Ensuring Equitable Access to PrEP for Minors in the South
In 2022, young people under 35 accounted for over half (56%) of all new HIV diagnoses in the United States. The Southern states bore a disproportionate burden of this epidemic, accounting for more than half of new HIV diagnoses that year. Particularly high rates among youth in this region highlight the urgent need for effective HIV prevention strategies tailored to young people. This alarming statistic underscores the urgent need to ensure that all young people, regardless of where they live or their family circumstances, have access to effective HIV prevention tools, including pre-exposure prophylaxis (PrEP). The CHOOSE study (Combatting HIV Or Other STIs Early), currently underway, offers a promising approach to increasing PrEP uptake among young gay, bisexual, and other men who have sex with men (YGBMSM) aged 13-24, a population at elevated risk for HIV. CHOOSE leverages the power of mobile health technology to provide tailored information, support, and reminders to help young people choose and adhere to PrEP.
However, the promise of CHOOSE and other similar PrEP initiatives for young people is threatened by a wave of restrictive policies and legal decisions in the United States, creating significant barriers for minors seeking to protect their health, especially those who live in the South. In Texas, the 5th Circuit Court of Appeals ruled that Title X-funded clinics must notify parents before providing sexual and reproductive healthcare services to minors, including contraception. This ruling has far-reaching implications for PrEP access, as Title X clinics are often the only source of sexual health services for young people, particularly those without access to private insurance. Similarly, in Tennessee, the state government's politically motivated decision to reject federal HIV prevention funding and redirect resources away from organizations serving marginalized communities, including those providing PrEP, further jeopardizes the health of young people.
These actions demonstrate a concerning trend of policies that prioritize parental control over the health and well-being of young people, even when those policies contradict evidence-based public health strategies and potentially put youth at risk. We must address these barriers to ensure that all young people in the South have equitable access to PrEP and other life-saving HIV prevention tools. Failing to do so will not only do material harm to vulnerable people but also hinder our collective progress towards ending the HIV epidemic.
The Landscape of PrEP Access for Minors
PrEP has proven highly effective in reducing the risk of HIV acquisition, particularly for young gay, bisexual, and other men who have sex with men. When taken as prescribed, PrEP can reduce the risk of sexual HIV transmission by up to 99%. Studies have shown that a majority of young people on PrEP demonstrate adequate adherence, further supporting its effectiveness as a prevention tool. However, realizing the full potential of PrEP for young people hinges on ensuring equitable access, a goal hindered by a complex and often restrictive legal landscape surrounding minors' consent to healthcare. While PrEP offers a powerful tool for HIV prevention, accessing this medication can be challenging for young people, particularly due to the complex legal landscape surrounding minor consent to healthcare.
The legal framework for minor consent to healthcare varies significantly across states, creating a patchwork of access for young people seeking PrEP and other sexual health services. Many state laws governing a minor's ability to give informed consent for STI and HIV services do not explicitly mention PrEP. This lack of clarity within these statutes leaves it unclear whether minors can consent to PrEP independently and confidentially. This ambiguity can deter healthcare providers from offering PrEP to minors and leave young people uncertain of their rights. The situation is particularly concerning in the South, where restrictive parental consent laws are prevalent and often extend to sexual and reproductive healthcare services more broadly.
The 5th Circuit ruling in Texas, requiring parental notification for Title X services, exemplifies this trend. Planned Parenthood, a leading provider of sexual and reproductive healthcare, condemned the ruling as "a significant and dangerous departure from decades of precedent that has allowed all young people to confidentially get basic health care like birth control through Title X." This ruling, and the legislation it protects, creates significant barriers for young people seeking basic sexual and reproductive healthcare, including PrEP. For example, a young person in Texas seeking PrEP who fears being outed to unsupportive parents due to their sexual orientation might forgo seeking this essential prevention method altogether to avoid mandatory parental notification, putting their health at risk. For those experiencing family conflict, abuse, or rejection due to their sexual orientation or gender identity, mandatory parental notification can be particularly dangerous, deterring them from seeking essential care.
