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eviCore Lab Management
MA06.034v

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

The intent of this policy is to communicate that the Company has delegated the responsibility for utilization management activities of genetic/genomic tests and certain molecular analyses and cytogenetic tests to CareCore National, LLC d/b/a eviCore healthcare (eviCore), with the exception of services performed in the emergency room or during an inpatient or observation unit stay.

PRE-SERVICE REVIEWS

The Company requires pre-service reviews for certain genetic/genomic tests through CareCore National, LLC d/b/a eviCore healthcare (eviCore), including but not limited to:
  • BRCA gene testing (breast and ovarian cancer syndrome)
  • Lynch syndrome gene testing
  • Cystic fibrosis full gene sequencing and deletion/duplication analyses
  • Select pharmacogenomic testing
  • Genetic Panels (e.g., cancer type panels for colon, breast, or neuroendocrine cancers)
  • Cancer gene expression tests (e.g., OncotypeDX®, MammaPrint®, Afirma® Thyroid Fine-Needle Aspiration [FNA] Analysis)
  • Tumor molecular profiling (e.g., FoundationOne®, neoTYPE™, OncoPlexDX®)
  • Expanded carrier screening panels (e.g., Carrier Status DNA Insight®, Counsyl Family Prep Screen, Pan-Ethnic Carrier Screening)
  • Genome-wide tests (e.g., microarray studies, whole exome testing, whole genome testing, mitochondrial genome or nuclear testing)
Refer to Attachment A of this policy for a complete list of procedure codes that represent genetic/genomic tests requiring pre-service reviews. In addition to the requirement for pre-service reviews, the procedure codes listed in Attachment A will undergo prepayment reviews.

Genetic/genomic tests, which are listed in Attachment A of this policy, that do not meet coverage criteria may be considered experimental/investigational or not medically necessary, and, therefore, are not covered.

PREPAYMENT REVIEWS

All genetic/genomic tests, along with certain molecular analyses (e.g., immunohistochemistry [IHC], morphometric analyses, flow cytometry) and molecular cytogenetic tests (e.g., fluorescent in situ hybridization [FISH], karyotyping), will be reviewed prior to claim payment through CareCore National, LLC d/b/a eviCore healthcare (eviCore).

In addition to the procedure codes in Attachment A, refer to Attachment B of this policy for a list of additional procedure codes that represent laboratory tests that will undergo prepayment reviews. The procedure codes listed in Attachment B do not require pre-service reviews.

Genetic/genomic tests, molecular analyses, and cytogenetic tests, which are listed in Attachment B of this policy, that do not meet coverage criteria may be considered experimental/investigational or not medically necessary, and, therefore, not covered.

EVICORE LAB MANAGEMENT PROGRAM CLINICAL GUIDELINES​

eviCore utilizes any official, applicable, and published policy related communications by Centers for Medicare & Medicaid Services (CMS), Medicare Administrative Contractors (MAC), and MolDX® Program administered by the Palmetto GBA MAC; and its Lab Management Program Clinical Guidelines for medical necessity determination related to the delegated genetic/genomic tests and certain molecular analyses and cytogenetic tests. Please see the administrative guidelines entitled Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing (MOL.AD.101.B) for further information. 

eviCore's Lab Management Program Clinical Guidelines are available at: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=Independence Blue CrossviCore healthcare​.

REQUIRED DOCUMENTATION

The individual’s medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.​

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, genetic/genomic tests, molecular analyses, and cytogenetic tests are covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria for the services are met. However, services that are identified as experimental/investigational or not medically necessary are not eligible for coverage or reimbursement by the company.

Procedure codes listed in this policy also continue to be subject to Company claims adjudication logic, eligibility, benefits, limitations, exclusions, referral requirements, provider contracts, and Company policies.

Description

The Company has delegated utilization management of genetic/genomic testing and certain molecular analyses and cytogenetic tests to Misspelled WordCareCore National, LLC d/b/a Misspelled WordeviCore healthcare (Misspelled WordeviCore). This utilization management program through Misspelled WordeviCore will encompass pre-service reviews and/or prepayment reviews as follows:
  • Pre-service reviews will be required for certain genetic/genomic tests.
  • All genetic/genomic tests, along with certain molecular analyses and cytogenetic tests, will be reviewed prior to claim payment.​
Misspelled WordeviCore utilizes any official, applicable, and published policy related communications by Centers for Medicare & Medicaid Services (CMS), Medicare Administrative Contractors (MAC), and Misspelled WordMolDX​® Program administered by the Palmetto GBA MAC; and its Lab Management Program Clinical Guidelines for medical necessity determination related to the delegated genetic/genomic tests and certain molecular analyses and cytogenetic tests. Please see the administrative guidelines entitled Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing (MOL.AD.101.B) for further information.​

Misspelled WordMisspelled WordeviCore's Lab Management Program Clinical Guidelines are based on peer-reviewed literature, evidence-based guidelines and recommendations from national and international medical societies, and evidence-based medical research centers, including, but not limited to, the National Comprehensive Cancer Network (NCCN), the American College of Obstetricians and Gynecologists (ACOG), the American College of Medical Genetics and Genomics (ACMG), the American Society for Human Genetics (ASHG), the European Federation of Neurological Societies (EFNS), the American Academy of Neurology (AAN), the National Society of Genetic Counselors (NSGC), the Society for Assisted Reproductive Technology (SART), the American Society for Reproductive Medicine (ASRM), the American Thoracic Society (ATS), the European Respiratory Society (ERS), and the American Society of Clinical Oncology (ASCO).

References

CareCore National, LLC d/b/a eviCore healthcare. Clinical Guidelines: Lab Management Program. Available at: https://www.evicore.com/provider/clinical-guidelines-details?solution=laboratory management&hPlan=Independence Blue CrossviCore healthcare​.

Coding

CPT Procedure Code Number(s)
See Attachments A and B.
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)
See Attachments A and B.
Revenue Code Number(s)
N/A

​

Coding and Billing Requirements

Policy History

Revisions From MA06.034v:​
07/01/2026This version of the policy will become effective on 07/01/2026.​

Effective 07/01/2026, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

Applicable procedure codes from the 29 new PLA codes: 0631U-0659U​: 0631U, 0632U, 0633U, 0634U, 0635U, 0641U, 0642U, 0643U, 0644U, 0645U, 0646U, 0647U, 0648U, 0649U, 0650U, 0651U, 0652U, 0653U, 0657U, 0658U, & 0659U. 

REVISED

Applicable procedures codes from the 04 PLA codes, which had non-substantive revisions: 0034U, 0488U, 0522U, 0598U


DELETED 

Applicable procedures codes from the 04 PLA codes, which were deleted in this release: 0029U, 0031U, 0423U, 0577U

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On July 01st, 2026, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2026. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

07/01/2026 Guideline Updates for eviCore Lab Management Program (Policy #: 06.02.52ao)

Executive Summary of Changes

There are two new guideline. 64 existing guidelines have been revised (including 32 with substantive criteria changes, which include 15 ​Billing and Reimbursement Process Updates ). Thirteen guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Hereditary Cancer Syndrome Genetic Testing
  2. Cologuard Plus Screening for Colorectal Cancer​

​Criteria Updates (Substantive):

  1. Immunohistochemistry (IHC)
  2. Experimental, Investigational, or Unproven Laboratory Testing
  3. Pharmacogenomic Testing for Drug Toxicity and Response
  4. Carrier Screening Panels, Including Targeted, Pan-Ethnic, Universal, and Expanded
  5. Familial Hypercholesterolemia Genetic Testing
  6. Liquid Biopsy Testing
  7. Mammaprint 70-Gene Breast Cancer Recurrence Assay
  8. Oncotype DX for Breast Cancer Prognosis
  9. Somatic Mutation Testing
  10. BCR-ABL Negative Myeloproliferative Neoplasm Testing
  11. Mitochondrial Disorders Genetic Testing
  12. Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental Disorders
  13. Respiratory Infection Pathogen Panel (RIPP) Molecular Testing
  14. Human Immunodeficiency Virus Laboratory Testing
  15. Infectious Disease Laboratory Testing
  16. Nail Disorder Infectious Disease Testing, Including Onychomycosis
  17. Urinary Tract Infection Molecular Testing 

​Billing and Reimbursement Process Updates


  1. Laboratory Billing and Reimbursement
  2. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  3. Charcot-Marie-Tooth Neuropathy Genetic Testing
  4. Early Onset Familial Alzheimer Disease Genetic Testing
  5. Epilepsy Genetic Testing
  6. Maturity-Onset Diabetes of the Young (MODY) Genetic Testing
  7. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  8. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  9. Hereditary Pancreatitis Genetic Testing
  10. Limb-Girdle Muscular Dystrophy Genetic Testing
  11. Noonan Spectrum Disorder Genetic Testing
  12. Hereditary Ataxia Genetic Testing
  13. Hereditary Connective Tissue and Thoracic Aortic Disease Genetic Testing
  14. Cardiomyopathy and Arrhythmia Genetic Testing
  15. Primary Ciliary Dyskinesia Genetic Testing​​

​Criteria Updates (Non-Substantive):

  1. Flow Cytometry
  2. Sexually Transmitted and Other Reproductive Tract Infection Testing
  3. UroVysion FISH for Bladder Cancer
  4. Afirma Thyroid Cancer Classifier Tests
  5. AlloMap Gene Expression Profiling For Heart Transplant Rejection
  6. Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)
  7. Non-Invasive Prenatal Screening
  8. Prenatal Aneuploidy FISH Testing
  9. Exome Sequencing
  10. Gastrointestinal Pathogen Panel (GIPP) Molecular Testing
  11. Decipher Prostate Cancer Classifier
  12. Genome Sequencing
  13. Helicobacter pylori Laboratory Testing
  14. Celiac Disease Testing
  15. Inflammatory Bowel Disease Biomarker Testing
  16. Human Platelet and Red Blood Cell Antigen Genotyping
  17. Human Papillomavirus (HPV) Molecular Testing
  18. Pathology Testing with Mohs Micrographic Surgery
  19. Special Circumstances Influencing Coverage Determinations
  20. Inherited Thrombophilia Genetic Testing
  21. Familial Malignant Melanoma Genetic Testing
  22. PTEN Hamartoma Tumor Syndromes  Genetic Testing
  23. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  24. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  25. Genetic Testing by Multigene Panels
  26. HFE Hemochromatosis Genetic Testing
  27. PCA3 Testing for Prostate Cancer
  28. ThyGeNEXT and ThyraMIR miRNA Gene Expression Classifier
  29. Lyme Disease Testing
  30. ThyroSeq​

Retired Guidelines:

  1. NETest
  2. Ashkenazi Jewish Carrier Screening
  3. Familial Adenomatous Polyposis Genetic Testing
  4. Hereditary Cancer Syndrome Multigene Panels
  5. Li-Fraumeni Syndrome Genetic Testing
  6. Lynch Syndrome Genetic Testing
  7. MUTYH-Associated Polyposis Genetic Testing
  8. Peutz-Jeghers Syndrome Genetic Testing
  9. Von Hippel-Lindau Disease Genetic
  10. BRCA Analysis
  11. PALB2 Genetic Testing for Cancer Risk
  12. Multiple Endocrine Neoplasia Type 1 Genetic Testing
  13. Multiple Endocrine Neoplasia Type 2 Genetic Testing​

Other Note:(E/I/U = Experimental, Investigational, or Unproven​) -- 

See the tables below that follow (which provide more details for the guideline (GL) changes):


New Guidelines:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) 
Hereditary Cancer Syndrome Genetic TestingMOL.TS.436.A81203, 81202, 81201, 81166, 81165, 81215, 81167, 81216, 81217, 81164, 81163, 81162, 81212, 0129U, 0102U, 81228, 81229, 81349, 0101U, 0157U, 0158U, 0159U, 0160U, 0161U, 0162U, S3840, 81403, 0474U, 0238U, 81432, 81479, 81435, 81437, 81404, 81405, 81294, 81293, 81292, 81297, 81296, 81295, 81300, 81299, 81298, 81406, 81401, 0103U, 81308, 81307, 81319, 81318, 81317, 0475U, 81353, 81351, 81352, S3842,  0136U, 0138U, 0134U, 0130U, 0137U, 0133UNew guideline managing germline testing for hereditary cancer syndromes, replacing multiple test-specific guidelines. Some clinical changes resulted from coalescing the criteria:

Known Familial Mutation Testing: standardized - now all KFM testing is coverable when mutation is identified in a 1st, 2nd or 3rd  degree relative

BRCA1/2:Personal and family history of breast cancer expanded to 1st, 2nd, or 3rd degree relative with male breast cancer

Panels: expanded coverage of panels for Li-Fraumeni Syndrome and personal history of paraganglioma or pheochromocytoma; Added exclusions for broad panels in individuals with somatic BRCA mutations and  Individuals with symptoms of Familial Adenomatous Polyposis outside of multiple polyps - these individuals are eligible for single gene testing.
Cologuard Plus Screening for Colorectal Cancer

MOL.CS.422.A		0464UNew guideline: Manages Cologuard Plus, changing coverage stance from EIU to covered with medical necessity criteria based on USPSTF recommendation of stool based multi-target tests for CRC screening, clinical validity study (Imperiale et al, 2024), NCCN 2025



​Criteria Updates (Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Rationale / supporting guideline for clinically significant updates 
Immunohistochemistry (IHC)MOL.CS.104.A88341, 88342, 88344Criteria: Removed detailed criteria for prostate biopsies- the more general language related to unnecessary or excess units is sufficient for review of appropriate testing (Ross, et al. 2020 and Magi-Galluzzi, 2018).  For Barrett's esophagus testing, IHC remains not medically necessary but language allowing exceptions on a case-by-case basis was added (Neyaz, et al.), added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro, admin edits.; Guidelines and Evidence: Added the associated Barrett's esophagus and Prostate-biopsy references for the criteria changes, admin edits.; References: updatedBarrett's Esophagus: Neyaz A, Rickelt S, Yilmaz OH, et al. Quantitative p53 immunostaining aids in the detection of prevalent dysplasia. J Clin Pathol. 2023;76(9):582-590. doi:10.1136/jcp-2022-208721

Prostate biopsies:
Ross J, Li G, Yang XJ. Application and pitfalls of immunohistochemistry in diagnosis of challenging genitourinary cases. Arch Pathol Lab Med. 2020;144(3):290-304. doi:10.5858/arpa.2019-0550-RA
Magi-Galluzzi C. Prostate cancer: diagnostic criteria and role of immunohistochemistry. Mod Pathol. 2018;31(S1):S12-S21. doi:10.1038/modpathol.2017.139
Experimental, Investigational, or Unproven Laboratory TestingMOL.CU.117.IADDITIONS: 0630U, 0628U; 0616U; 0617U; 0618U; 0619U; 0620U; 0622U; 0623U; 0625U; 0626U; 0627U; 0007M

DELETIONS: 81195, 0413U, 81451, 0329U, 0019U, 0300U, 0299U, 0298U, 0297U, 0586U, 81449, 81456, 0391U, 0560U, 0561U, 0307U, 0306U, 0498U, 0499U, 0340U		ADDITIONS: Added new PLA codes 0630U (BluePrint Molecular Subtyping Test - updated code and test description); 0628U (RenaDx: Comprehensive Renal Disease Panel Test); 0616U (TruD MDS Alzheimer's & MCI); 0617U (TruD MDS ASCVD); 0618U (TruD MDS Bipolar); 0619U (TruD MDS COPD); 0620U (TruD MDS Hepatocellular Carcinoma); 0622U (TruD MDS Major Depressive Disorder); 0623U (TruD MDS Multiple Sclerosis); 0625U (TruD MDS Osteoporosis); 0626U (TruD MDS Parkinson's); 0627U (TruD MDS Schizophrenia); added NETest (0007M) as test specific guideline was retired 

DELETIONS: Deleted from EIU and moved to Somatic Mutation Testing guideline: Altera (81479); Cytogenomic (genome-wide) analysis, hematologic malignancy, structural variants and copy number variants, optical genome mapping (OGM) (81195); DH Optical Genome Mapping/Digital Karyotyping Assay (0413U); GPS Cancer (81479); Hematolymphoid neoplasm or disorder, genomic sequence analysis panel, 5-50 genes, RNA analysis (81451); MI Tumor Seek Hybrid (81479); Oncomap ExTra (0329U); OncoTarget/OncoTreat (0019U); Praxis Somatic Combined Whole Genome Sequencing and Optical Genome Mapping (0300U); Praxis Somatic Optical Genome Mapping (0299U); Praxis Somatic Transcriptome (0298U); Praxis Somatic Whole Genome Sequencing (0297U); RNA Salah Targeted Expression Panel (0586U);
Solid organ neoplasm, genomic sequence analysis panel, 5-50 genes, RNA analysis (81449); Solid organ or hematolymphoid neoplasm or disorder, 51 or greater genes, RNA analysis (81456); Strata Select (0391U);

Deleted from EIU and moved to Liquid Biopsy Testing guideline: Haystack MRD Baseline (0560U); Haystack MRD Monitoring (0561U); Invitae PCM MRD Monitoring (0307U); Invitae PCM Tissue Profiling and MRD Baseline Assay (0306U); OptiSeq Colorectal Cancer NGS Panel (0498U); OptiSeq Dual Cancer Panel Kit (0499U); Signatera (0340U)

Deleted APOE genotyping (81401) as now managed by Pharmacogenomic Testing for Drug Toxicity and Response
Deleted Cologuard Plus (0464U) as this assay will now be covered under a new guideline

EDITS: 0319U (renamed PreTransplant Risk Assessment (PTRA); formerly Clarava); 85415 - corrected CPT code in criteria only (was listed as 8541)		 
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AN/ACriteria: under Targeted Pharmacogenomic Testing section removed DPYD criterion as FDA label has been updated and this testing is covered under the FDA-related criterion bullet (above; no change to clinical decision making), added procedure code G9143 to Targeted Pharmacogenomic Tests Considered Not Medically Necessary (no change to clinical decision making as Warfarin responsiveness is already NMN per existing criteria) and updated citations in this section, added Psych HealthPGx Panel (CPT 0173U) to Pharmacogenomic Panels Considered Experimental, Investigational or Unproven (no change to clinical decision making as this panel already fit the description of an E/I/U panel as described in the intro to this section), added statement in Other Considerations referring to administrative Laboratory Billing and Reimbursement guideline for correct coding requirements, admin edits throughout; Background: updated, added citation; References: updated, added references from health tech assessments for CYP2D6 testing for Tamoxifen and Warfarin response genotyping, additional updates 
Carrier Screening Panels, Including Targeted, Pan-Ethnic, Universal, and ExpandedMOL.TS.165.AMultipleCriteria: incorporated criteria from Ashkenazi Jewish Carrier Screening (81412) guideline; Billing and Reimbursement: restructured using standardized panel coding requirements (based on previously MAC-reviewed Laboratory Billing and Reimbursement guideline) setting limit of 5 genes to be individually reimbursable, with panel of more than 5 genes required to use a panel code; Also added language concerning 81443, a commonly used code for carrier screening panels, Added other consideration section to clarify that carrier screening panels consist of AR and X-linked disorders (as defined by ACMG), additional admin edits throughout; Background: admin editsSee administrative guideline, Laboratory Billing and Reimbursement; Gregg AR, Aarabi M, Klugman S, et al.  Screening for autosomal recessive and X-linked conditions during pregnancy and preconception: a practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(10):1793-1806. doi: 10.1038/s41436-021-01203-z
Familial Hypercholesterolemia Genetic TestingMOL.TS.169.A81479Criteria: updated known familial mutation analysis criteria to require that the member be at risk to inherit the mutation based on the family history to align with clinical use guideline for KFM testing (and per expert-authored review by Ison et al, 2025 and IAS, 2023 guidelines), updated single-gene criteria to provide coverage for PCSK9 deletion/duplication analysis (reported in FH families per Ison et al, 2025) and LDLRAP1 gene analysis (per Ison et al, 2025 and IAS, 2023 guidance), updated multigene FH panels criteria to allow approval of panels that include LDLRAP1 and other dyslipidemia genes (previously limited to LDLR, APOB, and PCSK9 only, but broader panels are supported by Ison et al, 2025 and a 2025 European Atherosclerosis Society guideline), added criterion to Exclusions and Other Considerations section to state that individual deletion/duplication testing of APOB is not medically necessary for FH due to reorganization of single-gene criteria (no clinical decision making change, but supported by Ison et al 2025 as APOB del/dups have not been reported to cause FH), added an exclusion for broad cardiac/CV panels for FH (none of the professional guidelines cited, including Ison et al, 2025, support such broad panel testing for this indication),  added a Billing and Reimbursement section to the guideline, addition to both to Exclusions and Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, added Billing and Reimbursement requirements for panel coding in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, admin and clarification of intent edits throughout; CPT code table: added entries for PCSK9 deletion/duplication analysis and LDLRAP1 sequencing and deletion/duplication analysis (all CPT 81479); Background: updated, added content for LDLRAP1 and autosomal recessive inheritance; Test Information: updated, added content for LDLRAP1 and broader hyperlipidemia/dyslipidemia panels; Guidelines and Evidence: updated, added updated ESC/EAS 2019, 2025 guidelines for dyslipidemia, ESC 2023 guideline for HoFH; References: updatedIson HE, Clark SL, Knowles JW. 2014 Jan 2 [Updated 2025 Jan 30]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2025. Available at: http://www.ncbi.nlm.nih.gov/books/NBK174884/

Watts GF, Gidding SS, Hegele RA, et al. International Atherosclerosis Society guidance for implementing best practice in the care of familial hypercholesterolaemia. Nat Rev Cardiol. 2023;20(12):845-869. doi:10.1038/ s41569-023-00892-0

For Billing and Reimbursement updates, see administrative guideline, Laboratory Billing and Reimbursement
Liquid Biopsy TestingMOL.TS.194.A0485U, 0326U, 0388U, 0585U, 0409U, 0571U, 0487U, 0499U, 0562U, 0179U

ADDED 0560U, 0561U, 0307U, 0306U, 0498U, 0499U, 0340U		Criteria: Added coverage for liquid biopsy testing for NSCLC for individual tumor markers and expanded coverage of panel (regardless of platform) testing to individuals in whom there is insufficient tumor tissue is available, the cancer is advanced, metastatic or recurrent, and either no panel testing has been performed or there is recurrence after EGFR-targeted therapy (per NCCN), added requirements to Billing & Reimbursement regarding requests for multiple panels per occurrence of cancer to align with related criteria, added reference to Laboratory Billing and Reimbursement admin guideline for additional coding guidance, additional admin and clarification of intent edits to Billing & Reimbursement; CPT code table: updated - see below

Added the following tests that were previously managed by the EIU guidleline - no change in clinical decision making: Haystack MRD Baseline 0560U, Haystack MRD Monitoring 0561U, Invitae PCM MRD Monitoring 0307U, Invitae PCM Tissue Profiling and MRD Baseline Assay 0306U, OptiSeq Colorectal Cancer NGS Panel 0498U, OptiSeq Dual Cancer Panel Kit 0499U, Signatera 0340U; Guidelines and Evidence		Riely GJ, Wood DE, Aisner DL, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2026 - December 2, 2025. Non-Small Cell Lung Cancer, available at:  https://www.nccn.org/professionals/ physician_gls/pdf/nscl.pdf . Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V2.2026 - December 2, 2025. ©2025 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines®, go online to NCCN.org.
Mammaprint 70-Gene Breast Cancer Recurrence AssayMOL.TS.200.A81521, 81523Criteria: Added new criteria that allow for OncotypeDx in select individuals who have not had SLNB (based on new ASCO guidelines on SNLB), admin edit to Criteria Introduction, added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro; Guidelines and Evidence: updated; References: updatedPark KU, Somerfield MR, Anne N, et al. Sentinel lymph node biopsy in early-stage breast cancer: ASCO Guideline Update. J Clin Oncol. 2025;43(14):1720-1741. doi:10.1200/JCO-25-00099
Oncotype DX for Breast Cancer PrognosisMOL.TS.211.I81519Criteria: Added new criteria that allow for OncotypeDx in select individuals who have not had SLNB (based on new ASCO guidelines on SNLB); Guidelines and Evidence: updated; References: updatedPark KU, Somerfield MR, Anne N, et al. Sentinel lymph node biopsy in early-stage breast cancer: ASCO Guideline Update. J Clin Oncol. 2025;43(14):1720-1741. doi:10.1200/JCO-25-00099
Somatic Mutation TestingMOL.TS.230.A0364U; Multiple CDx assays

ADDED 81479, 81195, 0413U, 81479, 81451, 81479, 0329U, 0019U, 0300U, 0299U, 0298U, 0297U, 0586U, 81449, 81456, 0391U		Criteria: admin edits, new approvable criterion in Non-CDx multigene tumor panel section allowing repeat panel testing in individuals with recurrent/progressive NSCLC that has progressed on EGFR-targeted therapy (NCCN 2026), added additional coverage for ClonoSEQ surveillance in CLL every 3-6 months during active treatment with an MRD-guided regimen listed in NCCN (NCCN 2025), added new section to address other tumor marker panels for MRD testing as EIU (no management change), added new section on tumor marker panel testing with components/methods that are EIU (no management change, previously addressed by EIU guideline); Billing and Reimbursement: included allowance for 2 approvals in progressive NSCLC to align with related criteria changes, added requirement for use of a panel code when at least 5 additional tumor markers are medically necessary on repeat testing (in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement), added reference to Laboratory Billing and Reimbursement admin guideline for additional coding guidance, additional admin and clarification of intent edits to Billing & Reimbursement; CPT code table: updated with tests previously managed by EIU guideline (see below); Guidelines and Evidence: Updated; References: admin edits

