CMS
High payment rates for tests for rare disorders in regions covered by two Medicare Administrative Contractors could spark debate about genetic testing fraud.
The company achieved two major milestones this year with the launch of its Guardant Shield test and Medicare reimbursement for its Guardant Reveal test.
Guardant Health Receives Medicare Coverage for MRD Liquid Biopsy in Stage II and III Colon Cancer
The Guardant Reveal assay will now be covered for this group of patients as long as testing is initiated within three months after surgery.
Adaptive Biotech's ClonoSeq Gets Expanded Medicare Coverage For B-Cell Lymphoma
The firm's assay is the first and only test to gain coverage for this patient population, for whom ctDNA MRD assessment can help personalize treatment.
The agency had originally planned to delete unspecified diagnosis codes for certain cancer tests covered under a national coverage decision.