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  1. #18331
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    First post. I have followed this thread with great interest for years but have been unable to post until now because of my email being gmail. I am impressed with the depth of much of the content and I am grateful to the members who have contributed. With regard to the recent negatives surrounding the successful appeal of a health insurance plan** against recompensing for a Cxbladder test - this is typical insurance company behaviour but to my mind it is very short sighted as they are, seemingly, opting to stick with urine cytology, which should soon disappear into the mists of antiquity, and cystoscopy which possibly has a little advantage re its specificity cf Cxbladder. However cystoscopy as a procedure is loathed by patients - well certainly by all I have dealt with over the years - and is inconvenient and very importantly as has been pointed out is not particularly "Covid safe" vs Cxbladder.
    I am not surprised that the AUA has not yet adopted Cxbladder as a guideline item as the widespread use of Cxbladder will be a major disrupter to urology and likely affect income stream significantly and this will also apply to privately funded hospitals- this being the majority in the US. Much better to have the revenue retained by a cystoscopy in your own system than to have it go to a third party lab......."follow the money."
    I have a growing concern that PEB picked the wrong target in choosing the US as its main marketing objective. The US health "system" appears to be one of awful inconsistencies and does not give the impression of being patient centred overall. The other general concern is the apparent descent of the US to a dystopia and the chaos that may inflict on US healthcare. Sorry to bring in politics......

    ** Oxford is the insurance company who brought the appeal - the published customer reviews are not flattering!

  2. #18332
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    Quote Originally Posted by Minerbarejet View Post
    If the test is investigational only in the guidelines why has Medicare approved it for coverage and KP adopted it to some (unknown)extent?

    If the so called guidelines were anything like up to date I suggest that actual definition would change.

    There will be some interesting Half Yearly and Full year reports from here on.

    Lab throughput of Medicare tests with payment approval as opposed to the ongoing 40% of all tests done going unpaid.

    The reality is that they are not going to get everyone on board but if they can manage a few % out of the USA they would do very well.

    I think the original objective was about 10% but at that rate they will be running out of lab space pretty quickly.
    Thanks Miner.
    The AUA Clinical guidelines are up to date - reviewed 2020, and in part read:

    In surveillance of NMIBC, a clinician should not use urinary biomarkers in place of cystoscopic evaluation. (Strong Recommendation; Evidence Strength: Grade B)

    In a patient with a history of low-risk cancer and a normal cystoscopy, a clinician should not routinely use a urinary biomarker or cytology during surveillance. (Expert Opinion)


    Hopefully the yet-to-be published studies you mention will change this view but that is guesswork for us right now, we know not content nor result.

    When Pacific Edge announced they had LCD for CxBladder they said it would be reimbursed if medically necessary. How many of the CMS tests would be considered medically necessary? If CMS, like the AUA, still view the tests as investigational, then not many.

    Approval might not mean reimbursement.

    This might be the interesting part in the next financials...
    Last edited by psychic; 09-09-2020 at 03:19 PM.

  3. #18333
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    You may very well be right but it would seem to me that approving a test, giving it codes, reimbursement fees and allowing it to be performed at all should indicate some willingness to part with a bit of dosh for the company providing the tests, eventually.

    All very well to come along after the test is done and dusted and saying (without any proof) it wasn't necessary, so "we aint payin, you all."

    The only thing that I can see why that would take place is if some urologist became a bit over enthusiastic and was ordering tests left right and centre without taking necessity into account.
    Would I be wrong in assuming the onus of necessity lies with the urologist/physician originating the test process rather than some other unconnected person in the bureaucratic nightmare of the US Medical System?


    Cheers
    Miner

  4. #18334
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    From the CMS Glossary of terms:

    MEDICALLY NECESSARY
    Services or supplies that: are proper and needed for the diagnosis or treatment of your medical condition, are provided for the diagnosis, direct care, and treatment of your medical condition, meet the standards of good medical practice in the local area, and aren't mainly for the convenience of you or your doctor.



    So would "the standards of good medical practice" not be those set by the AUA?

    The AUA did not say it approved the use of Cxbladder as Pacific Edge suggest. It said that there was a low level of evidence supporting the use of biomarkers generally in support of cystoscopy.

    I am not suggesting the tests won't get there, but doubt they are as far along the track as the market has been lead to believe.

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    So would "the standards of good medical practice" not be those set by the AUA?

    Sure.

    Only problem is that all doctors/urologists are not the same, interpret things differently, subject to second opinion, which is why they have the standards.

    Err on the side of caution?

    Do no harm?

    More likely the avoidance of litigation.




