Thanks, everyone, for joining us. My name is Eric Coldwell. I cover pharma services and distribution at Baird and have been a big and growing fan of the labs in recent years. Really excited about what's been happening, not only in fundamentals in the space, which have been very strong, but also, I think, both of the public players executing their core diagnostics businesses at higher and higher levels. So we're very big fans of this sector. We're honored to have Jim with us today. Jim, you've been at the company a long time, not so long ago, moved into the CEO role, really got your legs under you, and you've made a lot of great investments ever since. So I'm excited to talk about that. And of course, Shawn Bevec, I think arguably one of the strongest IROs on the Street. So it's really awesome to have Shawn.
I mean that seriously. You've been fantastic to work with over the years. Jim, I want to just kick it right off. A lot of macro stuff going on. I mean, it maybe belies the underlying strength of the lab market and what you've been doing, just the Street's consistent considerations over things like PAMA, health exchanges, Medicaid work requirements, you name it. At a high level, are there any big updates? I doubt it highly. It's only been a month since you reported, but are there any updates you'd like to share?
Yeah. Well, the big update on PAMA, and you might think we tried to time it for the conference, but it's out of our hands. Actually, today, there'll be a new bill introduced into both the House and Senate. The formal name of the bill is called the Results Act, and the Results Act is what is being put forward. Sponsors are sponsors in the House, sponsors in the Senate. Obviously, ACLA tried to shape what the bill will ultimately be, but that is actually hitting the House floor and the Senate floor today, so there'll be an official bill. Now, what that bill attempts to accomplish is ultimately PAMA reform. Recall, PAMA introduced in 2014 and significant issues with the data collection process, so the bill that is being put forth does the following. Number one, we're going to ask for price stability for 2026 and 2027.
There'll be a data collection process that kicks off in the first half of 2027 with analysis of that data in 2028, with new rates going into effect in 2029. Now, the fundamental change is in that data collection process. Recall, in the original data collection process from 2016, the independent labs are 50% of the lab industry, yet 90% of the data came from them. The hospital labs are 27% of the ambulatory industry, and less than 1% of the data came from them. The physician office labs are about 23%, and recall, 9% of the data came from them. So what this attempts to do, and recall, there were supposed to be fines levied against those that didn't submit the data. That never happened.
So rather than try to fix that process of extracting data from thousands of hospital labs, there are third-party databases out there that fairly represent the activity in the ambulatory market. And the act contemplates using one of those third-party sources to collect the data. So that is what is being put forth this morning. The bill then goes to the committees for markups, comes out of the committees, and then we'll wait and see, does it get voted on as an individual bill or act, or does it get attached to other healthcare legislation that needs to occur before year-end?
This was a very easily accepted, widely bipartisan group from both the House and the Senate, I believe.
We have Republican and Democratic sponsors on both the House and the Senate. We'll continue to build support for that. As the bill goes to markup, ultimately, it gets scored, and we'll watch the process unfold from there.
Now, correct me if I'm wrong. I still don't believe we've seen anything from the CBO scoring, which was a new process this year. That's correct, right? As of today, we still have.
As you know, look, it's been delayed for six years. Some of that was a result of CBO scoring that the next round of cuts would actually cost the government more money. Why is that? Because if they enacted the next round of cuts, it starts a new data collection process. When that data collection process is done fairly, it would result in rates going up. A cut triggers a new. Okay. Now, did anyone truly believe that it would save the government $3.5 billion when that number came out last year? I'm not sure we did, because we never said our lab prices, the independent labs, us and our nearest competitor, have talked about health plan pricing going up from 2020 to 2024. We certainly never said it was going up at the rate of inflation.
That is perhaps what was contemplated in that last CBO model. The year before, CBO said it would save $550 million. Yes, it ultimately has to get scored against some baseline. We trust CBO will do that.
You might have more trust than I do. Anyway, we can move on. But the CBO has made a number of mistakes over the years.
Okay, so if there is a cut, the current legislation says that the next data collection process is 2019.
Yeah.
Okay. If CBO actually believes that rates are going down, why would you collect data in 2019? You would actually push to collect data in the farthest year out. Having said that, in order to push that data collection period out, it requires a legislative change. So something has to change. We need a permanent fix, and that's what we're advocating.
