Skip to main content

LCD L37356: MolDX: EndoPredict Breast Cancer Gene Expression Test

LCD L37356, MolDX: EndoPredict Breast Cancer Gene Expression Test, is the Local Coverage Determination that CGS Administrators, LLC applies to claims from 2 states (KY, OH), effective 2026-04-16 and first in force 2018-03-06. The policy text runs 102 words, and its billing and coding article A56997 lists 16 ICD-10-CM codes that support medical necessity for 1 procedure codes. 3 other contractors publish a policy with the same title, so the criteria that apply depend on where the service is furnished.

QuickIntell editorial content · Legacy registry date · Review not verified

Data effective
Data currency: Medicare Coverage Database LCD export release of September 24, 2026 (effective September 20, 2026). Next CMS release: weekly (Thursdays) for the MCD.
Contractor
CGS Administrators, LLC
States and territories
2
KY OH
Revision effective
2026-04-16
Original effective
2018-03-06
Policy text
102 words
Covered ICD-10 codes (articles)
16

Where this LCD applies

Each contract number is a jurisdiction on the remittance; the policy binds claims processed under these contracts and no others.

Contracts that apply LCD L37356
ContractContractorTypeStates
15102CGS Administrators, LLCMAC - Part BKY
15202CGS Administrators, LLCMAC - Part BOH
15101CGS Administrators, LLCMAC - Part AKY
15201CGS Administrators, LLCMAC - Part AOH

Billing and coding: diagnoses and procedure codes

Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A56997 (Billing and Coding: MolDX: EndoPredict Breast Cancer 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.

A56997: Billing and Coding: MolDX: EndoPredict Breast Cancer Gene Expression Test (Billing and Coding, effective 2025-05-08)

Covered ICD-10-CM codes
16
1 group
Non-covered ICD-10-CM codes
0
Procedure codes listed
1
Full article
cms.gov record
First 16 covered ICD-10-CM codes in A56997
ICD-10-CMDescription (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—

Procedure codes: 81522.

Coverage indications, limitations and medical necessity

This Medicare contractor will provide limited coverage for the EndoPredict ® breast cancer gene expression test (Myriad Genetic Laboratories Inc., Salt Lake City, UT) for the management of post-menopausal women diagnosed with early-stage (TNM stage T1-3, N0-1) estrogen-receptor (ER) positive, Her2-negative breast cancer, who are either lymph node-negative or who have 1-3 positive nodes, and for whom treatment with adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors) is being considered. The test is used by physicians in the management of these patients by identifying those who have sufficiently low risk of distant recurrence (DR) at 10 years and may safely forego chemotherapy.

Summary of evidence (opening)

In 2016, approximately 247,000 cases of breast cancer were diagnosed in the United States. 1 Approximately 75% of early-stage breast cancers are estrogen receptor (ER)-positive and HER2-negative, leading to treatment with adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitors) that significantly improves prognosis. 2,3 Determining which patients with ER+/Her2- breast cancer will have a low enough risk of DR after 5 years of endocrine therapy to forgo adjuvant chemotherapy is a priority for physicians who manage these patients.

A 2012 meta-analysis by the Early Breast Cancer Trialist’s Collaborative Group demonstrated that all clinical risk groups of patients with early breast cancer experience a ~30% benefit from chemotherapy, in terms of decrease in DR rate. 4 Therefore, patients with a low 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 treatment-related toxicity and long-term side effects.

Tumor size, grade, and nodal status are currently used for assessment of a patient’s distant recurrence risk to make decisions about the addition of chemotherapy to endocrine therapy. However, molecular tests have been shown to improve prognostic accuracy compared to standard clinical features and have become increasingly important for patients with ER+/Her2- breast cancer. These assays have become standard of care in the treatment of early stage breast cancer, to identify patients who have a low risk of DR such that chemotherapy would not provide an overall benefit, to directly predict chemotherapy benefit, and to help curtail costly overtreatment.

In determining the cutoff to identify low risk patients, breast cancer prognostic tests commonly use a threshold of a 10% risk of DR at 10 years. Patients with a risk under 10% are categorized as low risk. This 10% cutoff is a well-accepted standard used by many currently available breast prognostic tests and accepted by the American Society of Clinical Oncology (ASCO). 5 In addition, while hormone receptor-positive early-stage breast cancer patients have a favorable prognosis overall, there is an ongoing risk of distant recurrence (DR) and death. 15,16 Women with node-negative disease who received 5 years of endocrine therapy have a 13% risk of recurrence 5-20 years after diagnosis. 15 Studies have offered conflicting results on the efficacy of continuing endocrine therapy beyond five years. A series of randomized trials that compared the benefit of extended endocrine therapy (EET; 10 years total) versus the 5-year standard of care demonstrated that EET led to a modest clinical benefit in disease free survival, although many were confounded by the inclusion of patients who received adjuvant chemotherapy or by unknown hormone receptor status. 17-23

The contractor cites 30 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.

Dates, lineage and related policies

Original determination effective
2018-03-06
Current revision effective
2026-04-16
Last reviewed by the contractor
2026-04-02
MCD version
17

Other related documents: A58708 (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 CGS Administrators, 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.

L37264
Palmetto GBA · 7 states · revised 2021-07-04 · 16 covered codes
L37295
Noridian Healthcare Solutions, LLC · 18 states · revised 2026-01-22 · 16 covered codes
L37663
Wisconsin Physicians Service Insurance Corporation · 48 states · revised 2025-05-01 · 16 covered codes

Frequently asked questions

What does LCD L37356 cover?

This Medicare contractor will provide limited coverage for the EndoPredict ® breast cancer gene expression test (Myriad Genetic Laboratories Inc., Salt Lake City, UT) for the management of post-menopausal women diagnosed with early-stage (TNM stage T1-3, N0-1) estrogen-receptor (ER) positive, Her2-negative breast cancer, who are either lymph node-negative or who have 1-3 positive nodes, and for whom treatment with… 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 L37356 apply to?

CGS Administrators, LLC applies it to Medicare claims in KY, OH. 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 L37356?

The companion billing and coding article A56997 lists 16 ICD-10-CM codes in 1 group that support medical necessity; the first 16 appear on this page and the complete list is in the article on cms.gov.

How do I appeal a denial under LCD L37356?

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.

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.