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UCR 294: Buy-and-Bill Drugs in Urology – Protecting Your Practice from Costly Mistakes

June 26, 2026

In this episode, Scott, Mark, and Dr. Ray Painter continue their discussion on buy-and-bill drugs, using ZUSDURI® as a case study to explore the clinical, operational, and reimbursement challenges facing urology practices. The conversation covers prior authorizations, payer eligibility checks, documentation requirements, medical record reviews, RAC audits, and strategies for successfully introducing new drug therapies into a practice. The team also discusses the importance of standardized protocols, staff training, monitoring reimbursement, and leveraging technology to reduce financial risk. The key takeaway: successful buy-and-bill programs depend on more than getting paid—they require the right processes to ensure practices get paid, keep the payment, and continue delivering innovative therapies to patients.

Key takeaways from this episode
  • Buy-and-bill drugs are paid at ASP plus 6 percent, so you have to collect on virtually every dose or you are underwater on the drug cost. Testosterone, antibiotics and bladder instillation drugs all carry the same thin margin, and drugs are now a stated target for RAC audits (which pay the RAC a one-third bounty), UPIC reviews and medical record requests.
  • If the prior authorization is not done, reschedule the patient; the drug cost cannot be recovered afterward. Practices that let prior auths lapse during staffing gaps lost the full drug cost, so keep written policies and protocols, watch payer bulletins for new prior auth requirements, and run eligibility checks all the way through, especially with Medicare Advantage plan changes.
  • Build the clinical justification for each drug into the EHR order so staff have what they need for prior auth and for any later takeback. A rule proposed for January would let payers review the order and full visit record through AI-assisted prior authorization portals, so attach the indication (for Zusduri, recurrent intermediate-risk non-muscle-invasive bladder cancer) to the order now.
  • Use a predetermination, not just a prior authorization, on high-cost drugs when the payer offers one. A predetermination works like a mock claim that reflects the patient's plan and expected payment, while a prior auth only answers yes or no on the code combination.
  • Traditional Medicare does not require prior auth, but it does take money back, so meet every LCD/LCA requirement before treating. Auditors are recouping over items as small as a missing bladder diary even when the note documents 50 percent improvement, and RAC audits are now arriving for services provided earlier the same year.
  • Manufacturers will not refund a drug lost to a takeback. They may offer prior auth support, checklists, payment plans or help finding grant or alternate funding, but the invoice stands once the drug is used.
  • Zusduri now has J code J9282, an established ASP and an FDA-labeled indication, so on-label traditional Medicare claims should pay with no NCD/LCD beyond following the label. For commercial payers, check whether your contract follows Medicare, run a predetermination for the first one or two patients, and "probe and then launch" by completing a full course on one patient before adding others.
  • Survive staff turnover with train, protocol, monitor. Use a set training program with videos rather than peer-to-peer training, enforce protocols with measurable evaluation, and monitor EOBs closely for unusual denial patterns and takebacks arriving under the wire.

Transcript

Lightly edited for readability; timestamps mark where each speaker turn begins in the recording. UCR 294, recorded June 2026, with Scott Painter, Mark Painter and Dr. Ray Painter of PRS Network.

Why buy-and-bill drug losses hurt more than other losses

[00:00] Scott Painter: On this episode, buy-and-bill drugs in urology, using Zusduri as a case study. Stay tuned. Welcome to episode 294 of the Urology Coding and Reimbursement Podcast. I'm your host, Scott Painter, with my co-host Mark Painter and Dr. Ray Painter. Today we want to continue our discussion. Mark presented information on our June 2026 monthly webinar about buy-and-bill drugs, which you can go check out, but we wanted to continue this discussion on the podcast. Mark wants to hit the highlights again of what's going on out there right now and what a practice can do to make sure they are protected on buy-and-bill drugs. So Mark, do you want to take us through this?

[00:51] Mark Painter: Sure. Drugs across the board have a low margin. We're at ASP plus six percent, whether it's your testosterone or your antibiotics or your bladder instillation drugs. Across the board, they've got a margin on them that really makes it such that if you do not collect on virtually all of them, then you're underwater with that particular variable cost relative to your practice.

