Process for Determining Self-Administered Drug Exclusions – Medical Policy Article

CMS requires contractors to determine self-administered drug exclusions on a drug-by-drug basis: drugs usually self-administered by Medicare beneficiaries (>50% self-administer) are excluded from Medicare payment, while drugs not usually self-administered—typically intravenous or intramuscular injectables and injectables given with chemotherapy—are generally eligible for coverage when furnished 'incident to' a physician's service. Determinations must be supported by specified evidence sources (peer-reviewed literature, practice guidelines, FDA label, compendia, utilization statistics), and contractors must provide a 45-day advance notice before denying payment for drugs subject to the exclusion.

"A drug that is not usually self-administered by Medicare beneficiaries (>50% of beneficiaries do not self-administer) is eligible for Medicare payment when furnished 'incident to' a physician's ser..."