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 A58211 (Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer) 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.
A58211: Billing and Coding: MolDX: Prognostic and Predictive Molecular Classifiers for Bladder Cancer (Billing and Coding, effective 2024-01-01)
- Covered ICD-10-CM codes
- 9
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 6
- 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 | — |
Procedure codes: 0016M, 81401, 81403, 81404, 81445, 81479.
Coverage indications, limitations and medical necessity
Coverage Indications
This contractor will cover molecular diagnostic tests for use in a beneficiary with bladder cancer when all of the following conditions are met:
• The beneficiary is being actively managed for bladder cancer.
• The beneficiary is within the population and has the indication for which the test was developed and is covered. The laboratory will make available the appropriate indications of the test to the treating/ordering physician.
• At least 1 of the 2 criteria are met:
• The patient is a candidate for multiple potential treatments, which could be considered to have varied or increasing levels of intensity based on a consensus guideline, and the physician and patient must decide among these treatments. OR
• The patient is a candidate for multiple therapies, and the test has shown that it predicts response to a specific therapy among accepted therapy options based on nationally recognized society consensus guidelines (i.e., National Comprehensive Cancer Network [NCCN], American Society of Clinical Oncology [ASCO], Society of Urologic Oncology [SUO], or American Urological Association [AUA]).
• If Next-Generation Sequencing (NGS) methodology is used in testing, the conditions set by NCD 90.2 are fulfilled (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously tested with the same test for the same genetic content)
• The test demonstrates analytical validity including both analytical and clinical validations. If the test relies on an algorithm (which may range in complexity from a threshold determination of a single numeric value to a complex mathematical or computational function), the algorithm must be validated in a cohort that is not a development cohort for the algorithm.
• The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population.
• The test successfully completes a Molecular Diagnostic Services Program (MolDX ® ) technical assessment that ensures the test is reasonable and necessary as described above.
• Only 1 test may be performed prior to the initiation of therapy UNLESS a second test that interrogates different genomic content AND meets all the criteria established herein, is reasonable and necessary.
• The genomic content interrogated by the test must be relevant to the therapy under consideration.
Summary of evidence (opening)
In the United States, the annual incidence of new bladder cancer is 83,730 patients with approximately 17,200 annual deaths. 1 The majority of bladder cancers originate from the urothelium, with the most important initial risk stratification decision made for these cancers based on whether it is invasive or non-invasive, and how deeply it has invaded if invasive. 2 Variant histology, common at higher grades, may represent risk of progression or different genetic derivation which may determine whether a more aggressive treatment approach should be considered. 15 In patients who do not have evidence of metastasis at the time of diagnosis, guidelines recommend considering a number of possible treatment approaches of varying intensity and invasiveness, often with recommended follow-up and potential escalation of therapy when there is persistent evidence of cancer. For clinical non-invasive papillary urothelial carcinoma potential treatment approaches include intravesical Bacillus Calmette-Guerin (BCG), intravesical chemotherapy, or even observation. 13 For clinical T1 tumors, potential treatment options include either transurethral resection of the bladder tumor (TURBT) or cystectomy. In patients with stage II or stage IIIa disease, potential treatment options include chemotherapy, radiation, chemoradiation, and surgery accompanied possibly by neoadjuvant and/or adjuvant chemotherapy. 13 While guidelines base recommendations for treatment of localized urothelial cancers heavily on risk stratification, within individual risk groups, the guidelines recommend consideration of multiple treatment strategies of varying levels in intensity and known significant side effects within individual strata. 13 Risk stratification for treatment decisions in patients who are not having or have not yet had a cystectomy are based on clinical staging information; evidence has shown that changes in staging based on pathologic information following cystectomy are common, altering disease risk. 3
Among the non-urothelial bladder cancers, squamous cell carcinoma, adenocarcinoma, and neuroendocrine (NE) tumors have been recognized as important for implications concerning treatment. 2 Current recommendations do not suggest chemotherapy for pure squamous or adenomcarcinoma of the bladder, with radiotherapy and /or surgical resection being the mainstays of treatment. 2 NE and NE-like tumors and those tumors with small cell features have been recognized to be a poor prognostic subtype for which aggressive treatment (including chemotherapy and possibly cystectomy and radiotherapy) is recommended regardless of stage. 2 The diagnosis of neuroendocrine NE and NE-like tumors in the bladder may be challenging, particularly on histology alone, and therefore often requires use of additional diagnostic information, such as special stains to look for NE features. 5,6
With current standards of care, patients diagnosed with bladder cancer have 5-year relative survival rates (compared to peers without bladder cancer) of 95.8% in cases of in-situ carcinoma and 69.5% in cases of localized cancer with absolute survival rates of 51% and 34% for in-situ and local disease respectively. 7
Molecular subtyping has emerged as a potential diagnostic aid in bladder cancer both to help identify the type of bladder cancer and to more accurately assess the risk and benefit profile of various treatment approaches and to aid in the diagnosis of bladder cancer subtype and risk.
The contractor cites 18 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2021-07-18
- Current revision effective
- 2026-04-16
- Last reviewed by the contractor
- 2026-03-05
- MCD version
- 10
The contractor lists one National Coverage Determination as related: NCD 90.2 Next Generation Sequencing (NGS). Where an NCD speaks, it controls; the LCD can only address what the NCD leaves open.
Other related documents: A59456 (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 Wisconsin Physicians Service Insurance Corporation 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 L38684 cover?
• The test has demonstrated clinical validity and utility, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision (in 4. above) in a clearly defined population. 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 L38684 apply to?
Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, 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 L38684?
The companion billing and coding article A58211 lists 9 ICD-10-CM codes in 1 group that support medical necessity; the first 9 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L38684?
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.