Year: 2024

Among the thousands of federal, state, local, and tribal criminal legal systems in the United States, there are over 1.9 million people in prisons, jails, detention centers, etc. Within that population, an estimated 65 percent of individuals meet the criteria for an active substance use disorder (SUD). The Prison Policy Initiative estimates that in jails, less than two-thirds of people are screened for opioid use disorder, and only 54% of those who qualify are provided medication for people experiencing withdrawal. When not treated adequately, opioid withdrawal can be a life-threatening condition that includes symptoms of sweating, nausea, vomiting, agitation, anxiety, etc. People entering the criminal justice system must be medically monitored and provided the treatment necessary to mitigate the harm and potential loss of life that can result from opioid withdrawal.

For a time, Corizon Health Inc., a private, for-profit medical contractor, was the nation’s largest for-profit provider of correctional healthcare. However, following over 1,000 lawsuits alleging substandard care, Corizon went through corporate restructuring, moving its debts to a new company called Tehum Care Services and then filing for bankruptcy, a move often known as a “Texas Two-Step.”  Now, Corizon operates under a new name, YesCare, and has signed a billion-dollar contract with the State of Alabama and has extended its contract with the State of Maryland to provide healthcare services in jails and prisons. It is incredibly concerning that a company, that has over a thousand suits relating to negligent medical care, many of which include wrongful death suits relating to negligent mismanagement of detox, is still responsible for the care of such an emotionally and medically vulnerable population.

Medical malpractice related to SUDs runs rampant throughout the correctional system in the United States, and the increased litigations shed light on the need to implement change that advocates for a population that is increasingly in need of advocacy. A common practice for managing withdrawal symptoms and promoting recovery includes the use of opioid agonists, such as methadone, buprenorphine, and naltrexone (these treatments are referred to as medication for opioid use disorder or MOUD), yet only 24% of jails use MOUD, and only 1% of people with a SUD in prisons report receiving MOUD. Not only are these treatments effective for addressing withdrawal symptoms, but they are also found to be effective in lowering overdose deaths following release from the criminal justice system. Not only are these medications lifesaving, according to a study done by the Bloomberg School of Public Health found them to be “a highly cost-effective intervention” among incarcerated populations. 

With the large sums of money, both from the opioid settlement funding ($55.2 billion) and the Tehum Care Services (Formerly Corizon Health Inc.) litigations resulting in a $75 million settlement, there is a massive amount of money on the table. If funneled appropriately, it can be used to implement MOUD in jails and prisons to reduce the harms of opioid withdrawal, SUD, and post-release overdose. Though the Tehum settlement will go to Tehum’s creditors, it will also go toward plaintiffs who suffered great losses through Corizon’s negligence. Following this impactful litigation, there must be justice for those lives lost and injuries that transpired because of the mismanagement and lack of treatment relating to SUD detoxification. MOUD is a feasible and effective solution to opioid withdrawal and given the funding available via the opioid settlements and Corizon litigations, now is the time to implement change.  

Pharmacy Benefit Managers (“PBMs”) have come under intense scrutiny recently. A recent report by the Federal Trade Commission (“FTC”) noted that PBMs are profiting “at the expense of patients.” However, before discussing the recent scrutiny of PBMs, it is important to understand what role PBMs play in the overall United States healthcare industry. 

What we consider everyday happenstance today—pharmacies dispensing prescription drugs—emerged in the early 1910s, for narcotics, and in the 1950s for nonnarcotics. Soon after pharmacies began dispensing prescription nonnarcotics, pharmacists founded PBMs. However, not long after PBMs were established, their industry underwent rapid horizontal and vertical integration. The FTC report stated that this integration has led to “the top three PBMs [to process] nearly 80 percent of the approximately 6.6 billion prescriptions dispensed by U.S. pharmacies in 2023, while the top six PBMs processed more than 90 percent.” 

