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.
Proposed Cigna-Humana Merger Raises Stakes for Healthcare Access Amid Election Uncertainty
Cigna Group and Humana are once again discussing a merger that could create a $140 billion insurance giant, further consolidating the U.S. healthcare system. The talks are in preliminary stages after collapsing last December over disagreements about financial terms. FierceHealthcare notes that while discussions have resumed, no formal agreements have been made yet.
The stakes of this merger extend far beyond corporate boardrooms; it directly impacts millions of people's access to essential healthcare services and affordable medications. With Cigna’s Express Scripts commanding 24% of the PBM market and Humana operating the fourth-largest PBM with 8%, the merger raises serious questions about market concentration and its impact on healthcare affordability and accessibility.
Election Outcome Could Determine Merger’s Fate
The timing of the renewed merger talks between Cigna and Humana is no coincidence, occurring just weeks before a presidential election that could heavily influence the merger’s prospects. Bloomberg reports, Wall Street analysts believe that the deal's future hinges on the election outcome, with talks likely "only tangibly moving forward if Trump wins."
Under a Trump Administration, a more favorable regulatory environment might be expected given the GOP's general preference for deregulation. However, skepticism about large corporate mergers from Trump's base and running mate JD Vance complicates this picture. Vance has even praised current FTC Chair Lina Khan, saying she is "one of the few people in the Biden Administration who I think is doing a pretty good job," indicating a potentially less favorable view of healthcare consolidation than the GOP has historically maintained. On the other hand, a Harris Administration would likely continue the Biden Administration's stricter stance on healthcare consolidation, focusing particularly on protecting underserved and rural communities.
TD Cowen analyst Ryan Langston suggests that any formal merger announcement before the election is unlikely, further underscoring the centrality of the election to the deal’s future. Meanwhile, federal scrutiny of pharmacy benefit managers (PBMs) remains high, with the Federal Trade Commission (FTC) accusing the largest PBMs of using negotiation tactics that inflate drug costs, adding another layer of complexity to the regulatory landscape.
Understanding the Scale and Implications of the Proposed Merger
The proposed Cigna-Humana merger would unite two companies with largely complementary business models. Modern Healthcare reports that Cigna dominates in commercial coverage with 16.1 million members, while maintaining a smaller Medicare presence. In contrast, Humana has fewer than 600,000 commercial customers and is withdrawing from employer-sponsored insurance, while standing as the second-largest Medicare insurer with 8.8 million members.
This complementary structure could ease some antitrust concerns, but the combined PBM operations present a more complex challenge. The American Medical Association's (AMA) position on the CVS-Aetna merger highlighted similar concerns, noting that such consolidation can limit competition and reduce patient access to specialty drugs, which may parallel the challenges presented by this merger. Healthcare Huddle's analysis suggests that a merger would create a PBM entity large enough to rival market leader CVS Caremark, potentially controlling 32% of the market. Such concentration in the PBM space has already drawn scrutiny from regulators and policymakers.
To address regulatory hurdles, Cigna is planning to finalize the sale of its Medicare Advantage business to Health Care Service Corporation for $3.3 billion, a move that Modern Healthcare suggests could ease antitrust concerns by eliminating overlapping services. Meanwhile, Humana has faced challenges, with its value dropping nearly 40% this year due to declining Medicare plan enrollments and performance shortfalls resulting in the Centers for Medicare and Medicaid Services (CMS) downgrading their Medicare Advantage (MA) plans’ star ratings.
The combined entity would have a market capitalization of around $121 billion based on October 2024 valuations. While still smaller than UnitedHealth Group's $528 billion market cap, the merger would establish a stronger competitor across both the insurance and PBM markets, potentially reshaping competitive dynamics in the healthcare sector.
PBM Consolidation: Increased Scrutiny as FTC Takes a Stand
The potential merger's impact on pharmacy benefit management deserves particular attention, especially given recent FTC actions against PBMs. Currently, three PBMs control approximately 80% of the market, with Cigna's Express Scripts commanding about 24% and Humana's pharmacy division holding 8% market share, according to Bloomberg Law analysis.
The timing is particularly sensitive given the FTC's September 2024 administrative complaint against major PBMs. As previously reported by CANN, the FTC alleges these companies engaged in anticompetitive rebating practices that artificially inflated drug prices. The FTC investigation has revealed troubling practices, with PBMs frequently prioritizing higher rebates over lower net prices, leading to the exclusion of lower-cost alternatives and driving up drug prices. A combined Cigna-Humana PBM would control 32% of the market, potentially creating an entity large enough to rival market leader CVS Caremark.
