Local Coverage Article Billing and Coding

Billing and Coding: Additional Claim Documentation Requirements for Not Otherwise Classified (NOC) Drugs and Biological Products with Specific FDA Label Indications


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General Information

Article ID
Article Title
Billing and Coding: Additional Claim Documentation Requirements for Not Otherwise Classified (NOC) Drugs and Biological Products with Specific FDA Label Indications
Article Type
Billing and Coding
Original Effective Date
Revision Effective Date
Revision Ending Date
Retirement Date
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CMS National Coverage Policy


Article Guidance

Article Text

General Documentation that is required on every claim for all products:

Hospital Part A:

Submit the following information for claims involving 'not otherwise classified' or 'unlisted' HCPCS codes for drugs, biological products, and radiopharmaceuticals (J3490, J3590, J9999, A4641, and A9699) with limited or specific indications:

• The appropriate NOC code
• The appropriate diagnosis
• The appropriate revenue codes for the drug and IV infusion
• Drug name, the National Drug Code (NDC) number and total dosage must be indicated

For claim submission, the documentation must be included in the remarks field (Field Locator 80) on the UB-04 (CMS 1450 form) or the equivalent 5010 electronic claim field.

Part B:

Please refer to the following articles on the Palmetto GBA website for general information regarding additional required documentation for NOC drugs, biological products and radiopharmaceuticals:

Unclassified or Not Otherwise Classified (NOC) Drug Codes: Rejected if Not Submitted Correctly

Product specific information that is required on both Part A and Part B claims:

For any new drug not given an assigned specific HCPCS code, Palmetto GBA must be able to ascertain that FDA labeling indications have been met in the use of the drug or radiopharmaceutical. In addition to the documentation listed above, documentation submitted for oncology drugs or oncology radiopharmaceuticals submitted with not otherwise classified codes (NOC) prior to that particular drug or radiopharmaceutical receiving a unique HCPCS code must also include:

1. The diagnosis code for the specific FDA label indication for the drug. If no diagnosis code exists that adequately describes or distinguishes the FDA label indication (e.g. the indication is squamous cell carcinoma of the lung and the only available diagnosis code is malignant neoplasm of upper lobe), a specific narrative description (i.e. squamous cell carcinoma) must accompany the appropriate (more general) diagnosis code.

2. If applicable, the narrative information must also indicate that any other FDA labeled criteria is met. The following are examples of such conditions:

a) There must be a statement that the disease is metastatic if the indication is only for a metastatic form of the malignancy in the FDA indication or a statement that the individual patient condition is consistent with any other FDA label criteria, (e.g., bony metastases, but no visceral metastases, etc.).

b) If the FDA indication states that the drug is for second or subsequent line treatment after other specific regimens have been employed and/or that the disease is progressive or recurrent after other specific drug regimens or protocols have been employed, a statement to that effect and/or the disease has progressed despite or after those regimens must be included in the narrative.

3. If applicable, a statement that any other criteria (not discussed above), required in the FDA label has been met. This requirement would apply to non-oncology drugs, biologic products, or radiopharmaceuticals, as well as, oncology related therapeutic agents with NOC codes.

Coding Information


Group 1

(5 Codes)
Group 1 Paragraph


Group 1 Codes

CPT/HCPCS Modifiers


ICD-10-CM Codes that Support Medical Necessity


ICD-10-CM Codes that DO NOT Support Medical Necessity


Additional ICD-10 Information


Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.


Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.


Other Coding Information


Revision History Information

Revision History DateRevision History NumberRevision History Explanation
10/03/2019 R4

This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles.

02/26/2018 R3 The Jurisdiction "J" Part A and Part B Contracts for Alabama (10111/10112), Georgia (10211/10212) and Tennessee (10311/10312) are now being serviced by Palmetto GBA. Effective 02/26/18, these 6 contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 6 Part A and B contract numbers) have been completed in this revision.
09/29/2016 R2 Under Article Text-Part B deleted the article “Drug and Biological Injections & Infusions: Use of the Quantity Billed Field (QB)” as the article was removed from the Palmetto GBA Website.
02/11/2016 R1 Under Article Test –Product Specific Information that is required on both Part A and Part B claims added the following verbiage to the first sentence of the first paragraph: “For any new drug not given an assigned specific HCPCS code…”

Associated Documents

Related Local Coverage Documents
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
09/26/2019 10/03/2019 - N/A Currently in Effect You are here
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