This integration has also caught the attention of antitrust authorities – in 2017 the Department of Justice (“DOJ”) blocked mergers of major health insurers Aetna-Humana and Anthem-Cigna. However, DOJ’s challenges opened the door for two of these insurance companies to merge with some of the largest PBMs in the market. In 2018, CVS Health (the largest PBM, with a 21.3% share of the market) acquired Aetna, while Express Scripts (the third largest PBM, with a 17.1%share of the market) merged with Cigna. PBMs merging with insurers seems to be the current trend—the FTC report noted that “five of the top six PBMs are now part of corporate healthcare conglomerates that also own and operate some of the nation’s largest health insurance companies, including three of the five largest health insurers in the country.”

Now that we know when PBMs originated and how they fit into the broader healthcare industry, it’s important to clarify their role. Essentially, PBMs are the middlemen between “drug companies, insurers, and pharmacies.” PBMs operate within a complex framework, and an entire paper could be written on what role they play; importantly, PBMS:

Act as negotiating entities between several actors in the prescription drug supply chain. Insurers work with PBMs as third-party contractors that manage their prescription drug benefits. PBMs create and update formularies of preferred drugs, with different prices and cost-sharing amounts that influence what beneficiaries pay out of pocket and which medications they can access through their insurance. PBMs negotiate rebates and discounts for an insurance plan from drug manufacturers and determine the prices insurers pay and the payments pharmacies receive. PBMs can also take on the administrative role of directly reimbursing retail pharmacies on behalf of an insurer. Both public and private insurers, including Medicaid, Medicare Advantage plans, employer-sponsored insurance plans, and individual market plans, use PBM services.

So what’s the problem? Along with the FTC report noting that few PBMs dominate the market, PBMs and insurers are generally a part of the same large conglomerate, the FTC importantly noted that PBMs are putting “profits before patients.” PBMs ensure their profits in a variety of ways. As mentioned above, just six PBMs control 90% of the market, so these PBMs, which decide which medicines you may receive and at what price, tend to steer people to the pharmacies they own. The FTC report noted that this creates a conflict of interest which would only lead to an “increase in medicine costs.” Further, PBMs make money through rebates and fees they charge, charges that are dependent on the price of the medicine they are selling—which means when the price of medicine rises, so do the profits of PBMs. Finally, it is worth noting that “PBMs get billions of dollars in rebates and discounts that reduce the cost of brand medicines by 50% or more … [y]et they often force patients to pay based on the full price.” So while PBMs dominate the market and can negotiate the cost of medicine, this cost-saving rate is not reflected in customer costs, who are still expected to pay full price. 

As Donald Trump prepares to take office in 2025, public health and policies are expected to shift significantly, particularly around vaccine policy. The Trump Administration, coupled with the appointment of prominent vaccine skeptic Robert F. Kennedy Jr. (RFK) to lead the Department of Health and Human Services, suggests a potential departure from the previous vaccine strategies implemented in recent years. 

Vaccines are among the most effective tools healthcare workers have to prevent disease. Vaccines have saved at least 154 million lives in the past 50 years. Kennedy, a vocal critic of vaccine mandates and mainstream vaccination programs, has consistently raised questions about vaccine safety and government oversight. As the head of health policy, he may prioritize “medical freedom,” allowing individuals more choices about vaccination and minimizing federal mandates. While Kennedy’s stance appeals to those wary of government intervention, it raises concerns among public health experts who worry that easing vaccine recommendations could lead to lower vaccination rates and the re-emergence of diseases, such as measles, mumps, and whooping. Kennedy has made false claims that vaccines cause autism, and his misinformation has been linked to a deadly measles outbreak in Samoa in 2019. Meanwhile, measles cases in the U.S. matched their 2023 total numbers in just the first months of 2024. 

Moreover, COVID-19 vaccines, which have been widely distributed and recommended by health authorities since their rollout, are also expected to see changes. Under the Biden administration, COVID-19 vaccines were central to managing the pandemic. Trump’s previous stance during the pandemic was to expedite vaccine development through “Operation Warp Speed,” though he opposed vaccine mandates. In 2025, Trump and RFK may continue cutting government funding for vaccination programs while advocating for natural immunity and alternative treatments. This could push states to loosen vaccine requirements and adopt a choice-drivel model, which may influence public perceptions and acceptance of COVID-19 boosters. 

