Payer perspective regarding decisions for covering the costs of molecular assays in oncology and reimbursing oncologists for treatments provided to patients while navigating long turnaround times associated with reflex testing.
Bruce Feinberg, DO: Eugean, I think in the community it's not quite that simple. The fact that the guidelines give some room but a clinician, who maybe is not thriving through that first cycle, is trying to make that determination. Am I going to proceed with this closing window of opportunity and give that second cycle or not? It also puts pressure on a payer because now there's no time for the prior authorization. And they're going to want an answer from you and you're going to be getting calls daily or multiple times a day. I've got this patient, it's an extreme situation. It's difficult to have guidelines when realities of patient care don't really fit the guidelines.
Eugean Jiwanmall, MPH, MBA: I'm going to answer this from a process perspective, and I think it's going to be there. But before that let me say a couple of things which I think will put me in good graces with my fellow panelists. When it comes to reflux testing depending on the situation it's not unknown. I want to put that out there that the situation we're talking about, reflux testing does get looked at from a critical perspective and depending on the situation is it won’t be that we're never going to cover, so that's a good part. The other part I'm going to put leverage upon has more product regarding NCCN [National Comprehensive Cancer Network] guidelines because we are speaking to proposals that are heavily involved in oncology world and NCCN is there.
When it comes to NCCN guidelines, they have different levels, everybody's familiar with them, you have level 1, categories 2A and 2B, and 3. So, depending on what evidence that they are based on, the references that they're basing it on would be from a therapeutic perspective something that my organization honors, and as we build our criteria and guidance, that is a specific resource that is valued and is honored across the board.
When it comes to the biomarker world, that's why I want to make the distinction. When it comes to the therapeutic portion or the intervention portion anything 2A and above in NCCN guidelines, no question asked, go ahead and do it, it's approved. When it comes to the biomarker world, things are not as certain. They don't give specific designations first… so we have to take into consideration time such as ours that wholeheartedly are they endorsing it? Or this thing maybe could be is it a definitive and then we have to go back to reference what Kenna was saying. How are you going to bring in the evidence piece? Some users for example, you look toward the reference for it but come to the emergency that we are talking about here.
As a payer at the health care management company, ….the turnaround time is within 14 days, and we can do it in 8 days. We have to worry about the quality assurance piece too. Just so you know, what you have been talking about in the past 10 minutes is extremely relevant, and we have to make that decision to go with this particular dietary lab because they're bringing in that clinical value [within turnaround times.]
All of these are relevant things that we must deal with daily too. We can only go back to the reliable data in order to make those decisions. But returning to your point, Bruce, from a process perspective it's not always going to be this is only prioritization. Even if we have a vendor that is looking for utilization management in this particular space, and we do, I think majority of suppliers do at this time. There's also peer to peer involved where somebody like Mark [G. Kris, MD,] is going to be or his or her patient, they are going to be on the phone with another physician on the line who's working for these different companies that actually are going into that particular space. That process is in place when there's an immediate urgent peer to peer, and don't quote me on this, but throughout the time depending on the urgency of the situation so it's not going to be 6 o'clock in Philadelphia vs 3 o'clock somewhere in California, so you're not going to get access to it. That's not the case.
Tools, mechanisms have been built in. And again, I'm not speaking for the whole marketplace, but I am because I'm the only one on here from there. It's hard to plan. Some plans call it on a case-by-case basis. Some plans call it an exception to the policy. Depending on who you're speaking with they have different terms. But the underlying thing is that there are built in processes across the board, even if you're dealing with a vendor, not directly with the plan, but a vendor of a plan that is a space where there's actually a payer to payer discussing all of these things. And I would like to bring in this part, and hopefully this will get me friends on this panel, is it's also off label usage. It's off label usage. It's not always that it's regulatory approval. We have policies in place where compendia are used and how that would actually impact and even if somebody is going to be put in a clinical trial, those policies are in place as well. So, all these considerations are considered in an emergency and there is a live conversation and discussion that happens to look at that case.
Transcript edited for clarity.