CROI 2026: The Tools Are Here. The Infrastructure Is Not.

The 33rd Conference on Retroviruses and Opportunistic Infections (CROI) convened February 22nd – 25th in Denver under extraordinary tension between a pipeline of HIV prevention, treatment, and potential cure tools that could reshape the epidemic's trajectory, and a global funding crisis actively dismantling the infrastructure required to deliver any of it. As Conference Chair Nicolas Chomont of the Université de Montréal stated in the Opening Session, "we share a responsibility to defend and sustain funding for international HIV programs and research." That charge framed every session that followed.

The Funding Crisis: New Data on the Damage

The consequences of disruptions to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the dissolution of the United States Agency for International Development (USAID), and National Institutes of Health (NIH) cuts are no longer hypothetical. The CROI session "Sleepless in Denver" presented the first systematic evidence of the damage. Ellen Brazier's survey data from the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium found that across 32 countries, 47% of clinics reported disruptions in HIV services, with similar rates of disruption to medication availability, laboratory services, and clinic operations. In KwaZulu-Natal, South Africa, Lindsey Filiatreau reported that 39% of clinics experienced disruptions affecting an estimated 830,000 people living with HIV.

The damage is not confined overseas. Aaron Richterman presented data from a rapid survey across three U.S. states showing that 47% of clinics reported HIV service disruptions, including medication shortages. He also demonstrated how cuts to the Supplemental Nutrition Assistance Program (SNAP), the country's largest targeted anti-poverty program serving more than 42 million Americans, directly undermine treatment outcomes. During the 2025 government shutdown, ART adherence among people living with HIV who receive SNAP benefits dropped to as low as 40%. The connection between food security and viral suppression is well established; cutting one predictably undermines the other. As Filiatreau put it, "These things [HIV services]… can be taken away overnight, but they can't be rebuilt overnight."

Prevention: An Expanding Toolkit, a Widening Access Gap

Against this backdrop, CROI delivered a prevention portfolio that is broader and stronger than at any previous conference. Final results from the PURPOSE 1 and PURPOSE 2 trials confirmed the efficacy of twice-yearly injectable lenacapavir for pre-exposure prophylaxis (PrEP). In PURPOSE 1, which enrolled cisgender adolescent and young women in sub-Saharan Africa, HIV incidence among lenacapavir recipients was 0.07 per 100 person-years, compared to 1.98 for oral emtricitabine/tenofovir alafenamide (F/TAF) and 1.94 for emtricitabine/tenofovir disoproxil fumarate (F/TDF), with only two seroconversions among more than 2,000 participants. PURPOSE 2, enrolling men who have sex with men and gender diverse people, showed HIV incidence of 0.11 per 100 person-years for lenacapavir versus 0.92 for F/TDF, with three seroconversions among 2,179 participants.

The five total seroconversions across both studies received considerable attention, with four showing lenacapavir-associated resistance mutations that researchers believe developed during PrEP rather than being transmitted. Research into why these breakthroughs occurred is ongoing. As Gilead's Stephanie Cox stated, "We don't know why these occurred… I think the efficacy is very high." San Francisco AIDS Foundation (SFAF) Medical Director Hyman Scott, MD, MPH, added context: "The breakthrough infections are important to evaluate but are extremely rare among the thousands of study participants."

The Prévenir study's final eight-year results from France reinforced that both daily and on-demand oral PrEP are safe and effective, with overall HIV incidence of 0.11 per 100 person-years across more than 3,200 users and 13,000 person-years of follow-up. Switching between daily and on-demand use was the norm rather than the exception, with 59% of daily users changing to on-demand at least once, and 52% doing the reverse. This carries a clear message for implementation: people need flexibility, and rigid one-size prescribing undermines persistence.

The prevention pipeline continues to expand. Merck's once-monthly oral PrEP candidate MK-8527 selected an 11 mg dose maintaining protective drug levels in at least 95% of participants, with Phase 3 EXPrESSIVE trials now enrolling. Gilead's PURPOSE 365 study, testing once-yearly lenacapavir for PrEP, is being designed. The SEARCH study showed that community health workers paired with digital tools reduced HIV incidence by 70% in rural populations, a reminder that prevention tools work best when embedded in community-driven delivery.

The problem is reach. Andrew Hill highlighted that only 2.3 million people are currently on oral PrEP, far below UNAIDS targets, and that injectable cabotegravir and lenacapavir represent just 2.9% and 0.9% of total PrEP use, respectively. We have a growing menu of prevention tools. Getting them to the people who need them is where the system breaks down.

