When the Target Is SSRIs, the Risk Is the Six Protected Classes
On May 4, 2026, Health Secretary Robert F. Kennedy Jr. closed a daylong Make America Healthy Again (MAHA) Institute summit on mental health and overmedicalization by announcing a federal initiative to reduce the use of selective serotonin reuptake inhibitors (SSRIs). The package includes new Centers for Medicare & Medicaid Services (CMS) reimbursement codes for clinicians who help patients taper off antidepressants, forthcoming Substance Abuse and Mental Health Services Administration (SAMHSA) training modules, a technical expert panel to develop deprescribing clinical guidelines, and a "Dear Colleague" letter to providers urging non-pharmacologic alternatives. No major medical organizations participated in the summit. Kennedy described the goal as ending "unnecessary dependence on medication" and returning control to patients. For readers familiar with how Medicare Part D's six protected classes (6PC) have been contested over the past two decades, the announcement reads less as a discrete clinical reform than as a foothold.
What Was Announced, and What the Evidence Says
The administration's framing rests on contested and, in some cases, fabricated premises. Kennedy has claimed, without evidence, that SSRIs are partly responsible for school shootings, a claim he first advanced during his confirmation hearings and repeated at the May 4 summit. He has also stated that SSRIs are harder to quit than heroin. The withdrawal evidence is more measured: a 2019 British study reported 56% of patients experienced withdrawal symptoms, while a 2024 placebo-controlled German analysis found roughly one in six experienced withdrawal effects and about 3% described them as severe. Roughly 16.6% of U.S. adults currently take an SSRI, and the American Psychiatric Association (APA) considers SSRIs a first-line, evidence-based treatment for depression.
The APA called the administration's framing an "oversimplification" that "ignores the larger reality" of access barriers to mental health care. Dr. J. John Mann of the New York State Psychiatric Institute was more direct, telling Reuters that "restricting use of these medications is not justifiable medically". The American Foundation for Suicide Prevention emphasized that decades of clinical, population-level, and health-system data show judicious antidepressant use reduces suicide risk overall.
Some elements of the initiative are defensible. Better tapering support, stronger informed consent, and broader access to talk therapy reflect long-standing clinical recommendations. The concern lies in what surrounds those elements.
A Reported Exploration of a Ban
Four days after the summit, Reuters reported that two sources familiar with internal discussions said HHS officials had explored whether the agency could ban specific drugs within the SSRI class in the week before Kennedy's announcement. HHS spokesman Andrew Nixon denied the discussions had occurred. The Food and Drug Administration (FDA) does not have authority to unilaterally ban approved medications absent new safety evidence, and manufacturers can refuse withdrawal requests, as Amgen did with Tavneos in April 2026. The reporting does not establish that a ban is imminent. It does establish that the agency's internal direction outpaces its public posture.
What the 2004 Black Box Warning Should Teach Us
Federal messaging about antidepressant risk has a documented track record of producing harm. The FDA's 2003 and 2004 advisories, followed by the October 2004 boxed warning on pediatric antidepressants and its 2007 extension to young adults, were based on a meta-analysis never designed to measure suicidality and that recorded no completed suicides. Subsequent research by Stephen Soumerai and Christine Lu found that rates of depression diagnosis, clinical visits, and antidepressant prescribing dropped by roughly one-third, while youth suicide attempts and deaths rose. No study has demonstrated that the warnings improved mental health outcomes. The lesson: federal rhetoric that vilifies a class of medications drives patients away from care, and the patients who disengage are often those at highest risk.
Why This Reaches the Six Protected Classes
Antidepressants are one of six therapeutic classes that Part D plans must cover "all or substantially all" drugs within. The other five are anticonvulsants, antineoplastics, antipsychotics, antiretrovirals, and immunosuppressants. The policy was established through CMS guidance in 2005, codified by the Medicare Improvements for Patients and Providers Act in 2008, and reinforced by the Affordable Care Act in 2010. It exists because Congress recognized that insurers, left to their own design, would engage in adverse selection against the sickest enrollees.
