Presentations from the 34th Clinical Meeting of the AAGL Advancing Minimally Invasive Gynecology Worldwide held November 2005 in Chicago, IL, USA
AUB Treatment Options and Their Effect on Practice ManagementTed L. Anderson, MD, PhD, FACOG
Associate Professor of Ob-Gyn
Vanderbilt University Medical Center,
Nashville, TN
Well, thank you very much. It is great to be here tonight to talk with you about endometrial ablation.
As a result of trying to look for alternatives to hysterectomy and the treatment of abnormal uterine bleeding, we began to see the development of endometrial ablation back as early as the 1970s. That technique was refined over the years, hysteroscopically using a variety of different energy sources, but there were a number of problems that were uniform regardless of what kind of energy source was used. For example, this was very skill dependent.
Certainly not in this audience, but if we look worldwide, only about 10% of gynecologists feel comfortable doing resectoscopic treatment of endometrium, and it does require general anesthesia. There are risks associated with that; risk of fluid and electrolyte imbalances, perforation and hemorrhage. In an effort to try to overcome some of these difficulties and make this technology available to more and more physicians, and more and more women, we saw the advent of the Global Endometrial Ablation. The entire cavity could be treated at one time and not really require the skill, but yet try to attain, the same effectiveness of the resectoscopic endometrial ablation.
In fact, with the NovaSure, here are the three year follow up data from the FDA trial, and you can see that the success rate in reducing abnormal bleeding at least to normal bleeding was very, very high in these patients. They compared quite comparably to that of the Rollerball.
If you looked at amenorrhea rates, this was the first trial in which the experimental tool, that is the NovaSure device, actually exceeded that of the control, which was the Rollerball.
And these data actually even continue after five years. You can see this slide is a depiction of both the success rate, and the amenorrhea rate, in patients over a period of five years with the NovaSure Endometrial Ablation device. It was actually quite effective.
A couple of secondary endpoints that were looked at that were a little surprising. And that is the effect it might have on PMS and on dysmenorrhea. You can see here that both with the NovaSure and the Rollerball there is a substantial decrease in PMS-like symptoms, and there is a tremendous decrease in dysmenorrhea. Although this was not developed as a treatment for PMS or dysmenorrhea, it does certainly offer some real benefits to those patients.
When you describe all of this to patients, it is not surprising that fully 50% of patients, when they understand all of these features, really prefer an endometrial ablation as their first line therapy for abnormal bleeding. In fact, nearly 70% of patients prefer hysterectomy as their last resort. I think that that is appropriate.
So, what effect is this having on the number of hysterectomies that we are doing every year? Dr. Purdon showed you a slide earlier about the number of hysterectomies that are being done in the United States, and it really has not significantly changed over the years. However, I would submit to you that even though the absolute number of hysterectomies may not have changed, our population is aging. Therefore there are more women in that category that might be considering a hysterectomy as one of their alternatives. The fact that we have more people in that population but are keeping the same number of hysterectomies, I have to interpret that as we are doing a little bit better at actually using alternatives. We want to look at these 120,000 hysterectomies per year that are due to just abnormal uterine bleeding. No real organic cause that can be detected.
Are we really making a dent here? Here are some data looking at six-year follow up in the ability to avoid hysterectomy. Interestingly, in this particular study, you can see that after six years, nine out of ten women who had an endometrial ablation for abnormal uterine bleeding were able to prevent having a hysterectomy. So it actually does in fact prevent hysterectomies.
This is that same slide you saw from the British Medical Journal earlier, showing in fact a decrease in the hysterectomies performed in the UK. So we are having some benefit by the endometrial ablation in reducing hysterectomies.
However, still, of those women who get surgical treatment for abnormal uterine bleeding, a very small percentage is getting endometrial ablation. Less than 20% of women who have surgical management are getting an endometrial ablation.
