Key takeaways from this episode

• Let the bladder cancer diagnosis code follow the patient's actual stage of workup. Use the hematuria code at presentation, D49.4 (neoplasm of unspecified behavior of bladder) after diagnostic cystoscopy, the C codes with tumor location after TURBT and during BCG or other drug treatment, and the Z history-of-bladder-cancer codes once the patient moves to surveillance.
• For intravesical drugs with their own J code, bill 51720 for the instillation plus the J code with the correct units and modifier JZ when a single-use vial has no wastage. Document the NDC number, lot number and amount instilled, and confirm the unit definition for each J code, since units range from 1 to 400 per code.
• Unlisted drugs such as Zusduri are billed with J9999, with the NDC, drug name, route and dosage in box 19, using the same wording on every claim. Mark's example: for an 80 mg vial with 60 mg instilled, list ME 60 for the dose, then ME 20 with modifier JW for the wasted amount.
• Reimbursement for an unlisted drug is usually set at WAC and tied to the NDC, so the fight is over coverage, not price. Prepare templates and a medical necessity letter (indication, why this drug over others, peer-reviewed support) before the first claim, and appeal for the reason actually stated in the denial: a records request needs the information and a cover letter, an "experimental" denial needs a rebuttal.
• Stay on the FDA label while a drug is on an unlisted code. Off-label accommodations may come later, but not during the introductory phase.
• Before treating, verify demographics and eligibility, confirm the record documents recurrent low-grade, intermediate-risk, non-muscle-invasive bladder cancer, then attempt prior authorization and a predetermination. Record who you spoke with and what they said, screenshot online responses, and tell the patient you may need their help securing coverage.
• Expect 90 to 120 days to first payment from a new payer, dropping toward 30 days after three or four claims. Set a tickler to track each claim, start with traditional Medicare before Medicare Advantage, and stage which payers you bring the drug to.
• A J code does not guarantee payment, but Medicare is very likely to cover an FDA-approved drug for its FDA indication. The unlisted J code calculator at prsnetwork.com/zusduri maps order dates, invoice due dates and expected payment dates for the six weekly instillations so you can negotiate invoice terms and plan cash needs.

Transcript

Lightly edited for readability; timestamps mark where each speaker turn begins in the recording. UCR 259, recorded September 2025, with Scott Painter, Mark Painter and Dr. Ray Painter of PRS Network.

Bladder cancer diagnosis coding from hematuria to surveillance

[00:00] Scott Painter: On this episode: bladder cancer reimbursement strategies. Welcome to episode 259 of the Urology Coding and Reimbursement Podcast. I'm your host, Scott Painter, with my co-host Mark Painter and Dr. Ray Painter. We want to talk a little bit about bladder cancer reimbursement strategies. We have a new product supporting the PRS Coding and Reimbursement Hub, and that is Zusduri, manufactured by UroGen. We have some new tools and some new pages that we want to tell you about. But first, Mark, do you want to share a little bit about the bladder cancer reimbursement landscape and what's happening?

[01:00] Mark Painter: Sure. Over the years we have talked a lot about diagnosis coding surrounding bladder cancer. It's important that your diagnosis flows throughout the entire process and is accurate. When the patient first comes in and they only have the symptom of hematuria, you're going to use that hematuria diagnosis. Then, as you start to diagnose the patient with diagnostic cystoscopy, you may move to D49.4 for neoplasm of unspecified behavior of the bladder, and then typically move to a TURBT or a resection of some type, assuming it's not muscle invasive or further along. At that point you're going to use your C codes, making sure you've got neoplasm of the bladder and you're accurately reporting the location of the neoplasm or neoplasms. Then we move down the road to where we are treating the bladder cancer with BCG or some other type of drug for the follow-up care and the immediate treatment, where we continue to use the cancer diagnosis. Eventually we get to the stage where we feel the patient is cancer free and move to surveillance, and maybe maintenance therapies, when we move to the Z codes for history of bladder cancer. So that's the diagnosis side.