However, recent actions by the federal government offer a glimmer of hope. In a case involving Oklahoma, the Supreme Court upheld the Biden administration's right to redirect federal family planning funds from states that restrict access to abortion information. This decision demonstrates the potential for using federal funding as leverage to incentivize states to comply with public health guidelines and protect access to care, even in politically charged areas like sexual and reproductive health.
Even in states where minors can legally consent to PrEP, confidentiality is not always guaranteed. Some states allow or require providers to notify parents or guardians, potentially compromising young people's privacy and putting them at risk. Additionally, the inadvertent disclosure of sensitive health information through insurance Explanation of Benefits (EOBs) sent to parents or guardians can further erode confidentiality. These policies fail to recognize the unique vulnerabilities of young people and the importance of confidential healthcare access in fostering trust and encouraging early intervention.
Political Interference: The Case of Tennessee
While restrictive laws present a significant barrier to PrEP access for minors, the case of Tennessee illustrates how political agendas can further undermine public health efforts, even in the absence of explicit legal restrictions. In 2023, the Tennessee government made the controversial decision to reject $6.2 million in annual funding from the Centers for Disease Control and Prevention (CDC) specifically designated for HIV treatment and prevention programs, including those supporting PrEP access. This decision, projected to result in 166 additional HIV transmissions and 190 additional deaths over 10 years, jeopardized years of progress in reducing new HIV diagnoses and expanding PrEP uptake in a state with one of the highest HIV burdens in the country.
This funding rejection was not driven by evidence-based public health priorities but rather by a politically motivated agenda to defund organizations like Planned Parenthood and shift resources away from communities deemed undesirable by those in power. The state government attempted to justify its actions by claiming a desire to prioritize other populations, such as first responders, but these groups have significantly lower HIV transmission rates, making this rationale dubious at best.
Following a public outcry and intense advocacy efforts by HIV organizations, the Tennessee legislature ultimately approved $9 million in state funding for HIV, and the CDC intervened by directly allocating $4 million to community-based organizations, resulting in a net increase in funding. While this outcome appears positive on the surface, the disruption caused by the initial funding rejection and the ongoing uncertainty surrounding the state's commitment to evidence-based HIV prevention strategies raise serious concerns.
The Tennessee case exemplifies the dangers of political interference in public health. The initial funding cuts disproportionately impacted marginalized communities, including young people, people of color, and LGBTQ+ people, who already face significant barriers to accessing healthcare. The attempt to redirect funding away from proven prevention strategies towards less vulnerable populations further demonstrates a disregard for health equity and the principles of evidence-based policymaking. This case also highlights the critical role of advocacy in holding policymakers accountable and protecting the health of vulnerable communities. The mobilization of HIV organizations and community members was essential in securing a partial reversal of the funding decision, demonstrating the power of collective action in challenging harmful policies.
The Promise of Telehealth and Other Innovative Solutions
As we grapple with the legal and political barriers hindering PrEP access for minors, it's important to explore innovative solutions that can circumvent these obstacles and reach young people where they are. Telehealth has emerged as a particularly promising approach, offering the potential to expand access, enhance confidentiality, and reduce stigma, especially in the South, where geographic barriers and social conservatism can be significant.
Studies have shown that telehealth interventions can effectively increase PrEP initiation among young people. For example, the PrEPTECH study demonstrated that a telehealth platform providing online education, home testing, and PrEP prescriptions significantly increased PrEP uptake among young men who have sex with men (MSM) and transgender women (TW) in Florida and California. Telehealth offers a convenient and discreet way for young people to access PrEP services, potentially overcoming logistical barriers and reducing the stigma associated with seeking sexual healthcare in person.
However, while telehealth holds promise, it's not a panacea. It's essential to recognize the limitations of telehealth and develop comprehensive strategies that address adherence challenges, digital equity, and the broader social determinants of health that can impact PrEP access and effectiveness. For example, young people may need additional support to adhere to daily PrEP regimens, and those without reliable internet access or digital literacy skills may face challenges navigating telehealth platforms.