Totally agree on that. We hit on that in one of our sector notes a few months ago where we talked about the absurdity of using 2016 and then eventually 2019 data.
To set 2028 rates.
It's mind-boggling. It's mind-boggling that hospitals and doctors' offices didn't have to participate in the survey, even though they were required to, and then there was no penalty. But it is what it is. I think one of the interesting concepts out there is that, and our team wrote on this a month or two ago, we talked about some of the exciting M&A and outreach deals that have happened in the space. And there's so much going on in the marketplace. But the truth is, you actually have pretty good insights into actual rates. Because you sit inside a number of hospitals doing.
Whenever we do these outreach deals.
Code collection or outreach work.
When we do these outreach deals, we get a look at what pricing the hospitals were getting from commercial payers. And it's no secret, okay, whether we see that data or we see it in these third-party databases that are widely available as a result of the price transparency work. So the data is out there. It's a fact that hospitals are getting paid 300%-400% of Medicare by commercial payers. Physician office labs, maybe not that high, but somewhere in that range. And again, when you look at the volume weighted median, we're convinced the Medicare prices should go up.
You think the government's going to allow Medicare pricing to go up?
Look, we're okay keeping rates flat to where they are.
So, it sounds like you, and I'm not asking you to put odds or give an update on your outlook, but it would seem that you're feeling maybe incrementally comfortable at this point, now that we've seen this draft bill come in, that maybe we don't have to worry about PAMA in 2026?
I think there's growing support that there needs to be a fix to the original PAMA legislation in 2014, so I think there's growing support. I think there's all sorts of healthcare fixes that need to get accomplished by the end of the year, whether it's the subsidies to the exchanges, whether it's the telehealth, and so our hope is that all of this will come together by year-end and get voted on appropriately.
Do you have an expected timeframe?
I think it'll play out in November.
November.
Early December.
Okay. What about on? There's also been some noise and news recently on health exchanges, right? Maybe some growing support to push off changes there.
Yeah. So just turning to the one big beautiful bill act, right? The Medicaid cuts that were contemplated, we said no impact in 2026. The states are given a year to get ready for that. Minimal impact in 2027. With respect to the healthcare exchanges, we said it's 4%-5% of our revenue. If a third of those lives came off, it would impact us 30-ish basis points from a volume standpoint. Recall, these are not heavy users of healthcare today. Over 35% of the people on the healthcare exchange had no healthcare activity in 2024. So now, over the weekend, yes, we saw growing both Republican and Democratic support to keep the subsidies in place one more year, right? We're already at the point where open enrollment starts, I believe, October 1st.
So a lot of uncertainty left out there, but I think there's growing support, and we'll see how that turns out as well.
I want to shift gears and talk a little bit about some of the exciting growth areas in core diagnostics. I don't know if we should start with advanced diagnostics and work back to Haystack or start with Haystack and then broaden to the rest of the group. Why don't we do Haystack first?
Yeah.
Give us some quick updates, but I think specifically, I'd love to hear your thoughts on the breakthrough device designation recently received at the FDA.
Yeah. So look, that's good news for the test. Those inside the FDA looked at the test, looked at some of the data that we've published from the test, and assessed that this thing, this test, can really help save lives. Okay? It's a significant test that can add value to the healthcare system. So it gets this Breakthrough Device Designation.
For a narrow.
For a narrow colorectal cancer stage two at this point. Okay? But that says a lot about the test. Okay? Now, we've introduced it commercially, and so the next big step is obtaining coverage and reimbursement. We have a PLA code that's been established. We submitted our pricing request to CMS. It was reviewed. We had no additional questions, and as you know, most of the pricing is finalized the Tuesday or Wednesday before Thanksgiving. So we expect. We provided a crosswalk to how we think we should get paid, had no questions. So we expect to have pricing in place by the end of the year. When it comes to coverage from a Medicare standpoint, our lab sits in Dallas, Texas. We deal with Novitas as our MAC. We are submitting claims to Novitas today. We are getting paid for those claims.
It requires some medical necessity, but we submit that, and we're getting paid for those claims.
On the commercial side?
On the Medicare side.
On the Medicare side. Okay. What about commercial?
