So, I was assigned to talk about reimbursement and quality metrics. So, we'll go over, and we'd like to hear, because reimbursement at my hospital is different from other hospital, because in Maryland, we know that the – it's really different from other hospitals in other states. So, we would like to hear the experience from other faculty as well. So, this is my disclosure. So, in terms of reimbursement, we have to separate into two parts. One is physician's reimbursement, and the other is facility. For the physician reimbursement, because there is no unique CPT code, it's recommended to use unlisted code. And usually, this unlisted code end with 99, and this table outline the unlisted code for each organ. Please note that even though it's EGD with ESD, but it's different code for esophagus and stomach, or even flexible sigmoidoscopy with ESD or colonic ESD is different code between colon and rectum. So, to submit the claim for unlisted code, the hospital set the charge, how much they want to charge for that procedure. So, we have to submit a cover letter with the claim, explain the procedure, equipment, the cost, and the comparison to the physician work in terms of time risk and intensity. So, the only procedure that I can think of that might be comparable or maybe a little bit lower in complexity compared with ESD would be complex ERCP. So, because this is unlisted code, oftentimes it's denied, and we have to submit the appeal, things like that. So, it's recommended for the unlisted code procedure, you may want to consider submit predetermination letter before ESD. So, this letter is in order to confirm with the insurance whether if we perform ESD, how much you're going to pay for that procedure. This is important for the procedure that they still consider experimental or investigational, like ESD is one of them. This is by insurance. By society, it's not experimental or investigational. So, at least we know that if we submit this, we get how much we get in terms of reimbursement. And we should outline the letter, include patient information specific for that particular patient, like four centimeter, lesion, this is the characteristic of the lesions, what is the risk of submucosal invasion, pathology, why this patient you think patient need ESD, and describe why not surgery, why not EMR, why this is important to perform ESD in terms of curative intent, complication, hospital stay, and overall cost, is it better. So, outline that and submit along with clinical study to support what you mentioned in the letter. I have to admit that I found out about this not long ago. So, people who do a lot of this is Dr. Ortman, Mohamed Ortman, and this is routinely submit predetermination request. This is different from prior authorization, not the same. And to make sure that he get reimbursement for all cases. So, we also should submit, should also mention the society recommendation. There's no guideline yet for ESD in the U.S., but AGA, clinical practice update, which written by several of the faculty here, can be used along with the letter that we submit, because it support our recommendation. For facility code, since October 2021, there's a new code. This is HCPCS code C9779. This is the hospital outpatient procedure for ESD. So, this is quite new. And the payment in 2022 was $2,500, has increased to $3,000 and $261 this year. So, it has the payment increased about 30% from last year. But I will say this is still not sufficient, thinking about the supplies that we have to use. This number, this $3,200, similar code for diagnostic ERCP, not complex ERCP. So, still probably, hopefully, it will increase more in the future. In terms of quality metrics, there's no commonly accepted quality metrics for ESD, but our European colleagues suggest all these following metrics, that we should record, document, and monitor your own performance to ensure quality control. First, we have to make sure we do ESD in the right indications and document that. Use morphology, and I will add surface pit pattern criteria. There are so many criteria, but we need to use these criteria to assess the lesion and document what you think it is. You think it's just a denorma or cancer? If it's cancer, is it deep invasion or not? We have to do all that before performing ESD. Document and track on block R0 and curative resection rates. Look at your own complications. When you have histology, try to look into more detail, like is this just a denorma, high grade, or if this is cancer, this is superficial cancer, SM1, 2, or even deeper. Location, go more specific rectum, near the dented line, colon, near appendicitis orifice, things like that. The technique used, we talk more about that, ESD volume per year and the procedure time. So in terms of indications, this is clinical practice update that outline indications of ESD for each organ location. And it's very helpful when we try to justify why we do it, so we can refer to this document. For optical diagnosis before ESD, we should use not only morphology criteria. For example, we use Paris classification, lateral spreading tumor classification for corrective lesions. We also should also describe enhanced imaging, chromoendoscopy examination, can be virtual, can be dye-based, can be both, and apply classification for each modality, NICE, GENET, KUDO, there's many more. We should use both of these, both morphology and enhanced imaging. In the meta-analysis of the look at the accuracy of optical diagnosis of NBI and magnified chromoendoscopy, so to look at, this is to compare with the just-used gloss morphology. The sensitivity and specificity of NBI, I focus on NBI because that's what we commonly use. We don't have magnifying chromoendoscopy in the U.S. But mostly, I know recently we have FUJI magnifying the score, but mainly still NBI in the U.S. Sensitivity and specificity to diagnose T1 colorectal cancer is quite good, 85% and 94%. And no significant difference in terms of this accuracy compared with magnifying chromoendoscopy. But if you compare accuracy with just look at gloss morphology to diagnose cancer, like we talk about non-granular, prominent nodule, depressed lesion, sensitivity is lower if you just use gloss morphology. So that alone is not adequate. In addition, to diagnose deep invasion of T1 cancer, sensitivity and specificity of using NBI and magnifying chromoendoscopy is also better than using just gloss morphology alone. So the bottom line of this is we should make sure we use both morphology criteria and enhanced imaging. And if we put this into perspective in terms of population, we look at the false negative of diagnosing T1 cancer, risk of misdiagnosed T1 cancer, because if you don't use this enhanced imaging, performing piecemeal resection on a T1 cancer, which we should not do that. You use gloss morphology alone, 71% of