A significant pivot in vaccine policy could challenge the infrastructure for managing vaccine-preventable diseases. The public health sector relies on high vaccination rates to maintain herd immunity, reducing the risk of outbreaks. By decreasing federal support for vaccinations, particularly in schools and workplaces, Trump’s administration may face challenges in maintaining this level of immunity. Lower vaccination rates could strain hospitals and public health systems especially, if vaccine-preventable diseases start to resurface. 

The future of public health under Trump, with RFK overseeing vaccine policy, may prioritize personal choice over federal mandates. While this approach appeals to advocates of medical freedom, it poses potential risks to the established public health framework. As these changes take effect, the impact on vaccination rates and overall health outcomes in the U.S. will gradually become evident. RFK and Trump’s proposed policies will likely fuel continued debate around the balance between individual choice and public health safety. 

Health is the way a person interacts with their environment. A person’s environment includes where they live, the quality of the home, the air, and access to nutritious food. These all influence a person’s opportunities to achieve health and affect the rates of life expectancy, infant mortality, and rates of chronic disease. 

One of the most influential public health factors for a person’s environment is where they live. An individual’s access to housing and the conditions of that housing can be a direct determinant of their health. Health and Housing are deeply intertwined. Having no housing options as well as housing that exposes occupants to unsanitary and hazardous living conditions can directly impact an individual’s susceptibility to illness.  

Previously allowing Medicaid funds to be used towards paying The Centers for Medicare & Medicaid Services (CMS) for housing expenses was prohibited but recently, issued new guidance on Medicaid Waivers giving states the flexibility to use Medicaid dollars to support housing expenses including rent and temporary housing. CMS approved section 1115 which allows states to choose to use some of their Medicaid funds towards time-limited housing and nutrition services.  

In November 2023, CMS reiterated its HRSN waiver policy outlining that the program includes coverage for “Housing” and “Nutrition”. The program included things such as short-term and post-transition housing for up to six months, people at risk of homelessness, and youth transitioning out of the welfare system. Other housing assistance in the waiver includes pre-tenancy and tenancy sustaining services, tenant rights education, and eviction prevention costs including security deposit, utility fees, moving, relocation, application expenses, and inspection fees. 

As well as obtaining housing, the funds can also be used to improve housing. The quality of a home can directly impact an occupant’s health. Things such as mold, inadequate plumbing, heat, and air conditioning can cause health issues for those living in these conditions. Additionally, fixing these issues can be expensive. The Section 1115 Waiver also allows funds to be used towards modifications to one’s home environment including air conditioners, heaters, air filtration devices, generators, carpet replacement, ventilation improvements, and mold and pest removal. These improvements would lead to improved health conditions and mitigate the need for hospital visits and medications related to illnesses caused by unhealthy living conditions. 

As of March 2024, at least 18 states had approved Section 1115 Medicaid demonstration waivers for housing-related services with eight states recently approved under the housing-related social needs waiver framework. Hopefully, more states will choose to use their Medicaid funds towards housing assistance for their citizens. This will directly improve the health conditions of its beneficiaries, contributing to the stability of the healthcare system overall.  

In 2022, JUUL, an e-cigarette company originally founded to help cigarette smokers quit, settled a lawsuit that alleged that Plaintiffs paid more for JUUL products than they would have if accurate information regarding the product’s addictiveness and safety had been provided. The lawsuit further alleged that JUUL products were unlawfully marketed to minors. The complaint, filed in the Northern District of California, noted that JUUL’s advertising techniques were specifically employed to garner interest from a younger consumer population and used long-banned cigarette advertising techniques. The $300 million settlement was paid out to consumers in the middle of October 2024, with some purchasers receiving thousands of dollars in return. 

In avoiding the risk of going to trial, JUUL’s settlement sets the stage for future claims against substance producers potentially marketing to children or concealing the risks associated with consuming their product. As research emerges regarding alcohol consumption’s link to increased cancer risk, companies that produce sweet liquors with fun colors could be at risk for marketing to children. Per the National Institute of Health, nearly 5.8% of cancer deaths worldwide are attributable to alcohol consumption. As of October 22, 2024, the United States does not require that alcohol bottles bolster a warning of cancer risk. Ireland recently became the first country to require cancer warning labels on alcohol bottles. Many liquors also appear to be marketed towards children in many of the same ways that JUUL products were; they are colorful, with sleek designs, and often fruity or exotic flavors. At what point do the same legal principles apply to alcohol litigation?

