ACLA

Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.

The government payor proposed rates that would reduce payment by $670 million, though CMS previously estimated a $390 million cut in 2018.

Entering a new chapter with a new leader, ACLA lends support to a draft bill that would regulate lab tests not as medical devices but as in vitro clinical tests.

The agency said it is giving labs 60 additional days to report private payor rates but is still expecting to launch the new clinical lab fee schedule in 2018.

ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.

The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs. 

According to multiple sources in Washington, DC, the FDA has been informing stakeholders in policy circles of the decision.

CMS gave labs an additional year to gear up for the implementation of the Protecting Access to Medicare Act of 2014 and clarified key programmatic definitions.

Since CMS has yet to issue a final rule, legislators are worried that the agency will "improperly rush" implementation to meet the Jan.1, 2017 deadline.

The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs. 

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The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.

Using gene drives to control invasive species might be too risky, an initial advocate of the approach says.

Researchers have grown tumors in 3D cell cultures to better understand cancer, the Economist reports.

In Science this week: intellectual property experts argue patent battles such as the one over CRISPR are wasteful, and more.