Status check: GLOBE and GUARD drug-pricing model rules remain unfinalized nine months after proposal

The Centers for Medicare & Medicaid Services proposed two Innovation Center payment models on December 23, 2025: the Global Benchmark for Efficient Drug Pricing (GLOBE) Model for certain Medicare Part B drugs, and a companion model called GUARD for certain Part D drugs ^[1]. As of this status check, neither rule has been finalized. The public comment period on GLOBE closed February 23, 2026, and CMS has not yet issued a final rule ^[1][2].

GLOBE would change how inflation rebates are calculated for a defined set of Part B drugs by comparing U.S. prices to international benchmarks, with the model set to run through a geographically randomized sample covering roughly 25% of Medicare Part B fee-for-service beneficiaries ^[2]. The proposal itself, published in the Federal Register under docket CMS-5545-P, runs 93 pages and covers which drugs would be included, how reference countries would be chosen, and how the test would be phased in ^[1].

The American Hospital Association filed formal comments on the GLOBE proposal on the day comments closed, raising concerns that go beyond hospital operations. The AHA noted that CMS itself acknowledged in the proposed rule that drug companies are likely to "seek to adjust prices in order to lower the amount of GLOBE Model rebates they owe" ^[2]. Because manufacturers control list prices, the AHA warned this could push down the Average Manufacturer Price and Medicaid Best Price for affected drugs, which in turn could raise the prices hospitals pay to acquire those drugs and affect 340B ceiling prices ^[2].

The AHA also flagged operational gaps in the proposal, including how CMS will identify which beneficiaries and manufacturers are subject to the model, how hospitals should handle beneficiary co-insurance when supplemental coverage like Medigap is involved, and the lack of an appeals process if CMS miscalculates a beneficiary's status ^[2]. The group additionally warned the model could push more manufacturers toward "white bagging," a dispensing practice the AHA says can delay patient access to prescribed drugs ^[2]. The AHA asked CMS to make participation in GLOBE voluntary rather than mandatory ^[2].

The sources reviewed here focus mainly on GLOBE. Details on how GUARD, the parallel Part D model, would work are not laid out in the available documents, so it is not yet known from these sources exactly how GUARD's rebate calculations would apply to Part D drugs.

Why it matters for patients

Most GLP-1 medications used for diabetes and weight management, including Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, and Foundayo, are dispensed through pharmacies and typically fall under Part D rather than Part B. Because GUARD, the Part D model, is not detailed in the sources available, it is not yet known exactly how these medications would be affected if that rule is finalized.

What is documented is a broader mechanism: if manufacturers respond to rebate pressure by adjusting list prices, that can ripple into Average Manufacturer Price and Medicaid Best Price calculations ^[2]. Patients covered by Medicaid or through 340B-participating providers could eventually see effects on drug availability or acquisition costs if this dynamic plays out for the drugs ultimately covered by either model ^[2]. For now, patients taking GLP-1 drugs should know that no changes have been finalized and that the rulemaking remains under review nine months after it was first proposed ^[1][2].

What happens next

CMS has not announced a target date for a final rule on GLOBE, and the comment period closed February 23, 2026 ^[1][2]. No timeline for finalizing GUARD is included in the available sources. Readers should watch for a final rule notice in the Federal Register, which would specify which drugs, including any GLP-1 medications, fall under either model's payment test.