As Applied Policy has previously reported, in 2025, the Centers for Medicare & Medicaid Services (CMS) announced an ambitious suite of drug pricing models designed to align what Americans pay for prescription drugs with prices in other countries. In April, the agency announced delays and deadline extensions in two of the models as implementation challenges emerged.
The models — the Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model, the GENErating cost Reductions fOr U.S. Medicaid (GENEROUS) model, the proposed Guarding U.S. Medicare Against Rising Drug Costs (GUARD) model, and the Global Benchmark for Efficient Drug Pricing (GLOBE)— share a common premise: that the United States pays too much for prescription drugs relative to other developed nations. Each uses different mechanisms within federal health programs to align U.S. drug prices with those paid in economically comparable countries through most favored nation pricing. Participation in BALANCE and GENEROUS is voluntary for manufacturers, states, and health plans. If finalized, GUARD and GLOBE would be mandatory for manufacturers.
Part D Delayed in BALANCE
On April 21, CMS announced it was indefinitely delaying the Medicare Part D component of its BALANCE model after failing to secure sufficient participation from private insurers. A voluntary program to expand GLP-1 medication coverage for obesity, the model required Medicare Part D plan sponsors representing at least 80 percent of Part D enrollment to apply by April 20. That threshold was not met.
Applied Policy’s Vice President for Health Policy, Brittany La Couture observed that “Part D plans are operating under significant and compounding pressure: recent PBM reforms, reduced agent and broker compensation for Part D enrollment, and consecutive years of funding that have not kept pace with rising medical costs have left plans with limited capacity to absorb additional uncertainty.” She also noted a specific structural consideration with BALANCE: Part D bids for 2027 are due June 1, 2026, leaving plans insufficient time to assess utilization risk for a drug class with no Medicare obesity coverage history.
In an earnings call the same day CMS announced the delay, UnitedHealthcare’s CEO of government programs, Bobby Hunter, told investors the company wanted to “find a path to yes” on BALANCE coverage “over time, but there are some notable challenges and outstanding questions with the currently planned structure.”
CMS framed the pause as an opportunity to collect utilization data. In the interim, the Medicare GLP-1 Bridge, a separate, narrower demonstration operating outside the Part D benefit structure, will be extended through December 31, 2027. This will provide eligible beneficiaries access to all formulations of Foundayo®, all formulations of Wegovy®, and the KwikPen ® formulation of Zepbound® at a $50 monthly copayment. UnitedHealthcare confirmed its participation in the Bridge model. Commenting to Axios, a representative of AHIP described the Bridge extension as “a common-sense step to maintain access for seniors and generate important learnings that can be applied to ensure sustainable coverage moving forward.”
Although the Medicare component is paused, the Medicaid portion of BALANCE is proceeding. State Medicaid agencies can apply through July 31, 2026, and begin participation as early as May 1, with participation agreements extending into early 2027.
GENEROUS Extension
On April 29, CMS extended the manufacturer application deadline for the GENEROUS model for the second time, from April 30 to June 11, after previously extending it from March 31. Manufacturer participation agreement deadlines and state application and agreement deadlines have similarly shifted. CMS attributed the latest extension to “overwhelming interest from prescription drug manufacturers, particularly those that are small to mid-sized,” but provided no figures on how many had applied.
The GENEROUS timeline creates something of a bind for manufacturers, who must decide whether to participate before knowing the final design of GUARD, the proposed mandatory counterpart to BALANCE for Medicare Part D drugs.
Watching GUARD and GLOBE
We continue to watch for CMS communications regarding GUARD and GLOBE. Because participation would be mandatory, CMS would have greater direct control over their implementation than with the voluntary models. These models also have a longer policy lineage than BALANCE or GENEROUS, having been in development in one form or another since the first Trump administration.
Both GUARD and GLOBE have drawn substantial opposition. In separate comment letters filed February 23, PhRMA described both models as “not only illegal but also profoundly harmful to American patients,” arguing that they exceed CMMI’s statutory authority, violate federal appropriations law, and raise constitutional concerns.
Notably, PhRMA cited CMS’s own impact projections showing GUARD would increase beneficiary costs, including both cost-sharing and premiums.
The Biotechnology Innovation Organization (BIO) wrote to congressional leaders in February, urging them to press CMS to rescind both GUARD and its Part B counterpart, Global Benchmark for Efficient Drug Pricing (GLOBE), warning the models would “eviscerate the innovation pipeline.” In their comment letter, the Association for Accessible Medicines (AAM) and its Biosimilars Council contend that “the GLOBE and GUARD models do not provide any relief to generic and biosimilar manufacturers and instead add greater uncertainty.”
Representatives of the Schaeffer Institute for Public Policy at USC called for both GUARD and GLOBE to be withdrawn. In a post explaining their reasoning, they argued, “The models’ reliance on international price benchmarks makes them vulnerable to gaming by foreign countries, fails to address the underlying economics of global pharmaceutical markets, and cedes pricing authority to foreign governments with different healthcare values.”
To meet GUARD’s proposed January 1, 2027 effective date, CMS will need to issue a final rule by November 1, 2026To meet GLOBE’s proposed October 1 launch, a final rule would need to be submitted by the end of summer. As of May 4, neither rule had been submitted to the Office of Management and Budget. CMS has said additional guidance on all models is forthcoming.