Medicare Administrative Contractors Finalize Local Coverage Determinations for Immucor PreciseType® HEA Test
NORCROSS, Ga., April 04, 2016 -- Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced that Medicare Administrative Contractors (MACs) that participate in Palmetto’s Molecular Diagnostic Services (MolDX) program have finalized coverage policies for the PreciseType HEA test – the first and only FDA-approved molecular diagnostic that evaluates blood compatibility between donors and patients to help prevent mismatches that can cause potentially life-threatening reactions.
Noridian Healthcare Solutions, a MAC which covers Medicare Part B in 14 states north and west of Colorado (Jurisdictions E and F), finalized its Local Coverage Determination (LCD) for the test last Friday, following the precedent set by Palmetto GBA in June of 2015, and CGH Administrators in October of 2015, who are the other MACs that currently participate in the MolDX program. LCDs give providers coverage guidance and enable them to code claims accurately for specified classes of Medicare patients who can benefit from better-matched blood. These include Medicare patients with conditions, or undergoing treatments, that result in anemia for which frequent transfusions may be required, including diseases such as sickle cell anemia and thalassemia.
“The PreciseType HEA test is the only molecular immunohematology test to have successfully completed the MolDX technical assessment − a process that involves demonstrating the test’s analytical and clinical validity to subject-matter experts, among other requirements," explained Joel de Jesus, Immucor's Senior Director of Government Affairs and Payer Relations.
Chief Marketing Officer Keith Chaitoff added, "This coverage determination becomes particularly important for patients and providers given the recent AABB Bulletin advising that patients receive a baseline phenotype or genotype test before initiating treatment with one of the new class of monoclonal-antibody-based therapeutics for cancer, recently approved by the FDA.” According to AABB, an US-based international association for transfusion medicine, these new therapeutic agents can result in interference with blood bank serologic tests and thereby cause delays in issuing red blood cell (RBC) units to patients receiving these agents.
Beyond the MolDX program, additional coverage in Alabama, Georgia, and Tennessee for the PreciseType HEA test became effective on April 1, 2016, when Cahaba released its LCD. The LCDs issued by Palmetto, CGS, Noridian, and Cahaba GBA provide guidelines for billing coders to follow for qualifying patients when submitting Medicare claims for payment for pre-transfusion testing using the PreciseType HEA test. The MACs have provided approximately 55 classifications of diseases (ICD-10 codes) that support medical necessity for their beneficiaries.
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 evaluates blood compatibility between donors and patients to help prevent mismatches that can cause 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.
CONTACT: Michele Howard 770.441.2051