So let's just say by the end of this year on the Medicare side, we expect to have everything in place to get paid. Now, Medicare Advantage. Medicare Advantage plans still look to MolDX for a technical assessment. We've submitted all the things we need to do to have MolDX assess the technology of our test, and we expect them to make some technology assessment by the end of the year so that we will then have Medicare Advantage coverage, right? That covers about 60% of all cancer cases. And from there, you then start working the commercial plans one by one. If they're paying for Medicare Advantage, we'd like to think they'll pay on the commercial side. But as you know, that takes negotiations and additional evidence, clinical evidence to convince them.
So do you have, or would you be comfortable sharing any views on how this could grow into 2026? I mean, I know you're live and you're expanding your audience today. You're getting some good news, but.
Look, what we've said is that we expected certainly to be less diluted to the P&L. We're investing in the test. Okay? We have dozens of clinical trials underway beyond colorectal for breast, for lung. These are prospective studies, retrospective studies. So we're investing to win in the long run. We're doing all the necessary things to win in this marketplace. Now, look, certainly there's a competitor out there that had a four- to five-year lead. Okay? But the wonderful thing about laboratory diagnostics is there's zero switching costs. Okay? It's not like putting an MRI scanner in a hospital and that scanner sits for 10 years and you've lost that socket. Okay? They may not switch with a patient that's already getting this test, but switching costs are minimal. Okay?
So yes, there's a competitor out there with a big lead, but we're doing the right things that we need to do, and we believe the test has significant advantages versus other tests in the marketplace today.
Can you talk at all about clinical adoption?
Of the MRD test?
Yeah.
We established this early experience program. We had over 75 users of the test from academic medical centers, national cancer institutes, community health plans, and I can tell you the test volume continues to grow week by week by week.
Fantastic. Thank you. Let's broaden it out. Advanced diagnostics. High hundreds of millions approaching a billion-dollar business overall. You have multiple categories growing double digits.
Yeah. The three that we feel, other than the advanced cancer testing, the other three that we feel very good about right now, first, neurological testing, primarily Alzheimer's and dementia. We launched first a series of tests for amyloid plaque and then other p-tau markers. I think there's other biomarkers to come. The research has not stopped. The adoption of these blood-based tests has exceeded our expectations. It is growing high double digits. We'll double the business year over year, and we expect it to keep growing. We're working with the two primary pharmaceutical companies to get those agents. It requires some type of diagnostic test. It doesn't say imaging. It doesn't say lab. And we continue to build confidence that this is a test that can be run in order to qualify for a therapeutic agent. So we're investing.
There's clinical studies ongoing comparing the efficacy of this to PET/CT. We feel really good about the space. Cardiometabolic, well beyond the Lp(a) and ApoB, which continues to gain adoption. We have lots of other cardiometabolic tests, Ion Mobility, OmegaCheck. There's other markers beyond C-reactive protein. Many of these tests are being ordered not just by cardiologists, but functional medicine practitioners that are out there. We continue to get great traction there. The last one is just autoimmune disorders, which unfortunately continue to grow in this country. We've introduced some tests for the primary care community that help them discern amongst the various autoimmune disorders which one that patient has in order to send that patient to the appropriate specialist.
So all of this contributing to solid test per rec improvements as well as revenue per rec, which we've noted is growing north of 3%.
So that opens several lines of questioning. First off, and I think the answer is going to be yes to all of the above, but better science, new products, broadening interest across the prescriber base to explore answers, not just very unique specialists going into functional health. GPs even we're seeing broadening prescribing or at least folks paying attention to these novel categories. Maybe an increase in comorbidities or unfortunately national health incidents as well, possibly. What do you think is there a horse in front of the cart here, or is it just everything's moving in the right direction to continue this growth?
I think the country's talking a lot about chronic conditions, right? Obesity, diabetes, other cardiovascular diseases. Eric Topol just published a whole new book on this. And it's going to grow before it slows down. Okay? And so certainly that contributes to a lot of the growth that we're seeing out there, just the management of these chronic care conditions. On the other end of the spectrum is this renewed interest, growing interest in consumer health. Some of this driven by functional medicine doctors. These are people that have practices. It's being driven by some of the consumer health companies. Our own consumer health company, our own consumer direct business is approaching. Last year it did $60 million. We said it could approach $100 million this year.