Treatment: More Options, Longer Intervals, Patient Choice

The treatment pipeline at CROI 2026 moved toward a central goal: giving people living with HIV more choices that fit their lives. Merck presented late-breaking data from three Phase 3 trials of doravirine/islatravir (DOR/ISL), the first ever once-daily, non-INSTI two-drug regimen. In treatment-naive adults, DOR/ISL demonstrated non-inferiority to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), with 91.8% achieving viral suppression at Week 48 compared to 90.6%, including participants with high viral loads and low CD4 counts. The U.S. Food and Drug Administration (FDA) has set an action date of April 28, 2026 for the DOR/ISL application. For people aging with HIV who manage multiple comorbidities, a two-drug, non-INSTI regimen addresses a real clinical gap. Research presented at this same conference linked the widely used INSTI dolutegravir to neuropsychiatric effects, including blocking a brain enzyme essential for memory and emotional regulation, with one study halted for ethical reasons after participants experienced worsening symptoms. For people navigating tolerability concerns, toxicity issues, or polypharmacy, having a non-INSTI alternative with fewer active agents matters.

Gilead's ARTISTRY-1 and ARTISTRY-2 trials demonstrated that a bictegravir/lenacapavir (BIC/LEN) single-tablet regimen can maintain viral suppression for people switching from complex multi-tablet regimens (96% at 48 weeks in ARTISTRY-1) or from Biktarvy (93.5% in ARTISTRY-2). For people who have been on complex regimens for years due to resistance histories, this potential simplification addresses a real quality-of-life gap. Gilead plans to submit these results to regulatory authorities.

Long-acting injectables continued their forward march. In ViiV Healthcare's EMBRACE study, lotivibart (a broadly neutralizing antibody, or bNAb) given as an IV infusion every four months plus monthly cabotegravir maintained viral suppression in 94% of participants at 12 months. Part 2 of EMBRACE, testing lotivibart infusions every six months, is now fully enrolled. ViiV also presented early data on VH-184, a third-generation integrase inhibitor with potential twice-yearly dosing, and VH-499, a capsid inhibitor supporting twice-yearly intervals. The VOLITION study showed that 85% of treatment-naive adults opted to switch from daily pills to bimonthly long-acting cabotegravir/rilpivirine (CAB+RPV LA), with 95% maintaining suppression. Data like VOLITION's 85% opt-in rate reinforce what the HIV community has long argued: when people living with HIV are offered options that fit their lives, they take them. Payers, formulary committees, and ADAP programs should take note. Treatment is not one-size-fits-all, and coverage shouldn’t treat it as such.

Community activist Shari Margolese put it plainly at CROI's final Community Breakfast Club: "As a community we need to get much angrier about the fact that we can't get access to the drugs." Francois Venter of Ezintsha in South Africa warned that without action, "we might be sitting here again in 10 years' time" celebrating breakthroughs that never reach communities.

Cure, Comorbidities, and the Equity Question

On the cure front, the RIO trial's Phase B results offered genuine encouragement. Among the 28 people who received a placebo in Phase A and were then given bNAbs teropavimab and zinlirvimab, 54% had prolonged viral remission after stopping antiretroviral therapy (ART), with two still off treatment after more than a year. Because ART was stopped six months after the bNAb infusions, these results point to an immunological "vaccinal effect" rather than direct viral suppression. A cure remains distant, but these are the kinds of incremental, well-designed steps that build the evidence base forward.

CROI also highlighted the growing urgency of managing comorbidities in aging populations living with HIV. The POPPY study found that depression affects 32.4% of people living with HIV over 50, linked to inflammatory markers rather than psychosocial factors alone. A study of over 1,500 men showed that the combination of age 65 and over, HIV, and metabolic syndrome produced significantly worse cognitive impairment than any factor alone. Metabolic syndrome is the modifiable factor in that triad, which means clinicians and patients can act on it now. CROI data on GLP-1 receptor agonists like semaglutide point toward a potential tool for doing so: in a study of people living with HIV-associated lipohypertrophy, semaglutide produced a 19% reduction in total body fat, a 31% decrease in visceral adipose tissue, and a nearly 50% drop in C-reactive protein, a key inflammatory marker. Separate data presented at the conference found that semaglutide did not worsen depression in people living with HIV, and that people with moderate or severe depression at baseline actually showed improvements. These findings warrant dedicated research into how GLP-1 therapies can address the long-term health consequences of chronic inflammation and aging with HIV. If the evidence continues to support their role, GLP-1 receptor agonists should be evaluated for inclusion in the HIV standard of care, with appropriate insurance and program coverage to match.

