What Not To Do In Venous Disease Treatment: A Round Table Discussion

Taking stimulus from VEIN Magazine’s earlier roundtable on the topic of ethics of venous disease treatment, “Absurd Vein Care: Can We Fix It?,” vascular surgeon, AVF founder and one of the most respected venous experts in the world, Bob Kistner, conceived of another topic for discussion. “It struck me that improper practices is something that we all see. Industry leaders have done a lot of good work with guidelines to help physicians who want to do things right. However, we have not at any time taken the exercise to identify things that should not be done,” he says.

Identifying the need to help guide physicians—particularly those who come into the field without a lot of background—away from improper practices, Bob undertook the exercise of creating a “list of don’ts.” To this end, VEIN Magazine invited some of the most experienced people in the field—Drs. Lowell Kabnick, of New York University; Jose Almeida, of Miami Vein Center; Steve Elias, of the Center for Vein Disease at Englewood Hospital; and two non-physician experts, Joe Zygmunt RVT, RPhS with Medtronic Vascular, and AJ Riviezzo, CEO of American Physician—to join him in a spirited discussion of what improper actions they are currently seeing in the field.

By making this list, the panel hopes this list will help those who do procedures and those who pay the bills understand that these things are off base. They should curtail reimbursement for such practices and discontinue the routine practice of maximizing income through shortcuts and improper and unnecessary treatments.

The conversation covered two primary areas: ethics and education. The resulting list is intended to appeal to those who know better but are stretching the boundaries of good vein care, as well as those who do not know better and who, despite their best intentions, have lost their way along the path—perhaps due to a lack of proper training.

This discussion was about superficial disease. Deep disease will be a whole other roundtable discussion. After an hour and a half conversation, and many more hours of thought and deliberation, our panel put forward the following list of what not to do in your vein practice.

1. Don’t treat a vein just because it has reflux, be sure there is clinical correlation

Bob: It’s not clear to me. I don’t think I’ve ever seen it in print, what extent of reflux would warrant an ablation versus one that would be treated by sclerotherapy, or treatment of the peripheral veins, and not warrant ablation of the GSV. That bothers me a great deal because one can exhibit a small focal area of reflux in the GSV and ablate the whole thing, and that is an improper thing. That’s not stated anywhere, so it may be that we haven’t given ourselves proper guidelines or proper communication about what really warrants an ablation.

Lowell: We’ve talked about the amount of time it takes for reflux, location of reflux, and size. The insurance companies set it at the start of the saphenofemoral junction, and we all know that that’s probably not true. It has to be a certain size, and that may or may not be true, according to some of the pathophysiology.

We all have done consults on patients who have come from another doctor who indicated four vessels of disease in one leg; yet, when you do your ultrasound, you demonstrate no reflux. If ultrasound is the diagnostics that the interventionalist relies on after considering other parts of the constellation, then how do we determine the accuracy of the test?

Jose: We’ve all seen in our practices that segmental reflux, either at primary disease (virgin leg) or in follow up, is often asymptomatic and don’t need treatment, they just need follow up.

I think the key point for venous practice is that you should follow your patient. Just because they have some segmental reflux now, doesn’t mean they won’t open up later and need something in two years. But that doesn’t mean they need something now. Maybe that could be some type of direction for guidelines without any real, empirical evidence to answer the question that you’re asking.

Bob: Maybe this isn’t the place to try to solve the answer, but to identify the problem.

Steve: There are multiple components that come into the picture as to who should have an ablation and who shouldn’t. One data point, either reflux volume or reflux time or size of vein, doesn’t in and of itself say whether someone needs an ablation or not. That’s where the problem comes in regarding vein disease. We don’t have one or two particular data points to hang our hat on to make a decision whether or not someone would benefit from an ablation. The treatment of vein disease is a Gestalt; multiple data points come into your decision process.

