Medicare's Urine Biomarker LCD for Microhematuria: What Labs Must Check
Short answer: The proposed Novitas LCD for urine-based biomarkers in microhematuria covers validated multi-analyte tests only for intermediate-risk patients who have not had a recent cystoscopy and intend to skip it based on results. Seven conditions must all apply, and repeat testing within six months is excluded.
What the LCD actually says
Novitas Solutions, the Medicare Administrative Contractor for jurisdictions JH and JL, posted the proposed LCD "Urine-based Biomarkers in Patients with Microhematuria" (DL40378) on May 14, 2026, according to the CMS Medicare Coverage Database. A Contractor Advisory Committee met on February 19, 2026, and an open meeting followed on June 18, 2026. The page's document note gives the comment period as May 14 to June 27, 2026.
On November 9, 2026, Photocure ASA reported that a newly published LCD on the subject, dated November 6, 2026, now exists. Photocure's release does not give an LCD number. Labs should pull the final LCD and billing article from the Coverage Database and compare them to the proposed criteria described here, because wording can change between proposed and final versions.
The seven conditions, and why each is a claims risk
The proposed text says these tests are reasonable and necessary only when every condition is met. Each one maps to something a lab can verify, or fail to verify, on the requisition.
The first two conditions require the ordering record to show that other causes of microhematuria were ruled out and that the patient has no current or prior urologic malignancy. The risk-category condition requires an intermediate-risk designation per published guidelines. The counseling condition is unusual: the patient must intend to forgo cystoscopy depending on the result, which turns an ordinary lab order into a documented clinical decision.
What the LCD says about the test itself
The proposed LCD sets four test-level criteria. A test must show accurate risk stratification that informs cystoscopy decisions, have adequately characterized methodology and analytes, have analyte clinical validity in peer-reviewed literature, and show sensitivity or specificity for urothelial carcinoma equivalent or superior to accepted methods.
The LCD does not name specific tests. It describes validated multi-analyte biomarkers, notes that Cxbladder Triage has the most microhematuria-specific evidence and is cited in the 2025 AUA/SUFU guideline, and treats single-analyte legacy tests such as NMP22, BTA, UroVysion FISH and cytology as inadequate for this use. Pacific Edge stated in May that the draft billing article, DA60424, proposed reimbursement for Cxbladder Triage (0363U) and Cxbladder Triage Plus (0420U) and no other urine-based biomarkers. Those identifiers should be checked against the live article, since the source text carried inconsistent numbering.
Limitations that deny claims
The proposed LCD lists four situations as not reasonable and necessary: testing after a cystoscopy within the preceding six months, repeat use of the same or similar biomarker within six months, use in patients clinically stratified as low risk, and use in patients clinically stratified as high risk. The ordering provider must also be the treating clinician responsible for the patient, understand how the result will affect care, and confirm the patient understands.
For billing teams, the six-month lookback is the operational problem. It requires visibility into prior cystoscopy claims and prior biomarker claims that a lab may not hold. Build an intake question on the requisition, and see our guidance on Medicare order and signature requirements for how ordering documentation should be captured.
Why labs outside this niche should still read it
This LCD is a template for how MACs are now writing narrow, criteria-stacked coverage for molecular tests: a defined population, a defined clinical decision, lookback windows and ordering-provider requirements. The same structure appears in other policies we have covered, including the MolDX non-NGS targeted panel LCD and the Medicare MRD coverage map. Labs should expect to see payers copy the criteria even when they are not bound by the LCD.
Photocure's release shows the other side. Its AssureMDx test is not included in the November 6 LCD, which identifies additional clinical evidence needed for future reconsideration, and the company said its Medicare coverage planning assumption remains 2028. Pricing is a separate process: CMS is expected to issue a final pricing determination before year-end 2026, effective January 1, 2027. See also how ADLT status affects Medicare payment.
How this differs from the existing cancer-suspicion policy
Pacific Edge distinguished the microhematuria policy from LCD L39365, which covers patients with cancer or a substantiated suspicion of cancer. The practical point for compliance staff is that the two policies address different patient populations, so a claim must be matched to the right policy before the medical-necessity logic is applied. The company also stated a Medicare price of $1,328 per test, against $760 for its legacy products. That price is a company claim, not an LCD finding, and labs should confirm rates in the Clinical Laboratory Fee Schedule.
A practical checklist for lab and RCM teams
First, download the final LCD and billing article and diff them against the proposed text. Second, add the seven conditions to the requisition or an order-entry hard stop, including the risk category and the counseling statement. Third, build a six-month lookback for prior cystoscopy and prior biomarker use. Fourth, decide how to handle tests the LCD does not cover, including an advance beneficiary notice process. Fifth, brief your ordering urologists and primary care clinicians. For a broader view of denial drivers, visit ScreenMyGene and our genetic testing denials guide.
Frequently asked questions
Does the LCD name specific covered tests?
The proposed LCD refers to validated multi-analyte urine-based biomarkers and does not name tests. Pacific Edge said the draft billing article proposed reimbursement for Cxbladder Triage (0363U) and Triage Plus (0420U) only. Confirm the final billing article before relying on any code.
Is a patient who had a cystoscopy last month eligible?
No. The proposed LCD treats testing within six months after a cystoscopy as not reasonable and necessary. It also excludes repeat use of the same or a similar biomarker within six months, so labs should check prior claims history before accepting orders.
Are low-risk and high-risk patients covered?
No. The proposed LCD limits coverage to intermediate-risk patients per published guidelines. Use in patients clinically stratified as low risk or high risk is listed as not reasonable and necessary, so the ordering record should document the risk category.
Who must order the test?
The ordering provider must be the treating clinician responsible for the patient. That clinician must understand how the result will affect care, discuss this with the patient and confirm the patient understands. Labs should confirm this documentation travels with the requisition.
Does this LCD apply to every Medicare jurisdiction?
It was issued by Novitas Solutions for MAC jurisdictions JH and JL. Other contractors have their own coverage processes, and commercial payers are not bound by it. Photocure noted the LCD does not block commercial reimbursement channels.
This article is educational decision support for laboratories and clinicians and is not legal, coding, reimbursement or medical advice. Coverage policies change; verify against the current LCD, billing article and your MAC before acting.
Sources: CMS Medicare Coverage Database, Proposed LCD DL40378 (Novitas); Pacific Edge, "Draft LCD Proposes Medicare Coverage For Triage and Triage Plus," May 15, 2026; Photocure ASA, "Update on AssureMDx and Anticipated Medicare Coverage Timeline," November 9, 2026.