The LePage Ruling and Implications for IVF by Samra Saleem

The recent LePage v. Center for Reproductive Medicine decision by the Supreme Court of Alabama has brought the legal status of embryos to the forefront. The opinion has fueled a renewed interest about the future of in vitro fertilization (IVF). Within days after the ruling, a slew of press detailed the far-reaching implications of this decision for IVF treatment and the future of reproductive autonomy, fetal personhood, and access to care.

The Science:

IVF is a complex and expensive fertility treatment aimed at addressing infertility and preventing the transmission of genetic diseases. The process involves collecting mature eggs, fertilizing them with sperm in a lab, and placing the resulting embryos in the uterus to facilitate pregnancy. Some embryos are cryogenically frozen to preserve these fertilized eggs for future usage. But this is also not a medical procedure and process without risks. According to Mayo Clinic, there is a high risk as some embryo may be destroyed during the freezing process.

The Case:

In December of 2020, a hospital patient at the Mobile Infirmary Medical Center wandered into the Center for Reproductive Medicine in Mobile, Alabama. Having found his way into the reproductive health center via an unsecured door, the patient entered the Center’s cryogenic storage facility and removed several embryos. However, because of the subzero temperatures at which the embryos were stored, the patient’s hands were burned, causing him to drop the embryos on the floor, destroying them. The owners of the destroyed embryos filed suit against the Center and its governing hospital, asserting claims under Alabama’s Wrongful Death of a Minor Act, and, in the alternative, common law negligence claims seeking damages for mental anguish and emotional distress. According to the Alabama Wrongful Death of a Minor Act, the “death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation.” The trial court dismissed these claims, in part, finding that “in vitro embryos . . . do not fit within the definition of a ‘person’ or ‘child.’” On appeal, the Supreme Court of Alabama reversed the dismissal and defined the cryogenically stored embryos as children. In LePage v. Center for Reproductive Medicine, the Supreme Court of Alabama ruled that under the state’s Wrongful Death of a Minor Act, the definition of a “child” included the unborn, irrespective of their location (inside or outside a biological uterus).

Implications for IVF:

The decision by the Alabama Supreme Court has not only shaken many in the legal community, with some seeing in it the anti-abortion perspectives given credence in the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, but it has also taken the health care industry by surprise. The implications of this decision are far reaching, both medically and economically.

Since the decision was handed down in February 2024, several IVF treatment centers have postponed performing IVF procedures because they fear that not doing so will place them in legal jeopardy as lawmakers—both in Alabama and elsewhere—scramble to make sense of the ruling.

This ruling by the court is wrong, however. The legal recognition of embryos as children from the time of conception raises concerns regarding the legal status and protection of early pregnancies. This can potentially influence reproductive liberty by limiting medical procedures such as IVF and, more ominously, criminalizing natural processes.

Embryonic development is a complicated process that begins within twenty-four hours of conception, with rapidly proliferating cells that eventually mature into a fetus by the eighth week. At this stage, the zygote/embryo lacks any traits that can be associated with a child. The choice to equate embryos with children simplifies the complexities of early pregnancy. The fetal phase, which begins nine weeks after conception, indicates the stage of uterine expansion (after implantation). Identifying embryos as children weakens this critical difference, raising questions about the legal repercussions for pregnancies in their earliest and most fragile stages.

The ruling’s impact is particularly worrying when considering the frequency of miscarriages and early pregnancy losses. The Cleveland Clinic states that “[b]etween 10% and 20% of all known pregnancies end in miscarriage. Most miscarriages (80%) happen within the first three months of pregnancy (up to 13 weeks of pregnancy).”

In a recent opinion piece by Dr. Gavin E. Jarvis of Cambridge University, he argues that “Complex biologic processes do not work perfectly all of the time, including human reproduction. A recent re-analysis has concluded that pre-implantation embryo loss is approximately 10–40% and that total loss from fertilization to birth is approximately 40–60%.” If the public accepts the LePage decision, would that imply that approximately 40 to 60% of women who experience miscarriages, a natural and common occurrence in early pregnancy, could potentially be considered to have committed wrongful death of a minor? This point raises critical questions about where the legal responsibility would be drawn – would it extend to the doctor performing the IVF or even the mother in the early stages of pregnancy, creating potential liabilities for these parties in cases of pregnancy loss?

Advocating for reproductive rights involves a sophisticated understanding of the early stages of pregnancy as well as a rejection of the idea that embryos are equivalent to infants. Individuals’ rights to make informed decisions about their bodies and fertility require a legal framework that recognizes the intricacies of reproductive biology. If sustained, the LePage decision may violate human liberty and interfere with medical treatments, underscoring the need for a more educated and nuanced approach.

In addition, this decision will also have a significant influence on the economy. The potential economic consequences of a state losing IVF services are noteworthy. According to Forbes, the average cost for an IVF treatment in 2024 is $15,000 to $20,000. If such legal and political impediments to IVF procedures continue, the result could be reduced business activity and downstream impacts on a state’s economy. There’s a concern that in states without criminal penalties for IVF, the average cost might increase significantly, possibly reaching $50,000. There is also the possibility of aggregation principle, affecting interstate commerce.

