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.
Lipid panel prices and prices for tests formerly bundled together as automated testing profiles are expected to rise in 2018, but fall in 2019.
The government payor made some adjustments in finalizing the 2018 clinical lab fee schedule, but the industry continues to feel CMS is ignoring its most salient concerns.
Though revenues from its non-invasive heart transplant rejection test AlloMap fell about 5 percent, CareDx is already being reimbursed by Medicare for its new AlloSure test.
The agency is excluding certain advanced diagnostic lab tests and molecular pathology tests from a billing regulation that created administrative headaches for many labs.