Documenting and billing intravesical drugs with J codes and modifier JZ

Today I'm going to focus not on procedural bladder coding, though I'll remind you that size matters when you're documenting a resection of a bladder tumor, but on the drugs, because we have a lot of activity now with a number of new drugs introduced into the market. Many of our drugs that have been around for a while, and some that have been around for a short while, have J codes associated with them. With those J codes specific to a particular drug, it's very important to document several things as you're using them. Obviously, you want to make sure you're recording the NDC number, the lot number and the amount instilled. You want to use 51720 for the instillation. You want to make sure you're clearly including the amount, and if there is no wastage on a single-use vial, you want to make sure you're using the JZ modifier. Make sure all of those things are well documented and your billing includes the correct units. Some are one, some are 400, so understand the units as they relate to that particular J code, be clear in your documentation as to what was instilled, and then add the JZ modifier to the J code and bill it in addition to your instillation code.

Unlisted drug codes for new agents like Zusduri: box 19, medical necessity and appeals

When we move into the unlisted codes, which we do have to use with some of our new drugs on the market like Zusduri, the documentation is the same: the right drug, the NDC, the lot number, the amount instilled, and whether or not there was wastage. But the unlisted code is going to require all those descriptions in box 19. You're going to have to make sure you're using language that is consistent from dose to dose, and you want to make sure you're doing appropriate follow-up for those codes, so that when the payer requests documentation, you can clearly supply the medical necessity for using that particular drug. That would include why this drug over others, as far as the medical necessity argument, and use any peer-reviewed articles potentially in that follow-up.

I'm going to encourage you as well, when you're looking at unlisted codes, to develop some standard form templates that will allow your RCM team to appropriately gather the information and appeal for payment. You're going to want to keep invoicing, although most unlisted drugs are going to be paid on the WAC cost at the very beginning. They're going to develop a specific fee tied to the NDC number, so we don't have the crosswalk issues we're stuck with for new technology and new procedures. Essentially we've got WAC pricing in the system that the payers can use to adjudicate the claims based on instructions from Medicare. So the reimbursement level will be fairly well set. Coverage is what we're dealing with, and that's where you want to make sure you have appropriate templates and all the documentation ready to go, to follow up and appeal those particular claims.

Make sure you're appealing for the right reason. If you get a denial on an unlisted code, respond to that denial. A lot of them are going to be requests for more information. That's simply where you provide that additional information and maybe a cover letter. Some may be denials for other reasons, such as experimental. This is where you're going to need a little more information about why it's not experimental and why you chose this particular drug to treat your patient. You do want to pay attention to the FDA labeling to make sure you're following it as initially released while you're in that unlisted drug code phase. Later on there are accommodations that could be made for off-label use, but that is not something you want to deal with while you're in the introductory phase using an unlisted code.

The other thing I wanted to address is what you need to do prior to administration. With standardized J codes for expensive or newer drugs, we are typically going to go for a prior authorization based on the appropriate coding, but then take the next step of pursuing a predetermination. A predetermination allows you to submit your ICD-10 codes, your patient numbers, and all of the CPT and J codes, like a mock claim, to see how the payer is set up to process those claims within their system. With an unlisted code, we're lucky if we get a prior authorization, and it's unlikely that a predetermination will give you any conclusive information. So with an unlisted code, as you attempt to get a pre-authorization, you want to document what you heard on those prior authorizations. If it's a phone call, document who answered the phone and what they said. If you tried online, certainly look at printing screenshots of that information out and putting them in your overall medical record.

You also want to do a good job of making sure you've got your demographics and your patient's eligibility, those things you do for every single procedure. In addition, you want to spend a little bit of time communicating with the patient, letting them understand exactly what you're trying to do to get them the treatment you think is best for them. That would include letting them know that as you go through this process, you may need their assistance to help finalize the coverage and payment for that particular unlisted drug. Don't be afraid to use printed forms to communicate with the patient what the step-by-step process is and why this is a little bit more difficult, while emphasizing why that particular patient really is a good candidate for this new and different drug for their particular disease state.

