URL for source document:

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LCD Title

MolDX: Plasma-Based Genomic Profiling in Solid Tumors

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights
Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the
AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or
indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or
not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No
portion of the American Hospital Association (AHA) copyrighted materials contained within this publication
may be copied without the express written consent of the AHA. AHA copyrighted materials including the
UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service,
solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA
materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for
internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative
work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04
Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express
license from the American Hospital Association. The American Hospital Association (the "AHA") has not
reviewed, and is not responsible for, the completeness or accuracy of any information contained in this
material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis
of information provided in the material. The views and/or positions presented in the material do not
necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA
or any of its affiliates.

Issue

Issue Description

1
This LCD outlines limited coverage for this service with specific details under Coverage Indications,
Limitations and/or Medical Necessity.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1862(a)(1)(A). Allows coverage and payment for only those services
that are considered to be reasonable and necessary.

42 Code of Federal Regulations (CFR) 410.32(a). Diagnostic x-ray tests, diagnostic laboratory tests, and other
diagnostic tests: Conditions.

CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1,
Part 2, §90.2 Next-Generation Sequencing (NGS) for Patients with Advanced Cancer.

CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, §80 Requirements for
Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, §80.1.1 Certification Changes.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

This is a limited coverage policy for next-generation sequencing (NGS) assays performed on solid tumor
cell-free deoxyribonucleic acid (DNA) in plasma, from here on called “liquid biopsies.”

Criteria for Coverage

Guardant360® is covered only when all of the following conditions are met:

2
Patient has been diagnosed with a recurrent, relapsed, refractory, metastatic, or advanced solid tumor that did
not originate from the central nervous system. Patients who would meet all of the indications on the Food and
Drug Administration (FDA) label for larotrectinib if they are found to have a neurotrophic receptor tyrosine
kinase (NTRK) mutation may be considered to have advanced cancer, and

Patient has not previously been tested with the Guardant360® test for the same genetic content. For a patient
who has been tested previously using Guardant360® for cancer, that patient may not be tested again unless
there is clinical evidence that the cancer has evolved wherein testing would be performed for different genetic
content. Specifically, in patients with previously tested cancer, who have evidence of new malignant growth
despite response to a prior targeted therapy, that growth may be considered to be sufficiently genetically
different to require additional genetic testing, and

Patient is untreated for the cancer being tested, or the patient is not responding to treatment (e.g., progression
or new lesions on treatment), and

The patient has decided to seek further cancer treatment with the following conditions:

The patient is a candidate for further treatment with a drug that is either FDA-approved for that patient’s
cancer, or has a National Comprehensive Cancer Network (NCCN) 1 or NCCN 2A recommendation for that
patient’s cancer, and

The FDA-approved indication or NCCN recommendation is based upon information about the presence or
absence of a genetic biomarker tested for in the Guardant360® assay, and

Tissue-based, comprehensive genomic profiling (CGP) is infeasible (e.g., quantity not sufficient for
tissue-based CGP or invasive biopsy is medically contraindicated) or specifically in NSLC Tissue-based CGP
has shown no actionable mutations.

If no alteration is detected by Guardant360® or if circulating tumor deoxyribonucleic acid (ctDNA) is

insufficient/not detected, tissue-based genotyping should be considered.

Other liquid biopsies will be covered for the same indications if they display similar performance in their
intended used applications to Guardant360®.

A wide array of cancer treatments have developed ranging from surgery to medications. One of the newer
approaches to the medical treatment of cancer has been to use drugs based on genetic features of a
malignancy. While many patients will not benefit from genetic testing to select treatment, for those whose
cancers have select biomarkers, the treatment of choice often includes therapy targeting that specific
biomarker or therapy being avoided because of a biomarker.1-13

In spite of the importance of actionable biomarker identification in cancer, research has shown that many
patients do not receive genetic testing for the presence of actionable mutations in their cancers, and there are
geographic disparities in testing with patients in rural areas and those receiving care at community treatment
centers being less likely to receive testing.14-16 In addition, logistical challenges to testing such as adequate
tissue and the availability of any tissue have been identified as barriers to tissue-based genomic testing.15

3
Additionally, even among patients whose cancers were genomically profiled at diagnosis and found to have a
mutation for which they are receiving targeted treatment, resistance to the initial targeted treatment may
emerge. For some patients, the identification of a new mutation, not present in the original tissue sample and
found in the blood, may allow the selection of a new targeted life-prolonging therapy.17

Summary of Evidence

Clinical utility of comprehensive genomic profiling using plasma-based testing

Traditionally, tumor genotyping has been conducted by direct interrogation of tumor tissue obtained through
invasive tissue sampling procedures. This diagnostic approach, however, is limited by the availability of
sufficient tumor tissue and the ability of patients to undergo invasive procedures. In a recent study of over 100
community-based oncologists, nearly one-third of non-small cell lung cancer (NSCLC) patients were not
tested for epidermal growth factor receptor (EGFR) or anaplastic large-cell lymphoma kinase (ALK), over
75% were not tested for ROS1 fusions, and fewer than 10% were tested for all guideline-recommended
alterations.15 These results were similar to a study in a single academic center where only 58% of
non-squamous NSCLC were tested for EGFR and 40% for ALK fusions, despite 13% of patients undergoing
repeat invasive biopsies to obtain sufficient tissue for genomic testing.18 Tissue availability was similarly
limited in several recent series, some of which reported that more than 50% of NSCLC patients had
insufficient or unobtainable material for tissue-based CGP.19-21

Even when successful, tissue acquisition procedures pose a significant morbidity and mortality risk to
Medicare patients. In a recent report, 19% of all lung tissue acquisition procedures resulted in a serious
adverse event,22 while the National Lung Cancer Screening Trial reported 1-2% mortality rates in their
cohorts.23 The FDA has also specifically approved a medication for patients who have cancer (cancer type
unspecified on the label) for which there is a high risk associated with surgical resection.24 Given the high
rates of inadequate genotyping described above, plasma-based CGP can provide an opportunity for non- and
under-genotyped patients to benefit from therapy matched to a genetic biomarker. Early studies suggested that
plasma-based CGP can identify potential genomic targets in both the first and second lines, with response
rates similar to those of patients identified using tissue-based CGP and tissue-based CoDX.20,21,25-27

It has been shown that the region of DNA sequenced is important, since alterations may occur outside the
sequenced region or involve complex alterations (e.g., indels, copy number alterations, or rearrangements)
that are not detectable by certain tests.28 Newer techniques such as next-generation sequencing (NGS), offer
the possibility of not only increased analytical sensitivity but also the ability to detect a broader range of
genomic alterations.29

4
While the evidence appears most developed for clinically actionable targets in NSCLC, targeted therapy for
cancer has been recommended for a number of other cancers as well. Genetic biomarkers associated with
specific guideline recommended targeted therapies for a number of conditions is summarized below in Table
1. These guidelines are updated frequently, so new genes not listed in the table may also become part of
guideline-consensus recommendations.

Non-small cell lung cancer6

EGFR

BRAF

MET

HER2 / ERBB2

ALK

ROS1

RET

MET

KRAS

Colorectal3,10

KRAS

NRAS

BRAF

Breast2

HER2 / ERBB2

BRCA1

5
BRCA2

Endometrial13

HER2 / ERBB2

Gastric and Gastroesophageal4

HER2 / ERBB2

Gastrointestinal Stromal Tumor11

KIT

PDGFRA

BRAF

Melanoma5

BRAF

KIT

Ovarian7

BRCA1

BRCA2

6
Pancreatic8

BRCA1

BRCA2

Prostate9

BRCA1

BRCA2

Thyroid12

BRAF

RET

Chordoma1

EGFR

Additionally, there are now medications, which are FDA approved for cancers based on the presence of
genetic mutations regardless of the tissue of origin.

Microsatellite instability

Microsatellite instability structures are composed of a repeated nucleotide sequences that emerge due to
defects in mismatch repair during DNA replication.30 The importance of them in cancer, is that Microsatellite
Instability High (MSI-H) tumors have been found to respond to immunotherapy,31 and one immunotherapy
drug, pembrolizumab, now has an FDA indication for the treatment of patients with unresectable or

7
metastatic, MSI-H solid tumors.32

NTRK

The tropomyosin receptor kinase (TRK) receptor family is family of transmembrane proteins, some of which
are encoded by the NTRK1, NTRK, and NTRK3 genes. Of these, Guardant360® tests for NTRK1 mutations
including fusions. Fusions in the NTRK genes lead to chimeric TRK proteins, which have oncogenic
potential, and have been viewed as a potential therapeutic target for cancer.33

Larotrectinib, a TRK inhibitor, has received FDA approval for NTRK positive (without a known resistance
mutation) tumors in patients with metastatic disease or where surgical resection is likely to result in severe
morbidity, and who have no satisfactory alternative treatments or that have progressed following treatment.24

Guardant360®

Guardant360® is a comprehensive genomic profiling test that identifies mutations in 73 genetic mutations. It
has demonstrated targeted therapy response rates similar to tissue-detected genomic targets in numerous
published NSCLC studies. 20,21,25-28 In addition to sequencing accuracy, research has been done evaluating
the ability of the test to identify actionable mutations across cancers originating in a number of organ systems.

