Category: Health Care Law

Curb Your Pollution: EPA Issues Final Rule to Reduce Toxic Air Pollution

EPA Issues Final Rule to Reduce Toxic Air Pollution from the Synthetic Organic Chemical Manufacturing Industry and the Polymers and Resins Industries

On April 9, 2024, the U.S. Environmental Protection Agency (EPA) announced its final rule that is touted to provide critical health protections to hundreds of thousands of people living near chemical plants. The final rule, signed March 28, 2024, will reduce emissions of hazardous air pollutants, including the toxic chemicals chloroprene and ethylene oxide (EtO). The rule implements sections 111 and 112 of the Clean Air Act.

When fully implemented, the final rule will reduce more than 6,200 tons a year of over 100 air toxics – including EtO and chloroprene – from covered equipment and processes at plants in Texas and Louisiana, along with plants in other parts of the country including Delaware, New Jersey, and the Ohio River Valley.

As part of the final rule, the EPA is also issuing new emissions limits for dioxins and furans. This will reduce more than 23,000 tons of smog-forming volatile organic compounds (VOCs) each year.

EPA’s final rule will also require plants to conduct fenceline monitoring if any of the equipment or processes covered by the rule use, produce, store, or emit EtO, chloroprene, benzene, 1,3- butadiene, ethylene dichloride or vinyl chloride. Fenceline monitoring is used to measure levels of pollution in the air around the perimeter of a facility. The fenceline monitoring provisions of the rule require owners and operators to ensure that levels of these six pollutants remain below a specified “action level.” Fenceline monitoring provides owners and operators the flexibility to determine what measures to take to remain below the action level, while ensuring that they are effectively controlling toxic air pollution.

The final rule will significantly reduce emissions of air toxins, especially those that are potentially harmful for surrounding communities. According to the EPA, these emission reductions will yield significant reductions in lifetime cancer risk attributable to these air pollutants, in addition to other health benefits.

©2024 Norris McLaughlin P.A., All Rights Reserved
For more on Air Pollution, visit the NLR Environmental, Energy & Resources section.

The Hidden Dangers: Long-Term Effects of Mild Traumatic Brain Injury

Traumatic brain injuries can have life-changing impacts on a person’s life, and understandably so because they result from injuries to the brain either through a massive blow to the head or injury by a penetrative object into the brain matter.

However, not all types of traumatic brain injuries have quite dramatic symptoms, and a mild TBI (traumatic brain injury) is one such injury. They result from a relatively minor blow to the head or a jerking of the head, causing injuries to the brain tissue.

While most mild TBIs resolve in a few weeks, some can affect the victim’s life in the long term.

Symptoms of a Mild TBI

If you have suffered a blow to the head in an accident, you need to pay attention to your symptoms, as it can help you identify signs of a mild TBI, also known as a concussion. Symptoms like passing out briefly, headache, memory loss, confusion, loss of balance, sensitivity to light and noise, problems keeping balance, tingling in your fingers, etc., are indicative of a concussion.

However, other injuries can present similar symptoms, so it is best to have a doctor make that determination. Also, it is important to note that concussions can go undetected for days because they tend to have delayed symptoms.

Unfortunately, taking too much time before seeking medical attention for a mild TBI can introduce treatment gaps, which can result in complications when seeking compensation for the long-term effects of a concussion. A timely hospital visit helps create a link between an accident and symptoms that could show days after the accident. Which is why personal injury lawyers always insist on seeking medical attention even when you feel okay.

Long-Term Effects of a Mild TBI

While most effects of a concussion will be gone after 90 days of suffering an accident, and this is for cases of severe injuries, there are situations where the effects of an injury can last years or a lifetime. Common long-term effects of a mild TBI on a person’s life include:

LONG-TERM MEMORY LOSS

Memory loss is pretty common after a concussion. However, it involves losing a recollection of the few minutes before and after an injury.

In some cases, the affected person can start remembering things once forgotten. However, in severe cases, memory loss can impact a person’s life in the long term.

DEPRESSION

Many people will develop symptoms of depression after a concussion, usually as a result of chemical changes resulting from the brain injury. While most symptoms will disappear as the brain recovers, some people may have to live with the symptoms for an extended period.

In some cases, symptoms of depression won’t show until some time after other symptoms are gone.

COGNITIVE IMPAIRMENT

In most cases, the effect of a mild TBI on a person’s thinking and cognitive abilities resolves in a few months at most.

But there is no guarantee that your cognitive abilities will return to your pre-injury levels, especially with relatively severe concussions or injuries that went undetected for a long time.

Treatment and Support for Mild TBI

You may not need hospitalization after a TBI. Often, doctors focus on treating the symptoms and may prescribe cognitive and behavioral therapy to address the psychological and injury effects on a person’s mental well-being.

If the injuries resulted from an accident and another person’s negligence was to blame, you could consider talking to a personal injury lawyer to help recover damages.

Buckfire & Buckfire, P.C. 2024
For more news on Traumatic Injuries, visit the NLR Personal Injury section.

