ADA & HIV Legal Protections

The fight for disability rights has been long and arduous, marked by significant milestones and persistent challenges. For people living with HIV (PLWH), this struggle intersects with ongoing battles against stigma, misinformation, and discrimination. While legislation like the Americans with Disabilities Act (ADA) has provided important protections, achieving true equality and inclusion demands vigilance and robust, consistent enforcement.

Systemic barriers often obstruct PLWH from educational opportunities and professional fulfillment. Take Robin Dugas, a cosmetology student in Arkansas. Despite being fully qualified, she was denied her license by the Arkansas Board of Cosmetology solely because she disclosed her HIV-positive status. This blatant discrimination, challenged by Dugas and the ACLU, exemplifies the ingrained stigma PLWH continue to face.

The ADA guarantees equal opportunity and prohibits discrimination against people with disabilities, including PLWH, recognizing that HIV, even in asymptomatic stages, can limit major life activities. However, as Dugas' case shows, legal protections alone don't ensure lived equality. PLWH still face stigma and discrimination, especially in healthcare, employment, and access to services.

The emergence of HIV in the 1980s led to widespread fear, misinformation, and discrimination, affecting marginalized communities and resulting in societal rejection, job loss, and denial of healthcare.

In response, the ADA was passed in 1990, marking a turning point against HIV discrimination by recognizing people with HIV as having a disability. This ensures their right to equal opportunities in employment, public accommodations, housing, essential services, and as we have seen recently, the justice system. The ADA’s impact was solidified in the Supreme Court case Bragdon v. Abbott (1998), where the Court ruled that even asymptomatic HIV qualifies as a disability. This decision underscored that discrimination based on HIV status is unlawful and affirmed the rights of PLWH.

The ADA as a Tool for Change

The ADA requires ongoing interpretation, enforcement, and adaptation. Recently, the U.S. Department of Health and Human Services (HHS) updated Section 504 of the Rehabilitation Act to strengthen protections against disability discrimination, particularly relevant to PLWH. Research shows that healthcare professionals sometimes harbor biases against PLWH, leading to a lower standard of care and poor health outcomes. The updated rule directly combats this by explicitly prohibiting discrimination in medical treatment decisions based on biases, stereotypes, or judgments about the value of life based on disability. Healthcare providers cannot deny, delay, or provide lower quality care to PLWH simply because of their HIV status.

Additionally, this update mandates accessibility for websites and mobile applications and works to ensure equal access for people with disabilities, including providing sign language interpreters and accessible medical diagnostic equipment, such as exam tables and mammography machines.

These updates enhance the legal framework to hold healthcare providers accountable for discriminatory practices and empower patients to advocate for their rights. As HHS Office of Civil Rights Director Melanie Fontes Rainer stated, “By removing barriers to healthcare and social services, this rule advances justice for people with disabilities who have for too long been subject to discrimination.”

Persistent Challenges: Evidence of Ongoing HIV Discrimination

Despite ADA protections, many PLWH still face discrimination. Recent cases and public health data highlight the need for robust ADA enforcement, education, and state-level policy reforms.

A 2021 UNAIDS fact sheet showed that in 7 out of 11 countries surveyed, 21% of PLWH were denied healthcare in the past year, and over 50% experienced job loss due to HIV-related discrimination. These findings highlight the global scope of the problem.

The ViiV Healthcare Positive Perspectives survey (Wave 1) found that 39% of respondents experienced institutional stigma, including denial of jobs, visas, health services, or education. Nearly a quarter worried that their HIV status would negatively impact their relationship with their primary care provider.

These data emphasize the need for interventions addressing HIV stigma and discrimination, particularly those intersecting with race, gender identity, and socioeconomic status. Legal protections like the ADA are essential but must be supported by enforcement, public education, and efforts to dismantle systemic barriers. Indeed, the necessity of robust enforcement and education becomes apparent when examining real-world incidents where these protections falter.

Case Study: Tractor Supply Company

In 2024, Tractor Supply Company settled a lawsuit filed by the Equal Employment Opportunity Commission (EEOC) for $75,000 on behalf of a Mississippi woman with HIV. The manager disclosed her HIV status to coworkers and then fired her after she complained about the resulting harassment. The woman endured verbal abuse and discriminatory treatment from colleagues fearing HIV transmission. The EEOC argued that Tractor Supply failed to protect her from a hostile work environment and retaliated against her for reporting the discrimination.