So the combination of our own consumer direct, other consumer health companies, whether they're in-person functional medicine doctors, we've discussed Function Health as a company, and we are the lab supplier for Function Health. All of this is driving this, and it's really renewed consumer interest in their health, and why do people flock to us from a consumer standpoint or to these other consumer health companies? Because many of the tests that they're trying to get are not going to be covered in a general health and wellness exam. And so if you want these tests, your primary care doctor is not likely to order them because your insurance company is going to deny them, so you're better off coming directly to Quest, directly to one of these consumer health companies and getting those tests directly from one of us.
I'm sure there is some, but talk to us about maybe opportunities to expand the reimbursement of some of these tests where you realize maybe an offhand example would be looking at who's saying GLP-1s are critical medicines, necessary medicines, right? They should be on everybody's coverage. Maybe some of these tests should be on everyone's coverage. Is there some kind of a push?
Yeah. Trust that that's a never-ending process, right? The whole philosophy in this country that we'll pay for certain tests when you're sick, but we won't pay for these tests as part of a general health and wellness exam, right?
To prevent you from being sick in the first place.
That's what to be replaced. Right. That's what has to be reversed. I mean, I can tell you today, there is not widespread coverage of ApoB and Lp(a). Okay? And what some of the commercial players will tell you is, "We don't want to cover Lp(a) because there's no therapeutic for it." Well, come on. There's not therapeutics for glioblastomas or ovarian cancer, but we still diagnose those things. So we work that every single day. And is there a broadening, awakening, a recognition that we have to move funds from sickness into general health and wellness and prevention? I think there is, and there's growing interest in that. So we work those reimbursement discussions every single day. But on the other hand, if consumers want to order them directly from us, we're happy to be there to enable people to get insights inside their body.
Let's shift gears. I could talk about this all day. This is the fun part.
It is.
But Corewell Health. So you've done another deal. This one's a little different. JV with Corewell and seems like a more sizable, maybe a little more investment, but I'd love to open it up, put it in context with other transactions of a similar nature, and then highlight how Corewell is unique or differentiated from those other deals that you've done.
Sure. So on these ambulatory programs, more often than not, the health system has decided to get out of that business, and they sell that book of business to us. In this case, Corewell wants to maintain some presence in that ambulatory market. They're not alone, right? We have a similar joint venture with UPMC in the Pittsburgh marketplace. We have a joint venture with UMass in portions of the state of Massachusetts. We have a joint venture with the Integris Health System in Oklahoma and in Arizona with the Banner Health System. Okay? So we've done these before. Now, state of Michigan, it's a billion-dollar ambulatory market. We had a book of business in the state that work was being done in our lab in Illinois. They had a book of business, ambulatory business, largely coming from physicians that they owned, but also physicians that were independent.
All of that work being spread among 21 different Corewell hospitals. What we're going to do is build a standalone laboratory. Our book of business, their book of business pours into that laboratory, and it will allow us to go compete for the rest of the state of Michigan. It's a $1 billion market. And I can tell you on day one, when we add our book of business and their book of business, there is plenty of room for growth. And so together, it'll be a joint venture company. Quest will own 51% of that, and that's how we're going to go to market in Michigan.
They'll also benefit from other volume you pick up from other systems.
That is absolutely right. Now, as a partner, they're also an investor in the lab. So capital requirements and things like that are 51% Quest, 49% Corewell. So the ROIC, while we only pay 51% of the capital, we keep 51% of the profit. So you have to think of it in those terms.
There's an efficiency and scale advantage to everyone, I would assume.
Look, there are no independent labs in the state of Michigan, right? We didn't have a laboratory there. Our nearest competitor may have a small reference RRL, I don't know, but this will be a significant laboratory in the state. There's other big health systems and other large groups of independents that we will target to grow that business now. Now, in addition to that, we have a co-lab agreement where Quest will be running the 21 labs inside the hospitals that Corewell owns today on the west side of the state as well as the east side.
That lab, the new lab, the build-out, is 27 that it opens?
The construction starts end of this year, all of 2026, and we expect to open early 2027.
Remind us how that works financially from here till there. Period of investment.
Period of investment, the two teams start to work together. We'll have phlebotomies. The phlebotomy teams come together, logistics come together. But the work in the meantime continues to be done in their lab and our lab. Our book of business goes to our Illinois lab. Their work stays in the hospital as we put this thing together.
Yeah. Sounds very neat.