Incorporating AI to Address Mental Health Challenges in K-12 Students

The National Institute of Mental Health reported that 16.32% of youth (aged 12-17) in the District of Columbia (DC) experience at least one major depressive episode (MDE).
Although the prevalence of youth with MDE in DC is lower compared to some states, such as Oregon (where it reached 21.13%), it is important to address mental health challenges in youth early, as untreated mental health challenges can persist into adulthood. Further, the number of youths with MDE climbs nationally each year, including last year when it rose by almost 2% to approximately 300,000 youth.

It is important to note that there are programs specifically designed to help and treat youth that have experienced trauma and are living with mental health challenges. In DC, several mental health services and professional counseling services are available to residents. Most importantly, there is a broad reaching school-based mental health program that aims to provide a behavioral health expert in every school building. Additionally, on the DC government’s website, there is a list of mental health services programs available, which can be found here.

In conjunction with the mental health programs, early identification of students at risk for suicide, self-harm, and behavioral issues can help states, including DC, ensure access to mental health care and support for these young individuals. In response to the widespread youth mental health crisis, K-12 schools are employing the use of artificial intelligence (AI)-based tools to identify students at risk for suicide and self-harm. Through AI-based suicide risk monitoring, natural language processing, sentiment analysis, predictive models, early intervention, and surveillance and evaluation, AI is playing a crucial role in addressing the mental challenges faced by youth.

AI systems, developed by companies like Bark, Gaggle, and GoGuardian, aim to monitor students’ digital footprint through various data inputs, such as online interactions and behavioral patterns, for signs of distress or risk. These programs identify students who may be at risk for self-harm or suicide and alert the school and parents accordingly.

Proposals for using AI models to enhance mental health surveillance in school settings by implementing chat boxes to interact with students are being introduced. The chat box conversation logs serve as the source of raw data for the machine learning. According to Using AI for Mental Health Analysis and Prediction in School Surveys, existing survey results evaluated by health experts can be used to create a test dataset to validate the machine learning models. Supervised learning can then be deployed to classify specific behaviors and mental health patterns. However, there are concerns about how these programs work and what safeguards the companies have in place to protect youths’ data from being sold to other platforms. Additionally, there are concerns about whether these companies are complying with relevant laws (e.g., the Family Educational Rights and Privacy Act [FERPA]).

The University of Michigan identified AI technologies, such as natural language processing (NLP) and sentiment analysis, that can analyze user interactions, such as posts and comments, to identify signs of distress, anxiety, or depression. For example, Breathhh is an AI-powered Chrome extension designed to automatically deliver mental health exercises based on an individual’s web activity and online behaviors. By monitoring and analyzing the user’s interactions, the application can determine appropriate moments to present stress-relieving practices and strategies. Applications, like Breathhh, are just one example of personalized interventions designed by monitoring user interaction.

When using AI to address mental health concerns among K-12 students, policy implications must be carefully considered.

First, developers must obtain informed consent from students, parents, guardians, and all stakeholders before deploying such AI models. The use of AI models is always a topic of concern for policymakers because of the privacy concerns that come with it. To safely deploy AI models, there needs to be privacy protection policies in place to safeguard sensitive information from being improperly used. There is no comprehensive legislation that addresses those concerns either nationally or locally.
Second, developers also need to consider and factor in any bias engrained in their algorithm through data testing and regular monitoring of data output before it reaches the user. AI has the ability to detect early signs of mental health challenges. However, without such proper safeguards in place, we risk failing to protect students from being disproportionately impacted. When collected data reflects biases, it can lead to unfair treatment of certain groups. For youth, this can result in feelings of marginalization and adversely affect their mental health.
Effective policy considerations should encourage the use of AI models that will provide interpretable results, and policymakers need to understand how these decisions are made. Policies should outline how schools will respond to alerts generated by the system. A standard of care needs to be universally recognized, whether it be through policy or the companies’ internal safeguards. This standard of care should outline guidelines that address situations in which AI data output conflicts with human judgment.

Responsible AI implementation can enhance student well-being, but it requires careful evaluation to ensure students’ data is protected from potential harm. Moving forward, school leaders, policymakers, and technology developers need to consider the benefits and risks of AI-based mental health monitoring programs. Balancing the intended benefits while mitigating potential harms is crucial for student well-being.

© 2024 ArentFox Schiff LLP
by: David P. Grosso, Starshine S. Chun of ArentFox Schiff LLP

For more news on Artificial Intelligence and Mental Health, visit the NLR Communications, Media & Internet section.

Importance of Negotiating Assignment and Subletting Provisions in Health Care Leases

In our ongoing series of blog posts, we examine key negotiating points for tenants in triple net health care leases. We also offer suggestions for certain lease provisions that will protect tenants from overreaching and unfair expenses, overly burdensome obligations, and ambiguous terms with respect to the rights and responsibilities of the parties. These suggestions are intended to result in efficient lease negotiations and favorable lease terms from a tenant’s perspective. In our first two blog posts, we considered the importance of negotiating initial terms and renewal terms and operating expense provisions. This latest blog post in our series focuses on negotiating assignment and subletting provisions.

It is imperative for a commercial tenant, particularly a private equity-owned health care tenant, to include provisions in a lease which allow the tenant the flexibility to assign and sublease the commercial space without the necessity of having to obtain the landlord’s consent and/or to meet burdensome landlord conditions.

