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

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](http://www.palmettogba.com/palmetto/providers.nsf/docscat/Providers~JM%20Part%20B~Browse%20by%20Topic~Drugs%20Biologicals~Unclassified%20or%20Not%20Otherwise%20Classified%20\(NOC\)%20Drug%20Codes%20Rejected%20if%20Not%20Submitted%20Correctly)  
  
 **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.