The potential loss of IVF services by a state because of legal challenges has the potential to cause substantial disruptions to both interstate commerce and the overall national economy. The implementation of such limitations may result in a decrease in commercial operations for healthcare providers, motivating individuals to pursue IVF treatments in alternative states where services are more readily available. This would lead to increased healthcare expenditures outside of the state, which would have a good influence on the economies of those states and a negative impact on the economy of the state that does not provide IVF. Moreover, the escalated expenses associated with IVF might potentially burden insurance systems and government healthcare programs. Healthcare companies may reassess their investments and operations in IVF unfriendly states, resulting in employment cuts, less tax income, and lower economic activity. The combined impact of these elements has the potential to initiate government action or regulation in order to rectify economic disparities and guarantee widespread availability of vital healthcare services across the country.

The LePage decision presents a substantial threat to reproductive rights. The ramifications extend well beyond the courtroom affecting the lives of millions of people navigating the complexities of pregnancy as well as the health care industry.

Physician-Assisted Suicide: A Patient’s Right to a Dignified Death by Simon Hernandez

For several decades, medical aid-in dying (better known as physician-assisted suicide (PAS)), has been at the core of a controversial debate in bioethics between federal and state legislatures. While the United States Supreme Court has deliberated over a patient’s right to refuse life-sustaining treatment against the state’s interest in preserving life, it has also rejected PAS as a substantive right protected under the Constitution. Despite this, several states have taken steps to ensure their citizens, specifically those suffering from terminal illnesses, have the right to die on their own terms. Currently, in the United States, ten states and the District of Columbia have legalized PAS for terminally ill patients. This has primarily been accomplished via state policy reform and implementation of “Death with Dignity” statutes. These state laws provide terminally ill residents with the legal right to obtain prescriptions that will allow them to end their lives. The question that remains, however, why are the federal government and non-death with dignity states reluctant to extend this decisional autonomy to the rest of the country? Given that the Constitution prevents the federal government from intruding into our personal and often private decisions, should we not be allowed to decide our means of death?

The core issue of PAS boils down to whether an individual right to end one’s life is guaranteed under the Constitution. In Washington v. Glucksberg, the Supreme Court was asked to decide whether Washington State’s prohibition on “causing” or “aiding” suicide went against the Fourteenth Amendment’s  due process liberty interest. Looking to the nation’s history and traditions around the treatment of suicide, the Supreme Court found that no such right to die existed, and that, in fact, it was quite distinct from the right to refuse life-sustaining medical treatment. The court used an originalist approach in its decision and concluded that the legalization of PAS would violate traditional notions of the Fourteenth Amendment’s Due Process Clause. However, they held that PAS legalization was a substantive issue for the states to decide.

States that allow for PAS often enact requirements that follow the regulations and requirements first established under Oregon’s 1997 “Death with Dignity” Act. Statutes like Oregon’s allow qualifying terminal patients the right to end their lives with a prescribed lethal medication approved by their physician. The law requires an extensive patient/physician request process. This ensures a physician provides the correct treatment option to their patient and that the patient is fully consenting and aware of the requested procedure and its outcome. States with “Death with Dignity” statutes will also require the patient be a legal adult, capable of deciding and voicing their own healthcare choices, have a diagnosis of a terminal illness that will result in death within six months, and a resident of the state but this requirement has become loosened in some PAS states. Additionally, the patient must submit various oral and written requests to their physician and may even be required to undergo a physiological evaluation. This decision is only that of the patient and at the discretion of their physician. By states introducing such statutes, they are creating an effective procedural process that, on a state level, would allow their citizens affected by terminal illness to have guaranteed substantive rights even if the federal Constitution does not encompass them.

Although states like Oregon and California have shown the benefits of enacting PAS statutes, there is still significant opposition from various coalitions representing medical professionals, religious groups, and disability rights groups that have made legislative progress towards expanding PAS availability quite tricky. This objection is often rooted in a divide between moral/ethical ideologies and the potential risk of harm to the medical field. There is no doubt that there is a divide between pro-life and pro-choice organizations, reformists, and legislatures who have contradicting views of the practice. Pro-life advocates find legislative initiatives in favor of PAS to defile the sanctity of life by putting a vulnerable population at greater risk of improper treatment and diminishing their rights. On the other end of the spectrum, PAS advocates, such as the organization known as Compassion & Choices, argue that PAS can empower a terminally ill patient to have complete control of the remainder of their life, while also calling for a “patient-directed system” that prioritizes a patient’s wishes while also reforming end-of-life care policy.

Aside from political influences, there is a concern that a wider acceptance of PAS may tarnish the medical field, including potentially increasing the risk for medical abuse. Many have pointed to the fact that a physician taking part in a PAS procedure is in direct contradiction to their role as a healer and violating their ethical duties to preserve life and do no harm. While this is true from a traditional perspective, more modern iterations of the Hippocratic Oath do not prohibit nor make physicians promise not to participate in certain practices. The development of the oath has recognized the necessity of modern medical interventions and shown an awareness of novel health care issues while maintaining a commitment to individuals receiving sufficient care and treatment. Thus, under the modern Hippocratic Oath, PAS could be deemed an acceptable form of care among physicians who choose to participate in the practice.

