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Phillip Koo: Hi, my name is Phillip Koo, and welcome to UroToday. We're kicking off a special educational program where we're focusing on how you operationalize and integrate a Lutetium-177-PSMA program into a large urology group practice. For the first segment, we're kicking off by talking about how you make the decision and figure out the next steps in actually standing up this program. And we're very fortunate to have with us Bill Oresick, who is the director of clinical services at the Summit Health Cancer Treatment Centers. Welcome, Bill.

Bill Oresick: Thank you.

Phillip Koo: So to kick things off, I think first, a group needs to make the decision whether or not to go down that path or not.

Bill Oresick: Right.

Phillip Koo: So can you talk to us about how you guys made that decision to start up an RLT program?

Bill Oresick: Sure. So it's similar to launching any kind of service line. First, you just want to take in a lot of information. You're going to talk to the folks from the company, you're going to talk to peers that have launched a similar program. You're going to review the literature about the efficacy of the drug especially. But assuming that everything looks good, and in our case it did, you're going to sort of do a cost analysis in terms of, A, what do I need to buy in terms of capital equipment, what's the staff time that's going to be required, what's the licensing that's going to be needed, and what's going to be the impact to the overall flow of my clinic.

Phillip Koo: So you guys clearly made the decision to move forward with this.

Bill Oresick: Yes.

Phillip Koo: Talk us through all the steps that you took to get this ready for a go-live.

Bill Oresick: Right. So the first step would be there was a full business analysis done in terms of looking at what are the codes that we're going to bill, like I said, what do we need to purchase, et cetera. Once we did decide, we did have to purchase a few things that I mentioned earlier. We had to put in place our policies and procedures. So how are we actually going to treat this, do it safely and implement this in the clinic? So the two big recommendations that I would make to any practice going down this road is, number one, get yourself a qualified physicist with a nuclear medicine background who can really guide you on some of the safety and the program implementation. And number two that we've found incredibly valuable is to hire, if you don't already have one, a nuclear medicine technologist who can sort of work just on a daily basis, come in on injection days. They're really pros at this, and they can do the parts that are outside of your comfort zone, make the day go a lot smoother and make it much safer for your patients.

Phillip Koo: That's great words of wisdom. Number one, the physicist is, I could attest, so valuable. Radiation safety, so many pieces that they provide. And the nuclear medicine technologists I think are wonderful and they really understand this space of dealing with unsealed sources of radiation. So then let's talk about a little bit about authorized users. What did you have to do to your RAM license and how did you identify the authorized users who are the ones, at least in New Jersey, who actually have to inject the drug?

Bill Oresick: Right. So there's two different routes you can take. So luckily for us, we had physicians on staff through our radiation centers that were qualified to be authorized users. Now, it's going to differ in every state, but in New Jersey you need to have a certain amount of hours of experience with this either in your schooling or professional training. We had somebody on staff that makes it easy.

The other option would be to just bring somebody in on a daily basis who is qualified to do this procedure. So I know a lot of urology groups have radiation centers that's sort of a natural fit. With the guidance of our physicist, you apply to the state, you have to attest to the qualifications of the authorized user. And then when the state approves all that, then you're good. They're added to your... Or I should say you're given a license to inject certain isotopes, and those authorized users are listed on that license.

Another tip from experience is put multiple authorized users on your license. It's always good to have a backup. You don't want to have to delay patient care because of a physician vacation or a change in staffing. So we've usually added one or two of our locum physicians or other physicians in the practice as a backup.

Phillip Koo: So when we toured your facility, I think we saw that the capital investments were relatively small, but I imagine for certain practices it could be a lot larger depending on what their physical space looks like today. Just to stay on the theme of financial considerations, I think dealing with these drugs that are high cost and have a very relatively limited short life, how do we mitigate the risk with regards to this? Because it is a high risk type of venture.

Bill Oresick: Yeah. So like you said, the equipment cost is relatively minimal. The real risk in this is with reimbursement. So if you're not doing everything right on the billing side because it's a high cost drug, you could eat some heavy losses. So we say tread very carefully. Trust your billing team and your rev cycle folks. Bring them into the process from the get-go. They should be doing investigations on all the codes, double checking your payer contracts to make sure that those will be covered services and reimbursed as expected. And then I like to walk before I run. We sort of micromanaged every claim until we are confident that we were getting paid. So maybe start your first injection day with one or two patients with payers that you're comfortable with before you really open the floodgates.

Phillip Koo: And is it safe to say that your experience thus far has been positive?

Bill Oresick: Very positive, yes.

Phillip Koo: So moving forward to other logistical considerations, what are we missing? What are the other pieces that practice leaders need to think about before going live and moving forward with this program?

Bill Oresick: Consider where this program fits into the overall flow of your clinic. Talk to your physician champions who really can give you an idea of what your patient load is going to be. You don't want to launch this program and find out that you're treating one patient a year. It's probably not logistically worth it. So have a good estimate. We've set aside set it two clinic days a month for our radiopharmaceutical mornings. And we have the staffing allocated, we have the physician time, we have the physical space allocated, so it flows nicely.

Phillip Koo: So, the PLUVICTO program has been very successful for your practice. Can you talk a little bit about the pre-auth process and how you mitigate that potential risk?

Bill Oresick: So we have a dedicated team at our practice for advanced therapies, and this falls into that team. So in addition to our clinical navigation team, we also have a clerical navigator. Now, that clerical navigator really takes the lead on patient enrollment, prior authorization like you discussed, scheduling and just management of that patient's flow through the clinic. So the first thing that'll happen if we identify a candidate and that they've met with our physician and want to move forward is they'll meet with that navigator. He'll have them fill out all the enrollment paperwork. We'll get all their insurance submitted, verified, discover whether or not prior auth is required. And if so, he'll work on that right away so that we're not delaying anybody's treatment waiting on that.

Phillip Koo: So there are clearly lots of pieces to this puzzle, but it's all very doable.

Bill Oresick: Yes.

Phillip Koo: In terms of FTEs, in terms of employees, did you have to hire up or hire additional resources in order to make this a viable?

Bill Oresick: No, we didn't. I mean, it really fell within the wheelhouse of our existing team. I mean, to give a time estimate, I mean, I would say this is something that our clerical navigator is probably spending anywhere from one to three hours a week when we're talking about maintaining existing patients. And maybe three to five hours if we're doing a new enrollment. It's not a huge time commitment either. And on the nursing side as well, because it's only two days a month. It hasn't required additional staff beyond the nuclear medicine tech we talked about who comes in on a per diem basis.

Phillip Koo: So looking forward, clearly you've had experience with Radium-223, now you have PLUVICTO, and the radioligand therapy space is obviously a very hot topic. How do you foresee this larger space incorporating into your multi-specialty oncology practice?

Bill Oresick: So it's been very beneficial for us. I mean, our goal has always been, and I think the goal of many groups like ours, has been that from diagnosis to end of life that we can sort of offer everybody, everything that can be helpful to them and have select partnerships with medical oncology for the few things we can't. So as our arsenal grows, I mean it really does a lot of good for patients. And this was a space that we didn't really have a lot to offer in the past, and our patients have done really well with it.

Phillip Koo: Well, we appreciate you sharing your experiences with us, and we really enjoyed seeing your facility. And I think it really inspires a lot of people out there to investigate and figure out whether this works for them or not. Thank you.

Bill Oresick: Thank you.