Where this LCD applies
Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.
Billing and coding: diagnoses and procedure codes
Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A55028 (Billing and Coding: Lab: Bladder/Urothelial Tumor Markers) carries the diagnosis and procedure lists the contractor loads as the claims edit. CPT codes are shown as bare numbers because the descriptors are licensed by the AMA; HCPCS Level II descriptors are public and shown.
A55028: Billing and Coding: Lab: Bladder/Urothelial Tumor Markers (Billing and Coding, effective 2025-11-06)
- Covered ICD-10-CM codes
- 60
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 5
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C67.0 | — |
| C67.1 | — |
| C67.2 | — |
| C67.3 | — |
| C67.4 | — |
| C67.5 | — |
| C67.6 | — |
| C67.7 | — |
| C67.8 | — |
| C67.9 | — |
| C7A.010 | — |
| C7A.011 | — |
| C7A.012 | — |
| C7A.020 | — |
| C7A.021 | — |
| C7A.022 | — |
| C7A.023 | — |
| C7A.024 | — |
| C7A.025 | — |
| C7A.026 | — |
| C7A.090 | — |
| C7A.091 | — |
| C7A.092 | — |
| C7A.093 | — |
Procedure codes: 86294, 86316, 86386, 88120, 88121.
Coverage indications, limitations and medical necessity
INDICATIONS
Gross painless hematuria is often the first manifestation of a urothelial tumor. Since the degree of hematuria bears no relation to the seriousness of the underlying disease, the microscopic finding of blood in the urine is a serious symptom until significant pathology has been excluded.
At this time, there is no published consensus from the following national organizations: National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), American Urological Association (AUA) and the International Bladder Cancer Consensus Group (IBCCG) regarding the management of persistent asymptomatic microscopic hematuria. Due to insufficient supporting data, the AUA’s 2001 best practices policy could not recommend routine use of voided urinary markers in the evaluation of patients with microscopic hematuria. (3)
Recommended surveillance schedules for patients with a previous negative evaluation for unexplained microscopic hematuria include annual urinalysis and voided urinary cytology until the hematuria resolves, or for up to three years if microscopic hematuria persists. The AUA has been silent regarding practice guidelines due to the paucity of prevalence studies on asymptomatic microscopic hematuria.
Cystoscopy in conjunction with bladder tumor markers is the standard practice to evaluate patients with symptoms suggesting bladder cancer and to monitor treated patients for recurrence or progression. Although cystoscopy is considered the “gold standard”, studies have shown that up to 20% of tumor can be missed. Urinary cytology has close to a 90%-100% specificity, but only 10%-50% sensitivity for low grade urinary cancer (UC) detection. Due to this deficit, clinicians have sought noninvasive tumor markers detectable in urine.
Upwards of 50% of patients have recurrence of bladder cancer within five (5) years.
After initial diagnosis and treatment, patients with UC are frequently monitored every three months for the first two years, every four months for the third year, and then usually twice a year for the fourth year. Annual monitoring is recommended during years 5 through 15.
Diagnostic and Surveillance Tests
• BTA TRAK ® - a quantitative determination of human complement factor H-related protein
• Nuclear matrix protein 22 (NMP-22®) – detects nuclear mitotic apparatus protein believed to be released during apoptosis; a quantitative assay, which is either positive of negative
• NMP-22® BladderChek ® – a CLIA-waved assay, point of care test with an immunochromographic qualitative format taking 20 minutes to perform
• The UroVysion ® Bladder Cancer Kit is fluorescence in situ hybridization (FISH) DNA probe technology. It is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus. This assay involves visualization of nucleic acid sequences within cells by creating short sequences of fluorescently labeled, single-strand DNA probes that match target sequences. The probes bind to complementary strands of DNA to identify the targeted chromosome(s) location. It is used to detect chromosomal abnormalities in voided urine to assist not only in bladder cancer surveillance, but also in the initial identification of bladder cancer.
Scientific studies demonstrate the sensitivity of BTA and NMP-22® are superior to urinary cytology. (1) Studies affirm the adjunctive value of BTA stat ® and NMP-22® in suspected and known bladder cancer in conjunction with cystoscopy. However, false positive results occur more frequently in the presence of hematuria, nephrolithiasis, recent GU instrumentation, inflammation and other urological malignancies. Administration of Bacillus Calmette-Guerin (BCG) within 2 years of testing decreases specificity to 28%.
The DNA probe assay has high sensitivity (81%) and specificity (96%) for high grade tumors but lower sensitivity (36-57%) for low grade and stage tumors. The assay specificity approaches that of cytology, and can be utilized in patients recently treated with intravesical BCG. This can result in a positive UroVysion ® test with a negative study for UC. This assay has also been shown to be useful in predicting tumor recurrence following BCG therapy.