Lowell: We don’t have real objective criteria or findings for C-0, 1, and 2, like we do for 4, 5, and 6. That takes some of the guesswork out for us on the upper end. It’s the bottom end that we’re having issues with, and nobody knows whether we really need to treat those patients. We know that only about 20% of those patients are going to progress to C-4A by the Bonn study. That being said, what do we do? As Bob said, I don’t think we need to clarify that, but we should all agree on what we shouldn’t do.

2. Don’t treat four vessels habitually or in C1 disease

Lowell: Can we agree that if somebody has C-0, C-1, C-2 disease that you shouldn’t be ablating four vessels in the same leg?

Bob: If you’re going to have an agreement, it ought to be something less than universal because there’s always an exception.

Steve: What percentage of patients in a practice should have four veins ablated all the times? Perhaps 5%. We’ve said for C-0, C-1 disease, probably don’t ablate the saphenous axial incompetence. What percentage of people do we think need more than one vein ablated for C-2 disease?

Jose: For C-1 disease, can’t say all, but the majority don’t even need an ultrasound, and the majority definitely do not need an ablation. Even C-1 with a little bit of reflux, if they happen to get an ultrasound, still doesn’t need ablation.

Steve: Exactly. If I’m doing an ablation for a patient who has varicosities and spider veins, you ablate the saphenous. Yes, the varicosities will be impacted many times, but the spider veins, almost never.

“People make claims that taking care of the saphenous vein will help cure the spider veins. They use words like “cure.” I think that may not be fraud; it may be miseducation. If we can put that out there, that would help a lot. There’s a lot of C-1 disease getting four vessels fried. I see that every day.”

Jose: People make claims that taking care of the saphenous vein will help cure the spider veins. They use words like “cure.” I think that may not be fraud; it may be miseducation. If we can put that out there, that would help a lot. There’s a lot of C-1 disease getting four vessels fried. I see that every day.

Steve: It’s hard to say the number of patients who need more than one or two vessels ablated in a single leg for C-2 disease. What are the guidelines that we should say to the insurers and to us and society; you’d better think twice about this doctor or this organization, they’re ablating two or three vessels on one leg for C-2 disease?

Joe: The challenge with your question is that we don’t have the data. It’s one of the things I’m hoping will come out of the Registries that have been started by the AVF and ACP.

AJ: Doing all the billing for multiple practices, where I really get nervous is when I start seeing a consistent pattern of both GSV and both SSV almost every single time. Whether they had the anterior accessory ablated or not is almost immaterial at that point.

Bob: It all depends on what’s wrong with the vein and what the symptoms are. One thing I think we should be able to agree on is what was already said: If you find four or more refluxing truncal and/or perforator vessels that require ablation as a more than rare occurrence in your practice, there is something wrong with that practice.

“There is nothing in the literature that helps us with not the degree, but the length of reflux. We’re looking at just one item. The reality is that it’s a constellation of symptoms, findings, and duplex findings. Even if you had rip roaring reflux of the great saphenous vein and you had no symptoms, there would be little, if any, indication for intervention.”

3. Don’t do prophylactic ablations

AJ: Everybody is getting cracked down by the payers for prophylactic treatments.

Bob: Prophylaxis of progressive disease by ablating normal veins is one practice that we should say that we don’t have supporting data for.

Steve: We have no data. We have zero data.

Bob: That’s a good point to include in the “list of don’ts.” Steve: For C-2 disease, there is no data that says you need to treat it now because something terrible is going to happen five, 10 or 15 years later. Don’t ablate a great saphenous vein from a prophylactic viewpoint in C-2 disease to prevent problems in the future.

4. Don’t ablate GSV without report of reflux in GSV

Steve: You can’t ablate a saphenous vein that does not have a report that it is significantly incompetent. Even if it is, you still need the correct constellation of symptoms.

Lowell: As Bob said, there is nothing in the literature that helps us with not the degree, but the length of reflux. We’re looking at just one item. The reality is that it’s a constellation of symptoms, findings, and duplex findings. Even if you had rip roaring reflux of the great saphenous vein and you had no symptoms, there would be little, if any, indication for intervention.