It hurts to lose money, and I've always looked at this through a couple of different lenses. It hurts to lose money that's based on time, without a doubt, so not getting your E/M codes paid for, or maybe not getting a procedure paid for. But boy, it hurts a little bit more financially when it's all about the variable cost and that money is out of your pocket, so you're paying to provide that care to someone else. For some reason that's just one of those things that mentally is tough, but a loss is a loss. So when we look at buy-and-bill drugs across the board, we really want to make sure that we are dotting all of our I's and crossing all of our T's, and we have seen a significant uptick in medical records reviews and RAC audits for specific drugs.

Those are focused on some of the higher-dollar items, and that's just the focus of the RACs, because they get a one-third bounty for recovery. We're also seeing the UPICs take a look at this. It's pretty obvious that drugs are a target for review, because we spend so much on drugs, and that's one of the faster-growing areas in healthcare costs. So Medicare's taking a look across the board.

Prior authorization: policies, portals and eligibility checks

But before we get deep into that part of the equation, I want to start with the prior auth part of this, because we've had a couple of groups that we've been working with that recently had some staffing issues. They weren't able to get prior auths on some of their drugs, and it went on for a little period of time. Going back and looking at things, it's painful to let a group know that we can't recover those costs because the prior authorizations were not done, or were not done appropriately. I certainly understand why that happened to them, but those losses are difficult to take.

So I wanted to first start off with making sure that we address that prior authorization portion when it comes to drugs, because sometimes those prior authorizations are not as clear as they should be. They're not as easy to work with as they should be. That's the payer side of the equation. Sometimes you'll get a pushback on a payer specifically, or a change in the regulations that didn't require a prior authorization and now does. So you've got to keep an eye on what requires a prior authorization. The other part of this that we're starting to see come into play, and it's one of those double-edged swords, is an increased use of patient portals and collecting information from the patients before they come into the office, which I think is a great idea, but it does still require significant monitoring and double-checks.

If you can get the information from the patient relative to their healthcare insurance, any change of address, any of that, before they come into the office, that lightens the load on your staff, so you definitely want to pursue that. But you do want to make sure you're checking those things when they come into the office. You want to make sure you're running your eligibility checks and seeing those eligibility checks all the way through. Those are mistakes that we see made. The EHRs and your tools are getting better at that, but they're not perfect. Ultimately, you want to make sure your staff is well trained and well focused on getting that information, because we do have a lot of migration as patients move from plan to plan, especially in Medicare Advantage situations.

So make sure you've got a good policy, protocol and procedure in place for those prior authorizations. Get those done, and if they're not done, it's time to reschedule. That's a risk that I know is hard to walk away from when the patient's there and has that need, but it really is a piece of the puzzle that has to fall in place these days in order for you to get your appropriate reimbursement for all of those services. So double-check things, watch your payer bulletins, and make sure you have good policies, procedures, and protocols relative to your prior authorizations.

AI-assisted prior auth, predeterminations and building the order

The other thing I'll mention really quickly is there are groups that are now trying out some of these AI-assisted prior authorizations. Those, again, are time savers if they work, and ultimately they should be leveraged. We should be trying all of this, but we do still need to monitor those things. The other piece I'll throw into the equation is that there is a new rule that's supposed to go in the first part of January that's going to increase the requirements for a prior authorization leveraging AI tools. This is really much more clinical information that can be submitted through the prior authorization portals in order to get the prior authorization.

Right now, a predetermination, which is yet another pathway to check whether or not a particular service is going to be paid and how much it is paid, requires a little more than a prior authorization. There's a little more information that's given up front. It takes more time, and not all the payers have predetermination set up. But the information you get back is relative to the patient's plan and should be reflective of what you're actually going to be paid. It's like a mock claim, if you will. Whereas a prior authorization is just, if these codes are submitted in combination, will these get me paid? And a general response of yes or no, plus a number that says, "Yeah, you checked this." So the predetermination, because of its extra work, isn't something you want to do all the time, but it might be something that you pursue for some of your higher-cost items.

But the change that's upcoming is going to allow the payers to look deeper into the order. We've got a lot of these new drugs that are out there, and Zusduri is a good example that is specifically targeted for recurrent intermediate-risk non-muscle-invasive bladder cancer. It's got a fairly specific use. This new process that they're supposed to implement in January, and I'm skeptical that they are going to actually implement it in January, everybody looks like they're a bit behind, but if they do implement it, it would actually allow the payer to check the order and the entire patient record of the visit prior, to see if the patient actually meets those underlying qualifications to receive the Zusduri.