There are about four and half million women out there who are getting no therapy at all, we have to ask; why is this? What is it that causes people not to get therapy or to get older, less advanced technology, more invasive technology? Well certainly there are women out who are not getting treatment because they have fertility concerns, because they have had experience with past ineffective therapy, they have just resolved themselves to "well, it's just going to be like this until I go through menopause". Many women are still unaware of alternatives. I am amazed every day of the number of women who come into my office with abnormal bleeding whose physicians have not told them about endometrial ablation.
A lot of women still do not recognize it as a problem. And unfortunately a lot of us, a lot of physicians, do not recognize this as a problem. So there are a lot of impediments.
The reasons for low utilization of endometrial ablation include just a perception that bleeding is normal; either by us or by the patient. Certainly patients are unaware of alternatives, and there are patients who do not seek therapy because they are afraid that the only option given them will be that of a hysterectomy.
You know a lot of women when they have abnormal bleeding will go see their gynecologists, but many women will go see their internist. I have found over the years that a lot of those women who go see their internist are those women who do not want a hysterectomy. That is the one thing their internist cannot do. So, develop good relationships with your internist because it has also been my experience that internists hate women who bleed. They like to send them to gynecologists. You can offer them wonderful options, especially if you let them know they are not going to be getting hysterectomies in those cases.
A lot of patients will come to you because they prefer definitive therapy, especially women who have been treated with lesser effective therapies in the past, and they are just tired of things that do not work. They are a little bit less receptive to alternatives. By the time they come to you they just want it out. That certainly influences the patient's perception of what is available.
Finally, there is the provider experience with past technology. A lot of us have had maybe bad experiences with certain kinds of technology that is out there and available, and that certainly influences your willingness to try newer technologies, and certainly influences your willingness to be more aggressive or assertive in the application of that technology into your practice. That is where evidence-based medicine and the data can really help you.
How do we go about improving utilization? What is it that we can do that will help us offer endometrial ablation and provide this technology to our patients in a better way, a more effective way, and have a greater impact on reducing hysterectomies? Well, certainly we need to recognize and diagnose bleeding. That is the number one thing. We cannot treat it if we do not recognize it. We need to also recognize the impact that this bleeding is having on our patients' lives. Once that becomes real to us, then we can be more aggressive and assertive about treating that.
There also needs to be more awareness of treatment options by women. That may be through our own education to women. It may be through limited direct to consumer marketing. There are a variety of different ways that this can be done through education. But our patients need to be more aware of the alternatives.
I think that we need to be more willing to accept these technologies as appropriate for first line intervention, and well studied, well evaluated, appropriately selected patients. As that is more and more available in an outpatient setting, then that allows us even greater options of offering this to women.
I would like to go over a new perspective that I think you may not have seen before. This was very eye opening to me as I began going through these numbers. But I want to do a little bit of comparison of hysterectomy vs. medical therapy vs. ablation.
All of you know most of this. If you look at the caveats of medical therapy, certainly there are a lot of women out there who cannot take medical therapy. It is not an option because of their age, and their co-morbidity; smoking, hypertension, over 35 and side effects, which are occasionally worse than the problem they came in for. There are on-going costs to the patient every year of birth control pills, largely an environment where their insurance companies are not paying for those. And then reimbursement to you as a physician is somewhat limited as well. We have to be realistic; we have to keep our lights on, right?
Now, what are the advantages of ablation therapy? Really, there are very rare contraindications to ablation. No drug interactions that you have to worry about, no additional medications to monitor, or to keep up with. You actually do get paid a little bit better, more proportionately to the amount of work that you perform when you do an ablation. And, if it does not work, you do still have other options available to you. So, it is a good introductory therapy.
What about hysterectomy? There are caveats to hysterectomy; it is an in-patient procedure and there are risks, and morbidity and mortality associated with hysterectomy. It requires general anesthesia, and this is especially more complicated as your patient becomes more medically complicated.
And then you have to go on round of these patients for two or three days while they are in the hospital, certainly with traditional abdominal hysterectomies. I know many of you in this audience are using minimally invasive hysterectomies; and laparoscopic supracervical hysterectomies, and the like, but still there is morbidity associated with that. You have to recognize that as a potential problem.