The equity question came into sharp focus with data from the ENCORE cohort. Black trans women in the U.S. had an HIV incidence of 15.5 per 1,000 person-years, compared to 1.4 for White trans women. Poverty, houselessness, and lack of insurance were significant drivers, and only 4% of trans women in the cohort used long-acting injectable PrEP. Dr. Sari Reisner of the University of Michigan warned that the current administration's erasure of gender identity data from federally funded datasets will make it harder to monitor disparities and determine what works. We cannot close gaps we refuse to measure, and they know that.

What Comes Next

CROI 2026 produced a clear picture: we have tools that can change the course of the HIV epidemic, and the systems required to deliver them are being actively undermined. The path forward requires specific action. We must defend and restore funding for PEPFAR, NIH, and the global HIV infrastructure that makes science reach people. State ADAP programs and payers must expand coverage for long-acting prevention and treatment options and remove administrative barriers that delay access. To do that, they need to be adequately funded. PrEP implementation must embrace the full range of validated modalities, from daily oral to on-demand to injectable to monthly oral, with flexibility built into delivery. Care for people aging with HIV must shift toward whole-person approaches that integrate cognitive screening, metabolic risk management, and mental health support alongside viral suppression. And we must protect the community-led surveillance and data collection that allows us to see and respond to disparities, especially for trans and gender-diverse communities.

Wes Sundquist of the University of Utah, who helped develop the science behind lenacapavir, reflected at CROI on the decades-long journey that produced this tool. He warned that while the field now has "a really powerful new tool in the arsenal," forces are blocking its use. "It will be a human tragedy," he said, "if we don't overcome those." The science has done its part. The rest is a question of political will, policy design, and whether we as a community can sustain the pressure long enough for these tools to reach the people who need them.

Warren and Hawley Want to Break Up Big Medicine. Here's What the Bill Actually Does.

On February 10, 2026, Sen. Elizabeth Warren (D-Mass.) and Sen. Josh Hawley (R-Mo.) introduced the Break Up Big Medicine Act, a bipartisan bill that would force the structural separation of healthcare conglomerates that simultaneously own insurance companies, pharmacy benefit managers (PBMs), pharmacies, physician practices, and drug wholesalers. The political pairing is unusual: a progressive Democrat and a populist Republican, finding common ground on the idea that a handful of corporate giants have rigged the healthcare supply chain in their own favor. The bill arrives as both parties scramble to address healthcare affordability ahead of the 2026 midterm elections, and just days after President Trump signed an appropriations package containing new PBM transparency rules and issued executive orders directing agencies to "reevaluate the role of middlemen" in prescription drug pricing. The political will to confront healthcare consolidation is clearly building. The question is whether this bill meets the moment.

What the Bill Does

The Break Up Big Medicine Act draws its inspiration from the Glass-Steagall Act of 1933, which separated commercial and investment banking after the financial system's collapse during the Great Depression. Applied to healthcare, the principle is the same: entities that are supposed to be bargaining competitively with one another should not be owned by the same parent company.

The bill establishes two core prohibitions. First, it bars any person or entity from simultaneously owning or controlling a medical provider or management services organization (MSO) and an insurance company or PBM. Second, it bars common ownership of a provider or MSO and a prescription drug or medical device wholesaler. Companies in violation would have one year to divest. Those who miss divestiture milestones would face automatic penalties, including 10% of profits transferred into escrow on a monthly basis and, eventually, a court-appointed divestiture trustee with authority to force asset sales. Revenue from seized profits would be deposited into a fund created by the Federal Trade Commission (FTC) and distributed to serve the healthcare needs of harmed communities.

An MSO is an entity that contracts with a medical provider to furnish administrative and business services such as payroll, payer contracting, billing and collection, coding, IT, and patient scheduling. While MSOs do not technically practice medicine, they have become the primary vehicle through which corporate entities, including insurers and private equity firms, exert operational control over physician practices without appearing on paper as the owner. The bill's explicit inclusion of MSOs is a recognition that corporate control of healthcare delivery does not require direct ownership; it can be achieved through the back office.

