 Well, we'll get started. Good afternoon, everyone. Thank you for joining us. My name is Leah Rand, and along with Dr. Aaron Kesselheim, we convened this Health Policy and Bioethics Consortia series with the program on regulation, therapeutics, and law, and also through the Center for Bioethics at Harvard Medical School and the Petrie-Flom Center at Harvard Law School. And we're excited to welcome you today for a discussion of the ethics and access to assisted reproductive therapies or technologies. And so quickly to go through the overview of the consortium objectives. First, to thank you for joining us. Sorry, some housekeeping. Please submit any questions you have using the Q&A feature. So that's at the bottom of your Zoom screen. Please put them into the Q&A box. And you're welcome to use the chat box for any technical questions you might have or issues. And you're also welcome to tweet about this. This is something you do using our hashtag policyethics. And the video of this event will be posted up on the Center for Bioethics YouTube page in a few weeks. And you're also welcome to subscribe to future events through the Center for Bioethics as well as Portals email list. So the objectives of the Policy and Bioethics Consortium are to think about key issues in health care systems and public health, what their ethical implications are, and to bring together experts with different perspectives on these issues to discuss what they are and as well as proposed solutions. And we hope that this will stimulate conversation as well as think about future directions of research that we can advance the health policy field. And I also want to flag for your attention our upcoming session. The final one of the year will be on April 8th and we'll be looking at financing and political commitments for public health. But for today, I'm gonna hand it over to our moderator, Beatrice Brown, who's a research specialist with Portal. B received her BA in Ethics, Politics and Economics from Yale University and her master's in Bioethics from Harvard Medical School. During her master's, B was a student fellow at the Petrie-Flam Center for Health, Law, Policy, Biotechnology and Bioethics at Harvard Law School. Some of her research interests include reproductive health care and its intersections with ethics and law, as well as the effects of risk evaluation and mitigation strategy programs on patient access to prescription drugs. So her work with Portal has been published in Analysts of Internal Medicine, the AMA Journal of Ethics, Health Affairs, JAMA Network Open and JAMA Internal Medicine, and she'll be attending law school this coming fall. So we're pleased to have her moderating today's discussion and over to you, B. Thank you so much, Leah. So I'll just be providing a quick overview of what exactly assisted reproductive technologies are, as well as a broad overview of the issues before handing it over to our two wonderful speakers for today. So to start off with what these technologies are, it can be an ambiguous term in terms of what assisted reproductive technologies covers. Some have proposed narrow definitions. So for instance, the CDC has based their definition on the 1992 Fertility Clinic Success Rate and Certification Act, which only includes treatments in which the eggs are surgically removed combined with sperm in the lab and then return to either the woman's body who the egg will retrieve from or to another woman. And this definition excludes techniques such as artificial insemination or simply stimulating egg production in a woman. However, assisted reproductive technologies can also be construed more broadly as any medical technique that is used to achieve pregnancy beyond sexual intercourse. So that would include both artificial insemination, for example, as well as intrauterine insemination. Regardless of what definition is used, assisted reproductive technologies can be extremely expensive. So for example, one cycle of in vitro fertilization or IVF can cost between $12,000 to $17,000 on average. And given that very high cost, there are unfortunately barriers to access for those who are less well off, which raises the question of whether or not assisted reproductive technologies should be only accessible to those who can pay or is there some sort of moral or legal right to procreate? 17 states now in the United States require insurance companies to cover infertility treatment. There are also two states, California and Texas, that have laws that require insurance companies to offer this coverage, but not necessarily that the treatment do be covered. So for example, in California, employers can decide themselves whether or not to provide the coverage to their employees that are covered on that health insurance. Even when there is coverage, these state insurance mandates vary substantially, leading to a patchwork of laws in the United States. And even when infertility treatment is covered, there may still be access issues for a variety of reasons. So for example, some laws do not require that IVF be covered, or if they do, they only cover a certain number of cycles or require that another treatment even be tried first, even if that may not make medical sense for a particular patient. Additionally, other states, for example, may require a certain definition of infertility to be met, which can preclude certain individuals, such as those who are single or same-sex couples from obtaining coverage for these expensive services. This raises a host of issues and questions that we're hoping to tackle today. For example, what are some of the ways that access to assisted reproductive technologies can be improved? How can we ensure that there is just access and ethical distribution of these technologies? What barriers may remain and what potential novel challenges lie ahead? We're really lucky today to be joined by two experts in this topic to discuss this very topic. First, we will have Dean Judith Dar, who is the Dean of the Chase College of Law at Northern Kentucky University and a professor of law there as well. Her scholarship sits at the intersection of law, medicine and ethics, and she is recognized as one of the leading experts in assisted reproductive technologies. Her most recent book, The New Eugenics Selective Breeding in an Era of Reproductive Technologies, warns how unequal access to these technologies may come to resemble the past atrocities of the eugenics movement in the United States. Professor Dar also served as chair of the Ethics Committee of the American Society for Reproductive Medicine from 2014 to 2020. Next, we'll be joined by Dr. Eli Adashi, who is a professor of medical science at the Warren Alpert Medical School at Brown University, where he also previously served as the Dean of Medicine in Biological Sciences. Dr. Adashi's extensive scholarship focuses on reproduction, medicine, science, public health, law, bioethics and human rights. And among his many achievements, he has served in leadership roles for multiple professional societies and organizations focused on healthcare and reproductive medicine, including as president of the American Gynecological and Obstetrical Society. He has also been a member of multiple National Academy of Medicine Consensus Committees and reports on reproductive medicine. Really excited for this discussion today and I will turn it over to you, Dean Dar. Well, thank you so much. Thank you, Bea. And thank you, Leah and Aaron for including me and Ellie. I'm just grateful to be in your shadow. I'm really delighted to be here and thank you for this opportunity. We'll go ahead and share my screen and then we can get started with our slides. I'm coming to you today from Nashville where we're here for the law school for an alumni event. And I'm excited to be able to join through this wonderful, I guess sometimes terrible technology we call Zoom. Go ahead and start my slideshow. Thanks everyone. Well, thanks Bea so much for that wonderful framing and to providing so many important foundational issues and facts. And I'll just begin by saying that, yes, we are here to talk about technology and advances in assisted reproductive technologies. But let's not forget that there's still a human quality to how we make babies. And I always feel that that gets short-scripted. So just to update the way that people meet and are introduced, we'll begin with Mr. Spur meeting Ms. Egg. I mean, that does seem to be the way that the world is going and increasingly that reproduction is unfolding. Well, again, thanks to Bea for creating these