An important update for all US Cxbladder Customers, 

Executive summary:

• Novitas has finalized an LCD for Genetic Testing in Oncology that removed coverage for Medicare beneficiaries for Cxbladder tests effective on April 24, 2025.
• We will continue to offer Cxbladder Triage for microscopic hematuria patients in accordance with the recent inclusion of Triage into the 2025 AUA/SUFU MH Guideline supported by 'Grade A' evidence¹.
• Cxbladder Detect will no longer be available to order starting on May 5, 2025.
• Cxbladder Monitor will continue to be available to all patients with a new billing policy to accommodate the change in Medicare coverage status. 

Medicare coverage update: 

As our customers know from previous updates over the past two years, we’ve been vigorously contesting the proposed Medicare coverage change to L39365, Genetic Testing for Oncology (please see our ​Medical Rebuttal​ highlighting the errors in their analysis), that would remove Medicare coverage for Cxbladder tests. Despite strong support for Cxbladder from the AUA, BCAN, LUGPA, and many additional groups, Novitas has recently finalized the Local Coverage Determination (LCD) and it became effective on 4/24/25. We were disappointed that Novitas decided not to consider all of the most current evidence that includes our randomized controlled trial (​STRATA​) and the inclusion of Cxbladder Triage in the ​AUA Microhematuria Guideline​ supported with 'Grade A' evidence.

What this means moving forward:

Beginning on May 5, 2025, our focus will be primarily on microhematuria evaluation and the appropriate use of Cxbladder Triage as per the recent guideline. We will continue to offer Cxbladder Monitor for use in the surveillance population, while Cxbladder Detect will no longer be available. 

Why we are making this change:  

• We are committed to providing Cxbladder products that provide both clinical and economic value to your patients. To do this effectively, we will offer both Cxbladder Triage and Monitor which have the most extensive published data to support reimbursement.
• With Triage now included in the updated 2025 AUA/SUFU MH Guideline, we believe that all payers should consider the test to be clinically valid and medically necessary for hematuria patients. 
• Since Cxbladder Detect and Triage have significant overlap in the intended use population, we will focus on Triage which provides the strongest clinical benefit to the greatest number of patients. 
• Furthermore, we are continuing to develop our next generation product, Triage Plus, which combines the best test performance characteristics from Triage and Detect into a single product. We have multiple ongoing clinical trials for Triage Plus, including a randomized controlled trial (CREDIBLE) to demonstrate the clinical utility of the test. 

What this means for customers:

Cxbladder Triage: 

• For Triage tests with Medicare as the primary insurance, we will process and provide the results to you and submit the claim to Medicare. If Medicare does not pay for the test, we will not bill your patient.
• We will not require an Advanced Beneficiary Notice (ABN) for Medicare Triage samples that are appropriately ordered. 
• For Medicare Advantage and commercially insured patients, we will continue with our current policy of billing the appropriate payer and sending an invoice to the patient for a maximum out-of-pocket of $295 if the claim is denied.
• All Triage requests will need to include a signed Statement of Medical Necessity (SOMN) and/or chart notes documenting medical necessity.
• We reserve the right to change this policy at our discretion.

Cxbladder Detect:

• If we receive a test requisition for Cxbladder Detect with a sample draw date prior to May 4, 2025, we will contact your practice and recommend that you authorize us to run Triage instead of Detect. This will require you to provide the necessary clinical factors (age, gender, smoking & hematuria history) to accurately process Triage. 
• For all test requisitions for Detect with a collection date on or after May 5th, we will no longer be able to process Detect tests and will strongly encourage you to authorize the sample to be processed with Triage using the necessary clinical factors and proper documentation. This will be the policy for all insurance types.
• We reserve the right to change this policy at our discretion.

Cxbladder Monitor:

• Beginning May 5, 2025, we will require all Monitor samples to have a signed ABN before we process the sample. 
• For Medicare Fee-for-Service (FFS) patients, we will bill Medicare and invoice the patient for $760 if the claim is denied. 
• For Medicare Advantage and commercial insurance patients, we will continue our current policy of: 
• Billing the appropriate insurance 
• We reserve the right to change this policy at our discretion 
• Cxbladder Monitor specimens require a cancer diagnosis, even if the patient has already received treatment.
• As a reminder, Cxbladder Monitor specimens can only be accepted after nine (9) months have passed after their resection transurethral resection of bladder tumor (TURBT) treatment.

We are committed to restoring coverage for our Cxbladder products. Novitas is currently evaluating a reconsideration request for Triage based on data from the STRATA study (RCT comparing Triage to standard of care in MH evaluation) as well as the AUA MH Guideline update. We have confidence that we will successfully regain coverage through this process.

While we are disappointed by the finalization of L39365 and the loss of Medicare coverage for Cxbladder, we remain confident and committed to providing the most valuable test results necessary to help you make treatment decisions for your patients with microhematuria (Cxbladder Triage) and those in surveillance for recurrent UC (Cxbladder Monitor). If you have any questions regarding these changes, please contact our Customer Service team at 1-855-292-5237, Option 1.

With kind regards, 

The Cxbladder Team

¹ Barocas DA, Lotan Y, Matulewicz RS, Raman JD, Westerman ME, Kirkby E, Pak L, Souter L. Updates to Microhematuria: AUA/SUFU Guideline (2025). J Urol. doi: 10.1097/JU.0000000000004490. 

​