EIU tests added to guideline (no coverage change): Altera 81479; Cytogenomic analysis optical genome mapping 81195; DH Optical Genome Mapping/Digital Karyotyping 0413U; GPS Cancer 81479; Hematolymphoid neoplasm genomic sequence analysis panel, 5-50 genes; RNA analysis 81451; MI Tumor Seek Hybrid 81479; Oncomap ExTra 0329U; OncoTarget/OncoTreat 0019U; Praxis Somatic Combined WGS and Optical genome mapping 0300U; Praxis Somatic Optical Genome Mapping 0299U; Praxis Somatic Transcriptome 0298U; Praxis Somatic WGS 0297U; RNA Salah Targeted Expression Panel 0586U; Solid organ neoplasm, genomic sequence panel, 5-50 genes; RNA analysis 81449; Solid organ or hematolymphoid neoplasm, 51 or greater genes, RNA analysis 81456
Strata Select 0391U		Riely GJ, Wood DE, Aisner DL, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2026 – December 2, 2025 Non-Small Cell Lung Cancer, available at:  https://www.nccn.org/professionals/ physician_gls/pdf/nscl.pdf Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®) for Non-Small Cell Lung Cancer v2.2026 – December 2, 2025 . ©2025 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guideline® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guideline®, go online to NCCN.org.;

Wierda WG, Brown J, Abramson JS, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2026 – October 10, 2025. Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma. Available at:  https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf Referenced with permission from the
NCCN Clinical Practice Guidelines in Oncology (NCCN Guideline®) for Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma v1.2026 – October 10, 2025. ©2025 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guideline® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guideline®, go online to  NCCN.org.
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.A81455Criteria: added Other Considerations with a statement that panels exceeding 50 genes are excessive and not medically necessary (aligns with existing criteria for hematological malignancy panels in Somatic Mutation Testing guideline), clarification of intent edits to panel criteria to more clearly indicate that they address all MPN panels, added reference to Somatic Mutation Testing guideline for requests for other hematological malignancies, added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro, admin and clarification of intent edits throughout the Billing and Reimbursement section; Guidelines and Evidence: admin edits; References: admin editsSomatic mutation testing guideline, Laboratory Billing and Reimbursement guideline
Mitochondrial Disorders Genetic TestingMOL.TS.266.AMultipleCriteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updated to allow for genomic sequencing procedure (GSP) codes for mtDNA and nuclear DNA (81440, 81460, 81465) to be approved simultaneously when all codes are medically necessary rather than requiring a tiered approach (UK Best Practices Guideline recommends simultaneous mtDNA and nucDNA testing), updates to both to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughout; Guidelines and Evidence: updatedSee administrative guideline, Laboratory Billing and Reimbursement

Mayraki E, Labrum R, Sergeant K, et al. Genetic testing for mitochondrial disease: the United Kingdom best practice guidelines. Eur J Hum Genet. 2023 Feb;31(2):148-163. doi: 10.1038/s41431-022-01249-w
Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental DisordersMOL.CS.289.A88235 88267, 88291 88280, 88230 88262, 88261

Deleted 88269		Criteria: opened criteria to allow chromosome analysis after negative chromosomal microarray (previously said CMA testing should not have been done) (per American Academy of Pedistrics guideline) Updated age for primary ovarian insufficiency diagnosis to 40 or younger (previously 30) based : ESHRE/ASRM/CREWHIRL/IMS GUIDELINE definition of POI; CPT code table: removed code 88269 as not applicable to this guideline;  Guidelines and Evidence: updated;  References: updatedPrevious CMA:  Rodan, L, Stoler, J, Chen, E, Geleske, T, Council on Genetics. Genetic evaluation of the child with intellectual disability or global developmental delay: clinical report. Pediatrics. 2025;156(1):e2025072219. doi:10.1542/peds.2025-072219    

Changing POI : ESHRE, ASRM, CREWHIRL and IMS Guideline Group on POI, Panay N, Anderson RA, et al. Evidence-based guideline: premature ovarian insufficiency†‡. Climacteric. 2024;27(6):510-520. doi:10.1080/13697137.2024.2423213
Respiratory Infection Pathogen Panel (RIPP) Molecular TestingMOL.CS.293.ACoverage change: 0115U

ADDED: U0002, U0001, 87498, 87501, 87502, 87503, 87634, 87635, 87913		Criteria: Removed statement that ePlex Respiratory Pathogen Panel  (0115U) was considered EIU - this test is now coverable per client request, added criteria for COVID-19 from SARS-CoV-2 (COVID-19) Laboratory Testing being retired this cycle (criteria remains the same but with a condensed format), added criteria for other single-organism testing for respiratory viruses (enterovirus, influenza, RSV) supported by numerous guidelines cited within the guideline (including IDSA/ASM, 2024), reorganized Criteria to better delineate panels from single-organism tests, added CPT code lists to beginning of Criteria and Billing and Reimbursement blocks for improved functionality, relocated existing statement regarding only one type of test being medically necessary for the same organism on the same date of service to a new Other Considerations section since this statement also applies to single-organism tests now addressed in the guideline, added reference to other guidelines for organisms and indications not addressed here, added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro; CPT code table: added the following codes to the table: U0002, U0001, 87498, 87501, 87502, 87503, 87634, 87635, 87913; Background: updated; Test Information: updated, added reused content language for nucleic acid testing and multiplex NAAT; Guidelines and Evidence: updated, added guidelines from the ADLM, ASCP, AST, ATS/IDSA, IDSA/ASM, and NCCN, removed outdated European guideline, added content from existing guidelines to address single-organism testing; References: updated; TITLE CHANGE: Respiratory Infection Pathogen Molecular Testing 
Human Immunodeficiency Virus Laboratory TestingMOL.CS.321.A87534, 87535, 87536, 87537, 87538, 87539Criteria: for nucleic acid testing - added coverage for testing of deceased organ donors (per AST guidelines); Background: updated citations and formatting; Test Information: updated; Guidelines and Evidence: added guidelines from NCCN, AST, WPSI/HRSA, and DHHS and updated guideline versions and expanded content for several existing guidelines to support criteria edits; References: updatedMalinis M, Boucher HW; AST Infectious Diseases Community of Practice. Screening of donor and candidate prior to solid organ transplantation-Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13548. doi: 10.1111/ctr.13548
Infectious Disease Laboratory TestingMOL.CU.398.A0109U, 0629U

ADDED: 0629U		Criteria: removed MycoDART Dual Amplification Real Time PCR Panel for 4 Aspergillus species (CPT 0109U) from list of E/I/U tests per AST 2019 guidelines which recommends testing for certain indications, added CRISPR-TB Blood Test (CPT 0629U) to list of E/I/U tests (new PLA code released by AMA), admin and clarification of intent edits throughout; CPT code table: added CRISPR-TB Blood Test (CPT 0629U); Background: updated; Test Information: updated; Guidelines and Evidence: added content and supporting guidelines regarding testing for mosquito-borne and other arthropod-borne illnesses, use of molecular testing for infectious disease diagnosis, and testing for immunocompromised populations, other updates; References: updatedHage CA, Carmona EM, Epelbaum O, et al. Microbiological laboratory testing in the diagnosis of fungal infections in pulmonary and critical care practice. An official American Thoracic Society clinical practice guideline. Am J Respir Crit Care Med. 2019;200(5):535-550. doi: 10.1164/rccm.201906-1185ST
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.AN/ACriteria: denial rationale for Nucleic Acid Tests in criteria to be changed from E/I/U to "not medically necessary" to align with EviCore definitions, added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro, admin edits to Criteria intro; Background: updated; Test Information: updated 
Urinary Tract Infection Molecular TestingMOL.CS.403.AMultiple

DELETED: 87490, 87491, 87492, 87510, 87511, 87512, 87528, 87529, 87530, 87563, 87590, 87591, 87592, 87660, 87661		Criteria: added a requirement that molecular testing is the appropriate diagnostic method for the tested organism  in the criteria for testing of immunocompromised individuals (per IDSA, 2024 guide), added ICD Z87.440 for Personal history of urinary (tract) infections to ICD table that was omitted from table, provided a specific list of single organisms addressed by the guideline that are not medically necessary to test molecularly for UTIs (no change to clinical decision making as IDSA and other professional guidelines cited do not recommend molecular testing so these would have been denied under existing criteria), reorganized single-organism criteria and provided a list of CPT codes at the top of each block of Criteria and Billing and Reimbursement requirements for improved functionality, pared down list of E/I/U multi-organism UTI panels to focus on panels with PLA codes (no change to clinical decision making as this list is not intended to be all-inclusive), added verbiage to Billing and Reimbursement section to clarify the administrative handling of requests billed with multiple single-organism procedure codes, admin edits throughout; CPT code table: removed CPT codes that are specifically addressed by the Sexually Transmitted and Reproductive Infection Testing guideline (87490, 87491, 87492, 87510, 87511, 87512, 87528, 87529, 87530, 87563, 87590, 87591, 87592, 87660, 87661); Background: updated; Test Information: updated, added content for antimicrobial resistance and susceptibility testing; Guidelines and Evidence: added updated 2025 version of AUA/CUA/SUFU guideline for recurrent UTI and new 2025 IDSA guideline for complicated UTIs, additional updates; References: updatedMiller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024). doi: 10.1093/cid/ ciae104
     
Billing and Reimbursement Process Updates    
Laboratory Billing and ReimbursementMOL.AD.412.BOADDED: Category III codesCriteria: added additional criterion for prioritization of procedure codes when multiple overlapping codes are requested to allow for the code with the most appropriate and comprehensive code description to be approved (per AMA codebook), added criteria allowing component procedure codes to be billed for multigene panels of 5 genes or less to allow for small, medically necessary panels to be approved when there is not a more specific panel code available (per AMA and NCCI guidance, which allows for unbundling in this circumstance), added a Component Procedure Code Hierarchy to standardize the process for selecting which billed component procedure codes to approve, relocated existing Add-on Code requirements to a separate block and added exclusions for Digital pathology digitization procedures (e.g., CPT 0751T-0763T and 0827T-0856T) and Shortwave infrared radiation imaging, surgical pathology specimen, to assist gross examination for lymph node localization in fibroadipose tissue (CPT 0961T) (these codes were previously listed as not covered under the Experimental, Investigational and Unproven Laboratory Testing guideline but relocation here allows for administrative denial), added a criterion to Correct Coding Requirements to clarify that billing separate steps of molecular analysis such as DNA extraction/storage is not reimbursable (per AMA codebook guidance) due to an increase in such coding identified in case review, relocated Multigene-Panel Coding requirements to a separate block for ease of use and standardized requirements for consistent coding enforcement across guidelines, clarification of intent edits to better define what is considered the most appropriate panel code for a multi-gene panel (per AMA codebook), admin edits throughout; CPT code table: added Category III codes; Guidelines and Evidence: updated, added blocks for Category III Codes and Add-on Codes; References: updatedAmerican Medical Association. CPT 2026 Professional Edition. Chicago, IL; 2025

CMS. Medicare NCCI Policy Manual. Updated January 1, 2025. Available at:
https://www.cms.gov/medicare/coding-billing/national-correct-coding-initiative-ncci-edits/medicare-ncci-policy-manual
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updates to both to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughout the Billing and Reimbursement section; Background: updated; Test Information: admin edits; Guidelines and Evidence: admin edits; References: updatedSee administrative guideline, Laboratory Billing and Reimbursement
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughout the Billing and Reimbursement sectionSee administrative guideline, Laboratory Billing and Reimbursement
Early Onset Familial Alzheimer Disease Genetic TestingMOL.TS.162.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of multiple EOFAD genes in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updates to both to Other Considerations (new block created in Criteria section) and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across guidelines in alignment with the Genetic Testing by Multigene Panels guideline,  additions to Other Considerations to clarify that the guideline only addresses analysis of the PSEN1, APP, and PSEN2 genes and providing alternative policies to use for other dementia tests/panels not addressed here, admin and clarification of intent edits throughoutSee administrative guideline, Laboratory Billing and Reimbursement
Epilepsy Genetic TestingMOL.TS.257.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, clarification of intent edits to the criterion about repeat testing to change the phrase about exceptions being considered for "technical advances" to "technical or clinical advances" (to better clarify that the advances could include either test methodology or gene content), admin edit to remove unnecessary information from Criteria introduction and update to align with our standard format, other admin and clarification of intent edits throughoutSee administrative guideline, Laboratory Billing and Reimbursement
Maturity-Onset Diabetes of the Young (MODY) Genetic TestingMOL.TS.258.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updates to Other Considerations (new section added to Criteria) and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughoutSee administrative guideline, Laboratory Billing and Reimbursement
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across guidelines in alignment with the Genetic Testing by Multigene Panels guideline, admin edits to remove unnecessary information from Criteria introduction and align with our standard format, other admin and clarification of intent edits throughoutSee administrative guideline, Laboratory Billing and Reimbursement
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement (may increase approvals for small panels because component billing was previously only allowed when the lab was unable to bill 81479; may also increase denials for Medicaid members since reimbursement is now limited to a max of 5 codes, rather than the 6 genes previously listed as reimbursable), updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughout the Billing and Reimbursement section; Background: admin edits; Guidelines and Evidence: admin edits; References: updatedSee administrative guideline, Laboratory Billing and Reimbursement
Hereditary Pancreatitis Genetic TestingMOL.TS.287.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, removed statement from Hereditary Pancreatitis Multigene Panels section regarding billing in order to align with Billing and Reimbursement updates, updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across policies in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughoutSee administrative guideline, Laboratory Billing and Reimbursement
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.ADELETED: 81443Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across guidelines in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughout; CPT code table: removed 81443 as this code is now addressed more generally in the administrative guideline Laboratory Billing and ReimbursementSee administrative guideline, Laboratory Billing and Reimbursement
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, removed statement from Multigene Panel Testing section regarding billing in order to align with Billing and Reimbursement updates, updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across guidelines in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughoutSee administrative guideline, Laboratory Billing and Reimbursement
Hereditary Ataxia Genetic TestingMOL.TS.425.ADELETED: 81443Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, clarification of intent edits to the criterion about repeat testing to change the phrase about exceptions being considered for "technical advances" to "technical or clinical advances" (to better clarify that the advances could include either test methodology or gene content), admin and clarification of intent edits throughout the Billing and Reimbursement section; CPT code table: removed 81443 as this code is now addressed more generally in the administrative guideline Laboratory Billing and ReimbursementSee administrative guideline, Laboratory Billing and Reimbursement
Hereditary Connective Tissue and Thoracic Aortic Disease Genetic TestingMOL.TS.425.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, clarification of intent edits to the criterion about repeat testing to change the phrase about exceptions being considered for "technical advances" to "technical or clinical advances" (to better clarify that the advances could include either test methodology or gene content), admin and clarification of intent edits throughout the Billing and Reimbursement sectionSee administrative guideline, Laboratory Billing and Reimbursement
Cardiomyopathy and Arrhythmia Genetic TestingMOL.TS.410.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement (will increase approvals for small panels since they previously could only be billed with unbundled codes when billing of 81479 was not possible; however, this change could increase denials for Medicaid cases meeting medical necessity for dilated cardiomyopathy panel testing, since approval of 6 genes was allowed previously for this subtype), clarification of intent edit to hypertrophic cardiomyopathy criteria to provide examples of echocardiogram measures used for wall thickness, clarification of intent edits to the criterion about repeat testing to change the phrase about exceptions being considered for "technical advances" to "technical or clinical advances" (to better clarify that the advances could include either test methodology or gene content), clarification of intent edit to facilitate consistent administrative handling of panels requested with both CPT 81413 and 81439 (no change to clinical decision making as previous billing and reimbursement requirements also did not allow approval of more than one panel code), additional admin and clarification of intent edits throughout; CPT code table: admin edits; Background: updated; Guidelines and Evidence: removed introduction, updated ACC/AHA guideline with 2024 guideline, reorganized content to group by cardiac subtype for improved ease of tracking professional guidance, reordered references; References: updatedSee administrative guideline, Laboratory Billing and Reimbursement
Primary Ciliary Dyskinesia Genetic TestingMOL.TS.419.A Criteria: updated Billing and Reimbursement section to allow for individual component codes to be billed for panels consisting of 5 genes or less in alignment with updates made to the administrative guideline Laboratory Billing and Reimbursement, removed statement from Multigene Panel Testing section regarding billing in order to align with Billing and Reimbursement updates, updates to Other Considerations and Billing and Reimbursement sections clarifying the handling of repeat panel testing and allowing exceptions based on "technical or clinical advances" to facilitate consistency across guidelines in alignment with the Genetic Testing by Multigene Panels guideline, admin and clarification of intent edits throughout the Billing and Reimbursement section; CPT code table: admin edits; Background: updated; Guidelines and Evidence: admin edits; References: updatedSee administrative guideline, Laboratory Billing and Reimbursement


Criteria Updates (Non-Substantive):

​
Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) 
Flow CytometryMOL.CS.103.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro, admin edit
UroVysion FISH for Bladder CancerMOL.CS.108.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro; Background: updated; Test Information: admin edits; Guidelines and Evidence: Updated AUA/SUFU guideline, updated AUA/SUO guideline, updated Selected Relevant Publication section with HTA updates; References: Added updated professional guideline references and references from HTA.
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
AlloMap Gene Expression Profiling For Heart Transplant RejectionMOL.TS.123.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro; Background: admin edits; Guidelines and Evidence: updated; References: updated
Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)MOL.TS.150.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Non-Invasive Prenatal ScreeningMOL.TS.209.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Prenatal Aneuploidy FISH TestingMOL.CS.218.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro; Background: admin edits
Exome SequencingMOL.TS.235.IN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Gastrointestinal Pathogen Panel (GIPP) Molecular TestingMOL.CS.277.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Decipher Prostate Cancer ClassifierMOL.TS.294.AN/ACriteria: Corrected the units for PSA in the Decipher for post RP criteria
Genome SequencingMOL.TS.306.IN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Helicobacter pylori Laboratory TestingMOL.CS.318.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Celiac Disease TestingMOL.CS.319.AN/ACriteria: clarification of intent edit to HLA-DQ Typing criteria to clarify that "any of the following" criteria can be met for approval
Inflammatory Bowel Disease Biomarker TestingMOL.TS.359.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro; Guidelines and Evidence: Added WPSI and HRSA recommendations; References: Added WPSI and HRSA
Pathology Testing with Mohs Micrographic SurgeryMOL.CS.363.AN/ACriteria: added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.AN/ACriteria: Added HB6771 for the State of Connecticut to the Broad Biomarkers table; Reformatted the Biomarker bills section to clarify that Broad and Cancer Specific are under the Biomarker header; References: Added reference for HB 6771 for Connecticut
Inherited Thrombophilia Genetic TestingMOL.TS.370.AN/ACriteria: clarification of intent edit - moved bullet on use of test results for guiding treatment under the Diagnostic testing section as was placed at the wrong level and does not apply to presymptomatic testing, added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro
Familial Malignant Melanoma Genetic TestingMOL.TS.170.AN/ACriteria: admin edits
PTEN Hamartoma Tumor Syndromes  Genetic TestingMOL.TS.223.AN/ACriteria: admin edits
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.AN/ACriteria: admin edits; CPT code table: admin edits; Guidelines and Evidence: reorganized NCCN section; References: updated
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.AN/ACriteria: In KFM section, removed prenatal criteria and added that member should be at risk for inheriting the mutation. Removed statement on why comprehensive panels are EIU. Added in EIU standard language. Admin edits. CPT code table: admin edits. Billing and Reimbursement: Added newly developed standard B&R panel language. Admin edits. Background: updated. Test information: updated. Guidelines and evidence: Added new AAP 2025 report, removed AAP 2014 report, updated. References: updated.
Genetic Testing by Multigene PanelsMOL.CU.116.AN/ACriteria: clarification of intent edits to the criterion about repeat testing to change the phrase about exceptions being considered for "technical advances" to "technical or clinical advances" (to better clarify that the advances could include either test methodology or gene content)
HFE Hemochromatosis Genetic TestingMOL.TS.183.AN/ACriteria: added Other considerations section to direct testing for genes other than HFE to other clinical guidelines (no change to clinical decision making); Guidelines and Evidence: Expanded EASL guideline section to include more info on specific test recommendations, including role of testing beyond HFE.
PCA3 Testing for Prostate CancerMOL.TS.215.AN/ACriteria: Amended approvable age range to aligns with pathway and FDA approved indication; Guidelines and Evidence: updated; References: updated
ThyGeNEXT and ThyraMIR miRNA Gene Expression ClassifierMOL.TS.259.IN/ACriteria: Removed Billing and Reimbursement section as all information is included in the medical necessity section of the criteria; Guidelines and Evidence: updated; References: updated
Lyme Disease TestingMOL.CS.332.A Criteria: added content for 0621U (TruD MDS Lyme Disease) to Criteria and Billing & Reimbursement sections as E/I/U (new PLA code released by the AMA) reformatted existing Nucleic Acid Testing criteria for improved readability, added reference to Laboratory Billing and Reimbursement guideline in Billing & Reimbursement intro, admin edits; CPT code table: added new PLA code: 0621U (TruD MDS Lyme Disease); Test Information: updated and reformatted; Guidelines and Evidence: updated and reformatted; References: updated
ThyroSeqMOL.TS.270.IN/ACriteria: Removed Billing and Reimbursement section as all information is included in the medical necessity section of the criteria; Test Information: updated; Guidelines and Evidence: updated; References: updated​

Retired Guideline:

​
Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) 
NETestMOL.TS.250.AN/ATest specific guideline retired - now managed under EIU guideline
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.AN/ATesting now managed under the Carrier Screening Panels guideline
Familial Adenomatous Polyposis Genetic TestingMOL..TS.168.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Li-Fraumeni Syndrome Genetic TestingMOL.TS.193.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Lynch Syndrome Genetic TestingMOL.TS.197.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
MUTYH-Associated Polyposis Genetic TestingMOL.TS.206.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Peutz-Jeghers Syndrome Genetic TestingMOL.TS.216.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Von Hippel-Lindau Disease GeneticMOL.TS.233.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
BRCA AnalysisMOL.TS.238.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
PALB2 Genetic Testing for Cancer RiskMOL.TS.251.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Multiple Endocrine Neoplasia Type 1 Genetic TestingMOL.TS.285.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.AN/ATesting now managed by new combined guideline Hereditary Cancer Syndrome Genetic Testing

​



Revisions From MA06.034u:

04/01/2026

This version of the policy is effective as of 04/01/2026 and is a result of code updates.

The following procedure codes were added to Attachment A (see eviCore Clinical Guidelines for more information):

0616U, 0617U, 0618U, 0619U, 0620U, 0621U, 0622U, 0623U, 0624U, 0625U, 0626U, 0627U, 0628U, & 0630U

The following procedure code was added to Attachment B (see eviCore Clinical Guidelines for more information):

0629U


​

Revisions From MA06.034t:
01/01/2026This version of the policy will become effective on 01/01/2026.​

Effective 01/01/2026, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)


0602U, 0611U, 0612U, 0613U, 81354, & 81524. ​

Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

 
87183, 87494, 87627, 0600U, 0605U, 0607U, & 0608U. 


 

REVISED

-- 06 PLA codes had non-substantive revisions: 0365U, 0524U, 0537U, 0565U, 0569U, & 0596U.
-- Revisions for 83015 & 83018 are not substantive. 


DELETED 

-- 10 PLA code deletions, including some relatively new codes: 0033U, 0131U, 0132U, 0135U, 0361U, 0508U, 0509U, 0544U, 0550U,&  0551U.  

