AHLA's Speaking of Health Law
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AHLA's Speaking of Health Law
Top Ten 2023: Reproductive Health Rights in a Post-Roe Era
Based on AHLA’s annual Health Law Connections article, this special series brings together thought leaders from across the health law field to discuss the top ten issues of 2023. In the first episode, Carol Carden, Managing Principal of Valuation Services, PYA, speaks with Devon Minnick, Associate, Epstein Becker Green PC, about the continued effects of the Dobbs decision on the health law landscape. They discuss state efforts to restrict or protect abortion access, conflict between state and federal law, and the impact on providers and employers. Sponsored by PYA.
Watch the conversation here.
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A H L A is pleased to present the special series highlighting the top 10 health law issues of 2023, where we bring together thought leaders from across the health law field to discuss the major trends and developments of the year. Support for A H L A in this series is provided by P Y A, which helps clients find value in the complex challenges related to mergers and acquisitions, clinical integrations, regulatory compliance, business valuations, and fair market value assessments, and tax and assurance. For more information, visit p y a pc.com.
Speaker 2:Happy New year to everyone joining us today, um, as we kick off the top 10 issues in health law for 2023. Uh, I'm Carol Card. I'm a principal with p y a and I lead our compensation evaluation and design practice. Uh, we'll be discussing today the article, reproductive Health Rights in a Post Row era, and I'm joined today by Devin McKen, one of the authors. Devin, you wanna give a quick, first of all, happy New Year, and would you like to give a quick, um, introduction of yourself?
Speaker 3:Yeah. Uh, happy New Year. My name's Devin Minnick, and I'm an associate at Epstein Becker and Green. Um, I work in the healthcare and life sciences practice, um, and since Dobbs have been focusing a lot on reproductive health issues as well as preventive care, um, and I also do managed care and, um, specifically Medicaid and Medicare Advantage work at the firm. I'm super happy to be here.
Speaker 2:Excellent. Glad to have you. And, and I'll tell you, Devin, when I read your article, it is so content rich that it was a little bit hard to figure out where to start with questions, um, to discuss it. So we all know this is a very, has really kind of thrown the industry for a bit of a loop. There's a lot of issues, um, that came along with the, the Dopps decision, but maybe if you could start off our conversation with a brief summary of what states have been doing, um, post Dobbs, both in terms of restricting abortion access as well as protecting or expanding it, and do we expect to see any changes, um, in 2023?
Speaker 3:Yeah, absolutely. Uh, I think that state activities can be bucketed into a few categories. Uh, the first category is constitutional amendments and the other is abortion related ballot initiatives. Um, in 2022, several states put abortion amendments to their constitution on the ballot as well as allowed the public to vote on abortion access. Several states, uh, and the election passed constitutional amendments that formally protected the right to abortion. Vermont, for example, voted to create a constitutional right to reproductive autonomy by a landslide margin, uh, and Michigan and California voters also voted to create a state constitutional right to reproductive freedom, including abortion and contraception. Uh, three states, Kansas, Kentucky, and Montana put restrictive constitutional and legislative abortion amendments on the ballot, none of which passed the selection cycle. Um, Kansas voters decided to keep abortion legal in the state, rejecting an amendment to the constitution that would have removed that. Right. Um, Kentucky rejected a constitutional amendment that would've said there was no right to abortion or requirement for the state to fund abortion. Um, and Montana rejected a law that would demo fetus at any gestational age to be a legal person, and that would have criminalized providers who don't attempt to say fetuses that are born during, during an abortion. So all in all, wherever abortion was on the ballot this cycle, the public voted to protect access. Um, this will most likely continue to stay relevant for upcoming years as abortion advocates look for alternative pathways to protect abortion on a state by state basis. Since, um, ROE has been overturned, as of today, the majority of states with a total or a six week abortion ban in effect do not have an existing mechanism to allow citizen as an initiated constitutional amendments, including Texas, but in seven states, this could be a future strategy to protect access, even though it's, it's certainly gonna be an uphill battle for advocates. Um, in fact, in Republicans in Ohio, which is a state that permits citizen as initiated constitutional amendments, um, republicans have proposed raising the threshold to pass a citizen initiated amendment. So this is definitely gonna be a battleground that health lawyers will be following closely in the next couple of years. Um, the second category of state activity is state's legislative actions to protect abortion. In the wake of Dobbs, several states immediately passed laws to protect reproductive health privacy, including from other state's subpoenas and to protect abortion. Um, for example, Connecticut passed a law and anticipation of the Dobbs decision that prohibits HIPAA covered entities from sharing reproductive health information, um, without the consent of the patient. And it also prohibits out-of-state request to issue a subpoena in Connecticut with regard to reproductive health