MolDX: Blood Product Molecular Antigen Typing

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Blood Product Molecular Antigen Typing L38240 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L38240 LCD Title MolDX: Blood Product Molecular Antigen Typing Proposed LCD in Comment Period N/A Source Proposed LCD DL38240 Original Effective Date For services performed on or after 10/25/2020 Revision Effective Date For services performed on or after 11/07/2024 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 09/10/2020 Notice Period End Date 10/24/2020 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or re

This policy provides limited coverage for molecular phenotyping of blood product antigens as part of the pre-transfusion evaluation for patients who may require or are expected to require a blood product transfusion(s) (Red Blood Cells [RBCs], Platelets or Leukocytes) when at least one of the following criteria is met: Long term, frequent transfusions are anticipated to prevent the development of alloantibodies (e.g., sickle cell anemia, thalassemia, chronic transfusion dependent hematologic disorders or other reasons); OR Autoantibodies or other serologic reactivity that impede the exclusion of clinically significant alloantibodies (e.g. autoimmune hemolytic anemia, warm autoantibodies, patient recently transfused with a positive DAT, high-titer low avidity antibodies, patients about to receive or on daratumumab therapy, other reactivity of no apparent cause); OR Suspected antibody against an antigen for which typing sera is not available; OR Laboratory discrepancies on serologic typing (e.g., rare Rh D antigen variants) Laboratory developed tests (LDTs) that perform molecular phenotyping of blood product antigens may be considered covered for the same indications if the test demonstrates validity and clinical utility equivalent to or better than covered tests as demonstrated in a technical assessment. Medicare does not expect molecular testing to be performed on patients undergoing surgical procedures such as bypass or other cardiac procedures, hip or knee replacements or revisions, or patients with alloantibodies identifiable by serologic testing that are not expected to require long term frequent transfusions. The medical necessity for molecular blood product phenotyping must be documented in the patient’s medical record. Blood product molecular antigen typing tests are considered germline tests and thus must comply with relevant Medicare or Contractor policies regarding germline testing. As molecular genotyping includes a review of many genes that code for cellular antigens that must be evaluated for proper patient care, single gene tests are not reasonable and necessary. If there is a rare instance that a single blood product antigen is reasonable and necessary, its utility must be appropriately documented in the patient's medical record for validation by medical review.