#Wd drive utilities 2.0 0.71 manual

#Wd drive utilities 2.0 0.71 manual

See Appendix D for the NCD manual language. Subject: Decision Memorandum on Diagnostic Laboratory Tests using Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced CancerĪfter considering the public comments and additional evidence, we are revising our proposed decision. See Appendix D for the NCD manual language.ĭeputy Director, Coverage and Analysis Groupĭirector, Division of Policy & Evidence Reviewĭeputy Director, Division of Policy & Evidence Review Medicare Administrative Contractors (MACs) may determine coverage of other Next Generation Sequencing (NGS) as a diagnostic laboratory test for patients with cancer only when the test is performed in a CLIA-certified laboratory, ordered by a treating physician and the patient has:

results provided to the treating physician for management of the patient using a report template to specify treatment options.

an FDA approved or cleared indication for use in that patient’s cancer and.

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).either not been previously tested using the same NGS test for the same primary diagnosis of cancer or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician and.either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer and.

The Centers for Medicare & Medicaid Services (CMS) has determined that Next Generation Sequencing (NGS) as a diagnostic laboratory test is reasonable and necessary and covered nationally, when performed in a CLIA-certified laboratory, when ordered by a treating physician and when all of the following requirements are met: