GUARD and GLOBE Pricing Models Could Test Manufacturer Rebates for Medicare Part B and D Drugs

As 2025 drew to a close, the Centers for Medicare & Medicaid Services (“CMS”) issued proposed rules for two mandatory pricing models aiming to reduce out-of-pocket costs for Medicare drugs.

The “Guarding U.S. Medicare Against Rising Drug Costs Model” (“GUARD Model”) would require manufacturer rebates for certain drugs payable under Medicare Part D when the price of the drug exceeds an international, as opposed to a domestic, benchmark, based on prices paid in economically comparable countries. Similarly, the “Global Benchmark for Efficient Drug Pricing Model” (“GLOBE Model”) would require manufacturer rebates for certain drugs payable under Medicare Part B when the drug exceeds an international benchmark.

The benchmark for both models would be based on either manufacturer-reported international pricing information, or information available to CMS, for countries with a real gross domestic product per capita that is at least 60 percent of that of the United States and having a minimum real economy size of $400 billion. Reference countries include Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, the Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.

Both models would be implemented in randomly selected geographic areas representing 25 percent of people with a Medicare Part D (GUARD) or Part B (GLOBE) plan. The purpose of random selection, for GUARD, is to balance the Part D population and Medicare expenditures nationwide (90 Fed Reg. 60356 (Dec. 23, 2025)). For GLOBE, random selection balances the Medicare beneficiary population with Medicare expenditures (90 Fed. Reg. 60264 (Dec. 23, 2025)).

If finalized, both models would run for 5 years, launching on January 1, 2027, and continuing through December 31, 2031, with rebate invoicing and reconciliation continuing into 2033.

The GUARD Model (Part D)

The GUARD Model would, according to CMS, test changes to the Part D inflation rebate calculation for certain drugs in the Medicare Part D Drug Inflation Rebate Program, including sole-source drugs and sole-source biologics in specific therapeutic categories.

GUARD categories include Analgesics; Anticonvulsants; Antidepressants; Antimigraine Agents; Antineoplastics; Antipsychotics; Antivirals; Bipolar Agents; Blood Glucose Regulators; Cardiovascular Agents; Central Nervous System Agents; Gastrointestinal Agents; Genetic or Enzyme or Protein Disorder: Replacement or Modifiers or Treatment; Immunological Agents; Metabolic Bone Disease Agents; Ophthalmic Agents; and Respiratory Tract/Pulmonary Agents.

A CMS Press Release notes that the GUARD Model would include Medicare Part D drugs including outpatient prescription drugs dispensed at retail, mail order, home infusion, and long-term care pharmacies. The model would factor in existing Medicare Part D manufacturer rates and discounts.

The GLOBE Model (Part B)

The GLOBE Model would include outpatient drugs and biologicals provided as part of a physicians’ service as well as drugs that are not usually self-administered. GLOBE Model drugs would be a subset of Part B rebatable drugs that:

• have the following listed USP DC categories: Antigout Agents, Antineoplastics, Blood Products and Modifiers, Central Nervous System Agents, Immunological Agents, Metabolic Bone Disease Agents, Ophthalmic Agents;
• are single source drugs or sole source biological products;
• have a HCPCS Level II code with Medicare Part B FFS spending greater than $100 million over a 12-month period; and
• are not excluded from the GLOBE Model due to having a maximum fair price in effect or meeting other exclusion criteria specified in the Proposed Rule.

A CMS Press Release states that GLOBE inclusion criteria would exclude biosimilars and their reference biologicals once a biosimilar enters the United States.  

The 2025 Executive Orders

The GUARD and GLOBE Models align with Executive Order 14297, issued in May 2025, outlining a policy of access to most-favored-nation (“MFN”) prescription drug prices to Americans; and Executive Order 14273, issued in April, outlining a policy to provide access to prescription drugs at lower costs to American patients and taxpayers (see EBG’s related blog post here). In the latter, the Secretary of Health and Human Services was directed to, among other things, develop and implement a rulemaking plan and payment model “to obtain better value for high-cost prescription drugs and biological products covered by Medicare, including those not subject to the Medicare Drug Price Negotiation Program.”

Takeaways

Under both models, rebates paid by manufacturers would continue to be sent directly to the Medicare Supplementary Medical Insurance Trust Fund. Note that health care providers would not be participants in either model.

Manufacturers and other stakeholders may (and should) comment on both proposed rules by February 23, 2026, referencing file code CMS-5546-P for the GUARD Model and CMS-5545-P for the GLOBE Model.  

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.