Most leases prohibit transfers by assignment and subletting or require landlord’s prior written consent subject to meeting certain burdensome conditions. In addition, landlords often include a “change of control” provision which provides that sale of a controlling interest is deemed a transfer requiring landlord consent. A health care tenant looking for flexibility for reorganization or internal transfer subject to private equity control will want to push back on change of control provisions and will want to ensure that their lease allows for certain permitted transfers that do not require landlord consent. Carving out “permitted transfers” customarily includes transfers to: (i) an affiliate of the named tenant under the lease (meaning, any entity, directly or indirectly, which controls, is controlled by or is under common control with tenant); (ii) a successor entity created by merger, consolidation or reorganization of tenant; or (iii) an entity which shall purchase all or substantially all of the assets or a controlling interest in the stock or membership of tenant. If the tenant is a management services organization (MSO), the lease should also include explicit landlord permission for a sublease between the MSO and the provider that will occupy the leased premises.

Landlords may accept the concept of permitted transfers but often seek to impose certain conditions to allowing such transfers. Certain conditions on permitted transfers are reasonable, such as requirements for advance notice, that the proposed permitted transferee assume all obligations under the lease, that the permitted transferee operate only for the permitted use set forth in the lease, and that a copy of the transfer document be provided to landlord. However, other conditions, such as requiring a net worth test for the assignee or financial reporting requirements, can be burdensome and serve to undermine the concept of permitted transfers without landlord consent. We advise our clients in these instances to push back or limit these conditions as much as possible.

Other common assignment and subletting provisions should expressly not apply to permitted transfers. These include recapture provisions which allow a landlord to terminate the lease and recapture the space, excess profit provisions which provide that any excess profits realized as the result of a transfer will be shared between landlord and tenant, and administrative fees and reimbursements to landlord which are often charged to tenants in connection with an assignment or subletting request. Restrictions on transfers should not apply to guarantor entities. Often with private equity, the guarantor is the parent entity and cannot be restricted by a landlord as to transfer, restructuring or reorganization at the top of its organization.

In the case of transfers that do not fall within the definition of “permitted transfers” and require landlord consent, a tenant will want to include language that landlord will not unreasonably withhold, condition, or delay such consent. Other tenant protections should also be considered, including a cap on administrative and review fees reimbursable by tenant to landlord, a reasonably short time period for landlord to approve or disapprove a request (i.e., 30 days) or be deemed to have approved, a reasonably short time period for landlord to exercise recapture rights or be deemed to have approved, and a provision that excess profits will be shared equally rather than all belonging to landlord.

Negotiation of assignment and subletting terms is critical for tenants, particularly with respect to private equity-owned health care tenants. The goal for tenants in negotiating these points is to provide flexibility for addressing future financial and operational needs. As with other highly negotiated lease terms, we recommend addressing assignment and subletting provisions in detail in advance in the letter of intent. This makes expectations of the parties clear, saves time and money by avoiding protracted negotiations, and results in an overall efficient lease negotiation process.

In our next post, we will cover the importance of negotiating maintenance and repair terms and will offer suggestions for limiting a tenant’s exposure.

©2024 Epstein Becker & Green, P.C. All rights reserved.
For more news on Health Care Leases, visit the NLR Health Law & Managed Care section.

The Antitrust Investigator Will See You Now: What Healthcare And Pharma Should Expect In A World Of Enhanced Antitrust Scrutiny

Highlights

  • Healthcare entities should expect heightened government scrutiny of mergers, acquisitions, and business behaviors that could be construed as restricting competition in healthcare and pharma
  • The FTC, DOJ, and HHS have advanced a “whole-of-government approach,” including data sharing, cooperative enforcement, and enhanced antitrust training
  • Businesses should take note of practices that are likely to trigger investigatory and enforcement actions

According to media reports, the Department of Justice (DOJ) has opened an antitrust investigation into UnitedHealth Group, which is the owner of the United States’ largest health insurer, UnitedHealthcare. The focus of the inquiry appears to be the relationship between the UnitedHealthcare insurance plan and one of its health services divisions, Optum, and the potential impact on rivals and consumers.

While tech giants have grabbed most of the headlines when it comes to enhanced antitrust scrutiny, this new matter is the DOJ’s second antitrust investigation into UnitedHealth Group in recent years, giving teeth to the administration’s claim that it has an aggressive antitrust policy in the healthcare sector.

In another example of increased antitrust scrutiny, the Federal Trade Commission (FTC) recently announced a new initiative in partnership with the DOJ and Department of Health and Human Services (HHS) to address what they consider to be the effects of anticompetitive behavior in the healthcare and pharmaceutical spaces. According to the government, these new efforts are aimed at lowering consumer costs and will include “partnering on new initiatives which include a joint Request for Information to seek input on how private-equity and other corporations’ control of health care is impacting Americans.”

Although interagency cooperation is the focus of the recent push to ramp up antitrust investigations and enforcement, each agency will still spearheaded their own regulatory activity.