While a state can legalize the practice of PAS, no law requires or forces physicians to take part in the treatment if they object to its practice on social, political, religious, or ethical grounds. There is also a concern about PAS becoming a sanctioned form of medical abuse were it to take some of the place of current end-of-life care. While this would be an extreme implication, such slippery slope arguments are not without merit given the history of medical abuses that have been targeted towards vulnerable communities. Based on this hypothetical, there is the concern that physicians could push PAS onto patients who cannot afford other treatment options, restrict hospital resources for terminal patients, or even coerce patients towards PAS because it could eliminate the “unnecessary” burdens related to long term care.

A federal right to PAS is unlikely, given the Supreme Court’s focus on only recognizing those rights deeply rooted in the nation’s history and traditions. Other avenues for future legalization, such as through congressional legislation, would be unlikely given Congress’s longstanding opposition to PAS, including a ban enacted by the 105th Congress that prohibits the use of federal funds for PAS programs. However, I envision other progressive states slowly moving towards implementing the pro-PAS legislature. Currently, state legislatures in Maryland, Massachusetts, and Michigan, to name a few, are optimistic about the potential that PAS-related bills will be introduced and voted on throughout 2024, given the uptick in public and legislative support.

The future success of PAS lies in limiting it to a genuine last-resort option. This would require the patient to undergo other treatment(s); if there is no success, then a physician can identify PAS to their patient. From there, the patient must follow the required PAS procedures to be considered a proper candidate for the treatment. Additional safety nets could also be established, such as third-party mediation between patient and physician interactions regarding the treatment and recording the number of patients who have undergone treatment at a particular facility or physician.

PAS is a remarkable treatment option for those who genuinely have exhausted all other options and are confronted with an end to their lives that lacks the dignity and control they’ve exuded throughout the rest of their lives. It allows the individual to have complete autonomy over themselves at a point of extreme vulnerability where they may feel powerless. While controversial, I believe PAS has widespread use within the medical field but must be under stringent regulation and only applicable to the most severe instances. However, we still have to work towards a future in which policymakers and the general public can feel confident in this treatment and change their views of PAS to one centered around the benefits of autonomy and preventing unnecessary suffering.

Maternal Health is Breaking in Rural America by Adam Andersen

The term “Rural America” invokes certain ideals and feelings on what it means to be American. The classic image that often springs to mind is that of American Gothic, which perfectly encapsulates what it is that so many in this country are nostalgic for. Family, arduous work, agrarianism, and even the woman being placed behind the man because she knows her place in that world: a perfect picture of an imperfect society. Yet, the yearning and desire to return to this simpler, more banal lifestyle is already taking a toll on its most vulnerable members: mothers and expectant mothers.

The current outlook for maternal health post-Dobbs v. Jackson has trended toward the negative. Maternal mortality rates have continued to rise in the U.S. without any sign of abatement and it is even worse for women specifically located in rural America. OBGYNs across the United States see worsened impacts on racial and ethnic inequities, management of pregnancy-related medical emergencies, mortality, and even attracting new OBGYNs to the field post-Dobbs.

This is just the general state of maternal health across the United States. In states that have enacted abortion bans the situation is becoming worse. In Idaho, there are fewer applications for OBGYNs seeking residency, in Texas more than half of its counties lack obstetrician-gynecologists, and in West Virginia, less than a third of its counties have hospital birthing centers. Among those states, the women who have access to reproductive care are often in the urban areas, whereas rural residents had a 9% greater chance to suffer maternal morbidity compared to urban residents, and the risks of preterm births (associated with issues such as intellectual disabilities, asthma, etc.) are higher without access to obstetrician care which rural women have less access to.

What’s more, the closure of rural maternity wards has continued to grow in a cyclical feedback relationship, with OBGYNs either not seeking employment in those communities or moving elsewhere due to conflicts with restrictive abortion bans which results in maternity wards closing.

As more maternal medical personnel leave a certain area, they create something called a maternity care desert. A maternity care desert forms when a county has no obstetric hospitals or birth centers and no obstetric providers. These maternity care deserts are going to continue growing and disproportionately impact rural women in the South and Midwest particularly. Further studies show that nearly two-thirds of the maternal deaths that occur are preventable had the expectant mother had access to a maternity ward. If the trend of rural maternity wards closing continues, then the number of dying mothers will also continue to grow even though their deaths are entirely preventable.

It is not enough that rural women already face poorer health outcomes and have less access to health care compared to urban women, but many live in states that have enacted the strictest bans on reproductive health while also providing the lowest support for maternal health. It would rise to the level of comedy if this issue were not impacting some of the most vulnerable citizens in the country. One counterargument to this is to point out that women and mothers can choose how to manage their health best, but that relies on the presumption that women have choices they can pursue in these situations.

Expectant mothers in rural America are often faced with a dichotomic choice: finance themselves by moving to a nearby urban area to safely give birth under the care of OBGYNs or attempt a homebirth with all the associated risks that come from the decision. This choice presumes that hopeful mothers can finance their way to give birth, but the issue is compounded when taking into account that rural areas in general have less financial support. This poverty, coupled with the fact that states that deny access to reproductive health care are condemning women and their children to deeper poverty, shows the powerlessness for many mothers in rural America from lack of financial support.

