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News items for the in vitro diagnostics industry for the week of Dec. 30, 2019

The LCD for the RNA gene expression test will take effect on Feb. 10, 2020, the Medicare contractor said.

Despite the availability of more precision therapies and complex biomarker tests, systemic gaps and lack of physician education continued to hinder access.

The registry is designed to help pathology practices comply with requirements under Medicare’s Quality Payment Program and Merit-Based Incentive Payment System.

While legislation and lawsuits sought to blunt PAMA's impact, labs also employed new technologies and strategies to cope with anticipated price cuts.

A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.

 

The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer. 

The firm attributed the decline to reluctance of US customers to buy additional units of its Epi proColon colon cancer test amid reimbursement uncertainty.

The test will now be considered medically reasonable and necessary for patients over 45 with moderately elevated levels of prostate-specific antigen. 

The liquid biopsy firm reported revenues of $60.8 million for the quarter, easily surpassing the consensus Wall Street estimate of $45.4 million.

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