So that's the other piece on the front end, before a patient gets a drug, that you want to make sure you're setting up. I'm going to recommend you do it now, even though we don't have this prior authorization wheel in place: really take care to set up your electronic medical record to put the clinical reasons why a patient is going to get a particular injection in the medical record and attach it to the orders, so that your team can easily get those prior authorizations because they've got all the information they need in that medical record, served up to them in the order. Take a little bit of time, look at what you can do with your orders to justify those drugs, and make sure that you're requesting the appropriate drug and authorizing the right drug and the units that are associated with it.

[10:20] Scott: Ray, do you have any comments or questions?

[10:23] Dr. Ray Painter: Mark, it sounds like you're saying you need to get all the information, including the insurance, from the patient as soon as you can. But before you give one of these expensive drugs in the office, you want to be sure your office has checked that you meet all the requirements that insurance company is requiring before you give the drug. So that morning or that day, you need to check and double-check. I'm at that age where I get to see a lot of doctors and how they practice from the other side of the fence. I'm on straight Medicare with a supplement, but I've got one procedure that I'm being scheduled for that had several preliminary things that had to be done, and the practice told me they had to wait for insurance approval at each step of the way. Well, Medicare doesn't require that, but their practice set it up so they would be sure and not miss anything.

Getting your money and keeping it: RAC and UPIC takebacks

[11:33] Mark: I'll put in one quick issue there and mention that, yes, expensive drugs are one thing, but all drugs are an issue across the board. It's not just the expensive drugs that we've got to look at. Obviously, that's one where you've got a little bit more margin to work with. But Ray, I think that's smart of that office, because that really goes back to the LCA or the LCD, right? Making sure that they've jumped through every hoop that is required for that procedure in their documentation if they get a UPIC or a RAC. You're right, Medicare doesn't have prior authorizations, but they do have takeback abilities.

The old days of "if you got paid for it, you were safe" are gone. The amount of RAC audits and the amount of UPIC activity that we're having right now is significant, and it's burying the RCM team. It is ridiculous, in my opinion, that we're focusing on such ticky-tack issues: there wasn't a bladder diary in the patient's chart when clearly all the documentation says the patient had fifty percent improvement. This is ridiculous paperwork administrivia that's being required. But that's the way the rules are set up, and so we really need to build our EHRs, as your office has done, to make sure that we follow those protocols. Even if it's not a prior auth, it's a protection from takeback. So it's a little bit of both: getting your money, yes, and then keeping your money.

[13:27] Scott: I've got a couple of questions for you. More of an advice question: what's your advice for these private practices out there that are having higher turnover? I know you've built into your own RCM team a lot of protocols and procedures, and that's what you're telling everybody to do, make sure you have those in place. How do you maintain those when that experiential knowledge leaves the practice? Do urologists have to learn this and be able to teach it? Or what do you recommend? Because you can't always depend on the admin staff to be there and to carry that protocol or procedure onward with the full experiential knowledge.

Surviving turnover: train, protocol, monitor

[14:28] Mark: It is incumbent on the admin staff to monitor this. We do lean hard on the admin staff, but we also try to distribute some of those responsibilities downstream to supervisors and those types of folks. Leadership is important, and it is leadership from the top down that really focuses on making sure that your personnel follow the protocols that you establish.

The team that we've put together has been very good across the board, and I give Marianne a ton of credit as our operating officer, who has really put into place a couple of different things. One is obviously the protocols, as you've mentioned. They need to be followed. They need to be fairly strict. They need to be understandable and executable. But the other part of it is the training that goes in place. When you have turnover and you're bringing on a new person, consistency in training is important. If you've got staff that is staying, that has trained a lot of the staff, and they have a set training program, that's helpful and certainly is something that should be executed. What I see a lot of practices do is leave the training of staff to other members of the team that are doing the same thing. While it's helpful to have those members of the staff communicate with their counterparts to give them hints here and there, they are probably not the best training folks.