Without the financial backing that is consistent with higher education and careers that accompany women with access to reproductive health care, it will only continue to make women in rural America more likely to become mothers without being ready to care for a child. This leads to them to become less financially stable, undereducated, and reliant on marital ties to make ends meet.

With such a bleak picture presented, the natural inclination is to ask what can be done. For example, Idaho has led the way in a new heterodoxic approach by simply discontinuing its maternal mortality review committee, becoming the only state without one.  While novel, it is not the approach that helps mothers if we elect to stop reporting their deaths.

The most straightforward solution is to legalize access to reproductive health care via abortion and contraceptives. There is endless evidence that when women are able to control their own reproductive health, it improves economic and healthcare outcomes. Since abortion continues to find itself as one of the seeming controversies of this century, there are alternatives.

One solution is to approve out-of-state healthcare providers as state Medicaid providers. This would allow the state to reimburse expectant mothers who need to travel across state lines to access obstetrician care and leave more money in their pockets to provide for their families. The current situation of Medicaid across the U.S. is heavily dependent on which state you are residing in, but if women in Coeur d’Alene, Idaho could go across the border to Washington for obstetrician care without incurring large amounts of debt, then they could receive much needed maternal support and prevent being one of the two-thirds of maternal deaths that were preventable.

Another solution is for the state to provide housing for expectant mothers who live far from maternity wards akin to Ronald McDonald House Charities. Maternity housing is usually run by anti-choice crisis pregnancy centers and these maternity houses are usually in states that have the highest rates of maternal mortality and poverty. If states were to step in and provide government-sanctioned housing before, during, and after birth, then they would be able to remove these predatory institutions that seem to thrive on using vulnerable women who often have no other place to go. The mother would have their room and board provided for by the state while staying and then, after delivery and subsequent evaluations, would be able to return to their rural communities without incurring monolithic amounts of debt and save the mothers from predatory pregnancy centers.

One last solution would be to expand telemedicine and clinic networks to facilitate access to maternal medicine consultation services. In Idaho again, telemedicine has been at the forefront of bringing much-needed medical access to rural communities in a cost-effective manner that was even able to weather the COVID-19 pandemic. If telemedicine is possible for deeply rural communities, then it is not much of a stretch to add on obstetrician care as an addendum. This issue is now gaining more traction as maternal telehealth becomes more in need for women who require contraceptives in states that have banned access to reproductive services and are looking for alternatives.

Ultimately, the patchwork of abortion laws that has sprung up post-Dobbs has resulted in increased maternal mortality rates that disproportionately affect rural women. If this new American Gothic is to continue, then instead of the woman being behind the man it would have to leave women out of the painting entirely, since rural mothers are the ones impacted most and have the least say in decisions over their reproductive health. If this continues, and rural America keeps leaving its women behind, how can the nostalgia for the rural parts of the nation continue when they only support half of their population?

The Predatory Tactics of a Wealthy Nonprofit Health System by Amna Cehaja

For a brief moment, imagine that you are a mother of three loving children whom you take care of to the best of your ability, despite living in a one-bedroom rental space. Unfortunately, one of your children has scabies, a rash that is an infestation of mites on the top layer of skin where they burrow and lay eggs; it is spread from person-to-person by direct exposure with an individual who has the disease, such as household members. To take the best precautionary steps, you take your three children to a pediatric doctor in hopes of treating the entire family before the scabies further spreads. However, your doctor only prescribes medicine for two of your children, the two that do not have scabies – yet. Your third child, with the scabies, cannot receive a prescription since their account has been locked due to unpaid bills surrounding their health issues. This is just one of many examples of a wealthy nonprofit health system taking advantage of its patients.

Allina Health System (Allina Health) is a large nonprofit system throughout Minnesota and Wisconsin where it manages more than 100 hospitals. Allina Health details on its homepage that, “Health care can be complicated but it doesn’t have to be.” However, do Allina Health’s words mean anything?

An investigative New York Times article discovered that Allina Health had not allowed patients to seek or receive care if they have unpaid medical bills. Not only that, but for patients to finally receive the care they truly need, their entire bill must be paid off. This policy was suspended in March 2020, but started back up in April 2021. Staff were instructed to withhold care, and even cancel appointments if a patient is in at least $4,500 of debt.

Since Allina Health is a nonprofit hospital system, it didn’t have to pay $266 million in taxes. However, in exchange of its nonprofit status, the Internal Revenue Service (IRS) requires Allina Health to help its community which requires providing free and/or cheaper care to individuals with low incomes. The IRS did not set a minimum low-income amount that Allina Health could use as a guide which resulted in Allina Health spending less than half of one percent of its assets on its deal with the IRS.

The issue at hand only involves patients who required treatment from specialists and clinics, not the hospitals. Per federal law, hospitals are required to treat those who come into its emergency room, notwithstanding whether or not the patient will be able to pay the bill at the end of their care. However, the Emergency Medical Treatment and Labor Act does not explain how patients should be treated when they are receiving other kinds of care.