definitions. And I'd like to add just a word or two about that. As Bea mentioned, I know in my scholarship I take a broader view of ART than does the CDC, for example. And it would include a basket of medical techniques used to achieve pregnancy by means other than sexual intercourse. So yes, that would include IVF, but it would also include, as Bea mentioned, ways in which the sperms introduced to the egg sometimes inside the body so that there's no need to extract the oocytes in the surgical procedure. And just to update ART, we'll talk a moment about the way in which this field is growing and changing. And that are techniques that are applied to gametes or early stage embryos to promote the health of a resulting offspring. And so that piece is going to figure in a little bit to my talk today, but certainly it looms in terms of access to these technologies. And I'll mention them specifically as we move on. Well, let's meet our founder in ways, Louise Brown. This is the cover of her book that she authored upon her 40th birthday in 2018. So Louise turns 44 this summer. It's hard to believe that IVF is middle age, but depending on your definition, it appears to be the case. Louise was the first human being to be conceived and born alive using in vitro fertilization. Born outside of London in July of 1978. So she's really our patient zero, if you will, in the field. And from Louise, we've certainly come a long way in 40 plus years. This just shows a bit of the epidemiology surrounding ART. So just looking at the most recent figures published by the CDC, which are published annually according to the federal law that be mentioned in the 1992 act. We collect very specific data on cycles of IVF. I'm around at the numbers a bit, but in 2019, the most recent year because of course there is a collection period and then there's a lag period from when the treatment is secured and the results are known typically 40 weeks later. But in that year, we had about 84,000 babies born through IVF. The TDI or therapeutic donor insemination is really an estimate. We don't know exactly how many children are born in the United States through donor insemination because we don't collect figures on that, but we think it's around 60,000. If you put these numbers together, ART accounts for over 3% of all US births. And so it's very significant in the way that we form our families. Worldwide, we have over 8 million and counting children born through IVF and the success rates on average. And there's so many variations in terms of treatment and diagnosis and so on. But overall, we have about a 35% success rate per cycle. And so again, you can see the attraction for this technology. There's increasing use of donor eggs and embryos. Egg freezing occupies a significant portion of cycles these days. You can see 20% of cycles are just for egg freezing. And then also I'll talk very briefly about pre-implantation genetic testing and its multiple uses and some of the ethical dilemmas that PGT raises for us. Just looking ahead briefly, these are some of the emerging technologies that are gonna be captured a bit in my talk about access, but wanted to give you a sense about what's on the horizon. And some on the call may be very steeped in this and I give my hat to you for help and just to acknowledge your work in the field. Mitochondrial replacement therapy is a technology that's used to overcome mitochondrial disease and is moving forward very slowly if at all in the United States based on our regulatory scheme, more so in other countries, particularly in the UK and a few others. In vitro gametogenesis is a technology that hasn't reached the clinical phase in human trials, but it's a technology in which somatic cells are sort of reversed engineers back to a stem state in which they can be then coaxed into any number of cell lines, including gametes. So the idea would be that an individual through let's say a blood cell or a skin cell could have that extracted, could have it reverse engineered if you will back to the stem state and then coaxed into becoming a gamete, either an egg or a sperm or perhaps both from a single individual. So leading to multiplex parenting and lots of configurations in parenting that we really haven't considered to date. And then of course, germline gene editing which made its way into the national dialogue in November of 2018 when Chinese scientists announced to a world gathering and I was in the audience so this is pictures from my iPhone of Heiji and Kui announcing that he had edited the genome for two at this time, two female twins who were born to a Chinese couple in order to create an opportunity to avoid infection with HIV. You might remember that it certainly got a lot of attention on the national stage. And you can see in the slide kind of in the upper middle portion that crush of media that was there when he made his presentation. It's interesting because when he finished the Chinese military marched on to the stage and ushered him off and essentially hasn't been seen in public since but it really did launch and start a debate about the ethics of emerging reproductive technologies which we continue to engage in to this day. And then finally just coming back to our country I'd like to mention that stem cell research which is related in part to the genome editing slide that I just showed remains of interest in the political arena. This past November, for example, California voters actually passed this prop 14 which was as you can see at $5.5 billion for medical research in the stem cell arena in California following up on an initiative that had expired 10 years prior. But again, my point here is that popular support does seem to continue for research at least therapeutic research in the field. And so it's captured in this question of access. Well, I always like to put this slide on for the lawyers in the group and then just as a matter of general information about how the law interacts with ART and to understand that we really have to travel back way in time to the height of World War II when a case reached the United States Supreme Court challenging an Oklahoma law that provided as punishment for certain criminals sexual sterilization. And Jack Skinner, who was the defendant in that case challenged the constitutionality of the Oklahoma criminal habitual sterilization act by saying that it was simply unfair under constitutional language to force him to be sterilized through vasectomy because he had committed certain in that case property crimes. Justice Douglas writing the opinion for the court agreed and declared the law unconstitutional. And in that case, we have very broad language about the meaning and import of procreation from a constitutional standpoint. Here, Justice Douglas you see calls procreation a basic civil right, a basic liberty and these words civil right and liberty are very meaningful to the law and of course to us as individuals in the way that our intimate conduct is governed and moves forward in a legal state. We'll come back to Justice Douglas but moving forward, when I teach this to my students I always have them pause and think about well, what did Justice Douglas know about reproduction in 1942? What did he think about it? And certainly he didn't know about IVF was many decades before that would come about even insemination was really not on the medical front at that point. So this broad pronouncement about the importance of protecting procreation and procreational choices from the law or prohibitions in the law is all we have. That's the only language we have from the Supreme Court it's the only time that they've ever talked about affirmative rights to engage in reproduction. And so today we don't know how the court would respond to the doctor's question or the patient's question, are you sure it's mine? And this comic is meant to show that there are many you can see the background. There are many ways in which a pregnant person can give birth to a child in which that child would not be hers at least from a legal family law framework. She could be a surrogate who had been paid $35,000 to carry the embryo for an individual or a couple. And in most states in the United States she would have no rights and it would not be hers if you will in any legal sense. What would Justice Douglas say about that? Is it acceptable to regulate surrogacy? A few states actually ban commercial surrogacy. Is that constitutional under his framework? Here there's a conversation in which one school girl says to another, basically if grades were so important that my