Its about risk stratification from do nothing to Full blown AUA Cystoscopy and Imaging.
It would appear that cxbladder would fit rather well into a cost/benefit ratio based on these findings.
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A lot less shares on issue back in those days though eh Winner. Still, heady days..
Crazy how the market says Fridays announcement worth $175m change in mcap . Had to be brought to PE attention 9 days after the event and then it seems it really was not as material as Dave made out..
https://www.cms.gov/medicare-coverag...eywordType=sta
Read the response to the cx bladder topic
It comes under necessary in the Social Security Act which would probably have more clout than the AUA
Oh, I did! But I'm not sure I really understood it! The response says:
Thank you for your comments, the CxBladder test is now covered utilizing the reasonable and necessary guidelines as outlined in Title XVIII of the Social Security Act, Section 1862(a)(1)(A) which states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. Therefore, CxBladder is not addressed in the LCD or billing and coding article.
It makes sense that the 1862 Act would prevent Medicare from paying for any services that are not reasonable and necessary.
If it is reasonable and necessary then it is covered, but the Act does not decide this. And "therefor cxbladder is not addressed in the LCD?
What is your interpretation of that?
The following I copied from the CMS site, it is the proposed LCD I think being discussed
Proposed Local Coverage Determination (LCD):
Biomarkers for Oncology (DL35396)
Consistent with the NCCN rating and literature review, the following Biomarker Panel will continue to be considered not medically reasonable and necessary:
CXBLADDER
NCCN Guidelines 4.201988 Bladder Cancer, for cTa high grade, cT1, and Tis, follow-up is recommended with a urinary cytology and cystoscopy at 3 to 6 month intervals for the first 2 years, and at longer intervals as appropriate thereafter. Imaging of the upper tract should be considered every 1 to 2 years for high-grade tumors (see Follow-up algorithm). Urine molecular tests for urothelial tumor markers are now available.88(p68)
Follow-up urine cytology every 3 months and consider urinary urothelial tumor markers (category 2B) for high risk, non-muscle-invasive bladder cancer at year one and annually up to 10 years and then as clinically indicated. Molecular/genomic testing should include analysis by RT-PCR for FGFR3 or FGFR2, and for FGFR, RGQ.88(p79)
As one can see when molecular/genomic testing mentioned in the NCCN Guidelines Version 4.2019 Bladder cancer, there is no shared commonality in the CXBLADDER test and the genetic alterations that should be included by NCCN guidelines, and even those mentioned in NCCN guidelines, are a 2B level of recommendation.
Davidson PJ, et al. (2019),89 is an observational cohort study conducted in New Zealand. The addition of CxBT to the routine investigation of hematuria was carried out following consensus between local clinicians. No other change to clinical practice was made and there was no randomization or control group. The review did not require ethical approval, as it constituted monitoring and improvement of usual patient care carried out by the Canterbury DHB.163 No blinding with diagnosis based on histology and cystoscopy. The results were the development of theoretical pathway. The patients were coached in the test and what it meant. This was carried out within one health board district in New Zealand with little follow-up. The limitation is a mandatory protocol pathway and no documented clinical utility, but healthcare insurer utility. The generalizability to the Medicare population was not specified. Seven year mean difference in patients not referred and referred patients with the older group referred to urologist. Nine year medial age difference. Proposed pathway for less than one year of data is not enough data to support a change of decision.
Konety B, et al. (2019),90 is a retrospective study of pooled data from three prospective clinical trials and one real world clinical study in which 1784 patients with hematuria or previously diagnosed UC provided 852 samples. According to the authors, CXBLADDER ruled out 35% of patients and NPV of 97% compared to 93% for cytology. CXBLADDER correctly adjudicated all patients diagnosed with UC among those with atypical cytology and equivocal cystoscopy and outperformed cytology for accurately identifying patients who do not have UC.162 The limitation is this was open access and not peer reviewed with a significant conflict of interest by the authors. Clinical utility is not part of this study and was only theorized. The generalizability to the Medicare population was not specified in the original article. However, in the supplemental table 3, the age in each study was given but not in relationship to the findings. The clinical utility was not documented.
Consistent with the NCCN rating and literature review, the following Biomarker Panel will continue to be considered not medically reasonable and necessary:
CXBLADDER
and this:
CXBLADDER
The literature submitted for the requested addition of the CXBLADDER panel was carefully reviewed. After consideration of the literature, NCCN rating, and relevance to the Medicare population, the CXBLADDER panel will continue to be non-covered at this time. The molecular/genomic testing mentioned in the NCCN Guidelines for Bladder cancer shared no commonality in the CXBLADDER test and the genetic alterations that should be included by NCCN guidelines. Additionally, those genomic/molecular tests mentioned in the NCCN guidelines only achieved a 2B level of recommendation. Further, the clinical utility and clinical validity was not supported in the literature and was not generalizable to the Medicare population.
Therefore in order for CMS to be making payments (which we are led to believe they are) the test must have been confirmed as reasonable and necessary otherwise they wouldn't be paying out, being bound by the Social Security Act
It is not addressed in the article because it was already in place and had been accepted is how I would interpret that.