Genetics - Extra Testing, Passthrough or Money Maker?

Danielle Soltesz of RMA New York discusses the complex economics and ethical considerations of genetic testing in reproductive medicine, exploring costs, patient care, and sustainability.

Hi everyone, my name is Danielle Soltesz. I'm the president of RMA of New York and also a new member of the U.S. Fertility Team. I'm also a proud member of the ARM Board, which is the Association for Reproductive Managers, and I'm honored to be here today to talk about pass-through testing or extra testing.

Is it a pass-through cost or a moneymaker? Or depends on who you talk to because it could also be a money loser. In a lot of the conversations I had in preparation for this talk, it's so interesting because I feel that this is a leading question, right, extra testing. But I think we also have to talk a little bit about pre-implantation genetic testing and what that means and how our industry has changed significantly over at least the 11 years that I've been in it.

And as I talk to colleagues, I know it's a very different field than it is today. I think our field is different also because there is also now private equity in our industry. And in many of the talks, I was a moderator at the Business of Medicine talk, and it was very interesting some of the dialogue and conversation in regards to whether or not there is this push and increase in PGT testing or expanded carrier testing due to the changes in our industry.

And it was a very interesting sort of sidebar conversation, but I think it's very relevant for the topic that I'm talking to you guys about today. I also sat through an amazing course on Sunday where Teresa Cacchione, one of our genetic counselors at RMA New York, talked about the improved clinical success that comes along with being able to offer this extra testing, right? So I'd be not myself to not say I could just talk about the business side because we know that this is much bigger than that, right? There's a very big picture of the clinical significance of this testing and what it can offer to our patients. However, this is a business, right? Every practice in order to be able to employ my three amazing genetic counselors, my nurses, my physicians, we need to make money in order to be able to do that.

So what defines extra testing? So I found an interesting article that was published earlier this year that according to Markets and Markets, the PGT industry is poised for remarkable growth. So from $0.7 billion to $1.2 billion by 2028. And this was, you know, through many different sources.

You get a little bit of a different number, but that's a significant amount, right? And I think from the clinic side of things, there's one perspective. And then there's the lab side and whether or not they would deem extra testing or genetic testing as it relates to PGT as a true moneymaker. I think there's been a tremendous amount of instability when it comes to genetics.

I hear NYU as a fellow New Yorker talk about, you know, some of the struggles of changes in labs and how that changes our operational processes. And so I question, you know, if we were to speak to people on the lab side, you know, if they would maybe say, is this a money loser? Is there so much investment in terms of the evolution of the technology in the resources that are needed to provide an adequate care delivery model that this is maybe not the most profitable? But according to the industry, it's a very profitable one. So what is driving the growth? Technology, as we talked about, it is growing tremendously.

We know it is not going to stop. I sat through a very interesting topic on the innovations in what is available. I think PGT is going to be very interesting for what it may bring to the industry.

And I learned a lot and was educated a lot about these additional opportunities or PGT complete or all these new products that are innovative and are going to evolve and adapt our field. Increase awareness from our patients, right? There is a demand, particularly being in the New York City market. We have highly educated patients by and large, and they're saying, I want this testing.

Is it clinically indicated? How do our physicians make these decisions? It's very interesting. And there's just an increased demand overall. According to SART data in 2019, PGT was down in 44% of cycles.

We all know that it's significantly more today. But the interesting portion is that looking at the programs that do a high number of PGT versus programs that do a low number of PGT, and how that difference may be based on geographic region, based on affiliation, all of these different things. But I think what many of us stand behind, at least at RMA New York and our practice, is the success rates, the lower multiple rates, the ability for us to screen out certain genetic conditions has been really powerful.

And we've seen many success stories. So, you know, what are the different models that exist from a business standpoint? I think it's important that we call out the regulatory and compliance component, right? Different states have different rules and regulations about what you can do for pass-through costs. Can a clinic charge a patient directly for the biopsy fee directly? You know, that's a service that they're doing.

So, yes, that's always allowed. But when it's not a service that you are directly performing, certain states allow you to pass through, and certain states say that that needs to be billed directly from the laboratory. And so I encourage everyone to look into what the state that they live in or that they work in, or some of us have multiple states, and what does that look like? There are different products that we talk about in terms of financing opportunities that can bundle different genetic testing services together.

And that can look like a, you know, PGT, patients can do as many embryos, right, until they achieve a live birth, and you can charge a certain rate for that. And we know statistically how likely, how many cycles it's going to take the average patient to get pregnant. And that is a business model, right? You can make money on these concepts.

But is it ethical? I think that many of us talk through the pros of what it offers to a patient, a program where they're able to know it's going to be one fee, and no matter how many embryos it takes, it's going to be one fee, and they can budget and they can get behind that. But the reality is, from a business standpoint, that is likely a profit-making opportunity for a clinic. The other thing that clinics can do is they can charge a coordination fee of some sort, right, for the services that are required as it relates to genetic testing or these genetic services.

And there's a great opportunity there. There's also, from a clinic standpoint, the biopsy itself, there's different models on how people charge for that. You can charge for per embryo biopsy.

You can charge for a certain number of embryos at scale, or it's one fee no matter how many embryos you have. And so there's a lot of different philosophies as it comes to that. But there is opportunity to ensure that, on the average patient, you're not losing money, right? The skill that's required by the embryologist to perform that biopsy, that is the highest skilled level of an embryologist.

And that costs money to the practice. And so I get back to, is this really a moneymaker? Or is it, you know, are we breaking even? Do we actually know the hard costs that it costs us for the average patient? I think we all know the average number of embryos created for our patient populations. But I would argue that there's a lot of unrelated costs that sometime are indirect costs that we're not looking at as it relates to genetic testing.

There's also, you know, the genetic counseling component. So at RMA New York, we employ three full-time genetic counselors, and I wish that it was like six. There is so much that goes into taking great care of patients, both from, you know, pre-counseling to once you get the results of the counseling of the testing and what the treatment plan is.

I think that our providers feel greatly supported by having in-house genetic counselors, but I know that that is not the model of everyone. There is also a big difference in ability to bill for genetic counselor, genetic counseling services, and it depends on the state that you're in, of whether or not they can bill directly or they have to be under a provider. And so that's a whole other added cost that a lot of people may or may not be looking at.

So I think as you can tell, my position is I don't think there's a direct answer to the question of whether it's pass-through, whether it's a moneymaker, or is it a money loser. But is it the best thing we can be doing for our patients to provide a robust offering of these different services? I would argue that all patients should be offered all the different testing options. They should be provided the data in terms of the clinical evidence for what that might help improve in terms of their outcome and their ultimate goal of achieving a family.

And I would say we should not be as focused on making money out of the service itself and addressing to ensure that it is a pass-through expense and that there aren't all these indirect costs that maybe we aren't quantifying in the appropriate ways. So in conclusion, I challenge us all to think about, you know, what the standard of care is as it relates to genetics. I think we're going to hear a little bit more today.

What are our ethical practices? What should and shouldn't we be billing for? What is the average biopsy rate? What makes sense to your clinic and their practice patterns? What is the most compliant structure for billing in your state? And ensuring that you're keeping that in mind in the models that you're developing. And what is the sustainability of the model that we're creating? With the innovation and evolution of our field, with the instability in some of our industry, it's really important that the models that we create take into account not just what's happening today but tomorrow and the day after, and how can we create a sustainable business model that allows us to take great care of patients and increase access to care. Thank you.