In case you thought I’d leaving you hanging, today’s newsletter has a summary on GLOBE. Sphere it below?

Calling it a Plan would be GENEROUS, but that’s a Whole Other Thing. On Thursday, the White House released a fact sheet urging Congress to enact President Trump’s “Great Healthcare Plan,” pitching it as a cost-cutting package that hits drug prices, premiums, insurer accountability, and transparency all at once.

The drug piece leans hard on Most-Favored-Nation (MFN) pricing, codifying “deals” intended to tie U.S. prices to lower prices abroad plus a push to make more drugs available over the counter. On the insurance side, the plan proposes shifting subsidy dollars away from insurers and “sending money directly” to eligible individuals, funding cost-sharing reductions, and targeting pharmacy benefit managers (PBMs) and brokerage middlemen kickbacks. And there is also the push for consumer-facing change: a “Plain English” insurance standard, public posting of insurer profit/overhead and denial rates, and expanded provider/insurer price posting tied to participation in Medicare or Medicaid.

Details are, let’s say, to be determined. It is less of a plan and more of a political statement. One with a lot of questions that would need to be answered, like: How does this tie into the MFN demonstrations in Medicare and Medicaid? Is there any interest in Congress for pursuing this framework?

Contract Pharmacies, Guilty Until Proven Helpful. In late December, IQVIA released a white paper taking aim at a central 340B talking point: that contract pharmacies expand patient access. IQVIA’s analysis finds no evidence that drug availability was impacted after manufacturer contract pharmacy policies, noting that while the number of contract pharmacies grew by 26%, fewer than 1% were closed, with no meaningful change tied to manufacturer changes.

Courts and policymakers often end up litigating 340B through competing narratives — hospitals say access and charity care; manufacturers say program integrity and duplicate discounts. IQVIA is trying to force the debate into measurement: if the access claim is true, it should show up in observable availability patterns. In other words, show me the data.

It’s Ain’t Over Til HRSA Says So. On Monday, STAT reported that the Department of Justice told the First Circuit it plans to dismiss its appeal in litigation over a 340B rebate pilot and return the challenged approvals to Health Resources and Services Administration (HRSA) for reconsideration. The underlying court filing is blunt: discussions are underway with the American Hospital Association and hospital plaintiffs, and the agency intends to resolve proceedings “promptly.” That’s not giving up.

The implication is that rebate 340B is not dead. For manufacturers, this creates a narrow window to push for program integrity guardrails (claims-level identifiers, clearer diversion standards, auditable contract pharmacy terms) without having to absorb a wholesale payment-model shift overnight.  

Made you Blink. In this month’s issue, Health Affairs published a study asking a very 2026 question: did biopharma change clinical trial behavior after the Inflation Reduction Act (IRA) created Medicare drug price negotiation? The authors used ClinicalTrials.gov data (2010–2024) and looked at whether trial initiations shifted after the IRA passed, especially for drugs potentially exposed to negotiation. The study found that overall trial activity remained stable, but that (no surprise), but manufacturers with drugs subject to negotiation began fewer trials.

Even without a dramatic cliff, the strategic signal is that policy design can create portfolio prioritization: companies may lean toward assets with clearer commercial runways (rare disease carve-outs, biologics timing, or indications that reduce Medicare exposure) and away from assets that feel like they’ll hit policy headwinds at peak uptake. Ultimately, manufacturers need predictable rules, because uncertainty is the real killer of innovation.

Rare becomes the Norm. On Tuesday, Regulatory Focus reported that the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 46 novel drugs in 2025  and that roughly half were for rare diseases.

IPAY28 On its Way. On Friday, reginfo.gov showed that the Office of Information and Regulatory Affairs approved (with change) CMS’s information collection for the Medicare Drug Price Negotiation Program’s initial price applicability year 2028. This is the unglamorous backbone of negotiation: the forms, data elements, and counteroffer mechanics. The next round of selected drugs will be announced on, or before, February 1.

The reginfo package lays out a few telling details including a burden estimates (47,620 annual hours; 405 responses), plus explicit references to negotiation and renegotiation for 2028. That’s a reminder that the IRA isn’t just selecting drugs, it’s building an ongoing administrative machine.

For manufacturers, it is a reminder that negotiation is about a compliance-and-analytics capability that needs repeatable data pulls, governance, and rapid internal alignment (clinical, finance, legal, government pricing). And, if you think you’re up for 2029, the time to start getting ready was yesterday.

The Lights Were On, But That Isn’t Enough.  On Tuesday, JAMA Network Open published a cohort study of over a half million Medicare beneficiaries undergoing colon or lung cancer surgery, comparing outcomes at hospitals that later closed vs. those that did not. Surgery at hospitals that subsequently closed was associated with worse postoperative outcomes, including higher complication rates and, in unadjusted numbers, higher 90-day mortality (8.8% vs. 5.7%).   

