AMP is WAC -- 6/19/26

ACO: Another Comment Opportunity

I was bribed this week; all it took was a slice of pizza. I was on the fence about going to a show at the Atlantis in DC and my husband promised me Andy’s pizza and, really, how could I say no? Turns out it was amazing (pizza + concert). The show was just joyful. An hour of a performer that just danced and played and had so much fun. It was a reminder that joy can sometimes be a choice and one that doesn’t get decided on a slice of burrata margherita.

If It Were Easy. Senate Finance Democrats released a sprawling RFI this week on lowering drug costs. Comments are due August 17.

But let’s be honest about what this document actually is. It’s a messaging document for whenever Democrats next hold the gavel, not a bill working its way through markup. The 70-plus listening sessions and the careful sourcing make it a serious piece of policy thinking. They do not make it law.

Looks like healthcare stakeholders all have homework this summer: figure out which of these ideas survive contact with an actual legislative session, and which ones quietly become 2027 talking points instead.

Win Some, Lose Some. Illinois wrapped up its spring session by passing two 340B bills that only make sense together. House Bill 2371 bars drug companies from blocking covered entities’ use of contract pharmacies to dispense 340B drugs, and limits what cost or income data those entities must disclose beyond what state or federal law already requires. That’s a win for community health centers and hospitals, who rely on contract pharmacy access to deliver the discount to patients (or, depending on who you ask, to themselves).

House Bill 4327 is the cost of that win. It orders the Illinois Department of Insurance to audit the program, requiring drugmakers to report their aggregate 340B discounts going back to 2020, and forcing some transparency on how much revenue covered entities and hospitals are generating off those discounts and where it goes.

The huge growth in 340B, with little visibility into where the margin actually lands, is exactly why states keep trying to legislate around a program that’s fundamentally a federal one. Illinois can audit covered entities all it wants. It can’t touch HRSA’s enforcement posture, can’t change the 340B ceiling price calculation, and can’t resolve the underlying fight over whether the discount is reaching patients or just padding margin somewhere in the supply chain.

Call this a transparency win wrapped around an access win, with the actual accountability question punted to whatever the audit finds.

If at First You Don’t Succeed. Colorado got Food and Drug Administration (FDA) approval to import prescription drugs from Canada, becoming only the second state ever to clear that hurdle, two years after Florida got the same approval (and still hasn’t actually imported a single pill.)

I mean it’s worth asking why the second state to clear this hurdle should expect a different outcome than the first. So, Colorado partnered with a wholesaler, Adira Medica, which will coordinate with Canadian manufacturers, ship drugs to a Pennsylvania subsidiary for testing, get FDA sign-off on the test results, relabel everything, and then send it on to participating pharmacies. The state’s initial wishlist covers 20 brand-name drugs treating things like blood clots, cystic fibrosis, and cancer, though the actual list depends entirely on which Canadian manufacturers agree to sell into the program, and that’s where this tends to fall apart.

Canada’s drug supply is sized for Canada. Manufacturers that distribute there have no obligation to sell extra volume into an American import scheme, and several have said as much. A federal judge already tossed one industry lawsuit against this framework in 2023, so the legal path is technically open. The commercial path is a different story.

Florida proved that getting the FDA’s signature is the easy part. Getting a willing Canadian seller, at scale, without straining Canada’s own market, is the part nobody’s solved yet. Colorado’s now free to try. My hunch is “free to try” and “actually does it” stay two different things for a while.

Ich Gebe Auf. On Monday, a German government source told Reuters that they are scrapping their plan for variable drug discounts, the kind that would have moved up or down depending on the country’s total drug spending and how much revenue the health system was pulling in. In its place: a fixed discount level, size still unannounced, so companies can plan ahead.

That’s the polite version. The real one is that Germany floated this self-adjusting rebate formula back in April as part of a plan to close a €20 billion funding gap and avoid hiking mandatory health insurance premiums, and industry didn’t just object, it threatened money. Eli Lilly’s CEO said the company would halve its planned €2.3 billion German investment. VFA, the German innovative pharma trade group, was more diplomatic, saying only that it had pushed for “a thorough impact assessment.” Lilly’s number is the one that moved this, not the diplomacy.

“Fixed” doesn’t necessarily mean “smaller.” The government hasn’t said what the new discount level will be, and the €20 billion hole still exists. What manufacturers won here is a number they can build a forecast around.

For anyone tracking the international reference basket feeding Most Favored Nation-style benchmarking, a flat discount is a far cleaner input than a formula tied to shifting national drug spend and health system revenue.

And, a side point, it is nice to see that other countries haven’t figured out healthcare spending either.

This Time, For Real. On June 15, the Health Resources and Services Administration (HRSA) published a Federal Register notice seeking comment on the data-submission burden for a revised 340B rebate pilot. It’s a clear signal -- the agency has not given up on the rebate model after the mess that was last winter.

Quick reminder for anyone not tracking this closely: HRSA stood up the original rebate pilot in 2025, limited to Inflation Reduction Act (IRA)-negotiated drugs. Covered entities sued. In December, a federal court in Maine granted a preliminary injunction, calling the agency’s administrative record “anemic” and finding that HRSA had not adequately considered covered entity interests, including the operational and cash-flow consequences of moving from upfront discounts to after-the-fact rebates. The First Circuit declined to stay the injunction. The government dropped the appeal in January, and by February HRSA was back at the drawing board with an RFI asking how a rebate model should be built. Comments closed April 20.