--------------------------------------------------------------------------------------------------------------


On January 01st, 2026, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 01st, 2026. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

01/01/2026 Guideline Updates for eviCore Lab Management Program (Policy #: MA06.034t)

Executive Summary of Changes

There are two new guideline. 47 existing guidelines have been revised (including 19 with substantive criteria changes). Ten guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Hereditary Ataxia Genetic Testing
  2. Hereditary Connective Tissue and Thoracic Aortic Disease Genetic Testing​

​Criteria Updates (Substantive):

Guideline Name
  1. Flow Cytometry
  2. Sexually Transmitted and Other Reproductive Tract Infection Testing
  3. Genetic Testing by Multigene Panels
  4. Experimental, Investigational,  or Unproven Laboratory Testing
  5. Preimplantation Genetic Testing (Formerly Preimplantation Genetic Screening and Diagnosis)
  6. Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)
  7. Lynch Syndrome Genetic Testing
  8. Somatic Mutation Testing
  9. Multiple Endocrine Neoplasia Type 2 Genetic Testing
  10. Facioscapulohumeral Muscular Dystrophy Genetic Testing
  11. Exome Sequencing
  12. Decipher Prostate Cancer Classifier
  13. Genome Sequencing
  14. Hemoglobinopathies Genetic Testing
  15. Celiac Disease Testing
  16. Human Platelet and Red Blood Cell Antige​n Genotyping
  17. Human Papillomavirus (HPV) Molecular Testing
  18. Infectious Disease Laboratory Testing
  19. Urinary Tract Infection Molecular Testing​

​Criteria Updates (Non-Substantive):

  1. Genetic Testing for Carrier Status
  2. Genetic Testing for Non-Medical Purposes
  3. Pharmacogenomic Testing for Drug Toxicity and Response
  4. Afirma Thyroid Cancer Classifier Tests
  5. Ashkenazi Jewish Carrier Screening
  6. Charcot-Marie-Tooth Neuropathy Genetic Testing
  7. Duchenne and Becker Muscular Dystrophy Testing
  8. Early Onset Familial Alzheimer Disease Genetic Testing
  9. FMR1-Related Disorders (Fragile X) Genetic Testing
  10. Peutz-Jeghers Syndrome Genetic Testing
  11. PTEN Hamartoma Tumor Syndromes  Genetic Testing
  12. Spinal Muscular Atrophy Genetic Testing
  13. Von Hippel-Lindau Disease Genetic Testing
  14. BRCA Analysis
  15. Maturity-Onset Diabetes of the Young (MODY) Genetic Testing
  16. Mitochondrial Disorders Genetic Testing
  17. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  18. Hereditary Pancreatitis Genetic Testing
  19. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  20. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  21. Inherited Thrombophilia Genetic Testing
  22. Noonan Spectrum Disorder Genetic Testing
  23. Special Circumstances Influencing Coverage Determinations
  24. Epilepsy Genetic Testing
  25. Gastrointestinal Pathogen Panel (GIPP) Molecular Testing
  26. Genetic Testing for Known Familial Mutations
  27. Respiratory Infection Pathogen Panel (RIPP) Molecular Testing
  28. Legius Syndrome Genetic Testing​
Retired Guideline:

  1. PancraGEN
  2. Ataxia-Telangiectasia Genetic Testing
  3. Dentatorubral-Pallidoluysian Atrophy Genetic Testing
  4. Friedreich Ataxia Genetic Testing
  5. Hereditary Ataxia Multigene Panel Testing
  6. Spinocerebellar Ataxia Genetic Testing
  7. Marfan Syndrome Genetic Testing
  8. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing
  9. Ehlers-Danlos Syndrome Genetic Testing
  10. Hereditary Connective Tissue Disorder Genetic Testing​

Other Note:(E/I/U = Experimental, Investigational, or Unproven​) -- 

See the tables below that follow (which provide more details for the guideline changes):


New Guidelines:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) 
Hereditary Ataxia Genetic TestingMOL.TS.425.A81177, 81178, 81179, 81180, 81181, 81182, 81183, 81184, 81185, 81186, 81284, 81285, 81286, 81289, 0216U, 0217U, 81443 , 81343, 81344, plus Tier 2 and non-specific codesNew guideline combining medical necessity criteria from multiple condition-specific ataxia guidelines
Hereditary Connective Tissue and Thoracic Aortic Disease Genetic TestingMOL.TS.427.A81411, 81410, plus Tier 2 codesNew guideline combining medical necessity criteria from multiple condition-specific connective tissue disorder guidelines


​Criteria Updates (Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Rationale / supporting guideline for clinically significant updates 
Flow CytometryMOL.CS.103.A88182, 88184, 88185, 88187, 88188, 88189Criteria and Billing and Reimbursement: Added new indications D72.1X and D72.824 eosinophilia and basophilia (supported by NCCN, WHO, and peer reviewed publications), Process change: Deleted ICD Code Table of non-coverable codes (Flow is coverable for many diagnoses in specific clinical scenarios that are not easily identified using the limited information provided on a claim, so this automatic stance of not coverable was removed) and added language to reflect that requests above limits may be subject to post service review or would be assessed on a case-by-case basis, also added statement in Cell Cycle and DNA analysis section to clarify that other uses will be considered on a case-by-case basis, admin updates; ICD code updates: Added D47.ZX (replacement for non-valid codes D47.5 and D47.7), Added R93.X (deleted from guideline in error - has remained reimbursable in claims rules so no clinical change), admin updates, Background: removed reference to Choosing Wisely; References: UpdatedEosinophilia:
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)--Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene Fusions [Version 2.2025 — April 4, 2025]

Shomali W, Gotlib J. World Health Organization-defined eosinophilic disorders: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022 Jan 1;97(1):129-148

Gotlib, Jason et al. Chronic Eosinophilic Leukemia: Diagnosis and Therapy. Clinical Lymphoma, Myeloma and Leukemia, Volume 21, S27 - S29

Basophilia:
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)--Chronic Myeloid Leukemia [Version 1.2026 — July 16, 2025]

Cortes, J.E., Talpaz, M., O'Brien, S., Faderl, S., Garcia-Manero, G., Ferrajoli, A., Verstovsek, S., Rios, M.B., Shan, J. and Kantarjian, H.M. (2006). Staging of chronic myeloid leukemia in the imatinib era. Cancer, 106: 1306-1315,

Khoury, et al The 5th edition of the World Health Organization Classification of Hematolymphoid Tumors: Myeloid and Histiocytic/Dendritic Neoplasms, Leukemia 2022;36(7):1703-1719. doi:10.1038/s41375-022-01613-1,

D Arber, et al. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data, Blood 2022;140(11):1200-1228)
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.A87798, 87528, 87529, 0527UCriteria: Bacterial Vaginosis section changed NuSwab Vaginitis Plus (non-specific CPT 87798) from not covered to covered per internal EviCore health technology assessment and supported by ASCP, 2024 best practice recommendations; moved Candida subtyping (including CPT 0068U) to a dedicated sub-block to avoid confusion with other criteria for direct/amplified probe testing; adjusted language in Infectious Agent, NOS section to accommodate coverage of NuSwab Vaginitis Plus; added additional symptoms for immunocompromised individuals listed in coverage criteria for HSV (CPT 87528, 87529, 0527U) per IDSA/ASM, 2024 guideline; admin edits throughout Criteria to rework language related to billing & coding so that it is more medical necessity focused (associated coding language retained in Billing & Reimbursement section); additional admin edits throughout. Billing & Reimbursement: updates to Bacterial Vaginosis section to align with criteria allowing approval of NuSwab, converted cobilled rules in both Bacterial Vaginosis and Infectious Agents NOS sections to ICD-based codes in order to allow coverage of NuSwab; creation of Candida subtyping sub-block in alignment with Criteria update described above; admin edits to M. genitalium billing requirements to better align with format of other sections; shortened existing ICD code table title for symptomatic individuals (and associated references to title) to improve ease of use, added additional ICDs to symptomatic table to align with symptoms of STIs and vaginitis that are addressed in the medical necessity criteria, removed code ranges in O23.X range that are specific to urinary tract infections and have thus been more appropriately addressed in the Urinary Tract Infection Laboratory Testing guideline, removed redundant table header information to improve readability; added new ICD table with additional STI screening and reproductive tract evaluation codes to facilitate identification of  Infectious Agents NOS codes billed for non-approvable bacterial vaginosis and/or STI assays (in place of previous co-billed rules used to identify these tests); Procedure Code Table: consolidated rows for infectious agent NOS codes to align with format of other code sets. Background: updated. Guidelines and Evidence: updated; References: updated.American Society of Clinical Pathologists. 2024 Effective Test Utilization Best Practices Recommendations. 2024. Available at: https://ascpcdn.s3.amazonaws.com/static/ISTP/ETU_Best+Practices+Doc.pdf
Genetic Testing by Multigene PanelsMOL.CU.116.A Criteria: removed bullets that did not contain medical necessity criteria and placed the content in either an introductory statement or the Other Considerations section and adjusted language to align with new context; admin edits (punctuation); Background: updated person/person's to individual/individual's, admin edits (punctuation); Test Information: updated VUS (from 'variant of uncertain significance' to 'variant of uncertain clinical significance') to align with how the phrase is defined in the Genetic Testing for Variants of Uncertain Clinical Significance guideline 
Experimental, Investigational,  or Unproven Laboratory TestingMOL.CU.117.IAdded: 0597U, 0575U, 0578U, 0576U, 0586U, 81538; DELETED: 87481, 87798, 0550UCriteria and CPT code table: Added: AidaBreast (0597U); HepatoTrack (0575U); Merlin Test (0578U); MyHPVscore (81479); OmniGraf Liver (0576U); RNA Salah Targeted Expression Panel (0586U);  DELETED: PCR Fungal Screen for Onychomycosis (87481, 87798 – managed by the nail dystrophy guideline); MyPRS (81479 - no longer available);  EDITED: Criteria only - HelioLiver Test (0333U - new lab) 
Preimplantation Genetic Testing (Formerly Preimplantation Genetic Screening and Diagnosis)MOL.CU.119.A Criteria: reorganized and reformatted this entire section. Moved criteria into separate blocks for PGT-M, PGT-A, PGT-SR, and PGT-P, specifically stated that PGT-P is EIU per ACMG (does not represent a clinical decision-making change, but adding a section to align with updated terminology list); Background: Updated to new terminology with the use of PGT-M, PGT-A, PGT-SR, and PGT-P; G&E: Updated; TITLE CHANGE: Preimplantation Genetic TestingACMG: Abu-El-Haija A, Reddi HV, Wand H, et al. The clinical application of polygenic risk scores: A points to consider statement of the American College of Medical Genetics and Genomics (ACMG).Genet Med. 2023;25(5):100803. doi:10.1016/j.gim.2023.100803
Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)MOL.TS.150.A81228, 81229, 81349, S3870Criteria: Retitled Fetal demise and stillbirth section to pregnancy loss (including fetal demise, stillbirth and miscarriage) and added coverage for pregnancy loss in the first trimester when there is a parental history of one or more prior pregnancy losses and reworded language for later losses to 2nd trimester (both per ACOG, 2024 clinical expert series), clarified that criteria apply to testing on products of conception; Background: Updated. Test Information: Updated. Guidelines & Evidence: Updated to add ACOG, 2024 clinical expert series and ACMG, 2024 practice guidance addendum. References: Updated.de Assis V, Giugni CS, Ros ST. Evaluation of recurrent pregnancy loss. Obstet Gynecol. 2024;143(5):645-659. doi: 10.1097/AOG.0000000000005498
Lynch Syndrome Genetic TestingMOL.TS.197.A81403, 81294,  81293, 81292, 81297, 81296, 81295, 81300, 81299, 81298, 81319Criteria: In Diagnostic Testing for Symptomatic individuals - added criteria for personal (any age) history of colorectal cancer or endometrial cancer plus family history (per NCCN), Predisposition/Presymptomatic section - added second-degree relatives (per NCCN),   grammatical edits, added clarification to previous testing section - "If there is a known familial mutation in the family, that mutation does not sufficiently explain the indication for testing",  updated footnote *** defining LS-associated tumors,  under "Other considerations" - added "The [NCCN] Panel also recommends considering tumor screening for MMR deficiency for sebaceous neoplasms as well as the following adenocarcinomas: small bowel, ovarian, gastric, pancreatic, biliary tract, brain, bladder/urothelial, and adrenocortical cancers regardless of age at diagnosis", in Figure A updated footnote +++ adding "Additional testing with MLH1 hypermethylation or BRAF testing may be performed with loss of MLH1 and PMS2 or loss of only MLH1", admin edits; Background: grammatical edits; Test Information: grammatical edits; Guidelines and Evidence: grammatical edits, updated NCCN; References: updatedNCCN: Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric, Version 1.2025
Somatic Mutation TestingMOL.TS.230.AAdded 0592UCriteria: added ALL to diagnosis-based list as an approvable cancer type (no clinical decision making change - was previously approvable based on NCCN recommendation for comprehensive testing), added clarification to billing & reimbursement about not allowing CDx codes to be approved using non-CDx tumor marker panel criteria- must use CDx criteria, admin updates; Guidelines and Evidence: updated, ASCO 2025 guidelines for genomic testing for metastatic prostate cancer & ovarian cancer added, removed ESMO multiple myeloma MRD guideline, updated; References: updated; AUGUST: CPT code table - added new PLA code Aventa Lymphoma  (0592U); edited test name for Guardant360 Tissue 
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.AS3840, Multiple Tier 2 codesCriteria: removed requirement for targeted testing prior to sequencing based on an expert authored review (reference GeneReviews) and necessitated by lack of commercial availability of targeted testing, grammatical edit; Background: grammatical edit; Guidelines and Evidence: updated direct quote and year of publication; References: updatedEng C, Plitt G. Multiple Endocrine Neoplasia Type 2. 27 Sept 1999 [Updated 10 August 2023]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2025. Available at:  https://www.ncbi.nlm.nih.gov/books/NBK1257/
Facioscapulohumeral Muscular Dystrophy Genetic TestingMOL.TS.290.ATier 2 codesCriteria: added additional symptoms to D4Z4 targeted analysis and haplotyping (based on an expert authored best practice guideline; guideline, grammatical edits; Background: updated and added reference; Test Information: added test for molecular combing; Guidelines and Evidence: added block on ENMC 2024 updated guideline for diagnosis of FSHD; References: updated.Giardina E, Camaño P, Burton-Jones S, et al. Best practice guidelines on genetic diagnostics of facioscapulohumeral muscular dystrophy: Update of the 2012 guidelines. Clinical Genetics. 2024; 106(1): 13-26. doi:10.1111/cge.14533
Exome SequencingMOL.TS.235.I81414, 81416, 81417, 0215U, 0214UCriteria: added cerebral palsy as an approvable neurodevelopmental disorder in the criteria section that requires "2 of the following" based on a peer reviewed systematic review/meta-analysis, clarified language within criteria related to inherited metabolic disorders and for when a "more appropriate targeted" test is available based on concern for a certain syndrome, clarification to criteria by removing the bullet stating "multiple targeted panels are appropriate based on the member's clinical presentation", added clarification to billing & reimbursement about not allowing WES on pregnancy tissue, admin updates; Background: updated; Guidelines and Evidence: added cerebral palsy reference, admin updates; References: updatedLewis SA, , Chopra M, Cohen JS, et al. Clinical actionability of genetic findings in cerebral palsy: a systematic review and meta-analysis. JAMA Pediatr. 2025 Feb 1;179(2):137–44
Decipher Prostate Cancer ClassifierMOL.TS.294.A Criteria: Changed Decipher Prostate for Biopsy from EIU to not medically necessary to better align with EviCore lab definitions, admin edits to section headers; CPT code table: updated test name here and throughout guideline; Test Information: updated; Guidelines and Evidence: updated, incorporated current EviCore HTA, admin edits; References: updated; TITLE CHANGE: Decipher Prostate Genomic Classifier 
Genome SequencingMOL.TS.306.I81425, 81426, 81427, 0213U, 0212U, 0567U, 0267U, 0265U, 0532U, 0094U, 0425U, 0426U; Added 0582U, 0583UCriteria: added cerebral palsy as an approvable neurodevelopmental disorder in the criteria section that requires "2 of the following" based on a peer reviewed systematic review/meta-analysis, clarified language within criteria related to inherited metabolic disorders and for when a "more appropriate targeted" test is available based on concern for a certain syndrome, clarification to criteria to by removing the bullet stating "multiple targeted panels are appropriate based on the member's clinical presentation", added clarification to billing & reimbursement about not allowing GS on pregnancy tissue, admin updates; Background: updated; Guidelines and Evidence: added more detailed overview in Selected Relevant Publications section, including cerebral palsy reference, admin updates; References: updated; CPT code table: added new PLA codes Rapid Whole Genome Sequencing (0582U), Rapid Genome Sequencing Family Member Comparator (0583U)Lewis SA, , Chopra M, Cohen JS, et al. Clinical actionability of genetic findings in cerebral palsy: a systematic review and meta-analysis. JAMA Pediatr. 2025 Feb 1;179(2):137–44
Hemoglobinopathies Genetic TestingMOL.TS.308.A Criteria: reorganized to remove multiple restatements of the same criteria in multiple sections - no change to clinical decision making, admin edit; Guidelines and Evidence: updated, admin edit; References; updated 
Celiac Disease TestingMOL.CS.319.A Criteria: Removed Billing & Reimbursement section since these CPT codes are not managed with claims rules. Guidelines and Evidence: Updated; References: Updated. 
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A Criteria: in Billing and Reimbursement section - clarification of intent adding a limit of one prenatal cfDNA test per pregnancy to align with limits in our NIPT guideline; Test Information: updated; Guidelines and Evidence: updated, incorporated current EviCore HTA, admin edits; References: updated, admin edits 
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.A Criteria; Billing and Reimbursement: removed block for Evaluation of Oropharyngeal Cancer since there are no claims rules configured; Background: updated; Guidelines and Evidence: updated; References: updated; CPT Code Table: Remove retired code 0500T, added flow cytometry codes 88184, 88185, and/or 88187 as they are addressed within the guideline. 
Infectious Disease Laboratory TestingMOL.CU.398.A0086U, 0311U

Added: 0595U, 0588U		Criteria and Billing and Reimbursement: Removed AcceleratePheno tests and codes (0086U, 0311U) from list of EIU Infectious disease tests, as they are now coverable based on 2025 EviCore HTA, supported by the 2024 IDSA guideline; Criteria: New PLA code 0588U (TriVerity) added to list of EIU tests for infectious disease; CPT code table: added new codes 0588U and 0595U (BIOFIRE FILMARRAY Tropical Fever (TF) Panel ), deleted G0567 as the code was redundantEviCore HTA (including clinical use studies  Babowicz F, LaPlante R, Mitchell C, et al. Impact of Accelerate Pheno and BacT/Alert Virtuo on Clinical Processes and Outcomes in Patients with Sepsis and Concurrent Gram-Negative Bacteremia. Antimicrob Agents Chemother. 2021;65(6). doi: 10.1128/AAC.02364-20 
and
MacVane SH, Bhalodi AA, Dare RK, et al. Improving outcomes and antibiotic stewardship (IOAS) for patients with Gram-positive bloodstream infections through use of rapid testing: a quasi-experimental multicentre study of the Accelerate PhenoTest BC Kit. J Antimicrob Chemother. 2021;76(9):2453-2463. doi: 10.1093/jac/dkab165

IDSA: (Miller JM, Binnicker MJ, Campbell S, et al. Guide to Utilization of the Microbiology Laboratory for Diagnosis of Infectious Diseases: 2024 Update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM) ∗. Clinical Infectious Diseases. 2024. doi: 10.1093/cid/ciae104
Urinary Tract Infection Molecular TestingMOL.CS.403.A87555, 87556, 87480, 87481, 87482, 87490, 87491, 87492, 87496, 87510, 87511, 87512, 87528, 87529, 87530, 87531, 87532, 87533, 87797, 87798, 87799, 87555, 87556, 87557, 87563, 87590, 87591, 87592, 87640, 87641, 87650, 87651, 87652, 87653, 87660, 87661

Added 0593U, 0590U		Criteria: added coverage criteria for urogenital M. tuberculosis testing by direct (CPT 87555) or amplified (CPT 87556) technique, supported by AST/IDSA/CDC guideline and expert-authored review on genitourinary TB; added coverage criteria for single-organism testing in immunocompromised individuals (previously only considered on a case-by-case basis), per IDSA, 2024 guidelines; relocated and provided clarification of intent edits to language indicating that single-organism testing for bacterial vaginosis and STIs is addressed in a different guideline, Sexually Transmitted and Other Reproductive Tract Infection Testing; admin edit to remove "Introduction" block titles. Billing & Reimbursement: reworked this section to replace cobilled rules for infectious agent NOS codes (87797-87799) to now include ICD-based rules to align claims rules with Criteria changes described above; added tables of ICD codes associated with new billing requirements; clarification of intent edit to indicate that list of non-reimbursable UTI panels is not intended to be all-inclusive; removed "Introduction" block title. Procedure Code Table: consolidated rows for infectious agent NOS codes to align with format of other code sets. Background: updated. Test Information: updated. Guidelines & Evidence: updated; added expert-authored 2025 guideline for dysuria, removed guidelines for testing that are beyond the scope of this guideline. References: updated.

Added new PLA codes to Criteria, Billing and Reimbursement sections and CPT code table: Taq Array Card Urinary Tract Infection PCR Panel (0593U); BIOTIA-IDTM Urine NGS Assay (0590U)		Lewinsohn DM, Leonard MK, LoBue PA, et al. Official American Thoracic Society/Infectious Diseases Society of America/Centers for Disease Control and Prevention clinical practice guidelines: diagnosis of tuberculosis in adults and children. Clin Infect Dis. 2017;64(2):111-115. doi: 10.1093/cid/ciw77820

Roddy K, Tobin EH, Leslie SW, et al. Genitourinary Tuberculosis. Updated August 16, 2024. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available at: https://www.ncbi.nlm.nih.gov/books/NBK557558/

Miller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease
society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024). doi: 10.1093/cid/ciae104​


Criteria Updates (Non-Substantive):

​
Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) 
Genetic Testing for Carrier StatusMOL.CU.110.AN/ACriteria: clarification of intent edit updating language to 'carrier testing' for consistency across the guideline; Background: updated; changed language to 'carrier testing'
Genetic Testing for Non-Medical PurposesMOL.CU.111.AN/ACriteria: admin edits
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AN/ACriteria: Admin edit to add updated test name used by laboratory for test described by code 0392U (EffectiveRX Neuropsychiatric Panel). Procedure Code Table: Updated test name for 0392U.
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.AN/ACriteria: clarification of intent edit (Billing and Reimbursement section) adding the word "separately" to this statement "Afirma Xpression Atlas is not separately reimbursable."; Guidelines and Evidence: updated; References: updated
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.AN/ACriteria: added "Rendering laboratory" statement to align with standard criteria section format, admin edit; Background: updated; Test information: updated; References: updated
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.AN/ACriteria: admin update- added "Rendering laboratory" phrase to all sub-sections to align with standard criteria section format, admin edit in Billing and Reimbursement; Background: updated. Guidelines and Evidence: updated; References: updated
Duchenne and Becker Muscular Dystrophy TestingMOL.TS.161.AN/ACriteria: admin update- reworded multiple bullets for clarity; Background: updated. Guidelines and Evidence: Updated; References: updated
Early Onset Familial Alzheimer Disease Genetic TestingMOL.TS.162.AN/ACriteria: grammatical edit; Background: updated and grammatical edits; References: updated
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.AN/ACriteria: grammatical edit. Guidelines and Evidence: Updated; References: updated
Peutz-Jeghers Syndrome Genetic TestingMOL.TS.216.AN/ACriteria: admin edits. Background: admin edit; Guidelines and evidence: updated; References: updated.
PTEN Hamartoma Tumor Syndromes  Genetic TestingMOL.TS.223.AN/ACriteria: grammatical edit; Background: updated table; Guidelines and Evidence: grammatical edits to NCCN, updated table, and removed special note; References: updated.
Spinal Muscular Atrophy Genetic TestingMOL.TS.225.AN/ACriteria: admin edit (deleted an extra space in KFM section), Background: updated; References: updated
Von Hippel-Lindau Disease Genetic TestingMOL.TS.233.AN/ACriteria: grammatical edit. Introduction: added "genetic"; Guidelines and evidence: grammatical edit, added ASCO guideline on selection of germline genetic testing panels in individuals with cancer and added on reference; References: updated.
BRCA AnalysisMOL.TS.238.AN/ACriteria: clarification of intent & admin edits, one redundant criterion removed; Background: updated: Guidelines and Evidence: added ASCO guidelines for ovarian and metastatic prostate, updated; References: updated.
Maturity-Onset Diabetes of the Young (MODY) Genetic TestingMOL.TS.258.AN/ACriteria: grammatical edit. Background: added gene to monogenic cause; Guidelines and Evidence: added information to ADA guideline; References: updated.
Mitochondrial Disorders Genetic TestingMOL.TS.266.AN/ACriteria: updated KFM language to "that would detect the familial mutation" to align with other KFM sections in guidelines, clarification of intent for other considerations section that excludes testing for nonspecific conditions; updated; CPT Code Table: added introduction statement, updated; Background: updated; Test Information: updated; Guidelines and Evidence: updated; References: Renumbered reference list and in-text reference numbers, updated
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.AN/ACriteria - Billing and Reimbursement section - corrected typo in CPT code (81741 to 81471); References: corrected error, updated incomplete reference
Hereditary Pancreatitis Genetic TestingMOL.TS.287.AN/ACriteria: grammatical edits and added "Rendering laboratory is a qualified provider of service per the Health Plan policy" to KFM section. Background: updated overall, grammatical edits, and updated information on pancreatic screening per reference already in guideline and added information from NCCN,; Test Information: grammatical edit; Guidelines and Evidence: grammatical edits; References: updated.
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.AN/ACriteria: admin edit; Background: updated; Test information: updated; Guidelines & evidence: updated; References: updated
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.AN/ACriteria: updated table of select IBMF syndromes; Background: updated reference order; Test Information: updated reference order; Guidelines and Evidence: admin edits and updated reference order; References: updated
Inherited Thrombophilia Genetic TestingMOL.TS.370.AN/ACriteria: admin edit; Background: updated; Guidelines and Evidence: updated; References: updated
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.AN/ACriteria: grammatical edits; Background: added one reference under "cause" and adjusted reference order; updated percentages under "cause"; Test information: grammatical edit, updated reference order; Guidelines and Evidence: updated; References: two added and updated.
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.IN/ACriteria: added IL SB2697; Background: Added statement "Please note: The information included in this guideline is current as of the publication date. Any additional laws and/or regulations impacting laboratory services not referenced in this guideline would be considered using the criteria outlined below."; References: updated; Throughout: updated in text reference numbers
Epilepsy Genetic TestingMOL.TS.257.AN/ACriteria: added sections for Genetic Counseling and Previous Genetic testing to both single gene and panel sections to align with criteria structure in other guidelines - no change in clinical decision making, removed conditions/genes/ applicable guidelines table from criteria, admin edits; Background: updated, added reformatted/pared down table of conditions/genes/ applicable guidelines table; genes
Gastrointestinal Pathogen Panel (GIPP) Molecular TestingMOL.CS.277.AN/ACriteria: Billing & Reimbursement section - added ICD code N19 Unspecified kidney failure that was erroneously omitted from end-stage kidney disease codes already included in Table: ICD Codes Indicating Cancer, Transplant, or Other Immunocompromise; Background: admin update; Test Information: admin update; Guidelines and Evidence: updated, admin edits: References: updated.
Genetic Testing for Known Familial MutationsMOL.CU.291.AN/ACriteria: added "Member is at risk based on the inheritance pattern of the disorder in question, AND" as clarification and to align with the KFM criteria that appears in the Genetic testing to Predict Disease Risk guideline; References: updated
Respiratory Infection Pathogen Panel (RIPP) Molecular TestingMOL.CS.293.IN/ACriteria: Billing & Reimbursement section, added ICD code N19 Unspecified kidney failure that was erroneously omitted from end-stage kidney disease codes already included in Table: ICD Codes Indicating Cancer, Transplant, or Other Immunocompromise
Legius Syndrome Genetic TestingMOL.TS.302.AN/ACriteria: added to sequence analysis section standard statement regarding pre- and post-test genetic counseling and reformatted section to align with standard, grammatical edits, reformatted del/dup section to align with standard; Guidelines and Evidence: updated quoted information; References: updated.