The 6PC have been targeted before. In January 2014, CMS proposed removing protected status from antidepressants, antipsychotics, and immunosuppressants. The proposal was rescinded within two months after opposition from patient groups, providers, manufacturers, and lawmakers. In May 2018, the first Trump administration's "American Patients First" Blueprint signaled renewed interest in weakening 6PC protections. In January 2021, the CMS Innovation Center released a Part D Payment Modernization Model Request for Applications that would have allowed participating plans to bypass the 6PC requirement for five classes starting in 2022, and for antiretrovirals starting in 2023. The HIV Health Care Access Working Group, of which CANN is a member, warned that restricting antiretrovirals would produce disruptions to care, decreased rates of viral suppression, increased rates of new infections, and more drug resistant strains of HIV. The Biden administration rescinded those changes.
People living with HIV (PLWH) have an immediate stake in this fight. Co-occurring serious mental illness and substance use disorders are common among PLWH, and the same statutory architecture that guarantees access to antiretrovirals also guarantees access to antidepressants and antipsychotics. Erosion of that architecture for one class establishes precedent for the others. A 2024 Health Affairs analysis from Weill Cornell Medicine estimated that removing protected class regulation could have reduced prescription drug spending by approximately $47 billion between 2011 and 2019, a figure that will be cited by anyone seeking to revisit the policy. The savings argument is not hypothetical, and it is not new. What they fail to factor into the equation (or willfully ignore), is that those saved dollars equal lost treatment access for real patients. There is always a cost, this one would be human.
The Pattern Around the Initiative
The SSRI initiative is not arriving into a stable regulatory environment. Since January 2025, HHS has eliminated the Administration for Community Living, the only federal agency dedicated to community living and civil rights for disabled and older Americans. HHS Office for Civil Rights staffing was cut and half of its regional offices closed. On May 12, 2025, the administration paused 2024 final rules requiring insurers to disclose how they restrict mental health claims under the Mental Health Parity and Addiction Equity Act. H.R. 1, signed July 4, 2025, imposed Medicaid work requirements and reduced Medicaid funding by more than $1 trillion over a decade. The Leadership Conference Health Care Task Force described the cumulative effect as a "wholesale assault on public health."
A campaign to reduce SSRI use, taken on its own, would warrant clinical debate. Layered onto this regulatory environment, it warrants vigilance.
What Advocates Should Watch and Do
Several specific actions matter now. First, monitor SAMHSA's forthcoming prescribing trend data and the deprescribing clinical guidelines expected this summer. The language used to justify reduced antidepressant utilization can be repurposed against other protected classes, particularly antipsychotics, which share co-prescribing patterns with antiretrovirals among PLWH with serious mental illness. Second, watch CMS for any Part D rulemaking or demonstration authority that quietly modifies formulary requirements. The 2021 Payment Modernization Model was rescinded because a broad coalition of cancer, HIV, mental health, and disability advocates spoke with one voice; that coalition infrastructure should be reactivated and ready. Third, engage in any HHS comment period touching deprescribing guidance, formulary design, or utilization management. Fourth, document and report plan-level changes affecting antidepressant or antiretroviral access, including new prior authorization requirements or step therapy protocols. Fifth, communicate clearly with patients that current treatments remain covered and that medical decisions belong with them and their clinicians. The chilling effect documented after the 2004 black box warning was driven by media coverage, not by any actual loss of access. We can blunt that effect by keeping accurate information in front of the communities we serve.
For PLWH and the organizations that support them, the connection to Ending the HIV Epidemic is direct. Viral suppression depends on uninterrupted access to the right antiretroviral regimen for each patient, and that access depends on the statutory protections that the 6PC framework provides.
