Originally Posted by
Balance
According to my biomed contact, PEB made a strategic mistake and blunder by not obtaining FDA clearance for CxBladder.
The situation regarding LCD inclusion since October 2018 is (summary) :
"Medicare Administrative Contractors (MAC) tasked with deciding what medical technologies qualify for Medicare coverage in local geographical areas will now be required to publish a summary of clinical evidence supporting their decisions, include a beneficiary representative and non-physician healthcare workers on advisory committees, and ensure that Contractor Advisory Committee meetings are open to the public." Section 4009 of the 21st Century Cures Act passed in September 2018.
The MAC give weight to FDA clearance of any medical devices and technologies.