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Fertility Genetics

228 The Inevitable Consolidation of Genetics and IVF with Dr. Mili Thakur and Amber Kaplun

Today’s Advertiser helped make the production and delivery of this episode possible, for free, to you! But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the Advertiser. The Advertiser does not have editorial control over the content of this episode, and the guest’s appearance is not an endorsement of the Advertiser.


Is the consolidation of fertility clinics leading to a shortage of genetic counselors required to support these expanding networks?

Returning guests Dr. Mili Thakur, Founder of Genome Ally, and Amber Kaplun, Lead Genetic Counselor at RMA America, provide their perspective.

In this episode we discuss:

  • Current procedures for genetics in IVF (and where they’re falling short)

  • What the ideal workflow should look like (for both patients and staff)

  • Why adding an in-house genetic counselor saves money (maybe even your clinic from legal trouble)

  • The 3 main ways clinics use genetic counseling (and which is best for long term growth)

Also check out these episodes that feature this episode’s guests:

Amber Kaplun
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IVI RMA America
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Dr. Mili Thakur, Genome Ally
Company Website
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Transcript

[00:00:00] Dr. Mili Thakur: Once there is consolidation has happened and then these networks are now going to start to look into the internal processes, like once acquisition happens and they are settled down in terms of what they are doing, I think I see two ways of how this is going to happen. Every practice that has to take care of their patients for the next five to ten years has to take care of their genetics.

Otherwise, they're not going to be able to be functioning. I'm 100 percent sure of that. 

[00:00:25] Sponsor: This episode was brought to you by Asian Egg Bank. Asian Egg Bank is pleased to bring you Dr. Mili Thakur , founder of Genome Ally, and Amber Kaplun, lead genetic counselor at RMA America, as they discuss if the consolidation of fertility clinics is leading to a shortage of genetic counselors.

To learn more about Asian Egg Bank, head to asianeggbank.com/for-professionals

Announcer: Today's advertiser helped make the production and delivery of this episode possible for free to you. But the themes expressed by the guests do not necessarily reflect the views of Inside Reproductive Health, nor of the advertiser.

The advertiser does not have editorial control over the content of this episode, and the guest's appearance is not an endorsement of the advertiser.

[00:01:20] Griffin Jones: Consolidation, consolidation, consolidation. 80 to 90 percent of the fertility clinics in the U. S. and Canada seem to be on their way to being owned by what will be three or four companies, and we've talked a lot about the vertical integration that is a result of that and will be a result of that. Same companies owning fertility clinics is owning genetics companies is owning egg and sperm banks, et cetera, et cetera.

But while this is happening, we might be losing the genetic counselors that we need to service the business model that works for what the field is turning into. My guests are Dr. Mili Thakur. She's been on the program before. Many of you know her background as a trained geneticist and a board certified REI.

She's a practicing REI in Grand Rapids, Michigan. She's also the founder of a company called GenomeAlly and consults with genetics companies and fertility centers. If you haven't listened to her last episode, it's about three revenue models for IVF centers as they relate to genetics. She's joined by Amber Kaplun in her last episode, which we'll also link to in the show notes.

It's about the rise of in house genetic counselors and the risks to fertility clinic networks when they don't have in house genetic counselors. The picture they paint in this discussion is one in which assisted reproductive technology and genetics. Think about the rise of both areas. Think about the untapped need for patients who are going to be using ART and why they're going to be using ART as part of why we expect this field to expand to multiples of what it is now.

With regard to number of patients seen and treated, in that world, do you still see genetics as being totally divorced from fertility treatment? I find their argument to be persuasive. So you, as someone that wants to scale and sell a fertility network, how are you going to incorporate that into your business model?

Dr. Thakur talks about the gaps in the process. Amber Kaplun talks about what the ideal workflow should look like. And in my view, this paints a more vivid picture of the infrastructure needed To support the business models, it will be able to take advantage of this explosive growth. And those that don't might lose a lot of money.

When I hear each of them talk, they're indirectly pointing to a solution or solutions that are needed in the way of workflow and technology. Think workflow software, EMR improvements, alternatives to EMRs. You hear and see a lot of those companies advertise on Inside Reproductive Health. I can't tell you which one's the best.

I'm not in your shoes. But when you listen to a conversation like today, does it not make you want to check out all of them? All of these new solutions that you hear about on Inside Reproductive Health or elsewhere, do their demos. Fill out those little forms that we run with their sponsorships. Some of them won't be up to your standards.

But we will not be able to provide patient care, manage our workforce, or be sufficient for market demands if we don't have the right tools for this integrated world that Dr. Thakur and Amber Kaplun are describing. Take this idea for a spin and let me know your thoughts. Enjoy the conversation. Dr. Thakur, Mili, Ms. Kaplun, Amber, welcome both of you back to the Inside Reproductive Health Podcast. 