  6. #18336
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    Quote Originally Posted by Retired Doc View Post
    First post. I have followed this thread with great interest for years but have been unable to post until now because of my email being gmail. I am impressed with the depth of much of the content and I am grateful to the members who have contributed. With regard to the recent negatives surrounding the successful appeal of a health insurance plan** against recompensing for a Cxbladder test - this is typical insurance company behaviour but to my mind it is very short sighted as they are, seemingly, opting to stick with urine cytology, which should soon disappear into the mists of antiquity, and cystoscopy which possibly has a little advantage re its specificity cf Cxbladder. However cystoscopy as a procedure is loathed by patients - well certainly by all I have dealt with over the years - and is inconvenient and very importantly as has been pointed out is not particularly "Covid safe" vs Cxbladder.
    I am not surprised that the AUA has not yet adopted Cxbladder as a guideline item as the widespread use of Cxbladder will be a major disrupter to urology and likely affect income stream significantly and this will also apply to privately funded hospitals- this being the majority in the US. Much better to have the revenue retained by a cystoscopy in your own system than to have it go to a third party lab......."follow the money."
    I have a growing concern that PEB picked the wrong target in choosing the US as its main marketing objective. The US health "system" appears to be one of awful inconsistencies and does not give the impression of being patient centred overall. The other general concern is the apparent descent of the US to a dystopia and the chaos that may inflict on US healthcare. Sorry to bring in politics......

    ** Oxford is the insurance company who brought the appeal - the published customer reviews are not flattering!
    Thanks Doc.Nice to hear from the inside

  7. #18337
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    Quote Originally Posted by Retired Doc View Post
    First post. I have followed this thread with great interest for years but have been unable to post until now because of my email being gmail. I am impressed with the depth of much of the content and I am grateful to the members who have contributed. With regard to the recent negatives surrounding the successful appeal of a health insurance plan** against recompensing for a Cxbladder test - this is typical insurance company behaviour but to my mind it is very short sighted as they are, seemingly, opting to stick with urine cytology, which should soon disappear into the mists of antiquity, and cystoscopy which possibly has a little advantage re its specificity cf Cxbladder. However cystoscopy as a procedure is loathed by patients - well certainly by all I have dealt with over the years - and is inconvenient and very importantly as has been pointed out is not particularly "Covid safe" vs Cxbladder.
    I am not surprised that the AUA has not yet adopted Cxbladder as a guideline item as the widespread use of Cxbladder will be a major disrupter to urology and likely affect income stream significantly and this will also apply to privately funded hospitals- this being the majority in the US. Much better to have the revenue retained by a cystoscopy in your own system than to have it go to a third party lab......."follow the money."
    I have a growing concern that PEB picked the wrong target in choosing the US as its main marketing objective. The US health "system" appears to be one of awful inconsistencies and does not give the impression of being patient centred overall. The other general concern is the apparent descent of the US to a dystopia and the chaos that may inflict on US healthcare. Sorry to bring in politics......

    ** Oxford is the insurance company who brought the appeal - the published customer reviews are not flattering!
    On the other, this chaotic health system may be a great opportunity to get a foot in the door, rather than an over regulated, bureaucratic tight ship that is in the pocket of multi nationals.

    This assumes that the American health system is not a chaotic over regulated bureaucratic tight ship in the pocket of multi nationals... it’s a great market to get into, and we’ve got a product that offers an economic alternative, and with people feeling the pinch in their pockets, it’ll be a no brainer .

  8. #18338
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    Quote Originally Posted by Retired Doc View Post
    First post. I have followed this thread with great interest for years but have been unable to post until now because of my email being gmail. I am impressed with the depth of much of the content and I am grateful to the members who have contributed. With regard to the recent negatives surrounding the successful appeal of a health insurance plan** against recompensing for a Cxbladder test - this is typical insurance company behaviour but to my mind it is very short sighted as they are, seemingly, opting to stick with urine cytology, which should soon disappear into the mists of antiquity, and cystoscopy which possibly has a little advantage re its specificity cf Cxbladder. However cystoscopy as a procedure is loathed by patients - well certainly by all I have dealt with over the years - and is inconvenient and very importantly as has been pointed out is not particularly "Covid safe" vs Cxbladder.
    I am not surprised that the AUA has not yet adopted Cxbladder as a guideline item as the widespread use of Cxbladder will be a major disrupter to urology and likely affect income stream significantly and this will also apply to privately funded hospitals- this being the majority in the US. Much better to have the revenue retained by a cystoscopy in your own system than to have it go to a third party lab......."follow the money."
    I have a growing concern that PEB picked the wrong target in choosing the US as its main marketing objective. The US health "system" appears to be one of awful inconsistencies and does not give the impression of being patient centred overall. The other general concern is the apparent descent of the US to a dystopia and the chaos that may inflict on US healthcare. Sorry to bring in politics......

    ** Oxford is the insurance company who brought the appeal - the published customer reviews are not flattering!
    Pretty astute stuff, Doc.
    Welcome aboard

  9. #18339
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    Balance, do you have any thoughts on the above?

  10. #18340
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    BTW. Furthermore I am a foundation holder and intend to remain so and I do have a high regard for the product.

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