Foundation Medicine Receives New ADLT Status for FoundationOne CDx™ from the Centers for Medicare and Medicaid Services (CMS)
FOUNDATION MEDICINE (FMI)
Last foundation medicine earnings: 5/2 04:01 pm
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Foundation Medicine, Inc. (NASDAQ:FMI) today announced that under the Protecting Access to Medicare Act of 2014 (PAMA) the Centers for Medicare & Medicaid Services (CMS) approved new Advanced Diagnostic Laboratory Test (ADLT) status for FoundationOne CDx™. FoundationOne CDx is the first FDA-approved comprehensive genomic profiling assay for all solid tumors that incorporates multiple companion diagnostics. The CMS determination confirms that FoundationOne CDx meets the criteria for classification as a new ADLT. The initial nine-month period for Foundation Medicine to collect and assess private payer rates under PAMA will begin July 1, 2018 and will end March 31, 2019. During this period, in accordance with PAMA and as described by HCPCS billing code 0037U, CMS will provide reimbursement for covered FoundationOne CDx tests at the rate of $3,500. Please visi
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