[00:04:27] Amber Kaplun: Thank you, Griffin. Glad to be here. Thank you, Griffin. 

[00:04:29] Griffin Jones: You've both been on before, and it was after a prolonged period of time where I hadn't made much progress. Content about genetics and people were like, where's the genetics content?

And then I had each of you on and people yeah, I got multiple emails from people saying yes more of that So I feel like we grew a lot in in the genetic segment of the audience after each of your episodes I look forward to serving them some more growing that some more and I want to get an idea of what's happening with vertical integration And some other things, particularly with regard to genetics.

I had Lou Villalba, and we talked about vertical integration across the fertility field. We're recording this episode, I'm not sure when it will air, but we're recording it in the wake of Invitae announcing their Chapter 11 bankruptcy. They sold 10 couldn't get enough debt off their books, apparently had about a billion dollars in debt.

Filed for Chapter 11. So what's happening in the, as it regards to vertical integration with genetics right now? 

[00:05:41] Dr. Mili Thakur: The best care to a patient right now is one of the biggest thing and our patients are changing too. That is like the influx of social media. They have access to all the information they need at their fingertips.

[00:05:53] Griffin Jones: You've got changing patient demographics, you've got changing workforce demographics, and as you say, we're moving away from single center IVF centers to multi centers integrated into networks. How does that consolidation that's happening on the clinic side What effect does that have on what's happening in genetics?

[00:06:18] Dr. Mili Thakur: I can speak from the physician point of view and then Amber can speak for the genetics workforce in totality. From a physician standpoint, physicians are stretched to their bandwidth with what they can do. Do to take all these patients through they are providing excellent care as best as possible Inside of an influx of patients and a constricted workforce so they need support for all of these new genetic tests that are out there and going to be available and Amber will tell you about how the genetics field is organized right now how small it is and how we are leveraging that workforce.

[00:07:01] Amber Kaplun: At this point, there is a lot of opportunity for genetics. I think it really depends on how the private equity in these networks really choose to support or not support their genetics programs. The benefit of having clinics consolidate into a network is that if that network has committed to having genetic services, you're going to have more clinics having more access to genetic counselors.

But if networks have decided that they would prefer to outsource their genetic counseling services. Then you may be running into some similar challenges that we've been seeing historically with single centers and, and people really using these third party services versus the benefit of having an in house genetic counselor.

So I think where we move forward from here really depends on the attitudes that these networks and the support that these networks are going to commit for genetic services. 

[00:07:49] Griffin Jones: Yeah, I want to talk about that support or perhaps lack thereof. And when Dr. Decker talks about leveraging the workforce, is it because we're not leveraging technology as much?

So what I see happening on the IVF lab side is I see a few key developments that have developed in the last couple of years. Two to four years. I'm not a scientist, I'm not a clinician, so I can't say unequivocally that these particular solutions are the direction that they should go, but after talking to enough people, it really seems like the people running the labs would really benefit from having a few of these solutions, and yet, I don't see them implemented at the network level very often, or Not happening very quickly, and I suspect it's because these solutions sometimes have big price tags that I can see the value, and I could see how you could see the value on the PNL within three or four years, but, and really have a much more sustainable operation, expand your lab throughput, but three or four years, Timeline for a private equity backed entity doesn't really work.

It's too much of an expense on the, the, the P& L up front. It doesn't, you can't make it depreciate fast enough to make your EBITDA worth it when you're trying to sell it at a, at a bigger multiple. Uh, and so I see solutions that I think would be implemented if there were more. People that were growing their business for the longterm and holding the equity in their business that we would see these solutions be implemented more commonly.

That's what I perceive on the lab side. To what degree is that happening on the genetic side? 

[00:09:47] Amber Kaplun: I think that when you're talking about making the commitment for genetic services, there are challenges to it, most notably being that genetic counselors are still in the process of advocating for CMS recognition as providers.

You can bill for genetic counseling services, and you can get reimbursement at this point. But in terms of the level of reimbursement, if the bills that are currently in the House, in the Senate, were to pass, and genetic counselors would be recognized as providers, that reimbursement would increase significantly.

With all of that being said, though, Having a genetic counselor and a genetics team on your staff is already going to be a financial benefit for you because you're protecting yourself against lawsuits that could potentially cost your practice millions of dollars. We're talking about like settlements of multiple millions of dollars, and so that settlement Could cover the salary of multiple genetic counselors for many years.

So even though it may not be something that you see right up front, there are those long term savings, and there is also going to be growth that I anticipate in terms of the amount for reimbursement that we can be getting. 

