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Jul 13, 2015

Palmetto GBA Finalizes Local Coverage Determination (LCD) for Immucor PreciseType™ HEA test

Palmetto GBA Finalizes Local Coverage Determination (LCD) for Immucor PreciseType HEA test

  • LCD covers test for Medicare patients who can benefit from better-matched blood
  • Critical step in helping healthcare providers obtain reimbursement for claims
  • Norcross, Ga., July 9, 2015 - Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has finalized a local coverage determination (LCD) for the PreciseType HEA test through its Molecular Diagnostic Services (MolDX) program.

    Under the LCD, Medicare will cover pretransfusion molecular testing using the PreciseType HEA test for the following categories of patients in MAC Jurisdiction M (NC, SC, WV and most counties in VA):

    • Long term, frequent transfusions anticipated to prevent the development of alloantibodies (e.g. sickle cell anemia, thalassemia or other reason);

    • Autoantibodies or other serologic reactivity that impedes 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, other reactivity of no apparent cause);

    • Suspected antibody against an antigen for which typing sera is not available; and

    • Laboratory discrepancies on serologic typing (e.g. rare Rh D antigen variants).

    "Although the PreciseType HEA test received a CPT code (81403), in order to receive reimbursement for the service, healthcare providers must demonstrate that it is a medically necessary test for that particular patient, which is why the issuance of this LCD is so important," explained Joel de Jesus, Immucor's senior director of marketing for molecular immunohematology.

    "The LCD has established that the PreciseType HEA test is medically necessary for four designated types of use. We are very pleased with this coverage determination and remain committed to helping providers and patients obtain reimbursement for molecular red cell antigen testing.

    "Our momentum continues in making personalized medicine a reality in transfusion medicine. From the FDA approval of our PreciseType HEA test, securing a CPT code for molecular HEA testing, to this LCD - we continue to be a catalyst in the evolution of immunohematology diagnostics," de Jesus added.

    About the PreciseType HEA test
    The first in the line of Immucor PreciseType personalized-medicine diagnostics, the PreciseType HEA (human erythrocyte antigen) test rapidly and accurately predicts blood compatibility between donors and patients to help prevent mismatches that can cause serious, potentially life-threatening reactions. It also allows blood centers to identify and maximize appropriate use of donor blood containing rare antigens. The PreciseType assay is the first-ever FDA-approved test for molecular red blood cell (RBC) typing of donor and recipient blood for blood transfusions.

    About Immucor, Inc.
    Founded in 1982, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient-donor compatibility. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. With the right match, we can transform a life together. To learn more, visit www.immucor.com.

    Michele Howard