'Not FDA-approved' denials
The plan says the drug or its specific use isn't FDA-approved. Distinct from 'experimental' — and appealable when off-label use is medically supported.
What this denial means
A not-FDA-approved denial (CARC 114, 188) means the plan classified the drug, dose, or specific indication as not having FDA approval. There are two patterns: (a) the drug itself isn't FDA approved (rare for legitimate clinical use), (b) the drug is FDA approved but not for the patient's specific indication — i.e., off-label use. Most denials in this category are about off-label use.
How to appeal it
Off-label-use denials win when the appeal documents: (1) the FDA-approved indication and how the patient's use relates; (2) the off-label use is supported by peer-reviewed literature; (3) the off-label use is recognised by a major compendium (NCCN, DRUGDEX, AHFS-DI, Clinical Pharmacology) — federal law requires Medicare and Medicaid to recognise compendium-supported off-label use, and many commercial plans follow the same standard; (4) the off-label use is consistent with the relevant specialty-society guideline. The appeal cites the compendium entry by name.
Frequently asked questions
What does “drug not FDA approved” mean?
A not-FDA-approved denial (CARC 114, 188) means the plan classified the drug, dose, or specific indication as not having FDA approval. There are two patterns: (a) the drug itself isn't FDA approved (rare for legitimate clinical use), (b) the drug is FDA approved but not for the patient's specific indication — i.e., off-label use. Most denials in this category are about off-label use.
How do I appeal a 'not fda-approved' denials?
Off-label-use denials win when the appeal documents: (1) the FDA-approved indication and how the patient's use relates; (2) the off-label use is supported by peer-reviewed literature; (3) the off-label use is recognised by a major compendium (NCCN, DRUGDEX, AHFS-DI, Clinical Pharmacology) — federal law requires Medicare and Medicaid to recognise compendium-supported off-label use, and many commercial plans follow the same standard; (4) the off-label use is consistent with the relevant specialty-society guideline. The appeal cites the compendium entry by name.
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