UnitedHealthcare® Medicare Advantage Policy Guideline Molecular // Genetic Testing

Guideline Number: MPG210.17 Approval Date: May 12, 2021  Terms and Conditions

Table of Contents Page Related Medicare Advantage Policy Guidelines Policy Summary ...... 1 • Biomarkers in Cardiovascular Risk Assessment Applicable Codes ...... 4 • Blood Product Molecular Antigen Typing References ...... 5 • BRCA1 and BRCA2 Genetic Testing Guideline History/Revision Information ...... 50 • Clinical Diagnostic Laboratory Services Purpose ...... 51 Terms and Conditions ...... 51 • Cytogenetic Studies (NCD 190.3) • Genetic Testing for Lynch Syndrome • Human Tumor Stem Cell Drug Sensitivity Assays (NCD 190.7) • Molecular Diagnostic Infectious Testing • Molecular Pathology/Genetic Testing Reported with Unlisted Codes • Molecular Pathology Procedures for Human Leukocyte Antigen (HLA) Typing

• Pharmacogenomic Testing for Warfarin Response

(NCD 90.1)

• Tier 2 Molecular Pathology Procedures

Related Medicare Advantage Reimbursement Policies • Clinical Laboratory Improvement Amendments (CLIA) ID Requirement Policy, Professional

• Laboratory Services Policy, Professional

Related Medicare Advantage Coverage Summaries • Genetic Testing • Laboratory Tests and Services

Policy Summary

 See Purpose Overview This policy overview addresses molecular and genetic tests that have proven efficacy according to CMS, in the diagnosis or treatment of medical conditions, including but not limited to the following:

Gene Expression Assays for Breast Cancer Treatment Examples include but are not limited to: Breast Cancer Index (BCI)® Genetic Assay EndoPredict®

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MammaPrint® Oncotype DX™ Oncotype DX DCIS Prosigna™ Breast Cancer Prognostic Gene Signature Assay

Molecular Assays for Prostate Cancer Examples include but are not limited to: ConfirmMDx Prostate Cancer Genomic Classifier Assay Oncotype DX™ Prostate Cancer PROGENSA® PCA3 Assay Prolaris™

Gene Identification Examples include but are not limited to the following genes: APC EGFR MUTYH BCR/ABL1 JAK2 NRAS BRAF KRAS SF3B1 CYP2C19 MGMT TP53 CYP2D6 MPL

Circulating Tumor Cell (CTC) Assay CTCs represent the point in the metastatic process of solid tumors when cells from a primary tumor invade, detach, disseminate, colonize and proliferate in a distant site. Detection of elevated CTCs during therapy may be an accurate indication of subsequent rapid disease progression and mortality in breast, colorectal and prostate cancer, noting that FDA labeling includes each of these . As a result of limited acceptable study data, CTCs are considered not medically necessary, for all indications.

Bladder Tumor Markers Examples of Bladder Tumor Markers tests include but are not limited to: BTA TRAK® Nuclear matrix protein 22 (NMP - 22) NMP - 22 BladderChek® The UroVysion® BTA (bladder tumor antigen) stat® Cxbladder™ The ImmunoCyt™.

Transplant Recipients AlloMap® Molecular Expression Testing is a non - invasive gene expression test used to aid in the identification of heart transplant recipients.

Assays for Rheumatoid Arthritis Examples include but are not limited to: Vectra® DA

Melanoma Examples include but are not limited to: • myPath® Melanoma Assay • Melanoma Risk Stratification Molecular Testing • Pigmented Lesion Assay

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Thyroid Examples include but are not limited to: • ThyraMIR® • ThyGeNEXT® • Afirma™ • ThyroSeq® • RosettaGX Reveal™ • thyroid MicroRNA test

Genetic Testing for Myeloproliferative Disease Myeloproliferative disorders are a group of conditions that cause abnormal growth of blood cells in the bone marrow. They include polycythemia vera (PV), essential thrombocytosis (ET), primary myelofibrosis (PMF), and chronic myelogenous leukemia (CML). The World Health Organization (WHO) further classifies PV, ET, and PMF as Philadelphia chromosome negative myeloproliferative neoplasms (MPNs). MPNs are characterized by an increase in the number of blood cells.

Genesight® Genesight is a combinatorial pharmacogenomic (PGx) test. A Combinatorial PGx test is a type of multi-gene panel that requires a proprietary algorithm to evaluate pharmacokinetic or pharmacodynamic relationships resulting in drug recommendations or warnings. The algorithms employed in combinatorial testing are also not currently considered reasonable and necessary components of multi-gene testing.

Genesight may be reported as a multi-gene panel, please see Phamacogenomics Testing references below for information on medical necessity and documentation requirements for multi-gene panels.

Next Generation Sequencing (NGS) Clinical laboratory diagnostic tests can include tests that, for example, predict the risk associated with one or more genetic variations. In addition, in vitro companion diagnostic laboratory tests provide a report of test results of genetic variations and are essential for the safe and effective use of a corresponding therapeutic product. Next Generation Sequencing (NGS) is one technique that can measure one or more genetic variations as a laboratory diagnostic test, such as when used as a companion in vitro diagnostic test. • National Coverage Determination (NCD) 90.2 outlines coverage of applicable diagnostic lab tests using NGS for somatic (acquired) and germline (inherited) cancer. • Local Coverage Determinations (LCDs) may determine coverage of diagnostic lab tests using NGS for RNA sequencing and protein analysis.

Guidelines Based on the Centers for Medicare & Medicaid Services (CMS) Program Integrity Manual (100-08), this policy addresses the circumstances under which the item or service is reasonable and necessary under the Social Security Act, §1862(a)(1)(A). For laboratory services, a service can be reasonable and necessary if the service is safe and effective; and appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is furnished in accordance with accepted standards of medical practice for the diagnosis of the patient's condition; furnished in a setting appropriate to the patient's medical needs and condition; ordered and furnished by qualified personnel; one that meets, but does not exceed, the patient's medical need; and is at least as beneficial as an existing and available medically appropriate alternative.

Compliance with the provisions in this policy is subject to monitoring by post payment data analysis and subsequent medical review. Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states " ...no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis and treatment of illness or injury...". Furthermore, it has been longstanding CMS policy that "tests that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered unless explicitly authorized by statute". Screening services, such as pre - symptomatic genetic tests and services, are those used to detect an undiagnosed disease or disease predisposition, and as such are not a Medicare benefit and not covered by Medicare. Similarly, Medicare may not reimburse the costs of tests/examinations that assess the risk for and/or of a condition unless the risk assessment clearly and directly effects the management of the

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 3 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc. patient. However, Medicare does cover a broad range of legislatively mandated preventive services to prevent disease, detect disease early when it is most treatable and curable, and manage disease so that complications can be avoided. These services can be found on the CMS website at http://www.cms.gov/PrevntionGenInfo/.

Many applications of the molecular pathology procedures are not covered services given lack of benefit category (preventive service) and/or failure to reach the reasonable and necessary threshold for coverage (based on quality of clinical evidence and strength of recommendation). Furthermore, payment of claims in the past (based on stacking codes) or in the future (based on the new code series) is not a statement of coverage since the service was not audited for compliance with program requirements and documentation supporting the reasonable and necessary testing for the beneficiary. Certain tests and procedures may be subject to prepayment medical review (records requested) and paid claims must be supportable, if selected, for post payment audit. Tests for or conditions that manifest severe signs or symptoms in newborns and in early childhood or that result in early death (e.g., Canavan disease) could be subject to automatic denials since these tests are not usually relevant to a Medicare beneficiary.

Documentation Guidelines Documentation must be adequate to verify that coverage guidelines listed above have been met. Thus, the medical record must contain documentation that the testing is expected to influence treatment of the condition toward which the testing is directed. The laboratory or billing provider must have on file the physician requisition which sets forth the diagnosis or condition that warrants the test(s).

Examples of documentation requirements of the ordering physician/non-physician practitioner (NPP) include, but are not limited to, history and physical or exam findings that support the decision making, problems/diagnoses, relevant data (e.g., lab testing, imaging results).

Documentation requirements of the performing laboratory (when requested) include, but are not limited to, lab accreditation, test requisition, test record/procedures, reports (preliminary and final), and quality control record.

Documentation requirements for lab developed tests/protocols (when requested) include diagnostic test/assay, lab/manufacturer, names of comparable assays/services (if relevant), description of assay, analytical validity evidence, clinical validity evidence, and clinical utility.

Providers are required to code to specificity however, if an unlisted CPT code is used the documentation must clearly identify the unique procedure performed. When multiple procedure codes are submitted on a claim (unique and/or unlisted) the documentation supporting each code should be easily identifiable. If on review UnitedHealthcare cannot link a billed code to the documentation, these services will be denied.

When the documentation does not meet the criteria for the service rendered or the documentation does not establish the medical necessity for the services, such services will be denied as not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act.

Applicable Codes

The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

CPT Code/HCPCS Code Molecular Pathology/Molecular Diagnostics/Genetic Testing: CPT/HCPCS Code List CPT® is a registered trademark of the American Medical Association

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Diagnosis Code Refer to Molecular Pathology/Molecular Diagnostics/Genetic Testing: Diagnosis Code List for diagnosis codes for CPT codes 0005U, 0018U, 0026U, 0045U, 0047U, 0080U, 0089U, 0090U, 0245U, 81170, 81175, 81176, 81261, 81263, 81272, 81310, 81314, 81321, 81323, 81334, 81335, 81340, 81342, 81345, 81347, 81351, 81352, 81519, 81522, 81529, 81542, 81545, 81546, 81552, 81554, 88120, and 88121.

Non-Covered Diagnosis Code Non-Covered Diagnosis Codes List This list contains diagnosis codes that are never covered when given as the primary reason for the test. If a code from this section is given as the reason for the test and you know or have reason to believe the service may not be covered, call UnitedHealthcare to issue an Integrated Denial Notice (IDN) to the member and you. The IDN informs the member of their liability for the non-covered service or item and appeal rights. You must make sure the member has received the IDN prior to rendering or referring for non-covered services or items in order to collect payment.