What Comes Next
The SSRI initiative may proceed entirely within the bounds of clinical policy. The deprescribing codes may improve care. The training modules may help clinicians who have long lacked tapering expertise. The protected classes may remain untouched. None of that is guaranteed, and the past eighteen months of HHS reorganization give us no reason to assume the most benign interpretation. What we can do is read the policy direction accurately, engage the regulatory process the way our coalitions have engaged it before, and keep the communities we serve informed. The six protected classes have survived three administrations' attempts to weaken them. Keeping them protected is ongoing work.
Profit Over Patients: Challenging the Understaffing Crisis in Healthcare
On December 31, 2023 former U.S. Representative Eddie Bernice Johnson suffered and died in a completely preventable yet entirely foreseeable tragedy. Rep. Johnson, a dedicated nurse and a fervent advocate for equitable healthcare, succumbed to an infection contracted in a rehabilitation facility, a direct consequence of medical neglect. This incident is a glaring example of the systemic issues plaguing our healthcare institutions, where intentional understaffing and profit-driven motives often come at the expense of patient care and staff well-being. Her experience tragically highlights the broader systemic issues in healthcare, including rampant understaffing and the consequences of healthcare system consolidation.
The Tragic Circumstances of Rep. Johnson's Passing
According to a Texas Tribune report, Rep. Johnson died a “terrible, painful death” from an infection caused by negligence at her Dallas recovery facility following back surgery. The infection was a result of being left to lie in her own feces and urine for roughly an hour while she repeatedly called for help that didn’t come. The facility reportedly told family that all staff were unavailable as she called for help due to being in a training. Her son, Kirk Johnson, minced no words as he stated, "She was screaming out in pain, asking for help. If she had gotten the proper care, she would be here today.”
The family notified Baylor Scott & White Health System and Baylor Scott & White Institute for Rehabilitation of their intention to sue on the grounds of medical negligence. The lawsuit, if not settled, will highlight the deadly consequences of inadequate patient care in healthcare facilities. This legal battle is complicated by Texas law, which limits medical malpractice lawsuit awards to $250,000. Such legislative decisions, influenced by powerful hospital lobbies, not only restrict legal recourse for patients but also reflect deeper systemic issues in healthcare governance where institutional profits often overshadow patient rights.
The limitation on medical malpractice awards in Texas exemplifies a troubling trend in healthcare legislation. These laws, as detailed in a Miller & Zois report, often protect healthcare institutions at the expense of patient health and safety while significantly limiting patients' ability to seek fair compensation for medical negligence.
This legislative backdrop, coupled with intentional understaffing in healthcare facilities, creates a perilous situation where patient rights are limited and institutions are insulated from liability when their cost cutting measures cost lives. Maximizing profit and administrative and shareholder value by understaffing care facilities heightens the risk of medical errors, burns out staff, and creates unsafe working conditions. Yet, when these cost-cutting measures lead to harm, patients find their legal recourse severely restricted by malpractice caps while hospital staff burns out and are exposed to greater occupational hazards. The only ones not on the losing end are the hospitals and their executives.
Staffing Shortages or Healthcare Profiteering?
Across the country, as healthcare corporations report burgeoning profits, the reality within their healthcare facilities tells a story of compromised care and strained resources. Let’s take Hospital Corporation of America (HCA), the largest hospital system in the country, as an example. As reported in The Guardian, a study by the Service Employees International Union (SEIU) highlights the disparities, revealing that staffing ratios at HCA Hospitals in 2020 were alarmingly 30% lower than national averages. Despite $7 billion in profits and $8 billion allocated to stock buybacks and paying out nearly $5 billion in dividends to shareholders, the investment in patient care, particularly in terms of staffing, remains inadequate.
The prevailing narrative of a nursing shortage in the United States is rigorously challenged by facts and voices from within the healthcare sector. National Nurses United (NNU) asserts that the core issue is not a lack of nurses but rather the widespread unwillingness of nurses to work under unsafe conditions. This perspective contradicts the healthcare industry's narrative and points to systemic issues in workforce management and underinvestment in medical staffing by hospital executives.