parents should have paid for a smarter egg donor. There's lots of controversy surrounding egg donation. Should it be commercialized? Should there be limits on how many cycles any particular woman can go through? What are the regulations surrounding egg banking and so on? We have no sense about that from the court. There's transparenting. We have many pregnancy capable people who can move forward. And here you see a trans man and his, I think husband I'm not sure for sure in this photo. But the question is what is the birth certificate going to say about this child's parentage? Are there two fathers? Is there parent one, parent two? And these dilemmas have come up in the law. And we need to think about how the law responds to these new ways in which family formation is moving forward. Well, with that sort of background, I do wanna talk to the main, move to the main topic, which are barriers. And be talked about cost. And of course we can't move forward with the barrier discussion without prominence in the cost area. But as you can see, I've listed a number of other ways in which there are barriers to accessing these marvelous technologies. And so very quickly, you can see from my points there, I have several to cover, so I'll do it very quickly. But cost of course is really a primary barrier to access. And the average cycle costs should slightly different numbers, but it's in the ballpark 12,000 to 19,000. And for this reason, treatment seeking in the US is very low for a developed country. We only have about 50% of individuals who could benefit from IVF, even beginning the journey to think about it. In other countries where insurance is more robust, treatment seeking is much higher. And again, I know Ellie's gonna talk at length about insurance coverage. So I'll leave that to him, but basically the bottom line is that mostly IVF is self-pay, about 85% of it is self-pay. The 19 states that be mentioned that require it, either require to cover or offer to cover, again, not really penetrating the majority. And also when you dig in, you'll see that some of the coverage is very slim. And so it doesn't necessarily mean that 19 out of 50 states are actually covering these techniques. We're seeing a little bit of breakthrough in private industry, who is trying to attract younger talent, female talent, and they're beginning to fill the void a bit by offering coverage. And I call it the technification of ART because it really did start in the large tech companies, Apple, Google, and so on. And it is catching a bit of wind. And so we might see some improvements in that in just in the industry itself. And just as an aside for law, federal law are really not helpful. And we can have a discussion afterward about whether we should think about a federal law. But right now, ERISA, which is a long-standing now 50-year-old and perhaps more federal law that governs employee benefits, it allows for the state mandates that do require insurance sometimes to be preempted in a variety of ways. And then the ACA, I know way back when, when the Obama administration was talking about it, I and others at ASRM lobbied hard to get infertility treatment as a covered benefit under the ACA, but that a last did not happen. Well, let's talk about other barriers. Race and ethnicity are barriers to ART in some unique and I think interesting ways. We're probably all on the call familiar with the Institute of Medicine report that documents disparities in access to healthcare and to clinical outcomes along racial and ethnic lines. That's well-known. So there's no surprise that that's the case as well in IVF. But in addition, we know, and I just, just to make sure I'm up to date, I just checked the literature on this and it remains the case that minority women are more likely to experience infertility for a variety of reasons. And when they do seek treatment, they have worse outcomes. They have pregnancy loss, they have difficulty, some morbidity and mortality associated with their IVF course. And so it's not just cost, but they're endemic and other external features that make race and ethnicity interact in a more negative way with ART. And just the final bullet point is that treatment seeking is even lower among women of color and men of color than it is in other populations. And there we could pick apart and we should, the reasons for that. We know that there are insurance disparities, but the interesting thing, and again, maybe Ellie will talk about this, in some of the equal access to treatment jurisdictions or areas such as the military, I think we still see treatment seeking even when the opportunity for treatment access is more equal, we still see less seeking among patients of color. And part of this is attributed to the well-known and well-documented history of racism and healthcare and mistrust that's been bred as a result in the United States. And then some cultural aspects of reproduction and infertility that creates stigma, self-stigma in some cases and racial stereotyping among providers that contributes overall to this access problem. I wonder whether provider conduct contributes to this stratification along race. And I think it actually does. A basic tenet of health law, as the lawyers on the column know, is that for the most part doctors can choose their patients. They, yes, there are civil rights discrimination laws and there are contract obligations, but a tenet of the healthcare system is that physicians are free to choose the patients they treat and the patients they don't treat. Again, it's a general matter. And so for me with that as a baseline, it's important to explore how does provider conduct interact with access. And here's just some of the findings I've noted over the course of my research in this arena. Generally, practitioners are less likely to refer minority patients for infertility workup. There's a study that looks at women presenting with certain symptomology and the women of color generally being referred for hysterectomy or other similar treatments, whereas non women of color referred for infertility treatment. And so that's one factor that we've documented. Another is just geography. The vast majority of ART clinics and there's about 500 of them in the US, just under. Most of them are located in minority white neighborhoods. So even just getting to the doctor is interesting. The book that you mentioned that I did, I actually looked at every single clinic and did a heat map of where the clinics are located and they're in places like Beverly Hills in New York, and I don't know New York as well as I know Los Angeles but in areas that you would expect would have this demography and that was true across the country. Also, I looked at websites and their landing pages and saw that you can see the wet landing pages had only white babies featured, mostly heteronormative heterosexual couples as well. Only 16% advertise that they have multilingual providers or can provide assistance. And this is an older study but it's still worth looking at that 80% of the physicians in the field are white and you can see the lower numbers that are in the Hispanic and Black communities. That in the last 10 years has changed and has improved but we have a long way as you can see to come given those low numbers even 10 years ago. Let's move on and talk about marital status and sexual orientation as barriers to accessing ART. Well, we know there's increasing or really stable births to unmarried women in the United States. We don't know if they're unpartnered because that's not the measurement that we're looking at but about 40% of children are born to unmarried women in the United States. So it's a significant number, about a third of all sperm bank clients are single women. And so we begin to see what the population is but we also know that state laws increasingly allow physicians to refuse treatment to patients based on the position's sort of conscious objection. It doesn't have to be a really robust objection in some cases. And the sort of moral and religious objection clauses are working their way through certain states and allowing physicians to refuse treatment. And so I do worry a lot about how this is going to impact ART and in terms of laws that protect marital status from discrimination or sexual orientation or gender identity, not that many about half of states protected in the state laws. And again, we can talk later about how the federal federalism interacts with those and what protections the states actually do provide. And again, as I say, protection of religious and moral