References

CMS National Coverage Determinations (NCDs) NCD 90.2 Next Generation Sequencing (NGS) Reference NCDs: NCD 90.1 Pharmacogenomic Testing for Warfarin Response NCD 190.3 Cytogenetic Studies NCD 190.7 Human Tumor Stem Cell Drug Sensitivity Assays

CMS Local Coverage Determinations (LCDs) and Articles LCD Article Contractor Medicare Part A Medicare Part B General Molecular Diagnostic Tests (may also include the specific tests/genes listed below) L36021 Molecular Diagnostic A56973 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Molecular Diagnostic Tests (MDT) L35160 MolDX: Molecular A57526 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Molecular Diagnostic MP, NV MP, NV Tests (MDT) L36256 MolDX: Molecular A57527 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Molecular Diagnostic ND, OR, SD, UT, ND, OR, SD, UT, Tests (MDT) WA, WY WA, WY L35025 MolDX: Molecular A56853 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: Molecular Diagnostic TN, VA, WV TN, VA, WV Tests (MDT) General Molecular Diagnostic Tests (may also include the specific tests/genes listed below) L36807 MolDX: Molecular A57772 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Molecular Diagnostic CA, CO, CT, DE, MO, NE Tests (MDT) 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

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LCD Article Contractor Medicare Part A Medicare Part B L34519 Molecular Pathology A57451 Billing and Coding: First Coast FL, PR, VI FL, PR, VI Procedures Molecular Pathology Procedures L35396 Biomarkers for A52986 Billing and Coding: Novitas AR, CO, DC, DE, AR, CO, DC, DE, Oncology Biomarkers for Oncology LA, MD, MS, NJ, LA, MD, MS, NJ, NM, OK, PA, TX NM, OK, PA, TX L35062 Biomarkers Overview A56541 Billing and Coding: Novitas AR, CO, DC, DE, AR, CO, DC, DE, Biomarkers Overview LA, MD, MS, NJ, LA, MD, MS, NJ, NM, OK, PA, TX NM, OK, PA, TX L35000 Molecular Pathology A56199 Billing and Coding: NGS CT, IL, MA, ME, CT, IL, MA, ME, Procedures Molecular Pathology Procedures MN, NH, NY, RI, MN, NH, NY, RI, VT, WI VT, WI Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia AML L36021 Molecular Diagnostic A55716 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia (AML) L35160 MolDX: Molecular A55711 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Abbott RealTime IDH1 MP, NV MP, NV and IDH2 testing for Acute Myeloid Leukemia (AML) L36256 MolDX: Molecular A55712 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Abbott RealTime IDH1 ND, OR, SD, UT, ND, OR, SD, UT, and IDH2 testing for Acute WA, WY WA, WY Myeloid Leukemia (AML) L35025 MolDX: Molecular A55695 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: Abbott RealTime IDH1 TN, VA, WV TN, VA, WV and IDH2 testing for Acute Myeloid Leukemia (AML) Abbott RealTime IDH1 and IDH2 testing for Acute Myeloid Leukemia AML L36807 MolDX: Molecular A55738 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Abbott RealTime IDH1 CA, CO, CT, DE, MO, NE and IDH2 testing for Acute FL, GA, HI, IA, Myeloid Leukemia (AML) 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 Afirma™ Assay by Veracyte L36021 Molecular Diagnostic A54185 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Afirma™ Assay by Veracyte Update L35160 MolDX: Molecular A54356 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Afirma™ Assay by MP, NV MP, NV Veracyte

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LCD Article Contractor Medicare Part A Medicare Part B L36256 MolDX: Molecular A54358 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Afirma™ Assay by ND, OR, SD, UT, ND, OR, SD, UT, Veracyte WA, WY WA, WY L35025 MolDX: Molecular A53098 MolDX: Afirma™ Assay by Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) Veracyte Update TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55139 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Afirma™ Assay by CA, CO, CT, DE, MO, NE Veracyte Update 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 Algorithm Definition N/A A58677 MolDX: Algorithm CGS KY, OH KY, OH definition as a component of a laboratory test N/A A58673 MolDX: Algorithm Noridian AS, CA, GU, HI, AS, CA, GU, HI, Definition MP, NV MP, NV N/A A58674 MolDX: Algorithm Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Definition ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A58650 MolDX: Algorithm Palmetto AL, GA, NC, SC, AL, GA, NC, SC, definition as a component of a TN, VA, WV TN, VA, WV laboratory test Algorithm Definition N/A A58689 MolDX: Algorithm WPS AK, AL, AR, AZ, IA, IN, KS, MI, definition as a component of a CA, CO, CT, DE, MO, NE laboratory test 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 Allograft Rejection for Solid Organ L38582 MolDX: Molecular A58061 Billing and Coding: CGS KY, OH KY, OH Testing for Solid Organ Allograft MolDX: Molecular Testing for Rejection Solid Organ Allograft Rejection Effective 06/06/2021 Effective 06/06/2021

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LCD Article Contractor Medicare Part A Medicare Part B L38568 MolDX: Molecular A58019 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Testing for Solid Organ Allograft MolDX: Molecular Testing for TN, VA, WV TN, VA, WV Rejection Solid Organ Allograft Rejection Effective 06/06/2021 Effective 06/06/2021 L38680 MolDx: Molecular A58207 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Testing for Solid Organ Allograft MolDX: Molecular Testing for CA, CO, CT, DE, MO, NE Rejection Solid Organ Allograft Rejection FL, GA, HI, IA, Effective 06/06/2021 Effective 06/06/2021 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 AlloMap L36021 Molecular Diagnostic A54186 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: AlloMap Anticipated Retirement 06/05/2021 L35160 MolDX: Molecular A54364 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: AlloMap MP, NV MP, NV L36256 MolDX: Molecular A54366 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: AlloMap ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L35025 MolDX: Molecular A53099 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: AlloMap TN, VA, WV TN, VA, WV Anticipated Retirement 06/05/2021 AlloMap L36807 MolDX: Molecular A55140 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: AlloMap CA, CO, CT, DE, MO, NE 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 APC and MUTYH Gene Testing L36910 MolDX: APC and A56828 Billing and Coding: CGS KY, OH KY, OH MUTYH Gene Testing MolDX: APC and MUTYH Gene L36882 MolDX: APC and A57352 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MUTYH Gene Testing MolDX: APC and MUTYH Gene MP, NV MP, NV Testing

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LCD Article Contractor Medicare Part A Medicare Part B L36884 MolDX: APC and A57353 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MUTYH Gene Testing MolDX: APC and MUTYH Gene ND, OR, SD, UT, ND, OR, SD, UT, Testing WA, WY WA, WY L36827 MolDX: APC and Billing and Coding: MolDX: APC Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MUTYH Gene Testing and MUTYH Gene Testing TN, VA, WV TN, VA, WV (A56824) L37224 MolDX: APC and A56901 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, MUTYH Gene Testing MolDX: APC and MUTYH Gene CA, CO, CT, DE, MO, NE Testing 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 Aspartoacyclase 2 Deficiency ASPA Testing N/A A54253 Billing and Coding: CGS KY, OH KY, OH MolDX: Aspartoacyclase 2 Deficiency(ASPA) Testing N/A A55088 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: Aspartoacyclase 2 MP, NV MP, NV Deficiency (ASPA) Testing N/A A55089 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: Aspartoacyclase 2 ND, OR, SD, UT, ND, OR, SD, UT, Deficiency (ASPA) Testing WA, WY WA, WY N/A A53602 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: Aspartoacyclase 2 TN, VA, WV TN, VA, WV Deficiency(ASPA) Testing Aspartoacyclase 2 Deficiency ASPA Testing L36807 MolDX: Molecular A55142 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Aspartoacyclase 2 CA, CO, CT, DE, MO, NE Deficiency (ASPA) Testing 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 ATP7B Gene Tests L36021 Molecular Diagnostic A54254 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: ATP7B Gene Tests N/A A55097 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: ATP7B Gene Tests MP, NV MP, NV

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LCD Article Contractor Medicare Part A Medicare Part B N/A A55098 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: ATP7B Gene Tests ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53550 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: ATP7B Gene Tests TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55143 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: ATP7B Gene Tests CA, CO, CT, DE, MO, NE 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 BCKDHB Gene Test L36021 Molecular Diagnostic A54255 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: BCKDHB Gene Test N/A A55099 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: BCKDHB Gene Test MP, NV MP, NV N/A A55100 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: BCKDHB Gene Test ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53600 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: BCKDHB Gene Test TN, VA, WV TN, VA, WV BCKDHB Gene Test L36807 MolDX: Molecular A55145 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: BCKDHB Gene Test CA, CO, CT, DE, MO, NE 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 BCR - ABL L36117 MolDX: Genetic Testing A56999 Billing and Coding: CGS KY, OH KY, OH for BCR - ABL Negative MolDX: Genetic Testing for BCR - Myeloproliferative Disease ABL Negative Myeloproliferative Disease A54686 Billing and Coding: MolDX: BCR - ABL

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LCD Article Contractor Medicare Part A Medicare Part B L36180 MolDX: Genetic Testing A57421 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, for BCR - ABL Negative MolDX: Genetic Testing for BCR - MP, NV MP, NV Myeloproliferative Disease ABL Negative Myeloproliferative Disease A55595 Billing and Coding: MolDX: BCR-ABL L36186 MolDX: Genetic Testing A57422 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, for BCR - ABL Negative MolDX: Genetic Testing for BCR - ND, OR, SD, UT, ND, OR, SD, UT, Myeloproliferative Disease ABL Negative Myeloproliferative WA, WY WA, WY Disease A55600 Billing and Coding: MolDX: BCR-ABL L36044 MolDX: Genetic Testing A56959 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, for BCR - ABL Negative MolDX: Genetic Testing for BCR - TN, VA, WV TN, VA, WV Myeloproliferative Disease ABL Negative Myeloproliferative Disease A53531 Billing and Coding: MolDX: BCR-ABL L36815 MolDX: Genetic Testing A57570 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, for BCR - ABL Negative MolDX: Genetic Testing for BCR - CA, CO, CT, DE, MO, NE Myeloproliferative Disease ABL Negative Myeloproliferative FL, GA, HI, IA, Disease ID, IL, IN, KS, A55233 Billing and Coding: KY, LA, MA, MD, MolDx: BCR-ABL 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 BDX-XL2 L37134 MolDX: BDX-XL2 A56947 Billing and Coding: CGS KY, OH KY, OH MolDX: BDX-XL2 L37054 MolDX: BDX-XL2 A57356 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: BDX-XL2 MP, NV MP, NV L37062 MolDX: BDX-XL2 A57357 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: BDX-XL2 ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L37031 MolDX: BDX-XL2 A56929 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: BDX-XL2 TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B L37216 MolDX: BDX-XL2 A57558 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, MolDX: BDX-XL2 CA, CO, CT, DE, MO, NE 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 bioTheranostics Cancer TYPE ID® L36021 Molecular Diagnostic A54188 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: bioTheranostics Cancer TYPE ID® L35160 MolDX: Molecular A54386 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: bioTheranostics Cancer MP, NV MP, NV TYPE ID® L36256 MolDX: Molecular A54388 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: bioTheranostics Cancer ND, OR, SD, UT, ND, OR, SD, UT, TYPE ID® WA, WY WA, WY L35025 MolDX: Molecular A53101 MolDX: bioTheranostics Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) Cancer TYPE ID® Update TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55147 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: bioTheranostics Cancer CA, CO, CT, DE, MO, NE TYPE ID® Update 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 Bladder/Urothelial Tumor Markers L36975 Bladder/Urothelial A56471 Billing and Coding: CGS KY, OH KY, OH Tumor Markers Bladder/Urothelial Tumor Markers Bladder/Urothelial Tumor Markers L36678 Lab: Bladder/Urothelial A55028 Billing and Coding: Lab: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Tumor Markers Bladder/Urothelial Tumor MP, NV MP, NV Markers L36680 Lab: Bladder/Urothelial A55029 Billing and Coding: Lab: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Tumor Markers Bladder/Urothelial Tumor ND, OR, SD, UT, ND, OR, SD, UT, Markers WA, WY WA, WY L33420 Lab: Bladder/Urothelial A53095 Billing and Coding: Lab: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Tumor Markers Bladder/Urothelial Tumor TN, VA, WV TN, VA, WV Markers

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 12 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B L36807 MolDX: Molecular A56332 Billing and Coding: Lab: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) Bladder/Urothelial Tumor CA, CO, CT, DE, MO, NE Markers FL, GA, HI, IA, Retired 02/25/2021 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 BLM Gene Analysis L36021 Molecular Diagnostic A54256 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: BLM Gene Analysis N/A A55113 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: BLM Gene Analysis MP, NV MP, NV N/A A55114 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: BLM Gene Analysis ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53540 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: BLM Gene Analysis TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55148 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: BLM Gene Analysis CA, CO, CT, DE, MO, NE 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 BRAF Tests FDA-Approved L36021 Molecular Diagnostic A54191 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: FDA-Approved BRAF Tests BRAF Tests FDA-Approved N/A A54418 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: FDA-Approved BRAF MP, NV MP, NV Tests N/A A54420 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: FDA-Approved BRAF ND, OR, SD, UT, ND, OR, SD, UT, Tests WA, WY WA, WY N/A A54018 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: FDA-Approved BRAF TN, VA, WV TN, VA, WV Tests

