CMS provides clarification regarding the use of HCPCS code C9399

CMS has revised Chapter 17 of the Medicare Claims Processing Manual to clarify the use of HCPCS code C9399 , Unclassified drugs or biologics . HCPCS code C9399 should be used by hospitals to report a new drug or biological that has been approved by the FDA on or after January 1, 2004 for which no HCPCS code has yet been created or assigned. Hospitals may report HCPCS code C9399 on or after the date of the FDA approval for a new drug or biological. When reporting HCPCS code C9399 , hospitals should report in the “Remarks” section of the CMS...

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Note:  The following article synopsis was NOT provided by the AHA. It was created by Find-A-Code/innoviHealth.

Article Overview

This brief CMS-focused article covers a revision to Chapter 17 of the Medicare Claims Processing Manual related to hospital reporting of an unclassified drug or biologic. It is relevant to hospital billing and coding staff, compliance teams, and anyone following Medicare outpatient drug reporting guidance. The article outlines the general circumstances addressed by the update and the documentation elements CMS indicates should accompany the claim.

Why This Topic Matters

Accurate reporting of newly approved drugs and biologics affects hospital claims submission and compliance with Medicare billing requirements. The update helps coders and billing staff understand the scope of the manual clarification and the information CMS expects to see with this type of claim.

What You Will Learn

  • What CMS revised in the Medicare Claims Processing Manual
  • The general reporting context for newly approved drugs and biologics
  • What claim-level information CMS indicates should accompany hospital reporting
  • How the guidance relates to Medicare hospital billing workflows

Who Should Read This

  • Hospital coders
  • Hospital billing staff
  • Revenue cycle teams
  • Compliance professionals
  • Health information management professionals

Codes Discussed


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