Arguably, JUUL’s massive settlement set the stage for future substance complaints and litigation, particularly as it concerns public health and concern for minors. The alcohol industry finds itself at a crossroads: how can it continue to innovate its product and increase its revenue while treading carefully to avoid bankruptcy-inducing settlement payouts? The question might actually be one of abandoning some long-held, capitalistic business practices, pivoting from seemingly marketing to a younger audience, and bolstering the existing market. Instead of creating fun designs with exotic flavors, perhaps leaning into a “sophisticated” type of marketing that emphasizes the exclusivity of being of age to consume alcohol. By moving away from the youth-targeted marketing, companies can instead generate excitement for a new consumer base by advertising anticipation of reaching the drinking age. Perhaps they can also shift marketing to reflect a slower, less volume-induced type of consumption. By elevating the experience and shifting marketing strategy to reflect a sophisticated, adult activity, alcohol companies can avoid potential marketing litigation as it pertains to childish advertising. In looking towards the future, alcohol companies should be prepared to comply with all warning regulations and potentially shift marketing materials to target an older audience. 

Chaos ensued in the nursing home industry after the federal Centers for Medicare and Medicaid Services (CMS) issued its final rule mandating minimum nurse staffing in every nursing home that accepts Medicaid and/or Medicare funds. This means virtually all U.S. nursing homes will be subject to the new rules as of April 22, 2024. The reaction has been swift, with 20 states joining together to sue the U.S. federal government over the requirements, representing a significant pushback against the Biden administration’s attempt to upgrade the quality of care in long-term care facilities (“LTCs”). The new rules require that nursing facilities have a registered nurse on campus twenty-four hours a day, seven days a week as well as additional specified staffing levels for all other nursing staff (e.g., licensed practical nurses and certified nursing assistants).

Staffing minimums in nursing homes are not new by any means; since 1987, with the passing of the Nursing Home Reform Law, facilities have been required to ensure sufficient staffing at all times so that residents can “attain and maintain her highest practicable physical, mental, and psycho-social well-being.” However, the law was rarely enforced, leading to a less-than-optimal standard of care. This new law adds a quantitative requirement to improve enforcement of the purely qualitative 1987 Nursing Home Reform Law. 

The real question is, how will this new law impact nursing homes now? The benefits of increased staffing are clear: more staff means more efficient care. But why would 20 states be suing over it? The slow implementation of the new rule puts current residents at risk; CMS is allowing years for facilities to comply with the rule, and facilities that have trouble staffing to the new minimum will likely have to stop admitting new residents. Additionally, the new rule gives so-called “hardship exemptions,” giving any facility that meets the requirement for hardship to skirt the rules, allowing for less than stellar care for residents. 

Furthermore, paying for the increase in staff is likely a non-issue for the majority of facilities as most nursing homes are run as for-profit businesses, with regular investments by Private Equity, Real Estate Investment Trusts, and other highly polished investors. In fact, nursing homes had total net revenues of $126 billion and a profit of $730 million in 2019. Additionally, spending for residents’ direct care comprised only 66% of net revenues, including 27% on nursing, in contrast to 34% spent on administration, capital, and others. 

Despite most nursing homes seeing large net profits, attorneys general from the twenty states participating in that lawsuit contend that the new requirements are not feasible in rural communities that don’t have the same venture capital presence. Moreover, traditionally, nursing home care has been regulated at the state level, arguing that this mandate “represents an overreach of federal power and fails to account for the diverse needs and resources of different states and communities.” States further assert that the new rule represents a one-size-fits-all model that fails to account for the unique needs of different patient populations. 

As the lawsuit proceeds through the legal system, it will likely have notable implications for nursing home care policy throughout the United States. The outcome of the case will likely set important precedents regarding state and federal authority over healthcare regulation.