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Impact of J-Code Naming Conventions on 505(b)(2) Drugs

Summary by Avalere Health
Since 2022, the Centers for Medicare and Medicaid Services (CMS) has been reviewing its approach for establishing Healthcare Common Procedure Coding System (HCPCS) Level II codes for products approved under the 505(b)(2) pathway. According to CMS’s current practice, products approved under separate 505(b)(2) New Drug Applications that are not rated as therapeutically equivalent in the Food and Drug Administration’s (FDA) Orange Book are consider…
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