In a study by Rozenblum et al., tissue biopsies from 101 advanced NSCLC patients were tested locally for
EGFR mutations and ALK fusions.34 Tissue-based CGP identified 15 EGFR and ALK alterations missed
locally, but could only be performed in 82 of the 101 (81%) patients because of tissue exhaustion.
Guardant360® was used in the 19 remaining patients, and two (11%) additional sensitizing EGFR mutations
were found that had been missed with local tissue genotyping. In addition, alterations including MET
amplification, ERBB2 (HER2) mutation, and two RET fusions were also identified (missed with local
non-CGP genotyping), for a total of 6 driver alterations in 19 patients (32%). Thus, Guardant360® changed
treatment in 32% of patients with insufficient samples for tissue-based CGP, with five receiving matched
therapy. These five patients achieved a 60% objective response rate and a 100% disease control rate.

A more recent study examined the clinical implications of using plasma-based testing in addition to
tissue-based testing in 229 patients with NSCLC.35 Of the 229 patients in whom both tissue and plasma
testing were ordered, the addition of plasma increased the percentage of patients eligible for targeted therapies
from 21% (47/229) to 36% (82/229). For the 128 patients with successful tissue testing results, 55 were found
to have a therapeutically targetable mutation. Of these 55, only 31 had this mutation found in tissue and
plasma, though not necessarily the same actionable mutation(s) in each testing method. For 16 patients, the
mutation was found in tissue only, and for 8, it was found in plasma only. To further assess whether the

8
selection of targeted therapy based on the detection of low allele frequency mutations that Guardant360® is
able to identify has a clinical benefit, the authors assessed the depth of response to targeted mutations
identified in plasma-based testing. A total of 42 patients received a targeted therapy consistent with the
plasma-based testing, 12 of whom had that mutation also detectable in tissue-based testing as well. Of this 42,
there were 36 (85.7%) who achieved a response of stable disease, partial response, or complete response.

The ability of Guardant 360® to identify actionable mutations in multiple types of cancer, including NSCLC,
gastric cancer, and melanoma, was examined in 194 patients with metastatic cancer but no availability of
tissue for NGS-based genotyping.25 Actionable mutations were found in the majority of patients, but the
study also evaluated treatment response when the patients were given therapy matching a genetic mutation in
the test. In the group with NSCLC, 15 received matched therapy, and 13 of them responded to the therapy.
Among those with gastric cancer, a total of nine received matched therapy, and 6 responded to treatment, with
one of those six have a complete response (a patient with an ERBB2 amplification). Only 2 patients with
melanoma received matched therapy, and one responded to this treatment.

Guardant360® has been validated recently across genetic mutation types (single nucleotide variants, indels,
fusions, and copy number amplifications) and a range of specific actionable mutations in a study using
orthogonal tissue and plasma-based methods.36,37 Analytical performance of Guardant360® is summarized
in the table below.

Mutation Type

LOD95

Sensitivity

Positive Predictive Value

SNVs

>0.25%

0.05 - 0.25%

9
100%

63.8%

99.2%

96.3%

Indels

>0.20%

0.05 -0.20%

100%

67.8%

98.2%

98.2%

Fusions

>0.20%

0.05-0.20%

95%

83%

100%

10
100%

CNAs

2.24-2.76 copies

95%

100%

Additionally, the study assessed the detection rate of tumor DNA using Guardant360® from 10,585 patients
with more than 20 different cancers. Detection rate was >60% for nearly all cancers and around 80-90% for
NSCLC, breast cancer, colorectal cancer, prostate cancer, gastroesophageal cancer, and gynecologic cancer.
For primary CNS malignancies, the detection rate was less 50%.

While MolDX initially covered the Guardant360® assay for the selection of targeted therapy in NSCLC, the
assay tests for the presence of mutations in over 70 genes and Microsatellite Instability (MSI). More recent
research looking beyond NSCLC has shown that the analytical and clinical performance of the Guardant360®
assay varies little between mutation type and tissue origin, with the exception of malignancies arising in the
central nervous system.36,37

Guardant360® Test Description and Intended Use

Guardant360® analyzes tumor-derived cell-free DNA (also known as ctDNA) to detect somatic alterations,
though it also reports germline alterations.

Guardant360® detects the following classes of alterations:

Base pair substitutions (also known as SNVs)

Small (≤20 bp) and large (>20 bp) indels

11
Copy number amplifications (CNAs)

Fusions

Microsatellite Instability

The analytical performance characteristics of Guardant360® are similar across mutation types, specific
actionable mutations, and tissue types, except primary CNS cancers.

Analysis of Evidence (Rationale for Determination)

Level of Evidence

Quality: Moderate

Strength: Limited

Weight: Limited

The clinical utility of plasma-based genomic testing for patients with advanced cancer at diagnosis or at
progression, as defined in the intended use above, appears to be a viable alternative to solid tumor genotyping,
when tissue is unavailable. At present, Guardant360®, one such assay, appears to have similar performance to
detect mutations regardless of the tissue of origin or mutation type.

While tissue-based testing remains the preferred tool to test for actionable mutations in cancer, for patients in
whom obtaining this tissue is not feasible, liquid biopsy with Guardant360® represents an alternative which
may allow more patients to get potentially effective cancer treatment.

General Information

Associated Information

N/A

Sources of Information

N/A

12
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NCCN Melanoma Panel. Cutaneous Melanoma Version 1.2019. November 1 2018.

NCCN Non-Small Cell Lung Cancer Panel. Non-Small Cell Lung Cancer Version 3.2019. January 18 2019.

NCCN Ovarian Cancer Panel. Ovarian Cancer Version 2.2018. March 9 2018.

NCCN Pancreatic Adenocarcinoma Panel. Pancreatic Adenocarcinoma Version 1.2019. November 8 2018.

NCCN Prostate Cancer Panel. Prostate Cancer Version 4.2018. August 15 2018.

NCCN Rectal Cancer Panel. Rectal Cancer Version 3.2018. August 7 2018.

NCCN Soft Tissue Sarcoma Panel. Soft Tissue Sarcoma Version 2.2019. February 4 2019.

NCCN Thyroid Carcinoma Panel. Thyroid Carcinoma Version 3.2018. December 20 2018.

NCCN Uterine Neoplasms Panel. Uterine Neoplasms Version 3.2019. February 11 2019.

Charlton ME, Karlitz JJ, Schlichting JA, Chen VW, Lynch CF. Factors associated with
guideline-recommended KRAS testing in colorectal cancer patients: A population-based Study. American
journal of clinical oncology. 2017;40(5):498-506.

Gutierrez ME, Choi K, Lanman RB, et al. Genomic profiling of advanced non–small cell lung cancer in
community settings: Gaps and opportunities. Clinical Lung Cancer. 2017;18(6):651-659.

Greenbaum A, Wiggins C, Meisner AL, Rojo M, Kinney AY, Rajput A. KRAS biomarker testing disparities
in colorectal cancer patients in New Mexico. Heliyon. 2017;3(11):e00448-e00448.

Mok TS, Wu Y-L, Ahn M-J, et al. Osimertinib or platinum–pemetrexed in EGFR T790M–positive lung
cancer. New England Journal of Medicine. 2017;376(7):629-640.

Lim C, Tsao MS, Le LW, et al. Biomarker testing and time to treatment decision in patients with advanced
nonsmall-cell lung cancer. Ann Oncol. 2015;26(7):1415-1421.

Hagemann IS, Devarakonda S, Lockwood CM, et al. Clinical next-generation sequencing in patients with
non-small cell lung cancer. Cancer. 2015;121(4):631-639.

Thompson JC, Yee SS, Troxel AB, et al. Detection of therapeutically targetable driver and resistance
mutations in lung cancer patients by next-generation sequencing of cell-free circulating tumor DNA. Clin
Cancer Res. 2016;22(23):5772-5782.

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Villaflor V, Won B, Nagy R, et al. Biopsy-free circulating tumor DNA assay identifies actionable mutations
in lung cancer. Oncotarget. 2016;7(41):66880-66891.

Lokhandwala T, Bittoni MA, Dann RA, et al. Costs of diagnostic assessment for lung cancer: A Medicare
claims analysis. Clinical Lung Cancer. 2017;18(1):e27-e34.

National Lung Screening Trial Research T, Aberle DR, Adams AM, et al. Reduced lung-cancer mortality with
low-dose computed tomographic screening. N Engl J Med. 2011;365(5):395-409.

