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 A57363 (Billing and Coding: MolDX: Breast Cancer Assay: Prosigna®) 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.
A57363: Billing and Coding: MolDX: Breast Cancer Assay: Prosigna® (Billing and Coding, effective 2026-01-22)
- Covered ICD-10-CM codes
- 21
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| C50.011 | — |
| C50.012 | — |
| C50.111 | — |
| C50.112 | — |
| C50.211 | — |
| C50.212 | — |
| C50.311 | — |
| C50.312 | — |
| C50.411 | — |
| C50.412 | — |
| C50.511 | — |
| C50.512 | — |
| C50.611 | — |
| C50.612 | — |
| C50.811 | — |
| C50.812 | — |
| C50.911 | — |
| C50.912 | — |
| D05.01 | — |
| D05.02 | — |
| D05.11 | — |
Procedure codes: 81520.
Coverage indications, limitations and medical necessity
This policy provides limited coverage of the Prosigna® Breast Cancer Gene Signature Assay to patients that meet the following criteria consistent with the United States (U.S.) Food and Drug Administration (FDA) indications for use:
• Post-menopausal female either
• ER+, lymph node-negative, stage I or II breast cancer; or
• ER+, lymph node-positive (1-3 positive nodes), stage II breast cancer.
Claims for Prosigna® testing will be denied when testing does not meet all of the above criteria.
Background
Women with early breast cancer and up to 3 locally positive lymph nodes whose tumor is estrogen-receptor positive will usually receive anti-hormonal therapy such as tamoxifen or aromatase inhibitors. U.S. (NCCN) and international (St. Gallen) guidelines predicate the decision for adjuvant chemotherapy on the size and grade of the breast cancer and other factors including genomic assays that provide additional information on risk of recurrence (Hernandez-Ava, et al., 2013). According to a 2014 review, “Prognostic factors provide an indication of whether a patient needs subsequent therapy.” (Paoletti & Hayes, 2014). Similarly, another 2014 review article states, “Efforts should be focused on reducing chemotherapy in patients unlikely to benefit.” (Rampurwala, et al., 2014). Accordingly, Medicare has covered breast cancer gene signature prognostic/predictive tests since 2006.
The PAM50 breast cancer gene signature test was developed in the late 1990s and initial studies showed a strong correlation with breast cancer recurrence and with complete pathologic response to neoadjuvant chemotherapy (Parker, et al., 2009). While test results are reported on a scale of 1-100 as a Risk of Recurrence (ROR) score, the underlying algorithm is also able to classify cases into the luminal A and B, Her2neu, and triple-negative subtype classifications.
The Nanostring nCounter® nucleic acid analysis system replicates the PAM50 algorithm, as an FDA cleared kit, the Prosigna® Breast Cancer Gene Signature Assay (FDA, 2013). The Prosigna® package insert was most recently updated in January, 2015 (FDA, 2015) reflecting additional studies (Sestak, et al., 2014). Notably, the Prosigna® platform and the original PAM50 platform have a 0.997 correlation (Dowsett, et al., 2013).
For the FDA, the Prosigna® test was validated in a large population of post-menopausal, estrogen-receptor positive women based on 1,017 cases of the TransATAC study (Dowsett, et al., 2013). The study showed a strong correlation with long-term breast cancer recurrence and added substantial additional prognostic information over a clinical treatment score based on standard clinical variables. This study was replicated in an independent population, also on the Prosigna® test, using 1,620 samples from the ABCSG8 trial (Gnant, 2014). A separate analysis of these trials validated prediction of distant recurrence in years 5-10 after initial diagnosis (Sestak, et al., 2014) and has been incorporated in the FDA labeling (FDA, 2015). The Prosigna® test is issued as separate reports, consistent with FDA review and labeling, for node-negative and node-positive (1-3 node) populations. Analytic performance, precision, reproducibility, and analysis of the clinical validations are provided in the FDA labeling (FDA, 2013; FDA, 2015).
Clinical utility of this breast cancer gene signature has also been assessed. The study of Martin, et al. (2015) showed a 20% decision impact on decisions for or against adjuvant chemotherapy in an all-comers population of 200 new cases of incident breast cancer, when Prosigna® test information became available after all other clinical information had been considered. The net rates of selecting adjuvant chemotherapy for low, intermediate, and high risk cases was similar to that observed in a meta-analysis of Oncotype DX decision data (Carlson & Roth, 2013). Additional support for the use of these test results in treatment decisions comes from Parker, et al. (2009), in which there was a strong association with neoadjuvant chemotherapy response. Low-scoring cases have a very low change of complete pathological response to neoadjuvant chemotherapy, while high-scoring cases approach a 50% chance of complete pathological response. The same findings have been observed for other breast cancer gene signatures based on prognostic algorithms (Chang, et al., 2008).
Summary of evidence (opening)
NA
The contractor cites 12 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2016-05-03
- Current revision effective
- 2026-01-22
- Last reviewed by the contractor
- 2021-03-03
- MCD version
- 27
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 L36380 cover?
This policy provides limited coverage of the Prosigna® Breast Cancer Gene Signature Assay to patients that meet the following criteria consistent with the United States (U.S.) Food and Drug Administration (FDA) indications for use: 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 L36380 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 L36380?
The companion billing and coding article A57363 lists 21 ICD-10-CM codes in 1 group that support medical necessity; the first 21 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L36380?
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.