[00:10:54] Griffin Jones: Having an in house genetic counselor might be something that if they're not looking in that long term view, they see it as Too great of an expenditure for their shorter term horizon.

What else besides genetic counselors? Is there certain technologies or therapies or other solutions that you're seeing not being implemented as quickly as they ought to be because People are looking at it too much as an expense in the short term. 

[00:11:23] Dr. Mili Thakur: Griffin, let's break down the whole IVF setup from a patient perspective into three categories.

So three groups come together to give patient care. So one is your clinical group, which is your doctor and the nursing staff and all of the front office and the clinical team. The second is the IVF team. where the embryology lab is working and creating embryos, biopsying embryos, sending out samples. And the third part of that complex situation is your genetic testing lab, which is outside of the embryology and the clinical practice.

From what I've seen, Amber was mentioning genetic counselors are part of your clinical team. Most of the time, physicians were traditionally the ones that were giving all the direction to the patient and genetic counselors in teams that have integration already, they would be part of that clinical team.

But advancements in all three of those. These have to be integrated to get patient the best care. The important thing in taking care of a patient who has genetic needs, you have to integrate all three. Because the PGT lab is sending the sample as directed by the physician directs and says, okay, this is what we are doing.

This is where the test's going. Lab takes those samples and sends, ships it off to the genetic testing company, which is outside of the physician and the lab's perspective. And then the lab sends out the test results, which comes back to the clinical team. However, the clinical team has to retrieve that information and call the patient back.

And then the IVF team might be the one that is thawing the embryos. And if it is an IVF situation, transferring the embryos along with the physician. So there is a lot of back and forth communication. And that's the, when we talk about vertical integration of genetics, That genetic team, which is embedded in all three of those quarters, is the one that's going to be able to coordinate the best care.

So, what I mean by that is, A genetic counselor who is part of a lab, like the genetic testing lab, which is the outside business, only sees their internal data and are able to give counseling to the patient based on the test. But they don't know what's happening in the embryology lab, they are not part of what the doctor's preferences are.

So I think advancements that will integrate all of these systems to be able to communicate better would be really important. What would make the genetic counselors the best suited for that job? 

[00:14:01] Griffin Jones: What are the barriers or what is the reluctance to integrating those verticals? 

[00:14:07] Dr. Mili Thakur: I think one of the key things is this is new.

We haven't had to deal with integration of, uh, genetics for, uh, Less than a few years, so I think all the practices, while they are taking care of their day to day patient care and also transitioning through this change between the seasoned professionals retiring and acquisitions and mergers and consolidation, on top of that, they also have to now think ahead, integrate those practices.

Systems, because right now they're in a mode of sustainability. They just want to take care of their patients. And there's a lot of patients that have to go through, and there's a lot of complex decision making that's happening. 

[00:14:54] Griffin Jones: Tell me how would the process work though? If so, and maybe Amber, you can speak to this.

If you want to have what you want to bring these teams together more, the genetics testing lab, the IVF lab. lab and the clinical team, so if you want to bring them together at the, at a company that has, by company, a clinic network that has multiple labs, multiple clinics, how do you do that? 

[00:15:24] Amber Kaplun: You're really going to have to figure out what workflow works best for your network, but it's really about being able to establish a workflow that will involve all of those people.

For example, something that I consider to be more optimal from a workflow perspective is that you have a patient or a couple come in, They meet with their physician. If there's an established need, perhaps for PGTM, that patient is then going to be handed off to a genetic counselor for genetic counseling.

That genetic counselor would then liaise with the PGT lab throughout the test development process. The IVF lab obviously comes in at the time that the embryos are created. The PGT lab does the testing, the results come back to the clinic and to the lab, and then most crucially is that discussion that happens around which embryos are we transferring, which embryos are we not transferring.

We're seeing increased requests. For transfer of PGTM positive embryos, and that's just really because our indications for pg TM are expanding. So for example, we may do testing for genes like B, rca, A one or B RCA A two, where they confer disease risk, but not necessarily a hundred percent certainty that a child would develop a condition.

So we are seeing in some cases requests to transfer those types of embryos, but there's obviously going to want to be very careful checks and balances in place if you are going to be doing that to establish, yes, this embryo is eligible for transfer at our clinic. Yes, we are transferring the correct embryo and making sure that everything goes off without a hitch.

[00:16:57] Griffin Jones: Break this down stepwise for me because I probably only followed you halfway through. And so couple comes in, that's you got your new patient visit, it's determined that they need. PGT, or some other type of genetic testing. 

[00:17:10] Amber Kaplun: PGTM, I think, is the best use case for this type of integration. PGTA, I think there can be such a high volume of patients that are going through it.

