LUGPA Policy Update - Draft Local Coverage Determination (LCD): Urine-Based Biomarkers for Microhematuria (DL40380)

June 2026

At-a-Glance Essentials

What’s Changing
Novitas Solutions and First Coast Service Options (FCSO) have issued Proposed LCD DL40380, which would establish limited Medicare coverage for select urine-based biomarker (UBB) tests, including Cxbladder, to support risk stratification of patients with microscopic hematuria (MH) undergoing evaluation for urothelial carcinoma (UC).

Why It Matters
This proposal represents a major shift away from longstanding non-coverage policies and moves Medicare toward broader acceptance of non-invasive diagnostic tools that can reduce unnecessary procedures and improve risk-based clinical decision-making.

LUGPA Position
LUGPA strongly supports the proposed LCD as a meaningful advancement in evidence-based, patient-centered urologic care.

Comment Deadline
June 27, 2026

Overview

On May 14, 2026, Novitas Solutions and FCSO released the Proposed LCD DL40380, which would establish limited coverage for validated urine-based biomarker tests used to evaluate patients with microscopic hematuria.

Historically, many Medicare Administrative Contractors (MACs), including Novitas and FCSO, have maintained restrictive policies that did not cover these tests in the microhematuria setting. As a result, clinicians have often relied heavily on cystoscopy and imaging, even in lower-risk patients, and have had limited ability to incorporate non-invasive molecular tools into routine diagnostic pathways.

The proposed LCD represents a notable shift in Medicare policy by recognizing the role of select urine-based biomarkers in helping clinicians better stratify risk for urothelial carcinoma and tailor subsequent evaluation.

Key Policy Provisions

Under the draft LCD:

• Covered tests: Select validated urine-based biomarker assays, including Cxbladder and potentially other qualifying tests
• Clinical indication: Evaluation of patients with microscopic hematuria being assessed for urothelial carcinoma
• Intended use: Risk stratification to support clinical decision-making regarding the need for further diagnostic workup
• Clinical goal: Differentiate lower-risk patients who may avoid immediate invasive evaluation from those who require further testing
• Jurisdiction: Applies to Medicare beneficiaries under Novitas and FCSO MAC regions

LUGPA has been particularly active on this issue, including prior submissions to CMS and other federal stakeholders emphasizing the clinical limitations and unintended consequences of blanket non-coverage policies for urine-based biomarkers. These efforts have consistently highlighted the need for coverage frameworks that reflect evolving clinical evidence and support individualized patient care.

Clinical and Policy Significance

If finalized, DL40380 would have several important implications for clinical practice:

1. Expanded Access to Non-Invasive Diagnostics
Medicare beneficiaries would gain access to validated urine-based biomarker testing that can be used earlier in the diagnostic pathway.

2. Improved Risk Stratification
These tools may help identify patients at sufficiently low risk of urothelial carcinoma to safely defer or avoid immediate invasive procedures such as cystoscopy.

3. Reduced Procedure Burden
Greater reliance on validated non-invasive testing could decrease unnecessary diagnostic procedures, reducing patient discomfort, anxiety, and procedural risk.

4. Support for Value-Based Care
The policy aligns with broader healthcare goals of improving diagnostic efficiency and ensuring that resource utilization is matched to clinical risk.

5. Strengthening Community Urology Practice
Community and independent urology practices would benefit from additional diagnostic tools that support high-quality, evidence-based care closer to where patients live.

LUGPA Position

LUGPA strongly supports Proposed LCD DL40380 and views it as a meaningful and positive policy development for both patients and providers.

The proposed shift reflects an important modernization of Medicare coverage policy—one that better aligns with contemporary urologic practice and emerging clinical evidence supporting the use of urine-based biomarkers in the evaluation of microscopic hematuria.

LUGPA encourages stakeholders to submit supportive comments during the open comment period and will continue to engage with CMS, MACs, and clinical partners to ensure that coverage policies support innovation, appropriate patient access, and physician-led decision-making.