Federal Trade Commission

FTC Chair Lina Khan has made it clear that her agency will devote more resources to enforcement in the healthcare industry, and emphasized that “safeguarding fair competition and rooting out unlawful business practices in health care markets is a top priority for the FTC.” In furtherance of these priorities, the commission has recently taken the following actions:

  • Orange Book Policy: The FTC challenged more than 100 patents held by pharmaceutical companies that they claim are inaccurately or improperly listed in the FDA’s Orange Book. The commission also released a policy statement explaining its renewed focus on Orange Book infractions.
  • Proposed Non-compete Rule: The FTC presented a new rule that would place a ban on non-compete clauses in employee contracts.

U.S. Department of Justice

Jonathan Kanter, Assistant Attorney General of the DOJ’s Antitrust Division, highlighted the division’s emphasis on the healthcare space when he said, “we are committed to weeding out anticompetitive practices and market consolidation that hinder Americans’ access to quality care at affordable rates, or deprive health care workers of fair wages and opportunity.” The following are just a few examples of how the DOJ has implemented this renewed focus:

  • Criminal Penalties: Recently, the DOJ’s Antitrust Division successfully secured a deferred prosecution agreement against Teva Pharmaceuticals, obtaining the largest monetary penalty ever (over $200 million) against a purely domestic producer that was allegedly operating an antitrust cartel.
  • Blocked Mergers: The Antitrust Division filed a suit to stop Aon plc’s $30 billion proposal to acquire Willis Towers Watson, two of the three largest brokers of health insurance and retirement benefits consulting. The companies later ceased their pursuit of the merger.

U.S. Department of Health and Human Services

HHS Secretary Xavier Becerra made his agency’s priorities clear when he recently stated that “the Biden-Harris Administration remains laser-focused on increasing access to high-quality, affordable health care for all Americans, like by making hearing aids available for sale over the counter and lowering prescription drug costs through the Inflation Reduction Act.” The department’s initiatives have included:

  • Ownership Transparency: For the first time, HHS, via the Centers for Medicare & Medicaid Services, made ownership data available on federal qualified health centers and rural health clinics on data.cms.gov. HHS hopes the release of this data will help catalyze enforcement actions by identifying common ownership.
  • Medicare Advantage Marketing: HHS also announced new efforts to crack down on what it considers “predatory marketing” that seeks to steer patients towards Medicare Advantage plans that “may not best meet their needs.”

Takeaways

In light of the government’s renewed focus on increased competition, expanded enforcement actions, access to quality care, more affordable services and products, and transparency of ownership in the healthcare and pharmaceutical industries, legal and compliance departments should consider being proactive about conducting thorough reviews of current practices. This is particularly true for mergers and acquisitions, competitive strategies, and pricing decisions, which are the business activities most likely to conflict with these recently energized regulatory bodies. Even healthcare providers with stellar compliance programs should expect to receive more frequent and targeted requests for information from enforcement authorities about their business partners, payors, and marketing practices.

© 2024 BARNES & THORNBURG LLP
For more news on Antitrust Enforcement in the Healthcare Sector, visit the NLR Health Law & Managed Care section.

Concussions and Their Impact: Recognizing the Signs and Seeking Help

A concussion is a mild form of traumatic brain injury and is usually caused by blunt force to the head. In some cases, it can result from a back-and-forth jerking of the head, resulting in the brain matter being dashed against the skull wall. It’s a pretty common injury in children, individuals engaged in contact sports, and Michigan car accidents.

Most concussions are not life-threatening. However, some cases can develop complications that could significantly impact a victim’s life. So, the first step in getting timely treatment is understanding its symptoms and what you ought to do after suffering an injury.

Signs and Symptoms of a Concussion

Symptoms and signs of a concussion fall into three categories: physical, cognitive, and psychological or emotional.

PHYSICAL SYMPTOMS

Where a significant blow to the head causes a concussion, the victim could pass out for a few seconds. However, this is not always the case, so you cannot use passing out as the litmus test for concussions. Often, patients exhibit symptoms like headaches, nausea and vomiting, blurred vision, dizziness, loss of balance, slurred speech, fatigue, ringing ears, tingling in the hands, loss of taste or smell, etc.

COGNITIVE SYMPTOMS

With a concussion being a brain injury, it is unsurprising that it may cause problems with brain function. In some patients, a concussion will cause problems with concentration, confusion, forgetfulness, feeling slowed down in your thinking, and trouble finding words.

EMOTIONAL SYMPTOMS

A concussion can, in some patients, cause emotional problems, resulting in a deviation from a person’s normal behavior. For example, patients may become easily irritable, report feeling foggy or “out of it,” experience immense sadness, and have anxiety.

When to See a Doctor

In most cases, symptoms of a concussion will start to show immediately after an accident, in which case seeing a doctor makes absolute sense. However, concussions are among the few types of injuries that tend to have delayed onset. In some cases, it can take up to 72 hours or even more for the first signs of a concussion to show.

If you are in an accident where you have suffered a blow to the head or are violently shaken, it is always a good idea to see a doctor. You may not have to call 911 if your symptoms are not as severe, but it is best to see a doctor on the same day or within 72 hours of an accident at most.