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 13 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B L36807 MolDX: Molecular A55161Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: FDA-Approved BRAF CA, CO, CT, DE, MO, NE Tests 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 BRCA1 and BRCA2 Genetic Testing L36499 BRCA1 and BRCA2 A57449 Billing and Coding: First Coast FL, PR, VI FL, PR, VI Genetic Testing BRCA1 and BRCA2 Genetic Testing L36456 MolDX: BRCA1 and A56971 Billing and Coding: CGS KY, OH KY, OH BRCA2 Genetic Testing MolDX: BRCA1 and BRCA2 Genetic Testing L36161 MolDX: BRCA1 and A57354 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, BRCA2 Genetic Testing MolDX: BRCA1 and BRCA2 MP, NV MP, NV Genetic Testing L36163 MolDX: BRCA1 and A57355 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, BRCA2 Genetic Testing MolDX: BRCA1 and BRCA2 ND, OR, SD, UT, ND, OR, SD, UT, Genetic Testing WA, WY WA, WY L36082 MolDX: BRCA1 and A56854 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, BRCA2 Genetic Testing MolDX: BRCA1 and BRCA2 TN, VA, WV TN, VA, WV Genetic Testing L36813 MolDX: BRCA1 and A57771 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, BRCA2 Genetic Testing MolDX: BRCA1 and BRCA2 CA, CO, CT, DE, MO, NE Genetic Testing 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 BRCA1 and BRCA2 Genetic Testing L36715 BRCA1 and BRCA2 A56542 Billing and Coding: Novitas AR, CO, DC, DE, AR, CO, DC, DE, Genetic Testing BRCA1 and BRCA2 Genetic LA, MD, MS, NJ, LA, MD, MS, NJ, Testing NM, OK, PA, TX NM, OK, PA, TX Breast Cancer Assay: Prosigna® L36425 MolDX: Breast Cancer A56989 Billing and Coding: CGS KY, OH KY, OH Assay: Prosigna® MolDX: Breast Cancer Assay: Prosigna®

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 14 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B L36380 MolDX: Breast Cancer A57363 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Assay: Prosigna® MolDX: Breast Cancer Assay: MP, NV MP, NV Prosigna® L36386 MolDX: Breast Cancer A57364 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Assay: Prosigna® MolDX: Breast Cancer Assay: ND, OR, SD, UT, ND, OR, SD, UT, Prosigna® WA, WY WA, WY L36125 MolDX: Breast Cancer A56949 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Assay: Prosigna® MolDX: Breast Cancer Assay: TN, VA, WV TN, VA, WV Prosigna® L36811 MolDX: Breast Cancer A57560 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Assay: Prosigna® MolDX: Breast Cancer Assay: CA, CO, CT, DE, MO, NE Prosigna® 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 Breast Cancer Index® BCI Gene Expression Test L37832 MolDX: Breast Cancer A56884 Billing and Coding: CGS KY, OH KY, OH Index ® (BCI) Gene Expression MolDX: Breast Cancer Index® Test (BCI) Gene Expression Test L37822 MolDX: Breast Cancer A57773 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Index® (BCI) Gene Expression MolDX: Breast Cancer IndexTM MP, NV MP, NV Test (BCI) Gene Expression Test L37824 MolDX: Breast Cancer A57774 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Index® (BCI) Gene Expression MolDX: Breast Cancer IndexTM ND, OR, SD, UT, ND, OR, SD, UT, Test (BCI) Gene Expression Test WA, WY WA, WY L37794 MolDX: Breast Cancer A56875 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Index® (BCI) Gene Expression MolDX: Breast Cancer Index® TN, VA, WV TN, VA, WV Test (BCI) Gene Expression Test Breast Cancer Index® BCI Gene Expression Test L37913 MolDX: Breast Cancer A56335 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Index® (BCI) Gene Expression MolDX: Breast Cancer Index® CA, CO, CT, DE, MO, NE Test (BCI) Gene Expression Test 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

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 15 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B CFTR Gene Analysis Retired; See Pharmacogenomics Testing L36021 Molecular Diagnostic A54258 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: CFTR Gene Analysis Retired 08/11/2020 N/A A55117 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: CFTR Gene Analysis MP, NV MP, NV Retired 11/04/2020 N/A A55118 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: CFTR Gene Analysis ND, OR, SD, UT, ND, OR, SD, UT, Retired 11/04/2020 WA, WY WA, WY N/A A53615 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: CFTR Gene Analysis TN, VA, WV TN, VA, WV Retired 08/06/2020 L36807 MolDX: Molecular A55156 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: CFTR Gene Analysis CA, CO, CT, DE, MO, NE Retired 08/06/2020 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 Circulating Tumor Cell Marker Assays L36973 MolDX: Circulating A57288 Billing and Coding: CGS KY, OH KY, OH Tumor Cell Marker Assays MolDX: Circulating Tumor Cell Marker Assays L35710 MolDX: Circulating A57815 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Tumor Cell Marker Assays MolDX: Circulating Tumor Cell MP, NV MP, NV Marker Assays L34066 MolDX: Circulating A57816 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Tumor Cell Marker Assays MolDX: Circulating Tumor Cell ND, OR, SD, UT, ND, OR, SD, UT, Marker Assays WA, WY WA, WY Circulating Tumor Cell Marker Assays L35071 MolDX: Circulating A56873 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Tumor Cell Marker Assays MolDX: Circulating Tumor Cell TN, VA, WV TN, VA, WV Marker Assays ConfirmMDx Epigenetic Molecular Assay L36006 MolDX: ConfirmMDx A57031 Billing and Coding: CGS KY, OH KY, OH Epigenetic Molecular Assay MolDX: ConfirmMDx Epigenetic Molecular Assay L36327 MolDX: ConfirmMDx A57605 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Epigenetic Molecular Assay MolDX: ConfirmMDx Epigenetic MP, NV MP, NV Molecular Assay L36329 MolDX: ConfirmMDx A57606 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Epigenetic Molecular Assay MolDX: ConfirmMDx Epigenetic ND, OR, SD, UT, ND, OR, SD, UT, Molecular Assay WA, WY WA, WY

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 16 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B L35632 MolDX: ConfirmMDx A56955 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Epigenetic Molecular Assay MolDX: ConfirmMDx Epigenetic TN, VA, WV TN, VA, WV Molecular Assay L37005 MolDX: ConfirmMDx A57561 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Epigenetic Molecular Assay MolDX: ConfirmMDx Epigenetic CA, CO, CT, DE, MO, NE Molecular Assay 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 Corus® CAD Assay L37787 MolDX: Corus® CAD A56950 Billing and Coding: CGS KY, OH KY, OH Assay MolDX: Corus® CAD Assay L37673 MolDX: Corus® CAD A57415 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Assay MolDX: Corus® CAD Assay MP, NV MP, NV L37675 MolDX: Corus® CAD A57416 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Assay MolDX: Corus® CAD Assay ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L37612 MolDX: Corus® CAD A56930 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Assay MolDX: Corus® CAD Assay TN, VA, WV TN, VA, WV Corus® CAD Assay L37770 MolDX: CORUS® CAD A57562 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, ASSAY MolDX: CORUS® CAD ASSAY CA, CO, CT, DE, MO, NE 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 L36713 Corus® CAD Test A56608 Billing and Coding: Novitas AR, CO, DC, DE, AR, CO, DC, DE, Retired 09/24/2020 Corus® CAD Test LA, MD, MS, NJ, LA, MD, MS, NJ, Retired 09/24/2020 NM, OK, PA, TX NM, OK, PA, TX Cxbladder L35396 Biomarkers for A52986 (Billing and Coding: Novitas AR, CO, DC, DE, AR, CO, DC, DE, Oncology Biomarkers for Oncology) LA, MD, MS, NJ, LA, MD, MS, NJ, A58529 Response to Comments: NM, OK, PA, TX NM, OK, PA, TX Biomarkers for Oncology

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 17 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B Decipher® Biopsy Prostate Cancer Classifier Assay Retired; See Prostate Cancer Genomic Classifier Assay for Men with Localized Disease L38077 MolDX: Decipher® A57796 Billing and Coding: CGS KY, OH KY, OH Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate Classifier Assay for Men with Cancer Classifier Assay for Men Intermediate Risk Disease with Intermediate Risk Disease Retired 11/07/2020; See Retired 11/07/2020; See L38303 A58371 L37834 MolDX: Decipher® A56984 Billing and Coding: Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate Classifier Assay for Men with Cancer Classifier Assay for Men Very Low and Low Risk Disease with Very Low and Low Risk Retired 11/07/2020; See Disease L38303 Retired 11/07/2020; See A58371 L36656 MolDX: Decipher® A56992 Billing and Coding: Prostate Cancer Classifier Assay MolDX: Decipher® Prostate Retired 11/07/2020; See Cancer Classifier Assay L38303 Retired 11/07/2020; See A58371 Decipher® Biopsy Prostate Cancer Classifier Assay Retired; See Prostate Cancer Genomic Classifier Assay for Men with Localized Disease L38147 MolDX: Decipher® A57962 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate MP, NV MP, NV Classifier Assay for Men with Cancer Classifier Assay for Men Intermediate Risk Disease with Intermediate Risk Disease Retired 12/05/2020 Retired 12/06/2020 L37818 MolDX: Decipher® A57645 Billing and Coding: Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate Classifier Assay for Men with Cancer Classifier Assay for Men Very Low and Low Risk Disease with Very Low and Low Risk Retired 12/05/2020 Disease Retired 12/06/2020 L38149 MolDX: Decipher® A57963 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate ND, OR, SD, UT, ND, OR, SD, UT, Classifier Assay for Men with Cancer Classifier Assay for Men WA, WY WA, WY Intermediate Risk Disease with Intermediate Risk Disease Retired 12/05/2020 Retired 12/06/2020 L37820 MolDX: Decipher® A57646 Billing and Coding: Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate Classifier Assay for Men with Cancer Classifier Assay for Men Very Low and Low Risk Disease with Very Low and Low Risk Retired 12/06/2020 Disease Retired 12/06/2020 L38029 (MolDX: Decipher® A57761 (Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate TN, VA, WV TN, VA, WV Classifier Assay for Men with Cancer Classifier Assay for Men Intermediate Risk Disease) with Intermediate Risk Disease) Retired 11/07/2020; See Retired 11/07/2020; See L38292 A58343

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LCD Article Contractor Medicare Part A Medicare Part B L37785 (MolDX: Decipher® A56921 (Billing and Coding: Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate Classifier Assay for Men with Cancer Classifier Assay for Men Very Low and Low Risk with Very Low and Low Risk Disease) Disease) Retired 11/07/2020; See Retired 11/07/2020; See L38292 A58343 L35868 (MolDX: Decipher® A56958 (Billing and Coding: Prostate Cancer Classifier MolDX: Decipher® Prostate Assay) Cancer Classifier Assay) Retired 11/07/2020; See Retired 11/07/2020; See L38292 A58343 Decipher® Biopsy Prostate Cancer Classifier Assay Retired; See Prostate Cancer Genomic Classifier Assay for Men with Localized Disease L38166 MolDX: Decipher® A57798 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate CA, CO, CT, DE, MO, NE Classifier Assay for Men with Cancer Classifier Assay for Men FL, GA, HI, IA, Intermediate Risk Disease with Intermediate Risk Disease ID, IL, IN, KS, Retired 11/07/2020; See Retired 11/07/2020; See KY, LA, MA, MD, L38433 A57106 ME, MI, MO, MS, MT, NC, ND, NE, L37911 MolDX: Decipher® A57564 Billing and Coding: NH, NJ, NM, NV, Biopsy Prostate Cancer MolDX: Decipher® Biopsy Prostate OH, OK, OR, PA, Classifier Assay for Men with Cancer Classifier Assay for Men RI, SC, SD, TN, Very Low and Low Risk Disease with Very Low and Low Risk TX, UT, VA, VT, Retired 11/07/2020; See Disease WA, WI, WV, WY L38433 Retired 11/07/2020; See A57106 L36791 MolDX: Decipher® A57565 Billing and Coding: Prostate Cancer Classifier Assay MolDX: Decipher® Prostate Retired 11/07/2020; See Cancer Classifier Assay L38433 Retired 11/07/2020; See A57106 Decision Dx-UM Uveal Melanoma L37130 MolDX: DecisionDx-UM A56981 Billing and Coding: CGS KY, OH KY, OH (Uveal Melanoma) MolDX: DecisionDx-UM (Uveal Melanoma) L37070 MolDX: DecisionDx-UM A57621 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, (Uveal Melanoma) MolDX: DecisionDx-UM (Uveal MP, NV MP, NV Melanoma) L37072 MolDX: DecisionDx-UM A57622 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, (Uveal Melanoma) MolDX: DecisionDx-UM (Uveal ND, OR, SD, UT, ND, OR, SD, UT, Melanoma) WA, WY WA, WY L37033 MolDX: DecisionDx-UM A56906 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, (Uveal Melanoma) MolDX: DecisionDx-UM (Uveal TN, VA, WV TN, VA, WV Melanoma)

