"You should not have to protect yourself from your doctor."
This week the New York Times ran an article that exposed a predatory network of medical device companies bankrolling private clinics and paying doctors to perform procedures on patients with peripheral arterial disease (PAD). Many patients received procedures they did not need for a condition that doesn’t often require surgical intervention.
Some people in this story received over a dozen procedures on the same leg in one year. One woman twice in two weeks. This practice was so damaging that they all needed their limb amputated. A leg that was never in danger of amputation in the first place.
We sat down with vascular surgeon Nicholas Morrissey, MD, to discuss how device companies can exploit and, in turn, harm patients through funding willing bad actors. In this conversation, Dr. Morrissey explains how the healthcare system and insurance billing can foster overtreatment from the profit-driven, and how treatment for PAD should work.
Let’s start with the condition, peripheral arterial disease (PAD). What is it, and when is it considered advanced?
You may have PAD, you may have blockages in your arteries, in your legs, and you may never need anything done about it. People come to me with 100% blockage of one of the arteries in their legs and they have no symptoms.
It's not like the heart, where if you're blocked, you really should open it up to prevent a heart attack. If you're blocked in the leg and you don't have symptoms, the general principle is to leave it alone. There was one patient in the article that said they actually came to that doctor with no symptoms. That's really problematic.
Now, the symptoms can be pain with walking, right? We'd call that claudication and it's a very simple concept. When you walk, you get cramps in the muscles, either in your thigh, your butt, or your calf. And it only happens when you walk or when you use your muscles. And when you stop, that pain goes away. And it's important to understand that it’s what we call non-limb threatening.
In other words, if you left that alone and just did things like risk factor modification, helping people quit smoking, control their sugar, and control their blood pressure, if you did nothing on those patients, most of them would either get better or stay the same, and definitely not get worse.
Is that what a lot of people in the article had, claudication?
Yes. And we, in general, don't intervene on them until they tell us, "I've tried everything and I can't walk. My life is miserable." Then it's reasonable to do an intervention and to try to open up the arteries to get them walking better. But make no mistake, the vast majority of those people, if you leave them alone, will not get into trouble, will not lose their limb.
I say to patients with claudication, "You will tell me when we're going to fix it. I'm not going to tell you."
Is that because the interventions are risky or lead to more intervention later?
Well, we say that you can always do harm to people anytime you touch an artery. Anytime you touch an artery, you're starting an inflammatory reaction. So, once you open an artery with angioplasty [a catheter-based non-surgical procedure to open blocked or narrowed arteries], there's a risk of what's called stenosis [when a valve narrows and blood cannot flow properly], and that can lead to failure of your intervention. And sometimes, it can make the patients worse afterward.
So, we have to really be cautious about intervening because we can actually make somebody worse. And you don't want to take somebody who is non-limb-threatening and then turn them into a limb-threat situation. And that does happen if you start to intervene on people a lot, like in this article.
Will you explain atherectomy? When is it necessary?
It is a technology that works well. When stents get clogged up with scar tissue, it can really be successful in cleaning that out and allowing the blood flow to resume. I think this happened because of the way that reimbursement has been set up, which takes place at the government level, at CMS [Centers for Medicare Services].
If you're in an outpatient center, which is what they're talking about in this article, and you own the procedure room and you do an atherectomy, the amount of money you get paid is really tremendous. It's a lot more than if you just do an angioplasty or a stent. Whereas in the hospital, you don't get paid as much. The hospital gets most of it.
So, there's an incentive financially to do atherectomy in the outpatient setting because you get paid a lot for it. And right now, there’s no limit on the number of times you can bill for it. It's a good technology and it works really well for a lot of people. But there are studies that have shown that if you analyze patients getting procedures in the office-based setting versus the hospital, you're more likely to see atherectomy done in the outpatient setting.
If you look at some other countries like Canada, where it's not a fee-for-service model, the interventions for claudication are dramatically lower than what we do here.
The article stated that when Medicare began paying for outpatient atherectomy in 2011, they reimbursed $86 million to doctors. In 2021 it was $612 million. So even within this for-profit system, outpatient centers can have an outsized profit motive.
Right. There’s definitely incentive there based on the way Medicare and private insurance pay for it. Having said that, we use it here in our outpatient lab. But we use it in the cases where we really feel like it's indicated. And not to say that academic medical centers are the greatest thing in the world, but we're very thoughtful in terms of making sure that when we're employing a technology, we're doing it when it's really indicated.
I think even in the vast majority of these outpatient centers that we're talking about, the people doing the procedures are driven by the same motivation we are. There are outliers and there are bad actors, and those are the ones that are going to get articles written about them.
So even in the outpatient setting, even with atherectomy generating more revenue, I think the vast majority of practitioners are ethically on the right side of this, and they're doing it for the right reasons.
Are there ever situations where you would perform an atherectomy on someone multiple times in quick succession?
That sends up red flags. Some people have commented that this is a sign of when you should question your practitioner about what's going on—when they're doing the same leg twice in two weeks. One patient they talked about had 14 interventions on one leg.
I think it's very difficult for patients because often, their initial response is not to go seek another opinion, not to question their doctor. We're fortunate in our profession to have earned centuries of respect from the people that we're supposed to be caring for. So unscrupulous actors may not be called out by their patients, but we have reached the point where patients and their families have to really advocate for themselves. And I think there are simple ways to do that.
How would you recommend patients advocate for themselves?
