Category: Blog

In a landmark 1984 case before the Supreme Court, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc. set forth a doctrine of judicial deference for administrative actions. The doctrine determined that a court should defer to an agency’s decision regarding an ambiguous statute whenever the agency’s action was reasonable, so long as it does not conflict with Congress. If the statute enabling the agency’s authority has a clear intent from Congress, that intent governs. If the intent of Congress is ambiguous, then the agency’s decision must be reasonable. If it is unreasonable, then the court may step in, but, otherwise, deference is given to the agency tasked with interpreting the ambiguous statute. The Chevron doctrine applies when agencies exert their discretionary authority in interpreting statutes. Chevron has had important implications across the legal field, being cited in nearly 1,000 judicial decisions yearly. The doctrine has also had a substantial impact on agency decisions in the healthcare field. The Food and Drug Administration (FDA) has used the doctrine for its decisions regarding new drug approvals. The Centers for Medicare and Medicaid Services (CMS) has relied on the doctrine in interpreting the Medicare Act daily, including reimbursement actions.

The Supreme Court is currently considering two cases that examine the Chevron doctrine: Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce. Both cases consider the overruling of the Chevron doctrine. It is anticipated that the Supreme Court will abolish or severely limit the doctrine as currently established, given the previous decisions weakening deference to federal bodies. The Court has already made a ruling in the healthcare field conspicuously rejecting the use of the Chevron doctrine despite its prevalence during oral arguments.

The abolition of the Chevron doctrine would make it easier for healthcare companies to bring litigation against an agency’s actions because the agency would no longer be afforded discretion. Abolishing Chevron would also bring large scale change to American healthcare, including the administration of Medicare and Medicaid, an insurance program for nearly half of Americans. Congress would be unable to practically draft and update statutes for Medicare and Medicaid administration post-Chevron, leaving a gap in the healthcare system’s ability to function.

The decision would also have a negative impact on science and technology. Courts lack the expert knowledge needed to understand some complex regulations, and pauses required to elaborate on statutes would represent a public health and environmental impracticality. Agencies that administer and regulate healthcare and health programs will need to change how they justify their proposed rules. However, all previous decisions on final rules for agencies like FDA and CMS will remain until challenged if Chevron is overruled.

In addition, a change from Chevron would result in a disruption of the financial stability these programs have afforded the healthcare system. With the overruling of Chevron, the first FDA new drug application approval may be overturned. Health agencies and industry are preparing for the possibility of Chevron upheaval and determining the impacts the change may bring.

Of note, Congress has the ability to alter or remove the Chevron doctrine by changing the Administrative Procedure Act (APA) to select a new standard of review in agency decision-making. A Congressional statute explicitly stating the standard of review for agency decision-making would establish a clear review regime and ensure that future judicial decisions were less likely to threaten well established agency decisions. The threat to all federal agencies of Chevron upheaval is looming, but it has farther reaching effects than federal agencies. The healthcare industry is trying to determine how to respond to the looming possibility of change, but it could result in an effect on patients, both financially and technically.

In vitro gametogenesis (“IVG”), a process through which scientists may induce any human cell to become either an egg or sperm cell, might eliminate the need for injections and painful egg retrieval procedures associated with in vitro fertilization (“IVF”). Though IVG has proven successful only in mice, hypothetical applications to human reproductive therapy may also extend to socially or situationally infertile non-heteronormative couples. This could enable gay and lesbian couples to have children genetically related to both partners.

Though some individuals feel unsettled by the implications of lab-created human life, a biotech start-up by the name of Conception opened research to human applications of IVG in 2023. As of this year, Conception scientists remain focused on their aim to create a ‘proof of concept human egg.’ Chief Scientific Officer Pablo Hurtado and Chief Executive Officer Matt Krisiloff both expressed hope that IVG would allow them to produce children genetically related to both parents in their respective partnerships.

Amid the flurry of research surrounding IVG in humans, bioethical literature entered a debate regarding the ethical hurdles should IVG become an approved Assisted Reproductive Therapy (“ART”). Such debates center around who might be precluded from IVG. If IVG, like IVF, emerges solely as an ART method, this could mean that IVG would only be accessible for those who would have the capacity to conceive but for egg and sperm count/quality challenges (heteronormative couples).

However, situational infertility also plays a role in IVG’s use as an ART. For example, should a man and a woman who knew prior to their union that neither had the ability to conceive with one another decide to marry in spite of this, their choice to pursue union would render them situationally infertile (i.e., but for their choice to be together, either party possess the potential to conceive). By the same parameters, non-heteronormative couples could be considered situationally infertile and, as such, eligible to use IVG as an ART. Despite this, questions of ART access stretch beyond the degree of infertility status.