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LCD Article Contractor Medicare Part A Medicare Part B L37210 MolDX: Decision Dx-UM A57566 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, (Uveal Melanoma) MolDX: Decision Dx-UM (Uveal CA, CO, CT, DE, MO, NE Melanoma) 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 EGFR Tests FDA-Approved L36021 Molecular Diagnostic A54192 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: FDA-Approved EGFR Tests EGFR Tests FDA-Approved L35160 MolDX: Molecular A54422 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: FDA-Approved EGFR MP, NV MP, NV Tests L36256 MolDX: Molecular A54424 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: FDA-Approved EGFR ND, OR, SD, UT, ND, OR, SD, UT, Tests WA, WY WA, WY L35025 MolDX: Molecular A54021 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: FDA-Approved EGFR TN, VA, WV TN, VA, WV Tests L36807 MolDX: Molecular A55193 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: FDA-Approved EGFR CA, CO, CT, DE, MO, NE Tests 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 EndoPredict® Breast Cancer Gene Expression Test L37356 MolDX: EndoPredict A56997 Billing and Coding: CGS KY, OH KY, OH Breast Cancer Gene Expression MolDX: EndoPredict Breast Test Cancer Gene Expression Test L37295 MolDX: EndoPredict® A57607 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Breast Cancer Gene Expression MolDX: EndoPredict® Breast MP, NV MP, NV Test Cancer Gene Expression Test L37311 MolDX: EndoPredict® A57608 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Breast Cancer Gene Expression MolDX: EndoPredict® Breast ND, OR, SD, UT, ND, OR, SD, UT, Test Cancer Gene Expression Test WA, WY WA, WY

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LCD Article Contractor Medicare Part A Medicare Part B L37264 MolDX: EndoPredict A56963 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Breast Cancer Gene Expression MolDX: EndoPredict Breast TN, VA, WV TN, VA, WV Test Cancer Gene Expression Test L37663 MolDX: EndoPredict® A57567 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Breast Cancer Gene Expression MolDX: EndoPredict® Breast CA, CO, CT, DE, MO, NE Test Cancer Gene Expression Test 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 Envisia, Veracyte, Idiopathic Pulmonary Fibrosis Diagnostic Test L37905 MolDX: Envisia, A56985 Billing and Coding: CGS KY, OH KY, OH Veracyte, Idiopathic Pulmonary MolDX: Envisia, Veracyte, Fibrosis Diagnostic Test Idiopathic Pulmonary Fibrosis Diagnostic Test L37887 MolDX: Envisia, A57419 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Veracyte, Idiopathic Pulmonary MolDX: Envisia, Veracyte, MP, NV MP, NV Fibrosis Diagnostic Test Idiopathic Pulmonary Fibrosis Diagnostic Test L37891 MolDX: Envisia, A57420 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Veracyte, Idiopathic Pulmonary MolDX: Envisia, Veracyte, ND, OR, SD, UT, ND, OR, SD, UT, Fibrosis Diagnostic Test Idiopathic Pulmonary Fibrosis WA, WY WA, WY Diagnostic Test L37857 MolDX: Envisia, A56898 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Veracyte, Idiopathic Pulmonary MolDX: Envisia, Veracyte, TN, VA, WV TN, VA, WV Fibrosis Diagnostic Test Idiopathic Pulmonary Fibrosis Diagnostic Test L37919 MolDX: Envisia, A57568 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Veracyte, Idiopathic Pulmonary MolDX: Envisia, Veracyte, CA, CO, CT, DE, MO, NE Fibrosis Diagnostic Test Idiopathic Pulmonary Fibrosis FL, GA, HI, IA, Diagnostic Test 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 FANCC Genetic Testing L36021 Molecular Diagnostic A54263 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: FANCC Genetic Testing N/A A55183 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: FANCC Genetic Testing MP, NV MP, NV

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LCD Article Contractor Medicare Part A Medicare Part B N/A A55184 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: FANCC Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53628 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: FANCC Genetic Testing TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55160 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: FANCC Genetic Testing CA, CO, CT, DE, MO, NE 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 Fragile X L36021 Molecular Diagnostic A54264 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Fragile X N/A A55241 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: Fragile X MP, NV MP, NV N/A A55242 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: Fragile X ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53638 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: Fragile X TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55163 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Fragile X CA, CO, CT, DE, MO, NE 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 GBA Genetic Testing L36021 Molecular Diagnostic A54265 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: GBA Genetic Testing N/A A55243 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: GBA Genetic Testing MP, NV MP, NV N/A A55244 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: GBA Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53542 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: GBA Genetic Testing TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B L36807 MolDX: Molecular A55164 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: GBA Genetic Testing CA, CO, CT, DE, MO, NE 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 HBB Gene Tests N/A A54267 Billing and Coding: CGS KY, OH KY, OH MolDX: HBB Gene Tests N/A A55253 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: HBB Gene Tests MP, NV MP, NV HBB Gene Tests N/A A55254 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: HBB Gene Tests ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53493 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: HBB Gene Tests TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55166 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: HBB Gene Tests CA, CO, CT, DE, MO, NE 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 HEXA Gene Analysis L36021 Molecular Diagnostic A54268 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: HEXA Gene Analysis N/A A55255 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: HEXA Gene Analysis MP, NV MP, NV N/A A55256 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: HEXA Gene Analysis ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53598 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: HEXA Gene Analysis TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B L36807 MolDX: Molecular A55168 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: HEXA Gene Analysis CA, CO, CT, DE, MO, NE 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 Histochemical Stains and Immunohistochemical Stains L36234 Special Histochemical A57708 Billing and Coding: First Coast FL, PR, VI FL, PR, VI Stains & Immunohistochemical Special Histochemical Stains & Stains Immunohistochemical Stains L35986 Special Histochemical A56536 Billing and Coding: CGS KY, OH KY, OH Stains and Special Histochemical Stains and Immunohistochemical Stains Immunohistochemical Stains Retired 12/23/2020

Histochemical Stains and Immunohistochemical Stains L36021 Molecular Diagnostic A54271 Billing and Coding: Tests (MDT) MolDX: (IHC) Indications for Breast Pathology L36351 Lab: Special A57611 Billing and Coding: Lab: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Histochemical Stains and Special Histochemical Stains and MP, NV MP, NV Immunohistochemical Stains Immunohistochemical Stains A57523 Billing and Coding: MolDX: Immunohistochemistry (IHC) Indications for Breast Pathology A55802 Billing and Coding: Lab: Special Stains and Immunohistochemistry (IHC) Indications for Gastric Pathology L36353 Lab: Special A57614 Billing and Coding: Lab: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Histochemical Stains and Special Histochemical Stains and ND, OR, SD, UT, ND, OR, SD, UT, Immunohistochemical Stains Immunohistochemical Stains WA, WY WA, WY A57797 Billing and Coding: MolDX: Immunohistochemistry (IHC) Indications for Breast Pathology A55803 Billing and Coding: Lab: Special Stains and Immunohistochemistry (IHC) Indications for Gastric Pathology

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LCD Article Contractor Medicare Part A Medicare Part B L35922 Lab: Special A56838 Billing and Coding: Lab: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Histochemical Stains and Special Histochemical Stains and TN, VA, WV TN, VA, WV Immunohistochemical Stains Immunohistochemical Stains A53704 Billing and Coding: MolDX: Immunohistochemistry (IHC) Indications for Breast Pathology A55718 Special Stains and Immunohistochemistry (IHC) Indications for Gastric Pathology Retired 12/23/2020 L36805 Lab: Special A57733 Billing and Coding: Lab: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Histochemical Stains and Special Histochemical Stains and CA, CO, CT, DE, MO, NE Immunohistochemical Stains Immunohistochemical Stains FL, GA, HI, IA, A55136 Billing and Coding: ID, IL, IN, KS, MolDX: Immunohistochemistry KY, LA, MA, MD, (IHC) Indications for Breast ME, MI, MO, MS, Pathology MT, NC, ND, NE, NH, NJ, NM, NV, A55739 Billing and Coding: OH, OK, OR, PA, Special Stains and RI, SC, SD, TN, Immunohistochemistry (IHC) TX, UT, VA, VT, Indications for Gastric Pathology WA, WI, WV, WY Retired 12/23/2020 Hypercoagulability/Thrombophilia Factor V Leiden, Factor II Prothrombin, and MTHFR L35984 MolDX: Genetic Testing A56980 Billing and Coding: CGS KY, OH KY, OH for Hypercoagulability / MolDX: Genetic Testing for Thrombophilia (Factor V Leiden, Hypercoagulability / Factor II Prothrombin, and Thrombophilia (Factor V Leiden, MTHFR) Factor II Prothrombin, and MTHFR) L36155 MolDX: Genetic Testing A57423 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, for Hypercoagulability / MolDX: Genetic Testing for MP, NV MP, NV Thrombophilia (Factor V Leiden, Hypercoagulability / Factor II Prothrombin, and Thrombophilia (Factor V Leiden, MTHFR) Factor II Prothrombin, and MTHFR) L36159 MolDX: Genetic Testing A57424 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, for Hypercoagulability / MolDX: Genetic Testing for ND, OR, SD, UT, ND, OR, SD, UT, Thrombophilia (Factor V Leiden, Hypercoagulability / WA, WY WA, WY Factor II Prothrombin, and Thrombophilia (Factor V Leiden, MTHFR) Factor II Prothrombin, and MTHFR) L36089 MolDX: Genetic Testing A56899 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, for Hypercoagulability / MolDX: Genetic Testing for TN, VA, WV TN, VA, WV Thrombophilia (Factor V Leiden, Hypercoagulability / Factor II Prothrombin, and Thrombophilia (Factor V Leiden, MTHFR) Factor II Prothrombin, and MTHFR)