Timely medical interventions help in several ways. It helps stop the deterioration of an injury, shortens recovery time, and provides the documentation necessary for filing a personal injury claim if you intend to seek compensation.

What to Do To Recover Damages

Once your health is taken care of, focus on evidence gathering, starting with scene documentation in pictures and video. If there were any witnesses to the incident, talk to them, record their statements, and get their contacts so you can easily trace them if you need help with your case. If it is a car accident, you will need to get the other driver’s insurance and vehicle registration details.

Besides evidence, you need to prepare for the legal battle. It doesn’t always have to go all the way to court, but you will still need to work with a personal injury lawyer to get the best chances at recovering fair compensation.

Personal injury lawyers bring knowledge, investigation and evidence-gathering skills, negotiation skills, and respect, which altogether help you in mitigating mistakes and increasing your chances of getting a fair outcome.

Buckfire & Buckfire, P.C. 2024
For more news on How to Handle a Concussion, visit the NLR Health Law & Managed Care section.

In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute

Background

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et al., SC-2022-0579, in which the Court reversed a trial court’s dismissal of the plaintiffs’ civil wrongful-death claims and allowed the plaintiffs to move forward with a cause of action under the Alabama Wrongful Death of a Minor Act (the “Act”).[1] In so holding, the Alabama Supreme Court found that fertilized pre-embryos stored outside of the human body are “extrauterine children” and thus are included in the definition of “minor children” for purposes of the Act.

Originally passed in 1872, when in-vitro fertilization (“IVF”) would have been considered science fiction, the Act allows the parents or legal representatives of a “minor child” to sue defendants in civil court for monetary damages for “any wrongful act, omission, or negligence” that caused the minor child’s death.[2] However, the Act does not define “child” or “minor child”. Instead, the Court relied on prior cases that interpreted the term “minor child” to include an “unborn child . . . regardless of the child’s viability or stage of development”.[3] The Court then extended that meaning to include pre-embryos, reasoning that “extrauterine children” must be children based on the Court’s interpretation of the dictionary definition of the meaning of the word “child”. As a result, the Court has created a pathway for plaintiffs to sue IVF providers under civil law for the wrongful death of a minor child for having terminated pre-embryos in Alabama. This type of decision has been a goal for those in the fetal personhood movement.[4]

Scope of the Alabama Supreme Court Decision

This decision is rightfully garnering attention from the IVF provider community and the wider public because it may be the first time a court has conferred even limited “personhood” rights to a pre-embryo that has never entered a human body. Historically, pre-embryos have been treated as property and have been the subject of disputes in the family law context across the country.[5] While some state abortion bans prohibit termination from the point of fertilization, such bans tend to govern only the activity that occurs within a uterus or at least within the human body.[6] Instead, re-classifying pre-embryos as human children in all contexts could make IVF treatment using pre-embryos impossible. For example, common practices such as cryogenic freezing of pre-embryos for long-term storage or disposal of stored pre-embryos for medical research purposes could be considered child endangerment or even homicide.

However, the Alabama Supreme Court’s decision is limited to the interpretation of what constitutes a “minor child” under the Act. The majority did not interpret the meaning of what constitutes a human being or a child under any other Alabama law. Thus, for the moment, the immediate impact of this decision is on the application of a particular statute – the Alabama Wrongful Death of a Minor Act – in a particular context – the alleged negligent termination of pre-embryos by a rogue patient in a fertility clinic.

Further, the Court did not resolve the defendant clinics’ claims that the plaintiffs waived the possibility of raising wrongful death claims by signing contracts with the defendant clinics that contained provisions governing the destruction of pre-embryos that had remained frozen for longer than five years, donation of pre-embryos to medical research, or discarding “abnormal embryos” created through IVF. Instead, the Court acknowledged the need for further briefing on whether the plaintiffs had indeed contractually waived wrongful death claims or were otherwise equitably estopped from bringing them against the defendant clinics.

In the near term, the defendant clinics could ask the Alabama Supreme Court to reconsider its decision, or the defendant clinics could petition the United States Supreme Court for certiorari. In the long term, the defendant clinics and other IVF providers could petition the Alabama legislature for an amendment to the Act that would define “minor child” in a manner that would exclude pre-embryos created and stored outside of the human body.

Impact on IVF in Alabama

Though the Alabama Supreme Court confined its holding to Alabama’s Wrongful Death of a Minor Statute, the limited nature of the ruling is causing confusion and uncertainty around what is and what is not allowed under Alabama law. For example, some fertility providers in the state have announced that they will pause IVF treatments to evaluate the impact of the Court’s decision.[7]

The majority justices were careful not to extend this interpretation of the meaning of a “child” to the state’s criminal code or other portions of Alabama law. Some future action would be required to apply this ruling beyond Alabama’s wrongful death statute, such as future litigation. Alabama’s criminal homicide and assault laws, at least, apply only to “unborn children in utero”.[8] Nevertheless, IVF clinics and providers in Alabama may not wish to serve as test cases for a possible expansion of the Alabama Supreme Court’s logic in the present case to laws such as Alabama’s child abuse and neglect laws, where the term “child” is similarly underdefined.[9] Alabama already has used Alabama’s child abuse and neglect laws to prosecute pregnant women for alleged harms to “unborn” children under a theory of child endangerment.[10] Moreover, aggravated child abuse – which includes abuse on more than one occasion or abuse that causes “serious physical injury” – is a felony in Alabama.[11]