At present the IBCCG has recommended that tumor markers be used in conjunction with cystoscopy. They also concluded that routine screening for bladder cancer is not cost-effective. (3) The US Preventive Services Task Force concluded bladder tumor markers do not have a proven role in screening of asymptomatic patients for early detection of bladder cancer. (3) NCCN, ASCO, and AUA are silent regarding the utilization of these bladder tumor markers.
Surveillance Tests
• BTA (bladder tumor antigen) stat ® - a qualitative CLIA-waved test that identifies a human complement factor H-related protein produced by several human bladder cell lines
• The ImmunoCyt™ test is cleared for monitoring bladder cancer recurrence only in conjunction with cytology and cystoscopy. The assay uses fluorescent labeled antibodies to 3 markers (carcinoembryonic antigen, and musicians LDQ10 and M344) commonly found on malignant exfoliated urothelial cells. The ImmunoCyt™ assay has also been shown to be more sensitive than urine cytology.
LIMITATIONS
Cystoscopy in conjunction with bladder tumor markers is standard practice to evaluate patients with symptoms suggesting bladder cancer and to monitor treated patients for recurrence or progression. Exceptions, such as high grade bladder cancers s/p radical cystectomy, do exist which preclude cystoscopy prior to testing. Testing indications, limitations and frequency do not apply to urine cytology.
Bladder cancer tumor markers performed by any technology, immunoassay, molecular or FISH testing are not covered for screening of all patients with hematuria. Bladder tumor markers are not expected to be performed until other diagnostic studies fail to identify the etiology of the hematuria. Urine cytology is not considered a bladder tumor marker.
All other bladder cancer marker assays, including but not limited to the following, regardless of the methodology are considered investigational and not covered by Medicare:
• BCLA-4
• BLCA-1
• Hyaluronic acid
• Hyaluronidase
• Lewis X antigen
• Microsatellite markers
• Quanticyt
• Soluble FAS TATI (tumor associated trypsin inhibitor)
• Soluble e-cadherin
• Survivin
• Telomerase
• UBC™ Rapid Test (urinary bladder cancer test for cytokeratins 8 and 18)
Summary of evidence (opening)
NA
The contractor cites 5 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2017-05-16
- Current revision effective
- 2025-11-06
- Last reviewed by the contractor
- 2021-03-02
- MCD version
- 33
Other related documents: A55457 (Response to Comments).
Using this policy on a claim
Match the documented indication to the covered indications above before the service is scheduled, carry a diagnosis from the article's covered list on the claim line, and keep the elements the documentation section asks for in the record, because the contractor can request it later through medical review. A denial under this policy arrives as CARC 50 with remark N115; the LCD lookup guide walks through the appeal path and the Advance Beneficiary Notice rules, and the Noridian Healthcare Solutions, LLC hub lists every other active policy from the same contractor.
The same policy title at other contractors
Contractors often adopt each other's policies and then revise them separately, so the criteria and the diagnosis lists drift apart. The topic comparison lines up every version.
Frequently asked questions
What does LCD L36678 cover?
Gross painless hematuria is often the first manifestation of a urothelial tumor. Since the degree of hematuria bears no relation to the seriousness of the underlying disease, the microscopic finding of blood in the urine is a serious symptom until significant pathology has been excluded. The full indications and limitations are reproduced on this page from the CMS Medicare Coverage Database export of September 24, 2026.
Which states does LCD L36678 apply to?
Noridian Healthcare Solutions, LLC applies it to Medicare claims in AK, AS, AZ, CA, CNMI, GU, HI, ID, MT, ND, NF, NV, OR, SD, SF, UT, WA, WY. A Local Coverage Determination binds only the contractor that wrote it; the same service in another jurisdiction is judged under that contractor's own policy or, where none exists, claim by claim.
Which diagnosis codes support medical necessity under LCD L36678?
The companion billing and coding article A55028 lists 60 ICD-10-CM codes in 1 group that support medical necessity; the first 24 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L36678?
The remittance carries claim adjustment reason code 50 with remark code N115, naming the LCD. Compare the documented indication with the policy's covered indications and the article's diagnosis list, then file a redetermination within 120 days with the record attached; if the service genuinely falls outside the policy, the patient can be billed only when a valid Advance Beneficiary Notice was obtained before the service.
Sources
Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-02. Verify against the primary file before billing or contracting decisions.
- Medicare Coverage Database, current LCD exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file lcd.csvSHA-256 2fcc4251b6ddd1eb…
- Medicare Coverage Database, current Billing and Coding Articles exportVersion MCD release 2026-09-24 · effective 2026-09-20 · file article.csvSHA-256 f31932f1df3b4035…
- ICD-10-CM FY2027 code descriptionsVersion FY2027 · effective 2026-10-01 · file icd10cm_codes_2027.txtSHA-256 3c0583a38ee0e848…
Disclaimer
The policy text and code lists are reproduced from the CMS Medicare Coverage Database export as an operational reference. Verify against the current LCD and article on cms.gov before billing; coverage depends on the full record and the contractor. Not legal, clinical or billing advice.