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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.

Women's health, drug monitoring,and the company's 23andMe collaboration led organic growth in diagnostics.

ACLA urged the court to reconsider its ruling, arguing that it would be impossible for laboratories to comply with it.

 The registry, which has been approved by CMS, is designed to demonstrate quality pathology practices and maximize reimbursements.

As the company continues to push back against the recently proposed PAMA rates, it said that its acquisition strategy will offset any impact from the new rates.

 

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