Retired Guideline:

​
Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) 
PancraGENMOL.TS.271.AN/ATest is no longer on the market
Ataxia-Telangiectasia Genetic TestingMOL.TS.130.AN/AIndividual guideline retired - all ataxia-related test-specific guidelines have been combined into new guideline Hereditary Ataxia Genetic Testing (MOL.TS.425)
Dentatorubral-Pallidoluysian Atrophy Genetic TestingMOL.TS.159.AN/AIndividual guideline retired - all ataxia-related test-specific guidelines have been combined into new guideline Hereditary Ataxia Genetic Testing (MOL.TS.425)
Friedreich Ataxia Genetic TestingMOL.TS.309.AN/AIndividual guideline retired - all ataxia-related test-specific guidelines have been combined into new guideline Hereditary Ataxia Genetic Testing (MOL.TS.425)
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.AN/AIndividual guideline retired - all ataxia-related test-specific guidelines have been combined into new guideline Hereditary Ataxia Genetic Testing (MOL.TS.425)
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.AN/AIndividual guideline retired - all ataxia-related test-specific guidelines have been combined into new guideline Hereditary Ataxia Genetic Testing (MOL.TS.425)
Marfan Syndrome Genetic TestingMOL.TS.202.AN/AIndividual guideline retired - all connective tissue disorder-related test-specific guidelines have been combined into new guideline Hereditary Connective Tissue and Thoracic Aortic Disease Genetic Testing (MOL.TS.427)
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic TestingMOL.TS.227.AN/AIndividual guideline retired - all connective tissue disorder-related test-specific guidelines have been combined into new guideline Hereditary Connective Tissue and Thoracic Aortic Disease Genetic Testing (MOL.TS.427)
Ehlers-Danlos Syndrome Genetic TestingMOL.TS.267.AN/AIndividual guideline retired - all connective tissue disorder-related test-specific guidelines have been combined into new guideline Hereditary Connective Tissue and Thoracic Aortic Disease Genetic Testing (MOL.TS.427)
Hereditary Connective Tissue Disorder Genetic TestingMOL.TS.268.AN/AIndividual guideline retired - all connective tissue disorder-related test-specific guidelines have been combined into new guideline Hereditary Connective Tissue and Thoracic Aortic Disease Genetic Testing (MOL.TS.427)​



Revisions From MA06.034s:

10/01/202​5

This version of the policy is a result of code updates effective 10/01/2025. ​

 

The following procedure codes were added to the policy:

 

0575U, 0576U, 0578U, 0585U, 0586U, 0588U, 0590U, 0592U, 0593U, 0595U, 0597U, 0582U, & 0583U.​


The following procedure codes were deleted from this policy because they have been termed:

0450U & 0451U.


Narratives for the following procedure codes were revsied:  ​


0333U, 0334U, 0365U, & 0503U.​




Revisions From MA06.034r:
07/01/2025This version of the policy will become effective on 07/01/2025.​

Effective 07/01/2025, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0552U, 0553U, 0554U, 0555U, 0560U, 0561U, 0562U, 0565U, 0566U, 0567U, 0569U, 0571U, and 0572U

Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

0556U, 0557U, 0563U, and 0564U

 

REVISED

0089U, 0220U, 0285U, and 0420U


DELETED 

0369U, 0370U, 0373U, and 0374U


--------------------------------------------------------------------------------------------------------------


On Jult 01st, 2025, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 01st, 2025. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

07/01/2025 Guideline Updates for eviCore Lab Management Program (Policy #: MA06.034r​)

Executive Summary of Changes

There are three new guideline. 48 existing guidelines have been revised (including 18 with substantive criteria changes). Two guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Celiac Disease Testing
  2. Helicobacter pylori Laboratory Testing
  3. Primary Ciliary Dyskinesia Genetic Testing​

​Criteria Updates (Substantive):

  1. Medicare: Hierarchy for Applying Coverage Decision for Laboratory Testing
  2. Afirma Thyroid Cancer Classifier Tests
  3. Duchenne and Becker Muscular Dystrophy Testing
  4. ThyGeNEXT and ThyraMIR miRNA Gene Expression Classifier
  5. ThyroSeq
  6. Flow Cytometry
  7. Sexually Transmitted and Other Reproductive Tract Infection Testing
  8. Experimental, Investigational,  or Unproven Laboratory Testing
  9. Pharmacogenomic Testing for Drug Toxicity and Response
  10. Liquid Biopsy Testing
  11. Somatic Mutation Testing
  12. Mitochondrial Disorders Genetic Testing
  13. Polymerase Gamma (POLG) Related Disorders Genetic Testing
  14. Human Immunodeficiency Virus Laboratory Testing
  15. Lyme Disease Testing
  16. Cardiomyopathy and Arrhythmia Genetic Testing
  17. Gastrointestinal Pathogen Panel (GIPP) Molecular Testing
  18. Respiratory Infection Pathogen Panel (RIPP) Molecular Testing​

Criteria Updates (Non-Substantive):

  1. Immunohistochemistry (IHC)
  2. Angelman Syndrome Genetic Testing
  3. ConfirmMDx for Prostate Cancer Risk Assessment
  4. Marfan Syndrome Genetic Testing
  5. MUTYH Associated Polyposis Genetic Testing
  6. Prader-Willi Syndrome Genetic Testing
  7. Prenatal Aneuploidy FISH Testing
  8. Rett Syndrome Genetic Testing
  9. BCR-ABL Negative Myeloproliferative Neoplasm Testing
  10. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  11. Neurofibromatosis Type 1 Genetic Testing
  12. Medical Necessity Review Information Requirements
  13. Date of Service and  Authorization Period Effective Date
  14. Human Platelet and Red Blood Cell Antigen Genotyping
  15. Inherited Thrombophilia Genetic Testing
  16. Multi-Cancer Early Detection Screening
  17. Nail Disorder Infectious Disease Testing, Including Onychomycosis
  18. CADASIL Genetic Testing
  19. SEPT9 Methylation Analysis for Colorectal Cancer
  20. Carrier Screening Panels, Including Targeted, Pan-Ethnic, Universal, and Expanded
  21. Hereditary Cancer Syndrome Multigene Panels
  22. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  23. NETest
  24. Ehlers-Danlos Syndrome Genetic Testing
  25. Genetic Testing for Known Familial Mutations
  26. CHARGE Syndrome Genetic Testing
  27. Infectious Disease Laboratory Testing
  28. Medically Necessary Laboratory Testing
  29. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  30. DecisionDX Uveal Melanoma​
Retired Guideline:

  1. HLA Typing for Celiac Disease
  2. HIV Tropism Testing for Maraviroc Response​

Other Note:(E/I/U = Experimental, Investigational, or Unproven​) -- 

See the tables below that follow (which provide more details for the guideline changes):



New Guidelines:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) 
Celiac Disease TestingMOL.CS.319.A81376, 81377, 81382, 81383New guideline that includes content from retired guideline HLA Typing for Celiac Disease (MOL.CS.146.A). Criteria unchanged from previous guideline; clarification of intent edit to ICD table in Billing & Reimbursement (replaced K90.0 and K90.9 with the full K90.X range for intestinal malabsorption, encompassing conditions already approvable per existing criteria).
Helicobacter pylori Laboratory TestingMOL.CS.318.A87513, 0008U, 87149, 87150, 87152, 87797-87799New guideline that addresses molecular H. pylori assays that adds more specific criteria than those previously used under the Infectious Disease Testing guideline; 0008U remains E/I/U (previously addressed in Experimental, Investigational, or Unproven Laboratory Testing)
Primary Ciliary Dyskinesia Genetic TestingMOL.TS.419.A81403, 81479, 81443New guideline addressing single gene and multigene panel testing for primary ciliary dyskinesia - covered with medical necessity criteria

​Criteria Updates (Substantive):
Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Rationale / supporting guideline for clinically significant updates What is the expected impact?
Medicare: Hierarchy for Applying Coverage Decision for Laboratory TestingMOL.AD.101.BAnyCriteria: Added ADLT criteria information per CMS requirements (https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule/adlt-information); Throughout: updated eviCore to EviCore, Background: admin edits; References: updatedCMS:  https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule/adlt-informationMore approvals
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.A81546, 81210Criteria and Billing and Reimbursement: Updated Afirma testing to two per date of service, regardless of the number of nodules submitted for testing. This was based on the CMS MUE for the testing.Medicare NCCI Medically Unlikely Edits: https://www.cms.gov/medicare/coding-billing/national-correct-coding-initiative-ncci-edits/medicare-ncci-medically-unlikely-editsMore approvals
Duchenne and Becker Muscular Dystrophy TestingMOL.TS.161.Aany in the guidelineCriteria: removed 'male gender' from criteria list as, although rare, females may present with classic dystrophinopathy symptoms per an expert authored reviewDarras BT, Urion DK, Ghosh PS. Dystrophinopathies. 2000 Sep 5 [Updated 2022 Jan 20]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1119/More approvals
ThyGeNEXT and ThyraMIR miRNA Gene Expression ClassifierMOL.TS.259.I0245U, 0018UCriteria: updated parenthetical examples of Bethesda III and IV to align with new definitions of these pathology classifications. Criteria and Billing and Reimbursement: Updated ThyGeNEXT and ThyraMIR testing to two per date of service, regardless of the number of nodules submitted for testing. This was based on the CMS MUE for the testing.; Guidelines and Evidence: updated; Added benefit/harm statement per CMS final rule; References: updatedMedicare NCCI Medically Unlikely Edits: https://www.cms.gov/medicare/coding-billing/national-correct-coding-initiative-ncci-edits/medicare-ncci-medically-unlikely-editsMore approvals
ThyroSeqMOL.TS.270.I0026U, 0287UCriteria: updated parenthetical examples of Bethesda III and IV to align with new definitions of these pathology classifications. Criteria and Billing and Reimbursement: Updated ThyroSeq testing to two per date of service, regardless of the number of nodules submitted for testing. This was based on the CMS MUE for the testing.; Guidelines and Evidence: updated, incorporated current EviCore HTA, Added benefit/harm statement per CMS final rule; References: updatedMedicare NCCI Medically Unlikely Edits: https://www.cms.gov/medicare/coding-billing/national-correct-coding-initiative-ncci-edits/medicare-ncci-medically-unlikely-editsMore approvals
Flow CytometryMOL.CS.103.Aany in the guidelineCriteria: Removed limits for flow testing [various units are needed depending on indication (establishing new diagnoses, subtyping, evaluating for MRD, prognosis/treatment planning) not available on a claim] based on NCCN ALL guidelines and peer reviewed literature; Billing and Reimbursement: Clarification of intent edits to align with medical necessity edits, combined ICD code tables for Tier 1 and Tier 2 testing into 1 due to significant overlap in content, deleted ICD table with indications for CPT 88182 and addressed in text of Criteria and Billing and Reimbursement sections;  Background: Updated; References: Updated.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia Version 3.2024 — December 20, 2024

Li W. Flow Cytometry in the Diagnosis of Leukemias. In: Li W, editor. Leukemia [Internet]. Brisbane (AU): Exon Publications; 2022 Oct 16. Chapter 4. Available from: https://www.ncbi.nlm.nih.gov/books/NBK586209/ doi: 10.36255/exon-publications-leukemia-flow-cytometry

Dunphy, C. Application of Flow Cytometry and Immunohistochemistry to Diagnose Hematopathology. Arch Pathol Lab Med. 2024:128:1004-1022		More approvals
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.AAdded:  0483U, 0484U, & 0527UCriteria: added sample types that can be used for C. trachomatis, N. gonorrhoeae and HSV and also expanded approvable indications for HSV per CDC, 2021 and IDSA, 2024 guidelines, incorporated combined HSV/VZV assay (CPT 0527U) criteria with coverage per guidelines from IDSA, 2024 & NIH/CDC/HMA/IDSA, 2024, incorporated N. gonorrhoeae ciprofloxacin resistance testing (0484U) with coverage criteria and M. genitalium macrolide resistance testing (0483U) as E/IU per CDC, 2021 guideline; Procedure code table: Added 0483U (Ciprofloxacin Susceptibility of Neisseria gonorrhoeae), 0484U (Macrolide Resistance of Mycoplasma genitalium, & 0527U (Abbott Alinity m HSV 1 & 2 / VZV Assay), which were relocated from Infectious Disease Laboratory Testing guideline, admin edits; Background: updated; Test Information: updated, added RCL and additional info on antimicrobial resistance testing; Guidelines and Evidence: updated, added NIH/CDC/HMA/IDSA, 2024 guideline and additional content for antimicrobial resistance testing; References: updated.Centers for Disease Control and Prevention. Sexually Transmitted Infections Surveillance, 2022. Updated January 29, 2024. Available at: https://www.cdc.gov/std/statistics/2022/default.htm

Miller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024).

Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents With HIV. National Institutes of Health, Centers for Disease Control and Prevention, HIV Medicine. Last updated December 16, 2024. Available at:  https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/whats-new		More approvals
Experimental, Investigational,  or Unproven Laboratory TestingMOL.CU.117.IADDED: 0540U, 0549U, 0534U, 0537U, 0544U; REMOVED: 0008U, 81328ADDED: Altera (81479);  New PLA codes: Bladder CARE (0549U), PROSTOX ultra (0534U), Shield (0537U), VitaGraft Kidney 2.0 (0544U); REMOVED: AmHPR Helicobacter pylori Antibiotic Resistance Next Generation Sequencing Panel (0008U) - managed by new H. pylori guideline, Statin Induced Myopathy Genotype SLCO1B1 (81328) - managed by Pharmacogenomic clinical use guideline; EDITED: Combined AlloSure Heart and AlloSure Lung into a single AlloSure test to align with new PLA description and code (0540U), Added alternate gene name SERPINE1 to  PAI-1' gene test for clarity, Updated test name and manufacturer of 0288U from DetermaRx from Oncocyte Corp to RiskReveal  from Razor GenomicsN/ANo clinical impact
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.Aadded 0533U, 81328Criteria: Clarification of intent edits to Criteria: Targeted Pharmacogenomic Tests (provided an example of a targeted panel, changed wording in criterion so that the FDA label must "require" dosage adjustments based on genotype rather than just "provide" them as clinical utility would be established for the former and not the latter, added a statement clarifying that any pharmacogenomic testing for general drug response or broad categories of drugs would not meet these criteria), clarification of intent edits to Targeted Pharmacogenomic Tests Considered Not Medically Necessary (removed genes that do not have medical necessity for any indication - VKORC1, CYP4F2 - and relocated them to E/I/U section to align with updated EviCore standard definitions, removed statement on CYP450 gene variants for general drug response or broad categories of drugs as this is now addressed by the more general statement added above), retitled criteria section from "Targeted Pharmacogenomic Tests Considered Experimental, Investigational, or Unproven" to "Criteria: Single-Gene Tests Considered Experimental, Investigational, or Unproven" to more accurately reflect the content of this section and provided clarification of intent edits (specified additional single-gene tests that are being added to our test database that do not have any FDA drug labels that recommend testing and would therefore meet updated EviCore definition of E/I/U - see FDA's Table of Pharmacogenomic Biomarkers at https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling; no change to clinical decision making as genes would previously have been denied not medically necessary under general criteria), retitled "Criteria: Pharmacogenomic Panel Tests" section to "Criteria: Pharmacogenomic Panels Considered Experimental, Investigational, or Unproven" to more accurately reflect content and added new PLA code 0533U (UCSF Pharmacogenomics Panel) to this section as well as clarification of intent edit (to clarify that panels may be addressed by this section regardless of the number of genes included), admin edits throughout (standardization of how test names are listed); CPT code table: added 0533U, 81328, and additional entries for individual genes now addressed by name in the guideline (all billed with 81479); Background: Added benefit/harm statement per CMS final rule, additional updates; References: Updated and added references addressing gene/drug pairs we consider not medically necessary.N/ANo clinical impact
Liquid Biopsy TestingMOL.TS.194.ANon-specific codesCriteria: Added coverage for liquid biopsy testing for the ESR1 gene based on ASCO 2023 and NCCN breast guideline. CPT Code Table: updated; added new PLA code 0539U (PredicineCARE Assay). Background: updated. Guidelines and Evidence: updated.  References: updated.Burstein HJ, Demichele A, Somerfield MR, et al. Testing for ESR1 mutations to guide therapy for hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer: ASCO guideline rapid recommendation update. J Clin Oncol. 2023;41(18):3423-3425

National Comprehensive Cancer Network (NCCN) Guidelines Version 6.2024 – November 11, 2024. Breast Cancer, available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.)		More approvals
Somatic Mutation TestingMOL.TS.230.A0364UCriteria: added coverage at more time points for ClonoSEQ for ALL and MM based on NCCN guidelines, admin edits; CPT code table: added new PLA codes 0543U (TruSight Oncology Comprehensive) and 0538U (PredicineATLAS Assay); Guidelines and Evidence: updated; References: updatedNational Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – December 20, 2024 Acute Lymphoblastic Leukemia, available at: https://www.nccn.org/professionals/physician_gls/pdf/all.pdf

National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2025 - September 17, 2024. Multiple Myeloma. Available at: https://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf.		More approvals
Mitochondrial Disorders Genetic TestingMOL.TS.266.Aany in the guidelineCriteria: In multiple sections including lists of clinical features - updated to align with more recently reported clinical findings in mitochondrial disorders per Mitochondrial Medicine Society consensus statement, updated clinical presentations in table, admin edits; Background: updated; Test Information: updated intro; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule; References: updatedParikh S, Goldstein A, Karaa A, et al. Patient care standards for primary mitochondrial disease: a consensus statement from the Mitochondrial Medicine Society. Genet Med. 2017;19(12):1380)More approvals
Polymerase Gamma (POLG) Related Disorders Genetic TestingMOL.TS.276.ANon-specific codesCriteria: expanded 'cerebellar ataxia' to 'movement disorder (incl extrapyramidal movement disorders such as parkinsonism & chorea, & cerebellar ataxia', added "cortical blindness and/or cataracts" based on external SME suggestion and expert authored review, admin edits; CPT table: admin edits; Background: updated; Test information: admin edit; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule, updated selected relevant publication; References: removed introduction and updated.Cohen BH, Chinnery PF, Copeland WC. POLG-Related Disorders. 2010 Mar 16 [Updated 2024 Feb 29]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2025. Available at: http://www.ncbi.nlm.nih.gov/books/NBK26471/)More approvals
Human Immunodeficiency Virus Laboratory TestingMOL.CS.321.AAdded 87999 Ifor HIV phenotyping; moved from HIV Tropism Testing for Maraviroc Response guideline)Criteria: Addition to Criteria for monitoring of preexposure prophylaxis (PrEP) for HIV prevention up to 6 times per year under HIV Nucleic Acid Testing per CDC guidelines, incorporated criteria for HIV genotyping and phenotyping from former HIV Tropism Testing for Maraviroc Response guideline (no change to criteria as they were written in previous guideline), removed Billing & Reimbursement section since frequency rules for NAT testing (87534, 87535, 87536, 87537, 87538, 87539) will be enforced during manual review and not in claims rules (frequency limits remain in Criteria section) and HIV genotyping tests have nonspecific codes and therefore cannot be enforced with claims rules (no change to related medical necessity criteria, which are enforced in manual review), admin edits throughout criteria; Procedure code table: addition of HIV-1 tropism phenotyping (87999); Background: updated; Test Information: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, added CDC 2021 guidelines for PrEP, USPSTF 2023 recommendation for PrEP, FDA drug labels for PrEP, and guidelines from former HIV Tropism Testing for Maraviroc Response guideline that were not previously cited in this guideline, additional edits/reorganization; References: updated.Centers for Disease Control and Prevention. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2021 Update. Updated 2021 Available at: https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf)More approvals
Lyme Disease TestingMOL.CS.332.A87475, 87476Criteria: Added coverage criteria for nucleic acid testing (CPT 87475 and 87476) for therapeutic decision making in seropositive individuals with suspected Lyme arthritis per IDSA/AAN/ACR guideline as well as for severely immunodeficient individuals due to their inability to mount an antibody response for serologic testing per expert-authored review, edits to Billing & Reimbursement to align with Criteria updates including addition of an ICD table for nucleic acid testing, admin edits to Introduction and throughout; Background: Updated; Test Information: Updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, incorporated CDC 2024 guidelines, additional updates; References: Updated.Lantos PM, Rumbaugh J, Bockenstedt LK, et al. Clinical practice guidelines by the Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR): 2020 Guidelines for the prevention, diagnosis and treatment of Lyme disease. Clin Infect Dis. 2020;72(1):e1-e48. doi: 10.1093/cid/ciaa1215

Branda JA, Steere AC. Laboratory diagnosis of Lyme borreliosis. Clin Microbiol Rev. 2021;34(2):e00018-00019. doi: 10.1128/cmr.00018-19		More approvals
Cardiomyopathy and Arrhythmia Genetic TestingMOL.TS.410.ANon-specific or panel codesCriteria: In list of required genes for hypertrophic cardiomyopathy panel approval, added PLN as this gene accounts for >1% of cases and is a definitive HCM gene per expert authored review, clarification of intent edit in Billing & Reimbursement to state that Brugada syndrome panel code S3861 is not reimbursable (no change to clinical decision making as such panels were already considered E/I/U per existing criteria), admin edits in "Exclusions and Other Considerations" section; Background: updated; Guidelines and Evidence: updated (admin edits); References: updated.Cirino AL, Ho C. Hypertrophic Cardiomyopathy Overview. August 5, 2008 [Updated July 8, 2021]. In: Adam MP, Feldman J, Mirzaa GM, et al, editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024. Available at: https://www.ncbi.nlm.nih.gov/books/NBK1768Possibly more denials
Gastrointestinal Pathogen Panel (GIPP) Molecular TestingMOL.CS.277.AN/AAdded Z92.21, Z92.22, Z92.241, Z92.25, and Z92.3 to Table ICD codes Indicating Cancer, Transplant, or Other Immunocompromise as additional codes representing this indicationN/ANo clinical impact
Respiratory Infection Pathogen Panel (RIPP) Molecular TestingMOL.CS.293.IN/AAdded Z92.21, Z92.22, Z92.241, Z92.25, and Z92.3 to Table ICD codes Indicating Cancer, Transplant, or Other Immunocompromise as additional codes representing this indicationN/ANo clinical impact

Criteria Updates (Non-Substantive):

