The AAMC submitted comments last Friday in response to two new Centers for Medicare & Medicaid Services (CMS) drug payment models aimed to address the provisions of a 2025 executive order focused on lowering prescription drug prices [refer to Washington Highlight, Dec. 31, 2025]. The Global Benchmark for Efficient Drug Pricing (GLOBE) Model targets certain drugs payable under Medicare Part B if their prices exceed those paid in economically comparable countries. The Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model is similar, but targets certain drugs paid under Medicare Part D. Both are proposed mandatory models with a five-year performance period.
In response to GLOBE (PDF), the AAMC urged the agency to conduct a thorough analysis of any unintended consequences of the model before finalizing the rule, including how the model could interact with other drug pricing policies and potential patient safety concerns. The AAMC requested that the CMS address how to implement the model in a way that minimizes imposing administrative burden on providers related to identifying GLOBE model beneficiaries and billing them adjusted coinsurance amounts.
The AAMC’s response to GUARD (PDF) included similar comments but depart from the GLOBE model comments on coinsurance, as the GUARD model did not include a mechanism to address cost sharing for beneficiaries. Instead, comments on the GUARD model raise concerns that, as currently designed, the model may not adequately address prescription drug affordability for patients and could jeopardize the agency’s ability to negotiate on drugs selected for Inflation Reduction Act drug price negotiation, ultimately eroding potential savings. Lastly, comments asked the CMS to remove incentives for manufacturers and health plans to engage in white-bagging (in Part B) and brown-bagging (in Part D) in order to preserve patient safety.