Category: Blog

Federal efforts to rein in prescription drug costs have attracted media coverage and legal opposition. Now, innovative state efforts to limit drug price increases are attracting significant legal scrutiny. At the end of March, Amgen filed a lawsuit in the United States District Court for the District of Colorado seeking to stop the state’s Prescription Drug Affordability Review Board (“PDAB”) from implementing a price cap on its arthritis drug Enbrel. The lawsuit highlights a growing push among states to create affordability boards to limit drug price increases, nine of which have passed similar laws as of late 2023.

In February 2024, PDAB unanimously declared that Enbrel was unaffordable, allowing the board to consider setting a price cap on transactions involving the drug. The decision came just weeks after Amgen announced that Enbrel produced fourth-quarter sales of more than $1 billion for the company. Amgen argued the statute authorizing PDAB was unconstitutional, providing four reasons to support the company’s claim. First, the company argued that the statute violated the United States Constitution’s Supremacy Clause by conflicting with federal patent laws. Second, the company argued that PDAB violated the Due Process Clause of the Fourteenth Amendment since it lacked a specific standard to determine whether a drug is unaffordable or when to implement a price cap. Third, the company alleged that PDAB violated the Supremacy Clause through the authorizing statute allowing PDAB to impose a payment limit that would apply to Medicare reimbursement. Fourth, the company argued that the statute’s regulation of transactions outside Colorado violated the Commerce Clause.

While Amgen’s actions have significant implications for the regulation of drug prices in Colorado, the lawsuit will be closely watched by states that have created similar boards or are contemplating doing so in the future. As of late 2023, nine states have passed legislation to create similar drug pricing boards, and other state legislatures have introduced more than 200 bills to create such boards. The attempts are designed to address the increasing cost of prescription drug prices but vary in their methods. Some, such as Colorado, allow for the establishment of upper payment limits to directly control the prices of what they deem to be unaffordable drugs, while others are only authorized to make recommendations to the state’s legislature. Colorado’s board is also notable in the sense that it can exert authority over commercial health plans, not just state health plans. In addition to varying levels of authority, the Commonwealth Fund noted that other important considerations in how the boards are structured have included ensuring a sustainable funding source, how members of the board are appointed, and the board’s ability to access data on the drugs it reviews.

The economic and legal outlook for Colorado’s attempt to rein in drug prices, and those of its fellow states, remains uncertain. Due to many states being in the early stages of the review process, it may be a while before policymakers and stakeholders get a good sense of whether these boards can create downward pressure on prices.

Similarly, the legal outlook for these boards remains clouded as well. Scholarly publications have noted the relatively novel legal issues that these boards present to the courts, with the only clues in a healthcare context provided dating back to a related Maryland effort. In 2017, the United States Circuit Court of Appeals for the Fourth Circuit struck down Maryland’s attempt to prohibit certain price increases on the grounds that the statute interfered with the federal government’s authority to regulate interstate commerce.

Amgen’s lawsuit in the District Court for Colorado will likely provide more clues as to whether these latest attempts to broaden access to unaffordable prescription drugs will present a viable and legal tool to lower prices. Regardless, it is clear that solutions, be they federal, state, or otherwise, are urgently needed to address what can only be called a crisis of affordability for drugs that provide life-changing results to patients across the country.

Four years since the beginning of the COVID-19 pandemic, experts are already planning for the next one. In addition to strengthening disease detection systems, pandemic preparedness should prioritize improving the condition of rental housing in the U.S. to eradicate health disparities and better position the tenant population to weather the coming virus.

Black patients are hospitalized for COVID-19 at a rate three times higher than White patients. For Hispanic patients, this number is four times higher. Native American patients are twice as likely to die of COVID-19 than White patients, and across all races, Asian patients face the highest relative risk of hospitalization and death. Social determinants of health, including transportation, education, and employment, provide a partial explanation for these disparities. But one of the most important social determinants of health is housing. Specifically: who has it, and what it looks like.

Through 2020 and 2021, even with a federal moratorium on evictions and a concomitant decrease in filings, evictions were still happening across the country. We now know these evictions were associated with increased infection and death rates, and that most tenants who were evicted were people of color, particularly Black and Latinx renters. In some cities, homeless mortality rates due to COVID-19 were 75% higher than the mortality rates of housed people, and most experts contend that homeless deaths were vastly undercounted. But even for tenants who remained housed, the threat of COVID-19 did not disappear, because it was in their homes.

