Item 8.01 Other Events.

On November 30, 2022, the Centers for Medicare and Medicaid Services ("CMS") made a preliminary recommendation to establish a dedicated Healthcare Common Procedure Coding System ("HCPCS") Level II billing code specific to Arch Therapeutics, Inc.'s AC5® Advanced Wound System ("AC5"). The preliminary recommendation was discussed at CMS' First Biannual 2022 HCPCS Public Meeting, which was held on November 30, 2022. The HCPCS code would better enable providers to bill third party payors for AC5 that is used in doctors' offices. Currently, providers report AC5 on claims using A4100 (Skin substitute, FDA-cleared as a device, not otherwise specified).

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