A query- what if there is no decision made in the times mentioned. BAU??
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At the end of the day, its a gamble... But in my opinion, there are a number of factors that suggest its more likely that medicare coverage will be kept. Firstly, PEB and it's tests have compelling support from the main players in the urology industry in the USA, advocating for Medicare to be maintained. The idea is that by maintaining Medicare coverage of these tests, there is a public health benefit/overall cost saving. Secondly, Novitus will need to rebutt the Strata research and the support that this research has gained. I'm not sure if they can feasibly do this in a way that doesn't compromise their procedure and position within the time period they have. Sure Novitas can just say no, but procedurally they should back that up with sound rationale or evidence, else legally, the decision could be easily challenged and it would be a terrible look. Lastly, I think Novitas has a few options, e.g. allow coverage to be kept or raise another lcd after this one had lapsed. Of the options, these two options are safer than canceling coverage. There are some other things like elections and the FDA adding another layer of compliance and PEBs tests possibly getting guideline inclusion, these points arnt here or there but are positive for maintaining Medicare coverage.
Please DYOR, these are just my thoughts.
Is the A Bank still in on this gamble ? :)
compelling support from the main players in the urology industry in the USA
Can you qualify this please
The American Urological Association (AUA), the Large Urology Group Practice Association ,(LUGPA), and the American Association of Clinical Urologists (AACU) and Kaiser support a decision for PEB to maintain Medicare coverage. Kaiser submitted their own research to support PEB.
I'm also not sure Novitas needs rebutt a study funded by Pacific Edge?
It's on the PEB website. Some of it is here
https://www.pacificedgedx.com/news-a...-medicare-lcd/ ,but the information will be scattered across a few pages.
Nothing specific about Detect but Cxbladder is mentioned expressly in their letter and the groups advocate for Medicare coveragw for Cxbladder to be kept. There letter can e donnloaded here: https://www.pacificedgedx.com/assets...CD-DL39365.pdf
Thank you. Note as a group they argue for the continued inclusion of approved Biomarkers generally and agree, they speak positively of the results of the unpublished Kaiser findings. But note that AUA does not include the use of Cxbladder in its own Clinical Guidelines....
Wouldn't you think the AUA would first change their guidelines if Cxbladder had their support?
A podium presentation of the clinical utility was part of the just concluded AUA conference.Not sure what weight this would carry but worth to note that this conference was attended by a lot of urologists across the world.
https://api.nzx.com/public/announcem...284-417563.pdf
I'm not an expert on AUA and guidelines. Reading between the lines, I think it takes time and research for inclusion. I think PEB is gunning for inclusion in guidelines, it's just not there yet. AUA is expressly supportive of the PEB tests and they have noted this in their letter. I think the safest thing for Novitas to do is to trigger another modified LCD and give PEB another year of coverage.
This is a article pushed out a few days ago: https://auanews.net/issues/articles/...cer-management .Cxbladder is mentioned and biomarkers are talked about favorably. The science is getting there... just not sure how far or close it is for inclusion...
There is also a part that comments on guidelines:
AUA guidelines do not currently recommend the use of urinary biomarkers to replace cystoscopy, but they do provide two clinical scenarios where biomarkers may be useful: (1) to adjudicate equivocal cytology or indeterminate cystoscopic findings and (2) to assess response to bacillus Calmette-Guérin (BCG).
Yes, article talks generally about biomarkers, not written by AUA as such. Big mention re opposition too.
In the two clinical scenarios you refer to the biomarkers approved are UroVysion Fish and Immunocyt, not CxBladder.
Totally agree, getting there. But still seems some way off.