benefits compared to the hassles of taking a medication get a little bit harder to weigh up. So I don't think anyone is strongly recommending treatment with drugs below that risk level. But in that five to ten percent risk range, more attention to treating people, or at least having the discussion about treatment.
Mike Pignone:Then the third element of those guidelines is just encouraging the use of additional information like the coronary artery calcium score for people in that low intermediate range to help guide those treatment decisions. So the fourth thing is just more attention to driving LDL cholesterol even lower in people that are at very high risk in the secondary prevention population. I wasn't gonna talk a whole lot more about that because that's a little bit specific to people who already had events or are at very high risk for events.
Jeff Byers:Gotcha. Yeah. And just, you know, we'll we'll get into the policy aspect of it, but, you know, I'm gonna I'll set the scene where, like, you know, this I wouldn't say hits close to home, but, like, for instance, I'm on a statin because I had higher LDL, and it wasn't until I got the genetic lipoprotein a test where they're like, oh, you should go on a statin, because all my other numbers looked good. So they and it took a little little bit of time, and they had a calculator, and they said, like, if all of your numbers stayed the same except for your age, you wouldn't have to be put on a statin until 65. And then long story short, I had to change doctors, and then they were like, let's get you this test.
Jeff Byers:Now I'm on a statin. So what is this genetic test, is what I'm getting at. Some people might not know about it.
Mike Pignone:Yeah, LP is a test that, first of all, it's very genetically mediated. It's not really a genetic test. It's a level of a lipoprotein in your blood, but it's very genetically determined rather than behaviorally determined. So the new recommendations do recommend measuring it once, it doesn't change and we don't have any current treatment targets that directly treat the LP level. So basically what it's doing is for people like the ones I've been talking about in low intermediate risk, if your LP little a level is higher, it might push you over the threshold of starting treatment earlier.
Mike Pignone:The thing is about statin decision making is there are very few real downsides to statins. They're inexpensive and they're safe, okay? So when you're weighing up, whether that information should or shouldn't guide your decision making isn't really clear in terms of the Lp, but it is recommended and it might be helpful in people just like you. I'll say conversely in someone like me, I'm 60, I have kind of that seven percent ten year risk range. I just decided, you know what, there's not too many downsides.
Mike Pignone:I'm gonna start taking a statin because I would prefer not to have a cardiovascular event in five, ten, or fifteen years when my risk goes up. And that really is, I think, the gist of the current guidelines. Conversely, I'll say, if you are somebody who really wanted to avoid taking a statin, you just don't like taking medications, the coronary artery calcium score, which, you know, is a radiologic test where they take a picture of your heart and then score the amount of calcium in your coronary arteries, If that is very low, meaning you get a score of zero, your short term risk of having a cardiovascular event is low. And so someone who's at low intermediate risk based on the prevent equations and really wants to avoid taking a medication might decide to have a CAC scan. And then if the CAC scan is zero, decide to forego treatment and reassess in five years.
Mike Pignone:That's the other kind of major thrust of the guidelines. It's a little bit more emphasized than in past guidelines.
Jeff Byers:So that gets a little bit of the clinical stuff out of the way. You know, getting into the health policy aspects of it, we've seen a lot of changes in recent guidelines, whether it's in breast screening, blood pressure, hypertension screening, or colon cancer screenings in recent years. These ultimately increase the pool of people screening and being treated for these conditions. Is that correct? You've done a little bit of research on this, right?
Mike Pignone:Oh yeah, I've worked on each one of those topics. It's a little bit different for each one. I think hypertension is probably the one that sits closest to the lipid lowering guidelines. And here we've just had better evidence in the last five or seven years that, you know, continues to support even lower blood pressure goals, particularly for higher risk people. So someone like me who, you know, started their training in the 1990s, you know, we've kind of generally practiced on there, if you get someone's blood pressure under 140 over 90, you're feeling pretty good, like you're doing a good job.
Mike Pignone:But now there's better evidence, certainly for higher risk people, people with diabetes, people who might have chronic kidney disease, that pushing below 130 over 80 and even towards 120 over 80 has demonstrable benefits. Now, you also, as you start pushing blood pressure lower, start to pick up some side effects. It's not a perfectly easy decision. It certainly requires work, both on the part of the patient and the part of the healthcare team to manage people into those more aggressive goals. But again, in cardiovascular prevention, heart attacks and strokes are so common and can be so devastating.
Mike Pignone:And then you also see benefits in terms of perhaps dementia prevention and prevention of progression to kidney failure, that it's probably worth it as a healthcare system for us to invest in being a little bit more aggressive because the cost effectiveness of doing so looks pretty good.
Jeff Byers:Well, let's go into that. So like how, like let's take the hypertension example. How has these change guidelines really affected the costs and use of healthcare services?
Mike Pignone:I think there's kind of the societal perspective, and then there's the perspective of health plans and healthcare delivery systems. Our particular way of financing healthcare in The United States is very procedurally oriented and, you know, our spending on primary care, which is where the work in treating hypertension mostly happens, is far below our other wealthy nation peers. I'm sure you had that discussion on previous pods, but, you know, we're spending at 4% of our healthcare budget on primary care, highest performing systems spend at 12%. So I don't think that our micro systems of healthcare financing are set up to do challenging things like manage blood pressure more aggressively very well. And you know, that comes out in their health system performance.
Mike Pignone:If you're healthy and you need a knee replacement in The United States, it'll be expensive but very high quality. I'm not sure that if you're, you know, suffering from multiple moderate chronic conditions, including hypertension, that our healthcare system is well set up to deliver that highest quality care. And that's something that we're working on intently to try to change. But the value is pretty good. Now, you brought up a couple other examples.