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Kim ST, Banks KC, Lee S-H, et al. Prospective feasibility study for using cell-free circulating tumor
DNA–guided therapy in refractory metastatic solid cancers: An interim analysis. JCO Precision Oncology.
2017;1:1-15.

Kim ST, Lee WS, Lanman RB, et al. Prospective blinded study of somatic mutation detection in cell-free
DNA utilizing a targeted 54-gene next generation sequencing panel in metastatic solid tumor patients.
Oncotarget. 2015;6(37):40360-40369.

Piotrowska Z, Drapkin B, Engelman JA, Nagy RJ, Lanman RB, Sequist LV. Plasma T790M result alters
treatment options in a previously T790 wild-type EGFR-mutant lung cancer. J Thorac Oncol.
2016;11(8):e95-e97.

Santos ES, Raez LE, Castillero LDC, Marana C, Hunis B. Genomic tissue analysis and liquid biopsy profiles
from patients diagnosed with advanced adenocarcinoma of the lung. Clinics in Oncology. 2016;1(1099):1-4.

Frampton GM, Fichtenholtz A, Otto GA, et al. Development and validation of a clinical cancer genomic
profiling test based on massively parallel DNA sequencing. Nat Biotechnol. 2013;31(11):1023-1031.

Dietmaier W, Wallinger S, Bocker T, Kullmann F, Fishel R, Rüschoff J. Diagnostic microsatellite instability:

Definition and correlation with mismatch repair protein expression. Cancer Research. 1997;57(21):4749.

Le DT, Uram JN, Wang H, et al. PD-1 blockade in tumors with mismatch-repair deficiency. New England
Journal of Medicine. 2015;372(26):2509-2520.

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Cocco E, Scaltriti M, Drilon A. NTRK fusion-positive cancers and TRK inhibitor therapy. Nature Reviews
Clinical Oncology. 2018;15(12):731-747.

Rozenblum AB, Ilouze M, Dudnik E, et al. Clinical impact of hybrid capture-based next-generation
sequencing on changes in treatment decisions in lung cancer. J Thorac Oncol. 2017;12(2):258-268.

Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the
delivery of personalized therapy in metastatic non-small cell lung cancer. JAMA Oncol. 2018.

Odegaard JI, Vincent JJ, Mortimer S, et al. Validation of a plasma-based comprehensive cancer genotyping
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3831.2017.

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Lanman RB, Mortimer SA, Zill OA, et al. Analytical and clinical validation of a digital sequencing panel for
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2015;10(10):e0140712.

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A59279 - Response to Comments: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

LCDs

DL39232 - MolDX: Plasma-Based Genomic Profiling in Solid Tumors

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URL for source document:

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Article Title

Billing and Coding: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

Article Type

Billing and Coding

15
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights
Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the
AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or
indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or
not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No
portion of the American Hospital Association (AHA) copyrighted materials contained within this publication
may be copied without the express written consent of the AHA. AHA copyrighted materials including the
UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service,
solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA
materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for
internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative
work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04
Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express
license from the American Hospital Association. The American Hospital Association (the "AHA") has not
reviewed, and is not responsible for, the completeness or accuracy of any information contained in this
material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis
of information provided in the material. The views and/or positions presented in the material do not
necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA
or any of its affiliates.

CMS National Coverage Policy

Title XVIII of the Social Security Act, §1833(e), prohibits Medicare payment for any claim lacking the
necessary documentation to process the claim

CMS Internet-Only Manual, Publication 100-02, Medicare Benefit Policy Manual, Chapter 15, §§ 80.1.2 A/B
MAC (B) Contracts With Independent Clinical Laboratories

16
CMS Internet-Only Manual, Publication 100-04, Medicare Claims Processing Manual, Chapter 23, §10
Reporting ICD Diagnosis and Procedure Codes

Article Guidance

Article Text

The information in this article contains billing, coding or other guidelines that complement the Local
Coverage Determination (LCD) for MolDX: Plasma-Based Genomic Profiling in Solid Tumors L39232.

To report a Plasma-Based Genomic Profiling in Solid Tumors service, please submit the following claim
information:

Select the appropriate CPT® code

Enter 1 unit of service (UOS)

Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for
the following Part B claim field/types:

Loop 2400 or SV101-7 for the 5010A1 837P

Item 19 for paper claim

Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT® code in the comment/narrative field for
the following Part A claim field/types:

Line SV202-7 for 837I electronic claim

Block 80 for the UB04 claim form

Select the appropriate ICD-10-CM code

Coding Information

CPT/HCPCS Codes

Expand All | Collapse All

17
Group 1 (3 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description

81445 TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, SOLID ORGAN NEOPLASM, 5-50
GENES (EG, ALK, BRAF, CDKN2A, EGFR, ERBB2, KIT, KRAS, MET, NRAS, PDGFRA, PDGFRB,
PGR, PIK3CA, PTEN, RET), INTERROGATION FOR SEQUENCE VARIANTS AND COPY NUMBER
VARIANTS OR REARRANGEMENTS, IF PERFORMED; DNA ANALYSIS OR COMBINED DNA AND
RNA ANALYSIS

81479 UNLISTED MOLECULAR PATHOLOGY PROCEDURE

0326U TARGETED GENOMIC SEQUENCE ANALYSIS PANEL, SOLID ORGAN NEOPLASM,

CELL-FREE CIRCULATING DNA ANALYSIS OF 83 OR MORE GENES, INTERROGATION FOR
SEQUENCE VARIANTS, GENE COPY NUMBER AMPLIFICATIONS, GENE REARRANGEMENTS,
MICROSATELLITE INSTABILITY AND TUMOR MUTATIONAL BURDEN

Group 2 (1 Code)

Group 2 Paragraph

These codes are non-covered

Group 2 Codes

Code Description

0179U ONCOLOGY (NON-SMALL CELL LUNG CANCER), CELL-FREE DNA, TARGETED

SEQUENCE ANALYSIS OF 23 GENES (SINGLE NUCLEOTIDE VARIATIONS, INSERTIONS AND
DELETIONS, FUSIONS WITHOUT PRIOR KNOWLEDGE OF PARTNER/BREAKPOINT, COPY
NUMBER VARIATIONS), WITH REPORT OF SIGNIFICANT MUTATION(S)

CPT/HCPCS Modifiers

Expand All | Collapse All

Group 1

Group 1 Paragraph

N/A

18
Group 1 Codes

N/A

ICD-10-CM Codes that Support Medical Necessity

Expand All | Collapse All

Group 1 (620 Codes)

Group 1 Paragraph

N/A

Group 1 Codes

Code Description

C00.0 Malignant neoplasm of external upper lip

C00.1 Malignant neoplasm of external lower lip

C00.2 Malignant neoplasm of external lip, unspecified

C00.3 Malignant neoplasm of upper lip, inner aspect

C00.4 Malignant neoplasm of lower lip, inner aspect

C00.5 Malignant neoplasm of lip, unspecified, inner aspect

C00.6 Malignant neoplasm of commissure of lip, unspecified

C00.8 Malignant neoplasm of overlapping sites of lip

C00.9 Malignant neoplasm of lip, unspecified

C01 Malignant neoplasm of base of tongue

C02.0 Malignant neoplasm of dorsal surface of tongue

C02.1 Malignant neoplasm of border of tongue

C02.2 Malignant neoplasm of ventral surface of tongue

C02.3 Malignant neoplasm of anterior two-thirds of tongue, part unspecified

19
C02.4 Malignant neoplasm of lingual tonsil

C02.8 Malignant neoplasm of overlapping sites of tongue

C02.9 Malignant neoplasm of tongue, unspecified

C03.0 Malignant neoplasm of upper gum

C03.1 Malignant neoplasm of lower gum

C03.9 Malignant neoplasm of gum, unspecified

C04.0 Malignant neoplasm of anterior floor of mouth

C04.1 Malignant neoplasm of lateral floor of mouth

C04.8 Malignant neoplasm of overlapping sites of floor of mouth

C04.9 Malignant neoplasm of floor of mouth, unspecified

C05.0 Malignant neoplasm of hard palate

C05.1 Malignant neoplasm of soft palate

C05.2 Malignant neoplasm of uvula

C05.8 Malignant neoplasm of overlapping sites of palate

C05.9 Malignant neoplasm of palate, unspecified

C06.0 Malignant neoplasm of cheek mucosa

C06.1 Malignant neoplasm of vestibule of mouth

C06.2 Malignant neoplasm of retromolar area

C06.80 Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89 Malignant neoplasm of overlapping sites of other parts of mouth