Jose: Dr. Raju published a recent paper quantifying saphenous reflux where he looked at reflux volume, and he has presented at meetings. He looked at duplex measured median time-averaged velocity, duration, and diameter to calculate reflux volume. The bottom line of the paper was that you need greater than 30cc of reflux volume and a greater than 5.5 mm diameter for it to be clinically significant. Then, Davies and Lane published a study stating that saphenous size does not matter. This nidus for this study was to provide evidence against insurance companies’ capricious and arbitrary policies.

Then the Merchant paper from 2002 where they first described recanalization from the sapheno-femoral junction; that greater than 5 cm length of reflux would be clinically significant.

“You should not do an ablation unless you can also manage or have someone you refer to that manages the branch varicosities. One needs the ability to finish the job, if necessary, either themselves or by referral.”

5. Don’t ablate GSV for short segment reflux

Bob: If you have reflux and it doesn’t have anything to do with producing venous hypertension in the area of the symptoms or signs, the reflux is not an indication for ablation. If you’re talking about ulcer disease, one of the really important things is axial reflux directly into the ulcer bed. There is pretty much agreement on that. There could be a minimum limit, so you could say reflux of 3cm, or 10cm, or 20cm in the GSV at the thigh certainly doesn’t warrant sacrificing a saphenous vein.

6. Don’t just treat the portion of the leg you are familiar with (e.g. GSV ablation), but be able to diagnose and treat the whole leg

Jose: The exceeding majority of ablative cases just require one truncal vein ablation and a phlebectomy. It would be nice if everybody could do a phlebectomy. Don’t do vein work if you can’t do a phlebectomy. There’s another “don’t” for you. These massive varicosities we all see ... I believe sclerotherapy is a disservice to these patients; these are best removed.

Lowell: You’re going to get criticism on that because some people just do sclerotherapy and get good results.

Steve: How about this way--you should not do an ablation unless you can also manage or have someone you refer to that manages the branch varicosities. One needs the ability to finish the job, if necessary, either themselves or by referral.

AJ: Sclerotherapy instead of a phlebectomy generates a lot of hematomas that they then bill for. This is inappropriate.

Lowell: I’m involved and hearing a lot of it, and I’m a phlebectomist from the word “go,” but it’s silly out there.

Steve: Sooner or later, sclerotherapy becomes a phlebectomy or an operation, whether you have to evacuate the hematomas. But it should not be billed as evacuation of hematoma.

AJ: Don’t just do the ablation, treat the whole leg.

Steve: You should not be doing an ablation unless you can manage the venous reservoirs by yourself or by referral (e.g. the varicosities). I tend to agree with Lowell. In general, you should be able to manage a disease state, and the exception should be that you can’t manage it. But the goal should be that you can manage it. Phlebectomy is not a difficult procedure. Anyone who has done any kind of procedure should be able to do it.

7. Don’t begin your venous patient care with only an industry or a brief venous course

Jose: Is there any statement we can make on minimal education requirements? Are there really people out there who just buy a box and get a rep to teach them their first case? Is that really what’s going on? They go from there without any CME or anything or any vein course?

Can we make some statement for the purposes of this article so people are at least thinking about it? What is the purpose of this whole IAC accreditation then? Nobody is following any of this stuff.

Lowell: There are no teeth to accreditation yet and we would hope that it would come to fruition.

Steve: Jose, if someone goes to the IVC, what is the maximum number of CME credits they can get?

Jose: They get about 21-22 CMEs.

Steve: Do we think we should say that people should get somewhere between 25 and 30 CMEs in specific venous courses?

Jose: Should we say they should at least attend one dedicated venous meeting?

Steve: I agree with you that people should have attended at least one dedicated venous meeting within the year.

AJ: We almost need to flip it slightly, that if you’re going to be in the phlebology space, be sure to go to at least one meeting, be sure to take advantage of the ultrasound, sclerotherapy, and phlebectomy classes that are out there. Almost from a proactive standpoint, if you’re going to be doing this, do it right.