Mike Pignone:Let's take the cancer screening ones. Colon cancer screening, that's a topic I've worked on most of my career. We've known for a long time that screening people 50 75 is effective and cost effective in terms of reducing colon cancer mortality, but we're seeing more colorectal cancer developing in people in their 40s. That is epidemiologically true. And so more recently, we've moved our guidelines to starting colon cancer screening at 45.
Mike Pignone:That makes sense and is probably, in terms of The U. S. Healthcare system, also cost effective in a vacuum. However, I would say that when I'm working with healthcare systems that are not performing well and screening people fifty to seventy five, starting to screen people 45 to 49 may be a distraction from screening people in the fifty five to sixty five range, where they're at even higher risk and screening is known to be clearly effective. As an implementation scientist, I worry a little bit about us expanding the range of recommendations when our performance in people that have been previously recommended remains suboptimal.
Jeff Byers:So implementation scientists, I think you get at something that I'm like, really wanted to touch on in this conversation. So looking at colon cancer, we've seen some high profile examples of people passing away before the age of 50, you know? And hearing that in the media can get people, maybe not anxious, but, like, more self aware or more aware of, like, that potential since as you noted that it is true that cases in people's forties are rising for colon cancer. So where do you see in that trade off of like cost utilization screening for the patient? I mean, is it I guess it's never probably gonna be a perfect world, but, like, how from a systems perspective, when you lower those guidelines, how does that affect the actual pool of patients for healthy outcomes and from a utilization and like saving, potentially saving money down the line?
Mike Pignone:Yeah, no, really good questions and really complex. First of all,
Jeff Byers:I'll just
Mike Pignone:say that like
Jeff Byers:We're not going to figure it out right here.
Mike Pignone:Well, I mean, there's like different buckets. So really early onset colorectal cancer is uncommon and tragic, and we don't understand it well enough. So when you talk about people that develop colon cancer under 40, don't have a strong or even any family history, we need to do, you know, basic ideologic research, epidemiologic basic science to understand that better, okay? Let's put that aside. You know, is still true that most colon cancer occurs in older people, okay?
Mike Pignone:Is going up, two things can be true. It's going up in younger people, most cancer cases still occur in older people, and most deaths certainly occur in older people, okay? So, I think it's just balancing up a little bit where we make investments to, you know, prevent the most, you know, untimely deaths, untimely cases of advanced cancer. You know, if I was 40 years old and I had my colon cancer death prevented, I'm gaining thirty years of life versus if I'm 75, I'm gaining five years of life or ten years of life. So there is a real rationale in making sure that we pay attention to prevention in younger people when we can.
Mike Pignone:But the average 45 year old is at considerably lower risk than the average 55 year old. And where this comes, you know, where the rubber hits the road, and the thing that I'm most concerned about right now is I think you ask any primary care doctor, they're having a harder time getting their patients into GI for colonoscopy. Like, I mean, for a number of reasons, but partly because of moving the screening age down to 45, we've increased demand and haven't increased supply at the same rate. And if you're failing to get high risk people, people that are having symptoms, blood in their stool, you know, positive stool based screening tests in for colonoscopy, in order to get the 45 year old at low risk in, we may be performing sub optimally. So we've got to pay real attention to risk stratification.
Jeff Byers:And then quickly moving back to cholesterol as we wrap up, you know, we talked about trade offs, we talked about risk stratification. Is there anything from the, you know, because the cholesterol is the more news based thing, any changes to expect costs, utilization, healthcare services in this area?
Mike Pignone:I think there's two streams. One is that we have very effective inexpensive medications that work for most people, right? So mostly what we're talking about in decision making about cholesterol treatment is whether to take a statin or not. And that you should be able to get a generic medium or high intensity statin and, you know, pay very little money out of pocket for that and get a lot of health benefit. There are novel agents.
Mike Pignone:The PCSK9 inhibitors are very effective in lowering cholesterol. They have mainly been used for very, very high risk patients, a very small portion of the population. If we start using these more expensive, very potent agents in more people, costs will start to rise. Benefits may offset those costs in the highest risk people, but, you know, as you increase that population, I think that's, you know, always a concern. And of course, the macro concern that we haven't talked about that sits around all of this is we also have the GLP-1s, which are very effective medications.
Mike Pignone:In high risk people, they also reduce cardiovascular events, but they remain expensive, and the money has to come from somewhere. I think there's an increasing appreciation that our multi trillion dollar health system cannot be sucking more money from other sectors of our economy into the health system. So how do we spend that money most effectively to take advantage of these new therapies that are really game changing innovations? That's the hard work of doing the health services research, the health economics research, and the implementation science research. So I just wanna, you know, maybe close by putting in a plug that we need good data to inform these discussions, and then we need good communication hopefully like this and other means of reaching our broad population of healthcare providers and the general public, who are sometimes patients, so that we can kind of get more of a consensus about how we go about that work rather than living in some corner.
Mike Pignone:I think we all need to take responsibility for weighing in appropriately on this topic.
Jeff Byers:Well, we don't have enough time. We don't have any more time in our conversation today, but it was really great to get a clinical perspective on some of these health policy aspects, and just seeing how the intersection of actually policy and practicing medicine works out, and in the in the research field too. So Mike Pignone, thank you again for joining us today on Health Affairs This Week. It was a pleasure. If you, the listener, enjoyed this episode, send it, you know, to the this this will come out the week after, but, you know, for anyone that's bemoaning the death of the two word health care AP style decision, you know, my hat and heart go out to you.
Jeff Byers:Take care and see you next week.