information in general. Um, other states have implemented a variety of protections such as explicitly protecting the right to abortion, increasing funding for reproductive healthcare, and protecting reproductive health information to a greater extent than hipaa. Um, as the fallout from Dobbs begins to settle, it's likely that 2023 is gonna see additional attempts by states to protect abortion access. The third category of state activity is kind of on the flip side, which is legislative action to restrict abortion. Um, 13 states had, um, quote unquote trigger laws on the books that immediately snapped into a place, um, upon the repeal of roe. Um, and these trigger law ban trigger laws ban abortion to varying degrees. Um, but the majority of them have now already gone into effect. Many of them impose jail time for providers who are found to administer an illegal abortion, as well as for individuals who quote unquote Aiden Abet a person getting an illegal abortion. Some of the abortion laws only provide exceptions for the health or the life of the mother, which in and of itself has and will continue to lead to litigation, both on one hand when it's unclear whether the abortion was medically necessary. And on the other hand, when physicians' delay providing lifesaving care resulting in injury or potentially even death of the mother for fear of violation, violating the abortion, the state's abortion law, um, still other states have exceptions for rape or for incest, but most do not provide a mechanism for the physician to be sure that the pregnancy that the patient seeking to terminate was actually a result of rape or incest. Um, some states actually require the victim to report the rape or incest to law enforcement before they're eligible for an abortion, which can obviously cause undue delay and access to care. Uh, but it also is unclear how a patient should convey the information to the provider and whether the provider can merely take the patient's word that the pregnancy was a result of a rape or incest or that it was reported to law enforcement, if that's a requirement of the state. Um, some state representatives have actually begun talks of removing existing exceptions for rape and incest, but it's unclear whether that'll actually come to pass. Um, but overall it is basically a guarantee that in 2023, more of these messy and complicated questions will be either ans answered by state's legislatures or through litigation.
Speaker 2:Wow. That is really, um, that's amazing with so many different rules by each state. It's just an incredible opportunity for different states have conflict with federal laws. Um, what's emerged in that area since the Dobbs decision and and what do we expect to see in this year? It just in, in regards to the conflict with federal laws.
Speaker 3:Yeah. Preemption issues have played out across a few major areas in 2022, and they're certainly gonna be continuing into 2023. Um, the first arena has been between states that are trying to restrict abortion pill access and, um, the Federal Food Drug and Cosmetic Act. Prior to the Dobbs decision, it was largely accepted that the Food Drug and Cosmetic Act preempted an outright ban on F D A approved medications, and it was unsettled as to whether state law could actually restrict access to an f fda, a approved drug in a way that stopped short of a full bullet ban. Um, now that Roe v Wade has been overturned, states are imposing abortion, um, or imposing bans on abortion, including those achieved through use of abortion pills. This has resulted in the f d approved medications, Mione and Misoprostol being banned for the purposes of abortion in several states and being seriously restricted in others. This exact preemption issue, um, was being litigated between Gen Bpro and the state of Mississippi even before the Dobbs decision in a case called Gen Bpro v Dobbs, um, Jen Bpro manufacturers a generic version of the abortion pill, MIFA Tritone, uh, and it challenged Mississippi's restrictions on prescribing mifa tritone such as requiring an in-person dispensing of the drug. This requirement is no longer present and the FDA's, um, risk evaluation and mitigation strategies, um, commonly known as rems, and therefore, GenPro argued that the state was placing restrictions on the drug that were not deemed necessary by the F D A in violation of the Food Drug and Cosmetic acts, um, preemption requirements. Um, GenPro recently with actually withdrew its case in Mississippi, but it has publicly indicated that it's considering refiling the case in the future. Um, so in 2023, it's likely that GEM Bio Pro or some other manufacturer will bring a case on the same or similar legal preemption theory. Um, so there's definitely gonna be a lot to follow in that space for the years to come. Um, let alone 2023, um, this federal versus state law conflict has occurred, um, with respect to emergency contraception such as Plan B. Um, as well, the preemption argument is actually stronger in the case of Plan B because the Food Drug and Cosmetic Act expressly preempts any state law that's more stringent than the FDA's regulation of over-the-counter medications, which includes Plan B. Um, individuals against legal abortion have opposed emergency contraceptives because of the misconception that they cause abortion by preventing implantation of an already fertilized embryo. Um, and while no state has successfully banned emergency contraceptives outright, Oklahoma, which currently has the most restrictive abortion law in the country, did try to ban them outright about a decade ago. Um, so likely in response to the possibility of a state like Oklahoma trying once again to ban emergency contraceptives. In light of the Dobbs decision, the F D A just a couple weeks ago decided to update the language on the leaflets that