The policy states that lab tests without FDA's blessing may pursue local coverage via Medicare contractors, but national coverage requires premarket approval or clearance.

The final determination also adds coverage for FDA-approved tests in stage III patients, and for repeat testing if patients receive a new primary diagnosis.

At the ACLA conference this week, FDA Commissioner Gottlieb outlined his vision for the agency in the realm of LDTs.

A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.

The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.

Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear. 

CureOne also received CMS's approval for 11 quality metrics around biomarker testing that doctors can report for MIPS-related payment. 

The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.

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.

The suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.


Robert Redfield is floated as the next director of the US Centers for Disease Control and Prevention, the Washington Post reports.

The New York Times writes that the National Institutes of Health's All of Us Research Program is "ambitious" and that some are concerned it might be overly so.

Representative Lamar Smith's criticism of the National Science Foundation has "changed the nature of the conversation," according to ScienceInsider.

In PLOS this week: non-coding RNA function in yeast, transcriptomic profiles of malaria parasites, and more.