The story of patient access this year is really two stories that meet in the same place. The first is structural: the insurance landscape is being rebuilt, reshaping how pharmacy benefits are paid for, how long people keep coverage, and what a marketplace plan covers. The second is where patients feel it: those shifts are landing hard on the copay, charity, and support programs they lean on when their coverage falls short. Watch the first story closely enough, and you can see the second one coming.
PBM pay is changing, and the approval process with it
For years, pharmacy benefit managers (PBMs) made much of their money from rebates tied to a drug’s list price. That model is now being pulled apart. The FTC has pursued claims against the three largest PBMs over rebating practices that allegedly inflated prices, particularly for insulin. Express Scripts settled in February 2026, OptumRx moved toward a resolution via a proposed consent agreement in June 2026, and CVS Caremark followed in July 2026. With landmark federal and state PBM transparency and 100% rebate-pass-through mandates now enacted, programs must actively evaluate how these new compliance requirements will reshape plan economics and utilization controls ahead of the 2028–2029 deadlines.
For patients, the reform may not feel like much. As PBMs lose rebate revenue, many are tightening prior authorization and step therapy to control utilization, so the near-term experience is more friction and longer approval timelines, not a simpler pharmacy visit. Where a patient sits matters, too: self-funded employer plans governed by federal ERISA rules can carry different requirements than state-regulated plans, and a Sixth Circuit ruling in April 2026, McKee Foods, confirmed ERISA shields self-funded plans from many state restrictions. OptumRx is now testing that same argument against California’s own PBM transparency law. The through-line is that a financial restructuring between plans and PBMs reaches the patient as administrative drag before the first fill.
TAKEAWAY
- For patients: the reform’s near-term effect is more friction, not less — expect longer prior-auth and step-therapy timelines before the first fill.
- Watch: the ERISA line. Self-funded plans (McKee Foods, Apr 2026) can sidestep state rules, so patient experience will vary by plan type and geography.
Medicare patients hit their cap early, and can pay it down in installments
The Inflation Reduction Act caps Part D out-of-pocket spending at $2,100 in 2026. That’s real relief, but it reshapes when help is needed rather than whether. Because the redesign eliminated the old sliding co-insurance, a patient on an expensive specialty drug can cross the annual cap within the first few months of the year and then owe nothing more, while the manufacturer’s share of cost in that early window climbs to as much as 20 percent. The need doesn’t disappear; it concentrates into Q1. Support programs built around steady, year-round demand should plan for an early spike instead.
The negotiation program keeps widening in parallel: Medicare issued its first price offers for the 2028 negotiated products June 1, with manufacturers given until July 1 to respond. Starting in 2028, negotiation reaches physician-administered drugs for the first time — Botox, Orencia, Entyvio, Xolair, Cimzia — which could change how willing some clinics are to keep administering them in-office.
Medicare offers a pressure valve for that early-year cost. The Medicare Prescription Payment Plan lets patients spread Part D out-of-pocket costs into monthly installments instead of paying the full amount at the pharmacy counter. It is a useful budgeting tool, but a sharp-edged one: manufacturer and hub teams should provide education and enrollment support, while avoiding any payment clearly not permitted under current CMS or OIG guidance. In practice, hubs can explain how the program works and help patients enroll; they should not touch the payment itself.
TAKEAWAY
- Plan for it: the $2,100 cap concentrates assistance need into Q1 for specialty patients. Staff and forecast for a front-loaded year, not even monthly demand.
- The MPPP trap: hubs can educate and support enrollment, but any help with monthly payments should be avoided unless clearly permitted by current CMS or OIG guidance.
Medicaid is getting harder to keep, usually for paperwork rather than eligibility
H.R. 1, the One Big Beautiful Bill Act, added Medicaid requirements that are expected to increase procedural coverage-loss risk as states implement them. The issue is often paperwork, not financial eligibility; adults must document qualifying work or community-engagement activity, with federal guidance pointing to an 80-hour monthly standard or equivalent income threshold. Eligibility for that group will also be checked more frequently, creating more opportunities for eligible patients to lose coverage because they miss a deadline.