At present, the most significant difference between allowing a plaintiff in Alabama to sue an IVF provider for the destruction of pre-embryos as property based on a theory of negligence versus allowing a plaintiff to sue for the wrongful death of a human child is the availability of punitive damages – plaintiffs cannot recover punitive damages from a claim of negligence in Alabama.[12] Moreover, there are no caps on punitive damages in wrongful death cases in Alabama[13] and thus, awards for damages can be exponentially higher in a wrongful death case.

At the very least, IVF providers in Alabama who wish to continue to offer the full range of IVF services in Alabama should evaluate whether they have in place appropriate controls to ensure pre-embryos are safely and securely stored and should also review insurance policies to ensure adequate coverage, given the possibility of expanding liability. Cautious providers in Alabama may choose to limit services, such as limiting the number of retrievals, so that no more than one pre-embryo is created at a time or eliminate storage options for multiple pre-embryos such as cryogenic freezing or only freezing eggs with the possibility of crossing state lines when it is time for the creation of the embryo. Unfortunately for patients in need of assisted reproductive therapies, the chilling effect of the Alabama Supreme Court’s decision in this case may mean some providers in Alabama may stop providing IVF services altogether. It will be interesting to see how other states respond in light of this new decision from the Alabama Supreme Court.

ENDNOTES

[1] Ala. Code § 6-5-391 (“When the death of a minor child is caused by the wrongful act, omission, or negligence of any person, persons, or corporation, or the servants or agents of either, the father, or the mother as specified in Section 6-5-390, or, if the father and mother are both dead or if they decline to commence the action, or fail to do so, within six months from the death of the minor, the personal representative of the minor may commence an action.”).

[2] Id.

[3] Citing Mack v. Carmack, 79 So. 3d 597 (Ala. 2011).

[4] See, e.g., Bloomberg Law, Alabama Embryo Ruling Gives Boost to Fetal Personhood Movement (Feb. 21, 2024)

[5] See, e.g., Davis v. Davis, 842 S.W.2d 588, 594 (Tenn. 1992), on reh’g in part, No. 34, 1992 WL 341632 (Tenn. Nov. 23, 1992) (“One of the fundamental issues the inquiry poses is whether the preembryos in this case should be considered “persons” or “property” in the contemplation of the law. The Court of Appeals held, correctly, that they cannot be considered “persons” under Tennessee law[.]”

[6] See, e.g., Idaho Code § 18-604(1) (““Abortion” means the use of any means to intentionally terminate the clinically diagnosable pregnancy of a woman with knowledge that the termination by those means will, with reasonable likelihood, cause the death of the unborn child”) and Idaho Code § 18-604(11) (““Pregnant” and “pregnancy.” Each term shall mean the reproductive condition of having a developing fetus in the body and commences with fertilization.”).

[7] Associated Press, Alabama hospital puts pause on IVF in wake of ruling saying frozen embryos are children (Feb. 21, 2024).

[8] Ala. Code § 13A-6-1 (emphasis added).

[9] See Ala. Code § 26-14-1 (defining “child” as “[a] person under the age of 18 years.”)

[10] Hicks v. State, 153 So. 3d 53, 58 (Ala. 2014). Note also that the Alabama Supreme Court in the present case cited to Hicks – which held that the term “child” included an “unborn” child – in support of extending the definition of “unborn child” to include an “extrauterine child”.

[11] Ala. Code § 26-15-3.1.

[12] Lafarge N. Am., Inc. v. Nord, 86 So. 3d 326, 335 (Ala. 2011) (“Punitive damages cannot be awarded on a negligence claim[.]”)

[13] Ala. Code § 6-11-21(j); see also Springhill Hosps., Inc. v. Patricia Bilbrey W., No. SC-2022-0719 (Ala. Aug. 4, 2023).

©2024 Epstein Becker & Green, P.C. All rights reserved.

by: Erin Sutton , Lynn Shapiro Snyder , Amy K. Dow , Susan Gross Sholinsky of Epstein Becker & Green, P.C.

For more news on the Alabama Supreme Court’s IVF Decision, visit the NLR Litigation / Trial Practice section.

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down.

From a governmental perspective, many federal agencies are embracing the possibilities of AI. The Centers for Disease Control and Prevention is exploring the ability of AI to estimate sentinel events and combat disease outbreaks and the National Institutes of Health is using AI for priority research areas. The Centers for Medicare and Medicaid Services is also assessing whether algorithms used by plans and providers to identify high risk patients and manage costs can introduce bias and restrictions. Additionally, as of December 2023, the U.S. Food & Drug Administration cleared more than 690 AI-enabled devices for market use.

From a clinical perspective, payers and providers are integrating AI into daily operations and patient care. Hospitals and payers are using AI tools to assist in billing. Physicians are using AI to take notes and a wide range of providers are grappling with which AI tools to use and how to deploy AI in the clinical setting. With the application of AI in clinical settings, the standard of patient care is evolving and no entity wants to be left behind.