[10:00] Scott: Ray, comments or thoughts?

Dr. Ray Painter: No, nothing to add.

Walking a Medicare Zusduri patient from eligibility check to payment

Scott: All right. I've got a question for you, Mark, using Zusduri as an example. Let's walk through from beginning to end, really quickly. What would you do if a Medicare patient walked in and you determined that the indications for Zusduri were met and that was the best course of treatment? What's the next action? What are the steps you would walk through? What is step number one to get things rolling?

[11:00] Mark: Step number one: I am absolutely going to make sure I've got all of the patient's information correct from a demographic standpoint, and I'm going to check their eligibility to make absolutely certain I am billing the correct insurance company. Step number two: I am going to look at the documentation I have for this patient, because they should be diagnosed with the appropriate cancer. That means I want to know that this patient has documented recurrent low-grade, intermediate-risk, non-muscle-invasive bladder cancer. I want to see that in the documentation supporting my orders for the new drug. Those are my front-end steps before I even proceed to prior authorization or anything else.

Once I've got everything lined up, now I'm going to go for the prior authorization. I'm going to check with the insurance company, try to get a prior authorization, and document my responses and who gave them to me. I'm going to try a predetermination in most cases, unless I've done it before with that particular payer, in which case maybe I would skip it. But in general, you're going to want to try a predetermination and see what information you get. Then we proceed to treatment, making sure, again, that the documentation reflects the diagnosis, the amount instilled and the pathway by which it was instilled, which of course is going to be an instillation with 51720. I want the lot number, the NDC number, all of those things documented.

Then I'm going to take it to my RCM team, and I'm going to make sure they enter all that information appropriately. We're going to use the appropriate J code, my J9999. I'm going to see how much was instilled and how much was left over. A full-dose vial is 80 milligrams. If I instill 60 milligrams, I am going to put in box 19 the NDC number, the drug name, the route of administration and the dosage given. So I'm going to use ME and then 60. Then I am going to list underneath that ME 20, followed by JW, to indicate how much was wasted. That's all going to go in box 19. The NDC number and the drug name need to go on every claim, and obviously the instillation is going to go on every claim. The thing most likely to vary from patient to patient is the dosage, so I'm going to make sure my RCM team is listing ME with the amount instilled, then ME with JW and the amount discarded or unable to be used.

Then I'm going to set up a timeline within the practice to follow that particular claim. I want reports from my AR team when it is first adjudicated by the payer, and based on that response I'm going to finalize my response letter, which I've already prepped ahead of time and which includes the indication. I'm going to take the medical necessity for that particular patient, place it into the letter and appeal that claim. Then I'm going to once again put it on a tickler to trace it and see what happens on the second pass. I'm going to expect that if this is the first time I'm billing the payer, it's going to take 90 to 120 days in total to actually get my reimbursement. I would expect that after the first three or four I've put in to that particular payer, my response time is going to drop. I may also not get a record request, or I may get payment without a denial, and that eventually can drop down to 30 days. It does take a little bit to educate the payer when it comes to unlisted drugs. But the payers can react, because it does cost them money. If they know they're going to pay it, it makes more sense for them to process it more quickly, because the cost of personnel and reprocessing claims is more than what they can earn on the interest by sitting on your money.

I would also say I'm going to continue my process of monitoring the overall payments by payer. I would likely start with traditional Medicare and then move into my Medicare Advantage plans once I know Medicare is processing these claims. So I'm going to stage who I'm going to bring this to in my practice, and in selecting my patients I'm going to look at the payer as well as the patient's condition.

Scott: Ray, thoughts?

Ray: Mark, does getting a J code guarantee Medicare coverage for the drug?