Currently, IVF is the ideal predecessor to which one could compare IVG’s eligibility for insurance coverage (should human applications come to fruition). The National Infertility Association advertises that only eleven states and the District of Columbia have passed broadly accessible fertility preservation coverage. Of these, only the Colorado Revised Statutes and the Illinois Compiled Statutes define ‘infertility’ in a flexible manner such that it could include situationally infertile non-heteronormative couples. These definitions indicate that IVG, like IVF, will not be available through insurance for non-heteronormative couples except within Colorado and Illinois. Even within Colorado and Illinois, degree of insurance coverage will heavily depend on the policy and coverage qualifications, which will not be measured uniformly among candidates. Because of this, IVG will become the next headliner in boutique baby making, accessible to very few individuals.

This predictable inaccessibility of IVG strikes a chord among reproductive justice advocates. Those who experience infertility often feel grief, depression, anxiety, and loss of self-esteem. Those who experience situational infertility within both heteronormative and non-heteronormative couplings experience a sense of social dissonance and distress. Lack of access to IVG may also propagate the harmful societal notion that adoptive children are inferior alternatives to genetic children. As reproduction is an inherently human function, reproductive justice advocates argue that equal access to all available reproductive therapy, regardless of one’s choice in partner, is a human right.

Nevertheless, amidst the current tumultuous battleground in Alabama over the ethical implications of IVF, many wonder whether some states will begin to block ARTs such as IVF and IVG altogether. From a practical perspective, issues concerning legal accessibility and insurance coverage (espoused above) will likely block such a high percentage of otherwise eligible couples as to render the restrictive implications of the Alabama IVF ruling obsolete where IVG is concerned. Should Conception and/or similar laboratories successfully patent a reproducible methodology for IVG in humans, such a patent would likely be sold to consumers in other nations whose healthcare and legal systems better cater to cellular inducement ARTs.

In a ruling on February 16^th, 2024, the Alabama Supreme Court declared that frozen embryos outside of the womb are classified as children. There are a few steps to in vitro fertilization (IVF); hormones are taken for the egg retrieval process, and then mature eggs are collected from the ovaries and fertilized in a lab with sperm. One or more of the fertilized embryos are then inserted into the uterus. Many complications can arise from inserting multiple fertilized embryos into the uterus, and since an IVF retrieval process will typically produce additional embryos, it is standard procedure to freeze the embryos not used in the current IVF cycle and keep them preserved in the fertility clinic. By freezing the extra embryos, couples can have additional IVF cycles without the strains that come with egg retrieval, which can include surgeries and hormonal treatments.

In the current case, three couples went through a standard IVF treatment and kept their extra fertilized embryos cryo-preserved at the fertility clinic, which resided within a hospital. Unfortunately, those embryos were destroyed when a hospital patient entered the cryo-preservation area, opened a tank where the frozen embryos were stored, and dropped them to the ground.

The couples sued under the Wrongful Death of a Minor Act. For the court to rule on the matter and determine if there is proper standing under the Act, the court first had to look to whether the embryos were considered unborn children. In analyzing the statute, the Alabama Supreme Court determined that fertilized embryos qualify as children, as nothing in the Act specified unborn children must be in utero. So, the Act “applies on its face to all unborn children, without limitation.” The Court concluded the fertilized embryos fall within the definition of children because “all parties to these cases, like all members of this Court, agree that an unborn child is a genetically unique human being whose life begins at fertilization and ends at death.” Dobbs v. Jackson Women’s Health Organization is noted as a ruling factor in the case, with the court stressing that unborn fetuses were widely recognized as living persons with rights and interests dating as far back as the 18^th century.  

The ruling poses serious risks to not only those who rely on IVF treatments, but for general family planning, as the holding implies that life beings at fertilization. Holding embryos as children creates a slippery slope where individuals can be held civilly and possibly criminally liable for destroying embryos.

IVF clinics in Alabama are already closing with concerns the clinics will be penalized, or individual embryologists, for what they deem safe to freeze or in turn discard. With worry over IVF in the state, both the Alabama House and Senate rallied together and voted to approve legal protections for providers of IVF. The bill would extend civil and criminal immunity to providers of IVF services. While this creates legislature specifically for IVF providers, nothing has been discussed in relation to family planning measures. This poses a serious question: how far can this holding go in terms of family planning, birth control, and autonomy of one’s own body?