This level of concentration raises serious concerns about negotiating power and drug pricing. Bloomberg Law notes that employer groups are particularly wary of the merger, fearing it could make an already complicated market even more opaque for health plans and potentially lead to higher costs for company health plans.
Impact on Healthcare Access and Specialty Care
Healthcare consolidation has long presented significant barriers for patients who rely on specialized care, including those living with chronic conditions like HIV. For example, patients often face more restrictive formularies, meaning fewer options for necessary medications, and increased prior authorization requirements, which can delay access to critical treatments. This is especially problematic for patients with chronic conditions like HIV, where timely and consistent access to specific medications is critical for maintaining health. Research published by Tufts Center for the Evaluation of Value and Risk in Health shows that consolidation often leads to restricted specialty care access, which can be particularly detrimental to people requiring ongoing care management. For instance, patients with cancer may find it harder to access specialized oncologists or newer, targeted therapies due to narrower provider networks and limited formularies. These barriers do more than inconvenience patients—they delay treatments, ultimately impacting patient outcomes.
The National Academy for State Health Policy (NASHP) reports that consolidated health systems frequently use their market power to implement restrictive contracts that can limit patient choice. These contracts often include clauses that prevent insurers from steering patients to higher-value care providers or limit the ability to negotiate better prices, ultimately restricting patient options and driving up healthcare costs. This can particularly impact people relying on specialty medications and services, like those living with HIV who need consistent access to specialists and specific drug regimens.
Consolidated systems often impose more stringent prior authorization requirements and narrower specialty pharmacy networks, as noted in the BMC Health Services Research study. The AMA highlights that merged entities often use their power to make access to specialty drugs more restrictive, which further limits patient options and exacerbates challenges for those needing specialized care. For people living with HIV, disruptions or delays in accessing antiretroviral medications could have serious health implications.
The combined entity's negotiating power could lead to more restricted provider networks. NASHP's research shows that consolidated entities often leverage market power to demand higher reimbursement rates, resulting in narrower networks that limit access to specialists, including HIV care providers.
Navigating Complex Regulatory Hurdles
The proposed Cigna-Humana merger faces significant regulatory scrutiny at both federal and state levels. The merger is likely to undergo a 12- to 24-month regulatory review, particularly given the current antitrust enforcement environment. Regulatory challenges are expected to include a detailed examination of the potential impact on competition, particularly in the PBM market, and whether the merger could lead to increased healthcare costs for consumers. The recent FTC crackdowns on healthcare companies, which could provide additional insights into the type of scrutiny expected during the review, particularly regarding anti-competitive practices and market concentration. Both the FTC and the U.S. Department of Justice are likely to scrutinize any potential overlap in services and demand divestitures to ensure that competition remains intact. Additionally, state-level reviews could require concessions to protect local markets from becoming overly concentrated.
Kaiser Family Foundation's analysis highlights how the FTC and Department of Justice have increased their focus on both horizontal and vertical integration effects. They now examine broader implications for healthcare costs and access, beyond direct market overlap.
State-level review adds another layer of complexity. KFF notes that 34 states and DC require notification of health insurance mergers, with 13 states requiring explicit approval. This multi-state review process could extend the timeline and require concessions to address state-level concerns.
Looking Ahead: Implications for Healthcare Access and Affordability
The proposed Cigna-Humana merger represents more than a business combination—it embodies the tension between market consolidation and healthcare accessibility. While the companies argue that their complementary business models could improve efficiency, the merger's impact on PBM market concentration and healthcare access demands careful scrutiny.
The immediate path forward hinges significantly on the November 5th election outcome, with analysts suggesting meaningful progress is unlikely before then. Beyond the election, the regulatory review process could extend into 2026, as federal and state regulators examine the merger’s implications for competition, drug pricing, and healthcare access.
For healthcare stakeholders, especially those relying on specialty care and medications, the merger’s outcome could significantly impact their care access and costs. The combined entity's expanded market power in both insurance and PBM sectors could reshape provider networks, prior authorization processes, and drug formulary designs.
Advocacy organizations and policymakers must carefully monitor and engage in the regulatory review process to ensure that any approved merger includes meaningful protections for healthcare access and affordability. The FTC’s current focus on PBM practices provides an important opportunity to address long-standing concerns about drug pricing and access in any merger approval conditions.
Biden’s Inaction Leaves Copay Assistance in Limbo
Inflated prescription drug costs in the United States continue to place a significant burden on people living with chronic conditions. Copay assistance programs, designed to help people afford their medications, have become essential. Yet recent policy decisions and industry practices have put these programs at risk, potentially jeopardizing access to necessary treatments.