​ 
Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) What is the expected impact?
Immunohistochemistry (IHC)MOL.CS.104.A
N/ACriteria: admin update- standardized introduction heading, reworded multiple sentences for clarity; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, Added Rodger C. Haggitt 2018 best practices statement for celiac disease, updated; References: updatedNo clinical impact
Angelman Syndrome Genetic TestingMOL.TS.126.AN/ACriteria: admin edits; CPT code table: admin edits; Background: admin edits, changed "Angelman Syndrome" to "AS" throughout document, moved information regarding 10% will not have a molecular etiology from Guidelines and Evidence to Cause section, Guidelines and Evidence: removed introduction and added benefit/harm statement per CMS final rule. References: removed introduction and updated.No clinical impact
ConfirmMDx for Prostate Cancer Risk AssessmentMOL.TS.153.AN/ACriteria and throughout - updated name of test to align with manufacturer's change; Guidelines and Evidence: Added benefit/harm statement per CMS final rule; TITLE CHANGE: Now Confirm mdx for Prostate CancerNo clinical impact
Marfan Syndrome Genetic TestingMOL.TS.202.AN/ACriteria: added word "genetic" to introduction, changed "pre" to "pre-", changed "MFS" to "Marfan syndrome. Background: grammatical changes to CPT code table, Test information: grammatical edit, Guidelines and Evidence: removed introduction, grammatical edit, added benefit/harm statement per CMS final rule, added publication for American Heart Association, References: removed introduction, updated references, added AHA reference.No clinical impact
MUTYH Associated Polyposis Genetic TestingMOL.TS.206.AN/ACriteria: clarification of intent edit in criteria for Testing for Asymptomatic/Presymptomatic Individuals (both the targeted and sequencing sections): amended language from 'partner of person with MAP' to 'partner of person with MAP-associated mutation(s)'No clinical impact
Prader-Willi Syndrome Genetic TestingMOL.TS.217.AN/ACriteria: updated language in introduction, changed "pre" to "pre-"; CPT coded table - admin edits; Background: admin edits, changed "Prader-Will Syndrome" to "PWS" throughout document, Guidelines and Evidence: removed introduction and added benefit/harm statement per CMS final rule. References: removed introduction and updated.No clinical impact
Prenatal Aneuploidy FISH TestingMOL.CS.218.AN/ACriteria: grammatical edit. Background: grammatical edits to CPT code table. Guidelines and Evidence: removed introduction and added benefit/harm statement per CMS final rule, References: removed introduction and updated.No clinical impact
Rett Syndrome Genetic TestingMOL.TS.224.AN/ACriteria: admit edit to wording of introduction, removed information on prenatal testing for at-risk pregnancies as this is addressed by clinical use guideline; Background: admin edit to CPT table, updated; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule, grammatical edit, References: removed introduction and updated.No clinical impact
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.AN/ACriteria: two grammatical edits. CPT code table: grammatical edits; Test information: grammatical edits; Guidelines and Evidence: removed introduction, grammatical edits, added benefit/harm statement per CMS final rule, References: updated.No clinical impact
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.AN/ACriteria: grammatical edits. CPT table: grammatical edits; Background: updated "cause" section; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule; References: updated.No clinical impact
Neurofibromatosis Type 1 Genetic TestingMOL.TS.301.AN/ACriteria: admin edit in Introduction, changed "pre" to "pre-", grammatical edit to tissue sample sections. Background: grammar edits to CPT table, updated; Guidelines and Evidence: removed introduction, grammar edit, added benefit/harm statement per CMS final rule, References: removed introduction and updated.No clinical impact
Medical Necessity Review Information RequirementsMOL.AD.304.AN/ACriteria: administrative updates changing 'policy' to 'guideline', capitalized EviCore; Background: Added benefit/harm statement per CMS final ruleNo clinical impact
Date of Service and  Authorization Period Effective DateMOL.AD.314.AN/ABackground: Added benefit/harm statement per CMS final rule; Criteria: administrative update changing eviCore to EviCore; References: updated formatNo clinical impact
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A0536UBilling and Reimbursement: clarification of intent. Added statement that targeted HPA genotyping is not reimbursable as part of a pharmacogenomic workup as well as information regarding how to determine if this is the case (this testing was already called not medically necessary in the clinical criteria; CPT Code Table: added new PLA code 0536U (Prenatal Detect RhD)No clinical impact
Inherited Thrombophilia Genetic TestingMOL.TS.370.AN/ABilling and Reimbursement: Directed reader to Pharmacogenomic guideline for more details.No clinical impact
Multi-Cancer Early Detection ScreeningMOL.TS.396.AN/ACriteria: admin update; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, Added ASCO/CAP 2018 ctDNA for cancer guideline, incorporated systematic review from EviCore HTA, updated; References: updatedNo clinical impact
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.AN/ACriteria: admin edit (corrected instances of CPT 87510 to instead be 87150 in both Criteria and Billing & Reimbursement); Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, other updates (minor reorganization of professional society guideline content); References: updatedNo clinical impact
CADASIL Genetic TestingMOL.TS.144.AN/ACriteria: grammatical edits. CPT code table: admin edits; Background: updated, admin edits; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule, updated; References: updatedNo clinical impact
SEPT9 Methylation Analysis for Colorectal CancerMOL.TS.164.AN/ACriteria: admin edits; CPT code table: admin edits; Background: updated; Test Information: updated; Guidelines and Evidence: removed introduction, updated, added benefit/harm statement per CMS final rule. References: removed introduction and updated.No clinical impact
Carrier Screening Panels, Including Targeted, Pan-Ethnic, Universal, and ExpandedMOL.TS.165.AN/ACriteria and Billing and Reimbursement: clarification of intent edits adding detail/examples and improving language clarity for existing medical necessity and coding requirements, added reused content language indicating that listed panel codes may not be all-inclusive and added statement referring reader to Laboratory Billing and Reimbursement guideline for general coding requirements.; admin editNo clinical impact
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.AN/ACriteria: clarified KFM languageNo clinical impact
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.AN/ACriteria: admin edit. CPT code table: grammatical edits;  Guidelines and Evidence: removed introduction, added ASCO statement, updated NCCN, updated reference order, added benefit/harm statement per CMS final rule; References: removed introduction, added references and updatedNo clinical impact
NETestMOL.TS.250.AN/ACriteria: grammatical edit. Test information: grammatical edit; Guidelines and Evidence: removed introduction and incorporated current EviCore HTA; References: removed introduction and updated.No clinical impact
Ehlers-Danlos Syndrome Genetic TestingMOL.TS.267.AN/ACriteria: in KFM section, clarification of intent edit - joiner between Diagnostic testing and Rendering provider requirements was updated from 'OR' to the correct 'AND' as appears in other sectionsNo clinical impact
Genetic Testing for Known Familial MutationsMOL.CU.291.AN/ACriteria: updated name of another EviCore guideline referred to in a note in this sectionNo clinical impact
CHARGE Syndrome Genetic TestingMOL.TS.324.AN/ACriteria: grammatical edits; CPT table: grammatical edits; Guidelines and Evidence: removed introduction, grammatical edit, added benefit/harm statement per CMS final rule; References: removed introduction and updated.No clinical impact
Infectious Disease Laboratory TestingMOL.CU.398.AN/ACriteria: admin edits, added Helicobacter pylori guideline under list of Test-Specific Guidelines since there is now a molecular version of that guideline, Added new PLA code 0531U (NeXGenTM Fungal/AFB NGS Assay) to EIU test list; Procedure code table: removed CPT codes 0483U, 0484U, & 0527U that are being moved to the Sexually Transmitted and Other Reproductive Tract Infection Testing guideline (MOL.CS.106.A), added new PLA code 0531U; Background: updated, Test Information: updated, added information on antimicrobial resistance and susceptibility testing; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, reordered professional societies to be in alphabetical order; References: Updated.No clinical impact
Medically Necessary Laboratory TestingMOL.CS.333.AN/ACriteria - Billing and Reimbursement section- updated guideline name in reference to Laboratory Billing and Reimbursement guideline, admin edit; Guidelines and Evidence: updated; References: updated No clinical impact
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.AN/ACriteria: grammatical edit, added block for clarification of intent of single gene testing for C9orf72, SOD1, FUS, TARDBP. Background: grammatical edits, updated; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule, References: updatedNo clinical impact
DecisionDX Uveal MelanomaMOL.TS.254.AN/ACriteria: For DecisionDX-UMSeq - added language referring to the Somatic Mutation Testing guideline where the assay is now addressed; Background: admin edit; Test Information: Admin Update, removed detail regarding DecisionDX-UMSeq; Guidelines and Evidence: Removed introduction, Removed DecisionDX-UMSeq information from Selected Relevant Publications section, Added three new references to Selected Relevant Publications, Added benefit/harm statement per CMS final rule; CPT Code Table: removed DecisionDX-UMSeq; References: UpdatedNo clinical impact​

Retired Guideline:


Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) 
HLA Typing for Celiac DiseaseMOL.CS.146.AN/ARetired guideline, assays now managed by the new guideline Celiac Disease Testing (MOL.CS.319)
HIV Tropism Testing for Maraviroc ResponseMOL.CS.185.AN/ARetired guideline, assay has been incorporated into the guideline Human Immunodeficiency Virus Laboratory Testing (MOL.CS.321)​



Revisions From MA06.034​​q:

04/01/2025

This version of the policy is a result of code updates effective 04/01/2025. 


The following procedure codes were added to the policy:


0531U, 0532U, 0533U, 0534U, 0536U, 0537U, 0538U, 0539U, 0540U, 0543U, 0544U, 0549U, and G0567. 

Narrative for the following procedure code was revised:


0288U


Revisions From MA06.034p​​​​​:
01/01/2025This version of the policy will become effective on 01​/01/2025.

Effective 01/01/2025, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0523U, 0529U, 0530U, 81195, & 81558 


Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

0527U, 0528U, 81515, 87513, 87564, 87594, & 87626 ​​
 

REVISED

  • Non-substantive revisions ​were made to multiple codes.

DELETED 

  • 0352U, ​​0380U, 0428U, 0448U, ​0456U

--------------------------------------------------------------------------------------------------------------


On January 1, 2025, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on January 1, 2025. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

01/01/2025 Guideline Updates for eviCore Lab Management Program (Policy #: MA06.034p​)

Executive Summary of Changes

There are 03 new guideline. 86 existing guidelines have been revised (including 20 with substantive criteria changes). Nine guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Laboratory Billing and Reimbursement
  2. ColoSense for Colorectal Cancer
  3. Inflammatory Bowel Disease Biomarker Testing​
​Criteria Updates (Substantive):

  1. Flow Cytometry
  2. Immunohistochemistry (IHC)
  3. Sexually Transmitted and Other Reproductive Tract Infection Testing
  4. Experimental, Investigational,  or Unproven Laboratory Testing
  5. Dentatorubral-Pallidoluysian Atrophy Genetic Testing
  6. Expanded Carrier Screening Panels
  7. Somatic Mutation Testing
  8. Von Hippel-Lindau Disease Genetic Testing
  9. BRCA Analysis
  10. Epilepsy Genetic Testing
  11. Gastrointestinal Pathogen Panel (GIPP) Molecular Testing
  12. Myotonic Dystrophy Type 1 Genetic Testing
  13. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  14. Human Platelet and Red Blood Cell Antigen Genotyping
  15. Pathology Testing with Mohs Micrographic Surgery
  16. Special Circumstances Influencing Coverage Determinations
  17. Urinary Tract Infection Molecular Testing
  18. Genetic Testing to Predict Disease Risk
  19. Whole Genome Sequencing
  20. Exome Sequencing​

Criteria Updates (Non-Substantive):

  1. Medicare: Hierarchy for Applying Coverage Decision for Laboratory Testing
  2. Unique Test Identifiers for Non-Specific Procedure Codes
  3. Genetic Testing for Carrier Status
  4. Genetic Testing for Non-Medical Purposes
  5. Genetic Testing for Prenatal Screening and Diagnostic Testing
  6. Afirma Thyroid Cancer Classifier Tests
  7. Alpha-1 Antitrypsin Deficiency Testing
  8. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  9. APOE Variant Analysis for Alzheimer Disease Testing
  10. Ashkenazi Jewish Carrier Screening
  11. Ataxia-Telangiectasia Genetic Testing
  12. Charcot-Marie-Tooth Neuropathy Genetic Testing
  13. Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)
  14. Cystic Fibrosis Genetic Testing
  15. Duchenne and Becker Muscular Dystrophy Testing
  16. Early Onset Familial Alzheimer Disease Genetic Testing
  17. Familial Adenomatous Polyposis Genetic Testing
  18. Familial Malignant Melanoma Genetic Testing
  19. FMR1-Related Disorders (Fragile X) Genetic Testing
  20. Hereditary Cancer Syndrome Multigene Panels
  21. HFE Hemochromatosis Genetic Testing
  22. Li-Fraumeni Syndrome Genetic Testing
  23. Lynch Syndrome Tumor Screening - Second-Tier
  24. Mammaprint 70-Gene Breast Cancer Recurrence Assay
  25. MUTYH Associated Polyposis Genetic Testing
  26. Non-Invasive Prenatal Screening
  27. Oncotype DX for Breast Cancer Prognosis
  28. Peutz-Jeghers Syndrome Genetic Testing
  29. Prosigna Breast Cancer Prognostic Gene Signature Assay
  30. PTEN Hamartoma Tumor Syndromes  Genetic Testing
  31. Spinal Muscular Atrophy Genetic Testing
  32. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing
  33. EndoPredict for Breast Cancer Prognosis
  34. Breast Cancer Index for Breast Cancer Prognosis
  35. PALB2 Genetic Testing for Breast Cancer Risk
  36. Oncotype DX Breast DCIS
  37. Confirmatory Genetic Testing
  38. Maturity-Onset Diabetes of the Young (MODY) Genetic Testing
  39. Mitochondrial Disorders Genetic Testing
  40. Ehlers-Danlos Syndrome Genetic Testing
  41. Hereditary Connective Tissue Disorder Genetic Testing
  42. ThyroSeq
  43. PancraGEN
  44. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  45. Multiple Endocrine Neoplasia Type 2 Genetic Testing
  46. Limb-Girdle Muscular Dystrophy Genetic Testing
  47. Genetic Testing for Variants of Uncertain Clinical Significance
  48. Legius Syndrome Genetic Testing
  49. Medical Necessity Review Information Requirements
  50. Hemoglobinopathies Genetic Testing
  51. Friedreich Ataxia Genetic Testing
  52. Hereditary Ataxia Multigene Panel Testing
  53. Spinocerebellar Ataxia Genetic Testing
  54. Medically Necessary Laboratory Testing
  55. Chromosomal Microarray for Solid Tumors
  56. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  57. Human Papillomavirus (HPV) Molecular Testing
  58. Inherited Thrombophilia Genetic Testing
  59. Infectious Disease Laboratory Testing
  60. Nail Disorder Infectious Disease Testing, Including Onychomycosis
  61. Cardiomyopathy and Arrhythmia Genetic Testing
  62. Pharmacogenomic Testing for Drug Toxicity and Response
  63. Lynch Syndrome Genetic Testing
  64. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  65. Noonan Spectrum Disorder Genetic Testing
  66. Genetic Testing by Multigene Panels​
 
Retired Guideline:

  1. Bloom Syndrome Genetic Testing
  2. Canavan Disease Genetic Testing
  3. Gaucher Disease Genetic Testing
  4. Niemann-Pick Disease Types A and B Genetic Testing
  5. Niemann-Pick Disease Type C Genetic Testing
  6. Tay-Sachs Disease Genetic Testing
  7. Laboratory Claim Reimbursement
  8. Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors
  9. Laboratory Procedure Code Requirements​


Other Note:(E/I/U = Experimental, Investigational, or Unproven​) -- 

See the tables below that follow (which provide more details for the guideline changes):



New Guidelines:
Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) 
Laboratory Billing and ReimbursementMOL.AD.412.BOallNew guideline replacing Laboratory Claim Reimbursement (MOL.CS.105) and Laboratory Procedure Code Requirements (MOL.AD.391)
ColoSense for Colorectal CancerMOL.TS.413.A81599New guideline managing ColoSense colorectal cancer screening test (standard non-coverage version)
Inflammatory Bowel Disease Biomarker TestingMOL.TS.359.A81401, 83520, 86021, 86255, 81479, 82397, 86140, 88346, 88350, 0203UNew guideline to manage molecular Inflammatory Bowel Disease testing

​​Criteria Updates (Substantive):
Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Rationale / supporting guideline for clinically significant updates 
Flow CytometryMOL.CS.103.A88182, 88184, 88185, 88187, 88188, 88189Criteria: Added criterion that flow cytometry is not medically necessary when performed in peripheral blood in cases of isolated anemia or thrombocytopenia (per ASCP Choosing Wisely), changed criterion regarding IHC and flow cytometry performed on same DOS - previously was considered always not medically necessary and now will be considered on a case by case basis such as for lymphoma (per NCCN guideline for B-cell lymphoma which supports doing both IHC and flow), admin updates and clarification of intent edits throughout, addition of approvable ICD codes in Billing & Reimbursement (addressed by existing coverage criteria; no change in decision making); Background: Added benefit/harm statement per CMS final rule, other updates; References: updated.ASCP Choosing Wisely recommendation (American Society for Clinical Pathology. Thirty Five Things Physicians and Patients Should Question. Updated September 1, 2020. Available at: https://www.ascp.org/content/docs/default-source/get-involved-pdfs/istp_choosingwisely/ascp-35-things-list_2020_final.pdf

 Zelenetz AD, Gordon LI, Abramson JS, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 2.2024 - April 30, 2024. B-Cell Lymphomas, available at: https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf
Immunohistochemistry (IHC)MOL.CS.104.A88341, 88342, 8844Criteria: removed unit limit rules, clarified language when IHC is performed on histological lesions, clarified coverage for H. pylori infections with chronic gastritis, clarified language around performance of IHC and Flow together (per NCCN); Billing and Reimbursement: Removed corresponding B&R rules to align with criteria changes. Guideline and Evidence: Admin editsKavus H, Ding Y, Dhesi M. Updates in Immunohistochemistry for Hematopoietic and Lymphoid Neoplasms. Arch Pathol Lab Med. 2024 Mar 1;148(3):292-298. doi: 10.5858/arpa.2022-0465-RA. PMID: 37270801

Batts KP KS, Kakar S, et al. Appropriate use of special stains for identifying Helicobacter pylori.  Recommendations from the Rodger C. Haggitt Gastrointestinal Pathology Society. Am J Surg Pathol. 2013;37:e13-e22

NCCN - https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.A81513, 81514, 0352U, 87510, 87511, 0068U, 87490, 87590, 87529, 87660, 87661; Added 0505UCriteria: added coverage criteria for 3 select BV assays previously considered E/I/U (CPT codes: 81513, 81514, & 0352U) per IDSA/ASM 2024 guide, changed Gardnerella vaginalis detection testing (87510, 87511) from covered with criteria to not medically necessary (per IDSA/ASM 2024 guide), added new PLA code to BV section (E/I/U) - 0505U (Vaginal Infection Testing from NxGen MDx), changed Candida subtyping test 0068U from E/I/U to NMN to align with new eviCore standard definitions since exceptions can be considered (no change in decision making), clarified symptoms associated with Candida in Criteria section, specified that repeat testing for test-of-cure is not medically necessary for Candida and BV (per IDSA/ASM 2024 and ACOG 2020 guideline for Vaginitis, added additional symptoms to existing list in criteria for Chlamydia and N. Gonorrhoeae per CDC and WHO, reduced frequency limits for direct probe studies from 3 units to1 unit per DOS for Chlamydia (87490) and N. gonorrhoeae (87590) (supported by CDC 2021 guideline, which only mentions amplified techniques for extragenital specimens), clarification of intent edit - specifying that T. vaginalis testing is medically necessary in individuals with an affected partner even if individual is asymptomatic (already included in Billing & Reimbursement section), increased frequency limit for amplified probe for HSV (87529) from 1 per DOS to 2 per DOS (per CDC STI guidelines, extragenital sites may also need to be tested), reduced frequency limit for T. vaginalis (CPT 87660 & 87661) from 3 units per DOS to 1 unit per DOS (CDC STI guideline does not mention the need to test multiple specimens or extragenital sites), removed ICD code table for NOS Testing for Genitourinary Conditions (currently not in use), admin and clarification of intent edits throughout; CPT code table: added 0505U; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; Background: added to guideline; Test Information: updated, added RCL for NAT/NAAT; References: updatedIDSA/ASM 2024 - Miller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease Society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024). doi:10.1093/cid/ciae104)

ACOG Committee on Practice Bulletins-Gynecology. ACOG Practice Bulletin,  Clinical management guidelines for obstetrician-gynecologists, Number 215: Vaginitis in nonpregnant patients. Obstet Gynecol. 2020;135(1):e1-e17

Centers for Disease Control and Prevention (CDC). Preexposure Prophylaxis for the Prevention of HIV Infection in the United States- 2021 Update: A Clinical Practice Guideline. Available at:  https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf  

WHO 2021 STI guidelines - World Health Organization. Guidelines for the management of symptomatic sexually transmitted infections. Updated 2021. Available at: https://www.who.int/publications/i/item/9789240024168
Experimental, Investigational,  or Unproven Laboratory TestingMOL.CU.117.IADDED new PLA Codes: 0507U, 0496U, 0506U, 0486U, 0497U, 0498U, 0493U, 0510U, 0501U, 0495U, 0508U, 0509U; DELETED: 0396U, 83520, 86021, 86255, 81479, 82397, 86140, 88346, 88350, 0203UCriteria: Added Guardant Reveal and BarreGEN, removed the following tests that are now addressed in Inflammatory Bowel Disease Biomarker Testing guideline (still E/I/U) Crohn's Prognostic, IBD sgi Diagnostic, PredictSURE IBD; CPT Code Table: Added Guardant Reveal and BarreGEN, removed Crohn's Prognostic, IBD sgi Diagnostic, PredictSURE IBD; Corrected PLA code for EarlyTect to 0452U; ADDED new PLA Codes: Avantect Ovarian Cancer Test (0507U), ColoScape PLUS (0496U), EndoSign Barrett's Esophagus Test (0506U), Northstar Response (0486U), OncoAssure Prostate (0497U), OptiSeq Colorectal Cancer NGS Panel (0498U), Prospera (0493U, new code and updated description), PurISTSM (0510U), QuantiDNA Colorectal Cancer Triage Test (0501U), Stockholm3 (0495U),  VitaGraft Kidney Baseline + 1st Plasma Test (0508U), VitaGraft Kidney Subsequent (0509U); DELETED: 0396U (Spectrum PGT-M); EDITED name or description for 0118U (Eurofins TRAC dd-cfDNA), 0465U (UriFind Urothelial Carcinoma Assay), 0403U (MyProstateScore 2.0); Background: Added benefit/harm statement per CMS final ruleN/A
Dentatorubral-Pallidoluysian Atrophy Genetic TestingMOL.TS.159.A81177Criteria: added white matter lesion as a feature for diagnostic testing, admin edit, clarified ethnicity language; Background: updated and added reference; Test Information: added information on ATN1 testing; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, deleted introduction, deleted redundant information present in other parts of the guideline, admin edit; References: deleted introduction, added reference, updated reference.Sugiyama A, Sato N, Kimura Y, et al. The cerebellar white matter lesions in dentatorubral-pallidoluysian atrophy. J Neurol Sci. 2020 Sep 15;416:117040;

Prades S, Melo de Gusmao C, Grimaldi S, et al. DRPLA. 1999 Aug 6 [Updated 2023 Sep 21]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024
Expanded Carrier Screening PanelsMOL.TS.165.A81479, 0400U, 81443, 0449UCriteria: Removed criteria for individual genes since this guideline now focuses on panels, opened up coverage for carrier screening panels per ACMG recommendation - previously had stricter coverage criteria; Billing and Reimbursement: Updated to align with broader coverage of carrier screening panels; CPT Code Table: removed individual genes; Background: admin edits; Guidelines and Evidence: Added ACOG Hemoglobinopathies and deleted section on concerns for large panels, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introduction; TITLE CHANGE: Carrier Screening Panels, Including Targeted, Pan-Ethnic, Universal, and ExpandedGregg AR, Aarabi M, Klugman S, et al.  Screening for autosomal recessive and X-linked conditions during pregnancy and preconception: a practice resource of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(10):1793-1806
Somatic Mutation TestingMOL.TS.230.AVarious panel codes - see CPT code table in guidelineCriteria: New indications for NGS panel testing in patients with metastatic prostate cancer and unresectable or metastatic biliary tract cancer- based on NCCN guidelines, admin update; Billing and Reimbursement: updated name of referenced guideline on coding;  CPT code table: added new PLA codes 0481U (IDH1, IDH2, and TERT Mutation Analysis, Next-Generation Sequencing, Tumor (IDTRT)), 0478U (Lung HDPCR), 0499U (OptiSeq Dual Cancer Panel Kit); Guidelines and Evidence: Added benefit/harm statement per CMS final rule; CPT code table: admin update; Guidelines and Evidence: updated, added Prostate cancer and Biliary Tract cancers NCCN guidelines; References: updated.Schaeffer EM, Srinivas S, Adra N, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 4.2024 – May 17, 2024 Prostate Cancer, available at: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

Benson AB, D'Angelica MI, Abrams T, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – July 2, 2024 Biliary Tract Cancers, available at: https://www.nccn.org/professionals/physician_gls/pdf/btc.pdf
Von Hippel-Lindau Disease Genetic TestingMOL.TS.233.A81401, 81403, S3842Criteria: expanded indications for testing of symptomatic individuals to include paraganglioma, endolymphatic sac tumor, pancreatic neuroendocrine tumor, admin edits, removed information on prenatal testing as this is addressed by a clinical use guideline; Intro and CPT code table: admin edits; Background: updated; Guidelines and Evidence: removed intro, added benefit/harm statement per CMS final rule, added a paragraph on clinical diagnostic criteria to support criteria changes; References: removed intro, added references, updated.van Leeuwaarde RS, Ahmad S, van Nesselrooij B, et al. Von Hippel-Lindau Syndrome. 2000 May 17 [Updated 2024 Feb 29]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024.