Marsha Rucker, a regional attorney for the EEOC, stated, “Tractor Supply Company created and maintained a hostile work environment for this employee by publicizing her private medical information and then failing to address the harassment this generated. Rather than protect this employee from harassment, the company fired her.” This case highlights the vulnerability of PLWH to workplace discrimination, even with clear legal protections.

Case Study: Tennessee’s Aggravated Prostitution Law

The criminal justice system can also be used as a tool of discrimination. The lawsuit OutMemphis v. Lee, brought by OutMemphis, the ACLU, and the Transgender Law Center, challenges Tennessee’s aggravated prostitution statute under the ADA and the U.S. Constitution. This ongoing case highlights how such laws disproportionately target and punish PLWH, effectively barring them from various social, employment, and housing opportunities due to the requirement to register as sex offenders.

Parallel to this, the Center for HIV Law and Policy (CHLP) submitted complaints to the Department of Justice (DOJ) which launched its own investigation, focusing on the discriminatory enforcement of the aggravated prostitution statute in Shelby County. The DOJ’s investigation found that the state and the Shelby County District Attorney’s Office violated Title II of the ADA by subjecting people living with HIV to harsher criminal penalties solely because of their HIV status.

When asked about the strategy to challenge the aggravated prostitution statute, Jada Hicks, staff attorney with CHLP’s Positive Justice Project explained, “if a person is accused of being a sex worker… that's a misdemeanor charge. If they then find out that they're HIV positive, it's a felony. That's it. That's all it takes. That is the most clear violation of the ADA that I can think of. It’s the perfect example of how you can violate the ADA based on someone's health status.”

The impact of this legal challenge has been profound, resulting in a landmark settlement agreement and a major win in the fight against HIV criminalization. This case marked the first time the ADA has been successfully used to challenge and dismantle such a law. Sean McCormick, a staff attorney at CHLP, highlighted the significance of this achievement: "This really reflects a tremendous milestone in this fight to use the ADA to attack HIV criminalization [as it] represents the first tangible, concrete change to laws, policies, practices that promote and enable HIV criminalization." There are currently 10 other states with similar aggravated prostitution laws that could be impacted by the Tennessee case, underscoring the broader potential for reform and the importance of strategic advocacy to address these unjust laws on a national scale.

In apparent backlash to these legal actions, Tennessee passed an amendment that expands the offense of aggravated rape to include cases where the defendant, knowing they are infected with HIV, commits rape and transmits the virus to the victim. This amendment, enacted in May of 2024, reflects ongoing legislative efforts that may further stigmatize and criminalize PLWH, highlighting the need for vigilant advocacy and legal challenges.

McCormick reflects on the role of HIV criminalization laws in oppressing marginalized groups, "the Tennessee experience with aggravated prostitution really speaks to the way that HIV criminalization continues to oppress marginalized folks... these laws are used as a way to target marginalized communities, particularly black trans and cisgender sex workers."

Hicks adds, "People who sit at the intersection of multiple identities are at an increased risk of interacting with the criminal legal system. For instance, if you're black, trans, inject drugs, and you're an immigrant, it's just increasing your chances of having an interaction with the carceral system."

This case serves as a potent example of how the ADA can be utilized to challenge similar laws in other states. As McCormick points out, "The most obvious translation is other states with very similar sentences and sentence enhancements for people who are convicted of aggravated prostitution." CHLP is actively working with advocates in states like Ohio and Pennsylvania to replicate the success achieved in Tennessee.

The Need for State-Level Reform

While federal laws like the ADA provide crucial protections for PLWH, as we have seen, state-level laws remain inconsistent and often inadequate. This patchwork of protections creates confusion and vulnerability, as PLWH may face different consequences depending on their state. Outdated HIV criminalization laws and sentence enhancements are still on the books in 30 states, highlighting the ongoing need for state-level advocacy and reform.

