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CureOne also received CMS's approval for 11 quality metrics around biomarker testing that doctors can report for MIPS-related payment.
Lab industry groups hope to change CMS's controversial 2016 decision allowing nurses to perform complex lab tests.
Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
ACLA alleges that HHS and CMS interpreted the Protecting Access to Medicare Act in a way that resulted in 2018 payment rates that are much lower than Congress intended.
The suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.
The final guidance is an update to an agreement between the FDA and CMS, which uses the FDA's policy in determining coverage for investigational devices.
Pricing for FoundationOne CDx, which received FDA approval and a proposed CMS national coverage determination yesterday, will be determined under PAMA.
The FDA approved FoundationOne CDx and the Centers for Medicare and Medicaid Services concurrently issued a proposed national coverage decision for the test.
Payors' demands for clinical utility evidence can be met through greater use of databases and registries, Harold Varmus and Rebecca Eisenberg said.
A number of experts have questioned the clinical validity underlying Interleukin's tests and hope Orig3n will not revive them.