are, um, inserted into packs of emergency contraceptive pills. Um, and this updated language actually makes it clear that the pills don't prevent a fertilized egg from implanting in the womb, um, which basically is stating outright that emergency contraceptives do not cause abortions, um, in the, you know, four states with expansive definitions of abortion being possible at fertilization. Um, so in 2023, it's possible that we'll see some preemption litigation around emergency contraceptives in addition to the abortion pills, but that's still, um, that still remains to be seen. Another major area of tension between federal and state law is respect is with respect to Tala. Um, ello requires hospitals to screen and to stabilize anyone who comes to the emergency department regardless of their ability to pay. Um, Ella expressly preempts any conflicting state laws, but some states, um, post Dobbs have implemented abortion laws that appear to conflict with emtala. In order to address this concern, h h s published a memorandum confirming that physicians can determine that an abortion is necessary under EMTALA in an emergency in order to stabilize inpatient. In fact, a standard interpretation of EMTALA would actually require a hospital to provide an abortion regardless of state law if it was necessary to stabilize a patient that came to the emergency department. This HHS memo was litigated in 2022, and they're actually conflicting outcomes across the country. Um, on the one hand, Texas and Texas, the State Attorney General sued h h s over this guidance, challenging the agency's assertion that abortion could be considered a legitimate response to a medical emergency. This past summer, a federal judge agreed with the Attorney, attorney General and preliminarily blocked the H H S Amala guidance in the state of Texas. On the other hand, in Idaho, the DOJ sued the state claiming that Idaho's abortion law conflicted with Tala. The judge in that case actually agreed with the Department of Justice and found that the law did not make appropriate exceptions to the abortion ban for serious impairment and dysfunctions threatening, um, patients, patients health. So now we have a circuit split, um, in 2023, we should expect a continuation of this litigation, which could spur, spur more states to take a similar interpretation as Texas if the case is resolved in favor of the Texas Attorney General. Um, this is definitely a case that could be ripe for the Supreme Court to grant to grant cert for due to the circuit split. And if the court did decide to take it on, it would be forced to grapple with the issues presented by some states ultras restrictive abortion bans when they're pushed up against established federal law like Tala.
Speaker 2:Wow, all these new state laws and litigation coming at you from all different directions seem to create a really confusing legal abortion landscape. How's this impacted providers and just the healthcare industry?
Speaker 3:Yeah, that's a great question. It's been impacting different aspects of the industry in interesting and unique ways. Um, on the physician side, all of the uncertainty I talked about before has resulted in an overall hesitance to administer abortions in states, restricting the service even when the situation at hand is a legal abortion. Um, tamala, for example, even though tala should technically preempt state law and protect a doctor from any repercussions of, you know, non negligently administering an abortion in an emergency situation, states like Texas and Ohio are pushing back against that interpretation, suggesting that an abortion may not actually be an acceptable remedy to an emergency. And stating that it's not appropriate for h h s to dictate that abortion could be a required stabilizing treatment for a patient in emergency. Um, regardless of state law, the situation becomes even more complicated when abortion is one of multiple possible interventions to stabilize a patient. Um, you know, for example, what if abortion is the procedure most likely to stabilize the patient, but another service may also stabilize them, even if it's a little bit less likely or a little bit riskier. Um, really what's a physician to do, then there's no clear legal guidance for situations like these at present. Um, overall, the overturn of ROE has resulted in a, in a strong chilling effect on providers and facilities in the abortion space within restrictive states. Um, lawyers are being brought in to the healthcare decision making process more than ever before due to all of these complexities, which could result in delayed care for the patient or potentially result in a different healthcare solution for the patient than the one that would've been decided by the doctor without legal guidance. Um, all of these complexities will certainly continue to play out among abortion providers and facilities in 2023 and beyond now that ROE is no longer the law of the land. Um, another interesting issue that may potentially be surprising to listeners is that the assisted reproductive technologies industry has been deeply, deeply impacted by state's re restrictive abortion laws. In particular in vitro fertilization or I V F has been under quick, has been under, um, quiet attack in restrictive states. I V F helps to combat infertility by extracting eggs from an individual's ovaries and then fertilizing viable eggs with a sperm outside of the body. Uh, each round of IVF can produce multiple viable and non-viable embryos. Non-viable embryos can include embryos with genetic abnormalities like Trisomy 13, for example, um, or down syndrome. And before Dobbs nonviable embryos were oftentimes simply discarded without threat, um, of legal repercussion. If that's what the, um, genetic parents wanted to do, then in, um, then IVF providers selectively implant the best embryos