Pacific Edge welcomes the strong industry and clinician support it has received during the open public meetings to take feedback on draft local coverage determinations (LCDs) that propose non-coverage of Cxbladder tests by Medicare, the US national health insurance provider.

At the meetings - hosted earlier this month by the Medicare Administrative Contractors (MACs) Novitas and First Coast Service Operations (FCSO) - the American Urological Association (AUA), the Large Urology Group Practice Association (LUGPA), and the American Association of Clinical Urologists (AACU) - the three most influential urological organisations, covering every practicing urologist in the USA - joined with the Coalition for 21st Century Medicine (C21), the American Clinical Laboratory Association (ACLA), and Pacific Edge to call for significant revisions to the draft determinations and continued Medicare coverage of Cxbladder.

Pacific Edge Chief Executive Dr Peter Meintjes said: “We are delighted with the way the urological community has quickly educated themselves on the ramifications of the draft LCDs and rallied for Cxbladder and other similar biomarkers to remain covered so providing benefits for Medicare patients.

“Leading clinicians representing the three largest professional societies and our industry partners share our view that the high negative predictive value of Cxbladder offers significant clinical utility to Medicare patients in the context of the standard of care in urology and that it has been repeatedly validated for this purpose in peer-reviewed publications,” Dr Meintjes said.

Novitas the MAC with jurisdiction for Pacific Edge’s US laboratory, held a hearing on the Draft LCD ‘Genetic testing for oncology’ (DL39365) on August 11¹ while, Novitas sister MAC FCSO, held a hearing on August 10 for an identical draft LCD with the same title but with a different code (DL39367) to cover test providers in its area of jurisdiction. Both draft LCD’s argue Cxbladder is not medically reasonable or necessary and therefore not eligible for coverage under the US Social Security Act.

In their joint presentations to Novitas and FCSO, the AUA, LUGPA, and the AACU noted Cxbladder and another urine tumor marker, UroVysion, play a crucial role in the diagnosis, management and surveillance of bladder cancer. Representatives of the organisations said the tests were for evaluation of hematuria patients and not ‘genetic tests for cancer’ so were beyond the scope of the draft LCDs, which have been worded to require a cancer diagnosis or substantiated suspicion of cancer. They argued the LCDs determination to outsource coverage to three external databases² was flawed and said the determinations ignored the clinical utility of the tests.

They also noted the draft non-coverage decisions by Novitas and FCSO:

• conflicted with AUA guidelines;
• were not supported by the clinical evidence they used to justify the draft decision;
• could lead to worse patient outcomes and higher costs; and
• could exacerbate existing disparities in bladder cancer care.

The presentations are available on Pacific Edge’s website at the following link.

The meetings were held in line with the statutory requirement for MACs to give a 45-day notice and comment period commencing 27 July 2023¹ and finishing 9 September 2023¹, during which time all interested stakeholders may submit comments to Novitas. Pacific Edge expects all of the groups that participated in the open public meetings, plus numerous individual urological key opinion leaders (KOLs) and groups of KOLs to submit written feedback through this process prior to 9 September 2023.

While the Open Public Meetings are an important part of the process, the written submissions are ultimately the most crucial, as MACs are required to respond to all comments in a process that is also reviewed by the Centers for Medicare and Medicaid Services (CMS).

Novitas and FCSO may take up to 365 days from the original publication date (27 July 2023¹) to withdraw or finalize the LCD including a response to those comments. When finalized, the MACs must provide a minimum of 45 days’ notice before the LCD becomes effective.

¹ US time.
² The draft LCDs outsources coverage decisions to three knowledge bases to determine coverage, rather than the MAC. They are Clinical Genome Resource (ClinGen); National Comprehensive Cancer Network (NCCN); Oncology Knowledge Base (OncoKB) knowledge bases.