Retroactive coverage has shrunk too — down to one month for expansion adults and two for traditional enrollees like people qualifying through disability — so a patient treated just before their coverage is official can face a bill they never saw coming. The Congressional Budget Office projects the Medicaid provisions alone will add close to 7.8 million people to the uninsured by 2034, with a broader estimate factoring in ACA subsidy changes closer to 10 million.
The operational reading matters more than the policy one. A sudden drop in a patient’s Medicaid status usually doesn’t mean they found other insurance. It means they missed a form, and they often don’t realize it until they’re turned away at the pharmacy. Their underlying need hasn’t changed, and they’ll need help within weeks. A program that flags an inactive Medicaid status and proactively bridges that patient catches this group early, instead of waiting for them to surface in crisis.
TAKEAWAY
- The operational read: new Medicaid requirements are expected to create procedural coverage-loss risk — a missed deadline, not necessarily a change in need. The patient may still need the drug.
- Do this: flag inactive Medicaid status and bridge proactively. A program that waits for these patients to surface catches them weeks too late
Marketplace plans are leaving people underinsured
Premium payments for ACA marketplace plans rose sharply after the enhanced federal subsidies that had held them down for several years expired, though the increase varies by income, geography, and plan choice. To keep monthly premiums manageable, many families are moving from Silver and Gold plans into lower-premium Bronze coverage, where deductibles and out-of-pocket exposure can be substantially higher. For a patient’s first specialty prescription of the year, a Bronze plan can feel almost like no insurance at all.
It shows up as a wave of patients whose copay assistance pays out its maximum on the very first claim of the year, in January or February, rather than partway through as older forecasting models assumed. A growing number of people look insured on paper and face uninsured-level costs for their first fills, and hub staffing and forecasting should plan for that front-loaded demand rather than assume utilization spreads evenly across twelve months.
TAKEAWAY
- The pattern: Bronze-plan migration means copay assistance now maxes out on the first claim of the year, in January or February, not partway through as older models assumed
- So what: a growing group looks insured on paper but faces uninsured-level first-fill costs. Forecast the front-loaded spike.
Copay assistance that doesn’t count toward the cap
Some plans classify certain specialty drugs as “non-essential,” which can keep manufacturer copay assistance from counting toward a patient’s deductible or annual out-of-pocket maximum. Whether that happens depends on plan design, state law, and employer plan status. Federal rulemaking has not fully resolved the issue, so states and regulators are moving on their own. In April, 45 state attorneys general backed a proposed Department of Labor rule that would require PBMs to disclose how they handle accumulator and maximizer strategies to the employers sponsoring their plans.
In May, regulators in Pennsylvania, Delaware, and West Virginia received formal complaints against Highmark Blue Cross Blue Shield over its “Copay Armor” program, which allegedly reclassifies specialty drugs as non-essential specifically to run this play. And California is moving fast. SB 1119, banning accumulator programs outright, cleared the state Senate 39 to 0, and SB 1199, requiring all cost-sharing to count toward the out-of-pocket maximum, passed 26 to 0. Both are still working through the Assembly.
The mechanics are what make this bite. A plan sets the patient’s monthly cost-share to match the full value of the copay card, draining a year of assistance in roughly 90 days — the industry’s “financial cliff.” Because none of that spending counted toward the patient’s cap, they’re then responsible for the full cost, and many stop filling at exactly that moment, concentrating abandonment in Q2 and Q3.
Alternative funding programs push further still: some plans now exclude specialty drugs from coverage entirely and route patients toward charity or free-drug programs, leaving them in “pending purgatory” for 60 days or more while a vendor hunts for outside funding. In March 2026 the FDA ruled that AFP vendors importing drugs from outside the U.S. to cut costs — a tactic some use — aren’t operating legally under Section 804 of federal drug law, and Aimed Alliance published guides in June flagging that the same practice draws Department of Homeland Security scrutiny. Copay assistance was built to help patients afford treatment; it’s increasingly a lever to shift cost from plans onto manufacturers, with patients caught in the middle.
