Laboratory Question for the Week of November 25, 2019

Laboratory Compliance Question of the Week


Did CMS make a decision to exclude blood banks from DOS exception at § 414.510(b)(5) in the final 2020 OPPS rule?


Based on the reasons outlined in the proposed rule combined with stakeholder support, the Centers for Medicare & Medicaid Services (CMS) is finalizing the revisions to exclude blood banks and centers from the laboratory DOS exception at § 414.510(b)(5). In the final rule, CMS states:

“To effectuate this policy change, we are revising § 414.510(b)(5) to exclude molecular pathology tests when performed by a laboratory that is a blood bank or center. We are defining the term “blood bank or center” instead of “blood bank and center” to reflect that a molecular pathology test is excluded when performed by either a blood bank or blood center. We are also defining “blood bank or center” at § 414.502 as an entity whose primary function is the performance or responsibility for the performance of, the collection, processing, testing, storage and/or distribution of blood or blood components intended for transfusion and transplantation.” Major stakeholders like the ACLA have previously supported this exclusion decision.

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