At AMCP Nexus 2025, Autumn D. Zuckerman, PharmD, BCPS, CSP, joined by Amy Niles, MBA, and Ashira Vantrees, Esq., unpacked 3 cost-shifting strategies that are reshaping access to specialty medicines: copay accumulators, copay maximizers, and alternative funding programs (AFPs). Their shared goal was to demystify how these designs work, clarify their downstream effects on patients and plans, and outline the policy and legal landscape catching up to them.

Why This Matters

Specialty therapies treat high-severity conditions such as cancer, autoimmune diseases, hepatitis C, and neurologic disorders. Although they serve a small slice of the population, they drive a disproportionate share of pharmacy spend. Employers—especially small and mid-size businesses—face a budget squeeze that has accelerated adoption of benefit designs intended to move costs off the plan and onto other entities, chiefly manufacturers and charities. The speakers emphasized that these strategies often create friction at the pharmacy counter, destabilize adherence, and, in some cases, push patients into nonstandard supply channels.

How the Designs Work

Copay accumulators allow manufacturer copay assistance to be used but refuse to credit those dollars to the member’s deductible or out-of-pocket maximum. When assistance runs out, the patient can experience a sharp mid-year cost spike. Copay maximizers typically reclassify certain drugs as non-essential health benefits, set member cost shares to exhaust the full annual value of copay assistance (often front-loaded in the year), and still do not credit those dollars toward deductibles or out-of-pocket limits. Alternative funding programs carve targeted specialty drugs out of coverage unless the member enrolls with a third-party vendor; enrollment commonly requires financial disclosures, a limited power of attorney, and applications to manufacturer patient assistance programs designed for the uninsured or severely underinsured. In some instances, AFPs route fills through international pharmacies.

A Patient Snapshot

The faculty walked through a real-world case, a 34-year-old patient with Crohn’s disease prescribed a $2000-per-month specialty drug, a $4000 annual deductible, 40% coinsurance thereafter, and an $8000 annual out-of-pocket cap. With a manufacturer copay card valued at $8000, a traditional design would let assistance lower his costs while still advancing him toward his deductible and cap. Under an accumulator, the same $8000 of assistance would not count toward benefits; when the card is depleted, the patient restarts at full cost sharing, creating a sudden affordability cliff. Under a typical maximizer, the patients’s monthly payment may remain low if the administrator correctly adjusts charges, but he still accrues no progress toward his deductible or annual limit, and the plan has effectively absorbed all available assistance.

Evidence on Access, Adherence, and Outcomes

Zuckerman presented multi-site health-system specialty pharmacy data from 2024 to 2025 that prospectively followed patients flagged for AFP involvement and matched them to commercially insured controls without AFPs. Non-AFP patients were substantially more likely to access therapy, with 95% starting treatment versus 83% in the AFP group. Time to first fill diverged markedly, with a median of eight days in the non-AFP cohort and 32 days under AFPs, even though health-system pharmacists actively shepherded access. Gaps in therapy were far more common with AFPs; 35% of AFP patients experienced interruptions despite stopgaps such as samples and courtesy fills, compared with 2% among controls. Clinical deterioration during the access process was documented in 11% of AFP patients versus 1% of non-AFP patients, including flares, disease progression, unscheduled visits, and ED or hospital use.

The pathways to medication also looked different. Most non-AFP patients filled at US pharmacies with minimal reliance on charitable safety nets. In contrast, AFP patients were frequently steered to manufacturer patient assistance programs—about two-thirds were required to apply—and roughly half of those applications were denied once manufacturers recognized AFP involvement. A meaningful share of AFP fills moved through AFP-preferred or “shell” pharmacies and, in some cases, international sources. The study also captured the operational burden: AFP cases required roughly double the pharmacy staff time, and many sites could not identify the AFP until after prior authorization decisions, complicating navigation and counseling.

What Patients Experience Under AFPs

Beyond the aggregate data, the session detailed case narratives. A patient with metastatic colorectal cancer lost coverage, was forced to seek PAP approval that was denied due to AFP enrollment, then had to obtain a passport and complete a telehealth visit with an international prescriber; the first shipment arrived 5 months later and was inappropriate for the regimen. Another patient with severe Crohn’s disease ricocheted among denials, an IV re-induction after a flare, a brief US fill under a maximizer, and then a mandated move to a Canadian source delayed by a labor strike—again a 5-month access odyssey. A third patient with psoriasis was made to apply for Medicaid despite clear ineligibility, then to PAPs, and finally could fill domestically only after enrolling in a foundation grant and a maximizer. These stories, the speakers argued, are not outliers; they illustrate the structural incentives of AFPs to try every non-plan avenue before allowing a covered fill.

