Only the costliest corner of Medicare’s drug spending will enter the agency’s new international price benchmark. A drug enters the GLOBE Model only if a single billing code for it brings in more than $100 million in Original Medicare Part B spending over a 12-month period, and only if the drug sits in one of seven named classes. Orphan-only drugs, plasma-derived products and approved cell and gene therapies are carved out, which keeps those products outside the model.
The $100 million test is applied to each HCPCS code
The final rule, published in the Federal Register on October 2, 2026, sets the eligibility test in specific terms. A drug must have a Healthcare Common Procedure Coding System (HCPCS) Level II code “with OM Part B spending greater than $100 million over a 12-month period ending 6 months prior to the start of the applicable calendar quarter.” OM stands for Original Medicare.
Three details in that sentence matter. The threshold is measured per billing code, not per manufacturer or per brand family, so a drug with several codes can have one code qualify and another fall short. The money counted is Original Medicare Part B spending only, which leaves out Medicare Advantage and Part D. And the measuring window is a 12-month period that ends six months before a given calendar quarter begins, so the test is tied to the quarter in which the model applies.
Seven USP drug classes inside the GLOBE Model
Clearing the spending line is not enough on its own. The rule limits the model to Part B rebatable drugs in seven categories of the USP Drug Classification: Antigout Agents, Antineoplastics, Blood Products and Modifiers, Central Nervous System Agents, Immunological Agents, Metabolic Bone Disease Agents and Ophthalmic Agents.
A high-spending drug in any class not on that list stays out of the model regardless of how much Medicare pays for it. The CMS announcement, titled as a new mandatory drug payment model, describes the scope as separately payable Medicare Part B drugs and biological products.
Six exclusions keep other drugs outside the benchmark
Even a qualifying code in a qualifying class can be excluded. The final rule’s exclusion list covers these categories:
- drugs before the first specified amount identified under 42 CFR 427.302(b);
- drugs with an active Medicare Drug Price Negotiation Program maximum fair price;
- products no longer classified as Part B rebatable drugs;
- orphan-designated drugs with only rare disease indications;
- products on the FDA’s Approved Cellular and Gene Therapy Products list;
- plasma-derived products as defined in 42 CFR 427.400.
The maximum fair price exclusion draws the line between the two federal pricing efforts. A drug already under a negotiated price does not also receive an international benchmark. The orphan carve-out is narrow in wording: it applies to orphan-designated drugs whose indications are only rare diseases, so a drug with an orphan designation and a broader use is not automatically exempt.
How CMS selects and removes drugs, and the no-appeal clause
Drug lists in the model are not negotiated with manufacturers. The rule states that “drug selection (and removal, if applicable) for the model test will be determined by CMS based on the eligibility criteria and will not be subject to appeal, pursuant to section 1115A(d)(2) of the Act.” In practice, a manufacturer whose drug is picked up by the spending test cannot challenge the inclusion through an appeal process.
To make the list visible, CMS says it will publish a GLOBE Model Drug HCPCS Level II Code List on the model’s website so that providers know which codes are affected. Because the spending window rolls forward with each calendar quarter and the rule refers to removal as well as selection, the set of drugs is not frozen. A code that crosses $100 million can come in, and one that no longer meets the criteria can leave. The CMS Innovation Center lists Nicholas Minter, at (410) 786-8914 or GLOBEmodel@cms.hhs.gov, as the contact for further information.
What the benchmark compares, and which drugs it never touches
For drugs that do enter, the rule builds the benchmark from prices in 19 reference countries: 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. Method I estimates the lowest country-level price using existing, commercially available international pricing information. Method II uses voluntary manufacturer-submitted net pricing data to set a benchmark based on an average international price, reflecting net prices realized by a manufacturer.
Drugs outside the scope never get that comparison. A Part B drug whose billing code falls at or under $100 million, a drug in any class outside the seven named, a negotiated-price drug, an orphan-only product, a plasma-derived product or a gene therapy is simply not subject to the GLOBE benchmark. The model is a targeted payment test, not a repricing of everything billed to Part B. How the cost-sharing math changes for drugs that are inside the model is a separate question that CMS handles through the payment design, and it is left to a companion article.
The timeline puts the first stage in view. According to the final rule, the model takes effect November 30, 2026, voluntary manufacturer data collection begins January 1, 2027, and the performance period starts April 1, 2027 and runs through March 31, 2032, with a payment period through March 31, 2034. The proposed rule appeared on December 23, 2025 at 90 FR 60244, and the final rule appears at 91 FR 62936.
Keeping Medicare drug costs and denials organized
Medicare beneficiaries who take several prescriptions often juggle Part D costs, coverage denials and state help programs without one place to track them. A single organized set of materials can cut down the scramble when a bill or a denial letter arrives.
The Medicare Cost & Coverage Protection Kit is a 10-page kit that includes the new Part D out-of-pocket cap, the prior-authorization appeal steps and a medication and cost tracker, which together give a reader a way to log what each drug costs and to follow the steps for appealing a denial.
Click here to get The Medicare Cost & Coverage Protection Kit and start a drug cost tracker →
This article was drafted with AI assistance from the cited official sources and checked against them before publication.
David M. Keller is a finance writer based in Columbus, Ohio, covering personal finance and consumer-focused economic topics. He earned his degree in journalism from Ohio University and began his career reporting on local business and economic trends for a regional media outlet. Since then, he has contributed to a variety of online publications, focusing on clear, practical coverage of topics such as cost of living, debt, and everyday financial decision-making.
