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This service does not meet the criteria described by Step 2 of the 5-step process: determination of whether the service is subject to the provisions of section 1834(m) of the Act

The clinical value of the intervention and its contribution to overall patient health outcomes should be weighed alongside the direct reimbursement amount

Inefficiencies associated with workarounds and custom processes can lead to further reductions in data quality, completeness, consistency, and interoperability

(b) Drugs and biologicals excluded from Part D rebate calculations

(2) updates to the historical benchmark

CMS refers to X months of run-out as the period between the end of the applicable calendar quarter and the date when CMS accesses information about the claims