Therefore, a multi-pronged approach is needed that combines telehealth with other innovative solutions tailored to the unique needs of young people. Youth-friendly clinics that prioritize confidentiality and provide non-judgmental care can create safe spaces for young people seeking sexual health services, including PrEP. Mobile testing units can bring PrEP services directly to communities with limited access to healthcare, and community-based outreach programs can raise awareness, reduce stigma, and connect young people to PrEP providers. By embracing a combination of strategies, we can create a more robust and equitable system for delivering PrEP to young people in the South.
Policy Recommendations and Call to Action
To truly protect future generations from the burden of HIV, we must move beyond simply acknowledging the barriers to PrEP access for minors in the South and embrace a proactive policy agenda that centers the needs of young people. This requires an approach that leverages our collective expertise and influence as advocates, healthcare professionals, and policymakers.
First, we must challenge the existing legal framework that hinders minor access to PrEP. Advocating for clear and consistent state laws explicitly granting minors the right to consent to PrEP confidentially is paramount. Removing ambiguity in statutory language and eliminating provider discretion will ensure legal clarity and empower young people to seek PrEP without fear of parental notification. Simultaneously, we must push for stronger confidentiality protections for all sexual and reproductive healthcare services for minors, recognizing the unique vulnerabilities and potential risks associated with mandatory parental notification.
Second, we must address the systemic inequities that disproportionately impact PrEP access for young people of color, LGBTQ+ people, and those living in rural communities. Adopting the PrEP Equity Ratio (PER) and other equity metrics as standard practice in program design and evaluation is necessary for monitoring progress and holding stakeholders accountable for achieving equitable PrEP access.
Third, we must actively engage in the political process to safeguard and increase federal funding for HIV prevention programs, particularly those targeting youth and communities of color. The Tennessee case exemplifies the vulnerability of public health funding to political interference. We must advocate for policies that protect these funding streams and ensure that resources are allocated based on epidemiological evidence and public health needs, not ideological agendas.
Finally, we must leverage the power of innovation to expand PrEP access and address the unique needs of young people. This includes supporting the expansion of telehealth services, promoting youth-friendly clinics, and investing in community-based outreach programs tailored to the specific challenges faced by young people in the South.
This is not a passive call to action; it is a call to mobilize our expertise, resources, and influence to create a policy environment that prioritizes the health and well-being of all young people. The time for bold action is now. Let us work together to ensure that no young person is denied the opportunity to protect themselves from HIV.
Eye on 2024: Federal Action on PBMs, 340B, and Telehealth
2024 stands as a pivotal year in federal healthcare policy, potentially overshadowed by a highly contentious and partisan political landscape during an election year. The backdrop includes ongoing budget fights, looming cuts threatening vital healthcare programs, and a shifting balance of power in Congress thanks to at least one member being removed from office and a couple of high-profile resignations, further complicating the path to meaningful bipartisan legislation. Amidst this chaos, key focus areas such as reforms related to Pharmacy Benefit Managers (PBMs) and the 340B Drug Pricing Program, as well as telehealth expansion are at the forefront of potentially significant policy shifts, all while renewed attacks on the Affordable Care Act (ACA) add to the uncertainty of healthcare reform in an election year.
Pharmacy Benefit Managers: Pushing for Transparency and Market Reform
PBMs have come under increasing scrutiny in the U.S. healthcare system, particularly regarding their role in prescription drug pricing. Dominated by just three key players, PBMs face criticism for opaque pricing models and practices that may contribute to rising drug costs. The Lower Costs More Transparency Act of 2023 represents a bipartisan effort to enhance transparency in PBM operations, requiring detailed disclosure of pricing and costs. The future of this legislation depends on whether the Senate will adopt the House version or introduce its own bill, with several Senate committees recently advancing similar proposals.
Experts, including those from the Brookings Institution, caution that while increased transparency is a positive step, it may only modestly impact overall drug costs. The effectiveness of these reforms hinges on addressing the complex relationships among PBMs, drug manufacturers, insurers, and healthcare providers.
