CMS Issues GLOBE Model Final Rule

• On September 30, 2026, the Centers for Medicare and Medicaid Services (CMS) issued a final rule on the Global Benchmark for Efficient Drug Pricing Model (GLOBE Model), a new mandatory Medicare payment model. 
   
• The model will use manufacturer-submitted international net pricing data to establish global benchmark prices and assess whether revised rebate calculations can reduce Medicare spending and beneficiary costs while preserving access to care and quality outcomes. 
   
• The GLOBE Model will apply to selected single source drugs and sole source biological products that are furnished to a cohort of beneficiaries in the fee-for-service Medicare program. There is an exclusion for “low-spend” drugs, defined as products with Medicare spending of less than $100 million over a 12-month period (adjusted for inflation over time). The Final Rule also excludes the following categories of products that were not previously excluded in the Proposed Rule:
  • Orphan-only drugs;
  • Plasma-derived products;
  • FDA-approved Cellular and Gene Therapy products; and
  • Manufacturers of GLOBE Model drugs where the manufacturer participates in the GENEROUS Model during the applicable calendar quarter. 
     
• CMS is making a number of important changes to GLOBE Model Drug inclusion and exclusion criteria from the Proposed Rule. In the Final Rule, CMS estimates that 19 manufacturers will initially participate in GLOBE, with 36 unique products initially selected for inclusion. CMS notes that if all manufacturers who are participating in the GENEROUS Model receive a waiver from GLOBE Model participation, the number of remaining manufacturers of GLOBE Model drugs would be four. 
   
• Collection of data will begin January 1, 2027. The GLOBE Model will be tested over 5 performance years from April 1, 2027 through March 31, 2032. The associated payment period will run from April 1, 2027 through March 31, 2034.

More on This Topic:

Final Rule
CMS Innovation Models - GLOBE

For questions, please reach out to Geni Tunstall.