Closures are often a marker of deeper instability (staffing, quality systems, volume, finances, etc.) long before the doors actually shut. That means “keeping a hospital open” is not automatically the same as “protecting access,” especially for complex, high-risk oncology surgery.

Perhaps this is a reframing opportunity. When policymakers talk about closures, the debate defaults to geography. This paper argues for adding a quality lens: access is not just distance; it’s outcomes. That matters for rare disease and oncology ecosystems where centers of excellence, referral networks, and coverage rules can either support appropriate regionalization or accidentally strand patients in low-capacity settings.

Reimbursement Fundamentals — GLOBE: Same Same, But Different (From GUARD)

On December 23, the Centers for Medicare & Medicaid Services (CMS) released a proposed, mandatory model called the Global Benchmark for Efficient Drug Pricing (GLOBE). It arrived as GUARD’s sibling, not its twin: same “international reference pricing via inflation rebate” chassis but installed in Medicare Part B’s buy-and-bill world, where beneficiary coinsurance and provider payment mechanics make the policy feel very different.

GUARD runs through Part D and where CMS explicitly says the GUARD rebate dollars flow to the Supplementary Medical Insurance (SMI) Trust Fund rather than the pharmacy counter. That is why GUARD can produce the weirdest headline in drug pricing: savings to the program paired with higher beneficiary costs.

GLOBE avoids that trap by connecting the international benchmark to Part B patient cost sharing. GLOBE would modify the Medicare Part B Drug Inflation Rebate calculation for selected Part B drugs by swapping the domestic inflation benchmark for an international benchmark derived from prices in economically-comparable countries. CMS proposes a reference-country set of 19 nations.

Crucially, CMS proposes a strict hierarchy of data sources for this benchmark. The agency will prioritize “Method I” (using existing international price datasets) to prevent gaming. “Method II” (voluntary manufacturer-submitted net data) is treated only as a fallback when public data is insufficient or unavailable.

The model would run for five years, launching October 1, 2026 and running through 2031, with rebate invoicing and reconciliation continuing into 2033. Comments are due February 23, 2026.

Scope and Selection: Once In, Always In

Scope is narrower than GUARD in some ways and broader in others. GLOBE targets a subset of Part B “rebatable drugs,” specifically single source drugs and sole source biological products and focuses on therapeutic areas CMS flags as high-stakes and high-spend in the clinic: oncology, rheumatology, immunology, ophthalmology, and endocrinology.

To land in the model, a drug must hit a spending screen: Medicare Part B fee-for-service allowed charges above $100 million over a 12-month lookback period (compared to $69 millilon in GUARD.)  A critical nuance here is that inclusion is like a fly trap: once a drug hits this threshold and enters the model, it remains subject to the GLOBE rebate for the model’s duration, even if spending subsequently drops below the $100 million line.

Like GUARD, drugs with a Maximum Fair Price are excluded. The Administration is avoiding overlap with IRA negotiation but still pushing a parallel pathway that can reach products that never get negotiated.

The Defining Difference: Beneficiary Impact

And then we get to the biggest operational difference versus GUARD: beneficiary cost sharing. In Part B, beneficiaries often pay 20 percent coinsurance on the allowed amount (although many have supplemental coverage that lowers cost sharing.)  Under GLOBE, CMS proposes to calculate a per-unit “GLOBE benchmark amount” in advance of each quarter and then, for purposes of beneficiary coinsurance and Medicare payment, use the lesser of the benchmark or the inflation-adjusted payment amount.

CMS explicitly frames this as a guardrail so beneficiaries would not face higher coinsurance than they would absent the model.  

The Money Flow

The money flow still ends in the same place. Like GUARD, manufacturer payments under GLOBE are manufacturer-to-government transfers deposited into the SMI Trust Fund. The difference is that GLOBE also attempts to reduce what Medicare pays on the front end by tying the payment calculation to the benchmark used for coinsurance computation, then layering the rebate logic on top so the manufacturer owes the difference between the relevant statutory “specified amount” and the benchmark, but not less than what would be owed under the existing Part B inflation rebate rules. In other words: GLOBE is “inflation rebate plus,” with “plus” defined by international pricing.

Like GUARD, CMS proposes a randomized geographic design affecting roughly 25 percent of traditional Medicare Part B fee-for-service beneficiaries, selected by randomly choosing 25 percent of zip codes. That matters for manufacturers because it creates a split world inside the same national market: some utilization becomes subject to a new pricing logic, some does not, and the operational reality of patient travel, referral patterns, and site-of-care shifts immediately complicates clean assignment.

CMS estimates GLOBE would generate $11.9 billion in overall Medicare Part B net savings over the seven-year budget window, with spillover savings projected in Medicare Advantage and premium effects.  

But here’s the real question – is it real? Will CMS move forward with these demonstrations or are the deals cut by the large pharmaceutical companies enough to feed the political beast? These companies are expected to be exempt from these models so, is it worth turning the payment systems on their heads if the savings are minimal?