Year: 2025

The ADHD Medication Shortage: DEA Regulations and Limitations to Addressing the Public Health Crisis

The United States is facing an attention-deficit/hyperactivity disorder (ADHD) crisis with issues arising out of the great demand for first-line pharmacotherapy amid widespread shortages. Concerns about overmedication, particularly in children and young adults, qualify the necessity of strategic industry regulations and practices. Enforcing a balance of proper access and production of ADHD pharmacotherapy while mitigating risks of substance abuse in this line of drug treatment is vital to the health and well-being of the public.

More than 3.4 million children are currently prescribed ADHD medications, leading to federal concern about overmedication for chronic conditions in pediatric populations. Further, the American Psychiatric Association reported that adult ADHD diagnoses rose annually from 2020 to 2023, adding additional pressure to a strained healthcare infrastructure.

Pharmacy supply shortages have resulted in patients often driving long distances to pick up their prescription, particularly impacting rural and underserved communities. Lacking medication as prescribed leads to patients experiencing detriments in managing their daily life, and severe physical and mental withdrawal symptoms.

Despite these robust demands, patients are facing widespread prescription treatment shortages. As of late 2025, the Drug Enforcement Agency (DEA) has acknowledged that the existing national inventory of Schedule II substances, including d-amphetamine and methylphenidate, is inadequate to meet “legitimate patient needs.” In response, the DEA increased the Aggregate Production Quotas (APQs) for these active ingredients of first-line ADHD treatments for 2025. This action allows manufacturers to increase production and pharmacies to increase inventory, better meeting medication demand.

The DEA is responsible for enforcing regulations governing ADHD medication dispensing under the Controlled Substances Act (CSA). Stimulant medications containing the active ingredients falling under the APQ increase are typically recognized by their brand names of Adderall, Vyvanse, Concerta, and Ritalin. These medications are allocated to the Schedule II class for their associated risks with “misuse, addiction, overdose, and diversion.”

Limitations to the authority of the DEA in addressing the stimulant pharmacotherapy access crisis intersect with the market. Despite the DEA increasing the quota, the inventory of this class of products is not expanding to the capacity allocated for production. An analysis by the DEA in 2022 found that manufacturers sold only 70 percent of the volume allocated by the quota, excluding one billion additional doses from production that could have gone to the market.

In another study between 2001 and 2023 analyzing derivatives for prescription amphetamine shortages, 58 percent of manufacturers did not disclose a reason for the shortage. Other manufacturers reporting on the shortage have cited a mismatch in supply and demand, and manufacturing problems and delays.

Anticompetitive actions by manufacturers have also created structural barriers to market access. The class action Barbara et al. v. Shire brought forth allegations that brand-name manufacturers were paying rival drug makers to delay releasing generic versions of Adderall XR. This lawsuit exposed violations of the Sherman Act which bans monopolies and unreasonable trade restraints, risking supply shortages and price inflation.  

The DEA works in conjunction with the FDA to regulate prescription stimulants. Recognizing the supply issues with the drugs, the two agencies issued a letter asserting their intention to understand, prevent, and reduce the impact of the shortages in pharmaceutical supply chains. However, neither agency manufactures drugs nor can they require pharmaceutical companies to increase production. While recognizing the importance of responsible prescribing practices, the agencies have called on pharmaceutical manufacturers to increase production to meet the quotas and help mitigate the stimulant drug shortage crisis the United States is facing.

COVID-19 Tests: Who’s Paying?

The COVID-19 pandemic was a time of turmoil across the nation. During the course of the public health emergency, one unlikely source of controversy: how to provide and pay for COVID-19 tests for uninsured individuals.

From February 20, 2020 to June 23, 2022, 912.77 million COVID-19 tests were administered in the United States alone. Over the course of the pandemic, the federal government sent many of these tests to American households for free. Private insurers covered additional tests. However, there has been controversy over payment and administration of these tests, including a civil fraud suit against providers and an ongoing fight in the United States Court of Federal Claims over who is responsible for paying for the tests that have already been administered.

During the course of the pandemic, the federal government introduced a free COVID-19 test distribution program. The program allowed each U.S. household to order four free at-home COVID tests shipped for free to the consumer via USPS. However, the government website stopped accepting orders March 10, 2025. Some insurers still cover the cost of at-home tests, but they may require a finding of medical necessity. It is now unclear how individuals can seek payment assistance or free tests.

In addition to the test distribution program, the federal government reimbursed claims under a claims reimbursement program for COVID-19 test administration. The government reimbursed claims for healthcare providers and facilities that tested individuals without insurance. However, the program has received its fair share of problematic billing. In June 2024, The U.S. Attorney General filed a civil fraud suit on behalf of the Department of Health and Human Services (HHS) against LabQ for fraudulently billing the federal government for COVID-19 tests. The lab submitted claims for COVID-19 testing where the testing had or would be reimbursed by another source or had been provided to someone with healthcare coverage.

