FAQs by Topic:
Model Purpose
Will the GLOBE Model affect access to Medicare Part B drugs?
The GLOBE Model is designed to lower out-of-pocket costs for certain Original Medicare Part B drugs while preserving or enhancing quality of care. CMS will evaluate whether beneficiary access to drugs changes under the model and will monitor for unintended access issues. For eligible beneficiaries, the model may reduce financial barriers to receiving GLOBE Model drugs by lowering coinsurance, when applicable. Beneficiaries may report access concerns that they believe may be related to the GLOBE Model by contacting 1-800-MEDICARE.
Will out-of-pocket costs change under the GLOBE Model?
Yes, CMS expects the GLOBE Model will reduce the out-of-pocket costs or coinsurance for beneficiaries who receive a GLOBE Model drug. However, the specific impact will depend on the drug, the alternative calculation for manufacturer rebates established, and the beneficiary's individual circumstances, such as their enrollment in supplemental insurance. In addition, all Medicare beneficiaries may experience a reduction in Part B premiums because of model savings.
Could the GLOBE Model result in changes to drug availability or shifts in how Part B drugs are covered?
The GLOBE Model is designed to preserve or enhance Medicare beneficiaries’ access to high-quality care. The model does not restrict beneficiaries’ access to Original Medicare Part B drugs or other Medicare covered services. As part of the model implementation and evaluation activities, CMS will monitor whether there are shifts in drug utilization, including potential shifts from Medicare Part B to Medicare Part D. CMS will also assess whether there are unintended consequences, such as changes in drug supply or prescribing patterns that may be related to the model test.
Model Features
Which drugs are included in the GLOBE Model?
The GLOBE Model includes certain high spend, single-source drugs and sole-source biological products covered under Original Medicare Part B. CMS determines which drugs meet the model’s eligibility criteria, which include the drug’s classification, Original Medicare Part B expenditures, and whether the drug is subject to an applicable exclusion.
Providers do not need to independently determine whether a drug meets these criteria. Before each calendar quarter during the model performance period, CMS will publish the GLOBE Model Drug HCPCS Code List on the GLOBE Model webpage. CMS will review and update the list quarterly to reflect drugs added to or removed from the model. Providers should refer to the current list to determine whether a drug is included for a particular calendar quarter.
Will this model qualify as an Advanced or Merit-based Incentive Payment System Alternative Payment Model (MIPS APM)?
No, health care providers will not be participants in the model and therefore the GLOBE Model would not qualify as an Advanced or MIPS APM under the Quality Payment Program.
Eligibility and Participation
Does the GLOBE Model drug coinsurance apply to all Medicare Part B beneficiaries?
No, the GLOBE Model reduction only applies to beneficiaries who are randomly selected by CMS to be a part of the GLOBE Model (called the model cohort). The GLOBE Model cohort includes Medicare Part B beneficiaries who have Original Medicare as their primary payer and whose address of record in CMS’ Medicare Beneficiary Database falls within randomly selected GLOBE Model geographic areas either at the time CMS selects beneficiaries for the model cohort or when a beneficiary newly enrolls in Original Medicare during the model performance period. Beneficiaries in the model cohort are eligible for the GLOBE Model drug coinsurance reduction and will be eligible for any Medicare Part B premium savings incurred as a result of the model. Beneficiaries who are not in the model cohort will not be eligible for the model coinsurance reduction but will be eligible for any Medicare Part B premium savings as a result of the model test. The model cohort will not include beneficiaries who do not have Original Medicare as their primary payer, for example, beneficiaries who have elected Medicare Advantage.
How do people with Medicare join the model cohort to receive reduced GLOBE Model drug coinsurance?
Beneficiaries cannot and do not have to do anything to be eligible for GLOBE Model reduced coinsurance. CMS will identify the set of included beneficiaries (called the model cohort) who represent approximately 25% of Medicare Part B beneficiaries who have Original Medicare as their primary payer and whose address of record in CMS’ Medicare Beneficiary Database falls within the randomly selected ZIP Code Tabulation Areas at the time CMS selects beneficiaries for the model cohort. Eligibility for reduced coinsurance will be determined by CMS at the time a claim for a GLOBE Model drug is processed for Medicare payment.
How can people with Medicare determine if they are eligible for GLOBE?