Realities Facing PLWH:

• Indiana: Indiana has HIV-specific criminal statutes that classify nondisclosure of HIV status to sexual partners, needle-sharing partners, or exposure to bodily fluids as felonies or misdemeanors. These laws discourage HIV testing and disclosure, perpetuating stigma and discrimination. Additionally, these statutes do not account for modern medical understanding of HIV transmission, leading to potentially unjust legal consequences.

• Tennessee: Despite removing aggravated prostitution as a "violent sex offense" requiring sex offender registration, Tennessee maintains the aggravated prostitution offense. This law penalizes PLWH harshly for consensual sex work, disproportionately affecting those who are already marginalized by race, gender identity, poverty and other intersectional social determinants.

• Louisiana: Louisiana's HIV-specific laws are particularly concerning. The state's broadly written statute criminalizes "intentional" exposure to HIV through sexual contact, even without transmission risk. The law's failure to define "intent" leaves interpretation to law enforcement and prosecutors, discouraging open communication about HIV status and leading to potential prosecutions without intent to harm. No actual transmission is required for conviction, meaning PLWH can be prosecuted for behaviors like spitting, biting, or consensual sex with a condom. The Center for HIV Law and Policy's analysis highlights how Louisiana courts have interpreted "sexual contact" broadly, allowing subjective enforcement and encompassing acts with no risk of HIV transmission.

The journey toward equality for people living with HIV (PLWH) has seen notable achievements, such as the protections offered by the Americans with Disabilities Act (ADA), yet it remains hindered by ongoing stigma and discrimination. Despite legal safeguards like the ADA, real-world equality requires consistent enforcement and proactive advocacy.

Discrimination in healthcare, employment, and through punitive laws like Tennessee’s aggravated prostitution statute highlights the significant challenges PLWH face. These laws disproportionately affect those at the intersection of multiple marginalized identities, making the vigorous application of the ADA across states crucial. The updated Section 504 of the Rehabilitation Act by the U.S. Department of Health and Human Services (HHS) is a step forward, ensuring that biases in healthcare and other services do not undermine the rights of PLWH.

Looking ahead, it's essential to support litigation efforts, push for legislative reforms, and educate the public to dismantle systemic barriers. Organizations like the ACLU and CHLP play a critical role in this fight, but broader community engagement is vital for sustained change.

By enhancing ADA protections and advocating for their robust enforcement, we can transform societal attitudes and ensure that all individuals with HIV live dignified lives, free from prejudice. For more information, visit the Americans with Disabilities Act homepage and the Center for HIV Law and Policy.

Equitable and Data-Driven Viral Hepatitis Quality Measures

Viral hepatitis remains a significant public health threat in the United States, affecting approximately 3.3 million people with chronic hepatitis B and C infections. In 2021, there were 12,715 reported cases of chronic hepatitis B (HBV) and 117,105 reported cases of chronic hepatitis C (HCV). Despite the availability of effective treatments, these infections disproportionately impact marginalized communities, including people who inject drugs, those experiencing homelessness, and Black and Indigenous populations. This reality underscores the urgent need for a comprehensive and equitable approach to viral hepatitis care.

Recognizing this challenge, the U.S. Department of Health and Human Services’ (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) has issued a call for public comment on proposed viral hepatitis quality measures for Medicaid. This initiative, aimed at supporting the nation's goal of eliminating viral hepatitis by 2030, focuses on a crucial measure: hepatitis C screening and treatment initiation.

OIDP's call for public comment presents a critical opportunity to advance health equity, strengthen data-driven decision-making, and foster collaboration to accelerate progress towards eliminating viral hepatitis as a public health threat. Engaging in this process is essential for ensuring that the final measures effectively address disparities, improve care, and ultimately save lives.

The Landscape of Disparities and the Need for Action

The urgency for action is amplified by the significant disparities that exist in HCV care. Research consistently demonstrates that Black, Indigenous, and people of color, as well as those with lower socioeconomic status, face significant barriers to timely diagnosis and treatment. A study of Medicare beneficiaries found that while disparities in Direct-Acting Antiviral (DAA) use between Black and White patients narrowed by 2016, socioeconomic disparities persisted, with those receiving a Part D low-income subsidy less likely to access these life-saving medications. As the researchers noted, "DAA use among Medicare patients remained far below the level needed to eradicate HCV. The black-white gap in HCV treatment was closed by 2016, but disparities by patient socioeconomic status remained."