In other cases, the federal government is being accused of failure to reimburse testing. On October 17, LabQ Clinical Diagnostics LLC, Dart Medical Laboratory Inc., and Community Mobile Testing Inc. filed a breach of contract claim against the U.S. government alleging they failed to reimburse $543 million worth of COVID-19 tests on uninsured individuals in New York City. They also filed claims for breach of the Coronavirus Aid, Relief, and Economic Security Act (CARES) Act and other pandemic-era statutes designed to provide relief. The CARES Act, signed into law March 27, 2020, was passed to provide $2 trillion in economic relief and established the Coronavirus Relief Fund to provide $150 billion of direct assistance to states and local governments. The providers submitted claims through a portal established by the program, and the U.S. Department of Health and Human Services states it would reimburse generally at 100% of the eligible Medicare rates for eligible tests. The complaint alleges a premature depletion of funds and termination of the program before plaintiffs were reimbursed.

The payment saga of the COVID-19 pandemic and the resulting lack of clarity in whether providers and hospitals will get tests covered is ongoing. It is one more result of the chaos that occurred across the globe. The United States’ disproportionately high death toll demonstrates that it is critical that better response plans to public health emergencies of this scale are developed and implemented.

The ‘Elder’ Medical-Legal Partnership and Caregiving from an Interdisciplinary Lens

New frameworks, interdisciplinary collaborations, and models of health care may need to emerge to address the impending “caregiving crisis,” or growing strain on the elder caregiving workforce with our aging population. The medical-legal partnership (MLP) model is one potential approach in addressing elder well-being, health, and the caregiving crisis. Medical legal partnerships are an established interdisciplinary framework, combining the legal and medical worlds to holistically serve a population’s needs. Within MLP clinical sites, attorneys are placed directly onsite to work with healthcare providers in identifying and remedying health-harming legal needs.

The model is based on the understanding that health issues are seldom solvable by addressing medical needs. For instance, an elder patient and their caregiver may need assistance in accessing incapacity plans or safe housing for an elder at risk for falls at home. By utilizing the MLP model, clinics can assist older adults and caregivers in navigating the multidimensional, overlapping legal and health issues that elders face, potentially reducing some of the burden on the caregiving population. Addressing common elder issues in one clinic with the expertise of two professions can help streamline access to other resources like public benefits, support the dignity and autonomy of elders, and address a variety of unmet financial, housing and legal needs. The MLP can also assist with the fact that elders have specific barriers to legal and healthcare related to mobility, transportation, and isolation by acting as a “one stop shop” for holistic support. Contributors to elder law also point out that medical providers and attorneys are well-positioned to collaborate so that providers can identify elder abuse.

While MLPs have become increasingly popular, they have scarcely been tailored to elder populations. The Medical-Legal Partnership for Seniors (MLPS) in San-Francisco, a law school clinic that trains medical providers on the legal needs of elders, is one example of an MLP tailored to the elder populations. But for the most part, MLPs have been utilized at the pediatric level where pediatricians are trained to identify the causes of their patient’s health conditions, which often stem from social determinants of health (SDOH) like poor housing conditions. Research has suggested that SDOHs are more important to individual health than genetic predisposition, where SDOHs such as socioeconomic resources, working conditions, housing, environment, race, and gender may be “fundamental causes” of health outcomes. These same SDOHs shape elder health, independence, and overall wellbeing, where intersecting factors and elder social identities may compound poor legal and health outcomes for elders. For example, a low income, older woman of color experiencing housing instability may face intersecting barriers that healthcare nor legal interventions alone can adequately address. Recognizing this, MLP interventions should be multi-pronged to address underlying social factors like structural racism and critically assess their own role in reinforcing systemic inequities. Elders are not a monolithic group, and ‘non-essentializing’ this population is critical in delivering equitable care.

Overall, the MLP framework could be more widely utilized to benefit the elder population and promote their health and justice. Having stronger societal supports like numerous MLPs tailored to elder needs may furthermore assist incrementally in the caregiving crisis, given that elder issues are only becoming increasingly relevant as our population continues to age. The MLP model thus may be a promising method to expand on caregiver and elder supports in the United States.

The Patients Over Profits Act: What It Could Mean for Patients and Providers

The Patients Over Profits Act (“POP Act”) was introduced in both Houses of Congress this fall. The proposed Act addresses vertical integration in the healthcare system, specifically covering various stages of insurance coverage. Vertical integration, as opposed to horizontal integration, is when multiple stages of a certain industry are all controlled by the same company. For example, vertical integration in the healthcare industry happens in various situations, but in this context happens when a certain company owns or controls both the insurer and the physician. 