The enforcement architecture is broad. The FTC, the Department of Justice (DOJ) Antitrust Division, the Department of Health and Human Services (HHS) Inspector General, state attorneys general, and private citizens can all bring civil actions. The private right of action provision allows treble damages (a legal remedy where a court triples the amount of actual, compensatory damages awarded to a prevailing plaintiff), attorney's fees, and equitable relief. The FTC and DOJ would also retain forward-looking authority to review and block future transactions that would re-create the prohibited conflicts of interest.

The bill's definition of "provider" is notably expansive: it includes pharmacies (both in-patient and outpatient), physician practices, ambulatory surgery centers, urgent care centers, post-acute care facilities, home-health providers, and hospitals. This means the legislation reaches well beyond PBM-owned pharmacies to encompass the full range of insurer-owned care delivery.

The Problem It Targets

The scale of vertical integration in U.S. healthcare is difficult to overstate. Three PBMs, CVS Caremark, Express Scripts, and OptumRx, manage nearly 80% of prescription drug claims for roughly 270 million people. Each is owned by a company that also operates a health insurance plan, physician offices, and pharmacies. Three drug wholesalers control 98% of U.S. drug distribution. As of 2023, UnitedHealth Group, through its Optum subsidiary, controls approximately 10% of all American physicians, making it the single largest employer of doctors in the country. Nearly 80% of physicians now work for a corporate parent, and since 2019, nearly 4,000 independent pharmacies have closed.

The evidence on what this consolidation does to costs and quality is damning. RAND Corporation testimony to the U.S. House of Representatives found that vertical integration of hospitals or health systems with physician practices does not lower spending and does not improve quality of care. Instead, it shifts care to higher-cost settings and increases payment rates through greater negotiating power. Hospital-physician vertical integration has been associated with 10 to 14% price increases for physician services. A Commonwealth Fund analysis found vertical consolidation associated with 14% higher physician prices and 10-20% higher total spending per patient.

The FTC itself has found that vertically integrated PBMs have both the ability and incentive to steer business to their own affiliated pharmacies, reducing competition and increasing prescription drug costs. PBMs engage in spread pricing, charging health plans more for a drug than they reimburse pharmacies and keeping the difference, while simultaneously reducing reimbursements to independent pharmacies to drive them out of business.

The conflicts run deeper. As Wendell Potter detailed in Healthcare Uncovered, the joint ownership of insurance companies, PBMs, provider organizations, and pharmacies allows parent companies to game the Affordable Care Act's (ACA's) medical loss ratio (MLR) requirement. The ACA mandates that insurers spend 80-85% of premium dollars on medical care. When an insurer owns the PBM, the provider group, or the pharmacy, it can count internal payments to those entities as "medical care" for MLR purposes, even though those payments are self-dealing. This accounting maneuver converts premium dollars to profits at a rate Congress never intended.

Antitrust enforcement has proven inadequate to the task. From 2000 to 2020, only 13 mergers out of 1,164 were challenged by the FTC. As Erin Fuse Brown, professor at Brown University's School of Public Health, noted during a recent KFF Health Wonk Shop panel, antitrust enforcement has largely looked the other way on vertical consolidation, and even when agencies have attempted to bring cases, they have struggled to convince courts that vertical mergers pose a competitive risk.

The Promise for Patients and Providers

If enacted, the bill could address several of the structural conflicts of interest that drive up costs and limit patient choice. Forced separation of PBMs from their affiliated pharmacies could create a more level playing field for independent pharmacies, which currently compete against entities that also control their reimbursement rates. For people living with chronic conditions who rely on specialty medications, the current system means that the company deciding what drug is covered, how much the patient pays, and which pharmacy fills the prescription can be the same company. Breaking those links could open real competition in both pricing and access.

The bill would also force the divestiture of insurer-owned physician practices, a development that could restore meaningful clinical autonomy for physicians and potentially slow the trend of care being steered toward affiliated, higher-cost settings. Consolidation has already narrowed provider choice for patients across the country. Hospital consolidation from 1998 to 2021 resulted in 1,887 mergers and reduced the number of hospitals nationwide by about 25%. The GAO reported that rural hospital closures force residents to travel roughly 20 miles farther for common inpatient services and about 40 miles farther for less common services. When consolidated systems close facilities or eliminate services that rarely turn a profit, such as maternity wards, primary care clinics, and emergency departments, patients in underserved and rural communities face fewer doctors, longer wait times, and greater distances to travel for care. For low-income patients who may lack access to paid time off, reliable transportation, or affordable child care, those distances can mean the difference between receiving care and going without. Reducing the financial incentive for insurers to steer patients exclusively to affiliated providers could, over time, help preserve a broader range of care options in the communities that need them most.