It should be of no shock that many individuals nationwide are in debt, especially medical debt. In Minnesota, where the majority of Allina Health hospitals are, 109,000 individuals in the state are in medical debt, totaling to $148 million. For a moment, recall the deal that Allina Health had with the IRS. Allina Health’s annual revenue is around $4 billion, and it could have wiped out the entire medical debt of Minnesota if they had upheld the end of their deal. Instead, the nonprofit did not have to pay taxes and it did not benefit their community, rather it served as a detriment.

Although money plays a large role in this issue, the immeasurable impact that this had, and continues to have, on families in the Midwest is detrimental and could be life-altering. Physicians of Allina Health have even come out and spoken against the nonprofit’s predatory practice. One doctor said that, “Nobody wins when patients can’t get preventive care.” Other employees of Allina Health have also shared their own experiences; a receptionist detailed that the computer system itself would not let her schedule appointments for patients in debt even if she wanted. Adding on, if an employee cancels an appointment, but the patient later pays off the bill, the canceled appointment is not restored. One Allina Health patient, JoLynda Anderson, had her appointment canceled due to her debt, and was enrolled into monthly payment plans. Even with the payment plans ready to go, Anderson could not attend the appointment since all her debt had not yet been paid off; she had been waiting for this appointment for nearly four months. Allina Health says that prior to taking away a patient’s care, its employees will call and send many letters about the patient’s debt before they reach the debt threshold. However, just because they notify the patient does not mean that it is a measure put into place for the patient’s best interest.

Minnesota Attorney General Keith Ellison is actively looking into the situation and urges those affected by Allina Health’s “aggressive billing practices” to contact his office to further understand whether any laws or agreements have been breached. Allina Health hospitals have a zero tolerance policy for abusive, harassing, oppressive, false, deceptive or misleading language when looking at medical debt. Keith Ellison is working hard to create a conversation and ask the hard questions that Allina Health does not want to hear.

Personally, I believe that as a nonprofit organization, Allina Health should not be taking advantage of patients who are vulnerable due to both their low-income status and health issues. What could possibly be the solution? Unfortunately, I do not see a definitive “fix” for this issue. There cannot be one solution since patients in the past have been subject to this predatory practice and nothing will change what they went through. Liz Reyer, a Democratic representative of Minnesota said it best: “[T]hey’re [patients] not buying nice new clothes or a nice new car; they’re taking care of their health.” Money cannot fix the problems of the past. However, money continues to be the most important factor for Allina Health.

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It sure seems as if Allina Health should update their home page. It cannot say that, “[Y]our [patients’] health is our top priority” if they refuse patient care the moment money is brought into the equation.

The quick-paced nature of the healthcare field is at play with this topic. In the midst of writing this blog post, the New York Times published an article entitled “Nonprofit Health System Pauses Policy of Cutting Off Care for Patients in Debt.” On June 9th, 2023, Allina Health announced that it would stop withholding patient care from those in debt as it takes a closer look at its policy. This is a large triumph; however, there is still one major fault. Although Allina Health is temporarily halting its predatory practice, it will not restore the care that has been withheld from patients in the past.

Matt Hoffman, an Allina Health physician, said that the stoppage of withholding care has given him hope that Allina Health will make the requisite changes that are needed. He hopes that Allina Health does the right thing and reinstates patients who have been affected.

I hope that Allina Health’s new policy change is not a scheme of false hope. After all, Allina Health stopped this particular practice when COVID-19 started to pick up. However, it was later put into practice again. I have low expectations for Allina Health, and it is only a matter of time before it upsets individuals once more if it continues its predatory practice.

Impacts of Health Insurance Discrimination Based on Sexual Orientation & Gender Identity by Sydney Dray

As of 2023, a whopping 26 states lacked legal safeguards to prevent discrimination by private healthcare insurance companies against LGBTQ+ individuals. States like Tennessee and Mississippi have recently passed legislation permitting medical discrimination against LGBTQ individuals, specifically the transgender community. Tennessee Senate Bill 0001 and Mississippi House Bill 1125 fully ban gender-affirming healthcare for transgender minors. These states are only two of many whose legislators have lobbied for restrictions on gender affirming related healthcare access or passed legislation to effectuate such restrictions.

 

Generally, gender-affirming healthcare is a supportive form of healthcare that consists of an array of medical, mental health, and non-medical services for transgender and nonbinary people. Gender-affirming healthcare for minors can consist of treatments such as hormone therapies, puberty blockers, and, on the rare occasion, surgeries. Typically, this care has been covered by insurance. However, recently, some states have either begun to put restrictions in place regarding a minor’s ability to receive this kind of care or have allowed for private insurance companies to refuse to cover such care all together.

 

Critics of legislation prohibiting gender affirming care and insurance safeguards worry that misinformation about gender-affirming healthcare invited tighter restrictions on obtaining gender-affirming healthcare. For example, Vanderbilt Medical Center had to deny rumors that surgeons performed genital surgeries on minors because misinformation was being spread as an attempt to criticize them for providing gender-affirming care. In fact, Vanderbilt has only ever performed limited chest surgeries for minors, which is still a procedure which requires the patient be at least sixteen years old and obtain full parental consent. In other words, just because a minor has access to gender-affirming care this does not mean that child is able to get any significant surgery or treatment at the drop of a hat, without parental consent, as critics suggest.