Binderup M, Smerdel M, Borgwadt L et al. von Hippel-Lindau disease: Updated guideline for diagnosis and surveillance. Eur J Med Genet. 2022 Aug;65(8):104538
BRCA AnalysisMOL.TS.238.AVarious codes - see CPT code table in guidelineCriteria: Based on NCCN HBOC recommendations - added indications 1) full gene sequencing for individuals with cancer and Ashkenazi Jewish ancestry, 2) dx of prostate cancer with close fam member w/ triple neg breast cancer or high risk prostate, admin updates; CPT code table: admin updates; Background: updated; Test information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, Added ASCO/SSO, AUA/ASTRO & AUA/SUO guidelines, updated; References: updatedDaly MB, Pal T, AlHilli Z, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – February 12, 2024. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, available at: https://www.nccn.org/professionals/physician_gls/pdf/genetics_bop.pdf
Epilepsy Genetic TestingMOL.TS.257.A81419Criteria: added indications for panel testing in drug resistant focal epilepsy and focal epilepsy with a positive family history suggesting of a monogenic cause (per peer reviewed literature and NSGC practice guideline), Billing and Reimbursement: updated name of referenced guideline on coding; CPT code table: admin edits; Background: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule; References: updatedKarge R, Knopp C, Weber Y, Wolking S. Genetics of nonlesional focal epilepsy in adults and surgical implications. Clinical Epileptology. 2023;36:91-97 

NSGC: Smith L, Malinowski J, Ceulemans S, et al. Genetic testing and counseling for the unexplained epilepsies: An evidence-based practice guideline of the National Society of Genetic Counselors. J Genet Couns. 2023 Apr;32(2):266-280. doi: 10.1002/jgc4.1646
Gastrointestinal Pathogen Panel (GIPP) Molecular TestingMOL.CS.277.A87505, 87506, 87507, 0369UCriteria - Billing and Reimbursement section - opened coverage for GIPP panels of any size in immunocompromised individuals per ACG guidelines on IBD that recommend ruling out infectious conditions that might mimic IBD inflammation; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updatedLichtenstein GR, Loftus EV, Isaacs KL, et al. ACG Clinical Guideline: Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018;113(4):481-517. doi: 10.1038/ajg.2018.27

Rubin D, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019 Mar;114(3):384-413. doi: 10.14309/ajg.0000000000000152
Myotonic Dystrophy Type 1 Genetic TestingMOL.TS.312.A81234, 81239, S3853Criteria: added "Posterior subcapsular cataracts with detectable red and green iridescent opacities on slit lamp examination" into criteria for symptomatic individuals, admin edit, Procedures addressed: admin edits; Background: updated with info on cataracts with associated reference and admin edits; Test Information: edited intro, admin edits; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, admin edits; References: admin edit, updatedBird TD. Myotonic Dystrophy Type 1. 1999 Sep 17 [Updated 2024 Mar 21]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2024

Moshirfar M, Webster CR, Seitz TS, et al. Ocular Features and Clinical Approach to Cataract and Corneal Refractive Surgery in Patients with Myotonic Dystrophy. Clin Ophthalmol. 2022 Aug 25;16:2837-2842
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A88341, 88342, 81301Criteria: updated name of referenced guideline, added esophageal and esophagogastric junction cancer as approvable cancer types based on NCCN guideline, updated; CPT code table: admin updates; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, added NCCN esophageal guideline, updated; References: updatedAjani JA, D'Amico TA, Barzi A, et al. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2024 – April 26, 2024. Esophageal and Esophagogastric Junction Cancers, available at: https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf)
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A81403, Added 0494U, 0488UCriteria: opened coverage for fetal RhD by NIPS in alloimmunized women with at-risk pregnancies per 2024 ACOG Clinical Practice Update; Guidelines and Evidence: updated, incorporated current EviCore HTA, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, admin edits, deleted introduction; Added new PLA codes: Rh Test - Natera (0494U), UNITY Fetal Antigen NIPT (0488U)American College of Obstetricians and Gynecologists. Clinical Practice Update. Paternal and Fetal Genotyping in the Management of Alloimmunization in Pregnancy. Obstet Gynecol ():10.1097/AOG.0000000000005630, June 4, 2024. | DOI: 10.1097/AOG.000000000000563
Pathology Testing with Mohs Micrographic SurgeryMOL.CS.363.A88342, 88341, 88344Criteria: updated to change IHC to medically necessary when performed in conjunction with Mohs procedures (per NCCN cutaneous melanoma guideline), admin edit; Billing and Reimbursement: admin edit; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introductionNCCN Guidelines Version 2.2024 Melanoma: Cutaneous, available at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.AvariousCriteria: Added Jurisdiction column to both tables along with description in table notes. Added the following bills to the Broad Biomarker Bills table: Colorado (SB 124), Connecticut (SB 307), Florida (HB 885), Indiana (S 273), Iowa (HF 2668), Minnesota (SF 2995), New York (A 8502). Added information for the following state bills under the “Other Applicable Bills": Illinois (HB 3202), Illinois (HB 2350), Minnesota (HF 5247), New Jersey (A5235), also added covered lines of business for existing state bills; Background: Added benefit/harm statement per CMS final rule, admin edits throughout; References: UpdatedDependent upon legislative requirements in various state bills
Urinary Tract Infection Molecular TestingMOL.CS.403.Avarious (see guideline);  Added 0504UCriteria: added new PLA code 0504U (Urinary Tract Infection Testing from NexGen MDx) to list of E/I/U UTI panels; added coverage criteria for single-organism tests and multiple-organism panels for select organisms for which nucleic-acid based testing is appropriate for diagnosis and management in UTIs (per 2024 IDSA/ASM and American Society of Transplantation guidelines), admin and clarification of intent edits throughout; CPT code table: added new PLA code 0504U (Urinary Tract Infection Testing from NexGen MDx); Background: updated; Test Information: updated, added Reused content language for NAT/NAAT; Guidelines & Evidence: updated;  References: updatedIDSA/ASM: Miller J, Binnicker M, Campbell S, et al. Guide to utilization of the microbiology laboratory for the diagnosis of infectious diseases: 2024 update by the Infectious Disease
society of America (IDSA) and the American Society of Microbiology (ASM). Clin Infect Dis. 2024 (Accepted manuscript published March 5, 2024). doi: 10.1093/cid/ciae104

American Society of Transplantation guidelines:   Goldman JD, Julian K. Urinary tract infections in solid organ transplant recipients: Guidelines from the American Society of Transplantation Infectious Diseases Community of Practice. Clin Transplant. 2019;33(9):e13507. doi: 10.1111/ctr.13507
Genetic Testing to Predict Disease RiskMOL.CU.115.AN/ACriteria: incorporated criteria from the Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors guideline and restructured to accommodate; Clarification of intent edit - added phrase 'Member is at risk based on the inheritance pattern of the disorder in question.' to the Known Familial mutation section; created a single Limitations and Exclusions section to apply to all criteria sections, admin edit in general criteria section; Background: Added benefit/harm statement per CMS final rule, updated with info on testing in minors; References: updatedN/A
Whole Genome SequencingMOL.TS.306.IN/ACriteria: clarification of intent edits - amended provider requirements to make clear that non-genetics providers can order testing, added epilepsy as an example in the list of complex neurodevelopmental disorders, admin update; CPT code table: added introduction, admin update; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updatedN/A
Exome SequencingMOL.TS.235.IN/ACriteria: clarification of intent edits - amended provider requirements to make clear that non-genetics providers can order testing, added epilepsy as an example in the list of complex neurodevelopmental disorders; CPT code table: admin edits; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updatedN/A


Criteria Updates (Non-Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) ​
Medicare: Hierarchy for Applying Coverage Decision for Laboratory TestingMOL.AD.101.BN/ACriteria: updated reference to Laboratory Procedure Code Requirements with the new name "Laboratory Billing and Reimbursement".
Unique Test Identifiers for Non-Specific Procedure CodesMOL.AD.107.AN/ACriteria: admin edits. Background: Added intro statement, added benefit/harm statement per CMS final rule
Genetic Testing for Carrier StatusMOL.CU.110.AN/ACriteria: updated language throughout from 'indicated' and 'considered' to 'is medically necessary', deleted Routine Carrier Screening section as this information is addressed in greater detail by multiple test-specific guidelines; References: deleted as references are no longer included; Background: Added benefit/harm statement per CMS final rule
Genetic Testing for Non-Medical PurposesMOL.CU.111.AN/ACriteria: expanded to specifically name beauty care/skin care testing, as this seems to be a growing market segment; Background: added new DTC companies, admin edits; Background: Added benefit/harm statement per CMS final rule
Genetic Testing for Prenatal Screening and Diagnostic TestingMOL.CU.112.AN/ACriteria: clarification of intent edits - in Prenatal diagnostic testing based on family history section added 'based on the inheritance pattern of the disorder in question' , in fetal infectious disease section updated language to medically necessary, admin edit; Note: deleted reference to Human platelet and Red Blood Cell Antigen Genotyping, as this referral is no longer needed; Background: format edit, added benefit/harm statement per CMS final rule; references: updated
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.AN/ACriteria: admin edits, clarification of intent edits; CPT code table: removed retired code-0204U; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Alpha-1 Antitrypsin Deficiency TestingMOL.TS.124.AN/ACriteria: admin edit. CPT table: admin edits; Background: updated. Test information: admin edits; Guidelines and Evidence: removed introduction, added benefit/harm statement per CMS final rule, formatted selected relevant publications but not change to content; References: removed introduction, updated.
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.AN/ABilling and Reimbursement: updated name of referenced guideline on coding
APOE Variant Analysis for Alzheimer Disease TestingMOL.TS.128.AN/ACriteria: admin edits. Background: management updated. Guidelines and Evidence: Added benefit/harm statement per CMS final rule, deleted ABIM/ACMG/Choosing Wisely block as information no longer available; References: admin edit and updated
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.AN/ACriteria - Billing and Reimbursement section: clarification of intent edit - Added clarification for repeat panel billing; Added clarification regarding one panel per lifetime rule; CPT code table: admin edits; Criteria: admin edits, added in Other Considerations for diagnostic testing of AJ conditions; Background: updated; Test information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Ataxia-Telangiectasia Genetic TestingMOL.TS.130.AN/ACriteria: admin edits, removed section on prenatal testing since this is addressed by clinical use guideline; CPT code table: admin edits; Background: updated; Test Information: admin edits; Guidelines and Evidence: removed intro, added benefit/harm statement per CMS final rule; References: removed intro and updated.
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.AN/ACriteria: admin updates, (Billing and Reimbursement) updated name of referenced guideline on coding & updated most common genes: CPT Code Table: admin update; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)MOL.TS.150.AN/ACriteria: admin edits to intro statement and Billing & Reimbursement; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, added an ACOG/SMFM consensus statement; References: updated; CPT Code Table: admin update
Cystic Fibrosis Genetic TestingMOL.TS.158.AN/ACriteria: clarification of intent edit in deletion/duplication section stating that member must be symptomatic or at high risk of being a carrier to have del/dup testing (not for population carrier screening), deleted note and added Other Considerations section to refer to related policies for indications not addressed in this guideline, admin edits in intro and KFM sections; CPT Code Table: admin update; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Duchenne and Becker Muscular Dystrophy TestingMOL.TS.161.AN/ACriteria: clarification of intent and admin edits; CPT code table: admin edits; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, admin edits; References: updated
Early Onset Familial Alzheimer Disease Genetic TestingMOL.TS.162.AN/ACriteria: admin edits. Billing and Reimbursement: updated name of referenced guideline on coding; Procedures addressed and CPT code table: admin edit; Background: admin edits and updated management; Test information: admin edits; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, removed intro and admin edits; References: removed intro and updated.
Familial Adenomatous Polyposis Genetic TestingMOL.TS.168.AN/ACriteria: admin edits. Introduction and Procedures addressed: admin edits; Background: admin edits; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, removed introduction, admin edit; References: updated and removed intro
Familial Malignant Melanoma Genetic TestingMOL.TS.170.AN/ACriteria: admin update; CPT code table: admin edits; Background: updated; Guidelines and Evidence: intro removed, added benefit/harm statement per CMS final rule, updated; References: removed intro, updated
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.AN/ACriteria: admin edits; CPT code table: updated; Background: updated; Test Information: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, added AAP guidelines for evaluation of ID/DD and autism; References: updated
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.AN/ACriteria: admin edits, Billing and Reimbursement: updated name of referenced guideline on coding; Background: updated; Guidelines and evidence: admin edits, removed introduction, added NCCN guidelines for neuroendocrine and  adrenal tumors and for kidney cancer, added ASCO guideline (PMID: 38759122), Added benefit/harm statement per CMS final rule, References: removed introduction and updated.
HFE Hemochromatosis Genetic TestingMOL.TS.183.AN/ACriteria: added introduction; Background: updated, Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Li-Fraumeni Syndrome Genetic TestingMOL.TS.193.AN/ACriteria: admin edits, removed information on prenatal testing as this is addressed by a different guideline, added information on Hereditary (Germline) Testing After Tumor (Somatic) Testing to "Other Considerations" block; Intro and CPT table: admin edits. Test Information: admin edit. Guidelines and Evidence: removed intro, admin edits, updated, removed one references, added benefit/harm statement per CMS final rule; References: removed intro, updated.
Lynch Syndrome Tumor Screening - Second-TierMOL.TS.199.AN/ACriteria: admin update, separated MLH1 and BRAF criteria w/ no change to criteria; CPT code table: admin update; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Mammaprint 70-Gene Breast Cancer Recurrence AssayMOL.TS.200.AN/ACriteria: admin edit. Guidelines and Evidence: removed introduction, admin edits, updated, incorporated current EviCore HTA, added benefit/harm statement per CMS final rule; References: removed introduction, admin edits, and updated.
MUTYH Associated Polyposis Genetic TestingMOL.TS.206.AN/ACriteria: admin edits. Introduction and Procedures addressed: admin edits; Background: admin edits; Guidelines and Evidence: removed introduction, admin edit, added benefit/harm statement per CMS final rule; References: updated and removed intro
Non-Invasive Prenatal ScreeningMOL.TS.209.AN/ACriteria: admin edits to introduction, in NIPS for single gene testing section, added referral to Human Platelet and Red Blood Cell Antigen Genotyping guideline for fetal Rh(D) testing while other indications remain EIU; CPT code table: added new PLA code 0489U (UNITY Fetal Risk Screen); Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated health tech assessment, other updates; References: updated
Oncotype DX for Breast Cancer PrognosisMOL.TS.211.IN/ACriteria: admin edit. Guidelines and Evidence: removed introduction, updated ESMO and NICE, admin edits, added benefit/harm statement per CMS final rule; References: removed introduction, updated.
Peutz-Jeghers Syndrome Genetic TestingMOL.TS.216.AN/ACriteria: admin edits. Procedures addressed: admin edits; Test information; admin edit; Guidelines and evidence: updated, added benefit/harm statement per CMS final rule; References: updated
Prosigna Breast Cancer Prognostic Gene Signature AssayMOL.TS.222.AN/ACriteria: admin edit. Background: admin edit; Test Information: admin edit; Guidelines and Evidence: updated, incorporated current EviCore HTA, removed introduction, admin edits, added benefit/harm statement per CMS final rule; References: removed introduction and updated.
PTEN Hamartoma Tumor Syndromes  Genetic TestingMOL.TS.223.AN/ACriteria: admin edit, clarification of intent, added cross-reference to guideline for germline after somatic testing; Procedures addressed: admin edits; Background: admin edits; Guidelines and evidence: removed intro, admin edits, added benefit/harm statement per CMS final rule; References: removed intro and updated.
Spinal Muscular Atrophy Genetic TestingMOL.TS.225.AN/ACriteria: admin & clarification of intent edits, added section to refer to related policies for indications not addressed in this guideline; Background: updated; Test Information: updated; Guidelines and Evidence: updated, added 2024 ENMC consensus statement on SMN2 testing, Added benefit/harm statement per CMS final rule; References: updated
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic TestingMOL.TS.227.AN/ACriteria: admin edits, Billing and Reimbursement: updated name of referenced guideline on coding; CPT table: admin edits; Background: updated; Guidelines and Evidence: removed introduction, admin edits, updated, added benefit/harm statement per CMS final rule; References: updated.
EndoPredict for Breast Cancer PrognosisMOL.TS.234.AN/ACriteria: admin edit. Guidelines and Evidence: removed introduction, admin edits, updated ESMO and NICE, updated selected relevant publications and incorporated EviCore HTA, added benefit/harm statement per CMS final rule; References: removed introduction and updated.
Breast Cancer Index for Breast Cancer PrognosisMOL.TS.248.AN/ACriteria; admin edits. Introduction: admin edit; Background: updated; Test information: admin edits; Guidelines and Evidence: removed introduction, admin edits, updated, added benefit/harm statement per CMS final rule; References: removed introduction, updated.
PALB2 Genetic Testing for Breast Cancer RiskMOL.TS.251.AN/ATITLE CHANGE: Removed "breast". Now says PALB2 Genetic Testing for Cancer Risk; CPT code table: admin edits; Criteria: admin edit; Background: updated; Guidelines and Evidence: Added new ASCO/SSO guideline, removed ESMO guideline, Added benefit/harm statement per CMS final rule, updated; References: updated
Oncotype DX Breast DCISMOL.TS.255.AN/ACriteria: admin edit. Background: admin edits; Test Information: admin edits; Guidelines and Evidence: removed introduction, updated, added benefit/harm statement per CMS final rule; References: removed intro, updated
Confirmatory Genetic TestingMOL.CU.256.AN/ACriteria: clarification of intent edit to specify what constituted a disease-causing mutation and the paths through which that information could be established for the purposes of confirmatory testing; Background: Added benefit/harm statement per CMS final rule
Maturity-Onset Diabetes of the Young (MODY) Genetic TestingMOL.TS.258.AN/ACriteria: admin update; CPT code table: admin updates: Billing and Reimbursement: updated name of referenced guideline on coding; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Mitochondrial Disorders Genetic TestingMOL.TS.266.AN/ACriteria: clarification of intent edits to Select Mitochondrial Disorders table, added MT-ND1 mutation to list of Associated Genes/Mitochondrial DNA mutations for Leber Hereditary Optic Neuropathy (per International LHON guideline cited in guideline); CPT code table: added MT-ND1 Targeted Mutation Analysis (81479)
Ehlers-Danlos Syndrome Genetic TestingMOL.TS.267.AN/ACriteria: admin edit, removed section on prenatal testing as this is in a different guideline, clarification of intent for testing (added newer gene, AEBP1, for classic-like EDS). CPT/Procedures addressed: admin edits; Background: updated; Test Information: removed information on multigene panel testing; Guidelines and Evidence: updated, removed intro; added benefit/harm statement per CMS final rule; References: admin edits and updated.
Hereditary Connective Tissue Disorder Genetic TestingMOL.TS.268.AN/ACriteria: admin edit, clarification of intent for testing (added newer gene, AEBP1, for classic-like EDS), billing and Reimbursement: updated name of referenced guideline on coding; CPT code table: admin edits; Background: updated; Guidelines and Evidence: updated, removed introduction, added benefit/harm statement per CMS final rule; References: updated.
ThyroSeqMOL.TS.270.IN/ACriteria: clarification of intent edit - added statements regarding no previous successful testing on the same nodule and rendering lab must be a qualified provider
PancraGENMOL.TS.271.AN/ACriteria: admin update; Background: updated; Test Information: updated; Guidelines and Evidence: updated, added benefit/harm statement per CMS final rule; References: updated
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.AN/ABilling and Reimbursement: updated name of referenced guideline on coding; CPT code table: updated HCSPS code from S3840 to S3844
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.AN/ACriteria: admin edit; Introduction and CPT code table: admin edit; Background: updated; Test Information: added reused content for KFM; Guidelines and Evidence: removed intro, admin edits, added benefit/harm statement per CMS final rule, updated; References: removed intro, updated.
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.AN/ACriteria: admin updates; Billing and Reimbursement: updated name of referenced guideline on coding; CPT Code Table: admin updates; Background: updated; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, updated; References: updated
Genetic Testing for Variants of Uncertain Clinical SignificanceMOL.CU.292.AN/ACriteria: in the General coverage section, previous testing - admin edit to align language with other guidelines; Background: Added benefit/harm statement per CMS final rule;
Legius Syndrome Genetic TestingMOL.TS.302.AN/ACriteria: admin edits. Procedures addressed: admin edits; Background: admin edits; Guidelines and Evidence: deleted intro and admin edit, added benefit/harm statement per CMS final rule; References: deleted intro, admin edit, updated
Medical Necessity Review Information RequirementsMOL.AD.304.AN/ACriteria: updated name of referenced guideline on coding
Hemoglobinopathies Genetic TestingMOL.TS.308.AN/ACriteria: deleted prenatal test criteria as this is addressed by another guideline, Added Other Considerations section to direct to appropriate guideline if testing is part of a carrier screening panel, admin edits; CPT code table: admin edits; Background: updated; Test Information: admin edits; Guidelines and Evidence: updated, added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introduction
Friedreich Ataxia Genetic TestingMOL.TS.309.AN/ACriteria: admin edits. Procedures addressed: admin edit; Background: updated; Test information: admin edit; Guidelines and Evidence: Added benefit/harm statement per CMS final rule, admin edits, removed introduction; References: updated, removed introduction
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.AN/ACriteria: admin edit. Billing and Reimbursement: updated name of referenced guideline on coding, Procedures addressed: admin edits; Test information: admin edit; Guidelines and Evidence: removed intro, updated, added benefit/harm statement per CMS final rule, restructured Selected Relevant Publications; References: removed intro, updated
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.AN/ACriteria: admin edit. Billing and Reimbursement: updated name of referenced guideline on coding; Introduction: admin edit; Background: updated, admin edit; Guidelines and Evidence: removed introduction; Added benefit/harm statement per CMS final rule, restructured Selected Relevant Publications section; References: removed intro, updated.
Medically Necessary Laboratory TestingMOL.CS.333.AN/ACriteria - Billing and Reimbursement section: updated terminology from 'post-service medical necessity review' to 'records review post claim for medical necessity'; Guidelines and Evidence: Added benefit/harm statement per CMS final rule; References: updated
Chromosomal Microarray for Solid TumorsMOL.TS.344.AN/ACriteria: admin edit; Introduction and CPT code table: admin edits; Test Information: admin edit; Guidelines and Evidence: removed intro, added benefit/harm statement per CMS final rule, updated, admin edits; References: removed intro and updated
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.AN/ACriteria: admin edits, updated table, Billing and Reimbursement: updated name of referenced guideline on coding; Background: admin edits. Guidelines and Evidence: Updated FARF section, added benefit/harm statement per CMS final rule, updated reference order.
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.AN/ACriteria: Oropharyngeal Cancer section clarification of intent edit updating language in medical necessity criteria and Billing and Reimbursement to be clearer that members may have both p16 IHC and direct HPV testing (no clinical decision making changes), admin edit, Criteria and CPT code table: added new PLA code 0502U (QuantiVirus HPV E6/E7 mRNA Test for Cervical Cancer); Test Information: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, admin edit, deleted introduction; References: updated, admin edit, deleted introduction
Inherited Thrombophilia Genetic TestingMOL.TS.370.AN/ACriteria: clarified language regarding use of test to direct therapy; Billing and Reimbursement: admin edit; Background: updated; Test Information: updated, including new mutation nomenclature; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule, deleted introduction; References: updated, deleted introduction
Infectious Disease Laboratory TestingMOL.CU.398.AN/ACriteria: admin and clarification of intent edits (added a sentence to the General Coverage Guidance to better define the meaning of the phrase "Newer methods must be proven to perform better than existing standard of care medical management options"); added Bacteria, Viruses, Fungus, and Parasite Metagenomic Sequencing, Spinal Fluid (MSCSF) to EIU panel list; CPT code table: added new PLA codes 0480U (Bacteria, Viruses, Fungus, and Parasite Metagenomic Sequencing, Spinal Fluid (MSCSF)), 0483U (Ciprofloxacin Susceptibility of Neisseria gonorrhoeae),  0484U (Macrolide Resistance of Mycoplasma genitalium) Test Information: updated; Guidelines & Evidence: updated (including updated version of IDSA/ASM guideline); References: updated.
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.AN/ACriteria: admin edits; Background: updated; Test Information: updated; Guidelines and Evidence: updated; References: updated
Cardiomyopathy and Arrhythmia Genetic TestingMOL.TS.410.AN/ACriteria: admin edit (updated guideline to refer to for additional panel code guidance in Billing & Reimbursement); Procedure Code Table: added S3865 and S3866; Guidelines and Evidence: Added benefit/harm statement per CMS final rule
Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.AAdded 0516U, 0476U; Deleted 0078UCriteria: Added AvertD; removed reference to GeneSight Psychotropic Testing guideline from "Other Considerations" since that guideline has been retired; CPT Code table: Added AvertD; Criteria and CPT code table: Added new PLA codes MyGenVar Pharmacogenomics Test (0516U), RightMed Mental Health Gene Report (0476U), RightMed Mental Health Medication Report (0477U); Deleted retired code 0078U (INFINITI Neural Response Panel)
Lynch Syndrome Genetic TestingMOL.TS.197.AN/ACriteria: clarification of intent - restructured to clarify LS genetic testing for indications outside of individuals with MSI/IHC + cancers; CPT Code Table: admin edits; Background: updated; Test Information: updated; Guidelines and Evidence: updated; Added benefit/harm statement per CMS final rule; References: updated
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.AN/ACriteria: clarification of intent - added criteria and B&R requirements for X-linked intellectual disability panels to clarify that these are not considered comprehensive ASD/ID/DD panels and are therefore approvable (supported by American Academy of Pediatrics and American College of Medical Genetics and Genomics guidelines), updated guideline names as needed in Other Considerations and Table: Common neurodevelopmental disorder genes, associated conditions, and applicable guidelines.
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.AN/ACriteria: removed prenatal KFM testing section as this is managed by a clinical use guideline; in Billing and Reimbursement section: updated approvable genes tested individually based on frequency data in Classic NS based on an expert authored review, admin updates, updated name of referenced guideline on coding; updated intro with NSD abbreviation; CPT code table: admin updates; Background: updated; Guidelines and Evidence: updated, Added benefit/harm statement per CMS final rule; References: updated
Genetic Testing by Multigene PanelsMOL.CU.116.AN/ACriteria: renamed Billing and Reimbursement section to Other Considerations, deleted coding requirements as this is addressed by Laboratory Billing and Reimbursement guideline, updated name of  referenced guideline to Laboratory Billing and Reimbursement; Background: updated; Test Information: admin edit; Guidelines and Evidence: updated, removed CMS section as billing/coding is addressed by Laboratory Billing and Reimbursement guideline, Added benefit/harm statement per CMS final rule, admin edit; References: updated


Retired Guideline:
Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) 

Bloom Syndrome Genetic TestingMOL.TS.132.AN/ARetired due to infrequent use
Canavan Disease Genetic TestingMOL.TS.145.AN/ARetired due to infrequent use
Gaucher Disease Genetic TestingMOL.TS.173.AN/ARetired due to infrequent use
Niemann-Pick Disease Types A and B Genetic TestingMOL.TS.207.AN/ARetired due to infrequent use
Niemann-Pick Disease Type C Genetic TestingMOL.TS.208.AN/ARetired due to infrequent use
Tay-Sachs Disease Genetic TestingMOL.TS.226.AN/ARetired due to infrequent use
Laboratory Claim ReimbursementMOL.CS.105.AN/AReplaced by new Laboratory Billing and Reimbursement guideline
Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in MinorsMOL.CU.298.AN/AInformation and criteria within were added to guideline Genetic Testing to Predict Disease Risk MOL.CU.115.A
Laboratory Procedure Code RequirementsMOL.AD.391.AN/AReplaced by new Laboratory Billing and Reimbursement guideline

​



Revisions From MA06.034o:

10/01/2024

This version of the policy is a result of code updates effective 10/01/2024. 


