Biotech Groups Sue CMS Over GLOBE Drug Pricing Model
Three biotechnology trade groups, the Biotechnology Innovation Organization, Biocom and California Life Sciences, filed a lawsuit Nov. 6 in the U.S. District Court for the Northern District of California challenging CMS's Global Benchmark for Efficient Drug Pricing Model, or GLOBE. The groups argue CMS exceeded its statutory authority, violated federal appropriations law, and breached separation-of-powers principles, contending the agency's testing authority is limited to models addressing a defined population with care deficits. Under GLOBE, manufacturers of certain Medicare Part B drugs would pay rebates based on the gap between U.S. prices and government-controlled prices in 19 foreign countries. The groups, representing over a third of U.S. biotech companies, cited a January 2026 analysis finding only 0.3% of Medicare Part B beneficiaries would have seen lower out-of-pocket costs, and warned the model could restrict patient access and discourage drug development.