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J3357, Ustekinumab (Stelara) is listed on the Self-Administered Drug Exclusion List: Medical Policy Article A53021, and it says “acceptable”. Does this mean it is excluded or not?

It means that it is excluded. The table referenced in Self-Administered Drug Exclusion List: Medical Policy Article A53021 lists drugs that are not covered by Medicare..

Acceptable evidentiary criteria indicates:

  • A/B MACs (A), (B), and (HH+H), and DME MACs are only required to consider the following types of evidence: peer reviewed medical literature, standards of medical practice, evidence-based practice guidelines, FDA approved label, and package inserts. A/B MACs (A), (B), and (HHH), and DME MACs may also consider other evidence submitted by interested individuals or groups subject to their judgment.