These disparities are deeply intertwined with social determinants of health. Factors such as poverty, limited access to healthcare, inadequate transportation, and low health literacy create significant obstacles to receiving quality HCV-related care. As one study aptly pointed out, "A variety of elements contribute to lower quality of care in rural areas, including shortages of medical equipment and services, poor health literacy, lack of transportation, and travel time and long distances."

Quality measures offer a vital tool for dismantling these barriers and fostering health equity. By tracking screening rates, treatment initiation, and outcomes across different populations, quality measures can illuminate where disparities exist and guide targeted interventions. They provide a data-driven framework for holding healthcare systems accountable for providing equitable care and for measuring progress towards eliminating viral hepatitis.

Analyzing the Proposed Measures

At the heart of OIDP’s proposal lies the HCV screening and treatment initiation measure. This measure, designed to track the percentage of Medicaid beneficiaries who receive both timely screening and treatment for HCV, is structured with a clear numerator and denominator. The numerator encompasses those Medicaid members who are screened for HCV and, if diagnosed, initiate treatment within a specified timeframe. The denominator includes all adult Medicaid enrollees within a defined age range, excluding those with evidence of Medicare or third-party insurance coverage.

This measure, viewed through an equity lens, holds immense potential for dismantling the barriers that prevent marginalized communities from accessing life-saving HCV care. By promoting universal screening, the measure encourages a proactive approach to diagnosis, reaching people who might otherwise remain unaware of their infection until they experience serious complications. Furthermore, the focus on timely treatment initiation is crucial for addressing disparities in treatment access. By tracking this metric, healthcare systems can be held accountable for ensuring that all patients diagnosed with HCV receive prompt and effective treatment, regardless of their background or socioeconomic status.

The transcript from HHS’s Viral Hepatitis Quality Measures Technical Consultation Meeting provides compelling insights into how similar measures have been leveraged at the state level to advance health equity. Dr. Su Wang, a clinician and advocate deeply involved in hepatitis care, shared her perspective, stating, "We really believe, those of us who have been doing this clinical work and also advocacy work, that quality metrics can really help us achieve hepatitis elimination by 2030." This sentiment is echoed by the experiences of states like Michigan, which has implemented a suite of HCV quality measures, including those focused on screening during pregnancy and medication adherence. These measures have not only helped Michigan track progress towards elimination but have also provided valuable data for identifying and addressing disparities in care.

Data Considerations

The success of this measure hinges on the feasibility of data collection and the robustness of the data sources used. While claims data, readily available through Medicaid programs, offer a practical starting point for tracking screening and treatment initiation, this source has limitations. Claims data primarily capture billing codes, which may not fully reflect the nuances of clinical encounters or capture social determinants of health that influence care access.

Electronic Health Record (EHR) data, on the other hand, hold a wealth of clinical information that can provide a more comprehensive picture of patient care. As noted during the technical consultation meeting, "There's a lot more information, digitally available through EHRs, health information exchanges, etc. that are readily available and allows us to get closer to real-time measurement and response." Leveraging EHR data could enhance the measure's accuracy and timeliness, enabling more rapid identification of disparities and interventions. However, widespread use of EHR data for quality measurement faces challenges, including variations in EHR systems, interoperability issues, and privacy concerns.

Additionally, capturing the influence of social determinants of health requires going beyond traditional clinical data sources. Integrating data from community organizations, social service agencies, and patient surveys could provide valuable insights into the social and economic factors that shape health outcomes. This multifaceted data approach, while complex, is essential for developing a truly equitable and effective hepatitis C quality measure.

Collaborative Action

The successful implementation of the HCV quality measure demands a collaborative approach that transcends traditional silos and brings together a diverse array of stakeholders. Public health agencies, Medicaid programs, healthcare providers, community organizations, and, most importantly, patients themselves must be actively engaged in the process.