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LCD Article Contractor Medicare Part A Medicare Part B L36400 MolDX: Genetic Testing A57571 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, for Hypercoagulability / MolDX: Genetic Testing for CA, CO, CT, DE, MO, NE Thrombophilia (Factor V Leiden, Hypercoagulability/Thrombophilia FL, GA, HI, IA, Factor II Prothrombin, and (Factor V Leiden, Factor II ID, IL, IN, KS, MTHFR) Prothrombin, and MTHFR) 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 IKBKAP Genetic Testing L36021 Molecular Diagnostic A54270 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: IKBKAP Genetic Testing N/A A55612 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: IKBKAP Genetic Testing MP, NV MP, NV N/A A55613 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: IKBKAP Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53596 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: IKBKAP Genetic Testing TN, VA, WV TN, VA, WV IKBKAP Genetic Testing L36807 MolDX: Molecular A55170 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: IKBKAP Genetic Testing CA, CO, CT, DE, MO, NE 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 4Kscore® Assay L36979 MolDX: 4Kscore® Assay A56944 Billing and Coding: CGS KY, OH KY, OH MolDX: 4Kscore® Assay L37120 MolDX: 4Kscore Assay A57336 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: 4Kscore Assay MP, NV MP, NV L37122 MolDX: 4Kscore Assay A57337 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: 4Kscore Assay ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L36763 MolDX: 4Kscore® Assay A56932 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: 4Kscore® Assay TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B L37013 MolDX: 4Kscore® Assay A57556 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, MolDX: 4Kscore® Assay CA, CO, CT, DE, MO, NE 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 L37798 4Kscore Test Algorithm A56287 Billing and Coding: First Coast FL, PR, VI FL, PR, VI 4Kscore Test Algorithm L37792 4Kscore Test Algorithm A56653 Billing and Coding: Novitas AR, CO, DC, DE, AR, CO, DC, DE, 4Kscore Test Algorithm LA, MD, MS, NJ, LA, MD, MS, NJ, NM, OK, PA, TX NM, OK, PA, TX L37733 Biomarker Testing Prior A56609 Billing and Coding: NGS CT, IL, MA, ME, CT, IL, MA, ME, to Initial Biopsy for Prostate Biomarker Testing Prior to Initial MN, NH, NY, RI, MN, NH, NY, RI, Cancer Diagnosis Biopsy for Prostate Cancer VT, WI VT, WI Diagnosis KRAS Tests FDA-Approved L36021 Molecular Diagnostic A54688 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: FDA-Approved KRAS Tests A54200 Billing and Coding: MolDX: therascreen® KRAS PCR Kit Guidelines L35160 MolDX: Molecular A54498 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: FDA-Approved KRAS MP, NV MP, NV Tests L36256 MolDX: Molecular A54500 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: FDA-Approved KRAS ND, OR, SD, UT, ND, OR, SD, UT, Tests WA, WY WA, WY L35025 MolDX: Molecular A54472 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: FDA-Approved KRAS TN, VA, WV TN, VA, WV Tests L36807 MolDX: Molecular A55162 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: FDA-Approved KRAS CA, CO, CT, DE, MO, NE Tests 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

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LCD Article Contractor Medicare Part A Medicare Part B L1CAM Gene Sequencing L36021 Molecular Diagnostic A54274 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: L1CAM Gene Sequencing Guidelines N/A A55277 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: L1CAM Gene Sequencing MP, NV MP, NV N/A A55278 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: L1CAM Gene Sequencing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53659 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: L1CAM Gene Sequencing TN, VA, WV TN, VA, WV L1CAM Gene Sequencing L36807 MolDX: Molecular A55192 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: L1CAM Gene Sequencing CA, CO, CT, DE, MO, NE 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 Lynch Syndrome L35349 MolDX: Genetic Testing A56882 Billing and Coding: CGS KY, OH KY, OH for Lynch Syndrome MolDX: Genetic Testing for Lynch Syndrome A56106 Billing and Coding: MolDX: Microsatellite Instability- High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors L36370 MolDX: Genetic Testing A54995 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, for Lynch Syndrome MolDX: Genetic Testing for Lynch MP, NV MP, NV Syndrome A56103 Billing and Coding: MolDX: Microsatellite Instability- High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors

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LCD Article Contractor Medicare Part A Medicare Part B L36374 MolDX: Genetic Testing A54996 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, for Lynch Syndrome MolDX: Genetic Testing for Lynch ND, OR, SD, UT, ND, OR, SD, UT, Syndrome WA, WY WA, WY A56104 Billing and Coding: MolDX: Microsatellite Instability- High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker Billing and Coding Guidelines for Patients with Unresectable or Metastatic Solid Tumors Lynch Syndrome L35024 MolDX: Genetic Testing A54987 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, for Lynch Syndrome MolDX: Genetic Testing for Lynch TN, VA, WV TN, VA, WV Syndrome A56072 Billing and Coding: MolDX: Microsatellite Instability- High (MSI-H) and Mismatch Repair Deficient (dMMR) Biomarker for Patients with Unresectable or Metastatic Solid Tumors L36793 MolDX: Genetic Testing A55135 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, for Lynch Syndrome MolDX: Genetic Testing for Lynch CA, CO, CT, DE, MO, NE Syndrome FL, GA, HI, IA, A56501 Billing and Coding: ID, IL, IN, KS, MolDX: Microsatellite Instability- KY, LA, MA, MD, High (MSI-H) and Mismatch ME, MI, MO, MS, Repair Deficient (dMMR) MT, NC, ND, NE, Biomarker for Patients with NH, NJ, NM, NV, Unresectable or Metastatic Solid OH, OK, OR, PA, Tumors RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY L34912 Genetic Testing for A57450 Billing and Coding: First Coast FL, PR, VI FL, PR, VI Lynch Syndrome Genetic Testing for Lynch Syndrome MammaPrint L36021 Molecular Diagnostic A54194 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: MammaPrint L35160 MolDX: Molecular A54445 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: MammaPrint MP, NV MP, NV L36256 MolDX: Molecular A54447 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: MammaPrint ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L35025 MolDX: Molecular A53104 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: MammaPrint TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B L36807 MolDX: Molecular A55175 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: MammaPrint CA, CO, CT, DE, MO, NE 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 MCOLN1 Genetic Testing L36021 Molecular Diagnostic A54277 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: MCOLN1 Genetic Testing Guidelines N/A A55283 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: MCOLN1 Genetic Testing MP, NV MP, NV N/A A55284 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: MCOLN1 Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53630 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: MCOLN1 Genetic Testing TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55176 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: MCOLN1 Genetic Testing CA, CO, CT, DE, MO, NE 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 MECP2 Genetic Testing L36021 Molecular Diagnostic A54278 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: MECP2 Genetic Testing N/A A55285 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: MECP2 Genetic Testing MP, NV MP, NV N/A A55286 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: MECP2 Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53574 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: MECP2 Genetic TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B L36807 MolDX: Molecular A55189 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: MECP2 Genetic Testing CA, CO, CT, DE, MO, NE 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 Melanoma Risk Stratification L38016 MolDX: Melanoma Risk A57165 Billing and Coding: CGS KY, OH KY, OH Stratification Molecular Testing MolDX: Melanoma Risk Stratification Molecular Testing Melanoma Risk Stratification L37750 MolDX: Melanoma Risk A57268 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Stratification Molecular Testing MolDX: Melanoma Risk MP, NV MP, NV Stratification Molecular Testing L37748 MolDX: Melanoma Risk A57290 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Stratification Molecular Testing MolDX: Melanoma Risk ND, OR, SD, UT, ND, OR, SD, UT, Stratification Molecular Testing WA, WY WA, WY L37725 MolDX: Melanoma Risk A56961 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Stratification Molecular Testing MolDX: Melanoma Risk TN, VA, WV TN, VA, WV Stratification Molecular Testing L38018 MolDX: Melanoma Risk A56636 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Stratification Molecular Testing MolDX: Melanoma Risk CA, CO, CT, DE, MO, NE Stratification Molecular Testing 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 MGMT Promoter Methylation Analysis L36113 MolDX: MGMT A56983 Billing and Coding: CGS KY, OH KY, OH Promoter Methylation Analysis MolDX: MGMT Promoter Methylation Analysis L36188 MolDX: MGMT A57432 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Promoter Methylation Analysis MolDX: MGMT Promoter MP, NV MP, NV Methylation Analysis L36192 MolDX: MGMT A57433 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Promoter Methylation Analysis MolDX: MGMT Promoter ND, OR, SD, UT, ND, OR, SD, UT, Methylation Analysis WA, WY WA, WY

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LCD Article Contractor Medicare Part A Medicare Part B L35974 MolDX: MGMT A56941 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Promoter Methylation Analysis MolDX: MGMT Promoter TN, VA, WV TN, VA, WV Methylation Analysis L37001 MolDX: MGMT A57577 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Promoter Methylation Analysis MolDX: MGMT Promoter CA, CO, CT, DE, MO, NE Methylation Analysis 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 myPath Melanoma Assay L37907 MolDX: myPath A56878 Billing and Coding: CGS KY, OH KY, OH Melanoma Assay MolDX: myPath Melanoma Assay myPath Melanoma Assay L37879 MolDX: myPath A57626 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Melanoma Assay MolDX: myPath Melanoma Assay MP, NV MP, NV L37881 MolDX: myPath A57627 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Melanoma Assay MolDX: myPath Melanoma Assay ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L37859 MolDX: myPath A56858 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Melanoma Assay MolDX: myPath Melanoma Assay TN, VA, WV TN, VA, WV L37923 MolDX: myPath A57580 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Melanoma Assay MolDX: myPath Melanoma Assay CA, CO, CT, DE, MO, NE 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 Neuroendocrine Tumors/Neoplasms L37851 Biomarker Testing for A57059 Billing and Coding: NGS CT, IL, MA, ME, CT, IL, MA, ME, Neuroendocrine Biomarker Testing for MN, NH, NY, RI, MN, NH, NY, RI, Tumors/Neoplasms Neuroendocrine VT, WI VT, WI Tumors/Neoplasms Next-Generation Sequencing for Myeloid Malignancies and Suspected Myeloid Malignancies L38070 MolDX: Next-Generation A57873 Billing and Coding: CGS KY, OH KY, OH Sequencing Lab-Developed MolDX: Next-Generation Tests for Myeloid Malignancies Sequencing Lab-Developed Tests and Suspected Myeloid for Myeloid Malignancies and Malignancies Suspected Myeloid Malignancies

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LCD Article Contractor Medicare Part A Medicare Part B L38123 MolDX: Next-Generation A57891 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Sequencing Lab-Developed MolDX: Next-Generation MP, NV MP, NV Tests for Myeloid Malignancies Sequencing Lab-Developed Tests and Suspected Myeloid for Myeloid Malignancies and Malignancies Suspected Myeloid Malignancies L38125 MolDX: Next-Generation A57892 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Sequencing Lab-Developed MolDX: Next-Generation ND, OR, SD, UT, ND, OR, SD, UT, Tests for Myeloid Malignancies Sequencing Lab-Developed Tests WA, WY WA, WY and Suspected Myeloid for Myeloid Malignancies and Malignancies Suspected Myeloid Malignancies L38047 MolDX: Next-Generation A57837 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Sequencing Lab-Developed MolDX: Next-Generation TN, VA, WV TN, VA, WV Tests for Myeloid Malignancies Sequencing Lab-Developed Tests and Suspected Myeloid for Myeloid Malignancies and Malignancies Suspected Myeloid Malignancies Next-Generation Sequencing for Myeloid Malignancies and Suspected Myeloid Malignancies L38176 MolDX: Next-Generation A57878 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Sequencing Lab-Developed MolDX: Next-Generation CA, CO, CT, DE, MO, NE Tests for Myeloid Malignancies Sequencing Lab-Developed Tests FL, GA, HI, IA, and Suspected Myeloid for Myeloid Malignancies and ID, IL, IN, KS, Malignancies Suspected Myeloid Malignancies 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 L37606 Genomic Sequence A56793 Billing and Coding: NGS CT, IL, MA, ME, CT, IL, MA, ME, Analysis Panels in the Genomic Sequence Analysis MN, NH, NY, RI, MN, NH, NY, RI, Treatment of Hematolymphoid Panels in the Treatment of VT, WI VT, WI Diseases Hematolymphoid Diseases Next-Generation Sequencing for Solid Tumors L38067 MolDX: Next-Generation A57870 Billing and Coding: CGS KY, OH KY, OH Sequencing for Solid Tumors MolDX: Next-Generation Sequencing for Solid Tumors L38119 MolDX: Next-Generation A57901 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Sequencing for Solid Tumors MolDX: Next-Generation MP, NV MP, NV Sequencing for Solid Tumors L38121 MolDX: Next-Generation A57905 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Sequencing for Solid Tumors MolDX: Next-Generation ND, OR, SD, UT, ND, OR, SD, UT, Sequencing for Solid Tumors WA, WY WA, WY L38045 MolDX: Next-Generation A57831 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Sequencing for Solid Tumors MolDX: Next-Generation TN, VA, WV TN, VA, WV Sequencing for Solid Tumors