The Biden Administration's recently proposed 2026 Notice of Benefit and Payment Parameters (NBPP) rule omits crucial regulations that patient advocates have long been demanding. This inaction allows insurers and pharmacy benefit managers (PBMs) to continue profiting from billions of dollars of drug manufacturer copay assistance intended for patients.
The State of Copay Assistance
Copay assistance programs, primarily offered by pharmaceutical manufacturers, provide financial support to help cover out-of-pocket costs for prescription medications. As health insurance plans increasingly shift costs to patients through higher deductibles and copayments, these programs have become crucial.
According to the latest data from The IQVIA Institute, manufacturer copay assistance offset patient costs by $23 billion in 2023, a $5 billion increase from the previous year. This figure represents 25% of what retail prescription costs would have been without such assistance. Over the past five years, copay assistance has totaled $84 billion, highlighting its importance in maintaining access to medications.
Despite the significance of copay assistance, copay accumulator and maximizer programs accounted for $4.8 billion of copay assistance in 2023—more than double the amount in 2019. Implemented primarily by pharmacy benefit managers (PBMs) and insurers, these programs prevent assistance from counting towards patients' deductibles and out-of-pocket maximums. This practice effectively nullifies the intended benefit of copay assistance, leaving people to face unexpected and often unaffordable costs later in the year.
Recent scrutiny of PBMs has brought attention to these practices. As discussed in our recent article on PBMs, the Federal Trade Commission (FTC) has filed a lawsuit against the largest PBMs for alleged anticompetitive practices that inflate drug costs and limit access to medications. These developments underscore concerns about how PBM practices, including the implementation of copay accumulator programs, impact medication affordability and access.
The impact on access is serious. IQVIA reports that in 2023, patients abandoned 98 million new therapy prescriptions at pharmacies, with abandonment rates rising as out-of-pocket costs increase. This trend highlights the critical role copay assistance plays in helping people not only initiate but also maintain their prescribed treatments.
Public opinion strongly supports action on this issue. A Kaiser Family Foundation survey found that 80% of adults believe prescription drug costs are unreasonable, with broad support for various policy proposals to lower drug costs. This sentiment reflects the public's recognition of the financial challenges faced in accessing necessary medications.
The Legal and Regulatory Landscape
The regulatory environment surrounding copay assistance programs has been in flux, with significant developments in recent years. On September 29, 2023, a federal court struck down a rule that allowed insurers to decide whether copay assistance would count towards patients' out-of-pocket maximums. This ruling reinstated the 2020 NBPP rule, which required insurers to count copay assistance towards patient cost-sharing, except for brand-name drugs with available generic equivalents.
Despite this, the federal government declared that it would not enforce the court's decision or the 2020 NBPP rule until new regulations are issued. This inaction has left patients facing continued uncertainty about the status of their copay assistance.
On January 16, 2024, the Biden Administration dropped its appeal of the court decision. While this action confirms that the 2020 NBPP rule will generally apply until new rules are issued, the lack of enforcement leaves plans and insurers in a gray area regarding their copay accumulator programs.
At the state level, there has been a growing movement to address copay accumulator programs. As of 2024, 21 states, the District of Columbia, and Puerto Rico have enacted laws addressing the use of these programs by insurers or PBMs. These laws generally require any payments made by or on behalf of the patient to be applied to their annual out-of-pocket cost-sharing requirement. While these state actions provide important protections, they do not cover all insurance plans, particularly those regulated at the federal level.
The 2026 Notice of Benefit and Payment Parameters Proposal
The proposed 2026 NBPP rule, released by the Centers for Medicare & Medicaid Services (CMS), has drawn criticism from patient advocacy groups for significant omissions related to copay assistance and essential health benefits (EHB).
Notably absent from the proposed rule are regulations clarifying whether copay assistance will count toward patient cost-sharing. This omission perpetuates uncertainty created by previous conflicting rules and court decisions, allowing insurers and PBMs to continue implementing copay accumulator programs that can leave people with unexpected and unaffordable out-of-pocket costs.
The proposal also fails to include a provision to ensure that all drugs covered by large group and self-funded plans are considered essential health benefits, despite previous indications that such a provision would be forthcoming. This failure to close the EHB loophole allows employers, in collaboration with PBMs and third-party vendors, to designate certain covered drugs as "non-essential," circumventing Affordable Care Act (ACA) cost-sharing limits designed to protect people from excessive expenses.
By exploiting this loophole, plan sponsors can collect copay assistance provided by manufacturers without applying it to beneficiaries' cost-sharing requirements. This practice effectively doubles the financial burden on patients: first, by accepting the copay assistance, and second, by requiring them to pay their full out-of-pocket costs as if no assistance had been provided.
