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Mitosol gets new HCPCS code

Mitomycin is sometimes used in trabeculectomy surgery as an antimetabolite (to inhibit scar formation). It has also been used by other ophthalmic specialties with the same goal; inhibition of scar formation. Until recently, no specific ophthalmic preparation existed for the drug and it had to be reconstituted to dilute it appropriately (either by the providers themselves or by a hospital or compounding pharmacy). In February 2012, the FDA approved Mitosol[1] for ophthalmic use in glaucoma surgery; the first shipments began in July from Mobius Therapeutics, the manufacturer. Coding for ophthalmic Mitomycin use has usually been via an unlisted drug code (J3490), but a few payers instructed that providers use a currently existing code – J9280 (mitomycin, 5 mg) even though the dosing in the J9280 descriptor did not match ophthalmic uses.

Recently, new HCPCS code J7315 was approved for use as of January 1, 2013. It should be used for reporting Mitosol use in physician offices and on HOPD claims. There is no separate ASC reimbursement under the 2013 ASC/HOPD Fee Schedule; it is bundled as a supply item and in the ASC setting is not reported on the claim.

Additionally, as part of setting up the new J7315 code, the descriptor for J9280 was modified. The new 2013 Health Care Procedure Coding System (HCPCS) codes for mitomycin are:

  • J7315 Mitomycin, ophthalmic, 0.2 mg
  • J9280 Injection, Mitomycin, 5 mg

Other information for Mitosol is as follows:

  • Mitosol (mitomycin solution) comes in individual vials with 0.2 mg of the drug in a lyophilized (dry) form to which 1 ml of sterile water is added to make the proper concentration for soaking the provided pledgets. In dry form, it can be stored for up to 2 years. Once re-constituted, it must be used within 1 hour.[2]
  • On claims, in box 19 of the CMS-1500 form or electronic equivalent, show the National Drug Code (NDC) for Mitosol (0.2 mg) as: 49771-002-01.
  • Mitosol has had “orphan drug” status when used in pterygium surgery since January 2011.[3]


[1] Mobius Therapeutics, LLC. Press Release. FDA approval. Link here.

[2] Mobius Therapeutics, LLC. Mitosol. Instructions for Use. Link here.

[3] Mobius Therapeutics, LLC. Press Release. Orphan drug designation for cornea indication. Link here.

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