Today we’re expecting to hear more about manufacturer Most Favored Nation (MFN) agreements and (if you trust the rumors) maybe more about the MFN demos – the Global Benchmark for Efficient Drug Pricing (GLOBE) Model and the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model.

I wasn’t planning on publishing the next two weeks, but if something big drops, I won’t be able to help myself. I’m a recovering corporate consultant turned policy maven and strategist. To those of you tuning out until January: happy holidays. To the rest of you—we’re suckers, but the best kind.

340B is 7 times Maine’s Annual State Budget. Last Thursday, the Health Resources and Services Administration (HRSA) posted 2024 purchase data showing $81.4 billion in covered outpatient drug buys by 340B covered entities.  The update is already a talking point for both expansion foes and defenders of the safety net.

For manufacturers, the implication is contracting and audit posture: larger 340B volumes increase duplicate discount risk when Medicaid managed care intersects with exchange and employer plans. For hospitals and clinics, the message is accountability — expect calls to tie savings to patient-visible services. Policymakers will read these figures into ongoing fights over contract pharmacy scope and data transparency.

And while we’re talking about 340B, today a Maine federal court will hear arguments on a temporary restraining order (TRO) in the American Hospital Association (AHA) and Maine Hospital Association (MHA) challenge to HRSA’s 340B Rebate Model Pilot Program. The suit targets HRSA’s plan to replace point-of-sale discounts in 340B with back-end rebates on Medicare negotiated drugs starting January 1. Hospitals say the shift front-loads cash costs, piles on administrative work, and risks access for safety-net patients; HRSA frames it as a test to prevent duplicate discounts and improve integrity.

The hearing matters for manufacturers and covered entities. If the TRO is granted, the pilot pauses. If denied, the rebate model kicks off while litigation continues.

Levers & Limits. On Thursday, KFF published a brief mapping current congressional proposals to regulate pharmacy benefit managers (PBMs), including delinking Part D compensation from list prices, prohibiting Medicaid spread pricing, and new reporting to plan sponsors and the Department of Health and Human Services.

The analysis also summarizes Congressional Budget Office scores showing relatively modest federal savings from PBM reforms alone. PBM reform is not a panacea. As PBM reform (eventually?) becomes reality, manufacturers should plan for more point-of-sale rebate conversations—and more pressure to document how net price translates into adherence and access.

The Value of Information. On Monday, theAmerican Journal of Managed Care published an analysis of launch-price communications for new molecular entities (2022–2024). Headline finding — about one-third of drug makers proactively disclosed launch prices; another third did so reactively, and the rest did not disclose. For plans and PBMs, this matters for formulary timing and member communications; for manufacturers, it underscores reputational tradeoffs when value frameworks (e.g., Institute for Clinical and Economic Review) fill the vacuum.

The paper suggests a policy opening: standardized, context-rich disclosure at launch. Manufacturers could link list price to net expectations, assistance programs, and value argumentation. The premise is that information asymmetry drives noise; consistent disclosures at launch can make coverage and access debates more fact-based. I think it is possible, but I’m a little skeptical. Too many ad boards have colored my view on these things.

Dual Duty (OIG + Duals) — On Wednesday, the Office of Inspector General (OIG) posted an analysis on Medicare-Medicaid dual-eligible beneficiaries’ access to prescription drugs under Medicare Part D. The topline is familiar: this population faces a higher burden of chronic disease and is more sensitive to utilization management. But it gets interesting when you dive into the data.

Digging in, the variation pops up in three ways – geography, pharmacy networks, and appeals.

Geography: overall coverage looks good, but county-level gaps persist, especially in rural areas and long-term-care settings.

Pharmacy networks: plan design choices (preferred vs standard cost-sharing pharmacies, specialty pharmacy carve-outs, and heavy mail-order reliance) can turn “covered” drugs into higher effective costs or longer waits if a beneficiary’s nearest pharmacy isn’t preferred or lacks stocking capacity for specialty items.

Appeals dynamics: few denials are appealed, but a large share are overturned when they are. This implies many dual-eligible beneficiaries live with avoidable barriers unless plans improve first-pass decisions and simplify exceptions.

This can and should be mined to push for targeted oversight: formulary adequacy reviews in counties with low preferred pharmacy density; audits where denial reasons cluster around documentation quirks; and enhanced monitoring for key therapeutic areas (antipsychotics, anticonvulsants, insulin.)

Planning Ahead. On Tuesday, Maryland’s Prescription Drug Affordability Board (PDAB) held informational hearings on Ozempic and Trulicity, signaling sustained scrutiny of high-spend categories and how any upper payment limit (UPL) might interact with formularies and utilization management. The board also posted a written-comment packet ahead of its recent meeting, with stakeholders pressing for patient-centered metrics, rebate-delinking, navigator programs, and clearer timelines if non-ceiling tools are used. For manufacturers, it makes clear the need to defend continuity of care and document real-world adherence risks of moving forward with UPLs.