cancer, because you misdiagnose, you perform piecemeal. End up this patient going to need surgery. The rate of that happen is lower with NBI and magnifying chromoendoscopy. Similarly, in terms of false positive, diagnose adenoma or superficial cancer as being deep invasive cancer is as high as 7% for all comers. So 7% of patient, if you just use gloss morphology alone, you will send the patient to surgery unnecessarily, compared with only 1% and 2%. So this is to support the recommendation to use both criteria morphology and enhanced imaging. And also important to look at your own data. What is your accuracy? How often that you have false positive, false negative? Do we have to get more training in terms of enhanced imaging to improve your accuracy? Next, in terms of resection outcome and complication, which is the primary metrics of ESD that we look at. Dr. Sethi already mentioned some of this. Outside the European recommendation, what is considered competent, which is on-block resection, more than 90%. This is the easiest parameter to look at, easy to assess and track over time. And we should also monitor it to make sure that we get better during the training. R0 resection, more than 80% to 85%. This parameter, not only for on-block resection, but negative vertical and horizontal margins. That means the endoscopist be able to identify the margins, circumscribe the lesions, adequate dissection of the lesion to ensure negative margins. So that's more difficult than just being able to remove the lesion in one piece alone. Curative resection, which in addition to R0 resection, you look at other morphologic features like lymphovascular invasion, tumor grading, and depth of invasion, should be at least 75%. And these metrics help us understand what is the usefulness of ESD to manage early cancer as an alternative to surgery. Because if curative resection is very low, then it's not very helpful for the patient. And perforation, less than 3%. This is from European recommendation. I know that some of the Japanese recommend 5%, but for perforation, they recommend less than 3%. And because most of this perforation should be able to manage by endoscopic closure, so the need for surgery should be less than 1%. However, this number is sometimes difficult to apply because it's very depends on many factors, not only skills, experience of the endoscopist, but also type of the lesion, which I think is probably the most important factor. If we perform lesions in difficult lesions, very large, difficult location, severe fibrosis, then on-block resection going to be lower. Devices, do we have all the device we need? If we have proper knife, cap, traction, anything that we need, then we might be able to do better. The technique, which other faculty mentioned earlier, like tunneling technique, traction assisted, so do we learn all of that? Do we use all of that? So in terms of technique, we need to make sure that we use the correct terminology when we document. In terms of standard ESD, it's the procedure that we perform both mucosal incision and submucosal dissection with the knife without using snare. That's difference from pre-cut EMR and hybrid ESD. So like in this example, using the multifunctional snare to perform pre-cutting EMR, you perform mucosal incision, circumferential incision, without dissection. So this is the key difference between pre-cut EMR and hybrid ESD, because some people mix it up and they look at the same outcome, which is not applicable. So like in this one, use the tip of the snare. This is a specialized snare that the tip is designed to perform mucosal incision. So once it's complete, mucosal incision is complete, then use the snare to perform complete unblocked snare dissection. So this is EMR, not ESD. The other example is hybrid ESD, which is after mucosal incision, you also perform submucosal dissection to some extent. The aim is still unblocked dissection. So you're going to want to perform dissection until we're pretty sure that after we put the snare, we can remove the entire thing unblocked. So this one, you can see that dissection has performed probably more than 50 percent of the lesion, just a little left before the snare was used. So this is hybrid ESD. So we need to make sure we document the correct technique and track our outcome, because unblocked dissection for hybrid ESD or pre-cut EMR is different from standard ESD. And if we start a procedure with the intention to perform standard ESD, but we have to convert to hybrid, meaning we cannot finish with standard ESD, we have to use a snare, we should also document that and provide a reason why. So because we didn't intend to do hybrid ESD at the beginning. In terms of volume of ESD per year, this strongly correlated with outcome, resection outcome and risk of complications. We should look at not only total volume, but volume per type of lesions and locations. So what is the volume that we should aim? The meta-analysis from 2017, they found that the center that performed ESD, two ESD or less per month, which overall less than 25 cases per year, had higher adverse events that required surgery. And because of that, the European recommend the minimum caseload of 25 per year to maintain proficiency. The more recent large German registry, a couple of years ago, they found that a high volume, not just a minimum volume, but a high volume, more than 50 cases per year, achieved a better outcome in terms of unlocked sero- and curative resection compared with a low volume. So minimum should be at least 25, but better higher than that, like 50. For procedure time, again correlated with the difficulty of the lesion and skills of endoscopist. So it's important to track our own procedure time. Do we get faster? It's also helpful to help plan for scheduling. If we later on from having to spend one hour to perform this type of lesion, this size, this location, the next time we can adjust our schedule accordingly. So our Japanese expert recommend that the competency for ESD is when the speed of ESD is faster than nine square centimeter per hour. This is because the expert tend to have a higher speed to perform dissection compared with the less experienced endoscopist. So in summary, for the physician billing, use unlisted code, consider predetermination later, and ask your industry. Boston Scientific has the billing specialist that can help you in terms of how to navigate through the process. Facility billing, use the HIPC code C9779. Now, given that there's no established quality metrics for ESD, but we know a number of proposed quality metrics that we should record and monitor, particularly the outcome of ESD. We need to make sure that we monitor that to ensure the competency. Thank you.

reimbursement

quality metrics

endoscopic submucosal dissection

predetermination letter

facility reimbursement codes