The current PBM model, often criticized for incentivizing high drug list prices through 'spread pricing,' is under review. Proposed reforms, like those in the Pharmacy Benefit Manager Reform Act, aim to eliminate spread pricing and ensure that rebates and savings directly benefit plan sponsors and patients.
Additionally, the PBM market's consolidation and “vertical integration” (or self-dealing by another name) raises concerns about market power and its influence on drug pricing. With a few firms controlling a significant market share, PBMs' market power could lead to disproportionate profits, underscoring the need for regulatory measures to ensure fair pricing and competition.
As the healthcare community navigates these reforms, the focus remains on ensuring that changes in PBM operations directly benefit patients, especially those in underserved communities disproportionately affected by high drug costs.
340B Program: Addressing Challenges for Future Reforms
The 340B Drug Pricing Program, essential for providing discounted drugs to healthcare providers serving underserved communities, is at a critical juncture. Facing legal challenges and calls for reform, 340B is under scrutiny, particularly regarding its operational complexities and the definition of a 340B-eligible patient. This definition, crucial in determining who accesses discounted drugs, has been a point of contention, with legal interpretations suggesting a need for broader inclusivity, as noted in Bloomberg Law's analysis.
Advocates, including those supporting people living with HIV, recognize the program's significant impact but seek more direct patient benefits, a sentiment echoed in CANN's blog. The current model's effectiveness in providing direct patient benefits, such as reduced drug prices, is being questioned.
Efforts for greater transparency and accountability are intensifying, with state-level initiatives aiming to ensure that program savings directly benefit patients, especially those with financial barriers to medication access, as highlighted in Avalere's insights. State authority to regulate 340B, however, is still in question as Arkansas and Louisiana face lawsuits around recently passed legislation.
Amidst these challenges, 340B's commitment to aiding underserved communities remains paramount. Collaborative efforts among lawmakers, healthcare providers, and patient advocacy groups are crucial to reform the program, ensuring it continues to provide equitable access to care and addresses key issues like medical debt.
Telehealth: A Defining Year in 2024
2024 is set to be a defining year for telehealth, a sector transformed by the COVID-19 pandemic. This year will witness crucial legislative decisions that could shape the future of access to telehealth services.
At the forefront are policy decisions regarding Medicare reimbursement flexibilities for telehealth, as noted in Modern Healthcare's article. Set to expire in 2024, these flexibilities are vital for the continued viability of telehealth, particularly benefiting small practices and those in rural or underserved areas.
Another key development is the anticipated update to remote prescribing rules for controlled substances. The decisions made will crucially balance the need for accessible care with the regulation of controlled substances, impacting how telehealth can be used for medication prescribing.
As 2024 unfolds, the healthcare community faces the challenge of navigating these legislative and policy changes to maximize the benefits of telehealth in patient care and access.
Budget Battles: Critical Healthcare Advocacy Amid Congressional Challenges
The intense budget battles in Congress, underscored by proposed cuts in the House L-HHS Appropriations Bill (H.R. 5894), are central to healthcare advocacy. These cuts, amounting to $767 million, pose a significant threat to essential HIV/AIDS programs, risking the reversal of years of progress in treatment and care. These programs are not just healthcare initiatives; they are vital lifelines providing necessary medications and support to individuals living with HIV.
The Coalition on Human Needs has expressed grave concerns about potential severe cuts to non-defense discretionary appropriations (NDD) for fiscal year 2024, which could drastically impact a range of vital services. In their sign-on letter to Congressional leaders, they warn that these cuts, potentially up to 9% according to the Center on Budget and Policy Priorities, would significantly harm programs essential for public health, education, environmental protection, and more, affecting diverse communities across America. The Coalition advocates for completing the FY24 appropriations process with a bipartisan approach, emphasizing the need to protect these crucial investments that support the nation's most vulnerable populations and uphold the commitment to public health and welfare.
