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  1. #16981
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    I think it's more complex than that.
    My read is...

    Patients need bladder tests
    CMS want PEB to do them.
    PEB want to do them, but don't have LCD inclusion
    They can't be deferred (patient safety) PEB don't want another supplier to do them, so they do the tests.
    PEB issues an invoice for the tests done but know they won't get paid until their LCD inclusion is obtained.
    So issues are - will they get LCD inclusion? and, will they be paid for the tests done prior to receiving it?

  2. #16982
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    Quote Originally Posted by Nigelk View Post
    I think it's more complex than that.

    So issues are - will they get LCD inclusion? and, will they be paid for the tests done prior to receiving it?
    According to my biomed contact, PEB made a strategic mistake and blunder by not obtaining FDA clearance for CxBladder. The MAC give weight to FDA clearance of any medical devices and technologies.

    The situation regarding LCD inclusion since October 2018 is (summary) :

    "Medicare Administrative Contractors (MAC) tasked with deciding what medical technologies qualify for Medicare coverage in local geographical areas will now be required to publish a summary of clinical evidence supporting their decisions, include a beneficiary representative and non-physician healthcare workers on advisory committees, and ensure that Contractor Advisory Committee meetings are open to the public." Section 4009 of the 21st Century Cures Act passed in September 2018.
    Last edited by Balance; 19-06-2019 at 05:11 PM.

  3. #16983
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    Quote Originally Posted by Balance View Post
    According to my biomed contact, PEB made a strategic mistake and blunder by not obtaining FDA clearance for CxBladder.

    The situation regarding LCD inclusion since October 2018 is (summary) :

    "Medicare Administrative Contractors (MAC) tasked with deciding what medical technologies qualify for Medicare coverage in local geographical areas will now be required to publish a summary of clinical evidence supporting their decisions, include a beneficiary representative and non-physician healthcare workers on advisory committees, and ensure that Contractor Advisory Committee meetings are open to the public." Section 4009 of the 21st Century Cures Act passed in September 2018.

    The MAC give weight to FDA clearance of any medical devices and technologies.


    It appears that stage 1 is getting a CPT code, stage 2 is a reimbursement rate set, then stage 3 the LCD inclusion. Stages 1 and 2 are completed and their language regarding 3 is pretty positive as you can see below (once PEB receives inclusion...)
    If FDA approval was required, you wouldn't have had CMS do so many (15K) tests on actual patients.

    The national reimbursement rate covers the Cxbladder tests awarded national CPT codes in the USA earlier this year.....and will apply to Cxbladder test claims submitted to CMS once Pacific Edge receives inclusion in the Local Coverage Determination (LCD) for Medicare coverage.

  4. #16984
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    Quote Originally Posted by Nigelk View Post
    It appears that stage 1 is getting a CPT code, stage 2 is a reimbursement rate set, then stage 3 the LCD inclusion. Stages 1 and 2 are completed and their language regarding 3 is pretty positive as you can see below (once PEB receives inclusion...)
    If FDA approval was required, you wouldn't have had CMS do so many (15K) tests on actual patients.

    The national reimbursement rate covers the Cxbladder tests awarded national CPT codes in the USA earlier this year.....and will apply to Cxbladder test claims submitted to CMS once Pacific Edge receives inclusion in the Local Coverage Determination (LCD) for Medicare coverage.
    I get the impression that PEB thought they had such a smoking hot (or is it piss hot) product that they would just sail through the approval & inclusion process with CMS and MAC.

    Should have spent a year or two getting FDA approval and would not have had to spend the last 5 years wandering in the wilderness, burning up tens of millions of cash year after year!
    Last edited by Balance; 20-06-2019 at 01:43 PM.

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    Great stuff, hindsight
    And not necessarily correct either.

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    Quote Originally Posted by Minerbarejet View Post
    Great stuff, hindsight
    And not necessarily correct either.
    Hindsight?

    Who has been deadly accurate on PEB and it’s diabolical performance on just about everything to date?

    But not to worry - directors and management have done very very very well, pulling in and burning tens of millions of dollars to pay big salaries* & enjoy the good life by dragging the story out.

    *$3.6m in the last 2 years for CEOs
    Last edited by Balance; 20-06-2019 at 09:29 AM.

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    Quote Originally Posted by Balance View Post
    Hindsight?

    Who has been deadly accurate on PEB and it’s diabolical performance on just about everything to date?

    But not to worry - directors and management have done very very very well, pulling in and burning tens of millions of dollars to pay big salaries* & enjoy the good life by dragging the story out.

    *$3.6m in the last 2 years for CEOs
    To put the $3.6m in perspective, the average CEO pay in NZ according to Payscale is $158k

    More glaring is the fact that David Mair of Skellerup gets paid $600k a year!

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    Quote Originally Posted by Balance View Post
    I get the impression that PEB thought they had such a shxt hot (or is it pissing hot) product that they would just sail through the approval & inclusion process with CMS and MAC.

    Should have spent a year or two getting FDA approval and would not have had to spend the last 5 years wandering in the wilderness, burning up tens of millions of cash year after year!
    Who did they bring on (if anyone...) early stage to manage regulatory/FDA compliance. Plenty of academics but they have very little (in my experience) to add in commercialisation and regulatory/QA.

    For agencies like FDA it matters very little how 'good' your product is, and very much so how well everything is documented and suitably validated.....

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    Quote Originally Posted by kiwidollabill View Post
    Who did they bring on (if anyone...) early stage to manage regulatory/FDA compliance. Plenty of academics but they have very little (in my experience) to add in commercialisation and regulatory/QA.

    For agencies like FDA it matters very little how 'good' your product is, and very much so how well everything is documented and suitably validated.....
    You are right there, kiwidollabill.

    I must admit that I was suitably impressed in the early days of commercialization with the academia in PEB's Scientific Advisory Board.

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    Quote Originally Posted by Balance View Post
    You are right there, kiwidollabill.

    I must admit that I was suitably impressed in the early days of commercialization with the academia in PEB's Scientific Advisory Board.
    I'm puzzled as to how naive they could be by taking the laboratory developed test pathway rather than FDA, particularly when you are reliant on a govt payment schedule. The other main cancer DNA tests I know of (or at least when my knowledge was better in this space a few years ago) all had FDA clearance otherwise they were sold as 'not for diagnostic use'. Moreover, the space for operating LDTs that are clearly for diagnostic use is going to get significantly harder (think the damage Theranos has done). Have they published a pathway to getting FDA cleared at all? Otherwise, getting on the CMS schedule might be essentially a no-go. Unless someone can point to other examples where comparabile LDTs are covered by CMS

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