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 A57619 (Billing and Coding: MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™)) 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.
A57619: Billing and Coding: MolDX: Oncotype DX® Breast Cancer for DCIS (Genomic Health™) (Billing and Coding, effective 2026-02-05)
- Covered ICD-10-CM codes
- 2
- 1 group
- Non-covered ICD-10-CM codes
- 0
- Procedure codes listed
- 1
- Full article
- cms.gov record
| ICD-10-CM | Description (FY2027) |
|---|---|
| D05.11 | — |
| D05.12 | — |
Procedure codes: 0045U.
Coverage indications, limitations and medical necessity
This contractor will provide limited coverage for the Oncotype DX® DCIS assay (Genomic Health, Inc., Redwood City, CA) for women diagnosed with DCIS who are planning on having breast conserving surgery and considering adjuvant radiation therapy.
Summary of evidence (opening)
Ductal carcinoma in situ (DCIS) is a heterogeneous group of neoplastic lesions confined to the breast ducts and lobules. It is one of the most commonly diagnosed breast conditions, accounting for approximately 20% of newly diagnosed breast cancers in the United States. 1 Women diagnosed with DCIS are at risk for local recurrence, which may be either DCIS or progression to invasive breast carcinoma. The management of patients with DCIS is an area of controversy and historically treatment has included both surgical excision and radiation therapy. 2 Following surgical excision alone, local recurrences occur in approximately 25% to 30% of women by 10 years. 3 The addition of radiation therapy has been reported to reduce local recurrence risk by approximately 50% but has not been demonstrated to prolong overall or disease free-survival. 3 In an observational study of patients diagnosed with DCIS from 1988 to 2011, prevention of invasive in-breast recurrence with radiation therapy after lumpectomy did not improve 10-year breast cancer-specific mortality compared with lumpectomy alone. 4 Therefore, treating all women with radiation therapy following surgical excision may represent overtreatment for many, especially given that the majority of cases do not recur following surgery alone. Clinical and pathologic features do not reliably predict the risk of recurrence; therefore, validated biomarkers are needed that identify patients at low risk of local recurrence for whom less treatment is indicated and conversely distinguish patients at high risk of progression to invasive disease for whom more intensive treatment regimens are appropriate.
Oncotype DX ® DCIS Score
Test Description
The DCIS Score is a ribonucleic acid (RNA) based assay measuring the expression of 5 proliferation genes, progesterone receptor (PR), GSTM1 and 5 reference genes (Figure 1) with results reported as a numerical score along with accompanying interpretive information. The assay is performed on formalin fixed paraffin-embedded (FFPE) tissue blocks containing DCIS. The DCIS Score was developed based upon analyses of multiple correlative science studies comparing gene expression profiles between invasive and DCIS tumor samples. 5 An algorithm was developed using scaling and category cut-points based on the analysis of the DCIS Score result in a separate cohort of DCIS patients. 6
the full summary and analysis of evidence are in the CMS record.
Dates, lineage and related policies
- Original determination effective
- 2017-03-27
- Current revision effective
- 2026-02-05
- Last reviewed by the contractor
- 2021-10-05
- MCD version
- 22
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 L36941 cover?
This contractor will provide limited coverage for the Oncotype DX® DCIS assay (Genomic Health, Inc., Redwood City, CA) for women diagnosed with DCIS who are planning on having breast conserving surgery and considering adjuvant radiation therapy. 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 L36941 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 L36941?
The companion billing and coding article A57619 lists 2 ICD-10-CM codes in 1 group that support medical necessity; the first 2 appear on this page and the complete list is in the article on cms.gov.
How do I appeal a denial under LCD L36941?
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.