ACLA filed a motion arguing that HHS' PAMA data collection process is flawed. It follows a July decision that overturned a lower court's dismissal of ACLA's lawsuit.
The agency has proposed rolling back exemptions gained in a 2018 revision of the rule that labs say are key to maintaining access to molecular testing.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
While industry organizations remain optimistic the bill will pass, others note challenges, including a lack of strong Congressional support and political gridlock.
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
The ruling overturned a lower court decision that blocked ACLA's suit challenging the data collection process used by CMS to set test prices under PAMA.
The bipartisan legislation would delay the reporting of lab payment data by a year and collect recommendations on improving PAMA payment reporting requirements.
CMS had received significant stakeholder feedback that germline NGS testing is not the same as somatic testing, and that the NCD as written would negatively impact patients.