This new notice is HRSA doing its homework and asking about the burden associated with manufacturer pilot plans, manufacturer purchase reports, and covered entity claims-data submissions. That matters because the first version failed, at least in part, because HRSA had not built a record showing it had seriously weighed the burden on covered entities before changing how 340B discounts would flow.

For manufacturers, the upside has not changed. A rebate model tied to specific claims gives them more visibility into which covered entity is claiming which dispense, and whether the same unit may be showing up in more than one place. Which makes sense.

For covered entities, a discount after the fact is not the same as a discount at the point of purchase. And I know I should be more sympathetic, but the big entities put themselves in this situation by being difficult about the claims data for years.

This is HRSA rebuilding the administrative record before taking another run at the same policy fight. Whether that is enough to survive the next lawsuit is a separate question. But the agency clearly heard the court’s message: if you are going to change the mechanics of 340B, you need more than a policy preference. You need a record and here it is.

All in the Family. This week, the Centers for Medicare & Medicaid Services (CMS) released a Request for Information (RFI) asking the industry to help define three words that are about to carry real legal weight: “PBM,” “affiliate,” and “bona fide service fee.” Starting in 2028, PBMs and their affiliates can’t charge fees tied to drug price, rebate amounts, or formulary placement for Part D services. The fee must be flat, tied to something the entity would have done anyway, and can’t get passed through to the client.

It only works if “affiliate” means something. The RFI asks whether specialty pharmacy, mail-order, wholesalers, rebate aggregators, and data vendors count. And those are the exact subsidiaries the three largest PBMs already own. If they count, the fee restriction follows the money. If they don’t, there is a legal pass-through, the same basic mechanism that let CVS allegedly route 340B spread through Wellpartner and a chain of sister companies the covered entity never saw.

For manufacturers, this RFI is the actual groundwork for whether 2028’s rebate ban has teeth or becomes the next workaround. Expect PCMA to be all in.

Carved in Reg

On Tuesday, CMS published a proposed rule on the Medicare Drug Price Negotiation Program. While comments are due August 17 and a final rule is expected this fall, the deeper story is why this rulemaking is happening now and the structural collision it creates for the pharmaceutical industry.

From “Guidance” to Permanent Regulation

The Inflation Reduction Act (IRA) gave CMS temporary authority to run the first three negotiation cycles (IPAY 2026, 2027, and 2028) through program instruction rather than formal notice-and-comment rulemaking.

That administrative shortcut is expiring. Starting with IPAY 2029, CMS must do this the hard way: through the Administrative Procedure Act (APA). This requires public comment, a defensive administrative record, and a final rule that cannot be quietly revised via a memo.

Substantively, much of the proposal codifies the last three years of guidance: restating selection criteria, negotiation factors, and the bona fide marketing test into formal regulatory language. It is the same substance, but it is becoming harder for a future administration to walk back.

Closing the Subcutaneous Loophole

However, CMS is also using this transition to plug what it sees as a gap. The agency calls it “closing a fixed combination drug loophole.” The industry has another word for it: evergreening.

Under current policy, a fixed combination drug with two or more active ingredients counts as a single drug for negotiation eligibility. To bypass this, manufacturers could launch a new formulation of a qualifying drug by adding an ingredient that enables a different route of administration (e.g., swapping an IV infusion for an under-the-skin shot). Under the old guidance, that new formulation escaped being aggregated with the original drug, effectively resetting the negotiation clock.

While CMS’s example in the proposal is anonymized (active ingredient X + hyaluronidase), the target is obvious. This architecture sits under some of the most recognizable, high-revenue names in oncology and immunology.

If a fixed combination drug shares active ingredients with another product from the same NDA or BLA holder, and the primary difference is an added ingredient enabling a new route of administration, CMS will treat them as a single drug. The agency will aggregate first and ask formulation questions later.

The Looming Policy Collision: IRA meets GUARD

Because this is 2026, this rule does not exist in a vacuum. The same week CMS proposed making the negotiation program permanent, a revised version of GUARD, the proposed Part D MFN pilot, went to the Office of Management and Budget for final review.

GUARD is designed to cover 25% of Part D beneficiaries, forcing manufacturers of sole-source drugs in designated classes to pay rebates when U.S. prices exceed international benchmarks. It is slated to launch January 1, 2027. And cost beneficiaries billions, but whatever, amIright?

These two programs are on a direct collision course:

1. A product selected for IRA negotiation gets a Maximum Fair Price (MFP) applied nationally.

2. If that same product is a sole-source drug in a GUARD pilot region, it faces a second, separate international-reference rebate.

The administration has not explained how to reconcile an already-negotiated MFP with a GUARD rebate. We have already seen a microcosm of this chaos: semaglutide’s negotiated MFP came in at $274, while a separate voluntary MFN deal set a Medicare price of $245. Same molecule, two competing federal numbers. GUARD threatens to turn that one-off anomaly into a permanent structural feature.

The Bottom Line

For manufacturers, codification cuts both ways. It buys predictability, but it also means a future, industry-friendly administration cannot simply soften enforcement with a memo; they would have to endure the same grueling rulemaking process CMS is undergoing now.

With the anti-evergreening fix narrowing reformulation strategies, and the small biotech temporary floor being resurrected for 2029 and 2030, the stakes are incredibly high. Comments close August 17. Nobody’s summer is getting easier.