The bill's expansive definition of "provider" and its inclusion of MSOs is significant: it closes the backdoor through which corporate entities use management services agreements to exert de facto control over physician practices without technically owning them. The private right of action with treble damages gives patients and affected parties a meaningful tool to hold companies accountable, something traditional antitrust enforcement has failed to do at scale.

The Pitfalls

The bill's ambition is also its vulnerability. A one-year divestiture timeline for restructuring trillion-dollar companies like UnitedHealth Group, CVS Health, and Cigna is aggressive by any measure. The logistics of unwinding these conglomerates, separating data systems, reassigning contracts, re-establishing independent management structures, present real operational risk. Corey Katz, a partner at Bates White Economic Consulting, cautioned during the KFF panel that policymakers should be careful of unintended consequences because the linkages in these systems are complex, and breaking them can produce adverse outcomes that were not anticipated. He pointed to the Haven joint venture between JP Morgan, Amazon, and Berkshire Hathaway, which sought to make healthcare more efficient and collapsed within five years, as evidence that restructuring healthcare delivery is harder than it appears.

Industry has already signaled opposition. CVS Health Group president David Joyner pushed back on the characterization of the system as market concentration at a House hearing in January, describing the integrated model as one that "works really well for the consumer." Evidence would seem to suggest otherwise, but Mr. Joyner is certainly welcome to his opinion.

The bill also has notable gaps. It does not address hospital-to-hospital horizontal mergers, which remain a primary driver of higher prices in local markets. It does not address private equity acquisitions of physician practices, which a GAO analysis found can lead to 4-16% increases in commercial insurance spending depending on the specialty. And it does not address the payment system incentives, particularly the persistent site-of-care payment differentials where Medicare pays two to four times more for identical outpatient procedures performed in a hospital setting versus a physician's office, that create the financial motivation for consolidation in the first place. Fuse Brown acknowledged that structural separation is a "blunt instrument" but argued that we have reached the point where antitrust tools have proven insufficient and bolder approaches are warranted.

What This Means for People Living with Chronic Conditions

For people living with HIV and other chronic conditions, pharmacy access is a persistent concern. The current vertically integrated system can dictate which pharmacy fills a prescription, what drugs appear on a formulary, and what a patient pays out of pocket. PBM-driven patient steering limits access to specialty pharmacies and 340B providers that play a critical role in serving people who are most affected by healthcare costs. Consolidation also disproportionately impacts communities of color, who, as the Commonwealth Fund noted, are more likely to face medical debt, are more vulnerable to increased costs, and are more likely to bear the brunt of the often cruel business practices that consolidation enables.

Separating PBMs from their captive pharmacies could expand real pharmacy choice for patients. But poorly managed divestiture could also temporarily destabilize specialty pharmacy networks or disrupt care coordination for people who depend on uninterrupted medication access. The details of how divestiture is structured and monitored will matter as much as the principle behind it.

Looking Forward

The Break Up Big Medicine Act faces long odds in a divided Congress. But its bipartisan sponsorship reflects a genuine shift in the political calculus around healthcare consolidation, one that cuts across party lines and ideological camps. Whether or not the bill advances, it establishes a policy framework that advocates, policymakers, and the public can build on.

We should watch closely for how recently enacted PBM transparency rules interact with these structural proposals, how state-level merger review and health equity impact assessments continue to evolve, and whether the FTC and DOJ use existing authority to pursue vertical consolidation cases more aggressively. We should also urge our elected representatives to support the bill and, critically, to demand that any restructuring of the healthcare system be evaluated for its impact on patient access, affordability, and health equity. Structural separation is a necessary conversation. Making sure the people most affected by consolidation are centered in that conversation is our responsibility.

PDAB Chicanery: How Drug Affordability Boards Are Undermining Public Engagement

Prescription Drug Affordability Boards (PDABs) across the country are playing a dangerous game with public engagement—one where they keep changing the rules and moving the goalposts. From inadequate notice periods to last-minute document releases, these boards are creating barriers that echo troubling federal trends, effectively sidelining the very people who have the most at stake: patients.

These state-level games mirror concerning federal developments, most notably the rescinding of the Richardson Waiver by U.S. Department of Health & Human Services (HHS) Secretary Robert F. Kennedy, Jr. This action removed a 50-year precedent requiring public input on HHS rules—effectively telling patients and advocates their opinions aren't welcome at the policy table.