Some clinics that have in house resources will require pre test counseling, others won't. But when you have an in house genetic counselor, almost invariably people that are having PGTM are going to have a connection with that in house genetic counselor. through that process to help improve their experience.

[00:17:37] Griffin Jones: So the clinician determines that they need PGT M, that they hand the patient off to the genetic counselor, genetic counselor liaises with the PGT lab, and then what, and then liaising back with the clinician, or is there some interaction with the patient first, or tell me what happens after the PGT lab.

[00:17:57] Amber Kaplun: There's going to be communication going on at multiple levels, right? The genetic counselor is going to be, um, communicating with the patient. Genetic counselor is going to be keeping the care team and the physician updated on progress. The PGT lab will come back to the clinic and quite often that can be both the physician and the genetic counselor if applicable.

Um, so there's multiple lines of communication that stay open throughout the process, um, really to make sure that everyone is staying on the same page, that. Expectations are appropriately managed in terms of what does a couple want eligible for transfer, what doesn't a couple want for transfer. 

[00:18:33] Dr. Mili Thakur: And I think, uh, Griffin from, from that same workflow, I think we can Talk about the gaps that there are.

So one of the gaps that starts when the patient shows up for a request, patient is there, many times patients have multiple things going on. They're not able to conceive, but by the way, they also had somebody affected with a genetic condition. And they also are like emotionally in a very vulnerable situation.

So they may not. up front say that there is a genetic need. So there has to be a process when the intake of the patient is being taken, where you would pick up an extra need for the patient. An example for that is a case study that I did. I saw a patient where she came in, was seen as an infertility patient.

Actually, she was a patient who was doing donor sperm, did IVF, and then embryos were tested for PGT A. And then come to find out when they were going to do the transfer, the patient said, Oh, I also wanted to mention, I hope that the embryos were tested for this autosomal dominant disease that I have. In that intake process, there was this gap of not picking up the disorder that needed to be tested.

You can't just assume that the patients understand. The second thing is, when the requisition is being sent, which lab are we going to choose? There is so many different labs right now. Each one, they're different technology. Which lab is the one that the patient will be best served from? And what is the pre test counseling associated with whatever test you are going to be doing?

So the pre test counseling right now for PGT A is very minimal. The doctor just says, we're going to look for the chromosomes in the embryo, which patients don't understand quite as they might. Once the requisition's gone and then the patient is doing IVF, then there is a big thing that happens in the lab.

So the lab has to see the requisition from the physician. This is the IVF lab I'm talking about. They have to pull out the right kit. So if you work with five or six different labs, you have to understand that same day, there could be a case that's going out to the different lab and another one going to another lab.

So you have to pick the right kit. You have to sample the embryo. All embryos are sampled, no matter which lab they go in the same way, but then you have to put them in the right buffer. You have to handle the embryos with the right buffer. You have to store them at the right place, label them appropriately, and then ship them to the correct company.

When it's received by the company, there's processes that should be in place for quality control, right? All companies that provide this kind of testing have to have those processes because then they're going to amplify the DNA, results will come back, and then Again, the gap happens when, I kid you not, there is like each person who takes care of genetics in the practice has to keep five or six, seven, sometimes, portals.

So the results come back into that genetic company, which is an outside business portal, and the staff has to go in and retrieve that result in a timely fashion. And then the patient has to be called back by the clinical team. And then you have to have the doctor in the IVF lab. Integrate again. So, when I talk about gaps, they can happen in any of those spots.

If, say, the results were there for a week and the staff just did not go into that portal, they will not know that the results are back. If the staff retrieved the results but are waiting for the doctor to call the patient because the results are abnormal, then there will be another gap that happens. If the doctor doesn't feel comfortable with the management of those test results, You know, in that situation, if genetics was already integrated, they would be able to give those test results.

And it doesn't finish there. You have to transfer the right embryo, which is, I think, the biggest. Biggest piece of that whole workflow that happens for months at a time. 

[00:22:34] Griffin Jones: When you say patient portal, Mili, are you talking, or when you say portal, are you talking about the patient portal through the EMR, or do the PGT labs have their own portal, or is there some other portal?

[00:22:45] Dr. Mili Thakur: So each PGT lab Because they're an outside business, outside of the clinical infrastructure, they have their own portals. And you have to have a username and password for networks. There could be an integrated username and password that the clinical team goes in and retrieves information every day. And each lab has their own way of submission of samples of requests.

So some labs will have a portal where you submit it. Others would use some sort of encrypted email. To receive those and then the same thing with the back workflow. 

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[00:25:13] Griffin Jones: So I want to come back to these gaps, but you've pointed me to something of reasons why.

