BCG Shortage An Update - Jonathan Rubenstein

May 4, 2019

Neal Shore and colleague, Jonathan Rubenstein provide an update on the advances and developments that have been communicated in regards to the truly important challenge of BCG shortage for the use of patients with a high-risk non-muscle invasive bladder cancer.

This is an international problem. In a previous program Neal Shore, Ashish Kamat, and Jonathan Rubenstein talked about alternative dosing and how to properly code for that. In this session, they provide updates on that, courtesy of Jonathan Rubenstein's great work on this as a consultant for the AUA, in his role as an expert in coding and as a senior partner at Chesapeake Urology. 


Jonathan N. Rubenstein M.D., Clinical Associate Professor, Department of Surgery, University of Maryland School of Medicine and is the Chief Compliance Officer, Chesapeake Urology Associates. Dr. Rubenstein is also the Chair of the American Urological Association Coding and Reimbursement Committee (CRC), a Member of the Regulatory Affairs Committee, American Urological Association, a Member, Telemedicine Committee, American Urological Association and a Member, Electronic Health Records (HER) Workgroup, American Urological Association. He is also a Member of the Laparoscopic Robotic and New Surgical Technology Committee, American Urological Association and an advisor representing the AUA on the American Medical Association, Alternate Current Procedural Terminology (CPT).

Neal Shore, MD The Medical Director of the Carolina Urologic Research Center. He practices with Atlantic Urology Clinics in Myrtle Beach, South Carolina.

Read the Full Video Transcript

Neal Shore: This is Neal Shore and I'm here with my very good friend and colleague, Jonathan Rubenstein. We want to update you on some of the advances are and developments that we've now been communicating on regarding this truly important challenge of BCG shortage for the use of patients with a high-risk non-muscle invasive bladder cancer.

And it's not just a national US problem, it's really an international problem. Previously we had a program where we talked about alternative dosing and how to properly code for that. We're going to give you some updates on that, that's really courtesy of Jonathan Rubenstein's great work on this as a consultant for the AUA, in his role as an expert in coding and as a senior partner at Chesapeake Urology. 

Additionally, we've previously talked about alternative therapies on a prior program we've done, when you don't have BCG in particularly using intravesical chemotherapies, one of the things that we've really come to recognize now is in the United States, we only have one manufacturer of BCG. We used to have two, we only have one now.

And in my conversations with them, they have absolutely maximized their capacity and their production. They have one facility, and it's a rather complex process for the BCG production. And so getting the opportunity to have additional production from outside sources or even within the United States, there is a regulatory process that has to be navigated.

It's very clear that the AUA and the Bladder Cancer Advocacy Network and LUGPA and SUO are weighing in the importance of addressing this shortage for our patients. It's really becoming a national healthcare crisis for patients who have high risk, non-muscle invasive bladder cancer.

We've talked previously about splitting the doses going to a half a dose or from one vial or a third of a dose. We've talked about curtailing the maintenance from the standard recommendation of three years to possibly a year.

But I think really what's important in this program today is to hear Jonathan Rubenstein explain to our colleagues, especially whether you're in academia or in the community is, “If I'm going to consider not using a full vial or a full dose how do I code for that? And what are the implications for reimbursement and what are the potential concerns regarding doing the process correctly to avoid the risk of being audited.” So Jonathan can you weigh in on this concern and some of the new developments that happened since our last conversation? 

Jonathan: Neal, thank you very much. So since our last conversation, obviously the main concern is, if we will be splitting doses of BCG and giving one single vial between two or three separate patients, is that something that regulatorily wise is okay to do and how's it done? But also can we get reimbursed for it? And what do insurance companies and especially in this case, we're going to talk about CMS and Medicare, what they think about it. 

So we have been in discussions with a number of people, a number of medical directors and again, the challenges still remain very similar to how they had been. CMS did tell us that splitting a vial of BCG and billing for the portion of the vial used would be consistent with CMS policy but also recommended that the medical directors of the various carriers, need to sign on for it. And also that we would need to see that in writing from the carriers before trying to bill and get reimbursed for the BCG. 

And that's where we've run into troubles obviously, medical directors are probably concerned about how the BCG is delivered and the efficacy of BCG before they agree to allow split vial billing. CMS did also say that the practice should not bill for entire vial if only a portion of a vial is administered. 

So if somebody does administer a portion of a dose and split a vial between patients, they should not be billing it to J9031 code for each one of the patients if they're trying to bill a full dose. Because as of right now, J9031 is for one full vial of BCG.

The American Urological Association did reach out and through some of their work, has actually gone to CMS and the HCPCS which is healthcare common procedural coding system work group got together and they decided due to this controversy that their code J9031 actually will go away on July 1st, 2019 and will be replaced with a new code with a descriptor for J9030 which should be one milligram of BCG live intravesical therapy.

So that will potentially help with split vial dosing in the future, if it ever comes to an agreement on how to actually bill it and whether contractors do believe that it's safe to do at least that's one step in the right direction. However, unfortunately until we get it in writing, we still should not try and bill J9031 if we're splitting a vial at this point. 

We're continuing to work, we're continuing to reach out to regulators and to reach out to payers and to see if we can get them just to really understand the gravity of the situation and to agree that split vial dose billing is not really consistent with policy but a safe and an effective for our patients. 

Neal Shore: Well that's a great summary, Jonathan. Thank you. We're making progress but it's still getting the various carrier directors to understand and agree with that new J code and you did mention this, the concept around agreeing to clinical trials or perhaps evidence that reduced dosing or limited maintenance dosing would be acceptable but frankly, we don't really have that luxury.

There are patients now who are not receiving BCG because they're in a clinical situation, whether it's an academic practice or a community practice where there's just no longer drug available. And what's become clear is the production is at capacity so we have to be judicious and realistic I think in terms of maximizing the material, the vials that we have.

And there are clinical trials they've been published previously in Europe, some in the United States, which demonstrates the efficacy of reduced vial utilization. I think this is being supported by key opinion leaders within Beacon and AUA and SUO. The key point as you say, we've done this previously we've reduced dose and cut down and vials for tolerability.

We're at this critical juncture now where you getting a third or a half of a dose is certainly better than getting no dose at all if a practice cannot access product. Other ways to get product through sources outside the United States or Pretax, another manufacturer in the United States don't seem to be a quick short term solution, I think there'll be a long term solution.

But all the information that you just spoke to this new J code getting not just CMS to sign off on it, but all the different carrier directors to agree to it so that we can optimally treat our patients is really where I think the house of urology has moved towards. 

Jonathan: Right Neal, that's a great point and the other thing is we discussed earlier if we believe that Merck is at full capacity, I know that they've worked hard to get as much BCG in production as possible. Someone asked me, “What about if they made one third size vials?” And then build it that way. 

To me, that is risking for only creating one third as much BCG, whereas if one could then split one vial into three separate doses of BCG, that way you can maximize the amount of BCG administered to individual patients. So that again, while that question had come up it doesn't sound like that would be the right direction to head for this crisis. 

Neal Shore: I fully agree. I think there's a regulatory burden for doing that sort of a manufacturing process that we would take a great deal of time to successfully achieve so I think that point is really well taken. So Jonathan, thank you so much, thank you for all the hard work you're doing and from a regulatory and coding standpoint.

There are a lot of folks who are working on this issue, this has really become, it is truly a national healthcare issue in the world of urologic oncology and especially for our patients who require the therapy. I really appreciate it and we'll keep everybody updated with future developments.