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LCD L39720: MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

LCD L39720, MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules, is the Local Coverage Determination that Wisconsin Physicians Service Insurance Corporation applies to claims from 48 states (AK, AL, AR, AZ, CA, CO, CT, DE and others), effective 2026-05-28 and first in force 2024-07-28. The policy text runs 318 words, and its billing and coding article A59560 lists 10 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
Wisconsin Physicians Service Insurance Corporation
States and territories
48
AK AL AR AZ CA CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MO MS MT NC ND NE NH NJ NM NV OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY
Revision effective
2026-05-28
Original effective
2024-07-28
Policy text
318 words
Covered ICD-10 codes (articles)
10

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 L39720
ContractContractorTypeStates
05101Wisconsin Physicians Service Insurance CorporationMAC - Part AIA
05201Wisconsin Physicians Service Insurance CorporationMAC - Part AKS
05301Wisconsin Physicians Service Insurance CorporationMAC - Part AMO
05401Wisconsin Physicians Service Insurance CorporationMAC - Part ANE
05102Wisconsin Physicians Service Insurance CorporationMAC - Part BIA
05202Wisconsin Physicians Service Insurance CorporationMAC - Part BKS
05302Wisconsin Physicians Service Insurance CorporationMAC - Part BMO
05402Wisconsin Physicians Service Insurance CorporationMAC - Part BNE
08101Wisconsin Physicians Service Insurance CorporationMAC - Part AIN
08102Wisconsin Physicians Service Insurance CorporationMAC - Part BIN
08201Wisconsin Physicians Service Insurance CorporationMAC - Part AMI
08202Wisconsin Physicians Service Insurance CorporationMAC - Part BMI
05901Wisconsin Physicians Service Insurance CorporationMAC - Part AAK AL AR AZ CA CO CT DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MO MS MT NC ND NE NH NJ NM NV OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY

Billing and coding: diagnoses and procedure codes

Since 2019 the codes live in the companion article rather than the LCD. Billing and Coding A59560 (Billing and Coding: MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules) 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.

A59560: Billing and Coding: MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules (Billing and Coding, effective 2026-04-16)

Covered ICD-10-CM codes
10
1 group
Non-covered ICD-10-CM codes
0
Procedure codes listed
2
Full article
cms.gov record
First 10 covered ICD-10-CM codes in A59560
ICD-10-CMDescription (FY2027)
D44.0—
D44.9—
E01.0—
E01.1—
E01.2—
E04.0—
E04.1—
E04.2—
E04.8—
E04.9—

Procedure codes: 81479, 81546.

Coverage indications, limitations and medical necessity

This contractor will cover molecular diagnostic tests for use in a beneficiary with an indeterminate or suspicious thyroid nodule when all the following criteria are met:

• The patient:

• Has an index nodule that has not been tested with the same or similar assay for the same clinical indication AND

• The nodule is indeterminate as defined by Bethesda categories III-IV OR

• The nodule is Bethesda category V and molecular testing may aid in further stratifying the type of malignancy.

• If the patient has multiple nodules, concurrent or reflex testing may be medically necessary, provided the above criteria are also met.

• The results of the test will be used to aid in surgical decision making after consideration of clinical, radiographic and cytologic features.

• The beneficiary is within the population and has the indication for which the test was developed. The laboratory providing the test is responsible for clearly indicating to treating clinicians the population and indication for test use.

• The test demonstrates analytical validity, including both analytical and clinical validation, on a cohort of patients appropriate for its intended use. If the test relies on an algorithm, the algorithm must be validated in a cohort that is not a development cohort for the algorithm.

• The test has demonstrated clinical validity and utility in peer-reviewed, published literature, establishing a clear and significant biological/molecular basis for stratifying patients and subsequently selecting (either positively or negatively) a clinical management decision in a clearly defined population.

• The test successfully completes a technical assessment that ensures the test is reasonable and necessary as described above.

• The performance characteristics of the test have been demonstrated to be as good or better than currently covered services.

NOTE: Next Generation Sequencing (NGS) performed to identify genetic variants in samples classified as malignant is not within the scope of this policy but may fall under other established policies.