This ideal process, the optimal workflow that you describe, Amber, where the couple comes in, the clinician decides they need PGT M, they're handed off to a genetic counselor who liaises with the PGT lab and the patient and the clinical team. What, if this is the ideal scenario, in your view, How, what percentage of clinics do you think are doing something close to what you're envisioning as the ideal scenario right now?

And then that's the first question. And the second question is for that percent that isn't, why aren't they? 

[00:25:51] Amber Kaplun: So I would say the clinics that have in house genetic counselors, I would assume it's very close to a hundred percent, if not a hundred percent that are using that optimal workflow. I think That the clinics that are likely not doing that, they may have a contract genetic counselor that they work with that sort of mimics that workflow.

Um, some places may have third party services that they work with, but there is always going to be a bit of a gap there because that is not someone that is directly employed by the fertility clinic and directly working within the fertility clinic. So how that may come up is just having knowledge about the, the clinics or the networks, policies, and procedures about.

Embryos that are eligible for transfer, not eligible for transfer, and being able to help set expectations through that workflow. 

[00:26:37] Griffin Jones: In your last episode, I think we talked about, we guessed what percentage of clinics had an in house genetic counselor. Remind me, was that like 20%? Was it less than that? 

[00:26:48] Amber Kaplun: Yeah, it was less than that.

I would say 10 percent or less of all of clinics that report to SART in the U. S. 

[00:26:56] Griffin Jones: And we, when, I don't even remember when we did that episode, was that a year ago or so? Maybe six, six months to a year, maybe? 

[00:27:02] Amber Kaplun: I think it was about a year ago, yeah. 

[00:27:04] Griffin Jones: How much has changed in that last year? Are we at 12 percent now or 15 percent or 20 percent or is it pretty much Pretty close to what it was this time last year.

[00:27:13] Amber Kaplun: It's probably pretty close to what it was. Yeah. I mean, with some of the consolidation and some of the network growing that we've seen, that has meant that some clinics have access to in house genetic counseling services where they didn't a couple of years ago, but it may not be a very large number of clinics that have actively decided to bring genetic counseling services in house since that time.

[00:27:32] Griffin Jones: Is it just the. The role of having the in house genetic counselor in house that allows this optimal workflow to be implemented, or is there also some kind of technical solution that's necessary? Because I'm just hearing, okay, genetics counselor, Liaising lab, liaising with IVF lab, liaising with patients, liaising with clinical team.

It just, that seems like a bunch of communication that could be really disruptive to workflow, that could easily get out of the channels because some communication's happening here and then, or also people might be waiting on things. So I could see Obstacles happening from that. Is there, is, is the current EMR ecosystem sufficient to support that communication?

[00:28:24] Dr. Mili Thakur: I don't think that is sufficient. Like in an ideal world, a solution would be that if there was like one integrated virtual system where you could, as a clinic, own that system, like you have bought that system and then you are able to have your staff, which is trained in genetics, hopefully a genetic counselor or a geneticist, go into that system.

Select the best test that is needed, and then go to the right lab, and then click the next thing, and everything comes back into that same portal, but instead of having different company portals that you have to open, it would be a portal that the clinic has, and then the clinic just goes in, and it goes back to their EMR, talks to the same EMR, and this is an ideal world situation where there is no restrictions on creating such a software, but With increasing number of cases, if you have to take a lot of IVF cases through and a lot of genetic testing has to happen for different tests, there's about six different tests.

that we do in our field. And so it's like trying to navigate through four or five different labs for each. I'm talking about 12 to 15 labs that are genetics. In an ideal situation, that's the solution. And from a genetic counseling standpoint, I think we have to talk a little bit, and Amber can like elaborate on this.

There are these roles. The scope of practice of each genetic counselor. So there's three different types of genetic counselors in our field right now, or genetic professionals to say. One is in house genetic counselors that are cross trained in the EMR that practice uses it and loads the doctor preferences.

Second type is the one that are telehealth genetic companies that are standalone practices, but they integrate In various different forms with the clinics. And the third one is the company genetic counselors, the genetic counselors from the genetic company. And lots of physicians are relying on genetic services or genetic counseling services from these genetic testing companies, which is invaluable at this time that that provides patients what they need.

However, that, the scope of practice of that genetic counselor is totally different. They are counseling the post test. counseling for the test. They will provide all options to the patient, they will give all the outcomes to the patient, but they don't know the exact situation of the patient. So they don't have clinical data with them when they're talking to the patient.

They have some clinical data, but they're not directive. And they're trained to be not directive because they're representing the testing company and the test results. And I think Amber can speak to it, how it's different for an in house genetic counselor and decision making and for a genetic counselor from a company.