Steve: I think what we’ve come up with for things you should do is attend at least one dedicated venous meeting within the year.

Lowell: Don’t expect to practice venous disease appropriately by a weekend course or getting a box and having someone in the industry help you.

Jose: Don’t expect to learn venous disease from a mobile ultrasound company.

Joe: Don’t expect your industry education to be your only source of education on venous disease—attend a conference and visit colleagues.

Steve: Don’t expect your industry education to be the only source of the guidelines for managing venous disease.

“One of the big warnings I would put out there is verify what you’re doing. You’re the physician; you’re the one responsible if something were to go bad or is done inappropriately. Further, if you were to have an insurance audit, they’re not going to penalize a mobile ultrasound servicer; they’re going to hold you accountable.”

8. Don’t incentivize the sonographer to show reflux

Bob: There are various reports about the sonographer being instructed to do a bilateral examination in 15 minutes. Joe, are there things in that area that we could agree would not be appropriate, not be allowable?

Joe: A lot of new physicians who are just starting have these “experienced” techs come in—mobile services—and they’re like, “I’ll find reflux in 95% of your patients. We’ll get you busy real fast. We’ll get you making lots of money.” If I’m a doc and I hear that, I would hope I’d run the other way. That would be the advice; I would try to get out of there.

From a sonographer’s standpoint, if you’re getting pressure, if your physician is telling you to go back in the room and find reflux and don’t come out until you do, maybe make an analogy to a carotid exam or something like that. You can’t fake results. You have an ethical and a moral responsibility to do the right thing and hopefully, as a sonographer, that’s what you’re doing.

AJ: I think we need to put the onus on who is responsible for the practice for that read, and that is the physician. The sonographers, some of them feel trapped. Advising them to do something better isn’t going to go as far as we would like.

Steve: Sonographers should be compensated not based on whether they find incompetence or not; they should be compensated because they are doing a good exam.

9. Don’t take the sonographer’s work as absolute, as you are responsible for the sonographer’s accuracy

Steve: I think we need to start with where we get the data from. We get the information as to whether a vein is normal or abnormal from the ultrasound exam. It all starts there. Whether it’s performed by the physician or an ultrasonographer, we can assume problems arise when either: a) people stretch what they call “pathologic reflux” or maneuver to elicit reflux that may or may not be pathologic reflux; or b) people honestly believe the patient has reflux but no one determines whether or not that exam was done correctly.

Joe: Doc, do you know how to interpret studies properly? Have you read the literature about appropriate techniques for diagnosis? What I mean by that is, doc, you’re purchasing services from your sonographer, whether it is a mobile service or an internal person. You are 100% responsible for the quality of that work. Do they know how to do a study? Are they doing it properly? Is it being interpreted properly? Are you interpreting it and not simply listening to what they’re telling you?

AJ: Don’t expect the ultrasound tech to be the physician for you.

Bob: That’s a good point, to define that the physician confirms the sonographer’s reported reflux is real and is appropriate to the patient’s symptoms.

Joe: One of the big warnings I would put out there is verify what you’re doing. You’re the physician; you’re the one responsible if something were to go bad or is done inappropriately. Further, if you were to have an insurance audit, they’re not going to penalize a mobile ultrasound servicer; they’re going to hold you accountable. And you’re not going to say, “The sales rep said this was ok.” Again, Doc, you are the person who will be held responsible in an audit.

Realize that Medicare LCDs require sonographer credentialing for reimbursement. There are many who simply get the credential by taking a course and passing the test, but they’re still the ones that are out there doing poor studies. I know we don’t have a licensure for sonographers right now, but to actually see something happen where there are some techs that suffer penalties and have those be publicized, not in the public community, but in the medical community, to let physicians know you just can’t trust the guy who walks in off the street or who gets put up in front of you as somebody reputable by a sales rep, because the rep is trying to make a sale, right?

Some of these mobile services that are simply crooked, they’ll swear up and down that what they do is right, but you never see them at a meeting or writing an article or printing a chapter in a book or anything. These guys exist on the fringe, and I think we need to warn our brethren as to who and what to watch out for.