Multiple industries have been trending towards vertical integration, and the healthcare industry is no exception. The Supreme Court has stated that any sort of integration is “highly relevant” in deciding whether anticompetitive effects exist. The Patients Over Profits Act seeks to address the effects of vertical integration in the healthcare industry on patients. 

Specifically, the supporters of the POP Act argue that insurers can now control physician practices, and then set their own policies regarding insurance. Supporting documents explain that these financial incentives surrounding insurance companies can in turn affect the care and treatment patients receive from providers who are owned by companies who control both the physicians and the insurance payouts. Proponents of the Patients Over Profits Act not only argue that the financial incentives can influence clinical decision-making, but they also have the ability and desire to increase costs and drive up profits for their company.  Recently, many insurance conglomerates have purchased clinics and other physician-groups, resulting in vertical integration. For example, UnitedHealthcare purchased a large physician-owned clinic in Oregon, after they had already purchased other similar medical groups in Oregon. This type of integration is not unique to Oregon, it is happening throughout the United States.  

Specifically, the Patients Over Profits Act addresses physicians and insurers participating in Medicare and Medicaid. Medicare and Medicaid protect our most vulnerable citizens. Medicare provides healthcare assistance through a federally funded insurance program to people who are sixty-five or older, and others who qualify or have certain disabilities. Medicaid similarly provides insurance assistance through federal and state funding for low income citizens. The POP Act addresses these concerns in many ways. First, it seeks to prohibit ownership of both a health insurance company and a medical provider who participates in Medicare and Medicaid. Further, it seeks to control Management Services Organizations  (MSOs) through their Management Service Agreements (MSAs). MSOs provide non-clinical services to medical providers, and they use their MSAs, which are contractual agreements, to govern these services. The POP Act seeks to restrict the mechanisms these entities can use to control the medical services the MSOs provide. Further, the Act seeks to enable federal enforcement through the Department of Justice, Federal Trade Commission, and the Department of Health and Human Services regarding those insurance companies engaging in vertical integration, especially those participating in Medicare and Medicaid. 

In short, the Patients over Providers Act seeks to protect patients, rather than providers of healthcare services and insurance companies receiving all of the benefits. By requiring these entities to disclose their information and subject them to strict enforcement through federal agencies, the Act hopes to ensure patients receive care with fair payment. If the POP Act passes, health insurers will need to disclose interests they have in medical practices, or they will be subject to high financial penalties or suspension from federal health programs, such as Medicare and Medicaid. 

What C.K. v. McDonald Mean for Children’s Mental-Health Access Through Medicaid

In August, it was announced that a landmark settlement agreement, was reached in a New York class action lawsuit against the New York State Department of Health (NYSDOH) and the New York State Office of Mental Health (NYOMH). This settlement follows settlements of similar cases in Michigan and Iowa, showing a movement towards systemic change for youth mental health and children’s advocacy. In C.K. v. McDonald, filed in 2022 by children and disability rights groups on behalf of four children in the U.S. District Court for the Eastern District of New York, the plaintiffs alleged that federal law requires mental health services be made available and provided through a state’s Medicaid program, yet, New York State’s services were “inadequate, inaccessible, and dysfunctional.” The plaintiffs primarily alleged that New York systematically denied Medicaid-enrolled youth access to community-based mental health care, which violated their federal rights and left them at risk of institutionalization and long-term harms. The complaint highlighted that the failure of NYSDOH and NYOMH disproportionately effect youth from low-income households and children of color.

Specifically, the plaintiffs cited a number of federal requirements that New York state was not adhering to, including the Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) provision, which requires that Medicaid beneficiaries under 21 receive a number of medical services, including mental health care. The plaintiffs also brought claims under Title II of the Americans with Disabilities Act (ADA), which, under 28 C.F.R. § 35.130, prohibits discrimination or exclusion of qualified individuals from participation in services of a public entity by reason of disability.  The plaintiffs noted that 29 U.S.C. § 794 maintains identical requirements for any program or activity that receives Federal funding. Finally, the plaintiffs cited to Olmstead v. L.C., where the Supreme Court held that the ADA requires states to “provide community-based treatment for persons with mental disabilities.”

 The settlement agreement outlines an 18-month plan of action that the State must implement to improve mental health services for children. The plan establishes that agencies must provide intensive care coordination, in-home behavioral health services, and crisis response planning that does not rely on police. Additionally, the settlement establishes that the State must increase Medicaid reimbursements and institute annual quality audits of these services. The State will also initiate screening and assessment for children who are eligible for services and ensure that an expert is hired in tracking New York’s progress in meeting the agreements of the settlement.

