AMP is WAC — 12/12/25

Much of this week felt like playing catch-up from past weeks. Good timing because rumors are swirling about Most Favored Nation (MFN) demonstration releases for late next week. Comment letter fun during the holidays!

For those of you who are new to these parts… welcome! I’m a health policy strategist focused on pharmaceuticals. My goal is to make health policy accessible in order improve patient coverage and access. I run my own company, Apteka, where I help clients through monthly policy check-ins, trainings/small group discussions, white papers/issue briefs and public speaking. I believe we can all work together to improve patient care.

MFN Impossible. On Monday, Paragon Health Institute argued for a different take on MFN drug pricing: make it prospective, not retrospective. The pitch starts with a familiar premise — peer countries pay less for identical brands — and says the United States should use MFN to push foreign prices up while nudging U.S. prices down, without harming research and development (R&D). The key difference from what we’ve seen from the Trump Administration: set MFN for future products and deals, not reprice today’s contracts to yesterday’s lowest foreign net price.

Paragon’s critique of retrospective MFN is straightforward. If the United States simply caps today’s prices at the lowest current foreign net price, manufacturers take an immediate, steep revenue hit with no guarantee other countries pay more; investment signals deteriorate, and access may suffer. By contrast, a prospective MFN would apply to new products and future negotiations, giving companies leverage to seek higher prices abroad while accepting lower prices here.

They tie this to Medicaid via the administration’s GENEROUS model: states opting in would seek supplemental rebates to align net Medicaid prices with the MFN benchmark; in return, states would adopt standardized coverage criteria for included drugs. Participation is voluntary on paper, but letters from the White House signal harder edges if firms “refuse to step up.”

Citizen Pain. On Tuesday, ProPublica documented that some Federally Qualified Health Centers (FQHCs) grantees have sued patients over very small balances, in one case as little as $59, and pursued wage garnishments.

One Kansas clinic filed 1,000+ suits since 2020; a Virginia system filed 7,000+ over a decade. Leaders cite financial instability and the need to keep doors open; critics argue the practice undercuts the mission embedded in grants and sliding-fee schedules. The story will draw Hill attention and questions for the Health Resources and Services Administration about how “reasonable efforts” to collect should be interpreted for grantees, what disclosures are required before litigation, and how fees, interest, and attorney costs balance with affordability obligations.

For plans, manufacturers, and advocates, this intersects with medical-debt policy and the 340B debate over who benefits from discounts. It feels like this will generate oversight letters land and states action, but we’ll see.

Don’t Put RWE in the Corner. Last Thursday, JAMA featured a Viewpoint that argued that real-world evidence (RWE) should sit at the center of how the Centers for Medicare & Medicaid Services (CMS) executes Medicare drug price negotiation under the Inflation Reduction Act (IRA). The Viewpoint urges CMS to rely on Medicare-specific adherence, persistence, and outcomes data rather than trial-only summaries that often underrepresent older adults.

This would shift attention from “can the drug work?” to “how does it perform in Medicare populations with polypharmacy, frailty, and gaps in adherence?” The authors press for transparent methods to translate claims and registry outcomes into the IRA’s “clinical benefit” construct and to compare therapeutically similar agents using endpoints that matter in routine care.

As CMS moves forward with 2028 negotiations early next year, it is unclear what will sway the process. Is it data provided by manufacturers playing a role? Do patient advocates really have a voice? Or is MFN pricing driving everything?

There will be Blood (Tests). Late last week, JAMA published an article on the implications of Roche’s Elecsys p-tau181 blood test for use in primary care (cleared by the Food and Drug Administration in October.) Think of it as a screening tool, not a final diagnosis. It’s good at telling when someone probably does not have Alzheimer’s disease; about 98 times out of 100 it’s right when the result is negative. But a positive result is much less clear. Roughly two in 10 positives will be true, which means most positives still need a follow-up scan (a PET brain scan) or a spinal tap to confirm before treatment is considered. This is a huge advance when you think that not long ago, Alzheimer’s disease could be confirmed only by autopsy. (I’m not dead.)

The test is meant for adults 55 and older with signs, symptoms, or complaints of cognitive decline. It is prescription-only.

What this means in practice: health plans will likely cover the test for specific patients, and they’ll ask providers why the test is needed. Clinics will feel the pinch on the next step, getting patients into imaging, neurology visits, and, if appropriate, treatment centers. What to watch next: updated primary-care guidelines, how Medicare Advantage sets coverage rules, and whether newer blood tests start to replace p-tau181 as doctors favor accuracy over convenience.

A Series of Unfortunate Billings. Last week, Health Affairs published an analysis linking county-level medical debt to lower screening and worse cancer outcomes, reframing “financial toxicity” as a population-health driver rather than a personal finance problem.

The authors report that higher shares of residents with medical debt correlate with lower breast and colorectal screening and higher cancer mortality, even when adjusting for community characteristics. For purchasers and plans, the implications are operational: high-deductible designs and aggressive cost-sharing can depress preventive uptake and shift diagnoses into later stages, raising total spend downstream. For manufacturers and patient groups, to get improved outcomes, debt and zero-dollar screenings could move the needle.

2026: A Coverage Odyssey. Last month, JAMA Health Forum laid out a blueprint for psychedelics: rein in misleading advertising, reduce unsafe self-directed use, standardize informed consent, and design coverage rules that fit labor-intensive care.

