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.

The False Economy of Rationing Life

Across the country, states are making a choice. Faced with budget shortfalls driven by flat federal funding, the expiration of enhanced ACA premium tax credits, and the downstream wreckage of H.R. 1's nearly $800 billion in Medicaid cuts, they are choosing to solve their fiscal problems by restricting access to the medications that keep people living with HIV alive and stop the virus from spreading. Eighteen states have implemented cost-containment measureson their AIDS Drug Assistance Programs, with five more considering changes. Florida slashed ADAP eligibility from 400% to 130% of the federal poverty level on March 1, cutting off more than 12,000 people and removing Biktarvy, which accounts for 52% of the U.S. ARV market, from its formulary. Louisiana is considering HB927, legislation that would repeal the state's long-standing statutory protections against prior authorization and step therapy for antiretrovirals in Medicaid.

The pressures are real. ADAP enrollment surged 30% from 2022 to 2024 as states shed Medicaid enrollees after the pandemic. NASTAD's February 2026 ADAP Watch reports 19 ADAPs forecast deficits for the upcoming fiscal year. When adjusted for inflation, ADAP appropriations have declined 31% since 2005, with the FY2025 appropriation carrying roughly the same purchasing power as FY1999 levels. Nobody disputes the math. What we dispute, forcefully and on the evidence, is the response.

Utilization Management on ARVs Is Clinically Indefensible

Step therapy requires a patient to "fail" a medication before accessing the one their provider has already determined is best for them. In HIV treatment, failure means the virus has replicated in the presence of inadequate drug levels and potentially developed resistance, rendering the entire associated drug class less effective or ineffective. For someone on PrEP, "failing" a regimen means they have seroconverted and acquired HIV, possibly with resistance that limits their treatment options from day one. Prior authorization creates gaps in access while paperwork is processed. Drug resistance can develop within several weeks of stopping ART, as some components of a combination regimen remain in the body longer than others, leaving HIV exposed to one or two drugs instead of a full suppressive regimen. CD4+ cell counts can decline by up to 100 cells/mm³ within weeks of interruption. The SMART trial demonstrated that episodic ART interruption was associated with increased risk of opportunistic disease and death, findings so conclusive the strategy was abandoned entirely.

The CMS Medicare Part D Manual specifically notes that utilization management tools like PA and step therapy are generally not employed in best-practice formulary models for HIV/AIDS drugs. The American Academy of HIV Medicine issued a white paper with a single recommendation: HIV medications should be exempt from prior authorization requirements. As of 2019, 14 states had enacted laws prohibiting at least some UM techniques for ARVs. The broader health policy world is arriving at the same conclusion about PA generally: a January 2026 KFF Health Tracking Poll found that four in ten people with chronic conditions say prior authorization is their single biggest healthcare burden beyond costs, and KFF President Drew Altman has openly questioned whether its short-term cost control benefits are worth the costs to patients in an already overburdened system. If the mainstream is questioning PA broadly, the case for applying it to ARVs, where the clinical stakes include drug resistance, viral transmission, and death, does not exist.

The Math Doesn't Work, and the Motive Is Worse

Here is where we need to stop treating this conversation as though it is happening in good faith.

The stated rationale for stripping UM protections from ARVs is cost containment. But anyone who has watched private insurance markets operate over the past two decades recognizes what utilization management on high-cost drug classes actually produces: leverage. Private payers have used UM as a negotiating tool for years, threatening to restrict formulary access unless manufacturers offer deeper discounts. The people whose treatment gets disrupted in the process are the collateral damage that makes the threat credible.

CANN has been warning for years that as state Medicaid programs face mounting budget pressure, the temptation to adopt this same playbook would grow. That is exactly what is unfolding. When states impose PA and step therapy on antiretrovirals, the practical effect extends well beyond cost management. It creates a bargaining position where patient access to life-saving medication becomes a concession to be traded for supplemental rebates from manufacturers. This is the private payer model of healthcare as revenue generation imported into public health programs responsible for managing a communicable disease. It transforms the health of people living with HIV into a bargaining chip, and it represents a fundamental betrayal of what public health programs exist to do.

The people whose medications get delayed, whose viral loads rebound, whose resistance profiles narrow while prior authorizations are processed are not an unfortunate side effect of this model. They are the leverage. That is not healthcare. It is government treating public health as a profit center.

The economics don't support it either. Every new infection from someone with a detectable viral load carries an estimated lifetime medical cost of $326,500, with the cost avoided by preventing that infection estimated at $229,800. More recent analyses from HIVMA put average lifetime expenditures between $500,000 and more than $1.2 million. A Precision Health Economics analysis estimated that allowing UM on Part D antiretrovirals alone could result in over 6,750 new HIV infections. Whatever supplemental rebate a state might extract by threatening formulary restrictions will be dwarfed by the downstream costs. And in a U.S. cohort studied between 2021 and 2023, 28% of people with HIV experienced a treatment interruption of 90 days or more, with those affected disproportionately women, Black, dealing with substance use, and less likely to have commercial insurance. These barriers concentrate harm on the people who are already most structurally vulnerable.

