Ann: Proteomics International seeks FDA approval for PromarkerD, page-232

Hi All,

Some very recent & important news on Medicare in the USA for medical devices & tests with Breakthrough Device Status with the FDA. This status can be awarded at anytime PRIOR to FDA Clearance.

What this now means is that devices (or tests) that have Breakthrough Device Status will have immediate Medicare coverage for patients to use the technology from the date that Breakthrough Device Designation is awarded for a period of 4 years.

This rule was changed only in January 2021. So if PIQ are recommended by the FDA to apply for Breakthrough Device status in this impending meeting & that is awarded (quick turn around time), that will mean that PIQ will have immediate Medicare coverage for 4 years for PromarkerD & then this is re-evaluated at the time for ongoing or permanent Medicare coverage from the US Govt.

Article below & this is pretty exciting news!! RenalytixAI were awarded Breakthrough status so I don’t see why PIQ shouldn’t (see my prior posts for more info if needed).

https://namsa.com/cms-rule-medicare-coverage-of-mcit/

GLTAH & it pays to read all the gobbledegook