Again, on the other hand, endometrial ablation offers a very safe alternative with rare contraindications. Usually a general anesthesia is not required. It is ideal for the medically complicated patient. So it is very, very good for this patient population and very low post-op complications as well. If it does not work, then you always have hysterectomy as an option as well.
Now this is a perspective I want to go into a little bit. I want to tell you at this junction, and I know that Dr. Purdon said this earlier, but I really want to tell you now that what I am about to show you here is entirely my opinion. This is not provided to me by anyone. But it was kind of an eye-opening experience when I saw this.
Let's look at the cost of providing these services. And these data that I am about to show you actually have come from the Medicare website.
This is the website that I am showing right here. When you go to the website, this is what you are going to see. I have taken these data that I am going to show you from right here. You can just click on this it will take you right to these fee schedules. You can simply look up your code of interest and it will tell you what the Medicare fee is. In order to give you a kind of relationship to Medicare, what your payers do, we are not going to go into all of the individual fees. We do not want to get into any Sherman anti-trust problems, this is the published Medicare fee schedule.
There are many components of treating these patients you have to take into consideration. Certainly first you have the consultation with the patient. Is this a consult? Is this a new patient? Is it an established patient? How, in fact, do you code for that?
Furthermore, how are you going to evaluate the patient? I would tell you that you need to do a transvaginal ultrasound and an endometrial biopsy as a minimum. But there certainly are other options as well; saline infusion sonography, you also get paid for the guidance of that infusion. Hysteroscopy is certainly another option. There are a lot of different ways that you can evaluate these patients. The question then becomes, when do you do that? We have been in this habit of one-stop shopping where all we hear is "well let's just go ahead and do the biopsy", "let's go ahead and do the ultrasound", but the truth is, if you do that, you are getting paid less for it than you do if that patient comes back, right? You have to take this into consideration, that timing actually is critical.
Let's look at this. Here are the fee schedules, right off the Medicare website. This offers a minimum. Here is your procedure; I just took an average consult, level three office consult. Here is your work, RVU. Here is your practice expense, RVU. Malpractice RVU, and then your non-facility total. Multiply that by the reimbursement, this is the dollars per RVU, and you can see the reimbursement for these various different procedures. This is your minimum - office consult, transvaginal ultrasound and biopsy. When you do that you are going to get reimbursed about $335 for doing the evaluation of this patient in this situation.
Now, if instead of that transvaginal ultrasound, you actually put a catheter in, infused some saline, and did a saline infusion sonography; perhaps the cavity is a little bit irregular and you want to see if there is a fibroid or a polyp, your reimbursement goes up substantially. So you actually get reimbursed much better for that. Now your reimbursement is closer to $500. That same evaluation, just a little bit of saline, is the big difference here, and then of course, the interpretation.
If you go this next step and you are doing hysteroscopy, office hysteroscopy for example, then that adds to the reimbursement figure, and increases it. Now you are getting a little over $600 for that same patient evaluation.
I am not telling you that you need to do this in order to increase your reimbursement. I am telling you that you need to know that the level of work you put into the evaluation of that patient is compensated. You need to think about that. Of course, you need to let the evidence drive your decision about which of these techniques you are going to use, but you need to be aware of how much the reimbursement is for these various different procedures.
So let's go back and look at that patient now that we have evaluated from a medical therapy standpoint. For our initial evaluation of our treatment of that patient we are getting somewhere between $335 to $662, depending on how we have done our evaluation, and when we have done our evaluation.
Once we have made that evaluation now we have to decide what procedure we are going to do in order to treat that patient. Is it going to be a hysterectomy? Is it going to be an endometrial ablation? And where are we going to do this procedure? Let's look at hysterectomies.
Many of you probably will not be surprised to know that regardless of whether you do a total abdominal hysterectomy, a total vaginal hysterectomy with a BSO or an LAVH, your reimbursement does not vary hugely. It really does not vary much at all.