Any major legislative changes will be at the mercy of presidential election year politics, and the congressional balance of power will only make it harder. Issues like PBM reform, or 340B reform, and Telehealth expansion will probably receive a lot of attention via hearings and news clippings, but legislative action remains in doubt.
Payers Seek to Expand Telehealth, in Libraries
In Louisiana's public libraries, a significant transformation is taking place. Amidst the traditional setting of books and quiet study areas, telehealth booths are emerging as highly accessible resources for health and wellness. These innovative installations, described by the State Library of Louisiana as looking like “futuristic phone booths,” are not merely modern fixtures; they represent an essential expansion of healthcare access, particularly benefiting those in low income and rural areas, and people experiencing homelessness.
Yet, this progress faces challenges from the current culture war, notably the attacks on LGBTQIA+ communities and the removal of related literature and displays. Libraries, long-standing bastions of knowledge and inclusivity, are now at the center of ideological disputes, potentially impacting the very access they aim to provide.
The Culture War's Impact on Library Access
Recent reports from Vice, Book Riot, and AP News highlight a concerning trend: libraries are increasingly becoming ideological battlegrounds. In Louisiana, actions such as the banning of LGBTQIA+ themed books and the removal of pride-related displays have created an environment of fear and exclusion.
The politicization of libraries could deter potential partners and funders, hindering the expansion of healthcare services. Insurance companies, crucial stakeholders in the telehealth initiative, may view libraries as contentious spaces and reconsider their support. This could significantly impact the availability and expansion of telehealth services, particularly to marginalized communities who stand to benefit the most. The culture war's escalation within these traditionally neutral and inclusive spaces poses a real threat to the continued provision and growth of essential health services in libraries.
Despite these hurdles, Louisiana’s telehealth initiative, supported by the Blue Cross and Blue Shield of Louisiana Foundation, demonstrates resilience. Telehealth booths in libraries like West Baton Rouge provide private spaces for virtual healthcare consultations, essential for those with limited access to healthcare or who are afraid of stigmatizing interactions at traditional points of service.
Of the most...interesting aspects of this partnership includes Louisiana’s incoming Governor, Jeff Landry, joining the board of directors of Blue Cross Shield of Louisiana. Landry has been a vocal critic of libraries running up to his gubernatorial campaign, though his tone has since softened some. By, “interesting”, we mean uniquely “Louisiana weird”.
The Role of Insurance Payers in Library Telehealth Initiatives
As telehealth services expand the role of insurance payers becomes pivotal. Their involvement is not just about funding; it's about influencing the broader narrative to support public health initiatives in nontraditional spaces like libraries. Amidst the escalating culture war, their decision to back libraries can be a powerful statement in favor of inclusivity and access to healthcare. By supporting telehealth in libraries, they can help ensure that these spaces remain open, welcoming, and free from the divisive impacts of cultural conflicts.
The integration of telehealth services into public libraries represents a significant leap forward in making healthcare more accessible and equitable. It's essential for insurance payers and other key stakeholders to recognize the role libraries and other nontraditional spaces play in bridging healthcare gaps. Their support can help counteract the negative impacts of the culture war, ensuring that libraries continue to serve as welcoming hubs of health and knowledge for all community members.
In this challenging landscape, the support of insurance payers and stakeholders is more than just a financial commitment; it's a commitment to upholding the principles of equity and access in healthcare. Their involvement can help steer the conversation away from divisive politics and towards a focus on the health and well-being of entire communities, no matter their minority status. As we navigate these complex issues, it's crucial to keep libraries as inclusive and supportive environments, where everyone has access to the health services they need, free from the constraints of political discord.