 

In addition to the challenges to accessing care stemming from misinformation campaigns, proponents of LGBTQ rights have continuously emphasized that access to gender-affirming healthcare saves lives. This is critically important when transgender individuals suffer from high rates of suicide. Research shows that gender-affirming healthcare improves the overall mental health and well-being of gender diverse adolescents. In particular, transgender minors are subject to significant health disparities compared to their cisgender peers. Therefore, legislation banning such care is likely to enhance such disparities since transgender minors are being restricted access to healthcare that can be truly lifesaving.

 

As a society that, in recent decades, has made leaps and bounds in promoting LGBTQ rights, we should be grateful for the progress made thus far. However, at the same time we should still be aware that these recent restrictions could begin to substantially erode that hard won progress. We still have work to do. Until all states provide LGBTQ individuals with inclusive insurance protections, both through private insurers and state employee insurance benefits, the fight for such rights is far from over.

Patient-Provider Communication in the Era of Texting, Email, and The Health Insurance Portability and Accountability Act (HIPAA) by Maya Ressler

Jim Sheldon-Dean has worked in HIPAA, health information privacy, and security regulatory compliance for 23 years. He speaks about HIPAA at conferences, conventions, and private educational sessions. I attended his webinar which discussed HIPAA, texting, and email.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal statute that prohibits the disclosure of patient health information (PHI) without the patient’s consent or knowledge. HIPAA seeks to prevent healthcare fraud by securing PHI and restricting access to health data. It mandates that all HIPAA-covered entities implement safeguards to secure sensitive personal and health information. (Why is HIPPA Important, The HIPAA Journal). HIPAA contains three rules: the privacy rule, the security rule, and the breach notification rule. The privacy rule governs uses and disclosures. The security rule applies to electronic PHI and employs a risk analysis to identify and plan the mitigation of security risks. The breach notification rule mandates that violations of PHI be reported to Health and Human Services (HHS) and the affected individuals.

The HIPAA Breach Notification Rule defines a breach as “an impermissible use or disclosure . . . that compromises the security or privacy of the protected health information.” In the event of a breach, entities must notify the affected individuals and HHS. Privacy breaches have detrimental effects on individuals and organizations. Noncompliant organizations incur penalties and fees, suffer reputational harm, and be subject to potential lawsuits. The exposure of the affected individuals name, address, credit card information, social security number, and medical conditions results in a loss of privacy and the potential for identity theft.

Patients and providers in healthcare are increasingly communicating through email and text messaging. Many patients prefer email or text messaging because it is a quick and convenient way for managing appointments, receiving test results, and asking healthcare related questions. Providers also prefer email and text messaging to access patient information, communicate with hospital staff, and maintain an appointment calendar.

While texting may be convenient in healthcare, it also has many shortcomings. Most importantly, there is an increased risk of violating HIPAA. Email and text messaging are insecure forms of communication that may be accessed or exposed by unknown third parties. Furthermore, there is no straightforward method for physicians to document the email or texting encounter. Finally, the inability to prioritize incoming text messages, may result in a crucial test result sitting in the patient’s inbox for more than 24 hours.

To reduce the risk of breach, organizations and providers must remain flexible. Organizations should provide and promote the use of secure communication solutions. Hospitals should educate staff on the dangers associated with plain email and explain what should not be sent through email or text message. There are also secure private emails and secure text messaging applications that can be used to safeguard communications of PHI. Cortext by Imprivata, TigerText, DocHalo are some secure text messaging and email options physicians can use. Lastly, it is essential for organizations to implement policies and procedures governing the use of email and text messaging. These policies should include a risk analysis, a process for approving and monitoring uses, guidelines for acceptable email and text messaging interactions, and the identification of secure services.

Overall, organizations should facilitate and try to comply with patient requests as much as possible. Patients have the right to choose their preferred mode of communication, even if it is an insecure method. However, providers should explain the risks associated with insecure communication methods, obtain the patient’s consent, and notify those with whom the patient communicates of their preference. Having policies in place will enable physicians to document and manage these requests appropriately.

In conclusion, email and text messaging are inherently insecure forms of communication. Even if individuals have a right to use insecure means of communication, they must be informed of the potential for security breaches. Recognizing the inevitability of these communications, healthcare organizations should implement policies addressing email and texting, and ensure these modes of communication are HIPAA compliant.

Giving Pharmacists Prescribing Power – A Solution to Increased Contraceptive Access by Maura McGinnity

In the months since Dobbs v. Jackson Women’s Health, access to birth control has become a contentious topic. Whether individuals have access to hormonal birth control is becoming a fear for people who rely on it for health reasons including regulating hormones and improving acne. Allowing pharmacists to prescribe and dispense hormonal birth control would help mitigate barriers and expand access to contraception.

Since 2020, more than ten states have expanded or strengthened pharmacists’ prescriptive power to include contraceptives. That means there are now twenty-four states and Washington DC that permit pharmacists to prescribe this important medication. There are many benefits to allowing pharmacists to prescribe and dispense hormonal birth control. Pharmacies are more accessible than a clinic or hospitals in many communities, they generally have more accessible hours, and do not always require appointments. These benefits allow more people to have convenient access to hormonal birth control.