The following procedure codes were added to the policy:

​

0476U, 0477U, 0478U, 0480U, 0481U, 0483U, 0484U, 0485U, 0486U, 0487U, 0488U, 0489U, 0493U, 0494U, 0495U, 0496U, 0497U, 0498U, 0499U, 0500U, 0501U, 0502U, 0504U, 0505U, 0506U, 0507U, 0508U, 0509U, 0510U, and 0516U


Narrative for the following procedure code was revised:


0403U​



Revisions From MA06.034n​​​​​:
07/01/2024This version of the policy will become effective on 07​/01/2024.

Effective 07/01/2024, the following procedure codes are part of this policy due to coding updates:

ADDED

Attachment A (Procedure Codes Requiring Pre-service and Prepayment Reviews)

0020M, 0452U, 0453U, 0454U, 0456U, 0460U, 0461U, 0465U, 0466U, 0467U, 0469U, 0470U, 0473U, 0474U, and 0475U


Attachment B (Procedure Codes Requiring Prepayment Reviews Only)

0455U, 0463U, and 0471U 
 

REVISED

  • 03 PLA codes had non-substantive revisions: 0047U, 0260U, and 0264U

DELETED 

  • 02 existing PLA codes are being retired: 0204U and 0353U

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On July 1, 2024, the following updates will be made to the eviCore Lab Management Clinical Guidelines. These guidelines will be used by eviCore during the utilization management reviews’ (i.e. medical necessity and/or prepayment reviews) processes starting on July 1, 2024. The updated guidelines are accessible via a link contained in the Policy section of this medical policy bulletin.

07/01/2024 Guideline Updates for eviCore Lab Management Program (Policy #: MA06.034n​)

Executive Summary of Changes

There is 01 new guideline. 135 existing guidelines have been revised (including 10 with substantive criteria changes). Eight guidelines were retired. See the below tables for details.

Below is a summary of the guideline changes

New Guidelines:

  1. Cardiomyopathy and Arrhythmia Genetic Testing​
​Criteria Updates (Substantive):

  1. Pharmacogenomic Testing for Drug Toxicity and Response
  2. Amyotrophic Lateral Sclerosis (ALS) Genetic Testing
  3. Chromosomal Microarray Testing For Developmental Disorders
  4. Prader-Willi Syndrome Testing
  5. Somatic Mutation Testing-Solid Tumors
  6. Gastrointestinal Pathogen Panel (GIPP) Molecular  Testing
  7. Molecular Respiratory Infection Pathogen Panel (RIPP) Molecular Testing
  8. Whole Genome Sequencing
  9. Human Immunodeficiency Virus Laboratory Testing
  10. Investigational and Experimental Laboratory Testing

   
Criteria Updates (Non-Substantive):

  1. Rett Syndrome Testing
  2. Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing.PA/CS.
  3. Flow Cytometry
  4. Immunohistochemistry (IHC)
  5. Sexually Transmitted and Other Reproductive Tract Infection Testing
  6. UroVysion FISH for Bladder Cancer
  7. Genetic Testing for Cancer Susceptibility and Hereditary Cancer Syndromes
  8. Genetic Testing for Carrier Status
  9. Genetic Testing for Prenatal Screening and Diagnostic Testing
  10. Genetic Testing for the Screening, Diagnosis, and Monitoring of Cancer
  11. Genetic Testing to Diagnose Non-Cancer Conditions
  12. Genetic Testing to Predict Disease Risk
  13. Preimplantation Genetic Screening and Diagnosis
  14. Afirma Thyroid Cancer Classifier Tests
  15. AlloMap Gene Expression Profiling For Heart Transplant Rejection
  16. Alpha-1-Antitrypsin Deficiency Testing
  17. Angelman Syndrome Testing
  18. APOE Variant Analysis for Alzheimer Disease
  19. Ashkenazi Jewish Carrier Screening
  20. Ataxia-Telangiectasia Genetic Testing
  21. Bloom Syndrome Genetic Testing
  22. CADASIL Genetic Testing
  23. Canavan Disease Genetic Testing
  24. HLA Typing for Celiac Disease
  25. Charcot-Marie-Tooth Neuropathy Genetic Testing
  26. Chromosome Analysis for Blood and Bone Marrow Cancers
  27. ConfirmMDx for Prostate Cancer Risk Assessment
  28. Cystic Fibrosis Genetic Testing
  29. Dentatorubral-Pallidoluysian Atrophy Genetic Testing
  30. Duchenne & Becker Muscular Dystrophy Testing
  31. Early Onset Familial Alzheimer Disease (EOFAD.) Genetic Testing
  32. SEPT9 Methylation Analysis for Colorectal Cancer (Formerly Sept9 Methylation Analysis for Colorectal Cancer)
  33. Expanded Carrier Screening Panels
  34. Familial Adenomatous Polyposis Genetic Testing
  35. Familial Hypercholesterolemia Genetic Testing
  36. Familial Malignant Melanoma Genetic Testing
  37. FMR1-Related Disorders (Fragile X) Genetic Testing
  38. Gaucher Disease Genetic Testing
  39. Hereditary Cancer Syndrome Multigene Panels
  40. Hereditary Hemochromatosis Genetic Testing
  41. HIV Tropism Testing for Maraviroc Response
  42. Huntington Disease Genetic Testing
  43. Li-Fraumeni Syndrome Genetic Testing
  44. Liquid Biopsy Testing
  45. Lynch Syndrome Genetic Testing
  46. Lynch Syndrome Tumor Screening - Second-Tier
  47. Mammaprint 70.Gene Breast Cancer Recurrence Assay
  48. Marfan Syndrome Genetic Testing
  49. MUTYH Associated Polyposis Genetic Testing
  50. Niemann Pick Disease Types A & B Testing
  51. Niemann Pick, Type C Testing
  52. Non-Invasive Prenatal Screening
  53. OncotypeDX for Breast Cancer Prognosis
  54. OncotypeDX for Colorectal Cancer Recurrence Risk
  55. PCA3 Testing for Prostate Cancer
  56. Peutz-Jeghers Syndrome Genetic Testing
  57. Prenatal Aneuploidy FISH Testing
  58. Prosigna Breast Cancer Prognostic Gene Signature Assay
  59. PTEN Hamartoma Tumor Syndromes Genetic Testing
  60. Spinal Muscular Atrophy Genetic Testing
  61. Tay-Sachs Disease Testing
  62. Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic Testing
  63. Tissue of Origin Testing for Cancer of Unknown Primary
  64. Von Hippel-Lindau Disease Genetic Testing
  65. EndoPredict for Breast Cancer Prognosis
  66. Exome Sequencing
  67. Cxbladder
  68. BRCA Analysis
  69. BCR-ABL Negative Myeloproliferative Neoplasm Testing
  70. Hereditary (Germline) Testing After Tumor (Somatic) Testing
  71. Breast Cancer Index for Breast Cancer Prognosis
  72. NETest (Wren Laboratories)
  73. PALB2 Genetic Testing for Breast Cancer Risk
  74. DecisionDX Uveal Melanoma
  75. OncotypeDX Breast DCIS (I/E)
  76. Confirmatory Genetic Testing
  77. Epilepsy Genetic Testing
  78. Maturity-Onset Diabetes of the Young Testing
  79. ThyGenX and ThyraMIR miRNA Gene Expression Classifier
  80. SelectMDx
  81. Mitochondrial Disorders Genetic Testing
  82. Ehlers Danlos Syndrome Genetic Testing
  83. Hereditary Connective Tissue Disorder Genetic Testing
  84. Autism, Intellectual Disability, and Developmental Delay Genetic Testing
  85. ThyroSeq
  86. PancraGEN
  87. Nonsyndromic Hearing Loss and Deafness Genetic Testing
  88. Polymerase Gamma (POLG) Related Disorders Genetic Testing
  89. DermTech Pigmented Lesion Assay
  90. Multiple Endocrine Neoplasia Type 1 Genetic Testing
  91. Multiple Endocrine Neoplasia Type 2 Genetic Testing
  92. Hereditary Pancreatitis Genetic Testing
  93. Limb-Girdle Muscular Dystrophy Genetic Testing
  94. Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental Disorders
  95. Facioscapulohumeral Muscular Dystrophy Genetic Testing
  96. Genetic Testing for Known Familial Mutations
  97. Genetic Testing for Variants of Uncertain Clinical Significance
  98. Decipher Prostate Cancer Classifier
  99. Genomic Prostate Score (formerly OncotypeDX for Prostate Cancer)
  100. Prolaris
  101. Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in Minors
  102. Neurofibromatosis Type 1 Genetic Testing
  103. Legius Syndrome Genetic Testing
  104. AlloSure for Kidney Transplant Rejection
  105. Hemoglobinopathies Genetic Testing
  106. Friedreich's Ataxia Genetic Testing
  107. Hereditary Ataxia Multigene Panel Testing
  108. Spinocerebellar Ataxia Genetic Testing
  109. Myotonic Dystrophy Type 1 Genetic Testing
  110. CHARGE Syndrome Genetic Testing
  111. Lyme Disease Testing
  112. Chromosomal Microarray for Solid Tumors
  113. Microsatellite Instability and Immunohistochemistry Testing in Cancer
  114. Inherited Bone Marrow Failure Syndrome (IBMFS) Testing
  115. Human Platelet and Red Blood Cell Antigen Genotyping
  116. Human Papillomavirus (HPV) Molecular Testing
  117. Pathology Testing with Mohs Micrographic Surgery
  118. Special Circumstances Influencing Coverage Determinations
  119. Inherited Thrombophilia Genetic Testing
  120. Noonan Spectrum Disorder Genetic Testing
  121. Laboratory Procedure Code Requirements
  122. Multi-Cancer Early Detection Screening
  123. Infectious Disease Laboratory Testing
  124. Urinary Tract Infection Molecular Testing
  125. Nail Disorder Infectious Disease Testing, Including Onychomycosis​
 
Retired Guideline:

  1. Somatic Mutation Testing - Hematological Malignancies
  2. Chromosomal Microarray for Prenatal Diagnosis
  3. Long QT Syndrome Genetic Testing
  4. Arrhythmogenic Right Ventricular Cardiomyopathy Genetic Testing
  5. Hypertrophic Cardiomyopathy Genetic Testing
  6. Dilated Cardiomyopathy Genetic Testing
  7. Brugada Syndrome Genetic Testing
  8. Genesight​

Other Note:(I/E = investigational & experimental) -- 

See the tables below that follow (which provide more details for the guideline changes):




New Guidelines:

Guideline NameGuideline #
Procedure Code(s) ImpactedSummary of change (to be reviewed in conjunction with guideline) Reason for Change
Cardiomyopathy and Arrhythmia Genetic TestingMOL.TS.410.AS3861, 81413, 81414, 0237U, 81439New molecular test-specific guideline addressing testing for inherited cardiomyopathies and arrhythmiasNew guideline



​Criteria Updates (Substantive): 

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Reason for Change
Rationale / supporting guideline for clinically significant updates ​

Pharmacogenomic Testing for Drug Toxicity and ResponseMOL.CU.118.A0034U, 0169UCriteria: NUDT15, TPMT, DPYD were previously coverable as single gene tests under FDA labels – we have changed our process to allow targeted tests (not large panels, but a small number of genes) to be coverable if all of the individual components of the panel are medically necessary and the test is billed with a single panel code; we removed the following tests from I&E status (now addressed by general criteria, with all but TYMS approvable with criteria): 5-Fluorouracil (5-FU) Toxicity and Chemotherapeutic Response [Proprietary panel of DPYD and TYMS gene variants to assess risk of 5-fluorouracil toxicity from ARUP Laboratory] CPT 81232 & 81346; NT (NUDT15 and TPMT) Genotyping Panel from RPRD Diagnostics CPT: 0169U; Thiopurine Methyltransferase (TPMT) and Nudix Hydrolase (NUDT15) Genotyping from Mayo Clinic CPT: 0034U, and NAT2 (changes made based on FDA drug labels that recommend testing of these genes);

Updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) and reclassified some tests from EIU to not medically necessary to align with definitions published by eviCore; language updates, as needed;

Reorganized criteria into sections for Targeted Pharmacogenomic Tests vs. Pharmacogenomic Panel Tests

Genesight Psychotropic Test is now addressed by this guideline, although it remains E/I/U.

Procedure codes table: updated. Background: updated. Test Information: section added. References: updated; clarification of intent edits throughout.		content clarification/informationFDA Labels for impacted drugs:
Mercaptopuring (Purixan) TPMT:  https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205919s003lbl.pdf
Azathioprine (Imuran) TPMT, NUDT15: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/016324s039lbl.pdf
5Fluorouracil DPYD:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012209s040lbl.pdf
Amifampridine Phosphate (Firdipase) NAT2 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208078s000lbl.pdf
Amyotrophic Lateral Sclerosis (ALS) Genetic TestingMOL.TS.125.A Criteria: added coverage criteria for ALS Multigene panels in symptomatic individuals with a family history of ALS in a first degree relative

Moved “Criteria" section to the beginning of the guideline for streamlined reviews; In Other Considerations - added a cross-reference to Pharmacogenomic Testing for Drug Toxicity and Response guideline; admin edits

Billing and Reimbursement: added a B&R section to align with the coverage criteria; Background: admin edit, updated table, updated management; Guidelines and Evidence: added two selected relevant publications regarding genetic testing for individuals with ALS and another regarding presymptomatic genetic testing; References: updated and added two.		professional society updateRoggenbuck J, Eubank BHF, Wright J, Harms MB, Kolb SJ; ALS Genetic Testing and Counseling Guidelines Expert Panel. Evidence-based consensus guidelines for ALS genetic testing and counseling. Ann Clin Transl Neurol. 2023;10(11):2074-2091. doi:10.1002/acn3.51895) and in consultation with our external SMEs at the University of Washington
Chromosomal Microarray Testing For Developmental DisordersMOL.TS.150.A81228, 81229, 81349Criteria: Added criterion for major congenital cardiac anomaly not specific to a well-delineated genetic syndrome for symptomatic individuals (including stillbirths), clarification of intent edits.

Added criteria from Chromosomal Microarray for Prenatal Diagnosis and restructured to accommodate; All sections: added relevant info so guideline applies to CMA testing in the prenatal and postnatal setting

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, ensured readability and updated language, admin updates; Guidelines & Evidence: Updated. References: Updated.

TITLE CHANGE: Chromosomal Microarray Testing For Developmental Disorders (Prenatal and Postnatal)		professional society updateWilde AAM, Semsarian C, Márquez MF, et al. European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) Expert Consensus Statement on the state of genetic testing for cardiac diseases. Europace. 2022;euac030. doi:10.1093/europace/030
Prader-Willi Syndrome TestingMOL.TS.217.A81331, 81228, S3870, 81229, 81349, 88271Criteria: Added new indication to methylation testing and deletion testing sections for neonatal hypotonia and feeding problems

Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin edits (added abbreviation and "genetic" to introduction), Background: updated; Test information: updated; Guidelines and Evidence: updated; References: updated.		Recommendation from expert authored reviewDriscoll DJ, Miller JL, Schwartz S, Cassidy SB. Prader-Willi Syndrome. 1988 Oct 6 [Updated 2023 Nov 2]. In: Adam MP, Feldman J, Mirzaa GM, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023. Available at: http://www.ncbi.nlm.nih.gov/books/NBK1330/0
Somatic Mutation Testing-Solid TumorsMOL.TS.230.A81450; Added new PLA codes 0444U, 0448UCriteria: Added confirmed or suspected diagnosis of myelodysplastic syndrome (MDS) as indication for a multigene panel

Added criteria from Somatic Mutation - Hematological Malignancies as these guidelines have been combined (and made required edits and additions throughout), TITLE CHANGE: to Somatic Mutation Testing

Clarification of intent edit specifying that clonoSEQ is approvable at diagnosis and once (added) for assessment after primary treatment, Clarification of intent edit to Note  regarding methodology for MSI testing (molecular vs non-molecular), Admin edit in Other Considerations. Clarification of intent edits in Billing & Reimbursement regarding billing of panels for hematologic malignancies.

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, ensured readability and updated language, as needed, due to the moving of sections; CPT Code table: added new PLA codes 0444U and 0448U and added MYD88 mutation analysis 81305, BTK gene analysis 81233, PLCG gene analysis 81320 and Leukostrat CDx FLT3 Assay 0023U; References: updated		professional society updateNCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes. V3.2023 https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf
Gastrointestinal Pathogen Panel (GIPP) Molecular  TestingMOL.CS.277.A87505, 87506, 87507, 0369UCriteria: Criteria: expanded acute diarrhea indications to acute diarrhea or moderate to severe GI infection to be aligned with CMS and added ICD code table to reflect appropriate diagnosis codes for this indication, expanded Immunocompromise ICD table to be aligned with CMS

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore.		editorialCMS Moderate/Severe GI infection codes and immunocompromise codes: A58710: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58710&ver=50&keyword=87505&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1
Molecular Respiratory Infection Pathogen Panel (RIPP) Molecular TestingMOL.CS.293.I87636, 87637, 87631, 87632, 87633, 0202U, 0115U, 0225U, 0223U, 0373U, 0240U, 0241UCriteria: Amended coverage of panels of 6 or more organisms to immunocompromised or inpatient individuals regardless of age (previously allowed large panels in pediatric patients regardless of immune status or site of testing) – supported by IDSA guidelines and EviCore Health technology assessment that found no clinical utility evidence for using large panels in children 

Expanded Immunocompromise ICD table to be aligned with CMS

Clarification of intent edit in billing and reimbursement to strengthen language regarding billing only for medically necessary organisms regardless of panel performed; Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; Guidelines and Evidence: incorporated current EviCore HTA; References: updated		Evidence form peer reviewed literatureUyeki T, Bernstein H, Bradley J, et al. Clinical practice guidelines by the Infectious Diseases Society of America: 2019 update on diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza. Clin Infect Dis. 2019;68(6):e1-e47;

2023 EviCore Health Technology Assessment evidence grade D  for multipathogen panels in pediatric population

CMS immunocompromise codes: A58710: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58710&ver=50&keyword=87505&keywordType=starts&areaId=all&docType=NCA,CAL,NCD,MEDCAC,TA,MCD,6,3,5,1,F,P&contractOption=all&sortBy=relevance&bc=1
Whole Genome SequencingMOL.TS.306.I81425, 81426, 81427, 0213U, 0212U, 0267U, 0265U, 0094U, 0425U, 0426UCriteria: Added coverage for Genome sequencing in the outpatient pediatric population with medical necessity requirements similar to exome sequencing

Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections, updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; added 'Rendering laboratory is a qualified provider of service per the Health Plan policy.' ; added Billing and Reimbursement section

TITLE CHANGE: Genome Sequencing		Professional Society update; Literature ReviewACMG: Manickam K, McClain MR, Demmer LA, et al. Exome and genome sequencing for pediatric patients with congenital anomalies or intellectual disability: an evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021;23(11):2029-2037. doi: 10.1038/s41436-021-01242-6

Meta-analysis:
Chung CCY, Hue SPY, Ng NYT, et al. Meta-analysis of the diagnostic and clinical utility of exome and genome sequencing in pediatric and adult patients with rare diseases across diverse populations. Genet Med. 2023;25(9):100896. doi: 10.1016/j.gim.2023.100896)

Clark MM, Stark Z, Farnaes L, et al. Meta-analysis of the diagnostic and clinical utility of genome and exome sequencing and chromosomal microarray in children with suspected genetic diseases. NPJ Genom Med. 2018;3(1). doi: 10.1038/s41525-018-0053-8
Human Immunodeficiency Virus Laboratory TestingMOL.CS.321.A87901, 87906, 0219UCriteria: Added indication for InSTI genotyping prior to antiretroviral therapy when there is suspicion that infection was transmitted from a partner with InSTI failure or if the individual previously received PrEP with cabotegravir. This was previously E/I/U

Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language, as needed, due to the moving of sections. Background: Updated. Test Information: Updated. Guidelines & Evidence: Updated. References: Updated.		professional society updateGandhi RT, Bedimo R, Hoy JF, Landovitz RJ, Smith DM, Eaton EF, Lehmann C, Springer SA, Sax PE, Thompson MA, Benson CA, Buchbinder SP, Del Rio C, Eron JJ Jr, Günthard HF, Molina JM, Jacobsen DM, Saag MS. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel. JAMA. 2023 Jan 3;329(1):63-84. doi: 10.1001/jama.2022.22246
Investigational and Experimental Laboratory TestingMOL.CU.117.Iadded 0349U, 0440UThroughout guideline: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; Added new PLA codes:  Epi+Gen CHDTM (0439U); PrecisionCHDTM (0440U), added Bladder EpiCheck (81599); Removed 4q25 atrial fibrillation risk genotype (81479) since now addressed in Cardiomyopathy and Arrhythmia guideline (still EIU).

TITLE CHANGE: updated title to Experimental, Investigational, or Unproven Laboratory Testing;		content clarification/informationNew CPT codes

 
Criteria Updates (Non-Substantive):

Guideline NameGuideline #Procedure Code Impacted by Update, if applicableSummary of change  (to be reviewed in conjunction with guideline) Reason for Change
What is the expected impact?
Rett Syndrome TestingMOL.TS.224.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews. In MECP2 sequencing clarification of intent edit added -ID & DD to approvable diagnoses in females after negative Fragile X and microarray testing

CPT code table: updated; Background: updated; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
Medicare: Hierarchy for Applying Coverage Decisions for Laboratory Testing.PA/CS.MOL.AD.101.B Criteria: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Background: updated external link; References: updated.		Content clarification/ InformationNone
Flow CytometryMOL.CS.103.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Immunohistochemistry (IHC)MOL.CS.104.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections; Clarification of intent edit regarding claims for IHC for skin lesions

Guidelines and Evidence: Added section for "Biopsies of HPV-associated lower anogenital squamous lesions"; References: Added and updated		Content clarification/ InformationNone
Sexually Transmitted and Other Reproductive Tract Infection TestingMOL.CS.106.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language, as needed, due to the moving of sections

clarification of intent edit to Billing & Reimbursement section for billing components of a panel.		Content clarification/ InformationNone
UroVysion FISH for Bladder CancerMOL.CS.108.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews.

