TAPP Submits Comments Urging Centers for Medicare & Medicaid Services to Withdraw Proposed GLOBE Model
The Trade Alliance to Promote Prosperity has submitted comments requesting that the Centers for Medicare & Medicaid Services (CMS) withdraw the proposed GLOBE Model prescription drug payment scheme.
In the comments, TAPP wrote the following:
As currently structured, GLOBE does not advance patient access or affordability, exceeds the intended scope of the Center for Medicare and Medicaid Innovation (CMMI), and risks undermining America’s global leadership in biopharmaceutical innovation.
First and foremost, none of the proposed Most Favored Nation (MFN) policies would meaningfully improve patients’ ability to access or afford their medicines. While the model would alter the reimbursement formula for certain Medicare Part B drugs, it does not address the structural barriers that drive out-of-pocket costs or delays in care. CMS acknowledges potential interactions with other Innovation Center models but does not provide explicit exclusions between GLOBE and GUARD, raising concerns about overlapping payment reductions and compounded instability in the Part B ecosystem.
The GLOBE Model also represents a significant expansion of federal authority under Section 1115A of the Social Security Act. Participation would be mandatory for manufacturers of included drugs—specifically single-source drugs or sole-source biologics in designated USP Drug Classification categories that exceed $100 million in annual Part B fee-for-service spending. This is not a limited, voluntary “test” of payment reform; it is a sweeping price-setting regime imposed on a randomly selected 25 percent of zip code–based geographic areas nationwide. Such scale and compulsory participation are inconsistent with the statutory intent of CMMI to conduct targeted, time-limited demonstrations.
The core of the proposal—importing foreign reference prices through an MFN benchmark—relies on prices set in 19 non-U.S. OECD countries, including Australia, Canada, France, Germany, Japan, South Korea, and the United Kingdom. Under Method I, CMS would use the lowest available foreign price. Under Method II, manufacturers could submit net pricing data, with CMS using a volume-weighted average of foreign prices. In either case, the proposal effectively imports pricing decisions made in health systems that rely on centralized price controls, restricted formularies, and delayed access to new therapies.
Adopting these foreign price benchmarks would not correct inequities in the U.S. healthcare system; it would simply import the flaws of other systems. Many of the referenced countries achieve lower prices through strict health technology assessments and rationing mechanisms that limit patient access to innovative treatments. Importing those prices risks replicating the access constraints that patients in those systems routinely face.
Moreover, the GLOBE rebate structure—requiring manufacturers to pay the greater of the GLOBE rebate or the statutory Part B inflation rebate—introduces substantial uncertainty and financial risk. Manufacturers would be subject to rebate obligations that could significantly exceed existing statutory requirements, particularly given the use of the lowest foreign price as a benchmark. Even with certain exclusions, such as 340B units, the model would create overlapping rebate liabilities that may discourage continued investment in Part B therapies.
Beyond domestic implications, MFN-style policies risk ceding American biopharmaceutical leadership to strategic competitors, including China. The United States has long been the global leader in biomedical research and development, in large part because its market-based system supports high-risk, long-term investment. If pricing is effectively tied to foreign government controls, the incentive structure that underpins U.S.-based innovation could weaken. Reduced investment in domestic R&D would have long-term consequences for American patients, workers, and the broader economy.
Finally, the scope and duration of the GLOBE Model—a seven-year test period with five performance years beginning October 1, 2026, followed by two additional years for reconciliation—underscore that this is not a narrow experiment but a fundamental restructuring of Part B reimbursement. Such a far-reaching policy should be debated transparently by Congress, not implemented administratively under the guise of a demonstration project.
For these reasons, the Trade Alliance to Promote Prosperity respectfully urges CMS to withdraw the GLOBE proposal and instead pursue reforms that directly address patient affordability, promote transparency across the supply chain, and preserve the United States’ position as the world leader in medical innovation.
TAPP encourages like-minded individuals and organizations also to submit comments here.