[00:31:19] Amber Kaplun: Yeah, when you're a genetic counselor working in house, you have a good idea about your institution's values and how you approach certain types of results. So if I'm counseling a patient on PGT A results, I can say to them, these embryos are going to be top of the list for transfer. These ones we'll put to the bottom of the list.

These embryos are not eligible for transfer at our institution versus if you have a genetic counselor that is counseling on those results from a lab, they're just going to say these are the different findings that were observed within the embryo biopsies. You're going to need to go back and talk to your doctor to figure out which ones you can transfer, which ones you can't, and in what order.

[00:31:54] Griffin Jones: The last time we're on, when in our conversation, Amber, it was about the benefits of having an in house genetic counselor and Mili, your episode was about three different revenue streams that fertility clinics can leverage with genetics. Is there a way that you see this becoming the standard in the world?

A few years time, apparently it hasn't budged since a year ago when Amber and I first spoke, but is this going to be the standard as consolidation happens more and then we're left with maybe four or five companies that own 80 plus percent of the fertility centers in the continent? Is this going, are we going to see that more than 50 percent of clinics have In house genetic counselors.

How much of that battle is left to fight? 

[00:32:49] Amber Kaplun: I think we will, and primarily that's just because when you look at The rate of requests for PGT M compared to requests for prenatal diagnosis, for example, there are certain areas in the world where requests for PGT M are far outpacing requests for prenatal diagnosis.

And you also have greater availability of genetic testing in medicine generally. I do think that we are going to be seeing more and more families, more and more couples coming to us. Specifically for IVF and PGTM, but then as Mili mentioned, we're getting more and more patients who come to us for reasons other than genetic testing and something comes up along the process of the workup and setting that patient up.

I would say if you are a physician or a nurse, and there has been more than a couple times where you've looked at a PGT A report or a genetic testing report and you find yourself scratching your head, That's telling you that you need more support in this genetics realm, and there's going to be some point at which that means that needing that support is going to be hiring someone and creating a team that can take on those responsibilities for you.

I am anticipating that these bills that are in progress are going to get passed in the near future, which I think will really eradicate a lot of barriers that clinics do tell us exist. And I think also if you're Hiring a genetic counselor, you don't necessarily need to hire someone that comes into your clinic every single day.

I can tell you from the number of requests that I get, genetic counselors have a lot of interest in this area of practice. If you expand your search to potentially the whole state that you practice in, potentially out of that state, you're definitely going to be able find someone that wants to work that job.

Some of the Things that I hear about there not being enough genetic counselors, I can tell you I've heard people in my area with open positions have been having 50, 100 applicants for their job. So there are a lot of people out there right now, particularly because some of the labs are laying off genetic counselors.

There's a lot of people out there. It's a good time for hiring. 

[00:34:48] Griffin Jones: I know a really good genetics counselor out there who wants to get back into the fertility field. So if anyone is listening that, that needs really good talent, I do know an A player that is in that situation that you described, Amber. 

[00:35:01] Dr. Mili Thakur: Yeah.

And Griffin, just to add to what Amber said, is I, the way I envision it, Once there is consolidation has happened, and then these networks are now going to start to look into the internal processes, like once acquisition happens and they are settled down in terms of what they are doing, I think I see two ways of how this is going to happen.

Every practice that has to take care of their patients for the next five to ten years has to take care of their genetics. Otherwise, they're not going to be able to be functioning. I'm 100 percent sure of that. There are so many 

[00:35:35] Griffin Jones: Tell me what that, tell me what that means, that they won't be able to be functioning if they're not also involved in the genetics.

Tell me, unpack that for me. 

[00:35:42] Dr. Mili Thakur: With increasing number of cycles happening, so if a network is going to do upwards of a thousand cycles, right, and they are, there are networks that are doing five to ten thousand cycles a year. Imagine the number of data that's coming into their system. And once you do that much of high volume, a lot of complex cases are entering the system.

The more you're going to serve, the more complexity there is going to be. Each practice that wants to excel in their business cannot look the other way and say, okay, genetics, we'll just take care of it through third party genetic companies or through the genetic counseling testing companies, because soon you will have a case.

That is going to be a hurdle. It's going to be coming back to the doctors. As soon as the doctors see it, it's a business case for them. They're going to integrate genetics in there. But what we are trying to say to our audience right now is instead of going to that point where that thing happens and then you look back and you say, oh, we should now get a genetic counselor or a genetics team on our setup.

The two ways I see it is one, All networks should look into their internal process of how they handle their genetic workflow. And professionals like us are happy to consult with them and say, okay, let's look at your processes and where everything lies. But the second way is Centers of Excellence for Genetics in Reproductive Medicine.

