A US blog has a summary of the speeches from the commentary for the lcd. It looks like the lcd impacts FISH and PEB tests negatively?
The following comment from the AUA was quite positive for PEB (link here:
https://www.discoveriesinhealthpolic...ishes.html?m=0 ):
AUA RUBENSTEIN
Dr. Jonathan Rubenstein, representing the American Urological Association (AUA), the Large Urology Group Practice Association, and The American Association of Clinical Urologists, expressed concerns regarding the proposed Local Coverage Determination (LCD) for certain diagnostic laboratory tests. He highlighted that this LCD encompasses urine markers used in the diagnosis and management of bladder cancer and discussed why these markers should be excluded from the scope of this LCD.
Dr. Rubenstein emphasized the importance of urine tumor markers in diagnosing and managing bladder cancer, citing their crucial role in screening, identifying tumors, predicting recurrence, and monitoring treatment responses. He mentioned that these markers are incorporated into screening guidelines and management strategies.
He expressed concerns that urine markers for bladder cancer, such as UroVysion and CxBladder, are not genetic tests within the scope of the LCD, as they function more like stains or immunohistochemistry rather than DNA or RNA-based tests. He argued that their clinical utility and long-standing use in clinical practice should exempt them from the LCD or be considered separately.
Dr. Rubenstein highlighted that the proposed LCD could lead to worse patient outcomes, increased costs, and conflicts with AUA guidelines, potentially exacerbating disparities in bladder cancer care. He also pointed out that restricting coverage for these markers might impact patient access and outcomes, particularly in regions with limited access to urologists.
In conclusion, Dr. Rubenstein urged Novitas to reconsider covering urine tumor markers, emphasizing their importance in managing bladder cancer effectively and efficiently. He recommended either excluding these markers from the LCD or using prior LCD guidance to determine appropriate coverage criteria, including expert input and stakeholder involvement.