From an industry perspective, the legal and business spheres are transforming as a result of new national and international regulations focused on establishing the safe and effective use of AI, as well as commercial responses to those regulations. Three such regulations are top of mind, including (i) President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of AI; (ii) the U.S. Department of Health and Human Services’ (“HHS”) Final Rule on Health Data, Technology, and Interoperability; and (iii) the World Health Organization’s (“WHO”) Guidance for Large Multi-Modal Models of Generative AI. In response to the introduction of regulations and the general advancement of AI, interested healthcare stakeholders, including many leading healthcare companies, have voluntarily committed to a shared goal of responsible AI use.

U.S. Executive Order on the Safe, Secure, and Trustworthy Development and Use of AI

On October 30, 2023, President Biden issued an Executive Order on the Safe, Secure, and Trustworthy Development and Use of AI (“Executive Order”). Though long-awaited, the Executive Order was a major development and is one of the most ambitious attempts to regulate this burgeoning technology. The Executive Order has eight guiding principles and priorities, which include (i) Safety and Security; (ii) Innovation and Competition; (iii) Commitment to U.S. Workforce; (iv) Equity and Civil Rights; (v) Consumer Protection; (vi) Privacy; (vii) Government Use of AI; and (viii) Global Leadership.

Notably for healthcare stakeholders, the Executive Order directs the National Institute of Standards and Technology to establish guidelines and best practices for the development and use of AI and directs HHS to develop an AI Task force that will engineer policies and frameworks for the responsible deployment of AI and AI-enabled tech in healthcare. In addition to those directives, the Executive Order highlights the duality of AI with the “promise” that it brings and the “peril” that it has the potential to cause. This duality is reflected in HHS directives to establish an AI safety program to prioritize the award of grants in support of AI development while ensuring standards of nondiscrimination are upheld.

U.S. Department of Health and Human Services Health Data, Technology, and Interoperability Rule

In the wake of the Executive Order, the HHS Office of the National Coordinator finalized its rule to increase algorithm transparency, widely known as HT-1, on December 13, 2023. With respect to AI, the rule promotes transparency by establishing transparency requirements for AI and other predictive algorithms that are part of certified health information technology. The rule also:

  • implements requirements to improve equity, innovation, and interoperability;
  • supports the access, exchange, and use of electronic health information;
  • addresses concerns around bias, data collection, and safety;
  • modifies the existing clinical decision support certification criteria and narrows the scope of impacted predictive decision support intervention; and
  • adopts requirements for certification of health IT through new Conditions and Maintenance of Certification requirements for developers.

Voluntary Commitments from Leading Healthcare Companies for Responsible AI Use

Immediately on the heels of the release of HT-1 came voluntary commitments from leading healthcare companies on responsible AI development and deployment. On December 14, 2023, the Biden Administration announced that 28 healthcare provider and payer organizations signed up to move toward the safe, secure, and trustworthy purchasing and use of AI technology. Specifically, the provider and payer organizations agreed to:

  • develop AI solutions to optimize healthcare delivery and payment;
  • work to ensure that the solutions are fair, appropriate, valid, effective, and safe (“F.A.V.E.S.”);
  • deploy trust mechanisms to inform users if content is largely AI-generated and not reviewed or edited by a human;
  • adhere to a risk management framework when utilizing AI; and use of AI technology. Specifically, the provider and payer organizations agreed to:
  • develop AI solutions to optimize healthcare delivery and payment;
  • work to ensure that the solutions are fair, appropriate, valid, effective, and safe (“F.A.V.E.S.”);
  • deploy trust mechanisms to inform users if content is largely AI-generated and not reviewed or edited by a human;
  • adhere to a risk management framework when utilizing AI; and
  • research, investigate, and develop AI swiftly but responsibly.

WHO Guidance for Large Multi-Modal Models of Generative AI

On January 18, 2024, the WHO released guidance for large multi-modal models (“LMM”) of generative AI, which can simultaneously process and understand multiple types of data modalities such as text, images, audio, and video. The WHO guidance contains 98 pages with over 40 recommendations for tech developers, providers and governments on LMMs, and names five potential applications of LMMs, such as (i) diagnosis and clinical care; (ii) patient-guided use; (iii) administrative tasks; (iv) medical education; and (v) scientific research. It also addresses the liability issues that may arise out of the use of LMMs.

Closely related to the WHO guidance, the European Council’s agreement to move forward with a European Union AI Act (“Act”), was a significant milestone in AI regulation in the European Union. As previewed in December 2023, the Act will inform how AI is regulated across the European Union, and other nations will likely take note of and follow suit.

Conclusion

There is no question that AI is here to stay. But how the healthcare industry will look when AI is more fully integrated still remains to be seen. The framework for regulating AI will continue to evolve as AI and the use of AI in healthcare settings changes. In the meantime, healthcare stakeholders considering or adopting AI solutions should stay abreast of developments in AI to ensure compliance with applicable laws and regulations.

