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Neal Shore: Hello everyone. My name is Neal Shore, I'm the Medical Director of Carolina Urologic Research Center in Myrtle Beach, South Carolina, and on the board of the Large Urology Group Practice Association, LUGPA. It came to our attention after a very thoughtful and carefully written list of recommendations that was stewarded by BCAN, the Bladder Cancer Advocacy Network, and then ultimately signed by the entire house of Urology, American Urologic Association, LUGPA, SUO, AACU, the International Bladder Guidelines Committee, and there's really good information detailing what to think about now during this BCG shortage which we're somewhat plagued with actually and how it's affecting the ability of our patients to receive appropriate uses of BCG. And so I strongly recommend that folks have an opportunity to read that statement and we'll provide information for that.

We want to focus on our two expert faculty, first Ashish Kamat from MD Anderson who is an expert in bladder cancer therapy and surgery, who will weigh in and talk about the alternatives to the use of BCG due to the shortage, and that would be primarily inclusive of intravesical chemotherapies, mitomycin C, gemcitabine, docetaxel, possibly even epirubicin, and Ashish will talk about how these chemotherapies could potentially be used induction and maintenance courses, and also how one could procure them. The second portion of the program will be Jonathan Rubenstein, who is a senior member of Chesapeake Urology. He's been on the AUA coding committee for many years. He's an expert in this area of urology, and then Jonathan will talk to us about an area that's of grave concern to many, is how to correctly code as to not run afoul or awry of proper invoicing techniques and procedures. So with that, Ashish, thank you. Really appreciate your expertise.

Ashish Kamat: My pleasure, Neal. As you mentioned, it's a very, very timely and important topic, and the question really is what do we do for our patients when there's a shortage of BCG. The first thing to recognize is that the shortage is created because of excess demand and supply not meeting that demand. So, the first thing to do is make sure that the utilization of BCG is appropriate because if you overuse BCG in patients with low-grade disease, we're denying our patients that have high grade, high-risk disease from getting the appropriate therapy. So first things first, when there's a shortage of BCG, really no patient that has low-grade disease should get BCG therapy. We recognize that patients who are intermediate risk category, which is the recurring low-grade tumors, are normally recommended to get BCG therapy, but in times of shortage the plea really is to restrict BCG therapy to those patients who truly are high risk, because the high grade, high risk patients are the ones that are in danger of losing their lives if they don't get BCG. It's not just recurrence, it's a progression that's dangerous. So that's number one. Use BCG only in high-risk patients.

Number two, the second recommendation, and Jonathan will weigh in a little bit on how this practice can be done but is to try and cluster patients in groups of three so you could give each patient one third the dose both for induction and maintenance therapy. This in the European large study, EORTC30962 was shown to be fairly equivalent to full dose BCG. So we can give three times the number of patients therapy if we just give one-third dose, but the practical issues are something that Jonathan can address in the second half. 

You alluded to chemotherapy, and that's very appropriate. So in patients that have low-grade intermediate-risk disease, instead of BCG, using induction chemotherapy once a week for six to eight weeks and then a monthly maintenance schedule for one year has very similar effects when it comes to decreasing progression and recurrences from bladder cancer. It's not as good as BCG, but it's very close. And in the United States today, the recommendation really is to use gemcitabine because it's more easily available, it's less costly, it has been shown to be very efficacious, and more importantly, patients tolerate it much better. But if you can't get gemcitabine or you don't have access to it, really any chemotherapy that we have used to instill into the bladder, mitomycin, epirubicin, thiotepa, docetaxel, they all have similar efficacy rates. So using any intravesical chemotherapy is appropriate. 

Now, what if there is absolutely no BCG at all? So let's say it's not a shortage, but there's an absolute lack of BCG. In that situation, when we have the high-risk patients with high-grade disease, the recommendation is to then use induction combination chemotherapy, which is a combination of gemcitabine and docetaxel, again, once a week for six to eight weeks and then a monthly maintenance therapy. But hopefully we won’t get to a point where we have absolutely no BCG, but that's something to keep in mind.

And then lastly, we shouldn't forget that in patients who are extremely high risk of progression of disease, those that have large, bulky, T1 high grade tumors, CIS in the prostatic urethra, or those that are just not responding to intravesical therapy, rather than continue them on intravesical therapy that's not effective, recommending early radical cystectomy is not only better for the patient but it also avoids us using BCG in a situation where we know it's not going to work. So those are medical recommendations in a summary, and I'll hand it over now to Jonathan for his part.

Jonathan Rubenstein: Great. So the most important thing is the split dose, and what's really important to urologists and urology groups is whether this is going to be paid for or not. And people can really run into trouble if doing things incorrectly, and we want to reduce practices' risks of being audited by government agencies or by any type of auditors. The issue currently is that one vial of BCG is considered one dose, and that's just how the package was created, and that's the current standard. So all of our contracts are based upon one vial is one dose. 

Other countries who have different health care systems, many people have probably heard from Canada that it's routine to split doses, but they have a national healthcare system, and that's not how things are set up here in the United States. Here we're basically contract-based. And whether our contract is with Medicare or with a private insurer, it's really important that we try and code things correctly. Unfortunately, right now there's no code for splitting doses. There is a code for discarding doses from Medicare. Let's say a patient was going to get a half dose or a third dose of BCG to help reduce toxicity in that patient. The way it's currently coded is that your bill for the portion that you gave, and the portion that you did not give you use a special modifier, discarded modifier to show that you threw that away, that's so you can get paid for the whole dose. 

So I've heard a lot of people say things such as, well I'll just find three people with the same insurance, I will charge one of them for the full dose, and I'll give the other two people for free. That's a really bad idea. You will get caught. Not only you break your contracts, but now you're charging one person three times the amount, or actually the full dose, and that's not what they're receiving. So if they're getting one dose they should be charged for one dose. But that really leaves us a new challenge, how can we get paid appropriately for giving a one third dose to a patient? Right now we have reached out to Medicare, we have not heard back from them yet, so hopefully we'll get a response from them, and hopefully they'll understand the current situation we're in, the current shortage, and come out with a better solution, but until we get it in writing there's a lot of difficulties and a lot of challenges with trying to do that. So I would recommend that people reach out to their private insurance companies they have contracts with, or their medical director at their local Medicare MAC, and try and make a plan with them. I would always recommend people get it in writing.

One thing the package insert for BCG says that any portion that has been reconstituted must be discarded within two hours of reconstitution. So that's just another thing to think about. So that's why the recommendation is, if you will end up doing split doses, make sure you're trying to get three patients together within two hours. But my hope is that we'll hear back for not only the legality but the coding and billing for split doses and hopefully we'll hear some point soon, and if we do we'll be able to give an update, but until that time the coding and reimbursement is a significant challenge and a potential barrier for the split dosing.

Neal Shore: Ashish and Jonathan, thank you so much. I think your discussion, your description of the challenges that we face on a clinical front as well as on a business administrative economic front were exceptional. We look forward to getting an update on this as well. Thank you for all the time that you both put into this in helping make sure that both clinicians and our patients can achieve optimal care. Really appreciate it. Thanks very much.