Additionally, research has demonstrated that patients are in favor of increasing prescription power because of convenience and accessibility. A study in California found that seventy-four percent of survey respondents chose to visit a pharmacist for contraception because it would be quicker than getting a doctor’s appointment. Real-world applications of this have already taken place in states like Oregon. Two years after Oregon implemented its pharmacist-prescribed contraception protocol, it prevented an estimated 51 unintended pregnancies and saved the state $1.6 million.

Even with all the benefits, expanding pharmacists’ roles creates some challenges. To begin these programs, states must implement sufficient billing infrastructure, find ways to pay pharmacists for their extra services, comply with privacy and confidentiality standards, and make sure pharmacists are adequately trained in prescribing hormonal birth control to ensure patient safety.

There are multiple legal and regulatory processes that must be put into place to allow pharmacists to expand prescribing power. One potential process is giving pharmacists outright prescriptive authority, which allows pharmacists independent power to prescribe hormonal birth control. This framework specifies certain conditions where pharmacists are authorized to prescribe certain medications. Pharmacists are given specific procedures from a state board of pharmacy, and they are required to follow the instructions given when prescribing birth control to patients. Another option is implementing a collaborative practice agreement. In this framework, pharmacists and pharmacies are in partnership with other healthcare providers, and the pharmacists are authorized by physicians to select, initiate, monitor, continue, and adjust medication regimens for patients.

By implementing these programs, individuals will be able to get birth control in a more convenient way. This is especially important for women and individuals needing birth control in a post-Dobbs world where access to contraceptives is being challenged throughout the courts.

Norfolk Southern Derailment Finds Citizens, Workers Getting Sick by Max Borushek

Norfolk Southern, the American railway giant, has found itself in the midst of a train derailment crisis. With two noteworthy derailments in the past two months, Norfolk Southern has vehemently denied that its derailment in East Palestine, Ohio will cause lingering health problems to the citizens of the town.

President Biden said Norfolk will be responsible for air testing and clean up after almost 120,000 gallons of vinyl chloride spilled during the 38-car derailment on February 3rd, 2023. The company has deployed air quality test squads in conjunction with the Environmental Protection Agency to assure residents of the town that they are safe to return to their homes. While there is obvious distrust between Norfolk Southern and the residents of East Palestine, an unexpected group has found themselves in the midst of this controversy: the workers themselves.

In an open letter to U.S. Department of Transportation Secretary Pete Buttigieg sent on March 1st, 2023, an American Rail System Federation official detailed how workers sent to help clean-up the contamination in East Palestine were becoming ill. Workers “inquired about the appropriateness of their personal protective equipment and the safety of their working conditions” and were met with little to no response from Norfolk Southern. J.B. Long, the General Chairman of the ARSF and author of the letter, alerts Secretary Buttigieg that Norfolk Southern is “Dangerous to America.”

Remediation workers and East Palestine residents have a right to be concerned. According to the Center for Disease Control, vinyl chloride is a toxic chemical readily absorbed into the lungs and can cause health issues, including damage to the central nervous system and death. Residents have expressed to multiple news outlets, that they have experienced nausea, headaches, and skin rashes due to chemical exposure.

Although air-quality testers and politicians have vocally reassured residents their homes are safe to enter, the optics hardly fit the narrative. “Right now they’re saying, ‘Oh, our team said they didn’t test anything in the air.’ Well, let’s talk about the soil, let’s talk about the residue, why are people getting sick if it’s… safe,” East Palestine resident Zsuzsa Gyenes told Vice News.

Now, almost three months after the devastating spill, independent testing conducted by a team from Purdue University has found carcinogenic chemicals in the air and water surrounding East Palestine. Andrew Whelton, an engineering professor at Purdue and a member of the testing team, told FOX Business, “Many statements by government agencies were being made about safety. ‘The air is safe, the water safe, your homes are safe.’ But they weren’t actually sharing a lot of the data. And that raised a red flag for us.” Whelton recently wrote a letter to the EPA asking for additional oversight on water testing in East Palestine.

The train derailment in East Palestine, while devastating, is just one of thousands of chemical spills that happen in the U.S. annually. Analysis of EPA data regarding chemical spills conducted by The Guardian found that the U.S. averages two chemical spills a day, causing environmental, health, and economic problems across the country. Even though Norfolk Southern is being held accountable, only time will tell how and when the site is fully cleaned up, and the long-term health implications of the spill. “I definitely don’t trust Norfolk or the team that they hired. I don’t think they should have been given the ability to hold the reins on the narrative,” said Gyenes.

The Return of the Medical Question Doctrine by Leonard Brahin

Last summer, I wrote about the Medical Question Doctrine, the theory that federal courts should defer to physicians on medical-legal questions. The relevance of my piece has resurfaced, now that Texas district court Judge Matthew Kacsmaryk issued a nationwide injunction prohibiting the FDA’s mifepristone approval.

Mifepristone is a one of two medications used for medical abortions. Mifepristone “blocks a hormone called progesterone that is needed for a pregnancy to continue.” The drug itself was first approved in 2000, and its approval was audited and validated in 2008. Mifepristone is effective and safe: the drug is 80% successful and sends fewer people to the ER than Tylenol and Viagra. In fact, only 24 out of nearly 3.7 million individuals who took mifepristone experienced a fatal side effect – and 6 of those cases coincided with alcohol and drug use. This puts the fatality rate of mifepristone at .00065%. Even compared to surgical abortion, medical abortion is indistinguishable with regards to safety and effectiveness.