Mark: As you know, a standard code is no guarantee of payment. It's one of those things where we have to look at coverage restrictions and all the other things that come into play, which is why we started this discussion with diagnosis codes and documentation. But I will say that Medicare's likelihood of covering an FDA-approved drug for an FDA indication is very high.

The Zusduri hub page and the unlisted J code calculator

[18:00] Scott: We also recommend, and you'll see this as you explore the hub, that if you look at the Zusduri example we just went through, you can go to prsnetwork.com/zusduri for examples of how this drug should be billed and reimbursed. It has a lot of resources, including an unlisted J code calculator, where you can enter your information and it gives you a schedule of what your plan should be for the drug. You can enter your lead time. You can enter your invoice due date, so if you can negotiate a longer term, like a 120-day due date, that gives you more time to get the claim processed so you're not out that cash while you're waiting to get paid, especially with drugs like this, which is six instillations one week apart. There's a certain amount you would have to outlay if you hadn't been reimbursed by that time. Go to prsnetwork.com/zusduri and click on "launch J code calculator" to enter your information and see when to schedule and when to order. It gives you a whole schedule and calculates the payment dates as well as the invoice due dates based on what you input. It's pretty handy: based on your parameters, you can see what cash you might need, if any at all, and what your revenue and reimbursement will be.

Let's wrap this episode up. I want to talk a little bit about the Urology Advanced Coding and Reimbursement Seminar that's coming up in Las Vegas in December and in New Orleans in January. With all the new codes, new rules, new denials, new pharmaceuticals, new audits and new technology, there's a lot going on in urology, so we'd love to see you at the seminar, where we can dive deep and spend two days discussing all this. This is one of the best ways to get your practice prepared for 2026 and beyond. If you go to prsnetwork.com/259, there will be links there for registration for the seminar, as well as the link to the hub for Zusduri. We want to thank ModMed for supporting this episode. If you're in the market for an EHR or a practice management system, you can go to modmed.com/prs for specials for our listening audience. We want to thank you all for listening. Let's get some final thoughts. Mark, final thoughts?

Final thoughts: the pioneers who educate payers, and the WAC pricing carrot

[21:00] Mark: A couple of things. One, we outlined a lot of steps for dealing with unlisted codes today, and I want to encourage folks: this isn't necessarily easy, but it is something we consider necessary as far as educating payers on the use of new drugs and new technologies. We've got to get demand out there before the payers are going to actually set up coverage parameters, and that includes for the J code once it's in place, which makes things a little bit easier. There are a number of folks who are going to wait for the pioneers to do this, but we really do need that payer education to occur, and the sooner we can get that education in place, the more likely we are to have smooth reimbursement moving forward. So we really need to take the time to thank those who are pioneers and willing to take on this little bit of extra work.

I also want to add that there is a little bit of a carrot for this. It does take some time for CMS to establish ASP plus 6%, and the original pricing for new drugs is based on WAC, so that gives you a little more room between your acquisition cost and your reimbursement to cover the extra work required to deal with unlisted codes. Take a look at those options and opportunities, and know that you're doing a service for your fellow urologists by tackling new technology early in the process.

[23:00] Scott: I'll add to that. One of the main objectives of the hub, and what we're trying to do, is to help the urology patient get this new technology faster, and give you, as the urologist and the urology practice, more tools in your arsenal to treat urology patients. And that can only happen if new technology is being reimbursed, as we know. So that's very important in the whole scheme of things. Ray, final thoughts?

[24:00] Ray: A couple of things. Listening to Mark talk about that, it sounded very complicated. But it's not; it's just detailed. If you have the documentation, you have the need, and you follow the rules, then you normally will get paid for an FDA-approved use of an FDA-approved drug. And Scott, I just wanted to say I took a look at your calculator on the hub, and that's pretty slick. I wish I'd had that back in my day. It would have saved me a lot of time and some money.

Scott: We do encourage you to go check that out. It is a great tool, and we really like how it turned out. That's all we have for today. Thank you all for listening. Take us out, Ray.

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