Originally Posted by
Greekwatchdog
This is what For Barr have to say for what its worth.
Proposed LCD has been finalised — not good news for PEB
The final LCD retains the reliance on evidence based guidelines for a test to be considered medically reasonable and necessary, and therefore tests to be covered. The requirement for a test to be within Category 1 or 2A of the National Comprehensive Cancer Network (NCCN) guidelines has been retained. Cxbladder is currently in Category 2B which by virtue of the reimbursement criteria rules it out of coverage. Our analysis suggests this is the only finalised LCD since 2010 to explicitly rely on NCCN guidelines as a coverage criteria. The final LCD effective date (when it appears reimbursement for PEB’s Cxbladder tests will cease) is 17 July 2023.
The key question from here is what the future coverage path within CMS looks like. A key change in the finalised LCD is that Novitas "will accept LCD reconsideration requests" as to whether tests meet CMS' reasonable and necessary criteria. The complex legalities means forming a strong view on the future coverage path right now is very difficult but US industry feedback suggests that a revision request can be lodged at any time, though the probability of a change in the near-term is “low”.
Rating and target price UNDER REVIEW until more information is provided
We have not yet had the opportunity to speak to the company and we acknowledge the coverage path from here is highly uncertain. There is a wide range of outcomes depending on the success of LCD reconsideration requests based off PEB's (and potentially others) likely objections to the finalised LCD. Until we get confirmation on the forward coverage path based off potential reconsiderations, and as new information comes to light, our rating and target price are UNDER REVIEW.