Newsletter quietly offers a few corrections to past embellishments I think, before a disappointing result is published next month.
The big news items taking the SP from about .10 to $1.30 over the past 10 months have been as follows:
Inclusion in NCCN guidelines
PE made much of Cxbladder being included in the clinical pathway but this was an exaggeration in the extreme.
It wasn’t.
There is no mention of Cxbladder in there at all, surveillance is still Cystoscopy and cytology. The guidelines simply, with the weakest of recommendations (2B), now say that the additional use of Biomarkers (in general) may be considered in surveillance but that it was unclear whether the additional information was useful.
Guidelines current March 2021
https://www.nccn.org/professionals/p...df/bladder.pdf
The newsletter now confirms that they have more work to do before inclusion.
NCCN Guidelines: The inclusion of urine molecular tests for UC markers into the NCCN
guidelines in 2019 is specifically for follow up of high-risk NMIBC with level 2B evidence,
as indicated. This inclusion language is a departure (improvement) from previous
versions which explicitly excluded the use of urinary UC markers for all follow up
patients. The use of urinary UC markers is specifically referenced in the NCCN review
language and collectively refers to those biomarker tests assessed in the 2015 Review
paper by Chou et al. which includes Cxbladder.
Deal with Kaiser June 2020
PE finally announced completion of Triage trial with KP in Nov 2016.
We still know nothing of the Commercial deal or number of tests being paid for.
But todays newsletter confirms that they are “using” Monitor only, Triage has not been adopted by KP
Kaiser Permanente (KP): The commercial arrangements of the relationship with KP are
confidential however as stated, the agreement covers all of the available Cxbladder
products. You are correct that the initial clinical evaluation of Cxbladder by KP was in a
hematuria evaluation setting and we would have expected this to translate to KP
adopting Cxbladder Triage, however KP indicated that they wished to introduce
Cxbladder into their organisation in the follow up surveillance setting to start with. This
is their decision and entirely understandable since it allows KP clinicians to maintain
contact with their bladder cancer patients as they socialise the Cxbladder technology
within the organisation (clinicians and patients alike). We have every expectation that
KP will at some point publish their hematuria study data and in time will also extend their
adoption of Cxbladder into the hematuria evaluation setting, but ultimately that is their
decision.
July 2020 LCD by CMS
Medicare now cover Cxbladder Monitor and Detect where medically necessary
Yet the Local Coverage Decision says Cxbladder is NOT considered medically necessary
https://www.cms.gov/medicare-coverag...d=38388&ver=13
The American Urological Assn directive last reviewed Jan 2021
https://www.auanet.org/guidelines/bl...sive-guideline
It says:
9. In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)
So the “medically necessary” tests PEB is saying are now being reimbursed by CMS I suggest are only a small portion of those being completed. As for reimbursement of all those past tests, again, I think very few will have been “medically necessary” so good luck with that.
July LCD by CMS: The link you have provided is an earlier version of the ‘proposed
LCD’ which was in circulation for consultation. The final published LCD is L35396 and
the exclusion language relating to Cxbladder you refer to was removed following
submissions from Pacific Edge and other parties such that now the only requirement for
reimbursement by CMS is the use of valid CPT codes and the statement of medical
necessity. Medical necessity is determined by the referring physician and does not
require that Cxbladder is used instead of cystoscopy, since in most cases Cxbladder is
used in addition to cystoscopy in the US. Provided these criteria are met (which they are
for all CMS patients) Pacific Edge is receiving 100% (full) reimbursement for claims
within 40 days of claim submission. As we noted in the newsletter and at the half year,
CMS related tests accounted for a significant proportion (~67%) of our commercial test
throughput in the US for the first half of FY21 – this is quite different from the ‘very few’
you suggest.
April 2021 United Healthcare covers Cxbladder
Well, they don’t, really. More exaggeration.
United has a Medicare Policy which is effectively back to back /underwritten by CMS as primary payer. Todays newsletter confirms that United doesn’t cover Cxbladder under its own Healthcare Plans. Neither do Aetna, Blue Cross or any others as far as I can see.
United has simply added the CPT codes so as to match Medicare for consistency
United Healthcare: As stated in the newsletter and as announced to the NZX United
Healthcare have commenced coverage of Cxbladder in the Medicare Advantage
policies. We have provided you with a link to their policy. View Full Policy - PDF (page
2 of 52).
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Originally Posted by Minerbarejet
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