In addition to facing a higher rate of evictions, renters of color are disproportionately impacted by poor housing conditions. Substandard housing can include asbestos, peeling lead paint, and rodent infestations, to name just a few. The health impacts of these conditions are pervasive and severe. Mold can produce allergens and exacerbate preexisting conditions such as asthma. Poor ventilation can increase exposure to smoke and is associated with higher mortality rates. Even the stress of living in an uninhabitable home is tightly linked to poor mental health, particularly for low-income women. Experts estimate that more than 4 million children across the U.S. live in substandard housing, thereby exposing them to illnesses that could determine their health for the rest of their lives.

The health conditions created by substandard housing, including poor respiratory capacity, impeded the ability of low-income renters to survive COVID-19. Across the country, counties with a higher percentage of households living in poor conditions also had higher incidence and mortality rates due to COVID-19. Looking ahead, the combination of substandard housing and Long COVID is potentially deadly. The pandemic pushed an already splintering healthcare system to its breaking point, such that there are now fewer physicians available to study and treat Long COVID and its nebulous impacts, even though the disease is estimated to affect almost 7% of the adult U.S. population. If the healthcare system is to survive the next pandemic, it must prioritize treating lingering respiratory conditions such as Long COVID, especially among low-income renters of color.

Improving housing conditions should be a top priority for policymakers seeking to improve U.S. pandemic preparedness. Tenant advocates and attorneys have long pushed for stricter enforcement of housing codes and common law standards like the implied warranty of habitability, which grants many tenants the contractual right to live in a home that is inherently suitable for human habitation. Some have even argued that enforcing a warranty of habitability would place downward pressure on rents and thereby save renters money at the expense of slumlords.

In the wake of 2020, which saw an unprecedented explosion of popular support for renters’ rights, policymakers should capitalize on this political moment. Not only will strengthening habitability standards create safer homes, it will also reduce health disparities across race, class, and gender, thereby better preparing vulnerable communities to defend themselves against the next virus.

The use of psychedelic substances to heal the mind and body is anything but new. For millennia, Indigenous peoples across the globe have used plants with psychedelic properties for “medicinal, ceremonial, and divinatory purposes.” However, Western medicine has been slow to embrace psychedelics and psychedelic-assisted psychotherapy (PAP).

The United States’ Tense History with Psychedelics

Psychedelics are psychoactive substances defined by their ability to induce altered states of consciousness, including changed or enhanced sensory perception, cognitive process, and mood. Common psychedelic substances include lysergic acid diethylamide (LSD), psilocybin (aka, magic mushrooms), 3,4-methylenedioxymethamphetamine (MDMA), dimethyltryptamine (DMT), ketamine, ayahuasca, ibogaine, and mescaline (the active compound in the peyote plant).

The United States started researching potential therapeutic uses of psychedelics in the mid-twentieth century. Between the 1950s and 1970s, researchers administered psychedelics like LSD and psilocybin to thousands of patients to treat conditions like addiction, depression, anxiety, and end-of-life distress. However, research came to an abrupt halt when President Nixon signed the Controlled Substances Act and categorized psychedelics as Schedule 1 drugs, declaring they had no acceptable medical use and had a high potential for abuse. This Act started the infamous war on drugs and stilted scientific research on the therapeutic uses of psychedelics. These substances remain classified as Schedule 1 drugs and it is still a felony for individuals to possess or use these substances.

The Re-Emergence of PAP in the United States

Inspired by the national wave of successful measures to legalize cannabis for medical and/or recreational use, psychedelics have recently made a comeback. Recognizing the positive effects of psychedelic drug use on treating depression, anxiety, substance use disorders, and post-traumatic stress disorder (PTSD), advocates are successfully changing the conversation about PAP becoming an accessible treatment option.

Across the country, one psychedelic substance is making localized headway at an impressive speed: psilocybin. In May 2019, Denver, Colorado became the first city to decriminalize psilocybin. This opened the floodgates for states and localities to embrace similar policy changes or authorize work groups to research possible medical use. However, the movement did not stop at decriminalization or work groups. Two states have taken significant strides to make PAP accessible within their borders: Oregon and Colorado. 

The Oregon Model

In November 2020, Oregon became the first state in the Country to legalize PAP when voters approved Ballot Measure 109, (now codified as ORS 475A), authorizing the Oregon Health Authority (OHA) to create a program permitting administration of psylocibin-producing mushroom and fungi products to persons at least 21 years of age. Importantly, the law allows anyone over 21 to self-select to receive treatment without requiring a prescription, medical referral, or proof of state residence.

The Colorado Model

In November 2022, Colorado voters passed Proposition 122, which adopts a framework similar to Oregon’s and establishes a regulatory structure and timeline for other psychedelics, including DMT, ibogaine, and mescaline, to be considered for decriminalization and use for PAP. This would further revolutionize access to PAP as it means that people seeking treatment could select the psychedelic substance they believe is best for them.

Will This Boom Also Bust?