Background: updated; Test information: admin edits; Guidelines and evidence; updated, admin edits; References: updated.		Content clarification/ InformationNone
Genetic Testing for Cancer Susceptibility and Hereditary Cancer SyndromesMOL.CU.109.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, admin editContent clarification/ InformationNone
Genetic Testing for Carrier StatusMOL.CU.110.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; References; updatedContent clarification/ InformationNone
Genetic Testing for Prenatal Screening and Diagnostic TestingMOL.CU.112.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; admin updatesContent clarification/ InformationNone
Genetic Testing for the Screening, Diagnosis, and Monitoring of CancerMOL.CU.113.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, admin editContent clarification/ InformationNone
Genetic Testing to Diagnose Non-Cancer ConditionsMOL.CU.114.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, admin updateContent clarification/ InformationNone
Genetic Testing to Predict Disease RiskMOL.CU.115.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; ensured readability and updated language, admin updateContent clarification/ InformationNone
Preimplantation Genetic Screening and DiagnosisMOL.CU.119.A Criteria: clarification of medical necessity language to align with definitions published by eviCore. Background: updated terminology

Guidelines & Evidence: updated, admin edit; References: updated		Content clarification/ InformationNone
Afirma Thyroid Cancer Classifier TestsMOL.TS.122.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore, updated language to ensure readability after moving sectionsContent clarification/ InformationNone
AlloMap Gene Expression Profiling For Heart Transplant RejectionMOL.TS.123.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarified medical necessity language as needed to align with published eviCore definitions

Test Information: admin edit; References: updated		Content clarification/ InformationNone
Alpha-1-Antitrypsin Deficiency TestingMOL.TS.124.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore; admin edit

Background: admin edit		Content clarification/ InformationNone
Angelman Syndrome TestingMOL.TS.126.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarification of intent edits to clarify that genetic testing can be approved even in the presence of a non-genetic cause if clinical suspicion of a gene mutation remains high, admin edits;

Test Information: updated reused content; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
APOE Variant Analysis for Alzheimer DiseaseMOL.TS.128.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCoreContent clarification/ InformationNone
Ashkenazi Jewish Carrier ScreeningMOL.TS.129.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Ataxia-Telangiectasia Genetic TestingMOL.TS.130.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Bloom Syndrome Genetic TestingMOL.TS.132.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
CADASIL Genetic TestingMOL.TS.144.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language.

Background: added AHA information; Test information: admin edit; Guidelines and Evidence; added AHA scientific statement, updated; References: updated.		Content clarification/ InformationNone
Canavan Disease Genetic TestingMOL.TS.145.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
HLA Typing for Celiac DiseaseMOL.CS.146.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore

Guidelines and Evidence: Updated. References: Updated.		Content clarification/ InformationNone
Charcot-Marie-Tooth Neuropathy Genetic TestingMOL.TS.148.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, defined abbreviation; clarified that genetic testing can be approved even in the presence of a non-genetic cause for the member's neuropathy if the suspicion for a genetic mutation remains high.

Guidelines and Evidence: admin edits.		Content clarification/ InformationNone
Chromosome Analysis for Blood and Bone Marrow CancersMOL.TS.151.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews.

Test information: updated; Guidelines and evidence: updated, reorganized NCCN guidelines, admin edit; References: updated.		Content clarification/ InformationNone
ConfirmMDx for Prostate Cancer Risk AssessmentMOL.TS.153.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; clarified medical necessity language to align with definitions published by eviCore

Background: updated statistics; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
Cystic Fibrosis Genetic TestingMOL.TS.158.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Dentatorubral-Pallidoluysian Atrophy Genetic TestingMOL.TS.159.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin edit.Content clarification/ InformationNone
Duchenne & Becker Muscular Dystrophy TestingMOL.TS.161.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
Early Onset Familial Alzheimer Disease (EOFAD.) Genetic TestingMOL.TS.162.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
SEPT9 Methylation Analysis for Colorectal Cancer (Formerly Sept9 Methylation Analysis for Colorectal Cancer)MOL.TS.164.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore;

Procedure code table: updated. Background: updated; Test information: admin edits; Guidelines and Evidence: updated and reformatted; References: updated.		Content clarification/ InformationNone
Expanded Carrier Screening PanelsMOL.TS.165.AAdded 0449UCriteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, added new PLA code 0449U to CPT code tableContent clarification/ InformationNone
Familial Adenomatous Polyposis Genetic TestingMOL.TS.168.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections, admin editContent clarification/ InformationNone
Familial Hypercholesterolemia Genetic TestingMOL.TS.169.A Criteria: In the Exclusions section - Changed testing for cholesterol treatment decisions in the absence of FH symptoms from I&E to not medically necessary to align with eviCore published definitions, moved “Criteria" section to the beginning of the guideline for streamlined reviews; added an introduction for readability

Background: admin edit		Content clarification/ InformationNone
Familial Malignant Melanoma Genetic TestingMOL.TS.170.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language as needed, admin editContent clarification/ InformationNone
FMR1-Related Disorders (Fragile X) Genetic TestingMOL.TS.172.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, updated language from "females" to "individuals assigned female at birth";

References: updated links		Content clarification/ InformationNone
Gaucher Disease Genetic TestingMOL.TS.173.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Hereditary Cancer Syndrome Multigene PanelsMOL.TS.182.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore.Content clarification/ InformationNone
Hereditary Hemochromatosis Genetic TestingMOL.TS.183.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
HIV Tropism Testing for Maraviroc ResponseMOL.CS.185.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language.

Throughout: updated "patient" to "individual"; Guidelines and Evidence: updated, admin edit; References: updated		Content clarification/ InformationNone
Huntington Disease Genetic TestingMOL.TS.188.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
Li-Fraumeni Syndrome Genetic TestingMOL.TS.193.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Liquid Biopsy TestingMOL.TS.194.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; Other Non-CDx Indications section - updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore and  updated language, as needed, for readability and clarity, admin edit.

CPT code table: removed 81445 & 81455, added 81462, 81463, 81464, removed duplicate 81270 code; Billing and Reimbursement: updated; Background: updated. Test Information: updated; Guidelines and Evidence: updated; References: updated.		Content clarification/ InformationNone
Lynch Syndrome Genetic TestingMOL.TS.197.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, admin updatesContent clarification/ InformationNone
Lynch Syndrome Tumor Screening - Second-TierMOL.TS.199.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updateContent clarification/ InformationNone
Mammaprint 70.Gene Breast Cancer Recurrence AssayMOL.TS.200.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Marfan Syndrome Genetic TestingMOL.TS.202.A Criteria: Moved "Criteria" section to the beginning of the guideline for streamlined reviews; removed Known familial mutation section - addressed by clinical use guidelines; admin edit.

Test information: admin edit and updated title of cross-referenced guideline; Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
MUTYH Associated Polyposis Genetic TestingMOL.TS.206.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Niemann Pick Disease Types A & B TestingMOL.TS.207.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language; Procedure code table: updatedContent clarification/ InformationNone
Niemann Pick, Type C TestingMOL.TS.208.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language; Procedure code table: updatedContent clarification/ InformationNone
Non-Invasive Prenatal ScreeningMOL.TS.209.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; To align with definitions published by eviCore: 1) NIPS for microdeletions and single gene diseases - updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U), 2) NIPS for aneuploidy - updated medically necessary phrasingContent clarification/ InformationNone
OncotypeDX for Breast Cancer PrognosisMOL.TS.211.I Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
OncotypeDX for Colorectal Cancer Recurrence RiskMOL.TS.213.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
PCA3 Testing for Prostate CancerMOL.TS.215.A Criteria: clarification of medical necessity language to align with definitions published by eviCore, moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language

Guidelines and Evidence: updated; References: updated		Content clarification/ InformationNone
Peutz-Jeghers Syndrome Genetic TestingMOL.TS.216.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languageContent clarification/ InformationNone
Prenatal Aneuploidy FISH TestingMOL.CS.218.A Criteria:  Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarification of medical necessity language to align with definitions published by eviCore", admin edit; Introduction: admin edit

Test information: admin edits; References: admin edits.		Content clarification/ InformationNone
Prosigna Breast Cancer Prognostic Gene Signature AssayMOL.TS.222.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
PTEN Hamartoma Tumor Syndromes Genetic TestingMOL.TS.223.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections.Content clarification/ InformationNone
Spinal Muscular Atrophy Genetic TestingMOL.TS.225.A Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language in exclusions section (copy number and targeted testing for purposes of prognosis in SMA) from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCore, ensured readability and updated languageContent clarification/ InformationNone
Tay-Sachs Disease TestingMOL.TS.226.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language

Background: admin edits; Test information: admin edit; Guidelines and Evidence: added ACMG practice resource, updated, admin edits; References: updated		Content clarification/ InformationNone
Thoracic Aortic Aneurysms and Dissections (TAAD) Panel Genetic TestingMOL.TS.227.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, ensured readability and updated language.Content clarification/ InformationNone
Tissue of Origin Testing for Cancer of Unknown PrimaryMOL.TS.228.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin edit

Guidelines and Evidence: updated; References: updated.		Content clarification/ InformationNone
Von Hippel-Lindau Disease Genetic TestingMOL.TS.233.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin update;

Throughout: amended condition name to von Hippel-Lindau disease or VHL for consistency		Content clarification/ InformationNone
EndoPredict for Breast Cancer PrognosisMOL.TS.234.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviewsContent clarification/ InformationNone
Exome SequencingMOL.TS.235.I Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, Prenatal exome: updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCore, and updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language due to sections moving

Clarification of intent edit - moved criteria bullet, removed redundant info, added clarification of intent edit regarding previous testing; added 'Rendering laboratory is a qualified provider of service per the Health Plan policy.';  Billing and Reimbursement: Reorganized and removed redundant information and non billing information.		Content clarification/ InformationNone
CxbladderMOL.TS.236.Aadded 0420UCriteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore.

Added CPT code for Cxbladder Detect+ (0420U); Background: added info on Cxbladder Detect+; Test information: added info on Cxbladder Detect+ and admin edit; Guidelines and Evidence: updated, incorporated current EviCore health technology assessment, admin edits; References: updated.		Content clarification/ InformationNone
BRCA AnalysisMOL.TS.238.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections; clarification of intent editsContent clarification/ InformationNone
BCR-ABL Negative Myeloproliferative Neoplasm TestingMOL.TS.240.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language to ensure readability and updated language, as needed, due to the moving of sections; Background: updated. Guidelines & evidence: updated; References: updated.Content clarification/ InformationNone
Hereditary (Germline) Testing After Tumor (Somatic) TestingMOL.CU.246.A Criteria: no updates. Guidelines and Evidence: added ESMO guideline, updated NCCN year of publication and one statement, added one publication to Selected Relevant Publications; References: updated.Content clarification/ InformationNone
Breast Cancer Index for Breast Cancer PrognosisMOL.TS.248.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections. Content clarification/ InformationNone
NETest (Wren Laboratories)MOL.TS.250.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore.

Test information: updated; Guidelines and evidence: added Polish Network of Neuroendocrine Tumours publication, incorporated current EviCore health technology assessment; References: updated		Content clarification/ InformationNone
PALB2 Genetic Testing for Breast Cancer RiskMOL.TS.251.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews.Content clarification/ InformationNone
DecisionDX Uveal MelanomaMOL.TS.254.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; Decision Dx-UM: aligned medical necessity language; DecisionDx -PRAME and UMSeq: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Background: admin edits; Guidelines and Evidence: updated, incorporated EviCore health technology assessment, admin edits; References: updated.		Content clarification/ InformationNone
OncotypeDX Breast DCIS (I/E)MOL.TS.255.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCoreContent clarification/ InformationNone
Confirmatory Genetic TestingMOL.CU.256.A Criteria: Updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; updated examples of E/I/U vs. not medically necessary tests per eviCore clinical guidelines.Content clarification/ InformationNone
Epilepsy Genetic TestingMOL.TS.257.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore, ensured readability and updated language, as needed, due to the moving of sections.Content clarification/ InformationNone
Maturity-Onset Diabetes of the Young TestingMOL.TS.258.A Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; Rare single gene section: updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCorecontent clarification/informationNone
ThyGenX and ThyraMIR miRNA Gene Expression ClassifierMOL.TS.259.I Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore

Test information: updated; Guidelines and Evidence: updated NCCN, admin edits; References: update		content clarification/informationNone
SelectMDxMOL.TS.264.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, added introduction section to Criteria section.content clarification/informationNone
Mitochondrial Disorders Genetic TestingMOL.TS.266.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections; updated criteria section header from "Targeted Mutation Analysis" to "Targeted Mutation Analysis or Single Gene Analysis" since these criteria also addresses TYMP gene sequencing; added POLG disorders to table with reference out to POLG Disorders guideline, admin edits in table and Billing and Reimbursement section

Background: admin edit, update; Test Information: admin edit; Guidelines and Evidence: updated, admin edit; References: updated. 		content clarification/informationNone
Ehlers Danlos Syndrome Genetic TestingMOL.TS.267.A Criteria: Format updates: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language, as needed, due to the moving of sections. Minor clarification of intent edit in "Other Considerations".content clarification/informationNone
Hereditary Connective Tissue Disorder Genetic TestingMOL.TS.268.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of medical necessity language to align with definitions published by eviCore, in the "Criteria" section; clarification of intent edits in multi-gene panel criteria and "Other considerations"; updated language, as needed, due to the moving of sections.content clarification/informationNone
Autism, Intellectual Disability, and Developmental Delay Genetic TestingMOL.TS.269.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, Updated panels from not medically necessary to E/I/U, clarification of intent update, admin edits in KFM section (updated biologic to biological), updated name of referenced guideline

Background: updated; Test Information: admin edit; Guidelines and Evidence: updated, admin edits; References: updated		content clarification/informationNone
ThyroSeqMOL.TS.270.I Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ThyroSeq CRC: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U); ThyroSeq: clarified medical necessity language to align with definitions published by eviCore, admin update

Guidelines and Evidence: updated, incorporated EviCore health tech assessment; References: updated		content clarification/informationNone
PancraGENMOL.TS.271.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Nonsyndromic Hearing Loss and Deafness Genetic TestingMOL.TS.273.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews. Replaced "biologic" with "biological".  

Background: updated; Guidelines and Evidence: "selected relevant publications" updated; References: updated. Clarification of intent edit to Billing and Reimbursement. Procedure code table: updated.		content clarification/informationNone
Polymerase Gamma (POLG) Related Disorders Genetic TestingMOL.TS.276.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews;  ensured readability and updated language, as needed, due to the moving of sections.

Guidelines and Evidence: updated FDA information; References: updated.		content clarification/informationNone
DermTech Pigmented Lesion AssayMOL.TS.282.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin updatecontent clarification/informationNone
Multiple Endocrine Neoplasia Type 1 Genetic TestingMOL.TS.285.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language, admin edit in Other considerations sectioncontent clarification/informationNone
Multiple Endocrine Neoplasia Type 2 Genetic TestingMOL.TS.286.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languagecontent clarification/informationNone
Hereditary Pancreatitis Genetic TestingMOL.TS.287.A Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; CLDN2, PNLIP, and CEL Analysis: updated language from investigational and/or experimental (I&E) to not medically necessary to align with definitions published by eviCorecontent clarification/informationNone
Limb-Girdle Muscular Dystrophy Genetic TestingMOL.TS.288.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewscontent clarification/informationNone
Chromosome Analysis for Reproductive Disorders, Prenatal Testing, and Developmental DisordersMOL.CS.289.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin edit.

Background: updated; Test information: updated; Guidelines and evidence: admin edits, updated; References: updated.		content clarification/informationNone
Facioscapulohumeral Muscular Dystrophy Genetic TestingMOL.TS.290.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updatecontent clarification/informationNone
Genetic Testing for Known Familial MutationsMOL.CU.291.A Criteria: admin updatescontent clarification/informationNone
Genetic Testing for Variants of Uncertain Clinical SignificanceMOL.CU.292.A Criteria: admin updatecontent clarification/informationNone
Decipher Prostate Cancer ClassifierMOL.TS.294.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; Decipher Prostate Biopsy: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Genomic Prostate Score (formerly OncotypeDX for Prostate Cancer)MOL.TS.295.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin editcontent clarification/informationNone
ProlarisMOL.TS.297.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, admin editcontent clarification/informationNone
Genetic Presymptomatic and Predictive Testing for Adult-Onset Conditions in MinorsMOL.CU.298.A Criteria: clarification of medical necessity language to align with definitions published by eviCore; admin updatecontent clarification/informationNone
Neurofibromatosis Type 1 Genetic TestingMOL.TS.301.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, ensured readability and updated language; deleted information on prenatal testing for KFM as this is addressed by clinical use guidelines; changed "patient" to "individual", updated name of referenced guideline

Background: changed "patients" to "individuals". Guidelines & Evidence: Updated (admin edit). References: updated		content clarification/informationNone
Legius Syndrome Genetic TestingMOL.TS.302.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviewscontent clarification/informationNone
AlloSure for Kidney Transplant RejectionMOL.TS.307.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore

Throughout: updated name of test from 'AlloSure' to 'AlloSure Kidney'; Test Information: updated; Guidelines and Evidence: updated, incorporated EviCore HTA; References; updated		content clarification/informationNone
Hemoglobinopathies Genetic TestingMOL.TS.308.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; Procedure code table: Updated.content clarification/informationNone
Friedreich's Ataxia Genetic TestingMOL.TS.309.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, admin updatecontent clarification/informationNone
Hereditary Ataxia Multigene Panel TestingMOL.TS.310.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews.content clarification/informationNone
Spinocerebellar Ataxia Genetic TestingMOL.TS.311.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languagecontent clarification/informationNone
Myotonic Dystrophy Type 1 Genetic TestingMOL.TS.312.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, ensured readability and updated language. Procedure code table: Updated.content clarification/informationNone
CHARGE Syndrome Genetic TestingMOL.TS.324.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; removed references from criteria and added a phrase referring to the table in the diagnosis section of the background, replaced "biologic" with "biological", admin edit to intro, removed information on prenatal testing and known familial mutation as this is addressed by clinical use guidelines; admin edit to add emphasis to the fact that individual may meet "ONLY ONE" of the criteria included in this section; adjusted formatting of table of criteria.

Background: updated, including terminology; Test information: admin edit; Guidelines and Evidence; admin edits; References: updated. TITLE CHANGE: CHARGE Syndrome and CHD7 Disorder Genetic Testing		content clarification/informationNone
Lyme Disease TestingMOL.CS.332.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; clarification of intent update to language to add the exception mentioned in the Billing & Reimbursement section for NAAT testing on synovial fluid to inform therapeutic decisions for seropositive individuals, to be considered on a case-by-case basis.

Background: Updated. Test Information: Updated. Guidelines & Evidence: Updated. References: Updated.		content clarification/informationNone
Chromosomal Microarray for Solid TumorsMOL.TS.344.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, clarification of medical necessity language to align with definitions published by eviCorecontent clarification/informationNone
Microsatellite Instability and Immunohistochemistry Testing in CancerMOL.TS.356.A Criteria:  Moved “Criteria" section to the beginning of the guideline for streamlined reviews, clarification of medical necessity language to align with definitions published by eviCorecontent clarification/informationNone
Inherited Bone Marrow Failure Syndrome (IBMFS) TestingMOL.TS.360.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language; clarification of intent edits.content clarification/informationNone
Human Platelet and Red Blood Cell Antigen GenotypingMOL.TS.361.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews, clarified medical necessity language to align with published eviCore terms/definitions; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Human Papillomavirus (HPV) Molecular TestingMOL.CS.362.ARemoved 0354UCriteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; ensured readability and updated language, as needed, due to the moving of sections; Deleted 0354U (retired PLA code) from Criteria and CPT code table.content clarification/informationNone
Pathology Testing with Mohs Micrographic SurgeryMOL.CS.363.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated languagecontent clarification/informationNone
Special Circumstances Influencing Coverage DeterminationsMOL.AD.364.A Criteria: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore, clarification of intent edit in IL HB 3817 bill; Added NY S01196A, CA SB496, and PA SB 8 billscontent clarification/informationNone
Inherited Thrombophilia Genetic TestingMOL.TS.370.A Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; For MTHFR: updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCorecontent clarification/informationNone
Noonan Spectrum Disorder Genetic TestingMOL.TS.371.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews; ensured readability and updated language;

Guidelines & Evidence: updated.		content clarification/informationNone
Laboratory Procedure Code RequirementsMOL.AD.391.A Criteria: added "When a prior authorization request is submitted for a group of procedure codes and at least one procedure code requires prior authorization, all submitted procedure codes that are under management by the Program (in any form) will be reviewed regardless of the authorization requirements for each code."content clarification/informationNone
Multi-Cancer Early Detection ScreeningMOL.TS.396.A Criteria: Moved “Criteria" section to the beginning of the guideline for streamlined reviews, updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; CPT code table: updated;

Background: updated; Test Information: updated; Guidelines and evidence: updated; References; updated.		content clarification/informationNone
Infectious Disease Laboratory TestingMOL.CU.398.A Criteria: Updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore. Procedure code table: Updated; Added 0140U-0142U and 0370U to procedure code table since these are addressed by general criteriacontent clarification/informationNone
Urinary Tract Infection Molecular TestingMOL.CS.403.ARemoved 0416UCriteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; clarification of intent updates to both "Criteria" and "Billing and Reimbursement" to make it more clear that single-organism testing for UTIs is also E/I/U, not just panels;

Deleted 0416U (retired PLA code) from Criteria and CPT code table		content clarification/informationNone
Nail Disorder Infectious Disease Testing, Including OnychomycosisMOL.CS.402.A Criteria: Moved “Criteria" and “Billing and Reimbursement" sections to the beginning of the guideline for streamlined reviews; updated language from investigational and/or experimental (I&E) to experimental, investigational, or unproven (E/I/U) to align with definitions published by eviCore; nucleic acid testing for onychomycosis, nail dystrophy, and other nail disorders changed from "not medically necessary" to E/I/U.content clarification/informationNone​


 
Retired Guideline:

Guideline NameGuideline #Procedure Code(s) ImpactedSummary of change  (to be reviewed in conjunction with actual GL) Reason for Change​

Somatic Mutation Testing - Hematological MalignanciesMOL.TS.313.AN/AGuideline is retired - testing now addressed by Somatic Mutation Testing (MOL.TS.230)Retired guideline
Chromosomal Microarray for Prenatal DiagnosisMOL.TS.149.AN/AGuideline is retired - Information on Prenatal microarray has been added into the Chromosomal Microarray for Developmental Disorders (Prenatal and Postnatal) guideline (MOL.TS.150)Retired guideline
Long QT Syndrome Genetic TestingMOL.TS.196.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Arrhythmogenic Right Ventricular Cardiomyopathy Genetic TestingMOL.TS.281.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Hypertrophic Cardiomyopathy Genetic TestingMOL.TS.189.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Dilated Cardiomyopathy Genetic TestingMOL.TS.284.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
Brugada Syndrome Genetic TestingMOL.TS.261.AN/AGuideline is retired - testing now addressed by new guideline  Cardiomyopathy and Arrhythmia Genetic Testing (MOL.TS.410)Retired guideline
GenesightMOL.TS.340.AN/AGuideline is retired - testing now addressed by  Pharmacogenomic Testing for Drug Toxicity and Response (MOL.CU.118)Retired guideline
​



Revisions From MA06.034m:

04/01/2024

This version of the policy is a result of code updates effective 04/01/2024. 

 

The following procedure​ codes were added to the policy:

0439U, 0440U, 0444U, 0448U, an​​d 0449U


The following procedure codes were deleted from this policy because they have been termed:

0354U and 0416U​



Revisions From MA06.034l:

01/01/2024

Effective 01/01/2024 this policy applies to New Jersey Medicare Advantage (MA) lines of business.​



7/1/2026
8/3/2026
MA06.034
Medical Policy Bulletin
Medicare Advantage
{"7660": {"Id":7660,"MPAttachmentLetter":"A","Title":"Procedure Codes Requiring Pre-service and Prepayment Reviews","MPPolicyAttachmentInternalSourceId":10816,"PolicyAttachmentPageName":"7bce1aaa-3142-4029-85eb-35540dbc12eb"},"7661": {"Id":7661,"MPAttachmentLetter":"B","Title":"Procedure Codes Requiring Prepayment Reviews","MPPolicyAttachmentInternalSourceId":10817,"PolicyAttachmentPageName":"21bcb815-834b-42f5-91aa-8adce5c9597d"},}
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Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.