1. Executive Summary and Strategic Context

The GLOBE Model is a proposed mandatory Medicare Part B drug payment demonstration using international pricing benchmarks to calculate manufacturer rebates for high-cost physician-administered drugs. Published as a Notice of Proposed Rulemaking (NPRM) on December 23, 2025 (90 Fed. Reg. 60,244), with comments due February 23, 2026, GLOBE would operate from October 1, 2026 through September 30, 2033 (5 performance years plus 2 years for reconciliation).

GLOBE targets single-source drugs and sole-source biological products with Medicare Part B FFS spending exceeding $100 million annually. CMS estimates that over two-thirds of Part B drug spending - roughly $46 billion annually - is concentrated in this category. The model would apply to approximately 25% of Medicare Part B beneficiaries in randomly selected geographic areas (zip code tabulation areas).

GLOBE implements the Trump Administration's Most Favored Nation (MFN) pricing policy, as directed by the May 12, 2025 Executive Order 'Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients.' CMS projects $11.9 billion in Part B savings, reduced beneficiary coinsurance (10% instead of 20%), and spillover savings in Medicare Advantage and Medicaid.

1.1 Strategic Significance

GLOBE represents the federal government's most explicit move toward international reference pricing in Medicare. Unlike IRA negotiation (which targets a limited number of drugs), GLOBE applies broadly across high-spending therapeutic categories. If finalized, it would fundamentally restructure the Part B drug reimbursement ecosystem, affecting manufacturers, providers who administer these drugs, and beneficiary out-of-pocket costs.

2. Model Architecture

2.1 Regulatory Framework

Authority: Section 1115A of the Social Security Act (CMMI demonstration authority).

NPRM Published: December 23, 2025 (90 Fed. Reg. 60,244). Docket No. CMS-2025-1889.

Comment Period: 60 days, closing February 23, 2026.

Proposed Start: October 1, 2026.

Performance Period: October 1, 2026 - September 30, 2031 (5 years).

Payment/Reconciliation Period: Through September 30, 2033.

Type: MANDATORY for qualifying manufacturers in selected geographic areas.

2.2 Eligible Drugs

GLOBE Model drugs must meet ALL of the following criteria:

1. Part B Separately Payable: Drugs and biologics reimbursed under Medicare Part B (physician-administered injectables, infusions).

2. Therapeutic Categories: Limited to USP DC categories: Antigout Agents, Antineoplastics, Blood Products and Modifiers, Central Nervous System Agents, Immunological Agents, Metabolic Bone Disease Agents, Ophthalmic Agents.

3. Single-Source/Sole-Source: Only single-source drugs and sole-source biological products. Biosimilars and their reference biologics excluded once biosimilar competition exists.

4. Spending Threshold: Medicare Part B FFS spending > $100 million over 12 months.

5. Not Excluded: No Maximum Fair Price (MFP) in effect under Medicare Drug Price Negotiation Program.

2.3 Reference Countries

19 OECD countries with PPP-adjusted GDP at least 60% of U.S. and minimum $400 billion: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, United Kingdom.