Drugs and Vaccines

Claims for Drugs Without a Product-Specific Code Assigned

National Government Services has noticed that when a claim RTPs for additional information to be added to the Remarks field concerning certain drugs, some providers attempt to provide more information than is required. Please review this article to better understand specifically what is required under these circumstances.

Additional Information May Be Requested

Medicare and NGS require that when additional information is requested for accurate claims processing, the provider must supply all information requested or risk not having the service paid. Providers should note that certain drugs and biologicals, typically those that do not have a specific CPT or HCPCS code assigned, may require additional information in order to properly price and process the claim.

NGS provides basic coverage guidelines in the Medical Policy, “Article For Drugs and Biologicals, Coding Article (A52855)” including that for claims submitted to the Part A MAC, the provider should list the appropriate J or C code to indicate the drug name. When a specific HCPCS code does not exist, list the appropriate NOC code C9399 (unclassified drug or biological). Facilities reimbursed under the hospital OPPS may use code C9399, billed as one unit, when the drug is FDA approved, but does not have an assigned HCPCS or the assigned HCPCS is not yet effective. Claims with C9399 are suspended and the drug is manually priced according to the remarks on the claim.

When HCPCS code C9399 is billed, the following information must be included in the Remarks (FL 80, or electronic equivalent) section of the claim:

  • Name of the drug
  • NDC in the proper 5-4-2 format including the dashes (Example: XXXXX-XXXX-XX)
  • Route of administration (IV, IM, SC, PO, etc.)
  • Date of administration
  • Total dosage (quantity) of the drug administered and frequency of administration for each date of service
    • The quantity of the drug should be expressed in the unit of measure applicable to the drug or biological
  • Medical necessity for the drug
  • If prior treatment with other drugs is required for the drug: Include any prior chemotherapy administered prior to the current drug

Specific to HCPCS code C9399, the provider must bill one unit with the HCPCS C9399 on the claim along with the charges. In addition, you must indicate the dosage in remarks and the CTP segment. As a reminder, the dosage amount listed in the remarks section should be the same as what is reflected in the CTP segment.

Note: For that some drugs additional information such as prior treatments received may be required. When additional information is necessary, NGS will return the claim to the provider along with a request for specific information.

FISS DDE information: The FISS Remarks Field (MAP1714) on claim page 04 is a 78 position alphanumeric field with ten lines available. Providers may utilize the <F6/PF6> key to scroll forward for two additional pages of remarks space, if needed. Thus, there are 10 lines per each of 3 pages available. Therefore, 78 spaces x 10 lines per page is 780 x 3 = 2340 spaces.

Note: The FISS system does not currently allow looking up the claims history for the C9399 claims. However, if the drug has previously been paid for a beneficiary and date of service is provided in the remarks, the nurse will check for the claim in history.

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Revised 5/31/2023