The intentional understaffing by healthcare facilities, as seen in cases like HCA Hospitals, is often driven by financial motivations. By keeping staffing levels low, these facilities aim to maximize profits, often at the expense of both patient care and staff well-being. This approach has led to a situation where the healthcare workforce is being pushed to its limits, leading to high turnover rates and a growing reluctance among nurses to work in such conditions.
The narrative of worker shortages is further complicated by the trend of healthcare system consolidation, which significantly reshapes healthcare markets, often at the expense of patient care and staff well-being. In May of 2023 The RAND Corporation gave testimony to the U.S. House of Representatives Committee on Ways and Means, Subcommittee on Health which underscored that consolidation frequently leads to higher healthcare costs without corresponding improvements in quality. Characterized by mergers and acquisitions across markets, this trend typically results in reduced competition, higher prices, and a focus on revenue generation over patient-centric values. Moreover, when private equity is involved, as highlighted by The British Medical Journal (BMJ), it often exacerbates patient harm.
The Human Cost of Cost-Cutting
Impact on Healthcare Workers: Nurses and other healthcare staff, the backbone of patient care, are stretched to their limits. A study by the University of Pennsylvania highlights the high levels of nurse burnout, a direct consequence of inadequate staffing. The study surveyed over 70,000 nurses and found that the chronic stress caused by high nurse-to-patient ratios significantly impacts their mental and physical health. The turnover rate in nursing, as reported by STAT News, is a testament to the unsustainable working conditions, with many nurses leaving the profession or seeking less demanding roles.
Patient Safety and Care Quality: The impact of understaffing on patients is equally alarming. According to the National Center for Biotechnology Information (NCBI), inadequate staffing in nursing homes is linked to increased incidents of falls, bedsores, and a general decline in the quality of care. This neglect is not limited to nursing homes; hospitals across the nation face similar challenges. As in the case of Rep. Johnson, patients often experience delayed care, unmet basic needs, and an increased risk of medical errors due to the high workload on understaffed healthcare workers.
The understaffing crisis extends beyond individual facilities. As National Nurses United points out, the issue is systemic and has become an industry standard practice. These ethically dubious practices have far-reaching consequences, eroding the sustainability of the healthcare system and diminishing public trust in its ability to provide competent and compassionate care.
Upholding Ethical Standards in Healthcare
The ethical implications of understaffing and system consolidation are profound. It's not merely a matter of operational efficiency; at its core, it's about honoring a fundamental commitment to patient care and worker dignity. The primary ethical concern in healthcare should be the obligation to provide safe, effective, and compassionate patient care, an obligation that is often directly undermined by profit-driven decisions.
The direct consequences of understaffing and consolidation, such as compromised patient safety, increased medical errors, and a decline in the quality of care, represent a breach of the ethical duty healthcare providers owe to their patients. When financial priorities overshadow patient needs, the very essence of healthcare's moral foundation is shaken. This shift not only impacts patient outcomes but also erodes public trust in healthcare systems.
The alarming levels of burnout, stress, and turnover among healthcare workers, particularly nurses, reflect a work environment that neglects their physical, emotional, and professional well-being. This neglect raises serious ethical concerns about the healthcare industry's commitment to its workforce. When staff well-being is compromised for operational efficiency or financial gain, the entire healthcare system suffers, leading to a demoralized workforce and diminished patient care.
The healthcare industry faces a critical ethical dilemma: balancing financial responsibilities with the imperative of humanistic care. While healthcare facilities have fiscal duties to their stakeholders, these must never be allowed to eclipse their ethical obligation to prioritize high-quality patient care and foster a safe and supportive work environment. The pursuit of profit must be balanced with the moral imperative to care for both patients and healthcare workers humanely. This balance is essential not only for the integrity of healthcare providers but also for the long-term sustainability of the healthcare system as a whole.