C06.9 Malignant neoplasm of mouth, unspecified

C07 Malignant neoplasm of parotid gland

C08.0 Malignant neoplasm of submandibular gland

C08.1 Malignant neoplasm of sublingual gland

C08.9 Malignant neoplasm of major salivary gland, unspecified

C09.0 Malignant neoplasm of tonsillar fossa

20
C09.1 Malignant neoplasm of tonsillar pillar (anterior) (posterior)

C09.8 Malignant neoplasm of overlapping sites of tonsil

C09.9 Malignant neoplasm of tonsil, unspecified

C10.0 Malignant neoplasm of vallecula

C10.1 Malignant neoplasm of anterior surface of epiglottis

C10.2 Malignant neoplasm of lateral wall of oropharynx

C10.3 Malignant neoplasm of posterior wall of oropharynx

C10.4 Malignant neoplasm of branchial cleft

C10.8 Malignant neoplasm of overlapping sites of oropharynx

C10.9 Malignant neoplasm of oropharynx, unspecified

C11.0 Malignant neoplasm of superior wall of nasopharynx

C11.1 Malignant neoplasm of posterior wall of nasopharynx

C11.2 Malignant neoplasm of lateral wall of nasopharynx

C11.3 Malignant neoplasm of anterior wall of nasopharynx

C11.8 Malignant neoplasm of overlapping sites of nasopharynx

C11.9 Malignant neoplasm of nasopharynx, unspecified

C12 Malignant neoplasm of pyriform sinus

C13.0 Malignant neoplasm of postcricoid region

C13.1 Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect

C13.2 Malignant neoplasm of posterior wall of hypopharynx

C13.8 Malignant neoplasm of overlapping sites of hypopharynx

C13.9 Malignant neoplasm of hypopharynx, unspecified

C14.0 Malignant neoplasm of pharynx, unspecified

C14.2 Malignant neoplasm of Waldeyer's ring

C14.8 Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx

C15.3 Malignant neoplasm of upper third of esophagus

21
C15.4 Malignant neoplasm of middle third of esophagus

C15.5 Malignant neoplasm of lower third of esophagus

C15.8 Malignant neoplasm of overlapping sites of esophagus

C15.9 Malignant neoplasm of esophagus, unspecified

C16.0 Malignant neoplasm of cardia

C16.1 Malignant neoplasm of fundus of stomach

C16.2 Malignant neoplasm of body of stomach

C16.3 Malignant neoplasm of pyloric antrum

C16.4 Malignant neoplasm of pylorus

C16.5 Malignant neoplasm of lesser curvature of stomach, unspecified

C16.6 Malignant neoplasm of greater curvature of stomach, unspecified

C16.8 Malignant neoplasm of overlapping sites of stomach

C16.9 Malignant neoplasm of stomach, unspecified

C17.0 Malignant neoplasm of duodenum

C17.1 Malignant neoplasm of jejunum

C17.2 Malignant neoplasm of ileum

C17.3 Meckel's diverticulum, malignant

C17.8 Malignant neoplasm of overlapping sites of small intestine

C17.9 Malignant neoplasm of small intestine, unspecified

C18.0 Malignant neoplasm of cecum

C18.1 Malignant neoplasm of appendix

C18.2 Malignant neoplasm of ascending colon

C18.3 Malignant neoplasm of hepatic flexure

C18.4 Malignant neoplasm of transverse colon

C18.5 Malignant neoplasm of splenic flexure

C18.6 Malignant neoplasm of descending colon

22
C18.7 Malignant neoplasm of sigmoid colon

C18.8 Malignant neoplasm of overlapping sites of colon

C18.9 Malignant neoplasm of colon, unspecified

C19 Malignant neoplasm of rectosigmoid junction

C20 Malignant neoplasm of rectum

C21.0 Malignant neoplasm of anus, unspecified

C21.1 Malignant neoplasm of anal canal

C21.2 Malignant neoplasm of cloacogenic zone

C21.8 Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C22.0 Liver cell carcinoma

C22.1 Intrahepatic bile duct carcinoma

C22.2 Hepatoblastoma

C22.3 Angiosarcoma of liver

C22.4 Other sarcomas of liver

C22.7 Other specified carcinomas of liver

C22.8 Malignant neoplasm of liver, primary, unspecified as to type

C22.9 Malignant neoplasm of liver, not specified as primary or secondary

C23 Malignant neoplasm of gallbladder

C24.0 Malignant neoplasm of extrahepatic bile duct

C24.1 Malignant neoplasm of ampulla of Vater

C24.8 Malignant neoplasm of overlapping sites of biliary tract

C24.9 Malignant neoplasm of biliary tract, unspecified

C25.0 Malignant neoplasm of head of pancreas

C25.1 Malignant neoplasm of body of pancreas

C25.2 Malignant neoplasm of tail of pancreas

C25.3 Malignant neoplasm of pancreatic duct

23
C25.4 Malignant neoplasm of endocrine pancreas

C25.7 Malignant neoplasm of other parts of pancreas

C25.8 Malignant neoplasm of overlapping sites of pancreas

C25.9 Malignant neoplasm of pancreas, unspecified

C26.0 Malignant neoplasm of intestinal tract, part unspecified

C26.1 Malignant neoplasm of spleen

C26.9 Malignant neoplasm of ill-defined sites within the digestive system

C30.0 Malignant neoplasm of nasal cavity

C30.1 Malignant neoplasm of middle ear

C31.0 Malignant neoplasm of maxillary sinus

C31.1 Malignant neoplasm of ethmoidal sinus

C31.2 Malignant neoplasm of frontal sinus

C31.3 Malignant neoplasm of sphenoid sinus

C31.8 Malignant neoplasm of overlapping sites of accessory sinuses

C31.9 Malignant neoplasm of accessory sinus, unspecified

C32.0 Malignant neoplasm of glottis

C32.1 Malignant neoplasm of supraglottis

C32.2 Malignant neoplasm of subglottis

C32.3 Malignant neoplasm of laryngeal cartilage

C32.8 Malignant neoplasm of overlapping sites of larynx

C32.9 Malignant neoplasm of larynx, unspecified

C33 Malignant neoplasm of trachea

C34.00 Malignant neoplasm of unspecified main bronchus

C34.01 Malignant neoplasm of right main bronchus

C34.02 Malignant neoplasm of left main bronchus

C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung

24
C34.11 Malignant neoplasm of upper lobe, right bronchus or lung

C34.12 Malignant neoplasm of upper lobe, left bronchus or lung

C34.2 Malignant neoplasm of middle lobe, bronchus or lung

C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31 Malignant neoplasm of lower lobe, right bronchus or lung

C34.32 Malignant neoplasm of lower lobe, left bronchus or lung

C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81 Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82 Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91 Malignant neoplasm of unspecified part of right bronchus or lung

C34.92 Malignant neoplasm of unspecified part of left bronchus or lung

C37 Malignant neoplasm of thymus

C38.0 Malignant neoplasm of heart

C38.1 Malignant neoplasm of anterior mediastinum

C38.2 Malignant neoplasm of posterior mediastinum

C38.3 Malignant neoplasm of mediastinum, part unspecified

C38.4 Malignant neoplasm of pleura

C38.8 Malignant neoplasm of overlapping sites of heart, mediastinum and pleura

C39.0 Malignant neoplasm of upper respiratory tract, part unspecified

C39.9 Malignant neoplasm of lower respiratory tract, part unspecified

C40.00 Malignant neoplasm of scapula and long bones of unspecified upper limb

C40.01 Malignant neoplasm of scapula and long bones of right upper limb

C40.02 Malignant neoplasm of scapula and long bones of left upper limb

C40.10 Malignant neoplasm of short bones of unspecified upper limb

C40.11 Malignant neoplasm of short bones of right upper limb

25
C40.12 Malignant neoplasm of short bones of left upper limb

C40.20 Malignant neoplasm of long bones of unspecified lower limb

C40.21 Malignant neoplasm of long bones of right lower limb

C40.22 Malignant neoplasm of long bones of left lower limb

C40.30 Malignant neoplasm of short bones of unspecified lower limb

C40.31 Malignant neoplasm of short bones of right lower limb

C40.32 Malignant neoplasm of short bones of left lower limb

C40.80 Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb

C40.81 Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb

C40.82 Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb

C40.90 Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb

C40.91 Malignant neoplasm of unspecified bones and articular cartilage of right limb

C40.92 Malignant neoplasm of unspecified bones and articular cartilage of left limb

