Self-Administered Drugs - Process to Determine Which Drugs Are Usually Self-administered By the Patient

Noridian determines coverage of outpatient injectable drugs by assessing whether a drug is 'usually self-administered' for the Medicare population using a three-step process: (1) categorical determination based on the nature of use (e.g., drugs requiring IV administration, procedures, physician titration, or acute courses <2 weeks are not usually self-administered and are covered), (2) utilization analysis using a 50% threshold of subcutaneous/chronic-frequent injections, and (3) evidentiary review using peer-reviewed literature, standards, and FDA information. Drugs self-administered >50% of the time across indications are excluded from coverage for all patients, providers must document analyses and evidentiary sources, and Noridian will post a 45-day public notice before changing a drug from covered to not covered; beneficiaries may appeal but ABNs are not required and providers may bill beneficiaries for excluded drugs.

"An injectable drug that is not usually self-administered (for example, drugs requiring intravenous or intrathecal administration, administration during a procedure, requiring physician titration, o..."