As these transparency rollbacks continue, people who rely on medications face increasing uncertainty about their access to life-sustaining treatments—while boards claim to represent their interests through processes that actively exclude them.

Maryland PDAB: How to Follow the Letter of the Law While Breaking Its Spirit

Maryland's Prescription Drug Affordability Board offers a master class in technical compliance that functionally blocks meaningful public participation. Their recent meeting preparation tactics exemplify how these boards can check procedural boxes while effectively sidelining patient voices.

On March 18, 2025, the Maryland PDAB posted a revised agenda for their upcoming March 24 meeting. This might seem unremarkable until you realize the public comment deadline was March 19—giving stakeholders exactly one day to review, analyze, and formulate responses to complex pharmaceutical policy documents. The revised agenda wasn't a minor update either. It contained material differences from the previous version, including a comprehensive cost review dossier for Farxiga, a medication critical for many people with diabetes and heart failure.

As CANN's letter to the board noted, "Posting the updated agenda with associated meeting materials the day before the deadline for comment is not a good faith effort in garnering public trust, nor does it display value in public input." The Maryland PDAB's approach creates a veneer of public engagement while practically guaranteeing that meaningful input will be minimal.

This pattern suggests the board views public comment as a procedural hurdle rather than a valuable source of insight. By technically fulfilling their obligation to post materials before the comment deadline (even if by mere hours), they've found a convenient loophole that undermines the very transparency standards that public notice requirements are designed to uphold.

The Maryland case isn't an anomaly. It's a symptom of a growing tendency to treat public engagement as an inconvenient formality rather than a crucial component of sound healthcare policy development.

The Federal Parallel: HHS and the Richardson Waiver

The state-level PDAB maneuvers don't exist in a vacuum. They mirror a troubling federal precedent set by HHS Secretary Robert F. Kennedy, Jr., who recently rescinded the Richardson Waiver—a decision that effectively slams the door on patient advocacy at the federal level.

The Richardson Waiver has a 50-year history. Established in 1971, it required HHS to subject matters relating to "public property, loans, grants, benefits, or contracts" to the American Procedures Act's notice and comment rulemaking guidelines. This waiver was created specifically to ensure public voices would be heard on matters that directly affect their health and well-being.

Now, that protection is gone. The new HHS rule claims the waiver "impose[s] costs on the Department and the public, are contrary to the efficient operation of the Department, and impede the Department's flexibility to adapt quickly to legal and policy mandates." This bureaucratic language translates to a simple message: we don't care what you think.

God forbid they remember who they work for.

And the impact is far-reaching. While Medicare remains protected under separate provisions of the Medicare Act, critical programs like Medicaid, SAMHSA, and the Administration for Children and Families now operate without mandated public comment periods. Legal experts note this could allow for swift implementation of controversial measures like Medicaid work requirements without going through normal rulemaking processes.

The timing is particularly ironic given the Office of Management and Budget's recent guidance letter emphasizing the importance of "broadening public participation and community engagement" and making it "easier for the American people to share their knowledge, needs, ideas, and lived experiences to improve how government works for and with them."

This federal retreat from transparency sets a dangerous tone that state-level boards appear eager to follow.

Other State PDAB Examples: Oregon and Colorado's Concerning Patterns

Maryland isn't alone in its questionable approach to public engagement. Oregon's PDAB recently decided to include Odefsey—an antiretroviral medication for people living with HIV—on its list for cost control exploration, contradicting previous discussions to protect these medications. While they claim they might reconsider based on affordability research, this flip-flop creates unnecessary anxiety for people who depend on these treatments.

Colorado's PDAB situation is particularly egregious. Since 2023, CANN has repeatedly requested that the board consult with the state health department about rebate impacts on public health infrastructure and patient affordability—concerns echoed by the former SDAP director and PDAB members themselves.

Yet Colorado PDAB staff have consistently avoided conducting a proper fiscal impact analysis, bluntly stating "We won't be doing that" when asked directly. This refusal persisted even as formal rulemaking began, which triggers statutory requirements for analyses under Colorado's Administrative Procedure Act.

The board has repeatedly postponed its first rulemaking hearing, effectively delaying compliance with transparency requirements. Meanwhile, the Joint Budget Committee has begun questioning the PDAB's financial accountability, receiving only partial responses about consultant costs and litigation expenses.

Most concerning is the disconnect between PDAB actions and demonstrated patient benefits. A 2024 analysis of Oregon's similar program showed states would need additional funds to maintain programs under an upper payment limit system—with no meaningful patient affordability improvements identified.