C41.0 Malignant neoplasm of bones of skull and face

C41.1 Malignant neoplasm of mandible

C41.2 Malignant neoplasm of vertebral column

C41.3 Malignant neoplasm of ribs, sternum and clavicle

C41.4 Malignant neoplasm of pelvic bones, sacrum and coccyx

C41.9 Malignant neoplasm of bone and articular cartilage, unspecified

C43.0 Malignant melanoma of lip

C43.10 Malignant melanoma of unspecified eyelid, including canthus

C43.111 Malignant melanoma of right upper eyelid, including canthus

C43.112 Malignant melanoma of right lower eyelid, including canthus

C43.121 Malignant melanoma of left upper eyelid, including canthus

C43.122 Malignant melanoma of left lower eyelid, including canthus

C43.20 Malignant melanoma of unspecified ear and external auricular canal

26
C43.21 Malignant melanoma of right ear and external auricular canal

C43.22 Malignant melanoma of left ear and external auricular canal

C43.30 Malignant melanoma of unspecified part of face

C43.31 Malignant melanoma of nose

C43.39 Malignant melanoma of other parts of face

C43.4 Malignant melanoma of scalp and neck

C43.51 Malignant melanoma of anal skin

C43.52 Malignant melanoma of skin of breast

C43.59 Malignant melanoma of other part of trunk

C43.60 Malignant melanoma of unspecified upper limb, including shoulder

C43.61 Malignant melanoma of right upper limb, including shoulder

C43.62 Malignant melanoma of left upper limb, including shoulder

C43.70 Malignant melanoma of unspecified lower limb, including hip

C43.71 Malignant melanoma of right lower limb, including hip

C43.72 Malignant melanoma of left lower limb, including hip

C43.8 Malignant melanoma of overlapping sites of skin

C43.9 Malignant melanoma of skin, unspecified

C4A.0 Merkel cell carcinoma of lip

C4A.10 Merkel cell carcinoma of unspecified eyelid, including canthus

C4A.111 Merkel cell carcinoma of right upper eyelid, including canthus

C4A.112 Merkel cell carcinoma of right lower eyelid, including canthus

C4A.121 Merkel cell carcinoma of left upper eyelid, including canthus

C4A.122 Merkel cell carcinoma of left lower eyelid, including canthus

C4A.20 Merkel cell carcinoma of unspecified ear and external auricular canal

C4A.21 Merkel cell carcinoma of right ear and external auricular canal

C4A.22 Merkel cell carcinoma of left ear and external auricular canal

27
C4A.30 Merkel cell carcinoma of unspecified part of face

C4A.31 Merkel cell carcinoma of nose

C4A.39 Merkel cell carcinoma of other parts of face

C4A.4 Merkel cell carcinoma of scalp and neck

C4A.51 Merkel cell carcinoma of anal skin

C4A.52 Merkel cell carcinoma of skin of breast

C4A.59 Merkel cell carcinoma of other part of trunk

C4A.60 Merkel cell carcinoma of unspecified upper limb, including shoulder

C4A.61 Merkel cell carcinoma of right upper limb, including shoulder

C4A.62 Merkel cell carcinoma of left upper limb, including shoulder

C4A.70 Merkel cell carcinoma of unspecified lower limb, including hip

C4A.71 Merkel cell carcinoma of right lower limb, including hip

C4A.72 Merkel cell carcinoma of left lower limb, including hip

C4A.8 Merkel cell carcinoma of overlapping sites

C4A.9 Merkel cell carcinoma, unspecified

C44.00 Unspecified malignant neoplasm of skin of lip

C44.01 Basal cell carcinoma of skin of lip

C44.02 Squamous cell carcinoma of skin of lip

C44.09 Other specified malignant neoplasm of skin of lip

C44.101 Unspecified malignant neoplasm of skin of unspecified eyelid, including canthus

C44.1021 Unspecified malignant neoplasm of skin of right upper eyelid, including canthus

C44.1022 Unspecified malignant neoplasm of skin of right lower eyelid, including canthus

C44.1091 Unspecified malignant neoplasm of skin of left upper eyelid, including canthus

C44.1092 Unspecified malignant neoplasm of skin of left lower eyelid, including canthus

C44.111 Basal cell carcinoma of skin of unspecified eyelid, including canthus

C44.1121 Basal cell carcinoma of skin of right upper eyelid, including canthus

28
C44.1122 Basal cell carcinoma of skin of right lower eyelid, including canthus

C44.1191 Basal cell carcinoma of skin of left upper eyelid, including canthus

C44.1192 Basal cell carcinoma of skin of left lower eyelid, including canthus

C44.121 Squamous cell carcinoma of skin of unspecified eyelid, including canthus

C44.1221 Squamous cell carcinoma of skin of right upper eyelid, including canthus

C44.1222 Squamous cell carcinoma of skin of right lower eyelid, including canthus

C44.1291 Squamous cell carcinoma of skin of left upper eyelid, including canthus

C44.1292 Squamous cell carcinoma of skin of left lower eyelid, including canthus

C44.191 Other specified malignant neoplasm of skin of unspecified eyelid, including canthus

C44.1921 Other specified malignant neoplasm of skin of right upper eyelid, including canthus

C44.1922 Other specified malignant neoplasm of skin of right lower eyelid, including canthus

C44.1991 Other specified malignant neoplasm of skin of left upper eyelid, including canthus

C44.1992 Other specified malignant neoplasm of skin of left lower eyelid, including canthus

C44.201 Unspecified malignant neoplasm of skin of unspecified ear and external auricular canal

C44.202 Unspecified malignant neoplasm of skin of right ear and external auricular canal

C44.209 Unspecified malignant neoplasm of skin of left ear and external auricular canal

C44.211 Basal cell carcinoma of skin of unspecified ear and external auricular canal

C44.212 Basal cell carcinoma of skin of right ear and external auricular canal

C44.219 Basal cell carcinoma of skin of left ear and external auricular canal

C44.221 Squamous cell carcinoma of skin of unspecified ear and external auricular canal

C44.222 Squamous cell carcinoma of skin of right ear and external auricular canal

C44.229 Squamous cell carcinoma of skin of left ear and external auricular canal

C44.291 Other specified malignant neoplasm of skin of unspecified ear and external auricular canal

C44.292 Other specified malignant neoplasm of skin of right ear and external auricular canal

C44.299 Other specified malignant neoplasm of skin of left ear and external auricular canal

C44.300 Unspecified malignant neoplasm of skin of unspecified part of face

29
C44.301 Unspecified malignant neoplasm of skin of nose

C44.309 Unspecified malignant neoplasm of skin of other parts of face

C44.310 Basal cell carcinoma of skin of unspecified parts of face

C44.311 Basal cell carcinoma of skin of nose

C44.319 Basal cell carcinoma of skin of other parts of face

C44.320 Squamous cell carcinoma of skin of unspecified parts of face

C44.321 Squamous cell carcinoma of skin of nose

C44.329 Squamous cell carcinoma of skin of other parts of face

C44.390 Other specified malignant neoplasm of skin of unspecified parts of face

C44.391 Other specified malignant neoplasm of skin of nose

C44.399 Other specified malignant neoplasm of skin of other parts of face

C44.40 Unspecified malignant neoplasm of skin of scalp and neck

C44.41 Basal cell carcinoma of skin of scalp and neck

C44.42 Squamous cell carcinoma of skin of scalp and neck

C44.49 Other specified malignant neoplasm of skin of scalp and neck

C44.500 Unspecified malignant neoplasm of anal skin

C44.501 Unspecified malignant neoplasm of skin of breast

C44.509 Unspecified malignant neoplasm of skin of other part of trunk

C44.510 Basal cell carcinoma of anal skin

C44.511 Basal cell carcinoma of skin of breast

C44.519 Basal cell carcinoma of skin of other part of trunk

C44.520 Squamous cell carcinoma of anal skin

C44.521 Squamous cell carcinoma of skin of breast

C44.529 Squamous cell carcinoma of skin of other part of trunk

C44.590 Other specified malignant neoplasm of anal skin

C44.591 Other specified malignant neoplasm of skin of breast

30
C44.599 Other specified malignant neoplasm of skin of other part of trunk

C44.601 Unspecified malignant neoplasm of skin of unspecified upper limb, including shoulder

C44.602 Unspecified malignant neoplasm of skin of right upper limb, including shoulder

C44.609 Unspecified malignant neoplasm of skin of left upper limb, including shoulder

C44.611 Basal cell carcinoma of skin of unspecified upper limb, including shoulder

C44.612 Basal cell carcinoma of skin of right upper limb, including shoulder

C44.619 Basal cell carcinoma of skin of left upper limb, including shoulder

C44.621 Squamous cell carcinoma of skin of unspecified upper limb, including shoulder

C44.622 Squamous cell carcinoma of skin of right upper limb, including shoulder

C44.629 Squamous cell carcinoma of skin of left upper limb, including shoulder

C44.691 Other specified malignant neoplasm of skin of unspecified upper limb, including shoulder

C44.692 Other specified malignant neoplasm of skin of right upper limb, including shoulder

C44.699 Other specified malignant neoplasm of skin of left upper limb, including shoulder

C44.701 Unspecified malignant neoplasm of skin of unspecified lower limb, including hip

C44.702 Unspecified malignant neoplasm of skin of right lower limb, including hip

