Outlook Therapeutics files for permanent J-code for Lytenava with CMS

Outlook Therapeutics, Inc. (Nasdaq: OTLK) has submitted an application to the Centers for Medicare & Medicaid Services (CMS) requesting a permanent, product-specific Healthcare Common Procedure Coding System (HCPCS) Level II J-code for its drug Lytenava (bevacizumab-vikg), according to a press release.

Lytenava is the only FDA-approved ophthalmic formulation of bevacizumab and is indicated for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). The company states it remains on track for a U.S. commercial launch before the end of 2026.

HCPCS Level II J-codes are standardized codes used by government and commercial payers to facilitate billing and reimbursement for physician-administered treatments. CMS reviews applications for drugs and biologicals on a quarterly basis.

"A permanent J-code would streamline billing, reduce administrative burden and support broader practice adoption and patient access," said Bob Jahr, Chief Executive Officer of Outlook Therapeutics.

The company noted that submission of the application does not guarantee CMS will assign a permanent J-code, and that any such assignment would be separate from coverage and payment determinations, providing no guarantee of reimbursement by Medicare or any other payer.

Outlook Therapeutics has already commenced commercial launch of Lytenava in Germany, Austria, and the United Kingdom for the treatment of wet AMD.

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