That's another way of doing it. Preimplantation genetic testing As an 

[00:37:10] Griffin Jones: insurance designation? Is that what you mean?

[00:37:12] Dr. Mili Thakur: No, as a center. So inside of the network, which networks can own more than 10, 15 centers, one of their center is actually a center of excellence where for pre implantation genetic testing and the more important portion of that is for PGTM.

As Amber said, these are complex cases. They don't take that one hour consult, like on an average when I work up a patient like that, it's five to ten hours of my time. Your regular IVF team should be doing the infertility management of the patients, taking them through and Making sure, but these patients that need extra time and extra workup have to be in a different environment that has to, that kind of team, the one that I envision will have a geneticist on staff, would have an REI on staff, would have a team of genetic counselors on staff, and will then liaison with all of the different labs and coordinate that complicated care.

And once you've developed that model, you can take that model and implement it in any site of that network, right? So basically these are complex cases. And because of my virtue of practice right now, I'm seeing patients from 17 different states. I work with all PGT labs and I'm getting second opinion referrals from most of the REIs from around the country.

And those cases, even for me, who's like, Board certified in genetics take extra hours of work. I have to look up things and I have to talk to these companies and say, which kind of tests can we do for it? Is this test even possible or feasible? And then on the back end, I have to counsel the patient to say, okay, your family is unique.

This is something that is very complex. It's going to take us a month or two to even get you to be able to do this. That kind of workflow to be fully integrated into a busy REI practice is. It's difficult, so challenging to say the least. So as we see, and this is like a projection that's available online, we are going to see increased number of requests for PGTM and SR.

And for these first two months of 2024, every practice has seen that increase already. And this is going to increase even more. So we have to address it. I don't think we can look the other way and say, we're going to just do things how we have done it traditionally. 

[00:39:36] Griffin Jones: How do APPs fit into all this? Because as you're talking about developing the workflows, the workforce, you're talking about having centers of excellence, and then you're talking about the clinician being the first person to decide what test is necessary and that, or then, or decide if something's necessary to hand it off to the Gen X counselor.

But what happens as APPs are starting to do more of the new patient visits. They're the ones doing the workups and, uh, and then the REI is at a more global level where they're overseeing multiple cases and, uh, so how do nurse practitioners, physician assistants play into all this? 

[00:40:16] Amber Kaplun: Yeah, I can speak to that because we have a great team of APPs, you know, across the network where I am, and they're acting very similarly to the role that Mili is mentioning, identifying these cases and then in consultation with the overseeing physician, really sending the cases our way.

So the workflow looks very similar. It's just that, as you mentioned, that first point of contact, maybe with the APP, Versus an MD or DO, but it doesn't really change much from a workflow perspective, at least in our experience. 

[00:40:46] Dr. Mili Thakur: Yeah. The only thing is that the, at the ASRM APP summit, which we had last year, most APP felt comfortable with being.

That first person of contact with the physicians to like triage patients and like different levels of complexity and getting them to where they needed to be. A question arises when test results have to be given, when genetic test results, especially pre implantation genetic testing of embryo test results have to be given, if they are the usual type of results.

Most APPVs will feel comfortable, but as soon as the results are abnormal, say a couple went through IVF and all embryos are abnormal, and now with different genetic testing companies, there's different level of abnormal. So there's a clear aneuploid, there is low level mosaic, and high level mosaic. So those kinds of test results and then answering questions in great detail is something that would not be part of their scope of practice.

That would be part of a, either a physician, uh, trained in REI and knowing the complexity or a genetics professional, a geneticist and a genetic counselor, even nurses. And I don't think even anybody who's not well versed in genetics would be able to handle that kind of results. 

[00:42:05] Griffin Jones: I'd like to give each of you the opportunity to close the conversation with your thoughts.

And I'm thinking in the direction of how we develop this workforce as. Clinics are consolidating, we see that, and other segments of the field are also integrating. And so, we need, we need the infrastructure for genetics to mirror that, but we need the workforce to be able to fulfill that. Um, so, um. Uh, you can conclude how, however you'd like on, on this topic of how we build this infrastructure, but, uh, how do we develop this workforce?

What needs to happen for this infrastructure to come into your place? And if you can, what would, for those executives listening that are at the MSO executive level, What first step can they take? 

[00:43:00] Amber Kaplun: So I can speak at least from a genetic counseling perspective. First off, I would say that there has been tremendous growth in the number of genetic counseling training programs over the last five to ten years.

So there are more and more genetic counselors that are graduating every single year. And I think we are also dealing economically right now with a bit of contraction of genetic testing labs. So as I alluded to earlier, that means that there is a ripe workforce out there ready and eager to really dig in.