C44.709 Unspecified malignant neoplasm of skin of left lower limb, including hip

C44.711 Basal cell carcinoma of skin of unspecified lower limb, including hip

C44.712 Basal cell carcinoma of skin of right lower limb, including hip

C44.719 Basal cell carcinoma of skin of left lower limb, including hip

C44.721 Squamous cell carcinoma of skin of unspecified lower limb, including hip

C44.722 Squamous cell carcinoma of skin of right lower limb, including hip

C44.729 Squamous cell carcinoma of skin of left lower limb, including hip

C44.791 Other specified malignant neoplasm of skin of unspecified lower limb, including hip

C44.792 Other specified malignant neoplasm of skin of right lower limb, including hip

C44.799 Other specified malignant neoplasm of skin of left lower limb, including hip

C44.80 Unspecified malignant neoplasm of overlapping sites of skin

31
C44.81 Basal cell carcinoma of overlapping sites of skin

C44.82 Squamous cell carcinoma of overlapping sites of skin

C44.89 Other specified malignant neoplasm of overlapping sites of skin

C44.90 Unspecified malignant neoplasm of skin, unspecified

C44.91 Basal cell carcinoma of skin, unspecified

C44.92 Squamous cell carcinoma of skin, unspecified

C44.99 Other specified malignant neoplasm of skin, unspecified

C45.0 Mesothelioma of pleura

C45.1 Mesothelioma of peritoneum

C45.2 Mesothelioma of pericardium

C45.7 Mesothelioma of other sites

C45.9 Mesothelioma, unspecified

C47.0 Malignant neoplasm of peripheral nerves of head, face and neck

C47.10 Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder

C47.11 Malignant neoplasm of peripheral nerves of right upper limb, including shoulder

C47.12 Malignant neoplasm of peripheral nerves of left upper limb, including shoulder

C47.20 Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip

C47.21 Malignant neoplasm of peripheral nerves of right lower limb, including hip

C47.22 Malignant neoplasm of peripheral nerves of left lower limb, including hip

C47.3 Malignant neoplasm of peripheral nerves of thorax

C47.4 Malignant neoplasm of peripheral nerves of abdomen

C47.5 Malignant neoplasm of peripheral nerves of pelvis

C47.6 Malignant neoplasm of peripheral nerves of trunk, unspecified

C47.8 Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system

C47.9 Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified

C48.0 Malignant neoplasm of retroperitoneum

32
C48.1 Malignant neoplasm of specified parts of peritoneum

C48.2 Malignant neoplasm of peritoneum, unspecified

C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C49.0 Malignant neoplasm of connective and soft tissue of head, face and neck

C49.10 Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder

C49.11 Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder

C49.12 Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder

C49.20 Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip

C49.21 Malignant neoplasm of connective and soft tissue of right lower limb, including hip

C49.22 Malignant neoplasm of connective and soft tissue of left lower limb, including hip

C49.3 Malignant neoplasm of connective and soft tissue of thorax

C49.4 Malignant neoplasm of connective and soft tissue of abdomen

C49.5 Malignant neoplasm of connective and soft tissue of pelvis

C49.6 Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8 Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9 Malignant neoplasm of connective and soft tissue, unspecified

C49.A0 Gastrointestinal stromal tumor, unspecified site

C49.A1 Gastrointestinal stromal tumor of esophagus

C49.A2 Gastrointestinal stromal tumor of stomach

C49.A3 Gastrointestinal stromal tumor of small intestine

C49.A4 Gastrointestinal stromal tumor of large intestine

C49.A5 Gastrointestinal stromal tumor of rectum

C49.A9 Gastrointestinal stromal tumor of other sites

C50.011 Malignant neoplasm of nipple and areola, right female breast

C50.012 Malignant neoplasm of nipple and areola, left female breast

C50.019 Malignant neoplasm of nipple and areola, unspecified female breast

33
C50.021 Malignant neoplasm of nipple and areola, right male breast

C50.022 Malignant neoplasm of nipple and areola, left male breast

C50.029 Malignant neoplasm of nipple and areola, unspecified male breast

C50.111 Malignant neoplasm of central portion of right female breast

C50.112 Malignant neoplasm of central portion of left female breast

C50.119 Malignant neoplasm of central portion of unspecified female breast

C50.121 Malignant neoplasm of central portion of right male breast

C50.122 Malignant neoplasm of central portion of left male breast

C50.129 Malignant neoplasm of central portion of unspecified male breast

C50.211 Malignant neoplasm of upper-inner quadrant of right female breast

C50.212 Malignant neoplasm of upper-inner quadrant of left female breast

C50.219 Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221 Malignant neoplasm of upper-inner quadrant of right male breast

C50.222 Malignant neoplasm of upper-inner quadrant of left male breast

C50.229 Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311 Malignant neoplasm of lower-inner quadrant of right female breast

C50.312 Malignant neoplasm of lower-inner quadrant of left female breast

C50.319 Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321 Malignant neoplasm of lower-inner quadrant of right male breast

C50.322 Malignant neoplasm of lower-inner quadrant of left male breast

C50.329 Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411 Malignant neoplasm of upper-outer quadrant of right female breast

C50.412 Malignant neoplasm of upper-outer quadrant of left female breast

C50.419 Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421 Malignant neoplasm of upper-outer quadrant of right male breast

C50.422 Malignant neoplasm of upper-outer quadrant of left male breast

34
C50.429 Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511 Malignant neoplasm of lower-outer quadrant of right female breast

C50.512 Malignant neoplasm of lower-outer quadrant of left female breast

C50.519 Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521 Malignant neoplasm of lower-outer quadrant of right male breast

C50.522 Malignant neoplasm of lower-outer quadrant of left male breast

C50.529 Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611 Malignant neoplasm of axillary tail of right female breast

C50.612 Malignant neoplasm of axillary tail of left female breast

C50.619 Malignant neoplasm of axillary tail of unspecified female breast

C50.621 Malignant neoplasm of axillary tail of right male breast

C50.622 Malignant neoplasm of axillary tail of left male breast

C50.629 Malignant neoplasm of axillary tail of unspecified male breast

C50.811 Malignant neoplasm of overlapping sites of right female breast

C50.812 Malignant neoplasm of overlapping sites of left female breast

C50.819 Malignant neoplasm of overlapping sites of unspecified female breast

C50.821 Malignant neoplasm of overlapping sites of right male breast

C50.822 Malignant neoplasm of overlapping sites of left male breast

C50.829 Malignant neoplasm of overlapping sites of unspecified male breast

C50.911 Malignant neoplasm of unspecified site of right female breast

C50.912 Malignant neoplasm of unspecified site of left female breast

C50.919 Malignant neoplasm of unspecified site of unspecified female breast

C50.921 Malignant neoplasm of unspecified site of right male breast

C50.922 Malignant neoplasm of unspecified site of left male breast

C50.929 Malignant neoplasm of unspecified site of unspecified male breast

C51.0 Malignant neoplasm of labium majus

35
C51.1 Malignant neoplasm of labium minus

C51.2 Malignant neoplasm of clitoris

C51.8 Malignant neoplasm of overlapping sites of vulva

C51.9 Malignant neoplasm of vulva, unspecified

C52 Malignant neoplasm of vagina

C53.0 Malignant neoplasm of endocervix

C53.1 Malignant neoplasm of exocervix

C53.8 Malignant neoplasm of overlapping sites of cervix uteri

C53.9 Malignant neoplasm of cervix uteri, unspecified

C54.0 Malignant neoplasm of isthmus uteri

C54.1 Malignant neoplasm of endometrium

C54.2 Malignant neoplasm of myometrium

C54.3 Malignant neoplasm of fundus uteri

C54.8 Malignant neoplasm of overlapping sites of corpus uteri

C54.9 Malignant neoplasm of corpus uteri, unspecified

C55 Malignant neoplasm of uterus, part unspecified

C56.1 Malignant neoplasm of right ovary

C56.2 Malignant neoplasm of left ovary

C56.3 Malignant neoplasm of bilateral ovaries

C56.9 Malignant neoplasm of unspecified ovary

C57.00 Malignant neoplasm of unspecified fallopian tube

C57.01 Malignant neoplasm of right fallopian tube

C57.02 Malignant neoplasm of left fallopian tube

C57.10 Malignant neoplasm of unspecified broad ligament

C57.11 Malignant neoplasm of right broad ligament

C57.12 Malignant neoplasm of left broad ligament

36
C57.20 Malignant neoplasm of unspecified round ligament

C57.21 Malignant neoplasm of right round ligament

C57.22 Malignant neoplasm of left round ligament

C57.3 Malignant neoplasm of parametrium

C57.4 Malignant neoplasm of uterine adnexa, unspecified

C57.7 Malignant neoplasm of other specified female genital organs

C57.8 Malignant neoplasm of overlapping sites of female genital organs

C57.9 Malignant neoplasm of female genital organ, unspecified

C58 Malignant neoplasm of placenta

C60.0 Malignant neoplasm of prepuce

C60.1 Malignant neoplasm of glans penis

C60.2 Malignant neoplasm of body of penis

C60.8 Malignant neoplasm of overlapping sites of penis

C60.9 Malignant neoplasm of penis, unspecified

C61 Malignant neoplasm of prostate

C62.00 Malignant neoplasm of unspecified undescended testis

C62.01 Malignant neoplasm of undescended right testis

C62.02 Malignant neoplasm of undescended left testis

C62.10 Malignant neoplasm of unspecified descended testis

C62.11 Malignant neoplasm of descended right testis

C62.12 Malignant neoplasm of descended left testis

C62.90 Malignant neoplasm of unspecified testis, unspecified whether descended or undescended