Summary of evidence (opening)

Thyroid cancer (TC) is the most common endocrine malignancy, consisting of nearly 3% of all newly diagnosed cancer cases in the United States each year. 1 Greater than 70% of those cases are women, representing the fifth most diagnosed malignancy in females. It is the second most common cancer among Hispanic and Asian/Pacific Islander women in the US, who also have the highest mortality rates. 2 Differentiated thyroid carcinoma is the most common form, accounting for around 90% of all cases and includes papillary thyroid carcinoma (PTC), follicular carcinoma (FC) and Hurthle cell carcinoma (HTC). 3,4 Medullary thyroid carcinoma (MTC), a rare neuroendocrine tumor that arises from the neural crest-derived parafollicular calcitonin-secreting thyroid C cells, represents 4% of all TC. 5 Anaplastic thyroid carcinoma (ATC) is the most aggressive thyroid tumor and while only around 1-2% of all TC, accounts for the majority of TC death. 6

The diagnosis of TC in the United States has tripled over the last 25 years. 1 Several studies attribute the significant increase to overdiagnosis of small indolent tumors that would otherwise not cause symptoms or require treatment with a majority of the increase being explained by PTC tumors 2 cm or smaller. 7-11 In fact, recent studies suggest the incidence rate of thyroid cancer stabilized between 2013-2016 and declined between 2016-2018. 12,13 This stabilization followed by decline has been postulated to be a result of changes in practice patterns and reclassification of some cancer types. In 2016, the Endocrine Pathology Society working group reported clinical outcomes and refined the diagnostic criteria for encapsulated follicular variant of papillary thyroid carcinoma (EFVPC) and proposed replacing the term with non-invasive follicular thyroid neoplasm with papillary-like nucleus features (NIFTP) to describe these tumors more accurately. 14 The American Thyroid Association (ATA) recommended this terminology change in 2017. 15 This led to the reclassification of approximately 10-20% of thyroid tumors from malignant to benign. 14 In addition, guidelines for the management of thyroid nodules have become increasingly more conservative regarding size thresholds for nodule biopsy and discourage biopsy for nodules 16,17 However, some studies have reported a true increase in advanced-stage and larger PTC tumors as well as incidence-based mortality that cannot be explained by overdiagnosis and suggest that lifestyle-related factors such as obesity may be contributory. 10,18 Also, there continue to be disparities in diagnosis and treatment of TC in patients based on race, ethnicity and socioeconomic status with patients from minority backgrounds more likely to present with larger tumors, and distant metastases than white patients. 2,19,20 However, a recent report from Ginzberg et al. suggests that the updated ATA guidelines ameliorated some of these disparities. 21

TC almost exclusively presents as thyroid nodules, occurring in 7-15% of cases depending on sex, age, radiation exposure, family history and other factors. 16 However, thyroid nodules are very common; most are asymptomatic and benign and do not require monitoring, treatment, or evaluation. In fact, over 60% of the population will have a thyroid nodule by the time they are over the age of 65. 16 Therefore, it is important to distinguish between benign and malignant nodules for patients to receive appropriate treatment and prevent unnecessary surgery.

The malignancy potential of a thyroid nodule is determined through a multimodality manner including physical exam, personal and family history, radiographic assessment, and fine needle aspiration (FNA) biopsy. FNA biopsies are the procedure of choice when evaluating clinically suspicious thyroid nodules and every year more than 500,000 of this minimally invasive procedure are performed. 22 The results of FNA biopsies are reported using the Bethesda System for Reporting Thyroid Cytopathology (TBSRTC). 23 This system was established to provide consensus recommendations for diagnostic categories for FNA specimens with a goal of standardizing classification and reporting across health care providers. It includes recommendations on sample adequacy, malignancy risk, report layout and management and has been widely adopted. As shown in Table 1 (reproduced from TBSRTC), the system recognizes six diagnostic categories and provides an estimated cancer risk for each, based on identification of cancer in a subsequent nodule resection.

The contractor cites 53 sources in the bibliography; the full summary and analysis of evidence are in the CMS record.

Dates, lineage and related policies

Original determination effective
2024-07-28
Current revision effective
2026-05-28
Last reviewed by the contractor
2026-04-16
MCD version
7

Other related documents: A59825 (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 Wisconsin Physicians Service Insurance Corporation 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 L39720 cover?

• The results of the test will be used to aid in surgical decision making after consideration of clinical, radiographic and cytologic features. 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 L39720 apply to?

Wisconsin Physicians Service Insurance Corporation applies it to Medicare claims in AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, 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 L39720?

The companion billing and coding article A59560 lists 10 ICD-10-CM codes in 1 group that support medical necessity; the first 10 appear on this page and the complete list is in the article on cms.gov.

How do I appeal a denial under LCD L39720?

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.