On Wednesday, Oregon’s PDAB met with agenda materials posted alongside its calendar. As we look ahead, it is reminder that 2026 will be the year that PDABs have to show what they can do or potentially move along. Expect Oregon to keep building its cadence, with public-comment windows and data-needs that will force sponsors to translate national dossiers into state-specific evidence.

State PDABs are converging on three levers: UPLs, non-UPL policy tools (e.g., PBM reform, patient navigation), and transparency asks. And while a UPL is pretty awful, the real risk is a patchwork of state actions that complicates contracting, coverage, and messaging across Medicare, Medicaid, and employer plans.

Policy Fundamentals: Patient Out-of-Pocket (OOP)

In my strategic advisory business, my philosophy that health policy isn’t impossible to learn – it just takes some effort and good teachers. Proof – Representative Jake Auchincloss (D-MA.) Rep. Auchincloss has taken an interest in PBMs and has learned a LOT.

And his new bill, the ACA Copay Cost and Affordability for Patients (CAP) Act of 2025 (H.R. 6171 gets straight to the heart of a problem that many Americans face. There’s a specific kind of gut-punch that happens at the pharmacy counter: patients did the “responsible” thing, bought insurance, paid the premium every month… and then the pharmacist tells them their OOP is $1,800. Because a plan’s benefit design puts the weight of prescription drug costs on the people who need drugs the most.

At its core, the bill amends the Affordable Care Act’s cost-sharing rules to establish a separate annual limit specifically for prescription drugs dispensed during the plan year:

• Starting in plan year 2027, the annual out-of-pocket cap for prescription drugs would be $2,000 for self-only coverage.
• For family (non-self-only) coverage, the prescription-drug cap would be twice that amount ($4,000).
• Beginning in 2028, the cap would increase each year using the ACA’s premium adjustment percentage, with increases rounded down to the nearest $50.

The important practical point: once an enrollee hits that prescription-drug cap, the plan can’t keep charging cost-sharing for covered prescription drugs for the rest of the year, even if the person hasn’t hit the plan’s broader medical out-of-pocket maximum. The bill includes a conforming change to make that “no more cost-sharing for drugs after the cap” rule work inside the ACA’s existing structure.

Auchincloss’s office frames it as a consumer-protection fix that preserves most plan design flexibility while stopping the worst cost-shifting onto patients who rely on medications.

The Reality of ACA Plans

Yes, ACA plans already have an overall out-of-pocket maximum. But that maximum is often so high that it fails the “real life” test, especially for people taking specialty drugs.

For example, the OOP limit for 2026 can be as high as $10,600 for an individual and $21,200 for a family. Not many middle-income families simply absorb that much over the course of the year, much less large chunks of that or all of it at once.

Add in that many plans have deductibles that are meaningful barriers on their own, and some have separate deductibles for medical services vs. prescription drugs, which can front-load pharmacy costs even when patients are not using much medical care. K

Then there’s specialty tier cost-sharing. In some non-standardized Marketplace designs, specialty drugs can be subject to 40–50% coinsurance after the deductible. If a drug has a list price of $6,000 a month, 40% coinsurance is $2,400. Which is not uncommon for a lot of autoimmune, oncology, and rare disease therapies.

We also have evidence that this burden is getting worse. A 2025 analysis cited by Auchincloss’s office (from No Patient Left Behind) found that ACA plans increased patients’ prescription drug costs by an average of 36% since 2021 and estimated 5.6% of enrollees had annual pharmacy out-of-pocket costs above $2,000.

The problem is that insurance designs are increasingly comfortable treating prescription drugs like a place to park costs, and the people with chronic illness become the financing mechanism.

The Right Direction

This bill restores the basic promise of insurance.

1. It stops cost-shifting to the sickest people. An OOP cap for drugs forces risk pooling to work the way it’s supposed to. Without it, plans can keep premiums attractive by pushing spending into deductibles and coinsurance that only a subset of enrollees will ever face.
2. It creates understandable protection. Under the Inflation Reduction Act’s Medicare Part D redesign, beneficiaries gained an annual OOP cap.  Auchincloss’s bill is essentially saying: if we agree this consumer protection is reasonable for Medicare beneficiaries, it’s hard to defend why ACA enrollees should be left with a $10k-plus exposure before meaningful relief kicks in.

What it doesn’t solve (and why it still matters)

Will this eliminate high drug prices at the point of sale? No. It’s not a rebate reform bill. It’s not a PBM overhaul. It’s a patient protection bill.

Could it put upward pressure on premiums or drive plans to tighten utilization management? Also possible, when you limit one lever (patient cost-sharing), plans look harder at other levers (networks, formularies, prior auth). That’s why this should be paired with transparency and accountability measures, not treated as the final chapter.

But as a move in the right direction, it’s solid because it’s a simple rule that targets a very specific failure mode in our current system: “you can have insurance and still be unable to afford your medication.”

That’s what makes it worth supporting. It’s not ideology. It’s basic functionality.