With broad public support, the DEA and FDA on board with permitting research on psychedelic substances, and with the worsening mental health crisis in the United States, it is unlikely that the current state-led shroom boom will bust. While there will undoubtedly be legal battles over patents, inequitable access to treatment, and a need for more training for therapists, facilitators, physicians, nurses, and social workers, the nation can look to Oregon and Colorado to assess the benefits of PAP in real time. 

In February 2020, Dominic Trumbo, a patient recruiter based out of Lexington, Kentucky was sentenced to 60 months in prison for receiving over $1 million in illegal kickback money from several home health agencies throughout the nation in exchange for information on Medicare beneficiaries. Trumbo instructed his employees to cold-call Medicare beneficiaries and offer incentives to get them to sign up for home health care. Trumbo then sold the Medicare beneficiary information to home health agencies around the country in exchange for illegal kickback payments. The evidence at trial further showed that Trumbo and his co-conspirators went to great lengths to conceal their scheme to defraud Medicare, creating sham contracts and fake invoices to cover their tracks. 

The Anti-Kickback Statute (AKS), enacted in 1972, is the criminal law that took down the Trumbo empire. The AKS prohibits the “knowing and willful payment” of so-called “remuneration” (essentially gifts; such as free rent, expensive hotels, meals, etc.) to induce and/or reward patient referrals. Criminal penalties for violating the AKS include large fines, prison time, and exclusion from participation in federal health care programs. The government need not even prove patient harm or financial loss to programs to prove a violation of AKS; taking money or gifts from medical sales companies, for example, can land physicians in serious trouble. Kickbacks can lead to overutilization, increased costs of healthcare services, and corrupt medical decision-making, steering patients away from medically valid services and/or therapies and unfair service delivery.

In December 2023, Community Health Network Inc., based out of Indianapolis, Indiana, was required to pay $345 million in a settlement to resolve allegations that it violated the False Claims Act by knowingly submitting claims to Medicare for services that were referred in violation of the Stark Law. The U.S. government alleged that the scheme began in 2008 when Community Health Network began to recruit physicians for employment for the purpose of capturing their “downstream referrals.” Over the years, Community Health Network successfully recruited hundreds of local doctors, in an array of specialties, by paying salaries significantly higher than market-rate at their own practices. 

The Physician Self-Referral Law, also commonly referred to as the Stark law, was first enacted in 1992 to limit the financial relationships that physicians may enter into, Stark further expanded in 1995 to encompass the “designated health services” (DHS) that patients receive. The DHS refers to the health facility or institution that performs services such as occupational therapies, clinical laboratory testing, radiology services, medical equipment, inpatient hospital services, outpatient prescription services, or home health services. The Stark law broadly seeks to prevent doctors from referring patients to the DHS if there is a financial relationship present between the physician and the healthcare entity, their immediate family member, and the healthcare entity. 

            On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released a final rule in hopes of modernizing and clarifying the regulations that interpret Stark law which has not been significantly updated since 1995. According to CMS, the final rule notes that “for the first time, the regulations will support the necessary evolution of the American healthcare delivery and payment system.”  Using this final rule, in 2022, CMS settled a record-breaking 104 Stark law self-disclosures, which totaled over $9.2 million, almost quadruple the 2021 settlements. 

Henry Ford Health is an integrated healthcare organization based in Michigan, and in an ongoing federal court case, Sparks v. Henry Ford Health System et al., the organization was sued for alleged disability discrimination in violation of the Patient Protection and Affordable Care Act (ACA).

The Plaintiff in this case, Kerri Sparks, is a frequent patient of one of the organization’s hospitals and requested an in-person interpreter for an upcoming pre-surgery education class since she is deaf and can only communicate through American Sign Language (ASL) and by lip reading. Due to a clerical error, the hospital’s in-person ASL interpreter was unavailable, so the hospital deployed a Video Remote Interpreter (VRI). Due to connection issues, Sparks was left without an interpreter. Sparks was given a printout of the information covered in the class and the instructor wore a clear face shield so that Sparks could lip read, but despite these efforts, Sparks was unable to understand what the instructor was saying and left the class confused about her upcoming surgery.

Despite Sparks’ request for an interpreter on the day of her surgery, the hospital failed to provide one. Although not fluent in ASL, the hospital had Sparks’ boyfriend interpret for her, leaving Sparks once again confused and unable to communicate with staff regarding her surgery.

Section 1557 of the Affordable Care Act prohibits “discrimination on the basis of race, color, national origin, sex, age or disability in a health program or activity, any part of which is receiving Federal financial assistance.” Congress implemented this provision with the understanding that discrimination in healthcare settings can contribute to disparities, especially when it results in a patient being unable to comprehend the nature and consequences of the healthcare services being provided to them. Section 1557 stipulates that healthcare providers receiving federal financial assistance, like Henry Ford Health, must “take appropriate steps to ensure that communications with individuals with disabilities are as effective as communications with others in such programs or activities.”