Recent research by the HIV+Hepatitis Policy Institute has revealed that over 150 employers and insurers are taking advantage of the EHB loophole. This list includes:
Major companies such as Chevron, Citibank, Home Depot, Target, and United Airlines
Universities including Harvard, Yale, and New York University
Unions like the New York Teamsters and the Screen Actors Guild
States such as Connecticut and Delaware
Insurers, including several Blue Cross/Blue Shield plans
Patient advocacy groups have reacted strongly to these omissions. Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, stated, "Every day these rules are delayed is another day that insurers and PBMs are pocketing billions of dollars meant for patients who are struggling to afford their drugs." This sentiment reflects the frustration of many who have long advocated for stronger protections.
The widespread exploitation of the EHB loophole underscores the urgent need for federal action to protect patients from these practices. The failure to address these critical issues in the 2026 NBPP proposed rule highlights a significant setback in efforts to improve medication affordability and access for people living with chronic conditions.
The Impact on Patients: Data and Experiences
The real-world impact of copay accumulator programs and the EHB loophole is reflected in both data and personal experiences. IQVIA reports that patient out-of-pocket costs reached $91 billion in 2023, an increase of $5 billion from the previous year. This rise in costs comes despite the $23 billion in copay assistance provided by manufacturers, highlighting the growing financial burden on patients.
Prescription abandonment is particularly concerning. Patients abandoned 98 million new therapy prescriptions at pharmacies in 2023, with abandonment rates increasing as out-of-pocket costs rise. More than half of new prescriptions for novel medicines go unfilled, and only 31% of patients remained on therapy for a year. These statistics highlight the direct link between cost and medication adherence.
People across the country are facing these challenges. For example, a mother whose daughter lives with cystic fibrosis shared her experience with a copay accumulator program. In early 2019, her family's out-of-pocket cost for her daughter's medication suddenly jumped from $30 to $3,500 per month when their insurance plan stopped applying copay assistance to their deductible. This unexpected change forced the family to put the cost on credit cards, creating significant financial strain and unnecessary medical debt.
Similarly, a person living with psoriasis faced steep increases in medication costs when their insurance company stopped counting copay assistance towards their deductible. The copay rose from $35 to $1,250 monthly, leaving them with only $26 from their disability payment after covering the copay.
These stories are not isolated incidents. People living with conditions such as HIV, hepatitis, multiple sclerosis, and hemophilia are facing similar challenges. The impact extends beyond financial stress, affecting medication adherence and, ultimately, health outcomes. For many, the choice becomes one between essential medications and other basic needs such as food and shelter—a decision no one should have to make.
Policy Recommendations and Advocacy Efforts
Patient advocacy groups are intensifying efforts for policy changes at both the federal and state levels. The All Copays Count Coalition, comprising over 80 organizations representing people living with serious and chronic illnesses, has been at the forefront of these efforts. In a letter to federal officials, the coalition urged for a revision of the cost-sharing rule to include clear protections ensuring that copayments made by or on behalf of a patient are counted towards their annual cost-sharing contributions. Specific recommendations include:
Maintaining the protections included in the 2020 Notice of Benefit and Payment Parameters.
Ensuring that copay assistance counts for medically appropriate medications, even when generic alternatives are available.
Limiting Health Savings Account-High Deductible Health Plan (HSA-HDHP) carve-outs to situations where using copay assistance would result in HSA ineligibility.
At the state level, advocacy efforts have led to the passage of laws restricting copay accumulator programs in 20 states, the District of Columbia, and Puerto Rico as of summer 2023. However, these state-level protections do not cover all insurance plans, particularly those regulated at the federal level, highlighting the need for comprehensive federal action.
Advocates are calling for:
Immediate enforcement of the 2020 NBPP rule, requiring insurers to count copay assistance towards patient cost-sharing in most cases.
Swift action to close the essential health benefits loophole for all plans, including large group and self-funded plans.
Increased oversight and regulation of PBM practices, particularly regarding copay accumulator and maximizer programs.
Passage of comprehensive federal legislation to protect those relying on copay assistance.
As Carl Schmid emphasized, "While they have gone on record that they will issue these rules, the clock is ticking and there isn't much time left." This reflects the growing frustration among patient advocates with the administration's delays in addressing these issues.
Policymakers must act swiftly to close the essential health benefits loophole and ensure that all copay assistance counts towards patients' out-of-pocket costs. Stakeholders across the healthcare ecosystem—from insurers and PBMs to pharmaceutical companies and patient advocacy groups—must collaborate to develop solutions that prioritize access and affordability. The health and well-being of millions depend on these critical policy changes.