objection from the physician community is gaining ground. Well, you might think, well, we have marriage equality. So it shouldn't really be an issue. If you're a same-sex couple, if you're married then you should have the marriage presumption and all of the rights that go along with that. But my research and others of course has indicated that that's not necessarily the case. Even marriage equality hasn't eliminated some of these access barriers that we experienced in this realm. So for example, a lot of the health insurance mandates that you talked about that you read about will only cover medical infertility, not social infertility, that is being in a same-sex relationship or being a single individual. And that access requires in many cases six months to a year of heterosexual intercourse without pregnancy resulting. Well, that's not the way that many individuals go about their sex lives or their reproductive lives. So if the insurance can only kick in, if you have 12 months of unprotected sex that eliminates many populations from that coverage. There's an interesting class action lawsuit that was brought pretty recently against Aetna based on this issue in which the individuals who don't engage in intercourse and heterosexual intercourse were still required to have a substitute for that in order to be eligible for treatment. They had to go through inter-unit and insemination as a way of kind of mimicking the intercourse process that's required. They had to pay for it even if it wasn't the most effective treatment which it's often not. You saw the success rates with IVF at 35%. IUI success rates hover around 15% range even lower in some cases. So already you're starting off with the treatment that isn't necessarily gonna be clinically effective and it had to be self-pay. So the lawsuit challenges this provision based on discrimination in other grounds and we'll follow it and see how it turns out. Also gamete donation, surrogacy of course is excluded and some cases even prohibited under these insurance laws and other laws. So again, being married isn't going to help in that case. And then finally, some of the surrogacy laws limit enforcement of the contracts to married couples in which the wife is unable to carry a pregnancy. And you can just spin out how difficult this would be for example, same-sex male couples not being able to legalize their relationship with the child because of these laws. I'll move on and talk about disability as a barrier because again, it's significant. We know that there are reported refusals by providers to treat patients with sensory, mobility and cognitive disabilities. We know this from studies that have looked at it and from some of the lawsuits that have been brought as a result. One survey found 13% of providers are unlikely to treat patients with so-called limited intellectual capacity. There's also, and I'll talk a little bit more about this in a minute, there are also what I call micro aspects of the access picture in which positions will refuse to transfer embryos with known genetic anomalies that are detected through PGT. And to me that's a form of access. And then finally in the HIV community there's very few clinics increasing there more but they're willing to treat HIV infected individuals. At ASRM during my time as the chair of the ethics committee, we wrote a number of reports on this and kept trying to survey the clinics that were willing to serve patients and the numbers were very low. I mean, the good news from that end on it in a different way is that treatments are of course very effective and some in many cases have alleviated the need for IVF or even sperm washing, other techniques. But nevertheless, accessing it is still rather difficult. All right, so let me move then to this sort of other part of what I call like digging into the access piece or the micro aspects of it. So that is to say, even if an individual has access to IVF or access to insemination, to treatment within that treatment dyad between the patient and the physician there are still access barriers that I think are worth investigating. And here you see I've listed the ones I'm gonna talk about here. So for example, we have the question of how many embryos to transfer. And we have the famous octomom. I don't know how many of you remember Nadia Suleiman but here she is right before she delivered at Kaiser Permanente, I think near Long Beach. And again, it set off a lot of discussion about embryo transfer, about responsibility and the IVF community and so on. And by the way, here you see her with her octoblets I think about last year, a year ago. And they are, as you can see, quite healthy. They may have, there might be some long-term issues that I'm not aware of, but for this photo she did an interview and what she talked about the loving family that she has and the health of her children. So in a way really outperforming if you will or certainly the odds, but it's an interesting follow-up and it's a lesson to us about prediction as well. In any case, surveys indicate that many IVF patients would like to have twins. That is a favorite outcome for them. And so there's often debate at the bedside about how many embryos to transfer back into the uterus. And there's an increasing movement toward SCT or single embryo transfer. Such that you can have a clash at the Petri dish, as I've called it, where the patients are really wanting to have the twins because sometimes they've reached the end of their financial journey for IVF and they're basically out of funds and certainly emotionally, psychologically, physically this is a very difficult journey. So often physicians refuse to make a double embryo transfer because really the standard of care is that single embryo is fast. And so that can be a way that access to some extent is barred. As I mentioned the second bullet point, we have many tremendous strides in multiple pregnancy, rate dropping from really one in three IVF outcomes to really now under one in 10. And again, we have a lot of professional urging toward single embryo transfer despite what patients really want for their outcomes. The PGT is also an interesting and important adventure to talk about. In, we know that through the use of testing we can detect numerous types of anomalies in this patterning, whether they're from aneuploidy or single gene disorders. We know a lot about embryos through IVF and raises questions about choice and selection. So these are just some points to think about with transferring embryos with known genetic anomalies. Again, just talk about parental desire, looking at family pedigrees that are well known to patients. They're sometimes quite accustomed to having a disease pattern in their family based on an anomaly. And they want to move forward with the pregnancy in some cases, particularly in this first bullet point, if there are no so-called normal embryos in a batch or at all, even in a frozen cycle. So patients often do express a willingness to raise an impaired child from a health status point of view because either they're familiar with the disease pattern based on familial symptomology or because they simply want to take whatever child they have formed through their embryos or through donor embryos and move forward. And this dilemma here really does hit, I think, the patient and their reproductive autonomy, which again, just as Douglas spoke so broadly about. And the provider is what I call professional conscience. And I have a slide later on just to investigate that a little more, but having talked over the years to many REIs, reproductive endocrinology and infertility specialists, they struggle mightily with this idea of transferring an embryo that they know will produce a child who will have significant health impairments. It's very difficult for them to move forward in that way. Although they know that it's not their child and they largely understand it's not their choice, they still feel professionally compromised by assisting in this way. And again, any good lawyer will say that if we do move forward with the transfer, informed consent should be robust and it should include voices from specialists in the disease profile and from the patient community, if possible, so that the most information possible is provided to the patient. The problem of prediction, I mentioned it with the octoplets, but it's also true when it comes to disease profiles. And many diseases, the genotype and the fetotype can be different in that the genotype is stable, but the phenotype can occupy a tremendous range. And I mean, these