DEA Appears Open to Tele-Script for Certain Controlled Substances
On August 7th, the Drug Enforcement Agency (DEA) issued a notice of meeting regarding telemedicine prescription of certain controlled substances (Schedule II only). The meeting(s) will be conducted as “listening sessions”, conducted Tuesday, September 12th, and Wednesday, September 13th from 9 a.m. to 5:30 p.m. at the DEA Headquarters (located at 700 Army Navy Drive, Arlington, VA). Participants must pre-register using this link, before or on August 21st. In-person requests will be granted via lottery and the sessions will be live-streamed. Similarly, those wishing to provide limited oral presentation, either in-person or via live-stream must also fill out the form. Again, these will be selected by DEA personnel based upon quality of summary of presentation. Presentations may be made by anyone with an interest in and expertise in the subject matter. The DEA has asked for feedback on the following questions:
If telemedicine prescribing of schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
Should telemedicine prescribing of schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of schedule II medications should be permitted in the absence of an in-person medical evaluation? If it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
If practitioners are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
If pharmacies are required to collect, maintain, and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
The listening sessions come as a direct result of the DEA receiving truly unprecedented responses to proposed rules published in March, in anticipation of the end of the COVID-19 public health emergency, and, thus, the DEA’s telemedicine waiver issued at the beginning of the COVID-19 pandemic. In all, the DEA received almost 40,000 comments across the proposed rules with much focus on the General Telemedicine proposed rule. We covered the content of those rules (and why they were a step backward as written) in March. In particular, we expressed concern over returning to pre-pandemic limitations on telemedicine when the pandemic-related waiver did not prove any spike in diversion and did, indeed, improve access to medication assisted substance use treatment for many patients. Along similar lines, because testosterone is considered a controlled substance, such a return at the height of bias-driven, state-based legislation limiting access to certain gender affirming care would have a disproportionately harmful impact among transgender men and undermine President Biden’s commitment to combat these hateful efforts.
The relationship between the DEA and harm reduction advocates has been long and fraught. Many harm reduction advocates criticize the role of law enforcement’s actions, particularly that law enforcement agency, working against best practices in public health, even those best practices recognized by federal public health agencies. For example, a couple of weeks ago, we highlighted the Substance Abuse Mental Health Administration’s document (currently open to public comment) aimed at formalizing certain policy positions, entitled Harm Reduction Framework. Nowhere in the “framework” is the conflict with law enforcement positions addressed.
Putting more pressure still on the DEA’s absolute refusal to meet its commitment from 2009 to introduce meaningful telemedicine rules (in response to passage of the Ryan Haight Online Pharmacy Consumer Protection Act) is the fact that the stimulant medication shortage is at its worst. Things are so bad the U.S Food and Drug Administration (FDA) and DEA issued a joint letter on August 1st to further detail actions being taken to address the shortage and consumer struggles. The problem with the letter is it is largely bypasses the responsibility the DEA has in the current situation. Leaning into a claim that manufacturers haven’t filled their annual quota limits in production and pointing fingers at an increase in legitimate prescription of stimulants to manage conditions like attention deficit hyperactivity disorder (ADHD), the letter fails to recognize that the DEA also places extraordinary limits and scrutiny on pharmacies dispensing stimulant medications. Known as “drug diversion”, the idea behind monitoring pharmacies has some merit when viewed under the lens that pharmacies have a responsibility to limit index events like those “pill mills” associated with the opioid epidemic. However, the DEA doesn’t take responsibility for pharmacy raids or strict enforcement against prescribing providers working to keep patients from turning to street supplies by providing legitimate prescriptions.
For the DEA to be a meaningful partner in combatting both illicit and harmful drug use and overdoses and help to address drug shortages, limiting harmful diversion, the agency needs to consider a dramatic shift from an “all drugs are bad, and the people who use them are bad” mindset. There needs to be a thoughtful “medium, wherein stakeholders other than law enforcement can engage in distinguishing best practices in supply chain security and harm reduction and readily identifying criminals taking advantage of patients seeking care by any means they can achieve it – including illegal and illicit channels.
Patient advocates outside of harm reduction and substance use disorder focuses and the industry stakeholders who serve these patients would do well to consider engagement in these and other opportunities to help re-shape and re-imagine the DEA’s role, ideas, and programs to better serve the public at large, better secure the supply chain and limit disruptions, and ensure patients can have ready, reliable, and modernized access to the care we need.
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.