In relation to IVF, even individuals who choose to discard their frozen embryos could be liable for killing a child, in theory. What if a couple decides they no longer want to continue keeping the embryos viable? What if one parent wants to unfreeze the embryo and the other doesn’t? If the embryos are never destroyed, but additionally are never given the opportunity to be birthed, does this constitute as the embryos essentially dying? These questions just pose the beginning of larger disputes regarding parental rights of fertilized embryos.

Outside of IVF, emergency contraceptives like Plan B contain a hormone that can keep a fertilized egg from implanting in the uterus. With this ruling, emergency contraceptives can be deemed as killing a child, and those that take it may be at risk for civil or criminal penalties. Additionally, after Dobbs, Alabama reinstated a total abortion ban. However, if a mother miscarries, she could be liable for the death of her own child. While it may seem severe, the door is now open for courts to rule in this manner. 

The demographic landscape in the United States is undergoing an unprecedented shift as the older population continues to increase. In the next decade, the number of people aged 65 or older is projected to outnumber those under 18. Older adults face unique social, physical, and economic challenges. As this population grows, our nation will need to find comprehensive alternatives to the current systems, which are already struggling to adequately support the complex needs of persons 65 and older.

As we age, daily tasks and activities become more difficult. While moving into an assisted living facility or nursing home may seem like the obvious next step for aging adults who need additional care and support, for many, this move may be unnecessary, unattainable, or unwanted.

Studies show that approximately 95 percent of older adults want to continue residing in their own homes and communities. This concept, known as aging in place, allows the nation’s growing population of older adults to live independently and “age with dignity.” This desire is driven by numerous factors, including high facility costs, the uncertainty of transitioning to a new and unfamiliar environment, the desire for independence, and the absence of their support systems.

However, there are challenges and risks associated with living independently in one’s own home, such as increased difficulty performing daily tasks, lack of transportation, a risky home setup, potential for isolation, and the need for additional care. Additionally, as the nation’s aging population grows, so will the fraction of vulnerable older adults who will require more assistance than those who are in good health, have strong social connections, and possess adequate resources.

Nevertheless, individuals can safely remain in their homes and communities with support. Given the increase of older adults who will inevitably age in place, and face challenges that can make independent living more difficult, the need for additional services and support is imperative.

On February 6, 2024 the Administration for Community Living (ACL) announced its final rule to update regulations for implementing its Older Americans Act (OAA) programs. This update reflects the increased needs of a nearly doubled senior population since the last substantial update to the OAA regulations in 1988.

First passed in 1965, the OAA authorized programs and services to help older adults remain in their homes and communities. Since the last substantial update to OAA regulations 36 years ago, there is a deeper understanding of how social determinants of health can be used to reshape healthcare, and health care service delivery models, through the use of non-medical services. OAA programs provide older adults with resources to remain in their communities and places of residence, empowering them to age in place and avoid institutionalization or hospitalization. The OAA offers a range of services and support, such as home-delivered meals, congregate meals, caregiver assistance, personal and home care services, preventive health services, and transportation. These services play a crucial role in enabling older adults to maintain their independence and place in their communities, ensuring that aging in place becomes a viable and sustainable option for individuals across the country.

Between 2019 and 2021, the market for mental health and wellness apps such as Calm, Headspace, and BetterHelp increased by 54.6%. In 2020 alone, the top 100 wellness apps were installed over 1.2 billion times. This increase can be attributed to the Covid-19 pandemic. Lockdowns and the rise of remote work led to an increased number of people turning to mobile apps to work on their health and fitness goals from home. Studies have also shown that individuals with existing mental health problems reported that their symptoms worsened during the pandemic. In this case, the convenience of mental health apps has enabled users to connect with therapists and mental health coaches from the comfort of their home. Today, an increasing number of physicians recommend their patients to use mental health apps to reduce stress and improve sleep habits, with apps such as Calm allowing patients to access content through their health insurance plan. 

But as mental health apps continue to grow in popularity, researchers have begun raising privacy concerns surrounding the collection of user data. For instance, the Federal Trade Commission (FTC) issued a proposed order in 2023 banning BetterHelp, an online counseling service, from sharing sensitive information about mental health challenges for advertising. This included requiring the app to pay a $7.8 million settlement to consumers. In this case, it is useful to consider what the current privacy concerns are as well as policy solutions to address the issue. One of the main issues concerns the volume of data that is collected by mental health apps. For instance, data collection can include geolocation information such as clinic visits and purchase history for healthcare services. Furthermore, mental health apps may collect other sensitive information such as a user’s full name, date of birth, or home address, as well as health biometrics on a user’s mood, sleep habits, or symptoms. In the case of BetterHelp, the app’s privacy policy now states that they are not paid for user data, but that they may share visitor data with third party advertisers such as Meta, TikTok, Snap, and Reddit. 

