Question:

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

Answer:

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.

This question was answered in an edition of our Laboratory Compliance Manager. For more hot topics relating to laboratory services, please visit our store or call us at 1.800.252.1578, ext. 2.

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