While the settlement is awaiting the court’s final approval, the case outcome demonstrates progression towards improvements in mental health care for the 2.5 million children under 18 who are enrolled in New York’s Medicaid. This step addresses a major gap in care for some of the State’s most vulnerable residents, who so often have to rely on hospitals and residential facilities for care rather than in-home and communal services, which can be extremely distressing and traumatizing. Beyond New York, this case represents  systemic challenges that have been prevalent throughout the country for decades. The New York case, as well as the Michigan and Iowa cases, reinforce a legal precedent that States must be held accountable for providing meaningful, community-based mental health services that are non-discriminatory for Medicaid-eligible and enrolled children. Given the threats to Medicaid funding and massive financial cuts at the Federal level, it is more important than ever that Medicaid funds be spent on proven and effective services.

A Crisis of Accountability: Medical Neglect and Preventable Deaths in Immigration Detention

On September 14, 2025, Hasan Ali Moh’D Saleh, a lawful permanent resident, was arrested by Immigration and Customs Enforcement (ICE) and transferred to Krome Detention Center in Miami, Florida for removal proceedings. On October 10th, Saleh was transported to Larkin Community Hospital due to a fever; the next day, he was dead.

As immigration raids take place in front of cameras across the country, an unseen crisis has developed behind heavily guarded gates. With the escalation of Immigration and Customs Enforcement-Related Operations (ERO) in the United States under the second Trump Administration, there is mounting public outcry and a flurry of legal challenges concerning the lack of due process regarding the arrests of undocumented migrants, asylum seekers, and green card holders like Mr. Saleh. Conflicting narratives have emerged between advocates and authorities regarding the safety and welfare of individuals detained in ICE-related actions. 

As of September 2025, the Trump Administration is holding nearly 60,000 immigrants in ICE detention facilities around the country, not including those held by local authorities under detainer requests from ICE. Seven in ten people detained have no criminal convictions; the majority are working age adults who deny serious medical complaints at intake. Even so, detainees are dying in custody at record speed, most often due to illness, according to reports made public by ICE. 

The agency maintains that relevant details linked to ERO-related deaths are published on its website within two days. However, the “relevant details” connected to the demise of immigrants like Mr. Ismael Ayala-Uribe at age 39 are often cloudy. According to ICE records, Uribe was arrested on August 17th, 2025. On September 18th, nurses noted that Mr. Uribe was in “10 out of 10 pain” near his anus, so a physician ordered a pain reliever and fiber. By September 21st, he was vomiting, sweating, and his heart rhythm was abnormal, having deteriorated to the point that medical staff needed to transfer him to a local hospital. The ICE press release, replete with an account of Uribe’s crimes, arrests, and his DACA status, states that early on September 22nd, he became unresponsive and died.

In the landmark Supreme Court case, Estelle v. Gamble, the Court found that such unnecessary suffering is inconsistent with contemporary standards of decency, codifying the common law view that “[we are] required to care for the prisoner who cannot by reason of the deprivation of his liberty, care for himself.” Given the inmate’s complete reliance on staff for medical treatment, the Court explained that the “deliberate indifference to serious medical needs” constitutes the infliction of cruel and unusual punishment involving the “unnecessary and wanton infliction of pain” forbidden by the Eighth Amendment. The Court further held that such neglect by prison doctors and guards can result in torture or lingering death, and in less severe instances, cause unnecessary pain and suffering which serves no legitimate penological purpose.

Legislators have worked to gain oversight of detention centers for the purpose of investigating welfare complaints and medical standards in settings where patients do not have the autonomy to make informed decisions about their healthcare. NPR received a rare look inside ICE facilities via inspection reports from experts hired by The Department of Homeland Security. In the findings from 2017-2019, inspectors cited negligent medical care that, in some cases, contributed to detainee deaths. 

One inspection revealed that in the Calhoun County Correctional Center, a man in ICE custody was sent into general population with an open wound from surgery and no bandaging, even though he still had surgical drains in place. Jesse Dean, a detainee at the same facility, was never referred to a physician although he had been unable to eat, lost almost 20 pounds in a short time, and suffered from severe nausea; he died in custody from an undiagnosed gastrointestinal hemorrhage.

A joint study published by American Oversight revealed that the overwhelming majority of incidents such as Dean’s could have been prevented if ICE detention medical staff had provided timely and clinically appropriate medical care to include correct, appropriate, and complete diagnoses for detained immigrants.

After 2020, loss of life in ICE custody attributed to chronic or acute medical conditions declined, and spiked recently in correlation to Trump-mandated mass ERO’s:

As ICE arrests surge, concern continues to grow over rising morbidity and mortality rates in immigration detention centers, along with the absence of accountability or consequences for responsible parties. While an analysis of factors contributing to preventable detainee medical deaths cannot cure those who are no longer alive, an honest post-mortem inquiry into systemic failures is vital in order to safeguard the living.