are just some of the ways in which that's true, whether it's with CF or Downs, that the phenotype is very different. And also just what are the chances that there can be breakthroughs in treatment and even cures along the way. We can always hope and we should always be open to that. So to say that a child should not be born with a disease really is short-sighted and doesn't look forward to what we can do from a medical and scientific point of view. I said I talked briefly about the role of provider autonomy. So I care a lot about what providers think and feel in this area. And I feel it's a little bit underserved because there's a lot of attention on patient autonomy, which is appropriate, but I always say the providers are entitled to equal dignity and equal humanity and the actions they take in the clinical setting and the AMA supports this. There's lots of language in the AMA, writings that out, refusal of care for reasons of personal conscience. And again, providers who do PGT have talked about the reason they do it is to promote the birth of a healthy child. And so to actually promote the birth of a child who will most decidedly be unhealthy in some ways is really against their professional identity. And the moral distress that, again, colleagues have expressed to me that they feel over these outcomes can be life-affecting, lifelong and very burdensome for providers. In ASRM, we've taken some time to think about this and we do have an ethics committee opinion that basically says that it's ethically acceptable for providers to refuse if they feel that there would be in this paper, serious child-rearing deficiencies. And that's really as to the parent's capability not to the child, him or herself. But again, there are certain lines that when you have the A as part of ART, the assisted, you naturally have third parties involved and their makeup and their preferences are relevant in addition to that of the patients. Some of you are probably familiar with the Proprietive Beneficence Theory. I'm just putting this in for the true ethicists on the call who study this theory. There are writers who talk about this duty-based admonition to produce the best child, if you will, of all of the embryos that there was a duty to select the embryo that would provide the best life and so on. And again, we can pick this apart for hours. There's many aspects to this that are problematic but just be known that these theories are at play in the field. Just to can't help but just do a little bit of law here. What is the legal landscape for these transfers of anomalous embryos? One of the, and this often comes up in this discussion where providers will say, well, the patient has agreed to sign a waiver. If I go ahead with the transfer, the patient will waive any liability that I might have for the health of the child moving forward. And as any good lawyer would say, it's worthless. It may be that the patient or the patient's partner or spouse can waive the right to future compensation but no future child's legal rights can be waived. So if the transfer occurs, if the child is impaired, in many states the child could or would have a claim against the physician. So waiver is not the answer for physicians. And the damages can be quite extensive. They can be lifelong and they can be staggering for the physician or the physician's carrier. And so if you think about it, looking at this from the front end, the liability for refusing to transfer is pretty low. In fact, I don't even know, and others might on the call of a successful lawsuit in which a patient has sued a physician for failing to make a transfer of an anomalous embryo and getting any kind of damages out of that versus when the transfers have occurred and the child has been impaired, there are some staggering actually toward recoveries in those kinds of cases. So just looking ahead, where are we going in our field? Well, again, going back to the emerging technologies, it's been over two decades since human embryonic stem cell therapies and possibilities were introduced. And the question is where have we come with that? And part of the reason I think we haven't come as far as we could is because of the regulatory team. And that's a topic for a whole mother case. I hope maybe you'll invite me back to talk about that. But restrictions in the US have certainly interacted, I would say negatively with advancing these fields. And so perhaps that has set a stage in a groundwork for access moving forward. That is that it would be highly impacted by a negative regulatory environment. But these new technologies, germline gene editing, MRT and IVG, which we spoke about, they are moving forward in a different way because they deal more with reproduction than with therapeutic medicine. But still they're facing as you see, political scientific funding challenges. And those are well known and well described. And again, I think it's no nothing too uncommon to say that should these technologies emerge, they would face the same kinds of barriers that I spoke about to achieve a true distributive justice environment in the field. And so with that, nobody's perfect, but we're working on it. And I thank you so much for this opportunity and look forward to hearing Dr. Adashi's remarks. Can you see the slides? This looks good. Thank you. Looks good. Can you hear me all right? Yes, we can. All right, thank you for the feedback. As like Judy, I will begin at the beginning of IVF, which occurred in 1978 with the birth of Louise Joy Brown, who is shown here in the arms of her mother, Leslie. It's interesting in retrospect to realize what a modest report followed this remarkable event. It was basically a letter to the editor, which you can see here, barely occupied the page that referred to this breakthrough that ultimately, before too long, was rewarded by the Nobel Prize. But at the time, it was barely a page in the Lancet. The United States was a tad behind on IVF. We finally caught up three years later. The individuals who were responsible for that breakthrough were Howard and Georgiana Jones, who at the time were in Norfolk at the Eastern Virginia Medical School. This last year, in fact, we were celebrating 40 years of that anniversary, that is to say the birth of Elizabeth Jordan Carr, who was the first American IVF baby, who was displayed on virtually every outlet around the nation from the Boston Globe to Life Magazine. And so in that respect, the state was set and we now had to begin to deal with the crisis and the consequences of these new technologies in the United States as well. As Judy mentioned, it's generally estimated that about eight to nine million babies worldwide were born as a result of IVF. In terms of access, we are looking at a house divided. In this case, a global house divided just to illustrate a few of those points. All of this is happening, of course, against the backdrop of what was already alluded to and that is the right to procreate, which is clearly spelled out in the Universal Declaration of Human Rights, which dates back to 1948, where in this sentence makes it very plain that procreation is an inherent human right. This notion of procreative liberty could or should, in principle, translate into the right to infertility care. But that is not always the case because infertility is not invariably defined as a disease and healthcare, of course, is all about diseases. And that's another struggle this field is continuing to try to overcome. It's not as if the notion of infertility as a disease is another one. The World Health Organization is very clear about it. It defines infertility as a disease of the reproductive system. Which is defined by the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected intercourse. In fact, the World Health Organization includes female infertility in its International Classification of Diseases, the so-called ICD classification. That said, the situation still is one where in the house is divided between those who can't access the system of reproduction and those who cannot. A global view, for example, of nations or regions where in universal health insurance is prevalent reveals that there is a significant variability in the absence or presence of universal health insurance. If you focus on North America, for example, Canada, of course, enjoys universal health insurance but the United States does not. Europe generally has embraced universal health insurance as did Australia. But as you can tell, there are lots of the globe that have yet to embrace universal health insurance. Despite