CMMI MFN Demonstration Projects: Globe & Guard (Part 3)

The aim of the Globe and Guard CMMI MFN demonstration projects is to link Medicare drug prices to international benchmarks for drugs covered under Medicare Parts B and D, respectively. While differences exist between the two programs, the basic framework for each program is similar. As proposed, the GLOBE and Guard Models would have a 5-year performance within a 7-year payment period with the demos starting on October 1, 2026, and January 1, 2027, respectively. Both Globe and Guard are still in proposed rulemaking with comments due by February 23rd.

The proposed models mandate participation for all manufacturers of selected Part B or D rebatable drugs, respectively. Selected drug products are limited to designated therapeutic categories that vary between Globe to Guard, and limit inclusion to single source or sole source products. Generics, biosimilars and IRA MFP negotiated products are excluded. Selected products must exceed annual inflation adjusted Part B and D annual FFS spending by $100M and $69M, respectively. CMS will utilize the same 19 reference countries for both GLOBE and Guard. The demo for both programs would be limited to 25% of traditional Part B and D beneficiaries identified based on coverage and geographic criteria, and specifically excludes Medicare Advantage patients.

The methodology is similar for determining the per unit Model benchmark payment amounts for Globe and Guard. For both programs, the benchmark is set at the higher of Method I which is determined as the lowest per unit country-level average price reported by private companies (IQVIA’s MIDAS and the Global Data Pharmaceutical Prices for Globe, and not yet specified by CMS for Guard) or Method 2 which is the weighted average net price across the 19 designated reference countries as voluntarily reported by the manufacturer. CMS will exclude “pricing information at the dosage form and strength level for a country that falls below 5 percent of the average price in the U.S.”

The benchmark amounts would then be adjusted by applying a de minimus add on amount of 2% for Method I and 5% for Method II, as well as a 6% add on for Part B drugs reimbursed based on ASP. While not a stated aim for Guard, Globe patient OPP costs would be tied to the international ASP benchmark and should result in lower patient OOP expenses for Medicare Part B beneficiaries. Manufacturer rebates from the Global Benchmark for the CMMI demos are directly excluded from a manufacturer's Average Manufacturer Price (AMP), Best Price (BP), and ASP, as are the claims for Model drugs that are submitted with a 340B modifier.

In the last part of this series, we’ll focus on key industry concerns and potential manufacturer strategies for all three CMMI MFN demos. It is not possible to summarize all the details of a 100+ page NPRM in a single LinkedIn post. Readers are encouraged to reach out to either me or Rita Numerof for additional details and strategies.