Lowell: As we know, RVTs or technicians with similar credentials, interventionalists and technicians know that a reflux test is a very specific test that a lot of people do not know how to do well. There is no standard of judging those people going through and getting their certificates. In combination with accreditation in which the sites are observed as well as the RVT doing the procedure for reflux testing, I think that’s another step where we could ascertain the ability of an ultrasonographer. I have asked ICAVL, if we’re basing a lot of our decision process on reflux testing, how do we know that the ultrasonographers are performing the test well and are accurate?

Joe, you and I have sat on the board of CCI for the venous module. That exam is a little bit more specific for venous disease, although, again, we don’t test the ability of an ultrasonographer performing the test. I think there should be some way of testing an ultrasonographer as to their competency to perform a reflux test.

Joe: The problem isn’t that it’s one of the most challenging exams to perform. The problem is that people have found sneaky ways to falsify things. When you really think about it, most of the time, what an insurance company gets is a dictated report. They almost never look at images, many of which I have seen in audits that are simply “non-diagnostic.” Lowell, you make a good point, a physical demonstration of scanning would be a very helpful testing parameter, although perhaps challenging to implement. I would be in favor of that for sure, kind of like the old oral exams physicians took.

Jose: One way to get to the bottom of all this is to become a significant stakeholder (e.g. Joint Venous Council) that can align with payers. We could review claims-based data and find the outliers. We could make recommendations to centers not practicing within the standard of care—these centers should not be reimbursed until X, Y, and Z criteria are met. It seems like it’s at the endpoint, the payer, where we’re going to have an effect.

Bob: In support of that, I think there are two areas to look at: One of these is the insurance companies who are processing these claims; the other one is the sonographers. A lot of the sonographers are exposed to practices that they recognize are well below the standard, and even sometimes much worse than that. Communication with those people in some way could be a source of discovering how big the problem is. We don’t really know how big the problem is.

10. Don’t believe that just because a patient has varicose veins, the leg symptoms are always venous in origin (sciatica, knee/ hip, lymphedema, obesity etc.)

Lowell: Sometimes it is very difficult to discern whether the patient’s symptoms are truly from the varicose veins or other leg issues. There can be significant overlap. This is where the history is important: type, location, duration, and progression of symptoms. Do graduated compression hose help?

Steve: I agree with you, and good, honest vein specialists let the patients know which symptoms are venous and which are not, and therefore won’t be helped by treating the vein component. The more upsetting thing is that all of us see everyday patients who have varicose veins but whose symptoms are not venous at all. Yet, the MD tells the insurance the patient has daily pain and trouble ambulating and, unfortunately, a reflux exam shows a problem.

I am talking about pure non-venous symptoms of pain, swelling, etc. such as sciatica, knee/ hip osteoarthritis, lymphedema. The practitioners ablating the veins in these patients either have not taken a good history or are abusing the system when they know full well that the symptoms are not venous. A (symptoms) + B (insufficiency) does not always equal C (venous symptoms).

In Conclusion: A Word of Caution

The panel raised concerns about both vein franchises who pressure doctors to meet volume requirements and vendors who tie monthly catheter purchases to “free generators.” Asked for comment on the issue, Joe Zygmunt adds: “I would simply caution not to be too hasty in judgment and understand this better. Most often these have relatively low thresholds and can come with a higher per catheter price as a result. My concern is for any physician who feels pressure to do increasing volume of cases, either for a generator or from their employer.

One of my highest hopes for the registries is that some information is developed on practice norms (e.g. the number of refluxing veins per patient). When you hear that a physician did three separate procedures to ablate the GSV from the groin to the knee, I cringe. This type of outlier will surely show in the data.

Medicine is a higher calling, caring for our fellow man, has ethical and moral responsibilities. Physician judgment should be free from business pressures of volume or revenue generation. Having run multiple practices over almost 18 years, I believe if we treat our patients well, like we would want our family treated if they needed it, the business will follow.”