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LCD Article Contractor Medicare Part A Medicare Part B L38158 MolDX: Next-Generation A57858 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Sequencing for Solid Tumors MolDX: Next-Generation CA, CO, CT, DE, MO, NE Sequencing for Solid Tumors 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 L37810 Genomic Sequence A56867 Billing and Coding: NGS CT, IL, MA, ME, CT, IL, MA, ME, Analysis Panels in the Genomic Sequence Analysis MN, NH, NY, RI, MN, NH, NY, RI, Treatment of Solid Organ Panels in the Treatment of Solid VT, WI VT, WI Neoplasms Organ Neoplasms Next-Generation Sequencing Testing in Cancer- Targeted and Comprehensive Genomic Profile L36021 Molecular Diagnostic A54901 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Targeted and Comprehensive Genomic Profile Next Generation Sequencing Testing in Cancer N/A A55624 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: Targeted and MP, NV MP, NV Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer N/A A56518 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: Targeted and ND, OR, SD, UT, ND, OR, SD, UT, Comprehensive Genomic Profile WA, WY WA, WY Next-Generation Sequencing Testing in Cancer L38045 MolDX: Next-Generation A54795 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Sequencing for Solid Tumors MolDX: Targeted and TN, VA, WV TN, VA, WV Comprehensive Genomic Profile Next-Generation Sequencing Testing in Cancer L36807 MolDX: Molecular A55197 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Targeted and CA, CO, CT, DE, MO, NE Comprehensive Genomic Profile FL, GA, HI, IA, Next Generation Sequencing ID, IL, IN, KS, Testing in Cancer 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

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LCD Article Contractor Medicare Part A Medicare Part B NRAS Genetic Testing L35442 MolDX: NRAS Genetic A56998 Billing and Coding: CGS KY, OH KY, OH Testing MolDX: NRAS Genetic Testing L36335 MolDX: NRAS Genetic A57486 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Testing MolDX: NRAS Genetic Testing MP, NV MP, NV L36339 MolDX: NRAS Genetic A57487 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Testing MolDX: NRAS Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L35073 MolDX: NRAS Genetic A56962 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Testing MolDX: NRAS Genetic Testing TN, VA, WV TN, VA, WV NRAS Genetic Testing L36797 MolDX: NRAS Genetic A57581 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Testing MolDX: NRAS Genetic Testing CA, CO, CT, DE, MO, NE 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 OncoCee™ L36021 Molecular Diagnostic A54292 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: OncoCee™ L35710 MolDX: Circulating A55593 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Tumor Cell Marker Assays MolDX: OncoCee™ MP, NV MP, NV L34066 MolDX: Circulating A55598 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Tumor Cell Marker Assays MolDX: OncoCee™ ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L35071 MolDX: Circulating A53112 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Tumor Cell Marker Assays MolDX: OncoCee™ TN, VA, WV TN, VA, WV N/A A55245 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, MolDX: OncoCee™ CA, CO, CT, DE, MO, NE 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 Oncotype DX® Breast Cancer Assay L36021 Molecular Diagnostic A54195 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Oncotype DX® Breast Cancer Assay

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LCD Article Contractor Medicare Part A Medicare Part B L35160 MolDX: Molecular A54480 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Oncotype DX® Breast MP, NV MP, NV Cancer Assay L36256 MolDX: Molecular A54482 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Oncotype DX® Breast ND, OR, SD, UT, ND, OR, SD, UT, Cancer Assay WA, WY WA, WY L35025 MolDX: Molecular A53105 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: Oncotype DX® Breast TN, VA, WV TN, VA, WV Cancer Assay Oncotype DX® Breast Cancer Assay L36807 MolDX: Molecular A55230 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Oncotype DX® Breast CA, CO, CT, DE, MO, NE Cancer Assay 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 Oncotype DX® Breast Cancer for DCIS Genomic Health™ L36951 MolDX: Oncotype DX® A56887 Billing and Coding: CGS KY, OH KY, OH Breast Cancer for DCIS MolDX: Oncotype DX® Breast (Genomic Health™) Cancer for DCIS (Genomic Health™) L36941 MolDX: Oncotype DX® A57619 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Breast Cancer for DCIS MolDX: Oncotype DX® Breast MP, NV MP, NV (Genomic Health™) Cancer for DCIS (Genomic Health™) L36947 MolDX: Oncotype DX® A57620 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Breast Cancer for DCIS MolDX: Oncotype DX® Breast ND, OR, SD, UT, ND, OR, SD, UT, (Genomic Health™) Cancer for DCIS (Genomic WA, WY WA, WY Health™) L36912 MolDX: Oncotype DX® A56870 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Breast Cancer for DCIS MolDX: Oncotype DX® Breast TN, VA, WV TN, VA, WV (Genomic Health™) Cancer for DCIS (Genomic Health™) L37199 MolDX: Oncotype DX® A57583 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Breast Cancer for DCIS MolDX: Oncotype DX® Breast CA, CO, CT, DE, MO, NE (Genomic Health™) Cancer for DCIS (Genomic FL, GA, HI, IA, Health™) 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

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LCD Article Contractor Medicare Part A Medicare Part B Oncotype DX® Colon Cancer Assay L36021 Molecular Diagnostic A54196 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Oncotype DX® Colon Cancer Guidelines L35160 MolDX: Molecular A54484 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Oncotype DX® Colon MP, NV MP, NV Cancer Oncotype DX® Colon Cancer Assay L36256 MolDX: Molecular A54486 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Oncotype DX® Colon ND, OR, SD, UT, ND, OR, SD, UT, Cancer WA, WY WA, WY L35025 MolDX: Molecular A53106 MolDX: Oncotype DX® Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) Colon Cancer Assay Update TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55231 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Oncotype DX® Colon CA, CO, CT, DE, MO, NE Cancer Assay Update 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 Oncotype DX® Prostate Cancer Assay/Prostate Score L36206 (MolDX: Genomic A56976 (Billing and Coding: CGS KY, OH KY, OH Health™ Oncotype DX® Prostate MolDX: Genomic Health™ Cancer Assay) Oncotype DX® Prostate Cancer Retired 11/07/2020 Assay) L37354 MolDX: Oncotype DX® Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer Retired 11/07/2020; See L38303 N/A A56345 Billing and Coding: MolDX: Oncotype DX® Genomic Prostate Score L36364 MolDX: (Genomic A56371 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Health™) Oncotype DX® Prostate MolDX: (Genomic Health™) MP, NV MP, NV Cancer Assay Oncotype DX® Prostate Cancer L37305 MolDX: Oncotype DX® Assay Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer

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LCD Article Contractor Medicare Part A Medicare Part B L36368 MolDX: (Genomic A56372 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Health™) Oncotype DX® Prostate MolDX: Oncotype DX® Genomic ND, OR, SD, UT, ND, OR, SD, UT, Cancer Assay Prostate Score WA, WY WA, WY L37321 MolDX: Oncotype DX® Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer Oncotype DX® Prostate Cancer Assay/Prostate Score L36153 MolDX: (Genomic A56285 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Health™) Oncotype DX® Prostate MolDX: (Genomic Health™) TN, VA, WV TN, VA, WV Cancer Assay Oncotype DX® Prostate Cancer Retired 11/07/2020 Assay L37262 MolDX: Oncotype DX® Retired 11/07/2020 Genomic Prostate Score for Men with Favorable Intermediate Risk Prostate Cancer Retired 11/07/2020 L36789 MolDX: (Genomic A56334 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Health™) Oncotype DX® Prostate MolDX: (Genomic Health™) CA, CO, CT, DE, MO, NE Cancer Assay Oncotype DX® Prostate Cancer FL, GA, HI, IA, Retired 11/07/2020 Assay ID, IL, IN, KS, KY, LA, MA, MD, L37667 MolDX: Oncotype DX® Retired 11/07/2020 ME, MI, MO, MS, Genomic Prostate Score for MT, NC, ND, NE, Men with Favorable NH, NJ, NM, NV, Intermediate Risk Prostate OH, OK, OR, PA, Cancer RI, SC, SD, TN, Retired 11/07/2020 TX, UT, VA, VT, WA, WI, WV, WY Ovarian Cancer Testing L38371 Multimarker Serum A57020 Billing and Coding: NGS CT, IL, MA, ME, CT, IL, MA, ME, Tests Related to Ovarian Cancer Multimarker Serum Tests Related MN, NH, NY, RI, MN, NH, NY, RI, Testing to Ovarian Cancer Testing VT, WI VT, WI Pharmacogenomics Testing L38394 MolDX: A58324 Billing and Coding: CGS KY, OH KY, OH Pharmacogenomics Testing MolDX: Pharmacogenomics Effective 08/03/2020 Testing L35332 MolDX: CYP2C19, A56864 Billing and Coding: CYP2D6, CYP2C9, and MolDX: CYP2C19, CYP2D6, VKORC1 Genetic Testing CYP2C9, and VKORC1 Genetic Retired 07/25/2020 Testing Retired 07/25/2020 L38335 MolDX: A57384 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Pharmacogenomics Testing MolDX: Pharmacogenomics MP, NV MP, NV Effective 08/17/2020 Testing

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LCD Article Contractor Medicare Part A Medicare Part B L36310 MolDX: CYP2C19, A57378 Billing and Coding: CYP2D6, CYP2C9, and MolDX: CYP2C19, CYP2D6, VKORC1 Genetic Testing CYP2C9, and VKORC1 Genetic Retired 08/16/2020 Testing Retired 08/16/2020 Pharmacogenomics Testing L38337 MolDX: A57385 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Pharmacogenomics Testing MolDX: Pharmacogenomics ND, OR, SD, UT, ND, OR, SD, UT, Effective 08/17/2020 Testing WA, WY WA, WY L36312 MolDX: CYP2C19, A57522 Billing and Coding: CYP2D6, CYP2C9, and MolDX: CYP2C19, CYP2D6, VKORC1 Genetic Testing CYP2C9, and VKORC1 Genetic Retired 08/16/2020 Testing Retired 08/16/2020 L38294 MolDX: A58318 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Pharmacogenomics Testing MolDX: Pharmacogenomics TN, VA, WV TN, VA, WV Effective 07/26/2020 Testing L35072 MolDX: CYP2C19, A56842 Billing and Coding: CYP2D6, CYP2C9, and MolDX: CYP2C19, CYP2D6, VKORC1 Genetic Testing CYP2C9, and VKORC1 Genetic Retired 07/25/2020 Testing Retired 07/25/2020 L38435 MolDX: A58395 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Pharmacogenomics Testing MolDX: Pharmacogenomics CA, CO, CT, DE, MO, NE Effective 07/26/2020 Testing FL, GA, HI, IA, ID, IL, IN, KS, L36398 MolDX: CYP2C19, A57717 Billing and Coding: KY, LA, MA, MD, CYP2D6, CYP2C9, and MolDX: CYP2C19, CYP2D6, ME, MI, MO, MS, VKORC1 Genetic Testing CYP2C9, and VKORC1 Genetic MT, NC, ND, NE, Retired 07/25/2020 Testing NH, NJ, NM, NV, Retired 07/25/2020 OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY L35698 CYP2C19, CYP2D6, A57704 Billing and Coding: First Coast FL, PR, VI FL, PR, VI CYP2C9, and VKORC1 Genetic CYP2C19, CYP2D6, CYP2C9, and Testing VKORC1 Genetic Testing Pharmacogenomic Testing for Warfarin Response N/A A53848 NCD - Pharmacogenomic First Coast FL, PR, VI FL, PR, VI Testing for Warfarin Response N/A A54687 Billing and Coding: CGS KY, OH KY, OH MolDX: CYP2C9 and/or VKORC1 Gene Testing for Warfarin Response Retired 08/10/2020 N/A A55179 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: CYP2C9 and/or VKORC1 MP, NV MP, NV Gene Testing for Warfarin Response Retired 11/04/2020

