Billing instructions for new drugs, biologicals and radiopharmaceuticals

CMS has indicated that for calendar year 2006, it will continue using the same methodology that is currently being used to pay for drugs, biologicals and radiopharmaceuticals that are newly approved by the Food and Drug Administration (FDA) and a national HCPCS code has not yet been created. CMS initially adopted the methodology for determining payment via Transmittal 188, Change Request 3287, and finalized the methodology in the CY 2005 final rule. In the CY 2005 final rule, the methodology was expanded from drugs and biologicals to include new radiopharmaceuticals for which a HCPCS code is not yet 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 explains CMS billing guidance for certain newly approved pharmaceutical products and radiopharmaceuticals in the absence of an assigned national HCPCS code. It is relevant to hospital billing and coding staff, compliance teams, and others who handle outpatient drug billing and CMS policy updates. The article focuses on the payment methodology CMS continued to use for calendar year 2006, the policy background from prior CMS transmittals and rulemaking, and the reporting elements tied to these products.

Why This Topic Matters

Understanding CMS guidance for newly approved products helps billing and coding teams apply current outpatient drug billing policy consistently and stay aligned with Medicare payment instructions.

What You Will Learn

  • How CMS handled payment policy for newly approved drugs, biologicals, and radiopharmaceuticals
  • The policy background and timing referenced by CMS
  • What general billing elements are tied to these products when no national HCPCS code exists
  • Which CMS publications and rulemaking actions are referenced as the basis for the guidance

Who Should Read This

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

Codes Discussed


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