Copyright © 2024, Sheppard Mullin Richter & Hampton LLP.
For more on Healthcare, visit the NLR Health Law & Managed Care section.

The False Claims Act in 2023: A Year in Review

In 2023, the government and whistleblowers were party to 543 False Claims Act (FCA) settlements and judgments, the highest number of FCA settlements and judgments in a single year. As a result, collections under the FCA exceeded $2.68 billion, confirming that the FCA remains one of the government’s most important tools to root out fraud, safeguard government programs, and ensure that public funds are used appropriately. As in recent years, the healthcare industry was the primary focus of FCA enforcement, with over $1.8 billion recovered from matters involving hospitals, pharmacies, physicians, managed care providers, laboratories, and long-term acute care facilities. Other areas of focus in 2023 were government procurement fraud, pandemic fraud, and enforcement through the government’s new Civil Cyber-Fraud Initiative.

Listen to this post 

© 2024 Bradley Arant Boult Cummings LLP
For more on the False Claims Act, visit the NLR Criminal Law / Business Crimes section.

Minimizing National Labor Relations Act Liability for Employers with Non-Unionized Workforces

This post continues our consideration of comments submitted in response to proposed regulations under the Mental Health Parity and Addiction Equity Act (MHPAEA).

Under current law, if a plan provides any mental health or substance use disorder (MH/SUD) benefits in any classification of benefits, benefits for that condition or use disorder must be provided in every classification in which medical/surgical (M/S) benefits are provided. Classifications for this purpose include inpatient, in-network; inpatient, out-of-network; outpatient, in-network; outpatient, out-of-network; emergency care; and prescription drugs. The proposed regulations modify this standard by providing that a plan does not provide benefits for MH/SUD benefits in every classification in which M/S benefits are provided unless the plan provides meaningful benefits for treatment for the condition or disorder in each such classification “as determined in comparison to the benefits provided for medical/surgical conditions in the classification.”

The term “meaningful benefits” is nowhere defined. The regulators nevertheless “recognize that the proposal to require meaningful benefits [ ] is related to scope of services.” “Scope of services” for this purpose generally refers to the types of treatments and treatment settings that are covered by a group health plan or health insurance issuer. The preamble to the proposed regulation invites comments on how the meaningful benefits requirement “would interact with the approach related to scope of services adopted under the 2013 final regulations.” The preamble of the 2013 final regulations addressed an issue characterized as ‘‘scope of services’’ or ‘‘continuum of care’’ but otherwise failed to provide any substance. Two examples from the proposed regulations do, however, give us a sense of what the regulators have in mind.

  • A plan that generally covers treatment for autism spectrum disorder (ASD), a mental health condition, and covers outpatient, out-of-network developmental evaluations for ASD but excludes all other benefits for outpatient treatment for ASD, including applied behavior analysis (ABA) therapy, when provided on an out-of-network basis. (ABA therapy is one of the primary treatments for ASD in children.) The plan generally covers the full range of outpatient treatments and treatment settings for M/S conditions and procedures when provided on an out-of-network basis. The plan in this example violates the applicable parity standards.
  • In another example, a plan generally covers diagnosis and treatment for eating disorders, a mental health condition, but specifically excludes coverage for nutrition counseling to treat eating disorders, including in the outpatient, in-network classification. Nutrition counseling is one of the primary treatments for eating disorders. The plan generally provides benefits for the primary treatments for medical conditions and surgical procedures in the outpatient, in-network classification. The exclusion of coverage for nutrition counseling for eating disorders results in the plan failing to provide meaningful benefits for the treatment of eating disorders in the outpatient, in-network classification, as determined in comparison to the benefits provided for M/S conditions in the classification. Therefore, the plan violates the proposed rules.

Notably, the newly proposed meaningful benefits requirement is separate from, and in addition to, the newly prescribed nonquantitative treatment limitation (NQTL) testing standards. These latter standards include a “no more restrictive” requirement, a “design and application” requirement and an “outcomes data and network composition” requirement. A handful of comments nevertheless urge the regulators to add scope of services to its non-exhaustive list of NQTLs. As a result, a plan’s scope of services would be subject to comprehensive NQTL testing. Or, put another way, they would be fed back into the NQTL testing loop. Using the first of the examples above, this would require that ABA therapy to be first compared to the treatment limitations imposed on some M/S benefits in each classification. But what benefits, exactly? The problem is that a plan’s scope of services – what types of treatments a plan will pay for and in what settings – is a high-level plan design feature and not an NQTL.

While reasonable minds can and do differ on much of the substance of the proposed regulations, we doubt that anyone would claim that they streamline or simplify compliance. Compliance with these rules is already complicated and expensive; if the final rule looks anything like the proposed regulations, compliance will only get more complicated and more expensive. The proposed meaningful benefits requirement is intended to prevent plans, as a matter of plan design, from satisfying the parity rules by offering nominal or insubstantial MH/SUD benefits when compared to similar M/S benefits in each classification. Treating a plan’s scope of services as itself a separate NQTL does not advance this goal.

© 2024 McDermott Will & Emery
by: Alden J. Bianchi of McDermott Will & Emery 

For more news on Health Care Law, visit the NLR Health Law and Managed Care section.