the fact that the World Health Organization is clearly considering universal health coverage as an overarching principle that all nations should abide by. The house is divided, of course, in the United States which is really where we wanna focus in terms of access to the technologies in question. And primarily this concerns the underwriting of infertility care, the provision of resources that would allow Americans to access infertility care. As I mentioned earlier, one major hindrance is the fact that in the United States, not just there are many other nations but in the United States, infertility is not recognized as a disease, the definition of the World Health Organization notwithstanding. The ASRM has sought on multiple occasions to address this issue beginning in 1993 and called for the notion of defining infertility as a disease that effort was reaffirmed in 2008 and 2013 and quite possibly beyond. But despite that efforts, we have yet to make the kind of progress I think we all hope for. And part of it has to do with the fact that the US of A has a significant streak of what we might call libertarianism, even though we are after all a pluralist democracy, we are not exactly the same as some of the social democracies of Europe or other parts of the globe. And for the most part, in the US there has been and remains a sentiment against the government, the notion of providing the population with care from cradle to grave or for that matter, universal health insurance. We have none of the above. You could say that this predominates perhaps the agenda of the Republican Party rather than the Democratic Party but beyond all of that, it is a streak that runs through, I think, the American psyche or the American worldview. When you compare it side by side, for example, with a worldview of an Norwegian citizen or a Swedish citizen. And then of course, we come back to the notion of failure to define infertility as a disease and we recognize that the poor patient essentially lacks recourse. Neither the public nor the private sector in the United States accept responsibility for the underwriting of infertility care in large measure because they're off the hook. Infertility is not a disease and therefore why should they cover this condition? That's not to say that there is no coverage and we will of course discuss that but the ground rules to begin with do not favor this outcome. As Judy mentioned, just take one look at the Affordable Care Act which we generally think of as a progressive forward-looking law which defined several so-called essential health benefits but did not include infertility care in that definition. And so underwriting of infertility care in the United States remains an issue. We have high under and uninsurance rate, high out-of-pocket costs, absent public payers, limited private payers and even though we have 19 infertility state mandates as Judy mentioned, they have substantial limitations some of which I will point out. Perhaps one way to look at the access to infertility care issue in the United States is to compare or at least assess the public versus the private sector. On the public side, health insurance in the United States is provided by Medicaid, by Medicare, it's provided by the Federal Employee Health Benefits Program, the VA and the Indian Health Service. I'll come back to try care a little bit later. And as you will see, Medicaid, Medicare of course do not cover infertility care. And then it comes to the Federal Health Employee Benefits and VA and IHS, the same holds true and I'll be a little bit more specific in the next minute or so. Over the years, there have been efforts to add IVF coverage to the Federal Employee Health Benefit Plans. As you know, Federal employees who are spread all over the country are generally attached to various health plans, but the determination of the benefits is central and comes from Washington. Several senators and representatives over the years, this is a little bit dated but there really hasn't been any activity since. Advanced bills to add IVF to the Federal Employee Health Benefit Plans but have failed to do so. None of these bills have been enacted. When it comes to the VA, the situation is difficult. We have 10 million beneficiaries who still have to abide by the so-called Veterans Health Care Act of 1992 where in the Secretary of Veteran Affairs may provide women the following health services except not including that is under this section, infertility services. In a word, the VA is prohibited by law from providing infertility benefits to appropriate beneficiaries. Despite the fact that these individuals risk their lives on behalf of the nation, et cetera, et cetera. There have been efforts to correct this circumstance as is shown here, but here again, none of these bills have at any point been enacted. Senator Patty Murray who has been an advocate for infertility care and has made significant contributions to this arena at least was able through an amendment which she introduced in 2016 to see to it that individuals who were seriously injured in a line of duty were in fact able to receive care. Tri-Care is a little different. There are about 9.5 active members who receive their benefits from Tri-Care. And Tri-Care interestingly subsidizes ART for all its beneficiaries, which is to say it doesn't cover everything but it provides hefty subsidies. In 2013, which is the last year I could get figures for, there were 1200 ART cycles under Tri-Care at an out-of-pocket cost of less than $7,000 per cycle which is less than you would pay in the private sector but by no means is covering the costs in full. At least what Tri-Care does, it covers ART for so-called wounded warriors, individuals who were so seriously injured that their fertility was compromised. And for those individuals, the entire cost of the entire bill is covered. These are severely injured service members. Moving now to the private sector, US private underwriting, which is dominated by self-insured employer-sponsored plans has existed at varying percentages over the years. You can see it here through approximately 2013. And when it comes to IVF, the data are mostly to be found in surveys that are conducted by Mercer, a human resources consulting firm. When you plot those data from 2005 to 2020 and examine IVF benefits by employer size, you realize that the larger the employer, the more likely the employee is to be covered in terms of their IVF benefits. Also, larger employer are more likely to cover not necessarily IVF, but a visit to the reproductive endocrinologist, the drug costs that may be necessary before IVF or during IVF. Excuse me. And they will more likely cover what is known as superovulation with intra-utronium insemination, which is a fertility promotion therapy that proceeds IVF before one actually moves to IVF. It's also interesting to note that there is a certain regional variation in the provision of coverage by private employers. It seems that in the Northeast, one is most likely to enjoy IVF benefits as compared with the West, South and Midwest. The reasons are not entirely clear, although we can speculate on why that is so, but those are the numbers. Here again, the region you live in has a lot to do with whether or not the benefits will include a visit with the reproductive endocrinologist, whether the benefits will include the coverage of drug costs or the coverage of superovulation with IUI. As for the infertility mandates, I will be brief in that they are highly heterogeneous. Not all of them, in fact, cover IVF. In fact, the minority of them cover IVF, but even if they do, the benefits are quite limited. We have recently submitted a paper yet to be published on the real-life benefits of the Massachusetts mandate, which is generally thought of as generous and advanced and enlightened, and it is all of the above, but when it comes right down to it, you can see that in Massachusetts, public health plans, Medicare, Medicaid, TRICARE, and the federal employee health benefits are exempted from the mandate by dint of federal or state statutes. In addition, self-insured employer-responsive health plans, as already was mentioned, are exempted from the mandate by dint of ERISA. So when it's all said and done, and we've quantified that, it follows that only 26 to 36% of state-based reproductive age women comprised eligible beneficiaries of the mandate in Massachusetts over the 2016-2019 interval. So really just one in three reproductive age women effectively ends up benefiting from the Massachusetts mandate, and