TAKEAWAY
- The mechanism: accumulators drain a year of assistance in ~90 days (the “financial cliff”), then patients owe full cost and many abandon — concentrating drop-off in Q2 and Q3
- Regulatory tailwind: 45 AGs, the Highmark complaints, and California’s SB 1119/1199 are all pushing back, but unevenly. Exposure still varies by state, payer, and employer plan
The charity safety net is consolidating, and manufacturers are becoming the default
The independent charities that have long helped cover patient costs are consolidating and rethinking how they operate. Two of the largest, the Patient Advocate Foundation and the PAN Foundation, have combined, with TotalAssist launching July 1, 2026 as a unified financial assistance program. The shift comes as OIG Advisory Opinion 24-02, a favorable, but time-limited opinion for one specific charitable patient-assistance arrangement with defined safeguards, remains in effect only through January 1, 2027. It should not be read as broad protection for every single-manufacturer-funded foundation model. That uncertainty is one reason why charities and manufacturers are reassessing how durable the current safety net will be after the opinion sunsets.
At the same time, hospitals are losing access to the 340B discount program as Medicaid disenrollment lowers the share of low-income patients they report. More than 300 hospitals are at risk of dropping below the federal threshold — 11.75 percent of disproportionate share adjustment percentage — that determines eligibility, and patients who once received discounted drugs through their hospital are being redirected straight to manufacturer assistance. The net effect is that patients can no longer count on an outside foundation as a reliable backup; manufacturers are becoming the primary source of help, not the secondary one, and some patients will land in PAP enrollment without understanding why their costs changed.
One population is especially exposed. Rare disease and gene therapy patients lean on this same charity channel for both copay and travel support, since treatment is often available at only a handful of centers nationwide. The populations are small and the per-patient need is large, and there isn’t yet a comparable internal program ready to absorb that volume as the charity channel tightens. What used to be a supplemental safety net is becoming the main one, and staffing and budgeting should reflect that shift, with rare disease and gene therapy programs planning earliest.
TAKEWAY
- The shift: with OIG 24-02 sunsetting Jan. 1, 2027 and 340B eligibility pressure affecting some hospitals, manufacturers may become a more important safety net, not merely the backup
- Most exposed: rare disease and gene therapy — small populations, large per-patient need, few treatment centers, and no comparable internal program ready to absorb the volume. Plan these earliest.
A new option: paying cash directly to the manufacturer
TrumpRx, the federal direct-to-consumer cash-pay portal, launched in early February 2026. It gives cash-pay patients access to discounted purchasing routes outside insurance and the traditional PBM channel. The portal channel opened for a defined slice of the market, including certain brand drugs, GLP-1s, and generics moving outside PBM formulary control. Because cash transactions bypass insurance, many accumulator, maximizer, and alternative-funding dynamics may not apply.
The catch is that the tradeoff is data, not money. A cash purchase doesn’t flow through the claims data that lets a hub see whether a patient refilled on time or stayed on therapy, so a patient using this route can become invisible to the very program meant to support them. For now the pathway is concentrated in GLP-1 medications; whether it spreads to other classes is worth watching.
Cash-pay can solve a real affordability problem, but unless a manufacturer builds a separate way to stay in touch, it trades that solution for a blind spot in how the patient is actually doing.
TAKEAWAY
- The tradeoff: cash-pay can bypass the PBM and many accumulator issues, but the tradeoff is visibility. A cash transaction can make the patient harder for the hub to track and support
- Scope check: for now this is mostly GLP-1s. Whether it spreads to other classes is the thing to watch — and the reason to build a separate way to stay in touch with cash-pay patients.
What ties it together
Every one of these shifts points the same direction: access pressure is arriving earlier in the year, spreading across more plan types, and moving into channels where the traditional claims trail goes quiet. The programs that will hold up are the ones that stop treating affordability, coverage continuity, and patient visibility as downstream cleanup and start treating them as one connected strategy: forecast for a front-loaded year, watch for procedural coverage loss, and build a way to see the patients who’ve slipped off the insured pathway before they slip off therapy.
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.
About the Author
Dana Edwards, Vice President, Patient Access & Strategic Engagement
Dana Edwards serves as the Vice President, Patient Access & Strategic Engagement at UBC. She brings more than 20 years of experience in executing patient service and market access strategies to this role. Ms. Edwards is a strategic advisor to pharmaceutical and biotech leaders on the design and implementation of patient service programs that synchronize the right people, services, and technology for their unique patient population and therapy.