We Have Already Watched This Fail

We don't need to theorize. We watched it happen with Hepatitis C. For years, state Medicaid programs and MCOs imposed PA, step therapy, sobriety requirements, and prescriber restrictions on curative direct-acting agents for HCV. People were denied treatment while their disease progressed. By the end of 2025, 34 jurisdictions had removed PA requirements for most Medicaid HCV patients, reflecting the national consensus that those restrictions never served patients or budgets. Louisiana itself now receives an "A" grade for HCV Medicaid access. As CANN's letter to Vice Chair McMahen on HB927 notes, the bill proposes substantially similar risks to HIV medication access as those once imposed on HCV, in a state that passed model PrEP and PEP legislation in 2024 that these same UM tools would undermine.

What Must Happen

Florida's own legislature proved these cuts are not inevitable when it passed HB 697 in mid-March with $31 million to restore ADAP eligibility for over 11,000 people. Bipartisan, responsive, and proof that different choices are available when the political will exists.

States must fight for adequate federal ADAP funding, which has been flat-funded since FY2014 while program costs have grown relentlessly. They must leverage 340B rebates and supplemental funding rather than cutting the people the programs exist to serve. They must design Medicaid formularies to ensure access following federal HIV treatment guidelines, not undermine them. And their federal legislators should realize that if we can fund the Department of Defense at a trillion dollars a year, we can surely pay to keep people from dying from AIDS.

There is no clinical necessity for removing ARV protections. Doing so will not balance budgets. It will create drug resistance, increase transmission, push people into more expensive care settings, and compound the harms of H.R. 1's Medicaid budget cuts and work requirements, which threaten coverage for 42% of Medicaid enrollees with HIV. At every level of analysis, this approach fails. What it succeeds at is transferring the cost of federal policy failures onto the bodies of people living with HIV, and that is not fiscal responsibility. It is abandonment dressed in budget drag.

Hepatitis C Medicaid Access Dashboard Provides 2023 Updates

In February, the Hepatitis C State of Medicaid Access project, operated by the Center for Health Law and Policy Innovation of Harvard Law School (CHLPI) and the National Viral Hepatitis Roundtable (NVHR), updated snapshot of the variety of restrictions and barriers to care prevalent in state Medicaid programs regarding accessing life-saving Hepatitis C (HCV) treatment. The project has been working to expand access to HCV treatment since 2014 and is a ready tool of state advocates seeking to end discriminatory program policies.

Last year, the project updated the monitored metrics to adjust to successes in advocating for policy and program changes but to also begin monitoring new ways programs are finding to restrict access to and coverage of care. Evidenced by the 2021 snapshot report citing changes since 2017, including 32 states having eliminated or reduced fibrosis restrictions, 21 states having loosened sobriety restrictions, and 25 states having scaled back provider restrictions, the 2022 report began tracking retreatment restrictions, disparities between fee-for-service (FFS) access and managed care organizations (MCOs) access policies, and “additional restrictions” including time-based lab requirements, past adherence to other prescription medications, and policies which prohibit replacement of lost or stolen medication. Restrictions not tracked yet but may be in the future include monthly prescribing limits and specialty pharmacy requirements.

The 2023 update notes that since 2022, seven states removed prior authorization requirements for most patients, no changes in fibrosis restrictions (with Arkansas and South Dakota being the only states remaining with this policy), six states having removed substance use restrictions, one state (Nevada) having removed prescriber restrictions, three states removing re-treatment restrictions, and, cumulatively, three more states have addressed disparities in FFS and MCO access to HCV treatment. Similarly, the 2023 snapshot also includes some nuanced updates with regard to prescriber restrictions, now noting a lack of restrictions for a “simplified” or “initial” treatment offering in Hawaii, Kansas, Kentucky, Utah, and West Virginia. Additionally, the FFS versus MCO access portion introduced layers of understanding, segregating out states which do not use MCOs from the overall graphic. While Colorado, Ohio, New York, and West Virginia addressed the issue of additional restrictions or a lack of transparency, Texas took a step backwards and found itself being added to the list of states with a lack of clarity and additional MCO restrictions on HCV care. One hallmark metric of the project also received a “facelift” by introducing a “grading” system for each state’s prior authorization policies, ranking from “A+” to “F”; 9 states received an A+ for having no prior authorization requirement for most patients, 12 states received an A for having removed prior authorization requirements for most patients and having minimal restrictions, 11 states received a B for removing prior authorization requirements for most patients with some restrictions, 12 states received a C for requiring all patients to obtain prior authorization though having few restrictions on accessing care, 6 states received a D for requiring prior authorizations for all patients with “many restrictions”, and 2 states received an F due to requiring all patients to obtain prior authorization and having “harsh” restrictions.

The snapshot and grade systems have proven to be extraordinary tools in targeting advocacy, including litigation, to improve access to curative HCV treatment for Medicaid patients. Recognizing access to care is not granted, even in public payer programs, also allows advocates and policymakers to make more conscious policy decisions and empower practical programmatic design aimed toward benefiting highly affected communities.

Areas of additional support are necessary as payer policy is but one barrier to care. Advocates can and should seek changes which address provider discrimination, incentivize screening by way of establishing HCV screening as a standard of care or otherwise covered in a state’s “essential health benefit” design, and encouraging policymakers to address disparities in screening and treatment in carceral settings. Addressing HCV in carceral settings might start by requiring state prisons and local jails to report these metrics to state health departments on a regular basis, rather than hiding data behind jail systems which require and are often slow to respond to public records requests.

Much work remains and we’re ever grateful to our friends over at CHLPI and NVHR for their astounding work.