The U.S. District Court in the Eastern District of Michigan found there to be genuine issues as to whether the hospital provided Sparks with the auxiliary aid necessary to ensure effective communication for surgery and was unable to resolve this question on summary judgment. The parties have yet to settle and are moving towards trial.

Deaf patients like Sparks experience significant health disparities and are at an increased likelihood of experiencing inadequate communication with doctors and other medical staff. It is estimated that there are around 500,000 to one million deaf users of American Sign Language (ASL) in the United States, and many of whom have experienced interpreter-related barriers to healthcare services. Deaf patients are more likely to experience misunderstandings and a lack of communication when sign language interpreters are not provided to them because only a small percentage of deaf patients who use ASL have to opportunity to directly communicate with their healthcare providers.

The lack of ASL interpreters in healthcare settings is a persist issue and will continue to disadvantage the deaf community until such needs are met. Patient-provider trust relationships and effective communication have been shown to result in positive health outcomes in patients, but when ASL interpreters are either not provided or are insufficient, there is an increased likelihood that the relationship between deaf patients and their providers will be negatively impacted. To protect patients like Sparks and ensure that they are provided with the necessary information to make informed decisions about their health, medical schools should consider implementing a Deaf Health Pathway (DHP) seminar. During DHP seminars medical students shadow medical interpreters to learn the intricacies of interpretation. Through DHP, medical students learn basic ASL and grammar before progressing to learning how to communicate with deaf patients themselves. DHP immerses students in ASL and deaf culture so that America’s future doctors can bridge the gap in care for deaf communities across the country. Although DHP seminars are currently in the early stages of development and studies are needed to explore the long-term outcomes of such programs, DHP seminars might be a solution for the lack of ASL interpreters in the healthcare industry. 

Transgender individuals’ access to gender-affirming care is increasingly under attack. In response, various states are protecting access to gender-affirming healthcare through shield laws. While shield laws vary by state, the laws have two primary goals: (1) to protect transgender individuals, their families, and their medical providers against such attacks and (2) to protect access to gender-affirming health care. For instance, if an individual travels from a state where gender-affirming healthcare is banned and receives that care in another state, a shield law can protect the recipient and/or provider of that healthcare against civil or criminal charges from the state where healthcare is banned.

Currently, the makeup of shield laws in the United States is as follows:

• 11 states and the District of Columbia have shield laws protecting access to gender-affirming healthcare,
• 3 states have a shield executive order protecting access to gender-affirming healthcare,
• 36 states and 5 territories have no shield law or policy protecting access to gender-affirming healthcare, and
• 24 states have state bans or restricts gender-affirming healthcare for transgender youth.

In 2022, California passed SB 107, a shield law protecting families of transgender youth under 18 from being criminally prosecuted if they travel to California with their children to obtain gender-affirming healthcare. On Tuesday, March 26, 2024, Sacramento, California, the state’s capital, took that protection one step further: the Sacramento City Council unanimously approved a resolution to protect transgender individuals by declaring the City of Sacramento a sanctuary city. As the City of Sacramento is already a sanctuary city for immigrants, transgender individuals would receive the same protections as immigrants— that no city resources would be used to detain individuals seeking gender-affirming healthcare or cooperate with other jurisdictions to enforce their laws criminalizing gender-affirming healthcare.

The Sacramento City council proclaimed the City as a sanctuary city in preparation of “future legislation that may criminalize those providing or seeking gender-affirming care” as well as its values of equity and inclusion: “It is important for the City of Sacramento to be proactive in reiterating our commitment to transgender rights and equal protections for transgender [individuals] by declaring ourselves a sanctuary city and a place of safety for transgender [individuals]. This resolution would also resolve to ensure the rights of transgender individuals in Sacramento are upheld.”

Sacramento City Councilmember Katie Valenzuela celebrated Sacramento’s adoption of the resolution. Valenzuela posted on X, formerly Twitter, that “[b]y affirming [Sacramento’s] commitment to supporting [the] LGBTQ+ community and ensuring that no city resources or staff time will be used to help enforce these harmful laws in other jurisdictions, the City has taken a step beyond state law and sent a powerful signal to everyone in our community that we are a safe place for everyone.”

Adopting the resolution did not impact the City in any way; it only helped the City. The resolution did not have any financial impact, and it simply guaranteed that none of the City’s resources will be used to enforce laws to restrict access to gender-affirming health care for transgender individuals. As the resolution will better everyone’s lives and has no negative ramifications for the City, other cities and states should adopt similar resolutions deeming their cities or states as sanctuary cities.