Patient Impact: Why This Matters

Behind the procedural games and policy maneuvers are real people whose lives hang in the balance. The Colorado PDAB's actions exemplify how these bureaucratic decisions create genuine fear and uncertainty for people with rare diseases and conditions requiring specialized medications.

Twelve-year-old Avery Kluck lives with Aicardi syndrome and faces life-threatening seizures that have been intensifying. Her doctors recommended Sabril, a powerful anticonvulsant costing up to $10,000 per month—a medication on Colorado's PDAB radar for potential price controls.

"We're to a point now where her seizures are getting more violent, and this is our last resort," explains Heather Kluck, Avery's mother. "And now I'm finding out she may not have access to it." The family faces an impossible choice between starting a medication that might become unavailable or watching their daughter suffer.

This uncertainty isn't theoretical. At least one pharmaceutical company has already threatened to pull drugs from Colorado if price caps are imposed. For medications like Sabril, which are dangerous to discontinue abruptly, such market exits could be catastrophic.

People living with cystic fibrosis also had to mobilize to prevent Colorado's PDAB from declaring Trikafta "unaffordable," with one parent describing the experience as "torturous for our family" and another stating: "It's an experiment, and it's really gross that they're doing it on people who are really sick."

The irony is painful: boards created to increase medication access may end up restricting it for those who need it most.

Conclusion

These boards, created under the guise of helping patients afford medications, are operating in ways that actively silence patient voices. From Maryland's last-minute document dumps to Colorado's refusal to conduct impact analyses and Oregon's policy reversals on critical medications, these boards are erecting barriers that exclude the very people who will bear the consequences of their decisions.

The problems run deeper than procedural failures. The fundamental approach of PDABs—attempting to control drug prices without adequately assessing impacts on patient access—risks creating catastrophic unintended consequences for people who depend on specialized medications. Avery Kluck and others living with rare conditions don't have the luxury of waiting while boards experiment with price controls that might make their life-saving treatments unavailable.

The pattern is clear: from the federal level with RFK Jr.'s dismantling of public comment protections to state PDABs playing administrative games, we're witnessing a coordinated retreat from meaningful public engagement in healthcare policy. This isn't just bad governance—it's dangerous for patients.

States should seriously reconsider whether PDABs serve any legitimate purpose beyond political theater. At minimum, stakeholders across the healthcare spectrum must demand that these boards either implement truly transparent, patient-centered processes or acknowledge they cannot fulfill their stated mission without causing harm to the very people they claim to help.

States Push PDABs Despite Warning Signs, Patient Concerns

The debate over how the U.S. tackles rising healthcare costs is as constant as the sun setting in east. Most Americans feel the financial pressures from the high cost of their healthcare, evidenced by individual households holding 27% of the nation’s $4.3 trillion health-related expenditure burden. Healthcare spending is fragmented and multifaceted, being comprised of expenses such as hospitals, residential and personal care facilities, medical providers, technology, and retail prescription drugs. Despite the complexities of the healthcare market, pharmaceutical expenditures are often the most simple target to attack, often accompanied by solutions that seem way too good to be true. The fact is, access to prescription drugs is a significant part of modern medicine but there is nothing simple about how prescription drugs are brought to market and sold to consumers. In 2022, $633.5 billion was spent in the U.S. on prescription drugs, yet overall prescription drug expenditures by the government, private insurers, and patients were less than $1 out of every $7 spent on healthcare.

In recent history, in an attempt to create a “simple” solution to the costs John and Jane Q. Public pay for prescription drugs, through legislation, several states have created PDABs. PDABs are Prescription Drug Affordability Boards, also called Prescription Drug Advisory Boards. In theory, a board created to lower the cost of drugs for patients sounds like a good thing. However, the manner in which PDABs are currently set to operate is more harmful than good. Patients are not included in the development of the PDABs' decisions when those decisions directly affect their lives.

That is why the Community Access National Network (CANN) entered this policy and advocacy space. The boards have the wrong focus and don’t have patients’ interests as the priority. There is a difference between access and affordability. Jen Laws, C.E.O. of CANN, states, “Ultimately, CANN's focus is 'access' - it's in our name. Cheap gimmicks often pose serious potential to disrupt access for patients because we're the interest group here with the least in the way of resources (time, money, manpower). It's why we do what we do, and it's why we're going to keep doing what we do."