For purposes of this talk, I have taken an average amount here and given us $904 - $905 for this. So, you are getting about $900 for your hysterectomy.
So if you go back and you add your consultation and your evaluation, and then your hysterectomy, your surgical procedure, you are getting about $1200 to $1500 for the evaluation and management of that patient in total. In fact, that takes care of the surgical procedure, the peri-operative management, the phone calls and everything.
Let's look at a hysteroscopy with endometrial ablation. Your reimbursement there is about $350 or so from Medicare.
You go back and add that with your evaluation and now you are getting about $700 to $1000. You are thinking will this is supposed to be a talk about endometrial ablation, is this guy nuts up here? What are we talking about?
Well, the question really is not what you are billing; it is irrelevant what you bill. In fact, I would submit to you that it is irrelevant what you collect. What is really relevant is how much does it cost you to provide that service? And, what is your time commitment, because that is valuable too. That is the only commodity you really have. So, let's look at it in this light.
If we look at an endometrial ablation you are talking about a half hour commitment. Usually it does not require a pre-certification because it is an outpatient procedure. Operative and operative support time is about 15 minutes. Dictating, getting the writing orders is another 15 minutes, so about a half hour.
If you look at a hysterectomy, an abdominal hysterectomy for example, operative, support time, getting your pre-certification, getting your patient admitted about 30minutes. Operative time is anywhere from 60 to 90 minutes, depending on the difficulty of your hysterectomy. And then you have got a round on this patient for a few days, and that adds to the time, so, I have estimated about three hours for this.
Let's look at this, for an endometrial ablation you are getting reimbursed about $366 for a half hour commitment that comes out to about $732 per hour. On the other hand if you look at a hysterectomy, you are getting reimbursed about $905 for a three hour commitment, which comes out to about $300 an hour. That was pretty eye opening to me.
An office hysterectomy now has a new practice expense added to that so you can actually recoup the cost of doing this in the office. You can see how I have compared the costs and reimbursements of doing this in a facility vs. reimbursement of doing this in your office. Look at the difference. It is pretty huge, over $2300.
Even if you take this $2300 and subtract that $950 for the device, and you estimate about a $100 for your disposables and drugs, what-have-you, and I feel more comfortable having a CRNA there, and I am paying that CRNA about $250 per case, my effective reimbursement at this point is still over a $1000.
So let's go back now and put that into our equation. We have endometrial ablation, getting about a $1000 reimbursement for a half hour commitment. That is over $2000 an hour. Compare with our hysterectomy, which is $302 per hour.
Added into that, you have to take into consideration where you are doing it, patient flow, and the follow up. You have this little thing called the global interval. Global interval means that included in that reimbursement will be all your care of that patient for related events that are part and parcel of that procedure that you performed.
In fact, with a hysterectomy that is 90 days. With endometrial ablation that is zero days. So, if you see that patient back tomorrow, it is a new visit.
Also, if you are doing this in your office it has an effect on patient flow. You can do this integrated into the normal flow of your office. You can be seeing annual exams, doing other procedures and seeing other patients at the same time that your staff is getting the patient prepared, getting the patient out the door, and ready for your next endometrial ablation. You are not even leaving the office. It really increases your efficiency.
The patients are also more comfortable because they are in a setting that they are familiar with, and that they are comfortable with, with people they are comfortable with. They are more likely to tolerate it better and have a good outcome at the same time.
Endometrial ablation does have a significant potential for impact on the hysterectomy rate. We have to recognize that abnormal bleeding is a common problem for women. We have to recognize that endometrial ablation is, in fact, a safe and effective treatment for women. It is minimally invasive, and minimally intrusive on their lifestyle. The technology can be offered by more physicians to more patients these days in a safe manner. This, in fact, can be offered in a very cost effective, cost efficient and fiscally sound method in your practice, particularly if you are doing it in your office.
This can be done either in an outpatient setting, or in your office setting.
I thank you very much for your attention.