Category: Blog

Earlier this month, a Texas judge granted an injunction to halt a New York doctor, Margaret Daley Carpenter, from prescribing and sending medication abortion pills to patients in Texas and imposed a $100,000 fine. The case is the first known to openly challenge an abortion shield law, passed by eighteen states and the District of Columbia in response to the Supreme Court striking down Roe v. Wade in 2022, and is expected to make its way to the highest court.

Dr. Carpenter is a reproductive health specialist based in New Paltz, New York, and co-founder of the Abortion Coalition for Telemedicine, which advocates for providing access to abortion medications in all 50 states. In December, Texas Attorney General Ken Paxton charged her with violating Texas law by providing two abortion medications (mifepristone and misoprostol) by mail to a 20-year-old woman in Texas that resulted in a medical abortion. Dr. Carpenter, who is facing similar charges in Louisiana, has not appeared in court in Texas, resulting in the judge declaring a default judgment in favor of the State. Instead, she is relying on the State of New York’s Abortion Shield Law to protect her from any punishment the State of Texas may try to exact from her activities. 

Abortion shield laws are designed to protect providers and patient medical records from civil and criminal consequences from assisting out-of-state patients with abortions, such as extradition, subpoenas, or medical records requests. Championed as a way to circumvent red-state abortion restrictions, pro-choice groups such as the Center for Reproductive Rights have proposed shield laws as the best solution to maintaining access to abortion care nationwide. Red states such as Texas, argue that these laws erode their state sovereignty and go against the full faith and credit clause of the Constitution, which requires states to honor the final judgments of courts in other states. Additionally, it is undisputed that the laws go against long-standing precedent of interstate cooperation and sharing of information. New York will likely argue that Texas has no jurisdiction over New York providers and Texas cannot get the assistance of the New York courts because of the shield law. 

Despite stringent restrictions imposed on abortions in the wake of the Dobbs decision, it is estimated that more than 10,000 pills per month are sent to women in states with bans. If shield laws are found to be unconstitutional, it could be the final nail in the coffin for abortion access in much of the country, and abortion providers acting under the protection of these laws could find themselves in legal jeopardy.

On February 3^rd, New York Governor Kathy Hochul signed into law a bill adding an extra layer of protection for providers, beyond their initial shield law, by allowing pharmacies to print a practice’s name on pill bottles rather than the prescriber’s. The Governor reiterated she would stand firm with abortion care providers and would not sign off on any extradition orders. The move seemed to signal that the State of New York will not give way to Texas or any other state’s demands, and they will see Attorney General Paxton in court.

Considering recent declines in research grants, the federal scientific workforce, and public access to research, the future of medical innovation is uncertain. However, even before these challenges arose, there were already parts of the system that limited progress. 

One problem is that pharmaceutical patents held by large drug manufacturers limit generic drug production. This is because a generic drug maker cannot apply for a generic drug approval if the brand name drug is still patented. The Food and Drug Administration will not approve a generic drug that infringes on an approved brand drug. 

One of the issues is that the FDA generally avoids getting involved with drug patents. The FDA publishes the Orange Book, in which it collects all the drugs it approves and their active patents, but these patents are reported by the pharmaceutical companies that hold them. While the FDA will ensure that all patents directly related to the drug or its method of use are published, the agency generally does not check or remove any other reported patents. The FDA’s role in Orange Book patent policing is “purely ministerial.” 

This can become a problem because many large pharmaceutical companies do not only patent the active ingredient and method of use of a drug; they usually build patent thickets. These are overlapping patents for the same drug that expire at different times; sometimes more than twenty years after the first patent related to a drug is filed. Pharmaceutical companies reported these additional patents to the FDA alongside the active ingredient and method of use patents. 

In the last two years, the Court of Appeals for the Federal Circuit has addressed some of this excessive reporting. In 2023, the Federal Circuit held in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC. that only drug and method of use patents, as narrowly defined by patent law, should be listed in the Orange Book. In December 2024, the Federal Circuit held in Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC. that these drug and method of use patents must specifically claim the active ingredient in the approved drug, and the approved drug product must infringe on the listed patents. A drug product includes the drug substance (active ingredient) and any other substance used to make the finished administrable medicine. In both cases, the court ordered the FDA to delist other patents they listed in the Orange Book. 

Overall, if drug developers are limited in the patents that they can list in the Orange Book, then the FDA is less likely to refuse to approve a generic drug because this approval would infringe on a listed patent. This would remove one hurdle to generic drug approval and allow more of these accessible drugs to enter the market. Of course, given the complexity of drug patenting, it is unclear how useful these changes will be. 

Telehealth, health care through technological services, has been an increasingly used form of care since the COVID-19 pandemic when digital health care became increasingly necessary to limit in-person interactions. Telehealth is conducted completely online and, therefore, has the potential to be revolutionary for disabled folks who would benefit from the convenience of a digital platform. The digital aspect of telehealth would allow patients to avoid barriers to accessibility that come with in-person appointments, such as issues like transportation and mobility or the need to avoid potential exposure to communicable diseases.