that have the highest likelihood of survival into the individual's uterus. Oftentimes, an IVF provider will implant more than one embryo. All of that's happening less and less, um, because they expect some of the embryos may not become a successful pregnancy. Um, however, in some cases, multiple embryos become successful pregnancies and in which in that case providers may engage in what's called, um, selective reduction or removing already implement implanted embryos to ensure that the pregnant individual has a safer, um, and successful pregnancy. After the fall of roe, some states implemented what are known as quote unquote personhood personhood laws. These laws present the strictest abortion restricted restrictions, defining personhood to begin at fertilization and accordingly banning abortion at fertilization. Most of these personhood laws do make it clear that fertilization must occur within the human body, but not all them. Uh, in the context of I V F in a state that prohibits abortion, beginning at fertilization, eliminating implanted eggs is likely considered an illegal abortion. In addition, in states banning abortion at the point of fertilization, without an explicit exception for I V F or without reference to implantation, um, of the embryo, there's uncertainty as to whether discarding unused, but fertilized eggs would constitute an abortion. So all of this uncertainty has result, has resulted in widespread confusion among the assisted reproductive technologies community, and in some cases actually impacts their ability to provide services at all in some states. Um, as a result, lawmakers are beginning to take steps intended to protect services like I V F, which were kind of an unforeseen impact of Dobbs. Um, for example, Democrats have introduced a bill called the Right to Build Families Act of 2022, which would prohibit state's abilities to limit anyone from a, from accessing assisted reproductive technologies or retaining their reproductive genetic materials. Um, it's likely in that in 2023 and that in the years to come, there will be litigation and increased legislation around assisted reproductive technology and I V F. So there's a lot to look out for in the years to come.
Speaker 2:Yeah, it really makes you wonder if the impact on IVF was an unintended consequence,
Speaker 3:Right.
Speaker 2:The Supreme Court, um, I guess we've at least touched on most of the areas of the article except for the impact of Dobbs on employers. So what do we think's gonna happen? Cause there's a whole different set of issues. Um, when you get into the employer community, what are, what are you expecting to see? What have we seen or what are we expecting to see there?
Speaker 3:Yeah, this, like everything else we've talked about, is in a state of complete flux and we'll likely see big developments in 2023, uh, and the years to come. One big trend that we're seeing right now in the employer sector is the increased offering of travel benefits, which may present risk to employers. These travel benefits, which are generally offered by self-funded employer plans, allow employees in abortion restrictive states to travel to another less restrictive state in order to receive a legal abortion. Some states are already taking steps to attempt to ban abortion related travel despite such attempts being a possibly unconstitutional impediment on interstate commerce. Um, for example, the Texas Freedom Caucus has already threatened law firm Sidley Austin for offering travel benefits, stating that it would seek to disbar lawyers who violated the state's abortion laws, which is wild<laugh>. Um, additionally, some states have implemented so-called aiding and abetting laws, which could be construed to apply to apply to employers who assist their employees in leaving the state to obtain an abortion that would have been illegal in the employee's home state. This is extremely uncertain territory, and it's likely that there's gonna be litigation in this space within the new year and in the coming years. Another interesting facet of this topic could come into play if the next presidential administration flips to Republican, um, in response to the increased trend of employers offering abortion related travel benefits, an xal Opportunity Commission official under the Trump administration, Sharon, um, fast Gustavson actually sent a letter to several companies that offered abortion related travel benefits stating that such travel benefits provided solely for abortion were discriminatory against people who needed other healthcare services not available locally. Um, the E O C has publicly stated that Gustavson did not have authority to speak on behalf of the agency. However, her letters may provide a preview of a future Republican E E O C'S interpretation on the issue. Um, and notwithstanding it's rebuffing Gustafson letter, it appears that E E O C commissioner Andrea Lucas has indeed filed a commissioner's charge against certain employers, alleging that the, that providing benefits only for abortion related benefits violated Title VII of the Civil Rights Act and the Americans with Disabilities Act. So much remains to be seen in this space. And we're gonna have plenty of issues to track in the new year.
Speaker 2:Yeah, definitely. You was just thinking, I don't think we've heard the last of this, so this has been a fascinating discussion. Devin, appreciate you writing the article and then spending some time with me today, um, discussing it. So thank you for your time.
Speaker 3:Yeah, absolutely. This was a pleasure.
Speaker 1:Thank you for listening. If you enjoy this episode, be sure to subscribe to a H L A speaking of health law wherever you get your podcasts. To learn more about a H L A and the educational resources available to the health law community, visit American health law.org.