So you want to make sure there is full training and understanding of what's being done, because often task-oriented workers don't understand the bigger picture, and that hinders the overall training and understanding of what's happening. Videos are a good thing. They're fairly easy to create these days with the technology that we have, so that people coming into the practice have a required set of training protocols that they need to go through. So train, have the protocols, and then the last part is the enforcement. It's having some measurable evaluation of those individuals to make sure that they are accomplishing what they're supposed to relative to those protocols. Train, protocol, monitor.

[16:57] Scott: I think that's great advice. My second question is around the audits and the UPICs and the RACs. When there are takebacks happening, is there any wiggle room at all to go back to the manufacturers if you made these errors? If you're out the drug money, is there any way to recoup that?

[17:17] Mark: Not really, is the easy answer. Technically, as you get those services you've billed for, you're only billing for costs incurred. The manufacturers might be able to help. Maybe they've got experience with others of their clients that have gone through the same thing. They might be able to provide some guidance and maybe some labor to help prepare those things, because obviously they want you to keep using their drugs. Some groups have had some ability to set up time payments and things along those lines. But generally speaking, the invoice is the invoice once that is done. Certainly there are manufacturers that have put together protocols and procedures and checklists, and they may have services that help do prior auths and figure out how to get additional money in place, to get grants to cover those if they ship to the patient. But it's not about getting a refund; it's about finding another way to get that revenue back, or to get revenue from another source. That really is where they help.

Bringing Zusduri into the practice: probe, then launch

[18:37] Scott: Makes sense. The final question I have is when you're looking at bringing a new therapy on board, and let's just use our case study. If you want to bring Zusduri into your office, can you walk us through the basic things you're looking at and how you would approach it? I think a lot of people are maybe sitting on the sidelines, waiting and trying to hear what others are doing. But if you think a therapy is good for your patient, and Zusduri has its own unique treatment for a specific type of bladder cancer, and you think that's beneficial, how would you go about bringing that into your practice?

[19:22] Mark: We're at a point with Zusduri where things are a little bit different. Obviously, we're past the initial phase of the unlisted drug code and the WAC pricing. We're now to a point where we have a J code, J9282. We've got an established ASP, and we've got an IFU, or instructions for use, that has a specific indication from the FDA. When you look at all of those, Medicare is pretty much a slam dunk with traditional Medicare. We need to make sure that they meet the requirements, that it's recurrent intermediate-risk non-muscle-invasive bladder cancer, and that ultimately we're in the right stage of treatment for that. If you've met those qualifications, then Medicare at this point in time should be relatively automatic.

Now, we did have one of the MACs out there that misloaded an NDC number, so payments were a little bit slow. But generally, coverage is good within Medicare. So you're looking at indications and checking to see if there are any NCDs or LCDs or LCAs, and there are not any. They're just general about following the labeling. If you're going off-label, that's where you need to slow down and take a look for Medicare. So we'll just stick with on-label use at this point in time.

Now, when you look at expanding this to your other payers, you want to check your contracts. Are you based on Medicare? Do you have a pathway to follow those Medicare payment guidelines with a commercial payer? And then, at least for the first two, if you can do a predetermination to see what your reimbursement's going to be, that's the next step I would take with the first couple that I do for a particular payer. If the pricing isn't going to work, then you might need to go back to your contracting to make sure that those adjustments are made ahead of time. If you can't do a predetermination and really see what the reimbursement's going to be for a particular payer, then I would start off with one patient, try it out, see what the reimbursement is, look for the expected payment.

Hopefully, somebody else in the market has already submitted it, so the payer has the processing set up. If another group in your market has not tried that with that payer, it may be a little bit slower. But follow it all the way through with one or two. With some of these drugs that require multiple treatments, where you start a patient on a pathway and they've got a few doses to get, you might want to stick with one. Go through that process, make sure it works all the way through and you get your reimbursement before you start adding other patients. So essentially, probe and then launch. And then, of course, do you have neighbors and friends, have you found out in the UPT network that things are flowing smoothly? Don't ignore your network of urologists who are doing the same thing to get information on how payers are doing things. They may not give you the exact pricing, but if the drug's being processed and paid at a reasonable rate, that's where you get some information to go ahead and start jumping into some of those other commercial payers.

