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Step therapy (Part B drugs)
A coverage requirement CMS checks is applied only to new administrations of Part B drugs, using a 365-day look-back.
For sampled Table 1 and Table 2 cases, CMS reviews whether the sponsoring organization applied step therapy only to new administrations of Part B drugs, using at least a 365-day look back period. The ANOC/EOC supporting its application is part of the supporting documentation.
Source: ODAG protocol, Processing of Coverage Requests 2.6, PDF p. 14; Supporting Documentation Submissions, PDF p. 48.