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LCD Article Contractor Medicare Part A Medicare Part B N/A A55180 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: CYP2C9 and/or VKORC1 ND, OR, SD, UT, ND, OR, SD, UT, Gene Testing for Warfarin WA, WY WA, WY Response Retired 11/04/2020 Pharmacogenomic Testing for Warfarin Response N/A A53524 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: CYP2C9 and/or VKORC1 TN, VA, WV TN, VA, WV Gene Testing for Warfarin Response Retired 08/10/2020 N/A A55532 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, MolDX: CYP2C9 and/or VKORC1 CA, CO, CT, DE, MO, NE Gene Testing for Warfarin FL, GA, HI, IA, Response ID, IL, IN, KS, Retired 08/10/2020 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 Pigmented Lesion Assay L38111 MolDX: Pigmented A57915 Billing and Coding: CGS KY, OH KY, OH Lesion Assay MolDX: Pigmented Lesion Assay L38151 MolDX: Pigmented A58052 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Lesion Assay MolDX: Pigmented Lesion Assay MP, NV MP, NV L38153 MolDX: Pigmented A58053 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Lesion Assay MolDX: Pigmented Lesion Assay ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L38051 MolDX: Pigmented A57868 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Lesion Assay MolDX: Pigmented Lesion Assay TN, VA, WV TN, VA, WV L38178 MolDX: Pigmented A57983 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Lesion Assay MolDX: Pigmented Lesion Assay CA, CO, CT, DE, MO, NE 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 PIK3CA Gene Tests L36021 Molecular Diagnostic A54295 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: PIK3CA Gene Tests N/A A55597 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: PIK3CA Gene Tests MP, NV MP, NV

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LCD Article Contractor Medicare Part A Medicare Part B N/A A55602 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: PIK3CA Gene Tests ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53558 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: PIK3CA Gene Tests TN, VA, WV TN, VA, WV PIK3CA Gene Tests L36807 MolDX: Molecular A55200 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: PIK3CA Gene Tests CA, CO, CT, DE, MO, NE 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 Plasma-Based Genomic Profiling in Solid Tumors L38065 MolDX: Plasma-Based A57917 Billing and Coding: CGS KY, OH KY, OH Genomic Profiling in Solid MolDX: Plasma-Based Genomic Tumors Profiling in Solid Tumors Effective 07/20/2020 L38043 MolDX: Plasma-Based A57867 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Genomic Profiling in Solid MolDX: Plasma-Based Genomic TN, VA, WV TN, VA, WV Tumors Profiling in Solid Tumors Effective 02/03/2020 L38168 MolDX: Plasma-Based A57936 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Genomic Profiling in Solid MolDX: Plasma-Based Genomic CA, CO, CT, DE, MO, NE Tumors Profiling in Solid Tumors FL, GA, HI, IA, Effective 03/15/2020 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 PreDx® L36021 Molecular Diagnostic A54296 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: PreDx® N/A A55594 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: PreDx® MP, NV MP, NV N/A A55599 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: PreDx® ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53489 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: PreDx® TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B PreDx® L36807 MolDX: Molecular A55201 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT)) MolDX: PreDx® CA, CO, CT, DE, MO, NE 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 Progensa® PCA3 Assay L36021 Molecular Diagnostic A54197 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Progensa® PCA3 Assay Coverage Update L35160 MolDX: Molecular A54489 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Progensa® PCA3 Assay MP, NV MP, NV L36256 MolDX: Molecular A54492 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Progensa® PCA3 Assay ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L35025 MolDX: Molecular A53107 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: Progensa® PCA3 Assay TN, VA, WV TN, VA, WV Coverage Update L36807 MolDX: Molecular A55202 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Progensa® PCA3 Assay CA, CO, CT, DE, MO, NE Coverage Update 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 Prolaris™ Prostate Cancer Genomic Assay L36002 MolDX: Prolaris™ A57303 Billing and Coding: CGS KY, OH KY, OH Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer Genomic Assay L37142 MolDX: Prolaris™ A56925 Billing and Coding: Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer for Men with Favorable Genomic Assay for Men with Intermediate Risk Disease Favorable Intermediate Risk Disease

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LCD Article Contractor Medicare Part A Medicare Part B Prolaris™ Prostate Cancer Genomic Assay L36348 MolDX: Prolaris™ A57509 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer MP, NV MP, NV Genomic Assay L37080 MolDX: Prolaris™ A57514 Billing and Coding: Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer for Men with Favorable Genomic Assay for Men with Intermediate Risk Disease Favorable Intermediate Risk Disease L36350 MolDX: Prolaris™ A57511 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer ND, OR, SD, UT, ND, OR, SD, UT, Genomic Assay WA, WY WA, WY L37082 MolDX: Prolaris™ A57691 Billing and Coding: Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer for Men with Favorable Genomic Assay for Men with Intermediate Risk Disease Favorable Intermediate Risk Disease L35869 MolDX: Prolaris™ A56918 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer TN, VA, WV TN, VA, WV Genomic Assay L37043 MolDX: Prolaris™ A56911 Billing and Coding: Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer for Men with Favorable Genomic Assay for Men with Intermediate Risk Disease Favorable Intermediate Risk Disease L36787 MolDX: Prolaris™ A57585 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer CA, CO, CT, DE, MO, NE Genomic Assay FL, GA, HI, IA, L37226 MolDX: Prolaris™ A57586 Billing and Coding: ID, IL, IN, KS, Prostate Cancer Genomic Assay MolDX: Prolaris™ Prostate Cancer KY, LA, MA, MD, for Men with Favorable Genomic Assay for Men with ME, MI, MO, MS, Intermediate Risk Disease Favorable Intermediate Risk MT, NC, ND, NE, Disease NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY Prostate Cancer Genomic Classifier Assay for Men with Localized Disease L38303 MolDX: Prostate Cancer A58371 Billing and Coding: CGS KY, OH KY, OH Genomic Classifier Assay for MolDX: Prostate Cancer Genomic Men with Localized Disease Classifier Assay for Men with Effective 11/09/2020 Localized Disease L38339 MolDX: Prostate Cancer A57372 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Genomic Classifier Assay for MolDX: Prostate Cancer Genomic MP, NV MP, NV Men with Localized Disease Classifier Assay for Men with Effective 12/06/2020 Localized Disease L38341 MolDX: Prostate Cancer A57236 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Genomic Classifier Assay for MolDX: Prostate Cancer Genomic ND, OR, SD, UT, ND, OR, SD, UT, Men with Localized Disease Classifier Assay for Men with WA, WY WA, WY Effective 12/06/2020 Localized Disease

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LCD Article Contractor Medicare Part A Medicare Part B Prostate Cancer Genomic Classifier Assay for Men with Localized Disease L38292 MolDX: Prostate Cancer A58343 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Genomic Classifier Assay for MolDX: Prostate Cancer Genomic TN, VA, WV TN, VA, WV Men with Localized Disease Classifier Assay for Men with Effective 11/08/2020 Localized Disease L38433 MolDX: Prostate Cancer A57106 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Genomic Classifier Assay for MolDX: Prostate Cancer Genomic CA, CO, CT, DE, MO, NE Men with Localized Disease Classifier Assay for Men with FL, GA, HI, IA, Effective 11/08/2020 Localized Disease 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 Repeat Germline Testing L38288 MolDX: Repeat A57141 Billing and Coding: CGS KY, OH KY, OH Germline Testing MolDX: Repeat Germline Testing L38351 MolDX: Repeat A57331 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Germline Testing MolDX: Repeat Germline Testing MP, NV MP, NV L38353 MolDX: Repeat A57332 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Germline Testing MolDX: Repeat Germline Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L38274 MolDX: Repeat A58017 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Germline Testing MolDX: Repeat Germline Testing TN, VA, WV TN, VA, WV L38429 MolDX: Repeat A57100 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Germline Testing MolDX: Repeat Germline Testing CA, CO, CT, DE, MO, NE 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 ResponseDX Tissue of Origin® L36021 Molecular Diagnostic A54198 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: ResponseDX Tissue of Origin® L35160 MolDX: Molecular A54494 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDx: ResponseDX Tissue of MP, NV MP, NV Origin® L36256 MolDX: Molecular A54496 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDx: ResponseDX Tissue of ND, OR, SD, UT, ND, OR, SD, UT, Origin® WA, WY WA, WY

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LCD Article Contractor Medicare Part A Medicare Part B ResponseDX Tissue of Origin® L35025 MolDX: Molecular A53108 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDx: ResponseDX Tissue of TN, VA, WV TN, VA, WV Origin® L36807 MolDX: Molecular A55204 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDx: ResponseDX Tissue of CA, CO, CT, DE, MO, NE Origin® 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 SEPT9 Gene Test L36021 Molecular Diagnostic A54300 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDx: SEPT9 Gene Test N/A A55623 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: SEPT9 Gene Test MP, NV MP, NV N/A A55628 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: SEPT9 Gene Test ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53702 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: SEPT9 Gene Test TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55206 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: SEPT9 Gene Test CA, CO, CT, DE, MO, NE 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 Short Tandem Repeat STR Markers and Chimerism L36021 Molecular Diagnostic A54830 Billing and Coding: Short CGS KY, OH KY, OH Tests (MDT) Tandem Repeat (STR) Markers and Chimerism (CPT® codes 81265-81268) N/A A54832 Billing and Coding: Short Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Tandem Repeat (STR) Markers TN, VA, WV TN, VA, WV and Chimerism (CPT® codes 81265-81268)

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LCD Article Contractor Medicare Part A Medicare Part B Short Tandem Repeat STR Markers and Chimerism L36807 MolDX: Molecular A55621 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Short Tandem Repeat CA, CO, CT, DE, MO, NE (STR) Markers and Chimerism FL, GA, HI, IA, codes 81265-81268 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 SLCO1B1 Genotype Retired; See Pharmacogenomic Testing L36021 Molecular Diagnostic A54286 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: SLCO1B1 Genotype Retired 08/02/2020 N/A A55626 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: SLCO1B1 Genotype MP, NV MP, NV Retired 11/04/2020 N/A A55630 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: SLCO1B1 Genotype ND, OR, SD, UT, ND, OR, SD, UT, Retired 11/04/2020 WA, WY WA, WY N/A A53698 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: SLCO1B1 Genotype TN, VA, WV TN, VA, WV Retired 11/04/2020 L36807 MolDX: Molecular A55207 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: SLCO1B1 Genotype CA, CO, CT, DE, MO, NE Retired 11/04/2020 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 SMPD1 Genetic Testing L36021 Molecular Diagnostic A54285 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: SMPD1 Genetic Testing N/A A55627 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: SMPD1 Genetic Testing MP, NV MP, NV N/A A55631 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: SMPD1 Genetic Testing ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53624 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: SMPD1 Genetic Testing TN, VA, WV TN, VA, WV

