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LCD L38284: MolDX: Predictive Classifiers for Early Stage Non-small Cell Lung Cancer

LCD L38284, MolDX: Predictive Classifiers for Early Stage Non-small Cell Lung Cancer, is the Local Coverage Determination that CGS Administrators, LLC applies to claims from 2 states (KY, OH), effective 2025-11-13 and first in force 2020-07-27. The policy text runs 127 words, and its billing and coding article A58038 lists 13 ICD-10-CM codes that support medical necessity for 2 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
2025-11-13
Original effective
2020-07-27
Policy text
127 words
Covered ICD-10 codes (articles)
13

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 L38284
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 A58038 (Billing and Coding: MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung 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.

A58038: Billing and Coding: MolDX: Predictive Classifiers for Early Stage Non-Small Cell Lung Cancer (Billing and Coding, effective 2023-11-16)

Covered ICD-10-CM codes
13
1 group
Non-covered ICD-10-CM codes
0
Procedure codes listed
2
Full article
cms.gov record
First 13 covered ICD-10-CM codes in A58038
ICD-10-CMDescription (FY2027)
C34.01—
C34.02—
C34.11—
C34.12—
C34.2—
C34.30—
C34.31—
C34.32—
C34.81—
C34.82—
C34.90—
C34.91—
C34.92—

Procedure codes: 0288U, 81479.

Coverage indications, limitations and medical necessity

This policy concerns the use of molecular diagnostic laboratory tests (tests of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and / or proteins) as a predictive classifier for non-small cell lung cancer (NSCLC).

Molecular classifiers are considered reasonable and necessary when beneficiaries meet all of the following criteria :

• The patient has a non-squamous NSCLC with a tumor size i.e. American Joint Committee on Cancer (AJCC) Eighth Edition Stages I and IIa)

• The patient is sufficiently healthy to tolerate chemotherapy

• Adjuvant platinum-containing chemotherapy is being considered for the patient

• The test is ordered by a physician who is treating the patient for NSCLC (generally a medical oncologist, surgeon, or radiation oncologist) to help in the decision of whether or not to recommend adjuvant chemotherapy

Summary of evidence (opening)

Non-Small Cell Lung Cancer (NSCLC) is a deadly cancer with estimated incidence of 41.2 per 100,000 people and an incidence in those 65 years of age and older of 238.1 per 100,000 people. 1 While mortality rates have improved since 1975, the 5-year relative survival is estimated to be only 24.2% for all stages of disease [(Surveillance, Epidemiology, and End Results (SEER) Summary Stages)] and only 60.1% for localized disease, the least advanced stage of disease. 1

Consensus guidelines recommend surgical resection for medically operable NSCLC due to research finding that this mode of therapy gives the greatest chance of cancer survival. 2 As with many cancers, adjuvant chemotherapy is a possible treatment following resection, and a meta-analysis pooling a number of high quality studies showed that the cisplatin adjuvant treatment tends to improve survival in patients with NSCLC with the benefit being more pronounced in those who have a higher risk disease based on a prior version of AJCC staging criteria. 3 Notably, within this meta-analysis adjuvant chemotherapy was not found to improve overall or disease free survival among those with early stage NSCLC, particularly Stage IA NSCLC. Risk grouping based on AJCC staging criteria has remained the basis of identifying groups of patients with NSCLC for selection of treatment intensity, 2 and AJCC staging criteria have evolved in recent years.

Consensus guidelines from the National Comprehensive Cancer Care Network for the management of NSCLC recommend consideration of chemotherapy for patients with Stage IB and Stage IIA cancer based on the most recent (eight edition) AJCC staging information. 2 For Stage IA cancer, chemotherapy is not a recommendation. For Stages IB and IIA cancer adjuvant chemotherapy is recommended to be considered, particularly for patients with additional high risk clinical or pathological factors. For medically operable higher stage disease, adjuvant chemotherapy, in addition to possible radiation, is recommended without further qualification. Notably, in 2017 the American Joint Committee on Cancer released the eighth edition of staging information for NSCLC, which redefined T1a tumors as no longer being tumors 4

While clear clinical and pathologic staging approaches have been developed to risk stratify patients and clear treatment guidelines-based risk strata have been published to guide management based on risk strata, disease recurrence is common. One large retrospective study of patterns of disease recurrence in early-stage patients was undertaken at a single large academic center. 5 The study reviewed the records of patients who underwent surgery for T1 and T2 and N0 and N1 NSCLC patients and looked for evidence of recurrence in the medical record. Records of 975 patients were reviewed, the majority of whom had Stage IA (45%) or Stage IB (39%) disease. Nearly all patients (96%) had negative surgical margins. Adjuvant chemotherapy was used in 7% and radiation treatment was used in 3%. The rate of local recurrence in this cohort was 23%, and the rate of distant recurrence was 34%, suggesting that disease recurrence is common even among patients with localized margin-negative disease classified as low risk based on available clinical and pathologic data. More recent data from the Surveillance, Epidemiology, and End Results database, shows that even among those patients with localized disease, 5-year survival rates are at around 60%. 1

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
2020-07-27
Current revision effective
2025-11-13
Last reviewed by the contractor
2025-11-04
MCD version
13

Other related documents: A58039 (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.

L38238
Palmetto GBA · 7 states · revised 2025-07-03 · 13 covered codes
L38327
Noridian Healthcare Solutions, LLC · 18 states · revised 2026-02-05 · 13 covered codes
L38443
Wisconsin Physicians Service Insurance Corporation · 48 states · revised 2025-07-03 · 13 covered codes

Frequently asked questions

What does LCD L38284 cover?

Molecular classifiers are considered reasonable and necessary when beneficiaries meet all of the following criteria : 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 L38284 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 L38284?

The companion billing and coding article A58038 lists 13 ICD-10-CM codes in 1 group that support medical necessity; the first 13 appear on this page and the complete list is in the article on cms.gov.

How do I appeal a denial under LCD L38284?

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.