CMS will publish on the CMS Model webpage ZIP Codes that help determine if a beneficiary may be in the model cohort. Beneficiaries and their healthcare provider can use the GLOBE Model ZIP Codes List to anticipate whether they may be eligible for reduced coinsurance for GLOBE Model drugs. The GLOBE Model ZIP Codes List will be available by January 16, 2027. Once CMS identifies beneficiaries as eligible for the model, if they move, or if there are changes in their ZIP Code, they will still be included in the model and still be eligible for GLOBE Model reduced coinsurance as long as they have Original Medicare as their primary payer.
Will people eligible for Original Medicare after the GLOBE Model goes into effect be able to be join the model?
Beneficiaries who newly join Original Medicare after the GLOBE Model has started and whose ZIP Code is on the GLOBE Model ZIP Codes List may be eligible to be part of the model cohort. CMS will identify the beneficiaries who are in the model cohort.
What happens if a ZIP Code in a GLOBE Model geographic area is split or redesignated during the model performance period?
CMS will not reassign ZIP Codes after the initial random selection of the model geographic areas. If a ZIP Code within the GLOBE Model geographic areas is split or redesignated during the performance period, it will remain in its originally assigned status.
Who is a participant in the GLOBE Model and how is a participant defined?
Participants in the model are pharmaceutical manufacturers of GLOBE Model drugs. For GLOBE Model purposes, “manufacturer” has the same meaning as defined in section 1847A(c)(6)(A) of the Social Security Act and 42 CFR 427.20, consistent with how CMS defines the term for the Medicare Part B Drug Inflation Rebate Program. This definition includes repackagers and relabelers, and situations where more than one manufacturer markets a GLOBE Model drug in the U.S.
How does GLOBE affect how providers are paid for administering Part B drugs?
Health care providers are not participants in the GLOBE Model. Providers administering GLOBE Model drugs to beneficiaries who are selected for the model cohort will not see a reduction in the Medicare allowed amount. If a GLOBE Model drug is furnished to a GLOBE Model beneficiary, the beneficiary may be eligible for reduced coinsurance, and the Medicare payment will be adjusted upward so that the allowed amount remains constant. For example, if the Original Medicare Part B allowed amount under the GLOBE Model is $100 and the GLOBE Model beneficiary coinsurance percentage is 10%, the provider would receive $90 from Original Medicare (instead of $80), and the beneficiary would pay $10 (instead of $20), maintaining the allowed amount of $100.
How will providers know which patients are GLOBE Model eligible Medicare beneficiaries?
CMS will publish the list of model geographic areas by ZIP Codes on the GLOBE Model website no later than January 16, 2027. Providers can use this list, in conjunction with the quarterly GLOBE Model Drug HCPCS Codes List, to anticipate which Medicare beneficiaries who have Original Medicare as their primary payor may be eligible for GLOBE Model reduced coinsurance for GLOBE Model drugs. When a providers claim for Medicare Part B payment is processed and paid by a Medicare Administrative Contractor (MAC), the remittance advice they receive will identify the beneficiary’s coinsurance liability.
Is a separate billing system required for GLOBE Model beneficiaries versus non-GLOBE Model beneficiaries?
No, providers should continue to submit Medicare Part B claims using their usual billing procedures. A separate billing system or GLOBE-specific claim modifier is not required for claims for GLOBE Model drugs that were administered to GLOBE Model eligible beneficiaries. CMS designed the GLOBE Model to operate within the existing Medicare claims processing infrastructure.
Are there monitoring, compliance, or audit requirements that apply to providers under the GLOBE Model?
CMS will conduct monitoring activities throughout the model performance period. The model evaluation will gather evidence on Medicare Part B spending, quality of care, and potential unintended consequences. CMS intends to use existing claims measures and survey instruments to reduce provider burden but may find it necessary to supplement with voluntary surveys.
How will the GLOBE Model affect the coinsurance collected from patients?
For GLOBE Model eligible beneficiaries, coinsurance may be reduced compared to standard Original Medicare Part B cost-sharing rules. Providers should be aware that the coinsurance amount collected from GLOBE Model eligible beneficiaries may differ from other Medicare beneficiaries for the same drug. Note that if a provider chooses to collect coinsurance prior to receiving payment from Medicare, the provider may need to issue a partial refund if the beneficiary is a GLOBE Model eligible beneficiary and the provider collected excess coinsurance.
Manufacturers
How do manufacturers obtain HPMS access for the GLOBE Model, and how long does the process take?
