The Centers for Medicare & Medicaid Services (CMS) released the Global Benchmark for Efficient Drug Pricing (GLOBE) Model final rule and an accompanying press release on September 30, 2026.
As Applied Policy has previously discussed here, here, and here, the GLOBE Model is a mandatory Innovation Center model that will test an alternative approach to calculating Medicare Part B drug inflation rebates for certain separately payable Part B drugs and biological products using international pricing benchmarks. The final rule is effective November 30, 2026. The model will begin on January 1, 2027, with voluntary manufacturer data collection, and performance years will begin on April 1, 2027.
Key Takeaways
Model Purpose and Duration: The GLOBE Model will begin January 1, 2027, with the collection of voluntary manufacturer-submitted international drug net pricing data (as opposed to the proposed October 1, 2026, start date). The model will include five performance years, from April 1, 2027, through March 31, 2032, and a seven-year payment period extending through March 31, 2034 (as opposed to the proposed October 1, 2026-September 30, 2031, performance period and payment period through September 30, 2033). The model will apply to approximately 25% of Original Medicare Part B beneficiaries in randomly selected geographic are
Drugs Included and Excluded: As proposed, the model will apply to certain high-expenditure, single-source Part B drugs and sole-source biological products within seven therapeutic categories: Antigout Agents, Antineoplastics, Blood Products and Modifiers, Central Nervous System Agents, Immunological Agents, Metabolic Bone Disease Agents, and Ophthalmic Agents. Included drugs must have more than $100 million in Original Medicare Part B spending over the applicable 12-month period. CMS will publish included drugs quarterly in the GLOBE Model Drug HCPCS Codes List on the GLOBE Model webpage. An illustrative list is provided in Table 4 (pages 131-132) of the final rule.
Exclusions: Drugs subject to a maximum fair price under the Medicare Drug Price Negotiation Program, drugs that are no longer Part B rebatable drugs, and certain drugs for which CMS has not yet identified a specified amount under the Part B Inflation Rebate Program are excluded. Biosimilars and their reference biologicals are also excluded once a biosimilar enters the U.S. market. The final rule adds exclusions for certain orphan drugs, FDA-approved cell and gene therapies, and plasma-derived products. Manufacturers participating in the GENEROUS Model and who have signed GENEROUS Model participation agreements as of August 17, 2026, will be excluded from mandatory participation in GLOBE for drugs covered under their GENEROUS Model participation agreement.
Notably, the final rule does not appear to establish an exclusion for manufacturers or drugs subject to Most-Favored-Nation (MFN) agreements with the Trump Administration, meaning such arrangements do not appear, on their own, to exempt a manufacturer or drug from the GLOBE Model. While CMS does not explicitly address how broad MFN agreements would interact with the GLOBE Model, all 26 manufacturers with MFN agreements are expected to participate in the GENEROUS Model, which would mean they would all likely be excluded. This significantly narrows the pool of drugs expected to be in the model.
International Reference Countries: The GLOBE Model will use pricing information from a set of economically comparable countries to establish the international benchmark used to calculate GLOBE Model rebates. CMS finalized its proposed criteria for selecting these countries, which must be OECD members, have purchasing power parity-adjusted per capita GDP of at least 60% of the U.S. level, and have purchasing power parity-adjusted aggregate GDP of at least $400 billion. Based on these criteria, CMS finalizes 19 reference countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
International Benchmark Setting: CMS will use pricing data from the reference countries to establish a GLOBE Model benchmark against which the applicable Part B amount will be compared to determine the incremental GLOBE rebate. Consistent with the proposed rule, CMS finalizes two approaches for establishing the benchmark. Under Method I, CMS will use commercially available international pricing information to estimate the lowest country-level price among the reference countries. Under Method II, manufacturers may voluntarily submit international net pricing data, which CMS will use to establish a benchmark based on the average international net price among the reference countries.
Rebate Payments: For included units furnished to GLOBE Model beneficiaries, manufacturers will owe a GLOBE Model rebate when the applicable Part B amount exceeds the GLOBE Model benchmark. The rebate will not be less than the amount otherwise owed under the Medicare Part B Drug Inflation Rebate Program.
Invoicing: CMS proposed two potential invoicing approaches: a combined invoice for the Part B inflation rebate and incremental GLOBE rebate, or separate incremental invoicing. CMS finalizes the incremental approach, under which the incremental GLOBE Model rebate will be invoiced separately following the standard Part B inflation rebate invoice. Manufacturers will have 30 calendar days after receipt of the final GLOBE Model Rebate Report to pay the amount due.
Beneficiary Coinsurance and Provider Payments: As proposed, GLOBE Model beneficiaries may receive reduced coinsurance for included drugs when the GLOBE Model benchmark is below the otherwise applicable inflation-adjusted payment amount. Providers and suppliers will continue to buy and bill for GLOBE Model drugs as usual. When beneficiary coinsurance is reduced, Medicare will increase its portion of the payment so that the provider or supplier continues to receive the applicable Medicare Part B allowed amount.
Expected Financial Impact: CMS estimates that the finalized model will generate approximately $440 million in Medicare Part B net spending savings over the seven-year payment period, substantially lower than the approximately $11.9 billion estimated under the proposed model. CMS attributes the reduction to finalized policy changes and updated assumptions, including the additional drug exclusions, delayed model start, and expected interactions with other Innovation Center models.
CMS has not yet released the final rule for the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model, which was proposed alongside GLOBE. Applied Policy will continue to monitor for its release and for additional CMS guidance and implementation details related to the GLOBE Model.
For a Deeper Dive:
In August, the Northern Virginia Health Policy Forum hosted a webinar examining international reference pricing in CMS Innovation Center drug models, including GLOBE. Moderated by Applied Policy President and CEO Jim Scott, the discussion featured Dr. Stefan Walzer, CEO, President, and Founder of MArS Market Access & Pricing Strategy GmbH, and Brittany La Couture, Applied Policy Vice President of Health Policy and a former member of the Innovation Center team that worked on the International Pricing Index (IPI) Model during the first Trump administration. Watch the recording below.
