ACLA

New Medicare rates established under PAMA will cause labs to scale back services, and in some cases shut down, the motion states.

ACLA alleges that HHS and CMS interpreted the Protecting Access to Medicare Act in a way that resulted in 2018 payment rates that are much lower than Congress intended.

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. 

Mertz outlined the lab industry group's policy positions after FDA's decision to delay final guidance on regulation of lab tests and upcoming implementation of a payment law.

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