While patients could avoid the barriers to in-person care through telehealth, telehealth has proven to come with digital barriers of its own, largely stemming from a lack of digital accessibility. Telehealth, in theory, would expand access to health care for disabled individuals. In practice, telehealth has not realized its potential because of the inequities associated with online access, such as website inaccessibility. This has resulted in an increasingly inequitable healthcare landscape, where disabled people continue to bear the brunt of systemic inaccessibility. The health care costs are higher for disabled folks with intersecting identities, whereas disabled Black and Latino folks are more likely to suffer from poor health outcomes.

Telehealth is usually inaccessible for several reasons that the Department of Justice (DOJ) has outlined, including poor color contrast, use of color alone to give information, lack of text alternatives on images, no video captions, inaccessible online forms, and mouse-only navigation. In an age where access to information and health services is a health determinant, inaccessible internet access is unacceptable. Digital accessibility is a civil rights issue.

While the Americans with Disabilities Act (ADA) does not explicitly discuss digital accessibility, courts have interpreted Title II of the ADA, a section on discrimination based on disability by state and local governments, to include protecting digital accessibility. This precedent supports protecting digital accessibility for government healthcare agencies. Despite this precedent, legislative action should establish enforceable website accessibility requirements under Title II.

Title III of the ADA, which discusses private businesses and public accommodations, is less resolved when it comes to its protections on website accessibility, creating a lack of uniform protections. Some courts have held that telehealth platforms are places of accommodation, meaning that they fall under ADA requirements of protection, but others have found that they do not qualify. Protections for disabled folks are therefore different by location and private telehealth services can have digital accessibility barriers without consequence. Because Title III lacks enforceable digital accessibility standards, these barriers remain unaddressed.

Given that telehealth is an increasingly relevant mode of healthcare, we should advocate for improved access to its services for everyone by enshrining digital accessibility into the ADA. The exclusion of disabled folks through digital barriers is unacceptable when they are a group that could benefit the most from its benefits. Disabled folks already disproportionately receive less health care because many are disproportionately below the poverty line, making payment impossible, and face issues with accessible in-person services, transportation, and communication. Making healthcare access more difficult by not improving accessibility in all spaces, including digital spaces, leads to more negative outcomes for disabled people, especially for disabled people with intersecting identities. Without stronger enforcement of compliance with digital accessibility guidelines, disabled patients will continue to face digital barriers to healthcare.

Health inequities affecting people with disabilities remain a persistent and often overlooked issue within the U.S. healthcare system. Despite efforts to make healthcare more inclusive, provider biases and financial challenges continue to prevent millions from receiving equitable care. With recent policy pushes for broader health equity, now is the time to address the unique needs of this population.

Provider bias and a lack of training on disability-specific care create another layer of inequity. Many healthcare providers have limited knowledge of the unique healthcare needs and challenges faced by people with disabilities. The National Council on Disability (NCD) reports that these gaps in provider training lead to miscommunication, inadequate treatment, and a lack of understanding about the disabilities themselves. This can result in healthcare providers making assumptions about patients’ quality of life or failing to take complaints seriously, impacting the overall quality of care. Addressing these biases is crucial to ensure that providers offer compassionate, informed care that respects everyone’s needs.

Individuals with disabilities often encounter significant financial challenges that impede access to necessary healthcare services. These challenges stem from increased medical expenses, limited employment opportunities, and systemic economic disparities. A comprehensive report by the Financial Health Network reveals that nearly half (46%) of working-age individuals with disabilities have unmanageable levels of debt, and only 51% can pay all their bills on time. This financial instability is exacerbated by the fact that people with disabilities are more likely to live on low incomes. The National Disability Institute reports that 45% of working-age individuals with disabilities have annual household incomes under $30,000, compared to 21% of those without disabilities. Public safety net programs, such as Supplemental Security Income (SSI) and Social Security Disability Insurance (SSDI), are intended to support individuals with disabilities. However, only about a third of working-age individuals with disabilities receive these benefits. Even among those with low incomes and significant barriers to employment, many do not receive the assistance they need. These financial barriers not only limit access to healthcare but also contribute to a cycle of poverty and poor health outcomes. Addressing these challenges requires comprehensive policy interventions aimed at improving employment opportunities, enhancing public benefits, and reducing the additional costs associated with living with a disability.

Recent policy efforts seek to address these disparities, but much work remains. The Americans with Disabilities Act (ADA) laid an essential foundation for disability rights, yet it does not mandate comprehensive healthcare accessibility or provider training. The National Council on Disability’s 2024 Progress Report recommends that policymakers enhance provider training in disability care, increase funding for facility accessibility improvements, and expand Medicaid and Medicare services to cover a broader range of disability-specific needs.

Ensuring health equity for people with disabilities will require more than incremental improvements; it demands systemic change. Addressing physical, educational, and financial barriers within the healthcare system is crucial. By pushing for stronger policies, comprehensive training, and expanded financial support, we can bridge the gap and create a healthcare system that serves everyone equally. Ongoing advocacy and reform are essential to ensure that all individuals, regardless of disability, receive the quality care they deserve.

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. 

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.