![]() ![]() The Transmittal number, Dated issued and all other information remain the same. This instruction is being re-communicated to include attachment that was omitted. UNTIL THAT TIME, THE MEDICARE ADMINISTRATIVE CONTRACTORS (MACS) SHALL BE RESPONSIBLE FOR IMPLEMENTING NCD 90.2.( TN 210) (CR10878)Ġ3/2019 - Transmittal 210, dated November 30, 2018, is being rescinded and replaced by Transmittal 214, dated, Mato extend the implementation date 30 days and update the attached diagnosis code list. 100-04 CLAIMS PROCESSING MANUAL UPDATE AND FURTHER, ACCOMPANYING INSTRUCTIONS. A SUBSEQUENT CR WILL BE RELEASED AT A LATER DATE THAT CONTAINS A PUB. THIS CHANGE REQUEST (CR) AND PUBLICATION (PUB.) 100-03 MANUAL TRANSMITTAL REFLECTS THE AGENCY’S FINAL DECISION DATED MARCH 16, 2018, REGARDING THE NATIONAL COVERAGE DETERMINATION (NCD) 90.2, ON NEXT GENERATION SEQUENCING (NGS). a risk factor for germline (inherited) cancer and,ġ1/2018 - The purpose of this Change Request (CR) is to inform contractors that effective March 16, 2018, the Centers for Medicare & Medicaid Services covers diagnostic laboratory tests using next generation sequencing when performed in a Clinical Laboratory Improvement Amendments- certified laboratory when ordered by a treating physician and when specific requirements are met.a clinical indication for germline (inherited) testing of hereditary cancers and,.either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer and,Įffective for services performed on or after January 27, 2020, MACs may determine coverage of NGS as a diagnostic laboratory test for patients with germline (inherited) cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, when results are provided to the treating physician for management of the patient and when the patient has:.The diagnostic laboratory test using NGS must have all of the following:Įffective for services performed on or after March 16, 2018, NGS as a diagnostic laboratory test for patients with acquired (somatic) cancer are non-covered if the cancer patient does not meet the criteria noted in section B.1., above.Įffective for services performed on or after March 16, 2018, Medicare Administrative Contractors (MACs) may determine coverage of NGS as a diagnostic laboratory test for patients with advanced cancer only when the test is performed in a CLIA-certified laboratory, when ordered by a treating physician, and when the patient has: not been previously tested with the same germline test using NGS for the same germline genetic content.ī.a risk factor for germline (inherited) breast or ovarian cancer and.a clinical indication for germline (inherited) testing for hereditary breast or ovarian cancer and,.results provided to the treating physician for management of the patient using a report template to specify treatment options.Įffective for services performed on or after January 27, 2020, CMS has determined that NGS as a diagnostic laboratory test is reasonable and necessary and covered nationally for patients with germline (inherited) cancer, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met:.an FDA-approved or -cleared indication for use in that patient’s cancer and,.Food & Drug Administration (FDA) approval or clearance as a companion in vitro diagnostic and,.The diagnostic laboratory test using NGS must have: decided to seek further cancer treatment (e.g., therapeutic chemotherapy).ī.not been previously tested with the same test using NGS for the same cancer genetic content, and. ![]() either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer and. ![]()
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