PAN Foundation Perspective and Patient Sentiment

Representing the PAN Foundation, Niles described a surge in referrals to “external companies” reported in polling of commercially insured adults. Nearly one-half of respondents said their plan had routed them to a third party to obtain medication, and 4 in 10 reported delays of at least a month; most said the delay carried physical or emotional consequences and triggered additional healthcare use. PAN has intensified monitoring to prevent AFPs from mass-enrolling patients in charitable programs meant for underinsured individuals. The foundation launched patient and provider education, including checklists and an interactive tool to help detect AFP hallmarks such as carve-outs, “non-essential” labels, mandatory third-party enrollment, and threats of 100% member liability if the AFP is declined. PAN and a 30-plus-member AFP Task Force are also engaging Congress and federal agencies to build awareness and press for policy solutions.

Legal and Regulatory Risks Emerging Around AFPs

Vantrees outlined 4 legal frameworks implicated by AFP tactics. Under the Affordable Care Act, prescription drugs are an essential health benefit in individual and small-group markets, and cost sharing for EHBs must accrue toward annual limits. Carving specialty drugs out as “non-essential” to avoid those protections conflicts with federal guidance in those markets and raises compliance concerns. Under the Food, Drug, and Cosmetic Act, routine importation of prescription drugs outside narrow exceptions remains largely prohibited; the US Food and Drug Administration’s (FDA’s) “personal importation” enforcement discretion is intended for individuals, not employer-mandated third-party routing. The Federal Trade Commission Act and state unfair-trade-practice statutes may apply where consumers face substantial, unavoidable harm without countervailing benefits, particularly when coverage is conditioned on third-party enrollment and opaque consent. Finally, ERISA fiduciary duties require plan sponsors to act prudently and solely in the interest of beneficiaries, emerging class actions contend that certain pharmacy benefit structures, fees, and routing decisions would not pass a prudent fiduciary standard, a line of argument that could eventually encompass AFP models.

Policy Status on Accumulators and Maximizers

The panel noted that by August 2025, 26 states, the District of Columbia, and Puerto Rico had enacted bans or restrictions on accumulators in individual and small-group markets. Evaluations of these laws associate them with reduced patient costs and improved adherence and persistence, though the protections remain fragmented without federal action and do not uniformly reach self-funded ERISA plans. Meanwhile, employer surveys show growing interest in maximizers, and mixed views on AFPs, with some large employers citing complexity, ethics, liability, and adherence risks as reasons not to adopt.

What This Means for Payers and Employers

The central promise of these programs is near-term plan savings. The counterfactual presented at Nexus is that savings are often achieved by diverting charitable dollars, extending time-to-therapy, and raising the likelihood of disease worsening, unscheduled care, and member abrasion. Employers also face nontrivial legal exposure if coverage conditions or importation practices prove inconsistent with federal requirements or fiduciary standards. The speakers urged employers to scrutinize vendor contracts, fees, and routing obligations; insist on transparency about sourcing and patient authorization; and model the medical cost implications of delayed or interrupted therapy before embracing AFP carve-outs.

Practical Considerations for Clinicians and Specialty Pharmacies

Clinicians should be alert to trigger phrases such as “non-essential health benefit,” “member advocacy program,” “limited power of attorney,” or mandatory enrollment with a third-party vendor as prerequisites for approval or dispensing. Early, explicit counseling about potential delays and documentation of disease activity during access disputes can protect patients and inform appeals. Health-system specialty pharmacy teams remain pivotal in navigating alternatives, arranging bridge supplies, and escalating safety concerns when international sourcing or non-prescribing providers appear in the chain of care.

Bottom Line

The session’s throughline was straightforward: copay accumulators and maximizers reduce plan liability by decoupling manufacturer assistance from patients’ deductibles and out-of-pocket progression, while AFPs go further by excluding coverage unless patients secure outside funding or imported product. Across datasets, case narratives, and legal analysis, the panel linked these strategies to longer waits, more treatment gaps, measurable clinical harm, and shifting of costs onto charities and patients. Absent comprehensive federal action, vigilance by employers, clinicians, and patient advocates will be the front line for safeguarding timely, safe access to specialty medications.

Reference

Zuckerman AD, Niles A, Vantrees A. Cracking the Code: Understanding Copay Accumulators, Maximizers, and Alternative Funding. Presented at: AMCP Nexus 2025; October 27-30; National Harbor, MD.