Addressing these ethical challenges is not just a moral imperative but a crucial step towards systemic reform for a more humane and effective healthcare system and, frankly, reducing costs to patients by way sufficient retention of nursing talent - reduced turn over means reduced labor costs which then translates to reduced insurance billing and less medical debt.
Concrete Steps Towards Reform
The reality of understaffing and the challenges posed by healthcare system consolidation in our healthcare system demand immediate and decisive action. We must engage in targeted advocacy and policy reform. Here are specific actions that individuals and organizations can undertake to drive meaningful change:
Contact Legislators: Advocate for federal and state legislation that mandates safe staffing ratios in healthcare facilities, addresses the challenges of healthcare consolidation and transparency, and holds hospitals accountable for malpractice. This includes challenging laws that limit malpractice awards, as these can protect healthcare institutions at the expense of patient rights.
Support Nursing Unions: Participate in advocacy campaigns of unions like National Nurses United, supporting their efforts for better working conditions and fair staffing levels. These unions play a crucial role in voicing the concerns of healthcare workers and advocating for their rights.
Engage with Healthcare Boards: Advocate for ethical staffing practices and policies that prioritize patient care over profit in healthcare organization board meetings. It's essential to influence decision-makers at the highest level to bring about systemic changes.
Advocate Against Unchecked Consolidation: Support policies that scrutinize healthcare mergers and acquisitions, as highlighted by the National Conference of State Legislatures (NCSL), to ensure they prioritize patient care and staff welfare. This includes backing state and federal initiatives to enhance oversight on healthcare mergers and acquisitions.
We must shift the focus from profit margins to the pillars of empathy, compassion, and quality care. It's time to honor the legacy of advocates like Rep. Eddie Bernice Johnson and ensure that our healthcare system upholds its fundamental commitment to patient care and worker dignity. Implementing these actions can lead to a more empathetic, compassionate healthcare environment, where patient care and staff welfare are prioritized, paving the way for a sustainable and trustworthy healthcare system.
Provider Survey: Prior Authorizations Harm Patients
The issue of prior authorizations (PAs) comes across my plate quite frequently. Really, it’s bigger than PAs. PAs are but one of several types of practices known as “utilization management” and it’s also one of the fastest ways to get me hot under the collar in a way reminiscent of the fury and frustration of a poison oak rash. But PAs are particularly notorious because they’re one of the methods of utilization management health care providers have to directly engage with, rather than something saddled in the lap of a pharmacist or patient at the point of sale. If you haven’t run into the issue of prior authorizations, let me back up some and give you a brief explanation.
The health insurance you get when it’s branded with a major corporation’s name (rather than a government program) is either a commercial plan or that of the same entity working as a “managed care organization” on behalf of a government funded program. But that package is generally two different types of benefits packaged as one, medical coverage over the cost of seeing your doctors and getting labs and pharmacy coverage over your prescription medications. Just like when your medical coverage limits the type of provider you can see or the facility “in-network” they’ll pay for you to go to, your pharmacy benefit may include a limit or design to steer you toward a limited network of pharmacies and that benefit decides what types of medications they’ll cover, what they’ll make you pay in cost sharing (co-pays), and what hoops you have to jump through when they don’t want to cover a particular medication because it’s costly. One of the ways both of these types of benefits seek to discourage patients from seeking out expensive care or medications is by making your provider ask them pretty please if you can have a particular treatment. This is a prior authorization.