A CMS P Number identifies a manufacturer’s account in the Health Plan Management System (HPMS). CMS uses P Numbers for several programs, including the Medicare Part B Drug Inflation Rebate Program. For the GLOBE Model, the applicable CMS P Number will be used to associate the manufacturer’s account with its GLOBE Model-related HPMS activities, including voluntary Method II data submissions. Manufacturers that do not already have a CMS P Number can request one through the existing Medicare Prescription Drug Inflation Rebate Program onboarding process.
What is the GLOBE Model rebate, and how is it calculated?
The GLOBE Model will test an alternative rebate amount calculation to the calculation of the Medicare Part B drug inflation rebate amount, using a benchmark derived from international drug pricing information.
The benchmark will be based on either voluntary manufacturer-reported international drug net pricing data or international drug pricing information in existing data sources available to CMS for a set of reference countries. The set of reference countries include: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. These countries are OECD members that have a real gross domestic product per capita that is at least 60% of the United States’ and with a minimum real economy size of $400 billion based on 2024 data in the CIA World Factbook.
How will CMS set the international benchmark?
The GLOBE Model uses international drug pricing information to establish benchmarks for the alternative rebate amount calculation. The GLOBE Model will test two benchmark methodologies, Method I and Method II, as specified in 42 CFR 513.410 and 513.420, respectively. Both benchmarks include an economic adjustment based on the difference in gross domestic product and purchasing power parity between the U.S. and the reference country, as specified in 42 CFR 513.430.
Method I will use existing, commercially available international drug pricing information to establish a benchmark based on an estimate of the lowest international price among the set of reference countries (see 42 CFR 513.310). Method II will use voluntary manufacturer-submitted international drug net pricing data to establish a benchmark based on an average international price among the set of reference countries.
What net pricing data will manufacturers be required to submit, and on what timeline?
Manufacturers are not required to submit net pricing data to CMS for the GLOBE Model. Manufacturers of GLOBE Model drugs can voluntarily choose to submit international drug net pricing data for all applicable international analogs to a GLOBE Model drug for the set of refence countries no later than 30 days after the end of the applicable ASP calendar quarter. A submission includes basic data elements that describe the applicable international analogs, including package size information, and net pricing data for sales for the reference countries that occurred during the applicable ASP calendar quarter. The first window for manufacturer reporting is January 1 through January 30, 2027, and manufacturer’s submissions will reflect sales during the calendar quarter October 1, 2026, through December 31, 2026. CMS will review each timely submission to determine if it meets completeness and validity criteria to be considered an applicable submission and available for CMS to use in identifying a Method II benchmark for the applicable calendar quarter. For example, if determined by CMS to be an applicable submission, voluntary manufacturer-reported international drug net pricing data reported during the first reporting window would inform Method II benchmarks for the calendar quarter beginning on April 1, 2027. If all manufacturers of a GLOBE Model drug do not voluntarily submit international drug net pricing data or CMS does not identify such submission as an applicable submission, CMS will not calculate a Method II benchmark for the applicable calendar quarter. The GLOBE Model follows the same timeline used by CMS for manufacturer Average Sales Price reporting.
How will the GLOBE Model rebate interact with the existing Medicare Part B Drug Inflation Rebate Program?
The GLOBE Model tests an alternative to the Medicare Part B drug inflation rebate amount calculation for GLOBE Model drugs; it does not eliminate or replace the existing program. The GLOBE Model rebate amount calculation applies specifically to GLOBE Model drugs furnished to GLOBE Model beneficiaries during the performance period. CMS will calculate, invoice, collect, and reconcile GLOBE Model rebates during the 7 payment years of the model test period using an incremental rebate invoicing approach, which will reduce administrative burden on manufacturers.
What is the timeline for rebate invoicing, collection, and reconciliation?
CMS will calculate and invoice GLOBE Model rebates quarterly during the 7 payment years of the model test period (covering the 5-year performance period plus 2 additional years for reconciliation). CMS will provide manufacturers of GLOBE Model drugs a Rebate Report no later than 8 months after the end of each applicable calendar quarter and a Reconciliation Rebate Report within 12 months of issuance of the Rebate Report for each applicable calendar quarter, consistent with 42 CFR 513.710.
What method did CMS use to choose the reference countries?
CMS selected a set of reference countries that is economically comparable to the United States. These countries are OECD members that have a real gross domestic product per capita that is at least 60% of the United States’ and with a minimum real economy size of $400 billion based on 2024 data in the CIA World Factbook. The 19 countries in the set of reference countries were established in the GLOBE Model final rule. The set of reference countries includes: Australia, Austria, Belgium, Canada, the Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
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