C62.91 Malignant neoplasm of right testis, unspecified whether descended or undescended

C62.92 Malignant neoplasm of left testis, unspecified whether descended or undescended

C63.00 Malignant neoplasm of unspecified epididymis

C63.01 Malignant neoplasm of right epididymis

37
C63.02 Malignant neoplasm of left epididymis

C63.10 Malignant neoplasm of unspecified spermatic cord

C63.11 Malignant neoplasm of right spermatic cord

C63.12 Malignant neoplasm of left spermatic cord

C63.2 Malignant neoplasm of scrotum

C63.7 Malignant neoplasm of other specified male genital organs

C63.8 Malignant neoplasm of overlapping sites of male genital organs

C63.9 Malignant neoplasm of male genital organ, unspecified

C64.1 Malignant neoplasm of right kidney, except renal pelvis

C64.2 Malignant neoplasm of left kidney, except renal pelvis

C64.9 Malignant neoplasm of unspecified kidney, except renal pelvis

C65.1 Malignant neoplasm of right renal pelvis

C65.2 Malignant neoplasm of left renal pelvis

C65.9 Malignant neoplasm of unspecified renal pelvis

C66.1 Malignant neoplasm of right ureter

C66.2 Malignant neoplasm of left ureter

C66.9 Malignant neoplasm of unspecified ureter

C67.0 Malignant neoplasm of trigone of bladder

C67.1 Malignant neoplasm of dome of bladder

C67.2 Malignant neoplasm of lateral wall of bladder

C67.3 Malignant neoplasm of anterior wall of bladder

C67.4 Malignant neoplasm of posterior wall of bladder

C67.5 Malignant neoplasm of bladder neck

C67.6 Malignant neoplasm of ureteric orifice

C67.7 Malignant neoplasm of urachus

C67.8 Malignant neoplasm of overlapping sites of bladder

38
C67.9 Malignant neoplasm of bladder, unspecified

C68.0 Malignant neoplasm of urethra

C68.1 Malignant neoplasm of paraurethral glands

C68.8 Malignant neoplasm of overlapping sites of urinary organs

C68.9 Malignant neoplasm of urinary organ, unspecified

C69.00 Malignant neoplasm of unspecified conjunctiva

C69.01 Malignant neoplasm of right conjunctiva

C69.02 Malignant neoplasm of left conjunctiva

C69.10 Malignant neoplasm of unspecified cornea

C69.11 Malignant neoplasm of right cornea

C69.12 Malignant neoplasm of left cornea

C69.20 Malignant neoplasm of unspecified retina

C69.21 Malignant neoplasm of right retina

C69.22 Malignant neoplasm of left retina

C69.30 Malignant neoplasm of unspecified choroid

C69.31 Malignant neoplasm of right choroid

C69.32 Malignant neoplasm of left choroid

C69.40 Malignant neoplasm of unspecified ciliary body

C69.41 Malignant neoplasm of right ciliary body

C69.42 Malignant neoplasm of left ciliary body

C69.50 Malignant neoplasm of unspecified lacrimal gland and duct

C69.51 Malignant neoplasm of right lacrimal gland and duct

C69.52 Malignant neoplasm of left lacrimal gland and duct

C69.60 Malignant neoplasm of unspecified orbit

C69.61 Malignant neoplasm of right orbit

C69.62 Malignant neoplasm of left orbit

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C69.80 Malignant neoplasm of overlapping sites of unspecified eye and adnexa

C69.81 Malignant neoplasm of overlapping sites of right eye and adnexa

C69.82 Malignant neoplasm of overlapping sites of left eye and adnexa

C69.90 Malignant neoplasm of unspecified site of unspecified eye

C69.91 Malignant neoplasm of unspecified site of right eye

C69.92 Malignant neoplasm of unspecified site of left eye

C70.1 Malignant neoplasm of spinal meninges

C70.9 Malignant neoplasm of meninges, unspecified

C71.0 Malignant neoplasm of cerebrum, except lobes and ventricles

C71.1 Malignant neoplasm of frontal lobe

C71.2 Malignant neoplasm of temporal lobe

C71.3 Malignant neoplasm of parietal lobe

C71.4 Malignant neoplasm of occipital lobe

C71.5 Malignant neoplasm of cerebral ventricle

C71.6 Malignant neoplasm of cerebellum

C71.7 Malignant neoplasm of brain stem

C71.8 Malignant neoplasm of overlapping sites of brain

C71.9 Malignant neoplasm of brain, unspecified

C72.0 Malignant neoplasm of spinal cord

C72.1 Malignant neoplasm of cauda equina

C72.20 Malignant neoplasm of unspecified olfactory nerve

C72.21 Malignant neoplasm of right olfactory nerve

C72.22 Malignant neoplasm of left olfactory nerve

C72.30 Malignant neoplasm of unspecified optic nerve

C72.31 Malignant neoplasm of right optic nerve

C72.32 Malignant neoplasm of left optic nerve

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C72.40 Malignant neoplasm of unspecified acoustic nerve

C72.41 Malignant neoplasm of right acoustic nerve

C72.42 Malignant neoplasm of left acoustic nerve

C72.50 Malignant neoplasm of unspecified cranial nerve

C72.59 Malignant neoplasm of other cranial nerves

C72.9 Malignant neoplasm of central nervous system, unspecified

C73 Malignant neoplasm of thyroid gland

C74.00 Malignant neoplasm of cortex of unspecified adrenal gland

C74.01 Malignant neoplasm of cortex of right adrenal gland

C74.02 Malignant neoplasm of cortex of left adrenal gland

C74.10 Malignant neoplasm of medulla of unspecified adrenal gland

C74.11 Malignant neoplasm of medulla of right adrenal gland

C74.12 Malignant neoplasm of medulla of left adrenal gland

C74.90 Malignant neoplasm of unspecified part of unspecified adrenal gland

C74.91 Malignant neoplasm of unspecified part of right adrenal gland

C74.92 Malignant neoplasm of unspecified part of left adrenal gland

C75.0 Malignant neoplasm of parathyroid gland

C75.1 Malignant neoplasm of pituitary gland

C75.2 Malignant neoplasm of craniopharyngeal duct

C75.3 Malignant neoplasm of pineal gland

C75.4 Malignant neoplasm of carotid body

C75.5 Malignant neoplasm of aortic body and other paraganglia

C75.8 Malignant neoplasm with pluriglandular involvement, unspecified

C75.9 Malignant neoplasm of endocrine gland, unspecified

C7A.00 Malignant carcinoid tumor of unspecified site

C7A.010 Malignant carcinoid tumor of the duodenum

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C7A.011 Malignant carcinoid tumor of the jejunum

C7A.012 Malignant carcinoid tumor of the ileum

C7A.019 Malignant carcinoid tumor of the small intestine, unspecified portion

C7A.020 Malignant carcinoid tumor of the appendix

C7A.021 Malignant carcinoid tumor of the cecum

C7A.022 Malignant carcinoid tumor of the ascending colon

C7A.023 Malignant carcinoid tumor of the transverse colon

C7A.024 Malignant carcinoid tumor of the descending colon

C7A.025 Malignant carcinoid tumor of the sigmoid colon

C7A.026 Malignant carcinoid tumor of the rectum

C7A.029 Malignant carcinoid tumor of the large intestine, unspecified portion

C7A.090 Malignant carcinoid tumor of the bronchus and lung

C7A.091 Malignant carcinoid tumor of the thymus

C7A.092 Malignant carcinoid tumor of the stomach

C7A.093 Malignant carcinoid tumor of the kidney

C7A.094 Malignant carcinoid tumor of the foregut, unspecified

C7A.095 Malignant carcinoid tumor of the midgut, unspecified

C7A.096 Malignant carcinoid tumor of the hindgut, unspecified

C7A.098 Malignant carcinoid tumors of other sites

C7A.1 Malignant poorly differentiated neuroendocrine tumors

C7A.8 Other malignant neuroendocrine tumors

C76.0 Malignant neoplasm of head, face and neck

C76.1 Malignant neoplasm of thorax

C76.2 Malignant neoplasm of abdomen

C76.3 Malignant neoplasm of pelvis

C76.40 Malignant neoplasm of unspecified upper limb

42
C76.41 Malignant neoplasm of right upper limb

C76.42 Malignant neoplasm of left upper limb

C76.50 Malignant neoplasm of unspecified lower limb

C76.51 Malignant neoplasm of right lower limb

C76.52 Malignant neoplasm of left lower limb

C76.8 Malignant neoplasm of other specified ill-defined sites

C80.0 Disseminated malignant neoplasm, unspecified

C80.1 Malignant (primary) neoplasm, unspecified

ICD-10-CM Codes that DO NOT Support Medical Necessity

Expand All | Collapse All

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

ICD-10-PCS Codes

Expand All | Collapse All

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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Additional ICD-10 Information

N/A

Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this
service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete
absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be
assumed to apply equally to all claims.