But who calls the shots when your doctor and the pharmacy benefit manager (PBM) disagree about you needing that specific treatment? That’s a complicated answer and what happens to patients navigating that space of waiting for your doctor and PBM to communicate and figure things out is not well studied in clinical terms. PBMs generally ask a third-party with expertise to make a medical decision on if you really need that particular treatment or if something else might be…ok based on the reasons your provider says you need that specific treatment. The thing is, the PBMs both pick and pay that third-party. There is no truly independent arbiter to navigate a coverage decision. That third-party has a vested interest in maintaining their business model and keeping the folks who write their checks happy. And those folks aren’t you or your doctor. They tend to view the PA under the lens of a singular condition, lacking the whole context of your health needs and history, and while “medical necessity” is the most common claim needed to get around a PA, proving that can often be a onerous and sometimes lengthy process.
None of that addresses that your doctor is your doctor for a reason. They’re intimate with your personal medical situation, co-occurring conditions, things like how big a pill you can swallow without choking, what vitamins you take, and more. There is never a better decision-making process than the one made between patient and provider.
The best way to explain the PA process is calling it “deny and delay”. Deny the claim, delay a patient getting the care they need. There’s a quiet and underlying assumption that patients and providers are picking their care based on what costs the most, which neglects the fact that plan designs already make it ridiculously challenging for the average person to afford even basic care, much less care required to manage chronic conditions. Sky-high premiums and deductibles to tune of thousands of dollars mean most patients simply can’t afford to pursue costly care, even if you need it.
The American Medical Association has sought to measure these experiences and outcomes with a physician survey, asking doctors and their administrative staff to quantify what’s going on for doctors offices and patients when running up against PAs. The survey findings are shocking but not surprising if you, dear reader, can recall any time you’ve already had to navigate a PA. Let’s run down the top line numbers:
- 93% of participants said PAs delay care for patients (up from 92% in 2017)
- 82% of physicians said PAs lead to medication abandonment at least sometimes (24% said “often” and 2% said “always”)
- 91% said PAs have a “somewhat or significant” negative clinical impact on patients
- 51% said their patients had to take time off work in order to navigate a PA
- physicians said they had to manage about 41 prior authorizations a week and have to dedicate about 2 full days a week to navigating PAs with about 40% of their staff solely working to manage the paperwork associated with PAs
Patient outcomes were seriously impacted by PAs with 34% of physicians reporting they had patients experience adverse events as a result of delayed care due to PAs, 24% of physicians said they’ve had patients hospitalized waiting on an approval from their insurer, 18% reported that a PA lead to a life threatening event for a patient, and 8 % of participating physicians said PAs have lead to patients becoming disabled, experiencing cognitive anomaly, permanent bodily damage, birth defects, or even death.
Here’s the kicker, while 98% of providers have found claims by insurers their PA policies are evidenced based, only 30% of physicians agreed those policies in practice were actually evidenced-based.
All of this is to say, providers see payer abuses of utilization management harming patients quite regularly all in the name of profit making for insurers and PBMs. An insurance policy isn’t worth the paper it’s written on much less the money spent if, in the end, patients can’t actually get the care they’re paying for. If a provider’s contentious process of educating a patient about their health, why they need a particular treatment, and monitoring of that health condition to a patient’s benefit is how a consumer would generally define “practicing medicine”, then the denial of that specific care must also be considered “practicing medicine”. We don’t pay insurers to practice medicine, we pay them to cover the costs of our care.
For their part, the AMA has also previously suggested 21 principles in the reform of utilization management in order to stop the practice of payers practicing medicine by utilization review. Clearly, more needs to be done on the legislative and regulatory fronts in order to protect patients from these predatory and abusive practices. Insurers and PBMs are excellent at planning ways to punish legislative action and patients if constraints are placed on them. It’s time our law makers and government begin responding to existing abuses of our health care ecosystem and affirmatively anticipate market adjustments favoring profit over patients. It’s beyond time government funded programs require payers to actively engage patients in feedback processes and meet minimum metrics of patient success and satisfaction as the government does with all other stakeholders receiving those dollars. Payers can no longer be exempt from the basic decency required to be a full-fledged player in health care rather than the grifter status they enjoy right now. Patients simply can’t afford it.