This leads to the question of what improvements can be made to protect sensitive data of users on mental health apps and what solutions are available to developers and policymakers. Currently, HIPAA regulations do not apply to most mental health apps unless it involves a covered entity, a business associate relationship, and the disclosure of electronic protected health information (ePHI). However, there are various steps that can be taken to safeguard user data. One study created a list of actions that stakeholders could take to ensure data privacy. This includes a variety of recommendations, including the creation of a privacy impact assessment and having readable privacy policies with accessible language. De-identification is another option that developers can take to protect user data, which can involve removing specific identifiers such as names and addresses. In addition, apps that do not fall under HIPAA regulations are now required to follow the FTC’s Health Breach Notification Rule, released in June 2023, which requires apps providing health care services or supplies to to notify consumers, the FTC, and often the media of data breaches. Overall, both new and current developers behind mental health apps can take these steps to better protect sensitive data and to build trust among users in the digital space. 

In the rapidly evolving world of reproductive technologies, in vitro fertilization (IVF) stands out as a beacon of hope for countless individuals striving to conceive. As this technology advances, it is increasingly confronted with complex ethical, legal, and medical challenges. These challenges highlight the ongoing struggle to maintain a balance between facilitating medical innovation and ensuring rigorous regulatory practices while also prioritizing comprehensive patient care.

A recent incident involving CooperSurgical, a major supplier in the fertility industry, brings to light this balance between innovation and regulation in the fertility industry. The company is facing several lawsuits from patients who claim that one of its products—a nutrient-rich liquid that helps fertilized eggs develop into embryos—was defective, destroying the embryos for potentially thousands of patients worldwide. This incident not only underscores the vulnerabilities inherent in assisted reproductive technology (ART) industries but also the critical importance of ensuring that the advancements in ART are matched with effective legal frameworks and ethical standards. Addressing these challenges is essential to safeguarding patient interests, and ensuring the pursuit of fertility treatment is safe and effective.

This week, the Food and Drug Administration (FDA) issued a notice stating that CooperSurgical recalled three lots of the liquid used for embryo transfer in multiple clinics during November and December. While CooperSurgical notified the affected clinics on December 13^th, it is unclear how many bottles of the botched media they used before the recall. In lawsuits filed by impacted patients, the plaintiffs assert that the defective product purportedly lacked magnesium, a key nutrient whose absence halted the development of their embryos, rendering those embryos unviable for transfer. These lawsuits further demonstrate the challenging and emotional journey of IVF for individuals seeking fertility treatment that is further complicated by corporate negligence and product recall. In the most recent of eight lawsuits filed, a couple received a phone call on Thanksgiving notifying them that all the embryos had stopped growing. Unaware of the product recall, the plaintiff attributed this failure to herself, blaming her age, before being notified two months later that the clinic used the defective CooperSurgical media on her embryos.

Infertility affects approximately 1 in 8 couples in the United States, many of whom turn to IVF as a solution. Fertility medicine and ART are relatively new fields with the first live birth from IVF occurring in 1978. However, since this breakthrough, IVF has rapidly become a common remedy for those seeking infertility treatment and now accounts for 1.6% and 4.5% of all live births in the United States and Europe. The growing demand for IVF incentivizes companies like CooperSurgical to position themselves as leaders in a largely unregulated industry. The regulatory landscape of assisted reproduction is complex as the U.S. Department of Health and Human Services exerts only limited oversight over fertility clinics. The lack of stricter federal regulatory practices incentivizes corporations to prioritize economic considerations over ethical principles in their decision-making. CooperSurgical owns multiple large sperm and egg banks, bringing in $1.2 billion in revenue last year with 40 percent coming from fertility services and supplies. This lucrative market for fertility treatment underscores the recent trend in manufacturing issues resulting from rapid growth and consolidations in those companies that supply the industry with their products. The IVF journey, while filled with hope for individuals facing infertility, is fraught with challenges that demand attention from medical professionals, regulatory bodies, and legal authorities. The issues that arise out of the case against CooperSurgical are a stark reminder of the devastating impact that corporate oversights, a lack of stricter regulatory practices, and overall disregard for an already emotional process can have on individuals’ lives. As the field of reproductive medicine continues to evolve, it must do so with a commitment to protecting patient care and ethical standards.