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LCD Article Contractor Medicare Part A Medicare Part B SMPD1 Genetic Testing L36807 MolDX: Molecular A55208 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: SMPD1 Genetic Testing CA, CO, CT, DE, MO, NE 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 Testing of Multiple Genes N/A A57910 Billing and Coding: CGS KY, OH KY, OH MolDX: Testing of Multiple Genes N/A A58120 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: Testing of Multiple Genes MP, NV MP, NV N/A A58121 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: Testing of Multiple Genes ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A57503 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: Testing of Multiple Genes TN, VA, WV TN, VA, WV N/A A57880 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, MolDX: Testing of Multiple Genes CA, CO, CT, DE, MO, NE 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 ThermoFisher Oncomine Dx Target Test For Non-Small Cell Lung Cancer N/A A55851 Billing and Coding: CGS KY, OH KY, OH MolDX: ThermoFisher Oncomine Dx Target Test For Non-Small Cell Lung Cancer L35160 MolDX: Molecular A55881 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: ThermoFisher Oncomine MP, NV MP, NV Dx Target Test For Non-Small Cell Lung Cancer L36256 MolDX: Molecular A55888 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: ThermoFisher Oncomine ND, OR, SD, UT, ND, OR, SD, UT, Dx Target Test For Non-Small Cell WA, WY WA, WY Lung Cancer

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 47 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B ThermoFisher Oncomine Dx Target Test For Non-Small Cell Lung Cancer L35025 MolDX: Molecular A55822 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: ThermoFisher Oncomine TN, VA, WV TN, VA, WV Dx Target Test For Non-Small Cell Lung Cancer L36807 MolDX: Molecular A55846 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: ThermoFisher Oncomine™ CA, CO, CT, DE, MO, NE Dx Target Test For Non-Small Cell FL, GA, HI, IA, Lung Cancer 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 TP53 Gene Test L36021 Molecular Diagnostic A54281 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: TP53 Gene Test N/A A55484 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: TP53 Gene Tests MP, NV MP, NV N/A A55487 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: TP53 Gene Tests ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY N/A A53591 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: TP53 Gene Test TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55221 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: TP53 Gene Test CA, CO, CT, DE, MO, NE 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 UGT1A1 Gene Analysis Retired; See Pharmacogenomics Testing L36021 Molecular Diagnostic A54280 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: UGT1A1 Gene Analysis Retired 08/11/2020 N/A A55482 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, MolDX: UGT1A1 Gene Analysis MP, NV MP, NV Retired 11/04/2020 N/A A55483 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, MolDX: UGT1A1 Gene Analysis ND, OR, SD, UT, ND, OR, SD, UT, Retired 11/04/2020 WA, WY WA, WY

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 48 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

LCD Article Contractor Medicare Part A Medicare Part B UGT1A1 Gene Analysis Retired; See Pharmacogenomics Testing N/A A53593 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, MolDX: UGT1A1 Gene Analysis TN, VA, WV TN, VA, WV Retired 08/06/2020 L36807 MolDX: Molecular A55222 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: UGT1A1 Gene Analysis CA, CO, CT, DE, MO, NE Retired 08/06/2020 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 Vectra™ DA L36021 Molecular Diagnostic A54201 Billing and Coding: CGS KY, OH KY, OH Tests (MDT) MolDX: Vectra™ DA L35160 MolDX: Molecular A54503 Billing and Coding: Noridian AS, CA, GU, HI, AS, CA, GU, HI, Diagnostic Tests (MDT) MolDX: Vectra™ DA MP, NV MP, NV L36256 MolDX: Molecular A54505 Billing and Coding: Noridian AK, AZ, ID, MT, AK, AZ, ID, MT, Diagnostic Tests (MDT) MolDX: Vectra™ DA ND, OR, SD, UT, ND, OR, SD, UT, WA, WY WA, WY L35025 MolDX: Molecular A53110 Billing and Coding: Palmetto AL, GA, NC, SC, AL, GA, NC, SC, Diagnostic Tests (MDT) MolDX: Vectra™ DA TN, VA, WV TN, VA, WV L36807 MolDX: Molecular A55223 Billing and Coding: WPS AK, AL, AR, AZ, IA, IN, KS, MI, Diagnostic Tests (MDT) MolDX: Vectra™ DA CA, CO, CT, DE, MO, NE 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

CMS Benefit Policy Manual Chapter 15; § 80.1–80.1.3 Clinical Laboratory Services

CMS Claims Processing Manual Chapter 12; § 60 Payment for Pathology Services Chapter 16, § 10.2 General Explanation of Payment; § 20 Calculation of Payment Rates - Clinical Laboratory Test Fee Schedules; § 40 Billing for Clinical Laboratory Tests

CMS Transmittals Transmittal 214, Change Request 10878, Dated 03/06/2019 (National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS))

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 49 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Transmittal 215, Change Request 10878, Dated 04/10/2019 (National Coverage Determination (NCD90.2): Next Generation Sequencing (NGS)) Transmittal 2200, Change Request 10859, Dated 11/08/2018 (International Classification of Diseases, Tenth Revision (ICD - 10) and Other Coding Revisions to National Coverage Determinations (NCDs)) Transmittal 2439, Change Request 11655, Dated 02/21/2020 (International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--July 2020 Update) Transmittal 4481, Change Request 11574, Dated 12/20/2019 (Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 – Laboratory Date of Service Policy) Transmittal 10092, Change Request 11749, Dated 05/01/2020 (International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--October 2020 Update) Transmittal 10193, Change Request 11655, Dated 06/19/2020 (International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--July 2020 Update) Transmittal 10261, Change Request 11905, Dated 07/31/2020 (International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--January 2021 Update) Transmittal 10346, Change Request 11837, Dated 09/11/2020 (National Coverage Determination (NCD 90.2): Next Generation Sequencing (NGS) for Medicare Beneficiaries with Germline (Inherited) Cancer) Transmittal 10624, Change Request 12124, Dated 03/23/2021 (International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs)--July 2021)

UnitedHealthcare Commercial Policies Carrier Testing for Genetic Diseases Cell-Free Fetal DNA Testing Chromosome Microarray Testing (Non - Oncology Conditions) Genetic Testing for Cardiac Disease Genetic Testing for Hereditary Cancer Genetic Testing for Neuromuscular Disorders Infertility Diagnosis and Treatment Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions Omnibus Codes Pharmacogenetic Testing Preimplantation Genetic Testing Whole Exome and Whole Sequencing

Others CMS Clinical Laboratory Fee Schedule, CMS Website Palmetto GBA MolDx Website

Guideline History/Revision Information

Revisions to this summary document do not in any way modify the requirement that services be provided and documented in accordance with the Medicare guidelines in effect on the date of service in question.

Date Summary of Changes 05/12/2021 Applicable Codes CPT/HCPCS Codes Provisional Coverage Added 0242U and 0245U Diagnosis Codes For CPT code 0245U (effective Apr. 1, 2021) Added D34, D44.0, D44.9, E01.0, E01.1, E01.2, E04.0, E04.1, E04.2, E04.8, and E04.9 For CPT code 0228U Removed C61 Supporting Information

Molecular Pathology/Molecular Diagnostics/Genetic Testing Page 50 of 52 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/12/2021 Proprietary Information of UnitedHealthcare. Copyright 2021 United HealthCare Services, Inc.

Date Summary of Changes Updated References section to reflect the most current information Archived previous policy version MPG210.16

Purpose

The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare Advantage claims processing activities and facilitate providers’ submission of accurate claims for the specified services. The document can be used as a guide to help determine applicable: Medicare coding or billing requirements, and/or Medical necessity coverage guidelines; including documentation requirements.

UnitedHealthcare follows Medicare guidelines such as NCDs, LCDs, LCAs, and other Medicare manuals for the purposes of determining coverage. It is expected providers retain or have access to appropriate documentation when requested to support coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this resource document. This document is not a replacement for the Medicare source materials that outline Medicare coverage requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply.

Terms and Conditions

The Medicare Advantage Policy Guidelines are applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its affiliates.

These Policy Guidelines are provided for informational purposes, and do not constitute medical advice. Treating physicians and healthcare providers are solely responsible for determining what care to provide to their patients. Members should always consult their physician before making any decisions about medical care.

Benefit coverage for health services is determined by the member specific benefit plan document* and applicable laws that may require coverage for a specific service. The member specific benefit plan document identifies which services are covered, which are excluded, and which are subject to limitations. In the event of a conflict, the member specific benefit plan document supersedes the Medicare Advantage Policy Guidelines.

Medicare Advantage Policy Guidelines are developed as needed, are regularly reviewed and updated, and are subject to change. They represent a portion of the resources used to support UnitedHealthcare coverage decision making. UnitedHealthcare may modify these Policy Guidelines at any time by publishing a new version of the policy on this website. Medicare source materials used to develop these guidelines include, but are not limited to, CMS National Coverage Determinations NCDs, Local Coverage Determinations LCDs, Medicare Benefit Policy Manual, Medicare Claims Processing Manual, Medicare Program Integrity Manual, Medicare Managed Care Manual, etc. The information presented in the Medicare Advantage Policy Guidelines is believed to be accurate and current as of the date of publication and is provided on an "AS IS" basis. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply.

You are responsible for submission of accurate claims. Medicare Advantage Policy Guidelines are intended to ensure that coverage decisions are made accurately based on the code or codes that correctly describe the health care services provided. UnitedHealthcare Medicare Advantage Policy Guidelines use Current Procedural Terminology CPT®, Centers for Medicare and Medicaid Services CMS, or other coding guidelines. References to CPT® or other sources are for definitional purposes only and do not imply any right to reimbursement or guarantee claims payment.

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81334 81335 81338 81339 81340 81341 81342 81343 81344 81345 81347 81348 81350 81351 81352 81353 81355 81357 81360 81419 81427 81437 81438 81445 81450 81455 81490 81503 81504 81518 81519 81520 81521 81522 81525 81529 81538 81539 81540 81541 81542 81545 81546 81551 81552 81554 81595 86294 86316 86386 88120 88121 88341 88342 81230 81234 81238 81239 81242 81243 81244 81248 81249 81257 81258 81259 81260 81271 81274 81284 81285 81286 81289 81290 81291 81302 81303 information81304 are81324 strictly 81325prohibited. 81326 81329 81330 81331 81336 81337 81346 81361 81362 81363 81364 81410 81411 81412 81413 81414 81415 81416 81417 81420 81422 81425 81426 81430 81431 81434 81440 81442 81443 81448 81460 81465 81470 81471 81493 81500 81506 86152 86153 0001U 0004M 0005U 0006M 0006U 0007M 0009M 0009U 0011M 0012U 0013U 0014U 0016U 0017U 0018U 0019U 0021U 0022U 0023U 0024U 0026U 0027U 0029U 0030U 0031U 0032U 0033U 0034U 0036U 0037U 0039U 0040U 0045U 0046U 0047U 0048U 0049U 0050U 0053U 0055U 0056U 0057U 0058U 0059U 0062U 0067U 0070U 0071U 0072U 0073U 0074U 0075U 0076U 0078U 0079U 0080U 0081U 0084U 0085U 0087U 0088U 0089U 0090U 0091U 0092U 0094U 0104U 0105U 0108U 0111U 0113U 0114U 0118U 0120U 0153U 0154U 0155U 0156U 0157U 0172U 81120 81121 81170 81175 81176 81177 81178 81179 81180 81181 81182 81183 81184 81185 81186 81187 81188 81189 81190 81201 81202 81203 81206 81207 81208 81209 81210 81218 81219 81220 81221 81222 81223 81224 81225 81226 81227 81231 81232 81233 81235 81236 81237 81240 81241 81245 81246 81247 81250 81251 81252 81253 81254 81255 81256 81261 81262 81263 81264 81265 81266 81267 81268 81269 81270 81272 81273 81275 81276 81277 81283 81287 81301 81305 81306 81309 81310 81311 81312 81313 81314 81315 81316 81320 81321 81322 81323 81327 81328 81332 81333 81334 81335 81340 81341 81342 81343 81344 81345 81350 81355 81427 81437 81438 81445 81450 81455 81490 81503 81504 81518 81519 81520 81521 81522 81525 81538 81539 81540 81541 81542 81545 81551 81552 81595 86294 86316 86386 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