Appropriate reporting of HCPCS code C9399

Drugs and biologicals that are defined as usually self-administered drugs as defined in the Medicare Benefit Policy Manual, Pub. 100-02, Chapter 15, Section 50.2 , should not be reported with HCPCS code C9399 , Unclassified drug or biological. HCPCS code C9399 should be reported by hospitals solely for new outpatient drugs or biologicals that are approved by the Food and Drug Administration (FDA) on or after January 1, 2004 and that are furnished as part of covered outpatient department services for which a product-specific HCPCS code has not been assigned. ...

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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 article reviews hospital reporting guidance for an unclassified HCPCS drug or biological code within the context of Medicare outpatient billing policy and FDA approval timing. It is intended for hospital coders, billing staff, and revenue cycle professionals who need to understand the scope of the policy and the types of items it applies to. The discussion focuses on when the article’s reporting guidance is relevant, what regulatory sources are referenced, and how the topic fits within outpatient department services.

Why This Topic Matters

Correct reporting of unclassified outpatient drug and biological services affects claim accuracy and helps hospitals align with Medicare policy and FDA-related requirements. The article is relevant for teams responsible for outpatient coding compliance and charge capture review.

What You Will Learn

  • The Medicare policy context referenced by the article
  • How the article frames hospital reporting for an unclassified HCPCS drug or biological code
  • The types of outpatient items and services discussed in relation to the guidance
  • Which regulatory sources and coverage frameworks are referenced

Who Should Read This

  • Hospital coders
  • Outpatient billing staff
  • Revenue cycle professionals
  • Compliance teams
  • Charge capture specialists

Codes Discussed


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The AHA Coding Clinic for HCPCS includes:

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