The prevalent tool PDABs utilize to lower costs is Upper Price Limits, or UPLs. The myopic focus is the allowable maximum a plan might reimburse a pharmacy or provider for any particular medication. However, this focus is not on lowering the price of what patients pay. A UPL does not determine what drug manufacturers charge for their drugs. It only sets the maximum that insurance plans will reimburse for drugs. That does not directly benefit patients because there is no mandate to pass any “savings” back to patients, for plans to retain medications with lower reimbursements, or for patients to have lower cost-sharing related to these medications. In general, patients pay for medications through co-pays and patient assistance programs. Although UPLs lower drug prices for payors, they increase the price patients potentially pay in terms of access by threatening the financial stability of providers and pharmacies, incentivizing utilization management that prioritize certain medications over others (regardless of an individual patient’s needs), and disrupt the provider-patient relationship by inserting the interests of payors over that of patients.

CANN has created multifaceted resources to educate the public about PDABs, their challenges, and possible solutions. People engage and comprehend in different ways. As such, CANN created varied communications. Long-form blog posts were written to be detailed sources of education and advocacy. A white paper was created as a downloadable handout to empower patients and enable them to engage with local PDABs or legislatures that are considering them in states that do not have them yet. For visual learners, CANN created an animated video that gives an overview of PDABs and their challenges, which is digestible and easily shareable.

With UPLs, the price patients potentially pay by losing access is more damaging than the monetary price tag of a drug a payor considers. UPLs that are set too low can cause drug manufacturers to reduce the production of drugs or place drug purchasing groups in the position of discounting distribution to a particular state altogether if low reimbursement makes them too costly to sell in that state. No purchaser or re-seller can sell to a state at a cost. No pharmacy can distribute a medication that costs them more to provide than they get paid in return. This creates shortages or removal of life-saving medications from the market, resulting in delays in care or patients being forced to utilize medicines that aren’t as efficacious as they and their physicians’ desired prescriptions.

UPLs also damage patient access by adversely affecting the 340B Drug Pricing Program entities that use the revenues from discounts to provide medications and other healthcare services to vulnerable populations without recourse for care. Lower revenues mean fewer services and possibly closures of facilities or program restrictions. AIDS Drugs Assistance Programs are largely dependent on using their 340B savings to extend access to care to poorest people living with HIV. We’re already seeing providers discuss this concern relative to insulin price caps. In a recent 340B Report article, the issue is summed up as follows: “Before 2024, most insulins had list prices of $300-$500 or more and were 340B penny-priced, so 340B providers earned savings of $300-$500 per prescription, Meiman said. However, now that many insulin list prices are $35, the 340B savings could drop to around $8 per prescription, she said. Historically, 340B savings on insulin have accounted for around 10% of community health system 340B revenue, she said.” Colle Meiman, a national policy advisor for the State & Regional Associations of Community Health Centers, also acknowledged this problem is a bit “counterintuitive” to how most policymakers think about drug pricing and reimbursements.

Moreover, lowering the price insurers are allowed to pay for medications is a double-edged sword. While on the surface, it seems like it would save payors money, it potentially only benefits PBMs in the short term and is an additional barrier to patient access. PBMs make their money from the profits they get via drug rebate revenues. Low UPLs will result in drug manufacturers lowering rebate levels and therefore lowering how much PBM’s might make on a particular medication. This means that PBMs could potentially increase the occurrence of benefit designs that restrict drug formularies to steer towards medications that result in more profit, not what is best for patients’ health. This already happens and is a concern many providers are beginning to voice. Additionally, they could enforce more utilization management, which again is a barrier to access but a way to increase their profitability.

CANN is energized to shine the light on PDABs and offer better solutions. Jen Laws explains, "Instead of nonsensical quick fixes, which aren't fixes to anything other than next quarter profits for payors, legislators should be focused on addressing the self-dealing nature of 'vertical integration', shoring up incentives for innovation, and meaningfully fixing benefit design that currently disadvantages patient access." Instead of a PDAB, states should consider a board focused on the patient perspective to evaluate benefit plan designs and offer recommendations to each state legislature about policy actions that will benefit patients as the priority stakeholder group.

In partnership with HealthHIV and The AIDS Institute, CANN will continue this work. It's crucial to stay abreast of the inner workings of policy and to advocate for the public proactively. Digging into the weeds with a patient focus enables advocacy groups to sound the alarm to the public as well as take the patient's perspective to those in power. Those in power are detached from the humanity behind the dollars and cents on their financial ledgers.