The authors submitted both comment letters to the Centers for Medicare & Medicaid Services on February 23, 2026.
Richard G. Frank, Kristi Martin, and Rachel E. Sachs provide the Centers for Medicare & Medicaid Services with comments on the proposed Global Benchmark for Efficient Drug Pricing (GLOBE) Model and the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model. In these companion comment letters, the authors draw on their expertise to address issues unique to each model as well as core concerns that apply to both.
In the GLOBE letter, they address:
- Alternative approaches for reporting, invoicing, and reconciliation/suggestion of error
- Audit, record access, record retention, and model termination parameters for GLOBE Model manufacturers
- Applying the 6% add-on
In the GUARD letter, they address:
- Adoption of alternative definition of Medicare Part D net price
Together, the letters underscore the need for GLOBE and GUARD models to both address:
- Establishment and updating of benchmark
- Approach to selection of geographic areas
- Mandatory manufacturer participation and inclusion/exclusion criteria
- Proposed severability policies
- Measurement of International Reference Prices
- Solicitation on Purchasing Power Parity and GDP adjustments in the benchmark price process
- Conflicting assumptions in the Regulatory Impact Analyses and assessing claims that the models will promote more aggressive industry negotiation, lower launch prices, and shift utilization
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Commentary
Comments on GLOBE and GUARD drug pricing models
March 2, 2026