The co-lab portion of it, though, starts end of this year and hopefully by the first quarter of 2026. Second quarter, all of those labs will be managed by Quest Diagnostics.
How many more of these deals are you going to do?
Hey, we're always looking on the ambulatory side, and we see more and more health systems just choosing to invest their capital, invest their capabilities in the things that are near and dear to their hearts, whether that's neurology, cardiology, oncology, and it just seems like laboratories are at the end of the rope when it comes to incremental capital.
Give us a quick update on LifeLabs. A little different twist there, but it also speaks to your capital deployment strategy, plan, and it sounds like it's been off to a decent, good start, but I'd love to get the update.
Yeah. I think I would use words beyond decent and good. We're very pleased with the progress of the LifeLabs teams.
Feel free to choose any adjective, adverb.
First of all, terrific team. Great leadership team up there. It was the largest independent lab in Canada, grew nicely under their own leadership. And that leadership team has largely stayed intact. So very happy with that. The synergies, which are largely on the laboratory side, first of all, there's no laboratories that come out, right? You are not moving specimens from north of the border into the U.S. The synergies are more around things like capital equipment that they use, equipment that we use, supplies, cost savings, right? We are the largest procurement company in lab supplies, lab equipment. So they're buying off of our contracts. There's some know-how synergies, how we run PSCs, how they run PSCs. And by the way, there's been some reverse synergies. We've learned quite a few things from them that we've implemented.
And then obviously, they were sending tests out to various parties, tests that they couldn't do in those labs, and some of those tests now get insourced into Quest. So we become the reference provider to them.
Maybe we finish two and a half minutes here. Maybe we finish. Of course, I can always ask about cash flow and balance sheet and what you're going to buy next, but you're making some pretty big internal investments. I'd love to hear not only what those are phasing, but also how they impact numbers near and long term, so Project Nova specifically, and you can expand beyond that. I know that's not the only thing that you're doing, but Project Nova would be great to get an update, 250-310, I believe, of investment over the next few years. Certainly a chunk to absorb, but also leads to some good outcomes, so give us that.
Yeah, and just to characterize that spend, it's all cash, but about 60% is expected to be CapEx, 40% operating equity.
It won't all impact the P&L of the company.
It won't all impact the P&L, and we've had a capital budget. We expect to work that largely within the capital budget that we've established. Look, what it is, is it's a redoing of the entire system architecture from order to cash. As you know, there's a physician journey along that path, a patient journey, and then the specimen moves along the path, but obviously information has to flow. So it's the systems that run our patient service centers. When patients come in, orders have to flow into that electronically into that patient service center, and then that information needs to flow to our laboratories. Our laboratories all have, in the manufacturing sense, an MRP system. We call it an LIS system.
While the regional labs have been largely standardized over time, our esoterics have other third-party laboratory information systems, which require, when you're moving specimens from a region to an esoteric site, some re-accessioning. So that architecture is going to be completely redone. It will help patients interact with us. It will help physicians interact with us, and it will allow us to retire a lot of on-premise legacy systems that were written in COBOL, in systems that were developed when you and I were in college.
Or, yeah, maybe earlier.
Or earlier.
Maybe before.
Maybe even before.
They were wearing jams back in the day.
We'll have a partner in this endeavor. We'll announce who that partner is within a month or so, but we're really excited about this.
So does everything transitions to one LIMS or LIS system?
Everything will be one LIS system, but as importantly, if you've used MyQuest, when you make appointments, getting your results back, that entire patient experience is going to be streamlined as well. So we're really excited about the transformational capability that this is going to give us.
Okay. We hit time. I didn't see a Q&A from the audience on the iPad, but I don't know, maybe in one sentence or even one word, level of excitement here, one to 10?
Yeah. Look, I'm always an optimist, so I'm always an eight or nine about this industry. Yeah, there's some things on the government side. We've dealt with them in the past. We'll continue to deal with them. The underlying utilization drivers are not changing in the short term, in the medium term. Laboratory testing is an essential part of healthcare. It leads to 70% of all the decisions physicians make. We're here for the long run. Utilization trends, there'll be new discovery, new insights, new biomarkers, and that's why we remain bullish on the industry and obviously our own company.
Really appreciate the update.
Yeah. Good. Thank you, Eric.
Thanks again. All right. Everyone, please join me in thanking Quest.