[22:55] Scott: Ray, any comments, questions?

[22:57] Ray: No.

Sponsors and final thoughts

[22:58] Scott: All right. Let's wrap this episode up here. We want to thank ModMed and UroGen for supporting this episode. If you're in the market for an EHR or a practice management system, you can go to modmed.com/prsnetwork for specials for our listening audience. And for Zusduri support and tools, you can go to zusduri.com. All right, let's get some final thoughts. Mark, any final thoughts today?

[23:28] Mark: We've touched on a little bit of a lot today. In summation, I think that from the clinical side of the equation, understand your drugs, how they're utilized, and build your documentation to support it, because it is both pre and post that you need to make sure that you are going to get and keep that money. So build your protocols, build your orders, build your electronic medical record, build your communication, and build your support infrastructure so that you are confident that, one, you're going to get paid, and two, you're going to keep that money. And then the second piece of this: double-check things as you go through that.

Again, we're getting a lot of look-backs at this point in time. UPICs, medical record requests, RAC audits, they are burying your revenue cycle management team in a truckload of work. The more you can streamline that by building all of this up front, so that your team can grab the records and push them out the door because they're confident that all the I's have been dotted and the T's have been crossed, the better off you're going to be.

So leverage all of that across the board. This is one of those areas where the wheel of fortune, as Ray dubbed it, the circle of life with revenue cycle management, whatever you want to call it, everybody has to play their part, and that's true more and more. The focus now on fraud and abuse, and the takebacks, and the re-reviews, and the waste in the marketplace is being turned up to 11, to borrow a phrase from Spinal Tap. It is really something that we have not seen before. We're seeing RAC audits for services provided earlier this year. We've never seen that before. So it really is turned up, and without that solid clinical support, we're not going to win RAC audits, we're not going to win record reviews. Having everything else in place is not going to overcome the miss on the clinical side of it. So make sure the clinical is there, make sure the administrative is there.

The last thing I will say is monitor your EOBs. Look at everything. Some of these takebacks are coming in under the wire with weird denial patterns. Look at the payment levels. Make sure you're collecting from your patients or you're getting your secondaries in place. All of that is very important. We're working on thin margins here, and a well-oiled machine really is a piece of it. And I would say, yes, leverage AI, but boy, you have to babysit it. It's a tool. Anything that doesn't fit into the right bucket as it's getting trained is not going to be covered. So monitor, train, protocols, build your templates. All of that is absolutely required in today's market.

[26:43] Scott: Ray, final thoughts?

[26:44] Ray: Two things. One, I want to emphasize that Mark and his team have been and are being very successful because, and Mark, you can correct me if I misstate anything, they build protocols, and they monitor those, and they update them. We're fortunate that we have a lot of data input from practices around the country and from things like the UPT group. But it's important to have good protocols. It's important to be sure you have staff that knows how to use them. And last but not least, you have to monitor to be sure everything's working correctly. That's, I think, the reason that PRS has been very successful in the RCM arena: we double-check in the beginning and double-check at the end. The second thing is, AI is being used by the payers, and that's what's racking up, no pun intended, all the audits, because they can do it much easier and they can identify potential profit.

[28:02] Scott: I also want to add that knowledge is power, as we have said over the years, and information is power. One of the things we've put together is our PRS Coding and Reimbursement Hub. On that hub is information on categories like kidney stones or bladder cancer, so we have the category information on what you need to know in order to get reimbursed at the proper rate. But we also have partnered with industry to bring information about products, and how specifically, as we talked about with Zusduri, these products are reimbursed. We have individual web pages on the hub for those products that you can go read and understand that information before you bring these new technologies into your office.

Because the new technologies are there to help the patients, and we want to try to make the reimbursement hurdles as small as possible. That's what the hub is set up to do, and to make sure that the practices out there do put in the protocols and the procedures with the right information. We also have our CodeMatrix guides set up, and they're free to download. You can go to prsnetwork.com/urologyhub. There's a lot of great information, and we're adding more every week. So we encourage you to get that knowledge, get that information, put it into your practice, and add more tools to your clinical toolbox with the technology out there. All right. That's all we have for today. Thank you all for listening. Take us out, Ray.

[29:58] Ray: Happy coding.


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