The transcript from the technical consultation meeting showcases inspiring examples of collaborative action from states at the forefront of viral hepatitis elimination efforts. In Pennsylvania, the Department of Human Services (DHS) and the Department of Health (DOH) forged a strong partnership to drive their elimination plan, recognizing the critical role of Medicaid in reaching those most impacted by HCV. As Lauren Orkis, HBV supervisor at the Pennsylvania DOH, emphasized, "Our Medicaid partners are absolutely critical in our elimination planning efforts, statewide. So we made the partnerships strong between DHS and DOH in Pennsylvania from the get-go as we got our elimination plan underway."

Similarly, Washington State's Bree Collaborative, a legislatively mandated group focused on quality improvement for Medicaid, exemplifies the power of multi-stakeholder engagement. This collaborative, which includes representatives from various sectors, has been instrumental in developing and recommending quality measures for a range of health issues, including HCV. By bringing diverse perspectives to the table, these collaborative models foster innovation, ensure buy-in from key stakeholders, and pave the way for effective implementation.

Conclusion

OIDP's call for public comment on proposed viral hepatitis quality measures presents a defining moment in the fight against this silent epidemic. By engaging in this process, we have the power to shape measures that not only track progress but also drive meaningful change, reduce disparities, and improve the lives of millions. Let us seize this opportunity to advocate for equity, data-driven decision-making, and collaborative action.

Submit your comments, raise your voice, and join the movement to eliminate viral hepatitis. Together, we can ensure that quality measures become powerful tools for achieving health equity and creating a future where viral hepatitis is no longer a threat to our communities. The path to elimination is within reach, and quality measures, shaped by our collective voice, can light the way.

MPOX and Beyond: Reforming Emergency Response

The MPOX—a smallpox-related virus outbreak of 2022 served as a painful reminder that the United States remains alarmingly unprepared for public health emergencies. In the early stages of the outbreak, CANN highlighted the need for swift action and equitable responses to mitigate its spread and impact. However, mirroring the challenges experienced during previous crises, the response to MPOX was plagued by familiar, deeply concerning failures – sluggish testing rollouts, inadequate communication, and a failure to prioritize the needs of the most vulnerable. A recent Government Accountability Office (GAO) report examining the U.S. Department of Health and Human Services (HHS) underscores these recurring failings, emphasizing systemic and persistent weaknesses continue to jeopardize the nation’s response capabilities. New data from the Centers for Disease Control and Prevention (CDC) indicates a troubling resurgence of MPOX cases, with this year's infection numbers already close to double those seen in 2022. If we fail to heed the lessons learned from the MPOX response and the countless warnings that emerged throughout past outbreaks, we risk even greater health inequities and unnecessary suffering in the next inevitable crisis.

GAO Report Highlights Recurring Crisis Weaknesses

GAO’s report on the MPOX response offers a damning indictment of the nation's emergency preparedness, concluding that "persistent gaps" continue to undermine effective responses to public health crises. Among the most critical failures exposed by the report were severe delays in scaling up testing capacity and a lack of clear and consistent communication from HHS. The report emphasizes that "delays in testing capacity...limited the ability to understand the scope of the outbreak," hindering efforts to target resources and protective measures effectively. Similarly, the absence of a cohesive HHS communication strategy led to confusion and mistrust, ultimately slowing the rollout of vaccines, treatments, and preventative information needed to contain the spread. GAO's Mary Denigan-Macauley underscored this reality on the GAO Podcast: "So communication is key. Who's being infected by this?... They also needed to make sure that they knew exactly how much of the vaccine was coming, because we don't have an unlimited supply…Some officials said CDC's risk communication at the beginning of the mpox outbreak did not clearly identify those who were most at-risk for mpox (men who have sex with men) and the most common mode of transmission (sexual contact).”

The GAO report goes beyond the specific issues surrounding the MPOX response to stress the recurring nature of these problems. Notably, HHS faced challenges with delays in testing capacity, communication hurdles, and a lack of interagency coordination – problems that directly mirror those seen in previous public health emergencies. The GAO criticizes the lack of a centralized, coordinated approach: "HHS–as the designated lead for the federal public health and medical response to emergencies—does not have a coordinated, department-wide after-action program to identify and resolve recurring emergency response challenges." This lack of a cohesive strategy and failure to learn from previous outbreaks has grave implications, with the GAO warning that it "may affect the department’s ability to respond to future emergencies that could be more infectious and lethal than mpox."

