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 A57773 (Billing and Coding: MolDX: Breast Cancer Index® (BCI) Gene Expression Test) 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.
A57773: Billing and Coding: MolDX: Breast Cancer Index® (BCI) Gene Expression Test (Billing and Coding, effective 2026-01-22)
- Covered ICD-10-CM codes
- 17
- 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 | — |
| Z17.0 | — |
Procedure codes: 81518.
Coverage indications, limitations and medical necessity
This Medicare contractor will provide limited coverage for the Breast Cancer Index® (BCI) gene expression test (Biotheranostics, Inc., San Diego, CA). The BCI test is used by physicians to provide a genomic-based estimate of distant recurrence risk when considering addition of chemotherapy, and/or late distant recurrence risk and endocrine responsiveness when considering extension of endocrine therapy, depending upon when in the continuum of care testing is requested.
The BCI test is covered for postmenopausal women with invasive breast cancer when the following criteria are met:
• Pathology reveals invasive carcinoma of the breast that is estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) and Human Epidermal Growth Factor Receptor 2 negative (HER2-); and
• Patient has early-stage disease {Tumor, Node, Metastasis (TNM) stage T1-3, pN0-N1, M0} and
• Patient has no evidence of distant breast cancer metastasis (i.e., non-relapsed); and
• Test results will be used in determining treatment management of the patient for chemotherapy and/or endocrine therapy.
Summary of evidence (opening)
Adjuvant therapy decisions initially and at 5 years in ER+ (or PR+)/HER2- node negative breast cancer
In 2017, approximately 253,000 patients were expected to be diagnosed with invasive breast cancer in the United States, 1 of which approximately 90% are diagnosed with early-stage disease. Hormone-receptor positive (HR+) breast cancer is the most common subtype of breast cancer (~80% of cases 1 ) and has the most favorable prognosis overall. 1 Standard-of-care treatment for HR+ disease includes primary adjuvant anti-estrogen therapy with tamoxifen, an aromatase inhibitor (AI), or a sequence of these. In addition to anti-estrogen therapy, 2 key treatment decisions are priorities in the management of early stage breast cancer. The first decision is whether the patient is of sufficient risk of recurrence to recommend systemic adjuvant chemotherapy. In addition, while HR+ early-stage breast cancer patients have a favorable prognosis overall, there is an ongoing risk of distant recurrence (DR) beyond year 5 (late recurrence), and 75% of deaths occur more than 5 years post-diagnosis. As such, the second key decision is whether to recommend extension of endocrine therapy beyond the initial primary adjuvant therapy. For each treatment decision, physicians and patients must weigh whether the potential benefit from the additional treatment regimen is likely to outweigh the risks of serious toxicities and side effects.
Improving Patient Stratification for Addition of Adjuvant Chemotherapy
Adjuvant chemotherapy has been shown to improve outcomes in patients with early stage HR+ breast cancer. In a meta-analysis of 100,000 women across 123 randomized trials, 2 the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) reported that patients with early-stage breast cancer experience an approximately 30% reduction in DR rate or benefit from adjuvant chemotherapy. Notably, this analysis also showed that proportional risk reduction was not affected by traditional clinical and pathologic factors (e.g., nodal status, tumor size, tumor grade). Patients, therefore, with a limited underlying risk of DR will have a lower absolute benefit from chemotherapy, compared to patients with a high underlying risk of DR. For each patient, the expected absolute benefit of chemotherapy needs to be weighed against the 2-3% chance of fatal, life-threatening, or life-changing toxicities. 3
The contractor cites 21 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2019-04-16
- Current revision effective
- 2026-01-22
- Last reviewed by the contractor
- 2025-05-08
- MCD version
- 19
Other related documents: A58669 (Response to Comments), A58670 (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 L37822 cover?
• Patient has early-stage disease {Tumor, Node, Metastasis (TNM) stage T1-3, pN0-N1, M0} and 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 L37822 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 L37822?
The companion billing and coding article A57773 lists 17 ICD-10-CM codes in 1 group that support medical necessity; the first 17 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L37822?
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.