the situation could well be worse in other states which provide that benefit. And then as I mentioned, so many other health mandates don't even cover IVF. Another issue that obviously divides us and has an impact on our conversation is the pro-life-portraits debate. In the United States, which is increasingly one of the last nations on earth to be preoccupied by that issue, we have a problem when it comes to IVF. We have a problem when it comes to human embryo research or human embryo loss. As far as research is concerned, you're probably familiar with the D.K. Wicker Amendment, which has been with us since 1996 and is religiously attached to the appropriation bills to HHS and NIH year in and year out. It prohibits the creation of a human embryo for research purposes or research in which human embryo is destroyed, discarded, or knowingly subjected to risk of injury or death. This does not directly affect IVF, but the implications are clear. We have a very different outlook in the United States on some of these issues and the bearing on IVF is inevitable. They are, in addition to that, ideologically motivated interventions. We had a few state personhood amendments over the years, all of which have failed to my knowledge, but indicate the ongoing unrest amongst a segment of the population that feels very uncomfortable with state, with IVF. The George Bush administration, interestingly, had the major embryo adoption initiative, again, with an eye towards diminishing, hopefully, embryo loss and in keeping with the view of that administration of the sanctity of human life as viewed from a religious point of view. So-called off-the-grid sanctuary or saving grace of IVF is the fact that so much of the coverage as you have seen so far is in the private sector, which is perhaps less preoccupied with these issues. I would also say that all these constraints notwithstanding, there is widespread public acceptance of IVF in that we all value substantially, of course, the ability to procreate and to establish a family. And so the public as a whole supports the notion of promoting fertility. And although it's not publicly recognized or stated, we can safely assume that many of our congressmen and senators have either benefited individually and personally from IVF or failing that may have observed the same in members of their family, possibly their children. And so there is a certain implicit support that is not articulated openly, but which nevertheless exists and almost certainly allows IVF to operate to this day without any direct restrictive legislation. What we need to do going forward, of course, is to define fertility as a disease, overcome these other issues, mostly the uneven underwriting policies and hopefully evolve the social-cultural norms and the raging moral debates that are currently plaguing this field. More specifically, every so often we get good news like the Pentagon would offer has offered to store eggs and sperm to retain young troops. We realize, as Judy said, that large companies such as Apple and Facebook offer to freeze eggs for female employees. Citibank and JPMorgan Chase have followed suit. And when you look at egg-freezing benefits back in 2015 anyway, again, it seemed like in the Northeast, those benefits were more likely than in other parts of the country. What we can do going forward is take the following steps if we can. First of all, we need to reach a consensus on infertility as a disease. And it would help if the Department of Health and Human Services took the lead in that undertaking. Second, we need to advocate for infertility underwriting by employer-sponsored plans. Employers begin to recognize the utility of this benefit in terms of recruiting and retaining high-quality employees, especially high-quality female employees. But there are still things to do. From the employer point of view, it's not only the right thing to do. It's really the smart thing to do because it attracts and retains valuable employees, promotes a family-friendly brand, reduces healthcare costs in terms of plural birth, tracks at less than $4 per member per month, and constitutes 1.5% really of the total health benefit costs. Third thing we may want to do is update infertility state mandates, which we mentioned have a lot, have left a lot to be desired. Four, we may want to press Congress to address the issue at the federal level, fund IVF for everybody in tri-care, fund IVF for all in the federal employee health benefit plans, and repeal the VA infertility ban, which has now been around since 1992. There have been some effort along the way. This is an old sponsored bill by the late Representative Lewis and Senator Kristen Gillibrand to amend the IRS code to provide tax credit for the cost of infertility treatment. This bill has not been enacted, but we need more of that kind of legislative initiative to really advance the cause. And finally, we need to explore and develop low-cost IVF options, so-called low-cost IVF. Already mentioned was the notion of in vitro gametogenesis and other new technologies, whether or not they'll actually pan out in terms of being more affordable, of course, remains to be seen. They should, because there will mostly be laboratory-based procedures. One will no longer require injections to stimulate egg production, and the whole role of the clinician will have to be entirely re-evaluated under those new circumstances, and that's coming. And so as we struggle to bring some sense and sensibility to the coverage of IVF, the technology is changing. It may not happen tomorrow, but it will happen in our lifetime. And so several things are happening all at once, and as usual, we're not given the benefit of planning and sort of carefully adjusting to a new situation. It's gonna be a bumpy ride, I think is probably the way I should end this, and hopefully we can discuss this some more at the later point in this context. So thank you very much again. So thank you both for wonderful presentations that were hopefully really informative for the audience. I'll kick us off first with a quick question here. So my question for you both is with the possible overturning of Roe v. Wade, looming at least seemingly, do you anticipate that future state laws that restrict abortion access may have an impact on ART policies? So for example, one thing I'm thinking of is, do you think for instance, it'll become less common to implant multiple embryos if selective reductions can no longer be performed? Judy, you wanna take that first? Sure, thank you, Bea. That's a great question, and it's one that I know I've been thinking about and I'm sure others as well. So as Elliot laid out, there's a really interesting relationship between ART and abortion. And I mean, if you just look at them positionally, that you can understand why. ART is about family formation, about engaging in reproduction, and abortion is about avoiding reproduction. So it's an uneasy relationship because of the aims, but at their heart, they do involve the same time periods and the same materials, if you will, at stake. So with that sort of said, I think the way in which the overturning of Roe could impact ART is by giving more space and oxygen to the possibility of more heavy regulation on the clinical practices themselves. So for example, there would be more energy toward prohibiting cryopreservation, that all the cycles have to be fresh cycles because the notion is that by freezing the embryos, many of which are unused and either remain in frozen storage or are thought and discarded is somehow similar to an abortion because the movement is of course steeped in the notion that, and I don't wanna generalize and I know everyone has wide range of views, but there is a sort of a dominating narrative that life begins at conception and we need to protect life from the earliest moments. And so that might include not putting embryos in frozen suspension for decades because we do have embryos that have been frozen since early 1990. So that might be one way, no cryopreservation. We also might get laws that say no PGT, no interaction with the embryos at the earliest moments because PGT does involve a manipulation. Right now the technology is that the trifectaderm, the portion of the embryo that will become the placenta is usually the portion that is involved in PGT. We've moved away from the actual inner cell mass, but we're moving still, and we might even be moving to actually just looking at the culture me and hopefully we will. But in any case, the point being that as there's more acceptability of