Community Impacts

The systemic failures highlighted in the GAO report weren't merely abstract concepts; their consequences were acutely felt within affected communities. The podcast analysis we conducted amplified concerns related to the very same issues raised by the GAO. Speakers emphasized how access barriers and limited testing, particularly within marginalized communities, exacerbated the spread of MPOX. Additionally, the lack of clear and inclusive messaging perpetuated harmful stigma, causing significant delays in people seeking testing or treatment.

Failures during the MPOX response didn't affect everyone equally. CDC’s data reveals significant disparities in MPOX case rates along the lines of race, ethnicity, and gender. Hispanic/Latinx and Black/African American people were disproportionately impacted. Underscoring the urgency of addressing this disparity, the CDC highlighted the reality that: as of April 2023, 78% of Black persons and 75% of non-Hispanic American Indian or Alaska Native (AI/AN) persons remained unvaccinated against MPOX. The CDC further states, "Achieving equitable progress in JYNNEOS vaccination coverage will require substantial decreases in shortfalls among Black and AI/AN persons." These disparities underscore the inequities at the heart of the U.S. healthcare system and crisis response mechanisms. The MPOX outbreak is merely a symptom of this larger systemic failure, demonstrating how pre-existing disparities create vulnerabilities that worsen the impact of any public health emergency.

The Need for Reform

The GAO analysis goes beyond identifying the problems to offering concrete recommendations. To prevent these same systemic failures from hindering future public health responses, the GAO calls for two key changes:

• Coordinated After-Action Program: The creation of a department-wide after-action program within HHS that would systematically and centrally analyze the lessons learned from each crisis. This program would ensure a comprehensive and coordinated understanding of recurring problems, essential to developing effective solutions.

• Stakeholder Involvement: The GAO emphasizes the importance of including "relevant external stakeholders", in these after-action reviews. This inclusion of community voices, public health experts, and other critical partners would bring diverse insights into the analysis, ensuring that solutions are comprehensive and address the on-the-ground needs that can often be missed in a purely bureaucratic approach.

Key Takeaway: The GAO's analysis highlights that the failures during the MPOX outbreak aren't isolated incidents but symptoms of systemic weaknesses within the nation's emergency preparedness systems. Unless these weaknesses are addressed with coordinated reform, the nation remains vulnerable to ineffective and inequitable responses to future health threats.

Case Surge: A Warning Sign

The specter of MPOX looms large once again. As of this writing, MPOX cases in the U.S. have nearly doubled compared to the same period last year. This surge, particularly in regions like New York City, DC/Virginia, California, and Florida, underscores the continued vulnerability to MPOX outbreaks and highlights the urgent need to address the root causes of the persistent failures observed during the 2022 outbreak. Complacency in the face of this surge poses a danger, especially given the devastating outbreak in the Democratic Republic of Congo (DRC).

The DRC is experiencing its largest ever MPOX outbreak, with about 400 suspected cases reported each week – the majority in children. This outbreak presents a "triple threat": a deadlier strain of the virus circulating with a fatality rate of nearly 1 in 10, alongside the virus' spread into new areas, new populations (including sex workers), and in new ways – including sexually – and evading diagnostic tests. This crisis emphasizes the need for global cooperation and proactive solutions to prevent the spread of deadlier strains and future outbreaks.

Beyond MPOX: Systemic Failures Demand Systemic Change

On the heels of the COVID-19 pandemic, the MPOX outbreak of 2022 was further evidence that recurring failures and persistent inequities within the U.S. healthcare system leave the nation dangerously unprepared for public health emergencies. The GAO's critical report highlights a chronic reliance on reactive crisis management and failures in coordination, directly contributing to the ineffective MPOX response. While containing MPOX remains important, the nation cannot afford to repeat the mistakes of the past. The GAO's call for a coordinated after-action program and stakeholder inclusion offers a starting point for the reforms needed to address these systemic weaknesses.