On a tenuous legal theory and even more strained medical analysis, Judge Kacsmaryk stayed the initial and subsequent mifepristone approvals by the FDA. In essence, Judge Kacsmaryk paused legal distribution and prescription of mifepristone (with a seven-day grace period). Judge Kacsmaryk’s decision rested on the administrative complaint that the FDA had improperly approved the drug and that patients and doctors may experience injuries from using mifepristone.

In response to this decision, legal scholars, newspapers, and the United States President have criticized the decision for adopting radical, conspiracy-like reasoning that badly misconstrues reproductive medicine (and administrative law). In making his decision, Judge Kacsmaryk relies on a new theory of standing, a dormant 1873 statute, and an unprecedented remedy.

Last year, I suggested that the Medical Question Doctrine ought to consider “[1] the breadth of science on the policy, [2] the good faith justification by the physician, [3] the interest convergence of industry in pushing the treatment, [4] the effectiveness of the treatment in past experimentation, and [5] the interests of the state in regulating the treatment.” While none of these factors are dispositive, the Medical Question Doctrine prioritizes dereference to the individual physician rather than substitute the physician’s expertise for the Court’s.

In contrast to these careful considerations, Judge Kacsmaryk’s nationwide remedy contravenes the particularized, case-specific reasoning that physicians use when prescribing treatment. Of course, subsequent FDA regulations had gone further, permitting a prescription without a doctor’s visit. However, Judge Kacsmaryk’s remedy prevented a prescription, even with informed consent (as the initial approval permitted). More than just a contempt for abortion, this decision joins a series of nationwide remedies that demonstrate serious misgivings about expertise and agency judgement. Broadly, this means that a court without medical training can override the best medical judgement of physicians, even when that physician believes that such a treatment may be the most effective medication.

This is especially troubling when the American Medicine Association Code of Medical Ethics requires that physicians “[k]eep[] current with best care practices.” What happens when Federal Judges prohibit the use of best medical treatments? How can doctors conform with their ethical duties when judges intervene into the medical practice? Even for a Court skeptical of the administrative state, the local and particular nature of medical practice should warrant greater deference to physicians who have the most amount of information and knowledge on a particular topic. As I’ve noted before, the US Congress has only had 27 physicians elected to office since 2005, so it is difficult to understand why politicians or judges without medical training should be left to unquestionably dictate best care practices.

While this article does not advocate “Chevron for Doctors,” it does require that a court consider its own expertise on the difficult decisions doctors are forced to make and defer to their on-the-ground training (much in the same way courts will defer to police officers when evaluating qualified immunity claims). Once again, the Supreme Court will be presented with an opportunity to recognize its limits. Rather than succumb to conspiracies about the “Clinton Administration,” the Supreme Court should commit to local decision making; not by politicians and judges who do not understand complex medical procedures, but by doctors who are on the ground making these decisions.

The Medicalization of Homelessness by Breeha Shah

“Medicalization” generally refers to a process in which previously nonmedical conditions come to be understood under the notions of disease and illness. Homelessness is not researched as a disease itself, yet situations for homelessness can be defined as a medical problem. Although medicalization has assisted the healthcare community in gaining awareness of the matter in question, the medicalization of homelessness focuses on cultural and circumstantial understandings rather than professional domain. The medical community reactively spends excessive amounts of money, services and resources on addressing the healthcare needs brought on by homelessness, rather than proactively providing for the tangible needs of the poverty-stricken areas before homelessness occurs. Although access to treatment and medication services is a step in the right direction, it reveals a problem with the medical model: it places homelessness as a potential consequence to disease, addiction or mental illness instead of understanding its contributing nature in creating disease, addition or mental illness.

Politicians and the press tend to link homelessness to mental illness, thus medicalizing a socioeconomic problem. While mental illness can contribute to homelessness, it is not the sole cause. Persisting from the beginning, poverty-stricken communities lacked supportive housing services for individuals experiencing homelessness with acute needs to physical or mental health issues. There was, and currently is, a desperate need for more than just housing. These individuals require additional help to become housed and stay securely housed, in order to maintain mitigate conditions such as a physical ailment or mental ailment exacerbated by homelessness.

Currently, the political and medical sectors focus on prevention and control for disease as well as substance abuse and mental health, which all thrive in poorly maintained areas where more than half the population is prone to experience a form of homelessness. Even with such data and research confirmation, policies continue to stray away from the problem: homelessness itself. The medicalized framework in the US is designed to treat symptoms rather than root causes of homelessness. As a result, legal and policy solutions focus on critiquing this medical framework from an outcome perspective, rather than implementing policies aimed at addressing those root causes. It is important to take a more holistic and systemic approach to address homelessness, one that recognizes the multiple factors that may be contributing to the cause of such debilitating conditions. Shifting the perspective to view homelessness as one of the factors that can create disease, addiction or mental illness may help policymakers create better homeless prevention laws at a federal level, rather than adequately address the notion that treating physical and mental conditions will decrease homelessness.