Four groups of Part B products fall outside Medicare’s new GLOBE drug payment model: biosimilars and their reference biologicals once a biosimilar is on the U.S. market, orphan-only drugs, plasma-derived products, and certain cell and gene therapies. The Centers for Medicare & Medicaid Services set out the carve-outs when it finalized the model on September 30, 2026.
The list matters because the model is mandatory and reaches roughly a quarter of people in Original Medicare. A patient in a selected area who takes one of the excluded products is, on the face of the CMS text, treated differently from a neighbor on a covered drug.
The exclusion language, item by item
The CMS announcement states that GLOBE excludes biosimilars and their reference biologicals once a biosimilar enters the market in the United States. It adds that the model will also exclude orphan-only drugs, plasma-derived products, and certain cell and gene therapies. Each carries a different kind of condition.
- Biosimilars and reference biologicals. The exclusion is conditional. A reference biologic is in the model until a biosimilar reaches the U.S. market, and at that point it and the biosimilar both leave.
- Orphan-only drugs. The wording is "orphan-only," which appears to reach products whose only uses are rare-disease indications rather than every drug that has ever carried an orphan designation; the release does not define the term further.
- Plasma-derived products. The release excludes the category without qualification.
- Certain cell and gene therapies. The word "certain" signals that some such therapies are excluded and others are not, and the announcement does not name which.
What is left inside the model
What remains are separately payable Medicare Part B drugs and biological products administered by clinicians in health care settings. The CMS GLOBE model page describes the covered drugs as a subset of Part B rebatable drugs from therapeutic classes where annual Original Medicare spending exceeds $100 million, and it does not publish a product-by-product list.
CMS also says the drugs are paid under Part B and administered by clinicians, which means the model touches treatments given in an infusion suite, clinic or similar setting. A prescription picked up at a retail pharmacy runs through Part D instead, and the announcement describes no change to that benefit.
The practical effect is that a patient cannot read a drug’s status off a public roster. Neither the press release nor the model page tells a beneficiary whether a named product is covered, excluded or simply not among the high-spending classes, and neither says that a notice will be sent to individuals.
Why the carve-outs change the money picture
GLOBE ties rebate amounts to international pricing benchmarks, and CMS says selected beneficiaries may begin to see reduced out-of-pocket costs on April 1, 2027. The model page frames the reduced coinsurance window as running from April 1, 2027 to March 31, 2032. An excluded product carries none of that reduction under this model, which leaves the patient’s share on that drug where the ordinary Part B rules put it.
Those ordinary rules are in Medicare’s published cost schedule, which for 2026 lists a $202.90 monthly Part B premium and a $283 deductible before Original Medicare starts to pay. That page carries no 2027 figures, so the baseline for any 2027 comparison is still the 2026 one.
CMS states no projected savings figure for the model. For a household facing rare-disease or plasma-derived treatment bills, the absence of a stated dollar effect and the exclusion of the product itself point in the same direction: the model’s coinsurance reduction is not a basis for budgeting on those drugs.
Open Enrollment arrives before the model does
The calendar adds a wrinkle for Original Medicare patients on these products. Open Enrollment runs October 15 through December 7, 2026, and CMS’s September 28 release on 2027 plans projects the average monthly Medicare Advantage premium at $12.00, down from $14.37, with about 34 million people, or 47.4% of Medicare, enrolled. GLOBE applies only to Original Medicare, so a beneficiary who moves to Medicare Advantage for 2027 would leave the pool that the model’s random draw is made from.
Whether that trade makes sense depends on the plan’s own drug coverage and network, which the GLOBE materials do not address. The model’s exclusions and its coinsurance reduction are the only GLOBE facts in the record; the rest of a plan decision rests on the plan documents.
Timeline for the whole model
The performance period starts January 1, 2027 and ends March 31, 2032, and pharmaceutical reconciliation continues until March 31, 2034, according to the CMS release. The exclusions apply across that span, so a biologic that is covered today could drop out once a biosimilar launches, with nothing in the announcement saying how patients would be told.
The CMS press release and the model page are the only places the exclusion terms appear in the materials reviewed, and they are the documents to check for any revision before 2027 begins.
A drug-by-drug record for treatments outside the GLOBE model
Biosimilar-linked, orphan-only, plasma-derived and gene-therapy products are carved out of GLOBE, and the lower coinsurance that begins no earlier than April 1, 2027 applies only to covered drugs. The open job for patients on these treatments is tracking what each prescription actually costs from month to month, so any later change can be spotted.
The Medicare Cost & Coverage Protection Kit pairs a medication and cost tracker with the prior-authorization appeal steps, laid out in a 10-page kit.
Sort the medication costs on one tracker →
AI assistance was used in drafting this report; the exclusion terms above come from the CMS announcement and model page linked in the text.