These recommendations aren't abstract ideals but a roadmap to protect public health, especially for the most vulnerable in our society. In order to effect change, policymakers, healthcare organizations, and all stakeholders must prioritize the following for effective crisis preparedness:

Recommendation 1: Proactive Preparedness

The GAO report highlights a chronic reliance on reactive crisis management, condemning the tendency to delay action until a health threat has escalated. To break this dangerous cycle, we must advocate for a shift towards data-driven early detection and proactive response planning. Investing in innovative surveillance and data systems is critical. As Mary Denigan-Macauley states, "It really wasn't until the White House stepped in and took control that... it became a better response from the federal government." We cannot afford to wait for the next crisis to strike before mobilizing the resources needed for timely intervention. And we can’t afford for agencies such as HHS to wait for the White House to react to a crisis. Policymakers should consider carefully how to equip agencies and subject matter experts to respond and act in the best interest of the nation and humanity when next public health crisis emerges.

Recommendation 2: Community-Centered Response

Public health experts and CDC data illuminate how failing to center the needs of marginalized communities can devastate crisis response efforts. Stigma, lack of culturally-competent communication, and inadequate access to testing and treatment all exacerbated the disparate impact of MPOX. Preparedness plans, communication strategies, and resource allocation must prioritize the specific needs of those historically underserved if we hope to prevent the repetition of such failures.

Recommendation 3: Tackling Systemic Inequities

The MPOX case, like so many public health crises, underscores that systemic inequities are at the root of health disparities. Policy changes are urgently needed to address structural barriers (lack of access, discrimination, etc.) that worsen the impact of outbreaks on vulnerable populations. While the specifics of these changes require development and debate, the World Health Organization emphasizes the importance of global collaboration, investment in health systems particularly in underserved regions, and addressing stigma to ensure an equitable and effective response to future outbreaks.

This focus requires investment, policy reform, and sustained advocacy to dismantle the chronic failures that turn each new health threat into a disproportionate crisis for marginalized communities.

*Editor’s Note: This blog uses the term MPOX to be consistent with CDC and GAO terminology, but CANN's earlier policy materials used the previous designation MPV.

DEA Proposed Rules Risk Harming Access to Care

Since the beginning of the COVID-19 pandemic, the United States Drug Enforcement Administration (DEA) has held certain relaxed or waived rules regarding prescribing of controlled substances. On January 30th, President Biden announced his administration would end the public health emergency (PHE) declaration related to COVID-19 in May of 2023, after one, last renewal in February. Part of what’s being called an “unwinding” of the PHE includes returning to “normal” operations for executive entities like the DEA. But times have changed dramatically in terms of healthcare access since the beginning of the COVID-19 pandemic, most notably around the issue of telehealth. Thus, on February 24th, the DEA announced two proposed rules regarding permanent telehealth access and prescribing related to controlled substances.

The DEA’s controlled substances list is…controversial, to say the least. The five category list includes those which the agency has deemed to have the “potential for abuse or dependency” characterization. Schedule “V” (five) having a “low” potential for abuse relative to other levels and having sufficient medical value, resulting in quantity limits but, typically, not more than that in terms of regulatory impact. These medications include certain cough medicines and an anti-diarrheal medication, among others. Schedule “I” (one) substances as having been deemed to have “no” medicinal value, a high potential for abuse, and a lack of accepted safety for use even under medical supervision. These substances include marijuana, “ecstasy”, LSD, and peyote. In between these, you’ll find certain pain killers, treatment for attention deficit disorder (ADD), anabolic steroids, and medications used to treat opioid use disorder (OUD). The DEA’s proposed telehealth rules (here and here) would allow for a provider who has never conducted an in-person assessment of a patient to only prescribe up to a 30-day supply of schedule III-V non-narcotic medications and a 30-day supply of buprenorphine. In order to get a refill or maintain treatment, a patient would have to then arrange for an in-person assessment. For patients referred by a provider who has already conducted an in-person assessment in the last year or for providers who are directly prescribing the medication and have already had an in-person assessment in the last year, the limitations on telehealth would not apply.

