Matthew Ong: What do you think of the draft guidance by the subcommittee? What are your general impressions?
John Stewart: It was striking. I looked at things through a holistic value-based care model where we provide the right care to the right patient at the right time.
So, absent having next-generation sequencing, we’re basically giving undirected chemotherapy, or limited chemotherapy.
In other words, we would recognize that a patient had, for instance, an ER/PR+ tumor and that will result in one therapeutic approach. If that approach fails, we move to second-line therapy—again, that is kind of an empiric therapy.
Now, what next-generation sequencing does is it allows us to understand specific drug targets that might work and will allow us to get to that appropriate next line of therapy that is tailored for that patient.
And so, what this ruling would do is that it potentially prevents us from providing tailored therapy to patients.
Specifically patients in Oregon who rely on Medicaid.
JS: Exactly.
Their recommendation is for non-coverage of NGS tests for solid tumor tissues, because they say that there is no direct evidence of clinical utility for patients with advanced solid malignancies. Is this true?
JS: The emergence of personalized medicine speaks to the necessity of there being next-generation sequencing for patients that move beyond first-line therapy.
I will tell you that this is particularly interesting to me, not just from a value-based care model, but also, this would create a system where a group of individuals, based upon their socioeconomic status, do not have access to state-of-the-art care.
So, what we’re doing is we’re creating a treatment divide that, again, is based upon socioeconomic status. Now, I think that there is a moral imperative for us to better understand their reasoning behind this ruling.
I could not see specifically who was on that advisory board.
Vinay Prasad is the chair.
JS: Who? Vinay Prasad? I don’t know him. Is he an oncologist?
He’s a hematologist-oncologist at the Oregon Health & Science University. He debated proponents of precision oncology this year at both ASCO and AACR, saying that genome-informed cancer medicine is “mostly hype.”
JS: So, he clearly had a pre-formed opinion about this?
I’d say so. He made it quite clear in his presentations, saying that there’s some benefit, but it’s mostly hype.
JS: He had a pre-formed opinion, so he probably should’ve recused himself from the conversation.
Since the subcommittee concluded that there is insufficient evidence, do they think that CMS made an error when it issued the National Coverage Determination for NGS tests? From what you know, is there evidence of clinical utility?
JS: In terms of citing specific data points, I don’t have that in front of me, if you gave me a day or two, I could pull it up. But, like I said, the fact of the matter is that we have the ability to understand what the appropriate treatment regimens are for patients based upon genomic data.
The unwillingness to provide patients with targeted therapies based upon their genetic profile, I think, is unconscionable.
If you read through that draft guidance, what it basically said is, “Yeah, you know, many of the people who have stage III and stage IV disease are ultimately going to become disabled, and then they will go to Medicare. Let Medicare pay for it.”
Yes, that’s what some of the [subcommittee] discussion [in the meeting’s minutes] essentially said.
Why would policymakers push patients toward Medicare, when you can pay for them now?
JS: Yes, and so again, it really gets to the value in medicine question of providing the right care to the right patient—at the right time. It’s not cost shifting, right?
Because what they’re looking to do is to cost-shift to Medicare.
How is that the right thing to do? How would treatment be effective if you wait for patients with metastatic disease to become disabled?
JS: That’s a zero-sum game, there. It is unfortunate.
How does it make sense for patients over 65 to get coverage for NGS tests, but not for low-income patients via Medicaid?
JS: It does not make sense. The logic to me behind that is, “It’s okay to be elderly and sick, but it’s not okay to be poor and sick.” That’s how the draft guidance reads to me, because you won’t have access to state-of-the-art diagnostics.
Would this exacerbate disparities?
JS: Yes, it would. It would create a therapeutic divide between patients with high socioeconomic status and patients with lower socioeconomic status.
If this becomes real policy at some point in Oregon, does it set a precedent for Medicaid programs in other states? Do you know of any other state Medicaid program that is trying to do this?
JS: It does. I don’t know if others have done it, but the precedence will surely follow. So, if we think about states that did not expand Medicaid, then they are at real risk, because they will tend to have straps on Medicaid budgets.
And they will try to cut any coverage if they can find a rationale for doing so?
JS: Yes.
What about private insurance companies? Will they also use this as an example and say, “Well, why should we pay if Oregon doesn’t?”
JS: Most private insurance companies kind of base their decisions on CMS decisions. I don’t think that it will have a sustainable impact on private insurers. If private insurance companies try to challenge this, then there’s a CMS coverage that will be able to provide a fallback. Very rarely do state Medicaid decisions provide coverage fallback for private insurance.
If this does happen in Oregon, does it have any implications for research in precision oncology in the state?
JS: The proposed policy concerns me at a state Medicaid level, both locally and potentially nationally. This is potentially an assault on the treatment of underrepresented populations with cancer.
