If anything I'm picking a Biden win will improve progress if related to getting control of Covid.
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I'd be very surprised if they're paid much of that at all. The LCD means the Cxbladder Monitor and Detect tests are covered - if medically necessary. And that, to me, is key. The use of Urinary biomarkers, including Cxbladder is considered investigational only by the American Urological Assn. Not medically necesary and not recommended. But they have a place.
CMS has not rewritten the gold standard. They won't be sending all their patients off for a CxBladder test until the AUA include in the clinical pathway.
And neither will the other Insurers.
I think there will be much disappointment when the actual numbers are revealed. They will be getting paid for a few more tests now, but not in the numbers thought here. And no show of recovering US$40m.
My opinion only.
Quote from recent newsletter "We have now had two full months of revenue from the CMS, with all of our eligible claims being paid to date. This is the key driver enabling our US business to post monthly record revenues in August and September."
Can the "few more tests" create record revenue!?
CMS has said that they will cover cxbladder tests presented to them by Medicare patients who have utilised the product with their urologist or physician.
These are all the folk over 65 and a number of others with disabilities.
40 million dollars worth have accumulated in that channel over say 5 years due to lack of authorisation.
Think we can assume 8 million bucks worth a year, minimum will be forthcoming from there for starters.
CMS does not send patients anywhere as far as I know.
They are there to provide coverage under the Medicare and Medicaid programmes.
July/ August / September are sort of holiday time in the US and historically have led to pretty diminished PEB revenue accruing around then.
Starting from a low base with that I think so a few more tests could make a big difference.
"all of our eligible claims to date" indicates that CMS is paying for Detect and Monitor tests for all medicare patients whose medical advisors have decided
to use the cxBladder test.
Kaiser will have Medicare patients under their wing so those will go through once PEB makes the claim.
What could be more necessary than keeping bladder cancer monitored patients out of the way of Covid as best they can.
With the full scale uptake by Kaiser imminent they will be quick to see that as medically necessary.
Kaiser has 1/27 of the US population on the books
80,000 added to the monitoring pop annually = 2900 as Kaisers share
3 tests a year = 8700 at 1000 a pop =8.7m
and dont forget the other 29000 who are Kaiser patients from the overall US populations 800,000 being monitored for bladder cancer already.
Thats just Monitor and back of the envelope figures