And as I mentioned, ARTIVF is a particular area of interest for many people. So I think really the first step for those executives and those MSOs is to be able to commit. to creating a genetics program. And after that commitment, I think consultation with people that are more experienced in this area to be able to carve out that business plan and the projections and things like that.

It's going to be really helpful for taking that first step and The Genetic Counseling Professional Group is always happy to assist in supporting people that are looking at starting a genetics program. We are obviously very committed to increasing the visibility and the presence of genetics programs within reproductive medicine to help ensure that we are meeting those levels of ideal patient care.

[00:44:10] Dr. Mili Thakur: I think from my standpoint, one of the key things that the, uh, Professionals in the field have to do is to acknowledge that genetics is here, it's growing, that these tests have to be taken care of and be mindful of the patient experience. Like it has to be completed, that workflow has to be completed to the point where we can get the patients to take the baby home, right?

The important thing is to have that vision that how to create genetics. As a workflow and develop it. The second thing is a commitment for the processes that are involved. Like Amber said, there's a lot of genetic counselors and genetic professionals who would love to be part of that team, but instead of cutting corners and making short decisions of, okay, right now, I just want these test results to be given for this next year, developing that process and putting those ground rules for your team as the, as the team grows.

[00:45:09] Griffin Jones: What are a couple of those ground? There are a couple of ground rules that you think of, if you will. Like what are those ground rules that, that should be established specifically to avoid cutting those corners? 

[00:45:20] Dr. Mili Thakur: So I think first is. Every patient coming into the fertility field, if they're coming with inability to conceive, should, there should be a process to take their history that is above and beyond what the doctor is able to do in a 45 minute or an hour long visit.

There should be a questionnaire. That questionnaire has to be made in collaboration with a genetics professional. So the right questions are asked and then they are somehow triaged. That is a gap that is very big in most clinics. So you can pick up the So who need that extra service. Then the second thing, that ground rule, should be that when we are taking care of a patient who needs a genetic test, ordering the appropriate test with the informed consent has to happen.

And then that informed consent is like a big legal important point is that informed consent is not just waving off and signing on a sheet of paper. It should be something that has embedded content inside the content. Like a video that the patient has to watch and be then truly be informed. So when they sign the paper, they know the pros and cons, which needs the pre test counseling.

Then in the lab, in the IVF lab, there has to be very straight ground rules of the processes of how we label embryos, how we store embryos, how the right kit is picked up. There should be, and most labs would have that process already, but it has to be even more. going with the higher volume and the complexity of the testing.

Then at the genetic testing lab, because these are all testing kits that are made by the lab, there has to be regulations there to make sure that quality control is well and reporting is done. Right now, each lab, by the way, reports their results in all different ways, so there is no single way of regulation of how reports come back.

There's different, uh, uses that they use. And then last but not the least, when the right embryo is getting picked up, like when there has to be a genetic professional inside of that decision making or the physician takes all of the responsibility of when the embryo is being thawed, because the lab that is going to be thawing is only given a number for the embryo to be thawed.

So I think it's very important to have all of those boxes checked off. And integrating the team of genetic professionals who understand this is easy for them would make it better for the practices. 

[00:47:53] Griffin Jones: You've persuaded me that integrating with genetics in this way with the clinical and the lab teams is necessary.

I think you persuaded me that it's inevitable and that the networks have to figure out a way to do it. I think from a, that they're going to need some, Some of the technology, some of the technology solutions that are emerging, the workflow softwares, the EMRs, the EMR alternatives that are emerging. And a lot of you hear those advertisers on this show.

I can't tell you which ones are better than the others, but you need to check them out. I would check out all of them. Every time you hear a new one on this show, do their demo. Click out that little form of whatever comes out, because I think what you're talking about for All of the different segments, lab side, genetic side, clinic side, being integrated absolutely has to happen as the networks continue to get bigger and people are going to need it.

Uh, the right tools to be able to, to actually implement that. And then I also want to plug the background for this conversation. Listen to Amber Kaplun’s episode about how to, how and why to use in house genetic counselors. Listen to Dr. Thakur’s episode about how to leverage three different revenue streams.

for genetics in your IVF practice. We're gonna link to both of those episodes in the show notes. Go back and listen to those, and I look forward to having you both back on, because I'm increasingly getting this feedback of this growth, Uh, in the genetics vertical, and we're, there's going to be more and more to cover.

And I'd like to get some updates on many of the tips that you gave today and how they're being implemented. Dr. Mili Thakur, Ms. Amber Kaplun, thank you both so much for coming back on the Inside Reproductive Health Podcast. I look forward to having you each on a third time. Thanks, Griffin. Thank you. 

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