Particularly, in the rules, the DEA argues medications used to treat OUD are at risk of diversion and misuse, despite evidence that misuse is relatively rare and declining and despite the fact that only about 11% of the population which could benefit from medication assisted treatment (MAT) have access, according to a report from the Substance Abuse and Mental Health Services Administration (SAMHSA). Reasons for limited access are slowly being addressed. Most notably, the “X-Waiver”, a program which limited which prescribers could offer buprenorphine and other MAT and how many patients they could treat. The “X-Waiver” requirements were repealed in Section 1262 of the Consolidated Appropriations Act of 2023 (otherwise known as the Omnibus). Another giant barrier to prescribing MAT is provider stigma. This stigma against people who use drugs (PWUD) often leads to patients having an exceptionally hard time finding a provider willing to help them, when they need it. Years of prescribing limits and the vagueness of the DEA requiring pharmacies to report “suspicious” orders (the DEA does not define what’s constitutes “suspicious”), has also left pharmacies, wholesalers, and distributors exceedingly cautious as not gaining the DEA’s ire. With these proposed rules, the biggest barrier to President Biden’s plan to expand access may be the bureaucracy he enabled as a Senator and Vice President (Politico details more here).

Additionally, some states are attempting to ban access to gender-affirming care; not just for minors but for anyone accessing public payer programs and even attempting to forbid private, commercial plans from offering gender affirming care. While these would not necessarily impact access to care for transgender women seeking out-of-state telehealth, it would adversely affect transgender men because testosterone is a schedule III controlled substance. Thus, under these rules, transgender men would have to have in-person assessment with a provider in order to begin or continue accessing prescribed testosterone replacement therapy. Where this is a bit of a “come uppins” moment for President Biden is in his historical record of championing the Anabolic Steroid Control Act of 2004, making testosterone and anything related to it a controlled substance. The law rose to a certain popularity because of major sports leagues in the United States insufficiently addressing steroid use among professional athletes. The world has changed greatly since then and most, if not all, of those entities have adopted tight controls and regular screenings of athletes (which do need some update to appropriately reflect the endocrinological variety the human species offers). A carve out in the law would allow for the DEA to exempt medications which “does not present any significant potential for abuse.”

Chronic pain patients, disability advocates, harm reduction advocates, and advocates for access to gender-affirming care are sufficiently outraged to see their life-saving care being ripped from the ease of telemedicine. Leo Beletsky, a law professor at Northwestern University said, “The fallout is going to be measured in lives lost.” Dr. Brian Hurley, the president-elect of the American Society of Addiction Medicine said, “I would posit that untreated opioid use disorder is a bigger threat to public safety currently than the risk of diversion.” “forcing people with disabilities who are immunocompromised or high-risk to choose between potential COVID exposure and forgoing vital medications is ableist and dangerous,” said Madeline T. Morcelle of the National Health Law Program. Adult ADHD patients are already fighting a shortage on their medications and providers who will prescribe them. And with the rural health care crisis limiting access to providers for queer people, disabled people, and PWUD, this rule will strip them of the only time they’ve seen their access to care expand in decades.

A bi-partisan, bi-cameral group of legislators have written a letter to the DEA cautioning against these rules and Senators Warren (D-MA) and Ed Markey (D-MA) have also written a letter to the U.S. Department of Justice, U.S. Department of Health and Human Services, and the DEA about de-scheduling testosterone. Neither letter has been answered yet. Orion Rummler of 19th News recently asked for an update and will be following up on the status of a response from the Biden Administration and executive agencies.

With these massive concerns on finding and accessing care, patients may well turn to the black market or grey market to self-manage the life-saving medications they need. This not only defeats the purpose of the DEA’s rules in attempting to prevent diverse by artificially creating a market for illicit trade, it exposes patients to risks of infections, counterfeit medications, and other safety hazards.

Patients should not have to risk their lives and even incarceration in order to access life-saving medications they have readily enjoyed over the last three years. The DEA should engage providers, advocates, and patients more than any other stakeholder from law enforcement to approach promulgation of these rules in a way that aligns with public health instead of carelessly chasing after ways to limit access to life-saving medications.

The proposed rules aim to come into effect in November. The public comment period ends on March 31, 2023. We encourage our partners, including those not directly involved in issues of substance use or production of controlled substances, to comment in support of adjustments to the proposed rules that would maintain telehealth access to care, meet the stated public health goals of the Biden Administration, and, most directly, maintain access to the life-saving medications patients depend upon. The public may submit comments here and here.