New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.
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.
The suit filed against the acting HHS secretary alleges that a flawed data collection process failed to establish market-based rates.
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.
A genetic genealogy analysis helped secure the release of a California man from prison after getting his murder conviction overturned, the Guardian reports.
Technology Review discusses the concerns that come along with the ability to quickly synthesize viruses like SARS-CoV-2.
Researchers have uncovered large bacteriophages whose genomes include translational machinery, Live Science reports.
In PNAS this week: role for Myc in alternative splicing regulation in prostate cancer, variation in methylation in Arabidopsis, and more.