N/A

Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to
report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article,
services reported under other Revenue Codes are equally subject to this coverage determination. Complete
absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article
should be assumed to apply equally to all Revenue Codes.

N/A

N/A

Other Coding Information

Expand All | Collapse All

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

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Revision History Information

Revision History Date Revision History Number Revision History Explanation

01/01/2023 R1

Under CPT/HCPCS Codes Group 1: Codes the description was revised for 81445. This revision is due to the
2023 Annual/Q1 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after
1/1/2023.

Associated Documents

Related Local Coverage Documents

LCDs

L39232 - MolDX: Plasma-Based Genomic Profiling in Solid Tumors

Related National Coverage Documents

N/A

Statutory Requirements URLs

N/A

Rules and Regulations URLs

N/A

CMS Manual Explanations URLs

N/A

Other URLs

N/A

Public Versions

Updated On Effective Dates Status

01/11/2023 01/01/2023 - N/A Currently in Effect You are here

45
URL for source document:
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59279&ver=3

Article Title

Response to Comments: MolDX: Plasma-Based Genomic Profiling in Solid Tumors

Article Type

Response to Comments

AMA CPT / ADA CDT / AHA NUBC Copyright Statement

CPT codes, descriptions and other data only are copyright 2022 American Medical Association. All Rights
Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the
AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or
indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or
not contained herein.

Current Dental Terminology © 2022 American Dental Association. All rights reserved.

Copyright © 2022, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No
portion of the American Hospital Association (AHA) copyrighted materials contained within this publication
may be copied without the express written consent of the AHA. AHA copyrighted materials including the
UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service,
solution or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA
materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for
internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative
work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04
Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express
license from the American Hospital Association. The American Hospital Association (the "AHA") has not
reviewed, and is not responsible for, the completeness or accuracy of any information contained in this
material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis
of information provided in the material. The views and/or positions presented in the material do not
necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA
or any of its affiliates.

46
Article Guidance

Article Text

The comment period for the MolDX: Plasma-Based Genomic Profiling in Solid Tumors DL39232 Local
Coverage Determination (LCD) began on 01/20/2022 and ended on 03/05/2022. The comments below were
received from the provider community. The notice period for L39232 begins on 11/10/2022 and will become
effective on 12/26/2022.

Noridian received comments from 6 different commenters.

Introduction to Responses

Noridian appreciates the comments received from stakeholders during the open comment period on the
proposed MolDX: Plasma-Based Genomic Profiling Local Coverage Determination (LCD). We reviewed the
comments in their entirety. Submitted comments that cite published, peer-reviewed literature provide suitable
evidence that may inform policy, while less rigorous comments (e.g., anecdotal, unpublished information not
subject to peer review) are much less influential to policy determinations.

NOTE: Noridian reviews all submitted comments; however, MACs may choose to consolidate similar
thematic comments, redact, or withhold certain submissions (or portions thereof) such as those containing
private or proprietary information, or inappropriate language. This may result in discrepancies between the
number of comments in the article and the actual number of comments received.

Response To Comments

Number Comment Response

Several commenters wrote in support of the LCD DL39230 coverage criteria, with the exception of the
requirement that prior to liquid biopsy, tissue testing/biopsy should be infeasible or incomplete. One wrote,
“As you know, neither blood-based nor tissue-based NGS has 100% sensitivity, but blood-based testing has
advantages for underserved/community practitioners and patients as a faster, less-invasive method to genotype
with comparable sensitivity and concordance in CRC (References submitted).

Tissue-based NGS has inherent limitations in CRC, including failure to capture clonal evolution, intratumor
heterogeneity (References submitted) and low adoption in community oncology practices (References
submitted). By requiring providers to attempt or document infeasibility of tissue-based testing, MolDx policy

47
limits the patient-provider decision making and introduces unnecessary delays and documentation
challenges.” All commenters requested for this criterion to be removed.

Noridian appreciates the commenter’s advocacy on behalf of Medicare beneficiaries. However, no literature
was submitted to support the claim that documentation requirements limit the appropriate use or adoption of
plasma-based genomic testing for solid tumors. We believe that the proposed LCD uses an evidenced-based,
patient-oriented approach, and focuses the documentation requirements to those that support medical
necessity for testing which is statutorily required by Medicare.

On commenter requested, “ coverage should be provided on all FDA-approved testing methods. We believe
that clinicians and their patients should determine the most appropriate choices for the diagnosis, therapy, and
post-therapy management of colorectal cancer, and that these choices are not determined or influenced by
financial considerations based on coverage. This is particularly important in that blood-based testing may
have advantages for underserved patients as it provides a faster, less-invasive method to genotype. As a
patient advocacy organization, we do not opine on specific elements of an LCD but support a positive
coverage determination so that physicians have access to this testing method without restriction.”

Thank you for the comment.

One commenter wrote that, “ considerable evidence demonstrates that first-line use of liquid biopsy is often
appropriate based on the emerging literature, precedent set by Medicare coverage and FDA approval, and
updated clinical guidelines supportive of plasma-based biopsy. When considered holistically, liquid biopsy
overcomes the significant issues of delay, assay incompletion, and heterogeneity that limit the benefits
patients may derive from tissue-based testing. When liquid is deployed as the first-line CGP methodology, it
is able to uncover an equivalent number of biomarkers much more rapidly than tissue CGP. As a result, we
respectfully request the removal of the tissue insufficiency prerequisite.”

Thank you for the comment; however, this is outside the scope of this LCD reconsideration.

48
Two societies jointly wrote, “ we are concerned that as drafted the policy sets difficult criteria and unclear
process for non-Guardant360 plasma-based genomic profiling tests. Historically, tests are regulated and
validated under the Clinical Laboratory Improvement Amendments (CLIA) program. AMP and CAP are
concerned that the proposed coverage criteria may unintentionally exclude tests with a long history of being
utilized successfully in CLIA-certified laboratories. Regulatory requirements stipulated in CLIA already
provide strict validation requirements that must be followed before an assay can be offered to patients.
Additionally, the use of these tests are often supported by well-established clinical guidelines that have been
developed and endorsed by leading scientists, subject matter experts, and National Comprehensive Cancer
Network and professional society guidelines, including those from AMP and CAP. Rather than requiring
other liquid biopsies to mirror the performance standards of Guardant360®, we recommend Noridian provide
coverage for other plasma-based genomic profiling tests when the test is performed in a CLIA-certified
laboratory. If a laboratory test is properly validated, meeting certain criteria and standards set forth by
regulatory programs, like CLIA, the laboratory test should be covered. No references were submitted.

Thank you for the comments; however, we respectfully disagree. Evidenced-based patient-oriented public
policy requires that the clinical validity and utility of diagnostic testing be proven based on data that is
published in peer-reviewed literature with a high degree of certainty in addition to the analytic validity upon
which CLIA certification typically focuses.

Another comment submitted by specialty societies asks for clarification of coverage of other tests whose
analytic performance is not explicitly published in the policy but may perform similarly in their intended use
applications.

This interpretation is correct; other next-generation sequencing assays will be covered for the same indications
if they display similar performance statistics published in this LCD and meet all the conditions stated in the
policy for coverage.

Another comment recommended guidelines be added to this policy to ensure that tests meet the necessary
requirements for coverage. They added, “we recommend that specific instructions, including parameter or
criteria requirements, be outlined clearly for compliance purposes. Laboratories are already complying with
certain standards and all coverage criteria should be clearly articulated. What if any specific documentation
of tissue insufficiency or invasive biopsy contraindication does Noridian envision, that tissue-based sampling
of a tumor is “infeasible”?

Thank you for the comment; however, this is outside the scope of this LCD reconsideration. We will take
these comments under advisement for clarifying guidance in the accompanying billing and coding article.

49
7

AMP and CAP recognize that Guardant360® identifies mutations in over 70 genes. As such, we believe their
assay would be consistent with CPT code 81455. As such, we recommend the inclusion of CPT 81455 to the
policy

Thank you for the comment; however, this is outside the scope of this LCD reconsideration.

Associated Documents

Related Local Coverage Documents

LCDs

L39232 - MolDX: Plasma-Based Genomic Profiling in Solid Tumors

Related National Coverage Documents

N/A

Public Versions

Updated On Effective Dates Status

11/03/2022 12/26/2022 - N/A Currently in Effect You are here

50