Measures will streamline claims, reimbursement effective April 2025
Fresenius Kabi, an operating company of Fresenius, announced that the Centers for Medicare and Medicaid Services issued a permanent, product-specific billing code for Otulfi.
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Under the Healthcare Common Procedure Coding System (HCPCS), the Q-code Q9999 is for “Injection, for subcutaneous use or intravenous use, ustekinumab-aauz (Otulfi), biosimilar per 1.0 mg.”
Otulfi (ustekinumab-aauz) is FDA-approved for subcutaneous and intravenous formulations to treat the same conditions as the reference product Stelara® (ustekinumab), including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
“This designation is an important milestone for broadening use of this biosimilar that supports quality patient care while reducing costs,” said Molly Benson, Senior Vice President, U.S. Biopharma at Fresenius Kabi. “As a recent addition to Fresenius Kabi’s biosimilar product offerings in the U.S., Otulfi is a key part of our company’s commitment to advancing biopharma to deliver enhanced care options.”
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The drug received FDA approval in September 2024 and was launched in the U.S. in March 2025. Developed by Formycon AG, a leading independent developer of biosimilars, this ustekinumab biosimilar is part of a global commercialization partnership that began in February 2023 between Formycon and Fresenius and covers key global markets.
A Q-code is a CMS reimbursement code used by healthcare providers and payers to process claims for drugs administered through injection, infusion or other means. Commercial insurers and government payers use them to standardize claims submissions and reimbursements. Pass-through payments are used by hospital outpatient department services through the Hospital Outpatient Prospective Payment System (OPPS) to support use of new devices, drugs, and biologicals that meet eligibility criteria for a period of at least two years but not more than three years.
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Source – businesswire