The authors point out that there is a new Current Procedural Terminology code (0820T) for psychedelic-assisted therapy is in the code set, but more policy is needed. They propose clear advertising oversight, consent forms that explain risks, registries to monitor outcomes and harms, and a national coverage approach through the CMS that bundles the full episode including preparation, supervised dosing, and integration visits.

Payers will look for guardrails that balance access with safeguards against adverse events and misuse. What to watch for: early Medicaid Section 1115 pilots, payer bundles that set the market price for supervision time, and professional-society guidance.

Reviewing the Fundamentals – The Villain is Pharma. Again.

On Monday, Arnold Ventures released a fact sheet meant to fuel price debates well into 2026: it says that, after rebates, U.S. brand-name drug prices are roughly 3× the Organization for Economic Co-operation and Development (OECD) average, and the United States accounts for about 60% of global sales revenue on roughly 24% of volume. It’s crisp advocacy. It’s also built on shaky measurement and market realities that the four-pager flattens.

Before diving in, a quick acknowledgment. Pharmaceutical pricing is controversial; many Americans view it as too high. Fair. But there are multiple, concurrent — and often conflicting — efforts to lower costs: MFN proposals, direct-to-consumer models, Medicare negotiation under the IRA, state importation and prescription drug affordability board experiments, and plan-side utilization rules. Layer that on top of a high list price/high rebate commercial architecture that payers have cultivated for years, and it’s clear there isn’t one villain and one fix. Pointing the finger at manufacturers alone won’t unwind a system that rewards high list/large rebate spread.

Back to the fact sheet. It’s the kind of framing that sounds definitive and powers the “spend less” chorus. But most of what bothers me about these numbers isn’t ideology (well, it is that but…); it’s measurement. If the yardstick changes, the story changes.

Start with the $716 billion figure. That total likely comes from manufacturer invoice sales, not what plans or patients actually pay and not what manufacturers keep after rebates, chargebacks, 340B discounts, and fees. It’s a useful signal for market size; it’s a poor proxy for affordability or net prices. The same government sources that cite invoice totals also publish “expenditures” series that are lower and grow more slowly, and industry compendia that estimate net manufacturer revenue land hundreds of billions below the invoice number. None of these are “wrong.” They’re answering different questions.

Per-capita math has the same problem. Depending on whether the measure is (a) retail pharmacy only vs. all channels, (b) list vs. net, and (c) nominal vs. inflation-adjusted dollars, you can produce very different slopes. A long-run per-capita line from the 1960s will look steep mostly because we’re treating more conditions with medicines (think hepatitis C, HIV, cancer, diabetes/obesity) that used to show up as hospital spend — or simply went untreated.

It is a pet peeve of mine when people say per-capita prescription drug spending has increased. And? Maybe we should be spending more than we do today, not less. The right test is value, not volume. Spending more makes sense when added dollars buy meaningfully better outcomes or avoid more expensive care. Much of recent growth at net is concentrated in areas with tangible clinical gains — oncology, immunology, diabetes/obesity — while broad net price inflation is flat to modest. That’s not an excuse to celebrate every launch price. Let’s not get crazy. But the blunt “too much” frame collapses very different categories into one villain.

If the debate is really about what patients feel, two mechanics matter more than invoice totals:

  • Benefit design. Coinsurance in Medicare Part D and many commercial plans keys off list price. Even if net prices are flat, out-of-pocket (OOP) can rise when discounts aren’t applied at the counter. Recent changes that move pharmacy price concessions to point-of-sale help, but coinsurance on list is still a major driver of nonadherence. Time after time, we see payers prefer high price/high rebate economics; manufacturers are giving their customers what they’ve designed and paid for.
  • Access timing. Cross-country “we pay more” slides often ignore launch timing and reimbursement lags. The United States is usually the first-launch market; other countries add new therapies slower and in fewer indications. Lower recorded spend can be as much about delayed or limited access as it is about better “prices.” Decide what the benchmark is, cheapest unit or fastest path to therapy, and say it out loud. Also, our generics are cheaper; pay more now for innovation, get it less expensive later.

If the goal is to improve affordability and keep the innovation pipeline aimed at hard problems, the to-do list is practical. Call it the magic wand:

  • Base patient cost sharing on net, not list. Coinsurance and deductibles should reflect the price after the rebates and fees everyone knows exist. That change helps the exact people who struggle most—no new bureaucracy required.
  • Publish class-specific snapshots in public programs. We don’t need every contract. We do need periodic summaries of net trends and utilization by class in Medicare and Medicaid so the debate stops leaning on invoice totals to make net-price claims.
  • Accelerate competition where it works. Push interchangeable biosimilars and automatic substitution where safe; keep patent/exclusivity reforms focused on clearing genuine thickets without chilling true follow-on innovation.
  • Cut friction that delays appropriate use. If prior authorization moves from faxes to portals but still blocks clinically preferred agents, patients won’t see value no matter what the invoice series says.
  • Be honest about trade-offs. If the policy choice is “pay less but wait longer” vs. “pay more but treat sooner,” say that plainly and let patients and clinicians weigh in—especially when time matters.

The headline numbers will keep showing up in hearings and op-eds. The better question for professionals and advocates is simpler: Which measure best reflects what patients and payers actually experience, and which levers change that reality fastest? Once the yardstick is clear, it’s easier to say where spending should go up, where it should go down, and how to structure benefits so people can afford the medicines that truly help.

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