Billing and Coding: Additional Claim Documentation Requirements for Not Otherwise Classified (NOC) Drugs and Biological Products with Specific FDA Label Indications
A54880
Claims using NOC/unlisted HCPCS drug, biologic, and radiopharmaceutical codes (e.g., J3490, J3590, J9999, A4641, A9699) must include specific documentation—NOC code, diagnosis, revenue codes, drug name, NDC, and total dosage—entered in UB-04 Field Locator 80 or the equivalent 5010 field so Palmetto GBA can verify FDA label indications. Oncology NOC submissions prior to assignment of a unique HCPCS code must supply a diagnosis matching the FDA label or a specific narrative (including statements about metastatic status, prior regimens, progression, or other label criteria) and Part B claimants should follow Palmetto GBA guidance on their website. Claims lacking the required documentation or sufficient facts to verify FDA-labeled criteria will be rejected or denied.
"For claims using not otherwise classified (NOC)/unlisted HCPCS codes J3490, J3590, J9999, A4641, or A9699 with limited or specific indications, submit required documentation in the claim remarks fi..."