protecting embryos at the earliest moments, then some of the things we do in IVF would not be acceptable to individuals. That said, and here's just makes it interesting and complicated as Ellie said, when you poll legislators about this issue, many of them either personally or through connections, no IVF, they've used it, they have families that have used it and so on. So they're really reluctant to get involved with prohibiting IVF. So while they're all about life begins at conception, let's ban abortion, they're not as ready to say, well, let's slow down or even interact negatively with IVF. So that doesn't answer your question, it just gives you a way that I think I'm certainly thinking about this area. I mean, I think that sums it up very well. All I would say is that state legislators have not lacked an imagination. Just look at the Mississippi abortion law or the Texas abortion law and more that are coming as we speak, of course, in almost, I don't know, how many state legislatures. At the same time, it's impossible to predict, of course, because of what we said about the fact that many legislators, whether they admitted or not, whether they discuss it in public or not, they have benefited from or relied on IVF directly or indirectly. I would only comment about the notion of no freezing that that's not going to be all that workable really, even for the imaginative legislator because invariably we end up with more than one embryo we may have 10, we may have 12. Okay, so if we don't freeze them, what do we do? I mean, one way or the other, they will be destroyed. If they're not frozen, they will be destroyed in fact. By being frozen, they will be preserved and give rise to future life. So I think that would be self-defeating if I were a pro-life legislator. So it's kind of hard to read the mind of those legislators, certainly at this point. All I would say is, just like I said at the beginning, imagination runs wild. If you end up in an abortion law that allows vigilantes to preclude women from proceeding to have an abortion, anything's possible. So I hate to predict. Thank you both. That was extremely helpful at least for me and kind of I've been thinking about this a lot. There's a question from one of the audience members who it's in the same vein. So I'll go ahead with this next. And this person's wondering whether or not there's any sort of discernible consistency or pattern with those 19 states that do have insurance coverage mandates in terms of whether or not that aligns with their legislative positions respectively on abortion rights. Do either of you know if there's a pattern there? I think that would be interesting, especially with the future of Roe Looming. Yeah, I'd have to actually look this up. I never really occurred to me as such. So many of these mandates are clearly in the Northeast. The first one was in Maryland. Massachusetts was next. And of course you have one in Connecticut, New Jersey, eventually New York, I believe. Illinois would take us closer to the center of the nation, California, of course. But I've never really made that effort. Maybe Judy knows whether or not the proclivity of the states had something to do with the nature of the mandate. That's a great question. And like Ellie, I can't answer that specifically, but just make a couple of comments about that. I think the states are one that are more geared toward communitarianism and public health the way that Ellie described, that they're more likely to take up the mantle of providing benefits under the notion that the state has a responsibility to let their citizens live their best lives, if you will. And so in that way, you see the distribution patterns that you do. But if you think about it, the states that have the most rigorous, restrictive abortion laws, and we'll see coming forward what that looks like, you could say are the most pronatalist. They have the most to say about family formation. And so should be the biggest advocates for IVF coverage. It's just the troubling intersection of the way in which IVF babies are formed and the pronouncements against IVF by the church and others that really interact with that direct tie from pronatalism to supportive IVF. So shifting gears a bit. A few people were asking about this idea of insurance coverage and allocating funds. So one question, for example, is even if there is a right to procreate, shouldn't there be a prioritization of sorts, especially if public funds are used? So for example, they gave the optimum example in how she had already had multiple children before using IVF. Two other related questions. One is about whether or not in terms of medical tourism, people are going overseas due to cost barriers. And another is kind of just questioning the justification for having coverage of IVF by health insurance in the first place, given kind of the need to cover other services for people who are very sick. You wanna tackle that, Judy? Sure, so the big question about prioritizing IVF, particularly in a zero-sum game that we live in in the United States health care puzzle, that's difficult. And for those of us who dwell in this area and we really see the import and we see the meaning that it has in people's lives and the intimacy with which they interact with this issue and the legacy issues. I can't help it myself as a tax-paying citizen be an advocate for this as a priority, but I understand 100% the limitations and the other priorities and others would feel equally passionately about the public interceding and helping in other ways. So I defer, I really have to defer on that. The tourism question is interesting. In the US is the source of tremendous importation and exportation of patients for assisted reproductive technologies. On the export side and be the questioners or right, there are many, and I don't know that we can, we don't track it and it would be difficult to track. We have many prospective patients who leave the US for treatment abroad. A lot of them because of third-party reproduction that they're looking for a donor, particularly donor eggs and oftentimes gestational surrogacy and those services can be much less expensive abroad. And there's a whole market advertising. I mean, if you Google IVF holiday, last check, I think there were hundreds of thousands, there may be millions now of hits and they're just a tremendous market in that way. But at the same time, we also import, if you will, patients to the United States because of particularly some of the states that have very favorable legal structures. California, where I spent most of my career before moving to Kentucky, but in California we used to say we were surrogacy central where over half of all of the surrogacy pre-birth orders in the California courts were from international patients. And so because of that, we also have an importation. Now it's not stratified along socioeconomic lines in the sense that the patients we import usually have means, have tremendous means and that's why they're able to come into the US. So overall, I just wanted to give a bit of a picture about tourism, both how we visit and how we welcome fertility tourists in the United States. The only minor, relatively minor point I would add to that is that in terms of importing tourism, there are also clinics in California that would be user friendly when it comes to sex selection, which seems quite important to some of our visitors from the Far East. So wealthy couples from that part of the world, not infrequently will make it to the West Coast and seek assistance when it comes to the selection of the sex of their offspring. So I think that too is a form of, you might say, reverse tourism, medical tourism that exists in the United States. Again, I don't have numbers. I don't really know that this is a huge sector or anything of the sort, but it exists. So unfortunately we're at the end of our time and I know we have a couple other questions but this has really been a great discussion. Thank you both so much for such detailed remarks and thoughtful commentary on this issue and giving us all a lot to think about. We are going to, and thanks also to Bee for moderating. And so we're gonna reconvene next month for our final health policy and bioethics consortium. We are gonna welcome Jim Kim, who's the former head of the World Bank to talk about ethical issues in providing funding for public health issues around the world. But thank you one more time to doctors Adashi and Judith Dar for being with us today. Thank you, thanks for the opportunity. Thank you. Everyone be well.