Article - Billing and Coding: Additional Claim Documentation Requirements for Not Otherwise Classified (NOC) Drugs and Biological Products with Specific FDA Label Indications (A54880)

CMS National Coverage PolicyN/AArticle TextGeneral 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 indicatedFor 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 CorrectlyProduct 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.