Off the bat, what struck me in that article, anybody who's getting half a million dollars a year from a device company is exquisitely problematic. Basically, I think they're paying these guys to use their device. They put it under the idea of ‘education’, but $467,000 that one guy got from one company before billing…that's more than 99% of the country makes in a year. It's really problematic.
The first thing anybody who's getting treated for PAD should ask their practitioners: Do you get paid by any companies for the work you do in vascular? It's a simple question and they have to answer yes or no.
The other is a website developed through the Sunshine Act. Anytime a company pays a doctor for anything, it gets reported. So, you can look up your doctor through Open Payments and find out how much they get paid from any given company.
Are there additional things you can look for before you schedule an appointment? Say, types of advertisements or language that may be suspect?
You don't necessarily want to go to places that advertise heavily. Our institutions have websites, but the clinics in the article have websites for amputation prevention. If you have claudication and someone intervenes on you to make you walk better, they didn't prevent you from having an amputation, you weren't going to have an amputation, to begin with.
Anytime somebody's website or advertising is sponsored by a company, we need to be really suspicious of it. And again, patients shouldn't have to be doing this research, but I think it's reached the point where they should. Simply ask questions of the practitioner, "Do you get paid by any companies whose devices you may use when you treat me? And if so, how much?” And if they’re not willing to be open about those answers, then you should go someplace else.
How often would you recommend someone get a second opinion?
We have a robust second opinion system in this country. And I would venture to say that most people who are recommended to have an intervention on their legs or any arteries would benefit from getting a second opinion. And again, not to say that academic centers are the greatest in the world, but I would lean toward getting it done in an academic center. There's a reason why people dedicate their lives to teaching students and residents and doing research. Any clinician who really believes in what they're doing will never be afraid of a second opinion, ever.
In the article, they explain that a lot of these patients were referred by their primary physician or someone they had seen before. Are these device companies helping build up this referral base?
Yep. They have these little get-togethers and they'll feed internal referring doctors at a dinner. Here's “the leg saver,” and this is what he does...Oh, by the way, dinner's paid for by the company that does atherectomy. Come have a steak and then I'll give you my cell number and just send all your patients. I'll take care of them.
I like marketing in the sense that I like people to know what I do, and I'd like to build my practice. But when I do that, I am doing it not with the idea that I'm going to use a company’s device every time that they come.
It really seems like the impact and influence these companies can generate is a massive issue, and, frankly, quite dangerous. Philips had a quote from “the leg saver” on their own website referencing that they helped him find his office building.
I happen to work with Phillips. I don't get any money from them, but they make some of the devices that we use. And I will tell you that from a corporate standpoint, a lot of this stuff is regional and local. In other words, it's the folks in the field that are allowed to have some leeway to do this.
I think these massive companies could have stuff happening at the local level that they're not necessarily fully aware of. That doesn't mean that they shouldn't police their website and aren’t responsible for it. But I was talking to my Phillips person the other day and we have a good relationship. I use their stuff when I need to use it and not when I don't need to.
Right. And interestingly, this was exposed by a vascular surgeon who reported the surgical repairs and amputations she had to perform on patients rushed to the ER after all these unnecessary interventions.
One of the things to keep in mind is that the people really vilified in that article are not vascular surgeons, they're cardiologists. So, in their training programs, as interventionalists, they do legs, they do aneurysms sometimes, and they do carotids, so they may get credentialed. They are trained to treat arteries. I don't want to cast aspersions because we work with them here, and they're terrific.
I have a lot of colleagues around the country who are interventional cardiologists who really specialize in lower extremity stuff and do incredible work. I learn from them sometimes, they're so good at what they do. And they're ethically above board. This is not a question of one specialty being on the right side of history and one not. It just happens that the ones that are vilified in this article are interventional cardiologists.
And this article was written finally because all these patients ended up in the emergency room, and this vascular surgeon had to clean up the mess. These outpatient centers, they're not attached to hospitals. If they have a big screw-up, their patient ends up in another hospital where someone else, someone like me who's not getting half a million dollars from a device company, must clean up the mess. And that doesn't happen infrequently. It's a common scenario.
There was a lot of focus on the doctors, which makes sense, of course, but do you think the device companies will be held accountable?
I feel like, in a way, this type of article is going to focus on the practitioners because they're identified, but the corporate machinery that drives this will probably come out unscathed. And that’s an issue because paying for procedures has been going on for a long time. It’s not just PAD.
That’s such an important point. It’s the healthcare system at large.
It's so true. Hopefully, these types of articles push outside agencies to get more involved. We do a good job of keeping ourselves ethical and doing the right thing, our societies demand the highest from their participants. But there are people that work outside the realm. At some point, maybe you can't pay for 15 interventions on somebody.
I've always said that Medicare, UnitedHealthcare, they should all have a system in place to grade the practitioners based on how they perform, not just their outcomes, but how many times they do a service and how likely are they to be doing things for the right reasons and whatnot. I think if you get onto the list of people who are clearly on the right side of things, then your requests will go through without being looked at so closely. But if you're someone who's done 12 procedures on the same patient, yeah, maybe you should be flagged as ‘Tell me exactly why this patient needs to go back to the operating room.’
I wish it wasn’t necessary to say, but the things I mentioned can help people do a better job of protecting themselves from these kinds of situations. You should not have to protect yourself from your doctor, but sometimes you have to.
We strive to do better all the time. And I think, as an institution, we do. As I said, even though this article kind of focused on a cardiologist versus a vascular surgeon, here at Columbia, we happen to have people in both specialties who do really good work and have a great working relationship together.
This conversation was about the New York Times reporting They Lost Their Legs. Doctors and Health Care Giants Profited. published 7/15/23.
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